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Enforcement Actions Penalties Medical Devices

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

Venable LLP on

On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Release Reporting/CERCLA Enforcement: U.S. Environmental Protection Agency and Morganfield, Kentucky Medical Device Design...

The United States Environmental Protection Agency (“EPA”) and Vibracoustic USA, Inc. (“VUI”) entered into an April 21st Consent Agreement (“CA”) addressing alleged violations of the Comprehensive Environmental Response,...more

Hogan Lovells

State Licensing Spotlight – Medical Device Manufacturers & Distributors: Compliance Strategies for Avoiding or Reducing Penalties

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Medical device manufacturers and distributors have come under increasing scrutiny from state licensing agencies and operating without a required license may lead to severe consequences. These can include financial penalties;...more

Gardner Law

State Licensing Requirements: Are You Prepared?

Gardner Law on

Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...more

The Volkov Law Group

FCPA Recidivists: Orthofix (Part II of II)

The Volkov Law Group on

In its continuing quest to push the message of aggressive FCPA enforcement, the SEC resolved FCPA charges against Orthofix, a medical device company, for $6 million in penalties and disgorgement. In a related action, the SEC...more

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