Manufacturers supervising medical doctors? In two words, they don’t. Yet plaintiffs, particularly in cases where preemption forecloses more normal product liability claims, try to get courts to impose such duties. We took a look at that issue back during the early days of the blog, when it was still a Bexis/Herrmann operation, in our September 17, 2009 post entitled “Limits to Duty.” It’s been ten years, so we thought that post deserved an update.
We’ll leave the older cases alone, since they were thoroughly discussed back in 2009, except to relist them:
Appellate decisions holding no duty by sales reps (or manufacturers generally) to supervise doctors:
E.R. Squibb & Sons, Inc. v. Farnes, 697 So.2d 825, 827 (Fla. 1997) (no duty to ensure doctor warned patient); King v. Searle Pharmaceuticals, Inc., 832 P.2d 858, 866 (Utah 1992) (no control over doctor’s technique); Pfizer, Inc. v. Jones, 272 S.E.2d 43, 45 (Va. 1980) (no nitpicky instructions); Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1283 (11th Cir. 2002) (no duty to warn a patient’s relatives); Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965, 975-76 (10th Cir. 2001) (no nitpicky instructions) (applying Kansas law); Wright v. Abbott Laboratories, Inc., 259 F.3d 1226, 1233 (10th Cir. 2001) (no duty to enforce product storage warning) (applying Kansas law); Christopher v. Cutter Laboratories, 53 F.3d 1184, 1193 (11th Cir. 1995) (no duty to provide more-than-adequate warning) (applying Florida law); Plummer v. Lederle Laboratories, 819 F.2d 349, 357-58 (2d Cir. 1987) (no nitpicky instructions) (applying California and New York law); Swayze v. McNeil Laboratories, Inc., 807 F.2d 464, 468, 472-72 (5th Cir. 1987) (no duty to supervise administration of anesthesia) (applying Mississippi law); Kennedy v. Medtronic, Inc., 851 N.E.2d 778, 785-87 (Ill. App. 2006) (no duty to prevent off-label use); Banner v. Hoffmann-La Roche, Inc., 891 A.2d 1229, 1241 (N.J. Super. A.D. 2006) (no duty to withhold prescribed medication); Kennedy v. Merck & Co., 2003 WL 21658613, at *5 (Ohio App. July 3, 2003) (no duty to ensure doctor warned patient); Brown v. Glaxo, Inc., 790 So.2d 35, 39-40 (La. App. 2000) (no duty to provide more-than-adequate warning); Pluto v. Searle Laboratories, 690 N.E.2d 619, 622 (Ill. App. 1997) (no duty to provide more-than-adequate warning); Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1155 (Pa. Super. 1996) (no duty to provide more-than-adequate warning); Disbrow v. Richards, Inc., 1996 WL 593780, at *2 (Tex. App. Oct. 17, 1996) (organizing instruments not unauthorized practice of medicine); .Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 819 (Cal. App. 1992) (no nitpicky instructions); Nichols v. Clare Community Hospital, 476 N.W.2d 493, 495 (Mich. App. 1991) (no nitpicky instructions); Dunn v. Lederle Laboratories, 328 N.W.2d 576, 581 (Mich. App. 1982) (no nitpicky instructions); Buckner v. Allergan Pharmaceuticals, 400 So. 2d 820, 822-24 (Fla. App. 1981) (no duty to ensure doctor warned patient); May v. Dafoe, 611 P.2d 1275, 1277-78 (Wash. App. 1980) (no duty to provide basic information).
Trial court decisions holding no duty by sales reps (or manufacturers generally) to supervise doctors:
Harrington v. Biomet, Inc., 2008 WL 2329132, at *7 (W.D. Okla. June 3, 2008) (no duty to advise surgeon about component size); Beale v. Biomet, Inc., 492 F. Supp.2d 1360, 1370 (S.D. Fla. 2007) (no duty to ensure doctor warned patient); Ames v. Apothecon, Inc., 431 F. Supp.2d 566, 573 (D. Md. 2006) (no nitpicky instructions); Stafford v. Wyeth, 411 F. Supp.2d 1318, 1321 (W.D. Okla. 2006) (no duty to ensure doctor warned patient); Gerber v. Hoffmann-La Roche Inc., 392 F. Supp.2d 907, 921 (S.D. Tex. 2005) (no duty to provide more-than-adequate warning); Evans v. Medtronic, Inc., 2005 WL 3547240, at *15-16 (W.D. Va. Dec. 27, 2005) (no duty to obtain and preserve explanted device); Taylor v. Pharmacia-Upjohn Co., LLC, 2005 WL 3502052, at *4 (S.D. Miss. Dec. 19, 2005) (no duty to ensure doctor warned patient); Lemon v. Anonymous Physician, 2005 WL 2218359 (S.D. Ind. Sept. 12, 2005) (no duty to assist doctors); Billone v. Sulzer Orthopedics, Inc., 2005 WL 2044554, at *5 (W.D.N.Y. Aug. 25, 2005) (no nitpicky instructions); In re Meridia Products Liability Litigation, 328 F. Supp.2d 791, 814 (N.D. Ohio 2004) (no duty to provide basic information), aff’d, 447 F.3d 861 (6th Cir. 2006); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 439-40 (E.D. Pa. 2004) (no duty to prevent off-label use); Harris v. Purdue Pharma, L.P., 218 F.R.D. 590, 596-97 (S.D. Ohio 2003) (no duty to prevent off-label use); Labzda v. Purdue Pharma, L.P., 292 F. Supp.2d 1346, 1355 (S.D. Fla. 2003) (no duty to control doctors’ prescribing habits); Kernke v. Menninger Clinic, Inc., 173 F. Supp.2d 1117, 1122 (D. Kan. 2001) (no duty to supervise informed consent); Prohaska v. Sofamor, S.N.C., 138 F. Supp.2d 422, 444 (W.D.N.Y. 2001) (no duty to ensure doctor warned patient); Little v. Depuy Motech, Inc., 2000 WL 1519962, at *9 (S.D. Cal. June 13, 2000) (no duty to prevent off-label use); Cox v. Depuy Motech, Inc., 2000 WL 1160486, at *8-9 (S.D. Cal. Mar. 29, 2000) (no duty to prevent off-label use); Lawrence v. Sofamor, S.N.C., 1999 WL 592689, at *4 (N.D.N.Y. Aug. 2, 1999) (no duty to provide basic information); Krasnopolsky v. Warner-Lambert Co., 799 F. Supp. 1342, 1346 (E.D.N.Y. 1992) (no duty to ensure doctor warned patient); Hunt v. Hoffmann-La Roche, Inc., 785 F. Supp. 547, 550 (D. Md. 1992) (no duty to ensure doctor warned patient or to require mandatory medical tests); Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1033 (D.N.J. 1988) (no duty to tell doctors how to practice medicine or to ensure they warned patients); Chamian v. Sharplan Lasers, Inc., 2004 WL 2341569, at *7 (Mass. Super. Sept. 24, 2004) (not guarantor of doctor competence).
Since 2009, plaintiffs have unsuccessfully attempted to impose upon manufacturers a general “duty to train” (non-employee) doctors in the use of their products. We’ve discussed that type of claim here and addressed it as a prohibited “educational malpractice” claim here. In the absence of: (1) an employment relationship. (2) a voluntary undertaking, or (3) an FDA-imposed duty, to provide training (and even these must be properly pleaded, e.g., McLaughlin v. Bayer Corp., 172 F. Supp.3d 804, 817 (E.D. Pa. 2016)), these claims have been unsuccessful.
In general, there is no duty to take affirmative action to assist or protect another. As the jury was instructed here, [defendant] had no duty to train physicians on the use of its . . . products.
Scott v. C.R. Bard, Inc., 180 Cal. Rptr. 3d 479, 490 (Cal. App. 2014). See Glennen v. Allergan, Inc., 202 Cal. Rptr.3d 68, 83-84 (Cal. App. 2016) (“The manufacturer of a prescription medical device has no duty to train a physician in using its medical device” because “manufacturers are not responsible for the practice of medicine”).
[Plaintiffs] attempt to circumvent the learned intermediary doctrine by characterizing the issue as one of training rather than of warning . . . . [T]his is a distinction without a difference. . . . Thus, [defendant] satisfied its duty . . . by providing clear, unambiguous information concerning the contraindications for [the product], as well as the risks associated with it. Whether [defendant] was “training” or “warning” [the treater] of these risks when it provided him the package insert is, as the district court recognized, an issue of semantics only. As a matter of law [defendant] discharged its duty to advise [the treater] of the risks associated with [the product] by providing clear, unambiguous information about these risks in the . . . package insert. [The treater] then owed a duty to [plaintiff] to read the package insert and exercise judgment in discussing those risks with [her] and in using the [the] product to treat [her].
Rounds v. Genzyme Corp., 440 F. Appx. 753, 756 (11th Cir. 2011) (applying Florida law). Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017), adopted Rounds’ non-precedential ruling. “Florida law does not allow the improper training theory to proceed . . . [because] the learned-intermediary doctrine bars this theory of negligence.” Id. at 1329 (affirming on the basis of Rounds).
Thus, an allegation that defendant “failed to train, warn or educate” physicians fails “to state a claim to relief that is plausible on its face”. Woodhouse v. Sanofi-Aventis U.S. LLC, 2011 WL 3666595, at *3 (W.D. Tex. June 23, 2011). See Richardson v. Bayer Healthcare Pharmaceuticals, Inc., 2016 WL 4546369, at *6 (D. Idaho Aug. 30, 2016) (finding no “relevant law . . . demonstrat[ing] that a manufacturer owes a duty under Idaho law to train physicians”); Williams v. Smith & Nephew, Inc., 123 F. Supp.3d 733, 747 (D. Md. 2015) (plaintiffs failed to establish that failure to train was “actionable under state law”); Sanchez v. Boston Scientific Corp., 2015 WL 631289, at *6 (S.D.W. Va. Feb. 12, 2015) (“West Virginia does not recognize a duty to provide training to physicians”); Wise v. C.R. Bard, Inc., 2015 WL 541933, at *8 (S.D.W. Va. Feb. 10, 2015) (“Texas does not recognize a duty to provide training to physicians”) (applying Texas law); In re Ethicon Pelvic Repair Systems Products Liability Litigation, 2014 WL 505234, at *5 (S.D.W. Va. Feb. 5, 2014) (“Texas cases recognize the duty of drug and medical device manufacturers to warn physicians, not to provide training to them.”) (applying Texas law). See also Glorvigen v. Cirrus Design Corp., 816 N.W.2d 572, 583 (Minn. 2012) (refusing to create generalized duty to train outside prescription medical product context); McKesson Medication Management, LLC v. Slavin, 75 So.3d 308, 314 (Fla. App. 2011) (no legal basis for failure to train claim against pharmaceutical services provider); In re Dicamba Herbicides Litigation, 359 F. Supp.3d 711, 739 (E.D. Mo. 2019) (“negligent training claims generally are not recognized outside the employer/employee context”).
The aforementioned Swayze decision supported rejection of failure to train and supervise surgeons in Sons v. Medtronic, Inc., 915 F. Supp. 2d 776 (W.D. La. 2013). “[E]ven assuming arguendo that plaintiff’s failure to train/instruct claims are not preempted. . . . It is well established that a medical device manufacturer is not responsible for the practice of medicine.” Id. at 783. In addition to Swayze, Sons cited this little Louisiana gem:
[The sales representative’s] purported statements addressed what type of spinal procedure [the surgeon] should perform on [plaintiff]. As a seasoned neurosurgeon, it is patently unreasonable for [him] to rely on a sales representative’s opinion about the type of procedure that should be employed in operating on a patient’s spine. . . . Because [the surgeon’s] reliance was unreasonable as a matter of law, the negligent misrepresentation claim against him must fail.
Hall v. Horn Medical, L.L.C., 2012 WL 1752546, at *3 (E.D. La. May 16, 2012) (citation and footnote omitted).
A similar purported duty – not designated as involving “training,” was likewise rejected in McCartney v. United States, 31 F. Supp.3d 1340 (D. Utah 2014). No duty exists “to ensure that the physician properly implanted the . . . device.” Id. at 1345.
This cause of action is one for [defendant’s] nonfeasance during [plaintiff’s] surgery. . . . [T]here is no special legal relationship between medical device manufacturers and patients such that medical device manufacturers owe a duty of care for their nonfeasance during a physician’s surgery. [Defendant] did not owe Plaintiff a duty to ensure the physician properly implanted the medical device at issue.
“There is a relatively new, yet now common practice, of having medical device company representatives attend surgeries.” McCartney, 31 F. Supp.3d at 1343. Because sales representatives perform many services not regulated by the FDA, plaintiffs facing strong preemption arguments often try to scapegoat sales representatives. We’ve discussed this situation before as well. Here are relevant post-2009 cases. In Wolicki-Gables v. Arrow International, Inc., 641 F. Supp.2d 1270 (M.D. Fla. 2009), aff’d on other grounds, 634 F.3d 1296 (11th Cir. 2011), the mere presence of a sales representative in the operating room did not create any duty:
Even if the finder of fact infers that [defendant’s sales representative] did have some interaction with [the surgeon] during that surgery, the Court does not know of any evidence that establishes that [the sales representative] had a duty to affirmatively tell [the surgeon], while [he] was performing surgery, that [the surgeon] should not [do what the surgeon did concerning the defendant’s device].
Id. at 1291. “[The surgeon] testified that the decisions made while he performed surgery were his own decisions.” Id. Thus, beyond the usual product warnings, there was no “duty to use reasonable care in the instruction and education of physicians.” Id. at 1279. See Suckow v. Medtronic, Inc., 971 F. Supp.2d 1042, 1047-48 (D. Nev. 2013) (sales representative “interrogating” medical device created no duty where, “it is the physician who interprets any data and makes decisions”); Millman v. Biomet Orthopedics, Inc., 2013 WL 6498394, at *5 (N.D. Ind. Dec. 10, 2013) (that sales representative “remain[ed] in the operating room throughout the procedure” as an “observer” did not, without more, create any duty); Patterson v. DePuy Orthopaedics, Inc., 2011 WL 3047794, at *4 (N.D. Ohio July 25, 2011) (“there is no duty owed between a sales representative and a patient”).
In Smith v. St. Jude Medical, Inc., 158 Cal. Rptr. 3d 302 (Cal. App. 2013), the plaintiff claimed that the surgeon acted “[u]nder the guidance and direction of” the defendant’s sales representative. Id. at 305. Summary judgment was granted and affirmed because that allegation was baseless. The “sales representative . . . did not instruct or direct [the surgeon] on how or where to implant the [device].” Id. at 309. Rather, “doctors choose to do whatever they need to do” and “the doctor, not [the sales representative], determines where to place the [device].” Id. The court also relied on Kennedy v. Medtronic, supra, finding it to be “consistent with California law.” Id. at 310.
Similarly, in O’Connell v. Biomet, Inc., 250 P.3d 1278 (Colo. App. 2010), the court invoked the “captain of the ship doctrine,” to affirm dismissal of negligence claims against a sales representative. Id. at 1283. “[T]he cases have not limited the doctrine only to hospital employees.” Id. Thus, a sales representative in the operating room is subject to the ultimate “control” of the surgeon – not vice versa:
The sole purpose of [the sales representative] being in the operating room was to provide [the surgeon] with information about the [device], which information [the surgeon] then used to make his medical judgments. That is, [the surgeon] remained in control of the surgery vis-à-vis [the sales representative] and all other non-physicians in the operating room. Because [the surgeon] remained in control of the surgery, anything [the sales representative] might have done during that surgery, including any advice he allegedly gave or should have given to [the surgeon], was done as a crew member, so to speak, of the surgical ship.
Id. at 1283-84 (adopting trial court opinion). Thus surgeons “ha[ve] the right to control and supervise” manufacturer’s sales representatives when such representatives are in the operating room. Id. at 1284.
In Small v. Amgen, Inc., 134 F. Supp.3d 1358 (M.D. Fla. 2015), aff’d, 723 F. Appx. 722 (11th Cir. 2018), the plaintiff “argu[ed] that [the prescriber] cannot be treated as a learned intermediary because defendants’ pharmaceutical sales representative advised” him. That advice, however, was “irrelevant” because “the prescribing physician had independent knowledge of the risk.” Id. at 1372. Sales representatives are under no duty to provide “guidance” to physicians:
The problem with this theory is that manufacturers are only required to warn the prescribing physician of the possibility that the drug may cause the injury alleged by the plaintiff. There is no duty to provide guidance under Florida law.
Id. (citation omitted).
The plaintiff in Greenwood v. Tehrani, 2017 WL 4083099 (N.Y. Sup. Sept. 15, 2017), alleged that the defendant’s sales representative “fail[ed] to ensure that [plaintiff’s] physician used the device in ‘a safe, indicated manner,’” that is, failed to prevent off-label use. Id. at *3. That claim was pitched. “[W]hile the manufacturer of a medical device has a duty to warn a patient’s physician of the risks associated with the device, the manufacturer is not responsible for how the physician uses the device and renders the medical care.” Id. (citing Prohaska and Lawrence, cited above).
Instead of manufacturers (or their sales representatives) supervising the medical community, the law has long taken the opposite position. After providing an adequate warning, a manufacturer “may reasonably assume that the physician will exercise his informed judgment in the patient’s best interests.” Tracy v. Merrell Dow Pharmaceuticals, Inc., 569 N.E.2d 875, 878-879 (Ohio 1991). Once giving sufficient warning, “the manufacturer may reasonably assume that the physician will exercise the informed judgment . . . in the best interest of the patient.” McKee v. American Home Products Corp., 782 P.2d 1045, 1050 (Wash. 1989) (citation and quotation marks omitted). “[T]he drug manufacturer could not be penalized for the failure of the doctor to impart knowledge concerning the dangers of the drug of which the doctor had been warned.” Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 105 (Fla. 1989). The “failure [of the learned intermediaries] to perform their duties from that point forward do not operate to create, or to extend, a manufacturer’s duty to warn . . . any persons other than the learned intermediary.” Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1283 (11th Cir. 2002) (applying Georgia law).
How the physician communicates the medicine’s dangers to the patient is the physician’s own decision, and his or her independent duty. There is no legal support for imposing upon a drug manufacturer an “advisory” role in that decision. Education of the physician, on the one hand, and communication to the patient, on the other, are distinct processes, and the manufacturer’s duty involves only the former.
Polley v. Ciba-Geigy Corp., 658 F. Supp. 420, 421 (D. Alaska 1987).
There are many such cases, and they are collected in Bexis’ Book, §2.03 at footnotes 45-46. Updating the 2009 post, the “law does not require that the drug manufacturer provide such detailed information or instructions so as to remove the medical judgment of the physicians.” Bergstresser v. Bristol-Myers Squibb Co., 2013 WL 6230489, at *7 (M.D. Pa. Dec. 2, 2013). The New Jersey Appellate Division reiterated that, after providing adequate warning, a manufacturer “has no duty to ensure that the warning reaches the patient.” Gaghan v. Hoffman-La Roche Inc., 2014 WL 3798338, at *12 (N.J. Super. App. Div. Aug. 4, 2014). Thus:
[in] these (and prior) proceedings Plaintiffs’ counsel have done their very best to conflate the [learned intermediary rule] with the informed consent doctrine. That’s simply not the law. When a prescribing physician comprehends the fact that a given medicine is associated with certain potential risks, and exercises his/her medical judgment in deciding whether and how to address those risks with his/her patient, the manufacturer cannot be held responsible for the prescriber’s decision.
In re Accutane Litigation, 2016 WL 5958375, at *5 (N.J. Super. Law Div. Oct. 12, 2016).
In Chao v. Smith & Nephew, Inc., 2013 WL 6157587 (S.D. Cal. Oct. 22, 2013), plaintiff argued that the defendant had a duty to veto a physician’s patient selection where the product was contraindicated. Id. at *4. However, “it is the surgeon, not the device manufacturer, who makes the final determination regarding patient selection.” Id.
Plaintiffs have cited no legal authority nor FDA regulation for the proposition that a device manufacturer owes a duty, beyond providing a warning, to dissuade a physician from using a device on a particular patient. . . . The evidence before the court shows that Defendant . . . provided adequate warning to [the implanting surgeon] . . . and that [he] decided to proceed anyway. The Court declines to impose an additional duty on a device manufacturer to second guess a practicing physician when that physician has already received the FDA mandated warnings.
Id. at *4-5. See Taylor v. Intuitive Surgical, Inc., 389 P.3d 517, 525 (Wash. 2017) (quoting above language in McKee); Falsberg v. GlaxoSmithKline, PLC, 2013 WL 4822205, at *3 (Wash. App. Sept. 9, 2013) (no duty “to include diagnostic tips, or otherwise instruct a physician on how to practice medicine”); Tortorelli v. Mercy Health Center, Inc., 242 P.3d 549, 560 (Okla. App. 2010) (defendant’s “duty as a manufacturer under [the learned intermediary rule] was not to provide an in-depth education to trained physicians in the underlying biochemistry . . . but to identify and warn of risks”); Olmo v. Davol, Inc., 2017 WL 1367231, at *5 (S.D. Fla. April 7, 2017) (quoting Farnes, supra); Vakil v. Merck & Co., 2016 WL 7175638, at *7 (D.N.J. Dec. 7, 2016) (“that [the prescriber] had not read [the] label in a number of years and did not explain its risks to Plaintiff is irrelevant”) (applying Virginia law); Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 2013 WL 12149265, at *7 (N.D. Ala. Oct. 31, 2013) (“plaintiffs cannot seek damages from these defendants [manufacturers/sellers] based on decedent’s treating physician’s choice of prescriptions”); Calisi v Abbott Laboratories, 2013 WL 5441355, at *17 (D. Mass. Sept. 27, 2013) (“what the prescribing physician did or did not do in response to warnings does not answer the initial issue of whether the warnings given were adequate.); In re Vioxx Products Liability Litigation, 2015 WL 1909859, at *10 (E.D. La. April 21, 2015) (if the warning is adequate, it is “no consequence whether the doctor relayed these warnings to the patient”) (applying Missouri law); In re Chantix (Varenicline) Products Liability Litigation, 881 F. Supp.2d 1333, 1340 (N.D. Ala. 2012) (“the decision as to use a medication as a first-line treatment is uniquely up to the prescribing medical professional”); Metz v. Wyeth LLC, 872 F. Supp.2d 1335, 1344-45 (M.D. Fla. 2012) (quoting Farnes, supra; no duty to ensure doctor warned patient), aff’d, 525 F. Appx. 893 (11th Cir. 2013); Donovan v. Centerpulse Spine-Tech Inc., 2010 WL 1269751, at *8 (W.D.N.Y. March 31, 2010) (“Nor is a manufacturer responsible for how a learned intermediary conducts his business.”), aff’d, 416 F. Appx. 104 (2d Cir. 2011); Mohr v. Targeted Genetics, Inc., 690 F. Supp.2d 711, 719 (C.D. Ill. 2010) (“Assuming the warnings were adequate, however, [defendant] would not be responsible for the physician’s failure to communicate them to the patient.”); Aaron v. Wyeth, 2010 WL 653984, at *10 (W.D. Pa. Feb. 19, 2010) (a prescriber’s “alleged incorrect belief” about what the warnings stated “is of no moment”); Cruz v. Mylan, Inc., 2010 WL 598688, at *3 (M.D. Fla. Feb. 17, 2010) (“the pharmaceutical company’s duty to warn stops at the physician”); Hildebrandt v. Johnson & Johnson, 2009 WL 3349913, at *5 (S.D. Ill. Oct. 19, 2009) (“where the facts of a case show that the manufacturer of a prescription medication gave adequate warning . . ., this operates to discharge the liability of everyone in the drug’s chain of distribution except the physician”).
Based on the foregoing, it seems that attempts to create tort duties that would require manufacturers or their sales representatives to assume supervisory responsibility for physician practice of medicine have been no more successful since 2009 than they were before. Unless the FDA requires some specific form of physician training with a product, or the manufacturer (or its representative) voluntarily undertakes such supervision, this sort of claim remains in the realm of liability overstretch.