How Can We Help?
Chapter Three | 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
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, 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.
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.
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.
- Find a product that features some form of risk associated with its use. What makes its warning sufficient/adequate?
- In Thomas v. Winchester, was the product inherently dangerous? Is the defendant liable?
- Should states require warnings about obvious dangers due to overriding public policy considerations?
- 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.
- Is the physician liable?
- Is the manufacturer?
- How did the duty to warn factor into the defects associated with Firestone tires?
- 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 defendant’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 refined petroleum distillates. May be harmful if swallowed, especially by children.
- Was the warning sufficient?
- Does the doctrine of reasonably foreseeability apply? If so, how?
- Is Boyle-Midway Inc. liable?
- Why were certain parties excluded from receiving any of the damages?
Appendix 3.1: OTC Drug Facts
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.
Here is an example:
More in Information for Consumers (Drugs)
Educational Resources: Free Drug-Related Publications:JumpStarting Drug Review
Questions & Answers
Buying & Using Medicine Safely
Antibiotics and Antibiotic ResistanceBuying Medicines Over the InternetBuying Medicine from Outside the United StatesCounterfeit MedicineEnsuring Safe Use of MedicineUnderstanding Generic DrugsMisuse of Prescription Pain RelieversUnderstanding Over-the-Counter MedicinesMedication Health FraudTips for Seniors
Tips for Parents
Prescription Drug Advertising
Background on Drug AdvertisingBasics of Drug AdsDrug Advertising: A Glossary of TermsPrescription Drug Advertising: Questions and AnswersPrescription Drug Advertising: Questions to Ask YourselfSample Prescription Drug AdvertisementsGive Us Feedback
“Protecting America’s Health Through Human Drugs”
Page Last Updated: 06/05/2015; accessed 5/5/16
Appendix 3.2: Recall Letter
December 2011 NHTSA Recall 11V-260Safety 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 ServiceMail Stop 500-2N-7A1919 Torrance Blvd.Torrance, CA 90501-2746If 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:AdministratorNational Highway Traffic Safety Administration1200 New Jersey Ave., SEWashington, DC 20590You 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 option4. You can also locate a dealer online at www.Hondacars.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 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:
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.)
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.)
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).
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.
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.
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.