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DAM Contractor's Underbidding Insufficient For FCA Liability

Client Alert | 1 min read | 01.21.05

Affirming summary judgment, the D.C. Circuit in U.S. ex rel. Bettis v. Oderbrecht Contractors (Jan. 11, 2005) held that evidence that a dam contractor (1) underbid, (2) reaffirmed its underbid, and (3) claimed that it would use cost-saving measures it never employed did not permit the conclusion that the contractor fraudulently induced the Army Corps of Engineers to award it the contract. The Court acknowledged that claims submitted for payment under a contract that was fraudulently induced can give rise to civil False Claims Act liability, but found in this case that the contractor's underbid was not a promise that its estimated costs were accurate, only that it would perform the dam work at the unit prices it bid, such that submission of claims for payment under the contract, including claims for equitable adjustments above the contract price, were not false claims.

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Client Alert | 6 min read | 09.03.26

FDA Seeks Input for Regulating GenAI-Powered Medical Devices

The U.S. Food & Drug Administration (FDA) is seeking feedback on a regulatory framework that could be used to evaluate generative artificial intelligence (GenAI)-enabled medical devices. Such devices could create new types of risks because their outputs can vary and evolve, unlike more traditional software-enabled devices. An August 18, 2026, discussion paper (“Considerations for the regulation of GenAI-enabled medical devices”) discusses potential regulatory considerations for GenAI-enabled medical devices. ...