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Read Constitutional Law updates, alerts, news, and analysis from leading lawyers and law firms:

FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

by Reed Smith on

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at...more

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

by Snell & Wilmer on

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

by Roetzel & Andress on

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

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

by Nexsen Pruet, PLLC on

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

A Favorable, New Climate for Challenging Medicare Appeals

by Latham & Watkins LLP on

Over the past decade, health care providers seeking to challenge Medicare claim denials have faced increasing delays in reaching what many consider the most important step in the Medicare appeals process - a hearing before an...more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

Court Declines to Prevent Merger of Washington Medical and Recreational Marijuana Markets

by Lane Powell PC on

Over the last year, the Washington state marijuana industry has anticipated the transition from an unregulated medical marijuana market to an integrated, medical-recreational market on July 1, 2016, under the Cannabis Patient...more

Hospice Requests Supreme Court Review of Medicare Hospice Annual Cap

by King & Spalding on

On June 8, 2016, Southeast Arkansas Hospice, Inc. (SEARK) filed a petition for a writ of certiorari to the Supreme Court to review an Eighth Circuit decision that upheld the annual Medicare payment cap for hospice services. ...more

House of Representatives v. Burwell: Another Blow to Obamacare

by Foley & Lardner LLP on

Federal Judge Rosemary Collyer’s May 12, 2016 ruling in House of Representatives v. Burwell, found that the Obama administration (the “Administration”) has been improperly funding an Obamacare subsidy program. House of...more

District Court Rules One Aspect of ACA is Unconstitutional—No Change for Employers

by Winstead PC on

You may have heard that a federal District Court ruled that the ACA was unconstitutional today. Do not start making any changes. This decision will not directly impact most employers and their health plans. We are sending...more

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

by Jackson Walker on

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more

Supreme Court Update: Luis V. United States (14-419)

by Wiggin and Dana LLP on

Here's a line-up you don't see in every (read: any) syllabus: "BREYER, J., announced the judgment of the Court and delivered an opinion, in which ROBERTS, C.J., and GINSBURG and SOTOMAYOR, JJ., joined. THOMAS, J., filed an...more

Fight the Good Fight Every Moment: Do Recent First Amendment Court Developments Deal a Blow to the Government?

by Arnall Golden Gregory LLP on

In the last month, the Food and Drug Administration has suffered setbacks relating to off-label promotion oversight. In both cases, one involving a pharmaceutical company and the other a medical device firm and its Chief...more

Five Key Lessons for Business Litigators from National Abortion Federation v. Center for Medical Progress

by Morrison & Foerster LLP on

On February 5, 2016, Morrison & Foerster secured a preliminary injunction on behalf of its client, National Abortion Federation (“NAF”), in National Abortion Federation v. Center for Medical Progress. The firm’s work on this...more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

by Pepper Hamilton LLP on

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

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

by Jackson Walker on

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

by Morrison & Foerster LLP on

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

Circuit Court Affirms $237.5 Million Judgment Against Tuomey

by King & Spalding on

On July 2, 2015, the Fourth Circuit affirmed a $237,454,195 judgment against Tuomey Health Care System (Tuomey) for violations of the Federal False Claims Act (FCA), which liability arose from violations of the Stark law....more

Fourth Circuit Upholds $237M Verdict Against South Carolina Hospital System for Stark Law Violations

On July 2, 2015, the United States Court of Appeals for the Fourth Circuit affirmed a $237 million judgment against Tuomey Healthcare System, Inc., in a federal False Claims Act (FCA) case arising out of violations of the...more

Horizon Avoids Data Breach Class Action For Lack Of Standing

by King & Spalding on

On March 31, 2015, a New Jersey federal judge dismissed a class action lawsuit against Horizon Healthcare Services Inc. alleging the company failed to protect the personal information of thousands of insurance network members...more

Supreme Court Rules NC Dentist Board Not Immune From Antitrust Scrutiny

In a 6-3 decision, the Supreme Court ruled that state professional boards comprised of active market participants are not immune from antitrust laws even though the boards are formally designated as a state agency, unless the...more

Class Action Claims: Gluing Together Systemwide Judicial Relief

by Best Best & Krieger LLP on

The award of class action certification is often the gateway for obtaining lifesaving systemwide judicial relief in broken correctional health care systems. It also can be the beginning of a decades-long, burdensome and...more

The Contraception Coverage Controversy Continues…

As we have been discussing, the Affordable Care Act (“ACA”) requires all health plans to cover preventive health services for women, including all Food and Drug Administration (“FDA”)-approved contraceptives, at no cost (i.e....more

Undoing MICRA

by Buchalter on

It has been over thirty-five years since California became a leader in healthcare reform, addressing the malpractice insurance crisis in a measured way. In 1975, the Medical Injury Compensation Reform Act (“MICRA”) capped...more

Complaint Filed Against HHS Alleges Medicare LCDs Deprive Beneficiaries of Necessary Clinical Laboratory Services

by King & Spalding on

On April 18, 2014, California Clinical Laboratory Association (“CCLA”) and “Jane Doe” (collectively, “Plaintiffs”) filed a lawsuit against HHS for equitable relief in the United States District Court for the District of...more

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