United States: Non-Physician Learned Intermediaries

Last Updated: March 2 2017
Article by James Beck

One of us was asked a question the other day that we couldn't answer immediately. "Does the learned intermediary rule apply to a physician's assistant?" We didn't remember any cases actually deciding that issue. So we did what we usually do in that situation and looked at Bexis' book. The book has a section (§2.03[2]) titled "Who Is the Learned Intermediary," which looked like it would cover this subject. It did, but while it had cases discussing nurses:

Yes: Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1281 (11th Cir. 2002) (applying Georgia law); Walker v. Merck & Co., 648 F. Supp. 931, 934 (M.D. Ga. 1986), aff'd without op., 831 F.2d 1069 (11th Cir. 1987); Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 93 (Tex. App. 2000); Holley v. Burroughs Wellcome Co., 330 S.E.2d 228, 235-36 (N.C. App. 1985), aff'd, 348 S.E.2d 772 (N.C. 1986); Singleton v. Airco, Inc., 314 S.E.2d 680, 682 (Ga. App. 1984); In re NuvaRing Litigation, 2013 WL 1874321, at *28 (N.J. Super. L.D. April 18, 2013) (applying California law). No: Mazur v. Merck & Co., 964 F.2d 1348, 1357 (3d Cir. 1992) (a nurse "not authorized to prescribe drugs") (applying Pennsylvania law); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1277 (5th Cir. 1974) (applying Texas law).

Cases discussing optometrists:

No: Prager v. Allergan, Inc., 1990 WL 70875, at *4 (N.D. Ill. May 2, 1990); Bukowski v. CooperVision Inc., 592 N.Y.S.2d 807, 809 (N.Y.A.D. 1993);

Cases discussing pharmacists:

No: Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1387 (Pa. 1991); Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa. Super. 1987);

A case discussing veterinarians:

Yes: Haste v. American Home Products Corp., 577 F.2d 1122, 1124 (10th Cir. 1978) (applying Wyoming law);

A case discussing physical therapists:

Yes: Seifried v. The Hygenic Corp., 410 S.W.3d 427, 433 (Tex. App. 2013); and

A case discussing medical societies:

No: Davis v. Wyeth Laboratories, 399 F.2d 121, 130 (9th Cir. 1968) (applying Montana law) . . . .

There were no cases specifically addressing P.A. prescriptions and the learned intermediary rule in Bexis' book.

As an aside, we note that, while the weird case we discussed last week from Washington State, Taylor v. Intuitive Surgical, Inc., ___ P.3d ___, 2017 WL 532497 (Wash. Feb. 9, 2017), wasn't phrased in such terms, it is effectively a ruling that a hospital can be a learned intermediary.

The only specific mention of physician's assistants in Bexis' book was quoting dictum in Perez v. Wyeth Laboratories, Inc., 713 A.2d 520 (N.J. Super. A.D. 1998), that although limited to "physicians" by statute, the learned intermediary rule might also apply to "dentists, optometrists, podiatrists, nurse practitioners, home health care service firms, physician's assistants, or others similarly permitted to prescribe or administer drugs on a limited basis." Id. at 522-23 (statutory citations omitted). That decision was, of course, famously reversed in Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 (N.J. 1999), another weird decision that created a "direct to consumer" exception to the learned intermediary rule (since rejected by every other state to consider it), and thus never had to reach the "who is" question.

The next thing we did was to run a ridiculously broad Westlaw search – looking for "learned intermediary" anywhere in the same case as "physician's assistant"?

Not too bad, this time. Less than 25 cases, including the two Perez decisions.

The most significant case on P.A.s and the learned intermediary rule is Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244 (Mont. 2010). As we discussed here and here, while Stevens is not overall a favorable decision for defendants, it did reaffirm the learned intermediary rule and extend it to a P.A.-prescribed drug. Stevens first mentioned the Third Restatement's version of the learned intermediary rule, Restatement (Third) of Torts, Products Liability §6(d)(1), which describes the rule in terms of warnings "provided to . . . prescribing and other health-care providers." 247 P.3d at 492 (emphasis added). The court then discussed the "evolution" of the rule "away from limiting the doctrine's applicability to the prescribing physician alone." Id. A P.A. could thus be a "learned intermediary" when fulfilling the "traditional" role of a physician:

The modern healthcare system, however, places far less emphasis on these traditional relationships, and patients today often receive the majority of their care from nurses, nurse practitioners, physicians' assistants, and physicians other than the prescribing physician. Appropriately, in situations where the underlying rationale of the doctrine − the traditional doctor-patient relationship − is no longer present, the doctrine has adapted to fit the realities of the situation.

* * * *

[T]he evolution of the doctrine [has been] through an expansion of the possible class of learned intermediaries. This development, likewise spurred by the fact that the medical professionals with whom patients most commonly interact are often no longer primary physicians, has led courts and secondary sources such as the Restatement to suggest that a variety of different healthcare providers may be considered learned intermediaries, depending on the unique facts of the patients' treatment scenario.

* * * *

We concur with authorities who consider the learned intermediary to be the healthcare professional actually responsible for making decisions related to the patient's care. . . . [Plaintiff] received much of her treatment from nurses, treating physicians, and nurse practitioners.

Stevens, 247 P.3d at 492-95 (footnote citing many of the cases in Bexis' book omitted).

Another case applying the learned intermediary rule to a physician's assistant is Luke v. Family Care & Urgent Medical Clinics, 246 F. Appx. 421 (9th Cir. 2007) (applying Washington law). The drug in question in Luke was prescribed by a P.A., id. at 423, and but the learned intermediary rule still applied:

[T]he district court properly decided that the [risk at issue] was not material and that the physician's assistant had no duty to warn [plaintiff] of the danger. Under Washington law, it would be contradictory to require a pharmacist to warn of the same danger when the "learned intermediary" had no duty to warn.

Id. at 425.

The learned intermediary rule also applied to a physician's assistant in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015) (applying Ohio law) – a case we usually cite for its preemption holdings. In Yates the prescriber ("Smith") was a P.A. Id. at 288. Without a lot of discussion of Smith's P.A. status, Yates found the learned intermediary rule applicable:

Smith 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]. The mere fact that Smith gave [plaintiff] options and a voice in determining which method of birth control would best fit her needs and lifestyle does not remove Smith from her status as a learned intermediary.

Id. at 293. Without any separate discussion of P.A. status, Czimmer v. Janssen Pharmaceuticals, Inc., 122 A.3d 1043, 1056-58 (Pa. Super. 2015), treated a prescribing P.A. as a learned intermediary. See also Canady v. Ortho McNeil Pharmaceutical, Inc., 2014 WL 1653349, at *4 (N.D. Ohio April 24, 2014) (applying learned intermediary rule in negligence action over drug prescribed by a P.A.; not applying learned intermediary rule to strict liability, due to peculiar Oregon statute); Woodhouse v. Sanofi-Aventis U.S. LLC, 2011 WL 3666595, at *2-3 (W.D. Tex. June 23, 2011) (applying learned intermediary rule to prescribing P.A. without regard to P.A. status).

As Stevens in particular demonstrates, expanding the learned intermediary rule to non-physicians such as P.A.s is something of a double-edged sword. On one hand, recognizing non-physicians who prescribe drugs or devices as learned intermediaries precludes plaintiffs from arguing for direct-to-patient warnings. On the other hand, the rule requires that adequate warnings be given to the learned intermediary – whoever that might be. Thus, expanding the categories of medical practitioners who qualify as "learned intermediaries" also expands the scope of a defendant's warning obligations to such practitioners, although not to plaintiffs themselves. Given the choice between a plaintiff coached to say whatever is necessary to obtain recovery, and a P.A. who usually won't be in the plaintiff's back pocket, we'll take our chances with the P.A.

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

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