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In order to better inform the public, a national coalition of distinguished plaintiffs’ attorneys has released a comprehensive guide on litigation surrounding GlaxoSmithKline’s popular anti-nausea drug Zofran. Recent studies have begun to establish a link between Zofran’s active ingredient, Ondansetron, and severe birth defects including cleft palate and congenital heart defects. Now, recently-filed lawsuits (filed under case numbers 1:15-cv-10429 and 2:15-cv-00709PD) claim that GlaxoSmithKline was aware of Zofran’s risks, but unlawfully marketed the drug to obstetricians and gynecologists as a safe treatment for morning sickness. Continue reading
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Mar 17, 2015 /prREACH/ -- Monheit Law, with a coalition of nationally-recognized law firms, has begun to investigate claims that GlaxoSmithKline’s anti-nausea drug Zofran can potentially cause severe birth defects. The two newly-filed lawsuits allege that the pharmaceutical manufacturer has been aware of Zofran’s possible dangers since at least the late 1980s. The complaints continue to claim that GlaxoSmithKline unlawfully marketed Zofran directly to obstetricians and gynecologists as a treatment for morning sickness, despite knowledge of its harmful effects on fetal development.
To inform individuals interested in this line of litigation, Monheit Law has produced an informative guide detailing the lawsuits’ claims against GlaxoSmithKline, as well as research that has found an association between Zofran and birth defects. Families who would like to learn more can download a PDF version of the guide at this link: "12 Core Facts About Zofran Litigation". A summary of the guide’s information follows.
GlaxoSmithKline has manufactured the anti-nausea drug Zofran, and its active ingredient Ondansetron hydrochloride, since the late 1980s. At that time, GlaxoSmithKline conducted tests to determine Zofran’s effects in pregnant rabbits and rodents. According to the allegations of two new legal complaints, these studies showed evidence of Zofran’s toxicity, including fetal malformations and intrauterine deaths.
In 1991, the US Food & Drug Administration (FDA) approved Zofran for the treatment of patients suffering from severe nausea in certain circumstances. Specifically, Zofran was approved for:
- cancer patients receiving chemotherapy
- cancer patients receiving radiation therapy
- patients undergoing surgical anesthesia
The FDA has never approved Zofran as a treatment for morning sickness, and the agency has never determined that the drug is safe for pregnant women to take for morning sickness; nor has GlaxoSmithKline taken Zofran through the process necessary to have a drug approved as a treatment for morning sickness in pregnant women. According to claims brought by the US Department of Justice in 2012, GlaxoSmithKline began marketing Zofran as a “safe” treatment for the vomiting and nausea common during early pregnancy as early as 1991.
According to the lawsuits, GlaxoSmithKline had received early notification of two children born with birth defects after their mothers had taken Zofran for morning sickness during the first trimester of pregnancy. By 2000, GlaxoSmithKline had received at least 32 such reports, which attributed birth defects to Zofran ingestion. As of today, there are over 200 reports associating Zofran with birth defects.
Beginning in the 1990s, several large epidemiological studies were conducted on ondansetron’s effects during early pregnancy. Their conclusions have begun to support an association between ondansetron taken during the first trimester and child birth defects, including:
- Cleft palate with and without cleft lip
- Congenital heart defects
According to the complaints, so far GlaxoSmithKline has never performed any clinical trials investigating Zofran’s effect on pregnant women or fetal development. The company has never initiated the process required to seek FDA approval for treatment of morning sickness, and has never modified Zofran’s label to include warnings of child birth defects.
In 2012, GlaxoSmithKline settled the case brought by the Department of Justice, and agreed to pay a record-setting settlement of $3 billion. The settlement included allegations of marketing Zofran to pregnant women suffering from morning sickness, and of paying kickbacks to physicians who prescribed Zofran during early pregnancy. Despite this fact, GlaxoSmithKline continues to deny all claims relating to the allegedly illegal marketing of Zofran, and of the drug’s potential link to birth defects. GlaxoSmithKline has not offered a warning that the drug is unfit for use by pregnant women, and has not asked the FDA to warn the public, either.
As of February 15, 2015, class actions and personal injury lawsuits are being filed against GlaxoSmithKline. If the allegations in these lawsuits summarized above are true, women who were prescribed Zofran during the first trimester of pregnancy, and then delivered children with birth defects, may be entitled to financial compensation. Families interested in learning more are urged to visit zofranlegal.com for further details.
ATTORNEY ADVERTISING. © 2015 Monheit Law. The law firm responsible for this advertisement is Monheit Law, 1368 Barrowdale Road, Rydal, PA 19046, 877-620-8411. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Media Contact Michael Monheit, Esq. Monheit Law http://zofran.monheit.com 877-620-8411
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