Hoping to avoid further litigation, GlaxoSmithKline, the world’s second-biggest pharmaceutical company, agreed to a $63.8 million settlement in a class-action suit brought against it by users of Paxil and Paxil CR. In the lawsuit, plaintiffs claimed that Glaxo promoted and marketed the antidepressant for the treatment of children and adolescents while failing to release relevant information about the drug’s safety and value.
Not surprisingly, the company refused to accept any liability and continues to deny all of the allegations in the suit. In the suit, plaintiffs claimed that Glaxo withheld information from four separate studies that challenged the drug’s effectiveness on children and found an upsurge in suicidal thoughts and behavior in children who’d taken it. The suit also claimed that patients overpaid for the drug.
This past spring, Glaxo changed its product labeling and, in conjunction with the FDA, notified healthcare professionals about the risks for Paxil use on children. In a May safety alert, the FDA warned consumers that a meta-analysis “showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo.â€
If the settlement is officially approved in a hearing next March, all parties who have purchased Paxil or Paxil CR for use with children or adolescents will be eligible for a full refund. If consumers cannot offer proof of purchase, they will receive a $15 reimbursement. Reimbursement amounts will be contingent upon the number of consumers who file a claim. Partial refunds will be given if the settlement is not large enough to cover all of the claims and any potential legal fees for the plaintiffs’ lawyers.
A webpage about the Paxil Pediatric Settlement in the case of Hoorman, et al v. SmithKline Beecham Corp. can be found at www.paxilpediatricsettlement.com.
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