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March 17, 1997


Appeal from the Circuit Court of Kane County. No. 92--L--516. Honorable Michael F. O'Brien, Judge, Presiding.

Released for Publication April 18, 1997.

The Honorable Justice Thomas delivered the opinion of the court. McLAREN and Rathje, JJ., concur.

The opinion of the court was delivered by: Thomas

JUSTICE THOMAS delivered the opinion of the court:

The plaintiffs, Lindsay Duran, by her mother, Ellen Duran, Ellen Duran, individually, and Joseph Duran, brought this medical malpractice action against the defendants, Dr. John P. Cullinan, Dr. Alan M. Haan, and the Oswego Medical Group, to recover damages for injuries to Lindsay allegedly caused by the defendants' prescription of Ovulen-21, a birth control pill, while Ellen was pregnant with Lindsay. The trial court granted the defendants' motion for summary judgment, finding that the plaintiffs' experts' conclusions as to causation were inadmissible under the standard enunciated in Frye v. United States, 54 App. D.C. 46, 293 F. 1013 (D.C. Cir. 1923).

The record reveals that Lindsay was born on December 2, 1983, with multiple birth defects including mental retardation; hearing, speech, and vision impairments; developmental delay; and facial dysmorphic features (i.e., bilateral blepharophimosis and unilateral nystagmus). Ellen had previously given birth to two other children who had birth defects.

On March 29, 1983, Ellen went to the Oswego Medical Group to see her gynecologist, Dr. Cullinan, suspecting that she might be pregnant. However, Ellen was instead seen by Dr. Haan, a family practitioner. Dr. Haan conducted a Gravindex pregnancy test and a physical examination. Neither the test nor the examination showed any indication that Ellen was pregnant. However, that particular test given in conjunction with a physical exam was not sufficient to rule out the possibility of pregnancy. Dr. Haan then prescribed Ovulen-21, an oral contraceptive, and directed Ellen to begin taking the drug. At that time, Ellen had been pregnant for approximately 27 days. Thereafter, she took one cycle of the birth control pills before discovering that she was pregnant.

On July 10, 1992, the plaintiffs filed the present lawsuit after voluntarily dismissing their original suit. The plaintiffs attached to their amended complaint the affidavit of Dr. Michael L. Berke, a specialist in obstetrics and gynecology. Dr. Berke stated that it was his opinion that the defendants breached the standard of care by failing to adequately rule out pregnancy and by prescribing birth control pills to a woman they should have known was pregnant. Dr. Berke further opined that the defendants' acts or omissions caused Lindsay's birth defects.

Dr. Paul Wong, board certified in pediatrics and medical genetics, stated in his deposition that he had been Lindsay's treating physician. He testified with a reasonable degree of medical certainty that Ovulen-21 did not cause Lindsay's birth abnormalities. He based his opinion on the absence of medical literature linking Ovulen-21 to the types of birth defects suffered by Lindsay. He further testified that it was significant that Lindsay had two siblings with birth defects and that she may have inherited a genetic disorder from her parents.

Dr. Joe Hoo, an expert in medical genetics, who was also one of Lindsay's treating physicians, testified in his deposition that Lindsay's birth defects were probably not caused by birth control pills. He stated that he was not aware of any link between Ovulen-21 and the type of birth defects suffered by Lindsay. Although he could not determine the cause of Lindsay's condition, Dr. Hoo stated that the cause could have been genetic.

Dr. Eugene Pergament, board certified in clinical genetics and cytogenetics, testified that he has access to the most recent scientific literature and medical opinion regarding the teratogenic impact of various agents. He noted that prior to his deposition he checked the data bases for information on whether the chemical agents that comprise Ovulen-21 are capable of causing the type of birth defects evinced by Lindsay. He testified that there is no teratogenic risk to children from exposure to the chemical agents comprising Ovulen-21.

Dr. Melvyn Bayly, an obstetrician and gynecologist, testified that, based on his review of the literature and his experience, Lindsay's birth defects were not caused by Ellen's ingestion of birth control pills during pregnancy. He expressed his opinion that Ellen's history of having children with abnormalities was more significant than the ingestion of Ovulen-21 in determining the cause of the defects.

In the course of the litigation, the defendants filed amended interrogatories pursuant to Supreme Court Rule 220 (134 Ill. 2d R. 220), requesting that the plaintiffs disclose the experts they expected to call at trial, the nature of their opinions, and the underlying bases for those opinions. In response, the plaintiffs identified their experts and submitted essays of each expert. The essays were nearly identical in content. They briefly described the time frame of Ellen's pregnancy and the ingestion of contraceptives, the ordinary development of the nervous system during pregnancy, and a Federal Drug Administration (FDA) rule promulgated in 1977 requiring patient warnings with progestational agents. The essays then stated that "additional supporting data for the causal connection between oral contraceptives and this unfortunate child's birth defects are extrapolated from a wide variety of defects appearing in the literature." The remainder of each essay consisted of general descriptions of 43 different studies identified by the author's last name and the year the study appeared in print. Some of the types of birth defects identified by the various studies included central nervous system defects, including memingomyelocele or hydrocephalus; anencephaly; spina bifida; neural tube defects; neurological disorders; cardiovascular defects; cardiac anomalies; VACTEL syndrome (vertebral, anal, cardiac tracheal, esophagal, and limb defects), osseous abnormalities; micrognathia; cleft palate; and dysmorphic features, including growth retardation, mental retardation, peculiar facies, umbilical eversion, sacral pit, and hypospadias (Lorber study). The essay concluded by additionally noting that animal studies indicate that oral contraceptives have significant teratogenic potential.

The defendants filed a motion to strike the plaintiffs' answers to their interrogatories and a motion for summary judgment. Substantively, the defendants contended that the opinions of the plaintiffs' eight experts lacked sufficient foundation for admissibility. The defendants argued that the "extrapolation" method used by the plaintiffs' experts in reaching their opinions on causation was not generally accepted in the scientific community as is required by Frye, 293 F. at 1014. In support of their motion, the defendants attached the affidavit of Dr. Thomas Shepherd, a board-certified pediatrician with expertise in teratology, who opined with a reasonable degree of medical certainty that Ovulen-21 did not cause the birth defects exhibited by Lindsay. He further opined that the plaintiffs' experts' attempt to "reevaluate" the scientific articles "to support plaintiffs' experts' opinions concerning a causal relationship between ...

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