Glaxo Must Pay $2.5M Over Paxil & Birth Defects

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paxilA Pennsylvania state court jury deliberated seven hours before finding the drug maker failed to properly warn docs and pregnant women about the risks of the antidepressant. This was the first of 600 cases, by the way, Bloomberg reminds us.

The jury awarded the money in compensatory damages to the family of Lyam Kilker; the 3-year-old was born with heart defects his mother blamed on the drug. “The first win is always huge, especially when you get a jury saying the drug caused the injury,” Sean Tracey, the family’s lawyer, tells the news service.

This is the first time a jury considered claims that Glaxo knew Paxil caused birth defects and hid risks to increase profits. The drug maker disagrees with the verdict and will appeal, spokesman Kevin Colgan tells Bloomberg. “While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition,” Colgan says.

The jurors found 10-2 that Glaxo officials “negligently failed to warn” the doc treating Lyam’s mother about Paxil risks and concluded the pill was a “factual cause” of the child’s heart defects, Bloomberg writes, adding that the Philadelphia Common Pleas Court panel also found that Glaxo’s handling of the drug wasn’t “outrageous,” meaning the family couldn’t seek punitive damages against the drugmaker.

Glaxo is also fighting suits in the US, Canada and the UK over claims that Paxil, whose generic name is paroxetine, causes homicidal and suicidal behavior. The drug maker settled some suicide claims, under undisclosed terms.

In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement required Glaxo to publicly disclose the studies.

In 2001, a jury in Cheyenne, Wyoming, ordered Glaxo to pay $6.4 million to the relatives of a man who shot his family to death and then turned the gun on himself after taking Paxil. The case was settled while on appeal, according to Colgan, the Glaxo spokesman.

Securities analysts, meanwhile, don’t see a financial threat. “I don’t think the link is proven, so there will likely be collective settlements which will keep costs low,” Navid Malik, an analyst at Matrix Corporate Capital in London, tells Bloomberg. “If this was a threat to GSK, the first verdict might have been 100 times greater.”

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  1. GSK Statement on Jury Verdict in Paxil Product Liability Trial in Philadelphia Court of Common Pleas

    On October 13, 2009, a jury in the Philadelphia Court of Common Pleas returned a verdict against GlaxoSmithKline in a case alleging that Lyam Kilker was born with a rare heart defect as a result of his mothers use of Paxil during pregnancy.

    GlaxoSmithKline disagrees with the verdict and will appeal. While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition. Very unfortunately, birth defects occur in three to five percent of all live births, whether or not the mother was taking medication during pregnancy.

    GlaxoSmithKline acted properly and responsibly in conducting its clinical trial program for Paxil, including sharing documentation and submitting results from studies on Paxil to regulators. Once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicines labeling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community and the public.

    US Media enquiries:
    Nancy Pekarek
    (919) 483 2839
    Mary Anne Rhyne
    (919) 483 2839
    Kevin Colgan
    (919) 483 2839
    Sarah Alspach
    (919) 483 2839

  2. WOW,.. GSK speaks! I have but one question for the individuals who have penned their names to this press release,… How do you sleep at night knowing that this drug mames and kills children around the world?

  3. GSK lost its first case involving Paxil birth defects: http://www.newsinferno.com/archives/13348

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