News & Analysis as of

Trade Agreements Act Medical Devices

Hogan Lovells

Medical Device Contractor Settles FCA Allegations Based on TAA Violations

Hogan Lovells on

On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade...more

Morgan Lewis

Trade Agreements Act Compliance Activity Increasing at VA

Morgan Lewis on

Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more

Cooley LLP

Blog: The Trade Agreements Act and Sales of Medical Devices to the U.S. Government

Cooley LLP on

Does your company sell medical devices to the U.S. Government, either directly or through a reseller or distributor? Are those devices or supplies manufactured at least partly in a country other than the U.S.? ...more

Knobbe Martens

Medtronic Settles Federal Lawsuit for $4.41 Million

Knobbe Martens on

On April 2, 2015, the United States Department of Justice announced that Medtronic, a medical device manufacturer based in Ireland, reached a settlement agreement with the United States government for $4.41 million over...more

Latham & Watkins LLP

Certifications Under the Trade Agreements Act: 10 Tips to Avoid TAA Traps for the Unwary

Latham & Watkins LLP on

On September 3, 2014, U.K.-based medical device maker Smith & Nephew (the ‘‘Company’’) agreed to pay $8.3 million (plus an additional $3 million in attorney’s fees) to resolve a lawsuit filed under the federal civil False...more

King & Spalding

Recent False Claims Act Decision Provides Important Guidance To Manufacturers And Resellers About Trade Agreements Act Compliance

King & Spalding on

The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court's dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

Morgan Lewis

Medical Device Manufacturer Settles Trade Agreements Act Suit

Morgan Lewis on

A whistleblower alleged that the manufacturer knowingly violated the Trade Agreements Act’s country of origin requirement. Government contractors must agree that the products they sell to the U.S. government under...more

King & Spalding

False Claims Act Update: GSA Contractor Reasonably Relied Upon Distributor Certifications Of Product Origin And Trade Agreements...

King & Spalding on

The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court’s dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

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