After thumbing through a few dictionaries, a judge has brought an abrupt end to a whistle-blower case against Pfizer Inc. that has bounced around the courts since 2004, producing several lengthy amended complaints along the way. In an 11-page order issued Thursday, U.S. district judge Brian Cogan dismissed with prejudice a former Pfizer employee’s claim that the company illegally promoted the cholesterol drug Lipitor for off-label uses.
Siding with Pfizer’s lawyers at Skadden Arps Slate Meagher & Flom, Cogan ruled that while Pfizer’s marketing of the drug may have violated certain industry guidelines, the company didn’t engage in fraud, because those guidelines were “merely informational and advisory rather than restrictive limitations.” To emphasize his point, the Brooklyn-based judge noted that dictionaries uniformly define the term “guidelines” to mean something that’s being suggested, not required.
Jesse Polansky, a doctor and the former director of outcomes management strategies at Pfizer, filed a False Claims Act case in 2004 against the company in the Eastern District of New York. He alleged that Pfizer urged doctors to prescribe Lipitor for millions of people with moderately raised cholesterol levels, even though the drug is only approved for treating people with high cholesterol levels. Millions of improper prescriptions were ultimately covered by government health care plans, Polansky alleged.
The qui tam case was stalled for three years while the U.S. Department of Justice weighed whether to intervene. In 2007, the department declined, prompting the original presiding judge, Edward Korman, to unseal the complaint, per FCA regulations. Two years later, Korman dismissed the case because of a pleading deficiency, but gave Polansky leave to refile. The judge ruled that the plaintiff never identified any specific physicians who were allegedly induced by Pfizer to write prescriptions for off-label uses. Korman’s comments weren’t lost on Milberg, which took over the case. In early 2010, the firm filed a beefed-up 168-page amended complaint on Polansky’s behalf.
Milberg’s efforts have now gone to waste. For unknown reasons, Korman recused himself from the case and Cogan took over. The judge spotted what he called a “fatal” problem with Milberg’s complaint—while it’s true that Lipitor isn’t recommended for all people with cholesterol issues, that recommendation is merely a guideline promulgated by the National Cholesterol Education Program.
“Plaintiff has attempted to turn an advisory snippet into a prohibitive mandate,” Cogan wrote. “I have reviewed numerous dictionaries trying to find a definition of ‘guidelines’ with a mandatory connotation, and although one may exist somewhere, the ones that I have found provide that ‘guidelines’ are by definition advisory,” the judge ruled.
Pfizer’s defense was led by Skadden partner Mark Cheffo and associate Mara Cusker Gonzalez. Cheffo declined to comment.
Pfizer said in a statement: “This dismissal affirms our longstanding belief that this lawsuit had absolutely no merit. The government declined to intervene in the case several years ago. As we have maintained all along, our policies and practices with respect to marketing Lipitor were proper and complied with all relevant laws.”
We didn’t immediately hear back from Kirk Chapman of Milberg, who represented Polansky.