The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community. Id. at 350. Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.” Id. at 351 n.5 (citation and quotation marks omitted).
We Report on FDA-Based Failure-To-Report Claims – A Fifty-State Survey (Part 3)
Now that all three parts of our 50-state survey examining the state of state law concerning allegations that a defendant can state a common-law cause of action where the allegedly liability creating conduct is failure to make a statutorily mandated report to a governmental agency has been published, we have consolidated all fifty states under
Testing, One, Two, Three….
The Ninth Circuit recently answered a preemption question that we had seen arise intermittently, mostly in food litigation, over the past couple of years. Because the relevant preemption clause closely resembles the language of the Medical Device Amendments (“MDA”), we thought it was worth a look.
In Webb v. Trader Joe’s Co., ___ F.3d
Zofran Preemption Victory – Entire MDL To Be Dismissed
We’re old enough that we remember the pre-Daubert Bendectin litigation. Bendectin was the only FDA-approved drug indicated for nausea and vomiting from pregnancy. Yellow journalism (the National Enquirer) and scientific fraud (deliberately falsified scientific data) fanned a birth defect scare, which led to an avalanche of factually baseless litigation – Daubert was
Quasi-Guest Post – Feel the Brr: Cryotherapy Manufacturer Wins in Florida
What follows is another “guest post” by our sixth (actually seventh)-man poster, Dean Balaes. It features litigation that the good guys won the old-fashioned way – with warnings that were adequate as a matter of law. Take it away Dean.
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Legal professionals know all too well that building a healthy and active lifestyle
What To Make of the Dan Abrams Case?
The recent appellate False Claims Act (“FCA”) decision in Dan Abrams Co. LLC v. Medtronic Inc., ___ F. Appx. ___, 2021 WL 1235845 (9th Cir. April 2, 2021), has us scratching our heads. It’s like riding a legal roller coaster. Some parts are really high, and others are really low.
Bexis first ran across
Useful Law Review Article on State MDL Practice
There is a lot of scholarship and other material out there on issues having to do with federal multidistrict litigation (“MDL”) practice. See, e.g., footnote three, in the article below. But state MDL equivalents? Not so much. The Blog’s co-founder wrote a book about this a while ago, see Herrmann, et al.,
We Report on FDA-Based Failure-To-Report Claims – A Fifty-State Survey (Part 2)
Now that all three parts of our 50-state survey examining the state of state law concerning allegations that a defendant can state a common-law cause of action where the allegedly liability creating conduct is failure to make a statutorily mandated report to a governmental agency has been published, we have consolidated all fifty states under
More Updates
This post is to update our readers about subsequent developments in matters covered in some of our prior blogposts.
First, slightly over a year ago we praised Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020), a prescription drug preemption decision holding, among other things, that a plaintiff could not claim “newly
Zantac Chronicles IV – The Preponderance of Preemption
The first three significant Zantac MDL decisions, which we chronicled here, here, and here, were all issued on December 31, 2020. Today’s installment, In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2021 WL 76433 (S.D. Fla. Jan. 8, 2021), was issued this year. For those of you who