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EPA Re-gains “Green Light” to Regulate Permitting Procedures - D.C. Circuit overturns lower court decisions on EPA permitting...

Two district court orders declaring the federal Environmental Protection Agency acted illegally when it implemented certain permitting procedures for coal mining operations have been vacated by a federal court of appeals....more

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

Employment Law - July 2014 #2

High Court’s Fall Docket Includes Major Employment Issues - Why it matters: While the 2013-2014 U.S. Supreme Court term may be over, the justices have granted certiorari in two major employment cases slated for the...more

U.S. Supreme Court Grants Review of Restrictions on Federal Agency Rulemaking in Mortgage Loan Officer Overtime Case

In our July 2013 alert, we reported on a federal appellate court ruling in Mortgage Bankers Association v. Harris. Mortgage Bankers Association challenged a U.S. Department of Labor (DOL) 2010 opinion letter in support of...more

Supreme Court Grants Certiorari to Review D.C. Circuit Decision Hampering Amtrak's On-Time Performance

On June 23rd, the U.S. Supreme Court granted the government’s Writ of Certiorari to review the decision of the D.C. Circuit that many believe may be hampering Amtrak’s leverage with freight railroads and its on-time...more

Federal Circuit Says Commission Must Toe the Line in Invisalign ITC Case

In Align Technology, Inc. v. International Trade Commission, the Federal Circuit held that ITC action that violated ITC’s own regulations warranted vacatur under the Administrative Procedures Act. While the case addresses...more

Federal Circuit Makes ITC Comply With Its Own Rules

In an opinion dated July 18, 2014, in Align Technology, Inc. v. International Trade Commission (Fed. Cir. July 18, 2014, No. 2013-1240, -1363) 2014 U.S. App. Lexis 13717, the Federal Circuit vacated and remanded a decision of...more

Labeling Laws for the Food and Beverage Industry – Unfair Competition and Mislabeled Products

In a recent unanimous U.S. Supreme Court ruling, the court opened the door for private parties, including competitors, to bring false advertising and misrepresentation claims under the Lanham Act even if the product labels...more

A Tale of Two Circuits: D.C. Circuit, Fourth Circuit Split on ACA Subsidies

It was the best of times for ACA subsidies, it was the worst of times for ACA subsidies. On Tuesday, the Court of Appeals for the D.C. Circuit (“D.C. Circuit”) and the Court of Appeals for the Fourth Circuit (“Fourth...more

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

Buckle Up—Unwinding Phoebe Putney’s Acquisition of Palmyra Down in Georgia May End Up Being Back on the Table

Almost one year ago, Federal Trade Commission (FTC) agreed to settle its antitrust challenge of Phoebe Putney Health System’s (Phoebe Putney) acquisition of Palmyra Medical Center (Palmyra) without requiring divesture or any...more

Environmental Protection Agency and U.S. Army Corps of Engineers Proposed Rule Defining “Waters of the United States” Under the...

On April 21, 2014, the United States Army Corps of Engineers and the Environmental Protection Agency (collectively the “Agencies”) released a proposed rule to define the scope of waters protected under the Clean Water Act...more

Only When a Permit is Required: The Supreme Court Caps the EPA’s Authority to Regulate Greenhouse Gas Emissions from Stationary...

Utility Air Regulatory Group v. EPA et al. 573 U.S. ____ (2014) - On June 23, 2014, the United States Supreme Court held that the Environmental Protection Agency (EPA) overstepped its authority under the Clean Air Act...more

Water, Water everywhere …

There were two court decisions this week regarding regulation of Maine rivers, one from the Maine Supreme Judicial Court, Watts v. BEP, and one federal, Friends of Merrymeeting Bay v. Hydro Kennebec, LLC. ...more

New Process for Conflict Resolution in WV Schools

Beginning in August, school districts will need to prepare for a new process to address conflicts and complaints from citizens. On August 11, the new/amended process, known as the “Conflict Resolution Process for...more

Clarification on the Statute of Limitations for Conditions of Confinement Cases

The Supreme Court of Virginia has recently addressed and clarified the application of Va. Code § 8.01-243.2, which provides: No person confined in a state or local correctional facility shall bring or have brought on...more

D.C. Circuit Says CMS Doesn’t Know What’s New

On Tuesday of last week the D.C. Circuit Court ruled that the Provider Review Reimbursement Board doesn’t know what’s new. It reversed the PRRB’s decision, along with the District Court’s decision that upheld it. In doing...more

Seventh Circuit Holds Federal Agencies Can Be Sued for Public Nuisance, But Affirms Dismissal of Claim

On July 14, 2014, the Seventh Circuit decided Michigan et al. v. U.S. Army Corps of Engineers et al. (Wood, C.J., writing for a unanimous panel). While the court ultimately affirmed dismissal of the underlying action, the...more

Settling Parties In Government Consent Orders Have CERCLA Claims For Contribution Not Cost Recovery

To the extent there was any remaining uncertainty, the Sixth Circuit has now made crystalline that a party settling some or all of its liability under CERCLA with the United States or a state has a contribution claim under...more

OFCCP Argument for Expansive Scope of Desk Audit May be Weakened

A federal trial court in Texas has entered an agreed order granting a joint motion for voluntary dismissal filed by the parties in Frito-Lay v. Department of Labor. As discussed in our prior Alert, in Frito-Lay, the company...more

Eight Is Not Enough: CEQA Challenge To Eighth Addendum To San Jose International Airport Master Plan EIR Is Rejected By Sixth...

In a decision filed June 6, but not certified for publication until July 2, 2014, the Sixth District Court of Appeal affirmed the trial court’s judgment upholding the City of San Jose’s eighth addendum to its Airport Master...more

The Fifth Circuit holds it lacks subject matter jurisdiction to hear petitions for review of Clean Air Act notices of violation

“Final actions” of the EPA under the Clean Air Act are subject to direct review by a United States Court of Appeals. 42 U.S.C. § 7607(b)(1). In a decision issued on July 3, 2014, in Luminant Generation Company, LLC v....more

D.C. Circuit Overturns PRRB’s Decision that Only Newly Built Hospitals Can Qualify for Favorable Capital Reimbursement Rates

In Select Specialty Hospital – Bloomington, Inc. v. Burwell, No. 15-5355 (D.C. Cir., Jul. 8, 2014), a group of long-term care hospitals (LTCHs) successfully challenged the Secretary’s determination that they were not “new...more

Sugar and Spice and Cases on Ice: Evaporated Cane Juice Case Stayed Until FDA Issues Formal Guidelines

Last week, a California federal judge revived a putative class action accusing Amy’s Kitchen Inc. of misleading customers by labeling sugar as “evaporated cane juice” on its products. In a finding that puts the case on hold...more

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