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Off-Label and Unapproved Use

This archive displays posts tagged as relevant to off-label marketing and prescribing of pharmaceuticals and medical devices. You may also be interested in our pages:

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June 6, 2016

Genentech Inc. and OSI Pharmaceuticals LLC agreed to pay $67 million to resolve charges they violated federal and state False Claims Act by making misleading statements about the effectiveness of the cancer drug Tarceva.  According to the government, Genentech and OSI made misleading representations to physicians and other health care providers about the effectiveness of Tarceva when there was little evidence to show that Tarceva was effective to treat those patients unless they also (i) had never smoked or (ii) had a mutation in their epidermal growth factor receptor, which is a protein involved in the growth and spread of cancer cells.  The allegations originated in a whistleblower lawsuit filed by former Genentech employee Brian Shields under the qui tam provisions of the False Claims Act.  He will receive a whistleblower award of approximately $10 million out of the proceeds of the government’s recovery.  Whistleblower Insider GA, MA, OH

May 27, 2016

Medical device manufacturer Paradigm Spine agreed to pay $585,000 to resolve allegations it violated the False Claims Act by marketing the company’s coflex-F® device for surgical uses that were not approved by the FDA.  The settlement further resolves allegations that Paradigm caused false claims by giving false recommendations on how to code health claims for procedures involving the company’s coflex® device.  The allegations originated in a whistleblower lawsuit filed by Chris Coyle, a former Paradigm Spine sales representative, under the qui tam provisions of the False Claims Act.  Mr. Coyle will receive a whistleblower award of approximately $105,300 from the proceeds of the government's recovery.  DOJ (DMD)

Tarceva Whistleblower Settlement Shows Government Willingness to Scrutinize Efficacy Data Even for On-Label Uses

Posted  06/8/16
By the C|C Whistleblower Lawyer Team On June 6, 2016, the Department of Justice announced that Genentech Inc. and OSI Pharmaceuticals would pay $67 million to resolve whistleblower allegations that the companies misled physicians and patients about the effectiveness of Tarceva to treat certain types of lung cancer.  The whistleblower’s complaint alleged that the companies deployed sales forces and physician...

October 7, 2015

Kentucky-based nursing home pharmacy PharMerica Corp. agreed to pay $9.25 million to resolve allegations it violated the False Claims Act by soliciting and receiving kickbacks from pharmaceutical manufacturer Abbott Laboratories in exchange for promoting the anti-epileptic prescription drug Depakote for nursing home patients.  The settlement is part of the continuing fallout of the $1.5 billion settlement Abbott entered into with the government in May 2012 to resolve Abbott’s liability under the False Claims Act for alleged kickbacks to nursing home pharmacies, including PharMerica.  The settlement partially resolves allegations raised in two whistleblower lawsuits brought by former Abbott employees Richard Spetter and Meredith McCoyd under the qui tam provisions of the False Claims Act.  Ms. McCoyd will receive a whistleblower award of $1 million from the federal share of the settlement amount. Whistleblower Insider

July 24, 2015

California oncologist Dr. Neelesh Bangalore has paid $736,000 to settle allegations that he improperly billed Medicare, Medicaid, and Tricare for certain chemotherapy drugs purchased from an unlicensed foreign pharmaceutical distributor, Warwick Healthcare Solutions Inc., also known as Richards Pharma, a former United Kingdom-based drug distributer that did not have a license to distribute drugs in the United States.  DOJ

July 1, 2015

The U.S. District Court for the District of New Jersey entered a consent decree of permanent injunction against Acino Products LLC and its president, Ravi Deshpande, to prevent the distribution of unapproved and misbranded drugs.  Specifically, the injunction involves hydrocortisone acetate suppositories under the brand names Rectacort-HC and GRx HiCort 25 and government charges these suppositories are not approved by the FDA and are misbranded because they do not bear adequate directions for use as required by law.  DOJ

June 26, 2015

Charlie Chi, the former president and CEO of OtisMed Corporation, was sentenced to two years in prison and to pay a $75,000 fine for intentionally distributing a medical device used in knee replacement surgery after its application for marketing clearance had been rejected by the Food and Drug Administration.  In September 2014, OtisMed, now a subsidiary of Stryker Corporation, was sentenced to a criminal fine of $34.4 million and ordered to pay $5.16 million in criminal forfeiture for this conduct.  In a related civil settlement, OtisMed agreed to pay approximately $41.2 million to resolve its civil liability for submitting false claims to the Medicare, TRICARE, Federal Employees Health Benefits and Medicaid programs.  DOJ

February 24, 2015

Louisiana oncologist Prabhjit S. Purewal agreed to pay $550,000 to settle allegations he defrauded Medicare, Tricare and Medicaid in violation of the False Claims Act by billing for chemotherapy drugs not approved by the FDA.  Dr. Purewal purchased the drugs from UK-based drug distributor Warwick Healthcare Solutions, Inc. (also known as Richard’s Pharma), which did not have a license to distribute drugs in the US.  DOJ

January 30, 2015

Pharmaceutical company Laclede Inc. and its president Michael A. Pellico entered into a consent decree of permanent injunction concerning the distribution of unapproved over-the-counter vaginal drug products sold under the name Luvena Prebiotic. According to the government, Laclede’s sale and distribution of the Luvena Prebiotic products violated various provisions of the Federal Food, Drug, and Cosmetic Act because they did not have the required FDA approval. DOJ

January 16, 2015

A federal court in California issued an injunction shutting down Health One Pharmaceuticals Inc., a manufacturer of dietary supplements and unapproved new drugs. The firm and its president, Richard S. Yeh, agreed to shut down and resolve the lawsuit as part of a consent decree. The government alleged, among other things, the defendants failed to meet current good manufacturing practices for dietary supplements by failing to conduct appropriate testing and misbranding the supplements because their labels did not include all the information required by federal law. DOJ


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