The Defective Product

The area of law termed products liability is a hybrid of both contract law (involving either express or implied promises, found in the law of warranties) and tort law (based upon specific conduct, oftentimes reflected in a negligence standard, or actions based on fraud or misrepresentation). In general terms, products liability refers to the obligations or duties of manufacturers, wholesalers (or other middlemen), or retailers/sellers (as well as other parties) to consumers, purchasers, users, and even bystanders when a product is found to be defective. No matter what the theory of liability, the predicate of a suit in products liability is a defective product.

Three Sources of a Defective Product

A defect in a product can arise from three common sources:

• A manufacturing or production defect — that occurs from a random and atypical breakdown in the manufacturing process;
• A design defect — that is characteristic of a whole product line (such as the Ford Pinto); or
• A marketing defect — involving inadequate warnings relating to risks or dangers, or inadequate instructions relating to how to properly or safely use a product. Many cases in the area of a marketing defect involve food, drugs, or more recently, children’s toys, cribs, or car seats).

Three Theories to Bring Suit

Under the common law, there were three theories under which a plaintiff could bring a suit for personal injury or property or economic damage caused by a defective product.

Negligence, a tort action, focuses on the defendant’s conduct or omission and whether that act or omission was reasonable in light of the defendant’s duty of due care for others. Negligence in a products liability action requires proof that a product was designed or manufactured in an unreasonable manner, or that the warnings or directions were inadequate under the circumstances. One of the features of a suit based on negligence is the requirement, in many cases, of expert proof that can be quite expensive for an ordinary plaintiff.

Another negative was the existence of the doctrine of privity. The the doctrine of privity made it difficult, if not impossible, to reach a negligent manufacturer with whom an injured plaintiff had not entered into a contract. What happened then if a plaintiff sued the retailer? The retailer was absolved from liability because the retailer had normally only passed on the product and was not ordinarily negligent.

Since there was no liability on the part of either the manufacturer or retailer, the common law doctrine of caveat emptor, or “let the buyer beware” was routinely applied to negligently made products. The requirement of vertical privity between the plaintiff and the manufacturer was later severely limited in the 1916 case of MacPherson v. Buick Motors.

A further negative was the defense of contributory negligence, which at common law, was an absolute bar to recovery by a plaintiff. Finally, the sometimes-tortured reasonable man standard could be problematic in negligence cases, more specifically, reaching a consensus on what would be the standard required of a reasonable manufacturer or reasonable designer or of a reasonable plaintiff or reasonable defendant under the circumstances of the case.

Misrepresentation and fraud actions focus on proof of a false representation or statement of a material fact (which may be found in words, actions, concealment, or in some cases silence where the common law found a duty to speak), upon which a plaintiff reasonably relied in entering into a contract. At common law, proof of falsehood was required to prove misrepresentation, and proof of scienter, the intent to deceive (arising from either knowledge of falsity or reckless disregard for the truth), was a part of the prima facie proof required in cases of fraud. An assertion of safety or of a safe product formed the basis of many fraud claims.

A drawback to a suit based on fraud was the common belief or even expectation that all sellers would in fact engage in a certain amount of sales puffing or exaggeration regarding their products, and the common notion that no matter how careful a manufacturer might be, no one could absolutely guarantee the safety of any product in all cases, thus negating the element of reasonable reliance.

Actions for breach of warranty were essentially based on contract promises, either express or implied. Warranties were subject to disclaimers on the part of sellers and could also be severely limited in their scope. Warranty actions also were subjected to severe notice requirements (that is, the injured party had to give the party causing the injury a notice that damage/injury had occurred within a rather limited period of time). Another drawback is the plaintiff had to show that he or she relied upon specific words or promises made by a seller in order to maintain a warranty action.

Warranties under the Uniform Commercial Code (UCC) arose in cases involving the sale of goods, and not in the myriad of other types of transactions that resulted in goods or personal property reaching the hands of a consumer—most notably through leases or bailments.
Under the common law, there was also an aspect of privity – horizontal privity—that limited a manufacturer’s liability under a warranty to the actual purchaser of a product and not to any other parties. Privity of contract was greatly expanded with the decision in Henningsen v. Bloomfield Motors (See Chapter 6 for the case), which saw the expansion of liability under the warranty of merchantability to persons other than the consumer/buyer (horizontal privity). This expansion of horizontal privity may be seen in UCC § 2-318, which significantly expanded the range of potential plaintiffs in a warranty action.

The drawbacks inherent in the three common law forms of action led to the development of the modern and now preferred theory in products liability cases—strict (or absolute) liability in tort. The theory of strict liability focuses exclusively on the existence of a product defect, and not on the nature of the conduct of the defendant (negligence), or on specific words or promises (warranty/misrepresentation/fraud). Strict liability permits an injured party (broadly defined) to sue a manufacturer directly, even in the absence of privity of contract and will not permit manufacturers to disclaim their duty of due care. Notice requirements under strict liability are less stringent than under warranty actions, which were often as short as three months. Actions under strict liability permit plaintiffs to sue within more generous statute of limitation time periods. (Under the Uniform Commercial Code, the Statute of Limitations can never be less than one year and may extend to no more than four years.)

What is a Product?

As a preliminary matter…. A product can be defined by making reference, for example, to the definition of a good, found in UCC Section 2-105-1: A good is defined as an item of personal property that is both movable and tangible. By definition, pure services would be excluded from the area of products liability. In cases under the UCC where both a good and a service are involved, courts will use the “which predominates” test to determine if the transaction involved is a good or a service. According to the UCC, food or drink served in a restaurant is considered a good by definition.

The definition of product is also sufficiently broad to include certain intangibles such as electricity, some natural products (crops, pets, plants), some writings (like a navigation chart—although in the case of certain writings, courts are properly solicitous of the implications of the First Amendment). In certain cases, real property, notably, defectively made mass produced or manufactured homes, may be considered as products, although there is still a pronounced reluctance to extend products liability to transactions involving land (real estate), buildings, or appurtenances (unattached buildings).

Questions

1. Find modern day examples of the following:
   1. Manufacturing or production defect
   2. Design defect
   3. Marketing defect
2. Given the shift from the three common law theories to the notion of strict liability, how is it different from its predecessors?
3. What were some of the drawbacks to the following common law theories:
   1. Negligence
   2. Misrepresentation & fraud
   3. Warranty Actions
4. How do courts use the “which predominates” test to determine if the transaction involved is a good or service under the UCC? Find a case to support this.
5. In the Ford Pinto case, which type of defect did the product exhibit? Moreover, which of the three common law theories can best be applied for the action?

How do we know if a product is defective in either design or manufacture? This area of law is very complex and no single rule or test will apply uniformly throughout the United States. Thus, courts will use one of the following: consumer expectations, assumption of risk analysis, or the risk-utility (risk-benefit) test.

Consumer Expectations Test

This test addresses the reasonable expectations of the consumer or purchaser. The test requires that the product must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.

This is the test discussed in Gray v. Manitowoc Co., Inc., which has its basis in Comment I of Section 402A of the Restatement of the Law of Torts.

Dean Prosser, the main author of the Restatement of the Law of Torts, restated the test as follows: “Would the ordinary consumer expect to encounter such a risk in using a product?”

Case Study: Gray v. Manitowoc Co, Inc.

Procedural Posture

Defendant manufacturer appealed from the judgment of United States District Court for the Southern District of Mississippi, which denied defendant’s motions for Judgment n.o.v. and for a new trial following a jury verdict in favor of plaintiffs husband and wife. Defendant claimed there was insufficient evidence to support recovery on plaintiffs’ theories of strict liability, implied warranty, and negligence.

Overview

Plaintiff husband was injured at his construction job when he was struck by the boom of a crane manufactured by defendant manufacturer. Plaintiffs husband and wife brought an action against defendant for strict liability in tort, implied warranty, and negligence, alleging that plaintiff’s injuries were caused by a design defect in the crane which prevented the crane operator from seeing to his left when the crane was operated in the “boom down” position. After a jury verdict for plaintiffs, the trial court denied defendant’s motions for judgment n.o.v. and for new trial. On appeal, the court determined that the defect of which plaintiffs complained was well known in the construction industry and thus was a patent or obvious hazard. Applying state law, the court held that a manufacturer’s liability for product defects under any of plaintiffs’ theories of liability could not, as a matter of law, be premised on the existence of an obvious hazard in a product which functioned properly for its intended purpose. As a result, the court reversed the judgment of the trial court and rendered judgment for defendant.

Outcome

The court reversed the judgment of the trial court and rendered judgment in favor of defendant manufacturer because it held that plaintiffs husband and wife had failed to establish liability for a design defect under theories of strict liability, implied warranty or negligence. The court held that the defect which plaintiffs complained of was obvious and within the expectation of the ordinary consumer who purchased it.

Note the similarity to the reasonable man test formulated in negligence cases, discussed earlier. Note also the intentional use of the word “ordinary” as a synonym for the word reasonable.

As will be seen in Chapter 9, this standard of consumer expectations is very close to that of merchantability found in the UCC, where in order to be merchantable, goods sold must be fair, average quality and fit for their ordinary purpose as determined by the ordinary or reasonable consumer.

Defects in products are of two general types: patent (or obvious) and latent (or hidden). Generally, courts apply the consumer expectations test more rigidly where a defect is latent because the consumer is completely unaware of any danger posed by a product and would therefore reasonably expect the product to be safe.

Brawner V. Liberty Industries, Inc.

Court of Appeals of Missouri, St. Louis District, Division One, 573 S.W.2d 376 (1978)

OPINION BY: SMITH, JUDGE

Plaintiff appeals the order of the trial court dismissing with prejudice his suit against defendants brought under a theory of strict liability in tort. We affirm.

Plaintiff is seven years old and was burned when he and Ray Middleton, Jr., also seven years old, removed the lid from a gasoline storage container and the gasoline ignited. The gasoline container was manufactured by defendant Liberty Industries, Inc., and purchased by Ray Middleton (presumably the younger Middleton boy’s father) from defendant National Food Stores, Inc. and its store manager defendant Ipellito. The allegation upon which plaintiff sought to invoke the strict liability doctrine was:

“That the failure of said gasoline storage container to be equipped with an opening device which would render same to unable to be opened by a child of seven years constitutes a defect in design and an unreasonably dangerous condition of said gasoline storage container.”

In Keener v. Dayton Electric Mfg. Co., 445 SW2d 362 (Mo. 1969), Missouri adopted the theory of strict liability in tort set forth in Restatement of Torts 2d, Sec. 402 A as follows:

“One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer or to his property, . . .”

In Missouri a defect in design can meet the requirement of “defective condition”. See Keener, supra; Higgins v. Paul Hardeman, Inc., 457 SW2d 943 (Mo. App. 1970).

Under Comments to Sec. 402 A para. (g), we find that a defective condition is a “condition not contemplated by the ultimate consumer which will be unreasonably dangerous to him.” Paragraph (i) of the Comments states that “Unreasonably dangerous” means “The article sold must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.” A gasoline container which does not have a child- proof spout does not meet the definition of either defective or unreasonably dangerous. A manufacturer is not an insurer nor must he create a product which is accident proof. See Royal v. Black and Decker Manufacturing Co., 205 So.2d 307 (Fla. App. 1968); Vincer v. Esther Williams All-Aluminum Swimming Pool, 69 Wis. 2d 326, 230 NW2d 794 (1975); Belotte v. Zayre Corp. 352 A.2d 723, 116 N.H. 52 (1976). We have found no case, nor have we been cited to one, where a product made for adult use is deemed defective and unreasonably dangerous solely because it has not been made child-proof. The trial court correctly dismissed plaintiff’s petition.

Plaintiff objects to the trial court’s failure to allow plaintiff an opportunity to amend. Initially, the record does not indicate plaintiff ever requested such an opportunity. Secondly, plaintiff has not indicated what amendment he would or could make to state a cause of action.

Judgment affirmed. All concur.

Brawner makes an important point, noting that a manufacturer is not an insurer; that is, a manufacturer does not promise or guaranty that he has manufactured a product that is accident-proof or safe under all circumstances. In Brawner, the court held that a product that is made safe for adult use is not necessarily defective and unreasonably dangerous solely because it has not been made childproof. There is no reasonable expectation that the product would, in fact, be childproof. Remember, however, the concept of the environment of use found in Spruill. If it could be foreseen that the product might or would be used by a child, the application of the consumer expectations test might lead to the conclusion that the product was defective. In Keller v. Welles Department Store of Racine (a design defect case), the court noted:

“If the average consumer would not reasonably anticipate the dangerous condition of the product and not fully anticipate the attendant risk of injury, it would be unreasonably dangerous and defective.”

A problem with the consumer expectations test arises in design cases because the product may be too complex to generate any concrete consumer expectations. Consumer expectations about safety are often vague or will oscillate between “it will never happen to me” or “all products are poorly made.” There is thus an anomaly that since most consumers are highly skeptical about products, it might never be seen as a reasonable expectation that a product is safe!

Keller v. Welles Department Store of Racine

Court of Appeals of Wisconsin, 88 Wis. 2d 24; 276 N.W.2d 319 (1979)

OPINION BY: BODE

This is a products liability case. On October 21, 1971, two and one-half year old Stephen Keller was playing with two year old William Sperry in the basement of the Sperry home. The boys were playing with a gasoline can which had been filled with gasoline by Wayne Sperry, William’s father. The can was manufactured by Huffman Manufacturing Company, Inc. (Huffman) and was purchased by Wayne Sperry at Welles Department Store (Welles). The children were near a gas furnace and a hot water heater when gasoline, which they had poured from the can, was ignited. Stephen Keller was severely burned. Although Mrs. Sperry was home at the time of the accident, the two boys were unsupervised.

The sole issue before this court is whether the complaint states a cause of action against the manufacturer and retailer of a gasoline can, in either strict liability or negligence, for injuries sustained by Stephen Keller resulting from the ignition of gasoline poured from a gasoline can without a child-proof cap.

In this case, plaintiff attempts to state causes of action both in strict liability and in negligence. Each theory will be considered separately.

STRICT LIABILITY

In Dippel v. Sciano, 37 Wis.2d 443, 155 N.W.2d 55 (1967), the Wisconsin Supreme Court adopted sec. 402A of Restatement, 2 Torts 2d, thereby accepting the concept of strict liability. The court immediately hastened to add, and has since reiterated, that strict liability makes a manufacturer neither an insurer nor absolutely liable for any harm resulting from the use of his product. On the contrary, to recover under the theory of strict liability the plaintiff must still prove:
(1) that the product was in defective condition when it left the possession or control of the seller, (2) that it was unreasonably dangerous to the user or consumer, (3) that the defect was a cause (a substantial factor) of the plaintiff’s injuries or damages, (4) that the seller engaged in the business of selling such product . . ., and (5) that the product was one which the seller expected to and did reach the user or consumer without substantial change in the condition it was when he sold it. Dippel, 37 Wis.2d at 460, 155 N.W.2d at 63.

To state a cause of action under strict liability then, the plaintiff must essentially allege that the product was defective and unreasonably dangerous. In the present case, the complaint clearly alleges that the defendants respectively manufactured or sold a gasoline can which was defective and unreasonably dangerous to children such as the plaintiff. The defect complained of was the failure to design the can with a cap sufficient to prevent children from removing it.

* * * The defendants contend that the motion to dismiss should have been granted because, as a matter of law, no jury could have reasonably concluded that the gasoline can was either defective or unreasonably dangerous. In support of their argument, the defendants rely on Vincer v. Esther Williams All-Aluminum Swimming Pool Co., 69 Wis.2d 326, 230 N.W.2d 794 (1975).

In Vincer, a young boy was visiting his grandparents’ home. While unsupervised, he fell into a swimming pool, remained there for a prolonged period of time, and sustained severe brain damage. The allegation was that a retractable ladder to the aboveground pool had been left in the down position, thereby providing easy access to the pool. The parents brought suit against the manufacturer of the swimming pool claiming that the pool was defectively designed in that it failed to provide a self-latching and closing gate to prevent entry to the pool. The Esther Williams Company demurred to the complaint for failure to state a cause of action. The trial court sustained the demurrer and the supreme court affirmed.

In its opinion, the court determined as a matter of law that the pool did not contain an unreasonably dangerous defect. The defendants believe the principles enunciated in Vincer mandate a similar outcome in the instant case. We disagree.
Comment g to sec. 402A of Restatement, 2 Torts 2d, states that a product is in a defective condition when “at the time it leaves the seller’s hands, [it is] in a condition not contemplated by the ultimate consumer, which will be unreasonably dangerous to him.” While this comment serves as a guideline, there is no general definition for “defect,” and a decision on whether a defect exists must be made on a case-by-case basis. Jagmin v. Simonds Abrasive Co., 61 Wis.2d 60, 66, 211 N.W.2d 810, 813 (1973).

The Vincer court concluded that the swimming pool could not have been defective for failure to have the suggested gate because it had a retractable ladder which rendered the pool “as safe as it reasonably could be.” Vincer, 69 Wis.2d at 331, 230 N.W.2d at 798. The product at issue here, a gasoline can, was not as safe as was reasonably possible since the cap was not designed in such a way as to prevent young children from removing it. Equipping the gasoline can with a child-proof cap would have rendered the can substantially safer and entailed only a nominal additional cost. The practical value of such a cap may readily be seen since gasoline cans, while not intended to be used by children unable to appreciate the attendant dangers of gasoline, are customarily stored in places accessible to children.

The second element to be considered is whether the defective product, the gasoline can, was unreasonably dangerous. Comment i to sec. 402A of the Restatement, in part, describes an article as unreasonably dangerous when it is “dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.” In Arbet v. Gussarson, 66 Wis.2d 551, 225 N.W.2d 431 (1975), the distinction between dangers which are latent or hidden and those which are obvious was explored in the context of this Restatement comment. The court observed that since an ordinary consumer would expect a Volkswagen to be less safe in an accident than a larger car, the small size would not make the Volkswagen unreasonably dangerous. Arbet itself dealt with a design defect in a Rambler Station Wagon which resulted in gasoline being retained in the passenger compartment. Since the danger arising from this defect was hidden rather than obvious, the supreme court reversed the trial court and upheld the complaint as against the demurrer of the car manufacturer.

Vincer noted that the patent-danger rule discussed in Arbet and stated that the Wisconsin test of whether a product contains an unreasonably dangerous defect was as follows: “If the average consumer would reasonably anticipate the dangerous condition of the product and fully appreciate the attendant risk of injury, it would not be unreasonably dangerous and defective.” Vincer, 69 Wis.2d at 332, 230 N.W.2d at 798. The court then concluded that the swimming pool did not contain an unreasonably dangerous defect for two reasons: first, because the absence of a self-latching gate was an obvious condition and second, because the average consumer would recognize the inherent danger of a retractable ladder in the down position when unsupervised children are about.

We think a different result is warranted in the present case. While the defect in the gasoline can was not concealed, this court is unable to conclude, as a matter of law, that the absence of a child-proof cap was an obvious as opposed to a latent condition. Nor do we believe the dangers to unsupervised children from a gasoline can without a child-proof cap are so apparent that the average consumer would be completely aware of them.

In this regard the factual circumstances in this case are clearly distinguishable from those in Vincer. It is common knowledge that children are attracted to swimming pools and that precautions must therefore be taken. See McWilliams v. Guzinski, 71 Wis.2d 57, 62, 237 N.W.2d 437, 439 (1976) (holding that an insufficiently guarded swimming pool in a residential area is an attractive nuisance to a four year old child). The danger to a young child from a swimming pool is obvious. The hazards to a child arising from a gasoline can without a child-proof cap are not so readily apparent. A child is not so clearly attracted to this product that an adult would immediately be put on guard to take precautions for the child’s safety.

Based on the foregoing discussion, we conclude the complaint stated a cause of action in strict liability.

Assumption of Risk Analysis

If a reasonable consumer knows about a risk and nevertheless proceeds to use a product, it may be said that the consumer has assumed the risk of such use.

These are the two elements of the defense of assumption of risk: knowledge of a risk, and voluntary acceptance of that risk. If there were a known risk (a patent or obvious risk), then a reasonable consumer would not have the expectation that the product is completely safe and would be expected to act accordingly. In that sense, the assumption of risk defense may be another formulation of the consumer expectations test.

The Risk-Utility Test or Risk-Benefit Test

This test looks to what a reasonable seller/manufacturer would do in the face of a product that carries with it a risk or a danger. It is essentially a negligence standard, based on the expected conduct of a reasonable manufacturer. This test has enormous ethical and social responsibility aspects! The risk-utility test places the burden of proof on a manufacturer in a design case to justify why a certain product was manufactured.

The risk-utility test often revolves around a simple concept: Whether the cost of making a safer product is greater than the risk from using the product in its present form. If the cost of making the change is greater than the risk created by not making the change then the utility of keeping the product as is outweighs the risk and the product is not defective. If the cost of making the change is minimal or is less than the risk created by not making the change, then the benefit or utility of keeping the product as is outweighed by the risk and the product is defective. This is obviously a balancing act – a judgment call – on the part of the trier of fact. In many cases, the cost of effecting any change will be the most significant or overriding factor in applying the risk- benefit/risk-utility test. The lower the cost, the more likely that a court or jury will find that the product without the change is in fact defective!

Case Study: Phillips v. Kimwood Machine Company

Overview

Plaintiff appealed a judgment of the lower court directing a verdict for defendant in product liability case. The court reversed and found that defendant did not warn plaintiff’s employer about possible problems that could arise because of the lack of safety devices on the sanding machine.

The court found, in determining whether a design is unreasonably dangerous, the fact finder must look at the surrounding circumstances and knowledge at the time the product was sold, and whether a reasonably prudent manufacturer would have designed and sold the product if he had known of the risks. Here, the court found the jury could find the product was unreasonably dangerous and defective because the manufacturer had knowledge of the product and inspected plaintiff’s machine before the accident. Further, the lack of warning to plaintiff of possible dangers associated with the use of the machine may have rendered the machine dangerously defective.

Outcome

The court reversed the judgment and remanded for a new trial because the jury could find the machine was dangerously defective, and the jury should decide whether the injury resulted from a design defect or misuse.

The common standards or factors used for determining risk-utility or risk-benefit are found in footnote number 13 in Phillips. They include:

• The usefulness and desirability of the product: There are some products that have little or no utility and would not even pass this ‘’threshold” test. Such products today might include assault weapons for skeet shooting, some large “home use” fireworks displays, or lawnmowers or boats without a ‘dead mans’ switch;
• The likelihood and probable seriousness of injury from the product as it is manufactured;
• The availability of a substitute product that would meet the same needs of the consumer and not be unsafe. If there are no substitute products, it might be difficult to find this particular product defective. Think of this in terms of an experimental drug used to treat cancer or AIDS. This drug may be very dangerous, but still may have a very high utility;
• The manufacturer’s ability to eliminate the danger without impairing the usefulness
  of the product or making the product too expensive. This is the essence of the standard from the standpoint of the manufacturer! If a product becomes “too expensive,” no one would be able to purchase it at all!;
• Given the nature of a danger, the user’s ability to avoid the danger—especially with proper warnings or instructions);
• The user’s anticipated awareness of the danger;
• The feasibility, on the part of the manufacturer, of spreading the risk by pricing decisions or through the purchase of insurance.

Under a risk-utility analysis, we are asked to determine that the product should never have been manufactured in the first place! Examples of such products might include the four foot high swimming pool with a diving/platform board attached; an assault weapon that the manufacturer advertised would be suitable for “backyard” shooting practice; or home-use bottle rockets (in effect, mini-mortars) for “safe use,” during the July Fourth holiday. Think about the risk-utility test in conjunction with the manufacturing of the Pinto automobile.

Phillips makes an important point in the following statement:

“A dangerously defective article would be one which a reasonable person would not put into the “stream of commerce” if he had knowledge of its harmful characteristics.”

This is a “presumed knowledge” standard that assumes that the manufacturer in fact knew of the danger or harmful characteristics of a product.

As noted, Phillips also suggests that if a change in a product could have been effected at a relatively small price, there is a good chance liability will be imposed for not making the change. This may be the most important consideration for a jury!

In sum, in employing the risk-utility test, manufacturers, first, and then courts must balance several factors:

• Product cost: the relative cost both to the manufacturer and the consumer of producing, distributing, and selling the original product as compared to the product with the alternative design;
• Technological feasibility of an alternative design (e.g., a child’s crib with larger slats, thus with smaller gaps);
• Time lag required to effect necessary changes or within which to implement the alternative design; (the shorter the time period needed to correct a problem, the more likely that a court would require the change to be made);
• The effect the new design has on product performance. Cars that travel at five miles per hour would be much safer but would they be practical or have any utility? Apple pie or coffee served by McDonald’s at room temperature would be much safer but would anyone want to purchase such a product?

Case Study: Liebeck v. McDonald’s

Overview

There is a lot of hype about the McDonalds’ scalding coffee case. No one is in favor of frivolous cases of outlandish results; however, it is important to understand some points that were not reported in most of the stories about the case. McDonalds coffee was not only hot, it was scalding — capable of almost instantaneous destruction of skin, flesh and muscle. Here’s the whole story.

Stella Liebeck of Albuquerque, New Mexico, was in the passenger seat of her grandson’s car when she was severely burned by McDonalds’ coffee in February 1992. Liebeck, 79 at the time, ordered coffee that was served in a styrofoam cup at the drive through window of a local McDonalds.

After receiving the order, the grandson pulled his car forward and stopped momentarily so that Liebeck could add cream and sugar to her coffee. (Critics of civil justice, who have pounced on this case, often charge that Liebeck was driving the car or that the vehicle was in motion when she spilled the coffee; neither is true.) Liebeck placed the cup between her knees and attempted to remove the plastic lid from the cup. As she removed the lid, the entire contents of the cup spilled into her lap.

The sweatpants Liebeck was wearing absorbed the coffee and held it next to her skin. A vascular surgeon determined that Liebeck suffered full thickness burns (or third-degree burns) over 6 percent of her body, including her inner thighs, perineum, buttocks, and genital and groin areas.

She was hospitalized for eight days, during which time she underwent skin grafting. Liebeck, who also underwent debridement treatments, sought to settle her claim for $20,000, but McDonalds refused.

During discovery, McDonalds produced documents showing more than 700 claims by people burned by its coffee between 1982 and 1992. Some claims involved third-degree burns substantially similar to Liebecks. This history documented McDonalds’ knowledge about the extent and nature of this hazard.

McDonalds also said during discovery that, based on a consultants advice, it held its coffee at between 180 and 190 degrees Fahrenheit to maintain optimum taste. He admitted that he had not evaluated the safety ramifications at this temperature. Other establishments sell coffee at substantially lower temperatures, and coffee served at home is generally 135 to 140 degrees.

Further, McDonalds’ quality assurance manager testified that the company actively enforces a requirement that coffee be held in the pot at 185 degrees, plus or minus five degrees. He also testified that a burn hazard exists with any food substance served at 140 degrees or above, and that McDonalds coffee, at the temperature at which it was poured into styrofoam cups, was not fit for consumption because it would burn the mouth and throat. The quality assurance manager admitted that burns would occur, but testified that McDonalds had no intention of reducing the “holding temperature” of its coffee.

Plaintiffs’ expert, a scholar in thermodynamics applied to human skin burns, testified that liquids, at 180 degrees, will cause a full thickness burn to human skin in two to seven seconds. Other testimony showed that as the temperature decreases toward 155 degrees, the extent of the burn relative to that temperature decreases exponentially. Thus, if Liebeck’s spill had involved coffee at 155 degrees, the liquid would have cooled and given her time to avoid a serious burn.

McDonalds asserted that customers buy coffee on their way to work or home, intending to consume it there. However, the company’s own research showed that customers intend to consume the coffee immediately while driving.

McDonalds also argued that consumers know coffee is hot and that its customers want it that way. The company admitted its customers were unaware that they could suffer third-degree burns from the coffee and that a statement on the side of the cup was not a “warning” but a “reminder” since the location of the writing would not warn customers of the hazard.

Outcome

The jury awarded Liebeck $200,000 in compensatory damages. This amount was reduced to $160,000 because the jury found Liebeck 20 percent at fault in the spill. The jury also awarded Liebeck $2.7 million in punitive damages, which equals about two days of McDonalds’ coffee sales.

Post-verdict investigation found that the temperature of coffee at the local Albuquerque McDonalds had dropped to 158 degrees Fahrenheit.

The trial court subsequently reduced the punitive award to $480,000 — or three times compensatory damages — even though the judge called McDonalds’ conduct reckless, callous and willful.

No one will ever know the final ending to this case.

The parties eventually entered into a secret settlement which has never been revealed to the public, despite the fact that this was a public case, litigated in public and subjected to extensive media reporting. Such secret settlements, after public trials, should not be condoned.

… excerpted from ATLA fact sheet. © 1995, 1996 by Consumer Attorneys of California Brought to you by – The ‘Lectric Law Library, The Net’s Finest Legal Resource For Legal Pros & Laypeople Alike. (http://www.lectlaw.com)

Manufacturers also may wish a court to take into account the benefits to the economy from continuing to provide a product in terms of employees hired, taxes paid or generated, charitable activities engaged in by a business, or other intangible benefits to society, e.g., the utility of an experimental vaccine during an epidemic. Note that in New Jersey and in many other states, courts will not permit the introduction of any evidence regarding any supposed benefits to society – with the possible exception of the benefits derived from an experimental drug.

Cigarette manufacturers have frequently attempted to introduce this type of “beneficial evidence” in cases involving potential liability (the most recent example were in Washington and Oregon) and cite to the “amazing work” of the various cigarette manufacturers or their substantial charitable foundations as evidence of their product’s utility or value to society.

Take careful note of the alternative theories under which a plaintiff can recover. The plaintiff can select either the consumer expectations test or the risk-utility test as a theory of recovery. If the plaintiff can prove either that the product fails the consumer expectations test or that its risk outweighed its utility, then the product would be defective.

Barker V. Lull Engineering Co.

Supreme Court of California, 20 Cal.3d 413, 143 Cal.Rptr. 225, 573 P.2d 443 (1978)

TOBRINER, JUDGE

Plaintiff was injured at a construction site while operating a high-lift loader manufactured by defendant. The loader tipped partially over, and plaintiff jumped off the loader and attempted to scramble away. He was injured when some lumber on the lift fell and hit him. Plaintiff claimed that the loader was defectively designed in several respects, including that it should have been equipped with “outriggers,” a roll bar, and seat belts. [Plaintiff] instituted the present tort action seeking to recover damages for his injuries. The jury returned a verdict in favor of defendants, and plaintiff appeals from the judgment entered upon that verdict, contending primarily that in view of this court’s decision in Cronin v. J.B.E. Olson Corp. (1972) 8 Cal.3d 121, 104 Cal.Rptr. 433, 501 P.2d 1153, the trial court erred in instructing the jury “that strict liability for a defect in design of a product is based on a finding that the product was unreasonably dangerous for its intended use * * *.”
** *

As we noted in Cronin, the Restatement draftsmen adopted the “unreasonably dangerous” language primarily as a means of confining the application of strict tort liability to an article which is “dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.” (Rest.2d Torts, ?402A, com. i.) In Cronin, however, we flatly rejected the suggestion that recovery in a products liability action should be permitted only if a product is more dangerous than contemplated by the average consumer, refusing to permit the low esteem in which the public might hold a dangerous product to diminish the manufacturer’s responsibility for injuries caused by that product. As we pointedly noted in Cronin, even if the “ordinary consumer” may have contemplated that Shopsmith lathes posed a risk of loosening their grip and letting a piece of wood strike the operator, “another Greenman” should not be denied recovery. (8 Cal.3d at p. 133, 104 Cal.Rptr. 433, 501 P.2d 1153.) Indeed, our decision in Luque v. McLean (1972) 8 Cal.3d 136, 104 Cal.Rptr. 443, 501 P.2d 1163 – decided the same day as Cronin – aptly reflects our disagreement with the restrictive implications of the Restatement formulation, for in Luque we held that a power rotary lawn mower with an unguarded hole could properly be found defective, in spite of the fact that the defect in the product was patent and hence in all probability within the reasonable contemplation of the ordinary consumer.

Thus, our rejection of the use of the “unreasonably dangerous” terminology in Cronin rested in part on a concern that a jury might interpret such an instruction, as the Restatement draftsman had indeed intended, as shielding a defendant from liability so long as the product did not fall below the ordinary consumer’s expectations as to the product’s safety (footnote excluded). As Luque demonstrates, the dangers posed by such a misconception by the jury extend to cases involving design defects as well as to actions involving manufacturing defects: indeed, the danger of confusion is perhaps more pronounced in design cases in which the manufacturer could frequently argue that its product satisfied ordinary consumer expectations since it was identical to other items of the same product line with which the consumer may well have been familiar.

Accordingly, contrary to defendants’ contention, the reasoning of Cronin does not dictate that the decision be confined to the manufacturing defect context. Indeed, in Cronin itself we expressly stated that our holding applied to design defects as well as to manufacturing defects (8 Cal.3d at pp. 134-135, 104 Cal.Rptr. 433, 501 P.2d 1153), and in Henderson v. Harnischfeger Corp. (1974) 12 Cal.3d 663, 670, 117 Cal.Rptr. 1, 527 P.2d 353, we subsequently confirmed the impropriety of instructing a jury in the language of the “unreasonably dangerous” standard in a design defect case. (See also Foglio v. Western Auto Supply (1976) 56 Cal.App.3d 470, 475, 128 Cal.Rptr. 545.) Consequently, we conclude that the design defect instruction given in the instant case was erroneous.
** *

Defendants contend, however, that if Cronin is interpreted as precluding the use of the “unreasonably dangerous” language in defining a design defect, the jury in all such cases will inevitably be left without any guidance whatsoever in determining whether a product is defective in design or not. * * * Amicus California Trial Lawyer Association (CTLA) on behalf of the plaintiff responds by suggesting that the precise intent of our Cronin decision was to preclude a trial court from formulating any definition of “defect” in a product liability case, thus always leaving the definition of defect, as well as the application of such definition, to the jury. As we explain, neither of these contentions represents an accurate portrayal of the intent or effect of our Cronin decision.
** *

Our decision in Cronin did not mandate such confusion. Instead, by observing that the problem in defining defect might be alleviated by reference to the “cluster of useful precedents,” we intended to suggest that in drafting and evaluating instructions on this issue in a particular case, trial and appellate courts would be well advised to consider prior authorities involving similar defective product claims.
** *

In general, a manufacturing or production defect is readily identifiable because a defective product is one that differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line. For example, when a product comes off the assembly line in a substandard condition it has incurred a manufacturing defect.

* * * A design defect, by contrast, cannot be identified simply by comparing the injury- producing product with the manufacturer’s plans or with other units of the same product line, since by definition the plans and all such units will reflect the same design. Rather than applying any sort of deviation-from-the-norm test in determining whether a product is defective in design for strict liability purposes, our cases have employed two alternative criteria in ascertaining, in Justice Traynor’s words, whether there is something “wrong, if not in the manufacturer’s manner of production, at least in his product.” (Traynor, The Ways and Meanings of Defective Products and Strict Liability, supra, 32 Tenn. L. Rev. 363, 366.)
First, our cases establish that a product may be found defective in design if the plaintiff demonstrates that the product failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner. This initial standard, somewhat analogous to the Uniform Commercial Code’s warranty of fitness and merchantability (Cal.U.Com.Code, §2314), reflects the warranty heritage upon which California product liability doctrine in part rests. As we noted in Greenman, “implicit in [a product’s] presence on the market * * * [is] a representation that it [will] safely “do the jobs for which it was built.” (59 Cal.2d at p. 64, 27 Cal.Rptr. at p. 701, 377 P.2d at p. 901.) When a product fails to satisfy such ordinary consumer expectations as to safety in its intended or reasonably foreseeable operation, a manufacturer is strictly liable for resulting injuries. * * * Under this standard, an injured plaintiff will frequently be able to demonstrate the defectiveness of a product by resort to circumstantial evidence, even when the accident itself precludes identification of the specific defect at fault. * * *

As Professor Wade has pointed out, however, the expectations of the ordinary consumer cannot be viewed as the exclusive yardstick for evaluating design defectiveness because “[i]n many situations * * * the consumer would not know what to expect, because he would have no idea how safe the product could be made.” (Wade, On the Nature of Strict Tort Liability for Products, supra, 44 Miss.L.J. 825, 829.) Numerous California decisions have implicitly recognized this fact and have made clear, through varying linguistic formulations, that a product may be found defective in design, even if it satisfies ordinary consumer expectations, if through hindsight the jury determines that the product’s design embodies “excessive preventable danger,” or, in other words, if the jury finds that the risk of danger inherent in the challenged design outweighs the benefits of such design. * * *

A review of past cases indicates that in evaluating the adequacy of a product’s design pursuant to this latter standard, a jury may consider, among other relevant factors, the gravity of the danger posed by the challenged design, the likelihood that such danger would occur, the mechanical feasibility of a safer alternative design, the financial cost of an improved design, and the adverse consequences to the product and to the consumer that would result from an alternative design. * * *
Although our cases have thus recognized a variety of considerations that may be relevant to the determination of the adequacy of a product’s design, past authorities have generally not devoted much attention to the appropriate allocation of the burden of proof with respect to these matters. * * * The allocation of such burden is particularly significant in this context inasmuch as this court’s product liability decisions, from Greenman to Cronin, have repeatedly emphasized that one of the principal purposes behind the strict product liability doctrine is to relieve an injured plaintiff of many of the onerous evidentiary burdens inherent in a negligence cause of action. Because most of the evidentiary matters which may be relevant to the determination of the adequacy of a product’s design under the “risk- benefit” standard — e.g., the feasibility and cost of alternative designs are similar to issues typically presented in a negligent design case and involve technical matters peculiarly within the knowledge of the manufacturer, we conclude that once the plaintiff makes a prima facie showing that the injury was proximately caused by the product’s design, the burden should appropriately shift to the defendant to prove, in light of the relevant factors, that the product is not defective. Moreover, inasmuch as this conclusion flows from our determination that the fundamental public policies embraced in Greenman dictate that a manufacturer who seeks to escape liability for an injury proximately caused by its product’s design on a risk-benefit theory should bear the burden of persuading the trier of fact that its product should not be judged defective, the defendant’s burden is one affecting the burden of proof, rather than simply the burden of producing evidence. * * *

Thus, to reiterate, a product may be found defective in design, so as to subject a manufacturer to strict liability for resulting injuries, under either of two alternative tests. First, a product may be found defective in design if the plaintiff establishes that the product failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner. Second, a product may alternatively be found defective in design if the plaintiff demonstrates that the product’s design proximately caused his injury and the defendant fails to establish, in light of the relevant factors, that, on balance, the benefits of the challenged design outweigh the risk of danger inherent in such design.
** *

Finally, contrary to the suggestion of amicus CTLA, an instruction which advises the jury that it may evaluate the adequacy of a product’s design by weighing the benefits of the challenged design against the risk of danger inherent in such design is not simply the equivalent of an instruction which requires the jury to determine whether the manufacturer was negligent in designing the product. (See, e.g., Wade, On the Nature of Strict Tort Liability for Products, supra, 44 Miss.L.J. 825, 835.) It is true, of course, that in many cases proof that a product is defective in design may also demonstrate that the manufacturer was negligent in choosing such a design. As we have indicated, however, in a strict liability case, as contrasted with a negligent design action, the jury’s focus is properly directed to the condition of the product itself, and not to the reasonableness of the manufacturer’s conduct.

** *

Thus, the fact that the manufacturer took reasonable precautions in an attempt to design a safe product or otherwise acted as a reasonably prudent manufacturer would have under the circumstances, while perhaps absolving the manufacturer of liability under a negligence theory, will not preclude the imposition of liability under strict liability principles if, upon hindsight, the trier of fact concludes that the product’s design is unsafe to consumers, users, or bystanders. * * *

The judgment in favor of defendants is reversed.

Thus, a product may be found defective in design even if it satisfies normal consumer expectations, if through hindsight, the jury determines that the design embodies excessive preventable danger, or if the risk of danger, inherent in the challenged design, outweighs the benefits of the design.

Barker states that the burden of proof is shifted to the manufacturer, once the plaintiff proves that a design defect caused the injury. Under the risk-utility test, the defendant must then prove that on balance, the benefits of the challenged design outweigh the risk of danger in such a design.

Note that Barker is contrary to the view that the plaintiff must present evidence of a feasible, alternative, and safer design and places the burden of proof on the defendant-manufacturer. The shifting in the burden of proof to the defendant seems to be in line with the general philosophy of strict products liability cases which places the burden on the party best able to pay or absorb this cost. Thus, Barker may represent the future trend in products liability cases that places the clear burden on the manufacturer-defendant rather than on the person who suffered injury.

Questions

1. Manitowoc Co, Inc., the defendant, is a manufacturer of cranes. Gray, the plaintiff, was injured at his construction job when he was struck by the boom of the crane man- ufactured by the defendant. Plaintiff asserted that the design of the crane prevented the crane operator from seeing to his left when the crane was operated in the boom down position.
   1. Does the consumer expectations test apply to this case? If so, how?
   2. Was the product defective?
   3. Is Manitowoc Co, Inc. liable?
2. Brawner, the seven year old child of the plaintiff, was burned when he removed the lid from a gasoline storage container that ignited shortly after. The container was manufactured by Liberty Industries Inc., the defendant. Plaintiff brought suit under the claim that the product was defective because it lacked a mechanism to prevent it being opened by a seven year old.
   1. How does the consumer expectations test come into play?
   2. Was the container defective?
   3. Does the concept of environment of use apply to this case? Is so, how?
   4. Is Liberty Industries Inc. liable?
3. Two and a half year old Stephen Keller was playing with his 2 year old friend in the basement of his friend’s home. They were playing with a gasoline can, which had been filled with gasoline by the friend’s father. The can was manufactured by Huffman Manufacturing Company Inc. and sold by Welles Department Store to the friend’s father. The children were near a gas furnace and a hot water heater when the gasoline was ignited.
   1. Would the average consumer reasonably anticipate the dangerous condition of the product?
   2. Does the doctrine of strict liability or negligence apply? If so, how?
   3. Is Welles Department Store liable? Is Huffman Manufacturing Company Inc. liable?
4. What is the flaw with the consumer expectation test? What is the alternative?
5. Kimwood Machine Company, the defendant, manufactures sanding machines. The defendants did not warn the plaintiff’s employer about possible problems that could arise because of the lack of safety devices on the machine.
   1. Did the lack of a warning make the product defective?
   2. Does the risk-benefit/risk utility test apply? If so, how?
   3. Is Kimwood Machine Company liable?
6. Stella Liebeck, the plaintiff, was in the passenger seat of her grandson’s car when she was severely burned by McDonald’s coffee in February 1992. The coffee was not only hot; it was scalding, capable of almost instantaneous destruction of skin, flesh, and muscle. A surgeon determined that Liebeck suffered full thickness burns on over 6% of her body, in particular, her inner thighs, perineum, buttocks, and genital and groin area.
   1. How does the consumer expectations test apply?
   2. Does the risk-utility test apply? If so, how?
   3. Was the coffee defective?
   4. Is McDonald’s liable?
7. The plaintiff, Barker, was injured at a construction site while operating a high-lift loader manufactured by defendant, Lull Engineering Co. The loader ripped open and the plaintiff jumped off the loader. Consequently, he was injured when some lumber fell on him. Plaintiff asserted that the product was defectively designed due to its lack of the following: outrigger, roll bar, and seat belts.
   1. Did the design defect cause the injury?
   2. Where did the shift of burden move to?
   3. How did the risk-benefit test apply?
   4. Is Lull Engineering liable?

A production or manufacturing defect exists “if the product differs from a manufacturer’s intended result or if the product differs from apparently identical products from the same manufacturer.” (A California judge’s instruction to a jury regarding the nature of a manufacturing defect…)

There are various formulations concerning a production or manufacturing defect:

• A product which comes off the assembly line in a substandard condition in comparison with other identical units; called the deviation from the norm test—sometimes termed as the Lee Test.
• Manufacturing defects are imperfections that occur in a typically small percentage of products of a given design as a result of the failure in the manufacturing process. If there are a large number of individual defects, this will be seen as a design defect and not an isolated manufacturing or production defect.
• Products that do not conform to their intended design;
• Products that do not conform to the great majority of manufactured products within the design;
• Products that are misconstructed or misassembled;
• Defects which result from a mishap in the manufacturing process or from improper workmanship, or because defective materials were used. This standard is even applied to component parts assembled by the primary manufacturer;
• Products which do not conform to the manufacturers’ own specifications.

In a large majority of manufacturing defect cases, courts use a simple test to determine if a product is defective: the reasonable expectations of the buyer/consumer. Let’s look at one small wrinkle to this test!

Hunt v. Ferguson-Paulus Enterprises

Supreme Court of Oregon Department Two

243 Ore. 546; 415 P.2d 13 (1966)

OPINION BY: LUSK, JUDGE

The plaintiff bought a cherry pie from the defendant through a vending machine owned and maintained by the defendant. On biting into the pie one of plaintiff’s teeth was broken when it encountered a cherry pit. He brought this action to recover damages for the injury, alleging breach of warranty of fitness of the pie for human consumption. In a trial to the court without a jury the court found for the defendant and plaintiff has appealed.

Plaintiff assigns error to the court’s failure to sustain his objection to a general finding entered in favor of the defendant and to the court’s refusal to enter special findings requested by the plaintiff, among which the following presents the plaintiff’s theory of the applicable law:

“Cherries in cherry pies are normally pit-less, and are offered to the public in that condition, and plaintiff did not reasonably expect to find a pit in the cherry pie and the defendants [sic] had no knowledge that any pits were baked into pies offered by it for sale.”

Plaintiff also requested the following conclusion of law which the court refused to make:

“That a consumer of a piece of cherry pie purchased from a vending machine to be consumed at the time of sale, does not reasonably expect to find a cherry pit in such pie.”

Under ORS 72.3150 if the cherry pie purchased by the plaintiff from the defendant was not reasonably fit for human consumption because of the presence of the cherry pit there was a breach of warranty and plaintiff was entitled to recover his damages thereby caused.

In the consideration of similar cases some of the courts have drawn a distinction between injury caused by spoiled, impure, or contaminated food or food containing a foreign substance, and injury caused by a substance natural to the product sold. In the latter class of cases, these courts hold there is no liability on the part of the dispenser of the food. Thus in the leading case of Mix v. Ingersoll Candy Co., 6 Cal 2d 674, 59 P.2d 144, the court held that a patron of a restaurant who ordered and paid for chicken pie, which contained a sharp sliver or fragment of chicken bone, and was injured as a result of swallowing the bone, had no cause of action against the restaurateur either for breach of warranty or negligence. Referring to cases in which recovery had been allowed the court said:

“All of the cases are instances in which the food was found not to be reasonably fit for human consumption, either by reason of the presence of a foreign substance, or an impure and noxious condition of the food itself, such as for example, glass, stones, wires or nails in the food served, or tainted, decayed, diseased, or infected meats or vegetables.”

The court went on to say that:

“* * * despite the fact that a chicken bone may occasionally be encountered in a chicken pie, such chicken pie, in the absence of some further defect, is reasonably fit for human consumption. Bones which are natural to the type of meat served cannot legitimately be called a foreign substance, and a consumer who eats meat dishes ought to anticipate and be on his guard against the presence of such bones.”

Further the court said:

“Certainly no liability would attach to a restaurant keeper for the serving of a T-bone steak, or a beef stew, which contained a bone natural to the type of meat served, or if a fish dish should contain a fish bone, or if a cherry pie should contain a cherry stone—although it be admitted that an ideal cherry pie would be stoneless.”

The so-called “foreign-natural” test of the Mix case has been applied in the following cases: Silva v. F.W. Woolworth Co., 28 Cal App 2d 649, 83 P.2d 76 (turkey bone in “special plate” of roast turkey); Musso v. Picadilly Cafeterias, Inc. (La App), 178 S2d 421 (cherry pit in a cherry pie); Courter v. Dilbert Bros., Inc., 186 NYS2d (App Div) 334 (prune pit in prune butter); Adams v. Tea Co., 251 NC 565, 112 SE2d 92 (crystallized grain of corn in cornflakes); Webster v. Blue Ship Tea Room, Inc., 347 Mass 421, 198 NE2d 309 (fish bone in a fish chowder).

Other courts have rejected the so-called foreign-natural test in favor of what is known as the “reasonable expectation” test, among them the Supreme Court of Wisconsin, which, in Betehia v. Cape Cod Corp., 10 Wis. 2d 323, 103 NW2d 64, held that a person who was injured by a chicken bone in a chicken sandwich served to him in a restaurant, could recover for his injury either for breach of an implied warranty or for negligence. “There is a distinction,” the court said, “between what a consumer expects to find in a fish stick and in a baked or fried fish, or in a chicken sandwich made from sliced white meat and in roast chicken. The test should be what is reasonably expected by the consumer in the food as served, not what might be natural to the ingredients of that food prior to preparation. What is to be reasonably expected by the consumer is a jury question in most cases; at least, we cannot say as a matter of law that a patron of a restaurant must expect a bone in a chicken sandwich either because chicken bones are occasionally found there or are natural to chicken.” 10 Wis. 2d at 331-332.

Among other decisions adopting the reasonable expectation test are: Bonenberger v. Pittsburgh Mercantile Co., 345 Pa 559, 28 A2d 913, 143 ALR 1417, Annotation at page 1421 (oyster shell in canned oysters used in making oyster stew); Bryer v. Rath Packing Co., 221 Md. 105, 156 A2d 442, 77 ALR 2d 1 (chicken bone in chow mein); Varone v. Calarco, 199 NYS2d 755 (struvite in canned tuna).

Other decisions upon the question may be found reviewed in Hursh, American Law of Products Liability, §§ 12.33-12.35. See, also, the Annotation, 77 ALR 2d 7, at 79. The foreign-natural test is criticized in Dickerson, Products Liability and the Food Consumer 184-189, and in an article by Mitchel J. Ezer, “The Impact of the Uniform Commercial Code on the California Law of Sales Warranties,” 8 UCLA California Law Review 281.

In view of the judgment for the defendant, we are not required in this case to make a choice between the two rules. Under the foreign-natural test the plaintiff would be barred from recovery as a matter of law. The reasonable expectation test calls for determination of a question of fact: Betehia v. Cape Cod Corp.; Bonenberger v. Pittsburgh Mercantile Co.; Bryer v. Rath Packing Co.; Dickerson, Products Liability and the Food Consumer, all supra. The court has found the fact in favor of the defendant and this court has no power to disturb the finding.

Plaintiff argues that the court based its decision on the foreign-natural rule. The court did so indicate in a letter to counsel announcing its decision, but in the same letter the court also spoke of what can be “reasonably anticipated and guarded against by the consumer” and said that the question was a “mixed question of law and facts.” Further, the court, as above stated, refused to make a finding of fact requested by the plaintiff that the plaintiff “did not reasonably expect to find a pit in the cherry pie.” The general finding entered by the court covered all the issues of fact in the case.

Plaintiff also assigns error to the admission in evidence of defendant’s Exhibit A, a pamphlet issued by the United States Department of Agriculture entitled “United States Standards for grades of Frozen Red Tart Pitted Cherries.” It is sufficient to say that on the trial plaintiff’s counsel stipulated to the admission of the exhibit.

There are no other assignments of error and the judgment is affirmed.

In summary, Hunt discussed both the foreign-natural test, i.e., the Mix test, and the reasonable expectation test that is applied to impure food cases. The court also distinguished between an injury caused by “spoiled, impure, or contaminated food or food containing a foreign substance, and injury caused by a substance natural to the product sold.”

After reading Hunt, which test is more favorable to plaintiffs? To manufacturers? What test seems most reasonable to you?

Design defects arise where the design of the product makes the product defective and unreasonably dangerous. Courts will use industry standards, trade customs or trade usage, applicable manufacturing codes, or consensus industry standards in order to determine the nature of any design defect. Design defect cases will always require expert proof, which must be authenticated, and the expert him/herself must be qualified to give objective/fact testimony or render a professional opinion. This requirement implicates what is called the Daubert Rule and requires a judge to act as a judicial gatekeeper in order to assure that any alleged expert testimony meets a basic level of fact based on real and not junk science.

A Few Words About The Use Of Expert Witnesses

Proof of a defect in a product may be shown at trial through the testimony of an expert witness, a witness who has knowledge of a technical subject. Technical experts can give opinions on scientific information that is beyond the general knowledge of the jurors. Because of his or her education, training or experience, an expert witness’s testimony may help the jury understand complex technical issues. Scientific methodology is based on creating a supposition or premise and testing it to see if experiments support the supposition. If they do, the supposition is regarded as a valid scientific theory and may be presented to the jury as the trier of facts.

Junk Science

Product liability cases in the 1980s and early 1990s were often characterized by the “battle of the experts.” Experts for both sides presented opinions that in many cases contradicted one another, leaving the jury to pick between the experts. It appeared that expert testimony was increasingly based on what some came to call junk science. Junk science refers to novel scientific theories that are based on biased data or inferences that are not scientifically proven.

Daubert Test Or Standard For Expert Testimony

In 1993, the United States Supreme Court established principles for the admission of expert testimony in the landmark case Daubert v. Merrell Dow Pharmaceuticals. The court stated that trial judges should act as gatekeepers and exclude testimony based on junk science. Daubert determined that scientific evidence had to be both relevant and reliable.

The court listed four standards for admitting scientific evidence:

• Has the theory been tested?
• Has the theory been subjected to peer review and publication?
• What is the known or potential rate of error and are there controlling standards?
• Does the scientific community generally accept the theory?

The trial court must apply these standards in deciding whether to admit expert testimony.

State of the art testimony will be utilized to determine the technology available at the time the product left the manufacturer’s hand in order to determine if a design defect exists.

Design defect cases recognize the fact that there is a risk involved in the production of many products. Then the question is asked: Did the manufacturer take reasonable steps to correct or at least minimize the risk?In determining the existence of a design defect, courts must necessarily balance the economic interests of the manufacturer against the safety interests of the consumer. Courts hold that the proper standard to be applied is as follows:

“A product is defective because of its design and unreasonably dangerous if the reasonable seller, having been made aware of the danger involved, would not sell the product.”

In many cases, courts will inquire whether or not the hazard, danger, or risk could have been obviated at a slight cost. (For example, selling or manufacturing a lawnmower without a dead man’s (cut-off) switch which could have been added or supplied for less than $5.00 – Burch v. Sears Roebuck.)

New Jersey follows the majority view. New Jersey courts require a plaintiff to prove that there is a “practical and technically feasible” alternative design that will not impair the core function of the product or unreasonably increase its cost.

The Boatland case (below) discusses the issues of feasibility (“the more scientifically and economically feasible the alternative was, the more likely that a jury may find that the product was defectively designed.”) This may be shown by proving that a safer alternative was available at the time of manufacture; or that there was evidence of the scientific and economic capacity to develop safer alternatives. Boatland also discusses “state of the art” evidence. After reading the case, which opinion (majority or dissent) seems more persuasive to you?

Today, many courts have imposed a duty on the part of a manufacturer to recall and/or possibly repair products which were not necessarily defective when they were designed
but which may have become defective at a later date, perhaps through obsolescence or the passing of time—especially if there “is a substantial risk of harm to a large number of persons and if the change required to make the product safer or substantially more safe would be a minimal one.” (See Daubert v. Merrell Dow Pharmaceuticals).

Boatland of Houston v. Bailey

Supreme Court of Texas

609 S.W.2d 743 (1980) 26 U.S. 310 (1945)

OPINION BY: McGEE, JUDGE

This is a product defect case involving an alleged defect in the design of a 16-foot bass boat. The plaintiffs were the widow and adult children of Samuel Bailey, who was killed in a boating accident in May of 1973. They sued under the wrongful death statute, alleging that Samuel Bailey’s death occurred because the boat he was operating was defectively designed. The boat had struck a partially submerged tree stump, and Bailey was thrown into the water. With its motor still running, the boat turned sharply and circled back toward the stump. Bailey was killed by the propeller, but it is unclear whether he was struck when first thrown out or after the boat circled back toward him.

Bailey’s wife and children sought damages under a strict liability theory from the boat’s seller, Boatland of Houston, Inc. At trial, they urged several reasons why the boat was defectively designed, including inadequate seating and control area arrangement, unsafe stick steering and throttle design, and the failure of the motor to automatically turn off when Bailey was thrown from the boat.

The trial court rendered a take-nothing judgment based on the jury’s failure to find that the boat was defective and findings favorable to Boatland on several defensive issues. The court of civil appeals, with one justice dissenting, reversed and remanded the cause for a new trial because of errors in the admission of evidence and the submission of the defensive issues. We reverse the judgment of the court of civil appeals and affirm that of the trial court.

EVIDENCE OF DESIGN DEFECT

* * * In Turner v. General Motors Corp., this court discussed the strict liability standard of “defectiveness” as applied in design defect cases. Whether a product was defectively designed requires a balancing by the jury of its utility against the likelihood of and gravity of injury from its use. The jury may consider many factors before deciding whether a product’s usefulness or desirability is outweighed by its risks. Their finding on defectiveness may be influenced by evidence of a safer design that would have prevented the injury. Because defectiveness of the product in question is determined in relation to safer alternatives, the fact that its risks could be diminished easily or cheaply may greatly influence the outcome of the case.

Whether a product was defectively designed must be judged against the technological context existing at the time of its manufacture. Thus, when the plaintiff alleges that a product was defectively designed because it lacked a specific feature, attention may become focused on the feasibility of that feature the capacity to provide the feature without greatly increasing the product’s cost or impairing usefulness. This feasibility is a relative, not an absolute, concept; the more scientifically and economically feasible the alternative was, the more likely that a jury may find that the product was defectively designed. A plaintiff may advance the argument that a safer alternative was feasible with evidence that it was in actual use or was available at the time of manufacture. Feasibility may also be shown with evidence of the scientific and economic capacity to develop the safer alternative. Thus, evidence of the actual use of, or capacity to use, safer alternatives is relevant insofar as it depicts the available scientific knowledge and the practicalities of applying that knowledge to a product’s design.

As part of their case-in-chief, the Baileys produced evidence of the scientific and economic feasibility of a design that would have caused the boat’s motor to automatically shut off when Bailey fell out. According to the Baileys, the boat’s design should have incorporated an automatic cut-off system or the boat should have been equipped with a safety device known as a “kill switch.”

The deposition of J. C. Nessmith, president of Boatland, was read, in which he stated that there were presently several types of “kill switches” available, and that they were now installed by Boatland when it assembled and sold bass boats.

The deposition of Bill Smith, who was a passenger in the boat with Bailey at the time of the accident, was also read. Smith had not heard of automatic kill switches before the accident, but afterwards he got one for his own boat.

The deposition testimony of George Horton, the inventor of a kill switch designed for open- top carriers, was also introduced. Horton began developing his “Quick Kill” in November of 1972 and applied for a patent in January of 1973. According to Horton, his invention required no breakthroughs in the state of the art of manufacturing or production. He stated that his invention was simple: a lanyard connects the operator’s body to a device that fits over the ignition key. If the operator moves, the lanyard is pulled, the device rotates, and the ignition switch turns off. When he began to market his “Quick Kill,” the response by boat dealers was very positive, which Horton perceived to be due to the filling of a recognized need. He considered the kill switch to be a necessary safety device for a bass boat with stick steering. If the kill switch were hooked up and the operator thrown out, the killing of the motor would prevent the boat from circling back where it came from. Horton also testified that for 30 years racing boats had been using various types of kill switches. Thus, the concept of kill switches was not new.

Robert Swint, a NASA employee who worked with human factors engineering, testified that he had tested a bass boat similar to Bailey’s. He concluded that the boat was deficient for several reasons and that these deficiencies played a part in Bailey’s death. According to Swint, when the boat struck a submerged object and its operator became incapacitated, the seating and control arrangement caused the boat to go into a hard turn. If the operator were thrown out, the boat was capable of coming back and hitting him. Swint also stated that a kill switch would have cut off the engine and the motor would not have been operative when it hit Bailey.

Jim Buller, who was fishing in the area when Bailey was killed, testified that his own boat did not have a kill switch at that time, but he ordered one within “a matter of days.”

Boatland elicited evidence to rebut the Baileys’ evidence of the feasibility of equipping boats with kill switches or similar devices in March of 1973, when the boat was assembled and sold.

In response to the Baileys’ evidence that the “Quick Kill” was readily available at the time of trial, Horton stated on cross-examination that until he obtained the patent for his “Quick Kill” in 1974 he kept the idea to himself. Before he began to manufacture them, he investigated the market for competitive devices and found none. The only applications of the automatic engine shut-off concept in use at the time were homemade, such as on racing boats. He first became aware of competitive devices in August of 1974.

Boatland introduced other evidence to show that kill switches were not available when Bailey’s boat was sold. The deposition of Jimmy Wood, a game warden, was read in which he stated that he first became aware of kill switches in 1975. He testified that he had a “Quick Kill” on his boat since 1976, and he thought it was the only kill switch made. Willis Hudson, who manufactured the boat operated by Bailey, testified that he first became aware of kill switches in 1974 or 1975 and to his knowledge no such thing was available before then. Ralph Cornelius, the vice-president of a marine appliance dealership, testified that kill switches were not available in 1973. The first kill switch he saw to be sold was in 1974, although homemade “crash throttles” or foot buttons had long been in use.

* * * After considering the feasibility and effectiveness of an alternative design and other factors such as the utility and risk, the jury found that the boat was not defective. The trial court rendered judgment for Boatland. The Baileys complained on appeal that the trial court erred in admitting Boatland’s evidence that kill switches were unavailable when Bailey’s boat was assembled and sold. The court of civil appeals agreed, holding that the evidence was material only to the care exercised by Boatland and thus irrelevant in a strict liability case.

In its appeal to this court, Boatland contends that the court of civil appeals misconstrued the nature and purpose of its evidence. According to Boatland, when the Baileys introduced evidence that kill switches were a feasible safety alternative, Boatland was entitled to introduce evidence that kill switches were not yet available when Bailey’s boat was sold and thus were not a feasible design alternative at that time.

The primary dispute concerning the feasibility of an alternative design for Bailey’s boat was the “state of the art” when the boat was sold. The admissibility and effect of “state of the art” evidence has been a subject of controversy in both negligence and strict product liability cases. In negligence cases, the reasonableness of the defendant’s conduct in placing the product on the market is in issue. Evidence of industry customs at the time of manufacture may be offered by either party for the purpose of comparing the defendant’s conduct with industry customs. An offer of evidence of the defendant’s compliance with custom to rebut evidence of its negligence has been described as the “state of the art defense.” In this connection, it is argued that the state of the art is equivalent to industry custom and is relevant only to the issue of the defendant’s negligence and irrelevant to a strict liability theory of recovery.

In our view, custom “…is distinguishable from “state of the art.” The state of the art with respect to a particular product refers to the technological environment at the time of its manufacture. This technological environment includes the scientific knowledge, economic feasibility, and the practicalities of implementation when the product was manufactured. Evidence of this nature is important in determining whether a safer design was feasible. The limitations imposed by the state of the art at the time of manufacture may affect the feasibility of a safer design. Evidence of the state of the art in design defect cases has been discussed and held admissible in other jurisdictions. In this case, the evidence advanced by both parties was relevant to the feasibility of designing bass boats to shut off automatically if the operator fell out, or more specifically, the feasibility of equipping bass boats with safety switches.

The Baileys offered state of the art evidence to establish the feasibility of a more safely designed boat: They established that when Bailey’s boat was sold in 1973, the general concept of a boat designed so that its motor would automatically cut off had been applied for years on racing boats. One kill switch, the “Quick Kill,” was invented at that time and required no mechanical breakthrough. The Baileys were also allowed to show that other kill switches were presently in use and that the defendant itself presently installed them.

Logically, the plaintiff’s strongest evidence of feasibility of an alternative design is its actual use by the defendant or others at the time of manufacture. Even if a safer alternative was not being used, evidence that it was available, known about, or capable of being developed is relevant in determining its feasibility. In contrast, the defendant’s strongest rebuttal evidence is that a particular design alternative was impossible due to the state of the art. Yet the defendant’s ability to rebut the plaintiff’s evidence is not limited to showing that a particular alternative was impossible; it is entitled to rebut the plaintiff’s evidence of feasibility with evidence of limitations on feasibility. A suggested alternative may be invented or discovered but not be feasible for use because of the time necessary for its application and implementation. Also, a suggested alternative may be available, but impractical for reasons such as greatly increased cost or impairment of the product’s usefulness. When the plaintiff has introduced evidence that a safer alternative was feasible because it was used, the defendant may then introduce contradictory evidence that it was not used.

Thus in response to the Baileys’ evidence of kill switch use in 1978, the time of trial, Boatland was properly allowed to show that they were not used when the boat was sold in 1973. To rebut proof that safety switches were possible and feasible when Bailey’s boat was sold because the underlying concept was known and the “Quick Kill,” a simple, inexpensive device had been invented, Boatland was properly allowed to show that neither the “Quick Kill” nor any other kill switch was available at that time.

It could reasonably be inferred from this evidence that although the underlying concept of automatic motor cut-off devices was not new, kill switches were not as feasible an alternative as the Baileys’ evidence implied. Boatland did not offer evidence of technological impossibility or absolute nonfeasibility; its evidence was offered to show limited availability when the boat was sold. Once the jury was informed of the state of the art, it was able to consider the extent to which it was feasible to incorporate an automatic cut-off device or similar design characteristic into Bailey’s boat. The feasibility and effectiveness of a safer design and other factors such as utility and risk, were properly considered by the jury before it ultimately concluded that the boat sold to Bailey was not defectively designed.

In cases involving strict liability for defective design, liability is determined by the product’s defective condition; there is no need to prove that the defendant’s conduct was negligent. Considerations such as the utility and risk of the product in question and the feasibility of safer alternatives are presented according to the facts as they are proved to be, not according to the defendant’s perceptions. Thus, even though the defendant has exercised due care his product may be found defective. When the Baileys introduced evidence of the use of kill switches, Boatland was entitled to introduce rebuttal evidence of nonuse at the time of manufacture due to limitations imposed by the state of the art. Evidence offered under these circumstances is offered to rebut plaintiff’s evidence that a safer alternative was feasible and is relevant to defectiveness. It was not offered to show that a custom existed or to infer the defendant’s compliance therewith. We would be presented with a different question if the state of the art in 1973 with respect to kill switches had not been disputed and Boatland had attempted to avoid liability by offering proof that Bailey’s boat complied with industry custom.

CONCLUSION

For the reasons stated above the judgment of the court of civil appeals is reversed. The judgment rendered by the trial court, that the Baileys take nothing against Boatland, is affirmed.

POPE, J., concurring, in which BARROW, J., joins.

CAMPBELL, Justice, dissenting.

I dissent.

“State of the art” does not mean “the state of industry practice.” “State of the art” means “state of industry knowledge.” At the time of the manufacture of the boat in question, the device and concept of a circuit breaker, as is at issue in this case, was simple, mechanical, cheap, practical, possible, economically feasible and a concept seventy years old, which required no engineering or technical breakthrough. The concept was known by the industry. This fact removes it from “state of the art.”

Boatland is a retail seller. It is not the manufacturer. From the adoption of strict liability in this case, and consideration of public policy, each entity involved in the chain of commercial distribution of a defective product has been subject to strict liability for injuries thereby caused, even though it is in no way responsible for the creation of a defective product or could not cure the defect. The remedy for a faultless retail seller is an action for indemnity against the manufacturer.

In products liability, the measure is the dangerously defective quality of the specific product in litigation. The focus is on the product, not the reasoning behind the manufacturer’s option of design or the care exercised in making such decisions. Commercial availability or defectiveness as to Boatland is not the test. Defectiveness as to the product is the test. If commercial unavailability is not a defense or limitation on feasibility to the manufacturer, it cannot be a defense to the seller.

The manufacturer of the boat, Mr. Hudson, testified as follows as concerns the concept of a “kill switch.” It is practically without dispute that this is one of the simplest mechanical devices and concepts known to man. Its function is, can be, and was performed by many and varied simple constructions. It is more a concept than an invention. The concept has been around most of this century. It is admittedly an easily incorporated concept. Was an invention required in order to incorporate a circuit breaker on a bass boat? Absolutely not! Did the manufacturer have to wait until George Horton invented his specific “Quick Kill” switch before it could incorporate a kill switch of some sort on its bass boats? Absolutely not! Mr. Hudson uses an even simpler electrical circuit breaker on his boats.

Mr. Hudson testified he could have made a kill switch himself, of his own, and of many possible designs, but simply did not do it. Why didn’t he do it? He didn’t think about it. He never had any safety engineer examine his boats. He hadn’t heard of such, he puts them on now, but still thinks people won’t use them.

What is this Court faced with in this case? Nothing more than a defendant seller attempting to avoid liability by offering proof that Bailey’s boat complied with industry practice (which it did at that time) but not because of any limitations on manufacturing feasibility at that time. This is an industry practice case. The evidence does not involve “technological feasibility.”

There is no dispute that commercially marketed “kill switches” for bass boats were unavailable to Boatland at the time it sold the boat. Horton’s “Quick Kill” was unavailable. The important point is that there is no dispute that at the time of the manufacture of Mr. Bailey’s boat, a circuit breaker, whether electrical or mechanical could have easily and cheaply been incorporated into the boat.

I would hold that the trial court erred in permitting such evidence by Boatland to go to the jury, and would affirm the judgment of the Court of Civil Appeals.

I further disagree with the majority opinion and agree with the Court of Civil Appeals on the submission of the issues pertaining to Bailey’s conduct in handling the boat. There is no evidence that Bailey was struck when first thrown from the boat. The evidence is that he was hit when the boat circled.

The theory of Valerie Bailey’s lawsuit is that if the manufacturer had incorporated a circuit breaker in the manufacture of the boat, the boat motor would have cut off when Mr. Bailey was first thrown from the boat. The boat would not have circled back to where he was thrown and struck him with a rapidly spinning propeller. Under this theory, Mr. Bailey’s conduct is not determinative of anything. The result would have been the same if he had been in a stump-free lake, hit a submerged log which had just drifted in, and had been thrown from the boat.

The evidence stated in the opinion of the Court of Civil Appeals clearly shows the alleged conduct of Mr. Bailey in operating the boat was reasonably foreseeable by Boatland. The foreseeability of that deviation in the manufacturer’s intended use of the product is relevant to the basic question of whether the product was unreasonably dangerous when and as it was marketed. General Motors Corp. v. Hopkins, 548 S.W.2d 344 (Tex.1977).

The harmful effect of the submission of these issues cannot be more vividly displayed than by considering the emphasis placed on them by counsel for Boatland in his argument to the jury. I would affirm the judgment of the Court of Civil Appeals.

RAY, J., joins in this dissent.

Failure To Warn

In general, in order for a warning to be adequate, it must make the product safe for both its intended and foreseeable uses, including any potential foreseeable misuse, especially by children. A warning must also take into account the “environment of use” of a product.
There are three criteria that are used by the courts to determine the adequacy of warnings:

• A warning must be displayed in such a way as to reasonably catch the attention of the person expected to use the product. This element deals with such factual questions as size, position, and even the color of the warnings.
• A warning must fairly apprise a reasonable user of the nature and extent of the danger and not minimize any danger associated with the use of a product.
• A warning must instruct the user how to use the product in such a way so as to avoid the danger—essentially how to safely use the product.

Courts emphasize that manufacturers must anticipate reasonable risks and warn of these risks. Manufacturers must also appreciate the “environment of use” of a product—as will be seen in Spruill v. Boyle-Midway, Inc. in the next chapter.
Think about ads for drugs or medical devices that you have either recently heard on the radio or seen on TV. Do these ads really warn the consumer about real risks? Is there such a thing as information overload? Do consumers sometimes turn a “blind eye or a deaf ear” to product warnings?
We will discuss products warnings in great detail in the next chapter.

Questions

1. Find a recent manufacturing defect case. How does the product exhibit a manufacturing defect, given its definition?
2. What flaw to the reasonable expectations test was revealed in Hunt v. Ferguson-Paulus Enterprises?
3. Boatland of Houston creates and designs boats. Samuel Bailey was operating one of these boats when it hit a partially submerged tree stump, causing Bailey to be thrown into the water. With its motor still running, the boat came back and killed Bailey after being struck by the propeller. It is unclear whether he was struck when he was first thrown out or after the boat came back. At the trial, the family of the deceased pre- sented several reasons why the boat was defectively designed such as inadequate seating and control arrangement, unsafe steering and throttle design, and a failure of the motor to automatically shut off when Bailey was thrown from the boat.
   1. Does the doctrine of strict liability apply to this case? If so, how?
   2. Was the boat defective?
   3. Is Boatland of Houston liable?
4. Ferguson-Paulus Enterprises, the defendant, owns and maintains a vending machine. Hunt, the plaintiff, bought a cherry pie from the vending machine. Upon biting the pie, the plaintiff’s tooth broke when it hit a cherry pit. He brought action to recover damage for his injury. Additionally, the plaintiff asserted that “a consumer of a piece of cherry pie purchased from a vending machine does not reasonably expect to find a cherry pit in such pie.”
   1. Does the foreign-natural test apply to this case? If so, how?
   2. Is Ferguson-Paulus Enterprises liable for Hunt’s injuries?

Unavoidably Dangerous Products

“There are simply some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use… Such a product, properly prepared, and accompanied by proper directions and warnings, is not defective, nor is it unreasonably dangerous.” (Feldman v. Lederle Laboratories, quoting Comment k to the Second Restatement.)

Examples of unavoidably dangerous products are especially common in the fields of drugs, vaccines, blood products, medical devices, and especially new or experimental medications. Recent examples are the host of drugs used in the treatment of AIDS – and perhaps handguns in the future.

McCarthy v. Olin Corp.

United States Court of Appeals, Second Circuit, 119 F.3d 148 (1997)

MESKILL, Circuit Judge:

Plaintiffs include two surviving victims and the estate of one deceased victim of the December 7, 1993 assault on the 5:33 p.m. Long Island Railroad commuter train. The bullets used in the shootings were Winchester “Black Talon” hollowpoint bullets, designed to enhance the injuries of their victims. This action was brought in New York State Supreme Court against, inter alios, Olin Corporation, the manufacturer of the bullets. The complaint asserted causes of action in the negligent manufacture, advertising and marketing of a product that was unreasonably designed and ultrahazardous, the making of an unreasonably dangerous product and strict liability in tort…The district court, Baer, J., granted the motion, finding that the complaint failed to state any claim under New York law upon which relief could be granted…Plaintiffs appeal from the order dismissing their suit, or in the alternative ask us to certify the question of ammunition manufacturer liability to the New York Court of Appeals. Finding sufficient precedents in New York law to evaluate the merits of plaintiffs’ claims, we decline to grant certification and affirm the judgment of the district court.

BACKGROUND

On December 7, 1993, Colin Ferguson boarded the Long Island Railroad’s 5:33 p.m. commuter train departing from New York City and opened fire on the passengers. Six people, including Dennis McCarthy, were killed and nineteen others, including Kevin McCarthy and Maryanne Phillips, were wounded in the vicious attack. Ferguson was armed with a 9mm semiautomatic handgun, which was loaded with Winchester “Black Talon” bullets (Black Talons). The injuries to Dennis and Kevin McCarthy and Maryanne Phillips were enhanced by the ripping and tearing action of the Black Talons because, unfortunately, the bullets performed as designed.

The Black Talon is a hollowpoint bullet designed to bend upon impact into six ninety degree angle razor-sharp petals or “talons” that increase the wounding power of the bullet by stretching, cutting and tearing tissue and bone as it travels through the victim. The Black Talon bullet was designed and manufactured by Olin Corporation (Olin) through its Winchester division and went on the market in 1992. Although the bullet was originally developed for law enforcement agencies, it was marketed and available to the general public. In November 1993, following public outcry, Olin pulled the Black Talon from the public market and restricted its sales to law enforcement personnel. Colin Ferguson allegedly purchased the ammunition in 1993, before it was withdrawn from the market.

Plaintiffs brought this action against Olin, Sturm, Ruger & Company Inc., the manufacturer of the handgun used by Ferguson, and Ram-Line Inc., the manufacturer of the fifteen round capacity magazine used with the handgun, in New York State Supreme Court to recover for the injuries of Kevin McCarthy and Maryanne Phillips and the death of Dennis McCarthy. The complaint was based on various theories of negligence and strict liability…

Olin moved to dismiss the complaint pursuant to Fed.R.Civ.P. 12(b)(6) for failure to state a claim upon which relief can be granted. The district court granted the motion. First addressing the issue of negligence, the court held that plaintiffs’ negligence theories must fail because Olin owed no duty to plaintiffs to protect them from criminal misuse of the Black Talon ammunition. With respect to the strict liability claims, the court held that plaintiffs failed to allege the existence of a design defect in the Black Talon because the ammunition must by its very nature be dangerous to be functional. Id. at 370-71. The risk of the Black Talon arises from the function of the product, not from a defect in the product.

Id. at 371. The court noted that to state a claim in either negligence or strict liability, plaintiff must demonstrate that defendant’s breach was the proximate cause of their injuries. Here, Ferguson’s conduct was an extraordinary act which broke the chain of causation…
Plaintiffs appeal the dismissal of their complaint, claiming that the issue of whether they will ultimately prevail is a matter to be determined on a factual basis and not merely on the pleadings…

DISCUSSION …

Appellants argue that in New York, there is no definite rule of law as to liability for ammunition manufacturers, especially ammunition designed to cause enhanced injuries beyond ordinary bullets, and therefore the district court erred in dismissing their complaint…

Strict Liability

Appellants’ first argument is that Olin should be held strictly liable for their injuries because the Black Talon ammunition was defectively designed and the design and manufacture of the bullets were inherently dangerous.

Design Defect

A manufacturer who places into the stream of commerce a defective product which causes injury may be held strictly liable. In New York, there are three distinct claims for strict products liability: (1) a manufacturing defect, which results when a mistake in manufacturing renders a product that is ordinarily safe dangerous so that it causes harm; (2) a warning defect, which occurs when the inadequacy or failure to warn of a reasonably foreseeable risk accompanying a product causes harm, and (3) a design defect, which results when the product as designed is unreasonably dangerous for its intended use. Appellants argue that the Black Talons were defectively designed because the expansion mechanism of the bullets, which causes ripping and tearing in its victims, results in enhanced injuries beyond ordinary bullets. The district court rejected this argument because the expanding of the bullet was an intentional and functional element of the design of the product. We agree.

To state a cause of action for a design defect, plaintiffs must allege that the bullet was unreasonably dangerous for its intended use. “[A] defectively designed product is one which, at the time it leaves the seller’s hands, is in a condition not reasonably contemplated by the ultimate consumer.” (applying the Robinson standard). “This rule, however, is tempered by the realization that some products, for example knives, must by their very nature be dangerous in order to be functional.” The very purpose of the Black Talon bullet is to kill or cause severe wounding. Here, plaintiffs concede that the Black Talons performed precisely as intended by the manufacturer and Colin Ferguson.

Sadly it must be acknowledged that: [m]any products, however well-built or well-designed may cause injury or death. Guns may kill; knives may maim; liquor may cause alcoholism; but the mere fact of injury does not entitle the [person injured] to recover … there must be something wrong with the product, and if nothing is wrong there will be no liability…

Appellants have not alleged that the bullets were defective. “As a matter of law, a product’s defect is related to its condition, not its intrinsic function.” The bullets were not in defective condition nor were they unreasonably dangerous for their intended use because the Black Talons were purposely designed to expand on impact and cause severe wounding.

Appellants next argue that under the risk/utility test analysis applied by New York courts, appellee should be held strictly liable because the risk of harm posed by the Black Talons outweighs the ammunition’s utility. The district court properly held that the risk/ utility test is inapplicable “because the risks arise from the function of the product, not any defect in the product.” McCarthy, 916 F.Supp. at 371. “There must be `something wrong’ with a product before the risk/utility analysis may be applied in determining whether the product is unreasonably dangerous or defective.” Addison v. Williams) (holding that Olin Corp. could not be held strictly liable for the manufacture of steel jacketed ammunition capable of causing enhanced injuries) (citing Note, Handguns and Products Liability, 97 Harv. L.Rev.1912, 1915 (1984)).

The purpose of risk/utility analysis is to determine whether the risk of injury might have been reduced or avoided if the manufacturer had used a feasible alternative design. (burden of proving product is unreasonably dangerous requires showing that product could have been designed more safely). However, the risk of injury to be balanced with the utility is a risk not intended as the primary function of the product. Here, the primary function of the Black Talon bullets was to kill or cause serious injury. There is no reason to search for an alternative safer design where the product’s sole utility is to kill and maim. Accordingly, we hold that appellants have failed to state a cause of action under New York strict products liability law.

Inherently Dangerous Product

Appellants also argue that Olin should be held strictly liable because the Black Talon ammunition is “unreasonably dangerous per se.” According to the appellants’ theory, a product is unreasonably dangerous per se if a reasonable person would conclude that the danger of the product, whether foreseeable or not, outweighs its utility. As the district court held, this is essentially a risk/utility analysis, which we have refused to apply. Under New York’s strict products liability jurisprudence, there is no cause of action for an unreasonably dangerous per se product. Thus, this claim was properly dismissed.

Negligence

In their complaint, appellants asserted causes of action for the negligent marketing and manufacture of Black Talon bullets. On appeal, appellants do not appear to pursue their negligent manufacturing claim but rather focus their argument on Olin’s negligent marketing of the ammunition. For the reasons discussed below, appellants cannot assert a cause of action under either theory of negligence.

The crux of appellants’ negligence theory is that Olin negligently marketed and placed the Black Talon ammunition for sale to the general public. Appellants argue that because of the severe wounding power of the bullets, Olin should have restricted sales to law enforcement agencies, for whom the bullet was originally designed. They also argue that Olin should have known that their advertising, which highlighted the ripping and tearing characteristics of the bullet, would attract “many types of sadistic, unstable and criminal personalities,” such as Ferguson.

To state a cause of action for negligence, the plaintiffs must show: (1) that Olin owed them a “duty, or obligation, recognized by law”, (2) a breach of the duty, (3) a “reasonably close causal connection between [defendant’s] conduct and the resulting injury” and (4) loss or damage resulting from the breach. W. Page Keeton et al., Prosser and Keeton on the Law of Torts § 30, at 164-65 (5th ed.1984) (hereinafter Prosser & Keeton). Becker v. Schwartz. “In the absence of a duty, as a matter of law, no liability can ensue.” Gonzalez v. Pius. “Thus it may be said that the defendant was negligent, but is not liable because he was under no duty to the plaintiff not to be.” Prosser & Keeton, § 30 at 164.

In tort cases, foreseeability is often confused with duty. Foreseeability “is applicable to determine the scope of duty — only after it has been determined that there is a duty.” Pulka v. Edelman. “The mere fact that a consequence might foreseeably result from an action or condition does not serve to establish a duty owing from a defendant to a plaintiff.” The existence of a duty is a question of law to be decided by the court. New York courts are reluctant to impose a duty of care where there is little expectation that the defendant could prevent the actions of a third party. See Pulka, 40 N.Y.2d at 786, 390 N.Y.S.2d at 397, 358 N.E.2d at 1022 (“While a court might impose a legal duty where none existed before, such an imposition must be exercised with extreme care, for legal duty imposes legal liability.” (citation omitted)). “[C]ommon law in the State of New York does not impose a duty to control the conduct of third persons to prevent them from causing injury to others. This is so … even where as a practical matter defendant could have exercised such control.” While there are of course many exceptions to this rule, we find that none of them is applicable here.

New York courts do not impose a legal duty on manufacturers to control the distribution of potentially dangerous products such as ammunition. Accordingly, although it may have been foreseeable by Olin that criminal misuse of the Black Talon bullets could occur, Olin is not legally liable for such misuse. As the district court pointed out, appellants have not alleged that any special relationship existed between Olin and Ferguson. Here, Olin could not control the actions of Ferguson. “[I]t is unreasonable to impose [a] duty where the realities of every day experience show us that, regardless of the measures taken, there is little expectation that the one made responsible could prevent the … conduct [of another].” Pulka, 40 N.Y.2d at 785, 390 N.Y.S.2d at 396, 358 N.E.2d at 1022; see also Forni, 648 N.Y.S.2d at 74 (“Plaintiffs did not, nor could they, show that defendants-manufacturers owed plaintiffs a duty of care…. New York does not impose a duty upon a manufacturer to refrain from the lawful distribution of a non-defective product.”).

It is “the responsibility of courts in fixing the orbit of duty, to limit the legal consequences of wrongs to a controllable degree and to protect against crushing exposure to liability.” To impose a duty on ammunition manufacturers to protect against criminal misuse of its product would likely force ammunition products — which legislatures have not proscribed, and which concededly are not defectively designed or manufactured and have some socially valuable uses — off the market due to the threat of limitless liability. Because Olin did not owe a legal duty to plaintiffs to protect against Colin Ferguson’s horrible action, appellants’ complaint does not state a cause of action for negligence and the claim was properly dismissed.

CONCLUSION

Because we hold that the Black Talon bullets were not defectively designed, we must affirm the dismissal of appellants’ strict liability claims. We also hold that Olin was under no legal duty to prevent criminal misuse of its product and therefore affirm the dismissal of the negligence claims. Although appellants are the victims of a horrible tragedy, under New York law, they have failed to state a cause of action upon which relief can be granted — in sum, New York law does not afford them a remedy. Accordingly, we affirm the judgment of the district court.

JUDGMENT AFFIRMED

In Wilkinson v. Bay Shore Lumber (1986), the court held that “the few reported decisions which refer to comment k overwhelmingly involve products such as drugs, vaccines, blood, and medical devices such as intrauterine devices and breast implants.” In these cases, courts are reluctant to apply strict liability, but not blanket immunity in all cases. The plaintiff can still win a case but must prove negligence, i.e., in manufacturing, preparation, or warnings or directions.

As we have discussed, in such a case the manufacturer would be required to adequately warn the physician (prescription drugs) or the consumer (nonprescription drugs) concerning issues of safety, fitness, suitability, or compatibility with other medications. Note Comment k which addresses the basis of liability:

“The seller of such products… is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.”

Effects Of Statutes And Regulations

Courts may adopt as the standard of conduct of a reasonable man either a law (statute) or an administrative regulation. This raises the stakes considerably in products cases!

In these cases, an unexcused violation of a statute or of an administrative regulation is termed negligence per se, and creates a presumption of negligence on the part of the actor that may only be overcome by strong, powerful, and conclusive evidence. The following are examples of possible excused violations of a statute or regulation: the inability to comply; an emergency situation; or where compliance would involve a greater risk of harm than non-compliance. Courts construe these examples very narrowly.

However, on the other side of the equation, compliance with a statute or regulation is not necessarily proof that a party acted reasonably and would not be a bar to recovery or a finding of negligence if a reasonable man [manufacturer] would have taken additional reasonable precautions. The statute or regulation is seen as the legally minimum standard, although in most states, compliance with the law or statute would be given a strong presumption—termed as a rebuttable presumption—that a party had acted reasonably under the circumstances.

A rebuttable presumption either of negligence or that a party has not been negligent is a marker, laid down by a court as a matter of law, but may be countered by clear and convincing proof or evidence to the contrary.

Examples of some actions that have resulted in imposition of negligence per se include failing to follow the proper steps in gaining approval of a drug (following the FDA Protocol); failing to file required health and safety reports; or filing such reports in a non-timely manner.

See The Drug Development and Approval Process found at the end of this Chapter for a depiction of the Drug Approval process.

Preemption

The doctrine of preemption can be found in the Supremacy Clause of the United States Constitution, which defines federal law as “Supreme,” provided that the federal law falls within the powers granted within Article I of the Constitution.
Congress is restricted to exercising the powers contained in Article I; therefore anything not mentioned in Article I is “reserved to the states” under the Tenth Amendment.

The Supremacy Clause, Article IV, Clause 2, states:

“This Constitution, and the Laws of the United States which shall be made in pursuance thereof; and all treaties made, or which shall be made, under the authority of the United States, shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the constitution or laws of any state to the contrary notwithstanding.”

Congress’ intent in enacting a wide variety of statutes in the context of preemption is often unclear as to how much state authority has been displaced or preempted.

The United States Supreme Court case may be found at 505 U.S. 504 (1992).

Did federal law preempt any or all of the state common law claims brought by the Cipollone’s? The plaintiffs sued on the basis of the theory that the defendant had failed to provide adequate warnings relating to the cigarettes they manufactured and sold. Section 1333 of the Federal Cigarette Labeling and Advertising Act provided for the required warnings.

In order to determine the validity of a claim of preemption, courts will initially look to the actual words of a statute, and to the legislative history of this act. There are four considerations in the preemption discussion; that is, in deciding whether a specific state regulation would or would not be preempted in the absence of an express preemption clause:

• Congress may intend to occupy the field in a given area because federal regulations may be so pervasive or the federal interest so dominant (Silkwood v. Kerr-McGee Corp.), as in federal labor legislation or in nuclear waste disposal;
• Where a state law or statute conflicts with a federal rule;
• Where a state law or statute stands as an obstacle to the accomplishment and execution of the purposes of a federal law as determined by Congress;
• Where it would be a physical impossibility to comply with both federal and state law.

In these cases, state regulations or causes of action based upon a state regulation or a state statute would be preempted. In Cipollone (which is important as well from an historical point of view- outlining the history of the required warnings on cigarette packages and the evolving form of the warning itself so as not to minimize the danger of smoking), the United States Supreme Court held that federal law preempts only those actions that related to the required warnings, advertising, or promotion of cigarettes. Other actions or theories of recovery offered by the plaintiffs, with the exception of those based on the required warnings, were not preempted and could proceed.

Cipollone v. Liggett Group, Inc.

United States Court Of Appeals For The Third Circuit, 789 F.2d 181 (1986)

HUNTER, Circuit Judge:

This case, before the court on the district court’s certification pursuant to 28 U.S.C. § 1292(b) (1982), presents the question whether the Federal Cigarette Labeling and Advertising Act, 15 U.S.C. §§ 1331-1340 (1982) (the “Act”), preempts any or all of the state common law claims brought by appellee Antonio Cipollone and his wife Rose in the district court. Several of the claims in the Cipollones’ complaint concern the alleged failure of the defendants, Liggett Group, Inc. (“Lorillard”), to provide an adequate warning of the dangers of the cigarettes that they manufactured and sold. Because these claims implicate the legislatively mandated warning provided in section 1333 of the Act, the answers of Liggett Group, Philip Morris, and Lorillard each included a defense based on the preemptive effect of the Act. The Cipollones responded by filing a motion to strike the preemption defenses. Lorillard, later joined by Philip Morris, then moved for judgment on the pleadings pursuant to Federal Rule Civil Procedure 12(c). Holding that the Act preempted none of the Cipollones’ claims, the district court granted the Cipollones’ motion to strike the defenses and denied the motion for judgment on the pleadings. Cipollone v. Liggett Group, Inc., 593 F. Supp. 1146, 1171 (D.N.J. 1984). On January 21, 1984, this court granted appellants Lorillard and Liggett Group permission to appeal. Because we disagree with the district court’s conclusion concerning the preemptive effect of the Act, we will reverse the district court’s grant of the motion to strike and will remand the case for further proceedings.

I.

A. The Complaint

In their complaint, Rose and Antonio Cipollone alleged that Mrs. Cipollone developed lung cancer as a result of smoking cigarettes manufactured and sold by appellants. The complaint, which was originally filed on August 1, 1983, further averred that Mrs. Cipollone began smoking in 1942 and developed lung cancer as a result of her smoking. Mrs. Cipollone died in October 1984, but her husband has continued prosecuting this action, individually and as executor of his wife’s estate. Mr. Cipollone is therefore the sole appellee in this case.

As observed by the district court, the fourteen-count complaint sets forth claims based on strict liability (Counts 2, 3, and 9), negligence (Counts 4 and 5), breach of warranty (Count 7), and intentional tort (Counts 6 and 8). The Cipollones claimed that the defendants’ cigarettes were unsafe and defective (Count 2) and that defendants are subject to liability for their failure to warn of the hazards of cigarette smoking on the basis of negligence (Count 4) or strict liability (Count 3). In addition, the Cipollones asserted, defendants negligently (Count 5) or intentionally (Count 6) advertised their products in a manner that neutralized the warnings actually provided, warnings made meaningless by the addiction created by cigarettes (Count 9). Finally, the complaint stated that the defendants ignored, failed to act upon, and conspired to deprive the public of medical and scientific data reflecting the dangers associated with cigarettes (Count 8).

B. The Federal Cigarette and Advertising Labeling Act

The Federal Cigarette Labeling and Advertising Act, originally enacted in 1965, was a response to a growing awareness among members of federal as well as state government that cigarette smoking posed a significant health threat to Americans. The original Act required the following warning label on cigarette packages: “Caution: Cigarette Smoking May Be Hazardous to Your Health.” 15 U.S.C. § 1333 (1970). Congress changed this warning, by amendment to the Act in 1969, to the following: “Warning: The Surgeon General Has Determined That Cigarette Smoking Is Dangerous to Your Health.” 15 U.S.C. § 1333 (1976). The Act, as amended in 1970, expressly stated the policy behind the required warning:
It is the policy of the Congress, and the purpose of this chapter, to establish a comprehensive Federal program to deal with cigarette labeling and advertising with respect to any relationship between smoking and health, whereby – the public may be adequately informed that cigarette smoking may be hazardous to health by inclusion of a warning to that effect on each package of cigarettes; and commerce and the national economy may be (A) protected to the maximum extent consistent with this declared policy and (B) not impeded by diverse, non-uniform, and confusing cigarette labeling and advertising regulations with respect to any relationship between smoking and health.

15 U.S.C. § 1331 (1982).

The Act also contains a preemption provision, which provides that:

No statement relating to smoking and health, other than the statement required by section 1333 of this title, shall be required on any cigarette package.

No requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this chapter. 15 U.S.C. § 1334 (1982).

Confronted with this provision, the district court did not question that the Act prohibits state legislatures from requiring a warning on cigarette packages that alters that provided in section 1333. Nevertheless, after a comprehensive analysis of the Act, the court concluded that section 1334 does not preempt state common law claims such as those that the Cipollones have asserted.

II.

C. Preemption Principles

The United States Supreme Court has identified several principles for ascertaining congressional intent to preempt state authority. To begin, Congress may preempt state law by express statement. Jones v. Rath Packing Co., 430 U.S. 519, 525, 51 L. Ed. 2d 604, 97 S. Ct. 1305 (1977). Without the aid of express language, a court may find intent to preempt in two general ways. Silkwood v. Kerr- McGee Corp., 464 U.S. 238, 104 S. Ct. 615, 621, 78 L. Ed. 2d 443 (1984). First, a court may determine that Congress intended “to occupy a field” in a given area because ‘the scheme of federal regulation may be so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it, ‘ because ‘the Act of Congress may touch a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject, ‘ or because “the object sought to be obtained by the federal law and the character of obligations imposed by it may reveal the same purpose. “

Fidelity Federal Savings & Loan Association v. De la Cuesta, 458 U.S. 141, 153, 73 L. Ed. 2d 664, 102 S. Ct. 3014 (1982) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 91 L. Ed. 1447, 67 S. Ct. 1146 (1947)). Second, in those instances where Congress has not wholly superceded state regulation in a specific area, state law is preempted “to the extent that it actually conflicts with federal law.” Pacific Gas & Electric Co. v. Energy Resources Conservation & Development Commission, 461 U.S. 190, 204, 75 L. Ed. 2d 752, 103 S. Ct. 1713 (1982). The Court has stated that such conflict arises when “compliance with both federal and state regulations is a physical impossibility,” Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43, 10 L. Ed. 2d 248, 83 S. Ct. 1210 (1963), or where state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Hines v. Davidowitz, 312 U.S. 52, 67, 85 L. Ed. 581, 61 S. Ct. 399 (1941). Finally, in applying these principles, a court must be mindful of the overriding presumption that “Congress did not intend to displace state law.” Maryland v. Louisiana, 451 U.S. 725, 746, 68 L. Ed. 2d 576, 101 S. Ct. 2114 (1981); see also Rice, 331 U.S. at 230.

B. Express Preemption

In applying these principles to the statutory scheme at issue here, we first express our agreement with the district court’s conclusion that section 1334 does not provide for express preemption of the Cipollones’ state common law claims. See Cipollone, 593 F. Supp. At 1154-55; accord Roysdon v. R.J. Reynolds Tobacco Co., 623 F. Supp. 1189, slip op. at 2 (E.D. Tenn. 1985); Roysdon v. R.J. Reynolds, No. 3-84-606, slip op. at 2 (E.D. Tenn. 1985). Because we are constrained by the presumption against preemption, we cannot say that the language of section 1334 clearly encompasses state common law. We find support for this determination in Congress’s failure to include state common law explicitly within section 1334, as it has in numerous other statutes. Indeed, in the absence of a preemption provision encompassing state common law, the Supreme Court has relied generally on principles of implied preemption in evaluating whether a statutory scheme preempts state common law. See, e.g., Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S. Ct. 615, 78 L. Ed. 2d 443 (1984); Chicago & North Western Transportation Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 67 L. Ed. 2d 258, 101 S. Ct. 1124 (1981). Accordingly, we turn to examining whether congressional intent to preempt the Cipollones’ claims may be inferred under the two general principles of implied preemption.

C. Implied Preemption

In pressing their implied preemption arguments in this appeal, each side relies extensively on the legislative history of the Act. As is often the case with legislative history, both sides have succeeded in gleaning passages that bolster their contrary positions. Although we find the legislative history to the Act informative, no materials have come to our attention that we deem wholly dispositive of the issue before us. Even more important, we find the language of the statute itself a sufficiently clear expression of congressional intent without resort to the Act’s legislative history. See Blum v. Stenson, 465 U.S. 886, 104 S. Ct. 1541, 1548, 79 L. Ed. 2d 891 (1984); Piper v. Chris-Craft Industries, Inc., 430 U.S. 1, 26, 51 L. Ed. 2d 124, 97 S. Ct. 926 (1977).

Under the principles of implied preemption, we must first determine whether Congress intended “to occupy the field” relating to cigarettes and health to the exclusion of state law product liability actions such as the Cipollones. Our examination of the Act leads us to agree with the district court’s statements that “Congress . . . intended to occupy a field” and “indicated this intent as clearly as it knew how.” Cipollone, 593 F. Supp. At 1164 (emphasis in original). Not only did Congress use sweeping language in describing the preemptive effect of the Act in section 1334, but it expressed its desire in section 1331 to establish “a comprehensive Federal program” in order to avoid “diverse, nonuniform, and confusing cigarette labeling and advertising regulations with respect to any relationship between smoking and health.” See Palmer v. Liggett & Myers Tobacco, Inc., 635 F. Supp. 392 (D. Mass. 1984) (Congress has preempted field with respect to cigarette labeling).

In determining the scope of this field, we observe that the Cipollones’ tort action concerns rights and remedies traditionally defined solely by state law. We therefore must adopt a restrained view in evaluating whether Congress intended to supercede entirely private rights of action such as those at issue here. See Rice, 331 U.S. at 230; Cipollone, 593 F. Supp. At 1165-66; see also Silkwood, 104 S. Ct. at 623-24; Florida Avocado Growers, 373 U.S. at 143-44. In light of this constraint, we cannot say that the scheme created by the Act is “so pervasive” or the federal interest involved “so dominant” as to eradicate all of the Cipollones’ claims. Nor are we persuaded that the object of the Act and the character of obligations imposed by it reveal a purpose to exert exclusive control over every aspect of the relationship between cigarettes and health. See Banzhaf v. F.C.C., 132 U.S. App. D.C. 14, 405 F.2d 1082, 1089-91 (D.C. Cir. 1968), cert. denied, 396 U.S. 842, 90 S. Ct. 50, 24 L. Ed. 2d 93 (1969); see also Southern Railway Co. v. Railroad Commission of Indiana, 236 U.S. 439, 446-48, 59 L. Ed. 661, 35 S. Ct. 304 (1915). Thus, we look to the extent to which the Cipollones’ state law claims “actually conflict” with the Act to ascertain whether they are preempted.

The test enunciated by this court for addressing a potential conflict between state and federal law requires us “to examine first the purposes of the federal law and second the effect of the operation of the state law on these purposes.” Finberg v. Sullivan, 634 F.2d 50, 63 (3d Cir. 1980) (en banc) (citing Perez v. Campbell, 402 U.S. 637, 29 L. Ed. 2d 233, 91 S. Ct. 1704 (1971)). As mentioned above, Congress has provided us with an explicit statement of the Act’s purposes in section 1331. That statement reveals that the Act represents a carefully drawn balance between the purposes of warning the public of the hazards of cigarette smoking and protecting the interests of national economy. See Banzhaf, 405 F.2d at 1090. Moreover, the preemption provision of section 1334, read together with section 1331, makes clear Congress’s determination that this balance would be upset by either a requirement of a warning other than that prescribed in section 1333 or a requirement or prohibition based on smoking and health “with respect to the advertising or promotion” of cigarettes. See 15 U.S.C. § 1334.

Having identified the purposes of the Act, we now must evaluate the effect of the operation of state common law claims on these purposes. In so doing, we accept the appellants’ assertion that the duties imposed through state common law damage actions have the effect of requirements that are capable of creating “an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” See Hines, 312 U.S. at 67; see also Dawson v. Chrysler Corp., 630 F.2d 950, 962 (3d Cir. 1980) (liability under common law has the effect of imposing requirements), cert. denied, 450 U.S. 959, 101 S. Ct. 1418, 67 L. Ed. 2d 383 (1981). As the appellants point out, several Supreme Court opinions reflect recognition of the regulatory effect of state law damage claims and their potential for frustrating congressional objectives. See, e.g., Fidelity, 458 U.S. at 156-59; Chicago & North Western Transportation Co., 450 U.S. at 324-25; San Diego Building Trades Council v. Garmon, 359 U.S. 236, 247, 3 L. Ed. 2d 775, 79 S. Ct. 773 (1959). Applying this principle, we conclude that claims relating to smoking and health that result in liability for noncompliance with warning, advertisement, and promotion obligations other than those prescribed in the Act have the effect of tipping the Act’s balance of purposes and therefore actually conflict with the Act.
Based on the foregoing, we hold that the Act preempts those state law damage actions relating to smoking and health that challenge either the adequacy of the warning on cigarette packages or the propriety of a party’s actions with respect to the advertising and promotion of cigarettes. We further hold that where the success of a state law damage claim necessarily depends on the assertion that a party bore the duty to provide a warning to consumers in addition to the warning Congress has required on cigarette packages, such claims are preempted as conflicting with the Act.

For the foregoing reasons, we will reverse the order of the district court to the extent that it granted the Cipollone’s motion to strike the appellants’ preemption defenses. We will also remand the case for further proceedings consistent with this opinion.

Questions

1. In Wilkinson v. Bay Shore Lumber, the plaintiff, a carpenter was building an outrigger on the roof of a house when he stepped on a board that broke due to internal dry rot, which was wholly concealed from view. Plaintiff sued under theories of negligence and strict liability.
2. Was the board an unavoidably dangerous product?
3. Is Bay Shore Lumber liable?
4. Is an airplane an unavoidably dangerous product? What are some circumstances where an airplane manufacturer could face a suit based on negligence?
5. In Silkwood v. Kerr-McGee Corp., the daughter of the plaintiff worked as a laboratory technician for the defendant, Kerr-McGee Corp. Silkwood began investigating health and safety issues at the plant. In addition, she accused the company of falsifying in- spection records. Shortly after, during a routine inspection, she was exposed to high amounts of plutonium. She blamed the company. On the way to a meeting with a journalist, she died in an unrelated car accident.
6. How could preemption come into play in this case?
7. Is Kerr-McGee Corp. liable?
8. What are some examples where negligence per se could apply? What are some specif- ic statutes or administrative regulations that could apply?
9. Liggett Group Inc., the defendant, manufactures and sells cigarettes. The wife of the plaintiff, Mrs. Cipollone, developed lung cancer and died as a result of smoking the defendant’s product. The plaintiff asserted that the defendant’s cigarettes were unsafe and defective due to their failure to warn about the hazards of smoking. Additionally, the plaintiff claimed that the defendant negligently and intentionally advertised in a way that neutralized the warnings actually provided, rendering them inadequate and insufficient. Finally, the plaintiff brought up the point that the defendant deprived the public of medical data reflecting the dangers associated with the cigarettes. The defendants made the claim that federal statutes preempted the claims, specifically the Federal Cigarette Label & Advertising Act.
10. Does the Federal Cigarette Label & Advertising Act preempt any or all state common law claims? Is Liggett Group Inc. liable?

Appendix 4.1

The Drug Development And Approval Process

Product Warnings

“… an insufficient warning is in legal effect no warning…” (Spruill v. Boyle-Midway, Inc.)

Spruill v. Boyle-Midway, Inc.

United States Court of Appeals for the Fourth Circuit, 308 F.2d 79 (1962)

OPINION BY: BELL, JUDGE

This is an appeal by the defendants, Boyle-Midway, Incorporated, from a judgment of the District Court for the Eastern District of Virginia entered upon a jury verdict for the plaintiffs in a wrongful death action. The defendants having preserved their right by proper motions throughout the trial now ask us to set aside the judgment and rule that the case ought properly not to have gone to the jury; or that if it was properly submitted to the jury that the evidence in the case does not support the verdict.

The defendants are manufacturers and distributors of a product identified as ‘Old English Red Oil Furniture Polish’. The plaintiffs in the court below were the parents and siblings of a fourteen months old infant who died as a result of chemical pneumonia caused by the ingestion of a small quantity of the defendant’s product.

The mother of the deceased stated that she had purchased the polish on the morning of November 13, 1959, and later in the day was using it in her home to polish furniture. While using it in the deceased’s bedroom she noticed a catalog which her mother had asked to see. While still in the course of polishing the furniture, she left the room and took the catalog next door to her mother’s home. She testified that she was out of the room for four or five minutes.

At the time she left the room the deceased was in his crib in one corner of the room which was near one end of a bureau. The child could reach the end of the bureau nearest the crib but could not reach articles beyond the very edge of the bureau. The mother placed the polish, prior to leaving the room, upon the end of the bureau that was out of the child’s reach. When she returned she found that the child had pulled a cover-cloth which was on the bureau into the crib, and the bottles and other articles sitting on the cloth came into the crib with it. The child had removed the cap of the bottle and had consumed a small portion of the polish.

The child was admitted to a hospital that same day, and according to the testimony of Dr. Barclay ultimately died on November 15th from hydrocarbon pneumonia. This particular type of pneumonia is a form of chemical pneumonia which usually results from the ingestion or inhalation of the petroleum distillate.

Old English Red Oil Furniture Polish is a liquid of a bright cherry red color contained in a clear glass bottle which is about 6 3/4’ tall and 2 1/4’ in diameter. The bottle has a red metal cap. The evidence shows that there are one and one-half to two threads upon the neck of the bottle and the cap.

The ingredients of Old English Red Oil Furniture Polish are 98.2% mineral seal oil, 1.8% cedar oil, a trace of turpentine, and oil soluble red dye. Chemical analysis of the product states: ‘This preparation consists almost entirely of (a) petroleum distillate which is somewhat heavier than kerosene and commonly designated as Mineral Seal Oil, or 300 degree oil, as it distills near 300 degrees C.’

The label consists of a piece of paper of deep red hue which passes completely around the bottle at its center. On the front part of the label appear the words ‘Old English Brand Red Oil Furniture Polish’ in large letters; beneath this in small letters ‘An all purpose polish for furniture, woodwork, pianos, floors’. The reverse side of the label, the background of which is white, contains the following printed matter: at the top in red letters about 1/8th of an inch in height, all in capitals, ‘CAUTION COMBUSTIBLE MIXTURE’. Immediately beneath this in red letters 1/16th of an inch high ‘Do not use near fire or flame’; several lines down, again in letters 1/16th of an inch in height, in brown ink, all in capitals, the word ‘DIRECTIONS’; then follow seven lines of directions printed in brown ink in letters about 1/32nd of an inch in height. On the eighth line in letters 1/16th of an inch high in brown ink appear the words ‘Safety Note’; following this in letters approximately 1/32nd of an inch in height:

‘Contains refined petroleum distillates. May be harmful if swallowed, especially by children.’

Following this is the name of the manufacturer and various other information with which we are not here concerned.

There was testimony that mineral seal oil is a toxic substance, and that it is a petroleum distillate. The defendants’ expert chemists testified that one teaspoonful of this product would kill a small child. There was uncontroverted evidence of several doctors that the child died of hydrocarbon pneumonia resulting from the ingestion of the defendants’ polish. Dr. Julius Caplan, one of the doctors treating the deceased, attributed death to the nature of the polish, and stated that because of its toxic quality it was capable of penetrating the intestinal tract, thus getting into the blood stream and thereby setting up fatal lung damage. Dr. James Morgan, another treating physician, testified that this polish contained a hydrocarbon that was toxic and that such resulted in the death of the child.

The mother testified that she had no knowledge that the defendants’ product would have caused injury or death to her child. She stated that she had read the statement at the top of the label in large colored letters ‘Caution Combustible’, but did not read the directions because she knew how to use furniture polish.

At the trial the plaintiffs were allowed to put into evidence certain interrogatories they had served upon the defendants together with the defendant’s answers and admissions which showed that the defendants had knowledge or notice of at least thirty-two cases of chemical pneumonia since 1953 resulting from the ingestion of this product. Ten of these thirty-two cases resulted in death. At least seven of these thirty-two cases were infants; four of these infants died as a result of chemical pneumonia. The defendants vigorously objected to the admission of this testimony, and on this appeal assigned its admission as error.

The jury in returning its verdict excluded the mother from sharing in any part of the judgment. The defendants made no request for a special verdict; therefore, the jury returned a general verdict. It was in favor of the plaintiffs other than the child’s mother.

* * * The defendants here have at no time raised the issue of lack of privity between themselves and the deceased and it appears that the point is conceded. In any event it is apparent that this case comes within the exception to the doctrine of Winterbottom v. Wright, 10 Mees & W. 109, 152 Eng. Reprint 402 (1842) which is made for inherently dangerous products. There can be no doubt but that this exception to that doctrine is well established in Virginia. General Bronze Corp. v. Kostopulos, 203 Va. 66, 122 S.E.2d 548 (1961); Norfolk Coca-Cola Bottling Works v. Krausse, 162 Va. 107, 173 S.E. 497 (1934); Robey v. Richmond Coca-Cola Bottling Works, 192 Va. 192, 64 S.E.2d 723 (1951). Indeed it is significant to note that the product involved in the leading case of Thomas v. Winchester, 6 N.Y. 397, 57 Am. Dec. 455 (1852), which firmly established the exception made for inherently dangerous products, was a poison.

Within the last year the courts of Virginia held that the test of whether a product is inherently dangerous is whether, ‘the danger of injury stems from the product itself, and not from any defect in it.’ General Bronze Corp. v. Kostopulos, supra. We hold that the danger of injury from the product stems from the product itself and nor from any defect arising out of, or resulting from, negligence in the course of manufacture. It is therefore, an inherently dangerous product.

The defendants have contended throughout that they are liable only for injuries caused in the course of the intended use of their product. Since their product was not intended to be consumed, they say, there is no liability for death or injury resulting from consumption of it. We agree with the general principle but the application the defendants would have us make of it here is much too narrow. Intended use’ is but a convenient adaptation of the basic test of ‘reasonable foreseeability’ framed to more specifically fit the factual situations out of which arise questions of a manufacturer’s liability for negligence. ‘Intended use’ is not an inflexible formula to be apolitically applied to every case. Normally a seller or manufacturer is entitled to anticipate that the product he deals in will be used only for the purposes for which it is manufactured and sold; thus he is expected to reasonably foresee only injuries arising in the course of such use.

However, he must also be expected to anticipate the environment which is normal for the use of his product and where, as here, that environment is the home, he must anticipate the reasonably foreseeable risks of the use of his product in such an environment. These are risks which are inherent in the proper use for which his product is manufactured. Thus where such a product is an inherently dangerous one, and its danger is not obvious to the average housewife from the appearance of the product itself, the manufacturer has an obligation to anticipate reasonably foreseeable risks and to warn of them, though such risks may be incidental to the actual use for which the product was intended. As the courts of Virginia have stated it,

‘The common law requires a higher degree of care and vigilance in dealing with a dangerous agency than in required in the ordinary affairs of life and business which involve small risk of injury.’ American Oil Co. v. Nicholas, 156 Va. 1, 157 S.E. 754, 757 (1931). See also Standard Oil Co. v. Wakefield, 102 Va. 824, 47 S.E. 830, 66 L.R.A. 792 (1904).

We have no doubt but that under the circumstances of its use the courts of Virginia would regard Old English Red Oil Furniture Polish as a dangerous agency. A very small quantity of it is lethal to children and extremely dangerous to adults, yet the product gives no indication by its appearance of its life endangering capacity. It appears as harmless as a bottle of soft drink, yet this product is sent daily into thousands of homes in which dwell persons incompetent to safely judge its capacity for harm. It goes there without any reasonable indication from its natural character of its death dealing power if improperly used. It would be quite reasonable to anticipate that in the process of using it for its intended purpose it would be placed in close proximity to children. They certainly cannot be expected to recognize it as a lethal poison. Under these circumstances we think that a reasonable jury could properly find that it was foreseeable that sooner or later some child would draw the fatal draught.

* * * However, even though a reasonable manufacturer should have foreseen that the product would have been consumed by humans, that manufacturer may not be liable if it has adequately warned of the danger to be reasonably foreseen. But a mere indication of danger, in and of itself, does not accomplish an inevitable tergiversation of liability. If warning of the danger is given and this warning is of a character reasonably calculated to bring home to the reasonably prudent person the nature and extent of the danger, it is sufficient to shift the risk of harm from the manufacturer to the user. To be of such character the warning must embody two characteristics: first, it must be in such form that it could reasonably be expected to catch the attention of the reasonably prudent man in the circumstances of its use; secondly, the content of the warning must be of such a nature as to be comprehensible to the average user and to convey a fair indication of the nature and extent of the danger to the mind of a reasonably prudent person.

The only protection available to children living in homes where this product is used is the caution of their parents, who are incapable of recognizing this harmless looking product for the dangerous agency it is. Without additional warning these adults have not the knowledge to invoke their caution on behalf of their young.

Under such circumstances as these the Virginia Courts have imposed upon the manufacturer or seller of the product a duty to warn of the danger.

‘A person who knowingly sells or furnishes an article which, by reason of defective construction or otherwise, is eminently dangerous to life or property, without notice or warning of the defect or danger, is liable to third persons who suffer therefrom.’ (Emphasis added.) McClanahan v. California Spray-Chemical Corp., supra; quoting with approval, 3 Cooley, Torts, § 498 at 467 (4th ed., 1932).

Where one is under a duty to warn another of danger and he fails to perform this duty by giving adequate warning, he is liable to the person to whom the duty is owed for injuries he suffers due to ignorance of the danger. Low Moore Iron Co. v. La Bianca, 106 Va. 83, 55 S.E. 532 (1906). The sufficiency of the warning is to be judged on the basis of the nature of the danger, and the degree of care required is ‘commensurate with the risk therefrom reasonably to be foreseen’. Sadler v. Lynch, 192 Va. 344, 64 S.E.2d 664 (1951).

The duty to call attention to the danger is properly on defendant under the Virginia law. Moreover the question of the sufficiency of the warning is normally for the jury. McClanahan v. California Spray-Chemical Corp., supra; American Oil Co. v. Nicholas, supra; C. F. Maize v. Atlantic Refining Co., 352 Pa. 51, 41 A.2d 850, 160 A.L.R. 449 (1945) quoted with approval in McClanahan, supra. See generally Dillard and Hart, ‘Product Liability: Directions For Use And The Duty To Warn’, 41 Va. L. Rev. 145, 177-78 (1955).

* * * Keeping in mind the nature of the danger as described above we think reasonable men could properly differ as to the sufficiency of the notice here given, and that the finding of insufficiency of notice made by the jury in this case is amply supported by the evidence. The notice here given was not printed on the label in such a manner as to assure that a user’s attention would be attracted thereto. Indeed, we think one might reasonably conclude that it was placed so as to conceal it from all but the most cautious users. It is located in the midst of a body of print of the same size and color, with nothing to attract special attention to it except the words ‘Safety Note’.

Further, even if the user should happen to discover the warning it states only ‘contains refined petroleum distillates. May be harmful if swallowed especially by children’. The first sentence could hardly be taken to convey any conception of the dangerous character of this product to the average user. The second sentence could be taken to indicate to the average person that harm is not certain but merely possible. The expert medical evidence in this case shows that ‘harm’ will not be contingent but rather inevitable, to young and old alike. Moreover, over, the last phrase of the sentence hardly conveys the thought that a very small quantity of the polish is lethal to children.

There were two elements of danger inherent in this product, first, its character as a lethal poison, and second, its combustibility. We think that a reasonable jury could conclude that the greater danger in the environment of the modern home, and therefore the danger which due caution would require to be given the greater prominence on the label, was its poisonous character. Certainly a reasonable jury could conclude that this danger was required to be given a prominence at least equal to that arising from its combustible nature. A jury convinced that the poisonous character of this polish poses the greater danger could reasonably conclude that a manufacturer which hides its warning of the greater danger within its warning of the lesser is indulging its mercantile interests at the expense of the duty of due care it owes to the purchasing public.

The defendants contend, however, that,

‘The question of the sufficiency of the warning is alleviated by the mother’s admission that she never read the label. Not having availed herself of the information contained on the bottle she cannot be permitted to ask for a more explanatory label.’

The short answer to this is that where the manufacturer is obligated to give an adequate warning of danger the giving of an inadequate warning is as complete a violation of its duty as would be the failure to give any warning. In this case had the warning been in a form calculated to attract the user’s attention, due to its position, size, and the coloring of its lettering, and had words used therein been reasonably calculated to convey a conception of the true nature of the danger, this mother might not have left the product in the presence of her child. Indeed, she might not have purchased the product at all, a fact of which the manufacturer appears to be aware. Having deprived the mother of an adequate warning which might have prevented the injury, it cannot be permitted to rely upon a warning which was insufficient to prevent the injury. This is the reasoning behind the rule laid down by the courts of Virginia that, ‘* * * An insufficient warning is in legal effect no warning’. Sadler v. Lynch, 192 Va. 344, 347, 64 S.E.2d 664, 666 (1951); McClanahan v. California Spray-Chemical Corp., supra. The jury in this case could reasonably find that the warning given was insufficient both in form and in content, and did, in fact, so find. The warning being insufficient, defendants cannot be permitted to take aid and comfort from it to any extent.

Perceiving no error by the court below, we Affirm.

There is a close relationship between a defect arising because of a failure to warn and a defect arising because of a defect in the design of a product. In some jurisdictions, the failure to warn may be seen as evidence of a design defect in the product itself because proper instructions and warnings are seen as an integral part of the design of a product.

The Spruill case was decided within the context of “inherently dangerous products” (the issue discussed in Thomas v. Winchester), where the “danger of injury stems from the product itself, and not from any defect in it” or not resulting from negligence in the course of manufacture.

The requirement of Spruill that the product must be inherently dangerous in order for there to be a duty to warn is no longer the law. A warning is required for any product, which may be considered dangerous if used in its intended fashion – encompassing a wide variety of consumer products, food products, and pharmaceuticals.

Spruill establishes that the basic test in a product warning case should be reasonable foreseeability and that a manufacturer must anticipate the environment which is normal for the use of its product.

By focusing on the warnings, the jury may be persuaded that a manufacturer should have changed or modified its warnings rather than change the design of the product. However, in either case, the product may be judged to be defective and liability would follow.

Here are some important points about “warnings.”

A warning is not adequate if it minimizes the danger associated with a product, especially if there is a known and documented problem. An example can be seen in the following warning: Inhalation of asbestos in excessive quantities over long periods of time may be harmful. In In re: Asbestos, Plaintiffs v. Bordelon, Inc., the court held that this warning was not adequate to inform insulation workers of the substantial risk of contracting asbestosis and cancer because of the presence of the word may in the warning.

A majority of courts have ruled that there is no duty to warn about obvious or known dangers or where it can be shown that the plaintiff has actual knowledge of a danger. This is substantially the assumption of risk defense that we will discuss in greater detail in the materials on negligence.

Restatement 402A, Comment j tracks this point and states: “A seller is not required to warn with regard to products, or ingredients in them, when the danger or potentiality of danger, is generally known and recognized.”

In such a case, it is argued that the warning would serve no practical purpose because it would tell the user nothing that he does not already know. Look at some examples of warnings that would probably not be required under Comment j:

• “Drinking of excessive amounts of alcohol can result in death”;
• “Diving into a 4 foot pool can cause spinal cord injury”;
• “Falling off a horse can result in injury”;
• “Cigarettes cause cancer.”

What about the following warnings?

• “Pregnant women should not drink alcohol”; or
• “Keeps arms and feet inside the car on the roller coaster ride.”

Some states, like New Jersey, require that warnings must still be given (and posted conspicuously) – even about obvious dangers – because of overriding public policy considerations.

There are several other important issues relating to product warnings:

• Warnings must be given to the user or consumer, but not to the general public, because it might be difficult or impossible to effect or monitor such warnings.
• Where products are sold to sophisticated industrial users for their use in the manufacturing process, the manufacturer or supplier is not required to warn the purchaser’s employees. The supplier can escape liability by adequately warning and training the purchaser. This rule would only apply to producer goods, as opposed to consumer goods, which are defined as goods purchased for personal, family or household use.
• Prescription Drugs: A manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician or pharmacist of any potential dangers that may result from the drug’s use. This is called the learned intermediary exception. Manufacturers, thus, have no duty to warn the patient directly. As to nonprescription (over-the-counter) drugs, the manufacturer must warn consumers directly by and through adequate labels, warnings, and directions.

This learned intermediary exception does not generally apply where a prescription drug such as a vaccine is distributed in a mass immunization program in which the drug manufacturer participated, where required by the FDA, or where a drug is distributed through public health clinics. In these cases, the role of the physician is minimal or perhaps practically nonexistent. Therefore, there is a duty on the part of a manufacturer to directly warn the consumer.

There are also significant minority views, especially regarding common drugs—most notably some antibiotics and birth control pills—because of their routine use and prescription, and again, because of the limited role of the physician. The FDA now requires direct consumer warnings.

Should there be a requirement of a duty to warn after the purchase of a product? A manufacturer or retailer may incur liability for failing to warn relating to dangers in the use of a product which come to its attention after manufacture or sale which occur as a result
of advancements in the state of the art, or through the manufacturer being made aware of accidents or problems involving dangers in the use of the product.

Whether such a warning must be given depends on:

• The degree of danger involved;
• The number of instances reported; and
• The cost of any change to the product that might be required in relation to the danger perceived.

What about the nature of such post-manufacture/sale warnings? Courts would have to balance the following:

• The nature and extent of any harm that may result from the continued use of a product without any such notice;
• The burden on the manufacturer involved in locating persons to whom the notice is required to be given;
• The attention expected from the recipient;
• The kind of product involved and the number of products manufactured or sold.

Manufacturers will frequently attempt to warn consumers through issuing a product recall. Look at the number of mass recalls in the past few years! Be attentive to consumer recalls initiated by the Consumer Product Safety Commission. Note how many of these warnings apply to children’s toys, baby cribs, and car seats!

Anderson v. Weslo, Inc.

Court of Appeals of Washington, Division 2, 906 P.2d 336 (1995)

OPINION BY: FLEISHER, JUDGE.

After he was injured while jumping on a trampoline, Anderson sued the owner and the manufacturer, alleging failure to warn, unreasonably dangerous design, and inadequate product warnings. He appeals the trial court’s granting of summary judgment for the defendants. We affirm, holding that: (1) premises liability has not been established; (2) the trampoline’s design is not unreasonably dangerous; and (3) with regard to the manufacturer’s warnings, Anderson has not shown proximate cause.

FACTS

Sixteen-year-old David Anderson was injured on May 8, 1990, while attempting to do a double flip on a trampoline manufactured by Weslo and owned by the Iszlers. Anderson landed on his head on the trampoline mat, fracturing a cervical vertebra.

After Anderson was injured, he brought a negligence/products liability action against the Iszlers and Weslo. He alleged that the Iszlers and Weslo’s user’s manual failed to warn him of the kinds of injuries that could result from doing somersaults on the trampoline. Anderson also alleged that the trampoline’s design is unreasonably dangerous. The trial court granted the defendants’ motion for summary judgment, and Anderson appeals.

Manufacturers’ liability for their defective products or warnings is covered by RCW 7.72.030, which states in pertinent part:

(1) A product manufacturer is subject to liability to a claimant if the claimant’s harm was proximately caused by the negligence of the manufacturer in that the product was not reasonably safe as designed or not reasonably safe because adequate warnings or instructions were not provided.
… .
(3) In determining whether a product was not reasonably safe under this section, the trier of fact shall consider whether the product was unsafe to an extent beyond that which would be contemplated by the ordinary consumer.

The standard for allegations of defective design and of inadequate warnings is one of strict liability…

FAILURE TO PROVIDE ADEQUATE WARNINGS

Anderson argues that a question of material fact exists with regard to whether the warnings Weslo, Inc. provided were adequate. RCW 7.72.030(1)(b) states:

(b) A product is not reasonably safe because adequate warnings or instructions were not provided with the product, if, at the time of manufacture, the likelihood that the product would cause the claimant’s harm or similar harms, and the seriousness of those harms, rendered the warnings or instructions of the manufacturer inadequate and the manufacturer could have provided the warnings or instructions which the claimant alleges would have been adequate.

As with a claim of defective design, a plaintiff may thus establish liability through either this “risk-utility” test or the “consumer expectations” test of RCW 7.72.030(3). But a plaintiff must first show that the lack of adequate warnings or instructions proximately caused his or her injury.

Therefore, we first address the issue of proximate cause, which can be resolved as a matter of law when no reasonable persons would differ. A plaintiff must show both components of proximate cause: cause in fact and legal causation. Cause in fact refers to the “but for” connection between an act and an injury, while legal causation requires a determination of whether liability should attach, based on logic, common sense, policy, and similar considerations.

Here, Weslo provided numerous warnings. Detailed warnings and rules for use are in the user’s manual, a placard with safety rules listed is provided for posting near the trampoline, and warning stickers are attached to the metal frame and sewn into the mat. Among the warnings listed in the safety section of the user’s manual is the following:

CAUTION SHOULD BE USED TO AVOID THE FOLLOWING TYPES OF ACCIDENTS

4. Landing incorrectly on the trampoline mat.

The list of rules in the user’s manual and on the safety card posted near the trampoline also contains this statement:

9. Do not attempt somersaults without proper instruction and competent coaching and supervision, or without the aid of safety apparatus such as overhead suspension, training rig, or spotting machine. Most serious trampoline injuries occur during somersaults.

With regard to cause in fact, when a person is aware of a risk and chooses to disregard it, the manufacturer’s warning “serves no purpose in preventing the harm.” Thus, the Washington Supreme Court held that inadequate warnings were not the cause in fact of an injury that occurred when two young boys rode their mini-bikes on a public street in disregard of the manufacturer’s warnings. Similarly, because Anderson was aware of the risks of injury, yet paid so little attention to the warnings that were given, it is unlikely that he would have changed his behavior in response to even more detailed warnings. Thus, Anderson has not established cause in fact.

But even if cause in fact presents a jury issue in this case, without the existence of legal causation, proximate cause has not been established. In Baughn, the court also found that there was no legal causation. The court pointed out that “[m]any products used by children may be capable of causing injury, but that alone does not mean they should be removed from the market….” On the other hand, the Ayers court held that the legal causation requirement was met when Johnson & Johnson failed to warn of the dangers of aspirating baby oil.

These cases demonstrate that determining the existence of legal causation is driven by policy considerations and common sense, which in turn stem from the particular facts of the case. Here, unlike in Ayers, detailed warnings were provided. Again, no matter how many warnings are given, or how detailed they are, it is simply impossible completely to prevent trampoline injuries. As one court has pointed out, providing more detailed warnings may very well reduce the chances they will be read, thereby increasing the risk of injury.

Anderson alleges the warnings were inadequate because they did not inform him of every possible injury that could occur or of the mechanism that would cause injury. But he was warned of the general risk of injury and of the serious risk of injury when doing somersaults. Moreover, a manufacturer does not have a duty to warn of obvious or known dangers. The risk of falling or landing incorrectly while jumping on a trampoline is obvious. Logic dictates that if that risk is obvious, it is also obvious that one could land on any part of one’s body, including the head, neck, or back, causing very serious injury. For these reasons, we hold that Weslo’s warnings adequately informed users of the risk, and therefore, that proximate cause has not been established as a matter of law.

JUDGMENT AFFIRMED

This duty to warn is especially relevant in prescription drug and automobile (and perhaps automobile tire) cases. In other cases, however, there is no general duty to warn regarding changes in technology that might improve safety. In these cases, courts will look to the nature of any industry; the life of any machinery; the shelf life of any drugs; the number of units sold, etc. And one other factor: In general, there might not be high consumer expectations regarding outdated products.

The continuing duty to warn problem is accentuated by difficulties in locating present owners and effectively communicating with them which ranges from difficult in some cases to impossible to others.

Questions

1. Find a product that features some form of risk associated with its use. What makes its warning sufficient/adequate?
2. In Thomas v. Winchester, was the product inherently dangerous? Is the defendant liable?
3. Should states require warnings about obvious dangers due to overriding public policy considerations?
4. Antonio dies from the use of a prescription drug. The manufacturer of the drug advised the prescribing physician of any potential dangers associated with the drug’s use.
5. Is the physician liable? Is the manufacturer?
6. How did the duty to warn factor into the defects associated with Firestone tires?
7. Boyle-Midway Inc., the defendant, manufactures and distributes Old English Red Oil Furniture Polish. The Spruill family, the plaintiffs, brought suit for the death of their 14 month old infant, who died as a result of ingesting a small quantity of the defen- dant’s product. Additionally, it should be noted that on the eighth line of the label on the product are the words ‘Safety Note’ in letter 1/16th of an inch high. Following this, in letters approximately 1/32nd of an inch in height are the words contains re- fined petroleum distillates. May be harmful if swallowed, especially by children.
   1. Was the warning sufficient?
   2. Does the doctrine of reasonably foreseeability apply? If so, how?
   3. Is Boyle-Midway Inc. liable?
   4. Why were certain parties excluded from receiving any of the damages?

Appendix 3.1

Warnings Relating To Over-The- Counter Drugs

The U.S. Food and Drug Administration (FDA) requires all over-the-counter (OTC) medications to have a Drug Facts label. This label provides basic information about a drug’s ingredients, instructions for use, and important safety cautions and interactions. This information will help you to select the correct medication and to use it properly.

The Drug Facts label is only required for OTC drugs, and it is not used for dietary supplements, such as vitamins, minerals, and herbal remedies.

The Drug Facts Label:

Whenever you use an over-the-counter (OTC) medicine, reading the drug product’s labeling is important for taking care of yourself and your family. The label tells you what the medicine is supposed to do, who should or shouldn’t take it, and how to use it. The labeling of OTC medicines has always contained usage and safety information for consumers. With the introduction of the “Drug Facts” label, the information is more uniform and easier to read and understand.

In the Federal Register of March 1999, the Food and Drug Administration published the OTC Drug Facts Label regulation. This regulation required most OTC drug products to comply with the new format and content requirements by May 2002. Manufacturers may continue to use old-format labels until their inventories are exhausted.

The OTC labeling rule applies to more than 100,000 OTC drug products.

Before simplifying the OTC label, the FDA conducted extensive research on how consumers use OTC drug product labels. One major problem has been the readability of the labels, especially for older Americans, who purchase almost 30 percent of the OTC drugs sold in the United States. The FDA also found that consumers thought words like “indications,” “precautions,” and “contraindications” were confusing and not easily understood.

Previously, information about product directions, warnings, and approved uses appeared in different places on the label depending on the OTC product and brand. Finding information about inactive ingredients has also been a challenge for those who may be allergic to an ingredient in a drug product.

Patterned after the Nutrition Facts food label, the Drug Facts label uses simple language and an easy-to-read format to help people compare and select OTC medicines and follow dosage instructions. The following information must appear in this order:
The product’s active ingredients, including the amount in each dosage unit. The purpose of the product.
The uses (indications) for the product.
Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. This section also describes side effects that could occur and substances or activities to avoid.
Dosage instructions–when, how, and how often to take the product.
The product’s inactive ingredients, important information to help consumers avoid ingredients that may cause an allergic reaction.

Along with the standardized format, the label uses plain-speaking terms to describe the facts about each OTC drug. For example, “uses” replaces “indications,” while other technical words like “precautions” and “contraindications” have been replaced with more easily understood words and phrases. The label also requires a type size large enough to be easily read and specific layout details–bullets, spacing between lines, and clearly marked sections–to improve readability.

If you read an OTC medicine label and still have questions about the product, talk to your doctor, pharmacist, or other health care professional.
See the example of an OTC medicine label.

Appendix 3.2

Recall Letter

Here is an example of a manufacturer (Honda of America) attempting to notify its buyers of a post-purchase problem through a recall letter:

December 2011
NHTSA Recall 11V-260 | Safety Recall: Driver’s Airbag Inflator

Dear Honda Owner:

This notice is sent to you in accordance with the requirements of the National Traffic and Motor Vehicle Safety Act.

What is the reason for this notice?

Honda has decided that a defect related to motor vehicle safety exists in certain 2001-2002 model year Accord vehicles, 2001-2003 model year Civic and Odyssey vehicles, 2002 model year CR-V vehicles and 2003 model year Civic Hybrid and Pilot vehicles. In some vehicles, the driver’s airbag inflator could produce excessive internal pressure. If an affected airbag deploys, the increased internal pressure may cause the inflator to rupture. Metal fragments could pass through the airbag cushion material possibly causing injury or fatality to vehicle occupants.

What should you do?

You must have your vehicle’s driver’s airbag inflator replaced; this work will be done free of charge. You must have the inflator replaced even if, earlier this year, you 1) had your vehicle inspected and were told that
the driver’s airbag inflator did not need to be replaced, as we have now determined that the inflator must be replaced, or 2) received a separate driver’s airbag recall notification letter and did not take any action in response to it. In all case, call any authorized Honda dealer and make an appointment to have the driver’s airbag inflator replaced. The replacement process may be completed in approximately 30 minutes; however, your vehicle will need to be at the dealer for a longer period of time. We recommend that you plan to leave your vehicle for half a day to allow the dealer flexibility in scheduling.

Who to contact if you experience problems?

If you are not satisfied with the service you receive from your Honda dealer, you may write to:

American Honda Motor Co., Inc. Honda Automobile Customer Service Mail Stop 500-2N-7A
1919 Torrance Blvd.
Torrance, CA 90501-2746

If you believe that American Honda or the dealer has failed or is unable
to remedy the defect in your vehicle, without charge, within a reasonable period of time (60 days from the date you first contact the dealer for a repair appointment), you may submit a complaint to:

Administrator
National Highway Traffic Safety Administration 1200 New Jersey Ave., SE
Washington, DC 20590

You can also call the toll-free Safety Hotline at (888) 327-4236 [TTY (800) 424- 9153], or go to http://www.safercar.gov.

Lessor Information.

Federal law requires that any vehicle lessor receiving this recall notice must forward a copy of this notice to the lessee within 10 days.

If you have questions.

If you have any questions about this notice, or need assistance with locating a Honda dealer, please call Honda Automobile Customer Service at (800) 999-1009, and select option 4. You can also locate a dealer online at wwwHondacars.com.

We apologize for any inconvenience this campaign may cause you.

Sincerely,

American Honda Motor Co., Inc. | Honda Automobile Division

Campaign #Q96 / Service Bulletin #08-093 the airbag cushion material possibly causing injury or fatality to vehicle occupants.

Appendix 3.3

The Black Box Warning

A black box warning is the sternest warning by the U.S. Food and Drug Administration (FDA) that a medication can carry and still remain on the market in the United States.

A black box warning appears on the label of a prescription medication to alert you and your healthcare provider about any important safety concerns, such as serious side effects or life-threatening risks.

A black box warning, also known as a black label warning or boxed warning, is named for the black border surrounding the text of the warning that appears on the package insert, label, and other literature describing the medication, e.g., magazine advertising. It is the most serious medication warning required by the FDA.

When Does The FDA Require A Boxed Warning?

The FDA requires a black box warning for one of the following situations:

The medication can cause serious undesirable effects (such as a fatal, life-threatening or permanently disabling adverse reaction) compared to the potential benefit from the drug. Depending on your health condition, you and your doctor would need to decide if the potential benefit of taking the drug is worth the risk.

A serious adverse reaction can be prevented, reduced in frequency, or reduced in severity by proper use of the drug. For example, a medication may be safe to use in adults, but not in children.

Or, the drug may be safe to use in adult women who are not pregnant.

What Information Does The FDA Require In The Black Box?

The FDA requires the boxed warning to provide a concise summary of the adverse side effects and risks associated with taking the medication. You and your doctor need to be aware of this information when deciding to start the drug or if you should switch to another medication altogether. Understanding side effects will help you make a better informed decision.

Examples Of Black Box Warnings

The following are examples of black box warnings that have been required for some commonly used medications:

Fluoroquinolone Antibiotics

According to the FDA, people taking a fluoroquinolone antibiotic have an increased risk of tendinitis and tendon rupture, a serious injury that could cause permanent disability. The FDA warning includes Cipro (ciprofloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin) and other medications containing fluoroquinolone. (Warning issued July 2008.)

Diabetes Medications

According to the FDA, people with diabetes taking Avandia (rosiglitazone) have an increased risk of heart failure or heart attack if they already have heart disease or are at high risk of suffering a heart attack. (Warning issued November 2007.)

Antidepressant Medications

According to the FDA, all antidepressant medications have an increased risk of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months). The FDA warning includes Zoloft (sertraline), Paxil (paroxetine), Lexapro (escitalopram), and other antidepressant medication. (Warning issued May 2007.)

What Does A Black Box Warning Look Like?

The following excerpt from the prescription label of Zoloft is an example of a black box warning.

Suicidality In Children And Adolescents

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).

Medication Guides

Along with a black box warning, the FDA also requires a drug company to create a medication guide that contains information for consumers on how to safely use a specific medication. The guides contain FDA-approved information that can help you avoid a serious adverse event.

These guides are meant to be given out by your pharmacist at the time you have your prescription filled. The guides are also available online from the drug company and from the FDA. For example, the medication guide for Avandia (rosiglitazone) is available from GlaxoSmithKline, the manufacturer of Avandia, and from the FDA Center for Drug Evaluation and Research.

If you are concerned that your medication has a black box warning, ask your pharmacist and, if available, obtain a printed copy of the medication guide.

Appendix 3.4

Reporting An Unsafe Product

Taken From The Office Of Compliance Of The Consumer Product Safety Commission:

This chapter contains information to familiarize companies with their reporting obligations under the Consumer Product Safety Act (CPSA). Companies that distribute consumer products subject to the provisions of the Federal Hazardous Substances Act (FHSA), Flammable Fabrics Act (FFA), Poison Prevention Packaging Act (PPPA), and Refrigerator Safety Act (RSA) also must comply with these reporting requirements. The information which follows will help you to recognize potentially hazardous consumer products at an early stage, and will assist you in understanding when you are legally obligated to report information about the product to the Commission.

The information contained in this Handbook does not replace the Commission Statutes or Commission Interpretative Regulations set forth in 16 C.F.R. parts 1115 and 1116. For more information about reporting, see also the Commission’s Statement of Enforcement Policy, 51 FR 23410 (1986) which may be obtained from the Regional Office.

Statutory Requirements | Reporting Under Section 15 Of The CPSA

Section 15(b) of the CPSA defines responsibilities of manufacturers, importers, distributors and retailers of consumer products. Each is required to notify the Commission if it obtains information which reasonably supports the conclusion that a product.

• fails to comply with a consumer product safety standard or banning regulation established by the Commission or a voluntary consumer product safety standard upon which the Commission has relied under section 9 of the CPSA;
• contains a defect which could create a substantial product hazard described in section 15(a)(2) of the CPSA; or
• creates an unreasonable risk of serious injury or death.

The Commission’s interpretative regulation (16 C.F.R. part 1115, as amended following the enactment of the Consumer Product Safety Improvement Act of 1990) explains the company’s obligations and those of the Commission. A copy of the regulations is included with the LOA or will be provided by the Regional Office upon request.

Reporting Products Involved In Lawsuits

In addition to the amendments to section 15 of the CPSA, a new section 37 reporting requirement has been added to the CPSA. This new section requires manufacturers (including importers) of a consumer product to report to the Commission if (1) a particular model of a consumer product is the subject of at least three civil actions that have been filed in Federal or State court, (2) each suit alleges the involvement of that model in death or grievous bodily injury (as defined in section 37(e)(1)), and (3) at least three of the actions result in a final settlement involving the manufacturer or in a judgment for the plaintiff within any one of the two year periods specified in section 37(b). The first two year period began to run on January 1, 1991 and ends on December 31, 1992. The second two year period starts on January 1, 1993; the third, on January 1, 1995; and so forth. Manufacturers must file a report within 30 days after the settlement or judgment in the third civil action to which the section 37 reporting requirement applies.

Why Reporting Is Required

The intent of Congress in enacting section 15(b) and section 37 of the CPSA was to encourage widespread reporting of potential product hazards. Congress sought not only to have the Commission uncover substantial product hazards, but also to identify risks of injury which the Commission could attempt to prevent through its own efforts, such as information and education programs, safety labeling, and adoption of product safety standards.

Although CPSC relies on sources other than company reports to identify substantial product hazards, reporting by companies under section 15 and section 37 provisions is invaluable because firms often learn of product safety problems long before the Commission does. For this reason, any company involved in the manufacture, importation, distribution or sale of consumer products should develop a system of reviewing and maintaining consumer complaints, inquiries, product liability suits and comments on the products they handle.
If a firm reports to the Commission under section 15 of the CPSA, it does not necessarily mean there is a substantial product hazard. Section 15 simply requires firms to report whenever a product (1) fails to comply with a consumer product safety rule; (2) fails to comply with a voluntary standard upon which the Commission has relied; (3) contains a defect that could create a substantial product hazard; or (4) creates an unreasonable risk of serious injury or death. Thus, a product need not actually create a substantial product hazard to trigger the reporting requirement.

When To Report

It is the Commission’s view that a firm should take that all important first step of notifying the Commission when the information available to the company reasonably indicates that a report is required. It is in the company’s interest to assign the responsibility of reporting to someone in executive authority. The individual’s knowledge of the product and the reporting requirements of section 15 and section 37 are valid reasons for assigning the responsibility.

Reporting Procedures

A company is considered to have knowledge of product safety information when such information is received by an employee or official of the firm who may reasonably be expected to be capable of appreciating the significance of that information. Under ordinary circumstances, five (5) days is the maximum reasonable time for that information to reach the chief executive officer or other official assigned responsibility for complying with the reporting requirements. Weekends and holidays are not counted in that timetable.

The Commission will evaluate whether or when a firm should have reported. This evaluation will be based, in part, on what a reasonable person, acting under the circumstances, knows about the hazard posed by the product. Thus, a firm shall be deemed to know what it would have known if it had exercised due care ascertaining the accuracy of complaints or other representation.

If the company is uncertain whether the information is reportable, the firm may elect to spend a reasonable time investigating the matter, but no evaluation should exceed ten (10) days unless the firm can demonstrate that a longer timetable for the investigation is reasonable. If a firm elects to conduct an investigation to decide whether it has reportable information, the Commission will deem that, at the end of ten (10) days, the firm has received and considered all information which would have been available to it had a reasonable, expeditious, and diligent investigation been undertaken.

Penalties For Failure To Report

Failure to report in accordance with the above referenced requirement is a prohibited act under section 19(a) of the CPSA which states: It shall be unlawful for any person to – (4) fail to furnish information required by section 15(b); (11) fail to furnish information required by section 37.

Any person who commits a prohibited act is subject to civil penalties under section 20 of the CPSA, including fines up to $1.25 million for a related series of violations, and criminal penalties under section 21 of the CPSA, which includes fines up to $500,000 or imprisonment not more than one year, or both. Chapter 1 of this Handbook provides additional details regarding the penalties.

… excerpted from the REGULATED PRODUCTS HANDBOOK, U.S. Consumer Product Safety Commission, Office of Compliance, February 1994 – 2nd Edition*

Brought to you by – The ‘Lectric Law Library: The Net’s Finest Legal Resource for Legal Pros & Laypeople Alike, http://www.lectlaw.com

Appendix 3.5

Some Examples Of Recent Product Recalls

May 05, 2016

BRP Recalls Side-by-Side Off-Road Vehicles Due to Loss of Steering Control and Crash Hazard (Recall Alert)
The steering coupling can strip on the rack and pinion assembly and result in a loss of steering control.

May 05, 2016

Munchkin Recalls Latch Lightweight Pacifiers & Clips Due to Choking Hazard
The clip cover can detach from the pacifier’s clip.

May 03, 2016

Cascade Designs Recalls Avalanche Rescue Probes Due to Risk of Suffocation
The lock button on the probe can fail to engage and lock, causing the probe not to function as intended. This can interfere with finding someone buried beneath snow.

May 03, 2016

Walmart Recalls Rival Electric Water Kettles Due to Burn and Shock Hazards

The heating element can fail and rupture, posing shock and burn hazards to the user.

April 29, 2016

Cub Cadet Recalls Challenger Off-Road Utility Vehicles Due To Crash Hazard (Recall Alert)

The parking brake cable can fail, posing a crash hazard.

April 26, 2016

Stile Products Expands Recall of Tern Folding Bicycles Due to Fall Hazard

The bike’s frame can crack at the hinge on the top tube.

April 26, 2016

One World Technologies Recalls Snow Blowers Due to Fire and Burn Hazards; Sold Exclusively at Home Depot

The snow blowers can overheat.

April 26, 2016

Alltrade Tools Recalls Ratcheting Tie Downs Due to Injury Hazard; Sold Exclusively at Sam’s Club

The ratchet handle can fail during use, releasing the secured load, posing an injury hazard to consumers.

US Consumer Product Safety Commission – Excerpts From “Recent Recalls And Product Safety News”

Lacrosse Helmets Recalled by Easton Sports Due to Facial Injury Hazard (Thu, 22 Mar 2012 16:00:00 GMT) The chin bar can break, causing the wearer to suffer a jaw or facial injury.

Adjustable Mattress Bases Recalled by Leggett & Platt Due to Fire Hazard (Thu, 22 Mar 2012 15:00:00 GMT) Electrical components in the motor control board can fail and short causing overheating, which poses a fire hazard.

Safety 1st Cabinet Locks Recalled Due to Lock Failure; Children Can Gain Unintended Access to Dangerous Items (Thu, 22 Mar 2012 11:00:00 GMT) Young children can disengage the cabinet locks, allowing access to cabinet contents and posing the risk of injury, due to dangerous or unsafe items.

Ceiling Fans Recalled by Westinghouse Lighting Due to Shock and Fire Hazards (Wed, 21 Mar 2012 19:45:00 GMT) The two 60-watt light bulbs included with the ceiling fans exceed the fan’s maximum wattage, which can cause the ceiling fans to overheat or fail. This poses fire and shock hazards to consumers.

Bon Hiver Recalls Freebase Snowboard Bindings Due To Fall Hazard (Tue, 20 Mar 2012 14:30:00 GMT) The binding’s base plate can fracture from impact during use, posing a fall hazard to snowboarders.

North American Product Safety Agencies Team Up in the Name of Poison Prevention (Mon, 19 Mar 2012 17:00:00 GMT) As the United States marks the 50th anniversary of National Poison Prevention Week from March 18-24, the U.S. Consumer Product Safety Commission (CPSC) is teaming up with product safety counterparts in Canada and Mexico to call attention to the dangers of unintentional poisoning.

Kawasaki USA Recalls Utility Vehicles due to Fire Hazard (Thu, 15 Mar 2012 14:00:00 GMT) The fuel tube can scrape against the air cleaner housing and develop holes, posing a fire hazard.

Hydrostatic Lawn Tractors Recalled by Hydro-Gear Due to Crash Hazard (Tue, 13 Mar 2012 16:00:00 GMT) A drive gear in the lawn tractor’s hydrostatic transaxle can fail causing brake failure, posing a crash hazard to consumers.
Guidecraft Recalls Children’s Play Theaters Due to Tip-over Hazard (Tue, 13 Mar 2012 15:00:00 GMT) The recalled children’s toys can unexpectedly tip over during play, posing an entrapment hazard to young children.

Umbro Boys’ Jackets with Drawstrings Recalled; Waist Drawstrings Pose Entrapment Hazard; Sold Exclusively at Ross Stores (Thu, 08 Mar 2012 16:30:00 GMT) The boys’ jacket has a retractable elastic drawstring at the waist with a toggle that could become snagged or caught in small spaces or doorways, which poses an entrapment hazard to children.

Lenovo Recalls ThinkCentre Desktop Computers Due to Fire Hazard (Thu, 08 Mar 2012 15:30:00 GMT) A defect in an internal component in the power supply can overheat and pose a fire hazard.

Locker Brand Recalls Rx Lockers Due to Failure Leading to Allowing Unauthorized Access to Medicine Containers (Wed, 07 Mar 2012 18:00:00 GMT) The medicine container can open by applying pressure to the latch when it is locked. This could result in unauthorized access to medicine bottles in the container.

Change Batteries in Smoke and CO Alarms This Weekend (Wed, 07 Mar 2012 17:00:00 GMT) The U.S. Consumer Product Safety Commission (CPSC) is urging consumers to replace the batteries in their smoke and carbon monoxide (CO) alarms this weekend for Daylight Saving Time. This year, Daylight Saving Time begins on Sunday, March 11. Fresh batteries allow smoke and CO alarms to do their jobs saving lives by alerting families of a fire or a buildup of deadly carbon monoxide in their homes.