News & Analysis as of

Criminal Prosecution Federal Food Drug and Cosmetic Act (FFDCA)

Foley Hoag LLP

United States v. Elizabeth Holmes and Ramesh Balwani

Foley Hoag LLP on

I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more

Alston & Bird

$19 Million Criminal Penalty Levied Against Food Manufacturer Serves as a Stark Reminder of the Importance of Food Safety...

Alston & Bird on

A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more

Skadden, Arps, Slate, Meagher & Flom LLP

Deputy Attorney General Monaco Announces Additional Measures Targeting Corporate Criminal Conduct: The Impact for Life Sciences...

In a speech on September 15, 2022, Deputy Attorney General (DAG) Lisa Monaco announced several important updates to the U.S. Department of Justice’s (DOJ’s) approach to investigating and prosecuting corporate crimes. These...more

Oberheiden P.C.

Did You Receive an FDA Warning Letter? Here's What to Do Next

Oberheiden P.C. on

What is an FDA Warning Letter? Did you receive an FDA warning letter? If so, then there are critical steps you can take today to prepare and to be able to respond promptly to the warning letter. The FDA will issue a...more

The Volkov Law Group

Avanos Medical Pays $22 Million to Settle Criminal Mislabeling Charges for Surgical Gowns

The Volkov Law Group on

Avanos Medical, a global medical device company, agreed to pay $22 million to resolve criminal charges relating to its fraudulent misbranding of its MicroCool surgical gowns....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

Health Care Compliance Association (HCCA)

Opioid manufacturer pleads guilty to fraud

Compliance Today (February 2021) - Purdue Pharma LP pleaded guilty to three felony offenses: “one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two...more

Mintz - Health Care Viewpoints

Not So Sweet: Failure to Timely Recall Contaminated Ice Cream Results in Major Consequences for Texas Manufacturer

On May 1, 2020, Blue Bell Creameries L.P. (Blue Bell) agreed to plead guilty to charges that it distributed contaminated ice cream products that were linked to a 2015 listeriosis outbreak. The Blue Bell outbreak made...more

The Volkov Law Group

DOJ Resolves Two Important Food Safety Criminal Cases: Blue Bell Creameries and Chipotle Mexican Grill (Part I of II)

The Volkov Law Group on

In an important set of criminal prosecutions for food safety violations, the Justice Department recently announced resolutions with Blue Bell Creameries and Chipotle Mexican Grill....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

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

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...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

Faegre Drinker Biddle & Reath LLP

Trump Administration Stands Firm on Prison Time for Strict Liability Offenses Under the Food, Drug, and Cosmetic Act

The Trump administration is urging the U.S. Supreme Court not to review the prison sentences given to Quality Egg LLC executives for their role in failing to prevent a national salmonella outbreak. This move indicates that...more

Katten Muchin Rosenman LLP

DeCoster Rehearing Denied—Food and Beverage Company Executives Face Risks of Prosecution as Responsible Corporate Officers

A recent Eighth Circuit decision that two corporate officers must serve jail time for failing to prevent the distribution of contaminated eggs despite the fact that they did not know the eggs were infected reaffirms...more

Snell & Wilmer

Ninth Circuit Upholds Felony Conviction of Urologist, Under FDCA, for Reusing Single-Use Needle Guides During Prostate Biopsies...

Snell & Wilmer on

In 2014, Las Vegas urologist, Dr. Michael Kaplan, was convicted by a federal jury for reusing single-use plastic needle guides during prostate biopsies. He was convicted of conspiracy to commit adulteration in violation of...more

Arnall Golden Gregory LLP

Federal Jury Convicts Two Former Acclarent, Inc. Executives on Misdemeanor Charges Related to Off-Label Marketing of Medical...

On July 21, 2016, two former executives of Acclarent, Inc., a medical device company owned by Johnson & Johnson, Inc., were found guilty of ten misdemeanor violations of the Food, Drug and Cosmetic Act (FDCA), following a...more

McGuireWoods LLP

Prison Sentence for Executives in Contaminated Egg Case Highlights Food Safety Risks

McGuireWoods LLP on

Last Thursday, July 7, 2016, a divided panel of the U.S. Court of Appeals for the 8th Circuit upheld a three-month jail sentence against Austin “Jack” DeCoster and his son Peter, the CEO and COO respectively of Quality Egg...more

The Volkov Law Group

Food Safety Criminal Prosecutions: When Compliance is a Matter of Life and Death

The Volkov Law Group on

Over the last ten to twenty years, we have witnessed the expansion of federal criminal prosecution of health and safety matters. Environmental and food and drug regulatory enforcement has been supplemented by aggressive...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

Skadden, Arps, Slate, Meagher & Flom LLP

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

Skadden, Arps, Slate, Meagher & Flom LLP

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...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

Ballard Spahr LLP

Criminal Charges Brought in Food Safety Case

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In another show of force against food processors, federal prosecutors in Colorado recently brought criminal charges against two brothers who owned a cantaloupe farm linked to a 2011 listeria outbreak that killed 33 people....more

Troutman Pepper

Misbranded Drugs: A Danger To Physicians And Patients

Troutman Pepper on

Mail-order businesses, including pharmacies, bombard doctors by fax, phone, and Internet offering an assortment of name-brand medications and treatments at bargain prices. These new options tempt physicians with the promise...more

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