Health Civil Remedies

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Nursing Home Arbitration Agreements: A Changing Landscape

Because arbitration proceedings often offer a less costly and more efficient alternative to the burdens of protracted courtroom litigation, arbitration agreements are increasingly common in the nursing home industry. However,...more

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

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

CMS Revokes Billing Privileges for Competitive Bid Supplier

The Centers for Medicare and Medicaid Services (CMS) has demonstrated that it will not hesitate to use one of its most crippling administrative enforcement tools—the revocation of Medicare billing privileges—against one of...more

Health Alert (Australia) January 23, 2017

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Court 13 January 2017 - Selia v Commonwealth of Australia [2017] FCA 7 - ADMINISTRATIVE LAW -...more

Court Refuses To Enforce Arbitration Clause Due To Lack Of Mental Capacity

In Oak Crest Manor Nursing Home, LLC v. Barba, a plaintiff sued a nursing home for negligently allowing a patient with mental disorders to leave the facility and jump from a bridge in an attempt to commit suicide. No....more

False Claims Act: 2016 Year in Review

We are pleased to present Bradley’s annual review of significant False Claims Act (FCA) cases, developments, and trends. From a relatively short article several years ago, the Review has grown to a significant publication...more

A Liar and A Cheat? 3 Ways to Pay...

Seyfarth Synopsis: Insurer gets to pick its remedy when hospital engages in dishonest billing and illegal kickbacks…to the tune of $41 million. Judge Lynn Hughes of the U.S. District Court for the Southern District of...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

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

U.S. District Court for District of Columbia Requires HHS to Eliminate Medicare Appeals Backlog by December 31, 2020

On December 5, 2016, a U.S. District Court for the District of Columbia granted summary judgment in American Hospital Association, et al., v. Burwell, in favor of the American Hospital Association (AHA) in its quest to reduce...more

New Texas Rule Regarding the Disposal of Fetal Tissue Stayed

The Texas Department of State Health Services recently issued a final rule implementing updated methods for the disposal of special waste from health care facilities, which includes fetal tissue. As such, the new rule would...more

Court Grants Motion to Dismiss for Lack of Case or Controversy Even Though Patent Holder Did Not Provide Covenant Not to Sue

Tech Pharmacy filed a patent infringement action against Defendant Alixa Rx LLC and Defendant Golden Gate National Senior Care LLC d/b/a Golden LivingCenters (collectively, "Defendants"). Tech Pharmacy subsequently filed its...more

Ninth Circuit Rejects FCA Suit Alleging Medical Device Inaccuracies

In United States ex rel. Ruhe v. Masimo Corp., 640 Fed. App’x 666 (9th Cir. 2016), the Court of Appeals for the Ninth Circuit affirmed a grant of summary judgment for defendant Masimo Corporation, a medical device...more

A Wise Decision: Recent Lessons on Evidence in Class Actions

Wise v Abbott Laboratories, Limited, 2016 ONSC 7275 was a recent pre-certification summary judgment decision, which was released after the Divisional Court's decision this past summer in Dine v Biomet Inc, 2016 ONSC 4029....more

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

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

It Ain't Over 'Till It's Over – First Circuit Rejects Settlement Agreements Between Providers and Intermediary and Upholds Cost...

On October 27, 2016, a three-judge panel for the United States Court of Appeals for the First Circuit issued an opinion concluding that a Medicare fiscal intermediary (Intermediary) does not have the authority to enter into a...more

OIG Issues Final Rule Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more

HHS OIG Issues Final Rules Adding New Anti-Kickback Safe Harbors, Expanding CMP Liability

On December 7, 2016, the HHS OIG issued a long-awaited final rule providing additional safe harbors under the federal anti-kickback statute (AKS) and changed the definition of “remuneration” in the civil monetary penalty...more

Impeding the Counterparty’s Ability to Satisfy a Condition Precedent Could Result in Liability

Justice Jeffrey K. Oing in the Commercial Division handed down a decision recently that discusses frustration of the occurrence of a condition precedent by parties to commercial contracts. Nesconset ZJ 1 v. Nesconset...more

‘Tis the Season for Giving: OIG Updates Policy on Gifts of Nominal Value to Medicare and Medicaid Beneficiaries

In Depth - On December 7, 2016, the Office of the Inspector General (OIG) of the US Department of Health and Human Services (HHS) issued a policy statement increasing its thresholds for gifts that are considered...more

Eighth Circuit Affirms that Retaliation Under False Claims Act Requires Showing that Retaliation Was Motivated Solely by...

On May 20, 2016, the Eighth Circuit affirmed the District Court’s grant of summary judgment to defendant on Plaintiff’s False Claims Act (“FCA”) retaliation claim against his former employer. In Elkharwily v. Mayo Holding...more

Federal Court Enjoins CMS Regulation Banning Arbitration of Nursing Home Disputes

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

Second Circuit Affirms Ruling that SPD Swiss Precision Diagnostics Falsely Advertised Clearblue Weeks Estimator Home Pregnancy...

In an important recent false advertising decision in a suit brought by home pregnancy test manufacturer Church & Dwight against its principal competitor SPD Swiss Precision Diagnostics, a Second Circuit panel unanimously...more

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