Opinion ID: 1403899
Heading Depth: 1
Heading Rank: 2

Heading: application of comment k

Text: As a condition to its application, comment k requires that the product be properly prepared, and accompanied by proper directions and warning... . There are three types of product defects: manufacturing flaws, design defects, and inadequate warnings regarding use. See Prosser & Keeton, The Law of Torts § 99, at 695-98 (5th ed. 1984); Savina v. Sterling Drug, Inc., 247 Kan. 105, 795 P.2d 915, 923 (1990). By its terms, comment k excepts unavoidably unsafe products from strict liability only to the extent that the plaintiff alleges a design defect; comment k's immunity from strict liability does not extend to strict liability claims based on a manufacturing flaw or an inadequate warning. The purpose of comment k is to protect from strict liability products that cannot be designed more safely. If, however, such products are mismanufactured or unaccompanied by adequate warnings, the seller may be liable even if the plaintiff cannot establish the seller's negligence. Toner v. Lederle Laboratories, 112 Idaho 328, 732 P.2d 297, 305 (1987). Both parties agree in this case that the prerequisite to a comment k exemption  that the drug was properly prepared and accompanied by warnings of its dangerous propensities  must be established on a case-by-case basis. This limitation on the scope of comment k immunity is universally recognized. [3] Even in the case of a clearly alleged design defect, however, comment k is unclear on the scope of its protection. [4] Until recently, most courts refrained from applying a design defect theory to products liability cases involving prescription drugs. Beginning with Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652 (1st Cir.1981), however, and more recently in Savina v. Sterling Drug, Inc., 247 Kan. 105, 795 P.2d 915 (1990), some states have permitted recovery for a strict liability claim based on the theory that the drug was defectively designed. Some courts have applied comment k on a case-by-case basis, conditioning application of the exemption on a finding that the drug is in fact unavoidably unsafe. See Savina, 795 P.2d 915; Toner, 732 P.2d 297; see also Feldman v. Lederle Laboratories, 97 N.J. 429, 479 A.2d 374, 382-83 (1984) (involving allegations of failure to warn, but stating, Whether a drug is unavoidably unsafe should be decided on a case-by-case basis ... .); Collins v. Eli Lilly Co., 116 Wis.2d 166, 342 N.W.2d 37, 52 (1984) (comment k applicable only if drug in question was placed on market without adequate testing because of exigent circumstances); Patten v. Lederle Laboratories, 676 F. Supp. 233 (D.Utah 1987) (federal district court predicting that Utah would adopt comment k). California was the first state to fashion a risk/benefit test to determine which drugs are entitled to comment k protection. In Kearl v. Lederle Laboratories, 172 Cal. App.3d 812, 218 Cal. Rptr. 453 (1985), [5] the California Court of Appeal specifically discussed the problems society would face by subjecting drugs to the same accountability as other products, allowing unlimited redress for plaintiffs injured by pharmaceutical products. Such problems, the court noted, include delayed availability of needed drugs and imposition of the costs of research, development, and marketing of new products beyond that which manufacturers, especially small manufacturers, might be willing to risk. 218 Cal. Rptr. at 459 (quoting Feldman, 460 A.2d at 209). The Kearl court expressed discomfort, however, with the mechanical method by which many appellate courts had concluded that drugs are entitled to special treatment. 218 Cal. Rptr. at 463. Thus, Kearl set forth a risk/benefit analysis to be carried out by the trial court on a case-by-case basis. Id. at 463-64. Under this approach, a product may be deemed unavoidably unsafe and thus exempt from a strict liability design defect cause of action only if the court concludes that (1) the product was intended to provide an exceptionally important benefit, and (2) the risk posed was substantial and unavoidable when distributed. Id. at 464. [6] Idaho adopted and to some extent refined the Kearl approach in Toner v. Lederle Laboratories, 112 Idaho 328, 732 P.2d 297 (1987), a case addressing a suit against the manufacturer of a vaccine to immunize against diphtheria, pertussis, and tetanus (DPT). Toner required the drug manufacturer to prove at trial, on a case-by-case basis, that the benefits of the drug outweighed the risks at the time of marketing. 732 P.2d at 305-09. To qualify as an unavoidably unsafe product under this approach, there must be, at the time of the subject products' distribution, no feasible alternative design which on balance accomplishes the subject product's purpose with a lesser risk. Id. at 306 (citing Belle Bonfils Memorial Blood Bank v. Hansen, 665 P.2d 118, 123 (Colo. 1983)); Kearl, 218 Cal. Rptr. at 464. If there were alternative drug product designs that could have effectively achieved the same purpose, the court reasoned, the risk would not be unavoidable or apparently reasonable and the marketing and use of the product would not be justified. Toner, 732 P.2d at 306. In direct contrast to those courts applying comment k's immunity on a case-by-case basis are courts holding that all prescription drugs are entitled as a matter of law to the exemption from strict liability claims based on design defect. In Brown v. Superior Court, 44 Cal.3d 1049, 245 Cal. Rptr. 412, 751 P.2d 470 (1988), the court addressed claims brought by plaintiffs who sued drug companies for injuries allegedly arising from their mothers' in utero exposure to diethystilbestrol, a synthetic hormone marketed for use during pregnancy. The court weighed the problem of whether imposing strict liability on drug manufacturers comports with the traditional goals of tort law, namely, deterrence and cost distribution. 751 P.2d at 478. The court acknowledged that a drug might be safer if pharmaceutical companies withheld it from the market until scientific skill and knowledge advanced to the point where all dangerous side effects could be discovered. Id. at 479. There was concern, however, that this delay, when added to the delay normally required for the FDA to approve a new drug, would not serve the public welfare. The court cited examples of several potentially useful drugs being withdrawn from the market or their availability seriously curtailed because of the liability crisis. Id. at 479-80. The Brown court acknowledged the appeal of the Kearl cost/benefit approach, yet found the mini-trial procedure unworkable because of its negative impact on the development and marketing of new drugs. Brown, 751 P.2d at 481. Another of the Brown court's objections to Kearl was that it left the trial court to hear and resolve mixed questions of law and fact, placing the trial court in the role of fact finder. Brown, 751 P.2d at 481-82. The court found the cost/benefit test too openended and predicted that it would lead to disparate treatment of the same drug by different judges. Id. at 482. The Brown court stressed three public policies mitigating against imposing strict liability for prescription drugs. First, drug manufacturers might stop producing valuable drugs because of lost profits resulting from lawsuits or the inability to secure adequate insurance. Id. at 479-80. Second, consumers have a vested interest in prompt availability of new pharmaceutical products. Imposing strict liability for design defects might cause manufacturers to delay placing new products on the market, even after those products receive FDA approval. Id. at 479. Finally, the added expense of insuring against strict liability and additional research programs might cause the cost of medication to increase to the extent that it would no longer be affordable to consumers. Id. The plaintiffs and amici curiae in Brown asserted that the language of comment k cannot be interpreted to grant blanket immunity from strict liability to all prescription drugs. Rather, they asserted that only those drugs that are unavoidably dangerous are eligible for such protection. Id. at 482 n. 11. The court, although conceding that the comment is not entirely clear on this point, noted that the comment was intended to and should apply to all prescription drugs. Id. (emphasis added). Brown concluded that because of the public interest in the development, availability, and reasonable price of drugs, the appropriate test for determining responsibility is the test stated in comment k... . Id. at 477. In Castrignano v. E.R. Squibb & Sons, Inc., 546 A.2d 775 (R.I. 1988), the Rhode Island Supreme Court had the opportunity to review Toner 's case-by-case risk/benefit analysis and Brown 's broad exemption approach when formulating its own approach to drug products liability. The Rhode Island court opted for the more restrictive case-by-case approach, id. at 781, and developed a directed verdict standard to balance the roles of the judge and the jury in applying comment k. Id. at 781-82. Under the Castrignano test, if at the time of marketing the apparent benefit outweighed the apparent risk, comment k applies and recovery for design defect is precluded. Id. If a trial judge concludes that reasonable minds could not differ in deciding that a drug's benefit exceeds its risk, then as a matter of law, the trial judge can extend comment k protection. Id. at 782. If the judge feels that reasonable minds could differ on the question, the judge must submit the issue to the jury. Id. In reviewing the approaches of other jurisdictions toward strict products liability for design defects in drug products, we are troubled by the lack of uniformity and certainty inherent in the case-by-case approach and fear the resulting disincentive for pharmaceutical manufacturers to develop new products. Toner 's attempt to clarify the unreasonably dangerous standard seriously curtails the defendants' chances of success in establishing comment k immunity as a matter of law. One commentator notes that a defendant would have an easier time rebutting a plaintiff's prima facie case of design defect under the traditional standard than meeting the tough burden of earning the comment k exemption. See Reilly, The Erosion of Comment k, 14 U. Dayton L.Rev. 255, 266 (1989). Toner applied a very literal and restrictive interpretation of comment k. For example, the comment cites examples of certain drugs and vaccines as products that supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. Based on this language, Toner opined that (1) comment k [c]learly ... contemplates a weighing of the benefit of the product against its risk and (2) was never intended to exempt all drugs from strict liability. Toner, 732 P.2d 297, 306. Even if we agree with the court in Toner that the comment contemplates a weighing of the drug's risks and benefits, we find it unnecessary to conclude that a court is the proper body to engage in that weighing process. Furthermore, we need not be bound by the specific language of comment k and may adopt and apply its fundamental policy without restricting ourselves to what we perceive to be its literal interpretation. Castrignano 's somewhat nebulous standard, designed to control when the question of comment k's application reaches the jury, leaves a great deal of room for plaintiffs to manuever cases to the jury. Additionally, like the traditional case-by-case approach, this standard ignores the effectiveness of the FDA's regulatory process. We agree with Brown that the case-by-case method first articulated in Kearl is unworkable, even in light of Toner 's refinement of the test. We find the Brown result more in line with the public policy considerations in the important area of pharmaceutical product design. We do not agree, however, with the Brown court's apparent attempt to use the plain language of comment k as the vehicle for exempting all prescription drugs from strict liability rather than relying on the policies underlying that comment. The American Law Institute's restatements are drafted by legal scholars who attempt to summarize the state of the law in a given area, predict how the law is changing, and suggest the direction the law should take. The restatement serves an appropriate advisory role to courts in approaching unsettled areas of law. We emphasize, however, that section 402A of the Restatement (Second) of Torts, as drafted in 1965, is not binding on our decision in this case except insofar as we explicitly adopt its various doctrinal principles. We agree with the principle comment k embodies, that manufacturers of unavoidably dangerous products should not be liable for a claim of design defect. We are persuaded that all prescription drugs should be classified as unavoidably dangerous in design because of their unique nature and value, the elaborate regulatory system overseen by the FDA, the difficulties of relying on individual lawsuits as a forum in which to review a prescription drug's design, and the significant public policy considerations noted in Brown. We therefore reach the same conclusion as did the California Supreme Court in Brown, albeit pursuant to a slightly different rationale.