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Zofran victims allege birth defects

Zofran lawsuits filed in numerous states contain serious allegations concerning an apparent link between an expectant mother's use of the "morning sickness" drug and the emergence of birth defects. Operating in all 50 states, attorneys with the Zofran Litigation Team at Reich & Binstock are taking cases from victims across the country.

Just about any Zofran lawsuit is very telling about the alleged damage related to the drug. For instance, a mother filed an action individually and on behalf of her minor daughter in February in U.S. District Court for the District of Massachusetts. The maker of the drug and the main defendant was GlaxoSmithKline.

Setting the stage for the prenatal injury allegations, the plaintiff pointed out that the U.S. Food and Drug Administration in 1991 did not approve Zofran as a morning sickness remedy. The drug was approved, and is still approved, to treat post-operative and chemotherapy-related nausea and/or vomiting. GSK had the audacity to promote Zofran "off-label" for unapproved use in the treatment of pregnancy-related nausea.

GSK agreed to assume liability for the promotion of Zofran for unapproved uses in a 2012 settlement with the U.S. Justice Department. In that settlement, the manufacturer had to pay $3 billion in criminal and civil penalties involving this and other activities.

In this prelude, the plaintiff was merely warming up. Scathing claims in regard to how the manufacturer's conduct led to her child's birth defects would follow.

As the Massachusetts lawsuit reads, "Unlike another anti-nausea prescription drug available on the market - which is FDA-approved in the United States for treating morning sickness in pregnant women - GSK never conducted a single clinical trial before marketing Zofran to pregnant women. GSK simply chose not to study Zofran in pregnant women or seek FDA approval to market the drug for treatment during pregnancy. GSK avoided conducting these studies because they would have hampered its marketing of Zofran and decreased profits by linking the drug to serious birth defects."

Although it may have seemed that the allegations could not possibly have become more incendiary, the plaintiff alleged this: "In the 1980s, GSK conducted animal studies which revealed evidence of toxicity, intrauterine deaths and malformations in offspring, and further showed that Zofran's active ingredient transferred through the placental barrier of pregnant mammals to fetuses. A later study conducted in humans confirmed that ingested Zofran readily crossed the human placenta barrier and exposed fetuses to substantial concentrations. GSK did not disclose this information to pregnant women or their physicians.

"In 1992, GSK began receiving mounting evidence of reports of birth defects associated with Zofran. GSK had received at least 32 such reports by 2000, and has received more than 200 such reports to date."

The plaintiff's daughter was born in the year 2000. Her mother was prescribed Zofran and began taking it for morning sickness beginning in the first trimester of her pregnancy. After birth, the child was diagnosed with "atrial septal defect, right ventricular hypertension and aortic arch hypoplasia. [She] has also subsequently been diagnosed with facial dysmorphia, low set ears, hearing loss, sensitivity to light, ingueno hernia, and webbed toes," according to the complaint.

The plaintiff told the court that her daughter underwent 10 surgeries by about the age of 12 to correct her "congenital abnormalities." The mother added that if she had known about Zofran's alleged unreasonable birth defects risk, "she would never have taken Zofran, and her child would never [have] been injured..."

Dennis Reich and I went into legal practice together in 1984 to fight for justice for those who have been damaged by no fault of their own. Zofran victims and their mothers are among them; indeed they are a high priority. The Zofran attorneys at Reich & Binstock have specialized experience and expertise in handling the most complex product liability litigation involving the pharmaceutical injury. They have the skills that the mother of a child born with Zofran-related birth defects wants on her side. And the case evaluation is free.

For a free consultation, contact Reich & Binstock either by calling the toll-free number, 1-866-LAW-2400, or by submitting an electronic message through this web page.

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