Patients’ Generic-Drug Lawsuits Questioned by High Court
The U.S. Supreme Court grappled with the limits on patients’ lawsuits against drugmakers, questioning a $21 million award to a woman who suffered debilitating injuries after taking a painkiller.
The justices, hearing arguments today in a case involving a Takeda Pharmaceutical Co. unit, debated whether to reinforce a two-year-old ruling that shielded generic-drug makers from claims that they failed to warn about possibly dangerous side effects.
The hour-long session in Washington pointed in different directions, at times suggesting a narrow ruling whose implications might vary by state. At other times, the justices hinted at a sweeping decision that would also affect brand-name drugmakers and potentially redefine the Food and Drug Administration’s mission when it clears drugs for sale.
“You’re basically saying the minute that the FDA gives you permission to sell, it’s a right to sell,” Justice Sonia Sotomayor told a lawyer for the Justice Department, which is backing the Takeda unit in the case. “And it can’t be altered by any state police power.”
Drug companies say a federal appeals court blasted a hole in the 2011 ruling by upholding the $21 million award. The lower court said the patient, Karen L. Bartlett, was pressing a different legal theory, focusing on the danger of the drug itself rather than the adequacy of the warning.
Failure to Warn
The generic-drug industry is supporting Takeda’s Mutual Pharmaceutical unit in the case. Units of Ranbaxy Laboratories Ltd. (RBXY), Teva Pharmaceutical Industries Ltd. (TEVA) and Mylan Inc. (MYL) are among the companies urging the court to throw out the award to Bartlett.
In the 2011 Supreme Court case, generic-drug companies successfully argued that failure-to-warn suits are “pre- empted” because federal law requires them to copy the packaging inserts used by brand-name manufacturers. The majority said it would be impossible for drug companies to comply with both federal labeling requirements and state-imposed duties to supply even stronger warnings.
The high court had previously ruled that brand-name companies had to defend against failure-to-warn suits.
In Bartlett’s case, the 1st U.S. Circuit Court of Appeals said so-called design defect claims were different. Mutual “certainly can choose not to make the drug at all,” the appeals court said.
Mutual’s lawyer, Jay Lefkowitz, argued that withdrawal of the product wasn’t a realistic option. “This is a classic case of impossibility pre-emption,” he said.
He drew skepticism from Sotomayor and Justices Elena Kagan and Ruth Bader Ginsburg. Kagan said the Federal Food, Drug and Cosmetic Act didn’t give drugmakers reason to expect a shield from traditional product-liability suits under state law.
“What we have in the FDCA is a statute that authorizes, that says, ‘You can sell this,’” she said. “But it doesn’t say you must sell it, and it doesn’t give you a right to sell it.”
Chief Justice John Roberts questioned the contention that Mutual couldn’t comply with both state and federal law.
The state is saying “if you do this, you’re going to have to pay for the damage,” he said. “It’s not a different duty.”
Under questioning from Kagan, Lefkowitz said a ruling in his client’s favor would probably also shield brand-name drugmakers from similar suits.
Bartlett suffered what the appeals court called “truly horrific” injuries after taking sulindac for shoulder pain. The anti-inflammatory medicine triggered an allergic reaction that caused her to lose more than 60 percent of her outer skin layer.
Bartlett spent months in a medically induced coma, was tube-fed for a year and endured 12 eye surgeries. She is almost blind and can’t eat normally because of esophageal burns.
Bartlett’s lawyer, David Frederick, spent the bulk of his time at the lectern discussing the finer points of New Hampshire law and arguing the jury award didn’t depend on a conclusion about the adequacy of the warning label. He said sulindac offered no benefits that other pain relievers couldn’t have provided, without the potential for catastrophic side effects.
“No warning would have made any difference to lessening the risk,” Frederick argued.
Roberts and Justice Antonin Scalia both questioned whether juries should be in the position of second-guessing the FDA.
The jury “said the risks outweigh the benefits, period, so you should not market this at all,” Roberts said. “And it does seem inconsistent with the federal regime.”
Ginsburg asked Frederick to respond to Mutual’s argument that a $21 million award would represent three times the company’s U.S. sulindac sales in 2005.
“If they are only making $7 million, they ought to withdraw from the market because their product causes such horrific injuries, it ought not to be sold,” Frederick responded.
The court will rule by June in the case, Mutual Pharmaceutical Co. v. Bartlett, 12-142.
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