A Massachusetts federal judge has refused to dismiss fraud-based claims from multidistrict litigation complaints alleging that GlaxoSmithKline PLC’s anti-nausea drug Zofran is linked to birth defects. U.S. District Judge F. Dennis Saylor IV said that claims about the drug’s labeling are sufficiently specific to pass muster. However, he found the suit’s marketing-campaign allegations too broad. Consumers say GSK knowingly misrepresented the safety of taking Zofran during pregnancy in its advertising and marketing campaigns. However, the plaintiffs haven’t provided a specific allegation — either in the master complaints or the individual ones — about any advertisements, brochures, presentations or the like. Judge Saylor said allegations that individual GSK sales representatives misrepresented the safety of taking Zofran during pregnancy to doctors were also expressed in very broad terms.
Judge Saylor found allegations that Zofran’s labeling misrepresented its safety during pregnancy to be sufficiently specific, pointing to a statement about teratogenic effects, which the suit alleges is misleading, that has been included in the drug’s prescribing information since 1993. The judge said:
Accordingly, because plaintiffs adequately pleaded the content, time, and place of the allegedly false representations made in Zofran’s product labeling, the fraud-based claims premised on that misrepresentation satisfy the requirements of Rule 9(b). Whether those representations were actually false is, of course, a question for another day.
The MDL plaintiffs accuses GSK of marketing and promoting Zofran to treat pregnancy-related nausea and vomiting, when the U.S. Food and Drug Administration cleared it only for nausea and vomiting related to chemotherapy, radiation therapy or operations. The plaintiffs say that the labels for Zofran and its generic equivalent, ondansetron, don’t specify that the drug has been linked to cardiovascular and cleft palate birth defects.
The plaintiffs are represented by Tobias L. Millrood of Pogust Braslow & Millrood LLC, Kimberly D. Barone Baden of Motley Rice LLC, M. Elizabeth Graham of Grant & Eisenhofer PA, and Robert K. Jenner of Janet Jenner & Suggs LLC and and Kimberly Dougherty of Andrus Wagstaff. The case is In Re: Zofran (Ondansetron) Products Liability Litigation (case number 1:15-md-02657) in the U.S. District Court for the District of Massachusetts.