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ANDA Update - March 2017 Volume 3, Number 1

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

What If We Win? Off-Label Promotion & Product Liability

Since the nomination of Dr. Scott Gottlieb to head the FDA, we’ve seen quite a few references to his opposition to the current FDA prohibition against off-label promotion – regardless of the truth of the promotion itself. We...more

Another Court Tackles Prescription Drug Design Defect

If you have been following along for a while, then you have surely run across our posts making some combination of the following points: 1) design defect claims rarely make sense for a drug because changing the design in...more

Solicitor General Urges Supreme Court to Reverse California’s Ill-Conceived Version of “Specific Jurisdiction”

The Defendant/Petitioner has filed its merits brief in the U.S. Supreme Court in BMS v. Superior Court. This is the case where the California Supreme Court expanded specific personal jurisdiction beyond recognition by basing...more

There’ll Always Be Posner: Reversal of Class Certification in the Blink of an Eye

We’ve seen it before. The Southern District of Illinois will certify class actions with no real cause of action and no real damages. While not as bad as the drive-through-class-certification state courts in southern...more

Hip Implant MDL Denies Summary Judgment on Claims of Plaintiffs Who Failed to Preserve Explanted Devices

Regular readers of this blog know that we have a pretty jaded view of many MDLs. Obviously consolidation makes sense, at least on paper, in terms of efficiency and the best use of scarce court resources. But, in practice,...more

JPML Refuses MDL for Proton Pump Inhibitor Kidney Injury Cases

A multidistrict litigation (MDL) can be a sound way of managing a mass tort. Efficiencies are available (e.g., deposing company witnesses only once) and the U. of Chicago part of us dreams of economies of scale. Then again,...more

What The Intuitive Ruling Means For Medical Device Makers

Last month, in Taylor v. Intuitive Surgical Inc., the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law — the duty to warn hospitals about potential risks their...more

Limiting Extraterritorial Reach of U.S. Patents: "Substantial" Means More than One

Last week, the Supreme Court provided much-needed clarity to U.S. companies concerned about their potential liability for supplying a single component of a multicomponent invention abroad. The Court’s decision in Life...more

Southern District of Indiana Excludes Plaintiffs’ Experts in Hernia Mesh Case

We loved La La Land. We were enchanted by the colors and the music and the dancing. We were transported by the dreams-come-true and saddened by the could-have-beens. We disappeared into the characters’ world for two hours...more

Wrong Inventor Defense Fails in Pharmaceutical Litigation

Addressing derivation and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s denial of a generic drug manufacturer’s attempt to invalidate a patent based on the theory that the...more

News from Abroad -- Swiss-style Patent Claims Can Be Very Valuable in Australia

The scope for enforcement of Swiss-style claims may be broader in Australia than for method of medical treatment claims. Second medical use inventions can be claimed in an ever increasing number of claim formats depending on...more

On Alternative Design, Take Two - Negligence

Back in 2013, inspired by a win of our own that we were actually allowed to blog about, we put up a post entitled “On Alternative Design.” Taking the alternative design requirement for strict liability as a given, we...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

Florida Supreme Court Rejects More Rigorous Expert Testimony Standard

The federal court system and 36 states have adopted the so-called Daubert standard in place of the Frye standard when it comes to qualifying expert witnesses under the rules of evidence. In 2013, the Florida Legislature...more

Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim

Over the years, comedian Adam Carolla has played the “Germany or Florida” game on his various radio and tv programs and podcasts. The game is based on the observation that many of the most bizarre stories of human ineptitude...more

Non-Physician Learned Intermediaries

One of us was asked a question the other day that we couldn’t answer immediately. “Does the learned intermediary rule apply to a physician’s assistant?” We didn’t remember any cases actually deciding that issue. So we did...more

What Is “Product Liability”?

We’re serious – we’re not planning to give a flip answer like “an extortion racket.” No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?” (Hint – that’s discussed...more

Briefing Complete in Appeal in Amgen v. Apotex

The parties in Amgen v. Apotex have completed briefing in Amgen’s appeal to the Federal Circuit from the district court’s judgment of noninfringment. As we have previously reported, in September 2016 the District Court for...more

The Anthem Breach – A Retrospective (Part II)

We published Part I of our “Anthem Breach Retrospective” in January 2017. Coincidentally, at around the same time several plaintiffs in one of the earliest filed cases arising out of the Anthem data breach voluntarily asked...more

Update: Praluent® Injunction Stayed by Fed. Circuit

On February 8, the Federal Circuit issued a stay of the permanent injunction granted against the sale of Sanofi and Regeneron’s Praluent® (alirocumab). The injunction was to have become effective on February 21, 2017, but as...more

Nebraska Daubert Order Finds Expert a Mile Wide at the Mouth, But Only Six Inches Deep

A case from Douglas County, Nebraska, caught our eye this week for a couple of reasons. It’s a great Daubert order in an Accutane case in Nebraska state court. In addition to that, this blogger’s mother grew up on a farm in...more

Borderline products: Marketing food supplements in the UK following the glucosamine case

In late December 2016, the Supreme Court rejected the Medicines and Healthcare Products Regulatory Agency's (MHRA) application for permission to appeal against the decision of the Court of Appeal in R. (on the application of...more

Unreliable Expert Causation Evidence Ends Birth Defect Case

We have posted several times in the last few years (like here, here, here, and here) about cases alleging birth defects from maternal SSRI use during pregnancy. Perhaps because of the inherent sympathy for the plaintiff...more

Product Liability Update: January 2017

Massachusetts Appeals Court Holds Birth Control Patch Manufacturer Had Duty to Warn Patient Directly But Packet Insert Adequately Warned of Greater Risk of Blood Clots As Compared to Birth Control Pill; Design Defect Claim...more

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