Off-label marketing for Lipitor’s now the focus of a class-action suit

I'm sure none of you missed this, but just in case....

A group of union and employee insurance plans is charging that Lipitor achieved its blockbuster clout in part through an ongoing fraudulent scheme that marketed the drug for off-label uses that are not approved by the Food & Drug Administration for treatment of high cholesterol.

Health care payors filed suit against Pfizer, asserting that as a result of the companys off-label promotion of Lipitor that they, along with other third-party drug plans and state Medicaid plans, have paid for billions of dollars in unwarranted Lipitor prescriptions over the last five years. In addition to charging Pfizer with fraud, violation of state consumer protection statutes and other state laws, plaintiffs assert claims under the federal anti-racketeering RICO statute.

The Welfare Fund of Teamsters Local Union 863 filed suit in New Jersey. Other plaintiff drug plans expected to join the class action are located in New York, Pennsylvania, Florida, Illinois, Ohio, and Indiana. As a group they are represented by noted securities litigation firm Grant & Eisenhofer, P.A. The first drug to achieve $10 billion in worldwide sales, Lipitor has generated more than $46 billion in revenue for Pfizer since 2000.

However, according to the drug plans lawsuit, "a significant portion of Lipitors sales" flows from Pfizers improper off-label marketing tactics that breached federal guidelines for treating cholesterol.

A statin drug that works by blocking certain cholesterol-producing enzymes, Lipitor received FDA approval in 1996. But it wasnt until 2001 that Pfizer launched a broad marketing and advertising campaign to increase awareness among physicians and consumers. The drug plans allege that Lipitors dramatic spike in sales “ from $5 billion in 2000 to $12.1 billion in 2005 “ reflects Pfizers aggressive off-label promotion of the drug during that period.

As noted in the plaintiffs complaint, "if a drugs manufacturer advertises uses not on its FDA-approved label, the drug is considered misbranded and its distribution in interstate commerce is prohibited."

The FDA has on two separate occasions cited Pfizer for improperly marketing Lipitor, including the way in which the company downplayed the drug's harmful side effects as well as for ignoring the critical role played by exercise and diet in lowering cholesterol. The complaint notes that Pfizers physician and hospital marketing materials have misrepresented treatment protocols established by the National Cholesterol Education Program, a set of evidence-based guidelines established in 2002 and known as Adult Treatment Plan III (ATP III).

Although the FDA does not regulate how doctors prescribe medications, the agency sets strict guidelines for approved treatments. As the complaint notes, "the FDA has approved Lipitor for use only in accordance with ATP III¦.Any marketing of Lipitor that runs afoul of ATP III is considered off-label marketing and violates FDA regulations."

Elsewhere, the complaint notes that "Pfizer also employed purported ˜independent third parties¦to promote Lipitors off-label use." In addition to paid consultants and marketing firms, 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 Lipitors off-label usage. As the complaint notes, "both organizations are fully funded by Pfizer" and have become an active part of the marketing plan for Lipitor.

"Once you connect the dots and see the elaborate sophistication and reach of Pfizers 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 Lipitors off-label use," said Jay Eisenhofer of Grant & Eisenhofer in explaining the racketeering claims.

"Between the companys 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.

"This is a classic case of unjust enrichment," he added. "Pfizer has built colossal sales of Lipitor through the pipeline of third-party payors such as our clients and countless other drug plans “ including Medicaid and Medicare “ much of it based on prescriptions that the FDAs guidelines say never should have been written in the first place."

Mr. Eisenhofer said that the plaintiff drug plans are seeking several layers of relief, including a court order enjoining Pfizer from continuing its deceptive off-label marketing. The plans are also asking for compensatory and punitive damages based on Pfizers alleged practices, including treble damages in accordance with the RICO claims.