News & Analysis as of

Park Doctrine Federal Food Drug and Cosmetic Act (FFDCA)

Gardner Law

FDA Violations and the Park Doctrine Threat

Gardner Law on

Did you know… As a leader at an FDA-regulated company, you could be held criminally liable for misdemeanor FDA violations even if you did not know about the activities leading to the violation....more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Saul Ewing LLP

The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know

Saul Ewing LLP on

In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with colleague Justin Danilewitz, a litigator in the Firm’s White Collar and Government...more

Dechert LLP

U.S. Executive and Legislative Branches Raise the Heat on Slave Labor and Trade Law Violations

Dechert LLP on

Weeks ago, on September 14 2020, the Trump Administration made news by announcing a ban on the importation of certain products made in China’s Xinjiang region, where widespread human rights abuses—including slave labor work...more

Stinson LLP

The Proposed Corporate Executive Accountability Act - Bending the Space-Time Continuum to Find Criminal Culpability of Corporate...

Stinson LLP on

Two core principles of American criminal liability are: (1) a crime does not occur unless the accused has both criminal intent (mens rea) and commits a criminal act (actus reus); and (2) the intent and the act must occur at...more

Cadwalader, Wickersham & Taft LLP

The Responsible Corporate Officer Doctrine in the Wake of DeCoster

Executive Summary: The most important Park doctrine case in over forty years may be heading to the Supreme Court – but not if the federal government has its way. The Responsible Corporate Officer doctrine (“RCO doctrine”),...more

Mintz - Consumer Product Safety Viewpoints

Eighth Circuit Issues Decision Significant for All Executives of FDA-Regulated Businesses

On July 6, 2016, the Eighth Circuit Court of Appeals issued its ruling in United States v. DeCoster, in which it upheld prison sentences for two executives under the “responsible corporate officer” (RCO) doctrine of...more

McGuireWoods LLP

Addressing Adulterated Food Risk

McGuireWoods LLP on

As we enter 2016, adulterated food-related investigations are leading the headlines—and should be leading companies in the food and beverage industry to ask what they can do to prevent and prepare for a potential outbreak on...more

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