The opinions of 33 doctors and scientists regarding the safety of Avandia could help plaintiffs resolve thousands of claims against the diabetes drug’s maker.
Twelve members of a U.S. Food and Drug Administration panel recommended this week that GlaxoSmithKline’s Avandia be taken off the market, since studies have shown it puts patients at greater risk for heart attacks. Seventeen panelists, however, voted to allow continued use of the drug as long as new warnings or restrictions are in place. And three participants on the FDA’s 33-member advisory panel maintained that the drug is safe to sell as is, echoing London-based GlaxoSmithKline’s position that the drug is safe when given to patients without a history of heart disease.
The result is that Avandia continues to be sold as before until FDA officials make a final determination about the drug’s safety, but the panel’s opinion could impact the thousands of Avandia lawsuits that remain unsettled from the 13,000 filed to date.
“We’ve heard there’s at least some agreement between scientists out there that it shouldn’t be on the market,” said Shawn Khorrami, partner at Khorrami Pollard & Abir in Los Angeles, who represents about 600 plaintiffs with Avandia claims against GlaxoSmithKline.
Khorrami said discovery is ongoing on behalf of his clients, but said that he is involved in discussions that could lead to settlements.
GlaxoSmithKline reportedly settled 10,000 claims for a total payout of $460 million after setting aside $3.5 billion in the first quarter of 2010 for legal expenses. The company previously settled 700 Avandia claims for $60 million.
Nancy Hersh, founding partner of Hersh & Hersh in San Francisco, said she has not entered into settlement negotiations with GlaxoSmithKline on behalf of the 400 plaintiffs that she represents.
“I’m always appalled when we get a case like this,” she said. “I have never had a case where the company didn’t know or have reason to suspect at the outset that the product posed dangers to the consumer.”
Avandia was the subject of an FDA review in 2007, when the regulatory agency forced the manufacturer to add a “black box” warning to the drug’s label, representing the highest level of warning printed in materials distributed to patients and doctors.
Terry Mahn, a partner at Fish & Richardson in Washington, D.C., said scientists, such as those on the FDA advisory panel, tend to think that warning labels are enough protection because doctors will advise patients accordingly.
But the decision that regulators face about allowing Avandia to remain on the market is more a political question than a scientific one.
Mahn noted that the FDA, with pressure from the Obama administration, is taking a closer look at the processes of approving drugs and reviewing approved products following The Food and Drug Administration Amendments Act of 2007.
The act gave the FDA authority to require a Risk Evaluation and Mitigation Strategy, or REMS, that are distributed in the packaging of certain drugs or therapies to make sure the benefits of a treatment outweigh its risks.
While the FDA has not approved a REMS plan for Avandia, Mahn said the FDA panel’s recommendations for the drug could set doctors up for future liability claims if a doctor prescribes it to their patient and the drug is linked to that person’s heart attack.
“But if the doctor screens the patient, warns the patient and the patient wants it anyway, then the doctor has done everything he can,” he said. “Most patients will want to take something else.”
Posted with the permission of Daily Journal Corp. (2010)