A drug by any other name? U.S. Supreme Court considers if generic drug suits are preempted

By Kimberly Atkins

The Daily Record Newswire

BOSTON, MA -- Two years after the U.S. Supreme Court ruled in Wyeth v. Levine that state law failure-to-warn claims against brand-name drug makers are not automatically preempted by federal law, the justices are considering whether that same rule applies to generic drug makers.

The plaintiffs in PLIVA. v. Mensing and consolidated cases allege that the makers of the drug metoclopramide, the generic version of the diabetes drug Reglan, should have amended its label to include stronger warnings of the risk of tardive dyskinesia, a severe neurological movement disorder.

After the 8th Circuit ruled that the plaintiff's failure-to-warn claims could go forward, the three manufacturers of the drug sought certiorari, urging the Supreme Court to hold that failure to warn claims should be preempted because drug makers are prohibited from varying the labeling of generic drugs from that of their brand-name counterparts. Although the Court has held that failure-to-warn claims against brand-name drugs are not preempted, because general drug manufacturers have less control over labeling the companies argue they should not be bound by that ruling.

The Supreme Court agreed to hear the case.

'We can't change the label'

Jay P. Lefkowitz, a senior litigation partner in the New York City office of Kirkland & Ellis, argued for the drug makers that 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."

But 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."

Even so, Lefkowitz said, "we can't change the label" -- only the FDA can.

When Lefkowitz argued that subjecting generic drug makers to state tort liability would conflict with federal rules, Justice Sonia Sotomayor pointed out 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.

"Any time a generic learns about an adverse report, it has to report it to the FDA," Lefkowitz said. "But when a company doesn't make appropriate disclosures to the FDA, even if people are hurt by that, [those] disclosure obligations are up to the FDA with its discretion to enforce."

Ginsburg pointed out that the FDA itself supports state tort suits "because they give the manufacturers an incentive to come forward."

"Everyone is interested in making sure that only safe drugs are marketed, [and state tort liability] encourages manufacturer to report," Ginsburg said.

Lefkowitz said the FDA has been inundated by thousands of requests for labeling revisions since the Wyeth v. Levine ruling in 2009.

"And there are far more generic manufacturers who would be burdened by this new obligation," he said.

"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 allow lower-cost generic drugs to enter the market quickly so patients could have access to them, Lefkowitz replied.

"We want to have generics selling [affordably], and [therefore Congress has] given branded and generics different obligations," he said.

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 [question] is whether it will be the FDA that ultimately 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?" Scalia asked.

"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" with the FDA, Bograd said.

"[But] the FDA has all that information," Breyer said.

Borgrad argued that the FDA has to monitor thousands of drugs, and it would be impossible for the agency know when a label change is needed unless companies give a heads up.

"The reason that manufacturers bear the primary responsibility is because they need to trigger the FDA's focus on a particular issue," Bograd 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."

But Scalia asked if the same duty could be applied to others.

"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 justices are expected to rule before the term wraps in June.

Published: Mon, Apr 4, 2011

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