Zofran Lawyers Monheit Law Report Arkansas Family Alleges Zofran Caused Son’s Cleft Lip

June 17, 2015 – – Monheit Law’s Zofran birth defect lawyers report that on May 21, 2015, a family living outside Little Rock, Arkansas brought a new legal claim against GlaxoSmithKline. On behalf of their minor son, parents allege that prenatal exposure to the pharmaceutical conglomerate’s nausea medication Zofran caused their child to develop a cleft lip.

The parents filed their claim under case number 4:15-cv-00284-BRW, in the US District Court for the Eastern District of Arkansas, Western Division. A copy of their complaint can be found at ZofranLegal.com.

The parents from Arkansas joins at least nine other families in alleging that GlaxoSmithKline has ignored mounting evidence of Zofran’s potential link to major birth defects. These families say that the company hid unfavorable early study results, and underreported birth defect reports to the US Food & Drug Administration. They accuse GlaxoSmithKline of failing to alert patients of Zofran’s alleged risks, while promoting the drug for use during pregnancy in violation of federal law.

In this recent complaint, the mother reports that she was prescribed Zofran during her first trimester as a morning sickness treatment. As plaintiff writes, Zofran is only FDA approved for the treatment of nausea and vomiting in patients undergoing chemotherapy, radiotherapy and surgical anesthesia.

In court documents, the family notes that Zofran has never been approved for use as a morning sickness treatment. They also refer to federal laws that prevent drug manufacturers from promoting their products for unapproved, or “off label” uses. But in 2012, the US Department of Justice accused GlaxoSmithKline of promoting Zofran as a “safe and effective” drug for the treatment of pregnancy-related nausea. While the company continues to deny this claim, plaintiffs are insistent, alleging that the company “continues to negligently and misleadingly market […] Zofran.”

Like previous complaints, the Arkansas family blames GlaxoSmithKline’s alleged off label promotion of Zofran for placing a drug with potentially disastrous effects directly into the hands of pregnant women.

Plaintiff writes that she delivered her son on June 1, 2012. He was born with a cleft lip, according to their complaint, a type of orofacial cleft. Three months after delivery, the child underwent a surgical procedure to repair his birth defect, plaintiffs claim. They report that he “suffered a permanent scar from the repair that is often red and inflamed.” Beyond this procedure, plaintiffs say that their son has suffered developmental delays due to the sedatives required in the surgical repair. “It took him longer to speak and walk than the average infant, and he has visited a speech therapist, a developmental therapist, and a physical therapist,” they write. A “team” approach, in which multiple specialists are employed, is the standard of care for treating children born with orofacial clefts.

This complaint is at least the second to be filed for a child born with an orofacial cleft. The first, brought in April of 2015 by a family from Montana, alleged that Zofran exposure caused the parents’ daughter to be born with a cleft lip and palate. According to that complaint, she has been forced to undergo ten surgeries over the course of her life. She is now 16, her parents write.

One of the first studies to investigate the potential effects of Zofran on early fetal development found that unborn babies exposed to Zofran’s active ingredient were more than twice as likely to be born with cleft palate, a split or opening in the roof of the mouth. Subsequent studies have found a marked association between Zofran and elevated risks for congenital heart defects. Parents in Zofran birth defect lawsuits claim that GlaxoSmithKline has ignored the results of these studies, which plaintiffs consider “warning signs.” Instead of alerting the health community and public to the drug’s association with birth defects, plaintiffs say GlaxoSmithKline has continued its alleged off label promotion of the drug as a “safe and effective” morning sickness treatment.

Joined by a multi-state alliance of plaintiffs’ attorneys, Monheit Law is investigating potential Zofran birth defect claims. Any parent who was prescribed Zofran during the first trimester and delivered a child with major birth defects may be eligible to file a lawsuit against GlaxoSmithKline. For a free case eligibility evaluation, call 1-877-620-8411.

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