News & Analysis as of

False Claims Act (FCA) Pharmaceutical Industry

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 Daily Dose of Financial News

by Robins Kaplan LLP on

Activist investor Carl Icahn has taken a sizeable stake in Bristol-Myers Squibb, a move that reportedly caught execs at the drugmaker unawares and sets the stage for a potential sale....more

Corporate Investigations and White Collar Defense - February 2017

When Regulatory Failings Turn Criminal: Car Edition Redux - Why it matters: To paraphrase the famous quote from the film “All About Eve”: Fasten your seatbelts, it’s going to be a bumpy car ride. In the first part of...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

First Circuit Affirms Dismissal of FCA Off-Label Marketing Case for Failure to Meet 9(b) Particularity Requirement

by Ropes & Gray LLP on

In Lawton v. Takeda Pharmaceutical Co. et al., 842 F.3d 125 (1st Cir. 2016), the First Circuit affirmed the lower court’s dismissal of a False Claims Act (“FCA”) suit alleging a drug maker fraudulently marketed a product for...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

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...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

U.S. Department of Justice Recovered More Than $4.7 Billion From Civil False Claims Act Cases in 2016

by Williams Mullen on

On December 14, 2016 the United States Department of Justice made its annual announcement of the amount of money recovered in civil False Claims Act settlements and judgments in Fiscal Year 2016. ...more

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more

This Is How A False Claims Act Case Works—And Fails

by Reed Smith on

It took us a long time to understand how off-label promotion of prescription drugs had anything to do with the False Claims Act, and we’re still not so sure that the two are a fit. The FCA penalizes anyone who presents, or...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Omnicare Inc. Settles Kickback Allegations for $28 Million

by Dorsey & Whitney LLP on

The United States Justice Department (DOJ) announced this week that Omnicare, Inc. (Omnicare), the largest nursing home pharmacy in the United States, will pay approximately $28 million dollars to resolve charges that it...more

Fourth Circuit Holds False Claims Act Relators Cannot Use Facts Learned by Their Attorney in a Previous Case to Defeat the FCA’s...

by Ropes & Gray LLP on

Earlier this year, the Fourth Circuit held in United States ex rel. May v. Purdue Pharma L.P., 811 F.3d 636 (2016) that the a complaint that is “based on” relators’ attorney’s work on a prior dismissed FCA action triggers the...more

Pharmaceutical Manufacturer’s Possible Settlement Shows Long-Arm of FCA

by Dorsey & Whitney LLP on

On Tuesday, August 2, 2016, pharmaceutical and biotech company Shire PLC filed a Form 8-K announcing a possible resolution to an ongoing FCA investigation into the sales and marketing tactics of Shire’s “Dermagraft” skin...more

Business Litigation Report - July 2016

Article: Increase in Vertical Price Restraint Enforcement in China - In recent months, Chinese anti-monopoly enforcement actions scrutinizing and penalizing pricing-related issues have noticeably increased. A growing...more

July 2016: Product Liability Update

Curbing False Claims Act Liability for Off-Label Promotion. As class actions have become harder to certify following Wal-Mart v. Dukes and Comcast v. Behrend, the plaintiffs’ bar has increasingly turned to qui tam litigation...more

Another Off-Label Promotion Third Party Payor Case Lacks Causation

by Reed Smith on

July in D.C. is hot and sticky. When scorching day follows scorching day, area residents look forward to evening thunderstorms, not just to water otherwise thirsty lawns and gardens but to cool things down. Lightning can be...more

Universal Health Services v. Escobar

by King & Spalding on

On Thursday of last week, the Supreme Court for the first time addressed the “implied certification” theory of liability under the False Claims Act. The Court ruled unanimously that the theory is valid in certain...more

Second Circuit Affirms Dismissal of False Claims Act Suit Based on “Off-Label” Marketing

by Arnall Golden Gregory LLP on

The United States Court of Appeals for the Second Circuit recently affirmed an Order of the Eastern District of New York dismissing a qui tam False Claims Act (FCA) suit based on “off-label” marketing of prescription drugs....more

A Blow Against False Claims Act Liability For Off-Label Promotion

by Reed Smith on

Recently, we noted that one of the first decisions we wrote a post about had been affirmed by the Second Circuit. Of the district court decision, we had penned “It is nice to see a judge with a proper understanding of how...more

AGG Food and Drug Newsletter - May 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

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