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Feb 27, 2014 by |

Pharmaceutical Company Settles False Claims Act Case For $171 Million


A Pharmaceutical company has agreed to pay the federal government over $171 million to settle a False Claims Act case.  Endo Pharmaceutical is a subsidiary of Endo Health Solutions, Inc.   A whistleblower lawsuit accused Endo Pharmaceuticals of off label marketing of the Lidoderm pain patch.  It was alleged that Lidoderm was marketed for uses not approved by the Food and Drug Administration.  California whistleblower attorneys say that many false claims lawsuits involve the health care industry.

The Federal Food and Drug Administration approved Lidoderm for the relief of pain associated with post-herpetic neuralgia.  The condition affects some people with a history of shingles.  It is alleged that Lidoderm was promoted for the treatment of other conditions such as lower back pain between 1999 and 2007.  Since those uses of Lidoderm were not medically accepted indications, federal healthcare programs would not cover such uses. The off label promotion of Lidoderm wound up resulting in healthcare providers submitting false reimbursement claims for uses that were not covered.  California whistleblower attorneys say that false claims cost taxpayers millions of dollars every year.

The whistleblower who brought this case was a former sales representative for Endo Pharmaceuticals.  Her portion of the settlement has not been decided yet.  In Qui Tam cases, private citizens can bring False Claims Act suits on behalf of the federal government.  California whistleblower attorneys are seeing an increase in the number of false claims cases.

A U.S. Attorney stated that pharmaceutical companies have a legal obligation to promote their drugs for only Food and Drug Administration approved uses.  A U.S. Justice Department attorney said that the Food and Drug Administration’s drug approval process is designed to ensure that pharmaceutical companies create products for uses that are proven to be safe and effective.    Endo Pharmaceutical has agreed to create an internal risk assessment and mitigation program as part of the settlement agreement.  The settlement also resolves related criminal liability.  Evans Law Firm, Inc. was not involved in this case, but will thoroughly investigate whistleblower claims.

Evans Law Firm, Inc. handles whistleblower/false claims, consumer fraud class actions, insurance and banking fraud, consumer product liability, elder abuse, and personal injury cases.  If you think that you have witnessed or are the victim of financial fraud by an insurance company, bank or individual then, contact Evans Law Firm, Inc. at (415) 441-8669 for a free and confidential consultation, or email

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