Despite [defendant’s] argument to the contrary, comment K offers no protection to [it]. In Grundberg v. Upjohn Co., the Utah Supreme Court ruled that comment K to section 402A provided protection to prescription drug manufacturers. Grundberg v. Upjohn Co., 813 P.2d 89, (Utah 1991). The court limited this ruling to design defect claims against prescription drug manufacturers. Id. at 92, 95. Utah law does not preclude strict liability design defect claims against medical product manufacturers.2012 WL 33360, at *5 n.6.
But then, the ALI wrote comment k in the early 1960s (§402A was adopted in 1965), and the concept of a "medical device" wasn't much developed. Congress, for example, didn't give the FDA explicit authority over medical devices until 1976.
Comment k, however, defines a category of “unavoidably unsafe” products that “when properly prepared, and accompanied by proper directions and warning, [are] not defective, nor ... unreasonably dangerous.” (Emphasis in original.) We agree with comment k’s basic proposition-that there are some products that have dangers associated with their use even though they are used as intended. We also agree that the seller of such products, when the products are properly prepared and marketed and distributed with appropriate warnings, should not be held strictly liable for the “unfortunate consequences” attending their use. Thus, we adopt comment k’s basic policy as the law to be applied in this state.Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991). Then the court goes on to reject making the comment k/unavoidably unsafe determination on a case-by-case basis with respect to the product before it – a prescription drug (Halcion).
- “[W]e are troubled by the lack of uniformity and certainty inherent in the case-by-case approach and fear the resulting disincentive for pharmaceutical manufacturers to develop new products.” Id. at 94-95.
- “[A] defendant would have an easier time rebutting a plaintiff’s prima facie case of design defect under the traditional standard than meeting the tough burden of “earning” the comment k exemption.” Id. at 95.
- “We are persuaded that all prescription drugs should be classified as unavoidably dangerous in design because of their unique nature and value, the elaborate regulatory system overseen by the FDA, the difficulties of relying on individual lawsuits as a forum in which to review a prescription drug’s design, and the significant public policy considerations.” Id.
- “[Drugs] will almost always pose some risk of side effects in certain individuals. Despite these risks, new drugs are continually approved by the FDA because of their social benefit in saving lives and alleviating human suffering.” Id.
- “The structured follow-up program imposed by law ensures that drugs are not placed on the market without continued monitoring for adverse consequences that would render the FDA’s initial risk/benefit analysis invalid.” Id. at 97.
- “The legislature has also acknowledged the important role of governmental standards in Utah Code Ann. section 78-15-6(3) . . . declar[ing] that there is a rebuttable presumption that a product which fully complies with the applicable government standards at the time of marketing is not defective. Id. (footnote omitted).
- “[I]f a manufacturer knows or should know of a risk associated with its product, it is directly liable to the patient if it fails to adequately warn the medical profession of that danger.” Id.
- “[W]e do not believe that a trial court in the context of a products liability action is the proper forum. . . . Although the FDA may have internal differences of opinion . . ., the individuals making the ultimate judgment will have the benefit of years of experience in reviewing such products, scientific expertise in the area, and access to the volumes of data they can compel manufacturers to produce. Nor is the FDA subject to the inherent limitations of the trial process.” Id. at 98.
- “In light of the strong public interest in the availability and affordability of prescription medications, the extensive regulatory system of the FDA, and the avenues of recovery still available to plaintiffs by claiming [non-design-related claims], we conclude that a broad grant of immunity from strict liability claims based on design defects should be extended to FDA-approved prescription drugs in Utah. Id. at *99.
Nope, we can’t find in Grundberg a single policy reason that medical devices shouldn’t enjoy the same comment k protections as prescription drugs .
Numerous courts have determined that they are applicable to prescription medical device cases. The parties have not pointed us to any case . . . and we can see no principled reason to distinguish between a prescription implantable medical device like a pacemaker and a prescription drug.
Id. Accord Breen v. Synthes-Stratec, Inc., 947 A.2d 383, 386-88 (Conn. App. 2008) (“[i]n light of existing case law and the language of comment (k) itself, we conclude that the application of comment (k) is not limited to prescription drugs only”); Wegryn v. Smith & Nephew, Inc., 2008 WL 803405, at *2 (Conn. Super. March 5, 2008); Allen v. Mentor Corp., 2006 WL 861007, at *7 (D. Conn. March 31, 2006) (“[m]edical products properly prepared, and accompanied by proper directions and warning [are] not defective, nor . . . unreasonably dangerous” under comment k; breast implant case).
While products liability law seeks to protect the public from unreasonably dangerous products, Comment k seeks to protect another facet of the public’s interest-that of having available new products whose benefits are great enough as to justify associated risks. It protects certain manufacturers who develop new products which at the time of manufacture are incapable of being made totally safe, and shields certain products by classifying them as “unavoidably unsafe” rather than as “defective.” Public policy favors the development and marketing of new beneficial drugs and devices because they can save lives, reduce pain and improve the quality of life. . . . Most courts which have considered the question have found that Comment k applies to medical devices, especially those which are implanted in the human body. . . . Following the guidance of our prior case law as well as that of other jurisdictions, we hold that Comment k can apply to medical devices, particularly those which are implanted.
890 P.2d 881, 885-86 (Okla. 1994 (lots of citations omitted). Accord McKee v. Moore, 648 P.2d 21, 23 (Okla. 1982) (comment k applies to IUD; it may be an “unavoidably unsafe” product, and thus not “defective”).
While a sound public policy might indeed dictate that such testing be undertaken before any product to be used on the human body is released in commerce, a decision of that kind rests with the legislative body. The principles stated in comment k do not rest upon a finding or an assumption that all drugs, vaccines or other products obtainable only through a physician have been tested by the Food and Drug Administration. Rather they have their basis in the character of the medical profession and the relationship which exists between the manufacturer, the physician and the patient.
Terhune v. A. H. Robins Co., 577 P.2d 975, 978 (Wash. 1978); see id. at 979 (lower court “quite properly held as a matter of law that the shield was not unreasonably dangerous or defective, as defined in comment k”). Accord Transue v. Aesthetech Corp., 341 F.3d 911, 915 (9th Cir. 2003) (“comment k provides an exemption for medical products generally”) (applying Washington law); Adams v. Synthes Spine Co., 298 F.3d 1114, 1118 (9th Cir. 2002) (“comment k applied (which is to say that strict liability did not apply) to prescription medical products without any separate determination”) (applying Washington law).
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 . . . . [W]e conclude that public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments.
Greenberg v. Michael Reese Hospital, 415 N.E.2d 390, 394-95 (Ill. 1980). Accord Mele v. Howmedica, Inc., 808 N.E.2d 1026, 1041-42 (Ill. App. 2004) (“Comment k . . . provides further support for use of risk-benefit analysis for evaluating the danger of the medical device defendant made”).
[T]he exemption from strict liability for design defect for prescription drugs is based primarily, if not exclusively on public policy considerations. It is not, as implicitly contended by plaintiffs, based on any inherent distinction between a drug and a device which makes design defect analysis unworkable with respect to prescription drugs. . . . The question, therefore, is not whether the [product] is a prescription drug or a device but rather whether the policy considerations . . . should be applied.
Id. at 817. Similarly, in Hufft v. Horowitz, 5 Cal. Rptr.2d 377 (Cal. App. 1992), the court held:
The differences . . . do not mandate rejection of the comment k standard. . . . [T]he important considerations underlying [comment k] apply with equal force to implanted medical devices, which like prescription drugs, are available only through a physician and can save lives or reduce pain and suffering. Such products are commonly crucial to the well-being of the patient. Some devices are so important that, as is the case with prescription drugs, the patient faces death without them.
Id. at 383. Accord Mitchell v. Acumed LLC, 2011 WL 2433038, at *4 (N.D. Cal. June 13, 2011) (“Plaintiff's argument to be wholly devoid of merit; Plaintiff makes no logical argument that [comment k precedent] should not cover the surgical screw at issue here”).
In applying comment k here . . . no significant distinction can be drawn between the device and the drug upon which the Supreme Court based its decision in Hahn [adopting comment k in a drug case]. . . . [Plaintiffs] contend that . . . comment k does not apply to medical devices because the comment text does not mention them. They cite no authority, however, for so restrictive an interpretation either of comment k or of Hahn, nor do they provide significant analysis of the language they seek to apply. We find no reason why the same rationale applicable to prescription drugs may not be applied to medical devices.
Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006). Both before and after Creazzo, Pennsylvania courts routinely applied comment k in medical device product liability cases – holding repeatedly that the same considerations applied to all prescription medical products. See Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *2 (W.D. Pa. Nov. 10, 2011) (comment k principles “extend to medical devices”); Esposito v. I-Flow Corp., 2011 WL 5041374, at *4 & n.4 (E.D. Pa. Oct. 24, 2011) (agreeing with Geesey); Geesey v. Stryker Corp., 2010 WL 3069630, at *4-5 (E.D. Pa. Aug. 4, 2010) (“the Pennsylvania Supreme Court would apply comment k to medical devices”); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (comment k “has been extended to medical devices”) (applying Pennsylvania law); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 749-50 (E.D. Pa. 2007) (“predicting . . . that Pennsylvania Supreme Court would extend §402A’s comment k to exclude prescription medical devices from strict liability”); Parkinson v. Guidant Corp., 315 F. Supp.2d 741, 746-748 (W.D. Pa. 2004) (“the court agrees . . . that the same considerations exempting prescription drugs from the ambit of §402A equally apply to prescription medical devices”); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 441-442 (E.D. Pa. 2004) (“[c]omment k precludes application of Section 402A to prescription medical devices”); Murray v. Synthes U.S.A., Inc., 1999 WL 672937, at *7 (E.D. Pa. Aug. 23, 1999) (“medical devices present the same or very similar risks and benefits” as prescription drugs, so comment k applies); Burton v. Danek Medical, Inc., 1999 WL 118020, at *7 (E.D. Pa. March 1, 1999) (“the same reasoning underlying comment k that excludes prescription drugs from Section 402A should also apply to prescription medical devices”); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *7 (E.D. Pa. Dec. 29, 1998) (comment k applies to medical devices because they present the same “unique set of risks and benefits” as prescription drugs in that “what may be harmful to one patient may be beneficial to another”); Lawrence v. Synthes Inc., 2002 WL 32747667, at *24 n.101 (Pa. C.P. July 25, 2002) (“[p]rescription medical devices must be analyzed similarly”), aff’d mem., 860 A.2d 1142 (Pa. Super. 2004); Ford v. McGhan Medical Corp., 142 Pitts. Leg. J. 201, 214 (Pa. C.P. Allegheny Co. 1994).