Whether the Physicians Desk Reference ("PDR") can be entered into evidence to establish, by itself, the proper standard of care for physicians prescribing medication for their patients.

No. The PDR constitutes hearsay, and cannot, standing on its own, establish the appropriate standard of care for physicians.

Plaintiff had been taking birth control pills for several years when she began to experience irregular menstrual bleeding in 1986. Plaintiff's first doctor prescribed a birth control pill which contained estrogen. A month later she was examined by Defendant, who sought to increase Plaintiff's estrogen level to help stop the bleeding. In order to cease the bleeding he diagnosed as dysfunctional uterine bleeding, he instructed Plaintiff to increase her dosage for five days and thereafter to continue at normal dosage levels. The PDR noted that patients often stop using oral contraceptives due to irregular menstrual bleeding, and also that changing to a pill with a higher estrogen content may increase the risk of thromboembolism, which leads to strokes.

Plaintiff's symptoms reappeared several months later, so Defendant, without examining patient, prescribed a new pill. The package for that drug contained an insert warning of the dangers associated with estrogen. The insert warned, inter alia, that while on estrogen, a person should be alert for signs of trouble including abnormal vaginal bleeding. Within one month of commencing the new pill, Plaintiff suffered a severe stroke rendering her a quadriplegic and unable to speak.

Plaintiff brought this action for medical malpractice alleging that the doctors did not properly monitor her health or examine her while prescribing the two oral contraceptives, and were otherwise negligent in their treatment, care, and management of Plaintiff. Plaintiff sought to introduce evidence from the PDR describing the medication and its possible effects. The trial court held that the product information from the PDR was hearsay. The trial court also rejected Plaintiff's request for a jury charge that New York law requires doctors to have knowledge of the risks and benefits of the drugs they prescribe and that this requirement includes the expectation that doctors will avail themselves of all the drug manufacturer's recommendations. Finally, the court rejected Plaintiff's additional request for a modification of traditional medical malpractice jury instructions to include a paragraph stating that the standard of care in New York requires doctors to have knowledge of the drug that they are prescribing. The court did include a summary of the factual contentions concerning the use and monitoring of birth control pills and estrogen to control Plaintiff's condition, and also instructed the jury that the standard of care for Defendants is measured by the degree of knowledge and ability of the average Board certified obstetrician/gynecologist in good standing practicing that specialty in the State of New York. The jury returned a verdict for Defendants and the court subsequently denied Plaintiff's motion to set aside the verdict or, in the alternative, for a new trial. The Appellate Division affirmed, holding that PDR product information was hearsay and was properly excluded, and that the trial court's refusal to give the jury charge requested by Plaintiff was not reversible error.

The Court of Appeals affirmed. The Court held that the PDR does not, by itself, constitute evidence of a physician's standard of care. The Court reasoned that the purposes of the PDR, its technical language, its creation by manufacturers instead of doctors, and its inability to be cross-examined combine to make the admission of the PDR as stand-alone evidence improper. The Court noted, however, that the PDR may have some significance in identifying a doctor's standard of care in the administration and use of prescription drugs, but is not the sole determinant. The Court cautioned that the information in the PDR would only be analyzed in the context of the medical condition of the patient and that expert testimony would be necessary in such a situation to interpret whether the drug at issue presented an unacceptable risk. In this case, therefore, Plaintiff was not prohibited from offering testimony concerning an expert's evaluation of Defendants' conduct, based in part, upon the PDR, but was prohibited from offering the contents of the PDR as stand-alone proof of the standard of care.

Further, the Court rejected Plaintiff's contention that it had created an implicit basis for admission of the PDR in enunciating the "learned intermediary doctrine" as set forth in Martin v. Hacker, 83 N.Y. 2d 1. That doctrine, which focuses on the scope of a drug manufacturer's duty to give adequate warning to a prescribing physician and physician's subsequent balancing of the risks and benefits of the various drugs, allows admission of the PDR to show the existence and adequacy of the warning, not to prove the truth of the warning. Therefore, the Court determined that the "learned intermediary doctrine" did not establish a new hearsay exception for the use of the PDR to set the standard of care in medical malpractice trials.

Finally, the Court held that trial court gave the appropriate jury charge, without modification, since the trial court supplemented the charge by accurately laying out the factual assertions of the parties concerning the prescribing and monitoring of the birth control pills. It should also be noted that the Court stated that since the PDR reprints the package insert information for most drugs, and although this particular plaintiff sought only admission of the PDR entries, the Court saw no substantive difference between PDR entries and package inserts and therefore, any reference to the PDR correspondingly applies to the drug package insert.

Additionally, Judge Smith concurred that the PDR is not, by itself, admissible as a standard of care in a medical malpractice action, but noted that the generalized Pattern Jury Charge on medical malpractice might have been insufficient given the particular facts of this case and that a plaintiff might be entitled to a charge that focuses on the appropriate standard of care in prescribing medications.