The lawsuits accuse GSK of “off-label” marketing, that is, it is prescribed for ailments (pregnancy) that is not mentioned in the drug’s official FDA labeling. Zofran’s 1991 FDA approval was for “treatment of nausea and vomiting related to chemotherapy and surgery.” According to San Francisco attorney Rachel Abrams, speaking at a bar conference in the city regarding the lawsuits, “If they’re marketing and pushing a drug for a certain indication, and don’t have FDA approval for that indication, that’s a problem for GSK in and of itself.”
Recent lawsuits in the past month from Illinois, North Dakota, and Ohio, against GlaxoSmithKline’s (GSK) popular anti-nausea drug Zofran over birth defects now bring the total number of claims against the drug to at least 34 in 20 different federal courts. This comes according to Michael Monheit, managing partner of the Monheit Law Firm, who is among several attorneys heading up a class-action lawsuit as the deadline to respond to GSK’s petition for multi-district litigation (MDL) approaches. The drug, which is primarily prescribed to prevent vomiting for patients who undergo chemotherapy and surgery, was approved by the Food and Drug Administration (FDA) in 1991, holding the exclusive patent until 2006. The claims allege that GSK failed to warn doctors of potential birth-defects, as the drug has also been often prescribed to pregnant women as a method of morning-sickness prevention during pregnancy. Although most of the claims involve congenital heart birth defects, recent lawsuits also accuse the drug of causing cleft-palate, as well as kidney and reproductive system defects.
The lawsuits accuse GSK of “off-label” marketing, that is, it is prescribed for ailments (pregnancy) that is not mentioned in the drug’s official FDA labeling. Zofran’s 1991 FDA approval was for “treatment of nausea and vomiting related to chemotherapy and surgery.” According to San Francisco attorney Rachel Abrams, speaking at a bar conference in the city regarding the lawsuits, “If they’re marketing and pushing a drug for a certain indication, and don’t have FDA approval for that indication, that’s a problem for GSK in and of itself.” Abrams also said that her firm is filing three more lawsuits this week and may have as many as 300 more pending. GSK defends its labeling, and physician discretion, according to spokeswoman Marti Skold Jordan, who stated in an email that “GSK fully respects the right of doctors to apply their knowledge and training in consultation with each patient to decide whether the benefits of a given medicine outweigh its potential risks in light of a patient’s specific medical condition and history.”
This is not the first legal issue for Zofran by any means. GSK paid $150 million to resolve a Justice Department fraud complaint in 2005 about the marketing of Zofran and another anti-nausea drug. Then in 2012, GSK negotiated a $3 billion settlement with the Justice Department to resolve more criminal and civil allegations of marketing fraud for several more drugs including Zofran. The FDA has recorded at least 200 adverse events from the drug as well. In addition to maintaining that prescribing the drug according to need during pregnancy is a matter of doctor discretion, GSK attorney Madeleine McDonough suspects that many of the cases do not actually involve Zofran, stating that “a number of cases pending already implicate the possible use of a version of ondansetron made by generic manufacturers.” GSK have filed motions to dismiss several of the lawsuits based on this claim. Although Abrams said that the previous federal penalties indicate a pattern of misleading marketing over the drug, Jordan noted that “there were no findings that GSK illegally marketed Zofran at any time, and GSK vigorously denies the Zofran allegations in both the settlement and civil complaints.”
Both GSK and Monheit are pushing to consolidate the claims into a single national lawsuit, the battle however, is over venue. GSK filed a petition to the Judicial Panel on Multidistrict Litigation (JPML) on July 6th, requesting that the litigation occur in U.S. District Court in Philadelphia, the home city of the company’s U.S. headquarters. While plaintiffs’ attorneys are also seeking a consolidated case, they are divided over the venue choice, although being anti-Philadelphia. Among their preferences include: Massachusetts, Alabama, Ohio, Louisiana, California or Illinois. In their filing to the JPML, plaintiffs’ lawyers warned the panel that the “number of filings will grow exponentially over the coming months.” Indeed, several suits have been added to the docket since last month’s filing, including the three most recent. Monheit stated earlier in the week that plaintiffs’ counsel will likely file official responses to the JPML within weeks. GSK attorney, The JPML will meet next on October 1st, in New York City.
Digital Journal – Michael Monheit
Legal Examiner – Roopal Luhana
National Law Journal – Amanda Bronstad
National Law Review – H.Matthew Taylor