Court Overseeing Zofran Birth Defects Lawsuits Allows Fraud-Based Labeling Claims to Stand

Published on April 25, 2017 by Sandy Liebhard

Plaintiffs pursuing Zofran birth defects lawsuits recorded a win yesterday after a federal judge in Massachusetts found that fraud-based allegations involving the drug’s labeling were adequately pled. However, U.S. District Judge F. Dennis Saylor IV did dismiss some fraud-based claims pertaining to Zofran marketing and promotional efforts, after finding those were too broad.

Zofran Background

Zofran is an anti-nausea medication marketed by GlaxoSmithKline. Introduced in 1991, it is currently approved to treat nausea in patients undergoing surgery or certain cancer treatments. While Zofran has never been approved to treat nausea or vomiting related to pregnancy, a 2014 analysis suggested that as many as 1 million expectant mothers are prescribed the drug on an annual basis in the U.S.

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.

The Zofran Litigation

At least 364 Zofran lawsuits are currently undergoing coordinated pretrial proceedings in the U.S. District Court, District of Massachusetts. Plaintiffs involved in the proceeding include parents and caregivers of children who were born with oral clefts, heart malformations and other congenital abnormalities allegedly related to their mothers’ use of Zofran during the first trimester of pregnancy. GlaxoSmithKline is accused of concealing evidence linking prenatal Zofran use to an increased risk of birth defects and of failing to adequately warn doctors and patients of this danger.

Zofran lawsuits put forth three types of fraud-based claims: Those pertaining to misrepresentations allegedly contained in the drug’s labeling; those pertaining to misleading statements made by Glaxo sales reps to prescribing physicians; and those pertaining to misrepresentations included in advertising and promotional materials for the drug. In dismissing claims involving Zofran’s marketing and promotional materials, Judge Saylor found that the plaintiffs’ master complaints did not identify the time, place, or content of any actual statements made by Glaxo.  He also found that there was “not a single allegation in the master complaint or any individual complaint as to any actual statement or representation made by any sales representative to any physician.”

However, Judge Saylor did find that fraud-based claims specific to the Zofran label were adequately pled.

“The labeling-based claims satisfy the requirements of Rule 9(b), because they are sufficiently specific as to the ‘time, place and content of the alleged false representation,’” he explained. “The content of the statement is specifically quoted in paragraph 50. The time of the statement is alleged to have been a continuous period beginning in 1993. And while the ‘place’ of the statement could no doubt be alleged with more particularity, it is a fair inference that the labeling statement was readily available to all physicians from a variety of sources. Whether those representations were actually false is, of course, a question for another day.”