Glaxo Paxil Birth Defects Settlements Total $1 Billion

GlaxoSmithKline (GSK) has agreed to pay in excess of $1 billion to settle hundreds of lawsuits over claims of birth defects linked to <"">Paxil, said Fierce Pharma. The $1 billion is from the drug maker’s $2.4 billion legal expense budget and will pay about $1.2 million to each of the families whose children were born with birth defects following their mothers’ use of Paxil during pregnancy, said Fierce Pharma.

Over 800 birth defect cases will be resolved with this massive settlement; over 100 additional cases remain pending according to Bloomberg News, wrote Fierce Pharma. Claire Brough, a spokeswoman for GlaxoSmithKline did confirm to Reuters that additional cases are pending and that three such cases are scheduled for trial later this year in Philadelphia, wrote Fierce Pharma.

“GSK has reached agreement to settle certain cases involving the use of Paxil during pregnancy,” Brough said, quoted Fierce Pharma. “The details of those settlements are confidential….The company has agreed to these settlements, despite its litigation defenses, in order to avoid the costs, burdens and uncertainties of ongoing litigation,” Brough added.

In July 2006, the Food & Drug Administration (FDA) instructed the makers of antidepressants such as Paxil to revise their labels to include information about PPN. That same year, a study in the New England Journal of Medicine showed that babies born to mothers who took these types of drugs—known as selective serotonin reuptake inhibitors (SSRIs)—during the second half of pregnancy had a significantly increased risk of being born with PPPHN.

GlaxoSmithKline lost the first Paxil birth defect lawsuit to go to trial last October, when a Philadelphia jury ordered the drug maker to pay $2.5 million to the family of a three-year-old boy who was born with heart defects. The jury found, in a 10-2 ruling, 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. The case, known as Kilker v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline, was seen as a leading indicator of the strength of more than 600 similar cases.

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