Plaintiff Vira Dee Mae Carmichael and her husband Richard Carmichael
A motion for nonsuit made by defendants Dr. Reitz, Dr. Dahlquist, and the Harriman-Jones Medical Clinic upon plaintiff resting her case in chief was granted and a judgment of nonsuit entered. Plaintiff appeals from this judgment only insofar as it concerns defendant Dr. Reitz.
The trial was completed as to Searle and the jury returned a verdict in its favor. Plaintiff also appeals from the judgment entered on the verdict.
Since the issues raised by the respective appeals are disparate except as the negligence, if any, on the part of Dr. Reitz might bear upon the issue of proximate causation in the case against Searle,
Appeal Against Dr. Reitz
Plaintiff, in this phase of her appeal, contends that the trial court prejudicially erred: (1) in granting the nonsuit since she had made out a prima facie case sufficient to go to the jury on the theories of (a) negligence, (b) failure to obtain an "informed consent," (c) res ipsa loquitur, and (d) strict liability; and (2) in ruling a certain question propounded by plaintiff's counsel to Dr. Reitz as argumentative.
I.
Before reaching the substantive aspects of the nonsuit, we ascertain in limine just what theories of recovery and what evidence are properly before us in this review of the nonsuit, because plaintiff's brief manifests confusion in this respect.
It is also noted Dr. Reitz was temporarily excused, after plaintiff's examination of him under Evidence Code section 776, upon the understanding that Searle would be given the opportunity to cross-examine him at a later date when he could again be in court. The trial judge did not rule immediately on the motion for nonsuit, indicating that he would prefer to first hear the balance of Dr. Reitz's testimony. But then in the course of Searle's cross-examination of Dr. Reitz, the trial judge granted the motion for nonsuit. No objection was made by plaintiff's counsel as to the point in time at which the trial judge ruled on the motion, nor did he request the judge to further defer his ruling.
Under the foregoing circumstances, any reference plaintiff makes to the testimony of Dr. Boyle or of any other physicians (including Dr. Reitz) who testified after the nonsuit was granted must be disregarded in determining whether the grant of nonsuit was proper.
The issue of "informed consent" is raised in the pleadings only as it is interwoven into the count pleading negligence. In his redirect examination of plaintiff, her counsel propounded to her two questions which sought to inquire whether she would have consented to take Enovid had she been told of the "so-called side effects and adverse reactions due to Enovid" which had been read into the record up to that time.
II.
With the foregoing limitations and criteria in determining the propriety of the nonsuit in mind,
In the course of taking plaintiff's past history, Dr. Reitz asked her whether she was allergic to or whether she had had any bad reactions to any medication or drugs. Plaintiff replied, "No." Dr. Reitz inquired, "What diseases have you had in the past?" Plaintiff replied that she had had diphtheria, and that she had also undergone a tonsillectomy and an adenoidectomy. She indicated that she had no family history relative to tuberculosis, cancer, or diabetes.
During this visit, Dr. Reitz conducted a physical examination which, in addition to the pelvic area, encompassed the chest, head, neck, abdomen, rectum, and extremities. Percussion and auscultation of the chest indicated no abnormality and no chest problems as of that time. An X-ray of the chest was also taken; it proved negative for abnormalities. During this physical examination, the doctor noted two unusual things: "One was the rate and intensity with which the deep tendon reflexes appear; and the other ... that when stretching the hands there was a small tremor present in the fingertips." These factors combined with a slightly larger than normal thyroid suggested possible hyperthyroidism. There were no varicosities (varicose veins) and arterial circulation was good. Blood pressure was normal. There was no indication of thrombophletbitis. A "Pap"
Dr. Reitz diagnosed a minimal case of endometriosis. He recommended that plaintiff attempt to become pregnant and prescribed Cyclex, a combination diuretic and tranquilizer, for the abdominal bloating and personality changes (premenstrual tension) of which plaintiff complained. He advised her to return in a year. On July 19, 1963, Dr. Reitz spoke to plaintiff on the telephone and advised her of the results of the laboratory tests enumerated above.
Plaintiff returned to Dr. Reitz's office on May 12, 1964. The doctor noted on this occasion that there had been no progression in her symptoms; in fact, they were slightly more favorable despite her having been unable to become pregnant since her July 10, 1963, visit. Plaintiff stated that she was desirous of becoming pregnant. She also said that she had experienced some nausea and loss of appetite during the several months preceding this second visit, but that her overall problems in 1964 were less than in July 1963. She informed the doctor that she had been suffering from "flu" for a few weeks prior to her visit.
On this May 12, 1964, occasion plaintiff was not given a complete physical examination. Dr. Reitz examined her chest by percussion and ausculation; the indications were that it was then clear. No X-ray was taken as less than a year had elapsed since his taking of the X-ray in July 1963. Plaintiff stated that she was being seen elsewhere for her chest problem. Dr. Reitz relied upon the physician treating her for her "flu" to take X-rays if that doctor should feel it necessary. He also believed that X-rays had been taken in that other doctor's office. Plaintiff did not complain of any present chest pain on this second examination. On the basis of the July 10, 1963, chest X-ray and his current physical examination of the chest area, Dr. Reitz at that time ruled out any pulmonary embolisms up to that time. Consequently, he did not inquire further about any chest pains.
He then believed that plaintiff's endometriosis had progressed from "minimal" to "moderate" even though the amount of pain plaintiff experienced had decreased slightly. An X-ray of plaintiff's uterus and fallopian tubes was taken on May 12, 1964, as part of a hysterosalpingographic examination,
Dr. Reitz decided to prescribe Enovid,
Dr. Reitz testified that he advised plaintiff of the risks and hazards of breakthrough bleeding, nausea, and vomiting in taking Enovid, and instructed her that if she had problems with the medicine to contact him. Plaintiff testified that Dr. Reitz discussed endometriosis with her; that it caused blood cysts; that he informed her that in some instances Enovid
Prior to his prescribing Enovid for plaintiff, Dr. Reitz knew of a statistical relationship between thromboembolic episodes and Enovid, but he did not believe that there was a causal relationship between the two. The Physicians' Desk Reference for 1964 (copyrighted in 1963), which he used, indicated that no contraindications were known. Plaintiff also called the attention of the doctor, during his Evidence Code section 776 examination, to certain product literature concerning Enovid, issued by Searle on March 5, 1964 (defendant's Exhibit "A"), which stated under contraindications: "Previous Thrombophlebitis or Pulmonary Embolism. Enovid-E is contraindicated in these patients unless the reason for its use in the judgment of the physician is overwhelming." Dr. Reitz was unable to recall whether he had seen this literature. As noted earlier in this opinion, there is no evidence that Dr. Reitz ever received it, which state of the evidence was acknowledged by plaintiff's counsel at the time of nonsuit. Dr. Reitz admitted there was no overwhelming need for prescribing Enovid to plaintiff. He was permitted to testify that in his opinion, at the time he prescribed Enovid in 1964, pulmonary embolism was not recognized to be an adverse reaction of Enovid in the medical community. And as earlier alluded to, he also testified that he had read and considered articles and books relating to Enovid other than the Physicians' Desk Reference for 1964, and that he considered these, as well as others mentioned by plaintiff's counsel, in arriving at his decision to prescribe Enovid.
The prescription was filled at a pharmacy on May 14, 1964. The directions on the label were: "One tablet daily for 14 days then one tablet 2 times a day." Plaintiff waited until May 25, 1964, before she started taking the pills as she had had "a rather bad time" with her menstrual period and she wanted to wait until it was over. Plaintiff, who did not normally eat breakfast, took her first pill on Monday morning, May 25, 1964, and within one hour became extremely nauseous. She "took it for one or two days" and then called Dr. Reitz, who advised her to continue taking the medication "if at all possible." By Friday, June 5, 1964, she was spitting up blood and experiencing chest pains and shortness of breath. Her pain had alleviated the following morning, but it grew more intense as the day wore on. On Sunday morning, she called the Harriman-Jones Clinic and was told to come in at 2 p.m. that afternoon. She did so and was seen by Dr. Horvitch, at which time an X-ray of the chest was taken and reported as being negative. Dr. Horvitch diagnosed plaintiff's complaints as being caused by bronchopneumonia and prescribed an antibiotic, Tetracycline.
Plaintiff was examined by Dr. Reitz on Monday, June 8, 1964, and was
On June 10, 1964, Dr. Dahlquist inquired into plaintiff's chemical exposure and learned that she had taken Enovid as prescribed by Dr. Reitz.
A D & T (diagnostic and therapeutic) conference was held at the Harriman-Jones Clinic following the operation. Prior to the conference, a more detailed history of the plaintiff was obtained. What plaintiff had characterized as "flu" consisted of "generalized chest pain and symptoms of coryza" (common cold). There were also revealed episodes in 1961 and 1963 wherein plaintiff had experienced a sudden onset of pain in the right chest with low-grade fever, along with coughing of blood in 1963.
In his report to the Food and Drug Administration, dated August 26, 1964, Dr. Reitz concluded that plaintiff had possibly suffered minor thrombophlebitic or embolic disorders in December 1961 and January 1963. They, however, had been diagnosed by the treating doctors as "flu."
It was stipulated that Dr. Samuels rendered no opinion on whether "Dr. Reitz in this case conformed to applicable standards of practice in this community under the circumstances."
The testimony of Laurence Pilgeram, Ph.D., as to his studies concerning Enovid was offered only as against defendant Searle.
Other facts or evidence may be referred to where pertinent to the discussion in the interests of keeping the opinion as short as possible. Its considerable length, however, cannot be avoided without sacrificing adequacy of treatment of the issues raised.
III.
Berkey is distinguishable on the facts and the law. The gravamen of a cause of action based on "informed consent" in terms of negligence is that the physician's failure or inadequacy of disclosure breached his duty of due care. The existence and scope of this duty normally must be established by expert testimony. (See: Plante, op. cit. supra, at pp. 656, 666; Note, Informed Consent in Medical Malpractice (1967) 55 Cal. L.Rev. 1396, 1399-1400, fn. 18.) We find no such expert testimony, which might be applicable to the nonsuit question, in this case. In the evidentiary posture of this case, the grant of nonsuit may not be disturbed on the theory of negligence or of "informed consent" as presented in this case.
IV.
Plaintiff does not claim that the Enovid was delivered to her and a charge made for it by the doctor, nor does she contend that the Enovid was chemically impure or in any condition other than that intended by the manufacturer. Its defect, if any, was only in the medical sense that it was not appropriate to her under the circumstances in which it was prescribed.
Our former Chief Justice Traynor (author of the Vandermark opinion) drew the distinction in Gagne v. Bertran (1954) 43 Cal.2d 481, 487 [275 P.2d 15]. In holding that there was no strict implied warranty liability on the part of a test hole digger who had erred in his opinion, he there stated: "He [the test hole digger] was not a seller of property who obligated himself as part of his bargain to convey property in the condition represented. The amount of his fee and the fact that he was paid by the hour also indicate that he was selling service and not insurance. Thus the general rule is applicable that those who sell their services for the guidance of others in their economic, financial, and personal affairs are not liable in the absence of negligence or intentional misconduct."
In Magrine v. Krasnica (1967) 94 N.J.Super. 228 [227 A.2d 539], affirmed 100 N.J.Super. 223 [241 A.2d 637], and 53 N.J. 259 [250 A.2d 129], the court approving the Gagne distinction declined to apply the doctrine of strict liability to a dentist whose drill, with a latent defect, broke while he was working on his patient and injured the patient. The court stated: "Of ... meaningful significance is a recognition that the essence of the transaction between the retail seller and the consumer relates to the article sold. The seller is in the business of supplying the product to the consumer. It is that, and that alone, for which he is paid. A dentist or a physician offers, and is paid for, his professional services and skill. That is the essence of the relationship between him and his patient." (Italics in original; 94 N.J. Super at p. 235 [227 A.2d at p. 543].)
In Babcock v. Nudelman (1937) 367 Ill. 626, 629-630 [12 N.E.2d 635,
The foregoing analogies lead us to conclude that there is a difference in status or classification between those upon whom the courts have heretofore imposed the doctrine of strict liability and a physician who prescribes an ethical drug to achieve a cure of the disorders for which the patient has sought his professional services. The former act basically as mere conduits to the distribution of the product to the consumer; the latter sells or furnishes his services as a healer of illnesses. The physician's services depend upon his skill and judgment derived from his specialized training, knowledge, experience, and skill. The physician prescribes the medicine in the course of chemotherapy only as a chemical aid or instrument to achieve a cure. A doctor diagnosing and treating a patient normally is not selling either a product or insurance. One of the requisites which the Restatement prescribes for the imposition of strict liability is that "the seller is engaged in the business of selling such product." (Rest. 2d Torts, § 402A.)
Appeal Against Defendant Searle
The case against Searle was tried on the theory of strict liability in tort,
I.
To put the foregoing assignments of error dealing with jury instructions in proper perspective, it becomes necessary to set forth some additional facts. The recital is not intended to be comprehensive,
The plication of plaintiff's vena cava inferior performed on June 14, 1964, by Dr. Gaspar was successful. Post-operatively, plaintiff was placed on Coumadin, an anticoagulant drug, by Dr. Dahlquist, who further instructed plaintiff to wear elastic stockings. She remained under Dr. Dahlquist's care, notwithstanding the fact that she had named him as a defendant in this action filed on May 3, 1965. When Dr. Dahlquist saw her on March 1, 1966, plaintiff had made an excellent recovery from her 1964 problems. She was not on any anticoagulant,
On May 13, 1967, plaintiff suffered a thrombophlebitis of the right calf. She had last ingested Enovid just prior to her admission to the Long Beach Community Hospital on June 10, 1964. It was almost one year after plaintiff had been completely taken off of anticoagulant therapy in July 1966. Plaintiff returned to Dr. Dahlquist for treatment; he again placed her upon Coumadin and a tranquilizer to minimize the risk of another pulmonary embolism.
While still under Dr. Dahlquist's treatment, plaintiff was referred by her attorneys in this action to Dr. Arthur Samuels for the purposes of his conducting a clinical experimental study on plaintiff involving the use of Enovid. He testified that because the May 13, 1967, thrombophlebitis was "spontaneous," there was some question as to its cause. One purpose of the
July 11, 1967. Dr. Samuels saw plaintiff for the first time. He took a detailed (some 10 pages) history from her, but he, like Dr. Reitz, did not pick up plaintiff's chest ailments of 1961 and 1963 other than as "flu" and accepted that to be true. A large blood specimen was taken for laboratory test purposes. On this date, Mr. Wolfe, plaintiff's associate counsel who had referred plaintiff to Dr. Samuels, advised the latter to keep this hematological consultation private and to refrain from contacting Dr. Dahlquist until further notice from Mr. Wolfe.
July 12, 1967. Dr. Samuels examined plaintiff physically. Although he found a rather prominent pulmonary sound (P-2), an indication that something might be wrong with her pulmonary circulatory system, he concluded that plaintiff was "medically asymptomatic and in a reasonable state of clinical equilibrium while taking her daily anticoagulant and tranquilizer therapy."
July 18, 1967. Actual studies were commenced. Another blood specimen was taken and laboratory tests thereon performed. Plaintiff told Dr. Samuels that she was experiencing pain in the lower right side of her chest. At this time, Dr. Samuels attributed these pains to anxiety-imagination. In retrospect, Dr. Samuels diagnosed these complaints as indicative of "thrombi and emboli possibly to lung for two weeks prior to discontinuation of Coumadin," and that plaintiff had "presence of pulmonary emboli" on July 18.
July 24, 1967. Plaintiff stopped taking Coumadin upon Dr. Samuels' direction. Mr. Wolfe instructed Dr. Samuels that he would now be permitted to contact plaintiff's personal physician.
July 25, 1967. Although good clinical practice called for tapering off when taking a patient off of an anticoagulant, Dr. Samuels in this instance suddenly stopped plaintiff's ingestion of Coumadin. He was aware of the hazard that thrombophlebitis could result from the "rebound" or "overshoot" reaction from suddenly stopping the taking of Coumadin. But he had advised plaintiff of this hazard as well as the hazard of having plaintiff take Enovid. In fact, this study on plaintiff was "a very hazardous life-threatening study." He testified that he informed both plaintiff and her husband of the risks involved. And according to him, plaintiff realized that to get her answers to her problems, "she might have to further submit herself to further hazards." Dr. Samuels had plaintiff execute a so-called
July 27, 1967. Plaintiff was still having pain in her mid-epigastrium and her lower chest.
July 28, 1967. Dr. Samuels noted an acceleration of blood clotting time in plaintiff after the discontinuance of the anticoagulant and tranquilizer. He also wrote a letter informing Dr. Dahlquist that he had "recommended" discontinuance of the anticoagulant therapy. He did not tell Dr. Dahlquist that it had in fact been discontinued, and that it had been discontinued abruptly. (Dr. Dahlquist testified that when he first heard of the sudden termination of the anticoagulant, his reaction was, "Oh, My God!") Dr. Samuels did not inform Dr. Dahlquist that one purpose of the study was to enhance plaintiff's position in this lawsuit against him. He did not inform Dr. Dahlquist of his intention of using Enovid in the study.
August 2, 1967. Dr. Samuels first talked to Dr. Dahlquist over the telephone.
August 3, 1967. Plaintiff was given one 10 milligram tablet of Enovid out of the 1964 container. No chemical assay of the tablets was made. Plaintiff also took one tablet daily on August 4, 5, 6, 7, 8, 9, 10, and 11, 1967.
August 7, 1967. Dr. Samuels noted that plaintiff reported to him as feeling nauseous and having abdominal pain. She was afraid. The pain did not resemble the pain of 1964, although the nausea did.
August 8, 1967. Dr. Samuels noted: patient reports symptoms of discomfort in the right calf. "Telephone conversation from Mr. Carmichael. Upset about lack of definiteness of effect of Enovid — patient not experiencing same effects — patient upset about not experiencing same effects — as two years ago and not producing results."
August 9, 1967. Dr. Samuels held a conference with Mr. Carmichael and Mr. Wolfe as to whether clinical study should be continued. Apparently, it was decided that it should be. Communication of the decision to plaintiff was left up to Mr. Carmichael.
August 10, 1967. Dr. Samuels noted: "Discomfort in right side of chest, particularly on deep breathing, particularly in back. Coughed up spot of blood in a.m. once. Tenderness in right calf." He testified that there was a Homan's sign, definitely showing thrombophlebitis and recurrent pulmonary emboli. He gave plaintiff the choice of taking or not taking the Enovid pill
August 11, 1967. Plaintiff took another Enovid pill. At this time Dr. Samuels had a thorough discussion with plaintiff; he warned her of the hazards of further continuing with the studies. At the same time he informed her that there were now good theoretical grounds on which "to expect that she might now demonstrate maximum sensitivity to Enovid." On this date she had thrombophlebitis in both legs. Plaintiff was re-started on her anticoagulant and tranquilizer therapy. She was given a maximum dose (4 tablets; 20 milligrams) of Coumadin and instructed to thereafter take 2 tablets (total of 10 milligrams) daily. Plaintiff turned out, however, to be "particularly resistant to anticoagulant therapy" so she was given 4 tablets for 3 days and 3 tablets per day for the balance of the week. She was given as much as 25 milligrams on one occasion. Dr. Samuels instructed her to return to Dr. Dahlquist on August 12 and then report back to him the following Monday.
In the meantime, diagnosis of endometriosis had been confirmed at the UCLA Medical Center. Dr. Samuels agreed that Enovid is a treatment for endometriosis.
August 17, 1967. Dr. Samuels received confirmation from Dr. Dan Simmons, a pulmonary expert, that Dr. Simmons' studies (which included a lung scan on August 17, 1967) were partially complete. The lung scan indicated "a far advanced degree of pulmonary disease particularly on the right, including lower base."
Plaintiff required a "ligation" operation as a result of her 1967 pulmonary embolisms, in which her inferior vena cava was entirely tied off. Dr. Samuels testified: "Very unexpectedly Mrs. Carmichael suffered a minimum of symptoms right after surgery, of which we were terribly delighted, and since that time has done extremely well." At the time she was examined by Dr. Joseph Boyle, an internist, on behalf of defendant Searle in 1969, plaintiff was working. He opined that plaintiff should be able to carry on life "in a completely normal fashion without any difficulty."
The question, whether Enovid caused plaintiff's thrombophlebitis and pulmonary embolism in 1964 or whether it was due to her idiosyncratic hypersensitivity resulting from her endometriosis and abnormal blood clotting time, was hotly disputed. On direct examination, Dr. Samuels stated: "I believe that Mrs. Carmichael was uniquely sensitive to Enovid and sustained an adverse effect on her blood-clotting mechanism as a result of that ingestion," which would make Enovid medically defective in her case. (Italics added.) On cross-examination he stated that he thought plaintiff's
On behalf of Searle, Dr. Robert W. Kistner, board-certified in obstetrics and gynecology, testified that there was no cause-and-effect relationship between Enovid and intravascular clotting, thromboembolism, or pulmonary embolism. He did not think the studies introduced into evidence established any definitive causal relationship. The pulmonary embolism in this case was not due to the ingestion of Enovid; the two events were coincidental. Dr. Joseph Boyle, an internist specializing in heart and lung disease, testified that plaintiff's pulmonary embolism in 1964 was caused by a chronic pelvic thrombophlebitis which had existed over a period of years. He noted the possibility of endometriosis itself having caused the thrombophlebitis in this case. The sudden discontinuance of Coumadin in the course of Dr. Samuels' clinical experimental study aggravated the plaintiff's problems due to her 1967 right calf thrombophlebitis episode. Dr. Herbert S. Sise, an internist specializing in cardiology and thrombosis, had no opinion as to the cause of the 1964 thromboembolism. His own studies performed in 1964 disclosed no really significant changes in the blood of women who took Enovid. He criticized Dr. Samuels' study as inadequate for lack of proper control data. Gerard Lanchantin, Ph.D., a biochemist, testified showing wherein biochemist Pilgeram's study was inadequate.
II.
III.
The rationale of the foregoing rule is: "(1) The doctor is intended to be an intervening party in the full sense of the word. Medical ethics as well as medical practice dictate independent judgment, unaffected by the manufacturer's control, on the part of the doctor. (2) Were the patient to be given the complete and highly technical information on the adverse possibility associated with the use of the drug, he would have no way to evaluate it, and in his limited understanding he might actually object to the use of the drug, thereby jeopardizing his life. (3) It would be virtually impossible for a manufacturer to comply with the duty of direct warning, as there is no sure way to reach the patient."
However, if the promotional features of communications to the doctors by the manufacturer unfairly and unreasonably predominate, a warning otherwise adequate may become inadequate and the adequacy of the warning may present a jury question. (Love v. Wolf (1964) supra, 226 Cal. App.2d at p. 400.)
IV.
V.
The instruction as given was one approved by the California and other courts upon implied warranty of merchantability and fitness for use. (Harris v. Belton (1968) 258 Cal.App.2d 595, 606-607 [65 Cal.Rptr. 808]; Magee v. Wyeth Laboratories, Inc. (1963) supra, 214 Cal.App.2d 340, 352; accord, e.g., Merrill v. Beaute Vues Corporation (10th Cir.1956) 235 F.2d 893, 898.) Even the case cited by plaintiff, Crotty v. Shartenberg's-New Haven, Inc. (1960) 147 Conn. 460 [162 A.2d 513], reaffirms this rule. (See also: BAJI (5th ed. 1969) No. 9.70.) The cases do carry over the implied warranty rules relative to personal idiosyncratic sensitivity of the user of drugs and chemicals to the strict liability field. (See, e.g., Lewis v. Baker (1966) 243 Or. 317, 322 [413 P.2d 400, 403]; Oakes v. E.I. Du Pont de Nemours & Co., Inc. (1969) supra, 272 Cal.App.2d 645, 651; see Rest. 2d Torts, § 402A, comment j; Prosser on Torts (3d ed. 1964) ch. 19, § 97, p. 684.) In absence of a showing that the manufacturer knew or should have known by reasonable "developed human skill and foresight" that the drug is dangerous, the court in Oakes stated that "to exact an obligation to warn the user of unknown and unknowable allergies, sensitivities and idiosyncracies would be for the courts to recast the manufacturer in the role of an insurer." (272 Cal. App.2d at p. 651.) Except for the Magee case, the others cited immediately above, did not deal with prescription drugs. But whether the drug in question is a proprietary
As we have earlier pointed out, the manufacturer of an ethical drug discharges its duty of warning if it adequately warns the doctor who may in the exercise of his medical judgment use the drug as a part of his chemotherapy, and there is no duty to directly warn the patient. Whether Enovid was a defective or unreasonably dangerous drug in treatment of plaintiff's endometriosis in 1964 was incumbent upon plaintiff to prove. As part of that proof, she had the burden of proving that Searle's warning to Dr. Reitz was inadequate. Insofar as proving the inadequacy of the warning is concerned, plaintiff would have to show that a warning of adverse effects to a woman of her physical idiosyncracies and hypersensitivity was incumbent upon Searle and that it failed to give such a warning. In that sense, plaintiff did have the burden of proof and the instruction in this regard was not inaccurate.
In this connection, the record reflects that the objection to this portion of defendant's proposed instruction was not specifically made. The objection was to the whole of defendant's proposed instruction number one: "We object to number one because it includes issues which are irrelevant. So if your Honor just wants to make a note, I object to number one." Plaintiff's counsel likewise objected to a detailed discussion of the instructions proposed by defendant and the trial judge's decision as to whether he would give them.
Disposition
For the reasons which we have set forth in the foregoing opinion, both the judgment of nonsuit in favor of defendant Dr. Reitz and the judgment
Both judgments appealed from are affirmed.
Stephens, Acting P.J., and Reppy, J., concurred.
A petition for a rehearing was denied June 22, 1971, and appellants' petition for a hearing by the Supreme Court was denied August 18, 1971. Schauer, J.,
FootNotes
"MR. JONES: Objected to on the grounds of being argumentative.
"THE COURT: Sustained.
"MR. JONES: May the answer be stricken?
"THE COURT: Yes, it is stricken.
"Q. BY MR. HARNEY: If the information that was read here in court had been told you by anybody, would you ever have consented or agreed to take the Enovid?
"MR. JONES: Just a moment. I will object to the question on the ground it is improper redirect examination and not raised in any way.
"THE COURT: Sustained.
"MR. HARNEY: That is all I have then."
The proposed instruction based on Canifax read: "Under the foregoing rule as stated to you, a product although faultlessly made, may nevertheless be deemed `defective' if the product is unreasonably dangerous to place in the hands of a user without a suitable warning as to the danger involved in the use of the product."
As a part of the instruction on burden of proof the trial judge gave the following (portion of instruction No. 1): that plaintiff had the burden of proving that Enovid as administered to plaintiff was "dangerous to an extent beyond that which would be contemplated by her physician who purchases it, with the ordinary knowledge common to the medical community as to its characteristics."
"(INSTRUCTION No. 6) The Seller of a product is liable only when the defective condition of the product makes it unreasonably dangerous to the user or consumer. Some drug products cannot possibly be made entirely safe for all consumption. [¶] In the field of drugs such a product, properly prepared, and accompanied by proper directions and warning is not defective, nor is it necessarily unreasonably dangerous. It may be that the marketing and use of the drug, notwithstanding a medically recognizable risk, is justifiable in certain instances. [¶] It is for the jury to determine whether or not the drug is properly prepared and marketed and proper warning is given. [¶] In deciding, therefore, whether Enovid is or is not an unreasonably dangerous product, it will be necessary for the jury to balance the benefits, if any, against the risks if any which are inherent in its use."
The comments to section 402A pertinent to this case are:
"i. Unreasonably dangerous. The rule stated in this Section applies only where the defective condition of the product makes it unreasonably dangerous to the user or consumer. Many products cannot possibly be made entirely safe for all consumption, and any food or drug necessarily involves some risk of harm, if only from overconsumption. Ordinary sugar is a deadly poison to diabetics, and castor oil found use under Mussolini as an instrument of torture. That is not what is meant by `unreasonably dangerous' in this Section. The article sold must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics. Good whiskey is not unreasonably dangerous merely because it will make some people drunk, and is especially dangerous to alcoholics; but bad whiskey, containing a dangerous amount of fusel oil, is unreasonably dangerous. Good tobacco is not unreasonably dangerous merely because the effects of smoking may be harmful; but tobacco containing something like marijuana may be unreasonably dangerous. Good butter is not unreasonably dangerous merely because, if such be the case, it deposits cholesterol in the arteries and leads to heart attacks; but bad butter, contaminated with poisonous fish oil, is unreasonably dangerous."
"j. Directions or warning. In order to prevent the product from being unreasonably dangerous, the seller may be required to give directions or warning, on the container, as to its use. The seller may reasonably assume that those with common allergies, as for example to eggs or strawberries, will be aware of them, and he is not required to warn against them. Where, however, the product contains an ingredient to which a substantial number of the population are allergic, and the ingredient is one whose danger is not generally known, or if known is one which the consumer would reasonably not expect to find in the product, the seller is required to give warning against it, if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of the presence of the ingredient and the danger. Likewise in the case of poisonous drugs, or those unduly dangerous for other reasons, warning as to use may be required.
"But a seller is not required to warn with respect to products, or ingredients in them, which are only dangerous, or potentially so, when consumed in excessive quantity, or over a long period of time, when the danger, or potentiality of danger, is generally known and recognized. Again the dangers of alcoholic beverages are an example, as are also those of foods containing such substances as saturated fats, which may over a period of time have a deleterious effect upon the human heart.
"Where warning is given, the seller may reasonably assume that it will be read and heeded; and a product bearing such a warning, which is safe for use if it is followed, is not in defective condition, nor is it unreasonably dangerous."
"k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk."
"n. Contributory negligence. Since the liability with which this Section deals is not based upon negligence of the seller, but is strict liability, the rule applied to strict liability cases (see § 524) applies. Contributory negligence of the plaintiff is not a defense when such negligence consists merely in a failure to discover the defect in the product, or to guard against the possibility of its existence. On the other hand the form of contributory negligence which consists in voluntarily and unreasonably proceeding to encounter a known danger, and commonly passes under the name of assumption of risk, is a defense under this Section as in other cases of strict liability. If the user or consumer discovers the defect and is aware of the danger, and nevertheless proceeds unreasonably to make use of the product and is injured by it, he is barred from recovery."
"Any relationship between a state of `hypercoagulability' and thromboembolic disease still remains undetermined. In any event, presently available data do not establish — or exclude — the possibility that Enovid produces hypercoagulability as defined by increases in components or acceleration of clotting kinetics. A number of blood coagulation factors are known to be modified during normal pregnancy. These include fibrinogen, fibrinolysin, prothrombin, factors VII, VIII and X, and other complicated measurements of the blood coagulation mechanism. Enovid also produces changes in these factors in the same directions as those observed during pregnancy. Although the significance of these changes is presently unknown, additional studies are in progress.
"Enovid was first distributed commercially in June 1957. As of June 1963, somewhat more than 400 thromboembolic episodes have been reported among Enovid users with thirty-seven fatalities in the United States as a result of the development of pulmonary embolism. On further investigation some of these cases and fatalities were unrelated to thromboembolic disease or the histories revealed definitive and generally-recognized causes for the development of the reported condition. Among the fatalities, more than one-third could be classified as idiopathic or having no clear cut (precipitating) etiologic factor.
"Available medical and statistical evidence relative to the incidence of thromboembolic episodes in non-medicated and nonpregnant women of childbearing age is singularly sparse and not completely reliable. Studies are in progress to attempt to rectify this defect in knowledge of the incidence of thrombophlebitis and pulmonary embolism in this segment of the female population. The expected incidence of thromboembolic episodes in `healthy' young women is difficult to determine from the available data but there is evidence that in such women in the age range of 20 to 44 years, not subjected to trauma and not pregnant, 926 cases of thrombophlebitis per million per year will occur, that among these sixty cases of pulmonary embolism will be seen and that 7.9 will die as a result of thrombophlebitis or pulmonary embolism.
"A recent panel survey (Feb.-Aug. 1963, J.A.M.A. 185:776 [Sept. 7] 1963) in analyzing the 1962 fatalities by age groups did not find a statistically significant increased rate of fatalities in any age group. Since the possibility of a real increase especially in the older age group remains this should be carefully weighed by the physician prescribing Enovid. Further data will be evaluated and reported.
"There is abundant evidence in the literature to support the concept that the incidence of thrombotic episodes increases with age, with parity, with obesity, with a history of previous occurrences, with a history of varicose veins or other vascular abnormality, with trauma or unusual activity, and with restricted movement combined with an interference with the dependent circulation (long automobile or airplane trips). Similar causal or contributory factors have been noted in the histories of many of the cases reported as occurring during Enovid administration. Women subject to such exposures or exhibiting these characteristics should be considered as being at risk of thrombosis."
Exhibit "A," aside from the foregoing, under the description of Code 264, March 5, 1964, carried a similar precaution, which was read into the record at pages A250 to A252 of the reporter's transcript.
The portion taken from plaintiff's request: "In this action, the plaintiff has the burden of establishing by a preponderance of the evidence all of the facts necessary to prove the following issues: That Enovid was defective; That such defect was a proximate cause of injury to plaintiff...."
The portion taken from Searle's request: "That the Enovid ingested by [plaintiff] was unreasonably dangerous. That is, dangerous to an extent beyond that which would be contemplated by her physician who purchases it, with the ordinary knowledge common to the medical community as to its characteristics. [¶] That the Enovid ingested by [plaintiff] was the proximate cause of the injury and damages claimed by plaintiffs. [¶] That the injuries claimed by [plaintiff] were not the result of an allergy or peculiar sensitivity common only to an insubstantial percentage of the population who might use Enovid.
"The defendant has the burden of establishing by a preponderance of the evidence all of the facts necessary to prove the following issue: That plaintiffs, and Dr. Samuels, were aware of any danger in the use of Enovid by [plaintiff] in August 1967, and nevertheless proceeded unreasonably to make use of Enovid despite such knowledge."
These were followed by paragraphs defining the meaning of preponderance of evidence and instructing the jury that in determining that issue all of the evidence should be considered regardless of who produced it.
"MR. HARNEY: It seems to me, your Honor, that they have gone over the instructions. I made my objections on the record. I don't know why we have to talk about them all day long."
Comment
User Comments