The federal judge overseeing the Zofran multidistrict litigation (MDL) in Boston has denied a request by GlaxoSmithKline (GSK) to dismiss the lawsuits, which argue the company failed to warn about the drug’s potential to cause severe birth defects.
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a birth defect after the mother used Zofran in 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 2, 2016 – Over 200 lawsuits alleging GSK failed to disclose Zofran’s link to birth defects have been consolidated into the MDL in the District of Massachusetts before Judge Dennis F. Saylor, IV. However, on Dec. 11, 2015, GSK argued in an Omnibus Motion to Dismiss (PDF) that the cases should be thrown out of court.
GSK Argues Lawsuits Preempted by Federal Law
According to GSK, the problem is that the complaints make allegations based on state laws. One of the most significant allegations, that the drugmaker failed to warn patients of Zofran’s adverse effects, is premised on state laws that require manufacturers to adequately present the potential health risks of a medication to the public.
This requirement, however, is ‘preempted by federal law,’ according to GSK. In effect, the company is arguing that the FDA would have rejected the Zofran warning label changes plaintiffs wanted.
The issue now is whether ‘clear evidence’ exists to support GSK’s claim. Following the supreme court’s 2008 decision in Wyeth v. Levine, drugmakers aren’t automatically protected against liability simply because their products are FDA approved. Approval by the agency doesn’t equal legal protection in all cases; however, it can if a defendant is able to demonstrate ‘clear evidence’ that the FDA would have rejected label changes advocated by plaintiffs in their lawsuit.
‘Clear Evidence’ Doesn’t Exist, Plaintiffs Argue
The evidence GSK seeks isn’t clear enough, according to a response (PDF) filed last month. Judge Saylor sided with the plaintiffs, citing the supreme court’s 2008 ruling that a citizen’s petition alone is not “clear evidence.”
Plaintiffs are now allowed to enter the discovery phase of litigation, where both sides gather evidence from each other and make their case. “The plaintiffs [should be given] some opportunity to develop the facts, whatever those facts may be,” Saylor said.
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 investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if your baby was harmed by Zofran side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.