Health Criminal Law

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Kickback Prosecutions Expanding Beyond Drugs and Devices to Care Networks

The DOJ has recently showed some new muscle by applying anti-kickback laws to care facility owners rather than drug manufacturers. The uptick in federal healthcare fraud prosecutions in 2016 has been well-documented, but...more

DEA Just Said No to Rescheduling Cannabis: Why It Matters

The U.S. Drug Enforcement Agency (DEA) recently denied a petition to initiate proceedings to reschedule cannabis under the Controlled Substances Act (CSA). Thus, Cannabis will remain a Schedule I substance under the CSA. ...more

DOJ Files FCA Complaint Against Recipient of Grant Funding

The FCA began as a response to procurement fraud by military contractors during the Civil War. In the intervening years, its reach has extended and increasingly the government is using the FCA as a tool in the context of...more

DEA Rejects Petitions Seeking to Reschedule Marijuana

The long-awaited decision maintains the illegal status of marijuana under federal law. On August 12, the US Drug Enforcement Agency (DEA), despite much speculation to the contrary, published in the Federal Register its...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: August 2016

Since our last issue, we have identified 31 recently unsealed health care-related whistleblower cases. In this Qui Tam Update, we analyze the trends and take an in-depth look at a few noteworthy cases....more

Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

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

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

Criminal Charges Brought in $1 Billion Alleged Medicare Fraud Scheme

If the June 2016 nationwide Medicare fraud takedown was not a sufficient indicator, today’s announcement that the U.S. Department of Justice (DOJ) has filed criminal charges against three Florida individuals alleging more...more

Corporate Investigations and White Collar Defense - July 2016

“Official Acts”—What They Are… and Are Not - Why it matters: On June 27, 2016, the Supreme Court decided McDonnell v. U.S., holding that, for purposes of the federal public corruption statutes, an “official act”...more

Ransomware Attacks on ePHI May Be a Data Breach Under HIPAA

On July 11, 2016, the Office of Civil Rights (“OCR”) at the Department of Health and Human Services issued new HIPAA guidance regarding the growing epidemic of malicious computer software known as “ransomware”....more

New Anti-Corruption Laws on the Health Care Sector in Germany: Is There Any Impact on the Food Industry?

Germany recently adopted new anti-corruption laws that now criminalize “taking bribes in the health care sector” and “giving bribes in the health care sector.” These new laws have implications for certain segments of the food...more

Health Care Fraud Prosecutions: Strong Seas and High Winds Ahead for Individuals and Corporations

During the past nine months, the U.S. Department of Justice (DOJ) has made several significant policy pronouncements that impact health care organizations and individual providers. These directives and initiatives reflect...more

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

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

Biodiagnostic Laboratory Services Sentenced; Another Physician Pleads Guilty

The long-running test-referral prosecution against Biodiagnostic Laboratory Services, LLC (“BLS”), a New Jersey clinical blood testing laboratory; its owner and employees; and BLS’s referring physicians recently reached...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

Jury Acquits Former Pharma Exec in One of the First Post-Yates Memo Health Care Fraud Prosecutions

Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s...more

For congressional overseers, red flags fly over issues at FDA

Congressional overseers of the federal agency that regulates drugs and medical devices have gotten red-flag warnings about problems at the Food and Drug Administration, including: two separate calls for improvements from...more

Federal Jury Acquits Former Warner Chilcott President

On June 17, 2016, a federal jury in the District of Massachusetts acquitted Carl Reichel, the former president of specialty pharmaceutical manufacturer Warner Chilcott, on a single count of conspiracy to violate the federal...more

Ask the Health Law Gurus™: Can a Prison Forcibly Medicate an Inmate with a Psychotropic Drug against the Inmate’s Will?

Question: Can a Pennsylvania prison forcibly administer a psychotropic medication to an inmate against the inmate’s will? Answer: In Pennsylvania, a prison’s ability to forcibly medicate an inmate with a psychotropic...more

DOJ Suffers Criminal Trial Setbacks: Warner Chillcott President Acquitted

Last week was a tough week for the Justice Department’s criminal prosecutors. Before everyone gets out their Yates Memorandum trending claims, it is important to recognize that DOJ’s loss in several high profile cases does...more

Does the Medical-School-to-Prison Pipeline Widen in Middle Age?

The trend of holding physicians personally responsible for healthcare crimes has continued unabated over the past year. As noted in a previous article, physicians are particularly attractive targets for federal prosecutors...more

Kansas Heart Hospital pays ransom but attackers renege on their word

In a rare and twisted result, Kansas Heart Hospital was hit with a ransomware attack on May 18th, and made the decision to pay a “small amount” to the attackers in order to get its data back. Kansas Heart stated that no...more

Also In the News - Data, Privacy, & Security Practice Report - May 2016 #2

K&S Client Alert: Third Try Is A Charm: Defend Trade Secrets Act Of 2015 Enacted Into Law—For the third consecutive year, Congress introduced legislation to create a federal civil cause of action for trade secret...more

Physician-Owned Distributor (POD) Update

For some time, we have been reporting on issues involving federal government scrutiny of physician-owned distributors ("PODs"). From the Department of Health and Human Services Office of Inspector General’s ("OIG") issuance...more

OIG Issues Revised Policy Statement Regarding Permissive Exclusion

On April 18, 2016, the Office of Inspector General of the United States Department of Health and Human Services (“OIG”) issued a revised policy statement containing the new criteria that OIG intends to use in implementing its...more

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