The 2008-2009 Supreme Court Term: (2) Preemption of Drug Warning Claims

     This year in Wyeth v. Levine the Supreme Court will decide whether or not people can sue a drug manufacturer under State law when the label for the drug is misleading or insufficient.  The drug manufacturers contend that these lawsuits are preempted by the Federal Food, Drug, and Cosmetic Act (FDCA). 

     The plaintiff, Diana Levine, lost her arm after she was injected with the drug Phenergan by means of an "IV push."  She sued Wyeth, the manufacturer, because the instructions for use of Phenergan published by the manufacturer stated that IV injection of the drug was a permissible use of the drug even though there would be a risk of gangrene in the case of accidental arterial injection.  Levine contended that the instructions were negligent because they should have utterly prohibited injection by means of IV push.  The Vermont jury agreed with Levine and awarded her $7.4 million in damages.  Wyeth's defense was that the Food and Drug Administration approved and even required these instructions, and that the decision of the federal agency should preempt state law (the state law of negligence) and prevent a recovery.

     When a state law conflicts with a federal law the state law it is said to be "preempted" – it is invalid, unconstitutional – under the Supremacy Clause of the Constitution, which 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, any thing in the laws or constitution of any state to the contrary notwithstanding."

The concept of preemption has been a bedrock principle of constitutional law since Chief Justice John Marshall's decisions in McColloch v. Maryland  (1819) and Gibbons v. Ogden (1824) upholding the right of the federal government to preempt state laws that conflict with federal laws and policies. 

     In civil rights cases liberals normally champion national power and conservatives celebrate states' rights, but in the area of business regulation laws it is the reverse – in these cases conservatives support federal preemption of state laws while liberals oppose preemption.  In particular, liberals on the Supreme Court vote to uphold state court lawsuits against manufacturers of dangerous products, while conservatives are more likely to find such lawsuits to have been preempted by federal statutes.

     One of the most significant cases where the Supreme Court found state tort claims to have been preempted by a federal statute was Cipollone v. Liggett Group (1992), where a plurality of the Supreme Court applied the principle of preemption to close off state common law tort claims against a cigarette manufacturer.  The plaintiffs in that case were a smoker who had contracted lung cancer and her husband.  They sued the cigarette manufacturer on a number of theories including fraud and negligent failure to warn under state law.  The Supreme Court ruled that all of the plaintiff's causes of action except fraud were preempted by the Public Health Cigarette Smoking Act of 1969, which required various warnings to appear on the labels and advertising of cigarette products, and which further provided:

"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 [lawfully] labeled."

     Earlier this year the Supreme Court decided another preemption case, Riegel v. Medtronic (2008).  The plaintiff in that case was a cardiac patient who sued the manufacturer of a balloon catheter used in his angioplasty, asserting various theories under state tort law including negligent design.  In an 8-1 decision, the Supreme Court ruled that the plaintiff's claims were preempted under the language of the Medical Device Amendments of 1976, 21 U.S.C. § 360(k)(a), which provides that

[A State shall not] "establish or continue in effect with respect to a device intended for human use any requirement-… (1) which is different from, or in addition to, any requirement applicable under [federal law] to the device, and … (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under" [relevant federal law].

     The difference between the Wyeth case and Riegel v. Medtronic and Cipollone v. Liggett Group is that in those earlier cases the federal statutes expressly provided that state law was prohibited from prescribing any different or additional legal requirements on the defendants.  In contrast, in the Wyeth case, the defendant must argue that the federal law implicitly prohibits the State of Vermont from imposing any additional or different labeling requirements on drug manufacturers. 

     Preemption cases are guided and determined by one bedrock principle – "Did Congress intend to preempt State law?"  The principal question that the Supreme Court has to answer is whether Congress intended to make the approval process of the Food and Drug Administration final and unassailable, or whether Congress regarded the F.D.A. as only the first line of defense against unsafe pharmaceutical products.

     It is possible, but by no means certain, that the Supreme Court will reverse the jury's verdict and find in favor of the drug manufacturer in this case.  If the Supreme Court reverses the verdict in favor of the Levine it would represent a broad expansion of federal preemption over state torts claims exemplified in Cipollone and Riegel .

Tagged as: Cipollone, constitutional law, preemption, Riegel, Torts, Wyeth v. Levine