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Zofran Lawsuit Alleges Link to Clubfoot

zofran bottleGlaxoSmithKline is facing a Zofran lawsuit that contends the off-label morning sickness drug is dangerous to the developing fetus. The complaint is just one among many others containing similar allegations regarding the anti-nausea medication and birth defects.

The case, filed in the US District Court for the District of New Jersey, demands compensatory and general damages for the defendant’s purported negligent misrepresentation of the safety of Zofran in pregnant women.

The plaintiffs are seeking relief for:

  • Related hospital and medical bills
  • General and consequential damages
  • Treble damages
  • Attorney fees and litigation costs
  • Punitive damages

Safety of Zofran as a morning sickness treatment

A type of 5-HT3 receptor antagonist that helps relieve nausea by reducing the effects of serotonin, Zofran has been on the U.S. market for nearly two decades. Though the drug is only approved by the FDA to treat cancer patients who are dealing with the unpleasant side effects of chemo and radiation therapy, the medication has been used “off-label” as a remedy for morning sickness in expectant women. It is alleged that drug maker GlaxoSmithKline (GSK) saw the financial potential of Zofran in this context, and actively began promoting Zofran as a morning sickness treatment, without first demonstrating the safety of its product to the developing fetus.

According to this lawsuit, GSK has not performed any studies of Zofran use in pregnant women, even though the company had the resources and ability to perform such research. The claim also states that following animal trials conducted by the defendant, GSK indicated that Zofran showed no harm to the fetus, though clinical data revealed signs of premature births, fetal deaths in utero, and incomplete bone growth in the babies of rabbits and rats exposed to the drug.

Early reports of birth defects

The lawsuit asserts that as early as 1992 GlaxoSmithKline was made aware of Zofran-related birth defects by women who had taken the drug.  Fifteen years ago, alleges the complaint, the defendant had gotten more than 30 reports detailing birth defects associated with Zofran treatment in pregnant women.

“These reports included congenital heart disease, dysmorphism, intrauterine death, stillbirth, kidney malformation, congenital diaphragmatic anomaly, congenital musculoskeletal anomalies, and orofacial anomalies, among others,” states the lawsuit.

Baby’s clubfoot may require tendon transplantation

The plaintiff in this case was given Zofran during her first trimester to help mitigate the debilitating effects of morning sickness. Other than this normal side effect of pregnancy, she was a healthy woman with no genetic history of congenital disorders. In 2011, she gave birth to her child, who was diagnosed with club foot, with both feet rotated internally at the ankle.

For the first 16 months of his life, the child endured special casts, shoes, braces and orthopedic devices to help gradually bring the feet into correct alignment. The claimants say that through the course of their child’s infancy he was unable to sleep normally due to the unwieldy bars and special shoes that often banged into the baby’s crib at night.

To this day, the child continues to wear the “Mitchell Boots & Dobbs bar” during sleep. But a recent medical examination suggested that his club foot has regressed, which will likely necessitate additional surgery and a possible tendon transplant.

The parents say that as a result of their child’s club foot, they have suffered great emotional and financial hardships, and their child’s “natural socialization” has been hampered by his immobility.