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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

Software Patent Eligibility: Preemption Gets Starring Role at the Federal Circuit

The Supreme Court decision Alice Corp. v. CLS Bank, 134 S. Ct. 2347 (2014) pronounced, in no uncertain terms, preemption “drives” patent subject matter eligibility and its exceptions. But after Alice, it appeared preemption’s...more

REDUCING RISKS: Court Finds Copyright Act Does Not Preempt State Trade Secret Claim

Over the years, it has proven difficult to fit software in any one category of IP protection. And while software’s ability to seemingly transcend patents, copyright, and trade secrets provides software developers and...more

McRo: Preemption Matters After All

The Federal Circuit has released its long-awaited opinion in McRo v. Bandai, reversing the lower court’s decision that the claims were ineligible subject matter. McRo’s invention in U.S. 6,307,576 was a method used in 3D...more

The Demise of the Presumption Against Preemption in Express Preemption Cases

We’ve always been bothered by the presumption against preemption – so much that this blog’s first major substantive post was on that subject. Even before that, back in the Bone Screw days, we remember the presumption against...more

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

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

FCC Thwarted in Efforts to Preempt State Broadband Laws

The U.S. Court of Appeals for the Sixth Circuit has struck a major blow to the FCC’s efforts to remove barriers to broadband service and promote competition in broadband markets. In State of Tennessee v. FCC, the court...more

Sixth Circuit Rejects FCC’s Effort To Preempt State Regulation Of Municipal Broadband Providers

The FCC’s February 2015 meeting yielded two significant and controversial orders premised on the agency’s authority under Section 706 of the Communications Act: its much-publicized Open Internet Order, and its less-publicized...more

California Court Clears The Way For Express Preemption

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

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

Another Prescription Drug Warnings Preemption Decision

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

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

Dismissing Drug Design Defect Based on Preemption

In a rare harkening to our past and discussion of specific judges, we recall that our first gig after law school was clerking for Judge Jon P. McCalla of the United States District Court for the Western District of Tennessee....more

San Francisco vs. The Monster (aka Federal Regulation)

There is a lawyer we worked with at another firm who had a standard move, kind of the way that Jerry Seinfeld had a standard “move” – and, come to think of it, with a similar intention. (“The Move” shows up in “Fusilli...more

Trimming Some Fat From Statin Litigation With Daubert and Preemption

In the mythical days of product liability yore, a big drug litigation was spurred by a notable event—like a study describing a new risk appearing in a major journal, a significant labeling change because of new or greater...more

Preemption: Oregon Has Not Gone Bananas

Can you get sued over a picture of a banana? It seems the answer might depend on where you live and probably not in Oregon. That is one takeaway from a good preemption case that came out of the District of Oregon last week,...more

C.D. Cal. Dismisses Infusion Pump Complaint

The plaintiff in Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump implanted to treat her chronic low-back pain. According to the plaintiff, the device...more

Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”

According to Black’s Law Dictionary, “a fortiori” is legal Latin meaning: - By even greater force of logic; even more so it follows. We’ve been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567...more

Comment K Case by Case – Falling Out of Favor?

When we examined Restatement (Second) of Torts §402A, comment k (1965), in our 2011 research post “Comment K, Some of the Way,” we remarked about how it said “a lot of things,” including: (1) that one can’t design away...more

Federal Preemption Claims: Clear Evidence and an Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The...more

Guest Post - Design Defect Preemption - It’s as Simple as One, Two, Three

Courts are starting to “get” the design defect preemption argument. That makes sense because the argument is simple. Any major changes in the design of a drug or a medical device require the prior approval or permission of...more

Silence Would Have Been Golden: Unnecessary Illogical Preemption Decision in Motrin SJS/TENS Summary Judgment Victory

We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard...more

Think Mink, part 2: Florida Federal Court Slams Door on Parallel Claims

Last November we blogged about "specialized" preemption issues in several cases, including Mink v. Smith & Nephew, Inc., 2015 WL 7356285 (S.D. Fla. Nov. 19, 1015). The plaintiff in Mink claimed physical injuries from a...more

Preemption And Causation Do Away With Contraception Lawsuit

With Spring Training well underway, we took notice of the solid base hit delivered last month by the Northern District of California in La Paz v. Bayer Healthcare LLC, No. C 15-03995, 2016 U.S. Dist. LEXIS 13058 (N.D. Cal....more

Patentable Subject Matter after Alice: Best Practices for Responding to 35 U.S.C. § 101 Rejections

It has been over 20 months since the Supreme Court handed down the landmark decision in Alice Corp. v. CLS Bank Int’l, effectively limiting the scope of patent-eligible subject matter. In particular, software and business...more

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