Terhune v. A. H. Robins Co.

• Citation: 577 P.2d 975,90 Wn.2d 9
• Decision Date: 27 April 1978
• Docket Number: No. 45110,45110
• Parties: Robert C. TERHUNE, Jr., and Deborah F. Terhune, his wife, Appellants, v. A. H. ROBINS COMPANY, Respondent.
• Court: Washington Supreme Court

Page 9

90 Wn.2d 9

577 P.2d 975

Robert C. TERHUNE, Jr., and Deborah F. Terhune, his wife, Appellants, v. A. H. ROBINS COMPANY, Respondent.

No. 45110.

Supreme Court of Washington, En Banc.

April 27, 1978.

McMullen, Brooke, Knapp & Alexander, Robert E. Brooke, Seattle, for appellants.

Williams, Lanza, Kastner & Gibbs, William J. Leedom, Seattle, for respondent.

ROSELLINI, Associate Justice.

This action was brought against the manufacturer of the Dalkon Shield, an intrauterine contraceptive device, to recover damages which the plaintiff wife allegedly sustained as a result of her use of one of these devices.

According to the evidence, after the birth of their second child the plaintiffs sought advice from their family physician, an osteopathic surgeon, regarding available methods of contraception. He informed them of the advantages and disadvantages of various methods, and they chose the Dalkon Shield. The defendant manufacturer supplied these shields only to doctors and not to the public, since their insertion required medical expertise and equipment. The doctor was instructed on the proper procedure to use in making the insertion and was advised of hazards connected with the use of these devices, including the danger of perforation of the uterus if the shield was not carefully inserted according to the directions given. The doctor was also supplied with brochures, which the doctor could, in his discretion, give to his patients, describing the device and touting its advantages over other contraceptive methods (although not claiming that it was 100 percent effective in preventing pregnancy).

The plaintiffs' doctor could not remember clearly whether he had read the warning about the danger of perforation, but testified that in any event he was fully aware of the danger when he made the insertion. The plaintiffs were given a brochure but were not told of the danger of perforation, according to their testimony. Two weeks after the insertion was made, the plaintiff wife returned to the doctor complaining of pain in the lower abdominal area. He checked a string attached to the shield, which was designed to afford a means of determining that the shield was in place, and was apparently satisfied that nothing was wrong.

A year later, after she had ceased nursing the second child, the plaintiff wife became pregnant. Her doctor contacted the defendant and asked for advice as to what to do about the shield. The defendant's house physician advised him to attempt to remove the shield by pulling the string attached to it; and if this could not be done successfully, to recommend an abortion, since there was a danger that the fetus might be injured by the presence of the shield. An attempt to remove the shield proved unsuccessful. The plaintiffs refused to consent to an abortion, although they were told of the risk involved. When the pregnancy had progressed to the fifth month, a spontaneous aseptic abortion occurred, which may have been caused by an infection in the urinary tract. There was no evidence that it was caused by the presence of the intrauterine device in the uterus.

The shield was not expelled when the fetus was aborted. It was located subsequently by use of X rays, and surgery was performed to remove it. The shield was not in its correct position but was found imbedded in a broad ligament adjacent to the uterus, which it had perforated. An infection was present which drained for a period of several months.

Three experts called by the defense, a doctor associated with the Virginia Mason Clinic in Seattle, who was chairman of Seattle Planned Parenthood, a professor of obstetrics and gynecology at the University of California at Los Angeles Medical School, and an associate professor of obstetrics and gynecology at Wayne State University, all testified that in their opinion the perforation occurred when the shield was inserted. All of these were board-certified gynecologists and obstetricians. Their testimony was buttressed by that of a professor of mechanical engineering at Drake University, whose studies had convinced him that spontaneous migration of the shield was physically impossible.

The only dissenting opinion was that of the plaintiffs' physician who inserted the shield, whose credentials did not rise to this dignity. ¹ His view was that the shield must have migrated from the correct position in which he had placed it, causing the perforation, but he conceded that his opinion was based on speculation.

After the shield was removed, the plaintiff wife again became pregnant and delivered a child without difficulty. She subsequently underwent a tubal ligation, performed by the Mason Clinic doctor who testified for the defendant.

It was the plaintiffs' theory that the injury resulting from the perforation of the uterus was caused by a defect in the defendant's product. They failed to prove that the shield was defective in either design or manufacture, and the court so instructed the jury. The assignments of error on appeal focus on the defendant's duty to warn of dangers attendant upon the use of the shield.

The rules which apply in circumstances such as these are found in Restatement (Second) of Torts § 402A (1965), which this court has adopted in a series of cases beginning with Ulmer v. Ford Motor Co., 75 Wash.2d 522, 452 P.2d 729 (1969). The principles were most recently applied in Haysom v. Coleman Lantern Co., 89 Wash.2d 474, 573 P.2d 785 (1978).

Section 402A embodies a doctrine of strict liability with respect to products which are introduced into the stream of commerce. We have approved the principle that, even where a product is faultlessly designed, it may be considered unreasonably unsafe if it is placed in the hands of the ultimate consumer unaccompanied by adequate warning of dangers necessarily involved in its use. Teagle v. Fischer & Porter Co., 89 Wash.2d 149, 570 P.2d 438 (1977); Haysom v. Coleman Lantern Co., supra. In accord: Haugen v. Minnesota Mining & Mfg. Co., 15 Wash.App. 379, 550 P.2d 71 (1976).

Comment k governs this case. It states:

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 justifies 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.

It will be seen that this comment speaks of "drugs, vaccines, and the like", including experimental drugs, which cannot legally be sold except to a physician. The comment does not purport to state what is "proper warning" where such a product is involved. However, it has become a well-established rule that in such cases, the duty of the manufacturer to warn of dangers involved in use of a product is satisfied if he gives adequate warning to the physician who prescribes it. Smith v. E. R. Squibb & Sons, Inc., 69 Mich.App. 375, 245 N.W.2d 52 (1976); Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974); McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 528 P.2d 522 (1974); Hines v. St. Joseph's Hosp. 86 N.M. 763, 527 P.2d 1075 (1974); Leibowitz v. Ortho Pharmaceutical Corp., 224 Pa.Super. 418, 307 A.2d 449 (1973); Mulder v. Parke Davis & Co., 288 Minn. 332, 181 N.W.2d 882 (1970); Basko v. Sterling Drug, Inc., 416 F.2d 417 (2d Cir. 1969); Johnston v Upjohn Co., 442 S.W.2d 93 (Mo.App.1969); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968); Stottlemire v. Cawood, 213 F.Supp. 897 (D.C.D.C.1963); Parker v. State, 201 Misc. 416, 105 N.Y.S.2d 735 (1951); Hamilton v. Hardy, 549 P.2d 1099 (Colo.App.1976).

The reasons for this rule should be obvious. Where a product is available only on prescription or through the services of a physician, the physician acts as a "learned intermediary" between the manufacturer or seller and the patient. It is his duty to inform himself of the qualities and characteristics of those products which he...