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Mother Says GSK Deceived Public about Zofran Birth Defects: Son Permanently Injured

pregnant woman cradles belly with visible fetusA mother from Marion County, Illinois, has filed a Zofran heart defect lawsuit against GlaxoSmithKline LLC (GSK), the manufacturer of Zofran, the anti-emetic also known as ondansetron.

The Plaintiff is the mother and natural guardian of her son, who the suit claims was born with a ventricular septal defect as a result of his mother’s use of Zofran during pregnancy.

The Zofran heart defect lawsuit, filed on August 13, 2015 in U.S. District Court of the Southern District of Illinois, is one of a number of suits brought against GSK for what the suit claims are “devastating, irreversible, and life-long consequences and suffering to innocent newborns and their families.”

The facts of the Zofran heart defect lawsuit

Zofran received FDA approval in 1991 for the specific use of combatting crippling nausea caused by chemotherapy and radiation therapy in cancer patients. However, the lawsuit claims that the success of the drug as an anti-emetic for cancer patients led GlaxoSmithKline to pursue another market.

In 1998, according to the suit, GSK began an aggressive marketing campaign urging physicians to prescribe Zofran to calm severe cases of morning sickness during pregnancy.

In 2009, the pregnant plaintiff was prescribed Zofran on the direction of her physician to ease her morning sickness. Neither the Plaintiff nor the physician knew at the time that GSK had conducted studies using ondansetron in the 1980’s on pregnant mammals which “revealed evidence of toxicity, intrauterine deaths and malformations in offspring,” according to the complaint. The studies also revealed that Zofran’s active ingredient was transferring through the placental barrier to the unborn fetus.

Since his birth, the Plaintiff’s son has experienced “… severe developmental delay, cannot run or play hard with other children, and has exhibited emotional challenges due to his injury” as stated in the suit.

The Plaintiff’s attorneys claim that the child “…was exposed to Zofran in utero during the periods when each of the tissues involved in the injuries described above were forming and were susceptible to developmental insult from environmental exposure…”

They also detail in the suit that the Plaintiff has given birth to two healthy siblings after full-term pregnancies during which she did not use Zofran.

Did GSK hide evidence of Zofran-related birth defects?

According to court papers, GlaxoSmithKline began receiving adverse reports of Zofran-related birth defects in the ‘90s and had received 32 such reports by the year 2000 and over 200 reports since.

Alleged Zofran-related birth defects that have been detailed in previous lawsuits are:

  • Congenital heart defects
  • Kidney malformations
  • Webbed toes
  • Low set ears
  • Facial dysmorphia

The suit claims that had the Plaintiff known about the hidden risks, she would have never ingested Zofran and her son would not have life-long injuries as a result.

GlaxoSmithKline pays the price for deception

According to the complaint, in 2012 GSK entered civil settlements with the United States Department of Justice that included more than $1 billion in payments for illegal marketing of various drugs, including Zofran, for promoting the sale and use of Zofran for conditions other than its FDA approved use, and paying illegal remuneration to physicians so they’d promote and prescribe Zofran.

It is not illegal in the United States to prescribe drugs “off label,” and despite the DOJ settlement, GSK admits no negligence or liability, and continues to believe in the safety record of Zofran.

The Plaintiff demands compensatory damages, as well as equitable relief to ensure that other pregnant women are fully informed about the risks and benefits of Zofran, and any other damages determined to be appropriate by the jury for injuries and birth defects as a result of exposure to Zofran.

  1. Toronto Star, Birth Defects Blamed on Unapproved Morning Sickness Treatment,
  2., Ondansetron,