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Baxter pays more than $18 million to resolve cGMP Criminal and Civil Liability

Tue, 07 Feb 2017 20:26:55 +0000

DOJ recently announced that Baxter Healthcare Corporation agreed to pay $18.158 million to resolve its criminal and civil liability arising from Baxter’s failure to follow current Good Manufacturing Practices (cGMP) when manufacturing sterile drug products in North Carolina. The resolution includes a deferred prosecution agreement and penalties and forfeiture totaling $16 million and a civil settlement under the False […]

Lab Fraud: Will a $256 Million Settlement Stop It?

Tue, 17 Jan 2017 20:30:12 +0000

In fiscal year 2016, Millennium Health (formerly Millennium Laboratories), agreed to pay the Government $256 million to resolve alleged violations of the False Claims Act.  The allegations included medically unnecessary urine, drug and genetic testing and as providing of free items to physicians who agreed to refer expensive laboratory testing business to Millennium in violation […]

The 2017 Healthcare Whistleblower: Agent of Change

Fri, 13 Jan 2017 18:55:28 +0000

New research by Jaron H. Wilde at the University of Iowa’s Tippie College of Business concludes that: …after truth tellers come forward with information about wrong doing inside their operations… [and after investigation, there was a] sharp and lasting drop in financial wrongdoing… Part of Mr. Wilde’s study explored large samples of companies to see if there […]

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. […]