Ortho Pharmaceutical Corp. v. Heath

722 P.2d 410, 1986 Colo. LEXIS 594

• Court: Supreme Court of Colorado
• Decided: July 7, 1986
• Docket: 83SA293
• Status: Published

Opinions

YOLLACK, Justice.

The defendant-appellant, Ortho Pharmaceutical Corporation (Ortho), a manufacturer of oral contraceptives, appeals a judgment entered upon a verdict of $975,000 and prejudgment interest in the amount of $506,542.80 in a products liability action for personal injuries suffered by plaintiff-ap-pellee, Jo Ellen Murphy Hyland Heath (Heath). Heath attributed her acute kidney failure in November, 1974 to her use of Ortho-Novum, a brand of oral contraceptive made by Ortho. The trial court denied Ortho’s motion for judgment N.O.V. and Ortho’s motion for new trial. Ortho appeals. We reverse and remand for a new trial.

I.

Heath first began taking Ortho-Novum in 1967. She stopped using oral contraceptives during the summer of 1970 because she wanted to become pregnant. She had a normal pregnancy and gave birth to a daughter in May, 1971. In February, 1972, her obstetrician-gynecologist, Dr. Clayton Evans, prescribed Ortho-Novum 1/50. In March, 1972, he increased her dosage to Ortho-Novum 1/80 after she reported one incident of break-through bleeding. She continued to take Ortho-Novum 1/80 until November, 1974. At that time, Heath, then aged 28, became critically ill with acute kidney failure, which eventually necessitated a kidney transplant. Subsequently, she developed cervical dysplasia which her doctors postulated was caused by the immuno-suppressant therapy she was receiving to minimize the risk of kidney rejection. Because of a perceived risk of cervical cancer, she elected to have a hysterectomy in 1979. The risk of cancer also stemmed from the corticosteroid or immuno-suppressant medication prescribed to prevent rejection of the transplanted kidney.

Heath filed suit against Ortho alleging injuries caused by Ortho-Novum 1/80. Both sides presented expert testimony. Her experts attributed her acute kidney failure to malignant hypertension or hemo-lytic uremic syndrome (HUS) induced by her use of Ortho-Novum 1/80. Ortho’s experts disputed the conclusions of Heath’s experts. The case was submitted to the jury on theories of strict liability and negligence.

Heath also presented evidence that the warning provided by Ortho regarding the use of Ortho-Novum 1/80 was inadequate in that physicians were not told to monitor blood pressure and were not alerted to the possibility of kidney failure. Moreover, Heath alleged that, despite Ortho’s compliance with the Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301-392, (1972), which regulates the labeling of drugs, the warning provided to users of Ortho-Novum 1/80 was inadequate. Heath claimed that there was a common law duty to warn users of Ortho-Novum 1/80 in addition to the warnings mandated by the Food and Drug Administration (FDA).

II.

Ortho first claims that Heath failed as a matter of law to prove that her kidney failure was caused by the use of Ortho-No-vum 1/80. Ortho argues that the testimony of Heath’s experts was purely conjectural and was based upon their subjective assessments. Specifically, Ortho argues that, because Heath’s expert witnesses based their opinions upon diagnoses that ruled out other possible causes of her kidney failure, it was error for the court to allow the jury to decide whether it was “more likely than not” that Ortho-Novum 1/80 was the cause of her HUS and kidney failure.

In a jury trial the determination of facts, credibility of witnesses, and weight and probative value of the evidence are committed to the wisdom and discretion of the jury. Kiefer, Inc. v. Hoffman, 193 Colo. 15, 562 P.2d 745 (1977). Heath presented numerous expert witnesses who testified that Ortho-Novum 1/80 caused her HUS and resulting kidney failure. Any conflicts in the evidence were for the jury to resolve. In reviewing the sufficiency of the plaintiff’s evidence, we have held that the evidence must be considered in a light most favorable to the plaintiff. It is not the province of this court to judge the weight of the evidence or credibility of the witnesses. Wilson v. Board of County Commissioners of Adams County, 703 P.2d 1257 (Colo.1985).

Accordingly, we hold that Heath presented sufficient evidence of the causal relationship between Ortho-Novum 1/80 and her illness to warrant a determination by the finder of fact. The defense motions to dismiss and for judgment N.O.V. were properly denied.

III.

Ortho contends Heath’s claim that Ortho-Novum 1/80 was defectively designed was not timely raised, and that the trial court did not have a sufficient factual basis to submit the claim to the jury. Alternatively, Ortho contends jury instruction no. 15, which set forth the elements of Heath’s design defect claim, was erroneous. Ortho further contends that FDA approval of Or-tho-Novum 1/80 precludes the giving of a design defect instruction under the Supremacy Clause, U.S. Const., art. VI, cl. 2. We discuss each contention separately.

A.

As to the timeliness issue, the record contains no information concerning the procedure by which Heath's assertion that Ortho-Novum 1/80 was defectively designed was recognized by the trial court. Ortho’s brief asserts that Heath made no motion to amend her pleadings to conform to the evidence, and Heath’s answer brief neither denies the assertion nor discusses the question of the timeliness of the amendment. Absent any basis in the record to suggest that the trial court abused its discretion in allowing Heath’s late assertion of the claim, we cannot rule that the claim was untimely raised.

Ortho also claims the trial court did not have a sufficient factual basis to submit a design defect claim to the jury. We disagree.

To assess whether Heath introduced sufficient evidence to justify submission of her design defect claim to the jury requires an analysis of the elements of such claim. Courts and commentators have recognized two types of defective product claims. The first deals with a defect in the manufacturing stage; the second involves products that are produced in precisely the form intended, but which are nevertheless unreasonably unsafe. Wade, On Product “Design Defects” and Their Actionability, 33 Vand.L.Rev., 551 (1980). Heath’s claim involves this second type of defective product. We have adopted section 402A of the Restatement (Second) of Torts in the context of the second type of defective product cases. Hiigel v. General Motors Cory., 190 Colo. 57, 544 P.2d 983 (1976); Union Supply Co. v. Prist, 196 Colo. 162, 583 P.2d 276 (1978). Under section 402A, Heath must establish that, while Ortho-Novum 1/80 was produced and marketed in precisely the form intended, it is unreasonably dangerous.

Because all products are dangerous when used improperly or for unintended purposes, Heath alleges that Ortho-Novum 1/80 is so designed that it is unreasonably dangerous when properly used for its intended purpose. A variety of tests have been developed to determine whether the defect (that degree of dangerousness inherent in all prescription drugs) is unreasonable. The California Supreme Court adopted the following two tests:

[I]n design defect cases, the court may properly instruct the jury that a product is defective in design if (1) the plaintiff proves that the product failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner, or (2) the plaintiff proves that the product’s design proximately caused injury and the defendant fails to prove, in light of the relevant factors, that on balance the benefits of the challenged design outweigh the risk of danger inherent in such design.

Barker v. Lull Engineering Co., 24 Cal.3d 413, 426-427, 143 Cal.Rptr. 225, 234, 573 P.2d 443, 452 (1978). The first test is based in part on section 402A of the Restatement (Second) of Torts, and it has been largely incorporated into our model jury instruction in C.J.I.-Civ.2d 14:19. The test has been characterized as the “consumer expectation test.” It relies in large part upon comment i of section 402A, which defines unreasonable conduct as follows:

The rule stated in this Section applies only where the defective condition of the product makes it unreasonably dangerous to the user or consumer.... The article sold must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.

The second test adopts a risk-benefit analysis to measure the reasonableness of a danger. If, under this second test, a plaintiff proves causation, the manufacturer is required to establish that the product’s benefits outweigh its inherent risks. The consumer expectation test or the risk-benefit test are the primary approaches used by courts faced with the question of adopting an appropriate test for design defect cases.¹

We believe the second test as set forth in Barker is the appropriate standard here. The dangerousness of Ortho-Novum 1/80 is defined primarily by technical, scientific information. The consumer expectation test fails to address adequately this aspect of the problem. The risk-benefit test focuses on the practical policy issues characteristic of a product such as Ortho-Novum 1/80, which is alleged to be unreasonably dangerous despite being manufactured in precisely the form intended. Under this test, Ortho in essence argues that the benefits of the extra thirty milligrams of estrogen in Ortho-Novum 1/80 outweigh the attendant risks of the higher estrogen content. Professor Wade suggested that among the factors which may be considered are the following:

(1) The usefulness and desirability of the product — its utility to the user and to the public as a whole.

(2) The safety aspects of the product— the likelihood that it will cause injury and the probable seriousness of the injury.

(3) The availability of the substitute product which would meet the same need and not be as unsafe.

(4) The manufacturer’s ability to eliminate the unsafe character of the product without impairing its usefulness or making it too expensive to maintain its utility-

id) The user’s ability to avoid danger by the exercise of care in the use of the product.

(6) The user’s anticipated awareness of the dangers inherent in the product and their avoidability because of general public knowledge of the obvious condition of the product, or of the existence of suitable warnings or instructions.

(7) The feasibility, on the part of the manufacturer, of spreading the loss by setting the price of the product or carrying liability insurance.

Wade, On the Nature of Strict Tort Liability for Products, 44 Miss.L.J. 825, 837-38 (1973); See also Cepeda v. Cumberland Engineering Corp., 76 N.J. 152, 386 A.2d 816 (1978); and see Twerski, Seizing the Middle Ground Between Rules and Standards in Design Defect Litigation, 57 N.Y. U.L.Rev. 521 (1982) (Professor Twerski expands upon the seven factors discussed by Professor Wade, and includes among his list the role government may have played in regulating the product’s design.).

Here, the record contained testimony which indicated that the increased risks of adverse reactions occasioned by the extra thirty milligrams of estrogen in Ortho-No-vum 1/80 outweighed any benefits the product might produce. The record also contained evidence that Ortho-Novum 1/80 was the only available product for patients who experienced break-through bleeding and, therefore, produced benefits that outweighed any increased risks. We believe there was a sufficient factual basis for the court to have given an instruction on Heath’s theory that Ortho-Novum 1/80 was unreasonably dangerous, without regard to the availability of warnings because of a design defect.² Where there is conflicting evidence, the question is properly submitted to the trier of fact. Converse v. Zinke, 635 P.2d 882 (Colo.1981).

B.

Ortho contends in the alternative that if the court did have a sufficient factual basis to submit the defective design claim to the jury, then jury instruction no. 15, which set forth the elements of Heath’s design defect claim, was erroneous. We agree.

Instruction no. 15 was the only instruction given to the jury on the defective design theory of the case. It states:

A product is defective when because of its manufacture or design it is not reasonably fit for the ordinary purposes for which such products are intended or may reasonably be expected to be used.

To be unreasonably dangerous, the product, because of the defect, must create a risk of harm to persons or property which would not ordinarily be expected.

This instruction simply states the “consumer expectation test,” a test not suitable in prescription drug cases when the actionable product is alleged to be unsafe by design notwithstanding its production in precisely the manner intended. The failure of the trial court to give an instruction on the risk-benefit test was reversible error.³

IV.

Ortho contends it was entitled to an instruction based upon comment k of section 402A of the Restatement (Second) of Torts. Ortho tendered such an instruction, based directly on comment k.⁴ The record does not indicate the basis for the trial court’s denial of the tendered instruction.⁵ We believe that a comment k instruction was warranted here. In Belle Bonfils Memorial Blood Bank v. Hanson, 665 P.2d 118 (Colo.1983), we stated four factors to be considered in determining whether a manufacturer is entitled to a defense based on comment k:

The product’s utility must greatly outweigh the risk created by its use; the risk must be a known one; the product’s benefits must not be achievable in another manner; and the risk must be unavoidable under the present state of knowledge.

Id., at 122.

As to the first factor under Belle Bon-fils, expert testimony was presented that because Ortho-Novum 1/80 prevented break-through bleeding, the specific problem Heath encountered on the lower dose of Ortho-Novum 1/50, the product’s benefits outweighed its risks. Regarding the second factor, several expert witnesses testified that as of 1974 medical studies indicated that higher estrogen dose oral contraceptives increased the risk of serious side effects, including the blood clotting which precipitated the plaintiff’s renal failure. Moreover, medical studies prior to 1974 recommend that the use of eighty milligram estrogen pills be curtailed. As to the third factor, Ortho presented testimony that no other alternative could prevent break-through bleeding and maintain the same high degree of effectiveness against pregnancy. Finally, Ortho introduced testimonial evidence that the risk was unavoidable. We believe there was evidence in the record to support the giving of the instruction. Converse v. Zinke, 635 P.2d 882 (Colo.1981); Greenwood v. Kier, 125 Colo. 333, 243 P.2d 417 (1952); C.R.C.P. 51.1.

Evidence introduced at trial satisfied Or-tho’s burden of going forward as to each of the elements of the comment k defense. Because other evidence rebutted Ortho’s evidence as to the comment k defense, the issue became one for the jury. See Belle Bonfils, 665 P.2d at 125, n. 12; Converse v. Zinke, 635 P.2d 882. We, therefore, conclude from a fair reading of the evidence that Ortho was entitled to an instruction based on the comment k defense.

In conclusion, because we reverse the trial court on its design defect instruction and on its failure to give a comment k instruction, we decline to address the other issues raised by Ortho.

Judgment reversed and remanded.

LOHR, J., dissents and QUINN, C.J., joins in the dissent. DUBOFSKY, J., does not participate.

1 . For examples of the consumer expectation test, see Caterpillar Tractor Co. v. Beck, 593 P.2d 871 (Alaska 1979); Farmer v. International Har-vaster Co., 97 Idaho 742, 553 P.2d 1306 (1976); Dunham v. Vaughan & Bushnell Mfg. Co., 42 II1.2d 339, 247 N.E.2d 401 (1969); Cremeans v. International Harvester Co., 6 Ohio St.3d 232, 452 N.E.2d 1281 (1983).

The following cases were examples of the use of risk-benefit analysis: O’Brien v. Muskin Corp., 97 N.J. 169, 463 A.2d 298 (1983); Wilson v. Piper Aircraft Corp., 281 Or. 61, 577 P.2d 1322 (1978); Turner v. General Motors Corp., 584 S.W.2d 844 (Tex.1979); Birnbaum, Unmasking the Test for Design Defect: From Negligence [to Warranty] to Strict Liability to Negligence, 33 Vand.L.Rev. 593, 605 n. 54 (1980) (and cases cited therein); Annot., 96 A.L.R.3d 22 (1980) (and cases cited therein).

2 . For a persuasive discussion of the policy-making function of courts in the use of multifac-tored criteria to determine whether to grant a motion for directed verdict on a defective design issue, see Twerski, Seizing the Middle Ground Between Rules and Standards in Design Defect Litigation, 57 N.Y.U.L.Rev. 521 (1982).

3 . Ortho also claims that, because of FDA regulation, a defective design claim as to Ortho-No-vum 1/80 is preempted by the supremacy clause, U.S. Const, art. VI, cl. 2. This contention was neither raised during trial nor in Or-tho’s motion for a new trial. We decline to address the issue. Colgan v. State, Department of Revenue, Motor Vehicle Division, 623 P.2d 871 (Colo.1981); Manka v. Martin, 200 Colo. 260, 614 P.2d 875 (1980), cert. denied, 450 U.S. 913, 101 S.Ct. 1354, 67 L.Ed.2d 338 (1981).

4 . Comment k to section 402A of the Restatement (Second) of Torts provides:

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 warnings, 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.

(emphasis in original).

5 .The plaintiff argues in part that because Ortho did not plead comment k as a defense it was not entitled to such an instruction. We note that the appropriateness of such defense no doubt became apparent only at the conclusion of all the evidence. Furthermore, because we find sufficient evidence in the record to justify the plaintiffs design defect claim, Ortho was equally entitled to amend its pleadings to conform to the evidence.