Criminal Law Products Liability

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Has the Ninth Circuit Criminalized Malpractice, Adulteration, and Off-Label Use?

Tell us that that the feds prosecuted a doctor for using a medical device off-label, and the hairs on the back of our neck start to rise and do the samba. After all, off-label use can be good medicine, even the best. Then...more

Responsible Corporate Officers’ Jail Sentences Upheld in Selling Contaminated Eggs

In an important decision, on July 6, 2016, the Eighth Circuit Court of Appeals affirmed the prison sentences imposed on Jack DeCoster, and his son, Peter, under the “responsible corporate officer” doctrine (aka Park doctrine)...more

The Supreme Court - June 2016 #7

The Supreme Court of the United States issued decisions in three cases today: McDonnell v. United States, No. 15-474: Former Virginia Governor Robert McDonnell and his wife, Maureen McDonnell, were federally indicted...more

Maker of dirty medical device hit with $623 million in penalties for kickbacks

Can the sleaze get any worse with the maker of a dirty medical device that investigators say sickened dozens and played a role in killing 21? Sadly, it can. Federal prosecutors say that the maker of a flexible scope used in...more

Podcast - Food Industry Needs to Take Product Safety More Seriously - Or Pay

There have been a number of examples lately of the U.S. Justice Department investigating and prosecuting the food industry on their product safety measures. The latest examples making headlines include Chipotle Mexican Grill...more

Criminal negligence causing death charge against auto mechanic reinstated by appeal court

A charge of criminal negligence causing death against an auto mechanic may proceed, the Ontario Court of Appeal has decided, holding that it was possible that a reasonable jury could find that the mechanic was a “significant...more

New Health and Safety Sentencing Guideline comes into Force

The definitive guideline on Health and Safety Offences, Corporate Manslaughter and Food Safety and Hygiene Offences (the Guideline) was published on 3 November 2015 and comes into force for all matters sentenced on or after 1...more

Addressing Adulterated Food Risk

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

Lawsuit “Immunity” for the Gun Industry and What the PLCAA Really Says

Do gun manufacturers really have blanket immunity from lawsuits? No, not even close. The 2016 campaign season has brought a big dose of gun policy debate, and some candidates have claimed that gun manufacturers have...more

First Amendment Follow-Up

The other day, we posted about, inter alia, the Department of Justice’s proposed jury instruction, in the Vascular Solutions case in Texas conceding the legality of truthful off-label promotion. In that post we asked, “Has...more

New sentencing guidelines for health and safety, corporate manslaughter, food safety & hygiene offences

On 3 November 2015 the Sentencing Council published the long awaited Definitive Guideline for the Sentencing of Health and Safety, Corporate Manslaughter and Food Safety and Hygiene offences. For the first time, courts in...more

The Internet of Things and the Inevitable Collision with Product Liability PART 4: Government Oversight

The exponential growth of the Internet of Things (IoT) is far outpacing the ability of stakeholders to address safety standards and security concerns. This is not unusual as rapidly developing technology often challenges...more

Pay Attention to the Man Behind the Curtain: DOJ Memorandum Adds Further Weight to CPSC Enforcement Efforts Against Corporate...

The United States Department of Justice (DOJ) recently issued a memorandum to various enforcement agencies. The memorandum, available here, focuses on holding individuals accountable for corporate fraud and misconduct. The...more

Tobacco Companies and 20 million Deaths — Without criminal penalty

Before its civil war began in 2011, Syria had a population of 23 million people. In the ensuing four years, 11 million Syrians have died or fled their homes, and nearly four million of Syria’s citizens fled the country...more

CEO Conviction Aligns With Trend of Aggressive Foodborne Illness Prosecutions

The former CEO of Peanut Corporation of America (PCA), has been sentenced to an unprecedented 28 years for his role in the 2008-09 Salmonella outbreak linked to the deaths of nine people and more than 700 illnesses. While it...more

Possible Life Sentence in Salmonella Case Raises Stakes for Food and Beverage Industry Compliance

Last week, federal prosecutors in Georgia filed papers supporting the local probation office’s U.S. Sentencing Guidelines calculation calling for a sentence of life in prison for Stewart Parnell, the one-time CEO of Peanut...more

Food for Thought: Jail Sentences Send Strong Message to Food Industry

On Monday, U.S. District Court Judge Mark Bennett in Sioux City, Iowa, sentenced Austin (Jack) DeCoster and his son Peter to three months in jail for their role in selling contaminated food across state lines. Their company,...more

2014 Year in Review: OPDP Warning and Untitled Letters

In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more

RICO Indictment of NECC Executives for Acts of Second-Degree Murder

An Unprecedented Approach to Regulatory Violations - In December 2014, the United States Attorney for the District of Massachusetts obtained a sweeping indictment that charges business executives of the New England...more

Federal Prosecutors Charge NECC Employees with Second Degree Murder: A Shot Across the Bow to Healthcare Companies Navigating...

Federal prosecutors charged the head pharmacist and the president of New England Compounding Center (NECC), a now-bankrupt Massachusetts compounding pharmacy, with second-degree murder and racketeering in the U.S. District...more

Third Circuit Holds That Insured Must Reimburse Insurer For Litigation Costs Paid In Excess Of Sub-limit

In CAMICO Mutual Insurance Co. v. Heffler, Radetich & Saitta, L.L.P., the United States Court of Appeals for the Third Circuit recently held that a $100,000 sub-limit for claims involving employee misappropriation, misuse,...more

The Pain Drain - The Continuing Impact of Pain Management on Health-Care Providers

Over a hundred million Americans suffer from chronic pain. To combat this epidemic, health-care providers have increasingly turned to opioid analgesics. As a result, opioid analgesic use has risen dramatically over the past...more

Guilty Convictions in Salmonella Trial May Signify Landmark in Criminal Food-Safety Prosecutions

This space has thoroughly explored the various forms of civil liability food companies face for the mislabeling and/or deceptive marketing of their products. Last week, a set of landmark convictions in a criminal food-safety...more

Do Not Pass Go: Federal Judge Orders Execs Jailed for Contempt of Recall Order

A recent federal decision has made clear that court-ordered recalls can have real teeth, not just for manufacturers but also their officers—especially when the court has reason to suspect a company’s execs are deliberately...more

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

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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