Test Paxil case hits court next week

GlaxoSmithKline and a bunch of plaintiffs' lawyers will have their eyes on a Philadelphia court next week. That court is hosting a bellwether liability case over claims that the antidepressant Paxil causes birth defects. Glaxo faces some 600 lawsuits with similar claims. "These cases are sort of like the canary in the coal mine," law professor David Logan told Bloomberg. "The early cases set the parameters for any global settlement negotiations."

In this first case, plaintiff Michelle David claims that Paxil caused heart defects in her son Lyam Kilker and that Glaxo failed to warn about the drug's potential to cause birth defects. As you know, FDA asked Glaxo in 2005 to update Paxil's label with information on heart defects in infants. Glaxo says the FDA's action doesn't prove that Paxil causes birth defects; its own studies after the warning "have been inconclusive with mixed results," the company says.

But David's attorney says that Glaxo failed to follow up on early animal studies that suggested Paxil might cause birth defects, and that the company designed Paxil studies to use low doses of the drug to avoid triggering adverse events. "In 1998, GSK internally concluded that it had received an ‘alarming' number of abnormal pregnancy adverse events for Paxil and failed to disclose this information to the FDA, physicians or the public," the lawyers said in a court filing. We'll be hearing much more from both sides next week.

- read the Bloomberg piece [1]

Related Articles:
Glaxo promises a public airing of all trial data [2]
Judge reverses Paxil preemption ruling [3]
U.S. Paxil probe broadens [4]
Grassley asks FDA for Paxil review [5]