Zofran Maker Accused of Wrongdoing in Birth Injury Lawsuits

Thursday, March 15, 2018

Families suing drug maker GlaxoSmithKline over alleged birth defects from their anti-nausea medication Zofran have raised new charges that the company hid safety data from the FDA and is blocking evidence of false advertising.

The allegations came in two recently-filed motions in a federal multidistrict litigation court, where more than 570 Zofran birth injury lawsuits have been filed.

Zofran is alleged to have caused birth defects such as club foot, heart deformities and cleft palates in children of mothers who were prescribed the drug for morning sickness.


Zofran Not Approved for Use in Pregnancy

Zofran was first approved in 1991 and has become a valuable tool in fighting nausea in patients with cancer, drug withdraw, irritable bowel syndrome or who have recently undergone surgery.

However, critics say GlaxoSmithKline also promoted it to doctors as a safe and effective way to help morning sickness in pregnant mothers, when it wasn’t approved for such uses by the FDA. In fact, the company paid $3 billion in federal fines in 2012 for similar crimes of false marketing.

In recent years, studies have shown that taking Zofran during the first trimester of pregnancy can double the risk of cleft palate, heart deformities and other birth defects, and may also have an extremely high rate of transfer from mother to fetus compared to other drugs.


GSK Hiding Safety and Marketing Data, Plaintiffs Say

Now, as part of the ongoing pre-trial discovery in hundreds of birth defect lawsuits, lawyers for the victims have asked GlaxoSmithKline for access to the database that contains all the side effects reported for Zofran.

Plaintiffs claim that, although data has surfaced linking Zofran to birth defects, GSK didn’t take the necessary steps to communicate these risks with the FDA or doctors.

And, while the company has claimed there is no evidence that Zofran increases the chances of birth defects, they’re fighting against access to the side effect database on the grounds of privacy and technology concerns.

Further, the victim families have asked GSK to turn over contracts it executed with more than 40 advertising partners for marketing Zofran.

This follows allegations that the company promoted Zofran for use during pregnancy despite the fact it wasn’t approved for such use and amid mounting evidence that such use could increase the risk for birth defects.

In its answer, lawyers for GSK have said they simply can’t find the advertising contracts after searching for over 8 months.


Zofran Class Action Lawsuit Continues to Grow

The number of children who’ve allegedly suffered serious birth defects from Zofran continues to grow as the parties fight over hiding reports and “missing” data.

The first Zofran lawsuits were filed in 2015 after studies surfaced showing use during pregnancy could increase birth defects. At the time, millions of mothers who had taken the drug while pregnant thinking it was safe were caught off guard.

As the number of claims continued to grow, the Judicial Panel on Multidistrict Litigation consolidated all federal cases on October 13, 2015 to a special MDL court in the District of Massachusetts under U.S. District Judge Dennis Saylor for expedited handling.

This case became known as MDL 2657, IN RE: Zofran (Ondansetron) Products Liability Litigation. At the present time, 571 individual lawsuits have been filed in this Zofran birth defect court, and the number continues to grow.

As the parties near the end of the evidence-gathering phase, the judge will begin scheduling bellwether trials, which are a series of test cases to determine how much juries are likely to award in damages. These will set the tone for negotiating settlements to avoid having to go to trial over 500 times.

Lawyers are still helping those whose children suffered birth defects after Zofran use file lawsuits to join the litigation. For more information on the drug and its warnings, or to speak directly with a lawyer, contact us today.



Noon, A. GSK Says It Can’t Find Marketing Contracts In Zofran MDL. Law360. (March 14, 2018). Retrieved from www.law360.com

Villani, GSK Hid Zofran Data from FDA, Families Say. C. Law360. (February 26, 2018). Retrieved from www.law360.com

Pending MDL dockets by district. JPML. (February 15, 2018). Retrieved from www.jpml.uscourts.gov

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