Case Name: Roberta Spensieri, Appellant, v. Charles W. Lasky et al., Respondents
Court: New York Court of Appeals
Jurisdiction: New York
Decision Date: 1999-12-02
Citations: 94 N.Y.2d 231
Docket Number: 
Parties: Roberta Spensieri, Appellant, v Charles W. Lasky et al., Respondents.
Judges: 
Reporter: New York Reports
Volume: 94
Pages: 231–241

Head Matter:
[723 NE2d 544, 701 NYS2d 689]
Roberta Spensieri, Appellant, v Charles W. Lasky et al., Respondents.
Argued October 19, 1999;
decided December 2, 1999
POINTS OF COUNSEL
Ainsworth, Sullivan, Tracy, Knauf, Warner and Ruslander, P. C., Albany (John W. Bailey, Colleen M. O’Connell and Rebecca A. Slezak of counsel), for appellant.
I. The content of a drug manufacturer’s package inserts represents the generally accepted practice, custom or standard of the medical profession when prescribing and monitoring prescription drugs, and, therefore, it was admissible at trial and the failure to admit the Physicians’ Desk Reference (PDR) into evidence constituted reversible error. (People v Huertas, 75 NY2d 487; People v Nieves, 67 NY2d 125; Lee v Illinois, 476 US 530; People v Brensic, 70 NY2d 9; People v Arroyo, 54 NY2d 567, 456 US 979; Martin v Hacker, 83 NY2d 1; Cruz v New York City Tr. Auth., 136 AD2d 196; Boltax v Joy Day Camp, 67 NY2d 617; Solomon v City of New York, 66 NY2d 1026; Akins v Glens Falls City School Disk, 53 NY2d 325, 54 NY2d 831.) II. The learned intermediary doctrine lends sufficient credence to the statements that are made in the PDR such as to make the truthfulness of the statements highly probable, allowing this Court to hold the contents of the PDR are an exception to the hearsay rule and the failure to admit the PDR into evidence constituted reversible error. (Martin v Hacker, 83 NY2d 1; Paul v Boschenstein, 105 AD2d 248; Wolfgruber v Upjohn Co., 72 AD2d 59; Eiser v Feldman, 123 AD2d 583; Tenuto v Lederle Labs., 90 NY2d 606; Bukowski v CooperVision Inc., 185 AD2d 31.) III. The trial court’s failure to instruct the jury regarding a physician’s duty with respect to prescribing and monitoring prescription drugs constituted reversible error. (J. R. Loftus, Inc. v White, 85 NY2d 874; Martin v Hacker, 83 NY2d 1; Armstrong v State of New York, 214 AD2d 812; De Long v County of Erie, 60 NY2d 296; Tenuto v Lederle Labs., 90 NY2d 606.) IV. The trial court’s repeated erroneous evidentiary rulings impermissibly interfered with plaintiffs right to prove her case and her right to cross-examine defense witnesses, prohibiting her right to a full and fair trial. (Delaney v Champlain Val. Physicians Hosp. Med. Ctr., 232 AD2d 840; Rodriguez v New York City Hous. Auth., 238 AD2d 125, 91 NY2d 76; John v City of New York, 235 AD2d 210; Runyon Mem. Fund for Cancer Research v Service Contr. Co., 34 AD2d 904; Peters v Gersch, 26 NY2d 976; Selly v Port of N. Y. Auth., 36 AD2d 861; Post & Co. v Sidney Bitterman, Inc., 219 AD2d 214; Hill v Arnold, 226 AD2d 232; Matter of Friedel v Board of Regents, 296 NY 347; McDermott v Manhattan Eye, Ear & Throat Hosp., 15 NY2d 20.)
Carter, Conboy, Case, Blackmore, Napierski & Maloney, P. C., Albany (Nancy E. May-Skinner of counsel), for respondents.
I. The PDR does not establish a physician’s standard of care. (Gibson v D’Amico, 97 AD2d 905; Toth v Community Hosp., 22 NY2d 255; McDermott v Manhattan Eye, Ear & Throat Hosp., 15 NY2d 20; Meiselman v Crown Hgts. Hosp., 285 NY 389; Armstrong v State of New York, 214 AD2d 812; Paul v Boschenstein, 105 AD2d 248; Martin v Hacker, 83 NY2d 1; Walton v United States, 770 F Supp 731.) II. The PDR was properly excluded as hearsay. (Rosario v New York City Health & Hosps. Corp., 87 AD2d 211; Nicolla v Fasulo, 161 AD2d 966; Gunnarson v State of New York, 95 AD2d 797; Stern v Waldbaum, Inc., 234 AD2d 534; Lieb v County of Westchester, 176 AD2d 704; Sadowsky v Chat Noir, Inc., 64 AD2d 697; Winant v Carras, 208 AD2d 618, 85 NY2d 812; Paul v Boschenstein, 105 AD2d 248; Martin v Hacker, 83 NY2d 1; Tenuto v Lederle Labs., 90 NY2d 606.) III. The trial court properly denied appellant’s request to charge her “prescription drugs” charge. (Dlugosz v New York Cent. Mut. Fire Ins. Co., 132 AD2d 903; Liebjott v City of New York, 213 AD2d 606; Killeen v Reinhardt, 71 AD2d 851; Farruggia v Town of Riverhead, 34 AD2d 1008; Gatto v Cooper, 201 AD2d 455; Paul v Boschenstein, 105 AD2d 248.) IV. The trial court properly exercised its discretion in ruling upon the evidentiary objections made during the course of the trial and the Court below properly affirmed that exercise of discretion. (Feldsberg v Nitschke, 49 NY2d 636; Selkowitz v County of Nassau, 45 NY2d 97; Poss v Feringa, 241 AD2d 877; Brady v Ottaway Newspapers, 63 AD2d 1031; Herrick v Second Cuthouse, 64 NY2d 692; Hambsch v New York City Tr. Auth., 63 NY2d 723; Natale v Niagara Mohawk Power Corp., 135 AD2d 955, 71 NY2d 804; Weinappel v Burke, 124 AD2d 936; Ulma v Yonkers Gen. Hosp., 53 AD2d 626; Hugelmaier v Town of Sweden, 144 AD2d 934.)
LeBoeuf, Lamb, Greene & MacRae, L. L. P., Albany (Jay G. Safer and Cindy M. Monaco of counsel), and Donald R. Moy, Lake Success, for Medical Society of the State of New York, amicus curiae.
I. The content of the PDR does not, as a matter of law, establish the physicians’ standard of care for prescrib ing and monitoring drug usage. (Gruntz v Deepdale Gen. Hosp., 163 AD2d 564; Koehler v Schwartz, 48 NY2d 807; Toth v Community Hosp., 22 NY2d 255; McDermott v Manhattan Eye, Ear & Throat Hosp., 15 NY2d 20; Meiselman v Crown Hgts. Hosp., 285 NY 389; Selkowitz v County of Nassau, 45 NY2d 97; Hammer v Rosen, 7 NY2d 376; Forstman v Arluck, 149 Misc 2d 929; Trimarco v Klein, 56 NY2d 98; Armstrong v State of New York, 214 AD2d 812, 86 NY2d 702.) II. If offered to establish the physicians’ standard of care, the PDR is inadmissible hearsay. (Rosario v New York City Health & Hosps. Corp., 87 AD2d 211; Winant v Carras, 208 AD2d 618, 85 NY2d 812; Gunnarson v State of New York, 95 AD2d 797; Matter of Hynes v Axelrod, 116 AD2d 830; People v Nieves, 67 NY2d 125; Fridovich v Meinhardt, 247 AD2d 791; Sperin v Good Samaritan Hosp., 250 AD2d 755; Labate v Plotkin, 195 AD2d 444; Walsh v Staten Is. Obstetrics & Gynecology Assocs., 193 AD2d 672, 82 NY2d 845.)

Opinion:
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 bleeding. 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 tives 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 in 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]).
Although this Court has never determined whether the PDR is evidence of a physician's standard of care, some courts have approved the use of the PDR for this purpose. Some have characterized this information as prima facie evidence of a standard of care (see, Ohligschlager v Proctor Community Hosp., 55 Ill 2d 411, 303 NE2d 392; Mulder v Parke Davis & Co., 288 Minn 332, 181 NW2d 882). Others allow the statements contained in the PDR only as some evidence that the fact finder may consider along with expert testimony on the standard of care (see, Morlino v Medical Ctr., 152 NJ 563, 706 A2d 721; Craft v Peebles, 78 Haw 287, 893 P2d 138; Ramon v Farr, 770 P2d 131 [Utah]).
The "Mulder rule" enunciated by the Minnesota Supreme Court provides that:
"Where a drug manufacturer recommends to the medical profession (1) the conditions under which its drug should be prescribed; (2) the disorders it is designed to relieve; (3) the precautionary measures which should be observed; and (4) warns of the dangers which are inherent in its use, a doctor's deviation from such recommendations is prima facie evidence of negligence if there is competent medical testimony that his patient's injury or death resulted from the doctor's failure to adhere to the recommendations" (Mulder v Parke Davis & Co., supra, 288 Minn, at 339-340, 181 NW2d, at 887).
Two Appellate Division Departments appear to have adopted the Mulder rule (Gatto v Cooper, 201 AD2d 455 [2d Dept]; Paul v Boschenstein, 105 AD2d 248 [2d Dept]; Armstrong v State of New York, 214 AD2d 812 [3d Dept], Iv denied 86 NY2d 702). Plaintiff urges that we do the same.
Generally, the standard of care for a physician is one established by the profession itself (Toth v Community Hosp., 22 NY2d 255, 262, rearg denied 22 NY2d 973). A physician will usually be insulated from tort liability where there is evidence that he or she conformed to accepted community standards of practice.
Drug manufacturers compose the information found in the PDR to comport with FDA regulations, to serve advertising needs, to provide necessary information to a doctor and to limit their liability (Morlino v Medical Ctr., supra, 152 NJ 563, 580, 706 A2d 721, 729; Martin v Hacker, supra, 83 NY2d 1, 8-10; see also, Comment, Package Inserts, op. cit., 44 U Chi L Rev 398, 424). The purposes behind the PDR render its content ill-suited to serve as prima facie evidence of a standard of care (Comment, Package Inserts, op. cit, at 416); they seek to cover a wide range of concerns not always directed at a diagnosis and course of treatment.
In the jurisdictions that have rejected the Mulder approach, expert testimony is required to explain the contents of the PDR since the information is not easily understood by a lay jury that has no medical training; drug manufacturers write PDR entries for the medical profession not the general public (Morlino v Medical Ctr., supra, 152 NJ 563, 580, 706 A2d 721, 729-730; Craft v Peebles, supra, 78 Haw 287, 300, n 17, 893 P2d 138, 151, n 17; see also, Comment, Package Inserts, op. cit., 44 U Chi L Rev 398, 425). Moreover, the admission of the PDR alone in place of expert testimony would result in a standard of care established by drug manufacturers instead of the medical profession (Morlino v Medical Ctr., supra, 152 NJ 563, 581, 706 A2d 721, 730; cf., Toth v Community Hosp., 22 NY2d 255, 262, supra) and would prevent parties from being able to adequately cross-examine this type of evidence submitted on the standard of care.
Thus, we reject the contention that the PDR constitutes prima facie evidence of a standard of care. 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. In our view, the information contained in the PDR can only be analyzed in the context of the medical condition of the patient. The testimony of an expert is necessary to interpret whether the drug in question presented an unacceptable risk for the patient in either its administration or the monitoring of its use.
In this case plaintiffs expert testified that in his opinion the PDR represented the standard of care for physicians in the use and administration of prescription drugs in 1986. In addition, he described the risks of prescribing the drugs in question in light of plaintiffs medical condition. Thus, plaintiff was not prohibited from offering testimony concerning her expert's professional evaluation of defendants' conduct based, in part, on reliance on the PDR. Plaintiff was barred only from offering the contents of the PDR as stand alone proof of the standard of care (see, Prince, op. cit., § 7-313; see also, Gunnarson v State of New York, 95 AD2d 797).
Plaintiff also argues that this Court has implicitly created a basis for the admission of the PDR when it enunciated the learned intermediary doctrine in Martin v Hacker (supra, 83 NY2d 1). The learned intermediary doctrine focuses on the scope of a drug manufacturer's duty to warn of the dangers of using the drug in question. That duty is fulfilled by giving adequate warning to the prescribing physician (id., at 9). The physician must then balance the risks and benefits of various drugs and treatments and act as an "informed intermediary" between manufacturer and patient (id.). When the PDR is admitted in this context, it is admitted solely to establish the existence of a warning, and its adequacy, to a physician. Under the learned intermediary doctrine, the fact finder evaluates the warning contained in the PDR or package insert for its accuracy, clarity and relative consistency (id., at 11). The warning is not offered for the truth of its contents. Thus, the learned intermediary doctrine does not create a new hearsay exception for the use of the PDR to establish a standard of care in medical malpractice trials.
Finally, plaintiff also contends that the trial court erred by refusing to modify the jury charge to include a physician's duty in prescribing and monitoring prescription drugs. The charge here substantially conforms with the Pattern Jury Instructions (PJI 2:150) and states the relevant principles of medical malpractice (see, Green v Downs, 27 NY2d 205, 208). We agree with the Appellate Division that the trial court supplemented the charge by accurately identifying the factual assertions of the parties with regard to the prescription and monitoring of the drugs in question. Thus, the charge in this case was appropriately given.
Plaintiffs remaining arguments are without merit.
Accordingly, the order of the Appellate Division should be affirmed, without costs.
The package insert information for most drugs is reprinted in the PDR (Comment, Package Inserts, op. cit., 44 U Chi L Rev 398, at n 2). Although plaintiff only sought admission of the PDR entries on Ortho-Novum in this case, we see no substantive difference between PDR entries and drug package inserts. Thus, any reference to the PDR correspondingly applies to the drug package insert.