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Compounding Animal Drugs from Bulk Ingredients

Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more

Hall v. Sebelius

Brief of the CATO Institute as Amicus Curiae in Support of Petitioners

When Brian Hall, former House Majority Leader Dick Armey, and other over-65 retirees requested to opt out of Medicare's hospital insurance coverage (because they preferred their existing private coverage), the Social Security...more

California Assembly Votes to Amend State False Claims Act

On August 16, 2012, the California Assembly passed a bill (AB 2492) amending California’s False Claims Act, Cal. Gov’t Code §§ 12650-12656 (“CA FCA”), which must be signed into law by Governor Jerry Brown. The amendments...more

The Supreme Court’s Immigration Decision May Give Clues On The Upcoming Decision On The Affordable Care Act’s Individual Mandate

Casey Stengel once advised that it is best not to make predictions, particularly about the future. So we will step into ill-advised territory with caution. Nevertheless, the Supreme Court’s decision in Arizona v. United...more

Employers in Florida Face State-Specific Employee Benefit Plan Issues

Employers with Florida employees face certain state-specific employee benefits compliance challenges. While in general ERISA preemption will serve to minimize the number of state laws applicable to the ERISA-governed benefit...more

The Gap Between Express and Implied Preemption Narrows In The Ninth Circuit

The Ninth Circuit Court of Appeals recently shrank universe of state law claims pertaining to Class III medical devices that remain untouched by Riegel express preemption or Buckman implied preemption. In Stengel v....more

Insurance Business & Regulatory News - Spring 2012

In This Issue: - NAIC Changes Target Insurance Holding Company System - Delaware Series LLC Captive Insurance Programs - State Spotlights - Insurance Business and Regulatory Law Excerpt from State...more

Case Study in Nevada: The Allegedly Unsafe Medical Provider and ERISA Preemption

In Cervantes v. Health Plan of Nevada, 263 P.3d 261 (Nov. 2011), the plaintiff commenced an action against a managed care organization (MCO) alleging it violated Nevada's quality assurance laws and regulations when MCO...more

Labor: Employment protections under medical marijuana laws

Originally published in InsideCounsel.com - February 20, 2012. Delaware’s Medical Marijuana Act exemplifies the battle between state and federal marijuana laws The age of medical marijuana has arrived. Sixteen...more

Effect of New Michigan Health Insurance Claims Assessment Act on Group Health Plans

The new Michigan Health Insurance Claims Assessment Act imposes a 1-percent tax on “paid claims” for health-related services of employer-sponsored health and welfare plans. Employer plan sponsors with...more

Nursing Home Catch-22 Case Has Implications for Release of Deceased Patient Records of All Healthcare Providers

It's a common scenario: A Florida nursing home resident dies, and his or her spouse, surrogate, proxy, or attorney requests the resident's medical records. However, if the nursing home releases the records, it might be...more

Pharmaceutical Sales Representative Case Goes to Supreme Court

In a previous post in August, I questioned whether the pharmaceutical companies were losing the exemption battle as it related to pharmaceutical sales representatives and the outside sales exemption. The Supreme Court had...more

Healthcare Update - November 2011 No. 4

In This Issue: A Look Ahead: Four Trends Healthcare Employers Should Continue to Watch By A. Kevin Troutman (Houston) With the year drawing to a close, this is a good time to examine four significant trends in...more

There They Go Again

A lot of people think that Ronald Reagan won the presidency in 1980 in his first debate when he replied jokingly “there you go again” to then-President Carter’s attempt to portray him as some sort of rightwing nut intent upon...more

False Claims Act Quarterly, Fall 2011

In This Issue: U.S. SUPREME COURT DECLINES TO SETTLE CIRCUIT SPLIT ON IMPACT OF FAILURE TO FOLLOW FCA'S FILING-UNDER-SEAL PROCEDURES The Supreme Court of the United States on June 27, 2011, denied certiorari in U.S....more

Successful Class II Medical Device Preemption Decision

We don't see many successful applications of preemption with respect to 510k, Class II medical devices since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), so when we do, it's a big deal. Here's one. Today, in Degelmann v....more

In-Network Provider Has Standing to Pursue ERISA Remedies, But State Law Reimbursement Claim Completely Preempted by ERISA

In Montefiore Medical Center v. Teamsters Local 272, 642 F.3d 321 (2d Cir. 2011), the U.S. Court of Appeals for the Second Circuit held that an in-network provider's state law based reimbursement claim is completely preempted...more

New Jerseyans with Disabilities: Still Second Class Citizens

New Jerseyans with disabilities are still second class citizens, despite Section 504 of the Rehabilitation Act, the Americans with Disabilities Act, the Indivisuals with Disabilities Education Acr, and New Jersey's Law...more

No Preemption for the Common Cold Remedy

Since the first sneeze, people have been trying to cure the common cold. While the cure remains elusive, everyone has a remedy for its symptoms – chicken soup, salt water gargle, fresh chopped garlic on crackers and, our...more

IOM Releases Controversial 510K Device Report

Earlier this week, an Institute of Medicine’s Committee released its report on the Public Health Effectiveness of the FDA 510(k) Clearance Process. The report offers a variety of recommendations and suggested reforms for...more

SmithKline Beecham Wins On "Outside Salesman" Exemption

The Ninth Circuit U.S. Court of Appeals (Alaska, Arizona, Hawaii, Idaho, Montana, Nevada, Oregon, and Washington) has added another chapter in the saga of whether pharmaceutical sales representatives (PSRs) qualify for the...more

Health Law Alert 2010 Volume 2: Physician Payment Sunshine Act

The Patient Protection and Affordable Health Care Act (H.R. 3590) signed into law in March 2010 includes the Physician Payment Sunshine Act (section 6002) (PPSA), which requires pharmaceutical, medical device, biological, and...more

Health Alert: Key Portion of Health Reform Bill Struck Down by Virginia Federal Judge

The "Commerce Clause," Article I, Section 8, Clause 3 of the United States Constitution, provides that: "[Congress shall have Power] To regulate Commerce with foreign Nations, and among the several States, and with the Indian...more

Pro Te: Solutio - Vol. 3, No. 4 - October 2010

In this issue: FDA Warning And Untitled Letters - Using Historical Reference To Avoid Receiving Them In The Future; Healthcare Reform - Actions That Can Be Implemented Today To Prepare For Changes; Generic Preemption After...more

Ninth Circuit Holds Medicare Act’s Exhaustion Requirements And Preemption Provision Bar Plaintiffs’ Common Law Claims

At long last, the Ninth Circuit Court of Appeals issued its second opinion in the Uhm v. Humana, Inc., -- F.3d -- (9th Cir. 2010), matter, which found the Medicare Act's exhaustion requirements and preemption provision barred...more