Perfetti v. McGhan Medical

BIVINS, Judge

(concurring in part, dissenting in part).

I agree with the majority’s decision as to express warranty, but disagree as to strict liability and implied warranties of merchantability and fitness for a particular purpose. These issues will be discussed under the same general headings as appear in the majority opinion.

The discussion which follows accepts the majority holding that Comment k to § 402A, Restatement (Second) Torts, applies to the mammary prosthesis, not because the evidence necessarily supports it, but because the jury was instructed on the prosthesis as an unavoidably unsafe product without objection. Plaintiff presents a persuasive argument as to why. Comment k should apply only to life-sustaining products; however, that issue as well as whether it is even proper to instruct on both Comment k and § 402A cannot be decided on this appeal.

1. Products Liability

A. Physical defect.

The majority says that since no theory of physical defect separate and apart from the product’s unavoidably unsafe character was submitted to the jury, failure to direct a verdict on that ground is a false issue. I agree that physical defect was a false issue, but disagree that this theory was not submitted to the jury.

The trial court instructed the jury that the plaintiff claimed the defendant was subject to products liability for putting on the market a product which had a “defect.” The claimed defects, according to the instruction, were:

1. That the mammary implant which was placed in the plaintiff failed in that it leaked into her body and deflated within twenty-five (25) months from the date that it was surgically implanted in her chest.
2. That the defendant failed to adequately warn the plaintiff of the unreasonable risk of injury to her.

The trial court also instructed the jury under U.J.I.Civ. 14.22, N.M.S.A.1978 (1980 Repl.Pamph.) that in order for the supplier to be liable, the injury must have been proximately caused by “a condition of the product which was not substantially changed from the condition in which the (particular) supplier placed the product on the market... . ” Further, the court instructed on circumstantial evidence. Read together the trial court did, in my opinion, submit to the jury the theory of physical defect. Moreover, that issue was strenuously argued by both sides on the defendant’s motions for directed verdict, which the trial court denied.

Thus, the question of whether there was substantial evidence that the prosthesis was physically defective when it left the hands of the manufacturer is squarely before us and should be decided.

While several possible causes for the prosthesis failure were offered, there appears to be no real disagreement as to the most probable cause. Plaintiff’s surgeon testified, “I feel that the capsule which forms around the implant allows the implant to get a little fold in it like that. And over a period of months to years, the implant gradually wears back and forth and eventually that little fold wears through and you get a little tear.... That is the kind of thing I’ve seen in almost every prosthesis which has deflated. . . . And that’s what I saw in Miss Perfetti’s case.” Plaintiff in her brief says this testimony as to cause is “unequivocal.”

Thus, we are not dealing with the type of situation presented in Lovington v. Cattle Feeders v. Abbott Lab., 97 N.M. 564, 642 P.2d 167 (1982), V. Mueller & Co. v. Corley, 570 S.W.2d 140 (Tex.Civ.App.1978) or Springer Corp. v. Dallas & Mavis Forwarding Co., 90 N.M. 58, 559 P.2d 846 (Ct.App.1976). In those cases there was no direct evidence as to what caused the failure. Here there was. Therefore, there was no need to resort to circumstantial evidence to prove the failure.

Nor are we concerned with whether that failure resulted from a defect in design, that issue having been withdrawn. Given the fact that deflation can occur from wear caused by the fold and that in this case such happened within 25 months after insertion, is that fact alone sufficient to draw an inference that this particular prosthesis had an imperfection and that the imperfection existed when it left the defendant’s hands? There is no evidence that this particular prosthesis failed sooner than others, or that there was any estimated life for a product of this kind. The surgeon testified that there was minimal evidence that a long-term complication of delayed deflation would occur, because there had not been a sufficient number of implants over a long period to make any statistical evaluations. The fact that the surgeon may have hoped that the prosthesis would last a lifetime or at least 10 to 15 years does not mean that he expected it to last that long. The mere fact that the prosthesis failed is not proof of a defect and raises no presumption of defectiveness. Gates v. Ford Motor Company, 494 F.2d 458 (10th Cir.1974). The lapse of 25 months from implant to failure, absent other circumstances, was insufficient to prove the existence of a physical defect in the product at the time it left the defendant’s hands. See Springer Corp., 90 N.M. at 60, 559 P.2d 846. To permit the jury, in the face of the evidence in this case, to draw such an inference was error.

B. Unavoidably unsafe product

The majority concludes that under the evidence Comment k to § 402A applied to the mammary prosthesis. As noted, an unavoidably unsafe product, properly prepared, and accompanied by proper directions and warning is neither defective nor unreasonably dangerous. Since, in my view, physical defect should have been withdrawn, the “properly prepared’’ element is not present in this case. Nor are we concerned with proper directions. This leaves the question of whether the prosthesis was accompanied by a proper warning. The majority states that “such a product is neither defective nor unreasonably dangerous if the warning was ‘proper’.”

Because a warning under the facts of this case was unnecessary, I do not discuss whether the warning was adequate.

As noted by the majority, since this product under federal law is obtainable only through the services of a physician, the defendant fulfills its duty if it warns the physician of the danger attendant upon its use. Hines v. St. Joseph’s Hospital, 86 N.M. 763, 527 P.2d 1075 (Ct.App.1974); Terhune v. A.H. Robins Co., 90 Wash.2d 9, 577 P.2d 975 (1978). The physician, in turn, has a duty to disclose dangers to the patient. Hines, supra. It is also his duty to take into account the propensities of the product and the susceptibilities of the patient and make an informed decision. Dalke v. Upjohn Co., 555 F.2d 245 (9th Cir.1977).

If the surgeon in this case had actual knowledge of the danger, then there was no duty to warn. See First Nat. Bk., Albuquerque v. Nor-Am Agr. Prod., Inc., 88 N.M. 74, 537 P.2d 682 (Ct.App.1975). Appreciation of some risk is not sufficient; in order to relieve the manufacturer of the duty to warn, the user must be aware of the nature and extent of the danger. See Trujillo v. Uniroyal Corp., 608 F.2d 815 (10th Cir.1979). The majority answers defendant’s contention that the surgeon knew of the risk of deflation and that deflation could occur anytime by saying, “[DJefendant’s duty was to warn of the nature and extent of the danger of a leak developing because of wear of the prosthesis at a fold resulting from capsular contracture” (emphasis added).

As I view the surgeon’s testimony, he did know of that risk. First, as to capsular contracture:

Q Doctor, before — Excuse me, before you go any farther, would you explain to the Jury what a capsular contraction is, please?
A These prosthetic devices which are inserted in the chest wall are a foreign body and the body normally walls this prosthetic device off by forming a capsule around it. This capsule is made out of fibrous tissue. In some patients, the capsule which forms around the implant tends to contract down and squeeze down upon the implant making it feel firmer than normal. This is a fairly common occurrence especially in people that have had subcutaneous mastectomys [sic] which Miss Perfetti had had. And this is one of the things that we were concerned about happening in the post-operative period. And when Miss Perfetti came in on 8/21/78, I noticed that her left breast was firmer than her right breast.

As to the expectancy of capsular contracture:

Q So, that’s not just a possible complication, the incapsulation is definitely going to happen. It’s the contracture part of it that is a possible complication; is that correct?
A That’s correct.
Q What do you mean by the contracture part of it?
A. At the present time, we’re not quite sure what causes the contracture. There appear to be a number of causes and a number of ways that this can occur, but basically in a percentage of people who have this operation, the capsule tends to contract down around the implant and when that happens, if the contracture is assymetrical, [sic] it just pulls and it sticks out like a big orange or grapefruit and the breast becomes firmer than normal. If the capsular contraction is assymetric, [sic] it can pull the breast medially or down or up or laterally. If the capsular contracture is severe on the chest wall side, it can cause pain and discomfort in the chest wall in addition to firmness.

As to what happened to plaintiff:

A. Here it is. In the prosthesis [sic] which I have seen that have deflated, secondary to a, what I call a fatigue crack, for want of a better term, all look the same and I have removed a number of prostheses with the same kind of a linear tear in them. I have my own opinion as to what causes it. I feel that the capsule which forms around the implant allows the implant to get a little fold in it like that. And over a period of months to years, the implant gradually wears back and forth and eventually that little fold wears through and you get a little tear. It shows up as a — when you look at it, as a linear crack in the prosthesis and that’s why the fluid leaks out. That is the kind of thing that I’ve seen in almost every prosthesis which has deflated that I’ve ■seen that had a problem. That’s the kind of thing that I almost always see. And that’s what I saw in Miss Perfetti’s case. I have had some prostheses which leaked secondary to a defective valve and — but in this case it wasn’t a defective valve and those are the only 2 kinds of deflations that I ever have had. One, when the valve was defective and you could see the fluid coming out through the valve. And the kind where you’ve got a little tiny crack in the shell. (Emphasis added)

What did the surgeon tell plaintiff before implanting the prosthesis?

Q And what did you tell her about the time limit as far as when and inflation might occur following putting the implant in?
A I told her that deflation could occur at two times. That occasionally and rarely, there could be an early leak in the prosthesis either secondary to a defective valve or some injury which might have occurred at the time of the insertion, but was unrecognized by me and if that should have happened, then the implant would deflate soon after surgery within usually a week to 2 months after insertion. That if it didn’t deflate initially, there was the long term risk of deflations which could occur at any time after insertion, but may occur for years after it’s been put in there. (Emphasis added).

Referring to the “folding,” the surgeon again acknowledged his awareness:

Q And this is a problem that you are aware of in the medical profession, you don’t rely upon the detailmen to tell you about the medical problems, do you?
A I usually don’t depend on them.

The fact that the surgeon may have hoped that the prosthesis would have lasted for a lifetime or at least 10 to 15 years does not alter the fact that he knew deflation from folding could occur “at anytime after insertion.” Because the surgeon had actual knowledge of the risk, there was no duty to warn. Therefore, this issue should not have been submitted to the jury.

2. Express Warranty

I concur with the majority for the reasons given.

3. Implied Warranty

The initial inquiry is: having held it proper to apply Comment k of § 402A to the prosthesis, was it proper to have instructed on warranties? In McMichael v. American Red Cross, 532 S.W.2d 7 (Ky. 1975) the court quoted from two other jurisdictions:

In Balkowitsch v. Minneapolis War Memorial Blood Bank, Inc., 270 Minn. 151, 132 N.W.2d 805 at 811 (1965), the court said:
“ * * * Moreover, it seems to us that under the facts in the case before us it would be unrealistic to hold that there is an implied warranty as to qualities of fitness of human blood on which no medical or scientific information can be acquired and in respect to which plaintiff’s physician has the same information, knowledge, and experience.”
We refer again to Jackson v. Muhlenberg Hospital, 96 N.J.Super. 314, 232 A.2d 879 (1967), its expression of the view that the concept of strict liability, whether in tort or on implied warranty, rests in substantial part on the theory of the existence of an implied representation by the seller that the product is safe, and its holding that in the case of blood containing hepatitis virus, where the producer could not know or control the condition, “there is no implied representation that the blood is free of the virus.”

Assuming implied warranties have a place in cases where the product is unavoidably unsafe, was it proper to instruct the jury under the facts here?

A. Merchantability

In order for there to be a breach of warranty of merchantability, the jury was instructed that the prosthesis must have been defective and unfit for the ordinary purpose for which it is used. Having reached the conclusion that the prosthesis was not defective nor unreasonably dangerous under strict liability, it follows that the product was not unfit for the ordinary purposes for which it is used under § 55-2-314, N.M.S.A.1978 (1980 Repl.Pamph.). See Springer Corp., 90 N.M. 58, 559 P.2d 846. As to comparability of standards between strict liability in tort and implied warranty of merchantability, see Committee Comment, U.J.I.Civ. 14.30, N.M.S.A.1978 (1982 Cum.Supp.). Implied warranty of merchantability should not have been submitted to the jury.

B. Fitness for a particular purpose

Breach of warranty fitness for a particular purpose is not applicable to this case. For § 55-2-315, N.M.S.A.1978, to apply there must be reliance on the seller’s skill of judgment to select or furnish suitable goods. Defendant asserts that there was no evidence that the surgeon relied on defendant’s skill or judgment. The majority agrees, but says the surgeon relied on the hospital; that the purchase by the hospital alone is evidence of its reliance; thus, the hospital’s reliance extends to the surgeon who was in the distributive chain. In my judgment this conceptual leap cannot be made. The surgeon relied on his own judgment as to the particular prosthesis selected, i.e., a high volume double lumen mammary prosthesis. He did not select a single lumen or any other variety. There is no evidence that the hospital did anything other than supply the prosthesis, which it purchased from defendant. The fact that the surgeon used a different brand than he had customarily used is of no consequence; he exercised his own skill and judgment and did not rely on defendant in making that selection. See Fear Ranches, Inc. v. Berry, 470 F.2d 905 (10th Cir.1972). Absent reliance, the instruction based upon § 55-2-315 should not have been submitted.

I concur with the result reached as to express warranty. Since there was no substantial evidence to support strict liability or implied warranties of merchantability or fitness for a particular purpose, I would remand with directions to dismiss. The majority being of the opposite view, I respectfully dissent.