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Largest Settlement to Date Announced With a PE Investor to Resolve Claims that a Portfolio Company Healthcare Provider Violated the FCA

USA - October 15 2021 This week, in a case we previously reported on here, a PE fund and two executives agreed to pay $25M to resolve claims that they caused the…

PE Investors - Even Minority - Exposed to False Claims Act Risk

USA - October 15 2021 As we have discussed in prior posts (here), private equity investors in the healthcare and life sciences industries increasingly face direct risk…

What do the FDA’s expanded ‘intended use’ regulations mean for safe-harbored communications about new uses?

USA - October 6 2021 FDA’s final rule to amend its medical product ‘intended use’ regulations has now been in effect since September 1. The changes which the final rule…

District Court Rejects Anti-Kickback Statute Claim Due to “Conclusory” Assertions of Unlawful Intent

USA - September 16 2021 A court in the District of Maryland recently dismissed a declined qui tam action in which the relator, a bariatric surgeon, alleged that two medical…

Fraud Theories Fail Under Rigorous Standards for “Worthless Services” and Materiality

USA - September 2 2021 Earlier this week, a court in the Eastern District of Pennsylvania dismissed a declined qui tam action in which the relator, a licensed nurse…

Split Seventh Circuit Panel Spars Over Escobar Interpretation

USA - September 2 2021 The United States Court of Appeals for the Seventh Circuit recently allowed a previously dismissed qui tam case to proceed against Molina Healthcare…

HHS Hires Four Outside Firms to Audit Provider Relief Fund Recipients

USA - August 27 2021 Federal records recently made available by ProPublica reveal that from late February through early April 2021, Health Resources and Services…

Finding No Materiality, Court Grants Summary Judgment for Defense in Fraudulent Inducement Case

USA - August 25 2021 On August 12, 2021, the United States District Court for the District of Minnesota granted Boston Scientific Corporation’s (BSC) motion for summary…

D.C. Circuit Reinstates Parts C/D Overpayment Rule

USA - August 19 2021 The D.C. Circuit Court of Appeals recently overruled an earlier district court vacatur of the CMS Parts C/D Overpayment Rule, resulting in…

Seventh Circuit Affirms That Safeco “Objective Reasonableness” Standard Applies to FCA Claims; Finds It Was Objectively Reasonable for Defendants to Charge Government Retail Cash Prices Instead of Discount Program Prices

USA - August 19 2021 In a 2-1 decision, the Seventh Circuit joined the Third, Eighth, Ninth, and D.C. Circuits in holding that the standard for “reckless disregard” under…