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Kickbacks Crackdown Worldwide: Will Pharma Finally Get the Message?

Mon, 29 Aug 2016 20:45:22 +0000

The Wall Street Journal recently reported that six employees of Novartis have been indicted in South Korea amidst allegations that the company paid $2.3 million to physicians in order that they prescribe the company’s drugs. Although the company said, “Novartis does not tolerate misconduct and we are already implementing a remediation plan in Korea based […]

Pharma Kickbacks to Physicians Could Trigger False Claims Act Conspiracy Liability

Wed, 29 Jun 2016 19:40:55 +0000

For years, courts have muddied the judicial waters when it comes to the appropriate pleading standards for False Claims Act complaints. Most of this confusion has centered on the heightened pleading standards mandated by Federal Rules of Civil Procedure 9(b), which requires a plaintiff to plead fraud “with particularity.” When courts have applied this “particularity” […]

Post-Market Research Fraud

Fri, 17 Jun 2016 18:50:05 +0000

Recently, Medtronic paid the government over $23.5 million to quiet allegations that it violated the False Claims Act by using physician payments related to post-market studies and registries to induce physicians to implant the company’s pacemakers and defibrillators. These allegations mirrored a prior False Claims Act recovery, in which St. Jude Medical paid the government […]

Annual HCFAC Report Highlights Need for Pharmaceutical Fraud Whistleblowers

Thu, 24 Mar 2016 18:29:26 +0000

In fiscal year 2015, healthcare anti-fraud programs operated by the Justice Department and HHS recovered $2.4 billion, a decrease from 2014 of over 37%. This single-year drop in healthcare fraud recoveries was one of the largest year-over-year decreases in the history of the programs. So what happened in FY 2015? FY 2015 was a victim […]

Justice Department Pursues Healthcare Qui Tam Allegations Involving Companies Who Knowingly Manufacture Defective Products

Fri, 05 Feb 2016 20:51:59 +0000

The Justice Department closed out 2015 by intervening and settling a healthcare fraud qui tam action alleging that a pharmaceutical manufacturer knowingly sold defective drug products for use by the pediatric population. Specifically, in December 2015, Endo Pharmaceuticals subsidiary Qualitest Pharmaceuticals agreed to pay the federal and state governments over $39 million for allegedly selling government […]

Fraudulent Labeling: Pharma Company Settles Fraud Charges for Half-Strength Supplements

Tue, 22 Dec 2015 15:35:51 +0000

The Government recently announced a $39 million settlement against Vintage Pharmaceuticals, LLC, d/b/a  QUALITEST PHARMACEUTICALS; Vintage’s corporate parent Endo Pharmaceuticals, Inc.; and seven of their corporate subsidiaries or affiliates (collectively, “QUALITEST”) in a civil fraud lawsuit.  The qui tam complaint alleged that QUALITEST violated the False Claims Act by knowingly manufacturing and selling understrength chewable […]

Echo: Orphan Drug Manufacturers Marketing Off-Label

Tue, 15 Dec 2015 21:38:23 +0000

Nolan Auerbach & White addressed orphan off label drug marketing in our blog on November 10, 2015. Orphan Drugs are used in the diagnosis, prevention and/or treatment of rare life-threatening or very serious diseases. The Orphan Drug Act (ODA) provides for orphan designation to a drug or biological product (“drug”) to treat a rare disease or condition. […]

Are Senior Pharma Executives Racing to File Qui Tam Actions?

Thu, 03 Dec 2015 18:58:41 +0000

Over the years, several high-ranking DOJ officials have stated that they will hold pharmaceutical fraud masterminds accountable for their actions. Their words have remained unfulfilled promises, prompting some experts to plea for criminal liability for individual pharmaceutical executives. For example, in Nature Medicine, Nolan Auerbach & White partner Jeb White penned the article “Masterminds behind […]

Is the $160 Billion Pfizer Merger with Allergan Unpatriotic?

Mon, 23 Nov 2015 21:21:38 +0000

President Obama has called today’s announcement unpatriotic due to the fact that the inversion process, merging a smaller foreign company with a larger one, will save both companies money, but will simultaneously effect our economy BIG TIME. This comment should be of no moment to either company: The actions of these two pharmaceutical giants have cost […]

Are Orphan Drug Manufacturers Ramping Up Off-Label Marketing Efforts?

Tue, 10 Nov 2015 20:29:51 +0000

Fraud goes where money flows. This statement is particularly true in the growing prescription drug market, which has been fraught with illegal marketing schemes for years. Government and private qui tam lawsuits showed that many of the world’s top 20 pharmaceutical manufacturers have allegedly illegally marketed drugs for unapproved uses. Manufacturers of orphan drugs have remained […]