In an effort to get its arms around massive litigation, GlaxoSmithKline has agreed to settle yet another wad of product-liability lawsuits involving one of its popular meds. The latest deal involves an agreement to pay more than $1 billion to settle some 800 cases alleging its Paxil antidepressant caused birth defects in children borne to women who took the drug, Bloomberg News writes.
A settlement has been reached in a lawsuit filed against a pharmaceutical company by a Watertown woman who linked her prescribed use of Paxil to the death of her infant son, according to court files. Jennifer Berg of Watertown sued SmithKline Beecham, doing business as GlaxoSmithKline, in October 2007. The complaint said Nathan Berg died in 2004 because of a heart disorder caused by her use of the antidepressant Paxil while she was pregnant.
British Pharma giant GlaxoSmithKline is expected to record a legal charge of $2.4 billion for the second quarter of this fiscal year in order to settle legal cases relating to its antidepressant Paxil and controversial diabetes pill Avandia. The British company announced two days ago that the money would be used not only to cover the settlements for Avandia but also other long-standing legal cases.
Ken Kramer, a researcher with the Citizens Commission on Human Rights of Florida, says the numbers underestimate the extent of the problem, because medical examiners do not track deaths attributed to antipsychotic drugs or to antidepressants, both of which carry black-box or black-label warnings. The warnings on antidepressants, required by the Food and Drug Administration, state that the drugs increase the risk of suicidal thinking and behavior in children, adolescents and young adults up to age 24. (Antidepressants include Paxil, Prozac, Zoloft, Effexor, Lexapro and Celexa.)
There have been numerous claims that a medication caused a suicide, but few lead to sweeping changes. In Canada, however, the suicide of 18-year-old Sarah Carlin, who had taken the Paxil antidepressant, is a clear exception. Following a coroner’s inquest, Canada’s provincial and federal governments were told to ensure patients are better informed about drug risks, tighten regulations on drugmakers and establish an independent agency to regulate medications.