November 16th, 2012 // 3:22 pm @ jmpickett
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A federal judge has dismissed a long-running whistleblower lawsuit filed by a former Pfizer executive, who accused the drugmaker of illegally scheming to boost Lipitor sales by misrepresenting product labeling and federal cholesterol guidelines; using misleading educational programs for doctors; unlawful sampling, and kickback schemes that resulted in off-label marketing that allegedly defrauded Medicaid and Medicare.
Jesse Polansky, who was director of outcomes management from April 2001 until July 2003, filed his lawsuit eight years ago, claiming that thousands of physicians prescribed millions the cholesterol pill to millions of patients for whom drug treatment was not recommended, and could even be dangerous, in some cases.
Yet the alleged scheme rang the register almost endlessly, helping to make Lipitor one of the best-selling medicines in history. However, Polansky charged that federal and state government healthcare programs, including Medicaid and Medicare, unnecessarily paid for prescriptions and this coverage amounted to fraud, according to his lawsuit.
One example: the lawsuit charged that Pfizer attempted to educate physicians about Lipitor through the National Lipid Education Council, which included many members with ties to the drugmakers. And Pfizer (PFE) allegedly limited distribution of samples of entry level doses ? 10mg or 20 mg ? so doctors would write more prescriptions for higher doses, which were more expensive and did not face generic competition.
Polansky, who claimed he was fired by Pfizer after complaining about marketing he considered improper, charged that the drugmaker allegedly disregarded distinctions in the National Cholesterol Education Program (NCEP) guidelines, which approved drug therapy for about 36.5 million Americans. However, the largest subset were ?moderate risk? patients, those with two or more risk factors and less than 10 percent risk of heart attack.
At the time he amended his lawsuit in February 2010, there were an estimated 14.6 million people who needed only therapeutic lifestyle changes, while drugs were recommended only for the remaining 2.8 million people. By off-label marketing to the rest, he charged, Pfizer realized ?it could increase revenues by billions of dollars,? the suit stated.
As we reported previously, Polansky charged that Pfizer wanted to extend Lipitor use beyond the indication found on the labeling by targeting people at moderate risk of developing heart disease or having a heart attack. He also maintained that educational programs for doctors deliberately misrepresented the labeling to encourage Lipitor prescriptions for people in the moderate-risk category who did not need the pill (here is his lawsuit).
As noted in earlier stories, Pfizer allegedly accomplished this by repeatedly and deliberately blurring distinctions between patient groups established in the NCEP guidelines in slide presentations and other materials used for continuing medical education programs; information distributed at health fair and screening programs; material provided by sales reps; on its Lipitor web site; and with inaccurate cardiac risk calculators used by physicians. In doing so, Pfzier was able to ?classify falsely many moderate risk patients as moderately high risk, making them eligible? for Lipitor prescriptions (back story).
A similar approach taken by Bristol-Myers Squibb (BMY) prompted the FDA to issue a warning letter in 2003 ? a year before Polansky filed his lawsuit ? to the drugmaker, which sold the rival Pravachol cholesterol pill. The warning letter noted that the drugmaker attempted to broaden the market for its drug and the agency cited the NCEP guidelines in admonishing Bristol-Myers executives (read here).
However, in his 13-page ruling, US District Court Judge Brian Cogan maintained that the NCEP guidelines are nothing more than guidelines. In his view, there was nothing that mandated Pfizer to market Lipitor only for people whose cholesterol levels fell within the ranges stated by the NCEP and the FDA had every opportunity to require such language in the labeling.
?The plain meaning of the word ?Guideline? is one of counseling and advice, not mandatory limitation. That is, the Guidelines ?guide,? they do not mandate,? he wrote, pointing out that the reference to the NCEP guidelines appeared in the 2005 version of Lipitor labeling, but an updated label that was issued in 2009. ?Everything about the two labels at issue in this case suggests that the NCEP Guidelines, as a matter plain language, fall well within the usual, non-compulsory definition of the word guidelines.?
??The full text of the guidelines, not included on the Lipitor label, also makes the advisory nature of the guidelines clear as it notes that the report ?should not be viewed as a standard of practice,? but that the guidelines ?represent general guidance that can assist in shaping clinical decisions? and ?should not override a clinician?s considered judgment in the management of individuals.? Once the doctor?s clinical judgment is introduced as the determinative factor in the decision making process, it must be apparent that this data serves as a recommendation, not a limitation or prohibition? (here is the ruling).
Polansky declined to comment, but it is possible he will appeal the decision, which was not dismissed with prejudice, a ruling that would have precluded further action of any sort. Moreover, the US Department of Justice has maintained interest in the case, even after declining to intervene ? or join ? a few years ago.
Two years ago, the feds filed what is called a Statement of Interest that picked apart portions of Pfizer?s argument to dismiss the case (read more here). As we wrote at the time, the act of filing the brief underscores the interest in how the courts go about interpreting and enforcing the False Claims Act (see here).
And the feds also specifically asked the court that if the case were to be dissmised, it should be done without prejudice toward the United States, suggesting the feds remain interested in the points raised by Polansky (read the fed statement of interest here).
A Pfizer spokesman sends us this: ?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.?
?Although the court previously allowed the plaintiff to amend his allegations when it dismissed his claims in May 2009, it described the plaintiff?s underlying theory as ?tenuous.? Judge Cogan agreed with Pfizer that that theory of wrongdoing was not just tenuous but did not constitute a claim under the False Claims Act and laws governing the marketing of prescription medications.?
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