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Zofran Cleft Lip Lawsuit Filed in Texas

Arkansas couple files a lawsuit against GlaxoSmithKline in Texas alleging that Zofran caused their son to be born with a cleft lip.

An Arkansas couple has filed a lawsuit against GlaxoSmithKline (GSK) in Texas alleging that the anti-nausea drug Zofran (generic: ondansetron) caused their son to be born with a cleft lip.

Free Zofran Lawsuit Evaluation: If your child or other loved one was born with a birth defect after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Zofran and our lawyers can help.

What’s the Problem?

The complaint, which was filed May 21 in the U.S. District Court for the Eastern District of Texas, accuses GSK of illegally marketing Zofran as a treatment for morning sickness while failing to warn about its potential to cause birth defects.

Plaintiff Jill Cox was prescribed Zofran in the early stages of her pregnancy to help treat the symptoms of morning sickness, and her son Jacob was subsequently born with a partial cleft lip, according to the lawsuit. He underwent surgery to repair his lip 3 months later and has a permanent scar as a result, the complaint says.

Cox maintains that had she known the truth about Zofran’s unreasonable risk of harm, she would’ve never taken the drug and her son would not have been injured. She is seeking compensation for negligence, strict products liability, fraud, breach of express and implied warranties, and unfair or deceptive acts or practices. The case is: Cox, et ux. v. GlaxoSmithKline, et al., No. 15-284 (E.D. Ark.).

GSK Accused of ‘Off-Label’ Marketing

The U.S. Food and Drug Administration (FDA) approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy, and for nausea and vomiting associated with certain types of surgery. However, GSK marketed the drug “off label” as a treatment for morning sickness, despite having performed no studies on the effects of the medication on pregnant women, according to the lawsuit.

The plaintiffs allege that GSK knew as early as 1997 that Zofran was unsafe for use by pregnant women, but the company failed to warn of these risks:

“GSK failed to state prominently in the Indications and Usage section of its drug label that there is a lack of evidence that Zofran is safe for the treatment of morning sickness in pregnant women, despite GSK’s knowledge that the safety of Zofran for use in human pregnancy had and has not been established; there have been hundreds of reports of birth defects associated with Zofran use during pregnancy; and epidemiology studies report an increased risk of birth defects in babies exposed to Zofran during pregnancy.”

Zofran Birth Defect Studies

In the 1980s, GSK conducted animal studies that revealed evidence of toxicity, intrauterine deaths and congenital defects in offspring exposed to Zofran in the womb, and further indicated that ondansetron (the active ingredient contained in Zofran) passed through the placental barrier of pregnant mammals to fetuses, according to the complaint.

The plaintiffs maintain that a later study performed on human patients confirmed that Zofran readily crosses the placental barrier and exposes fetuses to the medication; however, GSK failed to disclose this information to the public or medical communities.

“In 1992, GSK began receiving mounting evidence of reports of birth defects associated with Zofran,” the lawsuit says. “GSK had received at least 32 such reports by 2000, and has received more than 200 such reports to date. GSK never disclosed these reports to pregnant women or their physicians.”

GSK Fined $3 Billion for Illegally Marketing Zofran

In 2012, GSK paid $3 billion to resolve charges with the U.S. Justice Department that it illegally marketed Zofran and other drugs. According to court documents, the company gave doctors kickbacks to prescribe Zofran to pregnant women, and disseminated false information about the drug’s safety and effectiveness. Click here to learn more.

Arkansas Family Alleges Zofran Caused Son’s Cleft Lip

The same day the Texas Lawsuit was filed, a similar complaint was entered in U.S. District Court for the Eastern District of Arkansas by couple whose son was allegedly born with a partial cleft lip after the mother took Zofran in pregnancy. Plaintiffs in that case allege the boy “suffered a permanent scar from the repair that is often red and inflamed,” and that he now has developmental delays as a result of sedatives used during surgery to correct the defect. Click here to learn more.

Can I File a Zofran Lawsuit?

Only a qualified attorney can determine whether you are eligible to file a lawsuit against GlaxoSmithKline (GSK), the maker of Zofran, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.

Most cases involving pharmaceuticals allege that a drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect. In the case of Zofran, our attorneys suspect that patients may be able to take legal action in light of claims that Zofran failed to adequately warn doctors and patients about the risk of birth defects.

How Can Filing a Lawsuit Help Me?

By filing a lawsuit against the maker of Zofran, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your child’s birth defect, as well as for damages for pain and suffering. Additionally, filing a lawsuit can help hold the drug’s manufacturer accountable for releasing an allegedly defective drug into the marketplace, and to discourage other pharmaceutical companies from engaging in similar conduct.

Do I Have a Zofran Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran Lawsuits. We are handling individual litigation nationwide and currently accepting new birth defects cases in all 50 states.

Free Zofran Lawsuit Evaluation: Again, if your child or other loved one was born with a birth defect after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a Zofran Suit and our lawyers can help.

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