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The Marijuana Industry’s Big Win: The DEA’s Refusal to Reschedule

Earlier this year, when the U.S. Drug Enforcement Agency (DEA) indicated it would have an announcement regarding a now five-year-old petition to reschedule cannabis, numerous industries on the “outside looking in” were...more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

The silver lining in the DEA’s refusal to reclassify cannabis

As far back as 2011, elected officials have sent letters to the U.S. Drug Enforcement Administration urging it to reclassify cannabis by removing it from the list of Schedule I controlled substances. After promising a...more

The DEA Is Getting Past Just Saying No: Scientific Research Into Medical Uses of Marijuana Is a Bridge Toward a Policy Shift

The U.S. Drug Enforcement Agency (DEA)’s recent decision declining to reschedule cannabis is a step bridging the national discussion — a step toward a possible agreement on medical cannabis through scientific research. The...more

DEA Rejects Petitions Seeking to Reschedule Marijuana

The long-awaited decision maintains the illegal status of marijuana under federal law. On August 12, the US Drug Enforcement Agency (DEA), despite much speculation to the contrary, published in the Federal Register its...more

Health Care Update - March 2016

Senate HELP Committee Set for Second Mark Up on Cures Effort - This week, the Senate Committee on Health, Education, Labor and Pensions (HELP) will hold its second legislative mark-up on its counterpart to the...more

APCDs: One Solution to Obtaining Meaningful Performance Data

The American health care system is under immense pressure to control costs and improve quality. As a result, there is a corresponding need for access to health care data and the development of new methods to obtain value...more

Five of the Top Drug & Device Developments in 2015

As 2015 winds down, we reflected on some of the year’s most significant legal developments for drug and device manufacturers. In our opinion, the bench got it right (for the most part) this year. Here is a brief recap and...more

Pro Te: Solutio Vol. 8 No. 2

Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more

Washington State Amends Breach Notification Law to Expand Notification Requirements

On April 23, 2015, Washington State Governor Jay Inslee signed into law a bill strengthening the state’s data breach notification law (amending Wash. Rev. Code §§ 19.255.010 and 42.56.590 and creating a new section). H.B....more

April 2015: Product Liability Litigation Update

Defenses to Public Nuisance Claims in Pharmaceutical Products Litigation. For many years, plaintiffs have asserted the tort of nuisance to address purported harms from all sorts of products—including firearms, lead paint,...more

Breaking News - Caplinger Infuse Preemption Dismissal Affirmed

We thought our readers would like to know that today the InFuse preemption decision in Caplinger was affirmed by the 10th Circuit in a 2-1 opinion (here’s a link). Our non-Reed Smith bloggers will undoubtedly have more to...more

State Law Claims Based on HIPAA Guideline Violations Are Not Preempted by HIPAA

Though the Health Insurance Portability and Accountability Act of 1996 (HIPAA) precludes a private right of action in the event of a breach of confidentiality, recent decisions have found that claims based on such breaches...more

Failure to Warn About Dangers of Off-Label Use of Medical Device Preempted Under Federal Law

In Thorn v. Medtronic Sofamor Danek, USA, the Honorable Janet T. Neff dismissed the plaintiff's state law claims of failure to warn and negligence as preempted under the Medical Device Amendments of 1976 ("MDA"), 28 U.S.C. §...more

Generic Drug Cos. Face Failure-To-Warn Claims In Calif.

On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more

Ninth Circuit Upholds Alameda Safe Drug Disposal Ordinance, Triggering Implementation of King County Secure Medicine Return Rule

On September 30, 2014, the Ninth Circuit affirmed the Northern District of California’s summary judgment that the Alameda Safe Drug Disposal Ordinance (the “Ordinance”) does not violate the dormant Commerce Clause of the...more

A Brief Overview of the Case Law Regarding "Failure to Train" Claims - And Its Implications for Medical Device Manufacturers

In recent years, causes of action for “failure to train,” or allegations predicated on a duty to train, have been on the rise in cases against medical device manufacturers. Historically, however, such claims and allegations...more

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more

Second Circuit Holds In-House Lawyer Precluded from Blowing Whistle on Former Employer

The Second Circuit issued an opinion tackling the interplay between an attorney's ethical obligation to maintain client confidences and the ability to act as a "whistleblower" to report unlawful conduct to the government. The...more

Can A State Impose Civil Penalties On A Drug Or Device Company For Using A Federally-Approved Label?

Overview - States have increasingly brought actions under Medicaid fraud or consumer protection statutes seeking civil penalties and restitution from the makers of prescription drugs. Many top-selling drugs have been...more

Supreme Court May Decide Issue of the Level of Specificity Required Under Rule 9(b) in FCA Whistleblower Suits

The United States Supreme Court recently indicated its potential interest in hearing arguments in a key False Claims Act (FCA) case that would address a circuit split over the important issue of the level of specificity of...more

Washington Attorney General's Office Opinion Undermines Electronic Health Records Donation Programs

In 1949, the Washington Legislature enacted what has become known as the “anti-rebate statute,” codified as RCW Chapter 19.68. Rep. Eileen Cody recently asked the state Attorney General (AG)’s Office whether this statute...more

Health Law Alert 2010 Volume 2: Physician Payment Sunshine Act

The Patient Protection and Affordable Health Care Act (H.R. 3590) signed into law in March 2010 includes the Physician Payment Sunshine Act (section 6002) (PPSA), which requires pharmaceutical, medical device, biological, and...more

Electronic records mandates may clash with privacy laws: Patchwork of state laws adds complexity By Eric A. Klein and Christine C....

President Obama has declared that electronic medical records will “reduce error rates, reduce our long-term cost of health care and create jobs.” “Obama’s Prime Time Press Briefing,” N.Y. Times, Feb. 9, 2009. Congress has...more

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