News & Analysis as of

Manufacturers Fraud Medical Devices

Oberheiden P.C.

A 4-Point Guide for Pharmaceutical Whistleblowers

Oberheiden P.C. on

There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more

Kohn, Kohn & Colapinto LLP

Manufacturer of Defective Heart Devices Settles False Claims Act Case for $27 Million

St. Jude Medical Inc. (“St. Jude”), which was acquired by Abbott Laboratories in 2017, entered into a settlement last week with the United States Department of Justice (“DOJ”) for $27 million to resolve allegations it had...more

Faegre Drinker Biddle & Reath LLP

Summary of HB1125: Deceptive Lead Generation

Lawsuit advertisements—specifically ones that target prescription drugs and medical devices—can be dangerous. Nationwide, dramatized and exaggerated legal ads have flooded both televisions and the internet, often masquerading...more

King & Spalding

Are Pharma Speaker Programs Facing an Existential Crisis?

King & Spalding on

Exploring the Implications of HHS-OIG’s Special Fraud Alert and Groundbreaking Novartis CIA Requirements on Compliance Program Policies and Controls that Govern Speaker Programs - A Special Fraud Alert issued by the U.S....more

BakerHostetler

FDA and Pharmacy Weekly Digest - November 2020 #1

BakerHostetler on

Food - FDA Releases Resources on Food Traceability Proposed Rule – The FDA released a resource to allow users to explore the results of the Risk-Ranking Model for Food Tracing used in the development of the Food Traceability...more

Cozen O'Connor

Lack of Specificity May Kill Parallel State Law Product Claims, But Not Fraud Claim

Cozen O'Connor on

A Michigan district court judge determined last week that product liability claims against an FDA approved medical device manufacturer were preempted by federal law, but allowed the plaintiff’s claim of fraud against the...more

Manatt, Phelps & Phillips, LLP

Healthcare Law -- Aug 19, 2013

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more

Baker Donelson

OIG Calls PODs "Inherently Suspect"

Baker Donelson on

Making its most strongly worded statement to date, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert on Physician-Owned Entities on March 26, 2013, calling...more

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