Spensieri v. Lasky

723 N.E.2d 544, 94 N.Y.2d 231, 701 N.Y.S.2d 689, 1999 N.Y. LEXIS 3747
New York Court of Appeals·Decided December 2, 1999·Published·Cited by 43 cases

Opinions

OPINION OF THE COURT

Wesley, J.

During the course of this medical malpractice trial, the court rejected on hearsay grounds plaintiffs attempt to introduce the Physicians’ Desk Reference (PDR) into evidence to establish by itself the standard of care for a doctor in prescribing and monitoring a drug. We hold that the PDR as offered here constitutes hearsay and cannot, by itself, establish the applicable standard of care for physicians who prescribe medications for their patients.

Roberta Spensieri began taking birth control pills in 1978. In early 1986, she began experiencing irregular menstrual bleeding. In May of that same year, Spensieri was examined by defendant Dr. John H. Streit and was prescribed Ortho-Novum 10/11, a birth control pill containing estrogen. The following month she was examined by defendant Dr. Charles W. Lasky. Lasky noted that although Spensieri was taking an oral contraceptive, she was still experiencing irregular heavy bleeding with clots. After a physical examination, Lasky made a diagnosis of dysfunctional uterine bleeding. He sought to increase Spensieri’s estrogen level to help stop the bleeding and instructed her to take her birth control pill four times a day for five days and, thereafter, once per day.

According to the PDR, oral contraceptives such as Ortho-Novum carry with them a risk of thromboembolism leading to strokes. The PDR notes that patients often discontinue use of oral contraceptives when they experience irregular vaginal [235]*235bleeding. Furthermore, the PDR warns that changing to an oral contraceptive with a higher estrogen content may increase the risk of thromboembolic disease.

Spensieri’s bleeding and clotting reappeared in September 1986. Spensieri telephoned Lasky who, without seeing her, prescribed the estrogen Estinyl. The drug package insert for Estinyl notes that the dangers of estrogen include abnormal clotting leading to stroke, heart attack or pulmonary embolus. The package insert further warns that while on estrogen, a person should be alert for “signs of trouble,” including abnormal vaginal bleeding.

Within a month of taking Estinyl, Spensieri, then 29 years old, suffered a severe stroke rendering her quadriplegic and unable to speak. She commenced this medical malpractice action alleging, among other things, that defendants “in prescribing [Ortho-Novum and Estinyl] failed to timely and adequately monitor and examine [her] and otherwise were negligent in her care, treatment and management.”

At trial, Spensieri sought to introduce “product information” excerpts from the PDR. Her medical expert characterized the information as authoritative concerning the use and administration of drugs and further testified that manufacturers, by law, must provide this information to the Food and Drug Administration (FDA). He specifically noted that the PDR was a standard of care for physicians relative to the use and administration of Ortho-Novum in 1986. Spensieri then offered into evidence those portions of the PDR pertaining to Ortho-Novum. The court sustained defendants’ objection on hearsay grounds.

Spensieri’s expert then described the risks associated with birth control pills containing estrogen, including the significance of “thromboembolic problems,” such as myocardial infarction, heart attack and stroke. The doctor opined that the standard of care requires physicians to understand the risks associated with the use of any medication. Moreover, the acceptable standard of care requires the physician to do more than just prescribe birth control pills to address a problem of abnormal bleeding.

Defendants and their expert testified that the PDR is a source of information on prescription drugs, but is not authoritative as a standard of care. Lasky also maintained that he understood all the risks associated with estrogen and birth control pills. He further testified that the use of oral contracep[236]*236tives as a means to control abnormal bleeding is not a deviation from the standard of care.

At the close of testimony, Spensieri requested the court to charge the jury that New York 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. Spensieri’s proposed jury charge also included a statement that estrogen is regulated by the FDA and that doctors should know the contraindications or risks contained in the patient package inserts. The trial court rejected plaintiffs request.

Spensieri then sought to modify the traditional medical malpractice instruction found in the New York Pattern Jury Instructions (PJI 2:150) to include a paragraph stating that in the State of New York, the standard of care requires doctors to have knowledge of the drug that they are prescribing. The trial court did not modify the jury charge. The court summarized the factual contentions of the parties concerning the use and monitoring of birth control pills and estrogen to control plaintiffs condition and also instructed the jury that the standard of care for Lasky and Streit 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. Spensieri’s motion to set aside the verdict or, in the alternative, for a new trial, was denied.

The Appellate Division affirmed, holding that PDR excerpts were hearsay and thus, as offered, were properly excluded. The Appellate Division further concluded that the trial court’s refusal to give the requested jury charge on prescription medication was not reversible error. The court noted that the jury charge reviewed the parties’ factual assertions and instructed the jury on the relevant principles of medical malpractice in substantial conformance with the New York Pattern Jury Instructions. We granted plaintiffs motion for leave to appeal and now affirm.

Spensieri acknowledges that the PDR excerpts are hearsay; they were offered to prove the truth of the warnings in the PDR concerning Ortho-Novum (see, Prince, Richardson on Evidence § 7-313 [Farrell 11th ed] [“Scientific books or reports are excluded as hearsay when offered as proof of the facts asserted [237]*237in them.”]). She maintains, however, that the warnings and contraindications contained in the PDR should have been admitted into evidence because the PDR is a reliable tool generally recognized by doctors as a standard of care to which they must adhere in prescribing and monitoring medications. The question remains whether the PDR by itself can constitute evidence of the physician’s standard of care.

The PDR is an encyclopedia of medications, written and compiled by drug manufacturers, that is published annually (Martin v Hacker, 83 NY2d 1, 9). Along with the drug manufacturer’s package insert, the PDR is a means for drug manufacturers to make physicians aware of possible side effects of the drug in question (id,.). The information contained in the PDR and package insert must comply with the FDA’s guidelines for the proper labeling of prescription drugs (id.; see also, Comment, Package Inserts for Prescription Drugs as Evidence in Medical Malpractice Suits [Package Inserts], 44 U Chi L Rev 398 [1977]).

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Spensieri v. Lasky, 723 N.E.2d 544, 94 N.Y.2d 231, 701 N.Y.S.2d 689, 1999 N.Y. LEXIS 3747 (N.Y. 1999).

723 N.E.2d 544 (Spensieri v. Lasky) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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