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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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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

December 8, 2014

Medical products manufacturer OtisMed Corp and its former CEO Charlie Chi admitted to intentionally distributing knee replacement surgery cutting guides (called the OtisKnee) after the Food and Drug Administration (FDA) had rejected their application for marketing clearance. OtisMed agreed to pay more than $80M to resolve its related criminal and civil liability for distributing an adulterated medical device in violation of the Food, Drug, and Cosmetic Act (FDCA), and submitting fraudulent claims in violation of the False Claims Act. Whistleblower Insider

February 21, 2014

Endo Pharmaceuticals and its parent Endo Health Solutions agreed to pay $192.7M to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the FDA. The allegations were first raised in three qui tam lawsuits filed under the whistleblower provisions of the False Claims Act. DOJ

December 20, 2013

Genzyme Corp. agreed to pay $22.3M to resolve allegations that it marketed, and caused false claims to be submitted to federal and state health care programs for use of a “slurry” version of its Seprafilm adhesion barrier. The allegations were first raised in a qui tam lawsuit filed under the whistleblower provisions of the False Claims Act. DOJ

November 4, 2013

Johnson & Johnson agreed to pay more than $2.2B to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the FDA and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485M and civil settlements with the federal government and states totaling $1.72B. The allegations were first raised in a qui tam lawsuit filed under the whistleblower provisions of the False Claims Act. DOJ

October 8, 2015

43 states joined the federal government in a $9.25 million dollar settlement with PharMerica over allegations in two separate whistleblower actions that PharMerica conspired with Abbott Laboratories, a drug manufacturer, through a number of disguised kickback arrangements to increase overall utilization of the drug Depakote and to promote misbranded Depakote. FL; MA; NH

August 7, 2015

Constantine Cannon partner Tim McCormack quoted in the Law360 article, 5 Questions After Amarin's Off-Label Marketing Triumph.  Click here to read the article.

June 18, 2015

47 states and the District of Columbia reached a settlement with Inspire Pharmaceuticals, resolving allegations that Inspire violated state and federal False Claims Act laws by illegally marketing the drug Azasite for off-label uses not approved by the U.S. Food and Drug Administration. Approved only for the treatment of bacterial conjunctivitis (“pink eye”), Inspire marketed Azasite for the treatment of blepharitis, an inflammation of the eyelash follicles. While physicians are permitted to prescribe drugs for conditions other than those for which the drugs have been approved by the FDA, pharmaceutical companies are prohibited from marketing drugs to physicians for such off label conditions. It is contended that, as a result of Inspire’s illegal off label promotion, Inspire caused the submission of false and fraudulent claims for Azasite to the Medicaid program and other federal programs. NY

February 6, 2015

Minnesota-based medical device manufacturer Medtronic Inc. agreed to pay $2.8M to resolve allegations it violated the False Claims Act by causing physicians to submit false claims to federal health care programs for investigational medical procedures known as “SubQ stimulations” that were not reimbursable. According to the government, Medtronic improperly promoted the procedure and the use of its spinal cord stimulation devices for the procedure even though its safety and efficacy had not been established by the FDA. The charges were first raised in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by former Medtronic sales representative Jason Nickell. He will receive a whistleblower award of $602,000. DOJ
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