(PRWEB) March 26, 2014
The Corporate Whistleblower Center is urging medical doctors, or pharmaceutical representatives to call them if they have well documented proof of drug companies promoting off-labeling of FDA approved drugs because the rewards for this type of information can potentially be in the millions of dollars. For more information, potential whistleblowers are urged to contact the Corporate Whistleblower Center anytime at 866-714-6466. http://CorporateWhistleblowerCenter.Com
In a recent example, the government alleged that between 2002 and 2006, Endo Pharmaceuticals Inc. introduced into interstate commerce 'Lidoderm' which was allegedly misbranded under the Federal Food, Drug and Cosmetic Act (FDCA). The FDCA requires companies, such as Endo Pharmaceuticals Inc., to specify the intended uses of a product in its new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses.
During the period of 2002 to 2006, Lidoderm was approved by the FDA only for the relief of pain associated with post-herpetic neuralgia (PHN), a complication of shingles. The information alleges that, during the relevant time period, the Lidoderm distributed nationwide by Endo Pharmaceuticals Inc. was misbranded because its labeling lacked adequate directions for use in the treatment of non-PHN related pain, including low back pain, diabetic neuropathy and carpal tunnel syndrome. These uses were intended by Endo Pharmaceuticals Inc. but never approved by the FDA. The information further alleges that certain Endo Pharmaceuticals Inc. sales managers provided instruction to certain sales representatives concerning how to expand sales conversations with doctors beyond PHN and encouraged promotion of Lidoderm in workers’ compensation clinics.
The Corporate Whistleblower Center says, "What we are talking about here is off-labeling of prescription drugs and we believe these types of practices can put patients at extreme risk. The monetary rewards for well documented proof of this type of activity can be extremely lucrative for the whistleblower. Unlike any group in the nation, we will help a whistleblower package their information, and we will get them to one of the nation's top whistleblower attorneys. For more information, potential whistleblowers are urged to contact the Corporate Whistleblower Center anytime at 866-714-6466. http://CorporateWhistleblowerCenter.Com
Simple rules for a whistleblower from the Corporate Whistleblower Center:
For attribution purposes please refer to the February 2014 press release regarding this matter: http://www.justice.gov/opa/pr/2014/February/14-civ-187.html
Case number: The civil lawsuits are captioned United States ex rel. Ryan v. Endo Pharmaceuticals Inc., Civil Action No. 05-cv-3450, United States ex rel. Weathersby, et al. v. Endo Pharmaceuticals Inc., et al, Civil Action No. 10-cv-2039 and United States ex rel. Dhillon v. Endo Pharmaceuticals, Civil Action No. 11-cv-7767, all docketed in the Eastern District of Pennsylvania.