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EPA Proposes to Eliminate Affirmative Defenses for Many Clean Air Act Violations

The U.S. Environmental Protection Agency (EPA) issued a proposed rule on September 5, 2014 that would prevent states from including affirmative defenses in their Clean Air Act state implementation plans (SIPs) for emissions...more

CMS Clarifies Terms of Global Settlement Offer

As previously reported, on August 29, 2014, CMS issued a global settlement offer (GSO) to acute care hospitals with pending appeals of denials for inpatient claims. Specifically, CMS is offering to settle all qualifying...more

HHS Asserts the Everybody-Does-It Defense

If that sounds familiar, your child may have a future as a lawyer for Health & Human Services. Because that’s one of the primary arguments asserted by HHS last Friday in its motion to dismiss the lawsuit by the American...more

Drug-Device Apple Cart Upset Again

On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more

The EU Bank Recovery and Resolution Directive Bringing Stability Back to the European Banking Sector

The collapse of Lehman Brothers was a pivotal moment which had catastrophic effects on the European financial sector which are still reverberating. Inadequacies in banking regulation were highlighted as most jurisdictions had...more

Attention Hospitals! Act Now To Get 68 Cents For Your Medicare Dollar!

It’s no secret that CMS is drowning in appeals from denials of Medicare claims for inpatient care. The number of pending appeals was estimated at half a million back in February, and it’s only grown since then. One reason...more

Fifth Circuit Holds that Texas Public Utility Commission Can Limit Ability of Intermittent Wind Generators to Sell Their Power...

On September 8, 2014, the United States Court of Appeals for the Fifth Circuit (“Fifth Circuit”), in a 2-1 decision, reversed an opinion by the United States District Court for the Western District of Texas (“District Court”)...more

Supreme Court Will Decide Level of Deference, If Any, Given to TTAB Decisions Concerning Likelihood of Confusion

On July 1, 2014, the Supreme Court granted certiorari to review the Eighth Circuit’s decision in the case B&B Hardware, Inc. v. Hargis, Inc. (2013). B&B Hardware owns a registered mark for SEALTIGHT for self-sealing nuts and...more

PTAB Threatens Sanctions for Unauthorized E-mails

Samsung Electronics Co., Ltd., et al. v. Black Hills Media, LLC - Addressing a patent owner’s unauthorized e-mail arguing for additional discovery and the petitioner’s likewise unauthorized responsive e-mail, an...more

New draft regulation on resolution of disputes between electronic communication operators

The Italian Communication Authority (AGCOM) published a new consultation on a draft regulation relating to the resolution of disputes between electronic communication operators....more

No “Correct” Pronunciation for Trademarks that Are Unrecognized Words

StonCor Group, Inc. v. Specialty Coatings, Inc. - The U.S. Court of Appeals for the Federal Circuit, in affirming a Trademark Trial and Appeal Board (the Board) ruling finding no likelihood of confusion between the...more

CBP Issues Guidance on Acceptable Methods of Submitting Post-Importation Claims

As a follow-up to a memorandum issued by U.S. Customs and Border Protection (CBP) to its field offices on August 11, 2014, CBP has published a guidance to the trade community concerning "acceptable methods" for submission of...more

No Right to Cross-Examine a Declarant Not Under the Proponent’s Control

In Mexichem Amanco Holding S.A. de C.V. v.Honeywell International, Inc., IPR2013-00576, Paper 36 (September 5, 2014), the Board denied patent owner’s request for additional discovery – the deposition of Dr. Takashi Shibanuma,...more

Kappos v. Hyatt Applies Broadly to Raising New Issues in District Court Actions

Troy v. Samson Mfg. Corp. - Addressing the scope of permissible new issues and evidence admissible in 35 U.S.C. § 146 district court proceedings, the U.S. Court of Appeals for the Federal Circuit vacated and remanded a...more

Medicare Beneficiaries Sue HHS Over 489-Day Backlog in ALJ Appeals

The Center for Medicare Advocacy (CMA) filed a complaint last week on behalf of five Medicare beneficiaries in federal district Court in Connecticut requesting a court order requiring the Secretary of HHS to clear a massive...more

Special (Limited) CMS Offer to Settle Claims on Appeal

With little fanfare just before the Labor Day weekend, CMS announced a program in which it would enter into administrative agreements with eligible providers in exchange for the providers’ withdrawal of pending appeals...more

How Low Will They Go? A Lower Ozone NAAQS Begins to Have An Air of Inevitability

On Friday, EPA released its “Policy Assessment for the Review of the Ozone National Ambient Air Quality Standards.” EPA staff concluded: that it is appropriate in this review to consider a revised primary O3 standard level...more

Corporate Responses to Investigative Requests by the Federal Government

In light of these new realities corporations face, the first step a company should take is to establish internal guidelines addressing interaction with government agents. Companies should have a response policy in place and...more

TCPA Hot Issues: Is the Scope of Consent Unlimited?

What constitutes valid consent under the Telephone Consumer Protection Act? A hot issue in TCPA litigation is the scope of consent necessary to place automated calls to consumers where the consumer has provided a cell phone...more

California Federal District Court Grants Partial Dismissal to Suit Alleging Violations of the Endangered Species Act

Earlier this month, a federal district court in California partially granted motions to dismiss a second amended complaint filed by the Center for Biological Diversity and the Pesticide Action Network alleging that the...more

Federal Agencies Cannot Be Fined for Reliability Standard Violations

The D.C. Circuit concluded that sovereign immunity prevents FERC and NERC from imposing monetary penalties on federal agencies that violate Reliability Standards....more

Federal Court in District of Columbia Dismisses Whistleblower Claims of Former Fannie Mae Employee

On August 25, 2014, the District Court for the District of Columbia dismissed a claim brought by a former employee of Fannie Mae alleging violations of the anti-retaliation provisions of the Sarbanes-Oxley Act and the...more

CMS Makes Global Offer to Settle All Acute Care Inpatient Claims on Appeal

On August 29, 2014, CMS issued settlement terms to acute care hospitals with pending appeals of denials for inpatient claims. CMS is offering to settle all qualifying claims at 68 percent of the “net paid amount” of such...more

RAC Program to Resume Limited Reviews

On August 4, 2014, the Centers for Medicare and Medicaid Services (CMS) announced that it would allow the Recovery Audit Contractor Program (RAC) to resume a limited number of reviews in August. The program has been dormant...more

Characterization as “Essential Element” Amounts to a Disavowal of Scope

X2Y Attenuators, LLC v. International Trade Commission - Addressing the impact of an alleged disclaimer made in a patent on which asserted patents relied for priority, the U.S. Court of Appeals for the Federal Circuit...more

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