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Zofran Lawsuit Alleges Drug Causes “Devastating, Irreversible, and Life-Long Consequences”

zofran bottle

For many women, the hormonal fluctuations associated with pregnancy bring about unrelenting symptoms including nausea, vomiting and lightheadedness. In the most extreme cases, these women experience a condition known as hyperemesis gravidarum – which can cause dehydration and electrolyte imbalance. For years, doctors and healthcare professionals have prescribed a drug known as Zofran (ondansetron) to help combat and alleviate these symptoms. However, as more and more lawsuits emerge against GlaxoSmithKline (GSK), patients and practitioners alike are beginning to question whether the drug is actually safe for use during pregnancy – and whether drug makers knew (or should have known) that the drug could cause fetal harm.

Parents allege severe congenital defects

On October 30, 2015, the parents of a child born with severe congenital cardiac birth defects filed their lawsuit against GSK, alleging that the company lied to consumers about the safety of Zofran when used during pregnancy. The lawsuit, which was filed in U.S. District Court for the Southern District of Alabama, asserts that GSK has known about Zofran dangers for years, but continued to conceal the information from parents and providers in order to pad profits and increase sales. As a result, the plaintiffs allege, children and families have suffered irreversible, permanent damage that could have been avoided had the company fully disclosed the facts.

Zofran background

Zofran was first introduced to the American market in the 1990’s for the treatment of nausea and vomiting associated with chemotherapy and radiation. Shortly thereafter, drug makers began to tout Zofran’s effectiveness in treating early-pregnancy nausea, referring to Zofran as the “wonder drug.” Notwithstanding, GSK allegedly never conducted a single clinical trial to measure the safety of Zofran when used during pregnancy, and in fact excluded pregnant women from all clinical trials conducted for purposes of gaining initial FDA approval.

According to the Zofran lawsuit, GSK knew as early as the 1980’s that ondansetron could be problematic, as several animal studies revealed the onset of toxicity, intrauterine death and malformations of offspring. Further, these studies revealed that Zofran was capable of crossing the placental barrier, thereby placing developing fetuses at an increased risk of harm.

The plaintiffs continue their allegations by asserting that by the year 2000, GSK had received several dozen official complaints of congenital birth defects associated with Zofran use – a number that has swelled to as many as 200 reports today.

GSK should have warned patients, say plaintiffs

In 2012, GSK entered into a settlement agreement with the U.S. Department of Justice concerning “off-label marketing” – a practice involving the marketing of certain drugs for uses not approved by the FDA. GSK paid out approximately $1 billion to settle civil litigation relating to the off-label promotion of some of its drugs, specifically settling allegations it “made and/or disseminated unsubstantiated and false representations about the safety and efficacy of Zofran concerning the uses described in subsection (a) [hyperemesis and pregnancy-related nausea].”

In light of these revelations, the plaintiffs contend that – had they known the truth about Zofran and its adverse effects – the mother would have never taken the drug and her child would have avoided the onset of congenital atrial septal defects. Specifically, the plaintiffs alleged that GSK exposed pregnant women and children to an unreasonable risk of harm by failing to properly warn patients and doctors as to the truth about Zofran.

The plaintiffs are seeking compensation for the past, present and future costs of treating their child’s condition, as well as consequential and compensatory damages, costs, attorneys’ fees and any other appropriate relief.