Santoni v. Schaerf

Moylan, J., delivered the opinion of the Court. Mario Santoni, age 56, died on July 3, 1972, of hepatitis caused by his taking of the drug isoniazid (INH). The drug was dispensed to him in a tuberculosis prevention program conducted by the Baltimore City Health Department. As a result, on April 29,1975, Antoinette Santoni, his widow and the personal representative of his estate, brought a medical malpractice suit under the wrongful death statute against Dr. Allan S. Moodie, Director of the Bureau of Communicable Diseases of the Baltimore City Health Department and head of the Baltimore City tuberculosis program; Dr. Meyer W. Jacobson, Clinical Director of the Baltimore City tuberculosis program; and Dr. Herman Schaerf, a clinical doctor ⁵⁰⁰ in the Baltimore City tuberculosis program. 1 A trial of the case was held in the Superior Court of Baltimore City in February, 1980.

The trial consumed more than two weeks and involved the testimony of thirteen witnesses. The case was eventually submitted to the jury on the issues of the defendants’ negligence and the decedent’s contributory negligence. On February 29, 1980, a jury rendered a verdict finding no negligence on the part of Dr. Schaerf which caused or contributed to the decedent’s death but negligence on the parts of Drs. Moodie and Jacobson.

The jury also found, however, that the decedent’s own negligence caused or contributed to his death, thereby barring recovery by the plaintiff. After Mrs. Santoni’s motion for judgment n.o.v. and for a partial new trial or a new trial was denied, she filed this appeal. The defendants have filed a cross-appeal. On this appeal, the appellant raises the following contentions: 1) That the decedent was not contributorily negligent as a matter of law and that the trial court, therefore, erred in permitting the question of his contributory negligence to go to the jury; 2) That the trial court erred in its instructions on contributory negligence; 3) That the trial court committed reversible error in refusing to admit into evidence a certain conversation between the appellant and her husband; 4) That the trial court committed reversible error in admitting into evidence a "Danger Signs” poster; and 5) That the jury’s verdict was inconsistent and irreconcilable..

The defendant-appellees, on the other hand, in their cross-appeal contend that their motions for a directed verdict ⁵⁰¹ on the issue of immunity should have been granted. They also contend that the court erred in admitting evidence of twelve other deaths of persons who received INH therapy from the Baltimore City Health Department. The drug isoniazid (INH) has been used since the early 1950’s for the prevention and treatment of tuberculosis. Its metabolism is by the liver.

Until the mid-1960’s, it was thought to be one of the safest drugs on the market. In 1970, however, after two men who were participants in a tuberculosis prevention program in Washington, D.C., died from hepatitis, it was recognized that the ingestion of INH might be associated with liver disease, particularly hepatitis. As a result, in 1971, the United States Public Health Service recommended that certain screening and monitoring procedures be used on all recipients of the drug in any INH program. The Service also recommended that a study be made of persons taking INH to determine if there were any connection between the INH and liver disease.

Following up on its recommendation of a surveillance program, the Public Health Service sought to enlist the help of local health departments to report on the progress of patients in local health department INPI programs. The Service would keep the statistical information, while the local public health agencies would dispense the drug and monitor the people. Baltimore City at that time and for many years before had one of the highest tuberculosis rates in the country, both in number of cases and deaths. In order to expand its already existing prophylaxis program the Baltimore City Health Department agreed to participate in the special surveillance program.

The protocol for the surveillance program promulgated by the United States Public Health Service called for dispensing the drug, in pill form, only on a monthly basis. A patient would thus be required to return to the clinic once a month to receive his 30-day supply of pills. At the time of these visits, any adverse reactions would be noted, particularly any possible signs and symptoms of hepatitis. The protocol provided that the participant would be "ask[ed] specifically about jaundice, dark urine, sustained loss of ⁵⁰² appetite, marked fatigue and prolonged nausea or vomiting.” In any cases of suspected hepatitis, the isoniazid would be discontinued immediately.

A monthly report card would be sent to the Public Health Service on each patient. In 1972, Dr. Allan S. Moodie was the Administrative Health Officer in the Baltimore City Health Department in charge of the administrative aspects of the isoniazid program such as arranging funding and staff for the program. He arranged for the Baltimore City Health Department to participate in the United States Public Health Service surveillance program. Dr. Meyer W. Jacobson was the Clinical Director of the Baltimore City tuberculosis program.

Eventually approximately 3,000 persons entered the surveillance program. The program in Baltimore City provided that a clinic doctor would make the determination whether a person would be placed on INH therapy, based on the tuberculin skin test and chest X-ray. Thereafter, a nurse would instruct the patient on the use of the drug and any signs and symptoms of a reaction. At the follow-up monthly visits, at first only public health nurses were permitted to interview the participants in the program.

As the program expanded, however, health aides and clerical help were authorized to conduct the interviews. If a patient reported any side effects, the patient was to be referred to a clinic doctor for further examination. Any reaction to the drug was to be reported on a chemoprophylaxis register sheet and on the computer cards sent monthly to the Public Health Service. Mario Santoni became a participant in the Baltimore City isoniazid program in 1972.

Mr. Santoni, a native of Italy, came to the United States in 1955. Two years later, he married the appellant, Antoinette Santoni. In Italy, Mr. Santoni had completed only the fourth or fifth grade and, in this country, worked primarily as a painter and carpenter. In 1972, he spoke only broken English and had great difficulty reading it.

Prior to the illness which caused his death, his health had been excellent and, according to his wife, he had never been to a doctor for any illness. ⁵⁰³ In January, 1972, Mr. Santoni became a naturalized citizen of the United States and also became employed by Baltimore City as a maintenance man at the Southern District Police Station. As a prerequisite to his employment, he was required to undergo a medical examination with a tuberculin skin test and chest X-ray. The examination was done at the Eastern Health District Chest Clinic of the Baltimore City Health Department. It showed a positive tuberculin skin test but a clear chest X-ray.

This combination of a positive skin test and clear chest X-ray indicated that Mr. Santoni did not have active tuberculosis but that he had live tubercle bacilli in his body. It indicated that he had a greater than ordinary risk of developing tuberculosis. Dr. Herman Schaerf reviewed the test and X-ray and, on January 20, 1972, placed Mr. Santoni in the Baltimore City isoniazid program. The program called for Mr. Santoni to receive the drug isoniazid prophylactically for one year.

Although isoniazid is a prescription drug, no physician in the program ever saw Mr. Santoni, and no informed consent form to utilize the drug was ever signed by Mr. Santoni or any of the approximately 3,000 other people who were in this special surveillance program. Mr. Santoni faithfully went to the clinic each month to receive his monthly supply of the medication. He believed that in order to work for the City he had to take the isoniazid and regularly took his pills. In March, 1972, Mr. Santoni began to experience fatigue and decreased appetite.

By April, he noted fullness, abdominal discomfort, and increased flatulence. By May, fatty food intolerance became evident, his stools became lighter, and his urine became darker. By early June, Mr. Santoni began to look worse and to feel more tired. His final visit to the clinic was on June 12, 1972.

During the month of May, Mr. Santoni began to look more pale and began to experience more gastric discomfort. His wife was away for a month at the shore with other members of her family. He complained about his condition to a neighbor. When Mrs. Santoni returned home in mid-June, she became concerned about her husband’s condition and ⁵⁰⁴ consulted her doctor.

The doctor prescribed cbantigel and librium for her husband’s stomach problems and nerves. When Mr. Santoni’s condition became worse, Mrs. Santoni called Dr. Joseph Notarangelo at Mercy Hospital. Mr. Santoni was admitted to the hospital on June 22, 1972. At the time of Mr. Santoni’s admission to Mercy Hospital, he complained of excessive gas and indigestion and gave a fairly detailed history of his illness.

He did not, however, know that he was jaundiced. At the hospital, Mr. Santoni was diagnosed as suffering from hepatitis. There is no treatment for the disease, only care to prevent complications. Despite the absence of any complications, Mr. Santoni’s condition deteriorated rapidly and he died on July 3,1972.

Expert testimony placed the cause of death as a toxic reaction to isoniazid, causing hepatitis. Twelve other participants in the tuberculosis prevention program also died of liver disease in 1972. There was expert testimony that had the disease been diagnosed in early June, Mr. Santoni’s chances for recovery would have increased significantly. There was further testimony that Mr. Santoni was probably jaundiced at the time of his last clinic visit on June 12.

The chemoprophylaxis register sheet, which contained a history of Mr. Santoni’s visits to the clinic all along, however, made no mention of any adverse signs or symptoms. It was not until the fall of 1972 that Baltimore City officials first became aware of the large number of deaths of participants- in the City isoniazid program. It was then brought to light that there were thirteen deaths in 1972 of participants in the program (both the general program and special surveillance program combined) and that one of these (Mario Santoni’s) was directly related and seven were probably related to the INH therapy. Five were listed as possibly related to INH therapy.

The City INH prophylaxis program was thereafter severely restricted. Isoniazid was prescribed as preventive therapy only for certain high-risk individuals. In addressing the specific contentions raised in this appeal and cross-appeal, we note at the outset that the question of ⁵⁰⁵ negligence is not in issue here. That question was decided by the jury adversely to the appellees and was not raised in their cross-appeal.

We are concerned only with the question of contributory negligence — whether or not there was legally sufficient evidence of contributory negligence on the part of Mario Santoni to support the jury’s finding. If there were not, a directed verdict should have been granted on this issue and the jury should never have considered the question. Contributory negligence is a recognized defense in medical malpractice cases. It bars recovery where the patient’s negligence was an active and efficient contributing cause of the injury.

"The rule of contributory negligence requires that the patient’s negligence must be concurrent with that of the physician. If it occurs after the physician’s negligence and merely adds to the effects, as opposed to being the cause of the patient’s problem, it will not relieve the physician from liability; it will merely serve to 'mitigate’ or lessen the amount of damages awarded to the patient.” Holder, Medical Malpractice Law, p. 302 (2nd ed. 1978). The burden of establishing contributory negligence was on the defendants. In Batten v. Michel, 15 Md. App. 646, 652, 292 A.2d 707 , we said: "Contributory negligence is an affirmative defense and the burden of proving the plaintiffs contributory negligence rests upon the defendant. . ..

Contributory negligence, if present, defeats recovery because it is a proximate cause of the accident....” (Citations omitted.) A person is contributorily negligent when he fails to exercise ordinary and reasonable care for his own safety by doing something that a person of ordinary prudence would not do or failing to do something that a person of ordinary prudence would do, under the circumstances. In Menish v. Polinger Company, 277 Md. 553, 559 , 356 A.2d 233 , the Court of Appeals discussed this standard of care: "In measuring contributory negligence, the standard of care to be used as the criterion is that of an ⁵⁰⁶ ordinarily prudent person under the same or .similar circumstances, not that of a very cautious person. Sanders v. Williams, 209 Md. 149, 153 , 120 A.2d 397, 399 (1956); and what an ordinarily prudent and careful person would do under a given set of circumstances is usually controlled by the instinctive urge of one to protect himself from harm. Greer Lines Company v. Roberts, 216 Md. 69, 79 , 139 A.2d 235, 239 (1958); Martin v. Sweeney, 207 Md. 543, 548 , 114 A.2d 825, 827 (1955).” An important element of contributory negligence is the foreseeability of harm.

To be held contributorily negligent, a person must actually have been aware of or should have appreciated the risks involved and then failed to exercise reasonable and ordinary care for his own safety. The courts have on many occasions discussed this element of foreseeability of risks and failure to exercise ordinary care. In Menish v. Polinger Company, supra, the Court of Appeals, stated, at 277 Md. 560 -561: "Before the doctrine of contributory negligence can be successfully invoked, it must be demonstrated that the injured party acted, or failed to act, with knowledge and appreciation, either actual or imputed, of the danger of injury which his conduct involves. . . . Stated another way, when one who knows and appreciates, or in the exercise of ordinary care should know and appreciate, the existence of danger from which injury might reasonably be anticipated, he must exercise ordinary care to avoid such injury; when by his voluntary acts or omissions he exposes himself to danger of which he has actual or imputed knowledge, he may be guilty of contributory negligence.” (Citations omitted.) In Sanders v. Williams, supra, the Court stated, at 209 Md. 152 : "As is true of primary negligence, one measure of contributory negligence is the need, in a given sit ⁵⁰⁷ uation, to anticipate danger.

Presence or absence of reasonable foresight is an essential part of the concept. One is charged with notice of what a reasonably and ordinarily prudent person would have foreseen and so must foresee what common experience tells may, in all likelihood, occur, and to anticipate and guard against what usually happens. On the other hand, one is not bound to anticipate every possible injury that may occur or every possible eventuality.... Absent actual or constructive knowledge to the contrary, one may act on the assumption that he will not be exposed to danger that will come only by the breach of duty which another owes him.

He is not bound to anticipate negligent acts or omissions on the part of others unless, under the circumstances, an ordinarily prudent person would know, or should know, that it was not safe to make the assumption of due care on the part of the other person.” (Citations omitted.) With respect to this element of foreseeability, in discussing contributory negligence in medical malpractice cases, courts have noted the disparity between the knowledge and skill of a doctor and that of a patient. The patient is not in a position to diagnose his own ailment. Without being told, he does not know the risks of medication. He is not in a position to judge whether the prescribed course of treatment is in his best interest.

As a consequence, it is not contributory negligence for a patient to follow a doctor’s instructions or rely on his advice, Largess v. Tatum, 130 Vt. 271 , 291 A.2d 398 (1972), Los Alamos Medical Center, Inc. v. Coe, 58 N.M. 686 , 275 P.2d 175 (1954); to fail to consult another doctor when the patient has no reason to believe that the doctor’s negligence has caused his injury, Johnson v. United States, 271 F. Supp. 205 (W.D. Ark. 1967), Rahn v. United States, 222 F. Supp. 775 (S.D. Ga. 1963), Fairchild v. Brian, 354 So. 2d 675 (La. App. 1977); or to fail to diagnose his own illness, O’Neil v. State, 66 Misc. 2d 936 , 323 N.Y.S.2d 56 (1971). See also Martineau v. Nelson, 311 Minn. 92 , 247 N.W.2d 409, 417 (1976); Annot., Contributory Negligence or ⁵⁰⁸ Assumption of Risk as Defense in Action against Physician or Surgeon for Malpractice, 50 ALR2d 438. The patient has a right to rely on the doctor’s knowledge and skill.

The court in Halverson v. Zimmerman, 60 N.D. 113 , 232 N.W. 754, 759 (1930), stated well the nature of this reliance: "It is not a part of the duties of a patient to distrust his physician, or to set his judgment against that of the expert whom he has employed to treat him or to appeal to other physicians to ascertain if the physician is performing his duty properly. The very relation assumes trust and confidence on the part of the patient in the capacity and skill of the physician; and it would indeed require an unusual state of facts to render a person who is possessed of no medical skill guilty of contributory negligence because he accepts the word of his physician and trusts in the efficacy of the treatment prescribed by him. A patient has the right to rely on the professional skill of his physician, without calling others in to determine whether he really possesses such skill or not. The patient is not bound to call in other physicians, unless he becomes fully aware that the physician has not been, and is not, giving proper treatment.” 57 Am.

Jur. 2d, Negligence, § 324, discusses the comparative knowledge of the parties as bearing on the question of liability. "Since knowledge of danger, either actual or imputed, is an element of negligence, whether primary negligence on the part of the defendant, or contributory negligence on the part of the plaintiff, the question of liability is sometimes resolved in a negligence action by a comparison of the knowledge of the defendant as against the knowledge of the person injured. The proposition may be stated as follows: Liability is established when it is shown that the peril, being of the defendant’s creation, was ⁵⁰⁹ known to the defendant but not to the person injured; but no liability is predicable of the injury when it appears that the injured person’s knowledge of the danger surpassed or equaled that of the defendent.” Applying that body of law to the evidence, or lack thereof, in the case at hand, we note that there was no direct evidence at trial that Mario Santoni knew of the risks of taking INH. No informed consent form was ever signed by him nor was there any notation on his chemoprophylaxis register sheet that he was advised of the risk of hepatitis.

Whatever evidence was introduced on this issue was totally circumstantial. The appellees sought to establish through a series of inferences that Mr. Santoni was aware of the risks associated with isoniazid. The evidence showed that the protocol set forth by the U. S. Public Health Service for questioning a patient about the appearance of any adverse signs or symptoms was distributed to all the health clinics in Baltimore City. This protocol was discussed at the monthly meetings of the charge nurses from all the clinics.

The administrative nursing supervisor assigned to the Division of Tuberculosis Control testified that she sat in on some of the interviews and saw the procedure being followed. From this evidence, the appellees argue that the inference could be made that Mr. Santoni was aware of the risks of isoniazid. From that inference, they then contend another inference could be drawn — that the absence of any notation on the register sheet as to any adverse signs or symptoms was due to Mr. Santoni’s failure to advise the clinic personnel of these reactions. As a consequence, they urge that the jury could have made the ultimate inference that Mr. Santoni was negligent in continuing to take the INH after the appearance of his symptoms and through his failure to seek immediate medical attention was responsible for his death.

To be sure, from the defendants’ evidence itself, as well as from additional evidence on the issue offered by the plaintiff, a strong countervailing argument could also be mounted. A circumstantial predicate was established that arguably ⁵¹⁰ showed that Mr. Santoni did not indeed know of the risks of isoniazid ingestion or associate his symptoms with the medication because he was not properly questioned about adverse reactions. Mr. Santoni was an immigrant with little formal education. He and his wife spoke Italian at home.

He spoke only broken English and had great difficulty reading English. He did not go to doctors for any medical treatment. Under the impression that he had to take the INH to retain his job with the City, he went to the clinic regularly to get the medication. He had a right to rely on the clinic personnel in his treatment.

They were in a far superior position to recognize any adverse signs or symptoms. Mr. Santoni first began to notice ill-defined symptoms of fatigue and decreased appetite in March. The evidence indicates that he continued to associate his symptoms with stomach problems, as is evident on his hospital admission record. At the time of his admission, he complained of excessive gas and indigestion and did not know that he was jaundiced.

On the basis of his complaints, a preliminary diagnosis of a peptic ulcer was, in fact, made. The appellant offered evidence that argued against contributory negligence, if such countervailing evidence had been needed. Mr. Santoni was not accustomed to taking medication. Reactions to medication are not always clear-cut and definite.

A layman is not in a position to know that ill-defined symptoms are due to a drug. Doctors themselves many times are unsure. The symptoms are sometimes very prominent; at other times they are very subtle. When the symptoms, which the evidence indicates Mr. Santoni associated with his stomach, became more pronounced, Mr. Santoni did, indeed, seek medical attention.

This, furthermore, was not an isolated case where one man allegedly knew but failed to report signs and symptoms of hepatitis and died as a result. There were twelve other deaths in 1972 in Baltimore City of participants in the City’s INH prophylaxis program. There was no evidence that any of them complained of any adverse reactions. Dr. Schaerf, in