Zofran Defendant Seeks Dismissal of Lawsuits Involving Generic Equivalents

Published on November 10, 2016 by Sandy Liebhard

GlaxoSmithKline, the primary defendant in hundreds of Zofran birth defects lawsuits, is seeking to have more than two dozen federal cases dismissed that involve the drug’s generic equivalents. The company has also asked to have all fraud claims tossed from cases pending in the multidistrict litigation now underway in the U.S. District Court, District of Massachusetts.

Just over 300 Zofran lawsuits have been centralized in the District of Massachusetts, all of which accuse Glaxo of concealing the drug’s alleged association with birth defects. Plaintiffs further claim that the company improperly marketed Zofran as a safe and effective remedy for pregnancy-related nausea and vomiting.

In a Motion filed on October 13^th, Glaxo asked the Court to dismiss 27 generic drug cases, asserting that they were filed under state laws that purportedly “do not permit a defendant to be held liable for a product it did not manufacture, sell, or distribute.” In a second motion seeking dismissal of all fraud-based claims, the company argued that any “contention that GSK, through its marketing, promotion, and labeling, somehow misrepresented facts about Zofran […] lacks basic factual detail.”

Zofran birth defects plaintiffs fired back in a response filed on October 26^th, calling the motions “sweeping,” and characterizing both as an effort to “derail” the multidistrict litigation before discovery can even begin.

Zofran and Pregnancy

Zofran is an anti-nausea medication that is only approved to treat surgery patients and those undergoing certain cancer treatments. However, the medication is routinely prescribed to expectant mothers to relieve nausea and vomiting related to pregnancy, even though its effects on a developing fetus have not been well studied.

In 2012, GlaxoSmithKline agreed to pay $3 billion to the federal government in order to settle allegations that it had improperly marketed a number of medications. Among other things, the company had been accused of marketing Zofran as an off-label treatment for morning sickness.

In 2006, research published by Hong Kong scientists confirmed that Zofran crosses the placenta when taken by pregnant women. In November 2011, a study published in Birth Defects Research Part A: Clinical and Molecular Teratology concluded linked pre-natal exposure to Zofran to a more than a 2-foled increase in the risk for cleft palate.  And in August 2013, a study of more than 900,000 pregnancies listed in the Danish Medical Birth Registry indicated that children exposed to Zofran in-utero may be two to four times more likely to suffer a septal heart defect.