Zofran Birth-Defect Lawsuits Piling Up v. Glaxo

     BOISE (CN) – GlaxoSmithKline pushed its chemotherapy drug Zofran for morning sickness, an off-label use that causes birth defects, “experimenting with the lives of unsuspecting mothers-to-be and their babies,” with a “profit maximization” slogan for doctors, a mother claims in Federal Court.
     Doctors are allowed to prescribe drugs for off-label uses, but drug companies are not allowed to push the drugs to doctors or patients for uses not approved by the U.S. Food and Drug Administration.
     In 2012, GlaxoSmithKline agreed to plead guilty and pay $3 billion to settle criminal and civil fraud charges for promoting Zofran and other drugs “in a manner that is false or misleading,” the Department of Justice said in a July 2, 2012 statement.
     Yet in 1999 the FDA had ordered GlaxoSmithKline to “immediately cease distribution” of ads that “promote() Zofran in a manner that is false or misleading because it lacks fair balance,” Deana Brown says in her Oct. 29 lawsuit against GSK, citing statements from the Department of Justice and the FDA.
     Despite these warnings, Brown claims, GSK’s “fraudulent marketing campaign” made Zofran a “blockbuster” drug (a drug with more than $1 billion in annual sales), selling $1.4 billion of it worldwide in 2002, $1.1 billion of it in the United States.
     Brown, whose baby was born with birth defects, says GSK offered doctors a chance to get in on its lust for profits.
     GlaxoSmithKline is the defendant in 193 lawsuits filed about Zofran this year, according to the Courthouse News database — 16 of them on Friday alone in Alabama federal courts, and 11 more that day in Boston.
     The FDA approved Zofran in 1991 to control nausea and vomiting for chemotherapy patients. Brown claims that GSK knew that its safety during pregnancy had not been established.
     “But with more than 6 million annual pregnancies in the United States since 1991 and an estimated 70 to 80 percent incidence of pregnancy-related nausea, the absence of a prescription medication that was approved by the FDA for pregnancy-related nausea presented an extremely lucrative business opportunity for GSK to expand its sales of Zofran, which before its patent ran out in 2006 was one of the most expensive drugs available in the U.S. market,” according to the complaint. “GSK seized that opportunity, but the effect of its conduct was tantamount to experimenting with the lives of unsuspecting mothers-to-be and their babies.”
     GlaxoSmithKline, based in the United Kingdom, was rated by Forbes in 2014 as the sixth largest drug company in the world, with $35 billion in revenue that year.
     Brown’s complaint cites damning marketing material that she says GSK provided its sales staff in the early 1990s, directing them 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.'” (Brackets in complaint.)
     GlaxoSmithKline even developed a catchy motto for its sales staff to pitch to doctors about its premixed Zofran bag: “Profit Maximization – It’s in the Bag.” Brown claims GSK did this until the Department of Justice began investigating it in the early 2000s.
     Brown’s daughter was born in 2007 with congenital band syndrome and teratologic clubfoot, she says in the complaint. She was prescribed Zofran in her first trimester of pregnancy. She has no family history of these conditions. She says she sued GSK last week because she was not previously aware of the history of Zofran.
     “Plaintiffs did not suspect, nor did plaintiffs have reason to suspect, the tortious nature of the conduct causing the injuries, until a short time before filing this action,” the complaint states. “Additionally, plaintiffs were prevented from discovering this information sooner because GSK has misrepresented to the public and to the medical profession that Zofran is safe for use in pregnancy, and GSK has fraudulently concealed facts and information that could have led plaintiff to discover a potential cause of action.”
     Andrea Fischer, press officer for the FDA’s Center for Drug Evaluation and Research, said she could not comment on Zofran because of Brown’s lawsuit.
     Brown’s attorney in Boise, Kira Dale Pfisterer, with Hepworth Janis & Kluksdahl, would not comment on the case, referring Courthouse News to lead counsel Aimee Wagstaff, of Andrus & Wagstaff in Denver, who did not immediately respond to a request for comment.
     Brown seeks damages for negligence, product liability, fraudulent misrepresentation and concealment, breach of express warranty, breach of implied warranty, loss of consortium and violations of Idaho’s Consumer Protection Act, plus medical expenses and attorneys’ fees.
     Congenital band syndrome, also known as amniotic band syndrome, occurs when a fetus becomes entangled in fibrous, stringlike amniotic bands in the womb that can wrap around fingers, toes and limbs, restricting blood flow and normal development, and cause complete amputation.
     Teratologic clubfoot is one of two types of a deformity that cause unborn babies’ feet to rotate inward. Congenital clubfoot can be classified as “idiopathic,” an isolated skeletal anomaly, but teratologic clubfoot is thought to be the result of genetic syndromes, neurological disorders and “teratological anomalies,” which can be manifestations of abnormal development caused by toxic substances, according to the National Center for Biotechnology Information.

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