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Animal Studies Pivotal in Zofran Birth Defect Lawsuits

The focus has been put on by plaintiffs in the Zofran multidistrict litigation re: a number of ‘animal teratogenicity studies’ that GlaxoSmithKline allegedly performed in Japan after the drug met U.S. approval.

Plaintiffs in the Zofran multidistrict litigation (MDL) have called attention to several ‘animal teratogenicity studies’ GSK allegedly performed in Japan after the drug was approved in the U.S. which found a link between Zofran and congenital heart defects.

Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a birth defect after the mother took Zofran during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.

What’s the problem?

February 4, 2016 – Just three months after more than 200 Zofran lawsuits were consolidated into a multidistrict litigation in Boston, the defendant has asked that the cases be dismissed.

In a motion filed Dec. 11, GlaxoSmithKline (GSK) said the complaints were pre-empted by federal law, invalidated since the U.S. Food & Drug Administration (FDA) would have already changed Zofran’s warning labeling if the drug is, in fact, dangerous when taken in pregnancy. Plaintiffs allege that Zofran causes a wide range of severe birth defects, from cleft palate to congenital heart defects.

On Jan.5, plaintiffs fired back at GSK with a blistering response, stating that the drugmaker’s motion was “unripe, unprecedented and violates the established federal law.” Ripeness is a legal term that applies to a claim in which “the facts of the case have matured into an existing substantial controversy warranting judicial intervention,” according to the Cornell University Law Dictionary. However, the plaintiffs contend that it is inappropriate for Judge F. Dennis Saylor IV to intervene — either for or against dismissal — at this stage in the litigation.

For one, the discovery phase hasn’t started yet, so plaintiffs haven’t been able to look at GSK’s records. Additionally, little medical evidence on Zofran is available to the public, since the company never attempted to have the drug approved as a treatment for morning sickness. As a result, plaintiffs haven’t been given the opportunity to know what GSK knows about Zofran’s link to birth defects. Before this information is made available, there’s no way to decide what — if anything — the FDA would have done to change the drug’s warning label.

However, there is at least one “reason to believe that GSK has important evidence about the defects alleged […], and the link to Zofran,” according to the plaintiffs’ response.

They proceed to highlight a number of ‘animal teratogenicity studies’ conducted by GSK in Japan which identified a link between Zofran and heart defects. Plaintiffs allege that these studies were done after the FDA approved Zofran in January 1991. In one such study, plaintiffs claim pregnant animals gave birth to offspring with ventricular septal defects (VSD), a congenital heart malformation that has been associated with Zofran.

“Plaintiffs do not know whether GSK ever provided the FDA this or any other evidence of severe heart defects,” the response states. “What Plaintiffs do know, however, is that the Zofran warning labels and available marketing materials were silent as to such evidence.”

Do I Have a Zofran Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran lawsuits. We are handling individual litigation nationwide and currently accepting new birth defect cases in all 50 states.

Free Confidential Case Evaluation: Again, if your baby was injured by Zofran side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and our lawyers can help.

Free Confidential Case Evaluation

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