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Science, Computers & Technology Government Contracting Business Torts

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Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more

The Four Things That Surprised Us in the EpiPen False Claims Settlement

On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug...more

"Meaningfully Useful" Risk Mitigation Strategies for Providers Following the eClinicalWorks Settlement

by Jones Day on

The Health Information Technology for Economic and Clinical Health Act ("HITECH Act") established financial incentives under Medicare and Medicaid for eligible health care providers that adopt, implement, and demonstrate use...more

The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?

The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by...more

A Striking EHR Settlement: The DOJ pursues an EHR Vendor for "Causing the Submission" of False EHR Incentive Payment Claims

by Bass, Berry & Sims PLC on

On May 31, 2017, the U.S. Department of Justice (DOJ) announced a $155 million settlement with eClinical Works (ECW), a nationally-known electronic health records (EHR) software vendor. The settlement arises out of a lawsuit,...more

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

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 Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead

by Mintz Levin on

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. In January 2015, Andrew Weissmann...more

Court Concludes that Violation of a Corporate Integrity Agreement May Form the Basis for Reverse False Claim Liability

by Dorsey & Whitney LLP on

In late July, a federal district court in Pennsylvania denied a motion to dismiss brought by pharmaceutical company Cephalon, Inc., concluding that violations of a corporate integrity agreement (“CIA”) entered into by...more

Successful Rule 9(b) Defense of False Claims Act Whistleblower Litigation

by Butler Snow LLP on

The lure of significant monetary awards continues to stimulate high-risk whistleblower actions under the False Claims Act (FCA), and these claims are increasingly common in the pharmaceutical and medical device industry. The...more

Eighth Circuit Adopts Novel False Claims Act Fraud-in-the-Inducement Theory Long Espoused by Government

by Epstein Becker & Green on

On October 15, 2013, a divided three-judge panel of the United States Court of Appeals for the Eighth Circuit rendered a federal False Claims Act ("FCA") judgment against Bayer Healthcare Pharmaceuticals ("Bayer"), based on a...more

Tropp v. Conair et al.

Brief in Opposition to Defendants' Motion for Summary Judgment On the Ground of Non-Infringement

by Ronald Coleman on

Brief in opposition to defendants' post-Akamai motion for summary judgment on the ground of non-infringement....more

Tropp v. Conair et al.

Brief in Opposition to Defendants' Motion for Summary Judgment Based on 28 U.S.C. § 1498

by Ronald Coleman on

From the preliminary statement: Plaintiff David Tropp (“Tropp”), owner of U.S. Patent Nos. 7,021,537 and 7,036,728 (the patents-in-suit), submits this memorandum of law in opposition to the motion by Travel Sentry and...more

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