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New York Federal Court Takes Different Stance on Medical Staff Bylaws

On April 14, MedLaw Blog posted a comment about Villare v. Beebe Medical Center, a case in which a Delaware trial court granted summary judgment on the basis that the medical staff bylaws were held not to constitute a...more

Medical Staff Bylaws Are Not Contracts in Delaware

One of the fundamental issues in credentialing disputes is whether the Medical Staff Bylaws constitute contracts between the Hospital and the individual physicians. If the Medical Staff Bylaws do constitute a contract, then...more

Drug Quality and Security Act Creates New Laws for Compounding Pharmacies

On November 27, 2013, the Drug Quality and Security Act was signed into law. This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new...more

The Supreme Court to Hear Hobby Lobby Case: What does it mean for Title VII?

The Supreme Court announced last week that it will hear two cases in which for-profit businesses are challenging the Affordable Care Act’s (“ACA”) “contraceptive mandate” on freedom of religion grounds. The key issue before...more

Health Care Antitrust & the Supreme Court – Interview with Bruce Sokler, Member, Mintz Levin  [Video]

Attorney Bruce Sokler, Chair of Mintz Levin's Antitrust Practice, discusses the Supreme Court’s first ever health care antitrust merger decision and its implications for the future. ...more

Hospitals & Medical Staff Take Notice: HCQIA Immunity Is Not Given, It's Earned.

The Healthcare Quality Improvement Act of 1986 ("HCQIA") is a federal law enacted to establish a national tracking system of healthcare practitioners with a history of medical malpractice payments or adverse actions. A...more

Un test sulle ipotesi delle proiezioni a medio-lungo termine della spesa farmaceutica

We use the same methodology, that Ecofin-Oecd apply for projecting expenditure in the medium-long term, to reconstruct expenditure in the medium-long past. It is possible to compare the effective expenditure with the...more

Medical Device Company Files First Amendment Lawsuit Challenging OIG’s Criticism of Physician-Owned Distributors (PODs)

On October 8, 2013, Reliance Medical Systems, LLC (“Reliance”) filed a Complaint against the HHS OIG in the United States District Court for the Central District of California. The Complaint alleges that OIG’s assertion in a...more

Federal Court Upholds California County’s Safe Drug Disposal Ordinance

On August 28, 2013, the U.S. District Court for the Northern District of California issued an order upholding Alameda County's Safe Drug Disposal Ordinance as constitutional. The ordinance, passed in July 2012 by the Alameda...more

Recent Cases of Interest to Regulators

Investigative Powers - Sazant v. College of Physicians and Surgeons of Ontario, 2013 CanLII 22324 (S.C.C.), dismissing leave to appeal of a decision in 2012 ONCA 727 - In Sazant, a physician faced both criminal...more

Sixth Circuit Agrees: No Preliminary Injunction In ACA “Contraceptive Mandate” Case

Corporations are not exempt from the so-called "Contraceptive Mandate" authorized pursuant to the Patient Protection and Affordable Care Act of 2012 (the "ACA" / popularly known as "Obamacare") according to the opinion of the...more

The ERISA Litigation Newsletter - July 2013

As Amy Covert and Aaron Feuer discuss below, the U.S. Supreme Court granted certiorari in Heimeshoff v. Hartford Life & Accident Insurance Co. where it is expected to rule next term on whether plan sponsors may dictate in the...more

US District Court Prohibits Enforcement of California 340B Medicaid Mandatory Carve-In Law

The 340B program permits eligible hospitals and other “safety-net” providers (340B Covered Entities) to purchase outpatient drugs from pharmaceutical manufacturers at significant discounts. To address its fiscal woes,...more

A “Stark” Result for South Carolina Hospital: Stark Law Violations May Cost Up to $357 Million in Penalties

After a four-week retrial, a federal jury concluded on May 8, 2013 that Tuomey Healthcare System (Tuomey) violated both the Stark Law and the False Claims Act (FCA). The jury determined that Tuomey violated the Stark Law by...more

Groundhog Day for Tuomey: Jury Finds Hospital Violated Stark Law and False Claims Act

On May 8, 2013, a jury in the Columbia Division of the U.S. District Court for the District of South Carolina returned a verdict finding that Tuomey Healthcare Systems, Inc. (Tuomey) violated the Stark Law and the federal...more

Federal Court Orders FDA to Approve OTC Sales of “Morning-After Pill,” Finds Current Age and Point-of-Sale Restrictions to be...

On April 5, 2013, Judge Edward R. Korman of the United States District Court for the Eastern District of New York found that the Secretary of Health and Human Service’s (“HHS”) decision to limit over-the-counter (“OTC”)...more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

Stark Exception For ESRD Not Recognized In Florida

On January 10, 2013, the U.S. Court of Appeals for the Eleventh Circuit ruled in Fresenius Medical Care Holdings, Inc. v. Tucker, that an arrangement can violate Section 456.053 of the Florida Statutes, also known as...more

The Affordable Care Act Upheld: Now What For Our Clients?

On June 28, 2012, the Supreme Court issued its decision in a trio of cases which challenged the constitutionality of certain provisions in the Affordable Care Act. Ultimately, a majority of the justices concluded that the...more

The Supreme Court's Ruling on Health Care Reform: How Does it Impact Our Clients?

On June 28, 2012, the Supreme Court issued its decision in a trio of cases which challenged the constitutionality of certain provisions in the Affordable Care Act. Ultimately, a majority of the justices concluded that the...more

Fourth Circuit Discusses Stark Issues in Remand of Tuomey $45 Million Stark Verdict

On March 30, 2012, a three-judge panel for the United States Court of Appeals for the Fourth Circuit unanimously agreed to vacate a $44.9 million judgment against Tuomey Healthcare System, Inc. for Stark law violations,...more

California Anti-SLAPP Statute Protection Applies to Hospital's Termination of Physician Staff Contract

California Code of Civil Procedure section 425.16 – known as the anti-SLAPP (Strategic Lawsuit Against Public Participation) statute – provides a procedural mechanism to test, before costly discovery and pre-trial...more

Another Attempt to Curb the Sale of Prescription Data Comes Up Empty

Last year, the Supreme Court limited the ability of states to regulate the sale of prescription data.  In Sorrell v. IMS Health, the Supreme Court determined that a 2007 Vermont law that effectively banned the...more

Lo sviluppo delle copie economiche dei farmaci off-patent e il bottleneck della distribuzione al dettaglio

Lo sviluppo delle copie economiche dei farmaci off-patent e il bottleneck della distribuzione al dettaglio. Brevi riflessioni sull'Italia...more

First Amendment Smorgasbord

While we’re all waiting for the Second Circuit to decide the Caronia case – and, we hope, hold that the FDA’s prohibiting the truthful promotion of off-label use violates the First Amendment – we’d like to pass along some...more

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