Mutual Pharmaceutical Company, which makes generic drugs, is appealing to the high court. Three years ago, a New Hampshire federal jury awarded Karen Bartlett of Plaistow $21 million in damages. And an appeals court upheld the ruling.
At issue is a rare and severe side-effect of a drug related to ibuprofen.
Back in 2004, Bartlett was prescribed a mild anti-inflammatory for shoulder pain. The pharmacy gave her the generic version, called Sulindac. Within weeks, more than 60 percent of her skin burned away, her lungs and esophagus suffered heavy damage, and she lost most of her sight. Bartlett spent months in a burn unit, then in a medically-induced coma. She can no longer work or do a number of simple tasks.
Bartlett’s reaction is a known—although rare—side-effect of Sulindac , as well as a number of other drugs. She argues under New Hampshire liability law that Sulindac is defective, and should not be sold. Mutual Pharmaceutical says state law can’t supersede the federal authority of the FDA. And as a generic manufacturer, it doesn’t have the power to change the drug’s design, anyway.
The government has sided with Mutual in the case.
But Democratic California Representative Henry Waxman has sided with Bartlett in an amicus brief. As cosponsor of the bill that greatly helped generics compete in the marketplace, he says Congress knowingly left the door open for court action.
In a similar case two-years ago, related to drug labeling, the Supreme Court sided with the generic drug manufacturer.