Constitutional Law Health

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Religious Institutions Update: May 2016

Timely Topics - Has your nonprofit received a donation for a restricted purpose that has become impractical, impossible to achieve, wasteful or even unlawful? A donor may restrict a contribution to a charity for a...more

The Challenges of the Evolving Marijuana Industry: Reconciling State Legislation with Federal Prohibition

Cultivation, production, distribution, or possession of marijuana is a federal criminal offense under the Controlled Substances Act (the CSA). Yet, despite federal prohibition, state-sanctioned marijuana industries have...more

Anti-SLAPP Statute Raised in Planned Parenthood Protest Lawsuit

The DC anti-SLAPP statute has been invoked in a Superior Court lawsuit in which plaintiffs arguing that students need to be free from disruptions in the school environment are facing off against anti-abortion protestors....more

Settle or Fight FDA/DOJ Off-Label Use Allegations? WSJ Editorial Looks at Vascular Solutions Trial Win and Asks What's Next?

In an editorial this weekend entitled “No Justice for Business,” The Wall Street Journal hailed a recent trial win by medical device maker Vascular Solutions, Inc. (VSI) as a “victory for common sense and the First Amendment”...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs: Part Two

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more

Court Rejects End-Run of Medicare Appeals Rules

The Indiana Health Department sent a team to the Nightingale home health care and hospice group, in response to complaints. When CMS received the team’s report, it notified Nightingale that its Medicare certification was...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

Proposed Enrollment Rule Changes - de Facto Exclusion?

Proposed rules, touted as enhancing the provider enrollment process, would provide CMS with sanction authority that closely parallels the OIG’s exclusion authority. Under the proposed rules, CMS would have expanded bases 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

Fight the Good Fight Every Moment: Do Recent First Amendment Court Developments Deal a Blow to the Government?

In the last month, the Food and Drug Administration has suffered setbacks relating to off-label promotion oversight. In both cases, one involving a pharmaceutical company and the other a medical device firm and its Chief...more

New Jersey Township Files Challenge to Nonprofit Hospital’s Tax Exemption

On February 19, 2016, the Township of North Bergen in New Jersey filed a complaint challenging the constitutionality of a nonprofit hospital’s – Palisades Medical Center – property tax exemption. The complaint alleges that...more

Eighth Circuit Rejects Hospice’s Fifth Amendment Plea

But not the Fifth Amendment plea you’re thinking of. It was the takings clause, not the self-incrimination clause, that Southeast Arkansas Hospice (SAH) was pleading. And the Eighth Circuit wasn’t buying it....more

Governor Brown Signs Bill Giving Local Entities More Time to Ban or Regulate Medical Marijuana

History. Shortly after the Compassionate Use Act (CUA) became law in 1996 by California voter initiative, the Medical Marijuana Program Act (MMPA) (Health & S C §§11362.7–11362.83) was enacted by the legislature to clarify...more

Texas Open Carry Law: FAQs for Hospitals and Healthcare Facilities

As of January 1, 2016, concealed license holders in Texas can now legally carry their handguns visibly in hip or shoulder holsters. This comes at a time when violence in hospitals and healthcare facilities is on the rise....more

FDA and Amarin Reach Settlement on First Amendment and Off-Label Statements

FDA agrees to allow truthful and non-misleading off-label promotion. On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....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

Hospital property tax exemption under attack in Illinois

On Jan. 5, 2016, the Illinois Fourth District Appellate Court ruled in the Carle Foundation Hospital case that an Illinois state law providing for property tax exemptions for certain not-for-profit hospitals is...more

Health Update - February 2016

Better Late Than Never: CMS Provides Much-Needed Clarity on the 60-Day Overpayment Refund Requirements - On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the long-awaited final rule (Final...more

The Deadly 4-4 SCOTUS Split: What Happens in the Wake of Justice Scalia's Death

With the Supreme Court coming out of recess today, the practical implications of Justice Scalia's death will become more apparent. Justice Scalia's death last week has a tremendous impact on the upcoming sessions of the...more

Virginia’s Certificate of Public Need Law is Here to Stay (For Now)

Virginia’s Certificate of Public Need (“COPN”) law has been the subject of considerable debate in the General Assembly, in the media, and in federal court. At least for now, the discussion at the judicial level has ended,...more

Federal Appeals Court Rejects Challenge to Virginia's Certificate of Need Law

On January 21, 2016, the United States Court of Appeals for the Fourth Circuit (the “Court”) upheld Virginia’s Certificate of Public Need (“CON”) Program against a constitutional challenge. The Appeals Court held that the CON...more

Five Key Lessons for Business Litigators from National Abortion Federation v. Center for Medical Progress

On February 5, 2016, Morrison & Foerster secured a preliminary injunction on behalf of its client, National Abortion Federation (“NAF”), in National Abortion Federation v. Center for Medical Progress. The firm’s work on this...more

Pennsylvania Court Ends Ban on Ex-Offenders Working in Nursing Homes

The Pennsylvania Commonwealth Court recently declared that a portion of the Pennsylvania Older Adults Protective Services Act, 35 P.S. §§ 10225.101, et seq. (Act), which prohibited individuals with certain criminal...more

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