United States: Comment K And Non-Implanted Medical Devices

Last Updated: August 7 2017
Article by James Beck

About two years ago, in our post " How Does a Bad Idea Get Implanted," we discussed what at the time seemed a California peculiar argument that the "unavoidably unsafe" product doctrine epitomized by Restatement (Second) of Torts §402A, comment k (1965) was somehow limited to implantable – as opposed to non-implantable – medical devices. While most medical device litigation has historically involved implants, in that post we saw nothing in comment k, or the broader concept that prescription-only products have inherent risks (why their availability requires a doctor's prescription in the first pace), that is logically limited to implantable devices.

We pointed out in that post that this rather weird argument apparently originated in ill-considered dictum in Chandler v. Chiron Corp., 1997 WL 464827, at *4 (N.D. Cal. July 28, 1997), a case which ultimately dismissed the plaintiff's design defect claim on causation grounds (and was affirmed on that basis, see 176 F.3d 481 (9th Cir. 1999)), and was directly refuted by controlling California appellate authority: Armstrong v. Optical Radiation Corp., 57 Cal. Rptr.2d 763, 772 (Cal. App. 1996), which applied the comment k unavoidably unsafe rationale to intraocular fluid, a non-implanted surgical aid. As we put it then:

The issue is not whether the device is implanted, it is whether the device unavoidably poses risks even as it must be used by physicians to "save lives or reduce pain and suffering."

Quoting Brown v. Superior Court, 751 P.2d 470, 479 (Cal. 1988)).

We were recently contacted by fellow defense counsel about a similar argument being made by plaintiffs in a Pennsylvania case, since Pennsylvania, like California, also applies comment k across the board. We took a look at the case law and let them know that Pennsylvania precedent likewise has not recognized any artificial distinction between implanted and non-implanted prescription medical devices. Rather, in Wagner v. Kimberly-Clark Corp., 225 F. Supp.3d 311, 315 (E.D. Pa. 2016), a Pennsylvania court applied comment k/the unavoidably unsafe doctrine to bar strict a liability claims involving a prescription device that wasn't an implant. Wagner involved a temporary feeding tube used while the plaintiff was in intensive care, and the court dismissed strict liability design and warning defect claims, but not manufacturing defect claims, under Pennsylvania's broad reading of comment k. 225 F. Supp.2d at 315 & n.4. Indeed, Wagner essentially took the application of the unavoidably unsafe doctrine to design and warning claims as a given, as 9/10 of the opinion was about whether or not strict liability manufacturing defect claims could survive (which is a different issue we addressed here). Id. at 316-18.

Maybe a feeding tube, although not technically an implant, still seems "close enough," since such tubes do extend inside the body, albeit quite temporarily. OK, but there's plenty of precedent out there about devices that don't even temporarily penetrate the body.

In Racer v. Utterman, 629 S.W.2d 387 (Mo. App. 1981), the plaintiff was injured when "a disposable drape manufactured by defendant . . . caught on fire resulting in serious burns." Id. at 391. "The purpose of the surgical drape is to provide a sterile field and to serve as a barrier to prevent bacteria from reaching the operation site." Id. at 391-92. The appellate court affirmed application of comment k to this product:

Comment k to the Restatement recognizes that "unavoidably unsafe" products achieve protection despite their danger "when accompanied by proper directions and warning". . . . On the record before us we find the surgical drape here to be an "unavoidably unsafe" product. It is a highly useful product which affords substantially increased protection against infection during surgical procedures. Its water-repellant attributes increase these protections. In the state of knowledge at the time of the injury no method of making the product fire-resistant was available which did not adversely affect its barrier against infection or create potential injury to the patient from allergy or disease.

Id. at 393. The defendant still lost, but on warnings, id. at 395, not because comment k didn't apply to the drape because it wasn't implanted.

The Illinois Supreme Court applied comment k's unavoidably unsafe rationale to therapeutic x-ray radiation equipment in Greenberg v. Michael Reese Hospital, 415 N.E.2d 390, 394-95 (Ill. 1980).

The possibility that in certain cases protection of human life and health might be diminished by the imposition of liability has been recognized in section 402A of the Restatement. Comment k indicates that certain products, though dangerous, are necessarily so and do not warrant the imposition of liability. . . . [C]omment k presume[s] in their treatments that the denomination "product" has already been applied to the matter in question. Nevertheless, imposition of strict liability is a question of policy, and often the same policy concerns are involved in discussions which are ostensibly diverse, for example: the meaning to be given such terms as "product," "defective," "unreasonably dangerous," and "business of selling." For the reasons stated we conclude that public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments by a hospital.

Id. at 394-95 (citations and quotation from Prosser's On Torts omitted).

Two other cases have applied comment k's analysis to external patches that release drugs that are absorbed through the skin. In Edwards v. Basel Pharmaceuticals, 933 P.2d 298 (Okla. 1997), the court cited and quoted comment k ("the law regarding such products appears at Comment k") in a case involving nicotine patches. These were products "incapable of being made safe, but are of benefit to the public dispute the risk. Id. at 300. Likewise, in Mardegan v. Mylan, Inc., 2012 WL 12850781, at *6-7 (S.D. Fla. Jan. 31, 2012), a fentanyl "pain patch" was considered to be within the scope of comment k. The court refused to grant summary judgment, but only because it found "genuine issues of material fact . . . as to whether the patches at issue were incapable of being made safe," not because comment k was categorically inapplicable to non-implanted products. Id. at *7.

Most recently, in Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017), the court applied comment k to a surgical robot – a piece of equipment that assists in the conduct of surgery and is never implanted in the body. The court applied comment k analysis to the liability questions. Id. at 526-28. As in Racer, Taylor found that the comment k exception did not apply on the facts of the case, because it could not be said that the product warnings were adequate as a matter of law. Id. at 528 ("[e]xemption from strict liability under comment k is expressly limited to products accompanied by adequate warnings"). Once again, there was not a hint in Taylor that the fact that the robot was not an implant made comment k ipso facto inapplicable. Washington law "safeguard[ed] the public to the greatest extent possible without discouraging the development and marketing of unavoidably unsafe products." Id.

The great majority of product liability litigation involving prescription medical devices happens to involve implants. However, that descriptive fact is of no legal consequence to the applicability, or not, of the comment k/unavoidably unsafe product doctrine. That doctrine is interpreted in a variety of different ways – most notably case-by-case versus across-the-board application to prescription medical products. But no matter which way the doctrine is interpreted, its application is not dependent upon whether or not a medical device is implanted in the body. At least three state high courts, two state intermediate appellate courts, and a couple of federal district court agree. There is no contrary precedent, only the aforementioned dictum in Chandler, a 20-year-old district court case, the reasoning of which has never been adopted by any subsequent decision, and (as we already discussed) is refuted by the Cal. App. Armstrong decision.

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

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