"It's not about what they tell you, it's about what they don't."
~ Bob Fiddaman, Author, Blogger, Researcher, Recipient of two Human Rights awards
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Friday, February 26, 2010
GlaxoSmithKline Loses Bid for Immunity From Suicidal Behavior Lawsuits
Image: bahairants.com
Reproduced with kind permission.
Paxil’s manufacturer, GlaxoSmithKline [Glaxo] has lost its bid for immunity from suicidal behavior lawsuits. A Federal Court of Appeals in Chicago rejected Glaxo’s attempt to throw out a case arising from the suicide of a 23-year-old university student who was taking Paxil at the time she died. Her parents claim that Glaxo failed to warn that Paxil causes suicidal behavior.
Glaxo argued that FDA approval of a drug should shield its manufacturer from fault even when the company learns of harmful negative reactions after FDA approval. This theory, known as “preemption,” asserts that FDA approval “preempts” or nullifies any lawsuits against a drug. If Glaxo had succeeded, it would have made it extremely difficult for other injured consumers to seek compensation in Court.
In a unanimous opinion, the Court of Appeals rejected Glaxo’s arguments and refused to give immunity to drug manufacturers. The Court confirmed that injured consumers should be allowed to have their claims tried in a court of law and manufacturers must be held accountable for failing to disclose harmful negative reactions to their drugs—the manufacturers retain their obligation to warn of risks even after the FDA approves the drug for marketing.
Background to the case HERE
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