Opinion ID: 2617494
Heading Depth: 1
Heading Rank: 1

Heading: comment k and its applicability to medical devices

Text: Section 402A of the Restatement (Second) of Torts sets forth the elements of products liability. When a manufacturer sells a product in a defective condition which makes it unreasonably dangerous, and the product causes physical harm to the user of the product, the manufacturer can be held responsible for the damage caused if the product reaches the user without substantial change. We adopted manufacturers' products liability in Kirkland v. General Motors Corporation, 521 P.2d 1353 (Okla. 1974), as a legitimate cause of action in Oklahoma. The purpose behind manufacturers' products liability is to protect the ultimate consumer from the burden of loss caused by a defective product: It is to the public interest to discourage the marketing of products having defects that are a menace to the public. If such products nevertheless find their way into the market it is to the public interest to place the responsibility for whatever injury that may occur upon the manufacturer ... [T]he manufacturer is best situated to provide such protection. Kirkland, 521 P.2d at 1362, quoting Escola v. Coca-Cola Bottling Co., 24 Cal.2d 453, 150 P.2d 436 (1944). The manufacturer is in a position of control over the manufacturer and testing of the product. Further, the manufacturer is the party most likely to be capable of handling the financial burden caused by a defective product. Comment k of Section 402A speaks to products described as unavoidably unsafe. It seeks to strike a balance between manufacturer responsibility and the encouragement of research and development of new products. In certain instances it is in the public interest to allow products to be marketed which are unsafe, because the benefits of the product justify its risks. Comment k reads as follows: 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. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justified the marketing and use of the drug notwithstanding a medically recognizable risk. 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. 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. Hill v. Searle Laboratories, 884 F.2d 1064 (8th Cir.1989). 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. Hufft v. Horowitz, 4 Cal. App.4th 8, 5 Cal. Rptr.2d 377 (4 Dist. 1992). Strict liability might prove to be a dis-incentive to manufacturers to develop and market beneficial drugs because of `fear of large adverse monetary judgments' and the expense of strict liability insurance, costs that could `place the cost of medication beyond the reach of those who need it most.' Hufft, 5 Cal. Rptr.2d at 381 quoting Brown v. Superior Court, 44 Cal.3d 1049, 245 Cal. Rptr. 412, 751 P.2d 470 (1988). 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. See Hufft v. Horowitz, 4 Cal. App.4th 8, 5 Cal. Rptr.2d 377 (4th Dist.Ct.App. 1992) and Harwell v. Amer. Med. Systems, Inc., 803 F. Supp. 1287 (M.D.Tenn. 1992) (penile prosthesis was protected under Comment k); Snyder v. Mekhjian, 244 N.J. Super. 281, 582 A.2d 307 (A.D. 1990) aff'd 125 N.J. 328, 593 A.2d 318 (1991) (blood transfused into patient causing AIDS was covered under Comment k); Perfetti v. McGhan, 99 N.M. 645, 662 P.2d 646 (Ct.App. 1983) (Comment k applied to a breast implant); Allen v. G.D. Searle, 708 F. Supp. 1142 (D.Ore. 1989), McKee v. Moore, 648 P.2d 21 (Okla. 1982) and Terhune v. A.H. Robins, 90 Wash.2d 9, 577 P.2d 975 (1978) (Comment k applied to an IUD); Phelps v. Sherwood, 836 F.2d 296 (7th Cir.1987) and Brooks v. Medtronic Inc., 750 F.2d 1227 (4th Cir.1984) (pacemaker and heart catheter covered under Comment k). But see Hawkinson v. A.H. Robins Co., 595 F. Supp. 1290 (D.Colo. 1984) (Dalkon Shield); Coursen v. A.H. Robins. 764 F.2d 1329 (9th. 1985) (Dalkon Shield). See 70 A.L.R.4th 16 (1989) for a complete review of these cases. This Court, in McKee v. Moore, 648 P.2d 21 (Okla. 1982), applied Comment k to an implanted IUD, holding that it may be an unavoidably unsafe product under Comment k, and thus not defective. Id. at 23. In Hufft v. Horowitz, supra , and Harwell v. American Med. Systems, Inc., supra , penile implants were held to be within the protection of Comment k. The Hufft court held that these type of devices serve the salutary purposes of restoring a degree of normalcy to the lives of those who suffer organic dysfunctions and an impaired quality of life. Id. 5 Cal. Rptr.2d at 383. Comment k serves as an affirmative defense when the product is incapable of being made safe under present technology, but the social need for the product warrants its production. Hill, 884 F.2d at 1068; Larsen v. Pacesetter Systems, Inc., 74 Haw. 1, 837 P.2d 1273 (1992) (pacemaker did not fall under Comment k because it was capable of being made safer at the time of its manufacture). [T]he design must be as safe as the best available testing and research permits. Toner v. Lederle Laboratories, 112 Idaho 328, 732 P.2d 297, 306 (1987) cert. denied 485 U.S. 942, 108 S.Ct. 1122, 99 L.Ed.2d 282 (1988). There must be at the time of manufacture and distribution no feasible alternative design which on balance accomplished the subject product's purpose with a lesser risk. Id. 732 P.2d at 306. The manufacturers of the product are held to the knowledge and experience of experts in their fields. Id. 732 P.2d at 307; White v. Wyeth Laboratories, Inc., 40 Ohio St.3d 390, 533 N.E.2d 748, 753 (1988); Feldman v. Lederle Laboratories, 97 N.J. 429, 479 A.2d 374, 386-87 (1984) cert. denied ___ U.S. ___, 112 S.Ct. 3027, 120 L.Ed.2d 898 (1992). [1] The defense is available only when the product is properly manufactured and contains adequate warnings. Id.; McPheron v. Searle Laboratories, Inc., 888 F.2d 31, 33 (5th Cir.1989); Harwell v. Amer. Med. Systems, Inc., supra ; Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1149 (D.Ore. 1989). The Comment k defense does not apply when the product is defective due to faulty manufacturing or inadequate warnings. Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991). Several courts have held that a risk-utility analysis must also be employed before Comment k will bar recovery under products liability. See Hufft, 5 Cal. Rptr.2d at 383; Kociemba v. G.D. Searle, 680 F. Supp. 1293 (D.Minn. 1988); Toner v. Lederle Laboratories, 112 Idaho 328, 732 P.2d 297 (1987). The benefits of the product must outweigh its risks. Toner, 732 P.2d at 306; Kearl v. Lederle Laboratories, 172 Cal. App.3d 812, 218 Cal. Rptr. 453 (Div. 4 1985). This weighing process should consider the value of the benefit, the seriousness of the risk, and the likelihood of both. Toner, 732 P.2d at 306, citing Belle Bonfils Memorial Blood Bank v. Hansen, 665 P.2d 118 (Colo. 1983). Comment k implicitly, by its language, requires this risk-benefit analysis; the Comment speaks of a product's utility justifying its risks. [2] 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. The Comment does not provide blanket protection for all medical devices. Rather it applies only as an affirmative defense in those cases in which the following criteria are met: (1) the product is properly manufactured and contains adequate warnings, (2) its benefits justify its risks, and (3) the product was at the time of manufacture and distribution incapable of being made more safe. See Allen v. G.D. Searle Co., 708 F. Supp. 1142, 1149 (D.Ore. 1989); Coursen v. A.H. Robins Co., 764 F.2d 1329, 1338 (9th Cir.1985). These issues are generally questions for the jury's determination, and must be determined on a case-by-case basis. See Coursen, 764 F.2d at 1338; Kociemba, 680 F. Supp. at 1300; White, 533 N.E.2d at 752. Because it is an affirmative defense, the defendant bears the burden of proof. Id. 680 F. Supp. at 1338. Here, Tansy does not question the proper manufacture of the product. As for the warning requirement, we first note that Oklahoma has adopted the learned intermediary doctrine. McKee, 648 P.2d at 24. This doctrine permits a manufacturer to warn the physician, rather than the ultimate consumer, of the problems associated with the product. Here, neither party questions the doctrine's application to the present circumstances. Instead, Tansy urges that the doctor was not given sufficient information to evaluate the product. Tansy claims that Dr. Barnes was given incorrect information regarding the expected lifetime of the OmniPhase prosthesis. Dr. Barnes testified that a Dacomed representative told him the device would last for 10,000 activations. However, the brochure distributed by Dacomed made no claims as to its expected lifetime and also stated that certain movements of the prosthesis could affect its reliability. The documentation also showed that various complications could require the surgical removal of the device. Although the evidence was conflicting, there was evidence to support the defendant's assertion that adequate warnings were given. It was then a question of fact for the jury to determine. We find that the first criteria for Comment k's application was met. The next question is whether the product's benefits justify its risks. The OmniPhase prosthesis was a step forward in penile implant technology. Implants on the market before the OmniPhase had failure rates as high as 40%. The studies on the OmniPhase implant revealed a failure rate of between 3.7% and 6%. Furthermore, the cosmetic appearance of other implants required that tight or binding clothing be avoided. The OmniPhase implant permitted a man to wear the trousers of his choice. As stated in Huff, these implants help restore a degree of normalcy to the lives of those who suffer sexual dysfunction. We agree that a jury could reasonably conclude that the benefits of the OmniPhase prosthesis justified the risks associated with its implantation. As for the last criteria, Tansy argues that the OmniPhase could have been made safer. Dr. Barnes testified that a larger cable could have been used to avoid the cable fatigue. However, the Dacomed engineer testified that a thicker cable was tried, but its results were unsatisfactory because it decreased the ability of the penis to appear flaccid. The engineer also testified that no suitable alternative existed to avoid the mental rubbing on metal problem, as no other materials were of sufficient strength. A jury question was thus presented on this, the final criteria applicable. Tansy urges that Comment k does not operate to protect products which are defective, but only offers protection when the use of the product cases side effects. He urges that in McKee v. Moore, supra , Comment k applied because the product, an IUD, was functioning properly for its intended purpose of preventing pregnancy, but that it caused unwanted side effects. He claims it is only these side effects which were protected by Comment k. We disagree. First, in McKee the facts showed that the IUD had not functioned as intended to prevent pregnancy. Thus, McKee lends no support for to Tansy's assertion that side effects are protected while defects are not. Furthermore, the cases are clear that Comment k is meant to apply when a product is unavoidably unsafe because of a defect. In fact, courts hold that Comment k applies to re-classify a product from defective to unavoidably unsafe. Hill, 884 F.2d at 1068. As it expressly states, Comment k can apply to all consequences caused by the use of the device. The example used in Comment k illustrates this point. The Rabies vaccine could be considered defective because of its life-threatening side effects. However, it is the intent of Comment k to re-classify this product as unavoidably unsafe so that the public may have access to such a valued and necessary vaccine. As for the instruction given regarding Comment k, the only question remaining is whether the instruction was adequate to inform the jury of the law. We will not reverse a judgment where the instructions when viewed as a whole fairly presented the applicable law as raised by the pleadings and evidence. Dutsch v. Sea Ray Boats Inc., 845 P.2d 187 (Okla. 1992); Root v. Kamo Elec. Coop Inc., 699 P.2d 1083 (Okla. 1985). Here Comment k was the basis of the defendant's theory of defense. Since we have held that Comment k is applicable to this particular medical device, the trial court was correct to given an instruction explaining it. Tansy urges that the instruction did not adequately explain to the jury the legal definition of unavoidably unsafe. The instruction stated that a product was unavoidably unsafe if it was a prescription medical device which was incapable at the time of manufacture of being made totally safe... . Although we agree that the instruction could have been worded in more detail, it was sufficient to apprise the jury of the applicable law. In the future instructions regarding Comment k should include the conditions to its applicability as we have set out in this opinion.