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On its face, Osos v. Nuvasive, Inc., 2024 WL 3585092 (E.D. Mich. July 30, 2024), is a fairly routine medical implant product liability lawsuit, involving allegations of metallosis that have already been around the block quite a few times in hip implant cases.  Osos involves a somewhat different device, but the legal principles are no different.

But Osos involves Michigan law, and Michigan (as we first mentioned at the end of last year, and discussed more thoroughly here) only recently repealed a longstanding conclusive presumption of non-defectiveness based on FDA drug approvals.  That presumption, which “functionally foreclosed” most product liability claims against, such products, White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023, 1029 (W.D. Mich. 2008), undoubtedly reduced litigation by Michigan plaintiffs.  See Our “Michigan Diaspora” post.  The repeal will equally undoubtedly cause Michigan prescription medical product litigation to rebound.Continue Reading Possible Learned Intermediary Showdown in Michigan

Sometimes bench-bar conferences are actually useful.  Last week we wrote a post about a district court’s application of the New York statute of limitations to shut down a product liability lawsuit.  The key holding was that the statute of limitations began to run as soon as the plaintiff experienced relevant symptoms.  There was no need…

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…

Here are some things you probably will not hear very often, if at all:  1) a fervent supporter of a defeated political candidate agreeing that the winning elected official has done a good job, regardless of economic growth, infrastructure projects, public health progress, or some other measure of good government; 2) a fervent supporter of…

Sure, it was enjoyable to read In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, ___ F.3d ___, 2018 WL 1954759 (5th Cir. April 25, 2018) (“Pinnacle Hip”), to see plaintiffs’ counsel hoisted on their own petard of improper and prejudicial evidence and arguments.  But there’s more to Pinnacle Hip…

We have no personal anecdote to share, no movie to discuss, no holiday theme to weave in, and no (self-described) clever theme for our post.  It is a beautiful fall day where we have a relative lull in our slate of depositions, briefs, and arguments, so we will get right to it.  Last month, we had trouble making sense of a long Daubert and summary judgment order in a metal-on-metal hip implant bellwether case.  This month, we think that the evidentiary rulings in the same case make more sense.  Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 6704750 (N.D. Ga. Nov. 2, 2015).  Except for this:  neither side filed timely motions in limine, they submitted a joint “Position Statement” on evidentiary issues, and the court issued rulings complete with limiting instructions.  That was awfully generous of the court, as most judges will not rule on what evidence can come in absent a timely motion or objection.  It may be too simplistic to say that plaintiff lawyers in drug and device product liability cases prefer the rules of evidence to be fast and loose, allowing them to spin a narrative that riles up the baser instincts in the jury, whereas defense counsel in such cases prefer that evidence be focused on the issues that the jury will be asked to decide.  In any event, knowing what evidence will be coming in on what issues allows both sides to prepare their respective case so that the jury can hear something coherent.  The Federal Rules of Evidence give trial judges a fair amount of latitude to maximize the chance that the jury will understand the evidence presented and how it fits with what they are asked to decide.  The Christiansen rulings do a pretty good job of that.

In addition to what she could offer from her ten experts and apparently friendly implanting surgeon, plaintiff wanted to offer “fact” testimony from four other orthopedic surgeons who had not treated her and were not designated as experts.  We can think of three basic plausible ways, but maybe objectionable depending on the facts, that these non-treating surgeons could be fact witnesses:  1) they could have something to say about their personal involvement in designing the product at issue; 2) they could have some interaction with the manufacturer before the plaintiff’s implant that allegedly provided notice of the risk of the injury that plaintiff claims (“metallosis” per the prior decision); or 3) they could have done some study on the risks and/or benefits of the product that they will talk about.  No, plaintiff wanted them to talk about whether the product was defective under Utah’s consumer expectations test—with an orthopedic surgeon being the consumer for this prescription device—and what the manufacture told them about the device.Continue Reading Evening Things Out Some With Trial Evidence Rulings In A Bellwether Case

We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 115601 (N.D. Ga. Aug. 31, 2015), as a bit of penance.  This act may be appropriate given the recent Day of Atonement and, much like long Yom Kippur services during a fast, the decision drags on, repeats itself, has some highs and lows, and maybe induces some confusion and a touch of a headache.  While we are not looking for a scapegoat, some of the reasoning for why the issues were presented how they were presented and why they were decided is lost on the reader, at least this reader.  (Much like the original meaning of Azazel, to where/whom the original scapegoat was to be sent by Aaron.  Or maybe not at all like that.)  As a combination Daubert and summary judgment order on a bellwether case from an MDL for a product, a metal-on-metal hip implant, for which there is considerable litigation on similar products made by other manufacturers, there will likely to attempts to extend various parts of this decision to other cases.  So, we will resort to the dreaded use of subheadings in discussing it.

Background

Plaintiff had a left hip replacement in 1995 with a device that used a ceramic femoral ball, a polyethylene liner, and a metal acetabular shell.  In 2006, plaintiff had her right hip replaced with the defendant’s product, which utilized a ball and cup each made of cobalt-chromium with no liner.  In 2012, plaintiff started experiencing pain in her right hip and, within a week, had a revision surgery where the defendant’s product was explanted (and presumably something else was implanted).  All three surgeries were done by Dr. Lynn Rasmussen, who happened to have been consulting with defendant on designing hip implants in between the second and third surgeries.  In doing the third surgery, Dr. Rasmussen observed what he called “metallosis” (sometimes “metalosis” in the records and briefs), but did not send any explanted tissue or material for pathological evaluation.  Plaintiff sued under a range of product liability theories based on the risk of “metallosis.”  Thereafter, plaintiff named at least ten experts to weigh in on causation and defect in some form or other, most of whom relied to some degree on Dr. Rasmussen’s characterization of what he saw—and defendant filed a bunch of Daubert motions.  Plaintiff filed a “motion for partial summary judgment” that preemption and the learned intermediary doctrine did not apply to her claims and, at the court’s request, the defendant filed a motion for summary judgment on all the claims that plaintiff did not drop.  An affiliated defendant also filed for summary judgment on different grounds.  There were some other motions we are ignoring, but everything was addressed in one big decision.Continue Reading Making Sense of the Rule 702 and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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