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FCA Settlement Does Not Bar Third-Party Claims

Client Alert | 1 min read | 12.03.09

In Cell Therapeutics Inc. v. Lash Group Inc. (9th Cir. Nov. 18, 2009), the Ninth Circuit ruled that an FCA settlement entered into between a drug manufacturer and the government and relator did not preclude the drug manufacturer from bringing state common law claims against an expert in Medicare reimbursement protocol for having allegedly advised that the false Medicare billings were proper. Although a company found to have violated the FCA may not shift its FCA liability to a third party, the suit was not foreclosed because, first, "independent" claims for damages were asserted; and, second, a settlement agreement without an admission of FCA liability does not constitute a finding of FCA liability, which could preclude recovery against a third party.

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Client Alert | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...

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