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We recently recapped the law relating to when experts are allowed to opine on what was in the head of another and how a pending Supreme Court criminal case might affect things.  In our area, this issue comes up most frequently in the context of plaintiff experts trying to offer their spin about how the purportedly nefarious machinations of drug and device manufacturers affected decisions on the design, labeling, testing, etc., of the product at issue in the case or some argued alternative feasible design.  Almost as often, where the prescribing physician is not deposed or where the plaintiff elects not to ask the prescriber the relevant direct question about proposed changes to the labeling or to the known risk-benefit information on the product, plaintiff experts like to speculate on the impact that information would have had on the decision making of a particular physician they do not know.  Not only is it clearly the plaintiff’s burden to offer evidence from the prescriber herself that connects to the precise patient, point in time, and proposed additional information, but weighing this evidence is for a jury (if the judge lets it get that far) not an expert.  Still, many courts tend to muck up the handling of this issue, in part, we think, because of a general hesitancy to grant summary judgment on proximate cause for failure to warn in cases where the plaintiff has a plausible injury.  This dynamic seems to play out fairly often in cases that have been pending for a long time.

McCoy v. Depuy Orthopaedics, Inc., No. 22-CV-2075 JLS (SBC), 2024 U.S. Dist. LEXIS 72108 (S.D. Cal. Apr. 19, 2024), was certainly pending for a long time before the ruling on summary judgment and expert motions two weeks ago.  It was direct filed in late 2011 in a notorious hip implant MDL and languished there for eleven years before getting sent to the “home” district court, which issued the decision we are discussing about 16 months later.  We will not summarize all the questionable rulings from that MDL, or even those that featured in the well-publicized Fifth Circuit reversal of a runaway verdict, but plenty of them related to leniency toward plaintiff experts.  Some of those plaintiff experts were touted as working for free, but actually got paid.  More broadly applicable was the Fifth Circuit’s rejection of the significance the trial court had placed on expert testimony on what a “reasonable physician” would do with additional information, including allowing it to trump contrary testimony from the actual prescriber. One of the things that has happened since that MDL issued rulings on the admissibility of testimony from several generic and recurring experts is that Rule 702 was amended to emphasize the trial court’s gatekeeping function and that the burden is on the proponent of challenged expert evidence to show that it meets the standards for admissibility.  As we highlighted earlier this week in the context of a non-remanded knee implant case,

[M]any courts have held that the critical questions of the sufficiency of an expert’s basis, and the application of the expert’s methodology, are questions of weight and not admissibility.  These rulings are an incorrect application of Rules 702 and 104(a).

Sprafka v. Medical Device Business Services, Inc., 2024 WL 1269226, at *2 (D. Minn. March 26, 2024) (quoting Advisory Committee Note to 2023 Amendment).

We raise all this not just for purposes of making our segue seamless, but to highlight issues with the modern long-lived MDL.  A direct-filed case sits around for a decade.  It inherits Daubert and other rulings that may have been disfavored by an appellate decision or impacted by a change in the rules, yet the rulings will have some force if not be law of the case even when the case ends up pending in another circuit.  For McCoy and hundreds of cases in the same boat, there was an order requiring the filing of dispositive and expert motions a few weeks before remand to a district court that would set its own pretrial schedule and possibly allow additional discovery.  Experts named back in the MDL may no longer be around for the remand case come trial.  In McCoy, one of the plaintiff experts had been disqualified due to a conflict, so she was allowed to swap in a new one.  In short, this sort of protracted case history make for messy motions practice and the messiness tends to work in the favor of the plaintiff, particularly when the MDL from whence the case came was so overtly plaintiff friendly.

We will not try to unpack all of the issues addressed in McCoy, which included denying a motion for summary judgment as untimely and then finding genuine issues of material fact would have led to a denial on the merits anyway.  One of the summary judgment arguments that the manufacturer offered was that the implanting surgeon’s own testimony was insufficient to carry plaintiff’s burden on proximate cause for failure to warn.  2024 U.S. Dist. LEXIS 72108, *21.  Without ever mentioning “burden” or what plaintiff contended should have been added to the device’s IFU before the implant, the court approached the issue as if it were incumbent on the defendant to rule out the possibility that any additional information could have affected the prescriber in any way.  That, of course, is the wrong formulation of the question.  As such, the court’s linkage of the prescriber having read some promotional materials and some version of the IFU “at some point” and that he tended to get information from the “hip and knee replacement community” to the conclusion that it was possible that a “stronger warning” would have reached the prescriber through some route and changed his decision to use the particular device was based on an overly lenient standard.  Id. at *22-23.  Plaintiff’s expert evidence on what additional warning was required when and how that would have impacted the prescriber or some hypothetical reasonable prescriber was not part of the summary judgment analysis.

The rest of the McCoy decision addressed challenges to five plaintiff’s experts and we will discuss two of them, both frequent flyers.  The above quote from Sprafka on the amendment to Rule 702 related to a challenge to a biomedical engineering expert named Mari Truman, who was also challenged in McCoy on some facially similar opinions, albeit on a different device for a different surgery.  To start, the court allowed Ms. Truman to opine on case-specific medical causation, rejecting a challenge to qualifications in part because the Pinnacle MDL found a biomechanical engineer with different experience to be qualified.  Id. at *36-37.  Without mentioning burden, the court also found Ms. Truman’s specific causation opinion to be reliable even though she had no testing or data on plaintiff’s specific device to link up to her general theory, relying instead on plaintiff’s clinical symptoms to rule in a role for the purported defect in the device.  Id. at *37-38.  This was not even a differential diagnosis (by someone who is not a physician).  The court also rejected challenges to Ms. Truman’s opinions on the adequacy of warnings and testing, without mentioning burden or providing many details on her actual opinions, what the IFU said, or what testing was actually done.

When it came to Ms. Truman’s opinion on how different warnings would affect physicians in general—something that probably should not have been an issue for expert testimony at all—the court did consider burden.  (It also considered it in rejecting a challenge to her design defect and alternative design opinions.)  The analysis, however, was limited to qualifications, perhaps overly so.  The court rightly noted “courts treat warning causation opinions from experts not involved in medicine or a plaintiff’s medical car skeptically,” dropping a footnote that cited three cases that also happen to feature in the caselaw on expert opinions on corporate intentId. at *42 & n.13.  However, each of these cases actually involved the exclusion of opinions from medical doctors, specifically well-known plaintiff experts Parisian, Furberg, and Gueriguian.  Indeed, the full quote from In re Diet Drugs and Rezulin, included with some ellipses in the footnote, is that the excluded warnings causation opinion is “purely speculative and not based on scientific knowledge.”  (Emphasis added) So, while McCoy found that plaintiff did not establish the qualifications for Ms. Truman to opine in this area and that her opinions “seem to amount only to speculation,” this is not merely an issue of insufficient qualifications.  Id. at *42.  A similar dynamic played out in allowing Ms. Truman to opine on “information available to [defendants], what they should have known based on that information, and what actions such knowledge should have prompted.”  Id. at *46.  Unless the third part is linked to defined regulatory or industry standards, the resulting testimony is going to be personal opinion not expert opinion.  Similarly, the “should have” testimony is invariably an excuse to inject speculation that the defendant’s failure to do what the expert would have done was because of some improper motive, typically to place profits over safety.

McCoy also permitted Dr, Kessler, a former FDA commissioner who seems to have never met a medical device in litigation that he liked, to opine on purported ethical responsibilities and “what Defendants should have known and done based on his interpretation of internal records and the literature,” among other topics.  As to the former subject, the court relied on the Pinnacle MDL’s acceptance of “expert testimony regarding applicable ethical standards.”  Id. at *51.  There is a whole line of MDL decisions, again going back to In re Diet Drugs and Rezulin, that excludes ethical responsibility opinions against drug and device companies, even when offered by former FDA officials and other prominent healthcare professionals and purportedly grounded in regulatory or industry standards.  Among the obvious problems with testimony on purported ethical standards in a court of law is that it “merely tell[s] the jury what result to reach, somewhat in the manner of the oath-helpers of an earlier day.”  Fed. R. Evid. 704 advisory committee note.  As to the latter subject, the subjective “interpretation of internal records” that someone else created and the expert has only seen in connection with litigation will inevitably stray into opinions of why some possible course of action was not chosen.  That is mindreading and argument, not using an “expert’s scientific, technical, or other specialized knowledge [to] help the trier of fact to understand the evidence or to determine a fact in issue.”  Fed. R. Evid. 702(a).  It is also potentially quite impactful on the jury when offered from the witness stand by an expert, as opposed to from a lectern by an advocating attorney.  The proper course is to let the lawyer argue and the jury evaluate the evidence without allowing experts to say what was in the corporate defendant’s figurative head and whether it behaved ethically.