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Bexis was researching an off-label use issue recently and came across a couple of interesting duty cases that happened to appear, back-to-back, in his search results.

The first case, Howard v. Replogle, 450 P.3d 866 (Mont. 2019), grabbed our attention first because in involved instrumented spinal fusion and off-label use.  No, it wasn’t an anachronistic bone screw case (although pedicle screws were used in the surgery).  The off-label use involved what Howard described as an “expandable bone graft synthetic containment device.”  Id. at 868.  But off-label use wasn’t the duty at issue in Howard – at least not exactly.  Rather, the plaintiff’s surgeon had a financial relationship with the manufacturer of the device.  The surgeon “bought $110,000 worth of [company] stock and also entered into a consulting agreement.”  Id.

Since Howard was a case against the surgeon (the device manufacturer had settled out), the duty at issue was whether, during the informed consent process, the surgeon was required to inform his patient of the non-medical fact that he consulted with, and owned stock in, the company whose medical device he was using.  At trial, the parties proposed informed consent jury instructions differed in that the plaintiff’s contained an extra clause defining informed consent as including “any other information skilled practitioners would disclose to the patient under the same or similar circumstances.”  Id. at 870.  The court opted for the defendant’s instruction, that informed consent involved information about only “risks” of the procedure, and the jury returned a defense verdict.  Id.

In Howard, the Montana Supreme Court rejected the plaintiff’s duty argument, based on non-binding guidelines from two specialty medical societies and a California form jury instruction, id. at 870-71, and held that financial relationship disclosures were not required by Montana law of informed consent:

A reasonable mind could accept the testimony presented at trial that [a surgeon] was not required to disclose his financial interest in [the manufacturer of the instrumentation he was implanting] to obtain [the patient’s] informed consent prior to surgery.  The parties characterized the trial as a “battle of experts” below, and presented opposing expert testimony on the issue.  The jury believed [the defendant].

Id. at 871.

That’s sort of an odd way of handling a duty question – sending it to the jury.  But in rejecting the plaintiff’s California-based contention that informed consent included physician financial information, Howard thus rejected the leading case that had expanded informed consent in this direction, Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990).  Instead, Montana joins the majority of courts that have rejected the proposition that informed consent encompasses non-medical information about a treating physician’s financial relationships.  See Duttry v. Patterson, 771 A.2d 1255, 1259 n.2 (Pa. 2001); Whiteside v. Lukson, 947 P.2d 1263, 1265 (Wash. App. 1997); Otis-Wisher v. Fletcher Allen Health Care, Inc., 951 F. Supp.2d 592, 602 (D. Vt. 2013); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 659 (E.D. Pa. 1995).

Our second duty case, Avendt v. Covidien, Inc., 262 F. Supp.3d 493 (E.D. Mich. 2017), we discussed before, here, but primarily for its Daubert-related rulings (which were excellent, by the way).  But Avendt also addressed a duty question that we haven’t examined in any depth before:  whether the manufacturer of a §510(k)-cleared product has a duty to conduct clinical trials above and beyond what the FDA requires – and that are required only of products subject to pre-market approval.  Avendt held that no such duty existed:

Plaintiffs’ assertion that [defendant] should have performed a prospective “adequate clinical trial” on [its device] before releasing it to market seeks to hold [defendant] to a standard that . . . is not a realistic bar.  The issue of duty is one for the Court, and Court finds insufficient evidence in this record to conclude that [defendant] had a duty to perform a prospective randomized clinical trial on [its product] before seeking 510(k) approval and marketing [that product to practitioners.

Id. at 527-28 (citation omitted).

A simple search (“duty” in the same paragraph as “clinical trial”) turned up only a few similar holdings.  See In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings, 2018 WL 2416239, at *5 (N.D. Ill. May 29, 2018) (“plaintiffs have provided nothing to support a contention that . . . defendants have a duty to conduct safety studies in the United States”); Ixchel Pharma, LLC v. Biogen Inc., 2018 WL 558781, at *2 (E.D. Cal. Jan. 25, 2018) (absent a contract, the purported “obligation to conduct clinical trials” was a “nonexistent duty”); In re Traylsol Products Liability Litigation, 709 F. Supp.2d 1323, 1349 (S.D. Fla. 2010) (expert opinion about defendant’s “failure to . . . provide adequate large clinical trials; inadmissible due to failure to “discuss how and why [defendant] violated its duties under the relevant statute and regulation”); In re Traylsol Products Liability Litigation, 2010 WL 4102247, at *5 (S.D. Fla. Sept. 10, 2010 (expert opinion that defendant “did not conduct [comparative] clinical trials” was an “inadmissible personal opinion”).  Cf. Errant Gene Therapeutics, LLC v. Sloan-Kettering Institute for Cancer Research, 2016 WL 205445, at *2 (S.D.N.Y. Jan. 15, 2016) (“a contractual obligation to develop a treatment for [a particular condition] does not create a direct, enforceable duty to every individual with [that condition]”).

The only thing we found to the contrary was from the Pelvic Mesh dystopic fantasy world where the FDA does not exist, and plaintiffs’ experts can engage in rampant speculation completely unconstrained by the FDA’s requirements for marketing medical devices.  See In re C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation, 2013 WL 3821280, at *4-7 (S.D.W. Va. July 23, 2013) (allowing evidence that “implies” a defendant can have a “duty to conduct clinical trials” for purposes of design and punitive damages, but not warning, claims).

Simply for time reasons, we arbitrarily stopped looking at cases prior to 2010, since at that point our search had already generated more than 200 cases.  But 2010 was far enough back as to precede the advent of generic preemption in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and mentions of failure to conduct clinical trials were popping up (without definitive decision) in pre-Mensing generic drug cases.  And that, as much as anything, underscores our point.  Where the FDCA, as enforced by the FDA, does not require clinical trials, then preemption should preclude state-law claims that, without such trials, it was somehow tortious for a defendant to market a prescription medical product.

We have no doctrinal problem – we just dispute facts and inferences − with plaintiffs alleging that existing clinical trials were misinterpreted, ignored, hidden, whatever.  But once state-law claims go beyond that and contend that some state-law “duty” demands entirely new, non-FDA mandated clinical studies, plaintiffs have crossed a preemptive line and are trying to displace FDA decisions about when regulated products may be marketed.  The cases we cited above aren’t about preemption, but that’s because those courts were wise enough to construe state-law “duty” claims narrowly so as to avoid creating constitutional infirmities.