Supreme Court

Supreme Court Rules Generic Drug Makers Can't Be Liable for Injuries

If they follow the rules of the FDA


First Karen Bartlett lost more than 60% of her skin, suffered lung and esophageal damage and became legally blind after taking a generic painkiller. Now the Supreme Court has stripped her of a $21 million state court award.

In another example of its well-documented pro-business tilt, the high court ruled Monday that the generic drug maker wasn't liable for the painkiller's content or warning label because it must mimic the brand-name drug in both instances.

Not that the justices didn't sympathize with Bartlett's plight. The 5-4 decision, written by Justice Samuel Alito, said the case "arises out of tragic circumstances" and spread blame at the feet of doctors, Congress and the Food and Drug Administration.

Bartlett's injury "is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment below be reversed," Alito said.