Zofran (ondansetron) has been hailed as the most-prescribed pharmaceutical treatment for morning sickness. However, the U.S. Food and Drug Administration never approved the drug for that use. Families of children who suffered birth defects after mothers took Zofran while pregnant have sued GlaxoSmithKline over allegations that it marketed the drug to pregnant women without FDA approval and failed to warn about risks.
Heart defects, cleft palate, skull deformities — these are some of the birth defects mothers say resulted from their use of the anti-nausea drug Zofran during pregnancy. As a result, GlaxoSmithKilne (GSK), the company that originally marketed the drug, has been named in more than 500 actions in federal court.
The lawsuits against GSK involve allegations that the company unlawfully and fraudulently promoted Zofran as a way to treat morning sickness, a use not approved by the U.S. Food and Drug Administration (FDA). They also allege the company hid evidence of the medication’s risks and failed to warn the public about those risks.
In 1983, the maker of the only FDA-approved medication used to treat morning sickness withdrew the product, Bendectin, from the market, leaving pregnant women suffering from nausea and vomiting with no approved medical treatments.
Eight years later, in 1991, the FDA approved Zofran to help cancer patients with nausea and vomiting after chemotherapy or radiotherapy treatments or surgery. Some doctors whose patients suffered from morning sickness began prescribing Zofran to treat symptoms, even though it lacked FDA approval for that use. Because the medicine appeared to relieve symptoms, Zofran became popular.
Lawsuits allege GSK saw Zofran gaining popularity for morning sickness and began promoting it for that purpose, despite the fact that it’s illegal to promote drugs for off-label use.
Use of ondansetron, the generic name for Zofran, to treat nausea and vomiting in pregnancy jumped from 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, according to an article published in 2014 in the American Journal of Obstetrics and Gynecology. The surge occurred despite concerns regarding fetal safety.
An analysis by IMS Health found more than 21 million prescriptions for all uses of Zofran were filled in the U.S. in 2015, ProPublica reported. The amount of prescriptions is 10 times as many as in 2006.
Today, there are about 4 million pregnancies a year in the U.S. Some 1 million pregnant women in the country are exposed to ondansetron.
Nausea or vomiting during pregnancy (NVP), commonly referred to as morning sickness, can cause malnutrition and endanger the mother and unborn baby. Women turned to Zofran or the generic version of the drug to keep them and their babies safe from those complications. However, some Zofran users say their babies suffered severe birth defects that render them forever dependent on their parents for care.
In February 2015, a Minnesota mother filed the first Zofran lawsuit after two daughters were born with congenital heart defects. More lawsuits quickly followed. The Zofran-related legal claims center on the cause of birth defects and whether the drug maker is liable for injuries suffered by babies whose mothers took the medication while pregnant.
Court documents show GSK knew as early as 1992 that Zofran presented “unreasonable risk of harm” to developing babies because the drug passes through the human placenta. Despite this knowledge, the drugmaker continued to market the drug to expectant mothers. The company even paid doctors to prescribe it, lawsuits allege.
In less than a six month period, families filed Zofran lawsuits in federal courts across the country, including in Alabama, Arkansas, Louisiana, Massachusetts, Montana, New Jersey, Ohio and Texas.
In July 2015, GSK asked the Judicial Panel on Multidistrict Litigation (MDL) to centralize the lawsuits in Philadelphia. Plaintiffs in the cases agreed that centralization was warranted but disagreed about in which district the proceedings should take place. The judicial panel issued a court order in October 2015, transferring 12 Zofran lawsuits to the U.S. District Court of Massachusetts.
“Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary.”
Judge F. Dennis Saylor IV, the judge overseeing the MDL, appointed three veteran attorneys to lead the litigation against GSK: Kimberly Barone Baden of Motley Rice, Elizabeth Graham of Grant & Eisenhofer and Tobias Millrood of Pogust Braslow & Millrood.
By December 2015, more than 150 Zofran lawsuits had been centralized in the U.S. District Court of Massachusetts. That month, GSK filed a motion to dismiss the lawsuits. In January 2016, Judge Saylor ruled to allow more than 200 Zofran lawsuits to proceed, rejecting GSK’s arguments for dismissal.
The number of Zofran lawsuits jumped to 238 by March 2016. Two months later, 259 actions had been brought under the MDL.
As of May 2018, 594 total actions had been filed in the MDL; 446 actions were still pending. The discovery phase of the proceedings began in 2016. No trial date had been scheduled, and GSK had offered no settlements in pending cases in the MDL.
Prior to the wave of Zofran lawsuits in 2015, the U.S. Department of Justice had brought a lawsuit against GSK, alleging the company promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.
In 2012, GSK pleaded guilty to federal charges of fraud and illegal promotion of several drugs. GSK agreed to pay $3 billion to the U.S. and certain states as part of the legal settlement.
More than $2 million was allocated to Zofran and nearly $55 million was allocated for kickbacks for nine drugs, including Zofran.
The settlement was deemed the largest health care fraud settlement in U.S. history. Then-Deputy Attorney General James M. Cole called it “unprecedented in both size and scope.”
The Justice Department’s lawsuit was not the first time GSK came under fire for its marketing of Zofran.
In March 1999, the FDA issued GSK a warning letter for distributing promotional materials that present “Zofran in a manner that is false or misleading because it lacks fair balance.”
The agency’s Division of Drug Marketing, Advertising and Communications (DDMAC) concluded promotional material for Zofran violated the Federal Food, Drug and Cosmetic Act because it “fails to present any information relating to the side risks associated with the drug.”
The agency ordered GSK to “immediately cease distribution” of Zofran promotional material that lacks risk information.
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