36.

Background : The plaintiffs, Kathie J. Basten, Jonathan A. Basten, and Claire Abigail Basten, have brought this action against the United States of America, pursuant to the Federal Tort Claims Act (FTCA). This is a negligence action in which plaintiffs allege that the United States breached the standard of care governing the administration of fetal testing and genetic screening and is therefore responsive for all damages proximately flowing from this breach. The Supreme Court of Alabama has recognized a cause of action for wrongful birth.

Neural tube defects constitute a significant class of commonly occurring congenital malformations. A neural tube defect results from an abnormality of the skull and spinal canal, occurs during the first few weeks of pregnancy, and produces a wide range of problems relating to the brain and spinal cord. There are three types of common and serious neural tube defects known as spina bifida, with the most serious type known as spina bifida myelomeningocele. This occurs when the spinal cord, nerve roots, and a sac containing spinal fluid protrudes through an opening in the spinal column.

Depending on the severity of the defect and how high on the spinal column the defect occurs, persons born with spina bifida may have paralyzed limbs, no control of bladder or bowel function, and a life-threatening disorder of the drainage of spinal fluid from the brain, known as hydrocephalus. Spina bifida may or may not be consistent with long-term survival.

Most neural tube defects can be reliably detected by performing a simple, virtually risk-free screening test which measures the amount of maternal serum alpha-fetoprotein (MSAF or AFP), a substance produced by the growing fetus. The test requires no more than obtaining a blood sample from the mother, but for clinical and practical purposes, it must be administered within a narrow time frame during pregnancy (sixteen - twenty weeks). A fetus with a neural tube defect produces abnormally large amounts of AFP, which may be measured by taking a sample of the mother's blood. If the test indicates the possibility of a neural tube defect (NTD), it is repeated, and if still positive, other tests are done to confirm or refute the findings.

The AFP test is recommended even for women who would refuse to have an abortion, for in the event a defect is discovered, the doctor will know to make special preparations for the child's delivery or it will alert the doctor to the child's need for highly specialized care at another facility. Moreover, even if no AFP test is performed during the 16-20 week window of opportunity, some of the more severe instances of abnormality may be detected by using high resolution sonography.

AFP testing is highly reliable, inexpensive, and nonintrusive. When a neural tube defect is detected during an appropriate time during pregnancy, the fetus is aborted 90 percent of the time.

Facts: Kathie Basten became pregnant during the summer of 1988, while she was taking oral contraceptives. Dissatisfied with the care she was provided during her 1986 pregnancy with Abbie, her first child, Kathie Basten sought permission to obtain off-base care. Because her request was denied, she again attended the on-base clinic at Maxwell. After her pregnancy was confirmed, she obtained an appointment to begin obstetrical care at Maxwell.

On August 2, 1988, Kathie attended an orientation meeting for newly pregnant women which was held every other week at the library of the medical clinic at Maxwell. The meeting was attended by thirteen pregnant women and a few of their husbands, lasted for one and a half hours or two hours, and was conducted (at least in part) by Major Altringer, a nurse/midwife. During the meeting, the women were provided with various pre-assembled written materials, some of which constituted information packets and some of which constituted records to be completed for the medical chart. Kathie recalls no information on AFP testing being included in the packets she received. Kathie gave urine and blood samples for several screening tests, listened to various speakers, and made numerous entries in her medical chart. Part of the information Ms. Basten entered on her chart was that she had recently taken oral contraceptives .

Standard Maxwell policy required that the mother's chart contain a form explaining AFP testing and including a place for the mother to indicate her acceptance or refusal of such test. A one-page brochure on AFP testing was also customarily clipped to the form in the chart; however, Kathie's chart never contained either the form or the brochure. The women who attended the conference were told, as a group, that AFP was an optional test which would assay for birth defects and which the patient would discuss later with the health care provider. Both Ms. Basten and Ms. Jakel (another woman in attendance) testified that no one was informed that the burden to request AFP testing resided with the patient. No one was informed that she should identify the appropriate time within which to contact the hospital so that an appointment could be secured during the sixteen-twenty week window.

Kathie Basten was familiar with AFP testing only in the most general of terms. She knew nothing of the sixteen-twenty week window, knew nothing of the necessity for identifying that window, and knew nothing of her purported responsibility to initiate discussion on AFP testing. Although Maxwell health providers enjoyed numerous opportunities to discuss AFP testing with Kathie, the subject was never again mentioned until after the sixteen to twenty week window had closed. At no time did Kathie Basten refuse an offer for AFP testing; at no time was she told she had to request the test; and at no time did she know that the test had to occur during the sixteen to twenty week interval.

Following the orientation session, Kathie Basten next visited the clinic on August 12, 1988, whereupon she was attended by Major Altringer. This was a regularly scheduled appointment which occurred prior to the sixteenth week of Kathie's pregnancy. The medical chart contains no entry concerning AFP testing, although several notations were entered in the chart on that date. AFP testing was not mentioned during this visit.

On August 17, 1988, Kathie Basten received an ultrasound at the clinic. The purpose of the ultrasound was to confirm gestational age. Nothing about AFP testing was mentioned during this visit.

During the last few days in August until about September 7, 1988, Kathie was in Ohio, visiting her husband's family. Upon returning to Alabama, she called the clinic for an appointment, seeking to obtain the appointment before September 13, 1988, when she planned to visit her family in South Carolina. She was told that she could not obtain an appointment that week but that she could call again when she returned. When she returned from South Carolina on September 20 or 22, she called the clinic and received what was allegedly the first available appointment, on October 4, 1988.

Although both phone calls were made within the sixteen to twenty week window, and although there was no evidence in Kathie's chart to indicate she had refused AFP
testing, AFP testing was not mentioned to her.

On October 4, Kathie and her husband went to the clinic together. He remained with her throughout the visit. The October 4 date occurred after the window for AFP testing had closed, and pursuant to Maxwell policy, AFP was not mentioned to either Kathie or Jonathan. In addition, Major Altringer (again the attending health care specialist) made no record in Kathie's chart of any offer of AFP testing. AFP testing simply was not discussed during this visit, or on any subsequent visit, during which time Kathie was attended by various nurse/midwives, but never by a physician.

The next pertinent visit was December 19, 1988. At that time, Kathie had a four and one-half pound weight gain in two weeks, and had been sick with nausea and vomiting. A decision was then made to schedule another ultrasound. It was scheduled for January 5, 1989, and on that date Kathie and her husband went to the radiology clinic for an ultrasound. After the ultrasound was performed, the Bastens were instructed to wait.

They waited in the hall until they were taken to Dr. Kim Whittington's office. Sitting in the office with the door open, the Bastens were told of the neural tube defect. Kathie became extremely upset, and her husband tried to comfort her. During the meeting, Kathie Basten stated that she probably would not have terminated the pregnancy had she known of the problem earlier. Kathie stated either that she did not know the AFP test was necessary, or she did not know it was important. At no time during this meeting did Kathie admit that she had been offered, or that she had refused, AFP testing.

Subsequently, arrangements were made for the Bastens to travel to Keesler Air Force Base in Biloxi, Mississippi, where they were supposed to receive special care for the delivery of the baby. Molly Basten was born on February 2, 1989 by a caesarean section.

Molly Basten was born with the most serious type of spinal column defect, spina bifida myelomeningocele. She had a bony defect in her vertebral column on her back a little above the navel. Through this defect protruded a malformed meninges (the membranous covering which contains the spinal cord and spinal fluid), and malformed spinal cord. Operations were proposed to reduce (make smaller) the defects in the spinal column and cord, and to place a shunt in the child's brain in order that spinal fluid could be drained from the brain, thereby reducing life-threatening intracanial pressure.

The medical consensus was that Molly's chances for long-term survival were zero without corrective surgery. The consensus was also that with corrective surgery, assuming Molly survived it, she would probably be mentally retarded, paraplegic (having paralysis of her lower extremities), incontinent (of both bowel and bladder), and hydrocephalic (having an inability to adequately drain spinal fluid from the brain and requiring a mechanical shunt to drain it), and she would probably have a normal life expectancy.

The Bastens refused to consent to subjecting Molly to these procedures. After the
United States received a court order overriding the Bastens' wishes, the surgeries were undertaken and Molly's life was saved. Molly is now five years of age and she has a normal life expectancy of approximately seventy-six years. The pre-surgical prognostications about Molly's post-surgical fate were, in many respects, accurate. She is paraplegic. She is incontinent. She is hydrocephalic. She does have a normal life expectancy. Unlike predicted, Molly has a good intellect and a pleasing personality. Her problems are permanent ones.

Molly has also been forced to undergo additional neurosurgery, a revision of the shunt. Neurosurgery to revise the shunt again is likely to be necessary several more times during her life.

In addition to being incontinent of bladder and bowel, Molly has experienced and will continue to experience related kidney, ureter, and bladder problems. Because of these problems, Molly underwent an operation called a cutaneous vesicotomy. It created a channel from the bladder and through the skin so that the bladder now drains that way instead of normally. She also requires intermittent mechanical bladder emptying (catheterization) and diapers. These problems and requirements are also permanent ones.

Court Decision: In May 1985, the American College of Obstetricians and Gynecologists (ACOG) stated that it is "imperative that every prenatal patient be advised of the availability of [the AFP] test and that the [physician's] discussion about the test and the patient's decision with respect to the test be documented in the patient's chart. Both plaintiff's and defendant's expert doctors agreed that the standard of care, by the time Kathie Basten became pregnant with Molly, required the offering of AFP testing and documentation of the acceptance or rejection of such offer.

The Government admits that it departed from the standard of care by not obtaining documentation of the alleged declination of the test by Kathie Basten. If the Government's contention is accurate and Kathie Basten refused an AFP test, then the Government's failure to document this declination is the principal reason that this case is in court. One of the primary purposes for documenting the refusal to take the test is to remove as an issue whether the woman refused the test. The Government's failure to obtain such documentation buttresses this court's belief that the test was never offered and was never refused.

There is no dispute that AFP testing was not offered to Kathie Basten during the sixteenth and twentieth weeks of pregnancy. During this time frame, Kathie Basten twice phoned the Air Force clinic in hopes of receiving an appointment. On neither occasion did the clinic staff mention that the window for performing AFP testing had begun, despite the fact that Kathie's chart contained no documentation of a refusal to take the AFP test. Although Dr. Whittington testified that there would have been no problem seeing Kathie Basten during the window, the clinic staff failed to schedule her appointment until after the window had closed.

It is just as clear that no offer for AFP testing was made to Kathie Basten after the
window closed. Dr. Klaven testified placing the onus of discussing AFP testing on the patient violates the standard of care in two respects. First, the health care provider should be responsible for bringing up AFP testing. Second, the provider has a duty to convey with conviction the importance of taking an AFP test. As stated before, no documentation of a refusal to consent to AFP testing was ever made part of the chart.

The question thus remains whether the information provided to Kathie Basten at the orientation meeting was sufficient to satisfy the standard of care. Both Kathie Basten and Debra Jakel, who was called as a witness by the Government, testified that no one told them during the orientation that the patient retained responsibility for requesting and scheduling the AFP test. Debra Jakel testified that during both of her pregnancies in which AFP testing was offered, health care providers brought up the test at the appropriate time. Moreover, Kathie Basten recalls that AFP testing was mentioned at the orientation in only the most cursory fashion; Altringer has no specific recollection of that meeting but says her practice was to inform patients to request AFP if they wanted the testing done. Although this practice would most certainly violate the standard of care, it is doubtful that such an instruction was ever given.

Both Dr. Klaven and Dr. Whittington testified that in the absence of a refusal, AFP testing should have been discussed with the patient during the 16-20 week window. Dr. Whittington stated that if a patient showed up during weeks 16-20 and no information appeared on her chart regarding AFP testing, if AFP testing was not discussed at that time, the standard of care would not have been met. The sparse information provided to Kathie at the orientation cannot qualify as information sufficient to satisfy the requirement that AFP be discussed with the patient. The court finds that Kathie was not instructed that she was to notify the clinic in case she desired AFP testing, nor was she expected to identify the window within which the testing could be done. Had she been given such instructions, this too would have violated the standard of care.

Having found that the government breached its duty in several respects, the court has little trouble finding that these breaches proximately caused the wrongful birth. Both parties agree that AFP testing would have revealed the neural tube defect. In the absence of such testing, Dr. Klaven testified that an appropriately timed ultrasound would have also detected the defect.

The court finds that had Kathie Basten been offered an AFP test, she would have accepted it. She would have consented to an ultrasound as well, for she did undergo an ultrasound on August 17, a date too early to find the defects. Had Kathie undergone either one of these tests during the appropriate time, Dr. Klaven testified, and the government did not dispute, then the defect would have been discovered. Once the defect was discovered, Kathie Basten would have elected to have an abortion.

The parties stipulated that when a neural tube defect occurs, the pregnancy is terminated 90 percent of the time. Kathie Basten has evidenced her willingness to undergo an elective abortion. She had an abortion before her pregnancy with Molly, and she has had one since her pregnancy with Molly. In addition, the Bastens demonstrated their belief that Molly would suffer less if she was not forced to undergo lifesaving procedures when they withheld their consent to such procedures at Keesler Air Force Base in the absence of a court order. This is not to say that the Bastens do not love Molly now; it is only to say that their concern that she not suffer would have impelled them to abort the fetus had they been given the choice.

The Alabama Supreme Court has held that the birth of a seriously deformed child in a wrongful birth case results in conpensable injury to the child's parents. Kathie is awarded $900,000 for anguish and mental suffering; Jonathan, her husband is awarded $700,000 for anguish and mental suffering. The parents are jointly awarded $2,650,000 for the expenses and care incurred by Molly to date and she will incur in the future. In addition, Kathie is awarded $50,000 for loss of consortium; Jonathan is awarded $50,000 for loss of consortium.

Basten v. United States of America, 848 F. Supp. 962; 1994 U.S. Dist.

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