Supreme Court debates whether generic drug companies are exempt from state liability suits based on design flaws

WASHINGTON -  The Supreme Court justices questioned, discussed and debated Tuesday morning about whether a Philadelphia drug company, Mutual Pharmaceutical Co., was liable for injuries suffered by a New Hampshire woman who took the company's generic painkiller sulindac in 2004 and suffered horrific injuries.

"No warning label would have made a difference," attorney David Frederick argued on behalf of Karen Bartlett, who had a rare reaction to the medication in which her skin essentially sloughed off and she was left mostly blind. A federal jury awarded her $21 million in a case originally filed in state court.

Much of the debate was about when and whether federal law trumps state law and, specifically, whether a generic drug company can be sued in state courts over alleged design flaws in a drug.

Mutual, which is now owned by Sun Pharmaceutical Industries of India, asked the Supreme Court to overturn the jury verdict and the decision by the Boston-based U.S. Court of Appeals for the First Circuit, which upheld the verdict on Bartlett's claims of product design flaws.

A decision is likely before the high court's term ends in June.

Mutual's attorney, Jay Lefkowitz, argued that FDA rules say generic manufacturers must follow the formulation and label of brand-name drugs and by doing so, Mutual should not be liable.

But brand-name drug companies are backing Mutual in this case, hoping for greater protection from liability suits in state courts.

"We're not really dealing only with generics are we," Justice Elena Kagan asked Lefkowitz, "They are all in the same boat."

Government attorney Anthony Yang spoke up for the FDA and its support of Mutual, in this case, stressing the need for conformity to FDA regulations.

With that idea in mind, Justice Samuel Alito asked, "What if 49 states passed a law that says you have to drive on the right side of the road, but New Hampshire passes a law saying you have to drive on the left?

A key point of debate Tuesday was how this case might differ from a Supreme Court decision in 2011 in Pliva v. Mensing. In that case, a very divided court decided that generic companies can't be sued in state courts over failure-to-warn allegations.

But it was a 5-4 decision. And though Justice Anthony Kennedy voted with conservatives Alito, Clarence Thomas, Antonin Scalia and Chief Justice John G. Roberts, Kennedy did not agree with part of Thomas' majority opinion. Ruth Bader Ginsburg, Sonia Sotomayor, Stephen G. Breyer and Kagan voted the other way.

A link to the opinions in Pliva v. Mensing is here.