Constitutional Law Health

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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

3D Printing of Manufactured Goods: An Updated Analysis

(NEW YORK) December 15, 2016 – Reed Smith LLP today released “3D Printing of Manufactured Goods: An Updated Analysis,” a comprehensive new white paper that provides in-house counsel and industry leaders with an in-depth look...more

‘Standing Outside the Fire?’ D.C. Circuit Puts Off Question on House’s Standing to Sue Over ACA Subsidies—For Now

We will have to wait at least a bit longer—and perhaps indefinitely—to learn whether a striking ruling that members of Congress have standing to sue the executive branch over the funding of Affordable Care Act (ACA) subsidies...more

Federal Court Enjoins CMS Regulation Banning Arbitration of Nursing Home Disputes

The United States District Court for the Northern District of Mississippi issued a preliminary injunction barring the scheduled November 28, 2016, implementation of a Center for Medicare and Medicaid Services (“CMS”)...more

FDA Holds Hearing on Off-Label Communications

After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more

Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more

Guest Post – The FDA’s Two-Day Meeting on Manufacturer Off-Label Communications

Today’s guest post is by Liz Minerd, a Reed Smith associate, who closely followed the online feed of the recent FDA meeting that the Agency called to discuss what changes would be appropriate in its off-label promotion...more

Ninth Circuit Considers Limits to DEA Access to Oregon PDMP

On November 7, 2016, the US Court of Appeals for the Ninth Circuit heard arguments in Oregon Prescription Drug Monitoring Program v. United States DEA, No. 14-35402 (9th Cir. 2016). Here, the Drug Enforcement Administration...more

FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept...more

TCPA Update - October 2016

We are pleased to present the latest edition of Monthly TCPA Digest, bringing you insights on TCPA regulatory and legislative updates, class action developments, and trends. If you have suggestions for content you would like...more

Religious Institutions Update: October 2016

Timely Topics - The final rule implementing Section 1557 of the Patient Protection and Affordable Care Act (ACA) was issued by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) on May...more

Requiring A Flu Shot Over Religious Objections: Risky Business

It’s flu season and many employers, particularly those in healthcare, want to require employees to be vaccinated to minimize the spread of illness. But what happens when an employee refuses on religious grounds?...more

Upcoming FDA Public Meeting on Speech and Medical Products

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” ...more

Update on Prosecution for Truthful Off-Label Promotion

We have been following issues related to the interplay of off-label use, manufacturer statements about off-label use, the First Amendment, and FDA enforcement for a long time. (Like here, here, and here, among many posts.) ...more

Watching SCOTUS – ERISA Church-Plan Exemption Revisited

Seyfarth Synopsis: Currently before the Supreme Court are two petitions regarding the thorny legal question of which organizations can qualify for ERISA’s Church-plan exemption. If the Supreme Court grants certiorari and...more

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist....more

South Carolina Court Decides Key Health Care Case - Physical therapists win in employment lawsuit

The South Carolina Supreme Court has decided a case with great significance in the health care industry. The court overturned a ban on physicians employing physical therapists and gave guidance regarding how state agencies...more

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