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.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions