Jones v. Minnesota Mining & Manufacturing Co. , 100 N.M. 268 ( 1983 )

OPINION

WOOD, Judge.

Young and Jones received permanent implants of radioactive 1-125 (Iodine-125) in the treatment of cancer of the prostate. For the purposes of this appeal, it is not disputed that they received excessive radiation, and the excessive radiation caused the injuries. This appeal involves only the claims against 3M (Minnesota Mining and Manufacturing Company) for the injuries to Young and Jones. The trial court granted summary judgment in favor of 3M. The appeal involves the propriety of the summary judgment, specifically, whether there was a genuine issue of fact requiring trial. See Goodman v. Brock, 83 N.M. 789, 498 P.2d 676 (1972). We: (1) set forth the background of the litigation; (2) identify limitations in the appellate record; (3) discuss the products liability contentions; and (4) discuss the warranty contentions. Background

Two physicians, radiotherapists Simmons and Murrell with prior experience in utilizing other isotopes in the treatment of cancer, and in treatment of cancer of the prostate, undertook in 1977 to treat cancer of the prostate by implanting 1-125. Between December 1977 and the summer of 1979, Simmons and Murrell implanted 1-125 in the prostates of eighteen patients. Although the briefs do not correlate Young or Jones with a particular number, our reckoning is that their place in the sequence was approximately patients twelve and thirteen. There is some uncertainty as to which physician performed a particular implant, but this is of no consequence in this appeal. The patients were common patients of both physicians.

The 1-125 implanted was in the form of seeds. The radioactive strength of the seed was expressed in millicuries, compensated. Because the strength of the seed lessens with the passage of time, the shipping documents stated the strength on an assay date. The strength at time of implant was determined by use of a decay chart. There is no dispute, in this appeal, that the strength of the seeds implanted in Young and Jones was .56 millicuries at the time of the implants.

The radiation intended to be delivered by the implant is determined by the seed strength, the size of the prostate (stated as average dimension of the prostate, in centimeters) and the spacing of the seeds, also stated in centimeters. We refer to the intended dosage as the desired dose. “In almost all cases the volume to be irradiated corresponds to the entire prostate. It was not the practice of the physicians to prescribe limiting doses to the bladder, rectum or other normal tissues.”

The actual dosage is computed after the implant; this is referred to as dosimetry. The computations were for a minimum peripheral dose, defined as the minimum dose to any point on the margin of the prostate.

The computations require information as to the location and number of seeds implanted. This information was obtained from right orthogonal films consisting of an AP and lateral view. With this information, and the known seed strength, the actual dosage can be calculated. The calculation can be performed manually, but it is a chore because calculations must be made for each seed. These calculations involve the distance between seeds and the contribution of each seed. A computer can perform these calculations; a computer and a software program were purchased; the calculations were made by using the computer and the software program. There is no issue in this appeal as to the propriety of using a computer program for these calculations.

The computer calculations provided dosage information in terms of rads per hour. To determine actual dosage, rads per hour must be converted to rads to total decay because the radiotherapist needed to know the total rads. Total rads means rads in a year. The initial computer program did not make this conversion; it was done, manually, by the dosimetrist, Sachs. There is evidence that a manual conversion was performed in the Young and Jones cases.

After the conversion was made, a chart was prepared showing isodose curves, which are defined as lines of uniform dosage. The radiotherapist determines which is the appropriate isodose curve and, in doing so, considers the size of the cancer and the shape of the curves. The appropriate isodose curve shows the total rads or total dose.

The hospital records for Young show a total dose of 16,000 rads; a correction sheet in those records indicates the total dose was 75.000 rads. The hospital records for Jones indicate a total dose between 14,000 and 18.000 rads and a corrected dose of 74,664 rads. The lesser dosage shown for both patients was based on a factor of 445 in converting rads per hour to total rads. This conversion factor was erroneous; the corrected and greater dosage was based on the correct conversion factor of 2074. The desired dose, for both patients, had been a total dose between 16,000 and 24,000 rads. The corrected dose was excessive.

Limitations in the Appellate Record

The Young-Jones damage claims were asserted against multiple defendants. This appeal involves only 3M, the manufacturer of the seeds. Two general theories of liability were asserted against 3M — products liability and breach of warranty. Summary judgment was granted in favor of 3M on both liability theories.

The trial court identified seven depositions that it had considered in granting summary judgment. Plaintiffs’ request for the record proper and for a transcript of proceedings did not ask that all of the seven depositions be included in the appellate record. Portions of the seven depositions were included, as attachments, to pleadings filed in the trial court and are before us as part of the record proper. 3M requested, see NMSA 1978, Civ.App.R. 7(b) (Cum.Supp.1983), the depositions of Simmons, Murrell and Sachs. Those depositions are before us. 3M also requested all the exhibits to the depositions of Simmons and Murrell. We do not know of what “all” of the exhibits consists. We have Exhibits 12 and 13, found at the back of Volume II of Simmons’ deposition, and a separate box of exhibits numbered 27 through 69 and 92 through 108.

Our decision is based on the following appellate record: (a) the exhibits identified in the preceding paragraph; (b) the depositions of Simmons, Murrell and Sachs; (c) the portions of the depositions of Kelsey, Anderson, Leavitt and Syed included in the record proper. Plaintiffs attached to their reply brief portions of depositions not included in the record proper; we have not considered these attachments to the reply brief because they are not part of the appellate record.

Products Liability Contention

A. Identifying the Issues to be Decided

Because plaintiffs’ briefs make extensive scattershot arguments, we identify the products liability issues to be decided in this appeal.

1. Products liability law applies.

The claims against 3M were that the radioactive seeds were dangerous products and were products for the purpose of products liability, that 3M failed to adequately warn users of the seeds of the dangers of implanting the seeds into patients, and that because of an inadequate warning the seeds were defective. Plaintiffs argue, extensively, in their brief-in-ehief, that products liability law is applicable to their claims against 3M. See generally Stang v. Hertz Corporation, 83 N.M. 730, 497 P.2d 732 (1972). 3M does not claim that products liability is inapplicable; rather, it points out that its motion for summary judgment was based on products liability.

2. Duty to warn.

Plaintiffs contend that 3M had a duty to give adequate or proper warnings. See Restatement (Second) of Torts § 402A, Comments h and k (1965). One of the trial court’s conclusions was that 3M had no duty to “give warning which would be extensive enough to educate the treating physicians in correct treatment procedures.” Plaintiffs argue thé duty to warn in terms of foreseeability and misuse. See NMSA 1978, UJI Civ. 14.15 (Repl.Pamp.1980), the Committee Comment. This appeal does not involve the extent of the duty to warn. 3M agrees that, as a general proposition, there is a duty to warn, but any such duty was not applicable in these cases. The parties agree that, under the circumstances of these cases, any warnings to be given would be to the radiotherapists. Perfetti v. McGhan Medical, 99 N.M. 645, 662 P.2d 646 (Ct.App.1983); Hines v. St. Joseph’s Hospital, 86 N.M. 763, 527 P.2d 1075 (Ct.App.1974).

3. Factual issue as to adequacy of 3M’s warnings.

Literature issued by 3M, or for which it appears to be responsible, are Exhibits 12, 13, the portion of 39 which begins “1-125 SEEDS. FOR PROFESSIONAL USE ONLY[,] Revised: February 1978”, 93, 94 and possibly 92. Deposition questioning went into the “adequacy” of various statements in the publications, but most of this questioning is not pertinent to the warning aspect of these cases. The warning aspect in these cases goes to the warnings as to excessive dosages of radiation.

As to excessive dosage, plaintiffs assert there is a factual issue as to the adequacy of the warnings. We need not identify the specific arguments because adequacy of the warnings is not an issue in the appeal. Summary judgment was not granted on the basis of adequate warnings. The trial court’s ruling, quoted hereinafter in paragraph A(5), was that any appropriate warning would have added nothing to the knowledge of the radiotherapists.

4. Actual knowledge.

3M contends the radiotherapists had actual knowledge of the dangers involved. On the basis of actual knowledge, 3M asserts either there was no duty to warn or that any duty to warn had been satisfied. See Perfetti v. McGhan Medical.

Plaintiffs do not rely on a specific products liability concept. They argue “unreasonably dangerous” and “unavoidably unsafe” products as if they were interchangeable concepts; they do so by asserting the seeds were “inherently” dangerous. See Restatement § 402A, Comments i and k. It makes no difference in this appeal whether the seeds, and their use, are classified as unreasonably dangerous or unavoidably unsafe. 3M’s “actual knowledge” .contention has been considered applicable to the warning requirement under both concepts. Restatement § 402A, Comment j; UJI Civ. 14.15; Perfetti v. McGhan Medical; Hines v. St. Joseph’s Hospital; see Mulder v. Parke Davis & Company, 288 Minn. 332, 181 N.W.2d 882 (1970).

5. Trial court’s ruling.

Concerning the facts, the trial court ruled:

1. The facts show that the seeds were radioactive.

2. The facts show that the treating physicians and entities were fully aware of the radioactive nature of the seeds, and fully appreciated the risks and consequences of excessive dosages of radiation.

3. Any appropriate warning would have added nothing to the physician’s or patient’s knowledge in this situation.

The trial court concluded:

B. 3M fulfilled its duty to warn the treating physicians and entities involved in this lawsuit because all such persons knew that the 1-125 seeds were radioactive.

6. Basis for summary judgment.

Plaintiffs assert that summary judgment was granted on the basis “that the doctors knew the seeds were radioactive and that was all the warning needed.” This is a misreading of the ruling and apparently is based on the trial court’s conclusion without regard to the factual rulings. The factual rulings are that the radiotherapists were fully aware of the radioactive nature of the seeds, fully appreciated the risks and consequences of excessive dosages and any appropriate warning would have added nothing. Summary judgment was granted on the basis of “actual knowledge”.

7. Issues to be decided.

Anticipating our discussion in paragraph 6, plaintiffs assert: (a) the actual knowledge requirement is not to be applied to avoid the issue of adequate warnings, and (b) even if the actual knowledge requirement applies, there is a factual issue as to the extent of the radiotherapists’ knowledge. These are the two issues to be decided.

B. Applicability of Actual Knowledge Requirement

1. New Mexico law — generally.

Garrett v. Nissen Corporation, 84 N.M. 16, 21, 498 P.2d 1359 (1972), states:

There is no duty to warn of dangers actually known to the user of a product, regardless of whether the duty rests in negligence under § 388 Restatement (Second) of Torts (1965) or on strict tort liability under § 402A Restatement (Second) of Torts, supra.

See also Skyhook Corp. v. Jasper, 90 N.M. 143, 560 P.2d 934 (1977).

Michael v. Warner/Chilcott, 91 N.M. 651, 655, 579 P.2d 183 (Ct.App.1978), states:

[W]here the party is aware of the danger, the warning will serve no useful purpose and is unnecessary, and there is no duty to warn against risks which are open and obvious.

See also Richards v. Upjohn Co., N.M. 675, 625 P.2d 1192 (Ct.App.1980).

UJI Civ. 14.15 states: “The supplier has no duty to warn of risks which he can reasonably expect to be obvious or known to foreseeable users of the product.” The rationale for the knowledgeable user exception is that knowledge of the danger is equivalent to prior notice, “no one needs notice of that which he already knows.” Billiar v. Minnesota Mining and Mfg. Co., 623 F.2d 240, 243 (2nd Cir.1980).

2. Actual knowledge requirement applies to physicians.

The actual knowledge requirement has been applied in cases involving the knowledge of physicians. The question was not the application of the knowledge requirement, but the extent of the physician’s knowledge. See Perfetti v. McGhan Medical; Richards v. Upjohn Co.; Hines v. St. Joseph’s Hospital.

3. Ignoring New Mexico decisions.

In contending that the actual knowledge requirement should not be applied, plaintiffs ignore the New Mexico decisions. A quick answer to plaintiffs’ claim is that this Court must apply New Mexico Supreme Court decisions and approved jury instructions. Alexander v. Delgado, 84 N.M. 717, 507 P.2d 778 (1973). Thus, Garrett v. Nissen Corporation and UJI Civ. 14.15 dispose of plaintiffs’ claim.

4. Merits of plaintiffs’ claim.

Quite apart from the applicability of Supreme Court precedent, plaintiffs’ three arguments for not applying “actual knowledge” are without merit. First, plaintiffs rely on cases involving misdesign or safety devices. Treatment of that type of claim is covered by NMSA 1978, UJI Civ. 14.12 (Repl.Pamp.1980), not UJI Civ. 14.15. These cases do not involve misdesign or safety devices. Second, plaintiffs rely on cases indicating that current technologies, processes and operational methods make it almost impossible to know of the danger. If the actual knowledge requirement is not met, obviously it is not applicable. Actual knowledge is a question of fact. Difficulties in meeting the actual knowledge requirement is a different question than whether the requirement should be applied if there is a sufficient factual basis. Third, plaintiffs argue that there are situations where it is foreseeable that a user of a product will misuse it and there are situations where the manufacturer has misrepresented or actively contributed to a dangerous use. All of these items involve the duty to warn and the adequacy of warnings. See A(2) under this issue. These items do not go to the propriety of the actual knowledge requirement.

5. Actual knowledge requirement applies.

In deciding the propriety of the summary judgment on the products liability requirement, we apply the actual knowledge requirement.

C. Whether There is a Factual Issue as to the Actual Knowledge Requirement

1.The meaning of actual knowledge.

We have referred to the actual knowledge requirement, but we have not defined it. These cases involve excessive dosages of radiation; the trial court ruled the radiotherapists fully appreciated the risks and consequences of excessive dosages. The showing is that the radiotherapists knew the risks of excessive dosage — injury to structures in the immediate area of the prostate, rectal injuries that could require colostomies, urethral strictures that could require surgical correction, the development of fistulae. 3M states that these risks were exactly the same as the injuries plaintiffs allege they received. Thus, 3M asserts the actual knowledge requirement was met. We do not agree because this argument goes only to general knowledge of the danger in implanting 1-125 seeds.

We have previously pointed out that knowledge of the danger equates to prior notice; no one needs notice of what he already knows. The duty to warn involves putting one on notice. See Garrett v. Nissen Corporation. The adequacy of warnings involves the adequacy of notice given. A warning, to be adequate, must disclose the nature and extent of the danger. NMSA 1978, UJI Civ. 14.18 (Repl.Pamp. 1980). The knowledge that equates to this warning must be knowledge of the nature and extent of the danger. We applied this approach in Perfetti v. McGhan Medical. See Richards v. Upjohn Co. which refers to the scope of the danger. Compare Billiar v. Minnesota Mining and Mfg. Co. which required knowledge that the product could cause severe chemical burns. “Actual knowledge” in these cases means knowledge of the nature and extent of the danger of excessive radiation.

2. 3M’s argument.

3M recognizes that the propriety of the summary judgment on the products liability claims depends upon there being no factual issue as to the knowledge of the radiotherapists as to the nature and extent of the danger of excessive radiation. It undertakes to demonstrate the absence of a factual issue by showing what the radiotherapists knew. Our approach is to consider what they did not know.

3. Plaintiffs’ argument.

Plaintiffs seek to demonstrate what the radiotherapists did not know, but their briefs frequently fail to distinguish between negligence or malpractice and knowledge. For example, plaintiffs cite to evidence going to the inadequacy of the training of the radiotherapists and evidence indicating they were not qualified to implant 1-125 into prostates. Neither radiotherapist had implanted 1-125 in a prostate under supervision before beginning that treatment in 1977; neither had observed such an implant. We are not concerned with the practice or malpractice of the radiotherapists, in this appeal, except to the extent this bears on their lack of knowledge of the nature and extent of the danger of excessive radiation.

4. Lack of knowledge in the appellate record.

(a) In the “background” portion of this opinion, we pointed out that the radiotherapists did not prescribe limiting doses of radiation to the bladder, rectum or other normal tissues. The tissues adjoining the prostate received radiation in excess of normal tissue tolerance. Dr. Murrell deposed that the tissue tolerance of the rectum is the same as the minimum peripheral dose to the prostate, and that was 30,000 rads. This amount of rads exceeded the desired dose of 16,000 to 24,000 rads. Dr. Murrell has never known the tolerance dose to the bladder with 1-125 seeds. He did not know, at his deposition, the tolerance dose to the urethra with 1-125 seeds.

(b) The minimum peripheral dose is the dose to any point on the margin of the prostate. The periphery of the prostate is the capsule of the prostate. According to Dr. Murrell, for each implant “seeds were, by design, placed outside the capsule.” According to Dr. Murrell, this was acceptable procedure. Seeds placed outside the capsule would be closer to the adjoining tissue — such as the bladder.

(c) In the “background” portion of this opinion, we pointed out that the dosage, either desired or delivered, involves the spacing of the seeds. The radiotherapists spaced the seeds at one centimeter intervals. However, “in order to provide a good peripheral dose, the last seed deposited in any given needle may be half a centimeter from its predecessor.” Dr. Murrell had no idea why 3M recommended that seeds be spaced further apart when implanted into the perimeter, and did not know the effect on the minimum peripheral dose of increased seed spacing at the perimeter.

(d) The dosage delivered (the total dose) was part of the radiotherapists’ duties and responsibilities. When the implanting of 1-125 into prostates was begun in 1977, it was a new technique for the radiotherapists. They knew that the total dose had to be calculated, and that this was done by the dosimetrist, but Dr. Murrell did not know the means by which the dosage was calculated and took no steps to understand what calculations had to be made. The radiotherapists did not know of the manual calculation in determining total dose.

(e) Dr. Simmons agreed he lacked “sufficient insight into implant dose distribution in general to recognize the gross error in peripheral prostate dose that resulted.”

(f) When the radiotherapists began implanting 1-125 into prostates they knew that “too much” radiation was dangerous. Dr. Simmons had no recollection of literature indicating a maximum total activity for treating cancer of the prostate. Dr. Murrell recalled no warnings in the medical literature about a maximum dosage for I-125 in treating cancer of the prostate, and did not know of an acceptable upper limit.

(g)The radiotherapists did know of literature that recommended a dosage based on dimension averaging and knew that was 3M’s recommendation. They followed these recommendations in the earlier implants. Their information after the total dose was calculated was that the delivered dose was too low; the desired dose was 16,000 to 24,000 rads, the dosimetry report did not indicate this was the delivered dose. The radiotherapists were perplexed, they could not explain the low dosimetry figures. The radiotherapists knew of the reported low dosage by the third implant. In an effort to raise the radiation to the desired dose, the radiotherapists departed from dimension averaging, and increased the number of seeds implanted by as much as 20%. The decision to increase the number of seeds was “surely made” in the first half of the cases, and was based on the radiotherapists’ experience “in order to compensate for the understated dosage results * * Young and Jones were approximately patients twelve and thirteen; seeds were implanted in these patients in an amount larger than the recommended dosage. Simmons and Murrell knew of no guidelines in the medical literature about adding additional seeds in this situation. The decision to increase the number of seeds was based on erroneous dosimetry, and the erroneous dosimetry, in turn, was based on use of the erroneous conversion factor.

5. Factual issue.

We have not attempted to identify all of the matters explored in the depositions that go to the knowledge of the radiotherapists. The items set forth in 4 above pertain to their knowledge, and those items disclose a factual issue as to the radiotherapists’ knowledge of the nature and extent of the danger of excessive radiation in implanting 1-125 seeds in treating cancer of the prostate. There being an evidentiary dispute as to the radiotherapists’ knowledge, summary judgment was improper. Pharmaseal Laboratories, Inc. v. Goffe, 90 N.M. 753, 568 P.2d 589 (1977); Billiar v. Minnesota Mining and Mfg. Co.; High Voltage Engineering Corporation v. Pierce, 359 F.2d 33 (10th Cir.1966); see Perfetti v. McGhan Medical; Richards v. Upjohn Co.

6. Caveat.

Inasmuch as we have not reviewed testimony that went to the radiotherapists’ knowledge, it is appropriate to remind the reader that we have not decided any factual questions; those must be determined by the fact finder. Our holding is that there is a factual question to be decided as to the nature and extent of the radiotherapists’ knowledge. If the radiotherapists are determined to have the requisite knowledge, that is the end of the case. If they lacked the requisite knowledge, then the factual questions of the adequacy of 3M’s warnings to the radiotherapists and causation must be determined adverse to 3M before it can be held liable. Stephen W. Brown Radiology Assoc. v. Gowers, 157 Ga.App. 770, 278 S.E.2d 653 (1981).

Warranties

The trial court ruled that 3M did not breach any warranty with respect to the 1-125-seeds.

A.Express Warranty

Both plaintiffs claimed breaches of express warranty. The asserted express warranties were statements contained in 3M’s publications. Plaintiffs contend these statements were affirmations of fact. Assuming, but not deciding, these were affirmations of fact, these affirmations do not amount to express warranties unless they were part of the basis of the bargain. NMSA 1978, § 55-2-313(1); NMSA 1978, UJI Civ. 14.28 (Cum.Supp.1983); Perfetti v. McGhan Medical.

We are not concerned with any bargain between 3M and either Jones or Young. Perfetti v. McGhan Medical. The uncontradicted showing is there was no bargain between 3M and the radiotherapists. The hospital did not order the seeds; the radiotherapists did. The hospital did pay for the seeds. There is nothing indicating a bargain between 3M and the hospital. See Perfetti v. McGhan Medical. The uncontradicted showing is that use of the seeds came about because urologists in the area were interested in having the seeds used and “pressure” was put on Dr. Simmons to use the seeds. The hospital made no decision as to use of the seeds. This showing, uncontradicted, is sufficient to sustain the summary judgment as to express warranties. See Perfetti v. McGhan Medical.

B. Implied Warranty of Fitness for a Particular Purpose

Young, but not Jones, claimed a breach of the implied warranty of fitness for a particular purpose. See NMSA 1978, UJI Civ. 14.31 (Cum.Supp.1983). This implied warranty requires reliance. UJI Civ. 14.31; Perfetti v. McGhan Medical. Young’s brief-in-chief asserts “reliance of the most serious and intimate nature was placed on the products.” However, Young does not attempt to support this conclusion by reference to material included in the appellate record. The material in the record shows no such reliance, and sustains the summary judgment as to this warranty.

C. Implied Warranty of Merchantability

On appeal, both parties claim a breach of the implied warranty of merchantability. See NMSA 1978, UJI Civ. 14.30 (Cum.Supp.1983). Neither plaintiff pled a breach of this warranty. This issue, raised for the first time on appeal, will not be considered. NMSA 1978, Civ.App.R. 11; see St. Vincent Hospital v. Salazar, 95 N.M. 147, 619 P.2d 823 (1980).

The summary judgment on the products liability claims is reversed. The summary judgment on the express and implied warranty claims is affirmed. Plaintiffs are to recover one-half of their appellate costs.

IT IS SO ORDERED.

DONNELLY, J., concurs. LOPEZ, J., specially concurs.