A couple of cases we’ve posted about recently started us thinking – a dangerous turn of events, we know. There was that Beaumont Hospital case involving allegations about delivery of an incorrect free sample of a device. If somebody – anybody – at the hospital had simply looked at the thing, either when it was initially stored or later when it was taken back out for use, the error would have been readily apparent from the labeling, and the injury would never have occurred. See Johnson v. Settle, 2001 WL 585093, at *8 (Tenn. App. Oct. 29, 2001) (proper labeling trumped erroneous shipment of wrong medical product; incorrect use of properly labeled product held not reasonable foreseeable).
Then there’s the Kovach case, where the plaintiff tried to blame the maker of a measuring cup for a two-fold drug overdose – a whole cup rather than a half. Given the size of the overdose, no alleged illegibility of the little lines on the cup could possibly have made the slightest difference in the result.
What’s going on in those cases is the same thing we’ve already commented about in the context of the big preemption cases, Wyeth v. Levine, 129 S. Ct. 1187 (2009), and Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008) – and elsewhere. These days, a lot of cases that would once have been brought as medical malpractice cases are instead being repackaged (some better than others) as product liability cases. That may be due to strict liability being a less rigorous theory of liability than medical negligence (although our side tries every day trying not to let that happen), or it may be that there’s simply more money in product liability – usually due to malpractice damage caps. Or it could simply be that plaintiffs often would rather settle with the doctor (who’s an flesh-and-blood person that a jury may like) and take their chances with a large corporate defendant instead.
Whatever the reason for this phenomenon, it’s got us thinking about the limits to duty. We love doctors. They save people’s lives every day – that’s their job – and not incidentally they prescribe our clients’ products while doing that. But what happens when a doctor, as human as any of the rest of us, messes up? Do drug/device manufacturers have a legal duty to act as backstop where a doctor (or other healthcare provider) does something obviously wrong like not checking for drug interactions or failing to sterilize surgical instruments properly?
Not surprisingly, we don’t think so. A couple of cases, one relatively old and one relatively recent, illustrate the problems with imposing such liability on drug and device manufacturers.
The older case is Swayze v. McNeil Laboratories, Inc., 807 F.2d 464 (5th Cir. 1987). We were only baby lawyers back then. In Swayze, the plaintiff allegedly died from an overdose of surgical anesthetic. As stated in the opinion, “[d]uring the operation, a nurse anesthetist determined what dosage to administer [decedent] without receiving proper supervision from an anesthesiologist or the supervising surgeon.” Id. at 465. So did plaintiff sue the nurse and the surgeon? Yes, but plaintiff settled. Id.
There was nothing wrong with the drug’s labeling. It stated all the dosages correctly as well as the consequences of overdose. Plaintiff didn’t really contest that point, but argued instead that improperly supervised use of the anesthetic was “pervasive” among doctors, and thus the defendant could be liable for not “doing more to compel the medical community to properly supervise distribution of its drug.” Id. In blunter terms, the plaintiffs were advocating that drug companies should be medical police, that they had some legal duty to alter or control what doctors did.
Thankfully the court in Swayze essentially said “you’ve got to be kidding” – although it took its sweet time about it, not dismissing the case until a directed verdict motion at the end of the plaintiff’s case. On appeal, the court likewise rejected the plaintiff’s claim that, legally, “more should have been done to force physicians to supervise distribution of the drug.” 807 F.2d at 468.
We have two problems with the plaintiff’s position. First, it is the operating room procedure rather than the danger of the drug that the defendant is challenged to add to the warning. And, second, though defendant markets a reasonably safe product when accompanied by a prudent warning of its danger, we are asked to impose upon defendant an additional duty to intrude itself into the hospital operation as well as the doctor-patient relationship. We see no warrant for that position.
Id. The court found no legal duty for a manufacturer to “enforce” its warning. Once adequate warning is given, no more is legally required of the manufacturer. There was no duty to warn patients directly that doctors could use drugs negligently:
But what would patients do with this information? It might prompt would-be patients to put pressure on their physicians to better supervise, but physicians hardly need more incentive to be non-negligent. In all likelihood, such warnings would only lead to confusion, and perhaps undermine 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.
Id. at 471. Nor was there any duty for a manufacturer to act as “big brother” to prescribing physicians:
[T]his practice does not occur in every operating room. . . . 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. Finally, no common-law duty existed to require a drug company to remove its product from the market simply because doctors didn’t use it properly:
The problem here lies with individual physicians, in certain operating rooms. . . . The defendant cannot control the individual practices of the medical community, even if it is the prevailing practice, and we decline to impose such a duty. Drug manufacturers must adequately warn physicians of the potential side-effects of their prescription drugs; thereafter, the physician, with his special knowledge of the patient’s needs, assumes the burden of presiding over the patient’s best interests.
Id. at 472.
The more recent case (and another of Bexis’ PLAC amicus projects) is Kennedy v. Medtronic, Inc., 851 N.E.2d 778 (Ill. App. 2006). In Kennedy the doctor implanted a pacemaker, but incorrectly placed the lead in the wrong part of the heart. According to the opinion, he “admitted he deviated from the standard of care” in doing this. Id. at 780-81. There were other alleged oddities about the surgery, such as it being done on an “outpatient” basis at a just-opened clinic, the surgical assistant being unqualified (he was a dentist) and no record being kept of the patient’s vital signs. Id. at 780.
Sounds like a malpractice case, doesn’t it.
Well, a manufacturer’s representative was present for the surgery – to make sure the device was “correctly calibrated” and “functioning properly” – a service that the defendant routinely provided. 851 N.E.2d at 781. The representative “did not assist the doctor in inserting the pacemaker and lead and could not make a judgment as to whether the lead was placed in the appropriate ventricle,” a fact not in dispute. Id. The plaintiff’s theory of liability against the manufacturer was that, the corporate representative had a duty “to refrain from providing a pacemaker to [the surgeon] and from participating in the insertion of the pacemaker” because of its outpatient nature and lack of post-operative recovery facilities.” Id. at 782. It was another, somewhat more sophisticated variant of Swayze – that the manufacturer should have somehow prohibited the doctor from proceeding with the surgery. Id. (plaintiff claimed that without the representative’s calibration, the surgery could not have been conducted).
Again the court said no – this time on summary judgment. 851 N.E.2d at 782. Again the appellate court affirmed. The court of appeal found no legal duty to refrain from providing a medical device because of the doctor’s allegedly improper practice of medicine. The corporate representative was “not responsible” for the conduct of the surgery. Id. at 785.
[T]he burden and consequences of imposing the duty proposed by plaintiff [would] be substantial. It would be a significant burden to require [a manufacturer] to monitor the conditions under which a doctor performs surgery. . . . [A] central aspect of the learned intermediary doctrine. . .is that 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. It would be unreasonable, and potentially harmful, to require a [manufacturer’s representative] to delay or prevent a medical procedure simply because she believes the setting is not appropriate or the doctor is unqualified. To hold otherwise would place a medical device manufacturer. . .in the middle of the doctor-patient relationship. . . . Finally, as pointed out by amicus [PLAC], the consequences of requiring such screening by [defendant] would run the risk of imposing additional liability on the manufacturer 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. at 786. That’s three reasons for refusing to recognize a duty: (1) the interference with the physician/patient relationship; (2) the utter impracticality of requiring manufacturers to ride herd over doctors; and (3) the damned if you do/damned if you don’t quality of liability – that the manufacturer could also be liable for injuries to a patient if it withheld a prescribed product.
Nor did a manufacturer voluntarily assume (Restatement Second §324A) any duty by having a representative present during surgery:
[The representative] attended the surgery to provide technical support and ensure that the [device was] correctly calibrated and. . .functioning properly. This limited role did not entail her voluntarily assuming a duty. . .for the placement of the lead into the correct ventricle of the patient’s heart.
851 N.E.2d at 787.
These two cases, Swayze and Kennedy, accurately delimit the duties of drug and medical device companies – they are not obligated to tell doctors how to practice medicine. That extends to “matter[s] of general and elemental medical knowledge.” Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 819 (Cal. App. 1992). We’ve already discussed one aspect of this rule, that there’s no duty to warn doctors about first-year medical student information such as complications caused by notorious conditions such as high blood pressure or diabetes. See the “second hypothetical” in that post.
The issue of how much duty is too much has also arisen elsewhere. Allegations of liability for not providing extremely detailed medical monitoring instructions were rejected in In re Meridia Products Liability Litigation, 328 F. Supp.2d 791, 814 (N.D. Ohio 2004) (“[t]he law does not mandate that pharmaceutical manufacturers and marketers provide such specific instructions that they leave little room for doctors’ reasonable medical judgment”), aff’d, 447 F.3d 861 (6th Cir. 2006). “[S]uch judgments,” the court held, “are often better left to the doctors’ discretion.” Id. Similarly, liability for failure to tell doctors how to diagnose side effects was rejected in Nichols v. Clare Community Hospital, 476 N.W.2d 493, 495 (Mich. App. 1991) (a “manufacturer fulfills its duty to the medical community when it warns of the risk inherent in use of the drug. There is no requirement that the warning apprise the doctor of how to properly diagnose the condition that renders use dangerous”).
A claim that there was a common-law duty to prepare material for a prescriber to pass along to a patient was rejected in Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1033 (D.N.J. 1988). The court held that “a manufacturer has no duty to assist the learned intermediary in warning patients of the risks inherent in prescription medicine” Id. A manufacturer “does not have the authority to dictate to physicians how they should practice medicine.” Hunt v. Hoffmann-La Roche, Inc., 785 F. Supp. 547, 550 (D. Md. 1992). A manufacturer that had prepared information that doctors could give to their patients was under no duty to ensure that the doctors did so. Kennedy v. Merck & Co., 2003 WL 21658613, at *5 (Ohio App. July 3, 2003) (defendant “had no additional duty to ensure that the treating physician. . .provided the warning to [plaintiff]”).
Nor has any legal duty been imposed upon manufacturers to interfere with medical practice to ensure that their products are not put to off-label uses:
Neither party disputes that the [use in the case] qualified as an “off-label” usage. . . . [I]t is well established that the FDA does not prohibit “off-label” use of medical devices. While the FDA controls the marketing and labeling of medical devices, it does not attempt to interfere with the practice of medicine. . . . [O]ff-label use is an
accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.
Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 439-40 (E.D. Pa. 2004). Accord Harris v. Purdue Pharma, L.P., 218 F.R.D. 590, 596-97 (S.D. Ohio 2003) (defendant “cannot be held liable” for use of drug used more frequently than labeled “at the direction of [plaintiffs’] physicians”); Little v. Depuy Motech, Inc., 2000 WL 1519962, at *9 (S.D. Cal. June 13, 2000) (a doctor’s “decision to use [a] device in an ‘off-label’ manner does not subject the manufacturer to liability, even if it knows of the off-label use”); Cox v. Depuy Motech, Inc., 2000 WL 1160486, at *8-9 (S.D. Cal. Mar. 29, 2000) (“[the] seller is not liable even if it knows of the off-label use”).
Likewise, in Plummer v. Lederle Laboratories, 819 F.2d 349, 357-58 (2d Cir. 1987), and Dunn v. Lederle Laboratories, 328 N.W.2d 576, 581 (Mich. App. 1982), the courts held that nitpicking and rather basic “precautions” – such as “cleanliness” – were not necessary in cases involving infectious diseases (polio). Subsequent New York cases have distilled this reasoning into the proposition that a manufacturer is not “responsible for how a learned intermediary conducts his business.” Billone v. Sulzer Orthopedics, Inc., 2005 WL 2044554, at *5 (W.D.N.Y. Aug. 25, 2005) (device would break if overused); Prohaska v. Sofamor, S.N.C., 138 F.Supp.2d 422, 444 (W.D.N.Y. 2001) (failure to pass along warning to patient); Lawrence v. Sofamor, S.N.C., 1999 WL 592689, at *4 (N.D.N.Y. Aug. 2, 1999) (metal implant will eventually break if bone does not heal); Krasnopolsky v. Warner-Lambert Co., 1346 (E.D.N.Y. 1992) (failure to pass along warning to patient) (quoting Mazur v. Merck & Co., 767 F. Supp. 697, 711 (E.D. Pa. 1991)).
Courts have rejected other overreaching duty theories under various circumstances. For example, there is no duty to provide instructions on how to use a prescription medical product to foreseeable third persons who are not doctors, such as a patient’s relatives:
[T]he defendants here had a duty to warn the hospital physicians and nurses. They satisfied that duty. A hospital’s or medical staff’s failures to perform their duties from that point forward do not operate to create, or to extend, a manufacturer’s duty to warn third-party family members, bystanders, or any persons other than the learned intermediary. A manufacturer is not responsible for how a learned intermediary conducts his business.
Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1283 (11th Cir. 2002). There is no “duty to police” rogue doctors who prescribe a product in ways that created “a danger to [their] patients”:
[The] law does not impose a duty on the defendants to interfere with the physician-patient relationship, even if they were aware that the product may have been prescribed inappropriately. Nor have the plaintiffs shown that a special relationship, as defined in [state] law, existed between the defendants and [the prescriber]. Thus there was no duty to control [the prescriber’s] practice of prescribing [the drug].
Labzda v. Purdue Pharma, L.P., 292 F. Supp.2d 1346, 1355 (S.D. Fla. 2003) (involving prescription of controlled substance). See also Lemon v. Anonymous Physician, 2005 WL 2218359 (S.D. Ind. Sept. 12, 2005) (“[a] medical device manufacturer does not automatically have a duty to properly train, instruct or assist a physician on the surgical implantation and use of the device”); Hunt, 785 F. Supp. at 550 (manufacturer had no duty to impose “mandatory” medical testing requirement); Banner v. Hoffmann-La Roche Inc., 891 A.2d 1229, 1241 (N.J. Super. A.D. 2006) (no duty beyond adequate warning to ensure abstinence of persons taking drugs; court “cannot conclude that [defendant] had a duty to withhold from [plaintiff] a medication her doctor determined was an appropriate treatment”); Chamian v. Sharplan Lasers, Inc., 2004 WL 2341569, at *7 (Mass. Super. Sept. 24, 2004) (manufacturer training offered to doctor did not vitiate adequate warning; “[b]y providing training, [the manufacturer] did not become a guarantor of the competence of” the physician).
Thus, once a manufacturer provides an adequate warning to the prescribing doctor, its duty ends and no legal duty exists for it to do more.
[W]arnings must be brief and focused to be effective. It would require an extended discussion, in the nature of a medical journal article, to lay out the debate [at issue]. It is also hard to see what the doctor would gain even if he read the expanded discussion. . . . One must also bear in mind that the warnings are intended to be read by learned intermediaries who are presumed to have considerable medical training as well as the ability to access the medical literature if they require additional information.
Ames v. Apothecon, Inc., 431 F. Supp.2d 566, 573 (D. Md. 2006). See Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965. 975-76 (10th Cir. 2001) (the “law does not require that a warning warn against every conceivable risk under every conceivable circumstance”); Wright v. Abbott Laboratories, Inc., 259 F.3d 1226, 1233 (10th Cir. 2001) (no duty to instruct on how to store product; adequate warning of risks of product use satisfied duty to warn); Christopher v. Cutter Laboratories, 53 F.3d 1184, 1193 (11th Cir. 1995) (jury should not have been charged that the physician should have known more than what was in concededly adequate warning); Gerber v. Hoffmann-La Roche Inc., 392 F. Supp.2d 907, 921 (S.D. Tex. 2005) (“[r]egardless of [the prescriber’s] subjective opinion of how he might have done things differently had the. . .warnings been different, the warnings. . .were adequate as a matter of law”); Kernke v. Menninger Clinic, Inc., 173 F. Supp.2d 1117, 1122 (D. Kan. 2001) (being “on notice” that physicians were deficient in obtaining informed consent did not impose any further duty upon defendant that provided adequate warnings); E.R. Squibb and Sons, Inc. v. Farnes, 697 So.2d 825, 827 (Fla. 1997) (manufacturer may “rely. . .on the education and training of the ‘learned intermediary’ to explore questions raised by reviewing the insert”); Pfizer, Inc. v. Jones, 272 S.E.2d 43, 45 (Va. 1980) (adequate warning of risk precludes further duty to explain “exactly how the danger would operate”); Brown v. Glaxo, Inc., 790 So.2d 35, 39-40 (La. App. 2000) (“[w]e are not concerned with what [the defendant] could have included in the warning. The test is adequacy.”); Pluto v. Searle Laboratories, 690 N.E.2d 619, 622 (Ill. App. 1997) (where warnings about product were adequate, there was no further duty to warn against high risk “lifestyle choice”); Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1155 (Pa. Super. 1996) (where warning was adequate, there was no duty to include “helpful” information about how to treat adverse reaction); Buckner v. Allergan Pharmaceuticals, 400 So. 2d 820, 822-24 (Fla. App. 1981) (duty to warn not expanded by allegation that manufacturer aware that doctors were not passing warnings along to patients).
Basically, the law has wisely maintained the separate sets of duties for doctors on one hand and prescription medical product manufacturers on the other, based upon their essentially separate roles in the provision of safety-related information. Manufacturers provide product-related information to doctors. The doctors then filter that information through the lens of their personal knowledge of individual patients. Manufacturers can’t breach that lens (what the learned intermediary rule is all about), nor are they required to say or do other things that impinge upon a doctor’s right to practice medicine. Problems arising from professional choices made in the course of medical practice are addressed separately – through medical malpractice or through regulatory action.
We think that’s the way the law ought to be.