Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Saturday, April 11, 2015

Pfizer in Denial About Zoloft Birth Defects





So, multi-billion dollar making pharmaceutical company, Pfizer, are in court. They are (as expected) denying the link between their antidepressant drug, their multi-billion selling blockbuster Zoloft (Sertraline) and birth defects.

Are we surprised at their denial or surprised that Zoloft can cause birth defects?

Well, neither really.

So here's the case.

Logyn Pesante, (11) from California, was born with multiple heart defects, the most serious being transposition of the great arteries. In a nutshell, transposition of the great arteries occurs when the two main arteries going out of the heart (the pulmonary artery and the aorta) are switched in position, or “transposed”.Since his birth Logyn has undergone 25 procedures and six operations and has a pacemaker. The brave 11 year-old has also had to undergo three open-heart surgeries to address his multiple defects.

His mother, Kristyn Pesante, took Zoloft during the first trimester of her pregnancy and her attorney, Joseph Zonies of the Colorado law firm Reilly Pozner LLP, is claiming that birth defects and fetal deaths, reported by patients to Pfizer as early as 1991 should have seen Pfizer change its label on Zoloft or, at the very least, communicate these adverse events to physicians.

Pfizer's attorneys, Paul Weiss Rifkind Wharton & Garrison LLP. are arguing that that there is no evidence to prove Zoloft causes birth defects. This, despite the adverse events reported to them by patients and also a study published in the New England Journal of Medicine in 2007 which found that pregnant women taking Zoloft faced double the risk of having a child with a birth defect.

More damning, for Pfizer at least, is a document submitted as evidence by Pesante's attorneys that shows a May 2014 internal report at Pfizer sees them admit that women taking Zoloft (sertraline) had an increased risk of having babies with heart defects. The document, Pfizer claim, has been taken out of context. Pfizer claim that, “Plaintiffs have taken a single statement in one document, summarizing the results of a few studies, out of context.”

Robert Cabera, a doctor at a University of Texas institute, has been called as an expert witness for Pesante and told jurors that his review of research on babies born with medical issues convinced him that Zoloft was clearly “a risk factor for birth defects, especially heart defects.”

I'll leave the last words with Beth Wilkinson, (Pictured) one of the lawyers representing Pfizer.



"None of the mother’s doctors had identified Zoloft as the cause of her son’s birth defects and experts say its impossible to know exactly what causes such problems.

“Sometimes, bad things happen to good people,”

Hmmm.

The case is Pesante v. Pfizer Inc., 1222-CCO-2441, Missouri Circuit Court, 22nd Judicial District (St. Louis).

Sources:

Pfizer Accused of Knowing Zoloft Posed Birth-Defect Risk

St. Louis jury hears nation's first suit claiming Zoloft caused birth defects


Bob Fiddaman.






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