GlaxoSmithKline has paid out some big bucks – $1 billion, in fact – to settle Paxil lawsuits involving suicide, birth defects and other issues, according to Bloomberg.com.
According to Bloomberg.com, 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. The report also said Glaxo has settled about 10 birth-defect cases, for an average of $4 million each.
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, Bloomberg.com said.
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).
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 Bloomberg.com, about 600 Paxil birth defect lawsuits are still pending.
