Lawsuit by union and other health care payors challenging billions of dollars
in unwarranted Lipitor prescriptions; plaintiffs claim Pfizer marketed drug
outside approved FDA treatment guidelines for lowering cholesterol.
For large drug companies, the holiest
of grails is the blockbuster medication that makes a market and leads all
other treatments in brand recognition and sales, typically generating billions
of dollars. Such is the case with Pfizer, Inc's best-selling cholesterol-
lowering drug, Lipitor, the blockbuster of all blockbusters.
But now, 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 company's 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
federal court. 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. (See list of current plaintiffs below.)
There is no question that Lipitor is a certified blockbuster - "the most
widely used treatment for lowering cholesterol and the best-selling
pharmaceutical product in the world," Pfizer touted in its 2005 annual report.
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
Lipitor's sales" flows from Pfizer's 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 wasn't until 2001 that
Pfizer launched a broad marketing and advertising campaign to increase
awareness among physicians and consumers. The drug plans allege that
Lipitor's dramatic spike in sales - from $5 billion in 2000 to $12.1 billion
in 2005 - reflects Pfizer's aggressive off-label promotion of the drug during
that period.
As noted in the plaintiffs' complaint, "if a drug's 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
Pfizer's 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 Lipitor's 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 Lipitor's 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 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.
"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.
"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 FDA's 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 Pfizer's alleged practices, including treble damages
in accordance with the RICO claims.
List of Initial Plaintiff Drug Plans Participating in Class Action
Welfare Fund of Teamsters Local Union 863 (New Jersey)
Southern Illinois Laborers and Employers Health and Welfare Fund
Midwestern Teamsters Heath & Welfare Fund (Illinois)
NECA-IBEW Health and Welfare Fund (Illinois)
Cleveland Bakers and Teamsters Health and Welfare Fund (Ohio)
Electrical Workers Benefit Trust Fund (Indiana)
Sidney Hillman Health Center of Rochester (New York State)
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