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Medical Devices › Government Investigations

Goodwin

Common FDA Bioresearch Monitoring (BIMO) Violations: Updates from FY 2023 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Polsinelli

DOJ Telemedicine Offensive Pushes Forward with New Charges

Polsinelli on

For the past two years, telemedicine companies, durable medical equipment suppliers, pharmacies, and individuals and entities that market to such entities have been at the center of DOJ gunsights. In 2019, the Department...more

Bass, Berry & Sims PLC

GAO to Investigate PE-Backed Institutional Review Boards

Bass, Berry & Sims PLC on

The Government Accountability Office (GAO) has agreed to investigate the operations of for-profit Institutional Review Boards (IRBs) following a request made by Senators Elizabeth Warren (D-MA), Sherrod Drown (D-OH), and...more

Kramer Levin Naftalis & Frankel LLP

SEC-Mylan Settlement: The SEC Filed Suit Regarding Investigation Disclosure

Kramer Levin Naftalis & Frankel LLP on

On Sept. 27, 2019, the Securities and Exchange Commission (SEC) announced that Mylan N.V., a global pharma company that manufactures and sells EpiPen, which is used to treat serious allergic reactions, agreed to pay $30...more

King & Spalding

H1 2019: Latin America Enforcement Observations

King & Spalding on

The U.S. Justice Department, the U.S. Securities and Exchange Commission, and their enforcement partners throughout Latin America remain focused on actively investigating corruption activities and bringing enforcement actions...more

Hogan Lovells

U.S. and Brazilian Authorities Reportedly Cooperating in Investigation of Alleged Bribery and Price Fixing Related to Medical...

Hogan Lovells on

In a May 17, 2019 press report that has been widely distributed in Brazil and the United States, Brazilian Federal Prosecutor Marisa Ferrari confirmed that the U.S. Federal Bureau of Investigation (FBI), the U.S. Department...more

Butler Snow LLP

The Fifth Circuit Rules Findings from SEC Civil Investigation are Admissible Evidence at Trial

Butler Snow LLP on

The Fifth Circuit Court of Appeals appears to have handed white collar defendants a new tool for trial. In United States v. Gluk, — F.3d —-, 2016 WL 4150901 (5th Cir. Aug. 4, 2016), the court held that a little-noticed...more

Polsinelli

Olympus to Pay $632.2 Million to Resolve Allegations of Kickbacks

Polsinelli on

Olympus Corporation of the Americas, the United States’ largest distributor of endoscopes and related medical equipment, recently agreed to pay $623.2 million to resolve criminal charges and civil claims, according to a...more

Carlton Fields

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

Carlton Fields on

The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

King & Spalding

Medical Devices and Cybersecurity Risks - DHS investigates at-risk devices

King & Spalding on

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more

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