‘Impossible’ Logic: Supreme Court Ruling Could Threaten Safety of Generic Drugs

June 24, 2011
Guest Post

By Elizabeth B. Wydra, Chief Counsel, Constitutional Accountability Center. This analysis is cross posted at CAC’s Text & History blog.


Two years ago in Wyeth v. Levine, the Supreme Court refused to allow federal food and drug law to displace state consumer-safety law.  Instead, the Court held that Diana Levine, a Vermont musician whose arm had to be amputated after Levine suffered adverse effects from Wyeth’s brand-name drug, Phenergan, could hold the drug manufacturer liable under state failure-to-warn laws—laws which hold drug and other manufacturers responsible for inadequate safety labels.  Yesterday, in a 5-4 ruling, the Supreme Court held in PLIVA, Inc. v. Mensing that generic drug manufacturers may not be sued under state failure-to-warn law because it would be “impossible” for the generic drug manufacturers to comply with both state failure-to-warn law and federal law.  Given the nearly identical storylines, how did the Supreme Court come up with a happy ending for consumers in Wyeth but a happy ending for big business in PLIVA?

To be sure, there are important differences between the labeling laws for brand-name and generic drugs.  Federal law, for example, requires a generic drug to carry the same label as the brand-name drug it replicates.  But this “duty of sameness” for generic manufacturers is tempered by a duty under federal law to report problems with generic drugs.  So, while generic drug manufacturers cannot unilaterally change their labels, they can—and must—approach the FDA to seek to revise a drug’s label when they have reasonable evidence of a serious problem with the drug.  Such a label change would then go into effect for both brand-name and generic drugs. There is no guarantee, of course, that the FDA will act based on the information provided by the generic drug manufacturer, but the manufacturer’s attempt to achieve a safe and adequate warning label would nonetheless likely serve as a defense to state liability.  In other words, if the generic manufacturer did what it could under federal law, a state failure-to-warn claim should be preempted by federal law because it would be impossible for the manufacturer to comply with both federal and state law.

But if a generic drug manufacturer doesn’t even try to comply with federal drug safety law and state failure-to-warn standards, it is difficult to see how it is “impossible” for the manufacturer to comply with both sets of laws.  As Justice Sotomayor explained in her PLIVA dissent, “because federal law affords generic manufacturers a mechanism for attempting to comply with their state-law duties to warn, . . . federal law does not categorically pre-empt state-law failure-to-warn claims against generic manufacturers.”  

For the majority, led by Justice Thomas, to find impossibility preemption in this context is to twist the word “impossibility” beyond recognition.

The majority’s conception of impossibility is not the only part of the PLIVA ruling that doesn’t make much sense.  As Justice Sotomayor emphasized in her dissent as well as when the case was argued before the Court, Congress could not possibly have intended for a consumer’s rights against a drug manufacturer over an inadequately labeled drug to turn on the serendipity of how a pharmacist fills a prescription.  As Justice Sotomayor observed, under the Court’s ruling in PLIVA, if a doctor prescribes a brand-name drug to a patient but the pharmacist lawfully dispenses a lower-priced generic drug as an alternative, a claim by the patient against the generic drug manufacturer is pre-empted—but if the pharmacist fills the prescription with a brand-name drug, a claim by the patient against the brand-name drug manufacturer is not pre-empted.  This is an absurd result for America’s consumers.

It also interferes with the long-standing partnership between state and federal law on consumer safety.  In Wyeth, the Court recognized that “state law offers an additional, and important, layer of consumer protection that complements FDA regulation.”  With the majority’s opinion in PLIVA, as Justice Sotomayor pointed out in her dissent, this additional layer of consumer protection is now gone for generic drugs.  It is true that brand-name drug manufacturers will continue to have an incentive based on state-law liability to monitor and disclose drug safety risks, but many brand-name manufacturers leave the market once generic drugs are introduced. Given that more than 70% of prescriptions filled in the United States are filled with generic drugs, and that about a third of generic drugs have no brand-name competitors, this is no small thing.

State common law claims should be allowed to work in conjunction with FDA oversight, as neither the Constitution nor the principles behind it support displacing the States’ traditional role in protecting consumer safety and health in the absence of a direct conflict between state and federal law.  The federal Food, Drug and Cosmetic Act (FDCA) preserves state tort remedies as a complementary form of consumer protection.  While the FDCA has been amended to encourage development of low-cost generic drugs, there is nothing in the statutory text of these amendments to suggest that the amendments were intended to override the FDCA’s general preservation of state tort remedies.

Unfortunately, not only does the logic behind the majority’s opinion make little sense, but the opinion has the potential to be quite dangerous as well. See CAC’s brief in PLIVA here.

[image via Wikimedia Commons]