The U.S. Supreme Court this week let stand a jury verdict that ordered Pfizer to pay $142 million to Kaiser Foundation Health for the illegal marketing of Neurontin, an anti-seizure drug that is widely prescribed off-label to treat fibromyalgia and migraines.
The decision clears the way for lawsuits by Aetna and other health insurers against Pfizer for the off-label promotion of Neurontin, a drug once infamously described by a top Pfizer executive as “snake oil.”
The cases stem from a 2004 settlement with the U.S. Department of Justice, in which Pfizer agreed to pay $430 million dollars in fines to resolve misdemeanor criminal and civil charges for the marketing of Neurontin, which is also known by its generic name, gabapentin.
After the settlement, Kaiser and other insurers sued Pfizer to recover the cost of Neurontin prescriptions they paid for, but were prescribed for conditions the drug did not effectively treat.
Originally developed by Warner Lambert, which Pfizer later acquired, Neurontin was approved by the Food and Drug Administration in 1993 to treat epileptic seizures and in 2002 to treat some types of neuropathic pain.
But the drug companies also promoted the drug for other uses through publications, medical seminars and in private communications with doctors.
Neurontin soon became a blockbuster drug, with annual sales rising to $2.3 billion, as more and more physicians prescribed it off-label to treat a wide variety of conditions, including bipolar disorder, depression, diabetic neuropathy, migraines and fibromyalgia.
According to some estimates, over 90% of Neurontin sales are for off-label uses. Doctors are allowed to prescribe drugs off-label for uses that have not been approved by the FDA, but drug makers are prohibited from marketing their products for those conditions.
Neurontin’s popularity seemed to mystify some of Pfizer’s own executives. In a 1999 email under the subject heading “social phobia,” Christopher Wohlberg, who was then Pfizer’s executive medical director, wrote this:
“Gabapentin (Neurontin) is the ‘snake oil’ of the twentieth century. It has been reported to be successful in just about everything that they have studied.”
Another Pfizer executive wrote in a memo that there was “negligible evidence” supporting Neurontin’s use to treat bipolar disorder or depression.
“There is pretty good consensus among experts in the area that gabapentin is not a good anti-manic treatment,” wrote Atul Pande, then vice-president of Pfizer’s neuroscience division.
Both the memo and the email surfaced years after they were written, after discovery motions were filed by lawyers suing the company.
“The manipulated research and information behind the marketing of Neurontin misled physicians, pharmacists and patients alike into using this expensive drug for off-label uses where the evidence did not support it,” Kaiser Foundation Health said in a statement.
The Supreme Court ruling, which was made without comment, allows similar claims by health insurers against Pfizer to proceed. They could potentially turn into a class action lawsuit.
“While we are disappointed with the court’s decision denying the petition, the company has strong defenses on the merits in the cases that will now proceed in the lower court,” Pfizer said in a statement.