United States: Telemedicine And The Learned Intermediary Rule

Last Updated: September 4 2019
Article by James Beck

Somebody asked Bexis the other day whether he thought that the increasing reliance on "telemedicine" – physician consultations taking place online, perhaps followed by the prescription of a drug or medical device – posed any risks to the learned intermediary rule.

Bexis said, "no." Would you expect other answer?

That response was based largely on gut reaction. There is literally no caselaw. The number of cases containing both "learned intermediary" and "telemedicine" is precisely zero. Nor was substituting "telephone" any more illuminating.

This means that any legal analysis will have to be by analogy. So, the first thing to do when analyzing this problem is to make sure exactly what we're talking about. Defining the term "telemedicine," we mean legitimate consultations within an established physician-patient relationship.

What we don't mean is some unknown, unnamed, "doctor" "prescribing" some drug through a fly-by-night Internet "pharmacy" after a 60-second consultation that never produces a medical record that makes it into the so-called "patient's" files. That's illegal in the United States and, as for that category of patient, the most relevant legal principle is the in pari delicto rule, not the learned intermediary rule. Yeah, people can cut corners that way to get drugs cheaper and maybe more easily, but they know it's illegal, so if they are injured, it's their own damn fault.

One place to look for a more formal definition of "telemedicine" is the Code of Federal Regulations. For instance, to qualify for federal reimbursement by the Center for Medicare Services, providers of telemedicine:

must be composed of doctors of medicine or osteopathy. In accordance with State law . . ., the medical staff may also include other categories of physicians . . . and non-physician practitioners who are determined to be eligible for appointment by the governing body.

(1) The medical staff must periodically conduct appraisals of its members.

(2) The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of these candidates in accordance with State law. . . . A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section.

(3) When telemedicine services are furnished . . ., the governing body of the hospital whose patients are receiving the telemedicine services may choose, in lieu of the requirements in paragraphs (a)(1) and (a)(2) of this section, to have its medical staff rely upon the credentialing and privileging decisions made by the [provider] . . . [so long as] all of the following provisions are met:

(i) The [provider] providing the telemedicine services is a Medicare-participating hospital.

(ii) The individual distant-site physician or practitioner is privileged at the [provider], which provides a current list of the distant-site physician's or practitioner’s privileges. . . .

(iii) The individual distant-site physician or practitioner holds a license issued or recognized by the State in which the . . . patients are receiving the telemedicine services is located.

(iv) . . . [A]n internal review of the distant-site physician's or practitioner's performance of these privileges . . . [including] all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital's patients and all complaints the hospital has received about the distant-site physician or practitioner.

42 C.F.R. §482.22(a)(3). See also 42 C.F.R. §§482.12 and 485.616.

There are also a bunch of state laws specifying that "telemedicine" is more than a brief phone call or internet survey. A statute in Massachusetts, for instance, defines "telemedicine" as the "use of interactive audio, video or other electronic media for the purpose of diagnosis, consultation or treatment" but excludes "audio-only telephone, facsimile machines or email." Mass. Gen. Laws ch. 175, §47BB(a). Other state telemedicine definitional statutes or regulations are: Cal. Bus. & Prof. Code §2290.5(g)(3); Colo. Rev. Stat. §12-36-102.5(8); Ga. Code §33-24-56.4(b)(3); Haw. Rev. Stat. §453-1.(b); Ky. Rev. Stat. §205.510(15); La. Rev. Stat. §37:1262(4); Me. Rev. Stat. tit. 24-A, §4316(1); Md. Code, Health §19-319(e)(I)(ii); Mich. Comp. Laws §500.3476(2); N.H. Rev. Stat. §415-J:2(II); N.M. Stat. §13-7-14(H)(6); Okla. Stat. tit. 36, §6802; Or. Rev. Stat. §442.015(25); Tex. Gov. Code §531.001(8); Vt. Stat. tit. 8, §4100k(g)(4); Va. Code §38.2-3418.16(B)

Finally, the American Telemedicine Association describes "telehealth" on its website:

Services Provided by Telehealth

Sometimes tele is best understood in terms of the services provided and the mechanisms used to provide those services. Here are some examples:

Live videoconferencing (synchronous) – the delivery of a live, interactive consultation between Primary care and specialist health services. This may involve a primary care or allied health professional providing a consultation with a patient, or a specialist assisting the primary care physician in rendering a diagnosis.

Store and forward (asynchronous) – the use of store and forward transmission of diagnostic images, vital signs and/or video clips along with patient data for later review that enables a primary care or allied health professional providing a consultation the ability to render a diagnosis.

Remote patient monitoring (RPM) – including home telehealth, uses devices to remotely collect and send data to a home health agency or a remote diagnostic testing facility (RDTF) for interpretation. Such applications might include a specific vital sign, such as blood glucose or heart ECG or a variety of indicators for homebound consumers. Such services can be used to supplement the use of visiting nurses.

Mobile health (mHealth) – Consumer medical and health information includes the use of the internet and wireless devices for consumers to obtain specialized health information and online discussion groups to provide peer-to-peer support.

For any formal definition of "telemedicine," the requirement of real consultations within a true physician-patient relationship is pretty clear. Thus, so is the analogy to existing learned intermediary rule. Actually, this kind of debate has happened before – back in the 1960s and 1970s when governmental units across the country sponsored "mass vaccinations." Those vaccines were prescription medical products and like all such products, had inherent risks. That led to a line of cases that created the "mass vaccination" exception to the learned intermediary rule, the only exception formally enshrined in Restatement (Third) of Torts, Products Liability §6(c).

The mass vaccination cases are collected in Bexis' book §2.03[3][b]. This exception is applicable:

Where there is no physician to make an individualized balancing of the risks . . ., the very justification for the [learned intermediary rule] evaporates. Thus, as in the case of patent drugs sold over the counter without prescription, the manufacturer of a prescription drug who knows or has reason to know that it will not be dispensed as such a drug must provide the consumer with adequate information.

Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974) (applying Texas law). If the dispensing of a prescription medical product happens between an "anonymous member of the public and an equally anonymous dispenser of the medicine," the learned intermediary rule loses its justification. Stanback v. Parke, Davis & Co., 657 F.2d 642, 647 (4th Cir. 1981) (applying Virginia law). See Samuels v. American Cyanamid Co., 495 N.Y.S.2d 1006, 1013 (N.Y. Sup. 1985) (learned intermediary rule inapplicable to vaccines dispensed through a company clinic "without any meaningful appraisal by an 'informed intermediary'").

However, attempts to extend what is really a "no real prescriber" exception beyond its rather limited set of facts have failed. This "exception to the informed intermediary doctrine will apply only if an in-depth analysis of the benefits and risks to the individual of the [drug's] administration appears to be unlikely." Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 292 (6th Cir. 2015) (quoting Samuels) (applying New York law). The oral contraceptives in Yates were not prescribed is such an informal fashion:

[Plaintiff] was counseled meaningfully by her prescribing medical provider, such that no exception to the informed intermediary doctrine applies here. . . . [The clinic physician] adequately counseled [plaintiff's] regarding her different birth control options. [the physician] was aware of several personal matters that affected [plaintiff's] birth control selection. . . . [The clinic] is not a clinic designed to quickly process patients; rather, [the physician] testified that it is her custom to use her independent medical judgment when prescribing birth control products to patients, and she specifically testified that she discussed the risks and benefits of several different forms of birth control with [plaintiff].

Id. at 293. See DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601, 614 (S.D.N.Y. 2012) ("This is not a case when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings"; the prescriber "met with [plaintiff] individually prior to prescribing her [the drug]").

Several other cases have likewise held the exception inapplicable where a doctor is in position to exercise independent medical judgment. See Hexum v. Eli Lilly & Co., 2015 WL 4943959, at *8 (C.D. Cal. Aug. 18, 2015) ("This is not a case where a drug was dispensed en masse without any individualized assessment by a physician); In re Zyprexa Products Liability Litigation, 2010 WL 4052913, at *4 (E.D.N.Y. Oct. 12, 2010) ("no basis for" exception where the prescriber "considered [plaintiff's] specific symptoms and condition and made an individualized determination that treatment with [the drug] was appropriate") (applying North Carolina law); Porter v. Eli Lilly & Co., 2008 WL 544739, at *8 (N.D. Ga. Feb. 25, 2008) (exception "inapplicable to the instant case where [plaintiff] met individually with [the prescriber] who considered [plaintiff's] history and then decided to prescribe [the drug]"), aff'd mem., 291 F. Appx. 963 (11th Cir. 2008).

Indeed, the exception has been found inapplicable in vaccine cases where an individualized physician/patient relationship existed.

[B]ecause the physician-patient relationship existed, and because the doctor had thus assumed the role of learned intermediary, the fact that he had made no individualized judgment did not bar the application of the learned intermediary doctrine.

Hurley v. Lederle Laboratories, 863 F.2d 1173, 1179 (5th Cir. 1988) (applying Texas law). See Niemiera v. Schneider, 555 A.2d 1112, 1118 (N.J. 1989) (learned intermediary rule applies because this "vaccine is administered in a doctor's office on a case-by-case basis"); Stanback v. Parke, Davis & Co., 657 F.2d 642, 647 (4th Cir. 1981) ("The encounter in this case . . ., was between a patient and a physician whom she had previously visited on three occasions"); Dunn v. Lederle Laboratories, 328 N.W.2d 576, 580 n.11 (Mich. App. 1983) ("this case involves a single immunization to a single patient, administered by a physician, [so] . . . [defendant's] duty to warn . . . extends only to the doctor"); Snawder v. Cohen, 749 F. Supp. 1473, 1480 (W.D. Ky. 1990) (defendant's "duty extended no further than to provide a warning to Plaintiff's physician . . ., since the administration of the vaccine . . ., apparently took place in a physician's office"); Percival v. American Cyanamid Co., 689 F. Supp. 1060, 1062 (W.D. Okla. 1987) ("Nor do the facts give rise to the mass immunization exception. [The prescriber] was the treating physician and had treated [plaintiff] numerous times") (applying Oklahoma law); Williams v. Lederle Laboratories, Division of American Cyanamid Co., 591 F. Supp. 381, 389 (S.D. Ohio 1984) ("appropriate test . . . is whether the drug is commonly administered without individualized balancing by a physician of the risks involved and the individual's needs and circumstances") (applying Ohio law).

The lesson of the "mass vaccination" exception is thus that the learned intermediary rule is ousted only "when the manufacturer knows or should know that the advisory role of the health care provider will be greatly diminished." Larkin v. Pfizer, Inc., 153 S.W.3d 758, 765 (Ky. 2004). The only basis for the exception is the attenuation of the physician-patient relationship. But that is exactly the opposite of the purpose of telemedicine, described at length above, which is precisely to bring the benefits of individualized medical diagnosis and treatment to those who live too far from a physician (or for any other reason) to be able to receive medical treatment face to face. Thus, our conclusion remains that, as long as "telemedicine" is what it claims be – "a primary care or allied health professional providing a consultation with a patient, or a specialist assisting the primary care physician in rendering a diagnosis" – there is no logical basis to challenge the applicability of the learned intermediary rule simply because that physician was not in the same room as the patient.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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