Health Constitutional Law

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

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

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

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

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

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

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

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

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

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

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”

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

Litigation Alert: The Third Circuit Holds That Allegations That Personal Information Was Improperly Disclosed in Violation of the...

Last week, the Third Circuit held that allegations of the unauthorized disclosure of personal information in violation of the Fair Credit Reporting Act (FCRA) constituted a de facto injury sufficient to confer standing at the...more

Data Breach Class Action Reinstated Against Horizon Healthcare Services Inc.

The U.S. Court of Appeals for the Third Circuit has vacated a district court's dismissal of a data breach class action filed against Horizon Healthcare Services Inc., in the wake of the 2013 theft of two computer laptops...more

Breaking News – Supreme Court Takes BMS Personal Jurisdiction Case

The United States Supreme Court today granted certiorari in Bristol-Myers Squibb Co. v. Superior Court. Here is a link to the order. The California Supreme Court decision in this case was our worst case for all of 2016. ...more

Health Care Reform in Transition While Congress Deliberates

Changes are imminent for the Affordable Care Act and a range of other laws and regulations affecting the health care industry. Ballard Spahr attorneys established a Health Care Reform Initiative in 2008 to monitor and analyze...more

Obama FDA’s Parting Shot On Off-Label Promotion And The First Amendment

We haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part...more

Texas Court Enjoins Enforcement of Regulation that Would Forbid Discrimination in Healthcare on the Basis of Gender Identity and...

As LGBTQ rights have taken center stage in political and social issues, FordHarrison has been following ground-breaking litigation related to LGBTQ rights and providing updates. In the latest decision, a federal judge in...more

The Anthem Breach – A Retrospective

Many people and news outlets have opined, weighed in, and informed the public about the 2015 Anthem breach. It is still a hot topic in January 2017, because it currently lines up with other hot stories about hacking ordered...more

Medical Group Practice Can Once Again Employ PTs and PTAs

In December 2016, the South Carolina Supreme Court denied a petition for re-hearing, resolving a long standing dispute and allowing medical practices to employ directly physical therapists (“PTs”) and physical therapist...more

Mental Health, Baker Act, and Firearms: What's an Agency to Do?

Florida’s law enforcement agencies are frequently presented with calls for service involving individuals threatening others or themselves. When qualifying conditions are met, officers may involuntarily commit those who pose a...more

Employment Law 2016 Review

Preparing for Medical Marijuana in Pennsylvania - Marijuana legalization reached Pennsylvania in 2016, bringing with it a host of new questions employers are going to have to answer. Signed into law on April 17, the...more

The First Amendment Does Not Protect All Off-Label Drug Promotion

FDA is considering making off-label promotion easier, consistent with recent case law. The drug and biologics industry is also proposing an ease up of FDA regulation, which would allow it to “responsibly” promote new drug...more

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