Farkas v. Saary

• Decision Date: 02 March 1993
• Citation: 594 N.Y.S.2d 195,191 A.D.2d 178
• Parties: Janos FARKAS et al., etc., Plaintiffs-Respondents/Cross-Appellants, v. Dr. Zoltan SAARY, Defendant-Appellant/Cross-Respondent. and J. Leon Lascoff & Son, Defendant-Respondent/Cross-Respondent.
• Court: New York Supreme Court — Appellate Division

Page 195

594 N.Y.S.2d 195

191 A.D.2d 178

Janos FARKAS et al., etc., Plaintiffs-Respondents/Cross-Appellants, v. Dr. Zoltan SAARY, Defendant-Appellant/Cross-Respondent. and J. Leon Lascoff & Son, Defendant-Respondent/Cross-Respondent.

Supreme Court, Appellate Division,

First Department.

March 2, 1993.

Before SULLIVAN, J.P., and CARRO, KUPFERMAN and RUBIN, JJ.

MEMORANDUM DECISION.

Order of the Supreme Court, New York County (Stanley Sklar, J.), entered on or about April 10, 1992 which, inter alia, granted defendant J. Leon Lascoff & Son's motion for summary judgment dismissing the action against it and denied defendant Dr. Zoltan Saary's motion for summary judgment dismissing the complaint against him, affirmed, without costs.

On July 24, 1990, plaintiff Zsuzsanna Farkas gave birth to a son with a defect of the eye, referred to medically as left-sided microphthalmia, a condition in which the eye socket and eye are abnormally small, resulting in blindness to the affected eye. Plaintiffs commenced this medical malpractice action against the treating physician, Dr. Zoltan Saary, who prescribed progesterone to Mrs. Farkas while she was less than four months pregnant. Also named as a defendant was J. Leon Lascoff & Son, the pharmacy that dispensed the drug.

The complaint alleges that the child's defect was caused by use of progesterone during the first trimester of Mrs. Farkas's pregnancy. Malpractice is claimed to have resulted from Dr. Saary's failure to make a proper and adequate diagnosis of her condition, failure to disclose the risks of treatment and failure to obtain her informed consent. Defendant Lascoff & Son is alleged to have failed to supply the necessary warnings and literature to Mrs. Farkas, as required by applicable Federal regulations.

Progesterone, a natural hormone, was originally believed to prevent miscarriages. Because Mrs. Farkas had a history of miscarriages, Dr. Saary prescribed the drug which Mrs. Farkas ingested between December 9, 1989 and January 24, 1990, six months before her son was born. In 1977, Food and Drug Administration ("FDA") guidelines required that the drug be dispensed with information concerning the hazards of using progesterone during pregnancy, specifically the increased risk of birth defects in children whose mothers take the drug during the first trimester. Federal regulations in effect in 1989 required the physician to provide patients with information about the benefits and risks of the drug. In either case, the potential risk to be warned against as a result of the administration of progesterone concerned "genital abnormalities" in the child. No side effects relating to vision were noted.

Following joinder of issue, defendants separately moved for summary judgment. Both conceded failure to provide any warnings whatsoever. Lascoff, however, urged that its failure was not a proximate cause of the infant's condition because microphthalmia was not a listed side effect of progesterone. Furthermore, Lascoff noted that an October 31, 1990 examination of the infant by Dr. Judith Willner, Director of Clinical Genetics at Mount Sinai Hospital, resulted in the medical conclusion that the infant's deformity was most likely a "sporadic [genetic] occurance [sic]" and that he "may potentially transmit this trait to his offspring". Lascoff also relied on the affidavit of Dr. Kwame Anyane-Yeboa, an expert in pediatrics and genetics who reviewed the record and medical literature, concluding that microphthalmia is not one of the anomalies associated with progesterone, no correlation having been demonstrated. The doctor also noted that microphthalmia is a recognized symptom of a genetic disorder. Finally, Dr. Jesse Bidanset, an expert forensic toxicologist, expressed the same opinion on the basis that the child's unilateral microphthalmia was not consistent with the teratological effects of chemical agents administered during the first trimester.

Dr. Saary sought summary relief on the ground that the applicable FDA regulation regarding notice to users of progesterone did not list eye or vision problems as a possible defect. Dr. Saary's counsel noted that when the FDA labelling and warning regulations were amended in January 1989 (54 Fed.Reg. 1243), a requirement to warn patients concerning the risk of congenital limb and cardiovascular problems was deleted and a warning added concerning the possible occurrence of genital abnormalities. Defendant physician urged that the absence of any requirement to warn patients about possible vision defects refuted plaintiffs' allegation that a causal relationship exists between ingestion of progesterone and the defect to the infant plaintiff. Defendant Saary, a board certified obstetrician and gynecologist, submitted an affirmation together with the affirmation of Dr. Sherwin Kaufman, similarly an expert in obstetrics and gynecology, to the effect that there is no medical basis for the claim that the child's defect is related to the mother's use of progesterone.

In opposition, plaintiffs submitted, inter alia, the affidavit of Dr. Nicholas Criares, also an expert in obstetrics and gynecology who, upon review of the record and medical literature, stated it was "contraindicated to use progesterone to maintain a pregnancy where there is a threatened abortion", a fact known to gynecologists in 1989. He also asserted that progesterone is "associated with fetal malformations in * * * the special senses (including the eyes)".

Supreme Court dismissed the action against the pharmacy, which is predicated solely on a negligence theory, because the pertinent FDA regulation was not designed to warn patients of an eye defect, but was concerned with genital birth defects (citing O'Leary v. American Airlines, 100 A.D.2d 959, 475 N.Y.S.2d 285). With respect to the claim against Dr. Saary, however, the court found that the conflicting medical affidavits pose a question of fact concerning whether the eye defect is causally related to the use of progesterone. Consequently, the court denied Dr. Saary's motion for summary judgment and declined to order an immediate trial on the issue of causation on the ground that this is one of the major issues in the action.

The negligence action against J. Leon Lascoff & Son, which dispensed the hormone without the warning required by FDA regulations (54 Fed.Reg. 1243), was properly dismissed. The infant's vision defect was not the subject of the warning required by the regulation and, thus, no liability is attributable to the pharmacy's breach of that regulation (see, O'Leary v. American Airlines, supra ).

Summary judgment dismissing the complaint was properly denied as to Dr. Saary. The record demonstrates the existence of a conflict of opinion between the parties' respective medical experts as to whether the infant plaintiff's left-sided microphthalmia was proximately caused by defendant's prescribing ...