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Food and Drug Administration (FDA) › Personal Liability

Troutman Pepper

The Latest Successful Caremark Claim

Troutman Pepper on

In Teamsters Local 443 Health Services & Insurance Plan v. Chou, the Delaware Court of Chancery held, at the pleading stage, that plaintiff stockholders had stated a claim for Caremark oversight liability against certain of...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Products Liability Insights: Issue 1, 2020

Spilman Thomas & Battle, PLLC on

Welcome to our first Product Lines issue of 2020. Product Lines is our quarterly e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely...more

Foley & Lardner LLP

Health Care Provider Director and Officer Liability: Important Takeaways from Clovis and Marchand

Foley & Lardner LLP on

Health care provider boards of directors have been put on notice—given these two recent Delaware court decisions - Clovis and Marchand—that courts may be willing to significantly extend a corporate board’s Caremark duty to...more

The Volkov Law Group

Delaware Court Increases Scrutiny of Corporate Board Oversight and Monitoring of Compliance Programs

The Volkov Law Group on

On October 1, 2019, in In re Clovis Oncology, Inc. Derivative Litigation, a Delaware Chancery Court denied a motion to dismiss the plaintiffs’ claims under the Caremark decision against individual directors for failing to...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Mintz - Health Care Viewpoints on

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

Arnall Golden Gregory LLP

SEC Charges Biotech Company and Its Officers with Misleading Investors by Failing to Disclose FDA Concerns and Recommendations

Arnall Golden Gregory LLP on

On March 29, 2016, the Securities and Exchange Commission (SEC) announced charges against a biotech company and three of its officers for securities fraud. The company has agreed to pay $4 million to resolve the charges...more

Arnall Golden Gregory LLP

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

Arnall Golden Gregory LLP on

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

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Faegre Drinker Biddle & Reath LLP

Pin the Blame on the Corporate Officer: Senators Introduce Hide No Harm Act

Faegre Drinker Biddle & Reath LLP on

Three Senate Democrats recently introduced a bill that seeks to hold company executives of a product maker or seller criminally liable for knowingly "failing to inform and warn of serious dangers" associated with a product....more

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