News & Analysis as of

Personal Liability Medical Devices

Skadden, Arps, Slate, Meagher & Flom LLP

Failure to Report Adverse Events Results in Criminal Misbranding Settlement and Individual Liability

On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more

Poyner Spruill LLP

Corridors Fall 2018 - News for North Carolina Hospitals

Poyner Spruill LLP on

Recent Decision Highlights Potential Personal Liability of Hospital Directors Based on Breach of Fiduciary Duty - In a recent case, a federal bankruptcy court in Michigan reviewed important questions involving breach of...more

Harris Beach PLLC

Significant New York Drug and Device 2017 Product Liability Decisions

Harris Beach PLLC on

To prepare the best product liability defense for pharmaceuticals and medical devices as well as anticipate and strategically plan for future challenges in the medical and life sciences legal world, it is often helpful to...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

Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more

Nutter McClennen & Fish LLP

Sales Representatives Face Increased Risk of Being Named in Medical Device Product Liability Litigation

Why is there a rise in sales representatives being sued in medical device product liability cases? Robyn Maguire: Five to ten years ago, the primary reason sales representatives were sued in product liability cases was...more

Arnall Golden Gregory LLP

Officer/Director Liability for Violations of the US Federal Food, Drug, and Cosmetic Act

Officers and directors of Irish and Northern Irish companies whose products would be regulated by the US Food and Drug Administration (life sciences companies, specifically) should be aware of developments on the issue of...more

The Volkov Law Group

The FCPA Year in Review: Twist and Shout (Part I of II)

The Volkov Law Group on

We all like annual reviews and predictions for the upcoming year – it is a New Year’s rite of passage and one that brings perspective and a sense of order to our otherwise chaotic lives....more

Mintz - Health Care Viewpoints

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more

King & Spalding

Trade & Manufacturing - October 2014

King & Spalding on

In This Issue: - Export-Import Bank Is Reauthorized Through June 2015 - Roadblocks to Bali Package Implementation Remain As Summer Deadline Passes Without A Clear Path Forward - Customs Litigation: Federal...more

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