Tansy v. Dacomed Corp.

• Decision Date: 20 December 1994
• Docket Number: No. 80662,80662
• Citation: 1994 OK 146,890 P.2d 881
• Parties: Prod.Liab.Rep. (CCH) P 14,136, 1994 OK 146 Robert TANSY, Appellant, v. DACOMED CORPORATION, Appellee.
• Court: Oklahoma Supreme Court

Page 881

890 P.2d 881

Prod.Liab.Rep. (CCH) P 14,136, 1994 OK 146

Robert TANSY, Appellant, v. DACOMED CORPORATION, Appellee.

No. 80662.

Supreme Court of Oklahoma.

Dec. 20, 1994.

Certiorari to the Oklahoma Court of Appeals, Division No. 1.

Certiorari granted to review the opinion of the Court of Appeals, Division I, which affirmed the jury's verdict for the defendant. Plaintiff brought a manufacturers' products liability suit against the manufacturer of a penile prosthesis. We hold that the trial court, Honorable James Gullett presiding, correctly instructed the jury as to Comment k of the Restatement 2d of Torts, § 402A. We also hold that the trial court did not err with regard to evidence admitted under 12 O.S.1991 § 2404(B), nor in allowing certain expert testimony.

CERTIORARI PREVIOUSLY GRANTED; COURT OF APPEALS' OPINION VACATED; JUDGMENT OF DISTRICT COURT AFFIRMED.

Kevin L. McClure, Oklahoma City, for appellant.

Richard M. Eldridge, Rhodes, Hieronymus, Jones, Tucker & Gable, Tulsa, for appellee.

SUMMERS, Justice:

Plaintiff's penile implant failed and had to be surgically removed. He brought this products liability suit against the manufacturer. The jury reached a defendant's verdict and the plaintiff appeals, raising three issues for our resolution: (1) whether the jury was properly instructed on the law of "unavoidably unsafe products" as that rule appears in Comment k of the Restatement of Torts, (2) whether evidence of a doctor's prior acts were admissible under 12 O.S. § 2404(B), and (3) whether a witness was properly qualified to testify as an expert. We affirm.

Robert Tansy became impotent due to an adverse reaction to prescription medication for a neurological disorder. He went to a urologist, Dr. Barnes, and after trying several alternatives, decided on a penile implant. Dr. Barnes discussed with Tansy the different implants available. Eventually Tansy and Dr. Barnes decided on the OmniPhase prosthesis because of its cosmetic appeal. The OmniPhase implant was based on new technology and was manufactured and distributed by the defendant Dacomed. The literature on the OmniPhase implant stated that it had a relatively low failure rate as compared to others on the market, and was unique in its design and use of metal cables.

Tansy experienced no difficulty with the implant for a period of time. But less than two years after the implantation of the device, he developed a knot on the side of his penis. Upon returning to Dr. Barnes, it appeared that the cables contained in the prosthetic device had broken, and immediate removal was necessary to prevent further bodily damage. Tansy underwent surgery to remove the prosthesis.

The evidence showed that the cables in the device failed due to fatigue. Apparently the metal cables rub against one another when the device is activated. Over a period of time the cables break. Dacomed was aware of the possibility of cable fatigue. The plaintiff's expert testified that the design was defective, and could have been made safer by using larger cables and by avoiding metal rubbing on metal when it was activated. However, the leading engineer for Dacomed stated that these other options had been tested, and that the one chosen was the best option available under current knowledge.

                The evidence also showed that the OmniPhase implant was an important step forward in penile implant technology, as it was unique in its capability to "impart rigidity or flaccidity on demand."   It also had a much lower failure rate than the inflatable type of implant
                

The jury was given instructions on the plaintiff's theory of manufacturer's product liability. It was also instructed, over the objection of the plaintiff, as follows:

If you find that the penile prosthesis manufactured by Dacomed Corporation was unavoidably unsafe, in that it was a prescription medical device which was incapable at the time of manufacture of being made totally safe, it is not unreasonably dangerous if it was marketed with proper directions for use, or included adequate warnings of potential dangers or contraindications.

The jury returned a verdict in favor of Dacomed.

Tansy appealed and the Court of Appeals upheld the jury's verdict, holding that the instruction was appropriate. We granted certiorari to address the "unavoidably unsafe product" question, and now affirm the jury verdict.

COMMENT K AND ITS APPLICABILITY TO MEDICAL DEVICES

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 manufacture 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 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).

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.

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....