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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

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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

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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

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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

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Just last week we updated our discussion on the 2023 amendments to Rule 702 urging our readers to start using the amendments now before their official implementation in December.  That’s because the Report of the Rules Advisory Committee confirms that the change to Rule 702 is to correct the mistakes of those courts who have

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We’ve chronicled the path of the 2023 amendments to Fed. R. Evid. 702 pretty much from the beginning.  As we’ve discussed, those amendments reiterate what had always been (at least since 2000) the Rule’s requirements for analyzing the admissibility of expert witness testimony.  But courts had been ignoring critical elements – such as the burden of proof – that had been in comments rather than the black letter of Rule 702 itself.  So, as of December 2023, Rule 702 will provide that the proponent of expert testimony must meet all of the Rule’s substantive standards for admissibility by a preponderance of the evidence, and in particular that an adequate basis for such testimony is a prerequisite to admissibility. Continue Reading Don’t Wait – The Rule 702 Amendments Can Be Used Now