The Status of the Zofran Lawsuit

Recently, GSK’s motion to dismiss all the lawsuits was denied by the judge overseeing the case, F. Dennis Saylor, in Massachusetts District Court. Mounting evidence has tied Zofran, along with the generic equivalent medication ondansetron, to complications that include severe birth defects. There have been numerous reports of congenital heart defects, craniofacial malformations, musculoskeletal defects, and other abnormalities.

Zofran has been marketed off-label and prescribed to millions of pregnant women as a safe and effective treatment for morning sickness. If your family has been affected by Zofran complications, please contact a qualified pharmaceutical attorney to discuss your potential standing in the Zofran MDL.

Multidistrict Litigation

An MDL is not a class action lawsuit, but is made up of many cases filed by individual plaintiffs. This type of consolidation of multiple cases is common in product liability litigation. Plaintiffs benefit from the efficiency of combined discovery, yet each claim is still treated as an individual case. Plaintiffs retain their own legal counsel and make their own decisions concerning their claims and settlement offers.

Case Background and Updates

The timeline of the Zofran lawsuit extends back to the early-1990s. Zofran was approved by the Federal Drug Administration (FDA) in 1991 to treat nausea in cancer patients who were receiving chemotherapy and radiation treatment, but it has never been cleared for use by pregnant women. Starting in the late 1990’s, GSK aggressively marketed Zofran to pregnant women and their doctors, describing it as safe and effective for prevention of nausea and vomiting.

Zofran has been marketed off-label and prescribed to millions of pregnant women as a safe and effective treatment for morning sickness.

From the early 1980s until 2013, there was no FDA approved anti-nausea drug on the market for pregnant woman. Bendectin had been used for years prior, but was withdrawn in 1983. (The same drug combination has now been approved by the FDA under the trade name Diclegis.) OB-GYN doctors were looking to fill the void and treat pregnant women suffering from morning sickness, which affects 80 percent of pregnant women and can require hospitalization in severe cases.

Many doctors responded to GSK’s marketing campaign that was promoting Zofran as a preventive anti-nausea treatment. Doctors commonly prescribe drugs for off-label uses if they believe the treatment is effective and safe. However, it is not lawful for pharmaceutical companies to promote a drug for an application that is not approved by the FDA.

GSK has faced prosecution by the U.S. government for similar infractions before. In 2012, the company paid out over three billion dollars in fines and restitution for civil and criminal charges, one of the largest settlements in history. The charges included the illegal marketing of medications for unapproved purposes, fraud, and bribery.

There is evidence that GSK was aware of potential dangers to a developing fetus exposed to Zofran. The company deemphasized animal studies that were conducted in the 1980s that indicated that Zofran could cross the placental barrier and reach the fetus. As early as 1992, GSK began receiving adverse event reports of infants born with birth defects after the mothers took Zofran while pregnant.

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A July 2015 investigation revealed 475 reports to the FDA of adverse fetal outcomes connected to Zofran. In addition to stillbirths and spontaneous abortions, there were multiple references to congenital heart defects, primarily atrial septal defects and ventricular septal defects. There were also many other types of birth defects, including craniofacial defects, such as cleft lips and cleft palates, as well as respiratory defects, premature deliveries, and fetal growth restriction.

Clinical studies have verified the link between Zofran and specific birth defects. In a significant study published in October 2014, Swedish researchers found a documented connection between Zofran use in early pregnancy and congenital heart defects. The researchers concluded that babies were at a greater risk for cardiac defects, and specifically for septal defects.

FDA Labeling Change

In June 2015, the FDA announced plans to change their requirements for drug product labeling affecting pregnant women. Currently, medications are categorized using an “A, B, C, D, or X” designation, with category “A” meaning that there is no known risk to a fetus, and “X” indicating that there is positive evidence of fetal risk that clearly outweighs the potential benefits.

Moving forward, pharmaceutical companies will be asked to provide more detailed information including a summary of the drug’s specific risks, supporting data, and information intended to help physicians make appropriate decisions and counsel patients.

The FDA announced plans to change their requirements for drug product labeling affecting pregnant women.

This move is certainly relevant to Zofran, and may have even been inspired in part by reports of complications. Court-filed complaints have criticized GSK’s prescribing information, which currently categorizes Zofran as a “B” drug. For category “B”, the official description reads: “Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.”

Given the reports of adverse events and published clinical studies that outline fetal risks from exposure to Zofran, GSK should have categorized Zofran as a “D” drug. This category warns: “…positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans…”

In Canada, where a 12-party class action lawsuit against Zofran was filed in December 2015, the prescriber warning is clear: “The safety of ondansetron for use in human pregnancy has not been established,” and “the use of ondansetron in pregnancy is not recommended.”

Recently Filed Claims

Zofran lawsuits contain several allegations against GSK, including failure to warn the public about the potential risks associated with Zofran use during pregnancy. The Philadelphia-based corporation is also accused of marketing a drug for uses that are not approved by the FDA and misrepresenting Zofran as a safe treatment for morning sickness without conducting appropriate tests.

Recent cases filed include one in February 2016, by the parents of a Louisiana boy. The mother had taken Zofran to treat morning sickness in her first trimester and the baby was born with congenital heart defects. He was forced to undergo surgery right after birth as well as extensive follow-up treatments.

Also in February 2016, the Florida parents of an 11-year-old girl filed legal action against GSK. The girl had been exposed in utero to Zofran and was born with a ventricular septal defect in her heart.

In January 2016, an Oregon woman filed a lawsuit alleging Zofran is to blame for her baby’s craniofacial birth defects. Her son was born with a cleft palate and a laryngeal cleft, which causes feeding problems, stunted weight gain, and increased the risk of pulmonary infection.

Statute of Limitations Laws

Potential Zofran plaintiffs are affected by the statute of limitations laws in their state of residence, which dictate filing deadlines for legal actions. In most states, the time constraints for product liability claims begins when the injury is discovered, which is why many lawsuits have been filed on behalf of children born many years ago.

Schedule a Complimentary Case Evaluation

If you believe your family was impacted by the off-label use of Zofran, you can determine your legal options with the help of a qualified defective drug attorney. You and your family may be entitled to compensation for damages, including medical expenses, lost wages, and pain and suffering. Please contact our legal team to arrange a complimentary case evaluation.