Hollis v. Dow Corning Corp.

Hollis v. Dow Corning Corp.
Collection
Supreme Court Judgments
Date
1995-12-21
Report
[1995] 4 SCR 634
Case number
23776
Judges
La Forest, Gérard V.; L'Heureux-Dubé, Claire; Sopinka, John; Gonthier, Charles Doherty; Cory, Peter deCarteret; McLachlin, Beverley; Iacobucci, Frank
On appeal from
British Columbia
Subjects
Action
Torts
Notes
SCC Case Information: 23776
Decision Content
Hollis v. Dow Corning Corp., [1995] 4 S.C.R. 634
Dow Corning Corporation Appellant
v.
Susan Hollis and John Robert Birch Respondents
Indexed as: Hollis v. Dow Corning Corp.
File No.: 23776.
1995: February 2; 1995: December 21.
Present: La Forest, L'Heureux‑Dubé, Sopinka, Gonthier, Cory, McLachlin and Iacobucci JJ.
on appeal from the court of appeal for british columbia
Torts ‑‑ Manufacturers' duty to warn ‑‑ Learned intermediary ‑‑ Breast implant ruptured ‑‑ Patient not previously warned by doctor of post‑surgical risks or of possibility of implant rupture ‑‑ Whether or not manufacturer had duty to warn patient and/or doctor ‑‑ Whether or not principles of learned intermediary affecting duty of manufacturer to warn patient directly.
Torts -- Causation -- Whether subjective or objective test to patient's decision to undergo surgery knowing risks -- Whether manufacturer entitled to escape liability on what doctor would have done if properly warned.
Practice ‑‑ Appellate court powers ‑‑ Finding of fact ‑‑ Whether finding of fact can be made by appeal court or whether matter should be referred to trial court.
In 1983, Ms. Hollis, on the advice of her surgeon (Dr. Birch), underwent breast implant surgery to correct a congenital deformity. She was not warned by him of the risks of post‑surgical complications or of the possibility that the implants might rupture inside her body. In 1984, after further surgery and an examination by Dr. Birch, who gave the opinion that there was no problem with her breasts, Ms. Hollis began a baker's course which required vigorous upper body movement. In 1985, Ms. Hollis noticed a lump in her right breast and began to feel pain there as well as in her right side. She attended another surgeon, Dr. Quayle, who operated to remove the implant. He discovered that the left implant was intact but that the right implant had ruptured. Dr. Quayle removed the gel from the right implant but could not find the envelope. After the removal of the breast implants, Ms. Hollis' physical condition worsened. A visit to a third surgeon in 1987 resulted in Ms. Hollis' undergoing a successful subcutaneous mastectomy on both breasts and opting for a new, different model of breast implants.
Dr. Birch received little warning from the implant manufacturer as to the possibility of the implants' rupturing. Even as early as 1979, Dow was aware that implant ruptures could cause adverse reactions in the body arising from loose gel. While the 1985 warning referred to the dangers of "enlarged lymph nodes, scar formation, inflammation" and the potential, after a rupture, for "distant migration of the gel", the 1976 and 1979 warnings made no reference to any such potential consequences. Nor did these earlier warnings make reference to rupture occurring from anything less than "abnormal squeezing or trauma".
Ms. Hollis brought action in 1989 against Dow, Dow's Canadian agent, Dr. Birch and Dr. Quayle. At trial, she successfully claimed against Dow for the negligent manufacture of the breast implant and was awarded damages and costs; her other claims were dismissed. A majority of the Court of Appeal overturned the finding that Dow had negligently manufactured the implant, but dismissed the appeal on the ground that Dow had failed to warn Ms. Hollis adequately concerning the risks of rupture. A majority of the Court of Appeal allowed Ms. Hollis' appeal from the dismissal of her action against Dr. Birch and ordered a new trial in respect of that claim. The sole issue here is whether the Court of Appeal erred in finding Dow liable to the Ms. Hollis for failing to warn Dr. Birch adequately of the risk of a post‑surgical implant rupture.
Held (Sopinka and McLachlin JJ. dissenting): The appeal should be dismissed.
Per La Forest, L'Heureux‑Dubé, Gonthier, Cory and Iacobucci JJ.: A manufacturer of a product has a duty in tort to warn consumers of dangers it knows or ought to know are inherent in the product's use. This duty is a continuing one, requiring manufacturers to warn not only of dangers known at the time of sale, but also of dangers discovered after the product has been sold and delivered. All warnings must be reasonably communicated, and must clearly describe any specific dangers that arise from the ordinary use of the product. The duty to warn serves to correct the knowledge imbalance between manufacturers and consumers by alerting consumers to any dangers and allowing them to make informed decisions concerning the safe use of the product. The nature and scope of this duty varies with the level of danger entailed by the ordinary use of the product. In the case of medical products, the standard of care to be met by manufacturers in ensuring that consumers are properly warned is necessarily high.
The principles underlying the doctrine of "informed consent" apply to the relationship between manufacturers of medical products and consumers. The manufacturer‑consumer relationship, unlike the doctor‑patient relationship, is characterized primarily by a lack of direct communication which creates a relationship of complete dependency between manufacturer and patient. Manufacturers, therefore, can be reasonably required to make clear, complete and current informational disclosure to consumers concerning the risks inherent in the ordinary use of their products. A high standard for disclosure protects public health and yet does not place an onerous burden on manufacturers.
The "learned intermediary" rule applies where an intermediate inspection of the product is anticipated because the product is highly technical in nature or where a consumer is placing primary reliance on the judgment of a "learned intermediary" and not the manufacturer. In such cases, a warning to the ultimate consumer may not be necessary and the manufacturer may satisfy its duty to warn the ultimate consumer by warning the learned intermediary of the risks inherent in the use of the product. This rule generally applies either where a product is highly technical in nature and is intended to be used only under the supervision of experts, or where the nature of the product is such that the consumer will not realistically receive a direct warning from the manufacturer before using the product. The rule, which is in essence an application of the common law principle of intermediate examination and intervening cause, is an exception to the general manufacturer's duty to warn the consumer and operates to discharge the manufacturer's duty to the ultimate consumer, who has a right to full and current information about any risks inherent in the ordinary use of the product. The rule presumes that the intermediary is "learned", i.e., fully apprised of the risks associated with the use of the product. Accordingly, the manufacturer can only be said to have discharged its duty to the consumer when the intermediary's knowledge approximates that of the manufacturer. To allow manufacturers to claim the benefit of the rule where they have not fully warned the physician would undermine the policy rationale for the duty to warn, which is to ensure that the consumer is fully informed of all risks. Since the manufacturer is in the best position to know the risks attendant upon the use of its product and is also in the best position to ensure that the product is safe for normal use, the primary duty to give a clear, complete, and current warning must fall on its shoulders.
The "learned intermediary" rule is applicable in the context of this case. Dow's warning to the surgeon here was inadequate, however. There was sufficient evidence on the record to allow the Court of Appeal to make a full and proper re‑assessment of the duty to warn issue without sending the case back to trial. While appellate courts are generally, and justifiably, wary of making findings of fact without having the advantage of seeing and hearing testimony first‑hand, such concerns do not arise here because the bulk of the critical evidence adduced at trial was documentary, not testimonial.
The earlier warnings given the medical profession by the manufacturer implied that rupture would occur only in extreme cases of violent impact. The 1985 warning, however, made it clear that a patient who received an implant would have to consider altering her lifestyle to avoid rupture. A more accurate warning could quite reasonably have affected Ms. Hollis' choice of professional and her resulting exposure to unnecessary risk.
Dow knew or should have known of the risks referred to in the 1985 warning when the surgery was performed in 1983. Between 1976 and 1984, Dow received 78 field reports from doctors of post-operative "unexplained" ruptures occurring in its implants. It had a duty to convey its findings concerning both the "unexplained" rupture phenomenon and the possible harm caused by loose gel inside the body to the medical community much sooner than it did. Since implants are surgically placed inside the human body, and given that any defects in these products will obviously have a highly injurious effect on the user, the onus on Dow to be forthcoming with information was extremely high throughout the relevant period. The duty to warn is a continuing one and manufacturers of potentially hazardous products have an obligation to keep doctors abreast of developments even if they do not consider those developments to be conclusive.
Arguments based upon the assumption that Dow only had the obligation to warn once it had reached its own definitive conclusions with respect to the cause and effect of the "unexplained" ruptures necessarily failed. This assumption has no support in the law of Canada. Although the number of ruptures was statistically small over the relevant period and the cause of the ruptures was unknown, Dow had an obligation to take into account the seriousness of the risk posed by a potential rupture to each user of its implant. Indeed, it is precisely because the ruptures were "unexplained" that Dow should have been concerned. Certainly, it would not have been onerous for Dow to have included an update in their product inserts to the effect that "unexplained" ruptures had been reported which were not attributable to surgical procedures, and a list of the possible side‑effects of such ruptures.
With respect to causation, the subjective test (established in Buchan) as to whether or not the patient would have undergone the surgery if fully informed was adopted. The most serious concern raised about its application is that the plaintiff, with the benefit of hindsight, will always claim that she would not have used the product if she had been properly warned. In a suit against a manufacturer for failure to warn, this concern can be adequately addressed at the trial level through cross‑examination and through a proper weighing by the trial judge of the relevant testimony. A manufacturer of products cannot be considered coterminous with a physician whose duty is to give the best medical advice and service possible to a patient in a specific context. A manufacturer, given the greater likelihood to overvalue a product and underemphasize its risk, should from a policy perspective be held to a strict standard of warning consumers of dangerous side effects to these products. There is no reason, as in the case of a doctor, to modify the usual approach to causation followed in other tortious actions. Indeed the imbalance of resources and information between the manufacturer and the patient, and even the doctor, weighs in the opposite direction. Sufficient evidence was adduced here to satisfy the subjective test.
While some ambiguity existed as to Dr. Birch's warning practices in 1983, Dow cannot argue on this basis that no direct causal link existed between its breach of duty and the injuries suffered by the plaintiff. It is true that had Dr. Birch been adequately warned and not passed on the information to Ms. Hollis, Dow would have been absolved of liability by virtue of the learned intermediary doctrine. It does not follow from this, however, that, for Dow to be liable, Ms. Hollis must now establish that Dr. Birch would have informed her if he had known. To require her to do so would be to ask her to prove a hypothetical situation relating to her doctor's conduct -- a situation only brought about by Dow's failure to perform its duty. While the legal and persuasive onus in a negligence case generally falls on the plaintiff, the plaintiff is not required to prove a hypothetical situation of this kind.
The victim's power of proof is seriously undermined if called upon to prove what a doctor would have done in a hypothetical situation. The governing principle in a case of this nature is informed consent, namely, the right of the patient to be fully informed by the manufacturer of all material risks associated with the use of a medical product. This right to informed consent was not respected in this case. Dow's failure to warn was a cause of her injury; whether Dr. Birch's actions in the hypothetical situation posited by Dow might also have been a cause is not a matter for Ms. Hollis to prove. Ms. Hollis, who was in a position of great informational inequality with respect to both the manufacturer and the doctor, played no part in creating the set of causal conditions leading to her injury. Justice dictates that she should not be penalized for the fact that had the manufacturer actually met its duty to warn, the doctor still might have been at fault.
A manufacturer should not be able to escape liability for failing to give a warning it was under a duty to give by simply presenting evidence tending to establish that even if the doctor had been given the warning, he or she would not have passed it on to the patient, let alone putting an onus on the plaintiff to do so. Adopting such a rule would, in some cases, run the risk of leaving the plaintiff with no compensation for her injuries. She would not be able to recover against a doctor who had not been negligent with respect to the information that he or she did have; yet she also would not be able to recover against a manufacturer who, despite having failed in its duty to warn, could escape liability on the basis that, had the doctor been appropriately warned, he or she still would not have passed the information on to the plaintiff. Our tort law should not be held to contemplate such an anomalous result.
Per Sopinka and McLachlin JJ. (dissenting): La Forest J.'s analysis of the principles relating to the duty to warn, and in particular the way the learned intermediary principles apply, were agreed with.
The subjective test put forward in Buchan v. Ortho Pharmaceutical (Canada) Ltd. places no reliance on evidence as to what a reasonable woman would do and also fails to take into account the inherent unreliability of the plaintiff's self‑serving assertion. The most reliable approach in determining what would in fact have occurred is to test the plaintiff's assertion by reference to objective evidence as to what a reasonable person would have done. This difficult question of fact, notwithstanding the test adopted, should be determined at trial and not on appeal. The test for determining the same issue should not be different for the physician and the manufacturer.
To establish liability, the plaintiff must show not only a breach of duty by the defendant, but also that the breach in question was the cause of the plaintiff's injury. Here, Ms. Hollis must show that her doctor would have warned her of any dangers that had been brought to his attention and that if warned she would have refused the operation. Absent this form of proof, it cannot be said with any degree of certainty that the failure of Dow to warn physicians was the cause of the injuries suffered. The absence of cause cannot be finessed by sweeping it under the apportionment rug.
The cases referred to by La Forest J. with respect to reversal or relaxation of the burden of proof with respect to causation do not support treating causation as irrelevant. In any event the cases referred to do not support reversing the burden of proof in this case or, if they did, the issue of causation would not be resolved. There was abundant evidence to raise the issue of causation which should be weighed by the trial judge at a new trial.
A new trial should be ordered when disposing of an appeal on a legal basis that was not dealt with or resolved at trial and where crucial findings of fact concerning that issue were not made by the trial judge. A court of appeal is extremely reluctant to assume the role of the trial judge in making factual findings essential to resolving an issue. More importantly, there is considerable support for the view that the party affected is entitled to a new trial virtually as of right.
An appellate court may be in as good a position as a trial judge to make a factual finding in the following limited circumstances: (i) the trial judge has made the necessary findings albeit in respect of a different legal issue, or it can be safely assumed from findings actually made that but for the error of law the necessary findings would have been made; (ii) the evidence is not in dispute or conflict and no issue of credibility is involved; (iii) special circumstances exist in which the parties urge the appellate court to make necessary findings of fact. No circumstances were present which would bring this case within these criteria and this Court was clearly not in as good a position as the trial judge to make the requisite findings.
In addition to addressing issues relating to the duty, factual issues needed to be decided. No findings were made at trial as to whether Ms. Hollis would have consented to the operation, even if properly warned and as to whether Dr. Birch's conduct would have been the same whether or not Dow was in breach of the duty to warn. In the absence of a finding in this Court that evidence was lacking to raise the issues or that a weighing of the evidence cannot resolve the matter, a new trial would enable the trial judge to carry out this function. In any event, a new trial will be held with respect to Dr. Birch, and the judgment of this Court will not put an end to the litigation. This Court should not decide the issue because a subsequent trial judge would then not be able to decide otherwise. Finally, under the Negligence Act, where damage or loss is caused by the fault of two or more persons, liability for the damage should be apportioned in accordance with the degrees of fault.
Cases Cited
By La Forest J.
Approved: Buchan v. Ortho Pharmaceutical (Canada) Ltd. (1986), 12 O.A.C. 361; considered: Cook v. Lewis, [1951] S.C.R. 830; referred to: Lambert v. Lastoplex Chemicals Co., [1972] S.C.R. 569; Rivtow Marine Ltd. v. Washington Iron Works, [1974] S.C.R. 1189; Setrakov Construction Ltd. v. Winder's Storage & Distributors Ltd. (1981), 11 Sask. R. 286; Meilleur v. U.N.I.‑Crete Canada Ltd. (1985), 32 C.C.L.T. 126; Skelhorn v. Remington Arms Co. (1989), 69 Alta. L.R. (2d) 298; McCain Foods Ltd. v. Grand Falls Industries Ltd. (1991), 116 N.B.R. (2d) 22; Donoghue v. Stevenson, [1932] A.C. 562; Shandloff v. City Dairy, [1936] 4 D.L.R. 712; Arendale v. Canada Bread Co., [1941] 2 D.L.R. 41; Zeppa v. Coca‑Cola Ltd., [1955] 5 D.L.R. 187; Rae and Rae v. T. Eaton Co. (Maritimes) Ltd. (1961), 28 D.L.R. (2d) 522; Heimler v. Calvert Caterers Ltd. (1975), 8 O.R. (2d) 1; Hopp v. Lepp, [1980] 2 S.C.R. 192; Reibl v. Hughes, [1980] 2 S.C.R. 880; Ciarlariello v. Schacter, [1993] 2 S.C.R. 119; Schloendorff v. Society of New York Hospital, 105 N.E. 92 (1914); Canterbury v. Spence, 464 F.2d 772 (1972); Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (1966); Reyes v. Wyeth Laboratories, 498 F.2d 1264 (1974), cert. denied 419 U.S. 1096 (1974); Schenebeck v. Sterling Drug, Inc., 423 F.2d 919 (1970); Hoffman v. Sterling Drug, Inc., 485 F.2d 132 (1973); Dunkin v. Syntex Laboratories, Inc., 443 F.Supp. 121 (1977); Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87 (1980); Timm v. Upjohn Co., 624 F.2d 536 (1980), cert. denied 449 U.S. 1112 (1981); Stanback v. Parke, Davis and Co., 657 F.2d 642 (1981); Walker v. Merck & Co., 648 F.Supp. 931 (1986), aff'd 831 F.2d 1069 (1987); Plummer v. Lederle Laboratories, 819 F.2d 349 (1987); Davidson v. Connaught Laboratories (1980), 14 C.C.L.T. 251; Holmes v. Ashford, [1950] 2 All E.R. 76; MacDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65 (1985), cert. denied 474 U.S. 250 (1985); Prudential Trust Co. v. Forseth, [1960] S.C.R. 210; Davie Shipbuilding Ltd. v. The Queen, [1984] 1 F.C. 461; Nova, An Alberta Corporation v. Guelph Engineering Co. (1989), 70 Alta. L.R. (2d) 97; McCue v. Norwich Pharmacal Co., 453 F.2d 1033 (1972); Hamilton v. Hardy, 549 P.2d 1099 (1976).
By Sopinka J. (dissenting)
Buchan v. Ortho Pharmaceutical (Canada) Ltd. (1986), 12 O.A.C. 361; Cobbs v. Grant, 502 P.2d 1 (1972); Reibl v. Hughes, [1980] 2 S.C.R. 880; Cook v. Lewis, [1951] S.C.R. 830; Snell v. Farrell, [1990] 2 S.C.R. 311; McGhee v. National Coal Board, [1973] 1 S.L.T.R. 14; Wilsher v. Essex Area Health Authority, [1988] A.C. 1074; Just v. British Columbia, [1989] 2 S.C.R. 1228; Koschman v. Hay (1977), 17 O.R. (2d) 557; Chan v. Canada (Minister of Employment and Immigration), [1995] 3 S.C.R. 593; Davie Shipbuilding Ltd. v. The Queen, [1984] 1 F.C. 461; Jardine v. Northern Co-operative Timber and Mill Association, [1945] 1 W.W.R. 533; Nova, An Alberta Corporation v. Guelph Engineering Co. (1989), 70 Alta. L.R. (2d) 97; Glow v. Paquin, [1932] 1 W.W.R. 737; Patterson v. Township of Aldborough (1913), 11 D.L.R. 437; Colautti Construction Ltd. v. City of Ottawa (1984), 9 D.L.R. (4th) 265; Bank of Nova Scotia v. Dunphy Leasing Enterprises Ltd. (1991), 83 Alta. L.R. (2d) 289; Fitz Randolph v. Fitz Randolph (1918), 41 D.L.R. 739; McCarroll v. Powell, [1955] 4 D.L.R. 631; Hunt v. MacLeod Construction Co., [1958] S.C.R. 737.
Statutes and Regulations Cited
Negligence Act, R.S.B.C. 1979, c. 298, s. 2.
Sale of Goods Act, R.S.B.C. 1979, c. 370.
Authors Cited
Cross, Sir Rupert. Cross on Evidence, 7th ed. By the late Sir Rupert Cross and Colin Tapper. London: Butterworths, 1990.
Fleming, John G. The Law of Torts, 8th ed. Sydney: Law Book Co., 1992.
McCormick, Charles Tilford. McCormick on Evidence, 3rd ed. By Edward W. Cleary, General Editor. St. Paul, Minn.: West Publishing Co., 1984.
Peppin, Patricia. "Drug/Vaccine Risks: Patient Decision‑Making and Harm Reduction in the Pharmaceutical Company Duty to Warn Action" (1991), 70 Can. Bar Rev. 473.
APPEAL from a judgment of the British Columbia Court of Appeal (1993), 81 B.C.L.R. (2d) 1, 103 D.L.R. (4th) 520, 48 W.A.C. 108, [1993] 6 W.W.R. 609, 16 C.C.L.T. (2d) 140, ordering a new trial (with respect to John Robert Birch) and dismissing an appeal (with respect to Dow Corning Corporation) from a judgment of Bouck J., [1990] B.C.J. No. 1059, allowing Susan Hollis' action against Dow Corning Corporation and dismissing her action against John Robert Birch. Appeal dismissed, Sopinka and McLachlin JJ. dissenting.
D. J. Mullan, Q.C., and D. W. Donohoe, for the appellant.
Donald J. McKinlay, for the respondent Susan Hollis.
James M. Lepp and William S. Clark, for the respondent John Robert Birch.
The judgment of La Forest, L'Heureux-Dubé, Gonthier, Cory and Iacobucci JJ. was delivered by
1 La Forest J. -- The question raised in this appeal is whether a manufacturer of silicone breast implants may be held liable in tort to a patient who suffers injuries from an unexplained rupture in the implants when the manufacturer has failed to give adequate warning to the patient or the surgeon concerning the risks of rupture. The appellant, Dow Corning Corporation ("Dow"), is a United States corporation which, during the course of the 1970s and 1980s, developed and manufactured the silicone breast implant carrying the trade name "Silastic". On May 7, 1990, Bouck J. of the Supreme Court of British Columbia awarded damages and costs against Dow to the respondent, Susan Hollis, for the negligent manufacture of a Silastic breast implant that ruptured in her body approximately 17 months after it was implanted in 1983. Hollis' claims against the respondent Dr. John Robert Birch, who inserted the implant, Dr. James Quayle, who subsequently removed the implant, and Dow Corning Canada Inc. ("Dow Canada"), the Canadian sales agent for Dow, were dismissed. A majority of the Court of Appeal overturned Bouck J.'s finding that Dow had negligently manufactured the implant, but dismissed the appeal on the ground that Dow had failed to warn Ms. Hollis adequately concerning the risks of rupture. A majority of the Court of Appeal also ordered a new trial with respect to Ms. Hollis' claim against Dr. Birch.
2 Dow was granted leave by this Court to appeal the Court of Appeal's finding that Dow had breached its duty to warn, and asks this Court either to dismiss Ms. Hollis' claim or to order a new trial. For the reasons that follow, it is my view that Dow's appeal should be dismissed. The relevant facts are as follows.
Facts
3 In early June, 1983, Ms. Hollis, then 23 years old, was given a complete physical examination by her family physician, Dr. Ken Mills. Ms. Hollis was a shy and quiet woman who had never before had a complete physical examination. During the course of the examination, Dr. Mills determined that Ms. Hollis suffered from a congenital deformity of the breasts called "tubular breasts", which produced a cylinder-like shape in her breasts and caused blood to collect in the nipple area, resulting in a larger than normal areola. Ms. Hollis told Dr. Mills that she had suspected for several years that her breasts were deformed, and had been self-conscious about them, but that she had never felt the deformity was sufficiently serious to merit medical attention. Despite Ms. Hollis' reservations concerning her need for medical treatment, Dr. Mills suggested that she see Dr. John Birch, an experienced plastic surgeon, whom Ms. Hollis had seen earlier that year for treatment of a severe case of acne scarring on her cheeks.
4 Ms. Hollis met with Dr. Birch in July, 1983. During the meeting, Dr. Birch informed her that her breasts were indeed deformed and explained that surgery and implants could correct the shape of her breasts and the size of her areolae. Dr. Birch showed Ms. Hollis an implant and explained the surgical implantation procedure. He also told her that she would not be able to feel the implants inside her after the operation and that they would not prevent her from breast-feeding. However, Dr. Birch did not warn Ms. Hollis that there were risks of post-surgical complications. He also failed to warn her of the possibility that the implants might rupture inside her body. On the basis of Dr. Birch's advice, Ms. Hollis consented to surgery.
5 On October 21, 1983, Ms. Hollis underwent surgery for the implantation of two Silastic silicone breast implants at the Kelowna General Hospital in Kelowna, B.C. The implants were "gel-filled, low profile round" Silastic implants manufactured by the appellant Dow and purchased by Dr. Birch from Dow's Canadian agent, Dow Canada. These implants are sold only to doctors or medical establishments and are not directly available to the public. The operation went smoothly and Ms. Hollis experienced a normal recovery. However, by the spring of 1984, the abnormality in Ms. Hollis' breasts had returned. Dr. Birch operated on Ms. Hollis a second time. During the second operation, the plastic surgeon assisting Dr. Birch stretched the areolae of the breasts, which involved the application of light pressure to the breasts. In April, 1984, Ms. Hollis was examined by Dr. Birch, who found no problems with the breasts. On May 15, 1984, Ms. Hollis started a baker's course, which involved heavy upper body and arm movements.
6 In January, 1985, Ms. Hollis noticed a lump in her right breast, and began to feel pain there as well as in her right side. Concerned that the lump might be related to the implant, she went to see Dr. Quayle, another plastic surgeon, who referred her to Dr. Turner, an expert in breast surgery. Dr. Turner concluded that the lump was likely related to the downward slippage of the implants, although he noted that it could represent an area of benign breast disease. Dr. Turner recommended the removal of the implants. On January 29, 1985, Ms. Hollis was again examined by Dr. Quayle. He noted a degree of fullness in the right lower breast. She complained that her right side was becoming very painful.
7 On March 19, 1985, Dr. Quayle operated to remove the implants. He discovered that the left implant was intact but that the right implant had ruptured, causing irritation to the walls of the cavity in the right breast where the gel had come into contact with the tissue. The silicone gel from the right implant was lying in the breast cavity, which was red and swollen. Dr. Quayle removed the gel with sponges but was unable to find the silicone envelope that had surrounded the gel when the implant was originally inserted. Dr. Quayle did not preserve the gel for analysis, but returned the left implant to Ms. Hollis. The cause of the rupture of the implant in the right breast remains unknown.
8 After the removal of the breast implants, Ms. Hollis' physical condition worsened. Between May 1985 and February 1987, she continued to experience pain in her right breast and armpit and once again developed lumps in her right breast. The pain was especially severe when she raised her right arm and when she was busy at work. During that time, she met with several doctors and underwent numerous tests. On February 3, 1987, Dr. A. D. Courtemanche, a plastic surgeon, operated on Ms. Hollis and found a tender elongated mass in both lower quadrants of her right breast, which he thought was probably a remnant of the breast implant, although he did not find any silicone in the right breast. On June 10, 1987, Dr. Courtemanche performed a subcutaneous mastectomy on both breasts. For cosmetic purposes, Ms. Hollis elected to have Dr. Courtemanche implant two Dow Silastic II implants. These implants were of a different model and make-up than the original Silastic implants.
9 The subcutaneous mastectomy was successful, and Ms. Hollis has suffered no further complications since 1987. However, there is still residual scarring around the breasts and Ms. Hollis maintains a lingering belief that the ruptured envelope remains somewhere inside her body. She is worried that the new implants will break if she does routine exercises or returns to any vigorous job such as baking. These concerns have caused Ms. Hollis to suffer depression, for which she has received psychiatric help.
10 Ms. Hollis brought action in 1989 against Dow, Dow's Canadian agent, Dr. Birch and Dr. Quayle. The claim against Dow was for negligence in the manufacture of the implant placed in her right breast and, alternatively, for failure of a duty to give adequate warning to the medical profession or the public of the possibility that the implants could rupture. The claim against Dow's agent was for failure to warn about the possibility that the implant might rupture. The claims against Dr. Birch were for negligent advice and negligent surgery with respect to the original implants, as well as a claim, under the Sale of Goods Act, R.S.B.C. 1979, c. 370, that he sold her the implants when they were not fit for their intended purpose. The claims against Dr. Quayle were for negligence in failing to operate and remove the implants promptly when he discovered there might be a defect, and for failing to remove all the remnants of the gel from her right breast.
Judgments of the Courts Below
British Columbia Supreme Court, [1990] B.C.J. No. 1059 (Bouck J.)
11 Bouck J. found Dow liable to Ms. Hollis for negligently manufacturing the Silastic implants. He proceeded on the basis that there were four possible causes of the rupture: (i) an act or omission by Dr. Birch in inserting the implant; (ii) an act or omission by Dr. Quayle in removing the implant; (iii) external trauma to the implant during the time it was in Ms. Hollis' body; and (iv) an inadequacy in the design or manufacture of the implant. He made findings of fact that eliminated all causes of rupture except faulty manufacturing and, on that basis, reasoned that Dow was negligent either by inference or through the application of the doctrine of res ipsa loquitur. He stated:
I already found Dr. Birch took proper care to ensure the prosthesis remained undamaged from the time he took possession of it until he finished the surgical implantation. There is no evidence Dr. Quayle punctured the envelope when he removed it from the right breast of Miss Hollis. All the evidence is to the effect the implant ruptured at some earlier time. Nor is there anything to indicate Miss Hollis intentionally or unintentionally abused the implant in any way. She made use of it in the normal manner contemplated by Dow Corporation. All of these findings rebut the defendants' suggestion that the implant was damaged by others who had control of it, thus allowing the application of the doctrine of res ipsa loquitur.
Bouck J. drew further support for his conclusion from the fact that Dow had "replaced" the Silastic implant during the mid-1980s with the thicker and more durable Silastic II model. He observed that Dow had introduced the Silastic II "to counteract that defect in the earlier Silastic implant" and in response to 78 field reports Dow had received between 1975 and 1984 of unexplained ruptures in the Silastic implants. This, he reasoned, "is a piece of evidence from which an inference of negligence can be drawn".
12 Having found Dow liable for negligent manufacture, Bouck J. did not proceed to address Ms. Hollis' subsidiary claim that Dow had breached its duty to warn Ms. Hollis or the medical profession of the possibility of post-surgical implant rupture.
13 Bouck J. dismissed the actions against Dow Canada, Dr. Birch and Dr. Quayle. With respect to the claim against Dr. Birch, he found that Dr. Birch had not fallen below the standard of care for doctors in 1983, when he performed the surgery on Ms. Hollis, because the possibility of rupture of gel-filled implants was neither well-known to the medical community in 1983 nor prevalent in the medical literature. With respect to the claim against Dr. Quayle, Bouck J. found no evidence of negligence, and concluded that Dr. Quayle had followed the correct medical procedures throughout. With respect to the claim against Dow Canada, he found that Dow Canada did not breach its duty to warn consumers or doctors about the risk of rupture because it was only a sales agent; he further found that it did not contribute any technical knowledge to the production of the product, and therefore had insufficient knowledge in 1983 that the implants were defectively manufactured.
British Columbia Court of Appeal (1993), 81 B.C.L.R. (2d) 1 (Prowse J.A., McEachern C.J.B.C., Southin J.A.)
14 A majority of the Court of Appeal dismissed Dow's appeal from Bouck J.'s finding of liability by Dow, but allowed Ms. Hollis' appeal from Bouck J.'s dismissal of the action against Dr. Birch, ordering a new trial solely to resolve the question of Dr. Birch's liability to Ms. Hollis.
15 With respect to Dow's appeal, the Court of Appeal was unanimous in ruling that Bouck J. had erred in drawing an inference of negligence against Dow, finding that he had based his decision upon two erroneous factual findings: first, that the Silastic II implant "replaced" the Silastic I during the 1980s, when these two products in fact shared the market from mid-1983 until late 1987 and, second, that the evidence adduced at trial eliminated Ms. Hollis as a possible cause of the rupture. However, Prowse J.A., writing for a majority of the Court of Appeal on this issue (McEachern C.J.B.C. concurring), dismissed the appeal on the ground that Dow had failed to provide either Ms. Hollis or Dr. Birch with adequate warnings of the risk of post-surgical implant rupture arising from ordinary, non-traumatic, human activities.
16 Although Bouck J. declined to rule on the duty to warn issue, Prowse J.A. found there was sufficient evidence adduced at trial to substantiate Ms. Hollis' claim. In particular, Prowse J.A. found it significant that Dow had received reports of between 77 and 81 "unexplained" post-surgical implant ruptures during the period from 1975 to 1984, the majority of which were received prior to 1984, yet failed to warn the medical community until 1985 that the life expectancy of any implant was unpredictable and that an implant could rupture for a variety of reasons, including normal use. Prowse J.A. also ruled that Dow's breach of its duty to warn was the cause of Ms. Hollis' injuries, finding that a reasonable woman in Ms. Hollis' position would not have consented to the surgery in the face of an adequate warning. In support of this conclusion, Prowse J.A. observed that the surgery on Ms. Hollis was not medically necessary and that, in contrast to many women who consent to breast implant surgery, Ms. Hollis was not "pre-sold" when she first went to see Dr. Birch.
17 Southin J.A. dissented with respect to the duty to warn, observing, at p. 34, that Bouck J.'s failure to rule on this issue had created an "absence of findings on crucial issues of fact". Southin J.A. also ruled (McEachern C.J.B.C. concurring) that a new trial was necessary to resolve the question of Dr. Birch's liability. Southin J.A. decided that Bouck J. had erred in concluding that Dr. Birch did not have knowledge of the risk of rupture in 1983, but concluded that a new trial was necessary to determine whether that risk was material and whether its non-disclosure caused Ms. Hollis' injury. Prowse J.A. dissented on this issue, deciding that Dr. Birch had knowledge of the risk in 1983 and, as a result, found him liable for negligently failing to warn Ms. Hollis of the risk of implant rupture.
Analysis
18 The sole issue raised in this appeal is whether the Court of Appeal erred in finding Dow liable to the respondent Ms. Hollis for failing adequately to warn the implanting surgeon, Dr. Birch, of the risk of a post-surgical implant rupture inside Ms. Hollis' body. The appellant Dow does not contest Bouck J.'s factual finding that Ms. Hollis' seven-year surgical ordeal caused her great physical and psychological pain, residual scarring on her breasts, and a loss of past and future income. However, Dow submits that it was not responsible for Ms. Hollis' injuries. In support of this submission, Dow argues, first, that the warning it gave Dr. Birch was adequate and sufficient to satisfy its duty to Ms. Hollis, and second, that even if it did breach its duty to warn Ms. Hollis, this breach was not the proximate cause of her injuries.
19 For the reasons that follow, it is my view that the Court of Appeal reached the correct conclusion and that the appeal should be dismissed. Since Dow does not challenge the trial judge's findings concerning Ms. Hollis' injuries, I will concentrate on the issues of duty and causation which form the basis for Dow's submissions in this appeal. In the first part of these reasons, I will address the question whether Dow breached its duty to warn, and the related question whether Dow can rely on the so-called "learned intermediary" rule to absolve itself of liability. In the second part, I will consider whether Dow's failure to warn was a proximate cause of Ms. Hollis' in