Feds Create Special MDL Court For Growing Zofran Lawsuits

Wednesday, October 21, 2015

Earlier this year, DrugNews reported on the growing concern among doctors that Zofran, a drug prescribed off-label for morning sickness in pregnant mothers, might raise the risk of serious birth defects.

Now, amid increased attention and a swell of lawsuits by families whose children have suffered birth defects, a federal panel has created a specialized Zofran multidistrict litigation court (MDL) to handle the cases.

On October 13th, the United States Judicial Panel on Multidistrict Litigation transferred 12 similar cases from around the country alleging Zofran birth defects to a new federal court in Massachusetts under U.S. District Judge Dennis Saylor.

Currently, the number of pending Zofran lawsuits in the MDL court has grown to 15. Experts expect that, as word spreads, as many as 1,000 families whose children have suffered birth defects may come forward to file claims.

The formal case is known as MDL No. 2657 - IN RE: Zofran (Ondansetron) Products Liability Litigation.

Multidistrict litigation courts offer the benefits of a class action – shared legal resources and a unified consumer force, with the freedom of an individual lawsuit. Plaintiffs can pick their own counsel and have more control over the outcome of their case. They have been used in recent years to achieve massive settlement for victims of Vioxx, Yaz, Pradaxa and Actos.

While litigation could take several years, the formation of this special court will place pressure on the maker of Zofran, GlaxoSmithKline, to offer compensation to victims.

Zofran, also known by its chemical name ondansetron, was first approved by the FDA in 1991. It is considered a vital medication for curbing nausea in patients undergoing cancer treatment or who have recently had surgery.

However, due to its strong effects, GlaxoSmithKilne began urging doctors to prescribe it “off-label” for the unapproved use of morning sickness.

Recent studies have shown that the use of Zofran during the first trimester of pregnancy can double the risk for heart defects, cleft palate and other birth defects.

Since 2006, generic forms of Zofran have been available, so sales of the name-brand version have fallen. However, before that time, Glaxo was earning a reported $1.5 billion each year through their illegal marketing of the drug.

Anyone whose child was born with a birth defect after they used Zofran is urged to speak with a lawyer about their rights and joining the current litigation. It costs nothing to investigate your claim or file a case. Contact DrugNews today to talk directly with a lawyer handling these claims.



JPML Transfer Order. (October 13, 2015). Retrieved from www.jpml.uscourts.gov

Trader, S. JPML Consolidates Birth Defect Suits Over GSK's Zofran. Law360. (October 13, 2015). Retrieved from www.law360.com

birth defects

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