The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community. Id. at 350. Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.” Id. at 351 n.5 (citation and quotation marks omitted). Along these same lines, other courts have held that “[t]he decision to prescribe such ‘off-label usage’ . . . is regarded as a professional judgment for the healthcare provider to make.” Nightingale Home Healthcare, Inc. v. Anodyne Therapy, LLC, 589 F.3d 881, 884 (7th Cir. 2009) (applying Illinois law). “[D]octors are free to prescribe a drug for off-label use if they deem it medically appropriate for a patient.” Bennett v. Teva Pharmaceuticals USA, Inc., 2021 WL 797834, at *2 (D. Del. March 2, 2021). In light policy-laden holdings such as these, the question arises to what extent does – or should – state tort law presume to require the makers of FDA-regulated products to exercise control over this aspect of medical practice by imposing liability on manufacturers for not preventing medical professionals from engaging in off-label uses that turn out, in retrospect, to injure their patients.
We touched on this topic generally in our a couple of years ago, “Limits to Duty 2.0 − On Product Manufacturers Supervising Doctors,” which itself was an update of our earlier “Limits to Duty” post, so we’ll largely stick to off-label issues this time around. We start with an older appellate off-label use decision, Swayze v. McNeil Laboratories, Inc., 807 F.2d 464 (5th Cir. 1987) (applying Mississippi law). Even the term “off-label” hadn’t gained currency back in 1987, so it doesn’t appear in Swayze, but this case involved the claim about allegedly widespread medical use of “excessive dose[s]” of the defendant’s anesthetic, id., at 470 – a type of off-label use − in operating rooms across the state of Mississippi. Plaintiffs in Swayze claimed that common off-label use justified creation of a tort duty on the part of manufacturers to “enforce” their warnings against their physician customer, or else “remove its [product] from the market.” Id. at 471. Swayze rejected the contention that the defendant should have “compel[led] the medical community to properly supervise distribution of its drug.” Id. at 465.
Swayze flatly rejected the idea of a tort-mandated negligence “duty” to ride herd over the what amounted to medical profession’s off-label standard of care in using this particular prescription medical products. First, it was damaging to the physician-patient relationship. “When the physician-patient relationship does exist, as here, we hesitate to encourage, much less require, a drug manufacturer to intervene in it.” 807 F.2d at 471.
[T]his relationship encompassed much more than the dosage of [the drug that the decedent] would receive. Although in retrospect this decision . . . dwarfed all others, it was an integral part of [a physician’s responsibility. . . . [I]t is the physicians who have undertaken the responsibility of supervising [drug usage], and that responsibility cannot be shunted onto, or shared with, drug manufacturers.
Id. at 470.
Nor would Swayze “impose upon defendant an additional duty to intrude itself into the hospital operation.” Id. at 468. This particular off-label use of “excessive” anesthetic:
does not occur in every operating room in [the state]. The practice appears to be a variable one that depends on the particular diligence of the supervising physician and the resources of the hospital. . . . It is both impractical and unrealistic to expect drug manufacturers to police individual operating rooms to determine which doctors adequately supervise their surgical teams.
Id. at 471. Nor was removing the product from the market a workable alternative, since the off-label use “lies with individual physicians” so a manufacturer “cannot control the individual practices of the medical community, even if it is the prevailing practice, and we decline to impose such a duty.” Id. at 472.
Under the learned intermediary doctrine generally, product manufacturers are not legally required to intervene in medical decision-making.
One in a serious medical condition . . . as a general matter faces unwanted, unsettling and potentially harmful risks if advice, almost inevitably involved and longwinded, from non-physicians, contrary to what the doctor of his choice has decided should be done, must be supplied to him during the already stressful period shortly before his trip to the operating room.
Brooks v. Medtronic, Inc., 750 F.2d 1227, 1232 (4th Cir. 1984) (applying South Carolina law). Accord Glennen v. Allergan, Inc., 202 Cal. Rptr. 3d 68, 83-84 (Cal. App. 2016) (a “manufacturer of a prescription medical device has no to train a physician” because a it “is not responsible for the practice of medicine”) (citations and quotation marks omitted); Small v. Amgen, Inc., 134 F. Supp.3d 1358, 1372 (M.D. Fla. 2015) (manufacturer has “no duty to provide guidance” to prescribers); Chao v. Smith & Nephew, Inc., 2013 WL 6157587, at *4 (S.D. Cal. Oct. 22, 2013) (There is no “duty, beyond providing a warning, to dissuade a physician from using a device on a particular patient.”); Greenwood v. Tehrani, 2017 WL 4083099, at *2 (N.Y. Sup. Sept. 15, 2017) (“the manufacturer is not responsible for how the physician uses the device and renders the medical care”) (citation omitted).
Cases explicitly addressing off-label use make the same point – that a physician’s choice to use a prescription medical product off-label does not expand a manufacturer’s liability or create any obligation to prevent off-label use from occurring. Lack of FDA labeling “for that use did not bar Defendants from selling the device to . . . other physicians who could then decide how and when to use [it].” Healey v. I-Flow, LLC, 853 F. Supp. 2d 868, 880 (D. Minn. 2012). There was “ “no authority . . . that it was inappropriate for [defendant’s] sales representative to educate an orthopedic surgeon who chose to use the [device] in this off-label manner.” Id. at 881
Under the FDCA, manufacturers can continue marketing products they know could be put to off-label uses. “FDA would not regard a firm as intending an unapproved new use for an approved or cleared drug or device based solely on that firm’s knowledge that its product was being prescribed or used by healthcare providers for such use.” 82 Fed. Reg. 14319, 14320 (FDA March 20, 2017). The common law has been similar. “[K]nowledge that the prescribing doctor intends an off-label use” is ordinarily an insufficient basis for imposing liability on a manufacturer. Carson v. Depuy Spine, Inc., 365 F. Appx. 812, 815 (9th Cir. 2010) (applying California law). In Davenport v. Medtronic, Inc., 302 F. Supp. 2d 419 (E.D. Pa. 2004), the court likewise found no duty to prevent off-label use:
[The Court finds no basis for [plaintiff’s] secondary negligence claim that [defendant] was negligent in “allowing bilateral implantation . . . when [it] knew that the FDA had allowed only unilateral implantation of the device.” . . . This aspect of the negligence claim also fails because [plaintiff] has failed to produce any evidence or authority that shows that [defendant] was prima facie negligent in allowing [plaintiff’s surgeon] to perform a bilateral implant. . . . Neither party disputes that the bilateral implant of the [product] qualified as an “off-label” usage (i.e. use of a device for a purpose that has not been approved by the FDA). . . . While the FDA controls the marketing and labeling of medical devices, it does not attempt to interfere with the practice of medicine. . . . Courts have dismissed similar claims at summary judgment that were based on a manufacturer allowing a physician to use a medical device in an “off-label” manner.
Id. at 439-40 (citations and quotation marks omitted). Davenport cited Little v. Depuy Motech, Inc., 2000 WL 1519962, at *9 (S.D. Cal. June 13, 2000) (a doctor’s “decision to use [a manufacturer’s] device in an ‘off-label’ manner does not subject the manufacturer to liability, even if it knows of the off-label use”; a manufacturer “cannot be held liable for [a physician’s] decision to implant the [manufacturer’s] device in an off-label manner”); and Cox v. Depuy Motech, Inc., 2000 WL 1160486, at *8 (S.D. Cal. March 29, 2000) (“[a] seller is not liable even if it knows of the off-label use”).
Similarly, courts have refused to impose any legal duty on prescription medical product manufacturers to take affirmative measures to prevent their physician customers from using their products off-label. This issue was presented most starkly in Kennedy v. Medtronic, Inc., 851 N.E.2d 778, 786 (Ill. App. 2006), where a physician placed a left-side pacemaker lead on the right-hand side of the heart. Id. at 780. Plaintiff sued, alleging that the device manufacturer – through a representative who attended the implantation − had a duty to stop the surgery (done on an out-patient basis at the decedent’s insistence) from being performed. Id. at 785. The court found no such duty. First, “[f]ind[ing] the burden and consequences of imposing the duty proposed by plaintiff to be substantial. It would be a significant burden to require [defendant] to monitor the conditions under which a doctor performs surgery.” Id. at 786. Second, “a licensed physician . . ., has the knowledge of his patient’s medical history and background, and, therefore, he is in a better position, utilizing his medical judgment, to determine a patient’s needs and what medical care should be provided.” Id. Third, “[i]t would be unreasonable, and potentially harmful, to require a [manufacturer’s representative] to delay or prevent a medical procedure. . . . To hold otherwise would place a medical device manufacturer . . ., in the middle of the doctor-patient relationship.” Id. And fourth, “the consequences of requiring such screening by [a manufacturer] would run the risk of imposing additional liability . . . in the event it determined a physician was not in a position to properly implant a device, refused to provide one, and the patient suffered adverse medical consequences because he did not have access to a needed device.” Id.
Thus a prescription medical product manufacturer has no duty to interfere with physician’s “practice of medicine” in using its product in an off-label manner. Davenport, 302 F. Supp. 2d at 439-40. “[A] manufacturer has no affirmative duty to intervene in order to prevent off-label use of [a] product by a surgeon.” Seavey v. Globus Medical, Inc., 2014 WL 1876957, at *9 (D.N.J. March 11, 2014). “Once the doctor’s clinical judgment is introduced as the determinative factor in the decision making process, it must be apparent that this data [in the label] serves as a recommendation, not a limitation or prohibition.” United States ex rel. Polansky v. Pfizer, Inc., 914 F. Supp. 2d 259, 264 (E.D.N.Y. 2012), aff’d, 822 F.3d 613 (2d Cir. 2016). “[T]he decision as to use a medication as a first-line treatment is uniquely up to the prescribing medical professional.” In re Chantix (Varenicline) Products Liability Litigation, 881 F. Supp.2d 1333, 1340 (N.D. Ala. 2012). The same is true of non-physicians. In Tavilla v. Blue Cross & Blue Shield, Inc., 2014 WL 4473638 (Ariz. App. Sept. 11, 2014), a health insurer was not required to prevent its insureds from receiving off-label therapy.
[A]lthough [defendant] retained the right to refuse to pay for off-label prescriptions, the [policy] did not obligate [it] to do so. Through their argument, [plaintiffs] attempt to place on [defendant] an obligation it did not expressly or impliedly assume − that of protecting [them] from the decisions of their medical providers or otherwise interfering with their medical care.
Id. at *5. “[T]here is no duty for [defendant] to deny coverage of a medication because the medication could be harmful or addictive. T o impose such a duty would put [it] squarely between the insured and the insured’s own physician.” Id. at *5 n.10 (citation and quotation marks omitted).
This rationale extends to manufacturer’s representatives. A manufacturer’s representative is not subject to liability merely for knowing that intended treatment would involve off-label use:
“[O]ff label use,” within the context of medical treatment is not prohibited, as the FDCA does not regulate the practice of medicine. . . . [The prescribing surgeon’s] exercise of medical judgment was within [his] discretion, and [he] was free to do what [he] did. . . . [E]ven if such a claim [for off-label promotion] were present in this case, there is no private right of action for violations of the FDCA. There is a complete absence of evidence as to any claim for negligence based on “off label” marketing and promotion by [the sales representative].
Wolicki-Gables v. Arrow International, Inc., 641 F. Supp. 2d 1270, 1292 (M.D. Fla. 2009), aff’d, 634 F.3d 1296 (11th Cir. 2011). Thus, such a representative’s alleged “calculated silence” during off-label treatment is not actionable:
Plaintiff’s claim that [defendant’s] representative allowed “the misuse of the product through calculated silence” is insufficient to create an issue of material fact for trial as to failure to warn. Plaintiff . . . has cited no law indicating that “calculated silence” that fails to prevent a doctor from using a device off-label, is the equivalent of off-label marketing.
Seavey, 2014 WL 1876957, at *9. See also Rohlik v. I Flow Corp., No. 7:10-CV-173-FL, 2011 WL 2669302, at *3 (E.D.N.C. July 7, 2011) (finding no fraud where sales representative “watched” off-label surgery being performed).
Thus, as Bexis explained in his recent off-label use law review article:
A physician’s choice to use a prescription medical product off-label does not expand a manufacturer’s liability or create any obligation to prevent off-label use from occurring. . . . No legal duty is imposed on FDA-regulated manufacturers to take affirmative preventive measures against physicians’ off-label use of their products.
James M. Beck, “Off-Label Use in the Twenty-First Century: Most Myths & Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1, 102 (2021) (footnotes omitted).
We close with a recent case that, like Swayze, was about off-label use but did not use that terminology. Teva Parenteral Medicines, Inc. v. Eighth Judicial District Court, 481 P.3d 1232 (Nev. 2021), involved a physician’s improper reuse of “single patient vials,” thereby causing an infection risk. Id. at 1238. As a result, several hundred plaintiffs – none of whom was actually injured, id. (“all tests came back negative”) − sued for medical monitoring-type injuries. This litigation has been around, in one form or another, for a while. The offending doctor was dead, and the clinic bankrupt, so the plaintiffs targeted the manufacturers of the generic drugs allegedly “misused.” Generic drug litigation equals preemption, so to avoid dismissal, plaintiffs invented a novel theory that defendants “knew” of the off-label use and thus had a duty not to sell the larger of two drug sizes to this particular customer because the larger size was more likely to be reused. “Under plaintiffs’ negligence theory, [defendants] had a duty under state law not to package, market, or sell [larger] vials . . . to [this particular doctor’s clinics].” Id. at 1242.
Literally without citing any Nevada, or other state-law, precedent at all – only the Supreme Court’s generic preemption cases – the court in Teva allowed the theory to proceed. It held the claim was “not preempted even if it required [defendants] to change their vial size . . . because petitioners already have approval for that smaller vial size.” Id.
But does such a duty, on the part of a prescription medical product manufacturer, to take the drastic step of refusing to deal with a customer “known” to be using the product off-label actually exist under state law? We don’t know. There’s not a sentence, or a citation, in the entire Teva decision addressing state-law ramifications of the novel (we’ve read a lot of cases and have never seen this theory before) duty that the plaintiffs claimed.
We’re not sure, but the reason may be the limited issue before the court in Teva, which was a mandamus action rather than an ordinary appeal:
This original petition for a writ of mandamus arises from lawsuits brought against generic drug manufacturers. . . . The question presented to us is whether the plaintiffs’ state-law tort claims are preempted by federal drug regulations.
Id. at 1237. It could be that (although never clearly expressed) the Teva court simply assumed that whatever bizarre duty the plaintiffs made up existed under state law. In this respect, Teva resembles Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (discussed in more detail in our second failure-to-report post), in that the court simply “assumed” the relevant state law duty for preemption purposes, id. at 769, only for it to turn out later that the assumed duty did not actually exist (having been legislatively abolished). See Knoth v. Apollo Endosurgery US, Inc., 425 F. Supp.3d 678, 694 (S.D. Miss. 2019) (discussing abolition). One can hope, anyway.
What is certain is that Teva was not argued or decided as an off-label use case, although the use of the product alleged was precisely that. Thus, all of the law cited above weighs against actually recognizing the hypothetical duty to prevent off-label use postulated in Teva.