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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

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

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

"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

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...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

Supreme Court of Canada Releases Landmark Decision on Assisted Suicide

On Friday, the Supreme Court of Canada released its landmark end-of-life decision in Carter v Canada (Attorney General). The Court unanimously held that the prohibition on aiding or abetting a person to commit suicide in the...more

Uncovering Factory Farming - The Effects of Ag Gag Laws [Video]

Ag-Gag laws, or whistleblower laws specific to the factory farming industry, have been prevalent in recent news as new laws are both enacted and struck down in states across the nation. These laws illuminate the...more

Supreme Court Update: Dart Cherokee Basin Operating Co. V. Owens (13-719) And Heien V. North Carolina (13-604)

Greetings, Court fans Long before he became Chief, John Roberts quipped that "[o]nly Supreme Court justices and schoolchildren are expected to and do take the entire summer off." Right now, the Justices are in the midst...more

Combining Arms for Justice-Involved Veterans [Video]

Co-sponsored by Fenwick & West and Microsoft, Equal Justice Works Fellow Leo Flor is building enduring capacity in Washington State for complementary civil representation of criminal justice-involved veterans through client...more

Status Updates - October 2014 #8

..Doctor in the mouse. What if you could input a list of your current symptoms to Google, and quickly be connected with a doctor for a brief consultation? For a limited trial period, Google seems to have set up such a system...more

Illinois Supreme Court Debates Automatic Revocation of Certain Health Professionals' Licenses

Our reports on the oral arguments of the May term of the Illinois Supreme Court conclude this morning with Consiglio v. Department of Financial and Professional Regulation. Consiglio involves a constitutional challenge to...more

Status Updates - June 2014 #4

..Are threats made on social media protected free speech, or potentially criminal acts? The U.S. Supreme Court has agreed to examine the constitutionality of a federal law making it a crime to transmit communications...more

Health Reform + Related Health Policy News - January 2014, Issue 1

In This Issue: - Top News ..Congress Approves Budget Deal with Short-Term ‘Doc Fix' ..CMS “Two-Midnight” Rule delayed until March 31, 2014 ..Individuals with Canceled Insurance Policies May Apply for...more

Rodriguez Redux

Today, the Supreme Court of Canada granted leave to appeal in Carter v Canada (AG), which deals with the constitutionality of the assisted suicide provision of the Criminal Code. In 1993, in Rodriguez v British Columbia (AG),...more

Recent Cases of Interest to Regulators

Investigative Powers - Sazant v. College of Physicians and Surgeons of Ontario, 2013 CanLII 22324 (S.C.C.), dismissing leave to appeal of a decision in 2012 ONCA 727 - In Sazant, a physician faced both criminal...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...

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

Miranda Eviscerated: How Your Silence During a Government Interview Could Be Used Against You

Can your silence be used against you in a criminal proceeding? Most of us would assume that it cannot because of the Fifth Amendment to the U.S. Constitution and case law interpreting it....more

Health Reform + Related Health Policy News - June 2013

In This Issue: - Top News ..CMS Finalizes MLR Rule for Plans, Maintaining Application to Part D Sponsors ..Early State Filings Show Premium Reductions under ACA ..HHS Received More Than 830 Letters of...more

Counties in California Can Learn a Few Lessons from State on Inmate Health Care - BB&K Health Care Attorney Shares Tips on...

Inmates in the Riverside County jails served a federal class-action lawsuit last month, claiming the county is subjecting them to cruel and unusual punishment by depriving them of basic medical and mental health care. A...more

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

White Collar Watch - February 2013

In This Issue: - New HIPAA “Megarule” Broadens Enforcement - Government Declines to Seek Rehearing of Landmark Off-Label Speech Decision - Seizure of Rothstein Ponzi Assets Highlights Tension Between...more

False Press Release Leads To Exclusion From Federal Programs

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

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