We have lost track of how many times we have written on pelvic mesh cases as they have gone through a number of district courts on remand and occasionally up on appeal to circuit courts. One theme we have seen play out over and over is that plaintiff lawyers who took on more cases than
What’s the point of spilling virtual ink on Daniels-Feasel v. Forest Pharms., Inc., 2023 U.S. App. LEXIS 19448 (2d Cir. July 28, 2023), an unpublished Second Circuit decision? Well, the well-esteemed (at least by us) Washington Legal Foundation thought the decision was significant. It had filed an amicus brief with the Second Circuit and
A recent published opinion from the Ninth Circuit covers two issues near and dear to our hearts—federal preemption and claims based on outside laboratory testing. We care about federal preemption because . . . well, because we are the Drug and Device Law Blog, where there are some weeks when we write on preemption every
Here’s a shocker: being a tv star doctor does not make one a viable expert under Federal Rule of Evidence 702. That’s not just our say-so (or ipse dixit). One of our reliance materials is Thelen v. Somatics, LLC, 2023 U.S. Dist. LEXIS 101970 (M.D. Fla. June 12, 2023). The plaintiff in that case
We always thought that the decade-old Nargol v. DePuy False Claims Act litigation was a particularly abusive misapplication of the FCA for legal reasons. As discussed here, the primary allegations asserted the same sort of “fraud on the FDA” claim that, when brought as a common-law tort claim, were held preempted in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) – that the defendant purportedly misled the FDA to clear a §510(k) medical device, and that, as a result, every use of the device was ipso facto a false claim. No other causation needed. As the earlier post discussed, the First Circuit rightly put an end to that attack on FDA authority in United States ex rel. Nargol v. DePuy Orthopaedics, Inc., 865 F.3d 29 (1st Cir. 2017).
Then it turned out that a lot more was wrong with Nargol than just a bogus legal theory. The relators were p-side “experts,” Antoni Nargol and David Langton, who had access to documents from a couple of MDLs that targeted the defendant’s hip implant products. Critically:
Protective orders regarding confidential [defendant’s] product design information were issued in both of the multidistrict litigation cases (individually, the “ASR protective order” and the “Pinnacle protective order”; collectively, the “Protective Orders”).
United States ex rel. Nargol v. DePuy Orthopaedics, Inc., ___ F.4th ___, 2023 WL 3746534, at *1 (1st Cir. May 18, 2023).Continue Reading Dismissal of Experts-Turned-Plaintiffs’ FCA Case as Sanction Affirmed
Shortly after we recently posted our 50-state survey of state law concerning expert “gatekeeping,” we received a thoughtful email from friend-of-the-Blog Tom Hurney, of Jackson Kelly, informing us that there were additional gatekeeping-related issues in West Virginia that our search – limited to cases using the word “gatekeeping” – did not reflect. His
A little while ago, Bexis attended a Lawyers for Civil Justice semi-annual meeting, at which he received that organization’s “Outstanding Contributor Award” (in full disclosure, so did a half dozen other members). With the soon-to-be-adopted amendments to Fed. R. Evid. 702 having now been approved by the Supreme Court (with only the unlikely step of a congressional veto remaining), the question was what happens next.
These amendments expressly enshrine the expert “gatekeeper” function in the text of Rule 702. The next step is whether they can be duplicated – or paralleled − in state rules of evidence. We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “Frye” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this:Continue Reading 50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping
Last year, the federal court decision to exclude plaintiffs’ general causation expert in the In re: Onglyza and Kombiglyze XR Products Liability Litigation, MDL 2809 (E.D. Ken.),took a spot in our top ten best of 2022 (original post on that decision here). Without a general causation expert, it is not surprising that summary judgement
Stop us if you have heard us say “stop us if you have heard this before.” Pelvic mesh cases on remand have often faced the harsh realities of procedural requirements and burdens of proof because transferee judges have treated them like individual cases rather than items in an inventory. Decisions about the impact of failure
Duh. We apologize for the depth of our profundity, but there are some legal principles we think are really obvious. So obvious, in fact, that we might respond to question about these principles with this most dismissive of (clean) interjections. (We were somewhat surprised to learn from the interwebs that duh was supposedly first used