Keith Jensen obtained the largest verdict in NH history and that case is before the U.S. Supreme Court
By Greg Stohr - Mar 19, 2013 2:24 PM CT
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.