GlaxoSmithKline Hit with 193 Lawsuits over Morning Sickness Drug that Causes Birth Defects

Wednesday, November 11, 2015
(photo: Getty Images/iStockphoto/ThinkStock; photo illustration: Steve Straehley, AllGov)

GlaxoSmithKline (GSK) brought Zofran to market in 1991 to treat nausea brought on by cancer treatment, but wanted to expand the drug’s use—and the company’s profits—and pushed the drug to doctors as an off-label treatment for morning sickness. Now, the company is facing hundreds of lawsuits over birth defects caused by the drug.


As of November 2, GSK faced 193 civil cases concerning Zofran, according to Courthouse News Service. Twenty-seven were filed in just one day in federal courts in Alabama and in Boston.


One was filed by Deana Brown, who was prescribed Zofran as an off-label cure for her morning sickness. Brown’s daughter was born with congenital band syndrome and teratologic clubfoot, according to her complaint. Congenital band syndrome results in a fetus becoming “entangled in fibrous, string-like amniotic bands in the womb that can wrap around fingers, toes and limbs, restricting blood flow and normal development, and cause complete amputation,” Courthouse News Service reported. Teratologic clubfoot causes unborn babies’ feet to rotate inward.


Brown charges use of Zofran for morning sickness amounts to “experimenting with the lives of unsuspecting mothers-to-be and their babies.”


The suit charges that GSK was warned as early as 1999 by the Food and Drug Administration to “immediately cease distribution” of ads that “promote Zofran in a manner that is false or misleading because it lacks fair balance.”


Instead, the suit charges, GSK urged its sales staff to “emphasize to medical providers not only the benefits of Zofran but also the financial benefits to the providers by prescribing Zofran. Specifically, ‘[b]y using a 32mg bag [of Zofran], the physician provides the most effective dose to the patient and increases his or her profit by $__ in reimbursement.’”

-Noel Brinkerhoff, Steve Straehley


To Learn More:

Zofran Birth-Defect Lawsuits Piling Up v. Glaxo (by Philip A. Janquart, Courthouse News Service)

Glaxo Agrees to Pay Record $3 Billion Settlement for Fraud and Hiding Drug Safety Data (by David Wallechinsky and Noel Brinkerhoff, AllGov)

Glaxo Pays Out $1 Billion in Birth Defect Cases with 600 Lawsuits to Go (by Noel Brinkerhoff, AllGov)


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