Please ensure Javascript is enabled for purposes of website accessibility

Generic drug makers argue for federal pre-emption

WASHINGTON — Two years after the Supreme Court ruled that state law failure-to-warn claims against brand-name drug makers are not automatically pre-empted by federal law, the justices are considering whether that same rule applies to generic drug makers.

The generics claim a different standard should apply because, unlike the brand-name companies, they are not permitted to revise the labels their packages carry.

Federal law “requires generic drugs to have the same warnings as their brand-name equivalents, so state law can’t require generic drugs to use different warnings,” Jay P. Lefkowitz, a senior litigation partner in the New York City office of Kirkland & Ellis, told the court at oral arguments Wednesday.

Justice Ruth Bader Ginsburg asked if generic drug makers had other options.

“You could propose a revision of the label [to the FDA], and if you did that, then you would be home free,” Ginsburg said. “You would not be subject to the state suit.”

Justice Sonia Sotomayor added that the companies have “a legal obligation to advise the FDA when you have reports of adverse results that suggest the label may be wrong.”

“Are you disavowing your obligation to tell the FDA when something’s wrong?” Sotomayor asked.

No, Lefkowitz said, but pointed out that “disclosure obligations are up to the FDA with its discretion to enforce.”

Ginsburg, though, noted that the FDA itself supports state-tort liability because it “encourages manufacturer to report.”

Lefkowitz was arguing on behalf of three makers of metoclopramide, the generic version of the diabetes drug Reglan. The companies have been sued by plaintiffs who claim the label should have included stronger warnings of the risk of tardive dyskinesia, a severe neurological movement disorder.

The 8th U.S. Circuit Court of Appeals allowed the claims to go forward based on the high court’s 2009 ruling in Wyeth v. Levine.

“Counsel, do you think Congress really intended to create a market in which consumers can only sue brand-named products?” Sotomayor asked. “Because if that’s the case, why would anybody ever take a generic?”

Congress intended to create a system to give patients faster access to lower-cost generics and therefore gave “branded and generics different obligations,” Lefkowitz replied.

Question for the FDA or juries?

Louis M. Bograd, senior litigation counsel for the Center for Constitutional Litigation in Washington, argued that the drug companies, “in the face of considerable information that the warnings on their products were inadequate, did nothing.”

Justice Antonin Scalia asked who was best suited to make the call about drug labeling adequacy — the FDA itself or “a state court guessing what the FDA would have done.”

“This court said in Wyeth v. Levine … that state juries are a perfectly appropriate vehicle for assessing whether warnings in the past were adequately given,” Bograd said.

Justice Stephen Breyer tried to determine how far a company’s duty extends.

“Imagine a company that files every adverse incident report. Complies completely. Period,” Breyer said. “Now, in your view does it have an additional obligation?”

“It has the obligation to initiate a label-change process,” Bograd said. With thousands of drugs to monitor, the agency can’t know when a label change is needed unless companies give a heads up, he said.

Deputy Solicitor General Edwin S. Kneedler argued, as amicus in support of the patients, that federal law does not “absolve a manufacturer of his responsibilities [to] maintain the safety of the drug and the adequacy of the label.”

“I assume the patient’s physician has the same opportunity” to report problems to the FDA, Scalia said. “Anybody could go to the FDA and say a label ought to be changed, right?”

Federal law “does not regulate the responsibilities of physicians in those situations,” Kneedler replied.

The case is PLIVA Inc. et al. v. Mensing, 09-993. The justices are expected to rule before the term closes in June.

Lawyers USA is a sister publication of The Daily Record.