Zofran Birth Defect Lawsuits Cleared For Early Bellwether

Zofran Birth Defect Lawsuits Cleared For Early Bellwether

Introduction

U.S. District Judge Dennis Saylor issued a memorandum and order on February 5, denying summary judgment motion filed by GlaxoSmithKline to toss all Zofran birth defect lawsuits and allowed a group of cases to prepare for early bellwether trials.

GSK argued that the plaintiffs' failure-to-warn claims were preempted by federal law; however, Judge Saylor disagreed with the argument and indicated there was no clear evidence that GSK was prevented from updating Zofran's label warnings for birth defects. On the same day, Judge Saylor also issued a scheduling order for case-specific discovery, Daubert motions, and dispositive motions, affirming that the litigation is moving forward for a series of bellwether trials. The pretrial schedule stated that depositions including all case-specific experts must be concluded by May 24, 2019, and motions to exclude or restrict case-specific expert testimony or opinions, and case-specific dispositive motions must be filed by June 21.

Zofran is labeled as Pregnancy Risk Category B, meaning there is no evidence of risk to humans. Many mothers took this assurance to mean the drug was safe, but multiple studies show evidence to the contrary. Because Glaxo never proved the drug was safe, the FDA never approved market the drug to pregnant women. Regardless, Glaxo continued to advertise its anti-emetic for morning sickness.

Before getting a prescription for the Zofran drug, the patient must inform the doctor about being diagnosed with phenylketonuria (PKU) or not. Zofran is a disintegrating tablet that may contain phenylalanine. Patients should be aware of the side effects of Zofran which include blurred vision, trouble in breathing, anxiety, slow heart rate, and having urination problems.

If the patient comes across any of this problem, you should stop the use of Zofran immediately. The intake of Zofran should be avoided if the patient is using apomorphine (Apokyn) or allergic to ondansetron. To ensure the safety of the usage of Zofran drug, before getting prescribed, informed the doctor if you have been diagnosed with liver disease or not.

Also, if patients have a blockage in their digestive tract or suffer from a slow heartbeat, they should inform the medical prescriber about these health concerns, which will let them decide whether to go ahead with this drug or not.

More than 468 lawsuits have been filed against GSK alleging that the company knew about Zofran's pregnancy risks for several years, yet failed to adequately warn the medical fraternity. Zofran lawsuits were centralized in October 2015, before Judge Dennis F. Saylor as a part of multidistrict litigation (MDL No. 2657; In Re: Zofran (Ondansetron) Products Liability Litigation) in the District of Massachusetts.