Paxil Suicide, Birth Defect Lawsuit Settlements Detailed

<"">Paxil maker GlaxoSmithKline has paid over $1 billion to settle lawsuits involving the antidepressant since it came on the market in 1993, according to report on Many of the Paxil settlements involved allegations that the drug led to suicides, attempted suicides or birth defects.

Paxil is one of a class of drugs called selective serotonin reuptake inhibitors (SSRIs), and has been approved to treat symptoms of depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), panic disorder, generalized anxiety disorder (GAD), social phobia/social anxiety disorder, and premenstrual dysphoric disorder (PMDD). Paxil was also the first antidepressant formally approved in the U.S. for the treatment of social anxiety disorder.

In 2005, the U.S. Food & Drug Administration (FDA) requested that Glaxo add a black-box warning to the Paxil label warning that it increased the risk of suicidal thoughts among adolescents. In December 2005, the FDA also announced that it was requiring GlaxoSmithKline to add additional warnings about Paxil birth defects to the drug’s prescribing information. At the same time, the agency changed Paxil’s birth defect risk category from Category C (Risk of Fetal Harm Cannot be Ruled Out) to Category D (Positive Evidence of Fetal Risk).

According to, court records and other sources indicate that Glaxo has paid about $390 million in settlements for suicides or attempted suicides said to be linked to the drug. About 450 suicide-related Paxil cases were settled, while only about a dozen haven’t been, the report said. People familiar with the cases told that about 150 Paxil suicide lawsuits settled for an average of about $2 million, and about 300 over suicide attempts settled for an average of $300,000.

Glaxo has settled about 10 birth-defect cases, for an average of $4 million each, said. About 600 more Paxil birth defect cases remain, and at least one analyst has written that “a liability totaling $1.5 billion is possible,” said.

As we reported previously, Glaxo lost the first Paxil birth defect lawsuit to go to trial in October. A Philadelphia, PA jury ordered the drug maker to pay $2.5 million to the family of a 3-year-old boy, who was born with heart defects. The jury found 10-2 that Glaxo officials “negligently failed to warn” the doctor treating the child’s mother about Paxil’s birth defect risk. It also concluded the antidepressant was a “factual cause” of the child’s heart defects.

While the plaintiffs in the Pennsylvania Paxil lawsuit were not awarded punitive damages because the jury did not find Glaxo’s handling of the drug to be “outrageous,” the jury award was more than double the $1.2 million they had originally sought.

According to the report, Glaxo paid an average of about $50,000 per case to resolve about 3,200 claims linking Paxil to addiction problems. The company also paid $400 million to end antitrust, fraud and design claims, said.

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