News & Analysis as of

Pharmaceutical Industry Preemption

“Pre-Approval” Design Defects - No Such Thing

by Reed Smith on

As our post-Levine preemption cheat sheet demonstrates, Mensing/Bartlett preemption is breathing down the necks of all prescription drug design defect claims. Recent cases finding preemption of design defect claims due to...more

How Will The Supreme Court Choreograph The Biosimilar Patent Dance?

by Foley & Lardner LLP on

On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more

Breaking News: Cerveny – “Clear Evidence” Preemption Wins on What Matters Most

by Reed Smith on

On May 2, 2017, the Tenth Circuit affirmed in part, reversed in part, and remanded the post-Levine branded drug preemption decision in Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017). ...more

Breaking News: Cerveny – “Clear Evidence” Preemption Wins on What Matters Most

by Reed Smith on

On May 2, 2017, the Tenth Circuit affirmed in part, reversed in part, and remanded the post-Levine branded drug preemption decision in Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017). ...more

Amgen v. Sandoz: The Supreme Court’s First Tussle with the BPCIA

by Mintz Levin on

On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act...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

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

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

by Reed Smith on

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

What Is “Product Liability”?

by Reed Smith on

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

Iowa Drug Pricing Disclosure Law Bites the Dust

by Faegre Baker Daniels on

In 2014 Iowa enacted a statute requiring pharmacy benefit managers (PBMs) to disclose pricing methodologies to their network pharmacies and to the State Insurance Commissioner. Is the statute “a patchwork of costly mandates...more

SDNY Applies Preemption in Favor of Branded Drug

by Reed Smith on

On January 3, 2017, we commenced the dreary process of taking down the Christmas decorations. The German nutcrackers slid back into their cartons. Stockings marched from the mantle into plastic storage containers. We picked...more

The Peaks – The Ten Best Prescription Drug/Medical Device Decisions of 2016

by Reed Smith on

Today we’re going peak bagging – no, not to the Canadian Rockies or Patagonia (we leave that to Bexis) – for the high points in this year’s drug/medical device product liability jurisprudence. Last week, we visited the...more

Implied Preemption and Monograph Drugs

by Reed Smith on

The Reed Smith blogging team has just returned from this year’s annual ACI Drug & Medical Device Litigation conference. In addition to excessive amounts of eating, drinking, and socializing (now called “networking”), we kept...more

Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption

by Reed Smith on

When we first set foot on the University of Chicago Law School campus back in 1982, Chicago sports were a mess. But quickly – certainly more quickly than our ability to grasp the Rule in Shelley’s Case, Last Clear Chance, or...more

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more

IVC Filter Litigation – Judge says no to Protective Order

Plaintiffs in a Multi District Litigation (“MDL”) filed complaints against Cook Medical Inc. (“Cook”) and alleges that Cook knowingly presented false information regarding the safety profile of its IVC filters to physician...more

Wisconsin Preemption Ruling Makes Our Cheese Curdle

by Reed Smith on

A federal judge in Wisconsin issued an order a few weeks ago that covers two topics on which we often write—negligence per se and implied preemption. The two concepts are not unrelated. We most commonly see negligence per se...more

Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

by Reed Smith on

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison...more

California Court Clears The Way For Express Preemption

by Reed Smith on

Not everyone sees eye to eye on federal preemption, including judges. Take for example the conflicting opinions from the California Court of Appeal applying the express preemption provision of the Medicare Prescription Drug,...more

A One-Two Punch Case With An Off-Label Twist

by Reed Smith on

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

Something Went Right In Brazil

by Reed Smith on

Zika virus, Olympic unpreparedness, economic collapse, presidential impeachment - a lot of things have gone wrong in Brazil lately. But we’re not here to talk about any of that. Here’s something that went right: Brazil v....more

Another Prescription Drug Warnings Preemption Decision

by Reed Smith on

Not that our readers are dying for a glimpse behind the curtain into the making of the sausage (and mixed metaphors) of the blog, but we do try to first figure out what decisions may be blogworthy before we start writing up...more

The Difference Between Manufacturing and Design Defects

by Reed Smith on

Some plaintiffs seem to think that if they allege any problems about anything in the manufacturing process of a prescription medical product, then it falls under the rubric of “manufacturing defect.” They’re wrong, of course....more

Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking

by Latham & Watkins LLP on

FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more

Stick a Fork in It – FDA Anti-Generic Drug Preemption Proposal Postponed Until After the Presidential Election

by Reed Smith on

On May 18, the FDA extended the comment period for its proposed generic drug labeling rule until April 2017 – that is, until after the next presidential election. We believe that, for all practical purposes, this means that...more

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