Zofran Birth Defect Lawsuits: Frequently Asked Questions

Banville Law has joined forces with a coalition of experienced plaintiffs’ attorneys to investigate potential Zofran claims against the international pharmaceutical giant GlaxoSmithKline. After a series of large studies found an association between Zofran and major birth defects, families began to file lawsuits. There are now more than a dozen claims filed in Federal Courts, and more pending in State Courts.

But since over 1 million “off label” Zofran prescriptions are written for morning sickness every year, the legal community expects many other parents to step forward in the coming months.

Q. Why Are Families Filing Lawsuits?

By filing lawsuits against GlaxoSmithKline, parents who took Zofran and say the drug caused their children to develop birth defects claim damages for:

  • pain and suffering
  • emotional distress
  • past and future medical bills
  • lost wages
  • punitive damages

Many Plaintiffs have also expressed a desire to promote increased corporate accountability within the pharmaceutical industry and prevent future harm to patients and children.

Q. Have Any Suits Been Settled Yet?

No. It’s likely that settlements will only become a possibility after several of the initial lawsuits proceed to a jury trial, and none of the claims have reached that point yet.

To find out more about why settlements happen and what form we believe the Zofran litigation will take, follow this link.

Q. What Allegations Have Plaintiffs Made Against GlaxoSmithKline?

In their complaints, parents have claimed that:

  • GlaxoSmithKline promoted Zofran for use during pregnancy, in violation of federal law. Specifically, Plaintiffs say the company marketed Zofran to doctors as a safe treatment for morning sickness, without ever performing any clinical trials that involved pregnant women. This accusation was first raised in 2012 by the US Department of Justice.
  • Zofran causes birth defects, including cleft palate and congenital heart defects. At least three studies have found that women who are prescribed Zofran during early pregnancy are between two and four times more likely to have babies with those congenital abnormalities.
  • GlaxoSmithKline has received mounting evidence of Zofran’s link to major birth defects but concealed it from the FDA, health community, and pregnant women nationwide.
  • GlaxoSmithKline failed to warn the public of Zofran’s safety risks, by failing to revise the drug’s labeling with warnings about a potential increased risk for major birth defects.
  • If Plaintiffs had been informed of Zofran’s link to birth defects, they would have chosen a different treatment, like Diclegis, the only FDA-approved medication for morning sickness.

Q. Who Is Eligible To File?

Any parent who was prescribed Zofran as an “off label” morning sickness treatment and delivered a baby with major birth defects may be entitled to bring a claim against GlaxoSmithKline.

With that being said, every case is unique and your own eligibility will depend entirely on the facts of your situation.

We urge you to contact our experienced attorneys for a free consultation to learn more about your legal options.

Q. What If I Took A Generic Version?

The answer to this question depends entirely on circumstances individual to your own situation.

With that being said, some states recognize a legal theory known as “innovator liability,” under which “brand name” drug companies (like GlaxoSmithKline) can be held accountable for injuries that may have been caused by generic drugs. Vermont, California, Illinois and Alabama are some examples, although Alabama’s legislature recently passed a bill that will prevent “innovator liability” claims beginning in October 2015.

In short, you may be able to file a Zofran birth defect claim even though you were prescribed a generic version of ondansetron, but case eligibility hinges on unique considerations that should be discussed in a free consultation with one of our attorneys.

Q. Would I Be Joining A Class Action?

No, Banville Law does not believe that the Zofran litigation will become a class action. Our attorneys are filing individual personal injury lawsuits, and representing individual families, parents and birth defect survivors.

We do, however, believe that it is likely that Zofran lawsuits will be “consolidated” in a Multidistrict Litigation (MDL). To learn more about MDL, click here.

Q. What About Statutes Of Limitations?

A statute of limitations is the defined time period in which individuals have to file suit following an injury, but these statutes vary by state. Many states have statutes of limitation lasting two, three or four years, but there are many exceptions. For injuries involving children, some children have longer statutes of limitation.

In some cases, our attorneys may be able to argue that a statute of limitations should be “tolled,” or paused, based on the allegations that GlaxoSmithKline concealed vital safety information from patients for decades. This same argument has been presented in the majority of currently-filed Zofran birth defect lawsuits.

Q. Has The FDA Issued A Warning?

Yes, but not in relation to the drug’s potential association with birth defects.

To find more information on FDA Safety Warnings that involve Zofran, click here.

Q. How Much Would Hiring Banville Law Cost?

Our attorneys work on a contingency-fee basis: we only collect fees after winning a court award or settlement in your favor. If we don’t win, you owe us nothing. This allows us to offer experienced legal counsel to our clients no matter their personal circumstances. Learning more about your legal options is also free.

Additional Zofran Information