Zofran Litigation May See MDL Consolidation

GlaxoSmithKline, the manufacturer of Zofran, recently submitted a motion asking for consolidation of all Zofran lawsuits claiming birth defects into a multi-district litigation. The motion requested Pennsylvania as the consolidation venue, likely due to the fact the Philadelphia Navy Yard is where GSK’s headquarters are located.

MDL consolidation contributes to a more efficient process for the disposition of multiple cases with similar facts. Motions and pre-trial discovery in an MDL is shared, therefore more coordinated, and discovery already completed in some cases can be used in others. MDLs also offers consistency, in that the important decisions are made by a single judge who either is already an expert on the facts and the relevant laws associated with the issue or will be soon.

GlaxcoSmithKline Asks for MDL Consolidation Despite Potential Risks

Some defendants resist having lawsuits against them consolidated into an MDL because the publicity of an MDL can—and probably will—attract other plaintiffs. The more lawsuits faced by a defendant, the greater the exposure and the more pressure the manufacturer may feel to settle the claims. Despite the potential risks multi-district litigation offers to GlaxoSmithKline, the manufacturer apparently feels the benefits outweigh the risks.

Allegations against GlaxoSmithKline

Thus far, there have only been twelve Zofran lawsuits filed, with each complaint containing similar allegations—namely that GSK failed to warn women of the risks Zofran posed to unborn children. The complaints also allege GSK improperly marketed Zofran for off-label use as a treatment for severe morning sickness. Zofran gained FDA approval only for use in patients who suffered from the nausea associated with chemotherapy, radiation and other surgical procedures.

Most of the Zofran lawsuits filed as of July 7, 2015, involve congenital heart defects which required one or more surgeries to repair. One of the lawsuits involves a miscarriage resulting from in utero exposure to Zofran. Studies have linked Zofran to birth defects such as cleft lip, cleft palate, atrial septal defect and ventricular septal defect (hole in the heart).

Will GSK’s Motion for Consolidation Be Granted?

Lawsuits have been filed in the following states: Minnesota, Massachusetts, Montana, Louisiana, Ohio, Arkansas, Texas and California. For those who filed their lawsuit in state court, the case may be removed to federal court, then transferred to the MDL. It is widely speculated among those involved in the Zofran birth defect cases the motion to consolidate will be accepted.

Plaintiffs in the Zofran cases will likely cited studies which found a significantly increased risk of cardiac septal defects in babies whose mothers took Zofran during the first trimester of their pregnancy. One study performed at Harvard University definitively linked Zofran to cleft lip and cleft palate birth defects.

Off-Label Use of Zofran

While doctors are legally allowed to prescribe drugs off-label (for a condition not approved by the FDA), GSK actively promoted Zofran for use in pregnant women who suffer from morning sickness. GSK conducted only one Zofran study regarding the risks of birth defects which involved fewer than 200 pregnant women. Despite this, the company continued to promote the drug for morning sickness, and allegedly paid kickbacks to doctors who prescribed the drug for that purpose.

In 2012 GSK paid the U.S. Department of Justice $3 billion for misleading advertising which touted Zofran as a treatment for the nausea associated with pregnancy. Parents of babies born with birth defects can face months, years or even a lifetime of medical expenses. If Zofran was responsible for your baby’s birth defect, a knowledgeable personal injury attorney can seek justice on your behalf.

Contact Our National Dangerous Drug Lawyers

If you took Zofran during pregnancy and your baby was born with a congenital defect, it is important to speak one of the experienced national dangerous drug attorneys at Golomb Legal immediately. Our lawyers can answer all your questions regarding the current Zofran litigation and determine if you are eligible to file a lawsuit against the manufacturers of Zofran.

To learn more about your legal options or to schedule a free consultation call the Philadelphia class action lawyers at Golomb Legal today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb Legal have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.