GlaxoSmithKline Plc, the world’s second-biggest drug maker, started a Paxil trial in Philadelphia last month. Some call it a test case for more than 600 lawsuits over claims that GSK’s antidepressant drug causes birth defects. Patients and their parents claim internal company documents produced for trial show that GSK failed to warn about the risks of Paxil until forced to do so in 2005 by the Food and Drug Administration. The Plaintiff in the case, Michelle David, blames the drug for causing life-threatening heart defects in her three-year-old son Lyam.
Paxil, approved by the FDA in 1992, generated about $942 million in sales last year. GSK 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. In addition to the David case, GSK will face two more Paxil trials later this fall and early next year in state court in Philadelphia.
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