Sonya Lampkin filed the lawsuit on behalf of her son, an unnamed minor in the petition filed March 4, 2015 in Superior Court for the State of California in Alameda County.
The defendant, GlaxoSmithKline (GSK), is being sued by Ms. Lampkin for “compensative and punitive damages, equitable relief, and such other relief deemed just and proper arising from the injuries to (the boy) as a result of his prenatal exposures to the prescription drug Zofran, also known as ondansetron.”
Negligence, Product Liability, Fraud
The complaint demands a jury trial after listing damages which include: Negligence; Negligence Per Se; Strict Products Liability; Fraudulent Misrepresentation; Fraudulent Concealment; Negligent Misrepresentation; Breach of Express Warranty; and Breach of Implied Warranty of Merchantability and Fitness for Particular Use.
Zofran is a powerful drug developed by GSK to treat only those patients who were afflicted with the most severe nausea imaginable, such as that suffered by cancer patients undergoing chemotherapy or radiation treatments. The FDA approved Zofran for such patients in 1991.
Off-Label Marketing, Human Guinea Pigs
The complaint states that although the only FDA approval for this drug was for seriously ill patients, GSK marketed Zofran “off label” as a safe and effective treatment for the very common side effects of normal pregnancy such as nausea and vomiting, otherwise known as “morning sickness.” GSK did so, says the complaint, despite having knowledge that such representations were utterly false, as GSK had never once undertaken a single study on the effects of Zofran on a pregnant woman or her child in utero. GSK’s conduct, said the complaint, “was tantamount to using expectant mothers and their unborn children as human guinea pigs.”
The complaint also alleges that GSK knew Zofran was unsafe for pregnant mothers by virtue of its having conducted animal studies in the 1980s that showed evidence of toxicity, intrauterine deaths, and malformations in offspring. The petition also alleges that “a later study conducted in humans confirmed that Zofran crossed the human placenta barrier and exposed fetuses to substantial concentrations.”
The petition also alleges GSK received mounting evidence of harm to the offspring of pregnant women, that GSK had received at least 32 reports of Zofran-linked birth defects by 2000, and more than 200 such reports to date.
GSK pled Guilty to Criminal Charges
The petition also reminds the court that GSK pled guilty to criminal charges in the U.S. for its off label promotion of its drugs for uses never approved by FDA. GSK also entered civil settlements in the U.S. that included $1 billion in payments to the feds for the company’s illegal marketing of various drugs, which included Zofran.
Zofran Case alleges Birth Defects
The petition states that GSK’s conduct has caused “devastating, irreversible, and life-long consequences and suffering to innocent newborns and their families” like the plaintiff. The petition states the plaintiff’s minor child, J.S., was born in 2010 with a congenital heat defect after his mother was prescribed and began taking Zofran for morning sickness in her first trimester. It was also discovered after birth that the child suffered from a serious heart defect known as supraventricular tachycardia.
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