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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

Mobile Health App Developers Under Fire for Misleading Claims and Irresponsible Privacy Practices

by Dechert LLP on

Mobile health apps are becoming more and more popular as a tool for consumers in maintaining healthy lifestyles. However, there is a growing concern that the health-related benefits are being over-stated by mobile health app...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

POM Wonderful Returns – Lanham Act False Advertising Claim Against Home Pregnancy Tests Not Precluded by FDCA

by Dorsey & Whitney LLP on

On September 9, 2016, the Court of Appeals for the Second Circuit issued an interesting decision in a false advertising case involving a dispute between competitors in the home pregnancy testing market. Church & Dwight Co. v....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

CMS Fines Insurer for Misleading Medicare Part D Beneficiaries

by BakerHostetler on

The federal agency that oversees Medicare’s prescription drug program has alleged that a major U.S. insurance company misled beneficiaries about the pharmacies included in the company’s drug plan, and imposed a $1 million...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

Two-Party Market: Presumption of Confusion and Injury

by McDermott Will & Emery on

Merck Eprova AG v. Gnosis S.p.A., et al. - Clarifying applicable presumptions in Lanham Act false advertising cases, the U.S. Court of Appeals for the Second Circuit affirmed a district court’s use of presumptions of...more

Jury Verdict Against Millennium Provides Insight on Definition of Remuneration

by Baker Ober Health Law on

Ameritox won the latest volley of an ongoing legal battle with Millennium when a federal jury in Florida awarded it $14.75 million on June 16, 2014. Ameritox persuaded the jury that Millennium’s free point of care test (POCT)...more

Lawsuit Against Medtronic Alleges Racketeering Over Infuse Bone Graft

When one big industry sues another we learn a lot about how business as usual is conducted. In this case Humana, a giant health insurer, has sued the medical device company Medtronic, maker of the Infuse bone graft. ...more

Anti-Kickback and Stark Law Violations Form Basis for Unfair Competition Claims

by King & Spalding on

On June 16, 2014, a federal district court jury in Florida awarded $14.755 million to plaintiff Ameritox, Ltd., a Maryland-based clinical lab, for state law claims alleging tortious interference with business relationships...more

TransCardiac's State Court Complaint Avoids Raising Federal Question

by Womble Bond Dickinson on

Judge Totenberg remanded the case brought by TransCardiac Therapeutics, Inc. (“TransCardiac”), against Ajit Yoganathan, Ph.D, Jorge H. Jiminez, Ph.D., Vinod H. Thourani, M.D., Emory University, Georgia Tech Research...more

Health Services Provider’s Settlement with DOJ Includes Detailed Factual Admissions and Agreement to Cooperate Against...

by Ropes & Gray LLP on

On January 8, 2014, pharmaceutical provider BioScrip, Inc. (BioScrip) reached a settlement with the Department of Justice (DOJ) to resolve claims under the False Claims Act (FCA) and the Anti-Kickback Statute (AKS), stemming...more

Why a Class Action Lawsuit Against 23andMe? Quick Hit Q&A With Audet & Partners

by JD Supra Perspectives on

The bad news for 23andMe keeps coming. In late November, we learned that the U.S. Food and Drug Administration had ordered the company to stop selling its $99 DNA testing kit owing to a number of accuracy and validity...more

23andMe Named in Class Action Lawsuit

Things are getting worse for genetic diagnostics company 23andMe. On the heels of receiving a Warning Letter from the FDA over its Personal Genomic Services (PGS) test (see "FDA Threatens Agency Action Against 23andMe Over...more

Hodgson Russ Helps Clients in Largest-Ever False Claims Act Settlement In Risperdal Lawsuits Against Johnson & Johnson

by Hodgson Russ LLP on

The Justice Department announced that Johnson & Johnson will pay $1.273 billion to the federal government and most states to settle a civil False Claims Act investigation into its off-label marketing of its antipsychotic drug...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

Supreme Court May Decide Issue of the Level of Specificity Required Under Rule 9(b) in FCA Whistleblower Suits

by King & Spalding on

The United States Supreme Court recently indicated its potential interest in hearing arguments in a key False Claims Act (FCA) case that would address a circuit split over the important issue of the level of specificity of...more

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