Defendant Law Firm:
Shook Hardy & Bacon LLP.
The lawsuits claim allegation from women throughout the country that the prescriber was not properly intimated about the pregnancy risk that comes along with this anti-nausea drug. Families of these women claim that due to intake of Zofran during pregnancy, children were born with birth defects like cleft plates, ventricular septal defects, and other lifelong health issues.
Plaintiff Steering Committee
(As per MDL Order No. 8, December 17, 2015, ref: https://www.mad.uscourts.gov/worcester/pdf/2657%20orders%201-8.pdf)
Edward Blizzard - Esquire: Blizzard & Nabers
Kate Jaycox, Esquire - Robins Kaplan, LLP
Russell Budd, Esquire - Baron and Budd P.C.
Walter Kelley, Esquire - Kelley Bernheim Dolinsky, LLC
Amy Eskin, Esquire - Levin Simes
James Klick, Esquire - Herman, Herman & Katz
Wendy Fleishman, Esquire - Lieff, Cabraser, Heimann & Bernstein,LLP
Arthur Murray, Esquire - Murray Law Firm
Jeffrey Gibson, Esquire - Cohen & Malad, LLP
Steven Rotman, Esquire - HAUSFELD
Melissa Hague, Esquire - Anapol Weiss
Christopher Schnieders, Esquire - Wagstaff & Cartmell
Stephen Hunt Jr., Esquire - Cory Watson, P.C.
Anthony Tarricone, Esquire - Kreindler & Kreindler LLP
In 2012, GSK pled guilty to criminal charges filed by the U.S. Justice Department over the company’s illegal promotion of Zofran and other medications. Around the same time, GSK also entered civil settlements with the U.S. government that included over $1 billion in payments for its illegal marketing of numerous drugs, including Zofran.
In October 2015, lawsuits filed against GlaxoSmithKline (GSK) alleging that the anti-nausea medication Zofran caused birth defects were consolidated into a multidistrict litigation (MDL) in the District of Massachusetts before Judge Dennis F. Saylor, IV, forming MDL 2657 (In Re: Zofran (Ondansetron) Products Liability Litigation). Nearly 300 lawsuits are a part of the Zofran MDL.
Feb 2021: Judge F. Dennis Saylor IV of the U.S. District Court for the District of Massachusetts, overseeing the Zofran product liability litigation, announced that he is considering October as the start date for the first bellwether trial in the multidistrict litigation (MDL). The first bellwether trial was initially scheduled to begin in May 2020 but was put on hold in March due to the coronavirus pandemic.
Judge Saylor, during a monthly status conference, said that he proposed starting the trial after the Columbus Day holiday as he was feeling compelled to get a date back on the books. He also noted that the vaccination program in the state is also picking up and existing plans to have everyone in the court system vaccinated could help ease current jury trial restrictions.
The company and the plaintiffs involved in the litigation agreed for opening arguments to tentatively begin on October 18, 2021, and told the judge that the trial should last for two to four weeks.
June 2019: Based on an opinion re: Fosamax, an osteoporosis drug, released by the U.S. Supreme Court in May 2019, Judge Saylor asked the parties involved in Zofran litigation to submit a memorandum on how the court should proceed.
Following which GlaxoSmithKline asked U.S. District Judge Dennis Saylor overseeing Zofran birth defect lawsuits filed in the federal court to renew the request for summary judgment. The memorandum stated, ''Plaintiffs acknowledge that the FDA repeatedly rejected their proposed labeling change but claim that the FDA lacked four categories of information. This Court held that the materiality of those four categories was a question for the jury at trial. The Supreme Court has now made clear that this Court, not the jury, must resolve the materiality of such information.”
The plaintiffs submitted a separate memorandum requesting the Court to reject GlaxoSmithKline’s reasoning and proceed with the scheduled jury trials as planned for the following year.
August 2018 - The MDL proceeded with general discovery. The deadline was set to select potential bellwether trial cases before the end of 2018.
May 2018: U.S. District Judge Dennis Saylor overseeing hundreds of Zofran birth defect lawsuits ruled that GlaxoSmithKline can not be held liable in three cases where generic versions of the anti-nausea drug were ingested by three pregnant women that resulted in the dismissal of claims brought by the families. The generic versions were manufactured by other pharmaceutical companies, instead of the brand-name version of the drug GlaxoSmithKline developed and sold.
The plaintiffs involved in the lawsuits held GlaxoSmithKline liable for their injuries caused by the generic versions alleging GSK wisely promoted the off-label use of the anti-nausea drug for morning sickness that the FDA never approved Zofran to be used as an anti-nausea drug for pregnant women as safe and effective, and resulted in the prescription of generic equivalents.
Judge Saylor wrote in the decision: “[P]laintiffs seek to proceed on what is essentially a theory of intentional or negligent misrepresentation or negligent undertaking. The theory is based on the allegation that GSK ‘created a market' for the drug’s use to treat pregnancy-related nausea that led to the use of generic alternatives, and therefore should be liable for all injuries created by those products. None of the highest courts of the three states in question have issued rulings directly on point, and therefore this Court must endeavor to predict how those courts might rule.”