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Supreme Court Reinforces Need for Robust Adverse Event Reporting Process

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more

UK High Court confirms jurisdiction to grant cross-border declaration of non-infringement

In Actavis Group HF v. Eli Lilly & Co. the UK High Court has granted a declaration of non-infringement in the UK, France, Italy and Spain. A jurisdictional challenge in relation to the French, Italian and Spanish...more

Help Wanted: Supreme Court Looking for Expert to Fill In The Right Words for Patent Eligibility Test

There's a new job opening at the Supreme Court: Job Description: Complete test of patent eligiblity sketched out by this Court’s decisions in Bilski v. Kappos and Mayo v. Prometheus. Self starter required: must be...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

Judicial Notice of FDA Website Documents Can Be a Powerful Lever in a Medical Device Manufacturer’s Motion to Dismiss

A motion to dismiss can be a powerful tool in the hands of medical device companies to eliminate cases that should be dismissed from the outset on preemption grounds, before engaging in costly discovery. Oftentimes, however,...more

Fourth Circuit Limits Scope of Employers’ Claims Under Computer Fraud and Abuse Act

In July 2012, the United States Court of Appeals for the Fourth Circuit issued an important decision limiting the claims employers can bring against disloyal current and former employees under the federal Computer Fraud and...more

District Courts Staying Cases Pending CLS Bank, but the Federal Circuit Decides One

In December, the Supreme Court granted certiorari in CLS Bank Int’l v. Alice Corp., No. 13-298, in which the question presented by the petitioner is “[w]hether claims to computer-implemented inventions — including claims to...more

New Jersey punitive damages analysis ignores established precedent

Since 2008 New Jersey law has effectively granted pharmaceutical manufacturers immunity from punitive damages claims. While New Jersey state courts continue to recognise and enforce that immunity, some recent federal court...more

Allergan, Inc. v. Athena Cosmetics, Inc. (Fed. Cir. 2013) -- FDCA Does Not Preempt State Unfair Competition Laws

If you have ever wondered how popular eyelash enhancers like RevitaLash and Latisse produce their effects, Allergan, Inc. v. Athena Cosmetics, Inc. provides the answer: these products comprise prostaglandin derivatives. The...more

Industry Group To Weigh In On GMO Labeling Debate

With the rise in state legislative efforts to require labeling for foods produced using genetic engineering or “GMOs,” the Grocery Manufacturers Association (GMA) is poised to enter the labeling debate by working with federal...more

A Short-Lived Victory for Generic Manufacturers? – Part 2

In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual...more

Careful What You Say – No Preemption for Statements Made in Operating Room

Makers of medical devices marketed pursuant to the Food and Drug Administration’s (FDA) premarket approval process are generally relieved from defending state law failure to warn claims by operation of express preemption, a...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

Goodbye to Generic Preemption? FDA Publishes Proposed Rule

Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78...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

Thoughts on the Stored Communications Act, Federal Preemption and Supremacy, and State Laws on Fiduciary Access to Digital...

As of the date of this posting, seven states have recently passed laws and at least eighteen other states are considering new laws granting fiduciary access to an incapacitated or deceased person’s online accounts and other...more

International Patent Laws – Interview with Julian Crump, Managing Member, Mintz Levin's London, UK Office  [Video]

Attorney Julian Crump, Managing Member of Mintz Levin's London, UK office, talks about the differences between patent laws in the US and the EU and the importance of identifying those differences at the outset of 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

Illinois Supreme Court Invalidates 'Amazon' Sales Tax Law: Now What?

The Illinois Supreme Court, affirming a lower court decision, invalidated the state's "click-through" nexus law. This law required out-of-state Internet retailers who use in-state web marketing "affiliates" to collect sales...more

Illinois Click-Through Nexus Law Preempted by the Internet Tax Freedom Act

In a 6-1 decision, the Illinois Supreme Court affirmed an Illinois Circuit Court holding that Illinois Public Act 96-1544 (The Click-Through Nexus Act), requiring out-of-state retailers to collect and remit use tax, violates...more

Illinois Supreme Court Holds Federal Law Preempts Click-Through Nexus Law

In a decision released this October 18th, the Illinois Supreme Court upheld the Circuit Court of Cook County’s decision invalidating the Illinois click-through nexus statute in Performance Marketing Association v. Hamer. The...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

Federal Preemption Rules and Insufficient Pleading Results in Dismissal of Plaintiff’s Off-Label Claims

In a recent decision issuing from the Central District of California, the court evaluated requirements pertaining to federal preemption and pleading, and granted Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc.’s...more

A victory for generics suppliers

In late June the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

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