The lawyer for an ex-Pfizer employee bringing awhistleblower suit against Pfizer said he isn’t phased by the government’sdecision to refrain from the case.

The lawsuit, filed in U.S. District Court for the EasternDistrict of New York in February 2004, was recently unsealed when thegovernment decided not to get involved. “It’s not that unusualthat the government doesn’t intervene in major pieces of litigation like this,”said the plaintiff’s attorney, Steve Berman of Hagens Berman SobolShapiro. 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 thetime was the largest qui-tam settlement in history, Berman said. “Right nowwe’re going to go it alone and maybe the government will come back in, maybethey won’t.”

For now, though, the former employee, Dr. Jesse Polansky, has his work cut out. He alleged that thedrug maker committed off-label marketing under the guise of Lipitor education. Thesuit charges that the Pfizer-funded programs included “deliberatemisinformation promoting the idea that kidney-disease patients may need to betreated with statins,” according to TheWall Street Journal.

Polansky’s strategy turns on his ability toshow that “but for the illegal promotion of off-label uses, the doctorswouldn’t have used the product and therefore there would not have been claimssubmitted to the government,” said one defense attorney who wished to remainanonymous 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 theFalse Claims Act is challenging, however, because there are solid defenses that can beraised, said the attorney. The defense would be to prove that prescribing ofthe product was not prompted by the educational activities but by an article ina medical journal or presentation at a conference. And that depends on theevidence.

The WSJ Health Blog cited two dinner meetings where kidneydisease was discussed as being a risk factor for cardiovascular disease. “Thatwould place people in the highest risk category—the one which calls for placingpatients on Lipitor even when they have relatively low levels of badcholesterol,” notes the blog.

Whether or not chronic kidney disease (CKD) is indeed a riskfactor 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 managementstrategies for Pfizer from 2001 to 2003. The alleged misconduct occurred inearly 2004. Since then many manufacturers have removed authority for medicaleducation from marketing per OIG compliance guidance for manufacturers issuedin 2003.

Despite some industry reforms, Congress has expressedconcern that discussions of off-label uses for drugs could be used by a companyto expand the market for products. The Senate Special Committee on Aging held ahearing in June questioning the independence of off-label talks sponsored byindustry. That followed an April report by the Senate Finance Committee which foundthat regulators do not monitor courses or materials for accuracy or evidence ofbias.