Grundberg v. Upjohn Co., 813 P.2d 89

Grundberg v. Upjohn Co.

813 P.2d 89

Utah

1991

Check Treatment

*1 89 (1980), the federal sustained L.Ed.2d statutory appeal a right to

government’s policies ground that on the

sentence jeopardy clause are

underlying double procedure. such a

not offended 136, at 437. Court at 101 S.Ct.

U.S. the increased held DiFrancesco that

also imposed by an could be

punishment which review did not constitute court on

appellate of the dou-

multiple punishment violation 137, at jeopardy clause. See id.

ble at 437-38.

S.Ct. Lim, Lee opinion v.

This Court’s State (1932),turned on the P.2d 825

79 Utah illegal of an sen-

principle that correction jeopardy does not violate the double

tence juris- had that a trial court

clause and held Al- illegal sentence.

diction correct jeopardy

though question of double Court, issue, quot- at directly States, 214 F.

ing Bryant v. United “ Cir.1914), (8th is well settled stated: ‘It jeopardy to resentence it is not double prisoner had his first sentence vacat- who ’” at 79 Utah ed writ of error.... at 829.

P.2d

Affirmed.

HALL, HOWE, C.J., C.J., Associate ZIMMERMAN, JJ.,

and DURHAM

concur. GRUNDBERG, individually,

Ilo Marie Gray, personal represent-

and Janice Estate of Mildred Lucille

ative deceased, Plaintiffs,

Coats, COMPANY, a Delaware

The UPJOHN

corporation, Defendant.

No. 900573. of Utah.

Supreme Court

May 26, 1991.

Rehearing Denied June Pendleton, George, F. Earle St.

Gary W. Vuksinick, Lasseter, H. Ross Thomas R. *2 Workman, City, by physician Lake Neal recommended her Salt and C. was Sigelman, Pope, Upjohn’s Steven W. Sac- was consistent with recommended Daniel W. Ga., Atlanta, coccia, Kellogg, dosage. Grundberg H. Plaintiffs that Edward assert plaintiffs. for shot her mother while in a state of Halcion- intoxication, allegedly induced in- Baker, Felt, Thomas L. Merlin 0. Paul S. depression, cluded side effects as psy- Aeschbacher, Lake Kay, J. Salt Steven chosis, depersonalization, aggressive as- Bauer, D. E. City, Stephen and Lane behavior, compul- homicidal saultive Mo., Scheve, Stith, City, Laura D. Kansas sion. for defendant. complaint Plaintiffs’ states several DURHAM, Justice: action, including causes of common law negligence liability. and strict Plaintiffs pursuant comes to us to rule 41 This case Upjohn adequately claim that failed to Rules of Appellate the Utah Procedure certain side effects warn about adverse question as a certified from the United and that defectively Halcion Halcion was District Court District of States for the designed. The failure-to-warn claim is Utah. The issue before us is whether Utah The strict liability scheduled trial. adopts “unavoidably products” unsafe subject on design claim based defect is the exception liability to strict as set Upjohn’s judgment pending summary k to forth comment section 402A of motion, depends the outcome of which on (Second) (1965) Torts Restatement ques- this court’s resolution of the certified (“comment k”). This question presents tion. original dispo- issue of unanswered law for by

sition this court. parties agree The that the Restatement (Second) 402A, of Torts section comment k drug approved by that a We hold (1965) principles pro- and the it embodies Drug United Food and Administra- States exemption vide an (“FDA”), properly prepared, tion com- prod- claimed defect in the case of pounded, distributed, packaged, and cannot “unavoidably ucts that are unsafe.” as law be a matter of “defective” moving partial summary judgment, Up- inaccurate, incomplete, proof absence of john argued policy that public supporting misleading, or fur- fraudulent information development the research and of new by the nished manufacturer connection drugs requires holding FDA-ap- that all approval. acknowledge with FDA that proved prescription medications are “una- by characterizing FDA-approved pre- all voidably products” unsafe under comment scription “unavoidably medications un- as and, such, manufacturers those safe,” expanding we are the literal inter- drugs would not be a claim liable for based pretation of comment k. design. argue defective Plaintiffs that following facts are taken from “unavoidably whether a unsafe” court’s federal district certification order. ease-by-case must be determined on ba- age Lucille Coats died at 83 from Mildred sis, determination each case of gunshot by daughter, wounds inflicted her specific drug’s whether the benefit exceed- Grundberg, on Ilo June 1988. Grund- ed its risk at time it was distributed. Gray, repre- berg personal and Janice The district court to be a found this control- estate, brought of Coat’s this ac- sentative ling question of it to law and certified tion, alleging Grundberg her shot court. ingesting as a result of mother Specifically, Halcion, issues we address at prescription drug manufactured request of the federal court are: Upjohn defendant to treat insomnia.1 allege Grundberg took a .5 adopt “unavoidably Plaintiffs 1. Does Utah milligram day products” exception prod- dose Halcion the she shot unsafe to strict They allege her mother. this dose ucts as set forth the trade Halcion is name of the triaz- olam. standards), (Second) industry (punitive 78-18-2 402A of the Restatement section damages if (1965)? approved unavailable of Torts FDA). k, (a) adopt If Utah does *3 PDA-approved prescription drugs should entirety, In its comment k reads: as matter to have deemed a of law be Unavoidably products. k. unsafe pre- “unavoidably unsafe” satisfied which, products There some are exception, the comment k requisite to present knowledge, of human state are be made on a should determination quite incapable being made of safe case-by-case basis? ordinary their intended and use. These k, (b) adopt especially If does and if Utah comment are common field of outstanding example applica- its An is the it is further determined that ra- prescription vaccine for the Pasteur treatment of FDA-approved to tion bies, uncommonly not which leads to case-by-case basis, ought to made on a be very damaging consequences serious and ques- such a threshold is determination injected. when it is Since disease question for the trial court or tion invariably itself leads to dreadful presented jury? to properly to be death, marketing both the and the use of k (c) If it comment is determined that is fully justified, the vaccine are notwith- prescrip- applied FDA-approved to be standing high degree the unavoidable of basis, case-by-case on is tion they a product, risk which Such involve. pertaining to adverse side-ef- evidence accompanied by properly prepared, and not are al- fects from which warning, proper directions and is not personally leged to have been suffered fective, unreasonably danger- nor is it plaintiff by the relevant to “unavoid- many true other ous. The same is of ably unsafe” determination? vaccines, like, many of drugs, and the very legally which for this reason cannot I. LIABILITY UTAH LAW ON STRICT except physicians, or under the be sold (Sec- 402A of the Restatement Section physician. of a It is also ond) (1965) of the strict Torts addresses experi- particular many of new or true liability products. This court which, of sellers of because of mental as to 402A, adopted of comment k opportunity section for suffi- lack time Hahn, provision, experience, Inc. is one Ernest v. cient medical there can be no W. 152, Co., (Utah safety, or perhaps assurance of even Armco Steel 601 P.2d ingredients, experi- 1979). then, purity of but we have adhered to Since justifies marketing is ence there at 402A and to least one section notwithstanding use accompanying comments. See Mulherin v. recognizable medically risk. The seller (Utah Co., 628 P.2d 1301 Ingersoll-Rand again qualifi- with the products, of such 402A); 1981) section Dowland v. (applying they properly prepared cation that Shooters, Lyman 642 P.2d Products for marketed, warning giv- is proper (Utah 1982) (applying com- 381 n. 2 it, en, where the situation calls not appli- g). not addressed the ment We have liability for unfortu- held to strict pre- k in the context of cation comment use, consequences attending their nate Although scription drugs or otherwise.2 merely he has undertaken to because liability address the two Utah statutes public apparently use- supply the with manufacturers, they product do product, ful and desirable attended directly address the comment issues. not risk. apparently a known but reasonable 78-15-6(3) (1987) Ann. See Utah Code § exception to (rebuttable k establishes an presumption that Comment 402A according products liability the strict section if defective manufactured Sons, Inc., evi- we found that there was sufficient 682 P.2d v. E.R. In Barson (Utah 1984), negli- finding support jury’s this court considered dence unneces- case. We found it gence Id. at 837. claim. issue, however, sary, reach Keeton, in ser & Law at any product sells Torts imposes on who § “[o]ne (5th 1984); Sterling 695-98 ed. Savina unreasonably danger- condition a defective Inc., Drug, 247 Kan. or consumer or to his ous to the user [or terms, excepts By its 402A(1). This liabili- property_” § her] unavoidably products from strict li unsafe “the seller has ty applies whether or not plaintiff ability only to the extent that the possible prepara- care in the exercised all defect; alleges k’s im product....” of his tion and sale munity liability does not extend from strict 402A(2)(a). g defines a “defec- Comment liability claims on a manu to strict based “not tive condition” as a condition contem- *4 inadequate warning. facturing flaw or an consumer which will plated by the ultimate protect purpose of comment k is to dangerous unreasonably con- be [that liability products that cannot be from strict k, however, defines a Comment sumer].” If, however, safely. designed more “unavoidably products category of unsafe” products are mismanufactured or unaccom prepared, and properly that “when accom- warnings, panied by adequate the seller proper warning, directions and panied by may plaintiff be liable even if the cannot defective, unreasonably nor ... [are] negligence. establish the seller’s Toner v. dangerous.” (Emphasis original.) in 328, Laboratories, Lederle 112 Idaho 732 agree with comment k’s basic We 297, (1987). parties agree in P.2d 305 Both proposition products there are some —that prerequisite this case that the com dangers that associated their use have with exemption ment k “was —that though they even are used as intended. prepared accompanied by properly and prod also that the of such seller warnings dangerous propensities”— of its ucts, products properly pre when are case-by-ease must be established on a ba pared and marketed and distributed scope sis. This limitation on the of com appropriate warnings, should not be held immunity universally recogn ment k strictly for the liable “unfortunate conse ized.3 Thus, attending quences” their use. clearly alleged the case of a Even adopt policy k’s basic law defect, however, design comment k is un applied to be in this state and must now scope protection.4 clear on the of its Until apply turn to the issue of how to recently, apply most courts refrained from policy. ing design theory defect lia bility involving prescription drugs. cases K II. APPLICATION OP COMMENT Beginning with Brochu v. Ortho Pharma application, As a condition to its (1st Cir.1981), Corp., ceutical 642 F.2d 652 requires product comment k however, be recently and more in Savina v. “properly prepared, accompanied by Inc., 105, Sterling Drug, 247 Kan. 795 P.2d proper warning....” (1990), permitted directions There 915 some states have re types product covery are three defects: manu for a strict claim based on flaws, design defects, facturing theory defectively that the inade quate warnings regarding designed. use. See Pros 924; 159, Savina, (D.S.D.1967), Castrignano F.Supp. aff'd, See P.2d at v. 263 163 795 408 775, Sons, Inc., Schwartz, (8th 1969); E.R. & 546 A.2d 780 F.2d 978 Cir. V Unavoid Court, (R.I.1988); Superior Brown v. 44 Cal.3d ably Clarifying Meaning Products: Unsafe 1049, 412, 470, Cal.Rptr. P.2d 245 751 481 k, Policy Comment 42 Behind Wash. & Lee 305; Toner, (1988); Til P.2d at Feldman v. 1139, (1985); Willig, L.Rev. 1141 S. The Com 424, Laboratories, N.J.Super. 460 Lederle 189 Conceptual ment k Character: A Barrier to Strict (1983), grounds, NJ. A.2d 203 429, rev'd on other 97 545, Liability, 29 Mercer L.Rev. 546-47 (1984); v. Phar 479 A.2d 374 Brochu Ortho 652, (1st Corp., F.2d 657 Cir. maceutical 642 discussing 4. For a collection of cases whether Laboratories, 1981); Wyeth Reyes 498 F.2d v. products, including drugs, unavoidably un- denied, 1096, 1264, (5th Cir.), U.S. 1276 cert. 419 Annotation, safe, Liability: see Products What is 687, (1974); v. 42 L.Ed.2d 688 Davis 95 S.Ct. Product, “Unavoidably an 70 A.L.R.4th Unsafe” 121, Laboratories, Inc., Wyeth F.2d 128-29 (1989 Supp.1990). Inc., (9th 1968); Sterling Drug, Yarrow v. Cir. case-by-case k on the trial court on basis. applied have Some courts basis, conditioning approach, product applica- at 463-64. Under case-by-case finding may unavoidably unsafe and exemption that the be deemed of the on a tion exempt from a strict “unavoidably unsafe.” See thus drug is fact 915; 297; if Savina, Toner, only of action the court defect cause P.2d Laboratories, (1) was intended v. concludes also Feldman Lederle see 374, (1984) provide exceptionally important 479 A.2d 382-83 bene- 97 N.J. (2) warn, fit, posed the risk was substantial (involving allegations of failure to drug is and unavoidable when distributed. Id. at “Whether a unavoid- stating, but case-by- 464.6 ably unsafe should decided Co., basis_”); Eli Lilly Collins v. case and to extent refined adopted Idaho some (1984) 116 Wis.2d 342 N.W.2d approach Kearl Toner Lederle (comment ques- if applicable Laboratories, 732 P.2d 297 Idaho ade- on market without placed

tion was (1987), against addressing a case a suit exigent testing circum- quate manufacturer of a vaccine immunize *5 Laboratories, stances); v. Patten Lederle diphtheria, pertussis, and against tetanus 1987) (federal (D.Utah dis- F.Supp. 233 676 (“DPT”). required the manu- Toner Utah predicting that would trict court trial, case-by-case to at on a prove facturer k). adopt comment basis, of the out- that the benefits marketing. weighed to the risks at the time of the state fashion California was first qualify at To “una- drugs 732 P.2d 305-09. test to determine which risk/benefit voidably product” ap- In under this protection. unsafe are entitled to comment Laboratories, be, must at the time of the proach, 172 Cal. “there Kearl v. Lederle distribution, (1985),5 no subject products’ the feasible Cal.Rptr. 218 453 App.3d design specifically dis- alternative which on balance accom- Appeal of California Court purpose by subject product’s the with society plishes face problems cussed would (citing Belle accountability lesser risk.” Id. at 306 subjecting drugs to the same Hansen, Bank v. allowing unlimited re- Memorial Blood products, as other Bonfils (Colo.1983)); Kearl, 218 pharmaceuti- P.2d 123 plaintiffs injured by 665 dress If alternative Cal.Rptr. at 464. there were products. problems, Such the court cal designs could effec- noted, delayed availability drug product need- that have of include purpose, the court imposition tively of achieved same drugs and of costs ed reasoned, research, risk would not be “unavoid- development, marketing of and the “apparently manufac- reasonable” products beyond that which able” manufacturers, marketing product of would turers, and use small especially Toner, P.2d 306. justified. at 732 at willing Cal.Rptr. not be might be to risk. 209). Feldman, 460 A.2d at (quoting apply- to those courts direct contrast case-by- discomfort, immunity on ing comment k’s expressed The court Kearl pre- holding courts that all however, by are method case basis the “mechanical” with are as matter scription drugs entitled had concluded many appellate courts liability exemption from strict law to special treatment. are entitled In Brown Thus, on defect. forth claims based Cal.Rptr. 463. Kearl set at Court, 1049, 245 by Superior 44 Cal.3d out analysis to be carried a risk/benefit distributed, whether, (1) product when the California Su- overturned 5. Kearl was exceptionally im- Brown, was intended to confer an at Since preme Brown, in 751 P.2d 470. Court availability high- portant benefit made prescrip- is that in California all the rule desirable; (2) then-existing risk ly whether law to an entitled as a matter of tion are product posed "substantial” both liability exemption claims based from strict “unavoidable;” (3) whether the inter- upon design defects. availability (again as of the in measured est distribution) outweighs interest time to ex- would decide whether The trial court 6. accountability through promoting enhanced only taking evidence empt first after liability design review. strict defect considering: presence, jury's of the out Kearl, Cal.Rptr. at (1988), proval. Finally, at 479. Cal.Rptr. Id. the added ex- brought by plain- pense insuring against claims liability court addressed strict companies injuries programs might sued additional research tiffs who cause allegedly arising from their mothers’ the cost of medication to increase to the diethystilbestrol, syn- exposure útero longer extent that it no would be afforda- during thetic hormone marketed for use ble consumers. Id. weighed prob- court pregnancy. The plaintiffs and amici curiae Brown imposing lem whether language asserted that the of comment comports the tra- drug manufacturers interpreted grant cannot be im- blanket law, namely, goals ditional of tort deter- munity prescrip- from strict to all 751 P.2d at rence and cost distribution. drugs. Rather, they tion asserted that acknowledged 478. The court that a those “unavoidably that are companies might pharmaceutical be safer if dangerous” eligible protection. for such withheld it from the market until scientific court, although Id. at 482 n. 11. The con- point knowledge skill and advanced to the ceding entirely the comment is not dangerous effects could where all side point, clear on this noted that “the com- at 479. There was con- discovered. Id. apply ment was intended to and should cern, however, delay, that this when added prescription drugs.” (emphasis all delay normally required for the FDA to the added). Brown concluded that “because approve drug, a new would not serve the public development, interest public examples welfare. The court cited availability, price drugs, and reasonable potentially drugs being several useful appropriate determining test re- *6 withdrawn from the market or their avail- sponsibility is the test stated in comment seriously ability curtailed because of the k....” Id. at 477. liability at crisis. Id. 479-80. Sons, In Castrignano v. E.R. acknowledged ap- The Brown court the Inc., (R.I.1988), 546 A.2d 775 the Rhode peal approach, of the cost/benefit Kearl Supreme Island had the opportunity Court yet procedure found the “mini-trial” un- case-by-case to review Toner’s risk/benefit negative impact workable because of its analysis exemption ap- and Brown’s broad development marketing the and of new proach formulating approach when its own Brown, P.2d at 481. Another drug products liability. The Rhode Is- objections of the Brown court’s to Kearl opted land court for the more restrictive was that it left the trial court to hear and case-by-case approach, at id. de- fact, questions resolve mixed of law and veloped a directed verdict standard to bal- placing in the trial court the role of fact judge jury ance the roles of the the in Brown, finder. 481-82. The 751 P.2d at applying comment k. Id. at 781-82. Un- open- court found the test too cost/benefit test, Castrignano der the if at the time of predicted ended and that it would lead to marketing apparent outweighed the benefit disparate drug by treatment of the same risk, apparent applies k comment judges. different at 482. Id. recovery design precluded. for defect is public The Brown court stressed three judge If Id. a trial concludes that reason- policies mitigating against imposing strict deciding able minds could not in differ that First, liability prescription drugs. for risk, benefit exceeds its then as a might stop producing manufacturers valu- law, judge matter of the trial can extend drugs profits resulting because of lost able protection. comment k If Id. at 782. inability

from lawsuits or the to secure judge feels that reasonable minds could adequate insurance. Id. at 479-80. Sec- question, judge differ on the must sub- ond, in consumers have a vested interest jury. mit the issue to the prompt availability pharmaceutical of new reviewing approaches products. Imposing jur- strict of other sign might products liability defects cause isdictions toward strict manufacturers to market, delay placing products design drug products, on the in new defects we are products ap- uniformity even after those receive troubled the lack of and cer- ap- product design. We do not case-by-case pharmaceutical tainty inherent however, agree, court’s resulting disincentive with the Brown proach and fear apparent attempt plain language devel- to use the pharmaceutical manufacturers attempt exempting ’s to clari- of k as vehicle for Toner comment op products. “unreasonably dangerous” prescription standard all from strict fy the policies underly- the defendants’ chances seriously relying curtails rather than on the establishing k im- ing comment of success that comment. commenta-

munity of law. One as matter The American Law Institute’s restate- an defendant have notes that a would tor by legal who ments are drafted scholars rebutting plaintiffs prima easier time attempt of the law to summarize state design the tradi- defect under facie case area, given predict how the law tough meeting than tional standard changing, suggest the direction exemp- “earning” comment k burden of The should take. restatement serves law Comment Reilly, Erosion tion. See role courts in appropriate advisory an k, Dayton L.Rev. 14 U. law. approaching unsettled areas of We very literal and restric- applied a however, Toner section 402A of emphasize, that k. ex- of comment For interpretation (Second) Torts, tive as Restatement examples cer- comment ample, cites binding is not on our deci- drafted as that and vaccines tain except as ex- sion in this case insofar we public apparently use- “supply the with princi- doctrinal plicitly adopt its various product, attended with a and desirable ful ples. principle risk.” apparently known reasonable embodies, but of unavoid- manufacturers opined language, Based on this Toner dangerous lia- products should ably (1) “[c]learly contemplates ... design for a claim of defect. We ble benefit of the weighing persuaded all (2) intended against risk” and was never unavoidably danger- be classified should liability. drugs from exempt all unique na- their ous in because of Toner, if 306. Even value, regulatory the elaborate ture *7 in FDA, the court Toner that with system by the difficul- overseen contemplates “weighing” of the as a relying on individual lawsuits ties of benefits, find unnec- drug’s risks and we it a prescription in to review forum essary prop- is the to conclude that court significant public drug’s design, and the weighing pro- body engage in that er in noted Brown. We policy considerations Furthermore, not be bound cess. we need conclusion as did therefore reach the same language Brown, of and specific Supreme in Court the California policy may adopt apply and its fundamental slightly ratio- pursuant to a different albeit restricting to what ourselves without nale. interpretation. literal

perceive to be its UNIQUE III. stan- somewhat nebulous Castrignano’s OF DRUGS CHARACTERISTICS dard, question when the designed to control application reaches comment k’s of chemical prescription Because plain- great deal of room for jury, leaves with compounds designed to interact jury. Addi- cases to the to manuever tiffs physiological processes of chemical and case-by-case ap- tionally, like the traditional always pose body, they will almost human ignores the effective- this standard proach, in certain individu- some risk of side effects regulatory process. of the FDA’s ness risks, drugs are Despite these new als. approved by the FDA because case-by- continually that the agree with Brown We saving lives and of benefit is their social first articulated Kearl method case Toner’s, suffering. The health unworkable, alleviating human light re- even living system general and standard care test. find the Brown of the finement seri- country, example, would be public policy in line result more with impaired such essential ously without important area of considerations 96 quick potential as antibiotics that allow re- anism to ensure that the benefits

covery from once product outweigh ailments were debili- of the any associated Food, tating Drug or even fatal. See risks. The manufacturer initiates the re (1982). Cosmetic L.J. 15 by submitting Investigational view New Drug Application (“IND”), containing in addition, expansion of tort formation chemistry, about the man liability justified primarily is on the basis ufacturing, pharmacology, toxicology. deterring transferring inju- the cost of 355(b)(1) (Supp.1991); See U.S.C. § ries, appropriate it is to consider the in- (1990). C.F.R. 312.21 If FDA ap § creased costs that could result from the IND, proves drug’s sponsor may production prescrip- curtailment of the gather data safety efficacy on clinical drugs. tion commentator notes: One Drug needed for a Application New [Djrugs input are our most cost-effective (“NDA”), application. the formal license in supplying the demand for health. A very The NDA must include detailed re prescription frequently ten-dollar is ports of all animal studies and clinical test $2,000 hospital substitute worth ing performed drug, with the reports of produces services—a substitute that reactions, any any perti adverse other positive higher outcome with much fre- nent information world-wide scientific quency hospital than care.... we are If 355(b) (Supp.1991); literature. 21 U.S.C. § costs, minimizing serious about our 21 C.F.R. 314.50 § best bet is to increase the number of drug innovations. The approval process can re- Brozen, Statements, Drugs & Health: Eco- quire years testing By and review. Policy Objectives, nomic Issues submitted, 305 time an NDA is it often consists (Helms 1981) (emphasis added). ed. pages of thousands of of material describ- ing studies of the in several hundred risks, Despite inherent and in contrast patients. several thousand See Fed. any product, society other has deter- (Oct. 19, 1982). Reg. 46626 The FDA care- mined provide medications fully supporting scrutinizes the data unique benefit and so should be available NDA, requiring “substantial evidence” con- physicians appropriate warnings sisting adequate and well-controlled in- guidance as to use. The federal vestigations. 355(d) (Supp. U.S.C. government has established an elaborate 1991). application by phy- regulatory system, reviewed FDA, overseen sicians, pharmacologists, chemists, micro- approval to control the and distribution of statisticians, biologists, profes- these and other See U.S.C. 301-393. §§ *8 No other sionals within the FDA’s subject class of National Center special Drugs Biologies for and protections experi- restrictions or who are society. in evaluating drugs. our enced 47 Fed. (Oct. 19, Reg. 1982). Recommenda- FDA

IV. REGULATION professionals tions those are then re- by management viewed personnel within Congress “protect created the FDA to Drugs the National Biolog- Center for and dangerous products.” consumers from ies before the FDA makes a final determi- Sullivan, United States v. 332 U.S. approve reject nation to or the new 331, 335, (1948). 68 S.Ct. 92 L.Ed. 297 application. Id. In its role as a promoter “both health ... public and a protector,” ... the FDA em- premarket however, Elaborate screening, ploys comprehensive premark- scheme of approved does not ensure pre- review screening post-market et and surveillance scription medications where adverse reac- safety efficacy ensure the of all may appear tions preappro- after extensive licensed Fed.Reg. medications. 50 testing. reason, val For this the FDA also post-market conducts extensive surveil- licensing medication,

Before a new reports lance. All of adverse reac- employs FDA screening (“ADRs”) an extensive tions reported mech must be to the resulting from use of FDA, physician, injuries those regardless whether 78-18-2(1) manufacturer, believe re- Utah Code Ann. or others § “punitive 21 C.F.R. drug-related. (Supp.1990) damages states that action to be 314.80(b). The must also may drug causing manufacturer if a not be awarded § reports (a) as to what ac- periodically premarket submit claimant’s harm: received response to ADRs and must Food, it tions took approval or licensure the Federal stud- any post-marketing from submit data Act, Drug, and Cosmetic U.S.C. Section literature, ies, reports scientific designed seq_” policy, This et 301. marketing 21 C.F.R. foreign experience. discouraging manufacturers avoid .80(c). 314.80(b), The FDA has authori- §§ drugs, marketing FDA-approved applies reporting requirements; ty to enforce these inadequate even to marketed with may subject a manu- any comply failure to warnings. penalties. civil criminal facturer to (1972 Supp.1991). & legislature U.S.C. 332-34 also acknowl has §§ findings, the response to its surveillance edged important governmental role require labeling changes or if may FDA Code Ann. section 78- standards Utah approval NDA necessary withdraw section, legislature 15-6(3).7 In that thereby license market the revoke the pre that is a rebuttable declared there 355(e). medication. Id. at fully com sumption plies applicable government stan regulatory scheme We find this extensive marketing is not at the time of defect dards making capable appropriate of and ive.8 regarding preliminary determination drug’s prescription benefits out- whether a ap- prior supports law this Our case follow-up weigh risks. The structured its E.R. proach as well. In Barson v. imposed by law program ensures Inc., (Utah 1984), Sons, placed on the market without sufficiency of evidence for addressed monitoring continued adverse conse- negligently claim manufacturer render FDA’s ini- quences that would risks its failed to warn of associated with Allowing analysis invalid. tial risk/benefit meeting product. We held that even after juries to courts and/or contin- individual requirements, if there are governmental and benefits ually reevaluate risks dangers manufactur- about which regula- processes expert of this ignores the known, the manu- er or should have knew tory and the other avenues of recov- body liability. may subject Id. at facturer plaintiffs. ery available Thus, holding in with our consistent case, if manufacturer knows has Legislature that the Utah We note know of a risk associated with approval should recognized the value of patient if directly liable to the product, it is public in the avail- process and the interest pro- medical adequately it warn the affordability fails to ability danger. at 835. of that restricting the extent of fession drugs by Act, immunizing *9 argue drug Liability manu- that Plaintiffs 3 of the Utah Products 7. Section design -6, liability defects from strict was held facturers Ann. 78-15-1 to §§ Utah Code statute, that contrary to conclu- by Berry is this because court v. Beech this unconstitutional 1985), presump- (Utah an "irrebuttable a sion would establish Corp., 717 P.2d Aircraft drug or unrea- was not defective repose. was tion" that Because section 78-15-3 statute of Act, disagree. dangerous. sonably Plaintiffs other sections of from the not severable liability a claim may recover under the Products still that the remainder of we ruled demonstrating product was unreason- legislature that the re- Liability Act invalid. warning, dangerous inadequate ap- ably to an due pealed in an amended certain sections flaw, manufacturing mismarketing, misrep- or comply parent to with the court's con- effort cite resenting to FDA. We Although information was neither section 78-15-6 cerns. reenacted, legisla- only amended, to demonstrate specifically statutes repealed, these nor expertise cer- to legislature ture’s similar deference has no indication that the there is agencies, particularly governmental gov- changed policy regarding tain deference the FDA. standards. ernmental Moreover, opinion regarding particular standard in Utah to which whether drug application approved, should be drug must adhere to estab- manufacturers making judgment individuals the ultimate adequate warning very is strict. In lish years experience will have the benefit of Barson, we stated: reviewing products, scientific ex- determining In whether manufactur- area, pertise in the and access to the vol- duty adequately er has breached that [to they compel umes of data can manufactur- and the extent to which a manu- warn] produce. FDA subject ers to Nor is the required dangers facturer is to know of process, the inherent of the trial limitations drug, important inherent in its it is evidence, such as the rules of restrictions point out that the is manufacturer expert testimony, scheduling on expert particular held to be an in its mands.9 duty and is under a “continuous field keep develop- ... abreast argued One commentator has that courts of scientific touching upon ments as a respon- whole unsuited to render manufactur- notify pro- judgments er’s the medical design sible defect area Henderson, any generally. fession of additional side effects dis- See Re- Judicial covered from its use.” The manu- Design view Conscious of Manufacturers’ responsible Adjudication, is therefore for not Choices: The Limits facturer knowledge gained argues “actual from re- Colum.L.Rev. 1531 He arbitrary decisions in this area are reports,” search and adverse reaction but due to “polycentric” their nature in knowledge also constructive which “each as mea- point for decision is related to all the others sured literature and other scientific spider as are the strands of a web.” Id. at available means communication. litigate 1536. These issues are difficult to Barson, (emphasis 682 P.2d at 835-36 add- ed). pulled, complex pat- one strand is [i]f V. PROPER FORUM FOR readjustments tern of through- will occur RISK/BENEFIT out the entire If web. another strand is

ANALYSIS pulled, relationships among all the again readjusted. strands will A law- Finally, do not believe that a trial yer seeking argument upon to base [an] products liability court the context of a principle required established to ad- proper action is the forum to determine dress himself discourse to each of a whether, whole, particular as a prescrip- strands, issues, dozen or would find [the] outweighed tion benefits its risks at frustratingly impossible. task case-by-case the time of distribution. analysis, jury’s one court or determination particular drug

that a is or is not “defec- Although accept we do not the notion tively designed” bearing any has no that courts are unsuited to address result, future case. As a differences of in any defect claims ac- opinion among differing jurisdic- tion, courts in prescription drug we do tions leaves unsettled a manufactur- design presents precisely type “po- any given drug. Although er’s lycentric” problem. designed A may effectively specific have internal differences of be administered to indi- question terribly. case-by-case approach, 9. There is also a certain moral to be prod- Under a courts determining addressed when whether a juries significant must ask which is a more outweighs uct’s benefit its risk when faced with efficacy respect group interest: A versus *10 reality injured plaintiff. example, the of an For group B? harm to The FDA must ask the same vaccine, case a in the drug’s availability of certain benefits of the question: product the Does benefit of this out- A, group will accrue to the weigh its The risk? distinction is that the FDA prevented contracting individuals who are from objective posture is in a more and informed to individuals, the disease. A smaller number of Toner, make that determination. See however, may contract the disease and react (appendix transcript excerpt at 325-26 B: of or, violently component to a of the as argument). Malcolm E. Wheeler’s oral drug’s properties, some other result of the suffer I epidemic, or a fatal condition. believe a of indications. one or number viduals for “unavoidably” by is is meant out- what a benefit To determine whether exception apply complex be- unsafe. The would thus inherently is weighs its risk drugs to a small number of only conscious cause of the manufacturer’s —not drugs by FDA. gambit approved full of chem- regarding the numerous sign choices recognize problem I associated While their properties ical I not case-by-case application, do idiosyn- physiologic to the vast relationship great problem be as as think would each consumer whom cracies of opinion by majority since portrayed Society recognized has designed. is only relatively small number of re- response has complexity and in this fall into the class entitled to would FDA. authority in the posed regulatory exemption. screening and sur- Relying on the FDA’s find courts to veillance standards enables Supreme Court in Col- of Wisconsin inadequate liability under circumstances Co., 166, Lilly Eli 116 Wis.2d lins v. mismanufacture, warning, improper mar- (1984), adopted appli- a narrow N.W.2d FDA—avenues keting, misinforming the or k: of comment cation Al- for which courts are better suited. Drug sellers or companies like other plaintiffs one though approach denies manufacturers, duty produce have to rely theory to in a potential on which products. reasonably safe and market action, liability to so- products the benefits exigent in circum- recognize some development, avail- ciety in promoting the necessary place may be stances it price drugs justi- ability, reasonable adequate market test- on the before fies this conclusion. cir- ing may done. as these Insofar exist, in light strong public interest com- of the with the cumstances pre- availability affordability not be strict should ment [k] medications, regula- However, exigent extensive no scription imposed. we find FDA, avenues DES tory system of which would excuse circumstances plaintiffs by adequately from recovery still available or marketers producers warning, inadequate testing placed mismanufac- on the claiming DES before it was ture, marketing, misrepresent- Although improper there was societal market. FDA, in miscarriages we conclude ing preventing information interest immunity grant treatment was pregnancy, that a broad alternative problem ap- did defects not claims based available and pre- FDA-approved proach epidemic proportions. extended to should be scription drugs Utah.10 expressed United A similar view Judge Thomas Greene District J. States J., C.J., ZIMMERMAN, HALL, Laboratories, Lederle Patten concur. 1987), he (D.C.Utah where F.Supp. 233 HOWE, Associate Chief Justice: wrote: (dissenting). it, k does comment this court sees [A]s immunity pre- to all provide k blanket I I would limit comment dissent. language of the drugs. The wording scription as advocat- exception to its literal apply indicates it is apply I it would Stewart. ed Justice products.... The court considers ‘some’ only to class of a narrow extending protection lifesaving potential, which have un- would be entire class an risks but which attendant which have com- requirements of the light poten- wise they have the administered to its specifies prerequisite ment person who saving the life of tial of disease, application. by a to death probably doomed presented. response two certi- issues to the first of our 10. Because other not reach the questions, we need fied *11 Laboratories, 112 Idaho prescription drugs which do not Toner v. Lederle As to all 328, J., 297, (1987) (Huntley, 732 P.2d exempted fall within the class but Indeed, concurring specially). relying on FDA, I approved by the would have been approval, ignores FDA majority wholly presumption them a rebuttable accord E.R, Squibb our statement in Barson v. design. being of safe Sons, Inc., 832, (Utah 1984), FDA regulations prescription for STEWART, (dissenting): Justice drugs merely “are minimum standards.” majority I holds that a dissent. truth, safety procedures In FDA do not to human avoidably that is unsafe justify judicial responsibility. abdication of exempt life or health is from strict example, require FDA For does not FDA, design approved by if for defects developed existing drugs undergo newly though drugs provide can even alternative tests which would increase the likelihood same, better, therapy, less or even with that a is in fact safe. This was Thus, FDA-ap- risk to life or health. Barson, illustrated in 682 P.2d at proved drugs decongestants, as various ex- which this Court stated: deodorants, pectorants, growth hair stimu- Drug Since the Food and Admin- lants, moisturizers, cough skin (FDA) required teratogenici- istration has remedies,1 example, have the cold for same testing ty on all new immunity polio vaccines or as rabies guidelines regarding FDA established medications essential the treatment of teratogenicity testing. Delalutin Since disease, cancer, I heart or AIDS. see no by was not a “new” as defined drugs according used to treat basis guidelines, require- there was no federal comparatively minor ailments a im- blanket ment that test Delalutin for tera- munity design togenicity; testimony indicated that dangerous they unreasonably fects if Squibb had never done so. them.

to those who use congressional investigations Numerous demonstrated that the FDA has often have immunity The limited conferred com- drugs complete ignorance approved given only ment k on a few relating critical information to the hazards thorough after consideration the Ameri- of such which was contained either However, can Law Institute. this Court published in its own files or in the medical gives immunity blanket defects literature, example, or both. For the FDA FDA-approved drugs to all on the basis 19, 1982, approved April Oraflex on for the upon efficacy integri- blind reliance treatment of arthritis. The manufacturer ty procedures, of FDA about which withdrew the from the market on majority nothing. I knows almost 4, 1982, August because eleven deaths Huntley Supreme with of the Idaho Justice reported to associated were be Court, who stated: sixty- use in the United States and supreme yet state court has become [N]o reported in the one deaths were United convinced that the has either ade- Kingdom. principal Of concern were re- staffing, quate expertise, or data base to ports fatal of serious sometimes Ora- being ju- for the warrant substituted kidney flex-associated liver and disease. In system. dicial Regulation in FDA’s Deficiencies New H.R.Rep. Drug “Oraflex”, No. day any supreme I fear the when court (1983), Cong., 98th 1st Sess. the House agency can convinced that an such as Operations Committee Government FDA, well-intentioned, no (hereinafter “H.C.G.O.”), matter how congressional sys- FDA, supplant judicial overseeing can the American committee found that during the FDA tem. was unaware that Ora- (1990 ed.) Physicians’ 1. The Desk in- ries stated in the text. Reference catego- cludes in each of the *12 sia, diag- sedation for short four re- and conscious flex clinical it had received trials endoscopic procedures on Decem- and kid- nostic or ports of serious concomitant liver kidney 20,1985. Thereafter, of dis- Versed was asso- ney reports and two ber disease injury.2 reports At unaccompanied by ease liver ciated with numerous of life-threat- and, many instances, approved ening epi- the time the FDA Oraflex for fatal arrest, marketing, respiratory and for several months there- sodes of cardiac and after, it was unaware of the number of particularly for conscious seda- when used reports of adverse reac- Oraflex-associated The FDA concluded that these reac- tion. prior approval had to its of dose-related, tions it received until No- tions were but not approving Prior drug. Id. at 11-12. to were the recommended con- vember 1987 Oraflex, no to obtain the FDA made effort substan- scious sedation doses Versed safety foreign information on its from tially reduced. H.C.G.O. found that drug already countries had originally approved Versed doses therefore, was, un- been marketed and substantially high- sedation were conscious reports large of of aware of number er to effective. than those shown be fatal to serious and sometimes reactions Regulation New FDA’s Deficient to the British and Dan- submitted 1086, Versed, No. H.R.Rep. 100th Drug Id. at 13. The regulatory ish authorities. 2nd at 10 When it Cong., Sess. require- legal FDA failed enforce the to marketing, the FDA approved Versed report all ment that manufacturers studies, important despite was unaware of to under clinical adverse reactions published they the fact that had been investigation, information essential 20, literature, many id. at medical potential drug’s against risks its weigh the instances, agen- been submitted to had 22. benefits. Id. at cy. at 21. also found Id. H.C.G.O. of the manner in the FDA was unaware Merital for the treat- approved The FDA foreign na- regulated in which Versed was 31, 1984. depression on December ment of investigate the adverse tions failed from the market in Merital was withdrawn practices the manu- reporting reaction large number of January 1986 Versed, notwithstanding data facturer reports immune-allergic hy- of serious company agency received had reactions, including several persensitivity ne- that the firm had strongly suggesting fatalities, In its use. associated with agency reports of glected to FDA n to the submit Drug New report Regulation to the deaths known Versed-associated 206, Merital, Cong., H.R.Rep. 100th No. drug’s approval. Id. prior to the company (1987), found that 1st the H.C.G.O. Sess. at 37. Merital, FDA prior approving over- it had received of looked clinical evidence Zomax on October approved The FDA potential. allergy-inducing Id. moderately mild relief of for the of its ad- The FDA’s enforcement at 24. 4, 1983, marketing pain. March On severe requirements reporting was verse reaction by its manufacturer halted H.C.G.O. concluded inadequate. Id. at 71. reactions, allergic number of large to a due exposed the American the FDA had deaths, use. including associated Merital potential hazards of public to the 2,100 Eventually, reactions were more than drug’s efficacy requiring that the without Regula- FDA. FDA’s reported by substantial evidence supported be Zomax, H.R.Rep. No. 98th tion of adequate and well-controlled rived from (1983), found the H.C.G.O. Cong., 1st Sess. 80. studies. at in violation approved Zomax that the its bene- policy requiring that agency of an preopera- Versed for approved The FDA outweigh its demonstrated fits shown sedation, general anesthe- induction of tive [kidney] toxicity renal agency of "evidence ... of ignorance, the ence consequence of its aAs labeling Oraflex-as- approved which stated that clinical studies.” Oraflex] in [the Deficiencies Drug to "liver Regulation were confined at sociated liver reactions New FDA’s "Oraflex" “usually that were test abnormalities” function 9-10. altogether the exfst- and that denied transient" *13 102

carcinogenic Drug companies, at 5. The FDA like other risk. Id. sellers or manufacturers, analysis duty produce have a failed to make the risk-benefit reasonably products. and market safe placed prov- Court has within the exclusive recognize exigent that in some cir- Also, ince of FDA’s the FDA. monitor- may necessary place cumstances it be ing of Zomax-associated adverse reaction adequate on the market before reports was deficient. When Zomax was testing can done. be Insofar as these market, agency’s from removed exist, agree circumstances with the computerized tracking system showed that that strict should [k] reports the FDA 270 had received However, imposed. not be we find no reactions, allergic Zomax-associated where- exigent ex- circumstances which would drug’s actually as the had manufacturer producers cuse or DES marketers reports agency. 900 to the submitted adequately testing before it was DES at 11-12. The FDA also failed to note placed Although on the market. there suggesting possession evidence preventing was a interest in mis- societal posed higher Zomax risk of serious and carriages pregnancy, alternative treat- life-threatening allergic sometimes reac- available, problem ment was and the did class, particu- tions than other in its approach epidemic proportions. not larly among patients prior history with no assuming exigent Even there cir- were drug allergy. Id. at 16.3 necessitating cumstances the use Although FDA has a mechanism for in pregnancy adequate of DES without pharmaceutical agents withdrawal testing, years an additional ten had dangerous, 21 which are found to be U.S.C. elapsed by plaintiff’s the time the mother 355(e) (1988),the mechanism is slow and Thus, appear took DES. it would example, sometimes unreliable. For sever- drug companies had sufficient time to published early al studies were 1950s thoroughly original if test DES even put diethylstilbestrol which should have place need to it on the market foreclosed (DES) manufacturers on notice that DES adequate testing at that time. Accord- injured reproductive systems of female ingly, producers we hold that DES exposed fetuses whose mothers were to the may strictly marketers be held liable if drug. However, it was not until plaintiff the five elements establishes nearly later, twenty years that the FDA specified earlier. finally prevent the use of banned DES to Proposals Congress before and rules miscarriages, the most common use of the promulgated by the FDA to make it easier drug. Castrignano See v. E.R. pharmaceutical companies to obtain Sons, Inc., (R.I.1988). A.2d approval FDA for new would dilute lengthy FDA wait resulted in safety efficacy even further the stan- endangering generation of women be- FDA approval dards for See during cause their mothers had used DES Note, Regulation Investigational New pregnancy. Drugs: Step Dy- “Giant the Sick and ing?”, Georgetown L.J. 463 Per- relying efficacy ap on the of FDA haps truly unavoidably unsafe in- proval procedures dispens as the basis for life-threatening tended to treat ailments ing judicial remedy with the easily pub- should be more available to the liability, majority ignores simply lic, lessening safety but standards is protect public against failures to unnec argument liability, against. for strict essary unacceptable I risks. likely many Profit motivation is to lead to Supreme

with what the Wisconsin Court unnecessarily dangerous drugs. more Co., Lilly stated v. Eli Collins 166, 197, 37, 52, Furthermore, Wis.2d 342 N.W.2d cert. not a shred of evidence has denied, presented 469 U.S. 105 S.Ct. 83 been to this Court that indicates (1984): system L.Ed.2d 51 under the tort has The court in Toner noted other FDA failures. 732 P.2d at 311 n. 12. great. may comparatively A pharmaceutical companies from risk deterred example, utility may great, if be so introducing drugs. Even that were social case, chemotherapeutic agent used for treat- question that must be answer- ed, cancer, obviously holding, why ment of it would given majority’s exemption. Other proper qualify ac- for comment provide does not *14 drugs, sleeping compounds or competing policy all such dan- commodation of cures, utility may social not be before the druff whose interests involved issue order, high such a not automati- Why those who are serious- of would Court. should cally qualify. The Rhode Island court stat- ly injured or of the death suffer because prescription drug qualify ed that for a to expense have to stand the another exemption, k high profit margins in for comment support to losses drug industry? apparent must benefits risks, given the apparent exceed the sci- view, Supreme my the Rhode Island knowledge available when the entific adopted approach in Court a better Cas- drug was marketed. If the benefits out- Sons, Inc., 546 trignano E.R. risks, weigh recovery then (R.I.1988). 775 The Rhode Island A.2d If, sign-defect precluded. is truly only are products court held that however, apparent risks exceed the unavoidably qualify for comment unsafe benefits, then the is apparent protection. The court stated: design-defect liability exempt from provides a test This comment risk-benefit subject design- the traditional will be to that, products given present state analysis 402A. defect set forth § incapable of knowledge, human are at 782. 546 A.2d use. being made safe for their intended test satisfy Products that the risk-benefit Furthermore, given Congress has never unavoidably These are deemed unsafe. does, immunity, as this Court all broad products, drugs, will not be especially notwithstanding FDA drugs, unreasonably considered defective and Note, Prescription approval. See A dangerous under 402A because their Drugs Not Applying Liability: all Strict their perceived or benefits exceed known Immunization, Deserve Comment Therefore, perceived risks. known Court, Superior Cal.2d Brown v. 44 availability marketing of these (1988), Cal.Rptr. 21 withstanding justified, not is has, Congress Ariz.St.L.J. risk. however, immunity provided some from try to The authors of the comment public when the tort for some vaccines law drugs types should demonstrate required widespread their use. interest strict-liability analysis from be excluded Congress the Nation example, enacted For examples. The through Act, authors various Injury U.S.C. Vaccine al Childhood exemption (1988), state that comment’s which establishes to -34 300aa-l §§ drugs, like the rabies apply injured should children compensation scheme for vaccine, effects are harmful side pursuing whose as an alternative to by vaccines outweigh far known but whose benefits the manufacturers. against tort claims also The authors However, complete the known risks.... Act does not even that apply to exemption should plaintiffs state that this in liability for ly foreclose strict possess experimental drugs instead, vaccines; it new estab jured dangers undefined yet the trier of fact. obvious to aid presumptions lishes none- perceived 300aa-22(b)(2), -23(d)(2). benefits 42 U.S.C. §§ marketing. The justify their theless opinion that a case- majority The states provides that these drug compa- analysis leave by-case would a standard of strict not be held to should of im- regarding questions nies uncertain public policy favor- light of the patchwork ver- munity result and would products. availability of such ing the drug may be found dicts when A.2d at 781. exemption in one subject comment k exemption in subject to the but not clearly qualify for com- case Certain has little consideration drugs’ case. That though the another exemption, even ment k merit, my We tolerate nonuni- criminal homicide. Because of alienists’ re- view. negligence formity ports, Washington County prosecutor of result in cases all the bring Nothing does can dropped charges February time. Court all criminal respect uniformity about of result with Grundberg Gray, 1989. Mrs. and Janice already The divided on states personal representative of Mrs. Coats’ approval of a the issue of whether estate, filed this civil action later in 1989. immunity should confer At issue in this case is whether Halcion defects, although appears it that no state Grundberg’s was the cause of Mrs. bizarre gone has as far as Utah now does. Suffice night behavior on the of the homicide. apply say, a number of courts agent, If Halcion it was a causative case-by-case k on task that can- basis—a significant that Physicians’ Desk Ref- majority’s even under the not be avoided *15 (1990 ed.) hypnotic erence lists nine other coupled position if a strict claim is agents available for use. At least two claim, negligence usually as is with a hypnotics other and one other medi- case. sleeping cation listed as a aid are benzo- Significantly, Congress has not shared are, therefore, diazepines and of the same professed concern for uniform- Court’s addition, general type as Halcion. In ity. uniformity lack of there has Whatever same reference lists thirteen sedatives that cases has been insufficient to been majority ignores are on the market. The products liability justify uniform national the fact that the found Halcion to be Furthermore, Legislature legislation. unique particularly neither nor essential thought presumption that a of this State presented and no advancement exist- over protection was sufficient for manufactur- ing therapeutic Perhaps alternatives. outright immunity. ers rather than See appropriate all would have been medi- 78-15-6(3) (1987). Ann. Utah Code It is cations, many possible but with so alterna- policy uniformity indeed that the ironic tives, it is doubtful that Halcion should be weighs heavily more in this Court than in liability. immune from strict Congress the United States the Utah .or join I also Justice dissent. HOWE’s Legislature. We can deal with the Utah, possibility patch- law in and the

work verdicts on a nationwide is sim- basis short,

ply beyond power our to affect. In majority simply deprives Utahns of a

judicial remedy injuries sustained defectively designed drugs, despite the fact Wayne Mary A. WINEGAR may that citizens of other states recover wife, Winegar, his Plaintiffs injuries.

for those Appellees, case, plaintiff In this Ilo Marie Grund- berg taking variety of medications was CORP., corporation; FROERER a Utah depression anxiety. Hal- chronic Investments, part- P.F. a Utah limited cion, here, the medication at issue had first Froerer, III, nership; and Fredrick prescribed Grundberg Mrs. been Froerer, Froerer, Phyllis Zane indi- 1987, May Mrs. 1987.4 December viduals, Appellants. Defendants and and, Grundberg job shortly her there- lost No. 890160. after, mother, her Mildred moved with Coats, Hurricane, Utah, they where lived Supreme Court of Utah. together in home. On June a mobile May Grundberg Mrs. took three medi- Valium, codeine, and cations: Halcion. La- night, she shot killed her moth-

ter that Grundberg charged

er. Mrs. was triazolam, Halcion, 4. Halcion benzodiazepines. is the trade name for known as which is by Upjohn, approved by used for treatment of manufactured medication FDA in insomnia. Triazolam is one of a class of November 1982.