ZofranⓇ is a powerful drug developed by GlaxoSmithKline (“GSK”) intended to treat only those patients who were afflicted by the most severe cases of nausea. The Food and Drug Administration approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy. “Off label” use of Zofran for the very common side effects of nausea and vomiting during pregnancy, commonly known as “morning sickness,” however, was not approved. Quite tragically, Zofran has been shown to cause serious consequences to the children of pregnant women, including heart defects, cleft lip/foot, skull deformities, kidney malfunctions, fetal death, and other serious birth defects.
If you or a loved one has taken Zofran while pregnant and the child and has suffered from heart defects, cleft lip/foot, skull deformities, kidney malfunctions, fetal death, or other serious birth defects, contact the Zofran attorneys in the Locks Law Firm’s Pennsylvania, New Jersey and New York offices.
Zofran, manufactured by GlaxoSmithKline, is a dangerous pharmaceutical that has been linked to serious birth defects.
The Locks Law Firm is currently reviewing cases on behalf of individuals and their family members for children who were born with birth defects as a result of their exposure to Zofran during pregnancy.
The Zofran lawsuits allege that GSK marketed Zofran “off label” for the treatment of “morning sickness” without ever undertaking a single study on the effects of the drug on a pregnant woman or her child growing in utero or seeking FDA approval to market the drug for treatment during pregnancy.
In the 1980s, GSK conducted animal studies which revealed evidence of toxicity, deaths and defects in offspring, and showed that the active ingredient in Zofran transferred through the placental barrier of pregnant animals to fetuses. In 1992, GSK began receiving mounting evidence of reports of birth defects associated with Zofran. To date, GSK has received 200 such reports. In addition, large-scale epidemiological studies have demonstrated an elevated risk of developing birth defects. Yet, instead of disclosing any of the above information to pregnant women or their physicians, GSK sales representatives specifically marketed and promoted Zofran as a morning sickness drug. In 2012, GSK pled guilty to criminal charges and paid $3 billion to settle criminal and civil liability for the unlawful promotion of the drugs.
The Zofran lawsuits allege that GSK is guilty of negligence, failure to warn, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, breach of warranty, and should be subject to punitive damages for the deliberate and willful disregard for the rights and safety of pregnant women and their children.
If you or a loved one has taken Zofran and the child was born was birth defects, contact the Locks Law Firm today. Our Pennsylvania, New York, and New Jersey attorneys can provide information about filing a Zofran lawsuit during a free, confidential consultation and case evaluation.
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