Retkwa v. Orentreich

• Decision Date: 21 February 1992
• Citation: 154 Misc.2d 164,584 N.Y.S.2d 710
• Parties: Rosalyn RETKWA, Plaintiff, v. Norman ORENTREICH, M.D. and Orentreich Medical Group, Defendants.
• Court: New York Supreme Court

Page 710

584 N.Y.S.2d 710

154 Misc.2d 164

Rosalyn RETKWA, Plaintiff, v. Norman ORENTREICH, M.D. and Orentreich Medical Group, Defendants.

Supreme Court, New York County,

IAS Part 26.

Feb. 21, 1992.

DeBlasio and Alton, New York City by Steve A. Epstein, for plaintiff.

Bower & Gardner, New York City by Garrett P. Lewis, for defendants.

KRISTIN BOOTH GLEN, Justice:

Defendants move, in limine, to exclude evidence and testimony that liquid injectable silicone is not approved by the United States Food and Drug Administration ("the FDA") on the ground that, inter alia, ¹ it is irrelevant to any issue raised in this malpractice action. Plaintiff Retkwa has alleged two causes of action, one claiming injury from the negligence of the defendants by virtue of their departure from good and accepted medical practice, and the second, also in medical malpractice, sounding in lack of informed consent.

The issue to be decided is, therefore, one of first impression: whether information about the FDA status of an unapproved injectable substance is part of the information concerning "risk" covered by New York's extremely limited informed consent statute, Public Health Law Section 2805-d(1). Resolution of the issue in turn requires consideration of the history and case law exegesis of that statute.

STATUTORY HISTORY

The present statute is the result of more than 70 years of legal history. Recovery for injuries from an operation not performed with the "informed consent" of the patient was originally premised in the law of battery; the germinal case was Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914) where Judge Cardozo set forth the principles underlyingrecovery:

Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent, commits an assault, from which he is liable in damages ... this is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained.

Id. at pp. 129-130, 105 N.E. 92.

²

Because of problems with the battery approach, the 1960's saw a transition away from that theory towards negligence law for failure to obtain consent without full disclosure of all known risks. The original standard in informed consent negligence cases was directed to those disclosures which would be made by a reasonable medical practitioner under the same or similar circumstances. See, e.g., Natanson v. Kline, 186 Kan. 393, 350 P.2d 1093 (1960) rehearing den. 187 Kan. 186, 354 P.2d 670 (1960). This physician-based standard, considered the majority view, was generally adopted in New York, see e.g., Petterson v. Lynch, 59 Misc.2d 469, 299 N.Y.S.2d 244 (1969). Subsequent to the landmark decision in Canterbury v. Spence, 464 F.2d 772 (D.C.Cir.1972) New York adopted the Canterbury materiality standard of disclosure to protect the patient's right to self-determination. See, e.g., Fogal v. Genesee Hospital, 41 A.D.2d 468, 344 N.Y.S.2d 552 (4th Dept.1973); Garone v. Roberts Technical and Trade School, Inc., 47 A.D.2d 306, 366 N.Y.S.2d 129 (1st Dept.1975) (citing Canterbury and Fogal ), Zeleznik v. Jewish Chronic Disease Hospital, 47 A.D.2d 199, 366 N.Y.S.2d 163 (2nd Dept.1975) (same). See generally, Comment, Medical Malpractice in New York, 27 Syracuse Law Review 657, 727-738 (1976) ("Medical Malpractice ").

The statutory codification of the doctrine of informed consent was the result of legislative pressure to limit or abolish the doctrine in New York, Medical Malpractice, supra at p. 738-739, and was passed in response to the threat of a physicians' strike in 1975. See Siegel, Practice Commentaries to CPLR § 4401-a, at 440, McKinney's Supplement (1991). The statute returned New York to the so-called "majority view" ³ which employs a professional standard test. Thus, informed consent is measured not by what a reasonable patient would want or need to know, but what a competent physician believes the patient ought to know under his or her circumstances. The statute reads as follows:

1. Lack of informed consent means the failure of the person providing the professional treatment or diagnosis to disclose to the patient such alternatives thereto and the reasonably foreseeable risks and benefits involved as a reasonable medical ... practitioner under similar circumstances would have disclosed, in a manner permitting the patient to make a knowledgeable evaluation.

In addition, by statute, New York requires expert medical testimony to establish a prima facie case of lack of informed consent, CPLR § 4401-a. Thus, although the professional standard has been criticized as "anachronistic paternalism" e.g., Largey v. Rothman, 110 N.J. 204, 540 A.2d 504 ... ambiguities in statutory language as well as the existence of consent issues not contemplated by the statute, will require close judicial scrutiny in order to achieve equitable application of the doctrine.

                (1988) 4, it is, nevertheless, the standard which must be applied here.   However, as at least one commentator has suggested
                

Medical Malpractice, supra at p. 739.

STATUTORY INTERPRETATION

Since the enactment of Pub.Health L. § 2805-d(1), the courts of this state have engaged in just such "close judicial scrutiny" and sensitivity to the underlying bases of the informed consent doctrine. Although the ordinary malpractice informed consent case generally involves a claim that the doctor, usually a surgeon, did not inform the patient of certain risks of the procedure to be performed, the simple "risk" formulation does not take into account all of the manifestations of informed consent, and the courts have so recognized.

For example, in Nisenholtz v. Mount Sinai Hospital, 126 Misc.2d 658, 483 N.Y.S.2d 568 (1984) aff'd 115 A.D.2d 1022, 496 N.Y.S.2d 886 (1st Dept.1985), the court found that a description of the procedures to be performed rather than simply a doctor's statement of "risks" was necessary to enable the patient to determine the risks of the procedure for himself, and so to determine whether or not he wished to forego that procedure. ⁵ See also Brandon v. Karp, 112 A.D.2d 490, 490 N.Y.S.2d 904 (3rd Dept.1985) (discussion of procedure to be performed).

The underlying premise of these and similar cases is that determination of whether to undergo risk is still the patient's, and she is entitled to such information from the physician, albeit based on professional standard, as is necessary to assess the risk and make a reasonable decision about her treatment. The question presented here, whether the physician was required to tell the patient that the substance, liquid silicone, with which he was going to inject her had not been approved by the FDA, is a novel one, but fits relatively comfortable into the framework created by earlier decisions.

There can be little question that in assessing the risk of a drug or injectable substance, a reasonable patient would want information as to whether that drug or substance has been tested and/or approved by Federal...