We confess: we spend a lot an excessive amount of time on a distinguished social media platform. We submit approach too many footage of the Drug and System Little Rescue Canines. We observe the progress of our impending addition, a Customary Poodle present pet, at present in utero. We have interaction in pointless, offended, political debate. And we take a look at recipes we are going to by no means put together. One in every of our favourite recurring memes is the “you had just one job” meme. A package deal of sizzling canine rolls is labeled “Hamburger Buns.” A “One Means” road signal factors into oncoming visitors. Every of the bins in a towering pile is emblazoned with “Do Not Stack.” You get the thought.
Right software of Fed. R. Evid. 702 is the “one job” of a decide contemplating a movement to exclude consultants. And there’s the rub in in the present day’s case, in a cop-out recurring all through the opinion. Don’t get us mistaken – there may be numerous good in Cantrell v. Coloplast Corp., 2022 WL 2806390 (D. Minn. July 18, 2022), together with the final word consequence. However it’s pockmarked. Let’s work our approach by and also you’ll see what we imply.
Cantrell is a pelvic mesh case. The plaintiff’s pelvic organ prolapse (‘POP”) was repaired with the defendant’s polypropylene mesh implant, a product designed to be implanted trans-abdominally, not trans-vaginally (this turns into necessary). The plaintiff alleged that she “continued to expertise ache and pelvic ground dysfunction” after the mesh implant and that she wanted a number of revision surgical procedures. Cantrell, 2022 WL 2806390 at *1. She disclosed six knowledgeable witnesses, and the defendant moved to exclude all of them. We’ll take them in flip.
Urogynecologist/“design defect” knowledgeable:
The plaintiff disclosed a urogynecologist, who opined that the defendant’s “POP merchandise [were] defectively designed, that the implantation of the . . . merchandise [did] not lead to superior practical outcomes, and that [the defendant] knew about issues with its transvaginal POP merchandise.” Id. at *2. However right here was the issue: as we talked about, the plaintiff was not implanted with a transvaginal product – hers was transabdominal. The defendant argued that, because of this, the knowledgeable’s report didn’t embody the product at difficulty. The plaintiff contended that the report “pertain[ed] to the properties of mesh, not the tactic by which the mesh was implanted.” Id. Not so, because the court docket noticed: the report made clear that the defendant used the identical mesh for all of its comparable merchandise however that the opinions pertained “particularly to the dangers inherent in transvaginal implantation of pelvic-mesh implants.” Id. (emphasis in unique). The court docket concluded, “. . . [B]ecause the opinions in [the expert’s] report pertain solely to transvaginal implantation, [the] testimony can be unhelpful to a jury. . . . Accordingly the court docket grants [the] movement to exclude [the expert’s] testimony.” Id. To this point, so good.
Polymer scientist:
The plaintiff’s polymer science knowledgeable sought to testify that the floor layer of polypropylene mesh degrades within the human physique. The defendant argued that the opinion was unreliable as a result of peer-reviewed literature contradicted it. The court docket held that {that a} battle between competing scientific theories was “fodder for cross-examination;” that “Daubert neither requires not empowers trial courts to find out” which of such theories “has the very best provenance.” Id. (quotation omitted). However the court docket additionally mentioned this – the primary of many comparable feedback: “. . . [D]isputes concerning the factual foundation of an knowledgeable’s testimony ordinarily implicate the credibility—not the admissibility—of the testimony.” Id. (quotation omitted). We submit that this assertion flies within the face of Rule 702. To wit, the “factual foundation” of an knowledgeable’s testimony is a key consider figuring out the reliability of the knowledgeable’s methodology. And the shortage of a dependable methodology has at all times demanded exclusion of an knowledgeable’s opinion, beneath an trustworthy software of the Rule. That is the “cop-out” to which we referred and which, in our humble opinion, has been invoked to allow plaintiffs’ consultants’ sloppy opinions to outlive numerous Daubert/Rule 702 motions. The Guidelines committee knew this, and it’s amending Rule 702 accordingly. However keep tuned – there’s way more of this later in Cantrell.
Earlier than we get to that, a bit of extra concerning the polymer scientist: the court docket granted the defendant’s movement to exclude the knowledgeable’s opinion that the human physique assaults mesh implants with oxidants so long as the implants stay within the physique, as a result of the knowledgeable’s conclusion “overreach[ed] the bounds set by the authors of the article on which he relie[d].” Id. at *4. It held that the knowledgeable might testify concerning the common strategy of mesh degradation, however not concerning the particular properties of the defendant’s mesh, as he sought to depend on evaluation of a unique firm’s mesh implants. And it held that he was not certified to testify that antioxidants used to stop degradation of the mesh had been poisonous, as a result of he was not a toxicologist or a pathologist.
Regulatory knowledgeable:
The plaintiff’s regulatory knowledgeable sought to supply the opinions that the defendant didn’t conduct satisfactory medical testing on its mesh implants, didn’t embrace satisfactory warnings within the directions to be used (IFU) that accompanied the implants, and didn’t conduct satisfactory post-market surveillance on the merchandise.
The defendant argued that the knowledgeable was not certified to testify concerning the adequacy of the defendant’s testing as a result of she lacked related training and expertise. The court docket said (cop-out #2), “[The expert’s] lack of expertise with pelvic-mesh gadgets goes to the burden of her testimony, not its admissibility.” Id. at *6. Once more, because the Guidelines Committee emphasised in the middle of the latest modification proceedings, it has at all times been the case that each ingredient of Rule 702—together with {qualifications}—is a threshold admissibility query. The brand new language of the Rule underscores this, but it surely was at all times the case. If this knowledgeable lacked the {qualifications} to testify about pelvic mesh, she ought to have been excluded. Plain and easy.
The defendant additionally argued that the knowledgeable was not certified to testify concerning the adequacy of the defendant’s warnings as a result of her profession had centered on prescribed drugs, not medical gadgets. Furthermore, the defendant argued, the IFU didn’t have to comprise warnings generally recognized to surgeons who prescribe the gadgets, and the knowledgeable was not a surgeon and couldn’t opine about what surgeons did or didn’t already know. What did the court docket say? “Gaps in an knowledgeable’s {qualifications} or data typically go the burden of the witness’s testimony, not its admissibility.” Cop-out #3.
The defendant additionally argued that the knowledgeable’s proposed opinions concerning the adequacy of the warnings was inadmissible as a result of the knowledgeable didn’t adequately clarify the idea for her opinion and relied on an unreliable methodology. What did the court docket say? You guessed it — #4. And #5 exhibits up within the subsequent paragraph, discussing the literature on which the knowledgeable relied for her warnings opinions. The court docket did exclude the knowledgeable’s opinions to the extent that they had been based mostly on adversarial occasion stories about one other firm’s merchandise and her opinion about whether or not the IFU supplied satisfactory data for surgeons to acquire knowledgeable consent. However it admitted her “post-market surveillance” opinions over the defendant’s arguments about their unreliability as a result of . . . #6.
Psychiatrist:
The plaintiff disclosed a psychiatrist, who sought to testify that the mesh implant had injured the plaintiff’s psychological well being. However the knowledgeable’s report made solely a temporal connection between the mesh implant and the plaintiff’s declining psychological well being, and the court docket held that this was not adequate to represent a causation opinion.
Normal causation knowledgeable – Dr. Bruce Rosenzweig:
And now we come to the final causation opinions of Dr. Bruce Rosenzweig, acquainted to all who defend pelvic mesh instances. Dr. Rosenzweig supplied his ordinary opinions:
- Safer different designs: The defendant argued that Dr. Rosenzweig’s opinions about safer options had been unreliable. The court docket didn’t embrace any element concerning the proposed opinions, merely noting that Dr. Rosenzweig “base[d] his opinion on his expertise with most of the options he suggests, along with his evaluation of medical literature and different supplies,” and concluding that “disputes concerning the factual foundation go to weight, and never admissibility” (#7). The court docket did exclude Dr. Rosenzweig’s “options” to the extent that they had been surgical procedures, not medical gadgets.
- “Small pore, heavyweight” mesh: The defendant sought to exclude Dr. Rosenzweig’s opinion that the defendant’s mesh was faulty as a result of it was “small pore” and “heavyweight,” arguing that the opinions had been unreliable. The court docket held that Dr. Rosenzweig had cited “a number of medical research” for his characterization of the mesh, and that disputes concerning the factual foundation go to . . . . You already know the remainder (#8).
- Degradation: #9 and #10 happen within the context of the court docket’s determination to confess Dr. Rosenzweig’s opinion that mesh degrades within the physique and his opinions concerning the medical penalties of the supposed “degradation.”
- The court docket did maintain that Dr. Rosenzweig was not certified to supply opinions concerning the design and testing of medical gadgets, and it excluded his opinions to the extent that they pertained solely to mesh implanted transvaginally.
Particular Causation Skilled (Gynecologist):
The plaintiff disclosed a gynecologist to supply, inter alia, particular causation opinions. The knowledgeable opined that the plaintiff’s signs “had been brought on by the defects within the design, testing, and advertising and marketing” of the defendant’s product, and that they plaintiff’s signs had been “the results of her physique’s intrinsic international physique response.” Id. at *14. However, the court docket emphasised, the knowledgeable “[did] not clarify how the supplies he reviewed help[ed] his opinion” that the mesh implant triggered the plaintiff’s signs, and “his failure to incorporate the explanations for his opinions [were] neither considerably justified nor innocent” because the defendant wouldn’t be capable to put together its cross-examination with out this data. The court docket excluded the knowledgeable’s specific-causation opinions for these causes. We expect it was even easier: the knowledgeable didn’t determine a dependable methodology, so his opinions had been inadmissible. However the consequence was appropriate. (We should always point out that, on the way in which to this portion of the opinion, the court docket denied the defendant’s movement to exclude the knowledgeable as unqualified. Guess why. #11.)
Abstract Judgment:
The defendant moved for abstract judgment on all the plaintiff’s claims. The plaintiff opposed the movement solely as to her claims for negligent design, strict legal responsibility design defect, and failure to warn.
As to the negligent design declare, the court docket famous that, “[u]nder California regulation, a plaintiff advancing product legal responsibility claims should show {that a} defect within the product triggered damage.” Id. at *17 (quotation omitted). With out the (excluded) testimony of her particular causation knowledgeable, the plaintiff couldn’t fulfill this ingredient of her declare. The strict legal responsibility design defect declare failed because of this as properly, however it could have failed in any occasion as a result of California regulation doesn’t permit strict legal responsibility claims for design defects in medical gadgets. And the warnings declare, additionally doomed by the shortage of particular causation testimony, failed for the extra purpose that there was no proof of “warnings causation” – the plaintiff’s implanting surgeon testified that he didn’t learn the IFU and didn’t rely upon what the corporate instructed him concerning the product. As such, no alleged inadequacy of the defendant’s warnings might have proximately triggered the plaintiff’s accidents. Abstract judgment granted on all three claims.
As we mentioned at the start, there may be numerous good in Cantrell, together with the ultimate end result. However every time the court docket confronted a tricky name – or rigorous evaluation – of whether or not an opinion happy Rule 702, it threw up its fingers and defaulted to “weight not admissibility.” This isn’t what Rule 702 calls for of a “gatekeeper,” and we solely hope that the upcoming amendments drive this level dwelling. Within the meantime, as temperatures hover within the higher 90’s within the northeast and COVID proliferates, keep secure on the market.
