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Lack of Proximate Cause for Failure to Warn Nets a Directed Verdict

A week ago, in a post-script to a post on Daubert decisions, we reported that the trial court in Hexum v. Eli Lilly & Co., No. 2:13-cv-02701-SVM-MAN, 2015 U.S. Dist. LEXIS 109737 (C.D. Cal. Aug. 18, 2015), had granted...more

Preemption (and Other Things) Defanging Depakote Claims

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they...more

Central District of California "Discontinues" Much of Plaintiffs' Experts' Testimony in Cymbalta "Discontinuation Symptoms" Case

“I’m not a doctor, but I play one on TV” – shorthand for “I am pretending to know what I’m talking about, but I really don’t.” We have blogged frequently about experts inclined to such pretense and about courts’ varying...more

Life Sciences Companies and Free %$&*@# Speech

Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more

Data processing company hit with class action lawsuit for data breach and Judge denies class certification the next day

Advanced Data Processing, Inc. and Intermedix Corp. were sued in federal court in Florida last week for violating the Health Insurance Portability and Accountability Act (HIPAA) for failing to protect the health information...more

Telemedicine Prescribers Should Read This Case: U.S. vs. Zadeh

Health care providers who use telemedicine for remote prescribing of controlled substances should pay close attention to an important case currently pending at the Fifth Circuit Court of Appeals. The case will decide whether...more

How To Handle Homeopathy?

Search for “homeopathy” on the Internet, and one quickly discovers that this particular form of “alternative medicine,” does not have the greatest reputation. Wikipedia, not always an unimpeachable source, but usually OK for...more

Proposed class action case filed against Medical Informatics Engineering

Medical Informatics Engineering, Inc., an electronic medical record service provider, recently disclosed a data breach affecting approximately 4 million individuals. Within days of the disclosure, Medical Informatics was hit...more

The Supreme Court Addresses Scope of Section 11 Liability for Statements of Opinion

As the Supreme Court recently explained in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 135 S. Ct. 1318 (2015), that distinction is significant when it comes to liability under Section 11 of...more

Class action filed against UCLA following data breach

We previously reported that UCLA suffered a data breach affecting 4.5 million patients. Days following the announcement of the breach, plaintiffs filed a proposed class action lawsuit against UCLA, alleging that UCLA should...more

The Revolution that Wasn’t: New Jersey’s Direct-To-Consumer Exception to the Learned Intermediary Doctrine

The learned intermediary doctrine – in which a manufacturer’s duty to warn runs to the physician, not to the patient – is one of the most potent weapons in the arsenal for a pharmaceutical or medical device manufacturer faced...more

All About That Base: Claim Against Fat Loss Supplement Maker Fails For Lack of Ascertainability

Adam Karhu bought a dietary supplement called VPX Meltdown Fat Incinerator (“Meltdown”) in reliance on advertising by Vital Pharmaceuticals, Inc. (“VPX”) that Meltdown would result in fat loss. Concerned that Meltdown did not...more

Louisiana Appellate Court Overturns Improper Application of “Law of the Case” Doctrine

Today is the day when we will learn whether the Governor of Louisiana will enter the 2016 presidential race. That reminds us of Louisiana’s rather colorful collection of politicians, including Huey Long and Edwin Edwards....more

Recent Cases Consider Patent Eligibility Under Mayo/Alice “Two-Step” Test: Invoking Routine and Conventional Elements Is Not...

In a series of cases addressing whether inventions are eligible for patent protection under 35 U.S.C. § 101, the U.S. Supreme Court has adopted a two-step analysis. Two recent decisions by the U.S. Court of Appeals for the...more

Advocate Health data breach class action suit dismissal upheld by Appellate Court

In August of 2013, four computers of Advocate Health and Hospitals Corporation (Advocate Health) were stolen from one of its offices. The computers contained the names, dates of birth, Social Security numbers, health...more

Federal Circuit Finds Revolutionary Non-Invasive Fetal DNA Test Method Unpatentable Under Mayo

On June 12, 2015, in Ariosa Diagnostics, Inc. et. al. v. Sequenom, Inc. et. al., the Court of Appeals for the Federal Circuit invalidated claims in U.S. Patent 6,258,540 directed to methods for detecting paternally inherited...more

U.S. Appeals Court Finds Prenatal DNA Test Unpatentable

The United States Court of Appeal for the Federal Circuit in the District of Columbia came down with another blow for the patentability of biotech testing products on Friday, June 12, 2015. The Court affirmed the 2013...more

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

Lack of Typicality and Adequacy of Representation Prevents Class Certification in Health Care Data Breach

The opinion from the Philadelphia Court of Common Pleas reinforces lack of standing as a defense for companies facing data breach–related class actions. On March 25, the Philadelphia Court of Common Pleas provided...more

IP Newsflash - June 2015

FEDERAL CIRCUIT CASES - CAFC: If (No Factual Findings), Then (No Deference) - Two days ago, on remand from the U.S. Supreme Court, the Federal Circuit in Shire v. Watson again affirmed its reversal of the...more

Texas Telemedicine Rule Delayed by Antitrust Suit

A Texas Medical Board rule requiring a physician to conduct an in-person evaluation before prescribing certain drugs will not go into effect today, June 3, as originally planned. A federal court granted a preliminary...more

Health Alert (Australia) - June 1, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Australia. Family Court - 22 May 2015 - Re Ashley [2015] FamCA 37 The Family Court has found that a 17 year old...more

Actavis Loses Nameda® Appeal Over “Hot Documents”

The U.S. Court of Appeals for the Second Circuit’s opinion (issued May 22, 2015 with a public, redacted version available May 28, 2015), affirming the district court’s grant of a preliminary injunction in State of New York v....more

Product Hopping and Antitrust: Mylan Court Dismisses Claims on Summary Judgment, Citing Need to Avoid Chilling Pharmaceutical...

A recent summary judgment opinion from the Eastern District of Pennsylvania breaks new ground in the developing antitrust law on “product hopping” claims. “Product hopping” refers to the practice of changing the form or...more

What Does Pharmacogenomics Have To Do With Product Liability? – Potentially Everything

Recently, Bexis attended the DRI drug and device committee spring conference. Among other things he heard a bang-up presentation on genomics and personalized (also known as “precision”) medicine from Paige Sensenbrenner. On...more

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