Chapter Five | Unavoidably Dangerous Products, Negligence Per Se, and Preemption

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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.


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…


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.


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.


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.


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.


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.


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.


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.


  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

Posted in Chapters 1 - 5.