News & Analysis as of

Prescription Drugs Materiality

WilmerHale

Supreme Court Holds That False Claims Act Requires Subjective Inquiry

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On June 1, 2023, the Supreme Court decided a pair of closely watched False Claims Act (FCA) cases, U.S. ex rel. Schutte v. SuperValu Inc., No. 21-1326, and U.S. ex rel. Proctor v. Safeway, Inc., No. 22-111....more

K&L Gates LLP

K&L Gates Triage: Triage in 2019: Health Care Topics to Watch in the New Year

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As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more

McDermott Will & Emery

Health Care Enforcement Quarterly Roundup - Q4 | January 2019

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This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond. Leading off with the US Department of...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Year End Review: A Look Back…A Look Ahead

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Perhaps the single most appropriate word to describe the current state of the civil and criminal healthcare fraud enforcement environment is uncertainty. From changes in personnel and policy at the highest levels of...more

Perkins Coie

Belated Government Dismissal of False Claims Act Cases: DOJ Maneuvering in Post-Escobar and Granston Memo Era

Perkins Coie on

The solicitor general filed an amicus brief in the U.S. Supreme Court last month supporting the relators’ opposition to certiorari in Gilead Sciences, Inc. v. United States ex rel. Campie, et al., No. 17-936. Yet the...more

Bass, Berry & Sims PLC

DOJ Informs Supreme Court that It Will Dismiss FCA Case if Remanded to District Court

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On November 30, 2018, the Solicitor General of the United States filed an amicus curiae brief in the closely watched False Claims Act (FCA) lawsuit, Gilead Sciences Inc. v. U.S. ex rel. Campie. In what appears to be an...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

K&L Gates LLP

K&L Gates Triage: Triage in 2018: Health Care Topics to Watch in the New Year

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We expect 2018 to be another year of rapid change within the health care industry. In this episode, Mary Beth Johnston highlights some of the key topics that the health care practice group will monitor in the coming year,...more

Jones Day

False Claims Act's "Rigorous" Materiality Standard Enforced by Second Circuit

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The Situation: A decision by the U.S. Court of Appeals for the Second Circuit reinforces the growing body of case law regarding the strict materiality requirements of the False Claims Act. The Result: Coyne v. Amgen is...more

Sheppard Mullin Richter & Hampton LLP

Materiality Part II: Government Knowledge

Editor’s Note: This is the second in a five-part series on how U.S. district courts and courts of appeal have applied the materiality standard set forth in Universal Health Services, Inc. v. United States ex rel. Escobar, 136...more

Jones Day

Third Circuit Confirms Government Knowledge Can Defeat Scienter and Materiality Requirements for False Claims Act Liability

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The Situation: In Spay v. CVS Caremark Corp., the Third Circuit became the latest court of appeals to hold that, in False Claims Act litigation, scienter can be lacking when the government has knowledge of "the facts...more

McGuireWoods LLP

Ninth Circuit Ruling Weakens Materiality Standard under the FCA

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Last year in Universal Health Services, Inc. v. United States ex rel. Escobar et al. the Supreme Court reminded litigants that the False Claims Act “is not an all-purpose antifraud statute.” In that case, the Court expanded...more

Robinson+Cole Health Law Diagnosis

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more

Robinson+Cole Health Law Diagnosis

Third Circuit Recognizes Escobar “Heightened Materiality Standard” in Dismissal of False Claims Act Case Tied to Avastin

In May 2017, the U.S. Court of Appeals for the Third Circuit relied on the “heightened materiality standard” endorsed by the U.S. Supreme Court in its 2016 Escobar decision in dismissing a False Claims Act (FCA) whistleblower...more

Troutman Pepper

Third Circuit Weighs in on Materiality for First Time Since Escobar

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A recent circuit court decision will be a welcome development for False Claims Act defendants because it reinforces a significant pleading hurdle for claims to proceed, with the court citing lack of government intervention as...more

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