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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

Yet Another Failure-To-Update Claim Bites the Dust

In terms of the legal gyrations plaintiffs try to avoid preemption, we’ve already expressed our opinion that so-called “failure to update” claims take the booby prize. There are good reasons, discussed in these prior posts,...more

Vermont Act 120 and Beyond: Genetically Engineered Foods, Where Are We Now?

On July 1, 2016, Vermont’s genetically engineered food labeling law is set to become effective. Act 120 and its implementing rule (Vermont Consumer Protection Rule 121) require food manufacturers to label food products that...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

“GMO” Labeling Food Fight: How Vermont’s Act 120 Is Pressuring An Entire Industry

On July 1, 2016, Vermont’s Act 120 will require food manufacturers to indicate in the labeling of all products regulated by FDA when the food has been produced with the use of genetic engineering (GE). Unless Congress acts...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

FDA Biosimilars Guidance Not Conducive To Preemption

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for...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

FAA Releases Guidelines For Local Regulation Of Drones

In the past few years unmanned aircraft systems, commonly known as drones, have grown in popularity and availability. With the proliferation of drones comes some difficult privacy and public safety questions for school...more

Google Asks Congress For Self-Driving Car Help

As reported almost everywhere, on Tuesday, March 15, Google told a Senate Hearing that Congress should pass legislation regulating self-driving cars. Google, through Chris Urmson (Director, Self-Driving Cars), explained that...more

Privacy Regulation Regime Change: Bad or Good for ISPs?

The Federal Communications Commission (“FCC”) is on the verge of proposing new federal privacy regulations for internet broadband service providers (“ISPs”). ISPs were previously policed by the Federal Trade Commission...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

Health Care Update - March 2016

Senate HELP Committee Set for Second Mark Up on Cures Effort - This week, the Senate Committee on Health, Education, Labor and Pensions (HELP) will hold its second legislative mark-up on its counterpart to the...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

Liability for Brand Drug Manufacturers All But Clear

Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...more

School Districts and Drones: The Door Remains Open for Regulation Efforts

Unmanned Aircraft Systems ("UAS"), otherwise known as drones, are everywhere. Literally. And their recreational use is likely to become even more prevalent given the hundreds of thousands of UAS's that were projected to be...more

Upcoming Federal Circuit Decision Presents Opportunity for Clarification of Patentable Subject Matter

Since Alice, consistently defining the bounds of statutory subject matter in computer arts confounds even the most experienced attorneys. E-commerce software combining visual elements of multiple parties’ websites is patent...more

Drone on Drones: Arizona Bill Would Preclude Local Government Drone Regulation

The Arizona Senate has introduced new legislation creating a comprehensive state policy on drone use that would preempt cities from enacting their own regulations. While the bill is likely to see major changes before becoming...more

California AG Proposes State Consensus on Breach Laws

Businesses scrambling to comply with the dozens of varying state laws governing data privacy and security breaches may have a new ally in California Attorney General Kamala Harris, but they shouldn’t expect her to relax any...more

Drones - The Division Between Federal and State Law and What it Means to You

Underscoring the shifting regulatory landscape applicable to Unmanned Aircraft Systems (UAS or drones), the Federal Aviation Administration (FAA) on December 17, 2015 put state and local governments on notice that they cannot...more

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