Conflict of Laws Products Liability

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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

GMO Disclosures and Claims: A Possible End to the U.S. GMO Labeling Controversy?

On July 7, 2016, the U.S. Senate passed an important amendment to S. 764 to establish a mandatory nationwide labeling approach for genetically engineered (GE) foods, more popularly referred to as genetically modified...more

Forget About Vermont!: Congress Passes GMO “Labeling” Legislation

On July 14, 2016, the House of Representatives passed S.764 creating a National Bioengineered Food Standard. Importantly for food manufacturers and distributors, the law – expected to be signed by President Obama – will...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

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

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

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

New York, New York: The Status of Regulation of Children's Products in the Empire State

Recently, Albany County, New York enacted the “Toxic Free Toys Act” (the Act) prohibiting the sale of any children’s products in the county that contain certain heavy metals and chemicals. The Safe to Play Coalition (the...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

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

Federal Preemption Narrowed For Aviation Suppliers In Sikkelee v. Precision Airmotive Corp.

On April 19, 2016, the Third Circuit Court of Appeals issued its opinion on the issue of federal preemption in Sikkelee v. Precision Airmotive Corp. The sixty-one page opinion effectively narrowed the scope of federal...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

Third Circuit Limits Federal Aviation Act Preemption for Product Liability Claims

In a departure from a string of cases supporting field preemption of state-law aviation product liability claims under certain circumstances by the Federal Aviation Act (FAAct), the Third Circuit recently held that the FAAct...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

Federal Preemption of State and Local Laws Governing Children's Products

In January 2015, Albany County became the first of several municipalities in New York to enact a version of the “Toxic Free Toys Act” ("the Act") prohibiting any amount of six heavy metals and benzene in children’s products...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

Cut the Fat . . . Just Not Yet: Court Rules that PHO Claims Are Preempted

Northern District of California Judge Maxine Chesney recently granted Nestlé’s motion to dismiss a challenge to partially hydrogenated oil (PHO) in Nestlé’s Coffee-mate® coffee-creamer products, finding plaintiff’s claims...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

GMO Labeling Debates Forge On After Close Senate Vote

The GMO war rages on after a close vote in the Senate last week addressing proposed voluntary, national standards for GMO labeling. A 48-49 split means the Senate failed to invoke cloture to bring the Biotechnology Labeling...more

Testing 101: Court Dismisses Whole Foods’ Yogurt MDL over Failure to Comply With FDA Testing Requirements

On February 16, 2016, U.S. District Judge Sam Sparks of the Western District of Texas dismissed a multidistrict litigation involving 11 putative class action lawsuits against various Whole Foods corporate entities and...more

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