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Michael Monheit
Michael Monheit
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Montana Parents Say Zofran Caused Cleft Palate & Lip

baby with cleft lip and palate

Artist’s rendering of a baby born with a cleft lip.

Over the first months of 2015, at least seven families have filed lawsuits against GlaxoSmithKline, alleging that the company’s anti-nausea drug Zofran causes major birth defects.

The fifth claim, filed by parents from Montana in the United States District Court of Montana, is notable for naming cleft lip and cleft palate as the birth defects allegedly caused by Zofran. In 2012, medical researchers and public health officials at Harvard and Boston University found that women prescribed Zofran’s active ingredient during the first trimester were more than twice as likely to have babies with a cleft palate.

Family In Montana Claims Zofran Caused Daughter’s Cleft Palate & Lip

Filed under case number 1:15-cv-00026-SPW-CSO, the family’s complaint makes a number of serious allegations against Zofran’s manufacturer, international pharmaceutical giant GlaxoSmithKline. The lawsuit was filed on April 3, 2015.

Plaintiffs allege that their daughter, named as M.M. in court documents, was born with a cleft lip and palate, and claim that these birth defects were caused by prenatal exposure to Zofran.

The parents say that their daughter, who is now sixteen, has been forced to undergo 10 separate surgical procedures “to try and correct her cleft lip and palate.” They claim that the birth defect with which she was born “impairs her development” and hinders her ability to enjoy a normal life.

Plaintiffs Say GlaxoSmithKline Unlawfully Promoted Zofran For Use During Pregnancy

The US Food & Drug Administration has approved Zofran, a potent anti-nausea drug, for the treatment of patients suffering from severe nausea and vomiting during the course of cancer treatments, like chemotherapy and radiotherapy. And while Zofran’s approval was eventually extended to cover post-operative nausea, it has never been approved for use during pregnancy.

In the last 32 years, only one drug has been approved for the treatment of morning sickness, Diclegis. Unlike Diclegis’ manufacturer, GlaxoSmithKline has never studied Zofran’s effects in pregnant women, and has never investigated its potential to cause harm during fetal development. Despite that fact, Zofran quickly became one of America’s leading treatments for morning sickness after it was approved in 1991.

Doctors are allowed to prescribe drugs for any uses they consider medically appropriate, regardless of FDA approval. This practice, known as “off label” prescription, is surprisingly common and totally unregulated. But under federal law, pharmaceutical manufacturers are barred from promoting their products for off label purposes.

In this new Zofran birth defect lawsuit, plaintiffs say that GlaxoSmithKline violated federal law and promoted Zofran to doctors for unapproved use during pregnancy. In support of their claim, they cite a 2012 lawsuit, in which the US Department of Justice charged GlaxoSmithKline for promoting a number of drugs for off label use. One of the drugs named in the federal government’s case was Zofran, and federal prosecutors wrote that the company had “promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.” It should be noted that GlaxoSmithKline denied, and continues to deny, this allegation. Notwithstanding, the company ultimately entered a settlement agreement with the government for $3 billion.

Plaintiffs say that as a result of this alleged off label promotion, Zofran was placed into the hands of unsuspecting expectant mothers, including the plaintiff herself, across the country.

Parents Claim GlaxoSmithKline Knew Zofran Was Unsafe For Expectant Mothers

But the plaintiffs go further than that, alleging that GlaxoSmithKline has been aware of Zofran’s potential to increase the risk for major birth defects for more than two decades.

Animal Studies Allegedly Revealed “Signs Of Clinical Toxicity”

Plaintiffs say that GlaxoSmithKline’s alleged knowledge of Zofran’s risks began early, with animal reproductive studies conducted during the 1980s. Not only did these trials reveal that Zofran’s active ingredient readily crosses the placental barrier, plaintiffs also claim that the tests showed signs of “clinical toxicity.” They say that pregnant rats and rabbits were found to experience elevated rates of intrauterine death, and their offspring were born with significant malformations.

But according to plaintiffs, GlaxoSmithKline failed to disclose this information to the FDA in its approval application.

Plaintiffs Say GSK Has Received More Than 200 Birth Defect Reports

Almost as soon as Zofran came into use as an off label morning sickness treatment, GlaxoSmithKline began receiving reports of birth defects, plaintiffs say. Allegedly, these reports linked the drug’s prescription during the first trimester to major birth defects upon delivery. These parents claim that the company has received more than 200 such reports to date.

In their complaint, the parents write that “in many instances, GSK received multiple reports in the same month, the same week and even the same day. For example, on or about September 13, 2000, GSK received three separate reports involving Zofran use and adverse events. For two of these reports, the impact on the baby was so severe that the baby died.”

Epidemiological Studies Find Association Between Zofran & Increased Birth Defect Risks

Plaintiffs also cite three recent studies, performed in Europe to investigate the effects that Zofran exposure during early pregnancy may have on an unborn child’s development.

As the parents make clear, all three studies found indications that Zofran, when taken during the first trimester, may increase the risk of congenital heart defects substantially.

Plaintiffs Allege That GlaxoSmithKline Failed To Warn Public & Health Care Providers Of Zofran’s Potential Risks

In this new Zofran birth defect lawsuit, parents say that under federal law, GlaxoSmithKline was obligated to revise Zofran’s warning label. They claim that the company had both the ability, and a legal duty, to include a warning of the drug’s association with birth defects “as soon as there [was] reasonable evidence” of the link.

But as they note, GlaxoSmithKline has not yet revised Zofran’s warning label, and has made no public announcements on the association.

Can Others File Zofran Birth Defect Lawsuits?

If the allegations made in the seven Zofran lawsuits prove true, any woman who was prescribed Zofran during the first trimester and then delivered a child with major birth defects may be eligible to bring a claim against GlaxoSmithKline.

Led by experienced plaintiffs’ attorney Michael Monheit, Esq., Monheit Law has gathered a coalition of lawyers to investigate these allegations and pursue justice for parents and birth defect survivors. The alliance has established a website, Zofran.Monheit.com, where families can learn more about the ongoing Zofran litigation.

The attorneys are currently offering free consultations to any individual who believes their family may have been harmed by prenatal exposure to Zofran. For more information on case eligibility, call 1-877-620-8411.

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