Tansy v. Dacomed Corp.

OP ALA, Justice,

concurring.

The court affirms today the judgment on jury verdict for the defendant-manufacturer, holding that Comment k, 1 Restatement (Second) of Torts § 402A, 2 applies to medical devices, including penile prostheses, 3 which are implanted in the body. Comment k, which deals with unavoidably unsafe appliances, affords an affirmative defense against products liability claims where the manufacturer demonstrates that (1) the medical device is properly manufactured and contains adequate warnings, (2) its benefits justify its risks and (3) at the time of its production and distribution, the device was incapable of safer manufacture. 4

While I concur in today’s judgment and in the court’s opinion, I write separately to explain that the elements likely to be embodied in Restatement (Third) of Torts 5 would significantly modify Comment k jurisprudence.

*893 I

SECTION 8 OF THE PROPOSED RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY MODIFIES COMMENT K JURISPRUDENCE WHILE RETAINING ITS BASIC ELEMENTS

Section 8(a), which embodies a general statement of liability for manufacturers of prescribed defective drugs or medical devices, 6 would explicitly subject medical devices to the black letter rule of § 402A. It would replace the § 402A category of “unreasonably dangerous” products with a new rubric called “not reasonably safe.” 7 According to § 8(c) and (d), a medical device may be not reasonably safe (a) “due to defective design ” or (b) “because of inadequate instructions or warnings.” 8

A medical device is not reasonably safe because of a design defect when the foreseeable risk of harm posed by it is sufficiently great in relation to its prospective benefits that no reasonable health care provider, knowing those risks/benefits, would prescribe the device for any class of patients. 9 This wording represents a modification of the previous risk-utility analysis alluded to in Comment k and developed largely by extant jurisprudence. 10 The § 8 risk-utility approach is considerably more rigorous than that of its predecessor. Yesteryear’s “unavoidably unsafe” device must now have so little merit compared with its attendant benefits that no reasonable health care provider would prescribe it to any patient class. 11 The drafters justify this change in deference to the regulated market for medical devices and by giving proper weight to the intercession of professional judgment by learned intermediaries. 12

Under § 8(d) of the current draft, a medical device is not reasonably safe because of inadequate instructions or warnings when reasonable instructions or warnings are not given to the prescribing and/or other health care providers who may be in a position to reduce the risks of harm posed by the defective product. 13 This sentence articulates the so-called “learned intermediary rule” that de *894 fines a manufacturer’s Comment k duty to warn. 14

The new text (§ 8) would now acknowledge an exception to the “learned intermediary rule”. A medical device may be “not reasonably safe” because of inadequate instructions or warnings where none is provided directly to the patient-user (although the manufacturer knew or had reason to know that no health care provider would be available to receive the vicarious warnings expected by the “learned intermediary rule”). 15 The draft change reflects the trend of modern jurisprudence which has weakened the otherwise impregnable shield of the once all-exclusive “learned intermediary rule”. 16

II

SECTION 8 WOULD ABROGATE THE AFFIRMATIVE DEFENSE CONCEPT OF COMMENT K AND PLACE ON THE PLAINTIFF THE ONUS OF PROVING THE DEVICE NOT REASONABLY SAFE

Mainstream products liability jurisprudence, just as today’s pronouncement, generally interprets Comment k to create a manufacturer’s affirmative defense. 17 Section 8 would dramatically depart from this concept. It would transfer the burden of proof in its entirety to the plaintiff-user of the device. Its text mirrors the approach taken in those jurisdictions which require a high threshold test before liability may be deemed established at the summary judgment stage of the case. 18 In short, § 8 would reallocate the affirmative-defense regime spawned by Comment k and relieve the manufacturer of its present burden to show that the device falls within an exception to liability.

Ill

CONCLUSION

Currently debated changes in § 402A— reflected in Council Draft No. 2, Restatement (Third) of Torts: Products Liability, § 8 — generally track the current trends in “unavoidably unsafe” products jurisprudence. The next Restatement is more than likely to embrace different standards of producers’ liability for defective medical devices. The presently proposed § 8 draft retains all basic Comment k elements, but would tighten the risk/benefit analysis as well as create an exception to the “learned intermediary rule”. Taking the path lit by case law from several jurisdictions, the drafters would cast on the plaintiff the entire burden of proving that a medical device is “not reasonably safe.” This would discard Comment k’s present-day allocation-of-proof regime that now casts the onus probandi on manufacturers. 19

While not in complete accord with some evolving jurisprudential trends and with the intellectual underpinnings likely to influence the next Restatement, today’s opinion is entirely consistent with the mainstream of present-day Comment k case law. I hence concur.

. The pertinent portions of Comment k, Restatement (Second) of Torts, are:

"k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.... Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.... The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.” (Emphasis added.)

. Section 402A, Restatement (Second) of Torts, states in pertinent part:

“(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property....” (Emphasis added.)

. See Harwell v. Amer. Med. Systems, Inc., 803 F.Supp. 1287, 1300 (M.D.Tenn.1992).

. See Allen v. G.D. Searle & Co., 708 F.Supp. 1142 , 1149 n. 1 (D.Or.1989); Coursen v. A.H. Robins Co., 764 F.2d 1329, 1337 (9th Cir.1985).

. See Products Liability, § 8, Council Draft No. 2. The American Law Institute (ALI) has undertaken the process of drafting the Restatement (Third) of Torts: Products Liability. James A. Henderson, Professor, Cornell Law School, and Aaron D. Twerski, Professor, Brooklyn Law School, have been selected as reporters for the project. Several drafts of the third Restatement have been released: a preliminary draft in April 1993; Council Draft No. 1 in September 1993. The most recent version (and the one discussed here), Council Draft No. 2, was released September 2, 1994. Each distribution has spawned debate and discussion among the commentators. See, e.g., Roland F. Banks, Margaret O’Connor, Restating the Restatement (Second), Section 402A — Design Defect, 72 OrL.Rev. 411 (1993); Harvey L. Kaplan, Scott W. Sayler, Steven M. Thomas, Third Restatement: New Prescription for Makers of Drugs and Medical Devices, 61 Def. CounsJ. 64 (1994); see also James A. Henderson, Jr., Aaron D. Twerski, Will A New Restatement Help Settle Troubled Waters: Reflections, 42 Am. U.L.Rev. 1257 (1993); James A. Henderson, Jr., Aaron D. Twerski, A Proposed Revision of Section 402A of the Restatement (Second) of Torts, 77 Corn.L.Rev. 1512 (1992); Peter Nash Swisher, Products Liability Tort Reform: Why Virginia Should Adopt The Henderson-Twerski Proposed Revision of Section 402A, Restatement (Second) of Torts, 27 U.Rich.L.Rev. 857 (1993). For a cogent analysis of the Restatement (Third)'s modification of Comment k jurisprudence on drugs and medical devices, see Teresa Moran Schwartz, Prescription Products and the Proposed Restatement (Third), 61 Tenn.L.Rev. 1357, 1369-1377 (1994).

The terms of § 8, Council Draft No. 2, state in pertinent part:

"§ 8. Liability of Seller or Other Distributor for Harm Caused by Prescription Drugs and Medical Devices

(a) A manufacturer of a prescription drug or medical device who sells or otherwise distributes a defective product is subject to liability for harm to persons caused by the product defect. A prescription drug or medical device is one that may be legally sold or other *893 wise distributed only pursuant to a health care provider’s prescription.

(b) For purposes of liability under Subsection (a), a product is defective if at the time of sale or distribution:

⅜ ⅝ !⅜ ⅝! ⅜! 5⅜

(2) the drug or medical device is not reasonably safe due to defective design or because of inadequate instructions or warnings.

(c) A drug or medical device is not reasonably safe due to defective design when the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits so that no reasonable health care provider, knowing of such foreseeable risks and therapeutic benefits, would prescribe the drug or medical device for any class of patients.

(d) A drug or medical device is not reasonably safe because of inadequate instructions or warnings when

(1) reasonable instructions or warnings regarding foreseeable risks of harm posed by the drug or medical device are not provided to prescribing and other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or

(2) reasonable instructions or warnings regarding foreseeable risks of harm posed by the drug or medical device are not provided directly to the patient when the manufacturer knew or had reason to know that no health care provider would be in the position described in Subsection (d)(1).” (Emphasis added.)

. For the terms of § 8(a), Restatement (Third), see supra note 5.

. For the terms of § 8(b)(2), Restatement (Third), see supra note 5.

. See § 8(c) and (d)(1), Restatement (Third), supra note 5.

. See § 8(c), Restatement (Third), supra note 5.

. See Reporter's Note, Comment g, § 8, Restatement (Third), supra note 5, citing Tobin v. Astra Pharmaceutical Prods., Inc., 993 F.2d 528 , 536-537 (6th Cir.1993), cert denied sub nom, Duphar v. Tobin, — U.S. -, 114 S.Ct. 304 , 126 L.Ed.2d 252 (1993).

. See Comment b, Restatement (Third) of Torts: Products Liability (Council Draft No. 2, September 4, 1994).

. Id.

. See § 8(d)(1), Restatement (Third), supra note 5.

. McKee v. Moore, Okl., 648 P.2d 21, 24 (1982).

. For the pertinent provisions of § 8(d)(2), Restatement (Third), see supra note 5. The Reporter’s Note, Comment e (direct warning to patients), explains that many of the cases in this category deal with vaccines administered en masse at public health clinics, citing Givens v. Lederle, 556 F.2d 1341 (5th Cir.1977) (applying Florida law); Reyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir.1974) (applying Texas law); Davis v. Wyeth Labs., 399 F.2d 121 (9th Cir.1968) (applying Idaho law). For a criticism of the inclusion of these cases in the Reporter's Note, see Kaplan, supra note 5.

. Reporter's Note, Comment g, § 8, Restatement (Third), supra note 5; Tobin, supra note 10, 993 F.2d at 536-537; Reyes, supra note 15, 498 F.2d at 1277; Givens, supra note 15 , 556 F.2d at 1345 .

. Hill v. Searle Laboratories, 884 F.2d 1064 , 1068 (8th Cir.1989); Larsen v. Pacesetter Systems, Inc., 74 Haw. 1 , 837 P.2d 1273, 1285-1286 (1992).

. See Reporter's Note, Comment f, § 8, Restatement (Third), supra note 5, citing Williams v. Ciba-Geigy Corp., 686 F.Supp. 573, 577-579 (W.D.La.1988), aff'd, 864 F.2d 789 (5th Cir. 1988).

. Reporter’s Note, Comment f, § 8, Restatement (Third), supra note 5.