The filing is no doubt referring to a class action lawsuit filed against Pfzer in late March 2006, by the Welfare Fund of Teamsters Local Union 863 in US District Court in Newark, NJ, that accuses the company of marketing Lipitor for off-label uses not included in the federal guidelines.
The aggrieved plaintiffs are insurance companies and drug benefit plans that paid for off-label prescriptions that, according to the lawsuit, might not have been written if Pfizer had not marketed Lipitor off-label illegally.
In a nutshell, the lawsuit says Pfizer has been promoting the use of Lipitor for cholesterol levels that are below those specified in the guidelines in the Third report of the Adult Treatment Panel, developed by the National Cholesterol Education Panel, which is a panel of the National Heart, Lung, and Blood Institute (ATP III).
To that end, the lawsuit says Pfizer influenced doctors to prescribe Lipitor to patients with cholesterol levels lower than the guidelines recommend. Or simply put, Pfizer sold Lipitor to patients who did not need it.
The suit relies on the federal Racketeer Influenced and Corrupt Organizations Act (RICO) to build a national class of defrauded third-party payers, but in case the RICO class fails, the plaintiffs' lawyers say they are filing additional state lawsuits.
According to plaintiffs attorney, Geoffrey Jarvis, of Grant and Eisenhofer, in an interview with Pharmaceutical Executive on March 29, 2002, the law suit is about the low-risk people, those that have less than a 10% chance of contracting coronary heart disease in the next five years.
"For that group of people," he says, "according to the drug label, unless their cholesterol is above 160, statin drug therapy is not recommended."
The plaintiffs claim that Pfizer worked to get physicians to prescribe Lipitor to people with a low risk of heart disease and cholesterol levels below 160. "There are about 15 million people in that group," Mr Jarvis said in the interview. "Basically, they are trying to expand the market of the drug to people who really ought to not be on it."
The complaint also alleges that Pfizer misrepresented Lipitor's potential market to investors by claiming "millions more potential patients than would be expected under the government guidelines."
The complaint states that "Pfizer also employed purported 'independent' third parties ... to promote Lipitor's off-label use."
In addition to paid consultants and marketing firms, it says, the company engaged organizations such as Emerging Science in Lipid Management and the National Lipid Education Council to offer physicians continuing medical education courses as well as to publish articles extolling Lipitor's off-label usage.
The complaint claims, "both organizations are fully funded by Pfizer" and have become an active part of the marketing plan for Lipitor.
Critics are quick to point out that the off-label scheme described in the current complaint resembles the charges in the fraud case that Pfizer lost in 2004 where the company paid a $430 million penalty for promoting and marketing the epilepsy drug, Neurontin, for off-label uses not approved by the FDA.
"Once you connect the dots and see the elaborate sophistication and reach of Pfizer's plan to go way beyond the federally mandated guidelines for prescribing Lipitor, there is no other way to describe it except as a fraudulent scheme, whose true purpose has been to extract illegal payments from third-party payors for Lipitor's off-label use," said Jay Eisenhofer of Grant & Eisenhofer in explaining the racketeering claims, on the Freight Teamster's Web sit.
"Between the company's own off-label marketing and the coordinated campaign by its various consultants and captive physician education groups, Pfizer has reaped billions of dollars in insurance payments to cover prescriptions for patients for whom Lipitor therapy is not recommended under FDA approved usage standards," Mr Eisenhofer noted.
The drug plan plaintiffs allege that Lipitor's dramatic rise in sales from $5 billion in 2000 to $12.1 billion in 2005, is a direct result of Pfizer's off-label promotion of the drug during that period.
The aggrieved plaintiffs are insurance companies and drug benefit plans that paid for off-label prescriptions that, according to the lawsuit, might not have been written if Pfizer had not marketed Lipitor off-label illegally.
In a nutshell, the lawsuit says Pfizer has been promoting the use of Lipitor for cholesterol levels that are below those specified in the guidelines in the Third report of the Adult Treatment Panel, developed by the National Cholesterol Education Panel, which is a panel of the National Heart, Lung, and Blood Institute (ATP III).
To that end, the lawsuit says Pfizer influenced doctors to prescribe Lipitor to patients with cholesterol levels lower than the guidelines recommend. Or simply put, Pfizer sold Lipitor to patients who did not need it.
According to plaintiffs attorney, Geoffrey Jarvis, of Grant and Eisenhofer, in an interview with Pharmaceutical Executive on March 29, 2002, the law suit is about the low-risk people, those that have less than a 10% chance of contracting coronary heart disease in the next five years.
"For that group of people," he says, "according to the drug label, unless their cholesterol is above 160, statin drug therapy is not recommended."
The plaintiffs claim that Pfizer worked to get physicians to prescribe Lipitor to people with a low risk of heart disease and cholesterol levels below 160. "There are about 15 million people in that group," Mr Jarvis said in the interview. "Basically, they are trying to expand the market of the drug to people who really ought to not be on it."
The complaint also alleges that Pfizer misrepresented Lipitor's potential market to investors by claiming "millions more potential patients than would be expected under the government guidelines."
The complaint states that "Pfizer also employed purported 'independent' third parties ... to promote Lipitor's off-label use."
In addition to paid consultants and marketing firms, it says, the company engaged organizations such as Emerging Science in Lipid Management and the National Lipid Education Council to offer physicians continuing medical education courses as well as to publish articles extolling Lipitor's off-label usage.
The complaint claims, "both organizations are fully funded by Pfizer" and have become an active part of the marketing plan for Lipitor.
Critics are quick to point out that the off-label scheme described in the current complaint resembles the charges in the fraud case that Pfizer lost in 2004 where the company paid a $430 million penalty for promoting and marketing the epilepsy drug, Neurontin, for off-label uses not approved by the FDA.
"Once you connect the dots and see the elaborate sophistication and reach of Pfizer's plan to go way beyond the federally mandated guidelines for prescribing Lipitor, there is no other way to describe it except as a fraudulent scheme, whose true purpose has been to extract illegal payments from third-party payors for Lipitor's off-label use," said Jay Eisenhofer of Grant & Eisenhofer in explaining the racketeering claims, on the Freight Teamster's Web sit.
"Between the company's own off-label marketing and the coordinated campaign by its various consultants and captive physician education groups, Pfizer has reaped billions of dollars in insurance payments to cover prescriptions for patients for whom Lipitor therapy is not recommended under FDA approved usage standards," Mr Eisenhofer noted.
The drug plan plaintiffs allege that Lipitor's dramatic rise in sales from $5 billion in 2000 to $12.1 billion in 2005, is a direct result of Pfizer's off-label promotion of the drug during that period.
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