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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

Udall-Vitter TSCA Reform Bill Builds Momentum for Passage; Senators Boxer, Markey Respond with Competing Legislation

On March 10, 2015, Senators Tom Udall (D-N.M.) and David Vitter (R-La.) introduced the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697), to modernize the Toxic Substances Control Act (TSCA). ...more

Calif. Appellate Court Endorses Averaging Lead Exposure in Food and Beverage Prop. 65 Disputes

In a rare published decision concerning California’s expansive Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as “Prop 65,” the California Court of Appeal on March 17, 2015, dealt companies a victory in...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

FCC Releases Full Text of Order Preempting State Laws Limiting Municipal Broadband

On March 12, 2015, the Federal Communications Commission released the text of its order preempting provisions of North Carolina and Tennessee law that allow municipalities to provide broadband service but otherwise limit the...more

Can The FDA Do That?

A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common....more

FCC Preempts Two State Laws That Limit the Geographic Reach of Municipal Broadband Systems

On February 26, 2015, the Federal Communications Commission voted to strike down provisions of North Carolina and Tennessee laws that restrict the area in which municipally-owned broadband systems in those states are allowed...more

First Circuit Finds Federal Preemption of State Tort Claims That Conflict With A Medication’s FDA-Approved Labeling & Warnings

An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more

Is your confidential information “property” if it does not qualify as a trade secret?

The answer likely is “no” according to a recent decision from a federal court in San Francisco. The plaintiff in that case, a data storage company, alleged that a competitor misappropriated its trade secrets by illegally...more

Comments on USPTO’s Interim Patent Eligibility Guidance (Part 2)

The Preemption Requirement - Preemption is the core concern that drives the Court’s “exclusionary principle”. The Supreme Court in Alice stated...more

Financial Industry Backs Cybersecurity, Data Breach Notification Legislation

Why it matters - The financial industry has thrown its support behind data breach notification legislation as well as passage of a law that would encourage businesses to share cyberthreat information. Data security...more

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...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

Product Liability Alert: Failure-To-Warn Suit Against Generic Drug Maker Proceeds Despite Argument of Federal Preemption

On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva...more

Proposed Federal Breach Notification Law: Panacea Or Flash in the Pan?

The Obama Administration has just released the proposed text of the Personal Data Notification & Protection Act as the latest step in its uniform federal breach notification initiative. Similar legislative efforts in the past...more

Banking software patent is found to be invalid

Robinson, J. Defendant’s motion for summary judgment of invalidity is granted; plaintiff’s motion for validity is denied. Defendant’s motion for summary judgment of non-infringement is granted; plaintiff’s motion for...more

The Day the Exception Swallowed the Rule: Is Any Software Patent Eligible After Ultramercial III?

The Supreme Court has consistently cautioned that the judicial exceptions to patent eligibility need to be carefully applied: At the same time, we tread carefully in construing this exclusionary principle lest it...more

Federal Circuit Review - November 2014

Japan Airlines Activities For US Government Cannot Infringe - In IRIS CORP. v. JAPAN AIRLINES CORP., Appeal No. 2010-1051, the Federal Circuit affirmed a decision to dismiss due to a conflict of laws. IRIS owns...more

"Generic" Logic Helps Branded Drug Achieve Dismissal

A federal district court has held that design defect claims against a brand pharmaceutical manufacturer are preempted by federal law. Booker v. Johnson & Johnson, No. 3:12 oe 40000, 2014 WL 5113305 (N.D. Ohio Oct. 10,...more

Beginning to Close the POM Circle? – POM Wonderful and Drug Advertising: JHP Pharmaceuticals

Earlier this year, in POM Wonderful LLC v. Coca-Cola Co.,[1] the Supreme Court examined the interaction between the Lanham Act’s prohibition against false advertising and the FDCA’s prohibition against food, drug and...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

Patent Protection for Isolated Genetic Sequences Upheld in Australia

Last year in AMP v Myriad Genetics, the U.S. Supreme Court concluded that isolated, naturally occuring DNA are not patent eligible, which caused considerable consternation in the biotech community. However, this does not...more

The USPTO Patent Subject Matter Eligibility Guidance TRIPS Over Treaty Requirements

The “Myriad-Mayo” patent subject matter eligibility guidance issued March 4, 2014 reflects the USPTO’s interpretation of Supreme Court cases interpreting and applying 35 USC § 101 to claims involving laws of nature, natural...more

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

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