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FCA Issues to Watch: Pharmaceutical and Device Developments | INSIDE THE FCA

by Bass, Berry & Sims PLC on

The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more

District Court Rules Online Auction for Medical Supplies Violates Anti-Kickback Statute

by Jones Day on

On March 6, 2017, the U.S. District Court for the District of Connecticut held that an arrangement between a company operating an online portal for purchases of medical equipment and a supplier of medical products violates...more

Escobar in Action – Materiality is a Tall Hurdle to Clear

by Butler Snow LLP on

In the recent Third Circuit decision United States of America, ex rel. Gerasimos Petratos, et al. v. Genentech Inc; et al., No. 15-3805, 2017 WL 1541919 (3d Cir. May 1, 2017), the Third Circuit addressed a “false...more

Third Circuit Weighs in on Materiality for First Time Since Escobar

by Pepper Hamilton LLP on

A recent circuit court decision will be a welcome development for False Claims Act defendants because it reinforces a significant pleading hurdle for claims to proceed, with the court citing lack of government intervention as...more

Health Care E-Note - April 2017

by Burr & Forman on

An often overlooked and under publicized provision of the False Claims Act (“FCA”) is the retaliatory discharge prohibition. This is probably because retaliatory discharge claims do not grab headlines by winning multimillion...more

Healthcare Fraud and Abuse Review 2016

by Bass, Berry & Sims PLC on

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

Health Care Fraud and Abuse in the Middle District of Florida in 2016 - a Year in Review

by Carlton Fields on

The United States Attorney’s Office (USAO) for the Middle District of Florida (USAO-MDFL) prosecuted several civil health care fraud matters in 2016 and issued related press releases. A review of the USAO-MDFL’s criminal and...more

Your Cyber Minute: Ransomware attacks and what you need to know [Video]

by Hogan Lovells on

The conversation continues. Hogan Lovells Partner Harriet Pearson and Managing Principal of Hogan Lovells Cyber Risk Services Jeff Lolley address the threat around ransomware and the potential implications for companies that...more

First Circuit Affirms Summary Judgment for Defendant, Rejecting the Use of Aggregate Data to Prove False Claims and Clarifying the...

by Ropes & Gray LLP on

The First Circuit has issued an opinion affirming a complete grant of summary judgment for Pfizer, Inc. in United States ex rel. Booker v. Pfizer Inc., No. 16-1805 (1st Cir. Jan. 30, 2017), a False Claims Act (“FCA”) lawsuit...more

First Circuit affirms Pfizer victory in False Claims Act case

by DLA Piper on

The First Circuit has rejected an appeal in United States ex rel. Booker v. Pfizer, a False Claims Act (FCA) case alleging that Pfizer engaged in off-label promotion of the antipsychotic drug Geodon. In its ruling on...more

POD Update: Physician Investor of Physician-Owned Distributor Sentenced to Nearly 20 Years in Prison

by Ropes & Gray LLP on

On January 9, 2017, a physician was sentenced in federal court in the Eastern District of Michigan to 19 years, 7 months in prison for his role in criminal health care fraud totaling $2.8 million. The settlement has some...more

Northern District of Illinois Dismisses Whistleblower’s FCA Suit for Failing to Connect Allegations of Misconduct with Submission...

by Dorsey & Whitney LLP on

In United States ex rel. Keen v. Teva Pharmaceuticals USA, Inc., relator Janice Keen sued her former employer—the pharmaceutical company Teva—for violations of the FCA. According to Ms. Keen, Teva trained its sales force to...more

What Is The Trump Pharmaceutical Policy?

by Foley & Lardner LLP on

Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump...more

First Circuit Rejects Whistleblower’s Fraud on the FDA FCA Theory

by Ropes & Gray LLP on

On December 23, 2016, the First Circuit held that a relator under the federal False Claims Act (“FCA”) failed to plausibly plead that defendant medical device manufacturers caused the submission of false claims for...more

First Circuit Rejects Fraud-on-the-FDA Theory of FCA Liability

by Dorsey & Whitney LLP on

Affirming an earlier order handed down by the United States District Court for the District of Massachusetts, the First Circuit recently denied Plaintiff D’Agostino leave to amend his complaint, finding the proposed claims...more

Healthcare Law Update: December 2016

by Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

Ninth Circuit Rejects FCA Suit Alleging Medical Device Inaccuracies

by Ropes & Gray LLP on

In United States ex rel. Ruhe v. Masimo Corp., 640 Fed. App’x 666 (9th Cir. 2016), the Court of Appeals for the Ninth Circuit affirmed a grant of summary judgment for defendant Masimo Corporation, a medical device...more

3D Printing Quarterly Report: Q3 - 2016

by Benesch on

Study offers plan to make Northeast Ohio region the Silicon Valley of 3D printing - A report from the Youngstown Business Incubator and America Makes in Youngstown and Team NEO and Magnet in Cleveland offers a plan to...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more

Supreme Court Punts Again on FCA Claims Specificity

by Holland & Knight LLP on

The U.S. Supreme Court recently denied certiorari in United States ex rel. Walterspiel v. Bayer AG. This case, arising out of the Fourth Circuit, raised yet again the question of how much detail a False Claims Act (FCA)...more

New Federal Telemedicine Grants Announced; Florida Not Listed

by Foley & Lardner LLP on

The U.S. Department of Agriculture just announced new grant funding awarded to seven telemedicine and 11 distance learning projects across 16 states to use technology to expand access to health care, substance misuse...more

CMS's Payment Suspensions Wreak Havoc: Understanding the Risks

by Baker Ober Health Law on

CMS payment suspensions can cripple any provider's or supplier's operations. Yet, CMS has the authority to impose a payment suspension upon the mere existence of "reliable information" that an overpayment or fraud may exist....more

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

Health Update - August 2016

Section 1332 Waivers: Will We See More State Innovation? - Editor's Note: In a new essay for the National Institute of Health Care Management (NIHCM), summarized below, Manatt Health examines Section 1332 waivers and the...more

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