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Grant & Eisenhofer Represents Whistleblower Accusing Celgene Corp. of Off-Label Marketing of High-Risk Cancer Drugs Derived from



    Grant & Eisenhofer Represents Whistleblower Accusing Celgene Corp. of
    Off-Label Marketing of High-Risk Cancer Drugs Derived from Thalidomide

Unsealed federal lawsuit alleges that pharmaceutical giant engaged in unlawful
marketing schemes involving blockbuster drugs Thalomid and Revlimid in cancer
treatment, costing taxpayers hundreds of millions of dollars; charges of
kickbacks to physicians in pushing for unapproved treatments

PR Newswire

LOS ANGELES and WASHINGTON, Feb. 6, 2014

LOS ANGELES and WASHINGTON, Feb. 6, 2014 /PRNewswire/ -- Leading whistleblower
law firm Grant & Eisenhofer P.A. represents a key whistleblower in a false
claims lawsuit unsealed today against one of the nation's largest
pharmaceutical companies, Celgene Corporation (NASDAQ: CELG) involving charges
of off-label marketing of two of its cancer treatment drugs.  

The federal suit alleges that Celgene marketed its drugs Thalomid and Revlimid
to cancer patients and their doctors for unapproved purposes, and paid
kickbacks to physicians for prescribing the medications. Thalomid is a form of
thalidomide, a drug notorious for causing severe birth defects in the 1960s,
making the term "thalidomide baby" a shorthand for a generation of birth
abnormalities; its usage led Congress to strengthen FDA oversight of
pharmaceuticals. The suit alleges that Celgene engaged in unlawful marketing
schemes of both Thalomid and Revlimid, costing the U.S. government and state
healthcare payors hundreds of millions of dollars.

Filed in U.S. District Court for the Central District of California, the suit,
U.S. ex rel. Beverly Brown v. Celgene Corp., was originally filed under seal
in 2007.  The lawsuit was brought under both federal and state false claims
acts, as well as the California Insurance Frauds Prevention Act, which mandate
initial filing under seal.

Grant & Eisenhofer is representing Beverly Brown, a former top-performing
sales representative at Celgene who worked heavily on marketing both Thalomid
and Revlimid during her decade-long stint at the company (2001-11).   

Ms. Brown's complaint alleges that Celgene preyed on a vulnerable patient
population by aggressively marketing highly toxic drugs –Thalomid, and later
Revlimid – for high-risk cancer treatments that had not been approved by the
FDA. According to the suit, Celgene knowingly concealed the risks of venous
thromboembolism and deaths associated with Thalomid use in cancer patients.
The suit contends that when Celgene ultimately secured an indication for
treatment of multiple myeloma with Thalomid, the approval was conditioned on a
black-box warning on the drug's packaging, alerting doctors and patients of
the significant risks of venous thromboembolism and fatality.

The suit claims that Celgene violated explicit FDA regulations prohibiting
misbranding by promoting Thalomid and Revlimid for off-label use.  Celgene is
accused of flooding the market with sales representatives under heavy pressure
to sell both drugs to oncologists for whatever cancers they were treating,
including blood cancers as well as solid tumors, on the basis of minimal
evidence.  The complaint further alleges that Celgene sales reps encouraged
physicians to switch patients from Thalomid to Revlimid, regardless of whether
the patients were stable.

The suit also accuses Celgene of paying kickbacks to physicians to prescribe
Thalomid and Revlimid and encourage fellow doctors to prescribe the drugs.  As
a result of illegally marketing both medications for off-label usage, the
lawsuit alleges that Celgene caused federal, state and local government health
care programs, as well as private insurers, to pay for millions of
prescriptions that never would have been submitted for reimbursement but for
Celgene's activities.

The False Claims Act allows private citizens to seek redress in the name of
the U.S. government, while a number of states and cities have enacted
analogous statutes. The California Insurance Frauds Prevention Act allows
whistleblowers to bring claims on behalf of private insurers operating in the
state and regulated by the California Insurance Commissioner. In addition to
the U.S. government, the case against Celgene seeks redress on behalf of 28
states, the District of Columbia, the City of Chicago and private health
insurers in California. 

Cases similar to the one against Celgene, including those brought against
Abbott, Pfizer and GlaxoSmithKline, have resulted in the return of billions of
dollars to government treasuries.

"Celgene's illegal marketing of these two extremely toxic medications, derived
from a drug whose improper usage became an infamous lightning rod for
pharmaceutical regulation a half-century ago, has jeopardized vulnerable
patient populations," said Reuben Guttman, Director of the False Claims
Litigation Group at Grant & Eisenhofer P.A. 

"Honest medical information about treatment options includes direction on
appropriate drug regimens," Mr. Guttman added. "Patients ravaged by cancer are
among the most vulnerable and often desperate, and put extreme trust in their
doctors that their regimens have been approved by the FDA for safety and
efficacy. Unfortunately, we believe that this has not been the case in
Celgene's promotion of Thalomid and Revlimid. The company consistently
bypassed government regulations through its misbranding and marketing these
two drugs for off-label usage, putting countless patients at risk, and
burdening a health care system."

Grant & Eisenhofer is one of the nation's leading high-impact litigation
firms. In the last two years, its False Claims Litigation Group has had
unprecedented success representing lead whistleblowers in the government's
$1.6 billion settlement with Abbott (2012); its $1.04 billion settlement with
GlaxoSmithKline (2012); its $257 million settlement with Pfizer (Wyeth)
(2013); and its $24.9 million dollar settlement with Amgen (2013).

About Grant & Eisenhofer

Grant & Eisenhofer P.A. represents plaintiffs in a wide range of complex
financial litigation. G&E's clients include institutional investors,
whistleblowers and other stakeholders in bankruptcy litigation, securities
class actions, derivative lawsuits, consumer class actions, antitrust suits,
and cases involving the False Claims Act. G&E has recovered more than $13
billion for investors in the last five years and has consistently been cited
by RiskMetrics for securing the highest average investor recovery in
securities class actions. Grant & Eisenhofer has been named one of the
country's top plaintiffs' law firms by The National Law Journal for the past
nine years.

Contacts:
Allan Ripp 212-262-7477 arippnyc@aol.com
Elise Martin 302-622-7004 emartin@gelaw.com

SOURCE Grant & Eisenhofer

Website: http://www.gelaw.com
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