The idea of preemption is rooted in the Supremacy Clause of Article VI of the United States Constitution. When a manufacturer is sued for personal injuries attributable to its product under state law, there is a good chance the manufacturer will assert federal preemption as a defense to the plaintiff's claims. In many of these cases, the manufacturer will argue that a federal statute or regulation regarding the product at issue trumps the plaintiff's state's statutory standard or prevents any state common law tort action. Such preemption exists essentially in two forms: express and implied.
Express preemption is found where the very language of a federal statute or regulation expressly states that actions under state law may not go forward with respect to the subject-matter being regulated. An express preemption clause without more will be grounds for dismissal of the plaintiff's state claims. There is also implied preemption where although the federal statute does not expressly preempt any state statutory or common law, judicial analysis reveals a conflict exists where it would be impossible for a manufacturer to comply with both federal and state requirements or where the state law stands as an obstacle to the accomplishment of a Congressional or federal agency purpose or goal. Implied preemption is also found where the federal statute or regulation is so pervasive that courts have determined that Congress has intended to "occupy the entire field" with regard to regulation of the particular issue.
Many Supreme Court decisions have begun their analyses with the standard that there is a "presumption against preemption," especially where the federal law is seeking to regulate an area traditionally regulated by the states, such as the areas of health and safety; however, whether this presumption holds true largely relies on – much to the chagrin of critics – whether the case involves a question of express or implied preemption. The United States Supreme Court has been shaping preemption over the last twenty years as more and more manufacturers have come to rely upon the doctrine as a defense to state law claims and a means to prevent injured plaintiffs from having their day in court.
What the Supreme Court has decided has greatly influenced state court decisions so it is important for your attorney to understand the precedent in order to put forth and argue alternative claims that have not already been held to be preempted. Further, it's important to keep in mind that many of the Supreme Court decisions are based on narrow sets of facts that should be distinguished wherever possible. While it is difficult to determine how courts decide particular preemption issues due to the many seemingly contradictory holdings throughout the relevant jurisprudence, a close look at the different nuances of each opinion allows Arnold & Itkin LLP to formulate plan as to what causes of action to bring and what arguments to make in the face of a preemption defense.
The following cases provide just a sample of how the Supreme Court has come out on both sides of the same or very similar issues:
Geier v. American Honda Motor Co.
Geier involved a state negligence and defective design suit against Honda and whether the case could be brought for injuries resulting from Honda's failure to install airbags in the particular vehicle driven by the plaintiff. In assessing whether the suit could properly go forward, the court applied a three-part inquiry to the regulation at issue. The court first asked whether the regulation's express preemption provision preempted the state tort suit. The language of the applicable statute said that no state could establish or continue in effect any safety standard applicable to the same aspect of performance of a motor vehicle or item of equipment which was not identical to the federal standard. This language alone would have foreclosed the issue; however, the court found a saving clause in the statute which stated that compliance with the federal standard did not exempt any person from liability under common law. The court concluded that the presence of the saving clause made it clear that Congress did not intend for state common law actions to fall within the scope of the express preemption clause.
While the saving clause removed tort actions from the cover of the express preemption clause, the court asked its second question: does the saving clause foreclose or limit the operation of ordinary preemption principles insofar as those principles require preemption of state law where those laws actually conflict with the federal statute or regulation? The Court simply held that it did not, pointing to longstanding principles developed throughout the Court's preemption jurisprudence. The third question remained: whether the state action actually conflicted with the federal regulation.
The Court found that the federal regulatory objective set forth by the Department of Transportation aimed to give auto manufacturers leeway in choosing among different passive restraint systems for use in their vehicles. The DOT was also mindful of possible public backlash from mandating airbags in all vehicles since airbags were a novelty at the time. The court looked to the history of and the agency's explanation for the regulation which showed a desire to phase in passive restraint systems in order to allow manufacturers time to improve airbag technology and develop better systems. The purpose was not to produce a minimum standard for manufacturers to follow but rather to promote the creation of safer and more diverse restraint mechanisms. Consequently, the court held that allowing a state tort suit to go forward would stand in the way of the accomplishment of these goals.
Williamson v. Mazda Motor of America, Inc.
Following Geier, virtually all defective design suits regarding seat belts and airbags filed in state courts were dismissed as preempted by federal regulation applicable to passive restraint systems. However, the Supreme Court recently took up the issue again in Williamson, a strict products liability, negligence, and wrongful death action against Mazda. The family and estate of the decedent claimed that the absence of a lap-and-shoulder belt in the inner rear seat where the decedent was sitting caused her death as it would have prevented the fatal injuries sustained through use of the lone lap belt. The California state and appellate courts dismissed the claims as preempted since the matter seemed to be settled under the holding of Geier. Surprisingly, the Supreme Court granted certiorari to hear the case.
In an 8-0 decision (Justice Kagan did not participate), the court unanimously held that the claims against Mazda were not preempted by the same statute which preempted the claims in Geier. Under the third prong of the three-part inquiry, the Court found that the desire to promote a variety of safety restraint systems and to continue the innovation of safer and more accepted mechanisms was not the primary objective of the DOT in the case of allowing auto manufacturers to choose either lap-only or lap-and-shoulder belts in the rear inner seats. Neither did there exist any other important goals of the regulation that risked frustration by the pursuit of state law claims. The court found that although the regulation left manufacturers with the choice of installing either lap-and-shoulder belts or lap-only belts in inner rear seats, in this case such availability of choice was not a significant regulatory objective.
Under the 1989 regulation at issue in Williamson, the DOT mandated that manufacturers install lap-and-shoulder belts in rear outer seats, but did not require the same for inner rear seats. A look at the history of and the agency's explanation for the regulation revealed that the DOT was not concerned about promoting innovation of a diverse mix of safety restraints; rather, it was more concerned with the costs that would be imposed on manufacturers as installation of lap-and-shoulder belts in inner rear seats was at that time more expensive than installation of the same belts in the outer rear seats.
However, the Court found that this judgment regarding cost-effectiveness was not indicative of a desire by the DOT to preempt state law claims as holding otherwise would render all regulations inspired by cost-effectiveness judgments to be maximum standards prohibiting any state attempt to require stricter requirements, thus foreclosing the possibility that the federal agency sought only to set forth a minimum standard that could be supplemented by state law.
The DOT encouraged installation of inner rear seat lap-and-shoulder belts and pointed out the fact that costs have diminished as more and more manufacturers installed such belts—which today are almost the universal standard—in the rear inner seats of their vehicles. Finally, even the DOT admitted that the regulation did not preempt state law, a view to which the court gave deference. The holding in Williamson can be said to clarify Geier in that when there is an important goal that the DOT regulation seeks to achieve while giving manufacturers a choice, the state law will be preempted because it holds manufacturers liable for doing what the regulation seeks to achieve. Since most safety features in vehicles today are pretty much universally available and accepted, future reliance on Geier will very rarely be successful.
Wyeth v. Levine
The 2009 case of Wyeth v. Levine held that state failure-to-warn claims against brand-name manufacturers were not preempted by federal labeling duties set forth by Congress and administered by the Food and Drug Administration. In that case, the plaintiff lost her forearm to amputation after an IV-push of the brand-name drug Phenergan was accidentally injected into her artery, causing irreversible gangrene. The Vermont Supreme Court affirmed a jury verdict finding that the injury would not have occurred if Phenergan's label included an adequate warning regarding the IV-push method of administering the drug. The defendant-manufacturer argued the failure-to-warn claim was preempted for two reasons: 1) it is impossible to comply with both state law duties to warn and federal labeling duties, and 2) requiring it to comply with a state duty to provide a stronger warning label would obstruct Congress' purpose of entrusting the FDA with all drug labeling decisions. The court rejected both these arguments.
The court found the FDA's "changes-being-effected" regulation allowed the manufacturer the ability to unilaterally strengthen its warnings regarding the IV-push method. Had the manufacturer utilized the CBE regulation to strengthen its labels, it would have simultaneously fulfilled its state law duty to adequately warn. While such CBE changes would ultimately have to be approved by the FDA, the fact that the FDA could have rejected such changes was unpersuasive to the court. Further, the court was unmoved by the manufacturer's argument that compliance with state law would have stood as an obstacle to Congress' objectives. There was no Congressional authority in this case given to the FDA to preempt state law directly; in other words, there was no force of law or any persuasive facts giving merit to the assertion that state law was an obstacle to achieving Congress' statutory objectives.
PLIVA v. Mensing
In comparison to Wyeth, the court came to the opposite conclusion in Mensing where the drug at issue was a generic brand. Under current FDA regulations, a generic drug manufacturer can gain FDA approval by showing that its drug is equivalent to an already-approved brand-name drug and that the safety and efficacy labeling proposed for the drug is the same as that approved for the brand-name. Due to this simplified approval process for generic drugs, generic drug manufacturers may not unilaterally change or strengthen their labels' warnings through the CBE process.
Doing otherwise would violate the federal requirements because then the generic labels would no longer match their brand-name counterparts. Accordingly, the defendants argued, compliance with a state law duty to strengthen the labels would be in direct violation of the federal regulations, making it impossible to comply with both laws. As such, the federal regulation would preempt state law.
The plaintiffs argued that while generic drug manufacturers could not utilize the CBE process, they were permitted to propose label changes to the FDA when stronger labels were needed. If the FDA agreed that the existing labels were inadequate, it could initiate a change to the brand-name labels, triggering a corresponding change in the generic labels. At such point, a generic manufacturer would be in full compliance with both federal and state law.
As the dissent pointed out, the generic manufacturer could have also taken its product off the market completely until the changes were made and be in compliance, although this argument was not brought up. A 5-4 majority however rejected that argument, saying that state law required a safer label, not communication with the FDA about the possibility of a safer label. The court held that when a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes.
About 75% of all prescription drugs filled are generics. The Mensing decision dealt a major blow to consumers and exemplifies a major shift from the presumption against preemption. There is no doubt that alternative claims such as defective design, breach of express and implied warranty, and other alternative state tort claims will be asserted in state courts throughout the country, only to be met by preemption challenges from defendants.
If you would like to learn about preemption and how it can affect your case, it is highly encouraged that you do not hesitate to consult with an experienced medical injury lawyer from Arnold & Itkin, LLP as soon as possible. With extensive experience in handling pharmaceutical litigation, we have the experience that you need to take on even the most complex of cases.
Contact Arnold & Itkin today to discuss your case!