Lead Opinion
This is an appeal from a jury verdict in favor of appellees against Diane R. Garvey and her husband, Vincent M. Garvey, in a medical malpractice suit alleging that Mrs. Garvey developed tinnitus
I
In early March 1980, Diane Garvey, a first-year nursing student, sought medical treatment from Dr. J. Morgan O’Donoghue for a sore throat. Dr. O’Donoghue re
While hospitalized, Mrs. Garvey was under the care of several physicians, including Dr. J. Morgan O'Donoghue, an internist, Dr. Charles T. Gerber, a specialist in obstetrics and gynecology, and Dr. Joseph W. Giere, Mrs. Garvey’s obstetrician and gynecologist since 1975, all appellees in this case. Her doctors determined she was suffering from a left tubo-ovarian abscess seven centimeters in size. This diagnosis was later confirmed by sonography.
Throat and vaginal cultures taken .around the time of Mrs. Garvey’s admission to the hospital indicated thаt several antibiotics, including Tobramycin, would be effective against the offending organism, Beta Streptococcus Group A. Two potent antibiotics, Tobramycin (Nebcin-Lilly) and Cefoxiitin (Mefoxin-MSD) were administered intravenously for fourteen days; To-bramycin was administered in an initial dose of 80 mg. followed by 60 mg. every eight hours for the remaining thirteen days of Mrs. Garvey’s hospitalization. During this time, Mrs. Garvey showed steady improvement. Blood tests were conducted at least twice to monitor for side effects from the antibiotic; however, the last monitoring was conducted eight days before administration of the drug was concluded. At no time during her hospitalization did Mrs. Garvey complain of hearing loss, hearing impairment, or unusual sounds in her ears. She was released from the hospital on March 27, 1980.
Mrs. Garvey testifiеd she first noticed a “sound” in her ears a few weeks after being discharged from the hospital, but could not recall with certainty mentioning it to any physician before February 1981 when she told Dr. Giere.
At trial, Mrs. Garvey sought to show that Tobramycin is a highly toxic drug and that more suitable, less dangerous drugs were available. In addition, she attempted to show that both the dosage level and the duration of treatment with the drug exceeded the recommended standards for a person of her size.
Appellants presented the testimony of two expert witnesses. The first was Nicholas Criares, M.D., a board certified obstetrician and gynecologist, who had been employed since 1978 by the State of New
Appellants’ second expert was Linwood Tice, D.Sc., a retired Dean of the Philadelphia College оf Pharmacy, where he had taught various subjects including chemistry and pharmacology from 1938 through his tenure as dean until his retirement in 1975. During his career, Dr. Tice engaged in clinical research on aminoglycosides, the group of drugs to which Tobramycin belongs. He retired two years before Tobra-mycin was placed on the commercial market. Dr. Tice was qualified by the court as an expert in pharmacology.
Both Dr. Criares and Dr. Tice had reviewed Mrs. Garvey’s medical records. Both experts testified that Tobramycin belongs to a group of drugs called aminogly-cosides which have well-known nephrotoxic and ototoxic properties; that is, use of the drug in too high a dosage or over an extended period of time can cause kidney damage that is reversible and damage to the eighth cranial nerve (affecting hearing) that is irreversible. The ototoxicity of To-bramycin manifests itself in a variety of ways including hearing loss and ringing in the ears. Both experts testified that appropriate dosage is a function of the weight and renal health of the patient, that use of the drug should not exceed ten days, and that the patient should be monitored to detect signs of nephrotoxicity and ototoxicity. Dr. Criares stated that in his opinion the proper standard of care for treatment of a tubo-ovarian abscess is antibiotic therapy, but that because Mrs. Garvey’s condition was not life-threatening, Tobramycin was not the appropriate antibiotic to use. In addition, Dr. Criares testified that in his opinion Mrs. Garvey suffered from tinnitus caused by the impropеr administration of Tobramycin while under the care of appel-lees.
II
A.
At trial, appellants made repeated attempts to introduce into evidence both the pages of the Physicians’ Desk Reference (PDR) dealing with the drug Tobramycin and the drug manufacturer’s package insert on Tobramycin.
Appellants first contend that the documents are admissible as data reasоnably relied upon by experts in forming their opinions. In general, an expert witness may testify on the basis of data that is not itself admissible if the data is of a type reasonably relied upon by experts in the particular field in forming their opinions or inferences on the subject. Fed.R.Evid. 703; L.C.D. v. District of Columbia ex rel. T.A.H.D.,
Appellant next argues that the PDR сan be characterized as a publication prepared for and relied upon by physicians and pharmacologists and is, therefore, admissible as an exception to the hearsay rule. Fed.R.Evid. 803(17).
Finally, appellant argues that regardless of whether the PDR is admissible for the truth of the information contained therein, it is admissible as evidence of the applicable standard of care for administration of Tobramycin and as evidence that appellees knew or should have known about the recommended indications, contraindications, side effects, warnings, and dosage levels of Tobramycin. On this issue, the case law is unsettled. Although this court has not previously addressed the question, some courts have held that relevant package inserts or references from the PDR, accompanied by expert testimony, have a bearing on the standard of care or the defendant physician’s notice of the drug’s side effects.
Generally, the PDR “is not conclusive evidence of the standard or accepted practice in the use of the drug by physicians and surgeons, nor that a departure from such directions is negligent. But it is
We adopt this approach, and we hold that the applicable pages of the Physicians’ Desk Reference and the package insert for the antibiotic Tobramycin are relevant and probative evidence of the medical standard of care for selecting, administering, and monitoring the drug. Further, in a medical malpractice case alleging improper administration, dosage, and monitoring of the drug, they are admissible as both prima facie evidence of the standard of care and physicians’ notice of their contents. The trial court, therefore, erred in еxcluding these documents.
B.
As their second assignment of error, appellants contend that the trial court improperly limited the testimony of Dr. Linwood Tice. Dr. Tice was qualified by the court as an expert in the field of pharmacology, but was not permitted to testify about the proper or excessive dosage of Tobramycin, and whether Tobramycin was properly prescribed to Mrs. Garvey. In restricting Dr. Tice’s testimony, the court reasoned that to allow him to testify as requested would be tantamount to allowing a nonmedical expert to testify to a medical standard of care.
“In a medical malpractice case the plaintiff must prove, generally through expert testimony, that there was an applicable standard of care, that the defendant breached that standard, and that the breach was a proximate cause of the plaintiff’s injuries.” Psychiatric Institute of Washington v. Allen,
Traditionally, a physician’s standard of care may only be established by medical testimony and “medical testimony” means “testimony by physicians.” Rodriguez v. Jackson, supra note 7,
The border between what is peculiarly the province of medical doctors and that of pharmacologists or other professionals whose fields of expertise are closely related to the medical profession, has not, and we think cannot, be drawn with precision.
Such tolerance is particularly appropriate where the allegation is that a physician breached a duty of care by incorrectly using a product, device, or equipment. See, e.g., Monk v. Doctors Hospital,
Thus, we hold that the trial court erred in refusing to allow Dr. Tice to testify as to the effects of Tobramycin on Mrs. Garvey, the proper dosage of Tobramycin for a person of Mrs. Garvey’s size, and the propriety of monitoring the drug’s effects through the use of blood tests.
C.
Appellants’ third challenge is that the trial court improperly excluded one set of medical records created by treating physician George T. Nager, M.D., and improper
The document created by Dr. Nager is a two-page chartlike report of the results of Mrs. Garvey’s October 13, 1982 and July 25, 1984 hearing examinations at the Hearing and Speech Clinic of Johns Hopkins Hospital. In addition to test results, the document contains the two handwritten comments: “Hx: Bilateral tinnitus; ... for the past 2V2 years following [phenocomycin] Rx,” and “[T]he patient reports bilateral tinnitus.” The record reveals that the tests themselves showed no abnormalities in Mrs. Garvey’s hearing. The court ultimately excluded the entire document. We conclude that the statements are neither medical opinion nor medical diagnosis by the treating physician, and that the statements are unrelated to the actual hearing test results. We hold that it was improper to exclude the entire document, and that it would have been sufficient to redact the references to tinnitus and admit the hearing examination results. This is especially so, since on the record before us, Dr. Nager refused to testify to a reasonable degree of medical certainty that Mrs. Garvey had tinnitus at all, much less that such alleged tinnitus resulted from the administration of Tobramycin between March 11 and March 27, 1980.
The medical records prepared by Dr. Burch also contain references to tinnitus. Here, however, the references are diagnoses rather than mere recordings of Mrs. Garvey’s presenting complaints. The court ordered the references to tinnitus redacted on the grounds that Dr. Burch was not a witness and could not be cross-examined. As appellant points out, the document entries, even if inadmissible hearsay, in some circumstances may be admissible as the basis of expert testimony.
Both Dr. Burch and Dr. Nager were available to testify; in fact, Dr. Nager was listed in appellants’ pretrial statement as one of three expert witnesses appellаnts expected to call at trial. Still, appellants elected not to call either physician as a witness. Given the nature of the offending statements, the only possible proper use of them by appellants’ expert, Dr. Criares, would have been to establish that Mrs. Garvey was examined by the doctors and that Mrs. Garvey told the doctors she suffered from tinnitus. We hold, therefore, that the court did not abuse its discretion by ordering a portion of the patient’s medical record redacted. To allow the reference to tinnitus before the jury would have amounted to admitting two additional expert opinions on an ultimate issue in the case without benefit of cross-examination on the issue. Cross-examination of the treating physicians was particularly crucial here sinсe Dr. Burch and Dr. Nager were not willing to support a diagnosis of tinnitus at trial.
Ill
While we agree with appellants’ arguments as indicated, supra, II A.-C., we observe that “[w]hen reviewing such rulings, this court will ... reverse only if a party’s substantial rights are affected.” Pyne v. Jamaica Nutrition Holdings, Ltd.,
On the record before us, we conclude that the trial court’s erroneous evidentiary rulings do not warrant reversal. Prejudice arising from the exclusion of evidence may be mitigated where the same information or very nearly the same information is placed before the jury through another witness or in a different form. Boyle v. Smith,
We also note that the exclusion of the medical records of Dr. Nager was harmless, because it would have been appropriate to redact the references to tinnitus contained in them and because the remaining hearing examination results merely showed normal hearing functions.
Affirmed.
Notes
. Tinnitus is defined as "a subjective ringing or tinkling sound in the ear.” Taber’s Cyclopedic Medical Dictionary (14th ed. 1981).
. This action was commenced in March 1983, against J. Morgan O'Donoghue, M.D., Charles T. Gerber, M.D., Joseph W. Giere, M.D., and the President and Directors of Georgetown College. Eli Lilly and Company was added as a defendant in June 1983, by way of amendment to the complaint. Prior to trial, action as to the defendants President and Directors of Georgetown College and Eli Lilly and Company was dismissed.
. The record before us contains some indication that Mrs. Garvey had had previous medical problems with her ears. For example, Dr. O’Do-noghue’s record of Mrs. Garvey’s March 27, 1979 office visit refers to "tinnitus.” This record was admitted into evidence. Moreover, at trial Mrs. Garvey would not deny that she had suffered ear and hearing disorders prior to her exposure to Tobramycin.
Q. On February 14th [1978], did you ever complain to any physician that you had a sea shell sound in your ears and that you were unsteady?
A. I don’t recall.
Q; If you don’t recall that, let me see if I can refresh your recollection a little more. On February 14th, 1978, did you ever complain of any discharges from one of your ears and see a physician for it?
A. I don’t remember. I remember I had medicine from Dr. Burch once, when I had a sore throat and some pressure had built up in my ears from the sore throat [sic] of this sea shell type of sound.
******
Q. I am not concerned about your strep throat, Mrs. Garvey, I am concerned about whether or not you saw Dr. Bahr for ear problems, specifically sea shell sounds, unsteаdiness on your feet, discharge from your ear, and a question was made then or raised then of tinnitus?
A. No, I don’t recall that. I am not denying it, I am saying that I don’t recall it.
. The Physicians' Desk Reference is an annual publication compiling product information about pharmaceuticals. The information is provided by the drug manufacturers and is approved by the FDA. Each year the PDR and its ' supplements are sent free of charge to licensed physicians in the United States and abroad. A typical entry includes the trade name and chemical name of the drug, a description of the drug, indications and contraindications for its use, warnings, adverse reactions, administration and dosage, and information on managing and adjusting the dosage of the drug. At issue in this case is the admissibility of pages 1064-66 of the 1980 еdition. As conceded by all, the package insert for Tobramycin is virtually an exact copy of the information about Tobramycin as it appears in the PDR.
. Fed.R.Evid. 803(17) provides: "Market quotations, tabulations, lists, directories, or other published compilations, generally used and relied upon by the public or by persons in particular occupations” are not excluded by the hearsay rule regardless of the availability of the declarant.
. Appellant directs our attention to SK & F v. Premo Pharmaceutical Laboratories,
. See, e.g., Salgo v. Leland Stanford University Board of Trustees,
. See also Witherell v. Weimer,
. See, e.g., Gideon v. Johns-Manville Sales Corp.,
Dissenting Opinion
dissenting:
I agree with the conclusion reached by the majority, in Parts A and B of its opinion, that the trial court erred both in excluding from evidence the Physicians’ Desk Reference and package insert for Tobramy-cin, and in improperly limiting the testimony of Garvey’s pharmacology expert, Dr. Tice. Although I also agree with its conclusion in Pаrt C that the trial court properly ordered redaction of the diagnoses of tinnitus contained in the treating physicians’ reports, I am of the opinion that the court erred in preventing Garvey’s OB/GYN expert, Dr. Criares, from mentioning these diagnoses during his own testimony, a ruling which the majority does not discuss. More fundamentally, I think the erroneous evidentiary rulings here went to the heart of the standard of care issue, and very nearly eviscerated Garvey’s case; I do not, therefore, share the majority’s confidence that the judgment of the jury was not swayed by the' errors. I would not find these errors harmless.
I
With regard first to the reports of Drs. Nager and Burch, two non-testifying physicians who had treated Garvey, these reports were offered in evidence by Garvey as records relied upon by her expert, Dr. Criares, in formulating his expert opinion.
The proffered purpose of offering the treating physicians’ diagnoses was to “test the validity of the basis upon which ... [Dr. Criares’] expert opinion rests,” Smith v. United States,
However, the rationale for deleting the diagnoses from the medical records did not justify the court’s order that Dr. Criares not mention the diagnoses during his testimony. The majority does not address this ruling, which is, in my view, erroneous. The law of this jurisdiction clearly allows the expert to base his opinion on reports not in evidence, if of a type customarily relied upon in the practice of his profession. L.C.D. v. District of Columbia ex rel. T.-A.H.D.,
Physicians habitually rely upon the diagnoses of other physicians in making their own diagnoses and/or treating their patients. In Smith, supra,
Dr. Criares should have been permitted to testify as to the diagnoses contained in the treating physiciаns’ reports.
II
My more fundamental disagreement with the majority concerns its assessment of the effect of the erroneous evidentiary rulings upon Garvey’s substantial rights. D.C. Code § 11-721(e) (1981); Giles v. United States,
The PDR and package insert contained detailed information on the recommended dosage, monitoring, duration of treatment, contraindications, and sidе-effects of Tobra-mycin, information “not only admissible but .essential” to determining the standard of care in the use of the drug. Mueller v. Mueller,
Dr. Tice, though permitted to describe what the PDR and package inserts are, how they are compiled or produced, and the type of information contained in them, was never in any way permitted to testify directly as to the actual information contained in the PDR and package insert about Tobramycin. The majority is perhaps comforted by the fact that Dr. Tice, near the end of his testimony, answered generally that the PDR contained information about which he had testified. I find this indirect, non-spеcific reference to the information contained in the PDR a very poor substitute for the document itself. Besides, the majority itself concedes that the information about which Dr. Tice testified was itself severely restricted by the trial court, omitting such essential information as the proper dosage of the drug, its side-effects and the propriety of monitoring the drug's effects through the use of blood tests. Maj. Op. at 1147; see infra at 1152.
Neither did the information contained in the PDR and package insert come in through the testimony of Dr. Gerber, Garvey’s third witness (and also one of the defendants). Dr. Gerber was permitted to testify only that the PDR and package insert provide information about recommended dosage and duration of treatment; at no time did he testify as to what that information actually was. Garvеy’s attempt to elicit such testimony was objected to, and the objection sustained.
The actual information contained in the PDR and package insert came in only through Dr. Criares.
Garvey was entitled to show the jury in black and white the manufacturer’s data on the drug, information which was prima facie evidence of the proper standard of care. See Maj.Op. at 1145-1146 and cases cited.
The negative effects of the PDR/package insert rulings on Garvey’s ability to estаblish the standard of care were compounded by other rulings as to Dr. Tice’s testimony. Perhaps the jury’s inability to see the manufacturer’s information, or hear it through the mouth of Dr. Tice, might have been compensated for had Dr. Tice been permitted to testify from his own knowledge as to the proper standard of care in the administration of the drug. He was allowed to testify about its possible side effects and the proper frequency of monitoring; but in a series of erroneous rulings, his proffered testimony as to the most important issues — indications for the use of Tobramycin, proper dosage and duration of treatment, the propriety of monitoring treatment through blood tests, and the effects of the drug on Garvey — was consistently excluded. See Maj.Op. at 1147.
In short, the erroneous evidentiary rulings had the effеct of substantially depriving the jury of the testimony of one expert (Dr. Tice) on the proper standard of care, and entirely removing from it independent evidence of standard of care which Garvey was entitled to put before it (the PDR and package insert). Garvey’s evidence on the proper administration of the drug was thus reduced to a few minutes of testimony by a weak witness with no independent support.
When one further considers the exclusion from evidence of a treating physician’s diagnosis of tinnitus, it seems that the trial court could not have done more to debilitate Garvey’s expert testimony. The jury should have been permitted this information to test the bases of Dr. Criares’ opinions. See supra at 1150. The concurring diagnosis of a physician who had actually treated Garvey would have lent a firmer basis to Dr. Criares’ opinions.
In my opinion, this is a case in which it is impossible to say, “with fair assurance, after pondering all that happened without stripping the erroneous action from the whole, that the judgment was not substantially swayed by the error_” Kotteakos, supra,
. It appears that Drs. Nager and Burch were not called to testify for Garvey because they would not say with a reasonable degree of medical certainty that she had tinnitus or, if she did, that it was caused by the Tobramycin.
. In Smith, supra,
. A limiting instruction would have been appropriate to explain to the jury that this evidence was admitted to explain the basis of the expert’s opinion, not as substantive evidence of tinnitus. Sims, supra,
. Dr. Criares briefly testified as to the possible side-effects of Tobramycin described in the PDR and package insert, and the proper dosage and duration of treatment recommended therein. However, he never testified about the PDR’s warnings as to monitoring, an important issue in the case. (Garvey contended that she received only two blood tests, the last being eight days prior to the termination of her 14-day treatment.)
. In his voir dire conducted in the presence of the jury, Dr. Criares stated that although employed at a psychiatric institution in Bronx, New York where he administered gynecological and obstetrical care to institutionalized patients, he had not delivered a baby, performed surgery, or admitted any patient to a hospital for the past six to eight years. He could identify no text in his office to which he referred. He could not, without the help of cross-examining counsel, name any of the aminoglycosides, the genre of drug to which Tobramycin belongs. He had no specialized training in infectious diseases, one area of expertise for which he was offered as an expert. Ruling that he was qualified as an expert witness, the trial judge nevertheless stated that Dr. Criares had the “bare minimum” of credentials.
.The jury itself felt a need for this information, as evidenced by its note to the trial judge, during the course of its deliberations, requesting a copy of the PDR reference on Tobramycin and
