Sheller, P.C. Law Firm Instrumental in Pfizer's $2.3 Billion Settlement Today in...

Sheller, P.C. Law Firm Instrumental in Pfizer's $2.3 Billion Settlement Today
in Largest Pharmaceutical Whistleblower Case in History

Includes Allegations of Illicitly Promoting Antibiotic As Clinically Superior
When Its Own FDA-Approved Label Said Otherwise; First-Ever Qui Tam
Whistleblower Settlement of Its Type

PHILADELPHIA, Sept. 2 /PRNewswire-USNewswire/ -- Pfizer Inc. ignored a 2005
FDA Warning Letter to stop promoting its antibiotic Zyvox(R) as clinically
superior to the significantly less expensive, generic vancomycin when its own
FDA-approved label indicated otherwise. The drug giant also defrauded
federal and state taxpayers by marketing Zyvox off-label, according to a qui
tam whistleblower complaint filed by Philadelphia law firm Sheller, P.C. and
other documents unsealed with today's $2.3 billion Pfizer settlement.

The $2.3 billion settlement included off-label marketing allegations for the
withdrawn arthritis drug Bextra(R), which was included in the Sheller
complaint. Zyvox (linezolid) is an antibacterial agent that is approved by
the FDA to treat certain types of infections, including nosocomial pneumonia
and complicated skin and skin structure infections ("CSSSIs") due to
Methicillin Resistant Staphylococcus Aureus ("MRSA"). Worldwide sales of
Zyvox totaled $1.115 billion in 2008.

The largest pharmaceutical qui tam whistleblower settlement in history, the
$2.3 billion settlement was announced today by the U.S. Department of Justice
and the U.S. Attorney's Office for the District of Massachusetts.

Stephen A. Sheller, Esq., named partner of the Philadelphia firm earlier this
year, represented a relator, the legal term for a whistleblower, in the
largest single-drug whistleblower case in U.S. history when Eli Lilly &
Company paid $1.4 billion to settle Zyprexa(R) off-label marketing
allegations. The Sheller firm's lawyers have previously represented several
other whistleblowers in successful lawsuits.

Approximately $4.4 billion worth of Pfizer's Zyvox was sold from 2000 to 2008,
according to the company's annual reports. Explosive sales increases averaged
close to 200 percent per year. They also caused public health concerns of
drug resistance and immunity, according to court and public documents.

"The widespread off-label promotion of Zyvox by Pfizer for non-FDA approved
purposes poses a grave public risk because it increases the risk that
linezolid resistant eterococci will develop and also increases the risk that
more Zyvox resistant bacterial strains will develop," according to Sheller's
complaint.

In a 2007 letter to physicians, the New York State Health Department warned
that, "Overuse of [Zyvox] will accelerate the development of resistance and
limit its overall effectiveness."

"Let's hope this case helps put the brakes on the overuse of Zyvox so the New
York State Health Department's warning doesn't come true and patients can
continue to be treated effectively for the specific uses for which this drug
is effective and approved," said James J. Pepper, Esq., of Sheller, P.C. who
also represents the relator.

In its July 2005 Warning Letter, the FDA stated that Pfizer's ad misbranded
Zyvox, made misleading and unsubstantiated implied superiority claims, and
omitted important safety information. Although it paid lip service to the FDA
in response to the letter, Pfizer continued to make claims to physicians that
Zyvox was superior to vancomycin, according to Pepper. Zyvox costs
approximately tens times as much as the generic vancomycin.

"Our client had a tremendous amount of information about the illegal marketing
behind Zyvox that proved invaluable in making the case. We investigated his
allegations and then filed a complaint under seal in federal court. As a
result of what he observed and the careful cooperation our office had with
federal and state authorities, he's been able to return millions of ill-gotten
gains to taxpayers," said Brian J. McCormick, Esq., of Sheller, P.C. who also
represents the relator/whistleblower.

Among the off-label promotion by Pfizer for Zyvox, according to the complaint:

-- Promoting Zyvox for the treatment of catheter related skin infections
and concomitant bloodstream infections associated with catheter
related
skin infections. Zyvox's FDA approved labeling does not support
this claim and it constitutes an off-label promotion.
-- Promoting Zyvox for the treatment of surgical site infections or as a
prophylaxis for the prevention of surgical site infections.
Zyvox's FDA approved labeling does not support this claim and it
constitutes an off-label promotion.
-- Promoting Zyvox as clinically superior to vancomycin. Zyvox's FDA
approved labeling does not support this claim and it constitutes an
off-label promotion.
-- Promoting Zyvox as effective for all infections caused by MRSA
including
community acquired MRSA. Zyvox's FDA approved labeling does not
support this claim and it constitutes an off-label promotion.
-- Promoting Zyvox as an appropriate choice "anywhere on the treatment
continuum" regardless of the infection. Zyvox's FDA approved
labeling does not support this claim and it constitutes an off-label
promotion.

-- Promoting Zyvox as appropriate empiric therapy for all bacterial
infections even though it has no effect on gram negative infections
and
only partial effect on polymicrobial infections. The promotion of
Zyvox
as appropriate empiric therapy for all infections constitutes an
off-label promotion.

The government also discovered that Pfizer offered and paid illegal
compensation to health care professionals to induce them to promote and
prescribe Zyvox in violation of federal kickback laws.

"What Pfizer did with Zyvox was outrageous," Sheller said. "They effectively
ignored a corporate integrity agreement with the federal government following
an earlier 2004 off-label settlement."

"Our client showed tremendous courage when he came to us," Sheller said. "He
knew what Pfizer was doing was wrong and wanted to do something about it.
Without him, and the egregious promotion discovered in the investigation of
our case I don't believe the government's case against Pfizer on Zyvox could
have been made."

Under the FCA, so-called "qui tam" whistleblower actions, a term derived from
English Common Law meaning "he who sues on behalf of the king as well as
himself," allow private citizens with knowledge of fraud to help the
Government recover ill-gotten gains and additional civil penalties. The FCA
allows the Government to collect up to three times the amount it was
defrauded, in addition to civil penalties between $5,500 and $11,000 per false
claim. Whistleblowers usually have received rewards representing 15 to 25
percent of qui tam recoveries, according to Sheller, whose law firm represents
relators across the country.

Qui tam whistleblower cases recently settled by Sheller, P.C. have returned
more than $1.5 billion to the U.S. and states' treasuries.

Sheller praised the work of Assistant U.S. Attorney Sara Bloom of the District
of Massachusetts.

Sheller, McCormick and Pepper of Sheller, P.C. served as lead counsel in the
case. Steven Brooks and Robert Hillman of Deutsch, Williams, Brooks, DeRensis
& Holland, P.C., Boston, Massachusetts served as local counsel for the case.

U.S. ex. rel. Ronald Rainero v. Pfizer, Inc.;
District of Massachusetts, Case No: 07-CA-11728;

For more information about Sheller, P.C. and its attorneys, visit
www.sheller.com.
Sheller, P.C., 1528 Walnut Street 3rd Floor, Philadelphia, PA 19102,
215-790-7300

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SOURCE Sheller, P.C. Law Firm

Stephen A. Sheller, Esq., mobile, +1-215-301-9999, sasheller@sheller.com; or
Brian J. McCormick, Jr., Esq., mobile, +1-215-687-7965,
bjmccormick@sheller.com; or James J. Pepper, Esq., mobile, +1-267-994-2110,
jpepper@sheller.com, all of Sheller, P.C., +1-215-790-7300