April 10, 2015
By Mark Terry, BioSpace.com Breaking News Staff
A lawsuit taking place in St. Louis regarding claims that that the antidepressant Zoloft caused birth defects in a boy from California is stirring up bad press for drug maker Pfizer . The claimant’s attorney, Joseph Zonies of Colorado law firm Reilly Pozner LLP, made opening statements Thursday saying that Pfizer did not warn doctors about the potential risks of birth defects while taking Zoloft.
Zonies cites an internal May 2014 report Pfizer made indicating that newborns of women taking Zoloft were at risk for congenital anomalies.
“The science has never even suggested that birth defects were caused by Zoloft,” said Beth Wilkinson, one of Pfizer’s attorneys in a statement. “No treating physician or medical records say Zoloft is a cause.”
In this particular case, Logyn Pesante, of California, was born with multiple heart defects. The most serious of those defects was transposition of the great arteries, called TGA. This is when the two main arteries that leave the heart, the pulmonary artery and the aorta, are switched in position. According to the U.S. Centers for Disease Control and Prevention (CDC), about 1,901 babies are born with TGA in the U.S., or about 5 out of every 10,000.
In 2010 GlaxoSmithKline paid more than $1 billion in 800 similar lawsuits claiming that its antidepressant Paxil caused birth defects in some of the children of mothers taking the drug. The company also paid out another $1 billion over the years regarding claims the drug caused suicides, attempted suicides and addiction problems.
There are approximately 1,000 lawsuits filed against Pfizer regarding Zoloft and birth defects. In November 2014 the company asked a Pennsylvania judge to dismiss more than 500 of them. Those suits, of which there were 526, were combined into a multidistrict litigation, which is similar to a class action suit but the plaintiffs have their cases settled individually. Of those 526 cases, 443 were from Pennsylvania.
In a statement, Pfizer indicates that reports to the U.S. Food and Drug Administration (FDA) and the European regulators confirm the drug’s safety data and Pfizer hadn’t identified a “signal for congenital anomalies and that a comprehensive review of the literature did not support an association between use of Zoloft and birth defects, including cardiac anomalies. … Plaintiffs have taken a single statement in one document, summarized the results of a few studies, out of context.”
If the drug does cause birth defects, it must be a very rare event. Data compiled by the CDC indicates that about one in 10 people in the United States take antidepressants.
“Pfizer has great sympathy for families affected by birth defects,” said Pfizer spokeswoman Christine Regan Lindenboom in an email to BioSpace. “There is no valid and reliable scientific evidence to support the plaintiff’s claims. In fact, a range of independent organizations, such as the American Psychiatric Association, American College of Obstetricians and Gynecologists and the American Heart Association, have concluded that Zoloft’s use during pregnancy is not associated with birth defects, including those alleged in this case.”
BioSpace Temperature Poll
After last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
