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Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Smoke Screens & Side Shows

by Reed Smith on

We confess, we can’t think of any good reason for admitting evidence concerning product risks that the plaintiff in a particular case never actually encountered – yet plaintiffs try it with a straight face all the time. It’s...more

WDNY Holds that Tysabri Warnings are Adequate as Matter of Law and that Product Liability Claims are Preempted

by Reed Smith on

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn. Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff...more

Vast – Or at Least Half-Vast – Conspiracy Claim Dismissed

by Reed Smith on

Imagine a conspiracy so vast that it includes not only your usual plaintiff-side fantasy of the FDA conspiring with a drug company, but also high FDA officials, President Obama, Robert Mercer (noted Trump supporter and...more

Another One Bites the Dust: Plaintiff’s Causation Expert Excluded in Hernia Mesh Litigation

by Reed Smith on

We spent Sunday evening in the familiar confines of a top-notch local professional theatre. The production was a short (80-minute), two-character play. It was entirely dialogue-driven, so everything the audience learned came...more

Healthcare Fraud and Abuse Review 2016

by Bass, Berry & Sims PLC on

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

Plaintiffs’ Causation Expert Renounces His Own Conclusions – and Withdraws – in Mirena IIH Litigation

by Reed Smith on

We have blogged before about the Mirena IUD litigation. Cases alleging injuries from device migration and uterine perforation were centralized in an MDL in the Southern District of New York but summary judgment was granted...more

Another Step Toward Reasonable Preemption Case Law

by Morrison & Foerster LLP on

Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th...more

Non-Existent Duty to Warn of Mensing Not Enough to Get Around Mensing Preemption

by Reed Smith on

Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal. Part of why the defendant drug or device manufacturer may prefer federal...more

Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)

In inter partes review proceedings, is the U.S. Patent and Trademark Office's Patent Trial and Appeal Board required to take into account a final district court determination of non-obviousness of the same claims based on the...more

Does Buckman Preemption Apply to Antitrust and RICO Claims?

by Reed Smith on

We talk a lot on this blog about Buckman preemption. That isn’t just out of pride regarding Bexis’s role in the bone screw litigation that led up to the Buckman decision. The principle in Buckman is important. What happened...more

PTAB Life Sciences Report -- Part II - April 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Teva Pharmaceuticals USA, Inc. v. Allergan, Inc. - PTAB Petition: IPR2017-00576; filed...more

Parallel Claims in PMA Medical Device Complaint Warrant Federal Question Removal

by Reed Smith on

We were wondering when the courts would catch on to this Catch 22. In order to survive preemption, plaintiffs suing the manufacturers of pre-market approved (“PMA”) medical devices have to allege “parallel claims” in which...more

Update – Which Decisions Have Excluded Dr. Parisian, And About What?

by Reed Smith on

Back in 2013, we published a comprehensive post on the checkered Daubert history of the notorious and prolific (in equal amounts) plaintiff-side “FDA expert” (although she routinely attempts to opine way beyond FDA matters) –...more

Court Rules that Prisoner is Entitled to Off Label Drug Treatment

by Reed Smith on

Happy birthday to Eric Idle, one of the funniest members of the Monty Python troupe. In addition to writing bizarre, hilarious comedy skits, Idle also wrote songs. When he proposed a song for The Life of Brian, he ran into...more

Eleventh Circuit Affirms A Very Unhappy Unverdict Against Hip Manufacturer

by Reed Smith on

A funny thing happened on the way to a defense verdict last year—after the jury decided that the defendant’s product was not defective, the MDL judge told the jurors that perhaps they did not “fully understand” and instructed...more

Merck Fails to Obtain Summary Judgment on Preemption Defense – Third Circuit Rules “Impossibility Preemption” Presents a Question...

In re: Fosamax (Alendronate Sodium) Products Liability Litigation, Nos. 14-1900 et al. (3d Cir. March 22, 2017). In a precedential decision issued on March 22, 2017, the United States Court of Appeals for the Third...more

ANDA Update - March 2017 Volume 3, Number 1

by McDermott Will & Emery on

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

by Reed Smith on

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

by Reed Smith on

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”

by Reed Smith on

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

by Reed Smith on

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

by Reed Smith on

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

by Reed Smith on

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

by Morrison & Foerster LLP on

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

by Foley Hoag LLP on

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

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