Glaxo To Pay $1B To Settle Paxil Birth Defect Cases
6 CommentsBy Ed Silverman // July 21st, 2010 // 10:26 am
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 agrement 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.
The move comes after a Pennsylvania state court jury last October awarded a woman $2.5 million in damages for failing to properly warn docs and pregnant women about the risks of the antidepressant. This case, which was filed by the family of a three-year-old boy who was born with heart defects his mother blamed on the drug. It was the first of 600 such lawsuits and was seen as a test of Glaxo’s vulnerability (background).
Last week, Glaxo disclosed plans to take a $2.4 billion charge in its second quarter to settle product-liability lawsuits over its Avandia diabetes pill, litigation involving the Paxil antidepressant and a US government investigation into its manufacturing site at Cidra, Puerto Rico.
The Paxil deal, which would provide an average payout of more than $1.2 million to families of the affected children, leaves more than 100 similar cases pending. The birth-defect settlements bring to more than $2 billion the amount Glaxo has agreed to pay to resolve a variety of Paxil-related suits, including claims the pill caused suicides or attempted suicides and addiction problems, Bloomberg writes,
Last week, Glaxo settled about 10,000 of the roughly 13,000 Avandia lawsuits in the US for approximately $460 million. The move may allow the drugmaker to avoid a continual stream of headlines over Avandia, which has been linked to cardiovascular risk, although an FDA advisory panel last voted to allow the controversial diabetes pill to remain on the market, but with warnings.
“GSK believes it acted properly and responsibly in conducting its clinical trial program, in marketing the medicine, in monitoring its safety once it was approved for use and in updating pregnancy information in the medicine’s label as new information became available,” a Glaxo spokeswoman tells Bloomberg. added.
Matthew Holford
“”GSK believes it acted properly and responsibly in conducting its clinical trial program, in marketing the medicine, in monitoring its safety once it was approved for use and in updating pregnancy information in the medicine’s label as new information became available,” a Glaxo spokeswoman tells Bloomberg.”
Out of interest, you wouldn’t happen to know whether this “spokeswoman” was Mary-Anne Rhyne would you, Ed?
Anyway, importantly, an out-of-court settlement permits denial of all responsibility (as would a civil decision in favour of a plaintiff patient, in truth), and any further questions may be dismissed with “that’s all settled, so you can forget about it, because we have,” and the Company won’t have to change the way it operates, at all, as though everything really were settled. Great system!
Mind you, the issue of side effects, whilst I wouldn’t wish to diminish it, is secondary to whether the drug works, because if it doesn’t actually make people better, then the question of side effects should never arise. So, as a parting shot, does GSK believe that its drug has a level of efficacy that outstrips placebo, outside that presumed to be present solely on the basis that it has a marketing authorization (licence)? Because, obviously, GSK is big into beliefs, and is confident in putting its beliefs forward for scrutiny. So, let’s have at it, I say.
Matt
Biotruth
One may wonder if any of the OB-GYNs cautioned their patients about SSRI use during their pregnancy (especially during first trimester). The association of a pregnant woman’s first trimester paroxetine (Paxil) exposure with an increased risk of cardiovascular malformations, mostly ventricular (VSDs) and atrial septal defects (ASDs) has been documented.
Question: do any of these lawsuits involving “birth defects” mention neurodevelopmental problems in the children (or did they focus specifically on cardio defects)?
I raise this question because of the newest concern that SSRIs may be associated with autism (by disrupting 5HT homeostasis during early brain development).
Almost exactly 2 years ago, Dr. Rick Lin and his colleagues at the University of Mississippi’s Autism Spectrum Disease Research Group (ASDRG) were awarded a prestigious four-year, $1.2 million grant from NIH, known as a grant from the EUREKA program (Exceptional, Unconventional Research Enabling Knowledge Acceleration Program). This grant addresses an unconventional and compelling idea that the *rise in autism may be due (in part?) to the rise in the use of SSRI anti-depressant drugs.* Clearly, NIH paid attention.
“The group’s central hypothesis (from data based initially on rat moms and their pups) is that abnormal regulation of serotonin (5HT) during early brain development compromises oligodendrocyte function and interferes with the establishment of normal interhemispheric connections.” – from their website at http://www.umhc.com/wtn/Page.asp?PageID=WTN000064
This group hypothesizes that abnormal levels of serotonin during pregnancy (as a consequence of the pregnant human mom taking SSRIs) may be “the key environmental factor contributing to the recent surge of autism not only in the United States, but also in other highly developed, industrialized countries.”
Evelyn Pringle
I’ve been covering the SSRI birth defect litigation almost since it began and I have never heard of a case alleging neurodevelopmental injuries. I think they are mostly wrongful deaths, heart defects or a lung disorder.
Other injuries could have been added in the last year or so that I may not have heard about, but I think I would have.
Salmon
I would expect neurodevelopmental problems however, it’s more difficult to support a claim as injuries could also be attributed to genetic factors.
Salmon
Biotruth
Thanks for the feedback -
Evelyn Pringle
Salmon - I’m sure many infants born to mothers who took Paxil while pregnant probably have neurodevelopmental problems but I bet they’ll never get recognized for what they are. Sad.