Opinion
C.A. No. 03C-08-040 (JTV).
Submitted: March 22, 2007.
Decided: September 12, 2007.
Upon Consideration of Plaintiff's Motion In Limine.
DENIED.
Upon Consideration of Defendant's Motion In Limine
DENIED
William D. Fletcher, Jr., Esq., Schmittinger Rodriguez, Dover, Delaware. Attorney for Plaintiff.
Mason E. Turner, Jr., Esq, Prickett, Jones Elliott, Wilmington, Delaware. Attorney for Defendant Bayhealth Medical Center.
Richard Galperin, Esq., Morris, James, Hitchens Williams, LLP, Wilmington, Delaware. Attorney for Defendant Lee.
ORDER
Upon consideration of the above-stated motions, the opposition to each, and the record of the case, it appears that:
1. The plaintiff, Lisa Y. Gualtieri, alleges that Bayhealth, Inc. and others committed medical negligence which caused the premature birth and death of her son, Jason Edward Mousley. Ms. Gualtieri, a New Jersey resident, was visiting friends in Delaware. She had seizures and was taken to the Milford Memorial Hospital branch of Bayhealth, Inc. She was admitted at 3:15 a.m. on September 3. She was treated and released late in the morning of September 5. She was 27 weeks pregnant, although that fact was not known to her at the time and was undiscovered by Milford Hospital while she was there. She returned to New Jersey and was hospitalized again at 7:00 p.m. on September 6, this time at Underwood Memorial Hospital. During that hospitalization, it was discovered that she was pregnant. An ultrasound revealed that the fetus had no heartbeat.
The fetus was stillborn at 12:22 p.m. on September 9. An autopsy was performed at 6:00 a.m. on September 11.
2. Each side has retained a medical expert to express an opinion on the cause and time of death. The plaintiffs' expert is Dr. Richard L. Naeye, M.D. The defendants' expert is Dr. Harvey Jon Kliman, M.D. Each side has filed a motion in limine to exclude from trial the testimony of the other side's expert. I will first address the motion to exclude the testimony of Dr. Kliman.
3. "Trial courts have a gatekeeping obligation to ensure that all expert testimony is reliable and releva nt." This gatekeeping function requires that the court only allow a "witness [to] testify as an expert when [the witness is] qualified as an expert and [when] the witness has scientific, technical or other specialized knowledge that will assist the trier of fact[.]" To reach these admissibility determinations, the Delaware Supreme Court has crafted a "five-step test." This test provides that a witness' proffered opinion testimony will be admissible if this Court makes the following findings: (i) the witness is qualified as an expert by knowledge, skill, experience, training or education; (ii) the evidence is relevant and reliable; (iii) the expert's opinion is based upon information reasonably relied upon by experts in the particular field; (iv) the expert testimony will assist the trier of fact to understand the evidence or to determine a fact in issue; and (v) the expert testimony will not create unfair prejudice or confuse or mislead the jury.
White v. United States, 422 F. Supp.2d 1089, 1093 (D. Ariz. 2006).
Eskin v. Carden, 842 A.2d 1222, 1227 (Del. 2004). See also D.R.E. 702.
See Eskin, 842 A.2d 1222 at 1227.
4. Dr. Kliman's opinion can be summarized as follows. He states that the placenta was small; that there are three major factors which cause a placenta to be small; that those factors are low blood flow to the placenta, rejection of the placenta by the mother's body, and genetic defects; that all three factors were present in this case; that these factors caused an area of infarction which in turn caused an abruption, or separation of the placenta from the uterus; that the abruption caused the death of the fetus; that inspection of dead placenta tissue revealed that the nuclei were gone and it was quite old, at least four to five days old; that an absence of hemoglobin is consistent with this finding; and that because of these findings death must have occurred at least to five days before stillbirth.
5. The plaintiff contends that Dr. Kliman's testimony should be excluded from trial for the following reasons: that he draws no adequate connection between his findings concerning the placenta and the precise estimate of a death occurring at least four to five days before stillbirth and cites no medical literature or other medical basis for forming such an opinion; that the autopsy does not indicate that the placenta was properly fixed, or preserved, between date of stillbirth and date of autopsy; that a study on normal and abnormal placenta size is under inclusive because it did not include women with medical conditions like ones which pertain to the plaintiff; that Dr. Kliman is an expert in the general field of infertility but is not qualified to give an opinion on an interval between death of a fetus and stillbirth; and Dr. Kliman was unable to identify the nature of the genetic defect. These objections, the plaintiff contends, render Dr. Kliman's opinion unreliable.
6. Taking these contentions in order, I find that there is a sufficient nexus between Dr. Kliman's observations of the placenta and his opinion that death must have occurred at least four to five days before stillbirth. His opinion in this regard is based upon characteristics of the blood of the placenta and appears to be based upon established medical criteria used to assess when bleeding occurred. As to the fixation of the placenta between stillbirth and autopsy, I am satisfied that in the absence of any evidence to suggest otherwise, a jury can infer that proper medical procedures were followed in fixating the placenta, as opposed to the contrary. Dr. Kliman's opinion that the placenta was small was based upon data developed by Pinar. Dr. Kliman testified that Pinar's work is generally accepted by placental pathologists for the purposes for which he used it. Studies which establish average or normal sizes in the medical field are not uncommon and Dr. Kliman's description of Pinar's study is sufficient to establish its reliability for admissibility purposes. The plaintiff's contention that it is unreliable because it does not include certain classes or persons is unpersuasive. As to the contention that Dr. Kliman is not qualified, his background and qualifications establish that he has sufficient expertise in causes of intrauterine fetal demise to render the opinions he has. As to the genetic defect, Dr. Kliman testified in a detailed, logical and reasonable fashion as to how a physician may diagnose a genetic defect without being able to diagnose the precise genetic defect from among many potential defects. On the whole, Dr. Kliman's testimony was detailed and appears to be based upon accepted medical literature and principles. The plaintiffs' contentions go to the weight of his testimony, not its admissibility, and they are rejected.
The defendants argue that this contention would seem to be equally applicable to the plaintiffs' expert, a point that would seem to be well taken.
7. I turn now to Dr. Naeye. His opinion appears to be that the interval between death and stillbirth was not more than 24 hours. Within that range, his opinion moves among time frames. His preliminary opinion, contained in a draft report which he prepared, was that the interval between death and stillbirth was more than 18 hours. His opinion in his report submitted to plaintiffs' counsel dated December 7, 2004 was that the interval was within 18 hours. He testified that this revision was based upon his further consideration of the evidence. At his deposition, he testified that the interval was twelve or more hours. At the hearing on the motion in limine, his initial opinion was that it was "a few hours . . . less than six hours, but you can't be sure." He then testified, in substance, that because of uncertainties, a conservative opinion of an interval of within 18 hours was a better opinion. His final statement as to the interval, at the conclusion of his redirect testimony at the hearing, was the following:
Deposition, 6/2/05, Page 34.
Hearing transcript, page 147. When asked at the hearing on the motions why the noted absence of a fetal heartbeat upon the plaintiff's admission to the hospital wouldn't lead to a conclusion that the fetus had been dead at least 17 hours before delivery, he stated: "Well, not necessarily, because you never — you just — who listened and made the recording? You have to check that kind of a thing with all the other evidence."
Q. When you consider the whole picture, Doctor, that you've just described, that you described previously, is that the basis for your opinion that you believe that the fetal demise was within 18 hours or 20 hours or even 24 hours of birth?
A. Yes. I think that the interval between the time the baby died and the baby was born was at least 18 hours and probably quite a lot longer.
Q. I'm sorry?
A. The time between the baby died, the time the baby died and the baby was born, was at least 18 hours and probably somewhat longer.
Q. When you say somewhat longer, what are you saying?
A. I'm talking about a few hours longer.
Q. So is that up to that 24-hour idea, range?
A. Right. Right.
8. Dr. Naeye's opinion is based upon a study conducted by Dr. David R. Genest, M.D. and others. The study was published in 1992 in an article titled Estimating the Time of Death in Stillborn Fetuses: I. Histologic Evaluation of Fetal Organs; an Autopsy Study of 150 Stillborns. It was based upon 150 cases of stillborn children in which the interval of death prior to stillbirth, within reasonable limits, was documented based upon clinical records. One hundred of the cases were used to establish methods for determining the interval between death and birth, and the other 50 were used to test the methods. The study identified 23 tissue factors, or markers, for use in determining the interval between death and stillbirth. Each tissue factor, if shown by an autopsy to be present, served as an indication that death had occurred more than a certain period of time before birth. For example, one of these 23 markers, if present, would be an indication that death occurred more than four hours before birth. Another factor, if present, indicated that death occurred more than eight hours before birth. A third factor, if present, indicated that the interval was more than 18 hours. If any one of four other factors was present, an interval of more than 24 hours was indicated. Another factor indicated an interval of more than 36 hours. If any one of three other factors were present, an interval of more than 48 hours was indicated. If any one of two other factors was present, an interval of more than 72 hours was indicated. If any one of two other factors was present, an interval of more than 96 hours was indicated. If any one of three other factors was present, an interval of more than one week was indicated. Another factor indicated an interval of more than two weeks. Another factor indicated an interval of more than three weeks. Another factor indicated an interval of more than four weeks. Finally, if any one of two other factors was present, an interval of more than eight weeks was indicated. The factors are cumulative. In other words, if a factor indicating an interval of more than 24 hours was present and a factor indicating an interval of more than 36 hours was present, the estimated interval was taken to be more than 36 hours. The above-mentioned 50 fetuses were examined for these 23factors. Thirteen time "windows" were established which corresponded with the time frames set forth above for the interval from death to stillbirth; for example, 4-8 hours, 8-18 hours, 18-24 hours, and so on to a final window of 4-8 weeks. A determination was then made as to which window each fetus fell within based on the 23 markers. These results were then compared with the true, known interval. Based upon the results, the study concluded that the markers, in most cases, accurately estimate the approximate time of fetal death.
9. Dr. Naeye used primarily three of the 23 factors to formulate his opinion: (1) GI tract: mucosal epithelial nuclear loss of basophilia. If this factor is present, the interval from death to birth is estimated to be more than eight hours; (2) Lung: bronchial mucosal epithelial detachment; death to birth interval, more than 18 hours; and (3) Lung: bronchial curtilage matrix loss of basophilia, death to birth, more than 24 hours. With respect to the first one, Dr. Naeye found that the GI mucosal nuclei have not completely lost their nuclear basophilia, and that this indicated an interval from death to delivery of less than eight hours. With respect to the second, he found that there was no loss of basophilia in bronchial mucosal nuclei, and that this indicated an interval from death to delivery of less than 18 hours. With respect to the third, he found that there was no loss of basophilia in bronchial cartilage matrix nuclei, and that this indicated an interval from death to delivery of less than 24 hours. At the hearing on the motions, emphasis was placed on the fact that the markers measure the interval from death to delivery as "more than" a certain period of time. However the use of the markers in reverse — that a tissue feature if not present indicates an interval of "less than" or "not more than" — seems to be permitted by the Genest study since Dr. Genest could not have established all the various time windows which he did without going both ways with the factors. These findings are at the heart of Dr. Naeye's opinion and help place in some context apparent inconsistencies in his opinion. Inconsistencies in his opinion are within an interval of 24 hours and he seems clearly to rule out a period of four to five days.
Dr. Naeye testified that he did some re-reviewing of his findings between his draft report and his final report in which he did some comparing with other cases he became familiar with. Although the period of time between the draft and final reports was days or weeks, I do not conclude that his testimony is not credible. He testified he has done tens of thousands of examinations of placentas and/or fetuses during his career. Contentions that Dr. Naeye changed his testimony can be pursued by counsel in cross-examination.
10. The defendants contend that Dr. Naeye's opinion should be excluded from trial for the following reasons: that Dr. Naeye cannot establish that the Genest approach is scientifically reliable or generally accepted in the scientific community; that the plaintiff has no other witness to address this issue and no other evidence to establish the reliability or acceptance of the Genest approach; that Dr. Naeye acknowledges the questionable reliability of the Genest methodology and acknowledges that it cannot be correlated in every case, has inconsistencies within it and that a much larger study would need to be performed before such a methodology could be deemed reliable; and that even if the Genest methodology were reliable and accepted, Dr. Naeye does not apply the methodology reliably, specifically, that the Genest methodology requires consideration of at least 12 different specimens from different portions of the fetal remains.
11. Although it does not appear that there is direct evidence on the point, the record gives rise to an inference that estimating the interval between fetal death and stillbirth is a narrow medical area involving a relatively few number of physicians. The expert employed by the defendants in this case, for example, recalls no previous case in which he has been asked to given an opinion on the interval between fetal death and birth. No studies on the subject involving human fetuses were mentioned in the testimony other than the Genest study. Dr. Naeye's work on fetuses in general has been very extensive and includes conducting studies on fetuses for the Institute of Health and the World Health Organization. He is extremely well qualified in his field. He testified that he has performed hundreds of cases to determine the time of fetal death. His testimony persuades me that he approached the Genest study cautiously and found it reliable only after independently testing it over a period of time against cases he was familiar with in which the interval between death and birth was clinically established. I therefore conclude that the evidence offered by Dr. Naeye is relevant and reliable and is based upon information reasonably relied upon by experts in the particular field, specifically, him. I find that the other factors for admissibility of expert testimony mentioned in paragraph three above are also satisfied. The contention that the Genest method requires consideration of at least 12 different specimens from different portions of the fetal remains is rejected. While the study identifies the above-described 23 markers which come from multiple organs, the study does not seem to contain any requirement that at least 12 different specimens from different portions of the fetal remains be used before an opinion can reliably be rendered. Dr. Naeye testified that specimens from more than one organ must be used and that was done here.
12. The defendants contend that the Genest study has limitations, expressed in the study, which render findings based upon its method unreliable. I am satisfied, however, that Dr. Naeye took them into account and adequately explained why those limitations do not prevent him from giving a relevant and reliable opinion.
13. For the foregoing reasons, the respective motions to exclude expert testimony are denied .
IT IS SO ORDERED.