News & Analysis as of

Medical Devices Department of Health and Human Services (HHS) Whistleblowers

Paul Hastings LLP

At the Crossroads: Illumina Settlement Reflects the Intersection of Cybersecurity and Healthcare Law

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On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more

McGuireWoods LLP

DOJ and HHS Reestablish False Claims Act Working Group, Delineate Healthcare Enforcement Priorities

McGuireWoods LLP on

On July 2, 2025, the U.S. Department of Justice (DOJ) and U.S. Department of Health and Human Services (HHS) announced the reestablishment of the DOJ-HHS False Claims Act Working Group. Originally formed in December 2020 at...more

Sheppard Mullin Richter & Hampton LLP

DOJ and HHS Announce Joint False Claims Act Working Group and Enforcement Priorities

On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act...more

Hogan Lovells

DOJ-HHS False Claims Act Working Group reaffirms commitment to enforcement in healthcare fraud and abuse

Hogan Lovells on

Despite much recent attention to the new administration's plans to deploy the False Claim Act (FCA) to advance other policy objectives, a July 2, 2025 Department of Justice (DOJ) press release announcing a DOJ-HHS False...more

Ropes & Gray LLP

DOJ and HHS Announce False Claims Act Working Group & Enforcement Priority Areas

Ropes & Gray LLP on

On July 2, 2025, the U.S. Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”) announced the formation of the DOJ-HHS False Claims Act Working Group, signaling a continued and coordinated...more

Arnall Golden Gregory LLP

DOJ and HHS Launch Enhanced False Claims Act Working Group: Heightened Enforcement Ahead for Key Healthcare Sectors

The U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) have announced the formation of a newly strengthened False Claims Act (“FCA”) Working Group, signaling a more coordinated and...more

Epstein Becker & Green

DOJ, HHS Announce Revamped False Claims Act Working Group

Now in its sixth month, the second Trump administration has made clear that the False Claims Act (FCA) will remain a central tool in its efforts to combat fraud, waste, and abuse across federal programs....more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Miles & Stockbridge P.C.

Disregard Compliance at Your Peril: Compliance Officer Paid As Whistleblower

Miles & Stockbridge P.C. on

A medical device manufacturer learned what might seem an obvious lesson when it paid $18 million to settle a False Claims Act lawsuit brought by its former Compliance Officer: don’t ignore your compliance officer. The federal...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

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Knobbe Martens

Alere Settles False Claims Act Allegations for $33 Million

Knobbe Martens on

The United States Department of Justice announced in a press release that Alere Inc. and its subsidiary, Alere San Diego, reached a settlement agreement with the United States government for $33.2 million over allegations...more

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