Santoni v. Schaerf

• Decision Date: 14 April 1981
• Docket Number: No. 1187,1187
• Citation: 48 Md.App. 498,428 A.2d 94
• Parties: Antoinette SANTONI, Personal Representative of the Estate of Mario Santoni v. Herman H. SCHAERF et al.
• Court: Court of Special Appeals of Maryland

Page 498

48 Md.App. 498

428 A.2d 94

Antoinette SANTONI, Personal Representative of the Estate of Mario Santoni v. Herman H. SCHAERF et al.

No. 1187.

Court of Special Appeals of Maryland.

April 14, 1981.

Stuart M. Salsbury, Baltimore, with whom was Max R. Israelson, Baltimore, on brief, for appellant.

B. Ford Davis, Baltimore, with whom were William B. Whiteford, Francis J. Gorman, and Whiteford, Taylor, Preston, Trimble & Johnston, Baltimore, on brief, for appellees.

Argued before MOYLAN, MASON and COUCH, JJ.

MOYLAN, Judge.

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 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 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 INH 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 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.

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 consulted her doctor. The doctor prescribed coantigel 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,...