Kelley v. C.R. Bard, Inc., 2023 WL 2565853 (N.D. Ga. March 17, 2023), reconsideration denied, 2023 WL 3032063 (N.D. Ga. April 21, 2023), became the latest decision to follow what used to be (before the Pelvic Mesh litigation used the law in this area as a settlement tool) the overwhelming majority rule, that FDA decisions to allow products to be marketed – including §510(k) clearance – were routinely admissible.
Continue Reading Another Decision Admitting Evidence of FDA §510(k) Clearance
In updating chapter three of his book, on non-informational causes of action, Bexis had the opportunity to add the last several years of “alternative design” opinions. Quite a few states, as well as the Third Restatement of Torts, require plaintiffs alleging design defects to identify a “feasible” alternative design for the product as a prerequisite for asserting a design defect claim. Even where an alternative product design is not mandatory, plaintiffs frequently offer such evidence. In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.”
But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Thus, as a matter of logic and semantics, “feasibility” would seem to demand that any proposed “alternative” to the existing design of a product subject to FDA scrutiny must likewise have passed the same level of FDA scrutiny. For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims.
Today’s guest post is by Jim Fraser of Greenberg Traurig. Jim is a long-time product liability defense lawyer, but who also worked as a litigation attorney in FDA’s Office of the Chief Counsel (“OCC”). Utilizing his FDA perspective, he offers some useful suggestions on the regulatory aspects of defending drug or medical device product liability cases. As always, our guest-posters are 100% responsible for what they wrote, deserving all of the credit and (any) of the blame.
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Lawyers defending drug and medical device companies in product liability litigation routinely deal with FDA-related issues. For example, they present expert witnesses to testify that their clients complied with the applicable regulatory requirements, they move to exclude purportedly “bad” FDA documents (e.g., FDA Form 483s and Warning Letters), and they file summary judgment motions arguing that the FDCA or FDA regulations preempt plaintiffs’ claims.
Continue Reading Guest Post – What a Product Liability Defense Lawyer Learned While Working for FDA.
The defendants in Mixson v. C.R. Bard, Inc., ___ F. Supp.3d ___, (N.D. Fla. Sept. 16, 2022) (“Mixson I”), and Mixson v. C.R. Bard, Inc., 2022 WL 7581737 (N.D. Fla. Sept. 23, 2022) (“Mixson II”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results.
We have been consistently critical of the MDL system for encouraging judges presiding over such massive aggregations to manipulate the applicable law to create settlement pressure on defendants. We’ve seen that with federal preemption, willingness to create novel state-law causes of action, choice of law, and trial consolidation of multiple plaintiffs.
We’ve blogged numerous times about the tentative, non-final, and informal status of FDA warning letters (and untitled letters and similar enforcement precursors like Form 483s). We’ve cited precedent, FDA internal manuals, FDA’s own position taken in formal briefing, and learned treatises on FDA law. That an FDA warning letter has no binding legal effect (indeed,
Today’s guest post is by Camille L. Fletcher and Joshua Kipnees, both with Patterson Belknap. We actually sought out this guest post, which is rare. We first saw it on one of Patterson’s in-house firm blogs, and it was one of those rare law firm posts that did more than describe a
Today’s guest post, by Luther Munford of Butler Snow, engages in one of our currently favorite activities, that being informed speculation on what might be the consequences of a favorable Supreme Court resolution of its currently pending preemption appeal in Merck Sharp & Dohme Corp. v. Albrecht. We hope he’s right. As always, our
It is now 2019, but we are still finding bits of leftover 2018 business on our desk and in our emails. Towards the end of last year, we encountered an avalanche of good rulings from the Southern District of Indiana in the Cook IVC filters litigation. Here is one we found hidden in the toe
As we demonstrated in a post back in 2013, FDA compliance evidence generally − and the fact of a medical device’s clearance as “substantially equivalent” in safety and effectiveness to a predicate device under §510k of the Medical Device Amendments (now 21 U.S.C. §360c(f)(1)(A)) specifically – had for decades been admissible evidence in product