STATE OF WASHINGTON

COUNTY OF KING

W.L.H. Whittington, being of full age, does hereby depose and state the following:

1. My name is Wil Whittington. I am a research scientist at the Center for AIDS and STD, Department of Medicine, University of Washington. In addition, since 1996, I have served as Director of Epidemiology and Prevention Activities of the STD (Sexually Transmitted Disease) Control Program for the Seattle-King County Department of Public Health in Seattle, Washington. From 1991 through the present, I have also served as Director of the Neisseria Reference Laboratory for the Harborview Medical Center of the University of Washington in Seattle.

2. For the past 26 years, I have been involved in the study and detection of sexually transmitted diseases. From 1972 to 1975, I served as the Director of the STD Control Program for the Pennsylvania Department of Health.

3. Beginning in 1975, I held a variety of positions with the Centers for Disease Control (CDC) in Atlanta, Georgia. From 1975 to 1980, I served as the Assistant to the Chief in the Field Operation Section of the Venereal Disease (VD) Control Division at CDC. From 1981 until 1986, I served as the Chief of Epidemiology, and Program Studies Section, VD Control Division at CDC. During part of that time (1981-1983), I was also the Acting Chief of the Operational Research Branch and Acting Chief of the Clinical Studies Section for the Division of Sexually Transmitted Diseases of the CDC’s Centers for Prevention Services. From 1986 until 1996, I worked in the capacity of Biomedical Research Investigator with the Clinical Research Branch of the CDC’s Division of STD/HIV Prevention.

4. Additionally, from 1990 to 1992, I served on the faculty of the Emory University School of Medicine in Atlanta, Georgia, as an adjunct instructor in the Division of Infectious Disease and Immunology, Department of Pediatrics.

5. As my attached biographical sketch will attest, I have spent most of my professional career as a research scientist, studying, teaching and writing about sexually transmitted diseases. I have spent a significant amount of time researching matters concerning the proper identification of sexually transmitted disease organisms – in particular, methods to identify Neisseria gonorrhoeae, the organism that causes gonorrhea. See Whittington, Exhibit 1, attached hereto.

6. I was recently contacted by Amy Gershenfeld Donnella, counsel for Francisco Fuster-Escalona and asked to provide my expert opinion regarding the reliability of the gonorrhea testing performed on Noel Fuster in connection with Mr. Fuster’s conviction for child sexual abuse in 1985.

7. Counsel has provided me with the following documents: trial testimony of Dr. Judith Lederhandler; memo from Dan Casey to Richard Shiffrin on State Attorney letterhead dated February 19, 1985, entitled "Admissibility of Test Results;" deposition of Joseph Kyle, dated July 24, 1985; deposition of Freda Burstyn, dated July 24, 1985; a packet of documents sent by Jackson Memorial Hospital on June 27, 1986 to attorney Arthur H. Taylor, in response to a Subpoena Duces Tecum Without Deposition, requesting "any and all medical records, including medical test results, pertaining to the examination and/or treatment of Noel Fuster, during the years of 1983, 1984, 1985 and 1986;" Examination under Oath of Martha Goodman; Laboratory sheets prepared by Jackson Memorial Hospital for gonorrhea testing of TL, JC, BT, SM, and DL.

8. Counsel has asked me to review the above-listed documents and to answer the following questions if I can: 1) Was the testimony of the state’s witness, Dr. Judith Lederhandler – that the gonorrhea testing performed on Noel Fuster was incapable of producing a false positive – accurate? If not, why? 2) How reliable were the test procedures used on Noel? 3) Would the testing procedures used meet contemporary standards for diagnosis of gonorrhea in a forensic setting? 4) Would it be possible now to determine whether Noel Fuster actually had gonorrhea of the throat at the time he was diagnosed in 1984?

9. In summary, my opinion, to a reasonable degree of scientific certainty, is that the testimony offered at trial by Dr. Judith Lederhandler seriously misrepresented the likely accuracy of the testing performed on Noel Fuster’s throat sample. Contrary to Dr. Lederhandler’s assertions, the testing procedures that were performed on that specimen had a documented and important degree of unreliability, even if all steps in the testing procedure were performed perfectly. Also contrary to her assertions, the testing procedures employed once Noel’s culture plate reached the laboratory involved the exercise of skill and discretion at every step. Therefore, the test was highly susceptible to human error. Moreover, the documentation I have seen regarding the testing gives me several reasons for concern about the care that may have been taken in performing the necessary procedures and about the skill level of the laboratory technicians. Thus, based upon all the documents I have reviewed, I have substantial doubt as to the reliability of results reported in this case of supposed gonorrhea of the throat.

10. It is also my opinion, to a reasonable degree of scientific certainty, that the testing procedures used with the specimen taken from Noel’s throat do not meet contemporary standards for the diagnosis of gonorrhea in a child and certainly not in a child in a forensic setting.

11. Moreover, it would ordinarily be relatively simple to confirm at this point whether Noel had gonorrhea at the time he was initially tested in 1984. It is recommended practice that an isolate taken for testing in a medico-legal context such as Mr. Fuster’s case presented be preserved by means of freezing the bacterial isolate. Preservation of the specimen is recommended by both the American Academy of Pediatrics and the Centers for Disease Control. A frozen sample can be retested even decades after it has been taken. However, the documentation I have reviewed indicates that the sample taken from Noel Fuster was destroyed after three days. I also understand that, when Mr. Fuster arranged to have Noel’s biological mother take Noel for retesting, the test was performed under the auspices of the state and the culture was lost on the way to the laboratory. I also understand that, nevertheless, Noel was immediately treated with antibiotics which would have killed the gonorrhea, had he been harboring any. Thus, confirming the original test has been rendered impossible.

12. Further, the American Academy of Pediatrics and the Centers for Disease Control recommend that the identity of bacterial isolates from such cases of potential abuse be confirmed by testing at a reference laboratory. Clearly, the original isolate in this case was not forwarded to a reference laboratory for confirmation.

13. In the sections that follow, I explain my conclusions.

14. Gonorrhea is a disease caused by an organism classified scientifically as Neisseria gonorrhoeae. Neisseria is the name of the genus to which the organism belongs; gonorrhoeae is the species.

15. There are a number of problems associated with the identification of Neisseria gonorrhoeae, particularly when a diagnosis is to be used in a medico-legal context. These problems stem in large part from the fact that a number of the members of the Neisseria genus look alike, react similarly, and/or grow on gonococcal-selective media. These include: Neisseria meningitidis, Neisseria lactamica, Neisseria cinerea, Neisseria sicca, Neisseria subflava biovar perflava, Neisseria mucosa, Neisseria flavescens, and Neisseria polysaccharea. There are also two organisms, not part of the Neisseria family that share similar traits with Neisseria gonorrhea. These are: Branhamelia catarrhalis and Kingelia dentrificans.

16. The problem of identification is compounded in children, particularly with specimens taken from the mouth or throat. The reason for this is that several of the bacterial strains listed above are common inhabitants of children’s oropharynx.

17. For example, Branhamella catarrhalis has been isolated from the throats of healthy children and has been implicated as an etiologic agent in conjunctivitis, otitis media (ear infections), and respiratory tract infections. Likewise, in a study conducted in Connecticut, it has been reported that the oropharynx of 59% of healthy children had been colonized by Neisseria lactamica at least once by age 4.

18. A prime example of the difficulties in identifying Neisseria gonorrhoeae can be seen by reviewing a study in which I participated in 1983 and 1984 while serving as the Chief of the Epidemiology and Program Studies Section of the Venereal Disease Control Division at CDC. Laboratories throughout the United States sent us 40 isolates that they had identified as Neisseria gonorrhoeae. These isolates were sent to us to confirm the identity of the organism. Each of these strains had been collected from a child, some of whom were tested because of suspicions that they had been sexually abused.

19. Of these 40 isolates that had been tested previously by these other laboratories, 14 of them turned out not to be N. gonorrhoeae. None of these non-gonoccocal organisms was the cause of a sexually transmitted disease. Three of these isolates were confirmed at CDC to be Branhamella catarrhalis. (These samples had been taken from the children’s throats and eye.) Another three were confirmed by CDC to be Neisseria lactamica. (These samples too had been taken from children’s throats and eye.) Additionally, four samples misidentified as N. gonorrhoeae were in fact Neisseria cinerea, two others were Neisseria meningitidis, one was Kingella dentrificans, and one was an unidentified other Neisseria species.

20. Of these 14 isolates that turned out not be N. gonorrhoeae, 10 of the children from whom they had been collected had not previously been suspected of being the victims of sexual abuse. Nevertheless, the incorrect identification of these 10 organisms as gonorrhea resulted in the initiation of investigations of child abuse in 8 cases. It is probably safe to assume that in the four cases in which sexual abuse was already suspected, these misidentifications of gonococcal bacteria were used as proof that the abuse had occurred.

21. As a result of these findings and a review of procedures employed at various laboratories around the United States, the CDC and the American Academy of Pediatrics published guidelines, describing the difficulties involved in identifying gonorrhea, explaining the methods that needed to be used in order to prevent misidentification, and urging laboratories to adopt these procedures, particularly when the result of the testing procedures are to be used in any forensic setting.

22. Dr. Lederhandler’s testimony(transcript cite 9/4/85, 185 et seq.), is attached hereto as Whittington, Exh. 3.

23. Dr. Lederhandler testified at Mr. Fuster’s trial as a prosecution witness. Dr. Lederhandler testified that she took swab specimens from Noel Fuster’s anus, penis and throat. She also testified that she applied each specimen to a separate culture plate which she identified as being selective for the growth of N. gonorrhoeae. She said that she then sent these cultures to the microbiology lab at the hospital and received word sometime thereafter that Noel’s throat specimen had tested positive for gonorrhea. Exh. 3 at 190, 194.

24. Dr. Lederhandler was then asked what the implications were of the culture coming back positive. She replied that the culture process that had been used was incapable of producing a false positive. She testified that the culture had grown and that the growth of the culture meant two things: first, that the sample was properly taken, and second, that the sample had to be gonorrhea. Thus, she concluded that it was absolutely certain that Noel had gonorrhea of the throat at the time he was tested. Exh. 3, 195-196.

25. Dr. Lederhandler’s testimony was wrong on at least two major points. First, there is no known growth medium that is perfectly selective only for gonorrhea. A selective medium suppresses the growth of other organisms; however, other organisms including those that ca be confused with N. gonorrhoeae, can and do "break through." Thus, the growth of an organism on the culture plate that she described is not in any way conclusive of a diagnosis of gonorrhea.

26. Second, Dr. Lederhandler’s testimony that "there is no such thing as a false positive" gonorrhea test is at variance with the facts. False positives do occur and throat specimens from children are linked to a higher probability of such false positives.

27. According to the documents I have reviewed, including the depositions of Joseph Kyle and Freda Burstyn, lab technicians who prepared and tested Noel Fuster’s throat culture, the microbiology laboratory performed a series of procedures on the culture.

28. The lab received petri dishes which contained a medium identified as Martin-Lewis agar. Deposition of Joseph Kyle, attached hereto as Whittington, Exhibit 4, at 5. Next, according to Kyle, standard procedure would be to incubate the Martin-Lewis medium in a carbon dioxide environment at 37 degrees centigrade for 18 to 24 hours. Kyle did not know how long Noel’s isolate had been incubated but thought it was probably for 18 hours. Id., 14. Kyle did not perform any actual tests on the culture. Id.

29. Freda Burstyn stated in her deposition that she conducted tests on the culture when she received it. She indicated that she saw visible clusters of organisms growing on the petri dish so she performed tests that "we routinely do" to "make sure," presumably that this was gonorrhea. Freda Burstyn deposition, attached hereto as Whittington, Exhibit 5, at 4-5. Burstyn explained that she first did a gram stain to differentiate between organisms, some of which are gram positive and others which are gram negative, id., 6, and the specimen was then examined to determine if it contained gram-negative diplococci. Id, 8. The specimen was also tested to see if it was oxidase positive. Id.

30. Burstyn stated further that the specimen was then subjected to a biochemical test, which she referred to as an NH test. Documents I have reviewed from Jackson Memorial Hospital include the testing protocol that accompanied the test then in use at the laboratory, which is called the RapID/NH test. See Whittington, Exh. 6, attached hereto. Burstyn explained that this test was performed by "inoculat[ing] a broth and then inoculating a series of wells, each of which contained a reagent, on a small plate. Whittington, Exh. 5, 13-14. The plate would then be incubated for four hours, after which the "reactions are read." Burstyn stated that the reactions are "very specific, based on whether or not there is a reaction and what the reaction is, we identify the organism." Id., 14.

31. Burstyn said that it was her belief that this test was 100% accurate. Id., 18.

32. Even if everything went perfectly and there was no operator error in the use of this test, the RapID/NH test as constituted in 1984 was incapable of being 100% accurate. This was documented in at least one report published in the Journal of Clinical Microbiology in 1983 which reported misidentifications of isolates of Neisseria species. (See, Robinson MJ, Oberhofer TR. Identification of pathogenic Neisseria species with the RapID NH system. J Clin Microbiol. 1983;17:400-4.) The Journal of Clinical Microbiology is a standard peer-reviewed journal relied upon by clinical laboratories in the United States.

33. In 1985, the Journal published two additional articles. The first of these noted that the RapID/NH test had been found to not always differentiate Neisseria cinerea from Neisseria gonorrhoeae. (Boyce JM, Mitchell EB. Difficulties in differentiating Neisseria cinerea from Neisseria gonorrhoeae in rapid systems used for identifying pathogenic Neisseria species. J Clin Microbiol 1985; 22:731-4. As noted earlier, in tests at the CDC, Neisseria cinerea was misidentified as Neisseria gonorrhoeae in four of fourteen misidentified isolates sent for confirmation.

34. In yet another study, the RapID/NH test was found to correctly identify only 80% of strains of Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria lactamica, and Branhamella catarrhalis. (Philip A, Garton GC. Comparative evaluation of five commercial systems for the rapid identification of pathogenic Neisseria species. J Clin Microbiol. 1985; 22:101-104.)

35. The limitations of this test as described in the biomedical literature strongly suggest that the ability of this test to identify N. gonorrhoeae correctly from a throat specimen from a child is likely no better than three in four – assuming it must be stressed that the test was performed under ideal conditions by laboratory personnel who had the necessary finesse to conduct the test and interpret the test results.

36. This level of inaccuracy does not comport with contemporary standards that must be met before a diagnosis of gonorrhea is considered confirmed for forensic purposes.

37. Based on my review of the documents, I have little confidence that the testing of this sample was conducted with the necessary technical skill required of the testing procedures.

38. The RapID/NH test involves a substantial amount of subjective interpretive potential. This test is not comparable, for example, to a glucose dip-stick test or a home pregnancy test in which a color or a symbol appears, indicating a positive or negative result. Rather, this test requires a technician to read and interpret rather subtle color changes in a series of reaction test wells.

39. The testing process also requires a more basic understanding of Neisseria organisms and their reactions than Lederhandler, Kyle or Bustyn seem to have possessed. Dr. Lederhandler’s errors have already been noted. I note some examples from the depositions in which the laboratory technicians either misspoke or made important errors.

40. Kyle indicated, for instance, that Martin-Lewis agar is "selective for pathogenic Neisseria gonorrhea and particularly Neisseria gonorrhea." Whittington, Exh. 4, 5. This phrase has little meaning. Additionally, a number of other organisms (other than Neisseria species) grow on this particular selective medium.

41. Kyle also acknowledged that samples were incubated for 18 to 24 hours. When asked why, he stated that that was what the manufacturers recommended. He did not appear to know the significance of the incubation period. In fact, that period is extremely important. Moreover, when asked, he indicated simply that Noel Fuster’s culture had "probably" been incubated for 18 hours. The lack of documentation is, in itself, troubling. An 18 hour period of incubation, however, is close to the minimum required by the manufacturers of the RapID NH test. See Whittington, Exh. 6, package insert. (Burstyn was likewise unable to say how long the culture had been incubated initially.)

42. In Burstyn’s deposition, she uses language in a disturbingly loose fashion which tends to make me think she did not understand the distinction between members of the Neisseria genus and gonorrhea as a specific species within that genus. For example, she says, "Neisseria gonorrhea species, which gonorrhea being one of them." Whittington, Exh. 5, 2. Likewise, when referring to the results of the NH test, she says that "it comes up Neisseria," apparently not understanding that something that is Neisseria is not necessarily gonorrhea. Id., 11.

43. Additionally, Burstyn states that oxidase positive organisms other than Neisseria gonorrhoeae do not grow on Thayer-Martin agar. (Thayer-Martin is a medium similar to Martin-Lewis.) Id., 11. This is nonsense and is contradicted by the scientific literature. See, for example, Waldman CR, Gaydos JM, Synder FF. Office Laboratory identification of Neisseria gonorrhoeae. J Fam Pract. 1982; 14:35-37.)

44. When Burstyn describes the procedures used in the NH test, her description is consistent with what one would expect if a technician were simply reading from the product brochure. This does not give me great confidence that she had the capability to make critical judgments about test performance in general. I would have even less confidence that this technician had the necessary skills to interpret atypical results if such results were noted.

45. Of some importance, I note the failure of a laboratory to record times and dates accurately and consistently. Such failure may speak to a degree of carelessness one would hope not to see in any laboratory, let alone a forensic lab. It also indicates that the personnel may not adequately have understood the significance of time (or other testing) factors that affect the outcomes of these tests. Information as to who transmitted the specimen to the lab, how long it sat before being delivered to the lab, who handled the specimen in the lab, what tests were performed, what results were found at each stage of the testing process, and importantly, how long the specimen was incubated, also seem to be curiously missing from the documentation.

46. Finally, I note that the laboratory report on Noel Fuster’s throat culture indicates that the sample was tested for antimicrobial susceptibilities. No indication is given as to how this testing was done so I cannot comment on the accuracy of these results. However, it is of interest to note that, at this time in southern Florida, Neisseria gonorrhoeae were typically resistant to many of the antibiotics to which this test was reported as susceptible. (Zenilman Whittington et al. Sex Transmit Dis.) Such susceptibilities may be more suggestive of other Neisseria species than gonorrhea.

47. It has been well-understood in the medical community for many years that isolates which are collected for the purposes of criminal investigations and prosecutions should be preserved. The process for preserving a suspected gonococcal isolate is straight forward – it requires that the isolate be frozen at minus seventy degrees Centigrade or at minus twenty degrees Centigrade and then transferred to a minus seventy freezer. Most general laboratories and virtually all forensic laboratories would have had the equipment to preserve a gonococcal isolate in 1984. Once frozen properly, these isolates will last for many years in a condition that additional confirmatory tests can still be performed on them. Further, forwarding of such specimens to a reference laboratory is a recommended procedure.

48. The memo I have reviewed from assistant state attorney Dan Casey to assistant state attorney Richard Schiffrin indicates that the isolate taken from Noel Fuster’s throat was destroyed after three days. (I cannot tell from this whether it was destroyed three days after testing was completed or three days after it was collected.) The memo further notes that this destruction of the sample was done per standard operating procedures of the laboratory. Whittington, Exh. 2 at 2.

49. This must be regarded as inappropriate practice. The American Academy of Pediatrics and the Centers of Disease Control specifically recommend that a sample taken from a child suspected of having a sexually transmitted disease must be preserved. This is, and has long been, standard laboratory protocol when a sample has been collected for potential use in a criminal investigation.

50. To summarize my conclusions then, it is my opinion to a reasonable degree of scientific certainty that: The trial testimony given by Dr. Judith Lederhandler was inaccurate and highly misleading. The testing performed to determine that Noel Fuster had gonorrhea of the throat was unreliable and would not meet contemporary standards of accuracy. The destruction of isolate taken from Noel’s throat after three days does not comport with standards employed by laboratories either then or now where a diagnosis of gonorrhea dependent on that isolate is intended for use as proof in a criminal prosecution for child sexual abuse.

I would be happy to provide this Court with any further information that would be useful, either by additional affidavit or by testifying at an evidentiary hearing.

I hereby certify that the information I have provided above is true and accurate to the best of my knowledge, information and belief. I am aware that if I have purposely made any misrepresentations, I am subject to the penalties of perjury.

Affiant says nothing further.

This __ day of ___________, 1999.

_________________________________

W.L.H. Whittington

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