Zofran Lawsuits Cite 2012 Settlement to Back Off-Label Marketing Claims

Published on March 9, 2015 by Sandy Liebhard

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Plaintiffs who have recently filed Zofran lawsuits have cited a 2012 settlement GlaxoSmithKline reached with the federal government as evidence to support their allegations that the company illegally promoted the use of the anti-nausea medication as a treatment for pregnant women. According to the U.S. Department of Justice, the $3 billion settlement was the largest involving healthcare fraud.

Zofran is only approved to prevent nausea and vomiting experienced by post-op surgery patients, or those undergoing certain radiation or chemotherapy treatments for cancer. The drug has never been approved for nausea and vomiting related to pregnancy, but a growing number of Zofran cases allege that it is often prescribed off-label for this purpose. These claims have been filed on behalf of children who allegedly developed serious birth defects due to their mother’s use of the medication during pregnancy.

2012 Zofran Settlement

The 2012 DOJ settlement involved a number of Glaxo medications, including Zofran, Paxil, Wellbutrin, Advair and Lamictal. The company was accused of promoting the drugs for uses that had not been approved by the U.S. Food & Drug Administration (FDA), including the use of Zofran for morning sickness. Glaxo was also accused of paying doctors kickbacks to induce them to prescribe these and other medications.

“GSK’s sales force bribed physicians to prescribe GSK products using every imaginable form of high priced entertainment, from Hawaiian vacations to paying doctors millions of dollars to go on speaking tours to a European pheasant hunt to tickets to Madonna concerts, and this is just to name a few,” Carmin M. Ortiz, U.S. attorney in Massachusetts, said when the accord was announced.

Under the terms of the settlement, Glaxo pled guilty to promoting off-label use of Paxil and Wellbutrin, and to concealing safety data involving its diabetes drug, Avandia. However, it did not admit wrongdoing in resolving any of the other charges, including those that involved Zofran.

The $3 billion penalty paid by Glaxo included $1 billion in criminal fines and forfeitures. The remaining $2 billion covered civil settlements with the federal government, and with the state governments of Massachusetts and Colorado.

Zofran Birth Defect Litigation

Now, less than three years later, Zofran lawsuits are beginning to mount in U.S. courts, all of which accuse Glaxo of concealing data linking the drug to birth defects, and aggressively promoting its use in pregnant women. Among other things, Zofran birth defect plaintiffs point out that the medication has been classified by the FDA as a Pregnancy Category B drug, which indicates it has not been well-studied in pregnant women. The lawsuits also allege that Glaxo had data from animal studies conducted in the 1980s that linked the drug to intrauterine death and malformations, as well as data that suggested the drug could cross the placental barrier in pregnant mammals. They also contend that since 1992, the company has received hundreds of report of birth defects in children whose mothers were prescribed Zofran while they were pregnant.

The Zofran litigation over birth defects is just beginning to move forward, and Bernstein Liebhard LLP is actively investigating cases involving heart defects, kidney malformations, cleft lip and palate, and other congenital abnormalities that may be linked to this drug. If you would like to learn more about filing a Zofran lawsuit, please contact our office by calling to learn more about your possible legal options.

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