Reglan Lawsuit: Where Do the Supreme Court Justices Stand?

Richard Burke | April 8th, 2011 | Posted in Reglan Lawsuit News

A US Supreme Court Reglan lawsuit case may bring about far-reaching consequences for the generic pharmaceutical industry and the millions of Americans who take cheap generic medications every day.

The 9-member court isn’t likely to rule on the case of Pliva Inc. v. Mensing until later this summer, but the justices have already made their preliminary opinions known.

Justices share mixed views of Reglan lawsuit liability

Justice Antonin Scalia:

“I don’t see how you can hold them liable,” Justice Scalia said of generic drug companies, which are required by federal law to match the label warnings of generics with the warnings approved for their brand-name counterparts.

Plaintiffs in the Reglan lawsuit say the federal law is superseded by a state law that requires all drugmakers to adequately represent the risks posed by the drugs they manufacture.

“The argument here is whether it will be the FDA ultimately that determines whether there was a grave enough risk to modify the label or whether that call will be made by a state court guessing what the FDA would have done, right?” Justice Scalia said.

Justice Stephen Breyer:

Justice Breyer appeared to side with the plaintiffs involved in the generic Reglan litigation. He addressed Jay P. Lefkowitz, an attorney for the defendants:

“So your argument is that if we run across this tremendous… really serious problem, you’re saying the state has no right to say — even if we purposely didn’t tell anybody — they can’t get involved?”

Justice Sonia Sotomayor:

Justice Sotomayor also appeared to side with the plaintiffs, who have the backing of the Obama administration, the American Medical Association (AMA) and 42 states.

“Do you think Congress really intended to create a market in which consumers can only sue brand-named products? Because if that’s the case, why would anybody ever take a generic? And why in the world would Congress — or even the FDA — create a different obligation on brand-named products than generic products?”

Justice Samuel Alito:

Justice Alito speculated about the consequences of a ruling in favor of the plaintiffs in the Reglan lawsuit.

“Has the FDA made any calculation of the economic consequences of imposing this duty on generic drug manufacturers?” Justice Alito asked. “I don’t know whether this is a good idea or not, but it does seem to me that it may significantly increase the costs for generic drug manufacturers, and therefore counteract one of the objectives of the statute, which was to provide generic drugs at a low cost.”

Generic drugs make up 70 percent of the prescriptions dispensed in America. A decision on the Supreme Court Reglan lawsuit is expected at the end of June.