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Supreme Court to Decide Whether Generic Drugmakers Can Be Sued in State Court

With the cost of prescription drugs increasing each year, generic drugs have become an essential part of the pharmaceutics marketplace. They cost much less than brand name drugs, and are critically important to people on low or fixed incomes, especially older consumers who have health conditions that require continuous pharmaceutical care.

Generics became an option in 1984 after Congress enacted the Hatch-Waxman Act. The law permitted brand name drug manufacturers, such as Pfizer and Bristol-Myers Squibb, to have exclusive rights to a drug for a specified number of years. When the period of exclusivity expired, generic drug makers could petition the federal Food and Drug Administration (FDA) for approval to produce the drugs.

Congress intended to expedite the process of bringing generic drugs to market, so that consumers and health insurers would benefit from competition. It would be crucial for generics to be offered through public health programs such as Medicaid and Medicare. Public safety was equally important, so Hatch-Waxman provided a carefully structured series of processes that regulate production, safety and market entry.

In light of these safety provisions, drug makers have questioned whether the oversight process actually protects them from state tort laws governing defective drugs for failure to warn. Drug makers have a duty to warn consumers of a medicine's potential side effects and to provide detailed instructions regarding dosage. In 2009, Wyeth v. Levine the U.S. Supreme Court ruled in that brand name drug manufacturers were not exempt from state tort laws for faulty drugs or drug use instructions simply by going through the vigorous approval process required by the FDA. Essentially, state law failure to warn claims were not preempted by FDA approval.

Generic drug manufacturers are now facing the same question of whether state law claims are preempted. Through Pliva v. Mensing, a case consolidated with two related matters, Activas Elizabeth, LLC v. Mensing, and Activas, Inc. v. Demahy, the Supreme Court is tasked with deciding whether the same principle of law applies. In each case, the respondents were patients who allegedly developed tardive dyskinesia, a condition that results in involuntary, repetitive tic-like movements, primarily in the face, after taking metoclopramide, the generic form of the drug Reglan. They sued each manufacturer, claiming that the drug's labeling contained insufficient warnings about the risk of tardive dyskinesia; thus violating the manufacturers' duty to warn under state law

The Court accepted the case after the U.S. Court of Appeals for the Fifth and Eight Circuits disagreed on the reasoning for their respective holdings. Both courts found that federal law did not preempt state law claims, but they differed on extent of whether generic labeling could be different from brand name drugs.

The AARP and Public Citizen Legal Group submitted briefs urging the Court to the same reasoning from Wyeth to the present case. Both advocates believe that holding generic makers to a lower standard would punish consumers for choosing generics and would essentially label generics as being less trustworthy than name brand drugs - exactly the opposite of what Congress intended in enacting Hatch-Waxman. They also argue that generic makers are fully capable of managing the costs of post-marketing surveillance and that such costs would not negate the savings enjoyed by consumers.

In oral arguments, the Court appeared to place the onus on drug makers to seek guidance about their labeling, especially during the approval stage before the FDA. According to an article published by the New York Times, several justices said makers of generic drugs could take steps short of changing their labels, including urging the FDA to take action.

''You could propose a revision of the label, and if you did that, then you would be home free,'' Justice Ruth Bader Ginsburg told Jay P. Lefkowitz, a lawyer representing the drug makers. ''You would not be subject to the state suit.''

Justice Sonia Sotomayor seemed to doubt the notion that Congress had intended a two-track system. ''Do you think Congress really intended to create a market in which consumers can only sue brand-named products?'' she asked Mr. Lefkowitz. ''Because if that's the case, why would anybody ever take'' a generic medicine?

A decision in the case is expected this summer. Consumer advocates believe that a verdict applying the Wyeth reasoning would greatly benefit those who rely on generic drugs.

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