News & Analysis as of

Medical Devices Settlement Agreements

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more

Goodwin

Heating Up: Federal Sunshine Act Enforcement on the Rise

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After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more

Goodwin

Alere Pays $198.75 Million to Settle False Claims for Allegedly Billing Medicare for Defective POC Devices, Not Charging Copays,...

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Alere Inc. and Alere San Diego Inc. (collectively “Alere”) have come under fire recently by the U.S. Department of Justice (“DOJ”) and other government agencies, agreeing to settle several rounds of accusations of False...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2020

Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more

ArentFox Schiff

Investigations Newsletter: Medical Device Manufacturer Settles Improper Payment Allegations for $18 Million

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Medical Device Manufacturer Settles Improper Payment Allegations for $18 Million - Merit Medical Systems Inc. (MMSI), a Utah-based medical device maker, will pay $18 million to settle allegations that it engaged in a...more

Stinson LLP

Is Your Prior Authorization Program Demonstrably Compliant?

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A recent settlement announced by DOJ serves as a good reminder of the need for device and pharmaceutical manufacturers to periodically revisit their prior authorization assistance programs, to assure that the programs are...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Kramer Levin Naftalis & Frankel LLP

SEC-Mylan Settlement: The SEC Filed Suit Regarding Investigation Disclosure

On Sept. 27, 2019, the Securities and Exchange Commission (SEC) announced that Mylan N.V., a global pharma company that manufactures and sells EpiPen, which is used to treat serious allergic reactions, agreed to pay $30...more

Searcy Denney Scarola Barnhart & Shipley

Shouldn’t Protecting Our Soldiers Be an Absolute? 3M Apparently Thought Giving Second Rate Hearing Protection Was Enough — It...

Honor and Protect Our Soldiers - Tales of corporate wrongdoing have pervaded society for decades. Take the Takata airbag scandal, in which a Japanese manufacturer of the automobile-safety device churned out tens of...more

Knobbe Martens

Cook Medical Petitions for Inter Partes Review (IPR) of Medtronic “Jervis” Patent

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On November 9, 2018, Cook Medical LLC filed a petition with the Patent Trial and Appeal Board requesting inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc. The ‘141 Patent is...more

Pillsbury - Policyholder Pulse blog

Electing to Pay One Claim Over Another to an Insured’s Detriment Could Subject Insurers to Bad Faith Claims

A federal court in Michigan just breathed new life into a long-running legal saga—while at the same time issuing a warning shot across the bows of insurers—by declining to dismiss an insured’s bad faith cause of action...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Mintz - Health Care Viewpoints

Building a Health App? Part 4: Avoiding an FTC Enforcement Action

The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more

Bass, Berry & Sims PLC

Healthcare Fraud and Abuse Review 2016

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Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

Akerman LLP - Health Law Rx

Medical Devices And Risks Of Unauthorized Disclosure Of Protected Health Information

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) kicked off the holiday season by publishing a settlement agreement under the Health Insurance Portability and Accountability Act of 1996 (HIPAA)...more

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