Lawsuit Claims Zofran Didn't Properly Research Drug

A lawsuit filed in Idaho alleges that GSK was aware that animal studies couldn't reliably predict how pregnant women would be affected by Zofran. A lawsuit, filed in the United States District Court for the District of Idaho on August 14th, 2015, under case number 1:15-cv-00319-BLW, has alleged that GlaxoSmithKline (GSK) knew that animal studies were unreliable in determining if Zofran would be safe for expectant mothers and their unborn children. The complaint also alleges that the company unlawfully promoted the drug because it didn’t have the approval of the FDA and no human clinical trials had been performed involving pregnant women.

The Animal Studies Performed By GSK

When GSK submitted Zofran for approval to the U.S. Food and Drug Administration (FDA), it cited four separate animal studies that had been performed using the drug. Two of the studies were performed on groups of rats and two were performed on groups of rabbits.

Interestingly enough, even these studies showed adverse reactions in pregnant subjects. Several of the side effects that were noted in these studies included an increase in intra-uterine death, developmental retardation in offspring and fetuses, maternal weight loss, and “total litter loss”.

Animal v.s. Human Studies

Although humans have been testing new drugs on animals for centuries, the reality is that these tests don’t really give us much of an indication as to how the human body will react to the drug.

For example, the Diabetes Research Institute announced in 2006, that although their researchers had been using mice and rats for over thirty years in experiments, they had determined that the internal structure and function of the pancreatic islet cell of rats and humans are drastically different. One of their researchers stated that “We can no longer rely on studies on mice and rats. It is now imperative that we focus on human islets. At the end of the day, that is the only way to determine how they function.”

The FDA has also reported that nearly 92% of all of the drugs that get approval to move forward with human testing do not receive approval. That means that only 8% of the drugs that are tested on animals are determined to be safe enough for humans.

The Use Of Zofran During Pregnancy

Zofran, an antiemetic that was approved by the FDA to treat nausea and vomiting in patients undergoing chemotherapy and radiation treatments, or for patients experiencing nausea after being under anesthesia, has been widely prescribed by OB/GYN’s for years.

The drug became very popular after GSK began to advertise it as a safe and effective treatment for morning sickness, a condition typically experienced during the first trimester of pregnancy. However, the drug never received FDA approval for the treatment of this condition, and no human studies were performed showing that the drug was safe for expectant mothers and their unborn children.

Despite advertising the drug in this manner, GSK stated “animal reproduction studies are not always predictive of human response” on their prescribing information. The plaintiffs in the Idaho case have claimed that they believe this means that “GSK has been aware since at least when it began marketing and selling Zofran that GSK could not responsibly rely on its animal studies as a basis for promoting Zofran use in pregnant women.”

Zofran Birth Defects

Over the past two years, many families have come forward and filed lawsuits against GSK, all alleging that the drug caused a birth defect in an unborn child. In nearly every instance the child has been forced to undergo a series of corrective surgeries. In a few tragic cases, the birth defect was so severe that the child died shortly after it’s birth.

Birth defects noted in the growing litigation include clubfoot, kidney defects, atrial septal defect, ventricular septal defect, cleft lip, cleft palate, and respiratory distress syndrome.

Parents are seeking repayment not only for the money they have spent in medical expenses, but also for the pain and suffering that both the child and parents have suffered as a result of the birth defect.

About Laurence Banville

Attorney Contributor:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including negligent security cases, child sexual abuse and Dram Shop and liquor liability cases.

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