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Michael Monheit
Michael Monheit
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Arkansas Family Says Zofran Caused Son’s Cleft Lip


A family living outside Little Rock, Arkansas has filed a new lawsuit against GlaxoSmithKline, alleging that the pharmaceutical giant’s anti-nausea drug Zofran caused their son to develop a cleft lip.

The parents filed their claim in the US District Court for the Eastern District of Arkansas, Western Division on May 21, 2015. The case has been registered under case number 4:15-cv-00284-BRW, and the court documents can be read at ZofranLegal.com.

Parents Near Little Rock Claim Prenatal Exposure To Zofran Caused Their Child’s Cleft Lip

These parents, filing individually and on behalf of their child, who is still a minor, join at least 9 other plaintiffs in claiming that GlaxoSmithKline has been aware of Zofran’s potential to increase birth defect risks for more than two decades. In every Zofran birth defect lawsuit, claimants have alleged that GlaxoSmithKline concealed early study results, along with more recent reports of birth defects, from federal regulators and the public. And much like the US Department of Justice before them, plaintiffs say that the company unlawfully promoted Zofran directly to doctors as a safe morning sickness treatment.

In case 4:15-cv-00284-BRW, plaintiff says that she was prescribed Zofran “around September of 2011,” to treat the nausea and vomiting that most women experience during early pregnancy. She notes that she began taking Zofran during her first trimester.

Plaintiffs Claim GlaxoSmithKline Unlawfully Promoted Zofran For Use During Pregnancy

Zofran is approved to treat severe nausea and vomiting in three specific situations:

  • patients undergoing chemotherapy
  • patients undergoing radiation therapy
  • patients undergoing surgical anesthesia

The drug has not been FDA approved for use during pregnancy, and it is illegal for drug companies to promote their products for unapproved, or “off label” uses. But in 2012, the US Federal Government charged GlaxoSmithKline for promoting a number of medications off label. Among the government’s allegations were claims that the company had “promoted the sale and use of Zofran for […] conditions other than those for which its use was approved as safe and effective by the FDA […] including hyperemesis or pregnancy-related nausea.”

US DOJ Allegations Zofran GlaxoSmithKline

GlaxoSmithKline’s 2012 settlement agreement with the US Department of Justice resolved multiple allegations involving the off label promotion of Zofran.


GlaxoSmithKline denies this allegation, but the plaintiffs in Zofran birth defect lawsuits have blamed the company’s alleged off-label promotion for placing a drug with unknown effects on fetal development into the hands of unsuspecting pregnant women across the country.

The mother from Arkansas accuses GlaxoSmithKline of “failing to conduct adequate testing, including pre-clinical and clinical testing and post-marketing surveillance to determine the safety risks of Zofran for treating pregnant women.” Notwithstanding this alleged failure, she claims that the company “promot[ed] the use of Zofran and provid[ed] kickbacks to health care professionals to convince health care professionals to prescribe Zofran for pregnancy related nausea.”

Son’s “Partial Cleft Lip” Caused By Exposure To Zofran, Plaintiffs Allege

After taking Zofran during the first trimester, plaintiff delivered her child, a son, on June 1, 2012. The parents say that he was born with a “partial” cleft lip, a form of orofacial cleft in which the upper lip is split by an opening or “cleft.” Children with complete cleft lip have a cleft that extends upward to affect nasal tissues, while partial clefts do not.

The parents note that there is “no history of a cleft lip birth defect in [their] family.”

Around three months after his birth, plaintiffs’ son underwent a corrective procedure to repair his cleft lip, according to court documents. His parents say that he “suffered a permanent scar from the repair that is often red and inflamed.” They also note that his upper lip is “not symmetrical.” Due to the sedatives used during his procedure, the child has had developmental delays, parents claim. They write that “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.”

This “team” approach, in which a variety of medical specialists coordinate treatments, is the standard of care for children born with orofacial clefts.

In 2012, Researchers Found Significant Increase In Cleft Palate Risk After Zofran Exposure

The family from Arkansas has filed what is now at least the second Zofran birth defect lawsuit to claim damages for a child’s orofacial cleft. The first, brought by parents from Billings, Montana on April 3, 2015, claimed that prenatal exposure to Zofran had caused the plaintiffs’ daughter to develop a cleft lip and cleft palate in utero. In that earlier lawsuit, the family wrote that their daughter, now 16, “has been forced to undergo ten surgeries […] and more are planned and likely.”

In one of the first studies to investigate Zofran’s potential effects on fetal development, researchers at Harvard and Boston Universities found that women who had been prescribed Zofran’s active ingredient were 2.37 times more likely to deliver a child with cleft palate.

As in previous complaints, the Arkansas family claims that GlaxoSmithKline has ignored “warning signs” like the study results mentioned above. Rather than alert the health community and public to Zofran’s recent scientific association with major birth defects, plaintiffs allege that the company has “fail[ed] to issue sufficiently strengthened warnings following the existence of reasonable evidence association Zofran use with the increased risk of birth defects.”

At least three other studies have returned data indicating a significant increase in the rate of congenital heart defects among babies exposed to Zofran during the first trimester.

You can find a comprehensive overview of the studies that have linked Zofran to birth defects here.

The parents also accuse GlaxoSmithKline of misrepresenting the results of early animal studies in its reports to the FDA prior to Zofran’s initial approval. According to claimants, the company said that these tests, which involved pregnant rabbits and rats, “showed no harm to fetuses.” But in fact, “the data revealed impairment of ossification (incomplete bone growth) and other signs of toxicity,” they allege.

Other Families May Be Able To File Zofran Birth Defect Lawsuits

Monheit Law has joined forces with a multi-state coalition of plaintiffs’ attorneys to investigate potential Zofran birth defect claims. If the allegations leveled against GlaxoSmithKline in current lawsuits are true, any parent who was prescribed Zofran as an “off label” morning sickness treatment and then delivered a child with major birth defects may be eligible to bring a claim against the company.

Led by Michael Monheit, Esq., the attorneys are providing free consultations to any parent or birth defect survivor who believes they may have been harmed by prenatal exposure to Zofran. For a case eligibility evaluation, at no charge and no obligation, call 1-877-620-8411.

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