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Health Alert (Australia) 22 August 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 11 August 2017 - South Western Sydney Local Health District v Sorbello [2017] NSWCA 201 - NEGLIGENCE – assessment of damages...more

New York Appellate Court Curtails NY AG Investigatory Subpoena on Constitutional Grounds

by Jones Day on

On June 21, 2017, a New York appellate court curtailed on constitutional grounds an investigative subpoena issued by the New York Attorney General. In the Matter of Evergreen Assoc., Inc., 54 N.Y.S.2d. 135 (App. Div. 2017)....more

Pennsylvania Supreme Court Rules that Only Physicians – Not Their Staff – Can Obtain Informed Consent

by Tucker Arensberg, P.C. on

A recent Pennsylvania Supreme Court decision will have a major impact on how physicians across the Commonwealth obtain informed consent from their patients. In Shinal v. Toms, 2017 WL 2655387 (Pa. June 20, 2017), the 4-3...more

SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more

Fla. justices reject keystones of partisans’ plan to undercut patients’ rights

As congressional Republicans pursue their counter factual campaign this week to strip patients of their rights to pursue legal redress for harms they suffer while seeking medical services, the Florida Supreme Court has sent a...more

Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazadone drug submission

by Smart & Biggar on

On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that Apotex failed to mitigate the damage it incurred as the result of Health Canada’s misfeasance in public office and negligence in its...more

Fourth Circuit Excludes FDA Evidence in Transvaginal Mesh Products Liability Case

by Sands Anderson PC on

In the Southern District of West Virginia, Johnson & Johnson and its subsidiary, Ethicon, Inc., were sued for defective design and failure to warn for their transvaginal mesh TVT-O, in addition to a loss of consortium claim....more

Teva awarded section 8 damages regarding pregabalin and olanzapine

by Smart & Biggar on

On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations”) regarding pregabalin (Pfizer’s LYRICA)...more

Punitive Damages Overkill: J&J Hit With Still Another Disproportionate Punitive Award In Pelvic-Mesh Litigation

As early as 1967, Judge Friendly worried about the phenomenon of punitive damages overkill in mass tort litigation. Fifty years later, the problem persists....more

Government Solidifies Victory Blocking Chicago Hospital Merger

The Federal Trade Commission (“FTC”) and the State of Illinois successfully concluded their challenge to the proposed merger of Advocate Health Care and NorthShore University Health System earlier this month, when the U.S....more

False Claims Act Dangers on Display in Ruckh

by Bass, Berry & Sims PLC on

A recent jury verdict in an FCA lawsuit pending in the United States District Court for the Middle District of Florida resulted in a not-so-subtle reminder of just how high the stakes can be in such litigation....more

Nursing Home Arbitration Agreements: A Changing Landscape

by Fisher Phillips on

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

CMS Revokes Billing Privileges for Competitive Bid Supplier

by Foley & Lardner LLP on

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

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

Health Care Group News: Texas District Court Preliminarily Enjoins Partial Enforcement of Section 1557

by Murtha Cullina on

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

by Cozen O'Connor on

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

by Dorsey & Whitney LLP on

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

by Baker Ober Health Law on

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

A Wise Decision: Recent Lessons on Evidence in Class Actions

by Bennett Jones LLP on

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

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

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

by Baker Ober Health Law on

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

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

by Proskauer - Advertising Law on

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

Mississippi District Court Halts Implementation of New CMS Rule Banning Use of Arbitration Agreements in Long-Term Care Facilities

by Reminger Co., LPA on

Anyone familiar with long-term care litigation knows that the number of disputes regarding the use and enforcement of arbitration agreements in the context of assisted living/nursing home admissions has risen sharply over the...more

Federal Court Blocks CMS Ban on Pre-Dispute Nursing Home Arbitration Agreements Pending Legal Challenge: What the Ruling Means for...

Earlier this week, a federal court enjoined the federal Centers for Medicare and Medicaid Services (“CMS”) from enforcing a rule, promulgated on September 28, 2016, which barred pre-dispute arbitration agreements between...more

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