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Food, Drug and Cosmetic Act Criminal Prosecution

The Food, Drug and Cosmetic Act is a United States federal law enacted in 1938 in response to deaths following the legal marketing of a toxic elixir. The FDCA authorized the  Federal Drug Administration to set... more +
The Food, Drug and Cosmetic Act is a United States federal law enacted in 1938 in response to deaths following the legal marketing of a toxic elixir. The FDCA authorized the  Federal Drug Administration to set standards for food and drug safety, and to conduct factory inspections.  The FDCA was amended in 1962 to strengthen drug safety policies and implement new efficacy requirements. In 1976, Congress further amended the FDCA to apply safety and efficacy standards to new medical devices. less -

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

by Katten Muchin Rosenman LLP on

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

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

by 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

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

by Arnall Golden Gregory LLP on

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

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

by Michael Volkov 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

"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

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

by 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

Criminal Charges Brought in Food Safety Case

by Ballard Spahr LLP on

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

Misbranded Drugs: A Danger To Physicians And Patients

by Pepper Hamilton LLP 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

D.A.R.E. to Market Off-Label Uses of Prescription Drugs? Make Sure You are in the Second Circuit: United States v. Caronia and the...

by Ellis & Winters LLP on

Truthful, non-misleading off-label promotion of prescription drugs is not illegal. At least, not in the Second Circuit. This, despite the billions of dollars in civil and criminal penalties assessed against pharmaceutical...more

Years Later, PCA Employees Indicted

by Varnum LLP on

I had the following email exchange earlier this year with a concerned client: Client (in late January 2013): "Hi Steve, I was wondering if you knew of any cases where employees were prosecuted for not following...more

Second Circuit Vacates Conviction Against Sales Representative for Off-Label Promotion

by Foley Hoag LLP on

The Second Circuit, New York’s federal court of appeals, this week issued its long-awaited decision in United States v. Caronia and vacated the conviction of a pharmaceutical sales representative for off-label promotion. In a...more

"Second Circuit Vacates Conviction Based on Off-Label Promotion, Deals Blow to Government Theory in Drug Marketing Cases"

In a much-anticipated opinion, the U.S. Court of Appeals for the Second Circuit vacated and remanded the conviction of Alfred Caronia, a former pharmaceutical sales representative convicted of conspiring to introduce a...more

Second Circuit Holds First Amendment Bars Conviction Based Solely on Off-Label Promotion of FDA-Approved Drug

by Ropes & Gray LLP on

In its long-awaited decision in United States v. Caronia, the Second Circuit ruled today that the First Amendment bars the criminal prosecution of pharmaceutical manufacturers or their sales representatives for truthful,...more

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