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Despite a recent lull in activity, new families continue to join the growing Zofran litigation. Parents from across the nation say the nausea drug, manufactured by GlaxoSmithKline and often prescribed as an “off-label” morning sickness treatment, causes birth defects.

In two new lawsuits, both filed in the US District Court of Massachusetts on March 4, 2016, two mothers accuse GlaxoSmithKline of ignoring significant warning signs of Zofran’s potential risks, while illegally promoting the drug for use during pregnancy.

New Jersey Mother Says Zofran Caused Son’s Clubfoot

In her own lawsuit, a mother from New Jersey claims that her son, named J.C. in court documents, was born with a clubfoot after being exposed to a generic form of Zofran during the first trimester of a 2013 – 2014 pregnancy.

Registered under the case number 1:16-cv-10463-FDS, the family’s complaint has been made public by Monheit Law, a Pennsylvania-based plaintiffs’ law firm.

Family Demands Compensation For Surgeries, Extensive Therapies

J.C., now 2 years old, has been forced to undergo orthopedic surgery, his mother claims, as well as “serial casting.” American surgeons predominantly rely on the “Ponseti method,” in which a baby’s feet are gently stretched and placed in casts to maintain a correct alignment, as a preliminary treatment for the condition. His shoes have been outfitted with braces to hold his feet in a healthy position. Surgeons expect to operate on J.C. again in the future, the mother writes, and, for now, he has “difficulty standing and learning to walk.”

Overall, few lawsuits filed thus far have claimed damages for a child’s clubfoot. Most of the lawsuits focus instead on congenital heart defects, a range of abnormalities, many of which can be fatal, linked to Zofran exposure in multiple large-scale epidemiological studies. Also well-represented in the complaints is cleft palate, which was connected to Zofran in 2012, when an analysis of National Birth Defects Prevention Study data found that women prescribed the drug were more than twice as likely to have children with the condition.

You can find more information about the research around Zofran and cleft palate at

Florida Woman Claims Drug Led To Heart Defects

In the other complaint filed on March 3, a mother from St. Petersburg, Florida says her daughter L.A. was born with heart defects and “other defects” as a result of prenatal Zofran exposure. Now 15 years old, L.A. has not yet undergone surgery, but her mother “anticipates” invasive procedures in the future.

Like the mother from New Jersey, and 200 other families who have filed Zofran lawsuits, Plaintiff accuses GlaxoSmithKline of concealing the drug’s potential risks from health professionals and the public. She says the company has failed, on multiple occasions, to publicize crucial safety data that would have allowed pregnant women to make a fully informed choice about what they put in their own bodies.

Despite “receiving mounting evidence of reports of birth defects associated with Zofran,” GlaxoSmithKline chose instead to market the drug for use during pregnancy, the mother writes. Citing an extensive Justice Department investigation, one that resulted in a $3 billion settlement agreement, Plaintiff claims the company offered obstetricians and gynecologists illegal kickbacks to prescribe their patients more Zofran.

Her lawsuit was logged under the case number 1:16-cv-10461-FDS. A PDF copy of the complaint is available here. Along with the New Jersey mother’s complaint, the lawsuit was brought directly in the District Court of Massachusetts, where over 200 Zofran lawsuits have been consolidated for coordinated pre-trial proceedings.

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