Law

       As a defendant manufacturer in a drug or device product liability case, it is one of the last things you want to see. The key treating physician concludes that your product was to blame for the plaintiff's problems and sidles up to the plaintiff's lawyers. There are lawyers who reflexively identify every treating physician as a non-retained expert under Rule 26(a)(2)(B) and describe their anticipated testimony so vaguely that it is difficult to determine from the designation if you have the dreaded situation. The medical records may hint at it. If you learn that the plaintiff's lawyer has been providing materials to the doctor and/or meeting with her, then that hint may get stronger. Once she testifies, however—hopefully before trial—you will know. You can imagine the plaintiff lawyer advising the jurors that they can trust the "independent" doctor "who has not been hired by either side" and "who has no dog in this fight" (or similar colloquialism). You know that her testimony can be quite impactful, especially if she slams your product while giving her view on what happened with the plaintiff.

      But do the Rules of Evidence give the treating physician named as a non-retained expert extra leeway in offering whatever opinions she has by the time of trial? This was the situation addressed in Alarid v. Biomet, Inc., No. 14-cv-02667-REB-NYW, 2016 U.S. Dist. LEXIS 11496 (D. Colo. Feb. 1, 2016). The same orthopedic surgeon implanted the defendant's prosthesis in each of the plaintiff's shoulders (in separate surgeries) and then removed and replaced them a few years later after devices "fractur[ed] at the joint between the baseplate and the trunnion." Id. at **3-4. Plaintiff named him as a non-retained expert—we can only assume this was correct and he was not getting paid to review materials outside of his own records—and disclosed his anticipated opinion testimony as including blaming the need for reoperation on "bad engineering," a design with "wrong material and wrong thickness" and a "humeral tray [with] material too thin to withstand pressure," which he based on claimed "knowledge of medical device development, general safety procedures which should be followed in the development of medical devices, impedance matching and impact techniques and requirements for devices that connect with tapers." Id. at *5. If he really had that experience and could offer those opinions, then plaintiff had quite a free expert.

      Implicit in plaintiff's response to the manufacturer's motion to exclude the surgeon's opinions was that the standards for admissibility should be relaxed for a treating physician. In granting the motion, the court disagreed. First up was the claim that general experience as an orthopedic surgeon and consultant for defendant on shoulder prosthetics satisfied the Rule 702 requirement for relevant expertise for all the disclosed opinions. Because the surgeon did not claim expertise is biophysics, biomechanics, metallurgy, or biomaterials and because his consulting had not encompassed engineering, biomechanics, and materials selection, the court found him to have no more than "marginal familiarity" with the relevant subjects of device design and failure analysis. Id. at **6-7. Reviewing some materials on the biomechanical testing on the product—whether on his own after the reoperation or provided by the plaintiff's lawyer—did not change his lack of experience. He also could not avoid the qualification requirement by plaintiff's claim that his design and failure opinions were actually Rule 701 opinions. Rule 701 is titled "Opinion Testimony by Lay Witnesses" and starts with "If a witness is not testifying as an expert," so its applicability to a designated expert is a stretch. (We will omit the detour on the interplay between Rule 701 and Rule 702 in practice and the difference between framing a question to a treating physician or other fact witness with specialized training to seek what they thought in the past and what they think now. We have had more than a few depositions where each side objects with "seeks expert opinion" and a court gets to sort it out later.) At least under the Tenth Circuit law, there are relatively few opinions that an orthopedic surgeon might offer under Rule 701, which is limited to opinions within the scope of "common experience" that are formed in connection with being a fact witness. Such opinions typically relate to "the appearance of persons or things, identity, the manner of conduct, competency of a person, degrees of light or darkness, sound, size, weight, distance, and an endless number of items that cannot be described factually in words apart from inferences." Id. at *9 and n.5 (citations omitted). Put another way, the opinions cannot "require any specialized knowledge and could be reached by any ordinary person." Id. at *10 n.6 (citation omitted). Of course, "the design and manufacture of prosthetic should devices are [not] matters of common experience or otherwise within the ken of an ordinary layperson." Id. at *11.

      Plaintiff could also not avoid the requirements of Rule 702 by contending that explanting surgeons are required "to determine the reason for the failure" of the implant. This is where we get the Latin phrases of the post's title. The surgeon's failure analysis was circular: the materials in the implant must have been too weak because they failed, which he said "speaks for itself." The court said this was "conclusory," not "based on adequate facts or data," and "connected to the existing data only by the ipse dixit of the expert." Id. at **8-9 (citing Joiner). That is all well and good, but really thing this is an attempt at res ipsa loquitur, which means "the thing speaks for itself," just like the surgeon said. ("He said it himself" is one way to translate ipse dixit, so we see the confusion.) Res ipsa is the idea that the jury can infer negligence (or a rebuttable presumption of negligence) where the negligence of the plaintiff and third-parties have been ruled out and the event would not normally occur absent someone's negligence. While the testimony of the surgeon who both implanted and explanted the device is unlikely to implicate his own negligence as the reason for a reoperation, res ipsa generally will still not apply to surgeries with implanted medical devices, which fail for a variety of reasons. In any event, res ipsa is not a reason to admit opinion testimony that is unreliable or beyond the individual's expertise. The Alarid court did not. The surgeon could testify as a "percipient witness as to what he observed when he explanted the fractured device," but he could not "offer an opinion concerning the causes for the failures or the changes in the design, or otherwise opine regarding matters relating to the design and manufacture of such devices." Id. at *11. That seems like the right line to draw, although we can expect that the line will need to be policed at trial given the strong incentive for plaintiff to have the surgeon cross it.