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NC Legislative Update: May 2017 #3

by Nexsen Pruet, PLLC on

This Week - Following the passage of the Senate budget proposal last week, the Senate had a fairly light calendar this week. The House continued to work while House budget writers draft their own budget proposal. The...more

Speaking of the First Amendment...

by Reed Smith on

Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice...more

Supreme Court Reinforces the Primacy of the Federal Arbitration Act, Even Over a “Divine God-Given Right”

by Benesch on

Kentucky law speaks of the right to jury trial in theological terms. The Kentucky Constitution provides that “[t]he ancient mode of trial by jury shall be held sacred, and the right thereof remain inviolate, subject to such...more

N.D. Alabama Issues Mixed Bag of Branded Preemption Rulings

by Reed Smith on

We like bright lines in the law. They streamline arguments for lawyers and, more important, they make it easier for non-lawyers to conduct their affairs with some degree of predictability. Rear-end a car and you’re liable,...more

Client Alert: Medical Marijuana - Florida Legislative Update

When Florida’s regular legislative session came to a close on the evening of May 5, 2017, lawmakers had yet to reach a consensus on how to implement “Amendment 2” – the state’s recently passed addition of Section 29 to...more

What Employers Need to Know about Trump’s Religious Liberty Executive Order

by Fisher Phillips on

President Trump signed an executive order on religious liberty last week to commemorate the National Day of Prayer. Like many before it, the exact contents of this order were hotly anticipated, fueled by White House leaks and...more

Mobile targeting: A ‘secret weapon’ for good or ill?

by Thompson Coburn LLP on

It’s an advertiser’s dream — the ability to target customers through their mobile devices, right to down to where they are and what they are doing. But can such precisely targeted messages become a recipient’s nightmare?...more

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Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products.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

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