News & Analysis as of

Life Sciences Whistleblowers

Fenwick & West LLP

Securities Law Update - August 2024

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Welcome to the latest edition of Fenwick’s Securities Law Update. This issue contains news on...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Jones Day

DOJ Announces Record-Breaking Year for False Claims Act Settlements and Judgments

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Qui tam relators and the U.S. Department of Justice continue to expand usage of the False Claims Act....more

Goodwin

DOJ Renews Focus on Private Equity Amid Record False Claims Act Enforcement

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2023 was another record year for False Claims Act enforcement. On February 22, 2024, the U.S. Department of Justice (DOJ) announced that the federal government and whistleblowers were party to a record number of FCA...more

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - March 2023

Circuits Split Over Whether Targeting Is Necessary for Seller Liability - Key Points - - While courts have long held that solicitations must be tailored to a particular audience to precipitate statutory seller liability,...more

Goodwin

Whistleblower Lawyers Use False Claims Act to Target Private Equity Firms Invested In Healthcare and Life Sciences

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Recent developments demonstrate that sponsor-backed companies in the healthcare and life sciences sectors, and in some instances private equity firms and professionals, have entered a new era of heightened regulatory scrutiny...more

Health Care Compliance Association (HCCA)

Research Integrity ‘Whistleblower’: Don’t Ignore Outsiders, Train Senior Investigators

Report on Research Compliance 18, no. 7 (July 2021) - Elisabeth Bik will not be silenced. While Bik, who has a doctorate in microbiology, has been active in calling out fraudulent research for several years, she gained...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 5 – The Whistleblower

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 3 – Compliance Failures

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Foley & Lardner LLP

Third Circuit Creates Budding Circuit Split in United States v. Care Alternatives, Ruling That “Objective Falsity” Is Not Required...

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The United States Court of Appeals for the Third Circuit ruled last week that whistleblower relators need not show “objective falsity” to prove their claims, and that a dispute among physician experts about a clinical...more

Epstein Becker & Green

Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series

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$3 billion recovered under the False Claims Act (“FCA”). That’s what the US Department of Justice (“DOJ”) reported collecting in FY2019. The health care and life sciences industries accounted for $2.6 billion of the total...more

Troutman Pepper

Eleventh Circuit Says Difference Of Opinion Does Not Establish Falsity In False Claims Act Case

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On September 9, in a setback for AseraCare but an overall win for hospice providers, the Eleventh Circuit affirmed a Northern District of Alabama decision to grant a new trial in a False Claims Act (FCA) case against...more

Hogan Lovells

Eleventh Circuit Confirms: Mere Difference of Opinion Between Physicians Does Not Establish Falsity Under the False Claims Act

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More than two years after the Northern District of Alabama granted summary judgment in a False Claims Act (FCA) case in favor of AseraCare Inc., holding that “contradiction based on clinical judgment or opinion alone cannot...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Hogan Lovells

Government data mining leads to more aggressive investigations

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The government is leveraging its access to big data in order to aggressively pursue healthcare investigations. Maria Durant and Gejaa Gobena, partners in our Boston and Washington, D.C. offices, discuss the steps life...more

Hogan Lovells

Why Healthcare and Life Sciences Companies Need to Step Up Their Compliance Efforts in Advance of a U.S. Government Investigation

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In this hoganlovells.com interview, Hogan Lovells partner Gejaa Gobena discusses how the perception of compliance, remediation, and self-disclosure has evolved in the eyes of government prosecutors from how they factor at...more

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