Plaintiff's Lipitor off-label case hinges on proving false claims
The lawsuit, filed in U.S. District Court for the Eastern District of New York in February 2004, was recently unsealed when the government decided not to get involved. “It's not that unusual that the government doesn't intervene in major pieces of litigation like this,” said the plaintiff's attorney, Steve Berman of Hagens Berman Sobol Shapiro. He cited the Pfizer Neurontin off-label marketing case, in which the government declined to intervene and a private law firm prosecuted. The government eventually came back in and settled the case for what at the time was the largest qui-tam settlement in history, Berman said. “Right now we're going to go it alone and maybe the government will come back in, maybe they won't.”
For now, though, the former employee, Dr. Jesse Polansky, has his work cut out. He alleged that the drug maker committed off-label marketing under the guise of Lipitor education. The suit charges that the Pfizer-funded programs included “deliberate misinformation promoting the idea that kidney-disease patients may need to be treated with statins,” according to The Wall Street Journal.
Polansky's strategy turns on his ability to show that “but for the illegal promotion of off-label uses, the doctors wouldn't have used the product and therefore there would not have been claims submitted to the government,” said one defense attorney who wished to remain anonymous because her firm does business with Pfizer.
Dr. Polansky is seeking a share of money recovered from such claims, and that could be substantial given Lipitor's $8.6 billion in US sales last year, per IMS Health. Tying a case to the False Claims Act is challenging, however, because there are solid defenses that can be raised, said the attorney. The defense would be to prove that prescribing of the product was not prompted by the educational activities but by an article in a medical journal or presentation at a conference. And that depends on the evidence.
The WSJ Health Blog cited two dinner meetings where kidney disease was discussed as being a risk factor for cardiovascular disease. “That would place people in the highest risk category—the one which calls for placing patients on Lipitor even when they have relatively low levels of bad cholesterol,” notes the blog.
Whether or not chronic kidney disease (CKD) is indeed a risk factor warranting treatment with statins is a key plank of the plaintiff's argument. The defense is likely to try to show a break in the chain between the dinner meetings and physicians' prescribing of Lipitor in patients with CKD.
Polansky was formerly director of outcomes management strategies for Pfizer from 2001 to 2003. The alleged misconduct occurred in early 2004. Since then many manufacturers have removed authority for medical education from marketing per OIG compliance guidance for manufacturers issued in 2003.
Despite some industry reforms, Congress has expressed concern that discussions of off-label uses for drugs could be used by a company to expand the market for products. The Senate Special Committee on Aging held a hearing in June questioning the independence of off-label talks sponsored by industry. That followed an April report by the Senate Finance Committee which found that regulators do not monitor courses or materials for accuracy or evidence of bias.