By Amanda Bronstad, From The National Law Journal

More than 30 lawsuits have been filed by parents alleging that taking anti-nausea prescription Zofran for morning sickness during pregnancy caused birth defects in their children including congenital heart defects, cleft lip and cleft palate.

The suits target GlaxoSmithKline LLC’s alleged “off-label” marketing of Zofran, which the U.S. Food and Drug Administration approved in 1991 for the treatment of nausea and vomiting related to chemotherapy and surgery. The cases, citing various clinical studies mostly on animals, allege that GSK failed to warn doctors of the side effects of the drug when used in women to treat morning sickness in the first trimester of pregnancy.

Rachel Abrams of Levin Simes. HANDOUT.

“This is a heavily prescribed drug off-label for morning sickness during pregnancy,” said Rachel Abrams (left), of San Francisco’s Levin Simes, who spoke about the Zofran litigation at a plaintiffs bar conference last month in San Francisco.

GSK spokeswoman Marti Skold Jordan said 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.” Jordan added, “In recognition of the fact that prescription medicines have inherent risks, a manufacturer is not to be subject to liability when someone experiences a side effect when the medicine is accompanied by appropriate labeling.”

In 2005, GSK paid about $150 to resolve fraud allegations from the Justice Department in the pricing and marketing of Zofran and another anti-nausea drug. The settlement did not relate to off-label marketing. And in 2012, GSK agreed to pay $3 billion to settle a Justice Department civil and criminal investigation involving its off-label marketing of pharmaceutical drugs.

Abrams said the settlements show a pattern of GSK marketing drugs for off-label use, including Zofran. Her firm planned to file at least three cases in the next week and has potentially 300 more in the pipeline. “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,” she said.

But in those settlements, “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,” Jordan wrote.

In motions to dismiss filed in two Zofran cases, GSK cited the drug’s label: “Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.”

Zofran. Credit: National Library Medicine via Wikimedia Commons.

The Zofran litigation could face substantial preemption hurdles given that the vast majority of women potentially affected likely took the generic version.

In an Aug. 5 filing before the U.S. Judicial Panel on Multidistrict Litigation, GSK attorney Madeleine McDonough, co-chairwoman of the pharmaceutical and medical device practice at Shook Hardy & Bacon in Washington, noted that “a number of cases pending already implicate the possible use of a version of ondansetron made by generic manufacturers.”

Most of the suits, which span 15 states, were filed after GSK on July 6 asked the MDL panel to coordinate the federal litigation before either U.S. District Judge Cynthia Rufe or Judge Paul Diamond in the Eastern District of Pennsylvania, near its Philadelphia offices. Plaintiffs lawyers wrote that the “number of filings will grow exponentially over the coming months,” but they are divided over whether those cases should be coordinated in Massachusetts, Alabama, Ohio, Louisiana, California or Illinois.

The MDL panel’s next hearing is Oct. 1 in New York.

IMAGE: Credit: Fotolia

For more on this story go to: http://www.nationallawjournal.com/id=1202734732031/BirthDefect-Suits-Against-ZofranMaker-Pile-Up#ixzz3inb1Y09I