The Perils of Off-Label Promotion in the Zofran Litigation

With more than 230 Zofran lawsuits consolidated in MDL 2657, the Zofran litigation provides an opportunity to reflect upon the dangers of “off label” marketing by pharmaceutical companies. By definition, “off label” is defined as an unapproved use of a medication that has not been approved by the U.S. Food and Drug Administration (FDA). A common example of “off label” use occurs when the medication is prescribed to treat a disease or medical condition that has not been approved by the FDA. Although medical professionals have the ability to prescribe medications for off-label uses, it is illegal for pharmaceutical companies to promote their drugs for off-label uses. The allegations in the Zofran litigation provide a prime example of the dangers of off-label promotions by pharmaceutical companies.

By way of background, Zofran is a powerful drug developed by GlaxoSmithKline (“GSK”) intended to treat only those patients who were afflicted by the most severe cases of nausea. The Food and Drug Administration approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy. Yet, Plaintiffs GSK made the intentional decision to market Zofran “off label” as a safe and effective treatment for the very common side effects of nausea and vomiting during pregnancy, commonly known as “morning sickness.” Quite tragically, Zofran has been shown to cause serious consequences to the children of pregnant women, including heart defects, cleft lip/foot and other serious birth defects.

In the 1980s, GSK conducted animal studies which revealed evidence of toxicity, deaths and defects in offspring, and showed that the active ingredient in Zofran transferred through the placental barrier of pregnant animals to fetuses. In 1992, GSK began receiving mounting evidence of reports of birth defects associated with Zofran. In addition, large-scale epidemiological studies have demonstrated an elevated risk of developing birth defects. Further, the Zofran lawsuits allege that GSK marketed Zofran “off label” for the treatment of “morning sickness” without ever undertaking a single study on the effects of the drug on a pregnant woman or her child growing in utero, or seeking FDA approval to market the drug for treatment during pregnancy.

Instead of disclosing any of the above information to pregnant women or the physicians, GSK sales representatives specifically marketed and promoted Zofran as a morning sickness drug. In 2012, GSK pled guilty to criminal charges and paid $3 billion to settle criminal and civil liability for the unlawful promotion of the drugs.

The tragic reality is that there are numerous medications that are specifically approved for the treatment of morning sickness. To make matters worse, the women who took Zofran were not informed that the medication was associated with birth defects. As such, they were prescribed Zofran for an off-label use without ever being warned of the risks of birth defects.

As discovery unfolds in MDL 2657, further details regarding the off-label promotion and use of Zofran, along with the failure to warn, will become ever clearer. Yet, the victims of Zofran will never truly understand how or why they were convinced to take a morning sickness drug that circumvented the FDA’s approval process and essentially ignored scientific evidence regarding the risks of Zofran ingestion by pregnant women.

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