Zofran Class Action Dangerous Drug Lawsuit

On February 16, 2015, a Zofran lawsuit was filed in the U.S. District Court of Massachusetts. Plaintiff Tomisha LeClair filed the lawsuit individually and on behalf of her minor daughter against GlaxoSmithKline, LLC, the manufacturer of Zofran. Zofran was approved by the FDA in 1991 to treat the nausea suffered by cancer patients undergoing chemotherapy and radiation and to treat postoperative nausea. Although this is the only approved use for Zofran, GSK marketed the drug off-label as a safe, effective treatment for pregnant women with moderate to severe morning sickness.

According to the lawsuit, there were no studies and no clinical trials submitted to the FDA to determine the effects of Zofran on a pregnant woman or her unborn child. The lawsuit alleges these studies and clinical trials were deliberately omitted because GSK was aware of potential problems and wanted to continue marketing Zofran for morning sickness to increase company profits.

Studies Done in the 1980’s Show Zofran Crosses Placental Barrier

GSK did, however, conduct Zofran animal studies in the 1980’s. These studies clearly showed congenital defects and intrauterine deaths among the babies born to the rats and rabbits. The same studies concluded Zofran crossed the placental barrier, causing defects in the unborn mammals. A human trial was then done—also in the 1980’s—which showed the same results. Every sample of fetal tissue taken in the 41 pregnant patients in the study showed Zofran concentrations high enough to cause congenital malformations. GSK failed to make this information known to the pregnant women they were marketing the drug to or to physicians who prescribed the drug to their pregnant patients.

GSK Does Not Disclose Reports of Birth Defects

By the year 2000, GSK had received 32 reports of birth defects associated with Zofran, and that number is in the 100’s. Yet again, GSK neglected to make these reports known or available to expectant mothers and their doctors. Three recent epidemiological studies have examined the association between prenatal exposure to Zofran and the risk of congenital heart defects in babies. The results of the Pasternak study showed that mothers exposed to Zofran in the early stages of pregnancy had more than a doubled risk of having a baby with a congenital heart defect.

The results of the Andersen Study showed mothers who took Zofran in the first trimester had a two-to-four-fold greater risk of having a baby with a septal cardiac defect. The third study, known as the Danielson Study, found that mothers who took Zofran during early pregnancy had a 62 percent increased risk of having a baby with a cardiovascular defect and a two-fold increased risk of having a baby with a septal cardiac defect.

GSK Pleads Guilty to Criminal Charges and Pays $1 Billion in Civil Settlements

GSK pled guilty three years ago to criminal charges for promoting off-label use of several of the manufacturer’s drugs. Off-label use means a drug is being promoted, marketed and prescribed for uses not approved by the FDA. Zofran was one of those drugs. The complaint was lodged by the United States, through the Department of Justice. Soon after, GSK entered civil settlements with the United States which included more than $1 billion in payments for marketing specific drugs illegally—Zofran being named as one of those drugs.

In the written agreement GSK stated it promoted the sale of Zofran for ailments other than those for which it was approved, made false, unsubstantiated representations regarding the safety and efficacy of Zofran in the treatment of morning sickness and illegally paid money to physicians to induce them to prescribe Zofran to treat morning sickness.

Claims against GlaxoSmithKline

Numerous congenital defects in minor children have been discovered from the use of Zofran in early pregnancy sine 2000.

Children have suffered from:

  • heart defects, including septal or holes in the heart
  • facial dysmorphia, including cleft palates
  • hearing loss
  • kidney malformation

Contact Our National Dangerous Drug Lawyers

It is expected that more lawsuits will be filed against GSK as time goes on. If you took Zofran and your baby was born with a congenital defect, it is important to speak one of the experienced national dangerous drug attorneys at Golomb & Honik immediately. Our lawyers can answer all your questions regarding the current Zofran litigation and determine if you are eligible to file a lawsuit against the manufacturers of Zofran.

To learn more about your legal options or to schedule a free consultation call the Philadelphia class action lawyers at Golomb & Honik today at 1-215-278-4449 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

Additional Resources:

Zofran Lawsuit Charges GSK with Failure to Warn – Blog Post