Drug Collections

Paxil Litigation Documents


Paxil - Adult Suicide

Forst v. SmithKline Beecham Corp (GSK), Case number 2:07-cv-00612
Dolin vs. Glaxo SmithKline (GSK)

Background -
On March 17, 2004 Gary Forst, then 60, attempted suicide after two weeks of taking Paxil. Mr. Forst survived, but was permanently disabled. He and his wife sued Paxil manufacturer, SmithKline Beecham, d/b/a GlaxoSmithKline (“GSK”). The Forsts’ lawsuit alleged GSK was aware that patients given Paxil engaged in suicidal behavior during clinical trials at a rate over six times greater than patients given a placebo. GSK argued that, because the FDA did not mandate GSK warn about the suicidality risk, it could not have warned or disclosed these risks any sooner. GSK argued that Paxil’s FDA-approved label shielded GSK from liability for failing to warn doctors and patients of that elevated suicidal behavior risk, a legal defense called 'preemption.' The lawsuit alleged GSK had known about Paxil’s association with suicidality for over 15 years, but presented data to the FDA in a way that obscured the risk.

Mr. Dolin committed suicide in 2010 after taking Paxil/paroxetine for a few weeks. Per the lawsuit allegations, GSK failed to adequately warn Mr. Dolin’s doctor about Paxil/paroxetine’s association with an increased risk of suicidal behavior in adults of all ages. The Court previously ruled that, although GSK did not actually manufacture the pills Mr. Dolin took, the company was responsible for the label and knew or should have known any failure to warn would result in harm to those taking generic versions of the drug.

Scientific Therapeutics Information (STI) and Ghostwriting

This set of documents from Paxil litigation demonstrate the ghostwriting of a medical article for a core journal. The medical communications company, Scientific Therapeutics Information, Inc, (STI), wrote many articles for GSK including a piece for Study 352 (A Double-Blind Placebo-Controlled Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression) to be published in the American Journal of Psychiatry, with Charles Nemeroff and other physicians as 'official' authors.
Browse the STI ghostwriting documents.

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