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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

"New HHS OIG Criteria to Guide Resolution of Health Care Investigations"

The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more

You Can Pay Your Lawyer: Supreme Court Recognizes Limits on Pretrial Asset Restraints

Before the U.S. Supreme Court’s ruling last week in Luis v. United States, the government could freeze a criminal defendant’s assets before trial even if they bore no connection to the alleged crimes. With the ruling, if the...more

Supreme Court Update: Luis V. United States (14-419)

Here's a line-up you don't see in every (read: any) syllabus: "BREYER, J., announced the judgment of the Court and delivered an opinion, in which ROBERTS, C.J., and GINSBURG and SOTOMAYOR, JJ., joined. THOMAS, J., filed an...more

Department of Justice Launches 10 Regional Elder Justice Task Forces

On March 30, the Department of Justice (DOJ) announced the launch of 10 regional Elder Task Forces, including one in Washington state, for the purpose of coordinating and enhancing efforts to pursue nursing homes “that...more

Howard Young on Coming Changes To The Healthcare Space [Video]

Howard Young, co-head of the healthcare practice at Morgan Lewis, talks about some of the major forces driving change and consolidation within the healthcare industry. According to Young, innovations in technology and changes...more

Committee OK's Bill to Address Suicide Among Correction Officers and Prisoners

Here’s a thumbs-up to the legislature’s Joint Committee on Public Safety and Homeland Security. Last week, the committee rightly gave a favorable report to a bill, SB 1284, mandating a study of how to keep prisoners and...more

Pharmaceutical Diversion – Risks and Steps to Address a Major DEA Focus

The opioid crisis, an ever-increasing focus of the Obama administration and 2016 Presidential Primary field, has highlighted the efforts of the Drug Enforcement Administration (DEA) and the Department of Justice (DOJ) to...more

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

Justice Department Announces Largest Settlement Ever For Violations Of The Anti-Kickback Statute By A Medical Device Company

On March 1, 2016, the United States Department of Justice (DOJ) announced that Olympus Corp. of the Americas (OCA), the nation’s largest distributor of endoscopes and related equipment, had agreed to pay $623.2 million to...more

Health Care Fraud and Abuse Control (HCFAC) Program Logs $2.4 Billion in Recoveries for FY 2015

The federal government won or negotiated more than $1.9 billion in judgments and settlements, and attained additional administrative impositions in health care fraud cases and proceedings in FY 2015, according to the latest...more

The Downside of Being Number One

Americans are competitive. We generally think there’s nothing better than being number one—and not just at NCAA bracket time. But being number one isn’t always great. Just ask Dr. Michael Reinstein. He was the...more

Masked Man Robs Government; Faces 10 Years

The mask itself didn’t raise any suspicions. After all, the man wearing it—Richard Toussaint–was an anesthesiologist. But like so many other masked men, he turned out to be a thief. That’s why on March 4 he was convicted in...more

"One-Two Punch: Amarin Settlement Order and Vascular Solutions Acquittal Further Erode Off-Label Promotion Enforcement Regime"

In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more

K&S Effort Leads to Acquittal in Conspiracy and Misbranding Case Against Medical Device Company

On February 29, 2016, Minneapolis-based medical device company Vascular Solutions, Inc. (“VSI”) and its CEO Howard Root were acquitted by a jury of conspiracy and misbranding charges in a closely-followed trial in San...more

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