Opinion
Review dismissed and remanded Aug. 25, 1988.
Previously published at 195 Cal.App.3d 1539
No appearance for defendants.
Edward Barker and Juin D. Desrosiers, Los Angeles, for plaintiffs and appellants.
Gibson, Dunn & Crutcher, G. Edward Fitzgerald, Moore & Wood and Scott E. Wood, Los Angeles, for defendant and respondent.
OPINION
HAMLIN, Acting Presiding Justice.
On March 1, 1982, plaintiffs Chandra and John Collins filed their first amended complaint for medical malpractice, loss of consortium, and infliction of emotional distress against defendant Ortho Pharmaceutical Corporation as well as four doctors, two Plaintiffs' complaint alleged that defendant was engaged in the business of designing, manufacturing, and distributing intrauterine birth control devices (IUD's), that defendant knew such devices would be used by consumers without inspection for defects, that an IUD manufactured and distributed by defendant was inserted into plaintiff Chandra Collins for the purpose of birth control, and that the IUD was defective in its design, in its manufacture, and in its failure to be accompanied by warnings of the dangers inherent in using the IUD.
On April 4, 1984, defendant moved for summary judgment or, alternatively, for summary adjudication of issues based on defendant's contention that its duty to warn of any increased risk of developing certain medical problems from use of the IUD, specifically in this case the Lippes Loop, was discharged by warnings provided to plaintiff Chandra Collins' doctor, codefendant L.A. Graves, M.D. Plaintiffs opposed this motion, stressing that their theory of defendant's liability was a design defect, not a failure to warn, and further alleging that plaintiff Chandra Collins was not warned by Dr. Graves about possible side effects prior to his insertion of the IUD. Following defendant's reply that it was at least entitled to an order that any issue regarding defendant's duty to warn was without substantial controversy, the trial court granted such an order pursuant to Code of Civil Procedure section 437c, subdivision (f), that the following issues were without substantial controversy and were deemed established for all purposes in the action:
"1. Defendant Ortho Pharmaceutical Corporation discharged its duty to warn with respect to the prescription medical product in issue (Lippes Loop);
"2. Defendant Ortho Pharmaceutical Corporation's duty to warn in this case ran to the prescribing physician (Dr. Graves), not directly to the plaintiffs;
"3. Defendant Ortho Pharmaceutical Corporation discharged its legal duty to warn in this case by, at all relevant times, providing to Dr. Graves published information about the reported risk of pelvic inflammatory disease; ..."
On October 3, 1984, defendant again filed a motion for summary judgment or, alternatively, for summary adjudication of certain issues based on regulations adopted by the federal Food and Drug Administration (FDA) that IUD's like the Lippes Loop were generally safe and that the risks associated with use of the devices could be obviated by appropriate warnings, a duty which defendant had fulfilled. Plaintiffs opposed defendant's motion, contending such warnings were irrelevant under the risk/benefit theory of strict liability applicable to alleged design defects. Plaintiffs further argued that the factfinder must decide whether the risk outweighed the benefits, and thus summary adjudication was improper. The trial court granted defendant's motion for summary judgment on November 16, 1984, based on the following rationale:
"In its written and oral opposition to the present motion, plaintiffs have expressly disclaimed reliance on any issue related to warning. The sole remaining question is whether this product is 'defective.' An F.D.A. decision of product marketability disposes of the defect issue, 9 Cal.3d at 65, unless federal regulatory determination is to be displaced by jury determination under Barker v. Lull Engineering Co. (1978) 20 Cal.3d 413 [143 Cal.Rptr. 225, 573 P.2d 443.]. The only authority for the latter proposition is Justice Bird's dissent in Finn v. G.D. Searle & Co. (1984) 35 Cal.3d 691, 721 [200 Cal.Rptr. 870, 677 P.2d 1147.] "The court concludes that the Barker balancing test has not been extended to federally regulated prescription products under California law, and no issue remains as to the question of defect."
Judgment was entered in favor of defendant; plaintiffs appeal.
After the trial court granted summary judgment for defendant, Kearl v. Lederle Laboratories (1985) 172 Cal.App.3d 812, 218 Cal.Rptr. 453 was decided. There the court held that a strict liability cause of action against a manufacturer of prescription drugs is prohibited for public policy reasons if the court determines, after taking evidence, that the product complained of is "unavoidably dangerous." This case requires us to decide whether the trial court can determine, on a motion for summary judgment, that a prescription drug or device is unavoidably unsafe based on approval granted and restrictions imposed by the federal Food and Drug Administration (FDA). We hold it can; we will therefore affirm the judgment.
THE FACTS
In November 1979, plaintiff Chandra Collins was receiving obstetrical care from codefendant Drummond Medical Group. On November 7, Dr. Graves, a gynecologist employed by that codefendant, delivered plaintiff Chandra Collins' child at Ridgecrest Community Hospital, another codefendant. About seven weeks later, Dr. Graves inserted an IUD, the Lippes Loop, into plaintiff Chandra Collins for purposes of birth control.
In July 1980, plaintiff Chandra Collins began to experience lower pelvic discomfort and burning on urination. She consulted Dr. Graves, but the condition worsened until plaintiff fainted on her job on July 31, 1980. She was then admitted to Ridgecrest Community Hospital. Ultrasound examinations performed on plaintiff prior to her discharge on August 6 indicated "a complex retrouterine pelvic mass with a prominent fluid component." Because of continued problems, plaintiff again contacted the doctors employed by Drummond Medical Group on August 14, 1980. She was readmitted to the hospital on August 28, 1980, and tests performed prior to her discharge on August 30 indicated the mass had progressed. Plaintiff Chandra Collins was discharged from the hospital, but her condition continued to deteriorate and she was "therefore ultimately required to undergo on November 18, 1980 a total abdominal hysterectomy and removal of both ovaries such that she totally lost any further and future capability of bearing and giving birth to children."
Plaintiff alleges that the uterine problems from which she suffered and which ultimately resulted in the hysterectomy were caused by the Lippes Loop IUD manufactured by defendant and inserted by codefendant Dr. Graves.
DISCUSSION
The standard which governs the trial court in ruling on a motion for summary judgment is well established. As the court stated in Bonus-Bilt, Inc. v. United Grocers, Ltd. (1982) 136 Cal.App.3d 429, 440-441 186 Cal.Rptr. 357:
" 'The matter to be determined by the trial court in considering such a motion is whether the defendant (or the plaintiff) has presented any facts which give rise to a triable issue. The court may not pass upon the issue itself. Summary judgment is proper only if the affidavits in support of the moving party would be sufficient to sustain a judgment in his favor and his opponent does not by affidavit show such facts as may be deemed by the judge hearing the motion sufficient to present a triable issue. The aim of the procedure is to discover, through the media of affidavits, whether the parties possess evidence requiring the weighing procedures of a trial. In examining the sufficiency of affidavits filed in connection with the motion, the affidavits of the moving party are strictly construed (See also Lee v. Electric Motor Division (1985) 169 Cal.App.3d 375, 381-382, 215 Cal.Rptr. 195.)
Moreover, in reviewing a trial court's order granting summary judgment, an appellate court looks to the result reached and is not limited to the correctness of the underlying rationale. As the court stated in Barnett v. Delta Lines, Inc. (1982) 137 Cal.App.3d 674, 682, 187 Cal.Rptr. 219:
"However, a summary judgment will be upheld when the record establishes that there is no cause of action. [Citation.] We are not confined, in considering the granting of the summary judgment, to the sufficiency of the stated reasons. It is the validity of the ruling which is reviewable and not the reasons therefor. [Citation.] A motion for summary judgment necessarily includes a test of the sufficiency of the complaint and as such is in legal effect a motion for judgment on the pleadings. [Citations.]"
The trial court's rationale for granting defendant's motion for summary judgment is quoted above. Relying on Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 107 Cal.Rptr. 45, 507 P.2d 653, the trial court concluded that the so-called "risk/balancing" test articulated by the California Supreme Court in Barker v. Lull Engineering Co. (1978) 20 Cal.3d 413, 143 Cal.Rptr. 225, 573 P.2d 443 was inapplicable to prescription drugs which had been marketed with the approval of the FDA. We note the trial court impliedly included prescription devices, such as the Lippes Loop IUD, within the category of prescription drugs discussed by the Supreme Court in Stevens v. Parke, Davis & Co., supra. Although we have found no California case which expressly so holds, we are persuaded by the rationale of the Supreme Court of Washington in Terhune v. A.H. Robins Co. (1978) 90 Wash.2d 9, 13-17, 577 P.2d 975, 978-979 that prescription products, whether drug or device, which require FDA approval prior to marketing and are available only on the prescription of a physician must be treated alike. (See also McKee v. Moore (Okla.1982) 648 P.2d 21, 24-25.)
Stevens v. Parke, Davis & Co., supra, is a strict liability case based on the defendants' alleged failure to warn of the danger of a prescription drug. The court recognized that as to prescription drugs, a manufacturer's duty to warn ran to the prescribing physician and not to the ultimate consumer. This result is consistent with the trial court's ruling on defendant's first motion for summary judgment herein, i.e., defendant had satisfied its duty to warn. However, with respect to the role played by the FDA vis-a-vis prescription drugs, and limited by the issue before it, the court in Stevens said merely that "compliance with regulations or directives as to warnings, such as those issued by the United States Food and Drug Administration here, may not be sufficient to immunize the manufacturer or supplier of the drug from liability. However, we believe the trial court properly conceptualized the underlying weakness in maintaining a cause of action for design defect against the manufacturer of a prescription product. It simply had no controlling authority on which to rely.
With respect to the type of prescription drugs/devices here under discussion, i.e., those used by women for the purpose of birth control, we recognize that some courts have carved out an exception from the traditional rule that the drug manufacturer's duty to warn of a known danger runs to the physician, the "learned intermediary" between the manufacturer and the ultimate consumer. See, e.g., MacDonald v. Ortho Pharmaceutical Corp. (1985) 394 Mass. 131 [475 N.E.2d 65], holding that the greater degree of patient involvement in selecting a prescription birth control drug or device and the diminished degree of physician supervision during the course of treatment warrant treatment of birth control drugs and devices different than that afforded other ethical pharmaceuticals. Since the case before us is a design defect case rather than a failure to warn case, we need not decide whether the Supreme Court's decision in Stevens is ripe for rethinking.
In Finn v. G.D. Searle & Co. (1984) 35 Cal.3d 691, 694, 200 Cal.Rptr. 870, 677 P.2d 1147, the Supreme Court granted hearing to consider the application of strict liability principles to injurious side effects allegedly produced by prescription drugs. However, because the basis on which plaintiff had tried the case precluded the court from reaching this broader issue, the court was limited to a determination of whether modifications in proposed jury instructions adversely affected the judgment. Nonetheless, plaintiffs here place great reliance on Chief Justice Bird's dissent in Finn v. G.D. Searle & Co., supra, advancing principles of law she reiterated in her dissenting opinion in Murphy v. E.R. Squibb & Sons, Inc. (1985) 40 Cal.3d 672, 221 Cal.Rptr. 447, 710 P.2d 247. Despite plaintiff's understandable interest in the Chief Justice's view of the law as expressed in those dissents, it does not control our decision here. The Supreme Court has yet to squarely address the issue raised by plaintiffs.
Decisional law in California has established three theories on which a strict liability cause of action may rest: (1) design defect, (2) manufacturing defect, and (3) failure to warn. (See, e.g., Barker v. Lull Engineering Co. (1978) 20 Cal.3d 413, 143 Cal.Rptr. 225, 573 P.2d 443.
We note the court in Kearl v. Lederle Laboratories, supra, 172 Cal.App.3d at page 817, 218 Cal.Rptr. 453, has also concluded that while products which are unavoidably unsafe remain subject to strict liability for manufacturing defects, "such products are subject merely to negligence liability for warning defects." Since plaintiff herein does not proceed on a warning defect theory, we are not bound to accept or reject the Kearl analysis; we note, however, that court's scholarly review and analysis of cases considering warning defects and the conclusion reached by the court are consistent with the view long espoused by Dean Prosser. (See, e.g., Prosser & Keeton on Torts (5th ed. 1984) Products Liability, § 99, pp. 697-698.)
In Barker, the Supreme Court explained alternate bases for finding a product defective in design:
"First, a product may be found defective in design if the plaintiff establishes that the product failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner. Second, a product may alternatively be found defective in design if the plaintiff demonstrates that the product's design proximately caused his injury and the defendant fails to establish, in light of the relevant factors, that, on balance, the benefits of the challenged design outweigh the risk of danger inherent in such design." (Id. at p. 432, 143 Cal.Rptr. 225, 573 P.2d 443.)
Those relevant factors include "the gravity of the danger posed by the challenged design, the likelihood that such danger would occur, the mechanical feasibility of a safer alternative design, the financial cost of an improved design, and the adverse consequences to the product and to the consumer that would result from an alternative design. [Citations.]" (Id. at p. 431, 143 Cal.Rptr. 225, 573 P.2d 443.) "In addition, a product which is not otherwise defective may be rendered defective if a suitable warning as to the product's dangerous propensity is not given. [Citation omitted.]" (Rosburg v. Minnesota Mining & Mfg. Co. (1986) 181 Cal.App.3d 726, 732, 226 Cal.Rptr. 299.) Plaintiffs contend triable issues of fact existed on their design defect cause of action as to both of the criteria set forth in Barker v. Lull Engineering Co., supra, 20 Cal.3d 413, 432, 143 Cal.Rptr. 225, 573 P.2d 443. Specifically, plaintiffs contend the Lippes Loop failed to perform as safely as an ordinary consumer would expect, because of "an extremely high risk of infection." Plaintiffs further contend, relying on the Barker decision, that as to the second criterion plaintiffs need only show that the Lippes Loop caused the injury to plaintiff Chandra Collins to shift the burden to defendant to show that the benefits of the product outweighed the risk of harm. Defendant, on the other hand, contends summary judgment was properly granted because the Lippes Loop was an unavoidably unsafe prescription product pursuant to Restatement Second of Torts, section 402A, comment k (hereafter comment k).
"k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk."
The court in Kearl v. Lederle Laboratories, supra, 172 Cal.App.3d 812, 218 Cal.Rptr. 453 begins its discussion of the propriety of imposing strict liability for a design defect in prescription drug cases with the following fundamental observations:
"The prospect that a manufacturer might be subject to either of Barker's two standards for determining existence of a design defect may cause delay in marketing of products while manufacturers conduct various safety tests; in some cases the prospect of such review and concomitant increased likelihood of liability may deter research, manufacturing and marketing altogether. [Citation.] It is apparently assumed that such a result is socially beneficial in the vast majority of products cases; we are often willing to sacrifice speedier marketing of products, or we may be willing to sacrifice availability altogether, in return for greater accountability of manufacturers through imposition of strict liability. Although this may be an appropriate trade off when we are considering designs of appliances, cars, hand tools, or food, it might not be appropriate with regard to some special products that are extremely beneficial to society and yet pose an inherent and substantial risk that is unavoidable at the time of distribution." (Kearl, supra, at pp. 822-823, fns. omitted, 218 Cal.Rptr. 453.)
Discussing the prospects of (1) decreased availability and (2) increased cost to the ultimate consumer based on increased costs of insurance and product production, the court went on to state:
"All of this suggests that with regard to some special products the scale may tip away from enhanced accountability (i.e., strict liability analysis of design defect claims) and in favor of availability. It follows that to facilitate, and not frustrate availability in those special cases, some special products should be exempted from the normal strict products liability design defect analysis; instead of judging such products in the light of ordinary consumer expectations or The court in Kearl summarizes numerous prescription drug cases in which the manufacturer was not held strictly liable for an alleged design defect, either because the court declined to apply this theory of strict liability or because the plaintiff had not asserted it, relying instead on one of the two alternate theories of strict liability--manufacturing defect or failure to warn. The court noted only one case, Brochu v. Ortho Pharmaceutical Corp. (1st Cir.1981) 642 F.2d 652, sanctioning application of design defect strict liability principles to a prescription drug; Brochu is one of the cases on which the Chief Justice relied heavily in her dissenting opinion in Finn v. G.D. Searle & Co., supra, 35 Cal.3d 691, 200 Cal.Rptr. 870, 677 P.2d 1147. The Kearl court conceded the correctness of the result reached in Brochu v. Ortho Pharmaceutical Corp., supra, under the facts of that particular case, including proof that the defendant there marketed an equally effective, although significantly less dangerous, product at the same time the subject product was distributed. As the court in Kearl further observed, this particular set of circumstances would have sustained a traditional negligence cause of action for design defect, since a manufacturer who knows, or should know, of the comparative efficacy as well as the possible side effects of two of its products but nevertheless distributes the product which is no more efficacious but significantly more dangerous than the alternative product presumably falls below the applicable standard of care.
In the Chief Justice's dissenting opinion in Murphy v. E.R. Squibb & Sons, Inc., supra, 40 Cal.3d 672, 221 Cal.Rptr. 447, 710 P.2d 247 she notes that "[a]lthough this court has never directly held that strict liability principles apply to prescription drugs, it has clearly endorsed the idea. Sindell v. Abbott Laboratories (1980) 26 Cal.3d 588 [163 Cal.Rptr. 132, 607 P.2d 924] [ ...] addressed the applicability of strict liability to prescription drugs...." (Id. at p. 691, 221 Cal.Rptr. 447, 710 P.2d 247.) However, the cited passage from Sindell does not necessarily reflect the court's approval of strict liability under all possible theories against manufacturers of prescription products since strict liability was not the issue under consideration. Sindell dealt with joint and several liability albeit in the context of distribution of a prescription drug; the Supreme Court upheld the right of a plaintiff injured by her mother's ingestion of diethylstilbestrol (DES) to state a cause of action against all manufacturers supplying a substantial share of the market for that drug.
The court in Sindell recognized the well-established policy which favors placing liability for dangerous products on the manufacturers since they are deemed best able to insure against the risk. This policy was articulated in the seminal case of Greeman v. Yuba Power Products, Inc. (1963) 59
"[W]e believe that the test for defective design set out above is appropriate in light of the rationale and limits of the strict liability doctrine, for it subjects a manufacturer to liability whenever there is something 'wrong' with a product's design--either because the product fails to meet ordinary consumer expectations as to safety or because, on balance, the design is not as safe as it should be--while stopping short of making the manufacturer an insurer for all injuries which may result from the use of its product. This test, moreover, explicitly focuses the trier of fact's attention on the adequacy of the product itself, rather than on the manufacturer's conduct, and places the burden on the manufacturer, rather than the plaintiff, to establish that because of the complexity of, and trade-offs implicit in, the design process, an injury-producing product should nevertheless not be found defective."
Clearly, a certain degree of tension must arise when the interests of injured consumers, basing claims on principles of strict liability, are balanced against the interests of manufacturers whose liability stops at some point short of absolutely insuring their products. The court in Kearl v. Lederle Laboratories, supra, described itself as "uncomfortable with the rather routine and mechanical fashion by which many appellate courts have concluded that certain products, particularly drugs, are entitled to [special treatment as unavoidably unsafe products entitled to 'Comment k' protection.]" (Id. 172 Cal.App.3d at p. 829, 218 Cal.Rptr. 453.) However, we have concluded that comment k reflects an attempt to balance the competing interests of consumers and manufacturers in an area of the utmost importance to society's well-being. While we agree that comment k protection has often been extended to prescription products with little analysis, we must diverge from the Kearl court's three-step analysis, developed to determine "whether a drug, vaccine, or any other product triggers [the] unavoidably dangerous product exemption from strict liability design defect analysis." (Ibid.) Characterized by the court as a mixed question of law and fact, the court goes on to propose a "mini-trial" outside the presence of the jury at which the trial court "should take evidence as to: (1) whether, when distributed, the product was intended to confer an exceptionally important benefit that made its availability highly desirable; (2) whether the then-existing risk posed by the product was both 'substantial' and 'unavoidable'; and (3) whether the interest in availability (again measured as of the time of distribution) outweighs the interest in promoting enhanced accountability through strict liability Our disagreement with the analysis proposed by the Kearl court is not absolute; we need not here consider whether such a thoughtful inquiry would be appropriate in a strict liability/design defect case involving a product other than a prescription product. When the product which allegedly caused a plaintiff's injury is a prescription product, which is distributed with the approval of the FDA provided the manufacturer accompany the product with warnings of foreseeable risks, we conclude the product must be considered unavoidably unsafe as a matter of law and thus outside the parameters of strict liability for defective design.
We have found no authority that regulations or approval by the FDA are dispositive and insulate a drug manufacturer from strict liability for design defects in its prescription product. However, prescription drugs and devices differ substantially in kind, not merely in degree, from other products on the market. A determination by the FDA that a prescription product is "generally safe" but can only be distributed if accompanied by appropriate warnings of foreseeable risks or side effects must mean such a product is by definition unavoidably unsafe within the meaning of comment k.
In reaching this conclusion, we do not close our eyes to the fallibility of the FDA or, more importantly, to the imperfect state of drug testing. The grievous deformities suffered by infants whose mothers ingested thalidomide during pregnancy serve as a constant reminder of the price society may pay and the risks it necessarily assumes in exchange for the pain-free, tension-free, and disease-free life members of this society have come to expect. But the drug manufacturer who fails to adequately test a new prescription product, or who fails to continue the testing for a time sufficient to identify risks and side effects, or who misrepresents, negligently or purposefully, the results of those tests in seeking approval of the product remains liable for injuries resulting from such misfeasance or malfeasance under traditional theories of recovery for tortious wrong without resort to principles of strict liability.
However, assuming no such wrongdoing by a drug manufacturer, it follows that the FDA will base its approval of a prescription product on the results of properly conducted testing of adequate duration, accurately reported in the application for approval. When the FDA then determines, based on such testing, that a prescription drug or device is "generally" safe if accompanied by warnings of the risks and side effects identified in the product testing, this determination logically equates to a finding that the product is unavoidably unsafe, i.e., it is as safe as it can be made, given present knowledge and capability, but retains a risk which cannot be avoided but can be warned against.
We emphasize this opinion is not premised upon the doctrine of federal preemption since there is no question but that substantive tort law is within the province of California state law. However, the failure of the federal government to preempt an area of public concern does not render meaningless actions and decisions by federal agencies specifically created to police those areas. FDA approval of a prescription product affects alike all 50 states, i.e., a prescription product approved by the FDA is not approved for unrestricted distribution in one state, approved for distribution with warnings in another, and not approved for distribution under any circumstances in a third. Judicial interpretation of the effect of FDA approval by state courts which furthers this policy of interstate consistency is thus preferable to interpretation which undermines this goal.
Whether a jury was called upon to evaluate a prescription product for a design defect utilizing the two tests announced in Barker v. Lull Engineering, Inc., supra, or a trial court conducted the evidentiary hearing postulated by Kearl v. Lederle Laboratories, supra, to determine if a prescription Similarly, under a Kearl -type analysis, the FDA, in approving a prescription product for distribution in these circumstances, has necessarily determined that at the time of approval the product "was intended to confer an exceptionally important benefit that made its availability highly desirable." (Kearl v. Lederle Laboratories, supra, 172 Cal.App.3d at pp. 829-830, fn. omitted, 218 Cal.Rptr. 453.)
Admittedly, the court below was not dealing here with the type of life-saving drug or vaccine which has confronted courts in comparable cases involving strict liability. (See, e.g., Grinnell v. Charles Pfizer & Co. (1969) 274 Cal.App.2d 424, 79 Cal.Rptr. 369 and Gottsdanker v. Cutter Laboratories (1960) 182 Cal.App.2d 602, 6 Cal.Rptr. 320, both of which involve impure polio vaccine.) However, the Lippes Loop manufactured by defendant furthers the benefit of birth control or family planning, and the importance of that benefit must be assessed in light of the widespread use of various forms of contraception in modern society.
Among the documents presented to the trial court as part of defendant's motion for summary judgment are excerpts from the Federal Register of Tuesday, May 10, 1977, reporting the information relied upon by the Commissioner of Food and Drugs in his proposal to amend chapter 1 of title 21 of the Code of Federal Regulations to establish professional and patient labeling for IUD's. Concerning the addition of new section 801.425 to Code of Federal Regulations section 801, subdivision (b) provides, "The intrauterine contraceptive device (IUD) is a popular method of contraception used by several million women in the United States. Although this method of contraception is generally safe and effective, certain complications and side effects may result from its use." An excerpt from the Journal of the American Medical Association (JAMA) of February 26, 1982, also before the trial court, characterizes use of the IUD as "the second most commonly used contraceptive method in the United States." Despite potential differences in individual moral judgment about the propriety of birth control, from a legal standpoint the language quoted from the Federal Register and the JAMA establishes that the product, the IUD, was intended to confer an exceptionally important benefit, i.e., family planning, that made its availability highly desirable.
The documents presented to the trial court herein also make clear that the FDA considered "whether the then-existing risk posed by the product both was 'substantial' and 'unavoidable.' " (Kearl, supra, 172 Cal.App.3d at p. 830, 218 Cal.Rptr. 453.) As described in Kearl, substantial and unavoidable risks encompass "permanent or long-term disability (e.g., loss of body functions, With respect to "whether the product was designed to minimize--to the extent scientifically knowable at the time it was distributed--the risk inherent in the product" but also "the availability--again, at the time of distribution--of any alternative product that would have as effectively accomplished the full intended purpose of the subject product" (Kearl, supra, at p. 830, 218 Cal.Rptr. 453), we note this inquiry is markedly similar to the circumstances which underlay the decision in Brochu v. Ortho Pharmaceuticals, Inc., supra, 642 F.2d 652. We are persuaded, like the Kearl court, that this inquiry is not properly an aspect of strict liability but rather states elements which would sustain a cause of action sounding in negligence against the manufacturer. Clearly, if the attendant risk was not minimized to the extent scientifically possible at the time of distribution, the manufacturer fell below the appropriate standard of care in distributing the product. Likewise, a manufacturer who distributes one product, knowing of the availability of a second product which is just as effective and less risky need not be held strictly liable for resulting damages since liability could be readily predicated upon negligence.
Finally, the third Kearl criterion, i.e., "whether the interest in availability (again measured as of the time of distribution) outweighs the interest in promoting enhanced accountability through strict liability design defect review" (Kearl, supra, 172 Cal.App.3d at p. 830, 218 Cal.Rptr. 453), has been answered by the FDA's approval of the prescription product in favor of availability. The availability of the second most popular form of birth control is clearly significant. Similarly, given the emotional nature of the injuries which may result as an unavoidable side effect of these products, such as septic abortion, perforation of the uterus, hysterectomy, etc., it is likely that increased accountability under principles of strict liability (i.e., high, or even inflated, jury awards) might well result in nonavailability of the product or a significant increase in the cost of the product.
In deciding that a prescription drug or device, distributed with FDA approval and accompanied by requisite warnings, is unavoidably unsafe as a matter of law and thus cannot be the basis for a cause of action based on strict liability for a design defect, we again emphasize what we do not address based on the facts before us. We are here concerned with a plaintiff injured in precisely the manner about which the manufacturer had warned in connection with distribution of the Lippes Loop. We do not decide if an action in strict liability is barred when the plaintiff's injury, although caused by the prescription product, differs from the risks warned against. While it seems apparent that a risk which was foreseen but not warned against, or a risk which should have been foreseen in the exercise of reasonable care, could easily sustain a negligence cause of action, while an injury totally unforeseeable might well be "nonactionable" under settled principles of tort law, that issue is not before us and we do not decide it.
Therefore, we conclude the trial court was correct in granting defendant's motion for summary judgment. The judgment is affirmed. Defendant shall recover its costs on appeal.
BEST and AZEVIDO, JJ., concur.
Assigned by the Chairperson of the Judicial Council.