GlaxoSmithKline Fraud In Connection With Zofran

In June 2012, GlaxoSmithKline (GSK)—maker of Zofran, also known as ondansedtron—plead guilty to federal criminal health care fraud. In a watershed claim, a whistleblower came forward claiming that GSK wrongfully promoted Zofran for off-label prescription to expectant mothers, while also paying kickbacks to the doctors who were prescribing it for such use. In what would was the single largest health care fraud recovery in U.S. history, GSK was levied $1 billion in criminal penalties $2 billion in civil penalties.

Zofran was originally approved by the FDA to help mitigate nausea and vomiting for patients being treated with cancer; but, GSK soon realized that Zofran could also potentially be used to mitigate morning sickness for expectant mothers in their first trimester. To that end, GSK instituted a scheme, where they promoted the drug not for its approved use, but also for this off-label use. Doctors who prescribed the drug were given kickbacks for doing so. Additionally, GSK was found to be suppressing clinical trial data that showed adverse effects of Zofran.

A Global Scheme
GSK did not just institute this scheme in the U.S.; they took it global. In China, GSK is still reeling from their fraudulent activities, where a Chinese court found GSK guilty of the same misconduct. The Chinese court also levied GSK a $490 million penalty.

Users of Zofran
Given the scope of GSK’s scheme, coupled with FDA approval of the drug in 1991, it is still unknown exactly when the scheme started. But, the reach of GSK’s scheme, and the number of patients affected is numerous.

Expectant mothers who were prescribed Zofran in their first trimester to treat morning sickness have an increased risk of a child being born with serious birth defects. Most recently in LeClair v. GlaxoSmithKline (February 2015), the plaintiff’s mother was a user of Zofran during her first trimester. Operating under the assumption that it was safe based upon the GSK’s failure to warn users of the risks, Ms. LeClair took Zofran which – must unfortunately – cause her child to be born with several congenital birth defects. Ms. LeClair seeks monetary and punitive damages for GSK’s failure to warn her of the adverse effects of Zofran.

A Drug Manufacturers Duty
Given the background unearthed during the FDA’s investigation of GSK, the investigation indicated that GSK knew in the early 1990s—soon after the drug was approved for its original use—that Zofran presented an unreasonable risk of causing birth defects. Nonetheless, GSK went forward with its marketing and sale of the Zofran, and is accused of having suppressed adverse clinical trial data. GSK is accused of breaching its obligations by failing to:

  • Ensure that Zofran was safe before offering it to the public
  • Warn the public of adverse side effects of Zofran
  • Be forthcoming to the FDA with information regarding adverse results from clinical studies of Zofran

Getting Help
Drug manufacturers are charged with providing drugs that are safe and effective for the prescribed treatment. When those obligations aren’t met—especially when the risks of the drug are not fully disclosed—the drug manufacturer may be found legally liable for injuries sustained by a patient using the drug. Pursuing damages related to your injury, you can potentially recover compensatory or punitive funds.

Contact our defective drug lawyers today, to schedule your free initial consultation to review your possible claim for damages. The law firms associated with Jacoby & Meyers are located across the United States, so that Jacoby & Meyers can assist you no matter where you are located, or where the injury occurred.

Jonathan Cianfaglione, student intern Jacoby & Meyers