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Court Finds FDA Explanation of Knee Implant Reversal Lame

The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of...more

Judge Dismisses FDA Spying Case But Not Because It’s Innocent

Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer...more

E-discovery: May federal courts insist that litigants “Do as I say, not as I do”?

General Counsel of Acme Widget Corp. has had a trying morning. On her desk is a motion filed against Acme last night, demanding that a federal judge sanction Acme for failing to preserve what (to her at any rate) sounds...more

Scripts Newsletter - October 2014

In this issue: - Health Care Decisions — Who Decides? - Medical Software Licensing — Tips from the Trenches - An Ounce of Prevention — The Importance of Periodic Corporate Audits - ACA -...more

District Court Largely Rejects Challenges to CFTC's Extraterritorial Application of Dodd-Frank Swap Regulations

The United States District Court for the District of Columbia issued an opinion on September 16, 2014, available here, largely rejecting challenges to the Commodity Futures Trading Commission’s (“CFTC”) Interpretive Guidance...more

Promoting the False Claims Act By Dismissing Meritless Qui Tam Actions

The False Claims Act's qui tam action is a distinctive and atypical form of litigation. Through the qui tam mechanism, Congress created a unique way for the United States to recover for false claims by empowering private...more

Insurer Sues Department of Insurance Over Multi-Million Dollar Penalty

In suing the California Insurance Commissioner on July 10, 2014, PacifiCare Life Insurance Company sought a writ of mandamus ordering the Commissioner to set aside his Decision and Order imposing a record $173 million penalty...more

Court Holds Lack of Specificity Dooms Wyoming Wolf Delisting

On September 23, 2014, the U.S. District Court for the District of Columbia invalidated the final rule issued by the U.S. Fish and Wildlife Service (Service) delisting the Wyoming Gray Wolf distinct population segment from...more

District Court Rules that Claims Challenging Forest Management Are Ripe and Final

Last week, the United States District Court for the Middle District of Florida determined that a group of plaintiffs could bring a claim against the U.S. National Park Service challenging actions that were characterized by...more

Public Records Act Update: Washington Court of Appeals Endorses Flexible Approach to Agencies' Response Time to Public Records...

In Andrews v. Washington State Patrol, No. 32288-2-III, 2014 WL 4627656 (Wash. Ct. App. Sept. 16, 2014), a case involving response times to public records requests, the Washington Court of Appeals ruled in favor of the...more

Court Dismisses AHA’s Challenge to CMS Billing Policy

On September 17, 2014, the U.S. District Court for the District of Columbia dismissed a lawsuit brought by the American Hospital Association (AHA), three individual hospitals, and two health care systems that challenged CMS’s...more

CEQA Reform in the Courts – Public Agency Can Recover Costs Despite Petitioner's Election

After Governor Brown took office for the second time, CEQA reform through the Legislature seemed like a distinct possibility. While that possibility has all but evaporated, recent rulings suggest that courts are taking a...more

Oxfam America Takes A Stand, But Does It Have Standing?

Recently, I wrote about Oxfam America’s new lawsuit against the Securities and Exchange Commission for failing to adopt a final rule implementing Section 1504 of the Dodd-Frank Wall Street Reform and Consumer Protection Act. ...more

The SAB Enters the “Waters of the United States” Fray: Guess Which Side the Scientists Support

The Science Advisory Board has now provided its advice to EPA and the ACOE concerning their proposed rule clarifying the definition of “waters of the United States” under the Clean Water Act. In a brief letter that can only...more

School District Found to Have Engaged in ‘Bait and Switch’ on Teaching Assistant Unemployment Benefits

In Tameka Gladney v. Mississippi Department of Employment Security, the Mississippi Court of Appeals reinstated a teacher assistant’s unemployment benefits finding that the district had been less than fair to her. At the end...more

Discipline as Defamation: Title IX, Disciplinary Panels, and The Risks of Righteousness in The Wake of Wells V. Xavier and Harris...

LR-college-campus_med_rgbTwo recent court rulings illustrate some of the perils facing university administrators when handling internal disciplinary complaints against students who have been alleged to have committed...more

CEQA Administrative Record Preparation Costs – Who Pays and When? First District Provides Guidance In Coalition For Adequate...

In a published decision filed September 15, 2014, the First District Court of Appeal reversed and remanded a trial court’s post-judgment order granting an unsuccessful CEQA petitioner’s motion to tax the entire $64,144 cost...more

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

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