*1 55,655 No. Lynn Wooderson, Appellee, v. Ortho Pharmaceutical
Carol Corporation, Appellant.
(681 1038) P.2d *2 Opinion filed April 1984. York, Patterson, Tyler, Dobbins, Belknap, New Webb & of New F. of David Fleeson, Newkirk, Gooing, &
York, cause, argued Coulson R. of Donald Kitch, Wichita, appellant. for of was on briefs Hutton, Michaud, Michaud, Michaud, Cordry, & Hutton Gerald L. Corrin, cause, Dwight Wichita, argued A. H. Hutton and and Andrew firm, appellee. the brief for same were with him on opinion the court was delivered Plaintiff, Lynn Wooderson, brought Carol J.: Miller, Sedgwick County action the District Court for damages for personal injuries which she claims resulted her ingestion, from period years, contraceptive over a Ortho-Novum 1/80, defendant, manufactured Ortho Pharmaceutical Corporation (Ortho). trial, At the conclusion of a six-week jury returned a verdict and the judgment court entered against $2,000,000 damages Ortho for actual punitive damages $2,750,000. appeals. primary issues whether there competent was sufficient evidence to support verdict, and whether trial properly court sub- mitted the matter punitive damages jury. Other issues will be opinion. stated in the Lynn
Carol Wooderson consulted Dr. Richard L. Hermes of Lawrence, Kansas, physician specializing in obstetrics and *3 in gynecology, planning fall 1972. She was to be married contraception. and wanted some method pre- Dr. Hermes (o.c.), scribed an contraceptive 1/80, Ortho-Novum' manu- by factured the defendant. drug, This an “ethical” one obtain- only upon able prescription, distinguished as from a “proprietary” “patent” drug, one sold over the counter. good time; Plaintiff in pressure was health that at her was blood 100/56, any problems and she had never kidneys had with her high pressure. 1/80, blood pre- She took Ortho-Novum as by physician, scribed her continuously from the fall of 1972 until 1976, exception thirty days with the in early about June when she a physician had rash on her hand and a suggested that stop taking she pill away. until the rash went She Dr. saw 1974; Hermes in nothing December his notes reveal remarkable her except pressure about health at her that time that was blood prescription 130/80. The for Ortho-Novum 1/80 was extended for year. another Mrs. January Wooderson next saw the doctor 1976. His nothing except notes reveal remarkable her blood pressure cold, was 120/90. She had a and Tuss-Ornade was prescribed prescription for that. The Ortho-Novum was also 1/80 year. 4,May 1976, Hermes; extended for one On she called Dr. cold, still a prescription she had and he called a for Tuss-Or- 25, 1976, On again nade. reported she called him. She June pains stomach vomiting. stop vomiting Medication to go her to prescribed, Dr. Hermes advised was as was bed rest. hospital if she had no relief emergency at the room Next, 28,1976, Mrs. went to the office. night. on Wooderson June in, examined one of his Dr. and she was Hermes was not associates, pressure was 160/88. Her blood Dr. Howard Wilcox. nausea, dizziness, complained pain, headaches She of abdominal flu. coming felt like down with the and weakness. She she prescribed her the oral Dr. Wilcox took off of following day, Dr. She still On the she called Wilcox. Equagesic. breath, headaches, weak, and had sore felt was. short of had her with the Tuss-Or- He directed to continue cough. throat and 30, the office and On she called Equagesic. nade and the June Buck, authorized refill of with Dr. another associate. He talked later, July prescription. days on she saw the Tuss-Ornade Two vomiting; complained She was still she Dr. Wilcox his office. ached; exertion; legs slight her and she had upon of exhaustion pressure had reached sore throat but no fever. Her blood day tests and later that same 186/104. Dr. Wilcox ordered some Reid, internist, her and saw referred her to Dr. an who examined laboratory He the Lawrence reports. all of the directed July on 2. Her blood Hospital, Memorial which she entered pressure diagnosed having as chronic renal was 202/102. She was later, Sunday, July 4, she was days disease. Two U. in Kansas to the K. Medical Center transferred ambulance City, Kansas. center,
Upon she was described her arrival at the medical initially condition, diagnosed as being poor and she was dialysis suffering Peritoneal was com- from “renal failure.” later, days surgery performed A so immediately. menced few hemodialysis machine. Her that she could be connected *4 utterly failed, completely kidneys dependent she was had U. from the K. Medical hemodialysis. She was released upon 28,1976. hospital upon discharge her July The records Center on summary: following contain the case hemolytic secondary syndrome, uremic “FINAL DIAGNOSIS: Renal failure contraceptive induced. dependent. Hypertension, volume secondary Congestive overload. heart failure volume secondary to Anemia #1.
391 AND PROCEDURES: “OPERATIONS dialysis. Peritoneal open. biopsy, Renal leg External shunt. placement Internal fistula the left arm. - patient discharged following The on the “DISPOSITION: medications Atarax, mg. Inderal, mg. q.i.d.; p.o. p.r.n. itching p.o. Dalmane, mg. p.o. p.r.n. sleep; Coumadin, Colace, mg. p.o. daily; p.o. 2.5 1 tablet t.i.d; Alu-Caps, t.i.d.; p.o. 2 tablets Vitamin, p.o. daily. patient Renal Dialysis returning Outpatient will be weekly dialysis. Clinic thrice for in-center patient undergo, and husband will home dialysis training in the late summer or early fall. “PROGNOSIS: Fair.”
After plaintiff was discharged, she hospital had to return to the weekly three times from her home in dialysis Lawrence for In treatments. October she and her husband travelled to daily medical center for training four weeks and took dialysis. November, home got dialysis a home ma- chine, and gave thereafter her husband the treatments at first, dialysis hours; home. At six took later it was reduced to hours, five then to four hours. Mrs. Wooderson continued to have pressure blood problems kidneys until both of her were removed 1,1977. surgically February on eye problems, She had for which hospitalized she was regularly. 22, 1977, and treated On March kidney she had transplant from her brother. This was unsuc- cessful; rejected kidney. she the donated It was removed on April 12, 1977. 3, 1981,
On May dialysis, following very had low pressure blood cramps. and stomach grew progres- The latter sively worse. was She taken Hospital Lawrence Memorial and then transferred University ambulance to the of Kansas arrival, Medical Center the following morning. Upon she was having described as pain having severe abdominal symptoms classic peritonitis. Exploratory surgery abdominal performed immediately. Roughly one-third large of her intestine, colon, right be gangrenous, found to and was removed. Racteria that normally live inside the intestine were outside, peritoneal found in the cavity, and this was cause of *5 in the generalized infection abdomen. peritonitis George Emory operation, this Dr.
surgeon performed who Pierce, M.D., difficulty plaintiffs with the concluded that This, inadequate supply blood to intestine. bowel was due to pressure following dialysis. turn, by the low blood was caused surgery, well from abdominal Mrs. recovered Wooderson hospital May 1981. discharged from the and was has performed in November 1981 kidney transplant A second kidney, plaintiff has had receiving that proven successful. Since go rejection, back on the and she has not had one minor trial, gotten along dialysis the time of she had well machine. At pres- kidney new thirteen months. Her blood with the some right spots in the problem. She still has blind sure has not been Prednisone, steroids eye, taking and she is Imuran and drugs, well as a renal vitamin and immunosuppressant Colace, long the steroids so She will have to take a stool softener. involved, kidney. the risk Because of as she retains donated she will not have children. expenses up medical to the time out-of-pocket
Plaintiff s actual trial, to and plus wages mileage from home loss of $215,000. Damages sustained and hospital, exceeded from the drug monetary figure include future covered within not kidneys, (estimated $28,800), cataracts in loss of both expenses at eyes, the continued risk cancer because of both increased children, steroids, inability ingestion of to have loss blood necessitating major abdominal part large intestine flow intestine, risk of further surgery part and removal of pain suffering caused anguish, and mental surgery, intestinal repeated hospitalization, operations, extended hemodia- lysis years, for five brother’s donated and one-half loss of her kidney, fifty-five and some blood transfusions. Ortho does not argue $2,000,000 compensatory damages that the awarded as excessive, supported or that of the award is not the amount Instead, agrues evidence. there no substantial kidney plaintiffs evidence that caused failure; duty hemolytic risk that Ortho had no to warn of the (HUS); if it have the syndrome and that even did uremic relationship to Dr. warn, no causal its failure warn born plain- 1/80 for the prescribe Ortho-Novum Hermes’ decision to position did sustain the Thus, is not that tiff. Ortho’s *6 injuries claimed, damages but that Ortho did not cause them to responsible. challenges occur and is therefore not It causation responsibility, injury. OF
SUFFICIENCY
THE EVIDENCE
evidence,
The rules under which we review the
when chal-
lenged
sufficiency
verdict,
as to
support
are familiar. In
Co.,
681, 684,
Cantrell v. R. D. Werner
226 Kan.
See Realty Meyers, 304, also Hand Co. v. 306, 234 Kan. 672 P.2d (1983).
Similarly, in
v.
Corp.,
305,
Timsah General Motors
225 Kan.
(1979),
591 P.2d
concisely
Syllabus ¶
the rule
stated in
1:
ground
contrary
evidence,
a verdict is attacked
“When
on the
it is
it is not
appeal
weigh
pass
the function of this court on
the evidence or
on the
credibility of the witnesses. If the evidence with all reasonable
inferences
be
therefrom,
light
drawn
when considered in a
most favorable to the successful
party below,
support
will
the verdict this court should not intervene.”
“Substantial evidence”
pos
is defined as evidence which
sesses both relevance and substance and which furnishes a
substantial basis of fact from which the
reasonably
issues can
be
resolved. In
App.
re
Community Psychiatric
Need
Certif. of
Centers, Inc.,
802, 806, 676
(1984);
234 Kan.
P.2d 107
v.
Haddock
462, 233
66, 661
U.S.D.
(1983); Kelly
No.
Kan.
P.2d
v. Kansas
City,
Community
College,
Kansas
231 Kan.
THE PILL CAUSATION substantial, competent Was there evidence that the con- traceptive plaintiffs hemolytic Ortho-Novum 1/80 caused ure- kidneys? (HUS) consequent loss of and the syndrome
mic Plaintiff, that the support of her claim is the first issue. That specialists, Dr. Dennis HUS, presented three drug caused her physicians and mem- Cuppage, both Dr. Frank Diederich and Center, and Dr. at the K. U. Medical teaching staff bers Oregon Ph.D., pharmacology at Gabourel, professor John formerly University Oregon University, Health Sciences presented these witnesses she Through of Medicine. School journals, and scientific both many published in medical articles here and abroad. syndrome, HUS. A
First, hemolytic uremic a word about disease; symptoms it is a or constellation of syndrome is not a set *7 recognize help physician and which together, which occur or apart serious conditions and set it from less the condition than all —of at least less indicated when one —or diseases “Hemolytic” causing means hemo- present. symptoms “Uremic” means the red blood cells. lysis, the destruction of uremia, in the by pertaining presence of urine caused or Hemolytic thereby produced. and toxic blood condition flu-like syndrome usually manifests itself with first uremic nausea, fatigue, fever —and sometimes symptoms headache, — pressure. rapid. The onset is constantly increasing blood through symptoms main or features. recognizable is three HUS failure; (2) a (1) thrombocytopenia, kidney acute These are: platelets, small color- blood marked decrease in number of clotting coagulation in the in the blood which assist less cells blood; anemia, in which the (3) hemolytic a condition and of red blood cells. markedly in the number is deficient blood in or the kidney (resulting failure uremia symptoms, These three thrombocyto- blood), urinary in the presence constituents through examina- hemolytic anemia, can be detected penia, and abnormality reflected in syndrome is also tion of the blood. kidney; vessels in the intima small blood lining in cells mov- hemolysis the red blood or destruction of this causes Abnormality vessels injured lining. of the blood ing across extremely pathologically. HUS kidney may detected be downhill, relentlessly being Its course described serious. result. kidney failure the usual with irreversible department of in the professor of medicine is a Dr. Diederich He is board-certified K. U. Medical Center. medicine at internal in nephrology. practice, internal medicine and also in His and in teaches, the area which he diagnosing consists of various problems kidney, trying with the to determine the cause of the ailment, kidney treating the condition. He has in been nephrology department section of the of internal medicine at the K. by U. Medical telephone Center since 1969. He was alerted physician Lawrence, call from s present and was when arrived July 4, she at the medical center on 1976. She was directly There, taken to the intensive care unit. Dr. Diederich observed that pressure very her blood high. was She showed circulatory evidence of hard, overload. Her heart was beating her pulse pounding and her veins were distended. Her hands and feet were swollen. The breath sounds reflected moisture lungs. making very, very urine, She was small amounts of a catheter in her bladder demonstrated there was no flow of being new urine made kidneys. The blood in her vessels eyes evidenced dialysis increased tension. Peritoneal was em- ployed pressure to relieve and correct the blood filtration. Blood tests disclosed that expected she had less than half of the sample blood, normal amount of red blood cells of her and a 2,500 low 4,000 6,000 white blood cell rather than the count — normally which would be found. pounds Twelve to fifteen fluid peritoneal week, was removed dialysis. Later specimen small surgically kidney, taken from microscopically this was examined. history
Dr. patient Diederich was furnished with a *8 patient’s family. carefully of the He and out checked on ruled possible infection or plaintiffs the other causes condi- tion. He contraceptives testified that oral changes cause in the blood vessels kidney. expressed in the opinion He that the oral contraceptive by plaintiff taken responsible for the kidneys destruction of her generation malignant and the hypertension. hospital, When Carol first Wooderson entered the Dr. thought HUS, Diederich suffering that she was from brought by on contraceptives the oral taking. which she had been He still thought so when she was hospital July released from the on Thereafter, 1976. many he published read additional articles on subject in journals, various medical dozens of which were trial, received in in evidence this case. When he testified at the by Dr. Diederich still believed that the oral taken resulting loss of her caused her HUS and Carol Wooderson kidneys, eye problems, the loss of a section of her and intestine. M.D., was testimony Cuppage, of Dr. Francis Edward Cuppage patholo- is a deposition. Dr.
presented by video-tape kidney in or renal disease. interest gist, special area and his University of Kansas teaching at the staff He has been on professor a since he has been full Medical School since medicine, teaches, in acute and does research practices 1973. He he has pathologist, He is a board-certified renal failure. fifty-four journals, most of published articles in medical some kidney. are also related to blood them related to Some plaintiff and had not He had direct contact with the supply. no pathologist in deposition was taken. He is seen her before his such, charge biopsies U. Center. As of renal at K. Medical Diederich, a request Cuppage Dr. Dr. examined and at the 8,1976. kidney July portion had portion This of the s procedure Hermrick, surgeon, by Dr. been removed Arlo biopsy. sample was examined kidney wedge One known microscope, was examined and the other usual method microscopically Cuppage first microscopy. When Dr. electron history clinical tissue, plaintiff s he had not read examined this later these materials when laboratory He had read findings. kidneys, after their removal studies were conducted on early 1977. microscope prepared from explained the slides Cuppage Dr. kidneys, pointed and he out biopsy of Carol Wooderson’s in the vessels and major damage, in the blood areas of both why the slides glomeruli, kidney. explained He the filters of the kidney damage. might cause things rule out of the most contraceptive expressed opinion that the Cuppage Then Dr. 1/80, produce pill, can an alteration the blood Ortho-Novum plaintiffs cause of thought probable that the most vessels. He problems was blood vessel lesions resulting health HUS and her blood The lesions the small produced by contraceptives. first; damage kidneys hypertension came vessels in the He glomeruli the vascular lesions. followed as result of the time he was firmly convinced at that he was more stated correct than testimony original diagnosis was that his giving his and clinical pathological it. made All he had been when he *9 opinion. solidified his which he received later information Ph.D., Gabourel, pharmacology professor from the John Oregon University, length. Health Sciences testified at He re- degree pharmacology University ceived his Ph.D. in at the many subjects Rochester in 1957. He has conducted research on support many years. and has had national level research for He university, teaches medical students and nurses at the and also participates continuing practicing in courses education for the physicians his state. Included in the areas he teaches systematic system pharmacology organ pharmacology, specific drugs deals with the effect of on different tissues and organs body. thirty-one He has major authored some publications, plus a lesser number preparing of short articles. In testify case, portions he read abstracted medical many records of the original articles that had been previously obtained Dr. Diederich. He ran a Med.-Line computer own, search his discovered and read additional articles, Medicine, consulted Harrison’s Textbook of and in general everything read that he pub- could find had been relating lished particularly to HUS and occurrence women who have taking contraceptives. been oral He testified spent that he had almost all three weeks before he testified reading HUS, thinking running computer about more areas, searches in different talking people spe- to other areas, cialized including officials Drug of the Food and Admin- He expressed opinion 1/80, istration. Ortho-Novum women, some malignant hypertension, causes vessel wall dam- HUS, age, permanent failure kidneys. of and loss of the It professional was his opinion that Ortho-Novum 1/80 caused Carol Wooderson’s kidneys. HUS and the loss
Among the why reasons this witness concluded that Ortho- plaintiffs (1) Novum 1/80 caused HUS were: Plaintiff took the contraceptives long oral enough development of lesions of type Irey identified Dr. being Nelson caused oral contraceptives; (2) agency no other with known association to present; (3) HUS was (a estrogen compo- known effects of 1/80) nent of compatible (a) Ortho-Novum the alteration (b) platelet in blood vessel structure and enhancement (4) and aggregation; twenty-one reported adhesion there were cases having of women on HUS before *10 thirty-nine
plaintiff, patient at the trial were and time of there were with reported contraceptives cases wherein associated HUS; “re-challenge”— a (5) reports, there was in two of the contraceptives symptoms and showed who were on oral women contraceptives apparently and HUS were taken off the oral recovered, put and suffered were back on oral HUS; (6) pathological and severe examination recurrence nephrec- report February plaintiff after s bilateral done as tomy, with HUS. Dr. Gabourel ruled out was consistent agents drugs all of had taken causative the other opinion HUS. It his that Ortho- prior to the onset of her was wall and of the inner Novum caused inflammation occlusion 1/80 kidney kidneys. tiny arteries her This was followed malignant hypertension. suggested that her failure and then He January pressure highly significant, 1976 blood is 120/90 pre-oral Thus it contraceptive 30mm her measurement. rise over if catastrophy his have been avoided opinion this could Warnings have physicians properly her had warned. would been pressure physicians alerted monitor her blood more closely tests to conduct various urine and renal function and Early prevented earlier have the irre- in 1976. detection could kidney versible failure. of n Dr. Diederich testimony and Dr. Gabourel extends transcript. Cuppage’s deposition through of trial Dr. ten volumes lengthy physicians is also Other also document. testified. portion very but small brief summaries above reflect plaintiffs plaintiffs evidence in this case. Ortho contends that “conjectured” and on a proof of medical causation “based record, diagnosis Upon reviewing this of exclusion.” entire however, proof appears it to us that of medical causation is studies, detailed, upon commencing and scientific logical, based Irey. requisites pathologist Nelson One of those of arriving possible cause is to consider all at a conclusion this, expert gave causes. Plaintiffs witnesses did and each cause, why Ortho-Novum detail the reasons 1/80 why possible cause of be each other HUS had to in this case. We that there an abundance eliminated conclude finding competent support jury’s evidence of substantial HUS, the plaintiffs 1/80 caused her acute Ortho-Novum injuries kidney failure, resulting damages. and her DUTY TO WARN prescribing that it had no to add to Ortho contends might a statement that there instructions for Ortho-Novum 1/80 HUS, product the use of that be an between association support malignant hypertension, acute renal failure. (1965), §
contention, (Second) 402A cites Restatement of Torts it thereto, Lindquist Ayerst including Labo the comments ratories, Inc., 308, 319, 607 (1980). Lindquist 227 Kan. P.2d liability malpractice brought products was a and medical case Laboratories, Inc., Ayerst the manufacturer an anes against decedent, thetic which administered and the two had been *11 physicians who had administered the anesthetic. Verdict had and In the appealed. been entered for the defendants opinion, course of the we said: jury liability properly regarding strict “[T]he instructed doctrine of expressed (Second) (1965). jury § in Restatement of Torts 402A The was in- Ayerst provided they drug structed to find liable was in a defective found unreasonably dangerous persons might expected condition to who be to use it, Lindquist. where that defect caused or contributed to the death of Ayerst properly defective is the failure of warn and instruct the condition to profession respect possible consequences
medical the use and use to of 227 Fluothane.” Kan. at 319. Restatement, together applicable Section 402A the with the of portions thereunder, of Comment read as follows: J “§ Special Liability Physical 402A. of of Product for Harm User Seller to or Consumer “(1) any product unreasonably dangerous One who sells in a defective condition subject liability physical property to the user or consumer his is or to to for harm consumer, thereby property, caused to the ultimate user or his if or to (a) engaged selling product, the seller is in the of such a business (b) expected it is to and reach the user consumer does or without substantial change in the condition which it is sold. “(2) (1) applies although rule stated Subsection (a) possible preparation the seller has exercised all care in the and sale of his product, and (b) product any bought the user has or consumer not from or entered into contractual relation with the seller. j. Where, however, warning. product . . . Directions or contains an ingredient population allergic, to which a substantial number and the of ingredient danger known, generally is one whose is or if is one which not known reasonably expect product, the consumer would not find in is to the seller required give it, warning against knowledge, application he has or if of reasonable, developed knowledge, human skill and should have foresight presence ingredient danger. poisonous and the Likewise in the case reasons, may unduly dangerous warning
drugs, as to use be other or those for supplied.) required.” (Emphasis “if upon portion reading the comment Defendant that seizes reasonable, application of devel- knowledge, or he has have foresight skill should knowl- oped human contends, essence, that an ethical . . . edge warn- drug provide is bound to manufacturer not (prescription) frequent side is so and the ings until the occurrence of effects maker is itself drug clear-cut that the evidence of causation so problems. drug or to such causes contributes convinced This, conclude, drug duty we is the law. A manufacturer’s A is and the rules are stated numerous cases. warn discussed Pharmaceutical, leading case in this v. Ortho field McEwen (1974). brought suit Or. P.2d 522 Plaintiff McEwen Syntex alleged give appro- their failure to against Ortho and profession dangers priate warning which the medical reason know were inherent in the manufacturers knew had judgment and defend- products. use their Plaintiff recovered said: affirming judgment, court appealed. ants DOCTORS DUTY TO WARN PLAINTIFF’S “I. DEFENDANTS’ any question of defendants’ oral here defect in the manufacture “There no settled, prescribed. contraceptives, efficacy is well It their when taken as nor of however, drugs ethical bears the additional the manufacturer of making timely adequate profession dangerous warnings to the medical knows, E.g., produced by drugs has to know. side effects of which it reason 1966); Cornish, (8th Sterling Drug, & Co. v. 370 F2d Cir Parke-Davis Inc. *12 Parke, Co., Stromsodt, (8th 1969); & 9 v. Davis Cal 3d 411 F2d 1390 Cir Stevens 378, App 51, Rptr 45, (1973); 2d Cal 38 Wolf, 107 Cal 507 P.2d Love v. 226 653 Inc., (Mo Sup (1964); Krug Sterling Rptr Drug, 143 Ct 183 v. 416 SW2d Cal 300, (1965). 1967); (Second) § 2 of Torts 388 see Restatement dangers duty drug is manufacturer warn limited to those “The of the to ethical know, knows, has reason are inherent in the use of which the manufacturer to particular However, drug expert drug. is as an in its the manufacturer treated *** develop field, duty keep abreast is a to of scientific under ‘continuous notify product touching upon the the manufacturer’s to medical ments profession v. from its use.’ Schenebeck additional side effects discovered 919, (8th 1970);. Inc., & Sterling Drug, O’Hare v. 423 F2d 922 Cir accord Merck is, (8th 1967). duty drug Co., to Cir manufacturer’s warn 381 F2d therefore, gained knowledge with its actual from re commensurate reports knowledge but also with its constructive as search and adverse reaction and other available means of communication. scientific literature measured doctor, drug “Although duty of the manufacturer warn the the ethical is to directly patient patient, a the manufacturer is than the liable to rather Inc., duty. Sterling Drug, supra; v. Love v. Wolf, See Schenebeck breach of such duty supra. compliance prescribing with The manufacturer’s this enables the physician possible against gained by risk to balance the harm the benefits to be Moreover, drug. patient’s Sterling use that as observed the court Cornish, Drug, supra at Inc. 370 F2d 85: “ ‘*** purchaser’s intermediary pur- [T]he doctor is learned between the properly possibility chaser and manufacturer. If the is warned of doctor patients, symptoms normally a side effect in advised some and is of the accom- effect, panying injury patient the side there is an excellent chance that to can slowly***.’ particularly injury place be avoided. This is if the true takes “Although drug duty the ethical manufacturer’s to warn has been discussed prescribing physician, reasoning most often with reference to the the above applies equal treating physician. especially important is force It manufacturer’s, treating warnings impossible doctor receive where it is predict particular patient apt in advance whether a is to suffer adverse effects drug, treating may likely from a since the doctor be more to observe the actual symptoms drug’s consequences. prescribing physician of the untoward If the is deciding patient to make an entitled informed choice whether the should begin taking prescription drug, treating physician it that a follows should have making patient the same information his decision as to whether the should stop taking drug. duty extends, then, drug “The of the ethical manufacturer to warn to all profession patient of the members medical who come contact into with the in a decision-making capacity. satisfy duty, this To must manufacturer utilize warning reasonably effective, taking methods which will be into account both drug’s the seriousness of the adverse effects and the difficulties inherent bringing group large such information to the attention of a as diverse as profession. Drug, Yarrow, (8th Sterling medical See Inc. v. 408 F2d 978 Cir 1969). warning apprise general practitioner should be sufficient to ‘unusually sophisticated dangerous propensities well as the medical man’ drug. Stromsodt, 1390, 1400 (8th 1969). of the & Parke-Davis Co. v. 411 F2d Cir short, upon bring warning ‘it is incumbent the manufacturer to home to the Rheingold, Liability Drug doctor.’ Products Ethical Lia — The Manufacturer’s bility, Rutgers (1964). U RevL however, suggested, prescription drug “It been has that the of a manufacturer duty profession product should be under no to warn the medical that its dangerous allergic hypersensitive when certain used users. It is unreason- able, runs, argument upon duty impose so the manufacturer a to warn dangers threatening statistically insignificant doctors of of users. number We argument unpersuasive. find this negligence dangerous field “In the to warn is limited to those propensities knows, drug of which the manufacturer or has reason to know. allergic anticipate, If reactions are harder to be taken into account in should evaluating knowledge. the manufacturer’s It must be remembered that the liability negligence drug dangers the ethical restricted those manufacturer which are foreseeable. “Furthermore, simply impose liability that it is conclude unreasonable to *13 danger only statistically percentage the known where a small threatens of the drug’s beg very question negligence. users to the class The size of of 402 only factors to be considered endangered persons one—of the is one—albeit were, fact, warnings deciding reasonable. whether the manufacturer’s duty is, then, subject drug warn a to the medical to “The ethical manufacturer knows, profession manufacturer or has reason to of untoward effects which the Cornish, supra know, drug. Sterling Drug, use its Inc. v. are inherent in the Stromsodt, 1390; 82; supra 411 F2d Basko v. & v. 370 F2d Parke-Davis Co. 1969); Inc., (2d supra App Cal Sterling Drug, Wolf, Cir Love v. 226 416 F2d 417 143; Wyeth Inc., 378; Drug, supra Sterling 416 SW2d Davis v. Krug 2d v. cf. 1968). Wright Inc., (9th Laboratories, v. Carter Cir See also 399 F2d 121 (2d 1957); Hungerholt Products, Inc., v. Land O’Lakes Crea 244 F2d 53 Cir (8th (D 1963); 1962),
meries, Inc.,
F2d
Cir
Supp
aff'd 319
352
209 F
177 Minn
Co.,
45, 143
(1913).
Winthrop
48
But see
&
177 Mich
NW
Gerkin v.
Sehler
Brown
Crocker,
(Tex
Drug,
Sterling
2d
Civ
Inc. v.
SW 850
Division
Laboratories
1973).”
App
the knows know of the manufacturers, drug knowledge case of the standard of constructive is that of an expert Reyes Laboratories, (5th particular Wyeth 1974), in that field. v. Cir. Inc. ‘vitally important’ F.2d [citations omitted]. [D]ates . . . are with respect duty required to the warn. Because a to manufacturer cannot be to warn science, knowledge chargeable a risk unknown to the to him must be limited to period during using product question. that of the which the in the [Citations omitted.] important liability applies . “A second . . limitation on manufacturers to only [prescription] drugs. drugs by prescrip ethical of tion, Since such are available duty only profession, a manufacturer’s to warn extends to the medical (1978), [Citations the ultimate users. v. omitted.] not Terhune A. Robins Co. H. 9, 577 exception 90 Wash.2d 975. The this P.2d rationale for to the Restatement’s general rule is that ‘Prescription drugs likely medicines, complex are to be esoteric in formula and expert, prescribing physician varied in effect. medical As a the can take into propensities drug, susceptibilities account the of the as well as the of his patient. weighing against His is the task the benefits of medication potential dangers. one, choice an The he makes is informed an individualized judgment knowledge patient palliative.’ medical on a bottomed both Reyes Wyeth Inc., Laboratories, supra. court in A. Terhune v. H. The Robins Co., supra, elaborates further: product only ‘The reasons for this rule should be Where a obvious. is available prescription through physician, physician the a or services of the acts as a intermediary’ patient. ‘learned between the manufacturer or seller and the It is duty qualities products his to inform himself of the and characteristics of those prescribes patients, which he for or administers to uses on his and to independent judgment, taking knowledge exercise an into account his of the patient and, product. expected patient as well as the is it can be presumed, place primary upon’that judgment. physician does reliance patient. Thus, product properly decides what facts should be told to the if the is necessary fully warnings apprise labeled carries the instructions and physician procedures proper involved, dangers of the for use and the may reasonably physician manufacturer assume that will exercise the judgment thereby gained conjunction independent informed in with his own learning, patient. in the suggested best interest of It has also been that the necessary by ordinarily is rule made the fact that it is difficult for the manu- directly (Footnote omitted.)’ facturer to communicate with the consumer. summary, proper warning “In under k in Comment the context of the facts at bar, product communicates a risk attendant of the is on the use known to during period experts product in only the field in which the It need is used. doctors, patients directed to not be who ultimate users. summarize, product faultlessly designed may “To which is and manufactured unreasonably dangerous § meaning be nevertheless within the 402A if accompanied by proper warnings. required A manufacturer can be to warn during product using known of risks the time in which knowledge expert question, charged of an that field. he is however discharged adequate drugs, if manufacturer’s case of ethical the warning doctors, given act as ‘learned intermediaries’ between who adequate, warning be must be reason- the ultimate user. To manufacturer and matter, practical is determined As a under circumstances. able theory. application negligence inadequacy warnings, Chapman proof offered into Ortho’s “As of the testimony expert warnings question as the full text of written evidence profession argues knowledge at the time. Ortho in the medical to the state of expert opinion qualified give plaintiffs expert an was not experience warnings special training adequacy he had no since *15 warnings. reading writing This is not the test: and State, fairly appears Isenhour v. true to stated in the case of ‘The rule be 228, 517, 528, 62 40, 44, 87 Rep. 1901, 157 which St. in this court Ind. N.E. Am. up to a standard of scientific knowl said: “Courts have never undertaken set determined, may competency and edge be have not of a witness the testify only gone holding facts the that a scientific witness can from to extent of cases, general personal in in The rule such learned him from demonstration. that, state, least, degree of to a witness exhibits such this at seems be where books, observation, gained knowledge, experiments, from standard or other value, source, appear opinion he is to make it that his is of some reliable as court, discretion, testify leaving a sound to to the trial in the exercise of entitled shown, jury say knowledge right right say is to the to such and the the to when worth; discretion, and, opinion this will in all cases of court what the is as other clearly appears that discretion to the trial court when review action of ’ have been abused.” 180, 23 259, 263. (1939), Our of Steel Fuller 216 Ind. N.E.2d review Illinois Co. v. clearly qualifications expert’s was no us that there abuse convinces testimony. Regarding knowledge permitting in the state of in the discretion his time, expert being profession that ‘statistics were medical at testified relationship contraceptive pill published an the oral to to show the direct expert disposition develop clotting. .’ . . The increased in women to blood asked, reports ‘Was there studies. He informa- then summarized several studies, you year take here from these in the 1968 available to the defendant tion Committee, Studies, Reports, Wright the Heilman that did British pill thrombophlebitis?’ relationship use of the The establish a between the ‘yes.’ expert requested expert responded The was then to read aloud the follow- entry Physicians ing portion 1968 Desk Reference for Ortho-Novum: of Ortho’s data, yet comparable The British available in the United States. ‘No studies they magnitude especially the increased risks to individual as indicate the
patient, directly applied in which the to women in other countries cannot be occurring may spontaneously dif- thromboembolic disease be incidences added). (Emphasis expert opinion was asked to state his ferent.’ recess, objections, questions, adequacy warning. preliminary of the After ‘insufficient, opinion objections, warnings his were he stated that in more ” 42-44, misleading.’ App. incomplete Ind. 180 at 50-52. warn, duty to the manufacturer’s Again, with reference
405 Lindsay Corp., Second Circuit in v. Ortho Pharmaceutical 637 (2d 1980), F.2d 87 Cir. said: duty potential dangers knew, “The manufacturer’s is warn all which it known, Agnes the exercise of reasonable care should have exist. v. Baker St. supra, 81; Hospital, App. 405, 70 Div. at 2d 421 N.Y.S.2d v. Tinnerholm Parke Co., Supp. 432, (S.D.N.Y. 1968), grounds, Davis & 285 F. 451 on'd other 411 aff 1969). (2d duty one, requiring F.2d 48 Cir. a continuous the manufacturer keep knowledge products gained abreast through of the current state of of its research, literature, reports, adverse reaction scientific and other available Agnes Hospital, supra, App. methods. Baker v. St. 70 Div. at 2d 421 Except regulations provide, 81. N.Y.S.2d where FDA otherwise the manufac doctor, patient.
turer’s
is to
warn
not the
The doctor acts as an ‘informed
intermediary’
patient,
patient’s
evaluating
between the manufacturer and the
needs, assessing
drugs, prescribing one,
risks
and benefits of available
supervising
Co.,
Upjohn
supra, App.
its use.
v.
Wolfgruber
Div.
at
2d
95.”
N.Y.S.2d
that not be the factor to related the risk of throm- study, boembolism. Ortho has not claimed that it was unaware of this but the report package mg. was not contraceptive cited in the insert 2 for the oral or in the package any fact, contraceptive; insert for other oral the for insert each of products these was identical. which, “The study, absence of the reference to 1970 British unlike the four' actually insert, package provided studies referred to in the would have numerical physician relationship data the to on the dose-effect between thromboembolic contraceptives, ground jury finding warnings disease and oral for a that the factually inadequate. were is to To this be added the fact that the inserts each identical, despite of oral higher- Ortho’s were this evidence that estrogen-dose pills might present greater this, jury might risks to users. From mg. warnings pills inadequate. jury have concluded that the for the 2 were might question warning also have considered on the of the fact that the sales- person regularly Campbell orally who called did on Dr. not him that 2 inform mg. drug appeared present higher Sterling to a risk of thromboembolism. See 406 may Yarrow, 992, 993 (trial to find it unreasonable
Drug,
at
court
Inc. v.
408 F.2d
regularly
physicians
they
personnel
call
on whom
sales
to warn
fail to instruct
present
clearly
personnel
dangers;
sales
most
drug
to find such
not
erroneous
doctors).
warning
effective method
study
testimony
April
expert
1970
did establish
that the
“In view of the
estrogen
positive
the risk of
between the dose
existence of a
correlation
labeling
thrombosis,
fact
did not refer
this
and the admitted
that the
cerebral
testimony
provide expert
study,
did
claim that the Brochus
not
Ortho’s
inadequacy
holdWe that the manufacturer an drug duty ethical has a to profession warn the dangerous medical of side effects of its products knows, know, of which it know, has reason to or should upon position expert field, based its as an upon in the research, upon it, cases reported upon to develop- scientific ment, research, publications in the field. This is con- tinuing. determine, case, We do not duty, need to in this what if any, such a consumer, has manufacturer to warn the ultimate patient. Here, by Ortho, neither was warned but Ortho’s failure to physician warn the finding sufficient to sustain the of negligence duty against or breach it in of this case. argues
Ortho also that has FDA determined that contra- ceptive-induced warnings, HUS not merit does and that courts of Kansas must defer to the FDA’s determination. This argument centers around letter from the to FDA Searle Labo- ratories. had proposed package Searle fifteen or more insert changes, covering many subjects. Only and varied one of those possible mentioned of the inclusion HUS as a side effect. The responded FDA that it did not concur with the additional changes proposal. included in that This letter cannot be con- strued as a contraceptive- clear determination the FDA that induced HUS warnings, argument does not merit thus has merit. no
FAILURE TO WARN AS CAUSATION Ortho next contends that its failure to warn the association HUS, between product malignant the use of its hyperten- sion, and acute renal failure was cause in fact of s injury. contrary, To the think we the evidence was substantial early diagnosis that
that it There was abundant evidence was. kidney failure HUS, malignant hypertension, and of addition, that he extremely Dr. Hermes testified important. dosage daughters lower of Ortho-Novum 1/50 has of his on a two There was as a result of this case. of what he has learned because might prevented indicating dosage have lower evidence dosage estrogen HUS, higher contained and even if the attending given, Mrs. Wooderson’s Ortho-Novum 1/80 were have possibility might physicians warned of the HUS — —if which, according expert testi- diagnosis made an earlier testified that tragedy. Dr. Hermes mony, might have averted the symptoms. danger look for he and would is now alerted throughout that the duty warn, course, the time extends warnings given taking No were plaintiff was Ortho-Novum 1/80. physicians time, and thus the during period HUS, symptoms alert for were not informed to be on the failure, question malignant hypertension. kidney injury was was a cause of whether this failure to warn jury. respect warnings, properly submitted With Chapman said: court *20 presumption adequate § j provides . that an warn- [to 402A] “. . Comment ing operates a manufacturer where heeded. This to the benefit of would be however, inadequate, warnings given. warnings adequate in fact are Where App. presumption presumption Ind. at 55. is in of causation.” 180 essence
Similarly, Seley court said: “ adequately might might had warned ‘Whatthe or not have done he been doctor Hardy prove part plaintiff her case.’ Hamilton is not an must as a of element by 375, 549 (1976)], page provided App. at 387. The evidence [37 Colo. P.2d independently acquired knowledge is insufficient rebut Dr. as to his Froelich by j.” presumption St. 2d at 201-202. established Comment 67 Ohio case, inadequate. On the evidence warning In this inadequate it, this jury was entitled to find before injuries. warning caused Mrs. Wooderson’s plaintiffs theories —failure to other also contends by supported “design claim —are not test and a defect” jury theory on the to the of The case was submitted evidence. instructions, mentioned in the failure to warn. Failure to test recovery compensatory basis for specific was not made a but punitive with the in connection damages. We it later will discuss however, note, that there was evidence on damages issue. We jury which the fully could have found that Ortho had not tested product in that it had not examined certain renal blood vessels during studies, its animal after renal blood vessel lesions attrib- utable reported. to oral had been design defect upon claim is based dangers HUS, the fact that the malignant hypertension kidney and acute failure are consider- ably reduced dosage administered, when a lower is such as that contained in Ortho-Novum 1/50. There was some evidence in claim; the case support however, the matter was not jury submitted to the and was not made a recovery basis for compensatory damages. We find no error.
COMPARATIVE NEGLIGENCE argues Ortho next that the trial court erred in refusing to submit the issue comparative fault of the and of the physicians, Wilcox, Dr. Hermes and Dr. jury. argument This is made in light 60-258a, of K.S.A. which reads in part as follows: Contributory negligence recovery “60-258a. abolished, as bar to in civil actions when; damages comparative negligence; imputation award of negli- based on gence, when; special joinder findings; parties; proportioned verdicts and liability, (a) contributoiy negligence any party in a civil shall action party party’s legal representative bar such or said recovering damages from for negligence resulting death, personal injury property damage, party’s if such negligence negligence party was less parties against than the causal of the recovery made, whom claim damages any party but the award of in such proportion action shall negligence be diminished in to the amount of attributed party. any party to such claiming damages If such wrongful for a decedent’s death, negligence decedent, any, imputed party. of the if shall be to such “(b) comparative negligence parties any Where the of the such is an action issue, jury verdicts, special jury, shall return or in the absence of a the court special findings, shall determining percentage make negligence attributa- parties,
ble to each determining of the damages the total amount of sustained claimants, entry each of the judgment and the shall be made the court. general jury. No verdict shall be returned “(d) comparative negligence parties Where the action is an issue recovery against *21 party, and party is allowed more than one each such shall be portion liable damages any for that of the total dollar amount awarded as proportion claimant in negligence the that the amount of his or her causal bears to negligence parties against the amount of the causal attributed to all whom such recovery is allowed.”
We have held that the intent
purpose
legislature
and
the
of
adopting
impose
statute is to
liability
the
damages
individual
proportionate
based
the
parties
fault
all
to an
damages, whether
injuries
and
give
which
rise to
occurrence
joined formally
parties
as
persons
action.
or not those
Keill,
195,
(1978).
Ortho, alleged plaintiff that if the sustained directly negligence which contributed injury, guilty she injuries, that she failed to and proximately and as a cause of alleged intended. The answer also product in the manner use any, by negligence if caused plaintiff injuries, s were Dr. responsible. is not Hermes parties for whom Ortho other originally Wilcox, plaintiff gynecologists, were Dr. who were They action. re- as defendants this joined At pretrial at the time of the conference. mained in action Ortho, time, against claims enumerated various Dr. negligence as to Hermes she enumerated her claims of fully resulting position was set Dr. out Wilcox. Ortho’s order, that: included Ortho’s claim pretrial any, by plaintiff’s negligence, injuries, caused own causal “Plaintiff’s if were negligence this for whom defendant the causal other defendants individually equal negligence responsible, to or and said either combined negligence greater this . . . causal defendant than specific designation pretrial order was Also included in witnesses, parties expert lay, which each all of the action, and all of the during call the trial of intended to conference, During pretrial intended to exhibits each offer. Hermes and regarding the actions of Doctors position Ortho’s following excerpt of the was clarified shown Wilcox hearing: transcript of that Mr, contend, Wall, any you departure standard from “MR. MICHAUD: .Do practice part
approved of the defendant doctors? medical on the No. “MR. WALL: *22 So, concerned, they nothing wrong you did MICHAUD: so far as are “MR. plaintiff? in the the use of Ortho-Novum “MR. WALL: No. contending right, you are in this case that the doctors “MR. MICHAUD: All not anything wrong? did No, Gerry. “MR. WALL: Honor, require to Mr. Wall to “MR. MICHAUD: Your I would ask the Court it is their defenses in this case that the doctors did state whether or not one of anything wrong causing plaintiffs injury. insofar as any subject Gerry, plan bring experts that and have “MR. WALL: I don’t to evidence, you reports. Now, going bring agree I if I was to that kind of would no it. are entitled to “Now, however, that, completion Gerry’s agree, though, if at the I don’t me, lawsuit, points marginal that I am all of the evidence to the doctor and is as to appear precluded saying that it would to me that the from under the evidence minimal, least, against slight at and it evidence the defendant Ortho-Novum doctors, appears produced great against Mr. case and I Michaud has you I am think based on the evidence will find for the defendant Ortho-Novum. Fanning, precluded I think Bud H. W. who then [Mr. not from that. don’t represented precluded completion of Wilcox] Dr. Hermes and Dr. can be at the thing. saying the same you you saying is don’t intend to offer “THE COURT: I understand what any anything wrong. evidence that the did doctors exactly right.” “MR. WALL: That’s trial, pretrial conference, shortly prior plaintiff After the to Wilcox, settled with Dr. Hermes and Dr. with the result at against treating physicians there remained claims the two no settlement, made the time of trial. After both doctors motions by We summary judgment were sustained the trial court. which with the important this to deal do not deem it discussion case; physicians were removed from mechanics claims, prejudice, would simple dismissal of s objected the dis- accomplished have the same result. Ortho negli- sought have their physicians, missal of the and at trial gence compared. The trial court said: “My simply happened, machinery was conclusion is that as far as what’s put negligence the doctors in issue as
there and time Ortho wanted to doctors, they . . . Mr. Mi- have done that. between Ortho and the could questions nothing invitation were less than an chaud’s at the Pretrial Conference negligence doctors declined. . . . All of the to do that. The invitation was will be this action. It’s not in issue. It has been removed Mr. Michaud from compared. directly questions raised We are at issue with against the defendant Ortho.” opinion, plaintiff prin- length at earlier in
As discussed adequate cipal against give it failed to an claim Ortho was that possibility that Ortho-Novum warning physicians HUS, hypertension or acute renal malignant 1/80 could cause *23 specifically warning that such was undisputed It was no failure. by given provided physicians. the in the literature Ortho to hardly position vigorous with a Ortho was in a to come forth negligent in their of physicians assertion that the were treatment physicians the had the plaintiff since Ortho not warned the of counsel, pretrial, at was risks and had not alerted them. Plaintiff position, in the discussion concerned Ortho’s reflected effected, quoted If needed to above. no settlement was by prepared produced be to evidence Ortho of the meet negligence treating physicians. position of Ortho’s was the physicians departed made no claim that the clearly It stated: approved practice, it medical intended to no offer from anything wrong. If plain- that the physicians evidence the did part physicians, tiff the the s evidence were to disclose fault on matter right argue reserved to that. When the went to Ortho the trial, plaintiff negligence the offered no evidence of causal on part necessary physicians, the it was not for the trial thus evidence, jury. was court submit that issue to the There no to expert otherwise, actionable, part negligence causal on the or Hermes Drs. and Wilcox. Under circumstances disclosed case, by the record the evidence in this we conclude that refusing trial to the issue court did not err submit jury. comparative negligence physicians to plaintiff, negligence part As to claimed on points only go did not to the evidence that was her hospital emergency on 25 after she told room June physician get did 6:00 that to do if she not better o’clock so evening. evening, felt we do know. Whether she better not otherwise, suggests testimony, that There is no medical or go hospital 25 caused or contributed this failure to on June injuries 25. or that her condition reversible June Dr. and he did not send her to She saw Wilcox on June however, is, testimony that diagnosis that hospital at time. There might have averted the and treatment months earlier several support Mrs. disaster. We find evidence to the submission of no jury. negligence causal Wooderson’s CLAIM DAMAGE THE PUNITIVE damage claim punitive should claims that the Ortho next that the failure to jury. It contends submitted to have been inherently dangerous an warn of all dangers which potential drug might cause cannot support a product prescription as a such there was evidence It no punitive damage award. contends a known or established warn failure to of a willful or wanton that in 1976 there at most danger. defect It contends and that suggestion that oral caused HUS nor “suggestion” has neither been confirmed existence of refuted; therefore, is in fact an increased proof without that there risk, willfully failed to warn of the proof there is no that Ortho punitive damages proper were be- risk. Plaintiff contends HUS, malignant hypertension, cause Ortho failed to warn of kidney failure after it damage vessel wall and acute knew risks, put and —in effect —that Ortho should have known of the patients taking financial ahead its own interests *24 1977, January, pharmaceuticals. We that it was not until note failed, kidneys first included in its after reported in package warning insert a under “adverse reactions contraceptives,” an neither confirmed users of oral association “impaired refuted, Even that and later nor renal function.” malignant package inserts do not warn of acute renal failure, hypertension, HUS. applicable briefly helpful
It will be
here to review
some
v. R. D. Werner
Cantrell
In
governing punitive damages.
rules
Co.,
681,
(1979),
P.2d 1326
we said:
226 Kan.
602
recently
expansive
Appeals
given an
discussion of the rules
“The Court of
has
Towne, Ltd.,
relating
punitive damages
2
v. Park
Kan.
the case of Sanders
1131,
(1978):
App.
313, 318-19,
845
2d
578 P.2d
rev. denied 225 Kan.
malice,
fraud,
damages
permitted
elements of
‘[P]unitive
“are
whenever
(Malone Murphy,
controversy.
gross
mingle
2
negligence,
oppression
v.
in the
Case,
733,
250;
Keokuk,
94;
Cady
Wiley
26
v.
45 Kan.
Kan.
v.
6 Kan.
Albert
448.)
damages
special
in the
merit
Pac.
Such
are allowed not because of
wrongdoer
injured
case,
imposed by way
punishing
party’s
but are
injured party’s
malicious,
a willful and
invasion of
vindictive or
wanton
rights,
purpose being
the commission of like
to restrain and deter others from
912; see, also,
Drake,
142,
wrongs. (Stalker
v.
Townsend
v.
91 Kan.
136 Pac.
266,
700.)”
302,
1157;
Jur., Damages,
p.
§
102 Kan.
169 Pac.
15 Am.
Seefeld,
(1956).’
702, 705,
Layton,
Newton v.
v.
478
In
an award of
recovered,
damages
financial condition and
defendant’s
amount of actual
225, 229,
Christiansen,
Ayers
probable litigation expenses.
v.
222 Kan.
564 P.2d
(1977).’ p.
the defendant’s
properly
assessing punitive damages,
consider the character
the trier of fact can
act,
that the
the harm to the
nature and extent of
of the defendant’s
the defendant.”
cause and the wealth of
caused or intended to
defendant
381, 386, 646
Nesseth,
P.2d 1043
Binyon v.
231 Kan.
And see also
case,
same
7
(1982) ,
Appeals opinion in the
affirming the Court of
110,
(1981); Kearney
Public
v. Kansas
App.
Kan.
2d
“[T]he
manufacturer
***
developments touching
duty
keep
scientific
abreast of
under
‘continuous
any
notify
profession
upon
product and to
the medical
the manufacturer’s
drug
[Citations omitted.]
its use.’
side effects discovered from
additional
therefore,
duty
is,
warn
commensurate not
with its actual
manufacturer’s
gained
reports
knowledge
but also with its
from research and adverse reaction
knowledge
scientific literature and other available
constructive
as measured
unconvincing.”
(Emphasis supplied.)
findings safety efficacy reported Obstetrics and study previously Advisory August 1969. An American confirms Committee reported relationship between the use of studies in Great Britain which show a diseases. and the of certain thromboembolic occurrence carefully designed retrospective that users of oral contra- These studies show pulmonary ceptives likely thrombophlebitis than embolism are more to have throm- non-users. Studies in Great Britain show increased risk of cerebral also study contraceptives. British found a bosis and embolism in users of oral A (an morbidity) age per hospitalization 20-44 to be rate index or in women 100,000 per 100,000 compared five non-users. in users *26 designed between study, although evaluate differences not “The American disease may risk thromboembolic products, suggests an increased of there be also quantitated, and products. sequential in risk cannot be This difference in users of the observation. are needed to confirm further studies recently practitioners Drugs advised British on Safety “The Committee of estrogen containing mg. should country only products less 0.05 that that suspected reports indicated normally prescribed adverse reactions be because products contain- disorders with higher thromboembolic there is a incidence of containing products estrogen the smaller ing mg. than with or more 0.075 studies. other dose. This has not been finding confirmed safety continuing request your of oral assessment of our “I also assistance help this.” reports will us to do contraceptives. reactions Your of adverse (Emphasis supplied.) es- (gammas) of micrograms contains Ortho-Novum 1/80 of es- micrograms contains trogen, while 1/50 Ortho-Novum 10, 1970, Sales Bulletin on Ortho sent a trogen. April On men,” changes to its “detail subject labeling of Ortho-Novum directly upon call who representatives of the manufacturer sales para- extensively the first quoted from physicians. That bulletin letter, made no mention but graph acting commissioner’s advice British Committee’s concerning the paragraph of the third 1970, 15, Ortho sent out May physicians England. On Report Bulletin, subject of The on the another Sales one did Drugs. This bulletin British on the Committee Safety of letter, acting commissioner’s quote paragraph the third not It indicated that response thereto. obviously written in but was is no that there data indicates analysis of the British Ortho’s own and 100 75/80 statistically between significant difference containing 75/80 products micrograms mestranol. It stated than 50 if not lower a risk as low gammas of mestranol show gamma its 80 sale of gamma products. urged It continued “stampeded” to be people its sales product, and cautioned July 6, Sales Bulletin continued 50. A with the number 1/80, urged concentration urge sale of Ortho-Novum very “is concerned physician if the Ortho-Novum 1/50 asked about activity.” who estrogen physicians For using lowest products, the bulletin estrogen level switching patients to lower respond: suggested detail men you enough cause “Doctor, nothing evidence to sound in this British data offers saying for gamma We have been patients mestranol. are on 100 to switch who activity any drug say years use the least that it makes sense to and continue to therefore, you may move effectively accomplish purpose; wish to will activity products or ORTHO- patients as ORTHO-NOVUM 1/80 such to low *27 NOVUM 1/50.” the played Ortho down short, indicated that
In this evidence higher estrogen urge sale its of report British and continued entirely that satisified itself could be product until Ortho competitive posi- Apparently its causing damage. product was continuing the manufac- served tion in the market better were since other manufacturers product, sale its ture and of 1/80 dosage. producing the 1/50 also “Irey- is that of the plaintiff emphasizes
Another area which Irey, Forces Institute type” Dr. S. of the Armed lesions. Nelson it in a report published and Pathology, issued a of forty some journal The blood vessels of pathology 1970. were found posthumously. Lesions women had been examined every one of the vessels of in the inner wall or intima of the blood taking oral were known to have been bodies of those women who of in the bodies contraceptives; changes such were found no spite contraceptives. taking oral those who had not been damage, wall contraceptives to vessel report linking oral disprove prove or animal research to Ortho did no further the. cause by Irey: that proposition put forth who examined damage. pathologist vessel wall The lining inner kidney tissue found lesions to intima remarkably to those lesions kidneys similar blood vessels in her study. reported by Irey Dr. in his 1969 evidence and We that there was scientific conclude medical. failure, acute renal damage, wall tending to show that vessel extremely serious hypertension and HUS were malignant product; that Ortho with Ortho’s dangers which were associated scientific evi- accumulating medical and ignore chose to research dence; pursue the additional that Ortho did not urge the use of suggested; the data and that Ortho continued danger played down higher estrogen preparations, dangers warning of the physicians no products, gave those and that have found evidence, jury could involved. From this recklessly indifferent grossly negligent and Ortho err did not others, plaintiff. The trial court rights including this jury. punitive damages submitting the issue of damage punitive argues that the mere submission inflammatory prejudicial requires it that a claim was so that granted liability compensatory damages. We new trial be instructions, arguments have reviewed the court’s of counsel thereon, find ruling the court’s no error. punitive damage large award was so as to Ortho claims that the $2,750,000 is, course, shock the conscience. An award of $2,000,000 damages The for actual was also enormous. verdict of opinion, enormous. As we earlier in this Ortho does not noted challenge damages; argue the award actual it does not $2,000,000 excessive, compensatory damages awarded as supported hy the amount that award is not evidence. out-of-pocket were expenses actual medical enormous; injuries enormous; injuries were and her continuing permanent. punitive damage award must be sustained, light damages viewed in of the actual the actual award, case, damage the evidence circumstances *28 presented, positions the relative and the defend- of ant, Upon and the defendant’s financial a review of this worth. record, we find that an award less than one and cannot of damages punitive damages one-half times the actual is exces- sive. its size
Ortho also contends that the admission of evidence of profits length, and this at how- error. We need not discuss ever, for it is the rule in this state that the defendant’s financial punitive damages. circumstances See are relevant to the issue of Co., 555, Syl. ¶ v. Orkin 7. The Exterminating Ettus 233 Kan. admitting trial court did err in evidence. SUBSEQUENT
MITIGATING CIRCUMSTANCES and REMEDIAL CONDUCT permit argues refusing Ortho the trial erred in court circumstances,” present Ortho to and “mitigating evidence of “subsequent admitting the trial court erred evidence of targeted remedial conduct.” We have reviewed the evidence arguments these and find wished to introduce no error. Ortho regard evidence of benefits of oral safety and effectiveness. There was much evidence in the record contraceptives, of the and no modern almost universal use of oral jury widespread could be unaware of the use and effectiveness safety contraceptives. particular and of the usual of oral introduce, however, evidence was not evidence Ortho wished to used, “mitigating product widely circumstances.” That the safe, ordinarily ordinarily effective, does not excuse dangerous manufacturer’s failure to warn effects of side manufacturer knows has reason Evidence to know. widespread use, safety and beneficial usual and effec- tiveness, circumstances,” “mitigating not evidence excluding trial court did not err in it. “subsequent
The evidence of remedial conduct” was not such as to description. come within that It was evidence of contacts between Ortho’s Director of Medical Dr. Services and Die- derich, following plaintiff s bout with HUS. Much of the discus- sions complains about which place hearing Ortho out of the took jury. evidence admitted was offered show Ortho’s continuing course receipt of information conduct — linking high estrogen HUS, oral contraceptives with wall vessel damage, kidneys, loss hypertension continuing acute a—and failure of Ortho dangers to include warnings pre- of these scribing physicians products. or users of the We find no error the admission of this evidence.
Finally, argues rejection error in the admission or certain documentary lengthy trial, carefully evidence. This awas tried able experienced carefully counsel. We exam- have ined the record and find no prejudicial or reversible error. The judgment is affirmed. C.J., dissenting: comparative negligence This ais
Schroeder, brought by Wooderson, Lynn action Carol to recover damages personal injuries which she resulted from claims ingestion of the oral contraceptive Ortho-Novum over a 1/80 period years. The defendants named when the action was filed *29 were the Corportion (Ortho) Ortho Pharmaceutical and the plaintiff s gynecologists, Dr. Hermes and Dr. Wilcox. plaintiff alleged
The negligence part the her and on doctors part the pretrial When the Ortho. conference was con- ducted represented by the doctors were in the action counsel and plaintiff the pursuing against was as action the doctors well as Ortho. pretrial shortly trial,
After the prior and the conference plaintiff settled with the two doctors turn moved for who summary judgment which the trial sustained. This court court simple majority “a dismissal of states, opinion gratuitously
422 accomplished have the claims, prejudice, would s with plaintiff physicians, objected the dismissal of the same result.” Ortho compared. The trial negligence sought to have their and at trial the had negligence of doctors that the court ruled in substance and plaintiff from this action for the been removed counsel questions raised the with the the court was concerned plaintiff against the defendant Ortho. following
This, my for the opinion, was reversible error reasons. plaintiff alleged if the sustained
In its answer Ortho directly negligence which contributed injury, guilty she was failed to injuries, and that she proximately and as a cause of her The answer of product in the manner intended. use the any, injuries, s if were caused alleged plaintiff also that the responsi- parties is not negligence the other for whom Ortho . ble. statute, K.S.A. 60- comparative negligence
Addressing the 258a, says: opinion in its court adopting purpose legislature in “We have held that intent proportionate liability damages based on the impose statute is to individual for injuries parties gave rise to the all to an occurrence fault of parties joined damages, persons as formally whether not those (Emphasis added.) action.” Keill, P.2d cites Brown v. 580 properly Kan. court (1978), However, point on in proposition. from this for this v. Brown Keill without opinion completely ignores court precedent. Brown Keill validity further comment on the of this proposition controlling law on the was reaffirmed and asserted Northern, Inc., Burlington Gaulden v. 232 Kan. stated above (1982). similar to There a factual situation 654 P.2d involving the Federal presented in a case instant case seq., (FELA). et Act, § Liability Employers’ 45 U.S.C.A. plaintiff plaintiff Later sued the railroad James. Jack dismissed from and the trial court settled James James though plaintiff was entitled to recover lawsuit. Even negligence, percentage of judgment, entire less the railroad, and the case the trial court was reversed from the negligence with instructions sent back a new trial compared with that of must be James Keill, cited of Brown v. authority and other cases on the railroad *30 423 therein. comparative negligence The court referred to the stat- ute, 60-258a, K.S.A. and said: purpose impose liability damages “The of that statute is individual for based upon proportionate concept liability joint joint fault. The and several between longer applies, judgments upon tortfeasors no and since individual bewill based fault,
proportionate
among joint judgment
longer
contribution
debtors
no
required.
Keill,
(1978).
Brown
224 Kan.
P.2d
.
.
.
580
867
consistently
liability,
including
“We have
held that all
issues
the causal
negligence
parties
occurrence,
or fault
all
an
should be determined
one
lawsuit,
joined
participants,
parties
whether
are all
formally
Keill,
195;
Alkire,
lawsuit or not. Brown v.
224 Kan.
224
Eurich v.
Kan.
(1978);
Volkswagenwerk
P.2d 1207
Albertson v.
230 Kan.
Aktiengesellschaft,
368, 634
(1981);
Inc.,
643, 641
Magic
P.2d 1127
and Lester v.
230 Kan.
P.2d
Chef,
(1982).” (Emphasis added.)
Ry procedure, court, this given by and the instructions the trial stymied. substance, Ortho was jury permitted to have upon tunnel respond vision focused Ortho to for the total damages plaintiff. suffered
It successfully argued cannot be negli- were doctors gent drug, prescription administration or in their treatment young plaintiff, of this pressure after her blood December 1974 diagnosed by high, simply them as because charging settled them. The sued them negligence pursued against Only her claim them. after summary settlement was a judgment sustained doctors’ own motion. jury comparative negligence in this action should have permitted
been negligence to consider parties of all occurrence in order to comparative negli- fulfill the intent of the gence impose liability damages statute to individual based Northern, upon proportionate Burlington See Gaulden v. fault. Inc., at Kan. 212-13. declare, law,
For the court to as a matter of that there was no *31 plaintiffs jury to the issue of evidence for the consider on speculative. contributory negligence presumptuous health, good just in 1972 and in plaintiff, young woman married having high pressure diagnosed as blood her doctor (130/80) (120/90) January 1976. again in December 28, 1976, again until to her office She did not return doctor’s June May 4, 1976, symptoms as a although giving she called in 25,1976, vomiting. pains cold and on as These stomach June facts light the record must be viewed in of a situation where erroneously the case as the doctors have been removed from Had the parties negligence should have been considered. whose comparison case with the doctors the case for been tried Ortho, plaintiff and the evi- negligence their with that of the substantially simple issue may dence different. The have been evidence would upon which trial court admitted relevant ex- expanded upon which evidence have been to other issues cluded have been relevant. would tried,
By injury limiting jury to the issue the entire plaintiff upon With resulting damages heaped to the were Ortho. upon and with the nature and extent entire focus s damages, counsel it was not difficult fact, jury punitive damages. convince the to award substantial jury negligence parties had the all been submitted may may damages actual much less and there have have been punitive damages been no awarded. judgment
It the trial court respectfully submitted the conformity with granted in should be reversed and a new trial heretofore announced comparative negligence law of Supreme Court.