Court Opinion

ID: 9621985
Source: CourtListenerOpinion
Date Created: 2023-08-22 06:10:44.134179+00
Date Added: 2024-06-11T18:05:12.036217
License: Public Domain

STEWART, Justice
(dissenting):
I dissent. The majority holds that a drug that is avoidably unsafe to human life or health is exempt from strict liability for design defects if approved by the FDA, even though alternative drugs can provide the same, or even better, therapy, with less risk to life or health. Thus, such FDA-approved drugs as various decongestants, expectorants, deodorants, hair growth stimulants, skin moisturizers, and cough and cold remedies,1 for example, have the same immunity as rabies or polio vaccines or medications essential in the treatment of cancer, heart disease, or AIDS. I see no basis for according drugs used to treat comparatively minor ailments a blanket immunity from strict liability for design defects if they are unreasonably dangerous to those who use them.
The limited immunity conferred by comment k on a few drugs was given only after thorough consideration by the American Law Institute. However, this Court gives blanket immunity for design defects to all FDA-approved drugs on the basis of blind reliance upon the efficacy and integrity of FDA procedures, about which the majority knows almost nothing. I agree with Justice Huntley of the Idaho Supreme Court, who stated:
[N]o state supreme court has yet become convinced that the FDA has either adequate staffing, expertise, or data base to warrant its being substituted for the judicial system.
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I fear the day when any supreme court can be convinced that an agency such as the FDA, no matter how well-intentioned, can supplant the American judicial system.
Toner v. Lederle Laboratories, 112 Idaho 328, 732 P.2d 297, 313 (1987) (Huntley, J., concurring specially). Indeed, in relying on FDA approval, the majority wholly ignores our statement in Barson v. E.R, Squibb & Sons, Inc., 682 P.2d 832, 836 (Utah 1984), that FDA regulations for prescription drugs “are merely minimum standards.”
In truth, FDA safety procedures do not justify abdication of judicial responsibility. For example, the FDA does not require existing drugs to undergo newly developed tests which would increase the likelihood that a product is in fact safe. This was illustrated in Barson, 682 P.2d at 836, in which this Court stated:
Since 1962, the Food and Drug Administration (FDA) has required teratogenicity testing on all new drugs. In 1966, the FDA established guidelines regarding teratogenicity testing. Since Delalutin was not a “new” drug as defined by the guidelines, there was no federal requirement that Squibb test Delalutin for tera-togenicity; testimony indicated that Squibb had never done so.
Numerous congressional investigations have demonstrated that the FDA has often approved drugs in complete ignorance of critical information relating to the hazards of such drugs which was contained either in its own files or in the published medical literature, or both. For example, the FDA approved Oraflex on April 19, 1982, for the treatment of arthritis. The manufacturer withdrew the drug from the market on August 4, 1982, because eleven deaths were reported to be associated with the drug’s use in the United States and sixty-one deaths were reported in the United Kingdom. Of principal concern were reports of serious and sometimes fatal Ora-flex-associated liver and kidney disease. In Deficiencies in FDA’s Regulation of the New Drug “Oraflex”, H.R.Rep. No. 511, 98th Cong., 1st Sess. (1983), the House Committee on Government Operations (hereinafter “H.C.G.O.”), a congressional committee overseeing the FDA, found that the FDA was unaware that during the Ora-*101flex clinical trials it had received four reports of serious concomitant liver and kidney disease and two reports of kidney disease unaccompanied by liver injury.2 At the time the FDA approved Oraflex for marketing, and for several months thereafter, it was unaware of the number of reports of Oraflex-associated adverse reactions it had received prior to its approval of the drug. Id. at 11-12. Prior to approving Oraflex, the FDA made no effort to obtain information on its safety from foreign countries in which the drug had already been marketed and was, therefore, unaware of a large number of reports of serious and sometimes fatal reactions to the drug submitted to the British and Danish regulatory authorities. Id. at 13. The FDA failed to enforce the legal requirement that drug manufacturers report all adverse reactions to a drug under clinical investigation, information essential to weigh the drug’s risks against its potential benefits. Id. at 22.
The FDA approved Merital for the treatment of depression on December 31, 1984. Merital was withdrawn from the market in January 1986 because of a large number of reports of serious immune-allergic or hypersensitivity reactions, including several fatalities, associated with its use. In the report FDA ⅛ Regulation of the New Drug Merital, H.R.Rep. No. 206, 100th Cong., 1st Sess. (1987), the H.C.G.O. found that prior to approving Merital, the FDA overlooked clinical evidence it had received of the drug’s allergy-inducing potential. Id. at 24. The FDA’s enforcement of its adverse reaction reporting requirements was inadequate. Id. at 71. H.C.G.O. concluded that the FDA had exposed the American public to the potential hazards of Merital without requiring that the drug’s efficacy be supported by substantial evidence derived from adequate and well-controlled studies. Id. at 80.
The FDA approved Versed for preoperative sedation, induction of general anesthesia, and conscious sedation for short diagnostic or endoscopic procedures on December 20,1985. Thereafter, Versed was associated with numerous reports of life-threatening and, in many instances, fatal episodes of cardiac and respiratory arrest, particularly when used for conscious sedation. The FDA concluded that these reactions were dose-related, but not until November 1987 were the recommended conscious sedation doses for Versed substantially reduced. The H.C.G.O. found that the Versed doses originally approved for conscious sedation were substantially higher than those shown to be effective. FDA’s Deficient Regulation of the New Drug Versed, H.R.Rep. No. 1086, 100th Cong., 2nd Sess. at 10 (1988). When it approved Versed for marketing, the FDA was unaware of important studies, despite the fact that they had been published in the medical literature, id. at 20, and in many instances, had been submitted to the agency. Id. at 21. H.C.G.O. also found that the FDA was unaware of the manner in which Versed was regulated in foreign nations and failed to investigate the adverse reaction reporting practices of the manufacturer of Versed, notwithstanding data the agency had received from the company strongly suggesting that the firm had neglected to submit to the agency reports of Versed-associated deaths known to the company prior to the drug’s approval. Id. at 25, 37.
The FDA approved Zomax on October 28, 1980, for the relief of mild to moderately severe pain. On March 4, 1983, marketing of the drug was halted by its manufacturer due to a large number of allergic reactions, including deaths, associated with its use. Eventually, more than 2,100 reactions were reported to the FDA. In FDA’s Regulation of Zomax, H.R.Rep. No. 584, 98th Cong., 1st Sess. (1983), the H.C.G.O. found that the FDA approved Zomax in violation of an agency policy requiring that its benefits be shown to outweigh its demonstrated *102carcinogenic risk. Id. at 5. The FDA failed to make the risk-benefit analysis this Court has placed within the exclusive province of the FDA. Also, the FDA’s monitoring of Zomax-associated adverse reaction reports was deficient. When Zomax was removed from the market, the agency’s computerized tracking system showed that the FDA had received only 270 reports of Zomax-associated allergic reactions, whereas the drug’s manufacturer had actually submitted 900 reports to the agency. Id. at 11-12. The FDA also failed to note evidence in its possession suggesting that Zomax posed a higher risk of serious and sometimes life-threatening allergic reactions than other drugs in its class, particularly among patients with no prior history of drug allergy. Id. at 16.3
Although the FDA has a mechanism for the withdrawal of pharmaceutical agents which are found to be dangerous, 21 U.S.C. § 355(e) (1988), the mechanism is slow and sometimes unreliable. For example, several studies were published in the early 1950s which should have put diethylstilbestrol (DES) manufacturers on notice that DES injured the reproductive systems of female fetuses whose mothers were exposed to the drug. However, it was not until 1971, nearly twenty years later, that the FDA finally banned the use of DES to prevent miscarriages, the most common use of the drug. See Castrignano v. E.R. Squibb & Sons, Inc., 546 A.2d 775, 777 (R.I.1988). The lengthy wait by the FDA resulted in endangering a generation of women because their mothers had used DES during pregnancy.
In relying on the efficacy of FDA approval procedures as the basis for dispensing with the judicial remedy of product liability, the majority simply ignores FDA failures to protect the public against unnecessary and unacceptable risks. I agree with what the Wisconsin Supreme Court stated in Collins v. Eli Lilly Co., 116 Wis.2d 166, 197, 342 N.W.2d 37, 52, cert. denied, 469 U.S. 826, 105 S.Ct. 107, 83 L.Ed.2d 51 (1984):
Drug companies, like other sellers or manufacturers, have a duty to produce and market reasonably safe products. We recognize that in some exigent circumstances it may be necessary to place a drug on the market before adequate testing can be done. Insofar as these circumstances exist, we agree with the comment [k] that strict liability should not be imposed. However, we find no exigent circumstances which would excuse DES producers or marketers from adequately testing DES before it was placed on the market. Although there was a societal interest in preventing miscarriages in pregnancy, alternative treatment was available, and the problem did not approach epidemic proportions. Even assuming there were exigent circumstances in 1947 necessitating the use of DES in pregnancy without adequate testing, an additional ten years had elapsed by the time the plaintiff’s mother took DES. Thus, it would appear the drug companies had sufficient time to test DES thoroughly even if the original need to place it on the market foreclosed adequate testing at that time. Accordingly, we hold that DES producers or marketers may be held strictly liable if the plaintiff establishes the five elements specified earlier.
Proposals before Congress and rules promulgated by the FDA to make it easier for pharmaceutical companies to obtain FDA approval for new drugs would dilute even further the safety and efficacy standards for FDA approval of drugs. See Note, Regulation of Investigational New Drugs: “Giant Step for the Sick and Dying?”, 77 Georgetown L.J. 463 (1988). Perhaps truly unavoidably unsafe drugs intended to treat life-threatening ailments should be more easily available to the public, but a lessening of safety standards is an argument for strict liability, not against. Profit motivation is likely to lead to many more unnecessarily dangerous drugs.
Furthermore, not a shred of evidence has been presented to this Court that indicates that liability under the tort system has *103deterred pharmaceutical companies from introducing new drugs. Even if that were the case, the question that must be answered, given the majority’s holding, is why comment k does not provide a proper accommodation of all the competing policy interests involved in the issue before the Court. Why should those who are seriously injured or suffer because of the death of another have to stand the expense of such losses to support the high profit margins in the drug industry?
In my view, the Rhode Island Supreme Court adopted a better approach in Cas-trignano v. E.R. Squibb & Sons, Inc., 546 A.2d 775 (R.I.1988). The Rhode Island court held that only products that are truly unavoidably unsafe qualify for comment k protection. The court stated:
This comment provides a risk-benefit test for products that, given the present state of human knowledge, are incapable of being made safe for their intended use. Products that satisfy the risk-benefit test are deemed unavoidably unsafe. These products, especially drugs, will not be considered defective and unreasonably dangerous under § 402A because their known or perceived benefits exceed their known or perceived risks. Therefore, the availability and marketing of these products is justified, not withstanding the risk.
The authors of the comment try to demonstrate which types of drugs should be excluded from strict-liability analysis through various examples. The authors state that the comment’s exemption should apply to drugs, like the rabies vaccine, whose harmful side effects are known but whose benefits far outweigh the known risks.... The authors also state that this exemption should apply to new and experimental drugs that possess obvious yet undefined dangers because the perceived benefits of the drugs nonetheless justify their marketing. The comment provides that these new drugs should not be held to a standard of strict liability in light of the public policy favoring the availability of such products.
546 A.2d at 781.
Certain drugs clearly qualify for comment k exemption, even though the drugs’ risk may be comparatively great. A drug’s social utility may be so great, for example, a chemotherapeutic agent used for treatment of cancer, that it would obviously qualify for comment k exemption. Other drugs, such as sleeping compounds or dandruff cures, whose social utility may not be of such a high order, would not automatically qualify. The Rhode Island court stated that for a prescription drug to qualify for comment k exemption,
the apparent benefits of the drug must exceed the apparent risks, given the scientific knowledge available when the drug was marketed. If the benefits outweigh the risks, then recovery for design-defect liability is precluded. If, however, the apparent risks exceed the apparent benefits, then the product is not exempt from design-defect liability and will be subject to the traditional design-defect analysis set forth in § 402A.
546 A.2d at 782.
Furthermore, Congress has never given broad immunity, as this Court does, to all prescription drugs, notwithstanding FDA approval. See Note, A Prescription for Applying Strict Liability: Not all Drugs Deserve Comment k Immunization, Brown v. Superior Court, 44 Cal.2d 1049, 751 P.2d 470, 245 Cal.Rptr. 412 (1988), 21 Ariz.St.L.J. 809, 830 (1989). Congress has, however, provided some immunity from tort law for some vaccines when the public interest required their widespread use. For example, Congress enacted the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-l to -34 (1988), which establishes a compensation scheme for children injured by vaccines as an alternative to pursuing tort claims against the manufacturers. However, even that Act does not completely foreclose strict liability for plaintiffs injured by vaccines; instead, it only establishes presumptions to aid the trier of fact. 42 U.S.C. §§ 300aa-22(b)(2), -23(d)(2).
The majority opinion states that a case-by-case analysis would leave drug companies uncertain regarding questions of immunity and would result in patchwork verdicts when a drug may be found to be subject to comment k exemption in one case but not subject to the exemption in another case. That consideration has little *104merit, in my view. We tolerate nonuni-formity of result in negligence cases all the time. Nothing this Court does can bring about uniformity of result with respect to drugs. The states are already divided on the issue of whether FDA approval of a drug should confer immunity from design defects, although it appears that no state has gone as far as Utah now does. Suffice to say, a number of courts apply comment k on a case-by-case basis — a task that cannot be avoided even under the majority’s position if a strict liability claim is coupled with a negligence claim, as is usually the case.
Significantly, Congress has not shared this Court’s professed concern for uniformity. Whatever lack of uniformity there has been in drug cases has been insufficient to justify uniform national products liability legislation. Furthermore, the Legislature of this State thought that a presumption was sufficient protection for manufacturers rather than outright immunity. See Utah Code Ann. § 78-15-6(3) (1987). It is indeed ironic that the policy of uniformity weighs more heavily in this Court than in the United States Congress .or the Utah Legislature. We can only deal with the law in Utah, and the possibility of patchwork verdicts on a nationwide basis is simply beyond our power to affect. In short, the majority simply deprives Utahns of a judicial remedy for injuries sustained from defectively designed drugs, despite the fact that citizens of other states may recover for those injuries.
In this case, plaintiff Ilo Marie Grund-berg was taking a variety of medications for chronic depression and anxiety. Hal-cion, the medication at issue here, had first been prescribed for Mrs. Grundberg on May 21, 1987.4 In December 1987, Mrs. Grundberg lost her job and, shortly thereafter, moved with her mother, Mildred Coats, to Hurricane, Utah, where they lived together in a mobile home. On June 19, 1988, Mrs. Grundberg took three medications: Valium, codeine, and Halcion. Later that night, she shot and killed her mother. Mrs. Grundberg was charged with criminal homicide. Because of alienists’ reports, the Washington County prosecutor dropped all criminal charges on February 7, 1989. Mrs. Grundberg and Janice Gray, the personal representative of Mrs. Coats’ estate, filed this civil action later in 1989. At issue in this case is whether Halcion was the cause of Mrs. Grundberg’s bizarre behavior on the night of the homicide.
If Halcion was a causative agent, it is significant that The Physicians’ Desk Reference (1990 ed.) lists nine other hypnotic agents available for use. At least two of the other hypnotics and one other medication listed as a sleeping aid are benzo-diazepines and are, therefore, of the same general type as Halcion. In addition, the same reference lists thirteen sedatives that are on the market. The majority ignores the fact that the FDA found Halcion to be neither unique nor particularly essential and presented no advancement over existing therapeutic alternatives. Perhaps not all would have been appropriate medications, but with so many possible alternatives, it is doubtful that Halcion should be immune from strict liability.
I also join Justice HOWE’s dissent.

. The Physicians’ Desk Reference (1990 ed.) includes prescription drugs in each of the categories stated in the text.

. As a consequence of its ignorance, the agency approved labeling which stated that Oraflex-as-sociated liver reactions were confined to "liver function test abnormalities” that were “usually transient" and that denied altogether the exfstence of "evidence ... of renal [kidney] toxicity in [the Oraflex] clinical studies.” Deficiencies in FDA’s Regulation of the New Drug "Oraflex" at 9-10.

. The court in Toner noted other FDA failures. 732 P.2d at 311 n. 12.

. Halcion is the trade name for triazolam, a prescription medication used for treatment of insomnia. Triazolam is one of a class of drugs known as benzodiazepines. Halcion, which is manufactured by Upjohn, was approved by the FDA in November 1982.