Health Constitutional Law

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EXPECT FOCUS: Onboard Technology, NAIC Cybersecurity, DOL, ACA Litigation, SEC Regulation (Vol. III, Summer 2015)

In This Issue: IN THE SPOTLIGHT - - Your Data Breach Collided With My Personal Injury Coverage LIFE INSURANCE - - Phantom Injury Dooms “Shadow Insurance” Case - Latest NAIC Cybersecurity News - A...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

May an Employer Object to the Affordable Care Act’s Contraceptive Mandate Based Solely on Moral Grounds? A federal court has ruled...

Hobby Lobby took on the Affordable Care Act’s mandate that it must provide female employees certain contraceptives on religious grounds and won. March for Life, a pro-life organization, is trying to reach the same result but...more

Also In The News - Health Headlines - September 2015 #2

Final ACO Fraud Waiver Under OMB Review – The White House Office of Management and Budget (OMB) reported on September 9, 2015, that it began its review of the final rule (CMS-1439-F; RIN 0938-AR30), titled “Medicare Shared...more

Religious Institutions: September 2015

Respondeat superior (literally, "let the master answer" in Latin) is a doctrine that applies when an employer or principal has the ability and authority to direct and control the pertinent acts of the employee. Put otherwise,...more

First, Arizona Legislature v. AIRC, Now the ACA Subsidies: Standing for Political Institutions

Citing what some might call a quirk of the U.S. Supreme Court’s (SCOTUS) recent opinion in Arizona Legislature v. Arizona Independent Redistricting Commission (AIRC), U.S. District Court Judge for the District of Columbia...more

The Telehealth Top 10 for 2015

Telehealth continues to be an innovative alternative to traditional brick-and-mortar medicine. The number of providers offering telehealth services is rapidly increasing and states are enacting laws requiring health plans to...more

Illinois law now requires children to be vaccinated

Illinois law requires students to provide proof of immunization to be admitted into school. Until now, parents could exempt their students from this requirement for either medical or religious reasons. When based on...more

Employee Benefits Developments August 2015

Certain Closely Held For-Profit Employers Need Not Provide Women’s Contraceptive Services. Under the ACA, non-grandfathered group health plans must cover specified preventive services, including certain women’s preventive...more

Court Rejects Claim that a Doctor’s Loss of Privileges is an Antitrust Injury

A federal appeals court held that a doctor who lost his privileges at a local hospital failed to establish an antitrust injury sufficient to confer standing under the Sherman Act. The United States Court of Appeals for the...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

The Difficulty Of Challenging FCA Fine As Excessive

Last month, in U.S. ex rel. Drakeford v. Tuomey, No. 13-2219, (4th Cir. July 2, 2015), the Fourth Circuit affirmed a False Claims Act verdict against a nonprofit hospital in Sumter, South Carolina. In an area of the law where...more

“Opt Out” Accommodation Under Affordable Care Act Validated After Challenge from Religious Objectors

In what continues to be a controversial and developing area of employment law, a federal appellate court recently validated the Affordable Care Act’s (ACA) “opt out” provision, finding that requiring nonprofit employers to...more

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination

In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more

King v. Burwell: An Interchangeable Exchange

The Supreme Court ruled recently in favor of the Obama Administration and its defense of another provision of the Patient Protection and Affordable Care Act (ACA or the Act). King v. Burwell, No. 14-114 (U.S. June 25, 2015)....more

Two Federal Circuit Courts Weigh In Ahead of Gomez

Just two months before the U.S. Supreme Court hears argument in Campbell-Ewald Co. v. Gomez, two federal circuit court panels have ruled on jurisdictional issues presented in the case. Both the Seventh Circuit in Chapman v....more

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

Ruling on Economic Favoritism Puts ‘NC Dental’ Back in Spotlight

In a recent opinion, a divided panel of the U.S. Court of Appeals for the Second Circuit ruled that an economic regulation passed by a state agency solely to protect one group from competition would not violate the...more

One Small Step for Amarin & One Giant Leap for Pharmaceutical Companies? - Only Time Will Tell

Friday’s ruling in Amarin Pharma, Inc. v. United States Food & Drug Administration is a monumental event. It signals the dawn of a new era for prescription drug promotion....more

Manatt on Medicaid: Impact of Obergefell v. Hodges on Healthcare Coverage for Same-Sex Couples

In a 5-4 ruling in Obergefell v. Hodges released on June 26, 2015, the Supreme Court held that same-sex marriage is a fundamental right guaranteed by the 14th Amendment of the United States Constitution, expanding the right...more

Under the Dome: Inside the Maine State House

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. A Unanimous Decision - A sequence of events led to the creation of 65 controversial vetoes...more

Religious Institutions: August 2015

The decision by the United States Supreme Court on same-sex marriage has been greeted with praise and disdain by different corners of the country. The faith-based community has been especially outspoken. This is not...more

Is PPACA on the Road to Recovery?

Part I: Is PPACA on the Road to Recovery? The recent decision in King v. Burwell by the Supreme Court of the United States sent a strong message to critics of the Patient Protection and Affordable Care Act of 2010...more

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