In most states, it is well established, by statute and/or common law, that a manufacturer’s compliance with government regulations does not automatically insulate them from liability for harm caused by their products.1 In 1995, the U.S. Supreme Court stated that, in general, unless a statute contains clear language that compliance with the statute or regulations thereunder precludes common law actions, compliance with such statute or regulations may be considered as evidence by the trier of fact, but should not act as a bar to tort liability. Freightliner Corp. v. Myrick, 514 U.S. 280, 115 S.Ct. 1485 (1995). This body of law, which protects the rights of consumers to compensation for corporate negligence, is under constant attack from manufacturers who claim that federal safety regulations pre-empt common law. In those instances in which the manufacturers have been successful, not only have the Plaintiffs in those particular cases lost their access to court, but all victims who come after them under similar circumstances have lost opportunities for recourse as well.
The Defense in a Nutshell
Pre-emption is essentially a federalism issue. It deals with the balance of power between different levels of government, more often than not, between the federal government and the states. In the context of products liability, the issues are, generally, whether a federal statutory or regulatory scheme establishing safety standards for different types of products will either trump state safety statutes dealing with the same products, or bar tort claims under state common law. There are two primary kinds of pre-emption: express and implied. The latter is often referred to as “conflict” pre-emption. Express pre-emption occurs when a federal statute or regulation expressly states Congress’ intent that state statutes be pre-empted and/or that tort actions be prohibited. A federal law can also expressly state that it is not intended to pre-empt state law. A state statute or tort action will be impliedly pre-empted if: 1) there is clear evidence of an actual conflict with the federal requirements (an example of such clear evidence would be where it would be impossible for a manufacturer to comply with both the federal requirement and the jury-imposed requirement); or 2) the federal scheme is so pervasive that it is clear Congress intended to “occupy the entire field”; or 3) the state statute or tort action would “frustrate the purpose” of the federal requirements. If a federal statute expressly states that it pre-empts state law, in most cases, the particular claim is extinguished, unless the federal statute also includes a “saving clause” for tort actions. The opposite is not true when a federal statute expressly states it is NOT intended to pre-empt state law. Despite express language, manufacturers can still argue (and have done so with great success) in favor of implied preemption.
Pre-emption of Claims Based on Specific Products Motor Vehicles
An example of a statutory scheme that includes express pre-emption language is the Federal Motor Vehicle Safety Standards (“FMVSS”). The FMVSS includes an express pre-emption provision (15 U.S.C. § 1392(d) (1988 ed.) which states that any safety standard that is not identical to a federal safety standard applicable to the same aspect of performance is pre-empted. However, it also incorporates a “saving clause” which states that “compliance with safety standards is not to be a defense or otherwise affect the rights of parties under common law particularly those relating to warranty, contract, and tort liability.” Public Law 89-563, 89th Congress, S.3005, §§ 108(c), 9-9-66 (emphasis added). Additionally, chapter 15 U.S.C. § 1397(c) provides that compliance with federal regulations “does not exempt any person from liability under common law.”
In spite of the “saving clause”, there are a number of decisions, most of them from federal courts, that have found state laws and state tort actions to be pre-empted by the FMVSS. One victory for manufacturers was the case of Geier v. American Honda Motor Co., 120 S.Ct. 1913, 529 U.S. 861 (2000). Geier was a case in which the plaintiff alleged the vehicle was defective because it was not equipped with an air bag. In Geier, the U.S. Supreme Court stated that the express pre-emption provision in the FMVSS, when read together with the “saving clause”, should be interpreted as expressly pre-empting only state statutes and regulations rather than state tort actions. According to Geier, any state statute, even one that was in harmony with the FMVSS, would conflict with Congress’ intent to provide one uniform set of regulations for motor vehicles and, therefore, would be pre-empted. However, in the absence of an express pre-emption clause, or in a situation like in Geier where the statutory scheme incorporates both an express pre-emption clause and a saving clause, the manufacturer must establish that ordinary “conflict” pre-emption applies. The Court found that Geier’s case was not pre-empted under the express pre-emption provision of FMVSS, but that it did fall under implied pre-emption principles because a decision in favor of plaintiff would have created a direct conflict with FMVSS Standard 208.
Geier was based on a very specific set of facts that do not exist in most cases, and victims’ attorneys should argue vigorously against any expansion of Geier by generalization to different fact situations. The very narrow facts that resulted in the Geier decision included a fifty page policy statement by the National Highway Traffic Safety Administration indicating that the agency deliberately sought a mix of several passive restraints to allow a “phase in” period in which manufacturers could develop better technologies, collect information about the effectiveness of various systems and promote public acceptance of air bags. The Geier Court reasoned that a state court judgment finding Honda’s vehicle defective due to failure to incorporate an airbag would frustrate Congress’ intention to facilitate a “soft” phase in of air bags for safety reasons. The Geier decision is completely dependent on this very specific and narrow policy.
The Geier decision should not be treated as an insurmountable obstacle to all lawsuits claiming that a manufacturer failed to include safety options not specifically required by the FMVSS. In an amicus curiae brief filed by the United States in the Geier case, the United States indicated that a case claiming a vehicle was defectively designed because it did not include antilock brakes would not be pre-empted by 49 C.F.R. §571.105 (1999), the federal safety standard establishing minimum requirements for brake performance. This was also the holding in Freightliner v Myrick, supra. In Freightliner, the U.S. Supreme Court found that the plaintiff’s common law design defect claim based on failure to equip a truck with antilock brakes did not conflict with the federal standard, which was a minimum standard. A number of federal standards themselves indicate that they are intended to create only a floor which should be treated only as a minimum standard rather than as the common law standard of care. With respect to the FMVSS, there is also significant “informal” evidence that NHTSA intended all of the standards established by the FMVSS to establish only minimum standards.
Additionally, it should be remembered that in cases involving federal statutes that give manufacturers an option between different safety devices, failure to choose one over the other is not the only possible theory of liability. In appropriate circumstances, it may be possible to attack the manufacturer’s implementation of the option chosen. Because such a claim would not create a conflict with whatever policy might lay behind the safety standard, such a claim should not be subject to implied pre-emption.
Pharmaceuticals and Medical Devices
Another front on which manufacturers appear to be gaining momentum in their efforts to eliminate tort claims under the pre-emption doctrine is in the area of pharmaceuticals and medical devices. In a March 1, 2004, article in the National Law Journal, author Gary Young stated that the Food and Drug Administration has broken with longstanding tradition and adopted a strategy of pre-emption.2 According to the article, the FDA intervened in two lawsuits, one involving the antidepressant drug Paxil and the other involving a similar antidepressant, Zoloft, in support of manufacturers. In these cases, the FDA argued that public health will suffer if state courts are allowed to “second guess” the agency’s regulatory decisions.3 The FDA and manufacturers did not succeed in having plaintiffs’ claims pre-empted in those cases, however, the FDA has intervened in support of manufacturers of medical devices in two additional lawsuits which are pending. Since one important factor in determining whether a claim should be pre-empted is the intent behind the regulations, having the federal agency responsible for promulgating and implementing regulations openly aligning itself with manufacturers is certainly not a positive development for persons injured by pharmaceuticals or medical devices.
Food Products
In 2003, a products liability lawsuit was permitted to proceed against a meat processor who sold meat contaminated with a bacteria. The court rejected the processor’s pre-emption argument based on the Federal Meat Inspection Act, finding that the plaintiffs’ claims were consistent with the FMIA and since there was no conflict, there was not pre-emption. Estate of Kriefall exrel. Kriefall v. Sizzler USA Franchise, 665 N.W.2d 417 (Wis. App. 2003).4
Pesticides
Two recent failure to warn cases have held that the plaintiffs’ claims were pre-empted by the Federal Insecticide, Fungicide and Rodenticide Act, which contains labeling requirements.5 On the other hand, a plaintiff’s claim that a herbicide had caused property damage, namely the crops on which it was applied, was found not to be pre-empted, because FIFRA does to contain provisions requiring manufacturers to warn of crop damage.6 The law, in this case, provided relief for the victim of property damage but denied it for the victim who suffered personal injuries.
Aircraft
In an interesting compromise position, the District Court for the Northern District of Illinois, in 2003, held that the Airline Deregulation Act, which, according to the court, completely occupies the field of regulation of “rates, routes, and services” for airlines, did not preempt state tort remedies altogether, but did pre-empt state negligence standards. Therefore, the case, which involved a plaintiff who was injured while exiting an airplane, could proceed but the standard of care by which the airline would be measured was the higher federal standard which requires recklessness. Deahl v. AirWisconsin Airlines Corp., 2003 WL 22843073 (N.D. Ill. 2003).
Tobacco
Two recent decisions regarding pre-emption of state statutes regulating tobacco have gone against the tobacco manufacturers. In People ex rel. Lockyer v. R.JReynolds Co., 6 Cal. Rptr. 3d 58 (Cal. App.2003), the court held that a California state statute regarding free distribution of cigarettes was not pre-empted by the Federal Cigarette Labeling and Advertising Act. Although the FCLAA contains an express pre-emption clause for state statutes that deal with advertising and promotion, the court found that distribution of free cigarettes was “sale and distribution”, rather than “advertising and promotion.”
In EmpireState Tavern and Restaurant Assn. v. New York, 289 Fed.Supp.2d 252 (N.D.N.Y. 2003), tavern and restaurant owners claimed that a New York state statute prohibiting smoking in their establishments was preempted by Occupational Safety and Health regulations, which, according to the owners, completely occupied the field of worker exposure to tobacco smoke. The U.S. District Court held that OSHA regulations did not occupy the field. It’s decision was based on a number of factors, including a letter on OSHA’s website in which OSHA stated that it was not ready to issue regulations on workplace exposure to tobacco smoke. This last case underscores the fact that the information needed to defeat a pre-emption attack may be buried in mountains of paper including not only the legislation and implementing regulations themselves, but also legislative history and even such informal information as the letter posted on an agency’s website, or comments by an agency administrator at a seminar.
Florida Case Law
Two important pre-emption decisions involving tobacco products have come from Florida courts. In Liggett Groupv. Engle, 853 So.2d 434 (Fla. 3d DCA 2003), the Third DCA held that federal statutes pre-empted common law claims that selling cigarettes was a tort. In Laschke v.Brown and Williamson, 766 So.2d 1076 (Fla. 2d DCA 2000), the Second DCA held that products liability claims for failure to warn and fraud were barred with respect to all acts that occurred after 1969 when the FCLAA was enacted. However, the court held that the plaintiff’s design defect and misrepresentation claims were not pre-empted. Unfortunately, the Second DCA provided no analysis of its decision, so this case has limited precedential value.
In a decision that has not yet been released for publication, the Fourth DCA held that, where a case boils down to a claim that a pesticide label failed to warn of the injury suffered by the plaintiff, it will be preempted by the express pre-emption clause in FIFRA. E.I.DuPont Du Nemours v. Aquamar, S.A., So.2d , 29 FLW D811 (Fla. 4th DCA 3-31-04). The court stated that the express pre-emption clause in FIFRA, which prohibits states from imposing any requirements for labeling or packaging in addition to or different from those required under FIFRA, has been interpreted as prohibiting state common law causes of action based on failure to warn through its label. Aquamar, citing, In re DuPont- BenlateLitig., 859 F.Supp. 619, 622 (D.P.R.1994); and ISK BiotechCorp. v. Douberly, 640 So.2d 85, 88 (Fla. 1st DCA 1994).
On March 27, 2003, the Supreme Court of Florida made an important pre-emption decision which, while it was in a medical malpractice case rather than a strict products liability case, could have important implications for products liability cases, as well. Villazon v. PrudentialHealth Care Plan, Inc., 843 So.2d 842 (Fla. 2003). In this case, the Court quashed in part and remanded in part a Fourth DCA decision holding that a plaintiff’s claim for negligence for failing to provide, arrange for or supervise qualified doctors to provide medical treatment for plan participants was pre-empted by the Employee Retirement Income Security Act. The Supreme Court in Villazon held that a state law wrongful death claim against an HMO, based on vicarious liability for medical negligence of its member physicians, does not “relate to” administration of the ERISA plan and, therefore, is not pre-empted by ERISA. The court further held that ERISA did not preempt claims concerning negligent failure to provide adequate medical treatment.
This article contains only a small sampling of recent cases on pre-emption. A pre-emption challenge calls into play a very large and complex body of case law, in addition to the sea of information necessary to prove legislative intent with regard to a major regulatory scheme. Manufacturers are fighting these battles all over the country everyday, and they enjoy a base of knowledge and experience that most victim’s attorneys cannot match. Considering the success they have had so far, it is certain that pre-emption issues in products liability cases will continue to vex victims’ attorneys well into the future.
Before you find yourself up against a serious threat of having claims dismissed on pre-emption grounds, seek out support from attorneys with experience fighting these claims. Two good places to start would be the Academy of Florida Trial Lawyers and Trial Lawyers for Public Justice (www.tlpj.org). TLPJ offers information packets with pre-emption briefs and decisions and, in important cases, they may submit amicus curiae briefs.
In addition to these organizations, since pre-emption is essentially an issue of federalism and states rights, consider whether the state has an interest in the outcome of your case, and therefore, might be a potential source of support. For example, if pre-emption of the claims in your case could unconstitutionally infringe on the state’s ability to protect the interests of its citizens, or would shift the burden of paying for corporate negligence from the manufacturers to the state, you may find the state to be a formidable ally, particularly if the claim is that a state statute, as opposed to common law tort claims, is pre-empted.
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1 While it is still clear in many states that compliance with government regulations is nothing more than evidence of a lack of negligence, statutes have popped up in various states, including Florida, stating that compliance with government regulations creates a “presumption of no defect.” F.S. §768.1256. It can and should be argued that this statute creates a “bursting bubble” presumption that, once Plaintiff has come forth with some evidence of negligence, bursts and disappears from the case. To the extent it is argued that this presumption is a conclusive presumption, it should be attacked on constitutional grounds.
2 FDA Strategy Would Pre-empt Tort Suits, The National Law Journal, March 1, 2004.
3 Motus v. Pfizer, Inc., 358 F.3d 659 (9th Cir.Cal. 2004); In re Paxil Litigation, 218 F.R.D. 242 (C.D. Cal. 2003)
4 Estate of Kriefall ex rel. Kriefall v. Sizzler USA Franchise, Inc., 665 N.W.2d 417 (Wis. App. 2003).
5 Eyl v. Ciba-Geigy Corp., 650 N.W.2d 744 (Neb. 2002); Dow Agrosciences LLC v. Bates, 332 F.3d 323 (5th Cir. 2003).
6 American Cyanamid Co. v. Geye, 79 S.W.3d 21 (Tex. 2002).
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