Posted Sep 04, 2013 02:10 pm CDT
In June 2013, for the third time in four years, the U.S. Supreme Court dealt with the question of when federal law preempts state tort liability for those injured by prescription drugs. What emerges from these cases is a strange distinction: Those who take the brand name version and are injured may sue, but those who take the generic version are out of luck. All nine justices agree that this is a distinction that makes no sense, but the five justices in the majority say that it must be for Congress to bring rationality to the law in this area.
The first of the trilogy of cases was Wyeth v. Levine in 2009. Diane Levine, a musician in Vermont, went to a hospital emergency room with a severe migraine. She was given Demerol to counteract her pain and Phenergan to lessen the nausea she was suffering. Phenergan is known to be highly corrosive and is supposed to be diluted in a saline solution and given through an intravenous line. Levine, though, was administered the Phenergan via a shot into her vein. Because of Phenergan’s corrosive effect, Levine developed gangrene in her arm, which had to be amputated. She sued the drug company for failing to provide adequate warnings to patients.
Wyeth, the drug company, said that its warning label had been approved by the Food and Drug Administration and therefore a state could not allow recovery; it said that the approval by the FDA preempted any liability under state tort law.
The Supreme Court ruled in favor of Levine, finding that allowing tort liability would further the federal regulatory goal: informing doctors and patients of the dangers of prescription drugs. The court concluded that nothing in federal law precludes drug companies from providing more information, and that allowing drug companies to be sued would further the federal objective of drug safety. Drug companies always can engage in more speech–through advertisements, “dear doctor” letters, and requests to the FDA to change the warning label.
Two years later, in 2011, the court decided Pliva v. Mensing, which involved patients who took Metoclopramide, a drug designed to speed the movement of food through the digestive system. The drug is often prescribed for those with diabetes. The FDA first approved Metoclopramide tablets, under the brand name Reglan, in 1980. Five years later, generic manufacturers also began producing Metoclopramide. Studies have shown that long-term Metoclopramide use can cause tardive dyskinesia, a severe often irreversible neurological disorder which involves involuntary, uncontrollable muscle movements.
The case involved two women who used the drug for a long time and developed tardive dyskinesia. Both women took the generic version of Metoclopramide. They sued the drug manufacturer for failing to provide adequate warnings. The drug company argued that it could not be sued for failing to adequately warn patients because the drug had the warning label that had been approved by the FDA.
The Supreme Court, in a 5-4 decision, held that such suits against the manufacturers of generic drugs are preempted by federal law. By contrast, Wyeth v. Levine differed because it involved a brand name drug. Justice Clarence Thomas wrote the majority opinion and was joined by Chief Justice John G. Roberts and Justices Antonin Scalia, Anthony M. Kennedy, and Samuel A. Alito.
Justice Thomas based his opinion denying relief to the injured women on a federal law, the Hatch-Waxman Amendments, which ironically was meant to protect consumers by making it easier for companies to sell generic drugs. The law says generic drugs may gain FDA approval by showing equivalence to a drug that has already been approved by the FDA. Under the Hatch-Waxman Amendments, warning labels for generic drugs are to be the same as those for the brand name drug approved by the FDA.
The result is that a patient who takes a brand name drug may sue the maker for failure to warn, but the patient who takes a generic version of the same drug may not. Even the majority conceded this made no sense and declared: “We recognize that from the perspective of Mensing and Demahy, finding preemption here but not in Wyeth makes little sense. Had Mensing and Demahy taken Reglan, the brand-name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be preempted. But because pharmacists, acting in full accord with state law, substituted generic Metoclopramide instead, federal law preempts these lawsuits.”
The court then said that despite this irrationality, the plaintiffs were out of luck: “We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing, Demahy, and others similarly situated. But ‘it is not this [c]ourt’s task to decide whether the statutory scheme established by Congress is unusual or even bizarre.’”
In Mutual Pharmaceuticals v. Bartlett, decided in June 2012, the court extended Pliva v. Mensing and found that design defect suits against generic drug makers are also preempted by federal law. Karen Bartlett took a generic form of the prescription pain reliever, Sulindac. She then experiences a horrific side effect, called toxic epidermal necrolysis. About 65 percent of the surface of her skin deteriorated, was burned off, or turned into an open wound. She spent months in a medically induced coma, underwent dozens of surgeries, and is now severely disfigured and is nearly blind. She sued Mutual Pharmaceuticals on a design defect claim and the jury awarded her $21 million.
The Supreme Court held that this claim was preempted by federal law. Justice Alito wrote for the court in a 5-4 decision. The court explained that New Hampshire law requires that manufacturers may not sell drugs, or other products, that are “unreasonably dangerous.” The court said that in the context of prescription drugs it would be necessary to redesign a drug to increase its usefulness or reduce its risk of danger.
But the maker of a generic drug can not redesign it; federal law requires that it must be identical to the brand name version for it to be sold. Therefore, Justice Alito reasoned, the only other way for a generic drug company to reduce the risk would be to strengthen the warning for consumer. Pliva v. Mensing, though, held that generic drug companies may not change the warning label, but instead must include exactly the same warning label approved for the brand name drug.
The result is that makers of generic drugs cannot be sued on a design defect theory or a failure to warn theory. In a dissent, Justice Stephen G. Breyer, who was joined by Justice Elena Kagan, disputed the majority’s contention that it is impossible to comply with both federal and state law. He said that there was a way for the drug company to do this: Cease selling the product in the state or decide to pay the penalty for doing so.
Justice Sonia Sotomayor also wrote a dissent, which was joined by Justice Ruth Bader Ginsburg, strongly objecting to the court extending Pliva to design defect claims. Like Justice Breyer, she said that it was possible for a drug company to comply with both federal and state law. She explained that “a manufacturer of a drug that is unreasonably dangerous under New Hampshire law has multiple options: It can change the drug’s design or label in an effort to alter its risk-benefit profile, remove the drug from the market, or pay compensation as a cost of doing business.”
Pliva v. Mensing and Mutual Pharmaceuticals v. Bartlett mean that makers of generic drugs cannot be sued for failure to warn or for a design defect, no matter how badly the drugs injure people. Yet, according to the FDA, nearly 80 percent of all prescriptions are filled with generic drugs. When there is a generic equivalent to a brand name, greater than 90 percent of the time a generic is prescribed.
Pliva v. Mensing and Mutual Pharmaceuticals v. Bartlett involved the Supreme Court interpreting federal statutes. Congress can remedy this by revising these statutes to make clear that makers of generic drugs can be sued—just like makers of brand name drugs—for claims based on failure to warn or design defects.
Erwin Chemerinsky, Dean and Distinguished Professor of Law, and Raymond Pryke Professor of First Amendment Law at the University of California, Irvine School of Law, is one of the nation’s top experts in constitutional law, federal practice, civil rights and civil liberties, and appellate litigation. He is the author of seven books, the latest being The Conservative Assault on the Constitution (Simon & Schuster, 2010). His casebook, Constitutional Law, is one of the most widely read law textbooks in the country. Chemerinsky has also written nearly 200 law review articles in journals such as the Harvard Law Review, Michigan Law Review, Northwestern Law Review, University of Pennsylvania Law Review, Stanford Law Review and Yale Law Journal. He frequently argues appellate cases, including matters before the U.S. Supreme Court and the U.S. Court of Appeal, and regularly serves as a commentator on legal issues for national and local media. He holds a J.D. from Harvard Law School and a B.S. from Northwestern University.