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FDA Regulatory Experts: When do they Cross the Line by Instructing the Jury on the Law?


When you depose the other side’s expert, there’s always that string of questions where you collect the admissions of non-expertise.  “You’re not an expert in x?  You’re not an expert in y?  You’re not an expert in z?”  Etc.   Sometimes the expert does some clever fencing.  E.g., “What do you mean by expert?”  Or worse, “I am not sure what you mean by expert, but I have acquired some knowledge over the years via education, training, and experience, so I do know some things about x that might help the finder of fact.” Ugh.  Such an expert has been well trained to use Fed. Rule of Evid. 702 against us.  

But there is a follow-up that usually works pretty well: “You don’t hold yourself out as expert in x, do you?”  Even a skillful witness usually falls for that, and ruefully admits that, no, the witness does not hold him or herself out as an expert in x.  Not our experts, though.  They know to challenge the notion of holding oneself out as an expert.  What does that mean, anyway? Does it mean hanging out a shingle?

Whatever it means, there’s no denying that we hold ourselves as possessing some expertise on the subject of experts.  At least that’s what last week’s DRI program said.  A ballroom full of clients, competitors, and the idly curious sat through 90 minutes of our fellow panelists uttering very wise things, while we mostly ranted.  Our rant was not without some substance. Through education, training, and lots of experience (and lots and lots of mistakes) we have learned a few things about Fed. Rule of Evid. 702 that might be helpful to interested folks, maybe even including you, our readers.

To the extent our rant got especially ranty (raised voice, clenched fists, strained neck muscles), it was on the subject of experts who endeavor to instruct the jury on the law.  That’s almost always a no-no, and rightly so.  There are hybrid areas that are fair game, such as the ways in which industry customs inform contract interpretation.  But in the area of drug and device litigation, most expert efforts to interpret FDA regulations amount to usurpations of the roles of both the judge and jury.

Rebotix Repair, LLC v. Intuitive Surgical, Inc., 2022 U.S. Dist. LEXIS 142875 (M.D. Fla. Aug. 10, 2022), is an interesting example, even if it is an antitrust rather than tort case.  The plaintiff was a company offering a service whereby it “repairs” surgical implements manufactured by the defendant. The court inserted the quotation marks around “repairs,” so something is up with that. Reading between the lines, it appears that the plaintiff’s “repairs” converted the surgical implements from limited use to unlimited use.  The court did not tell us what the alleged antitrust violation was, but it obviously had something to do with the defendant manufacturer trying to shut down or limit the “repair” service.  If the “repair” extended the life of the medical devices, it is not hard to figure out the economic impact at stake. 

The dispute at issue is whether the “repair” service was actually “remanufacturing” of a type that required FDA section 510(k) review and clearance.  After the case was filed, the FDA sent correspondence to the plaintiff insisting that such review was required, but the court did not regard that as a final, dispositive decision.  Thus, the case was not moot and the controversy, at least for now, came down to a battle of the experts.   The issue was what those experts could and could not say.  The plaintiff expert opined that the plaintiff was not a manufacturer or remanufacturer of a medical device and, therefore, no FDA regulatory review was implicated.  The defense expert opined that the plaintiff was remanufacturing a medical device that had been cleared for limited use, and the conversion to unlimited use required FDA clearance.  Each side sought to exclude the opinions of the other side’s expert. The court granted both motions in part and denied them in part.  

The court held that the defense expert could offer opinions that would “help the jury understand the Section 510(k) regulatory framework and provide an explanation of the FDA’s practices and procedures.”  Nevertheless, the expert could not offer an ultimate opinion as to the plaintiff’s “compliance or noncompliance with regulatory requirements.”  That outcome rests on the notion that an expert cannot render a “legal” opinion that certain conduct did or did not violate the law.

Similarly, the court split the baby with respect to the plaintiff expert.  The court brushed aside the objections to the plaintiff expert’s qualifications.  (Yawn.) The court did not brush aside the plaintiff expert’s reliance on a Deutsche Bank report that 510(k) clearance was not required for the plaintiff’s “repair” service.  The report was hearsay resting on unnamed “regulatory consultants,” was not shown to be the type of thing that regulatory experts would rely upon, and was not admissible to demonstrate that the plaintiff expert’s opinion was in accord with a “consensus opinion held by FDA experts.”  Finally, the plaintiff expert could not parade before the jury the ultimate, legal opinion that the plaintiff was not required to obtain FDA regulatory clearance for its “repair” service.  

The Rebotix court’s decision was internally consistent. It forbade both side’s experts from mouthing a “legal” opinion as to whether the “repair” service required FDA regulatory clearance.  The opinion is also consistent with most opinions we have seen addressing regulatory experts.  Courts will not let experts explicitly pronounce conduct as being legal or illegal. But we are uncomfortable with the result in the Rebotix case.  Maybe the permitted opinions about the FDA regulatory framework go just so far and no further.  Maybe they go right up to the line.  But we can’t help but believe that a clever lawyer and clever expert can end up functionally instructing the jury on the law.  Why can’t the judge receive submissions from the parties and then craft a stipulation or jury instruction that sets forth the regulatory framework in a minimal, neutral fashion?



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