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No Old Kentucky Home for Parallel FDCA-Based Tort Claims

by Reed Smith on

Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following: "In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the...more

False Claims Act's "Rigorous" Materiality Standard Enforced by Second Circuit

by Jones Day on

The Situation: A decision by the U.S. Court of Appeals for the Second Circuit reinforces the growing body of case law regarding the strict materiality requirements of the False Claims Act. The Result: Coyne v. Amgen is...more

California Court of Appeal Limits Duty of Clinical Study Sponsor to Intervene in Treaters’ Care of Study Participants

by Reed Smith on

Last week, we took a short Western Caribbean cruise to celebrate a jarringly-advanced birthday. While the weather wasn’t an asset (it was 43 degrees when we departed Fort Lauderdale, and hovered in the 60s for most of the...more

Materiality Part II: Government Knowledge

Editor’s Note: This is the second in a five-part series on how U.S. district courts and courts of appeal have applied the materiality standard set forth in Universal Health Services, Inc. v. United States ex rel. Escobar, 136...more

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

by Smart & Biggar on

The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Florida Supreme Court Says Right to Privacy Survives Death and Prohibits Ex Parte Interviews in Medmal Actions

by Rumberger Kirk & Caldwell on

In the case of Weaver v. Myers, a sharply divided Florida Supreme Court recently struck down part of the 2013 amendments to Fla. Stats. §§766.106 and 766.1065, which govern the informal discovery process of the medical...more

CMS imposes massive cuts on 340B program; Hospital associations’ legal challenge dismissed

by Bricker & Eckler LLP on

On November 1, 2017, CMS issued a final rule that became effective January 1, 2018, under which hospitals serving a disproportionate share of low-income patients (DSH hospitals) will receive nearly 27 percent less in...more

Vermont Legislative Update 1-5-18 - An analysis from DRM's Government & Public Affairs Team

The merger between the Department of Labor and the Agency of Commerce and Community Development as proposed by the Scott Administration is off the table, but work that was spawned by consideration of the idea has gathered...more

In a Word - Incredible

by Reed Smith on

Summary judgment isn’t normally available for credibility issues. During the “summary judgment trilogy” of 1986, the Supreme Court stated, “[c]redibility determinations, the weighing of the evidence, and the drawing of...more

340B Drug Pricing Program Litigation Update

In November of last year, we wrote about a preliminary injunction being sought by hospital advocacy groups attempting to stop implementation of the Trump administration’s cuts to the 340B Drug Pricing Program (“340B...more

D.C. District Court Clarifies Standard for Laboratory Determination of Medical Necessity

by Epstein Becker & Green on

This past June, a federal district court in the District of Columbia made headlines when it declined to dismiss an action brought by a qui tam plaintiff (“Relator”) against defendant Boston Heart Diagnostics (“Boston Heart”),...more

D.C. Circuit Upholds CMS’s Outlier Reconciliation Process Finding Notice and Comment Rulemaking Was Not Required

by King & Spalding on

On December 26, 2017, the United States Court of Appeals for the District of Columbia Circuit overturned a summary judgment decision of the District Court and held that the provisions of the 2010 Medicare Claims Processing...more

Avandia Case Flunks Warning Causation

by Reed Smith on

We’re now into the New Year but aren’t completely done with the old one. The name of the first month of the year, January, is conventionally attributed to Janus, the Roman god of beginnings, gates, transitions, and doorways....more

Where To Find Our Research 3.0

by Reed Smith on

Happy New Year! - It’s been 3 ½ years since we last updated our index to our online research resources. That’s almost ? of the total life of the blog, which started in way back in 2006. We’ve been blogging now for well...more

Ending The Year With Another Good Personal Jurisdiction Decision

by Reed Smith on

Having already issued our posts on the best and worst cases of 2017, we will resist the temptation to comment on the year as a whole, particularly on the powder keg that is politics. We will note, however, two non-legal...more

The Highs - Celebrating the Ten Best Prescription Drug/Medical Device Decisions of 2017

by Reed Smith on

Ending the year on a high note is one thing that the blog tries to do – with the top ten drug/device product liability decisions of the year. Occasionally, a court will do something that ruins the party, with an eleventh-hour...more

Inauspicious Debut for Depakote Plaintiffs’ First Amendment Argument

by Reed Smith on

We’ve been aware of the other side attempting to construct a First Amendment counter-argument to our preemption defense for some time. It first cropped up in a 2015 360 article by a P-side thought leader (no, not necessarily...more

The Case of the Double-Dipping, Creative-Editing Plaintiff

by Reed Smith on

This week saw the birthdays of two folks who were sort of prominent in our youth. First, Uri Geller, the Israeli ‘psychic’, turned 71. He showed up on our tv constantly in the 1970s and 80s, bending spoons with his mind. ...more

Addendum to the Worst Prescription Drug/Medical Device Decisions of 2017

by Reed Smith on

Sometimes it happens.  For eleven years, we have published our annual “worst of” the year post on the Thursday before Christmas and our annual “best of” the year post on the Thursday before New Year’s....more

Breaking News: TH v. Novartis – California Supreme Court Recognizes New Tort Duties as Traditional Limits Slide into the Sea

by Reed Smith on

We posted our 2017 “Worst 10 decisions” list a day too soon, because the California Supreme Court issued its anticipated decision in TH v. Novartis, No. S233898, slip op. (Cal. Dec. 22, 2017) today, and if it is not the worst...more

Banner Health Class Action Claims Survive Motion to Dismiss

Wednesday, a federal district court in Arizona denied in part and granted in part Banner Health’s motion to dismiss class action claims arising from a 2016 data breach. ...more

D.C. Federal District Court Clarifies that Laboratories Are Not Required to Independently Determine the Medical Necessity of Tests...

by King & Spalding on

On December 11, 2017, the United States District Court for the District of Columbia granted in part and denied in part defendant Boston Heart Diagnostics Corporation’s (Boston Heart) motion to reconsider the court’s ruling on...more

The Lows - Mourning the Worst Prescription Drug/Medical Device Decisions of 2017

by Reed Smith on

The second most successful college basketball coach of all time (in terms of NCAA Division 1 national championships) has said “All of life is peaks and valleys. Don’t let the peaks get too high and the valleys too low.” ...more

Virginia Supreme Court Considers Terms Of Assumption Reinsurance Transaction In Determining Obligations Of Insolvent Insurer

by Carlton Fields on

A group of Kentucky hospitals sought reimbursement for legal fees incurred in two lawsuits related to the insolvency of their insurer, Reciprocal of America (“ROA”). In the 1970s and 1980s, the hospitals created two trusts to...more

Rx IP Update - December 2017

by Smart & Biggar on

PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

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