No. 14407 IN THE SUPREME COURT OF THE STATE OF MONTANA 1979

VICTOR F. HILL and MINNIE M. HILL, Plaintiffs and Appellants,

SQUIBB & SONS, E.R., A FOREIGN CORPORATION; and FREDERIC S. MARKS, M.D., Defendants and Respondents.

Appeal from: District Court of the Thirteenth Judicial District, Honorable Robert Wilson, Judgepresiding. Counsel of Record: ForAppellants: Kelly and Foley, Billings,Montana William T. Kelly argued,Billings, Montana For Respondents: Crowley,Haughey, Hanson,Toole & Dietrich, Billings,

Montana Jack Ramirez argued, Billings,Montana Anderson, Symmes, Brown, Gerbase, Cebull & Jones,

Billings,Montana

Submitted: February 8,1979 

### qp:, 

## -i1979 Decided: ' "-5 - - Filed: .c. ;

### -;rq -Mr. Chief Justice Frank I. Haswell delivered the Opinion of the Court. This is an appeal by plaintiffs from judgments entered in the DistrictCourt of Yellowstone County on a directed verdict in favor of defendant Squibb & Sons,a partial directed verdict in favor of defendant Frederic S. Marks, and a jury verdict rendered in favor of Dr. Marks on the remaining claims against him. PlaintiffVictor I?. Hill suffers from severe allergic reactions (contactdermatitis) to a variety of substancesand most severely to petroleum based products. Hill was a mechanic by trade,and thus was subject to constant exposure to those products. He was first treated by defendant Dr. Marks in 1952, at which time the flareups of his dermatitis were occurring only about twice a year. By themid-19601s,however,plaintiff's conditionhad worsened to the point where he was seeing Dr. Marks three or four times a month. After 1969,thevisits to Dr. Marks averaged about two times amonth. A well recognized treatment of skin problems is the use of a class of drugs known as steroids, a kind of synthetic cortisone. Cortisone and all cortisone related drugs have significant and well-known side effects. Dr. Marks initially treated plaintiff with injectionsof ACTH, a chemical which stimulates natural production of cortisone by the adrenal glands. TheACTH was administered in conjunction with topical steroid creams applied directly to the affected areas and prescriptions for steroid pills to be orally ingested. In 1965,Dr. Marks began using an injectible steroid called Kenalog40which had recently been put on the market by defendant Squibb & Sons. From 1965 to 1970,Dr. Marks gave plaintiff injections of Kenalog-40, togetherwith oral and topical steroids,at approximately twoweek intervals. Occasional injectionsof ACTH were also given to plaintiff during that period.In the summer of 1970plaintiff spilled brake fluid over a largepart of his body, causing an extremely severe flareup of the dermatitis. Dr. Marks increased the steroid treatments by supplementing the ACTH and Kenalog-40 injections with

more oral steroids. Over the last five months of his treatment by Dr. Marks,up to his finalvisit on January 18, 1971,plaintiff was treated with a total of 1450mg. of sterane, an oral steroid, and 440mg. of Kenalog-40by injection. At his lastvisit to Dr. Marks in January 1971,plaintiff was referred by Dr. Marks to the Billings Clinic. Plaintiff had some facial swelling which Dr. Marks wanted the clinic to check into. On January 20, 1971, the Billings Clinic referred plaintiff to its staff dermatologist, a Dr. Smoot. Upon learning of plaintiff's history, Smoot immediately discontinued the injectionsof steroids because he "could seenothing but problems down the road." Dr. Smoot continued to prescribe oral steroids and steroid creams,gradually tapering them off. As the steroid treatmentwas lessened, the dermatitisworsened,until in July 1971 it was so bad Hill was disabled completely and had to give up his job. InMarch 1971,while under treatment at the Billings Clinic,Hill firstnoticed blurring vision and in the fall of that year he required surgical removal of cataracts. In 1973,he developed back pain and was diagnosed to have osteoporosis,a loss of calcium in the bones. Cataracts and osteoporosis of the types that plaintiff exhibited are both characteristic side effects of steroid treatment. On September 9, 1974,a complaintwas filed in Yellowstone County District Court by Victor and Minnie Hill alleging that plaintiff's cataracts and osteoporosis were the result of the actions of Squibb & Sons and Dr. Marks, The claim against ~quibb & Sonswas framed in three counts,alleging negligence,strict liability in tort, and breach of express and implied warranties. The central theory of the claimwas that Squibb's Kenalog-40 was negligently marketed and was a defectiveproduct because the package inserts provided with the drug did not warn specifically enough of its dangerous side effects. As to Dr. Marks, the complaint alleged, in summary, negligence in failing to fully advise plaintiffs in regard to the risks associated with steroid treatments and in failing toproperly monitor the effects of the treatment onVictor Hill over the nearly twenty year period inwhich steroidswere administered to him. After aperiod of extensive discovery, jury trialwas had on thematter before Judge Robert H. Wilson. Plaintiffs testified that Dr. Marks had never told them of the side effects of steroid treatment,and that if he had, thenVictor Hill would have quit his job to avoid exposure to the substanceswhich caused his dermatitis. Dr. Marks and his nurse,on the other hand, testified that while the specific side effects were never enumerated,plaintiffs were informed many times that steroid treatment was dangerous, that Dr. Marks hesitated to continue using it, and thatVictor Hill should get another job. Therewas evidence that plaintiff did, in fact, try to seek other employment but had no alternative skills. Therewas also testimony that plaintiff's conditionwas a severe one, that long-term steroid therapy,while risky,was not entirely unheard of, and that the decision to undertake such therapy is amatter of informed judgment by the treating physician after weighing the risks and benefits. At the close of plaintiffs' case,defendant Squibb & Sons' motion for directed verdict was granted on the ground that there

was no expert testimony that thepackage insert Squibb included with Kenalog-40 was inadequate inwarning of its side effects, ~efendant Marks alsomoved for directed verdict, raising the statute of limitations as a bar and arguing further that plaintiffhad failed to establish a prima facie case because there had been no expert testimony that Dr. Marks had failed to act as a reasonably prudent physician in the areawould have acted in the same circumstances. The court denied Marks' motion,holding that in regard to the statute of limitations therewas a question of fact for the jury as towhen plaintiffs' claim arose; and thatwhile lack of expert testimonywas fatal to the plaintiffs' claim in regard to the question of malpractice, the issue of lack of informed consent should go to the jury because the question of whether plaintiffs had been told enough to make their

own judgment as to continuation of the treatmentwas a question "readily ascertainableby the layman." The case was submitted to the jury in that posture, and a verdict in favor of defendant Marks was returned. Theverdictwas rendered in a general form; it does not appear from the record whether the jury found the statute of limitations issue to be determinativeor if it was rather themerits of the informed consent question that controlled. On appeal,plaintiffs raise the following issues: 1. Whether the filing of an ex parte trial brief by de- fendant Squibbwas a violation of plaintiffs' dueprocess rights. 2. Whether the trial court erred in granting a directed verdict in favor of defendant Squibb. 3. Whether the trial court erred in excluding from evidence certain of plaintiffs' proposed exhibits. 4. Whether the trial court erred in granting a directed verdict in favor of defendantMarks on the issue of malpractice. 5. Whether the trial court erred in submitting the issue of the statute of limitations to the jury rather than treating it

as amatter of law to be decided by the court. Plaintiffs first objected to Squibb's ex parte trial brief - in the lower court in a motion for a new trial. Plaintiffs' specific objection was that Squibb's ex parte brief had compromised 

### -plaintiffs' case in that it failed to citemany pertinent decisions and distorted plaintiffs' evidence and the applicable law. Plaintiffs also objected to thepractice of allowing 

### - ex parte trial briefs in general, contending that itviolates a party's right to an adversary hearing. Rule 19 of the Rules of Practice of the District Court of the Thirteenth Judicial District specifically allows the filing of trial briefs to be used solely for the benefit of the trial court and not divulged to opposing counsel. There is little authority addressed to the propriety or impropriety of this practice. The ABA Code of Professional Responsibility, DR 7-llO(B), contemplates submission of trialbriefs without service on opposing counsel where "authorizedby law". "[Iln the absence of statute,rule,direction of the court, or agreement between counsel requiring service on opposing counsel, it isnot necessary, and indeed not wise, to exchange trial briefs because of the possibility of educating opposing counsel as to the lawyer's theories in regard to his case." 5Am.Jur.Trials p. 92-93. The literature on preparation for trial in products liability cases strongly recommends filing of trial briefs by plaintiffs in such actions. Cf. 12Am.Jur. Trialsp. 121. We recognize that theoretically a rule allowing for the filing of ex parte briefs may be suspect in that it conflicts - with the spiritof openness and cooperation underlying the modern rules of civilprocedure. Nonetheless, judgeshave a right to

secure a trial brief from the attorneys in a cause and, indeed, in a complex case such a brief may be indispensible to inform the judge of the nuances of the arguments that will be forwarded at trial. In our opinion, if the fact that the contents of the brief will be divulged inhibits counsel from accomplishing thatend and thereby impedes the ability of the judge to be fully informed, then a rule allowing for 

### - ex parte trial briefs is defensible. In any event,plaintiffs' attack on the rule here on constitutional grounds isnot persuasive. Plaintiffs themselves could have filed such a brief if therewere matters they felt

were in need of clarificationor explanation. Plaintiffspresented testimony for eight days,at the conclusion of which Squibbmoved for directed verdict. Thereafter,both the attorney for Squibb and the attorneys forplaintiffswere given ample opportunity to argue themotion. Under these circumstances,we cannot find that plaintiffswere denied due process. Furthermore, our reading of the trial brief in conjunctionwith the record and our review of the authorities cited in it does not indicate thatplaintiffs' casewas in any way compromised thereby. 

### We find no error on thispoint. We now turn to the second issue on appeal; alleged error in the directed verdict for Squibb & Sons. Squibb maintains that the directed verdict was proper because plaintiffs failed to produce expert testimony that the package insert in Squibb'sproduct inadequately warned of dangers. Squibb contends that because of this failure plaintiffs did not establish a prima facie case. We agree. As a general rule, the duty of a drug manufacturer to

warn of the dangers inherent in a prescription drug is satisfied if adequatewarning is given to thephysician who prescribes it. Dyer v. Best Pharmical (Ariz.App. 1978), 118Ariz. 465, 577 P.2d 1084; Terhune v. A. H. Robins Co. (1978),90Wash.2d 9, 577 P.2d 975;McEwen v. Ortho PharmaceuticalCorp. (1974), 270 Or. 375, 528 P.2d 522; Davis

### v. Wyeth Laboratories, Inc. (9thCir. 1968), 399 ~.2d 121; 28 C.J.S. Drugs & Narcotics Supplement 857. By logical extension, then, since the warning isdirected to physicians,only they or someonewith similar expertise concerning pharmeceuticalswould be qualified to determine whether or not thewarning was adequate. There are no Montana cases specifically holding that a plaintiff must produce expert testimony to sustain an action against a drug company for failure to warn adequately of side effects of itsproducts. There are,however, numerous Montana decisions to the effect that, in a malpractice suit against a doctor or dentist, expert evidence is the only proper guide and without it a plaintiff cannot recover. Cf. Llera v. Wisner

(1976), 171 Mont.254 

## , 557 P.2d 805, 33 St.Rep. 1211; Collins

### v. Itoh (1972), 160Mont. 461, 503 P.2d 36;Callahan v. Burton (1971), 157Mont. 513,487 P.2d 515; Negaard v. Feda (1968)

## , 152Mont. 47, 446 P.2d 436. We hold that the reasoning of these decisions extends to the situation involved here. Inmatters "withrespect to which a layman can have no knowledge at all, the court and jurymust be dependent on expert evidence." Callahan, 157Mont. at 520, 487 P.2d at 518-519. The adequacy of a warning directed to physicians is such amatter. This conclusion is consistentwith the only other casewe have found where on similar facts an attemptwas made to reach the jurywithout expert testimony that the warning was inadequate. Carlsen v. Javurek (8thCir. 1979,526 F.2d 202. In Carlsen, of a directed verdict in favor of themanufacturer/ an anesthetic

was upheld on appeal. Here, as in Carlsen, there was no expert testimony that thewarning was inadequate. On the contrary,the only expert testimony on the issue was that of Dr. Marks,who stated that in his opinion the warning was 

### -adequate. Therefore,

even viewing the evidence in the lightmost favorable to plaintiffs,we find that the directed verdict in favor of Squibb & Sons was correct.The third issue on appeal involves alleged error in exclusion from evidence of several of plaintiffs' proposed exhibits. The contested items are a 1977Handbook of Practical Pharmacology stating that osteoporosis could be a complication of long-term steroid treatment, and a Contac package. We find

no error in the exclusion of the former because a 1977publication is no proof of knowledge that could be imputed to Squibb & Sons during the period 1965 to 1971when plaintiff was being treated. Plaintiffs argued that the Handbook should have been admitted under Rule 407,Mont.R.Evid. That rule has no application here because the Handbook did not originate with Squibb and was not a subsequent remedialmeasure takenby Squibb. As to the Contac package,plaintiffs apparently offered it as an exhibit because defense counsel in his opening statementnoted that Kenalog-40 was "likea Contac pill" in that the drug is suspended in the bloodstream and dissolved into the system over a period of time. From this,plaintiffs sought to use the warning on the Contac package that it is "not for frequentor prolonged use" as evidence of inadequacy of thewarning on the Kenalog-40 package insert for lack of that phrase. Plaintiffs' argument iswithoutmerit. The Contac packagewarning has no relevancebecause Contac is a nonprescription drug and the warning is not intended for the informed use of a physician but for thepatient himself. The District Court properly excluded both exhibits. The fourth issue under consideration concerns the directed verdict for Dr. Marks on the issue ofmalpractice. The District Court held thatplaintiffs! failure to produce expert testimony in that regard was fatal to their cause of action. Plaintiffs contend that thiswas error because Dr. Marks allegedly admitted that he had violated the applicable standard of care and thereby provided against himself sufficient expert testimony to establish a prima facie case.It is true that in several recent caseswe have cited with approval Evans v. Bernhard (1975), 23 Ariz.App. 413, 533 P.2d 721, for the proposition that third party expert testimony is not necessary if a defendant doctor's own testimony establishes the standard of care and departure from it. Montana Deaconess Hospitalv. Gratton (1976), 169 Mont. 185, 545 P.2d 670;Llera

v. Wisner (1976), 171Mont.254 

## , 557 P.2d 805, 33 St.Rep. 1211. Further, in Thomasv. Merriam (1959),135Mont. 121, 337 P.2d 604, we indicated that negligence of a doctor may be shownby his own admissions. The crux of this issue is, then,did Dr. Marks in fact testify what the standard of carewas and that he had violated it? We find that he did not. In urging that Dr. Marks did so testify,plaintiffs rely primarily on the following exchange that occurred during crossexamination: "Q. Is it fair to say thatwith respect to Vic Hill, from the standpointof the standard of care,you didn't apply to him in administering Kenalog that standard of care that you think you should have, is that correct? A. In retrospect. "Q. The answer is yes? A. Yes." This short colloquy taken out of context does not,however,when read in balancewith the rest of Dr. Marks' testimony, have the conclusive effect plaintiffswould give it. Itdoes not appear that Dr. Marks ever established what the standard of care was,

or admitted that he violated it. At one point he says "Iwas 

### - the standard of care",since he was the only doctor in the community with specialized training in the treatment of disorders like that of Victor Hill. He also testified that in Victor Hill's case, in his best medical judgment, there were no alternatives to the treatment he gave. Plaintiffs' contentions in this regard are not bor~out by Dr. Marks' testimony, and the District Court did not err in directing a verdict in his favor on the malpractice claim for lack of expert testimony. In conjunction with the directed verdict on the malpracticeissue,Dr. Marks has asked us to review the trial court's denial of his motion for directed verdict on the issue of informed consent. Marks contends that the trial court erred in submitting the issue of informed consent to the jury in view of the fact that therewas no testimony, expert or otherwise, that

an ordinarily prudent physician would have been more specific inwarning of the possible side effects of steroid treatment. Marks maintains that even though he has not cross-appealed on this matter we can review the denial of his motion for directed verdict on the informed consent issue under Rule 14,M.R.App. Civ.P. From our research into the authorities construing the statutory predecessors of Rule 14,M.R.App.civ.P., it does not appear that Marks comes within either its scope or its purpose

on the circumstancespresent here. Franciscov. Francisco (1948), 120Mont. 468, 191 P.2d 317, 1 ALR2d 625; J. M. Hamilton Co. v. Battson (1935), 99Mont. 583, 44 P.2d 1064, 101A.L.R. 520; 5

### Am Jur 2d Appeal and Error 8653. Thereforewe decline to undertake the review requested by Dr. Marks in this regard. Nonetheless,we note in passing that the doctrine of informed consent is one concerning which there is significant confusion caused by a failure in many of the reported cases to recognize distinctions. See 36 Ford.L.Rev. 639 (1968). "In most cases involving this issue, courts have held that expert testimony isnecessary to establish the existence and scope of a physician's duty to informhis patient of the risks of a proposed treatment. The type of expert testimony required is testimony

as to the degree of risk or,more commonly, testimony as to the standardmedical practice to disclose risks under the same or similar circumstances or, similarly, testimony as to whether a reasonablemedical practitioner would have disclosed a given risk under the same or similar circumstances." Annot. 52ALR3d 1084, 1088. Montana follows the latter version of themajority rule.Negaard v. Feda (1968), 152Mont. 47, 446 P.2d 436; Doerr v. Movius (1970),154Mont. 346, 463 P.2d 477; Llerav. Wisner

(1976),171Mont. 254, 557 P.2d 805, 33 St-Rep.1211. The trial court judge in this casewas aware of these Montana decisions when he ruled on Dr. Marks' motion for directed verdict. He allowed the issue of informed consent to go to the jury despite the absence of expert testimony because he felt that the circumstancesof the case came within language from Llera, that expertmedical testimony isnot necessary if "the conduct complained of is readily ascertainableby a layman." Llera v. Wisner, 557 P.2d at 811, 33 St.Rep. at 1217-1218. We note that this language from Llera goes to the question of the establishment of a standard of care to demonstrate negligence generally rather than to a standard of sufficiency of the physician's disclosure. In our opinion, there are different considerations involved. Cf 36 Ford.L.Rev. 639 (1968). In any event, since the jury found for Dr. Marks, if therewas error in submitting the informed consent issue to them it was harmless error. Therefore,any further discussion of the correctness or incorrectness of the distinction drawn by the trial court judge would be inappropriatehere. The final issue involved in this appeal is alleged error by the court in submitting to the jury the question of whether plaintiffs' claimwas barred by the statute of limitations. Plaintiffs contend that in Montana the application of the statute of limitations is to be determined by the court as a matter of law. In support of that position plaintiffs rely on Hornung v. Richardson-Merrill, Inc. (D.Mont. 1970), 317 F.Supp. 183. Hornunq was a products liability action against a drug manufacturer where the defendant's motion for summary judgment on the statuteof limitations was denied because therewas an issue of fact as to when the plaintiffs should have become aware of the causal connection between the damages at issue and the defendant'sproduct. JudgeRussell Smith stated that on the trial of the case the Court would resolve that issue of fact on the basis of the evidence presented. In a footnote to that statement,Judge Smith noted: "Iwould have thought that the factproblems surrounding the applicationof a statute of limitationswould be resolved by a jury in a jury case,but apparently the rule is otherwise." Hornung, 317 F.Supp. at 185. The cases cited in support of that footnote are Falls Sand & Gravel v. Western Concrete, Inc. (D-Mont.1967), 270 F.Supp. 495, and Owensv. White (9thCir. 1965), 342 F.2d 817. Our review of those decisions and the cases cited in them indicates that they represent a line of authority that was inapplicable to the circumstances,and that the initial thoughtmentioned by Judge Smith in his footnotewas correct. Falls Sand & Gravel, supra, was a case involving alleged negligent misrepresentationby a contractor of the amount of materials to be furnished by a supplier. The court equated negligent misrepresentation with fraud and cited several Montana fraud

cases holding that the time at which there has been a discovery of facts constituting fraud to start the running of the statute of limitations is a question of law. Kerriganv. O'Meara (1924), 71Mont. 1, 227 P. 819; Ray v. Divers (1928),81Mont. 552, 264 P. 673. As to Owens, supra,that was a malpractice action, but it was a decision construing Idaho lawunder which the issue of when a plaintiff's claim accrued for purposes of the statute of limitations is apparently a preliminarymatter of law in every case "and like all issues of lawmust be resolved by the court even though thiswill require evidence." Owens, 342 F.2d at 819. In relying on Falls Sand & Gravel and Owens, the court in Hornung overlooked the line of authority which controls here and should have been controlling there. Accordingly, plaintiffs' reliance on Hornung here is inappropriate. The rule in Montana and in themajority of jurisdictions is thatwhether an action isbarred by the statuteof limitations isfor thejury when there isconflicting evidence astowhen the cause of action accrued. Staggv. Stagg (1931), 90 Mont. 180, 300 P. 539; 54 C.J.S. Limitations of Actions S399. That was the casehere. Plaintiffsmade some unsubstantiated allegationsthat Dr. Marks had somehow concealed their cause of action from them, but there is

no evidence inthe record thatwould support application of the special rule infraud caseshere. Wehold thatthe District Court properly submitted the issue of the statuteof limitations tothejury. None of the specifications of error raised by plaintiffs have merit. The judgments entered by theDistrictCourt are affirmed.

Chief JusticeJustice John C. Sheehy, specially concurring: I concurwith the foregoing opinion, but Iwant to expressmy disapproval of Rule 19 of the Thirteenth Judicial District, or any rule like itwhich permits the filing of - ex parte briefs with the Court. Ido not find in this case that the filing of the - ex parte trial brief deprived the plaintiff of due process, but I can conceive of situations in which substantial harm would be done to a party's casewhere trial briefs (ineffect, private communications to the trial court that are not served upon the other party) deprive the District Court of the benefit of the adversary process. The spirit of the federal rules of civil procedure, upon which the Montana rules of civil procedure are based, is full and open disclosure of fact and law. That spirit is best expressed in Burton v. Weyerhaeuser Timber Company (D.C. Oregon 1941), 1 F.RR 571, where the trial court said: 

# ".

. . I can sympathizewith the desire of counsel, experienced in the older forms of practice, to withhold disclosure of such dramatic issuesuntil the midst of trial, but itmust be made clear that surprise,both as a weapon of attack and defense, is not to be tolerated under the new federalprocedure. 

# . . "Faithfully administered in spirit, as my senior colleague and I are endeavoring to administer them, the new rules outlaw the sporting theory of justice from Federal courts." 1 F.R.D. at p. 573. All attorneys practicing under the Montana Rules of Civil Procedure should come to know that the guidepost of practice under the rules is full disclosure of law and fact. This ismost effectually done by adherence to pretrial procedure. At that time, as the Court said in Burton, supra:"1. Parties are expected to disclose all legal and fact issueswhich they intend to raise at trial, save only such issues asmay involve privilege or impeachingmatter. As to these two exceptions, disclosuremay be made to the judge conducting the pretrial hearing without disclosure to opposing counsel, and a ruling will be made on the exception claimed. "The test to be applied on impeaching matter or any factual issue,which counsel feels should not be disclosed to his opponent in advance of the trial, is the simple one--whether disclosure or nondisclosurewill best promote the ends of justice. That is for the judge conducting the pretrial hearing to determine." 1 F.R.D. at 572. The day isgonewhen the prototype old fashioned attorney produced the hidden witness at trial or the uncited but decisive case and left the opposing attorney lying bloody

on the courtroom floor. Justice is achieved,under the spirit of our modern rules, by full and open disclosure of law and fact. The statements in Burton were approved in the Ninth Circuit Court of Appeals in Walker 

### v. West Coast Fast Freight Inc. (9thCir. 1956), 233 F.2d 939.