National Alliance of Attorneys Filing Zofran Birth Defect Lawsuits


A national alliance of plaintiffs’ attorneys have begun filing Zofran birth defect lawsuits. Several independent studies have linked Zofran to a potential increased risk of child birth defects such as cleft palate, and congenital heart defects.

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Mar 11, 2015 /prREACH/ -- Philadelphia, PA - March 9, 2015

Multiple independent research studies have suggested a link between Zofran, a powerful anti-nausea medication often prescribed to pregnant women “off-label” for morning sickness, and severe birth defects. Two recent lawsuits (filed under case numbers 1:15-cv-10429 and 2:15-cv-00709PD) allege that Zofran’s manufacturer, multinational pharmaceutical conglomerate GlaxoSmithKline, was aware of the drug’s potential dangers but failed to warn the health community and public. Now a coalition of respected plaintiff’s attorneys have begun investigating cases of birth defects that may have been caused by Zofran.

Ondansetron, an antiemetic drug that blocks the neurotransmitter serotonin, has been manufactured as Zofran by GlaxoSmithKline since the late 1980s. By 1991, the US Food & Drug Administration (FDA) had approved Zofran to treat cancer patients suffering from the severe nausea and vomiting that often accompanies chemotherapy and radiation. While the drug’s indication was later extended to treat certain patients suffering from post-operative nausea, the FDA has never approved Zofran for use during pregnancy and GlaxoSmithKline has presented no evidence of the medication’s safety for unborn children.

Nonetheless, Ondansetron quickly became America’s most popular drug for the treatment of nausea and vomiting during pregnancy.

In recent years, several epidemiological studies have suggested an increased incidence of birth defects in children born to women who took Zofran during pregnancy. Researchers from Harvard’s School of Public Health and Boston University’s Slone Epidemiology Center found that women who used Zofran to treat morning sickness were 2.37 times more likely to have children with cleft palates. In Denmark, a group of researchers surveyed 903,207 births and found that women prescribed Ondansetron during the first trimester were 4.8 times more likely to deliver babies with “atrioventricular septal defects,” a congenital heart condition commonly referred to as “hole in the heart.”

Two lawsuits now claim that GlaxoSmithKline performed studies to test Zofran’s effects on pregnant rabbits and rodents during the ‘80s. These tests allegedly presented evidence of the drug’s toxicity in animals, including multiple intrauterine deaths. The cases accuse GlaxoSmithKline of hiding these results from the FDA. In addition, the plaintiffs allege that GlaxoSmithKline has received more than 200 reports of Zofran-related birth defects to date. The company has never modified the drug’s warning label to include information pertaining to birth defects.

In 2012, GlaxoSmithKline settled claims filed by the US Department of Justice in the largest case of alleged healthcare fraud in US history. The federal government’s allegations included multiple counts of unlawfully promoting medications for unapproved purposes directly to physicians. Zofran was named explicitly in the DOJ’s case, and the government accused GlaxoSmithKline of paying kickbacks to doctors who prescribed Zofran to pregnant women suffering from morning sickness. While the company eventually settled with the Department of Justice for $3 billion, GlaxoSmithKline continues to deny all allegations relating to Zofran and the harm it potentially presents to pregnant women and their children.

In response to these recent allegations, a group of prominent law firms have partnered to investigate claims of birth defects caused by Zofran.

The alliance is led by Michael Monheit, Esq., managing partner of the firm Monheit Law. Mr. Monheit, the father of a child with special needs, sits on the board of the Cleft Lip And Palate Foundation Of Smiles. With over 20 years of trial experience, Monheit has litigated several noteworthy cases involving large pharmaceutical companies. As chair of the Fosamax litigation group, Mr. Monheit represented individuals who developed esophageal cancer and irregular heartbeats after taking the osteoporosis drug Fosamax.

Mr. Monheit is joined by Elizabeth Graham, Esq., who leads the complex pharmaceutical and medical device litigation practice at Grant & Eisenhofer. With over 26 years of experience litigating mass tort lawsuits and class actions, Ms. Graham has been selected lead counsel in several multimillion dollar cases.

From the firm of Janet, Jenner & Suggs, LLC, Robert Jenner, Esq. brings over 30 years of experience representing individuals harmed by dangerous drugs. Mr. Jenner leads JJS’ Mass Tort Division and is frequently honored by the nation’s most prestigious peer-nominated legal ranking services.

Brian Mittman, Esq., of Markhoff & Mittman, P.C., comes with over 20 years of trial experience. Mr. Mittman, a supporter of the Pediatric Cancer Foundation, focuses his practice on Social Security and disability law.

Rounding out the team is Laurence Banville, Esq., a former defense attorney for companies within the asbestos industry, Mr. Banville brings a keen knowledge of how large corporations defend against allegations of wrongdoing.

Women who delivered children with birth defects after taking Zofran for morning sickness can learn more by visiting

Contact Info

Michael Monheit


As a parent of a child with pervasive developmental delays and special needs, and as a board member of "The Cleft Lip and Palate Foundation of Smiles", I understand what you are going through. This is personal to me.
- Michael Monheit, Esq.
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