On January 22, 2016, United States District Judge F. Dennis Saylor IV denied pharmaceutical giant GlaxoSmithKline’s motion to dismiss lawsuits filed against the company regarding its anti-nausea medication Zofran. Many women who took Zofran for morning sickness during pregnancy gave birth to babies born with severe abnormalities, including cleft palates, congenital heart defects, club feet, vision and hearing issues, and facial deformities.
GlaxoSmithKline Argument
GSK’s argument was that the plaintiff’s suits about its failure to warn pregnant women of the risks were based on state, not federal, laws. It also referenced a possible FDA denial of a label change on Zofran. The plaintiffs response was that GSK’s motion for dismissal was “unprecedented and violates established federal law.”
Zofran
Zofran received U.S. Food and Drug Administration approval as an anti-nausea drug for cancer patients during chemotherapy. Although obstetricians began prescribing it to women with morning sickness, the FDA never approved it for that use. The FDA does permit doctors to prescribe drugs “off-label” for other than their intended use, but doctors did not warn women that taking Zofran increased the risk of their child developing birth defects.
Reasons Dismissal Denied
The court cited three issues in its decision to reject GSK’s motion to dismiss the lawsuits. These are:
- Reluctance to approve the motion without allowing the plaintiffs time to gather facts showing the warnings were inadequate.
- A misplaced charge by GSK because the company is equating changes in a citizens’ petition sent to the FDA in 2013 – rejected by the FDA in October, 2015 – with one requested by a drug manufacturer. The court stated there was no “clear evidence” that the FDA would have rejected a request by GSK for a stronger warning label for Zofran.
- Lack of clarity on why warnings requested by the citizens’ petition were rejected by the FDA.
Previous GSK Fraud Case
GSK previously settled a tremendous fraud case brought by the U.S. Department of Justice, and agreed to pay a $3 billion fine. Among the complaints brought by the USDOJ was that GSK promoted Zofran to pregnant women without FDA approval, and paid kickbacks to health care providers to prescribe the company’s drugs to patients.
What This Means for Zofran Lawsuits
In his order, Judge Saylor states, “The plaintiffs [should be given] the opportunity to develop the facts, whatever those facts may be.” The judge’s decision means that plaintiffs may now move on to the discovery phase, in which both sides can seek information prior to a trial.
The Goldwater Law Firm – Nationwide Drug Injury Lawyers
If you or a loved one took Zofran during pregnancy and delivered a child with birth defects, you may be eligible to seek compensation. This may include compensation for the child’s medical expenses, as well as pain and suffering. Our attorneys will evaluate the case details and make sure you understand your rights and options before moving forward as part of a Zofran lawsuit. Contact the Goldwater Law Firm for a free consultation today.