News & Analysis as of

White Collar Crimes Anti-Kickback Statute Pharmaceutical Industry

Skadden, Arps, Slate, Meagher & Flom LLP

Speaker Program Settlement Highlights Compliance Risks for Life Sciences Companies

On April 29, 2025, the U.S. Attorney’s Office for the Southern District of New York (SDNY) announced a $202 million civil False Claims Act (FCA) settlement with Gilead based on allegations that the company’s speaker program...more

Polsinelli

Swing and a Miss: the Government Strikes Out in Pharmacy Executive Kickback Trial

Polsinelli on

Last week, the government submitted its decision to the federal court not to retry partially-acquitted pharmacy executive, Chad Beene, for conspiracy and illegal kickback allegations. At the end of last year, a New Jersey...more

K&L Gates LLP

The False Claims Act and Health Care: 2023 Recoveries and 2024 Outlook

K&L Gates LLP on

On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...more

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

Stinson LLP

Is Your Prior Authorization Program Demonstrably Compliant?

Stinson LLP on

A recent settlement announced by DOJ serves as a good reminder of the need for device and pharmaceutical manufacturers to periodically revisit their prior authorization assistance programs, to assure that the programs are...more

The Volkov Law Group

DOJ Criminal Generic Pharma Price-Fixing Investigation Gathers Steam: Taro Pharmaceuticals Agrees to Pay DOJ Total of $419 Million

The Volkov Law Group on

The DOJ Antitrust Division’s multi-year criminal cartel investigation of the generic pharmaceutical industry is gaining steam.  The latest company to settle is Taro Pharmaceuticals which agreed to enter a deferred prosecution...more

Akerman LLP - Health Law Rx

Novartis’ Simultaneous Settlements Break Records

Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 3 – Compliance Failures

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Foley Hoag LLP - White Collar Law &...

White Collar Year in Preview: Healthcare Fraud Trends in 2020

Editors’ Note: This is the second in our start-of-year series examining important trends in white collar law and investigations in the coming year. Our previous entry discussed SEC enforcement in 2020. Up next: a look at...more

The Volkov Law Group

Two Charitable Foundations Pay $6 Million for Anti-Kickback Violations

The Volkov Law Group on

Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million.  The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2...more

The Volkov Law Group

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

The Volkov Law Group on

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

Jackson Walker

Opioids, Healthcare Enforcement, and Increased Scrutiny of Corporate Conduct for Criminal Prosecution

Jackson Walker on

The national opioid epidemic is almost unprecedented in every conceivable way—its catastrophic death toll, its broad effect on a wide swath of this country’s population, its rapid escalation (which is alleged to have been...more

The Volkov Law Group

Three Pharmaceutical Companies Pay a Total of $122 Million to Settle Kickback Allegations Involving Co-Pay Assistance Foundations

The Volkov Law Group on

In a significant False Claims Act enforcement action, DOJ announced settlements with three pharmaceutical companies – Jazz Pharmaceuticals, Lundbeck, and Alexion Pharmaceuticals – under which they agreed to pay $122 million...more

The Volkov Law Group

Pharmaceutical and Medical Device Company Payments to Healthcare Professionals (Part II of III)

The Volkov Law Group on

Given the significant risks posed by transfers of money and other items of value to physicians, pharmaceutical and medical device companies have to implement appropriate controls governing such payments. ...more

Thomas Fox - Compliance Evangelist

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

The Volkov Law Group

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

The Volkov Law Group on

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

The Volkov Law Group

Justice Department Charges Pharma President with Kickback Conspiracy

The Volkov Law Group on

In the public relations battle following the issuance of the Yates Memo, the Justice Department can now cite one example for the new policy – the recent arrest and charging of Carl Reichel, former President of Warner...more

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