Health Civil Procedure

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News from Abroad: Summary Report on the Final Guidance from the English Court of Appeal on Second Medical Use Patents

The final decision of the Court of Appeal in the Lyrica® litigation was handed down on 13 October 2016. This litigation, relating to the painkiller pregabalin marketed by Warner-Lambert for the treatment of pain under the...more

Eighth Circuit Rules That ERISA Expressly Preempts Iowa Pharmacy Benefit Law

The United States Court of Appeals for the Eighth Circuit recently held that ERISA expressly preempts an Iowa law that imposes onerous regulatory requirements on pharmaceutical benefit managers operating in Iowa. The reversal...more

Guest Post – MDL Court: Preemption Leaves No “Glimmer of Hope” for Labeling Claims Against a Pharmacy

What follows is a post authored by Jaclyn Setili, a Reed Smith associate. She is discussing what we believe is the first extension of Mensing/Bartlett preemption to claims involving pharmacies – something we’ve previously...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

Medical Causation Experts Pass Daubert Test, But Cannot Opine on Plaintiff’s Lack of Capacity to Sign Release

We typically write about product liability cases, not medical malpractice actions. But the two are not mutually exclusive, and similar issues arise in those cases. Medical causation is an issue we often see in both. Capacity...more

“Regulatory Causation” Roundup

Last week’s Westlaw search (that’s one way we find the cases we discuss in the Blog) brought a blast from the past – a case almost three years old showed up discussing – and rejecting – expert testimony about so-called...more

Northern District of Texas Blocks Enforcement of the Non-Discrimination Regulations of the ACA

On December 31, 2016, the US District Court for the Northern District of Texas issued an opinion and order in Franciscan Alliance, Inc. et al v. Burwell, which preliminarily enjoins the US Department of Health and Human...more

Choice of Forum and the Parties Matter in Med Device Cases (Particularly in Minnesota)!

The medical device industry has seen a litigation boom in recent years in non-compete litigation. A new case out of the District of Minnesota involving Medtronic, Inc. (“Medtronic”), one of the med device industry leaders,...more

Medical Malpractice and Healthcare Quarterly - Winter 2016

Delaware Superior Court Clarifies “Wrong Body Part” Exception to Affidavit of Merit - The Delaware Superior Court recently dismissed a plaintiff’s claim against a physician and clarified the meaning of one of the...more

Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation

For those of us who spend large chunks of our professional lives in mass tort MDLs, expressions like “settlement inventory” are ubiquitous. It is too easy to lose sight of the fact that these expressions put the rabbit in the...more

Health Care Group News: Texas District Court Preliminarily Enjoins Partial Enforcement of Section 1557

In May of last year, the United States Department of Health and Human Services ("HHS") enacted regulations implementing Section 1557 of the Affordable Care Act. These regulations aimed to enhance language assistance and...more

Lessons Emerging from Pinnacle Hip Bellwether Trials

In a staggering verdict, a Texas jury recently awarded over $1 billion against Johnson & Johnson (“J&J”) and its subsidiary DePuy Orthopaedics Inc. (“DePuy”) (collectively referred to as “Defendants”) to six California...more

First Circuit Rejects Whistleblower’s Fraud on the FDA FCA Theory

On December 23, 2016, the First Circuit held that a relator under the federal False Claims Act (“FCA”) failed to plausibly plead that defendant medical device manufacturers caused the submission of false claims for...more

Federal Judge Blocks Transgender Protections

On Saturday, December 31, 2016, a federal judge in Texas entered a nationwide preliminary injunction barring the enforcement of antidiscrimination protections pertaining to transgender and abortion health services and...more

2016 in Arbitration Law: Fleeting Victories for Consumer Advocates?

If I had drafted this annual summary post on November 7, 2016, it would have looked different. At that point, the year had produced numerous (final or proposed) federal regulations that significantly restricted the use of...more

Portions of Section 1557 of the Affordable Care Act Enjoined by Texas Federal Court – Majority of Regulation Remains Intact.

In May 2016, the Office of Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“DHHS”) issued a Final Rule implementing Section 1557 of the Affordable Care Act (“ACA”). Section 1557 prohibits “covered...more

SDNY Applies Preemption in Favor of Branded Drug

On January 3, 2017, we commenced the dreary process of taking down the Christmas decorations. The German nutcrackers slid back into their cartons. Stockings marched from the mantle into plastic storage containers. We picked...more

Honeywell Defeats Retirees’ Class Action Suit for Lifetime Health Benefits

A federal district court in Ohio dismissed retirees’ claims for lifetime healthcare benefits from Honeywell.  Honeywell provided healthcare benefits to plaintiffs through a series of collective bargaining agreements and,...more

Blue Cross Plans Effort to Escape MDL Antitrust Case on Jurisdictional Grounds Fails

On December 21, District Judge David Proctor (N.D. Alabama) denied an attempt by nine Blue Cross plans to escape the In re Blue Cross Blue Shield Antitrust Litigation. Finding that the Blues (Mississippi, Triple-S Salud...more

Guest Post – Failure to Warn Claim Dead on Arrival Without Testimony from Prescribing Physician

This is a guest post from Michael Salimbene, an associate at Reed Smith. It’s about learned intermediary causation, and the need for prescriber testimony. Not infrequently, in mass torts with lots of solicited plaintiffs,...more

UPDATE: District Court Denies Preliminary Injunction in AARP Suit to Block Final Rules on Employee Wellness Programs

The U.S. District Court for the District of Columbia (Judge Bates) has denied AARP’s request to block the implementation of the EEOC’s final wellness regulations pending a decision on the merits. As we have discussed...more

First Circuit Rejects Fraud-on-the-FDA Theory of FCA Liability

Affirming an earlier order handed down by the United States District Court for the District of Massachusetts, the First Circuit recently denied Plaintiff D’Agostino leave to amend his complaint, finding the proposed claims...more

Decision Limiting Duties regarding Automated External Defibrillators Does Not Shock The Conscience

Ponder the following: A man attends an exercise class at a facility run by a local religious institution. Assume that he belonged to this facility, wanted to attend an exercise class because his fitness was less than...more

Court Throws Out Back Massager Trade Dress Infringement Claims on Motion to Dismiss

As the first-filed paper in nearly any litigation, the complaint is typically subject to rigorous scrutiny from the named defendant to identify any flaws that may dispatch the case via a motion to dismiss. A plaintiff in the...more

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