Saturday, September 12, 2009

GlaxoSmithKline to Defend Paxil in Birth-Defect Case (Update1)

GlaxoSmithKline Plc, the world’s second-biggest drugmaker, begins a trial in Philadelphia next week in what may be a test case for more than 600 lawsuits over claims its antidepressant drug Paxil causes birth defects.

Patients and their parents claim internal company documents produced for trial show Glaxo failed to warn about the risks of Paxil until forced to do so in 2005 by the U.S. Food and Drug Administration. In a trial set for Sept. 14, Michelle David blames the drug for causing life-threatening heart defects in her son Lyam Kilker, 3.

The London-based company faces two more such trials a month from October through January in state court in Philadelphia. The first group will show both sides how the rest of the lawsuits may fare, said David Logan, dean and professor of law at Roger Williams University in Bristol, Rhode Island.

“These cases are sort of like the canary in the coal mine,” Logan said in a phone interview. “The early cases set the parameters for any global settlement negotiations.”

Paxil, approved by the FDA in 1992, generated about $942 million in sales last year, 2.1 percent of the total for the company. Glaxo has settled other Paxil-related cases, including a suit brought by the New York Attorney General’s office accusing the company of withholding safety data about the antidepressant.


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