U.S. Supreme Court

Supreme Court to Decide if Pre-Emption Bars Design Defect Suits Against Generic Drug Makers

The U.S. Supreme Court has agreed to decide whether generic drug makers can be liable for making products that are unreasonably dangerous.

The court granted cert on Friday in a suit brought by a New Hampshire woman who suffered severe injuries while taking the generic drug sulindac for shoulder pain, report the Wall Street Journal (sub. req.) and Bloomberg News.

Karen Bartlett was awarded $21 million after she suffered an allergic reaction that caused her to lose more than 60 percent of her outer skin layer, Bloomberg says. She is nearly blind and can’t eat normally because of burns to her esophagus.

Mutual Pharmaceutical Co. argues that Bartlett’s state-law design defect claims are pre-empted by federal drug regulations that require generics to be the same as their name-brand counterparts. The company relies on a 2011 Supreme Court ruling that held failure-to-warn claims against generic companies are pre-empted by federal laws that require their warnings to be the same as those issued by brand name drug makers.

The Boston-based 1st U.S. Circuit Court of Appeals had ruled for Bartlett, saying the two kinds of claims are different. Though the drug company cannot change the composition of sulindac, the court said, “it certainly can choose not to make the drug at all.”

The case is Mutual Pharmaceutical Co. v. Bartlett.

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