Paxil Lawsuit Information
By April 2001, when the U.S. Food and Drug Administration (FDA) approved Paxil for the treatment of GAD, it was widely being claimed that GAD affected “more than 10 million Americans, 60 percent of whom are women.”
In the United States, in June 2001, a court in Cheyenne ordered GlaxoSmithKline to pay US$6.4 million to the family of Donald Schell who shot his wife, daughter and grand-daughter and then killed himself two days after his doctor prescribed Paxil for depression. Schell just had two Paxil pills before the unfortunate incident. The jury of five women and three men decided that the drug was 80 per cent responsible for the deaths. It was the first-ever verdict against a pharmaceutical company for a psychiatric side effect of a selective serotonin reuptake inhibitor (SSRI)–the most popular class of antidepressants on the American market. Attorneys for GlaxoSmithKline, the makers of Paxil, argued that Schell’s rampage was precipitated by his depression, not by his exposure to the drug. But jurors were persuaded by David Healy, the British psychiatrist, who testified that SSRIs cause agitation and violence in some patients. Schell had no history of violence of any kind. The jury took less than three hours after a two-and-a-half-week trial to return a guilty verdict. The damages awarded was four times greater than the biggest previous award in Wyoming.
The United States FDA had never approved the use of Paxil in children but some doctors used the drug to treat children suffering from depression. Studies did not indicate any positive effect of Paxil but the FDA had safety concerns and ordered an reanalysis of the data. The reanalysis revealed that children given Paxil was three times more likely to suffer from suicidal tendencies than other children. The FDA subsequently released a statement recommending that physicians refrain from prescribing Paxil to new patients under 18.
In 2004, the New York Attorney General accused the company of hiding information about suicidal tendencies associated with Paxil. In 2005 the United States FDA issued a warning that consumption of Paxil during the first trimester of pregnancy can result in the baby being born with birth defects.
Since then many lawsuits have been filed against GlaxoSmithKline including some by parents whose children were born with birth defects because the mother was prescribed Paxil during the first trimester. By 2010, the company agreed to pay more than a billion dollars to settle over 800 cases. The average settlement paid by the company was about $1.2 million.
In 2012 GlaxoSmithKline agreed to pay a $3 billion fine for failure to report safety data. The United States Department of Justice as part of its investigation claimed that the company did not provide regulators with adverse data about its various drugs including Paxil and also illegally promoted its antidepressant Paxil to children. This is the largest such settlement in the United States.
While the Company agreed to settle the Paxil lawsuits, it has not admitted any wrong doing or negligence on its part. All Paxil lawsuits are essentially personal injury lawsuits. In a personal injury lawsuit, the Plaintiff claims that the actions of the Defendants caused an injury or loss to the Plaintiff and therefore the Defendant must compensate the Plaintiff for the injury or loss. In a Paxil lawsuit, the Plaintiff must prove that the consumption of Paxel resulted in some loss or injury to the Plaintiff.