News & Analysis as of

Health Constitutional Law

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

Ninth Circuit: Medical Providers Lack ERISA Standing

The Ninth Circuit affirmed two district court decisions that concluded medical providers were not “beneficiaries” under Section 502(a) of ERISA and therefore lacked standing to bring an ERISA claim...more

Health Care Providers Should Review Assignment of Benefit Forms After 9th Cir. Decision

by Pepper Hamilton LLP on

A federal appeals court recently brushed aside the claims of several health care providers, in large part because of the language in the assignment forms signed by their patients. The opinion from the U.S. Court of Appeals...more

Illinois Supreme Court Declines to Rule on Constitutionality of Illinois Hospitals' Property Tax Exemption Law

by Hinshaw & Culbertson LLP on

There have been two new developments in the long running saga over a charitable property tax exemption for hospitals in Illinois....more

A Judicial Reinterpretation of the Brazilian Constitution’s Right to Health Care

by Ropes & Gray LLP on

In recent years, there has been a spike in right-to-health litigation in Brazil wherein citizens seek court orders mandating that certain medications be dispensed through the public health system (Sistema Único de...more

IL Supreme Court Avoids Ruling on Constitutionality of Hospital Exemption

by Franczek Radelet P.C. on

The Illinois Supreme Court has issued an opinion in Carle Foundation v. Cunningham Township, the case involving the constitutionality of the statute granting hospitals a special property tax exemption. In remanding this case...more

DELAYED: The FDA’s Intended Use Rule

by Strasburger & Price, LLP on

The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018. The comment period will remain open until May 19, 2017....more

Antitrust Not Always Available in Competitor Disputes in the Healthcare Sector

The antitrust injury and antitrust standing defenses/doctrines are alive and well in healthcare.  A recent case, SCPH Legacy Corp. et al. v. Palmetto Health et al., shows that a competitor is not always the most legally...more

District Court Dismisses Antitrust Suit Against Palmetto Health

by King & Spalding on

On March 2, 2017, the U.S. District for the District of South Carolina dismissed all of Providence’s antitrust and State law claims against Palmetto Health stemming from Palmetto Health’s employment of more than 330 employees...more

Florida Supreme Court Rejects PSQIA Preemption of Florida Constitution

On January 31, 2017, the Florida Supreme Court held that adverse medical incident reports produced in accordance with Florida law cannot constitute confidential and privileged patient safety work product (PSWP) under the...more

Do Arbitration Agreements Between Nursing Homes and Patients Violate Public Policy-- or Are They Enforceable Under the FAA?

by Pullman & Comley, LLC on

The Federal Arbitration Act (FAA) provides for enforcement of arbitration agreements in a “contract evidencing a transaction involving commerce” in the district court. A nursing home sought to enforce arbitration agreements...more

House Republicans and Trump Administration File Joint Motion to Delay Suit Challenging Obamacare Subsidies

by Ruder Ware on

An interesting development transpired Tuesday, February 21, 2017 in a case pending in Federal District Court in the District of Columbia that challenges subsidy payments from the Federal Treasury to support Obamacare. The...more

Florida Supreme Court Rules That Hospital "Adverse Medical Incidents" Reported to a PSO Are Not Privileged From Discovery: Impact...

Southern Baptist Hospital of Florida (Hospital) was sued in a medical malpractice action in which the plaintiff sought to discover records relating to "adverse medical incidents" that occurred at the Hospital and involved any...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

Amendment 7 Stands Its Ground Against the Federal Patient Safety and Quality Improvement Act

by BakerHostetler on

It is well known in Florida that Article X, Section 25 of the Florida Constitution (Amendment 7) provides patients with access to any adverse medical incident report (even involving other patients) created by healthcare...more

Florida Supreme Court: Federal PSQIA Does Not Pre-empt State's Constitution

by Holland & Knight LLP on

In Charles v. Southern Baptist Hospital of Florida, Inc., published on Jan. 31, 2017, the Florida Supreme Court held that the federal Patient Safety and Quality Improvement Act (PSQIA) is not and was never intended to be a...more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

FDA Issues Three Key Documents Relating to Medical Product Manufacturer Communications

by Ropes & Gray LLP on

On January 18, 2017, the Food and Drug Administration (“FDA”) released three key documents outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in...more

Is EEOC Regulation of Wellness Plans Legal? — Seventh Circuit Declines to Say Yes

by Seyfarth Shaw LLP on

The Seventh Circuit has stymied an EEOC attempt to declare that employer wellness plans violate the Americans with Disabilities Act (“ADA”). The court decided that the issues raised by the suit are moot, and deferred to...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

by Pepper Hamilton LLP on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

Seventh Circuit Declines To Address The EEOC’s Challenge To The Legality Of Employer’s Wellness Plan

by Seyfarth Shaw LLP on

Seyfarth Synopsis: After an employee lost his employer-funded health insurance because he failed to complete a medical examination required by his employer, the EEOC sued the employer under the ADA’s ban on involuntary...more

FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

by Reed Smith on

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at...more

Guest Post – Midnight Madness - The FDA Continues To Discount First Amendment Implications Of Restrictions On Off-Label Promotion

by Reed Smith on

This guest post is from Liz Minerd, an associate at Reed Smith. She previously wrote the post on the FDA’s off-label promotion meeting last November, so when she indicated that she’d like to write about the FDA’s “Midnight...more

FDA Defends Its First Amendment Position in “Memorandum”

by King & Spalding on

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more

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