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Bass, Berry & Sims PLC

12th Annual Healthcare Fraud & Abuse Review - A Critical Resource for Healthcare Providers

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We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q2 2023

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There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023.  Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....more

Bass, Berry & Sims PLC

11th Annual Healthcare Fraud & Abuse Review 2022

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We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q3 2022

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The third quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several over $20 million and one in the high nine figures. This post summarizes key settlements of interest to healthcare...more

Bass, Berry & Sims PLC

10th Annual Healthcare Fraud & Abuse Review

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Bass, Berry & Sims is pleased to announce the release of the 10th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2021. Compiled by the firm’s Healthcare Fraud & Abuse Task Force,...more

The Volkov Law Group

Merit Medical Systems Settles False Claims Act Case for $18 Million (Part I of II)

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Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to...more

Goodwin

Novel DOJ Settlement For Sunshine Act Violations

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On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...more

Robins Kaplan LLP

Robins Kaplan Justice Report Winter 2020 | VOL. 14 NO. 1

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DUSTING SPRAY DEATHS AND INJURIES - Robins Kaplan LLP is investigating and litigating “dusting” cases, which arise when someone inhales—or “huffs”—compressed gas dusting spray for its intoxicating effects while driving and...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Annual Review 2019

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Bass, Berry & Sims is pleased to announce the release of the 2019 edition of its Healthcare Fraud & Abuse Annual Review. Compiled by the firm’s Healthcare Fraud Task Force, the Review is an in-depth and comprehensive analysis...more

A&O Shearman

Medical Device Manufacturer Enters Into Second FCPA Settlement In Five Years With SEC

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On September 28, 2018, the Securities and Exchange Commission (“SEC”) announced a settlement with a Michigan-based manufacturer and distributor of medical devices, over allegations that the company had violated the books and...more

The Volkov Law Group

Stryker Suffers “Strike Two” and Settles SEC FCPA Case

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Stryker Corporation has suffered a second FCPA enforcement action, and will now bear the stigma of FCPA “recidivist.” In reaching a settlement with the SEC and agreeing to pay a $7.8 million civil penalty, Stryker will now...more

Knobbe Martens

Theranos Charges Provide Perspective for Medical Device Companies, Biotechnology Companies, and Investors

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On March 14, 2018, the Securities and Exchange Commission (SEC) announced it filed charges against the founder and CEO of Theranos Inc., Elizabeth Holmes, and its former president, Ramesh Balwani....more

Skadden, Arps, Slate, Meagher & Flom LLP

Health Care Investigation Trends: Corporate Integrity Agreements No Longer a Given

2017 was slightly above average for new corporate integrity agreements (CIAs), with 46 entered into by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and companies and individuals...more

Baker Donelson

Update on Regulatory Compliance in the Global Health Care Industry

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A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

Carlton Fields

Peerless, This is Not: Sixth Circuit Finds No Latent Ambiguity in Consent to Settle Requirement in Excess Policy

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Disputes between policyholders and excess insurers often involve events that occurred before the underlying defense costs or indemnity payments reached the excess layer. In Stryker Corp. v. Nat’l Union Fire Ins. Co. of...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Mintz - Health Care Viewpoints

Five Things to Know About the Mylan EpiPen “Settlement” – What It Is and What It Isn’t

Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate...more

Mintz - Health Care Viewpoints

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

Carlton Fields

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

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The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

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