Fisher v. Winding Waters Clinic - 2017 U.S. Dist. LEXIS
Fisher v. Winding Waters Clinic - 2017 U.S. Dist. LEXIS
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2017 U.S. Dist. LEXIS 19691 *; 2017 WL 574383
FACTUAL BACKGROUND
3 "[G]enerally 5 "A
permanent brain injury resulting from a lack of developmental anomaly characterized by a defect on the
oxygen or inadequate blood flow to the brain . . . ." Hypoxic ventral surface of the penis so that the urethral meatus is
ischemic encephalopathy, Stedman's Medical Dictionary proximal to its normal location . . . ." Hypospadias, Stedman's
289320 (2014). Medical Dictionary 430330 (2014).
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Fisher v. Winding Waters Clinic
WES "examines the protein coding signals in . . . genes. believe[s] it is unlikely that X.S.F.'s brain damage has a
. . . More specifically, 30 million DNA bases [are] genetic cause." Id. ¶ 4. He states that "X.S.F. has had
analyzed and compared to reference (normal) gene appropriate genetic testing to address the possibility of a
sequences. Any abnormalities detected are compared genetic syndrome as an explanation for his . . .
to databases describing known genetic syndromes and congenital abnormalities. Such testing included a
diseases." Id. ¶ 9. Dr. Ward claims that "[t]here are chromosomal microarray analysis using up-to-date
several diagnosable syndromes which match [X.S.F.'s] technology. . . . [N]o other genetic testing is medically
finding quite closely . . . ." Id. He concludes his indicated." Id. ¶ 5. He testifies that X.S.F.'s brain MRI
declaration by repeating his "professional opinion" that and electroencephalogram (EEG) scans are "consistent
"in similar cases with children like [X.S.F.] that [*6] with hypoxic-ischemic brain damage rather than a
there is a greater than 50% probability that valuable genetic syndrome." Id. ¶ 6. Moreover, "[o]f the known
information concerning the medical diagnosis and what genetic syndromes that include X.S.F.'s . . . congenital
caused it will be uncovered through the proposed abnormalities—but have no other major anomalies—
testing." Id. ¶ 10. none are associated with head MRI findings such as
those seen in X.S.F.'s head MRI." Id. ¶ 7.
III. Plaintiff's Opposition Dr. Raff also opines on the proposed WES testing. He
asserts that it "uncovers [*8] vast amounts of genetic
Plaintiff argues that defendants' Motion to Compel is information that has nothing to do with the potential
legally and factually insufficient. Pl.'s Resp. (Docket No. genetic syndrome." Pl.'s Resp. (Docket No. 39), Ex. 2,
39). She argues that Dr. Ward's testimony is deficient Raff Decl. ¶ 8. He characterizes WES technology as "so
for failing to identify specific genetic syndromes or new and the experience so limited" that many insurers
conditions for which defendants seek testing. She consider it "investigational and experimental" and so do
observes that one type of genetic testing—comparative not cover it. Id. He states that WES is "not considered
genomic hybridization (chromosomal microarray)—has standard-of-care genetic testing in children for whom the
already been performed on X.S.F., with normal results, remote possibility of a genetic diagnosis has been
and that these test results have been provided to raised." Id. ¶ 9. "Accordingly, whole exome sequencing
defendants. See Ward Decl. (Docket No. 34) ¶ 7; Pl.'s (WES) is unlikely to determine the cause of [X.S.F.'s]
Resp. (Docket No. 39), Exs. 5 & 7.6 brain damage." Id.
the action; and concluding that "[w]hile DNA testing for Supreme Court found this was in error. The tractor-
identification purposes is ubiquitous, Defendants' trailer company relied solely on a "general conclusory
proposed testing, to determine the genetic cause of a statement" that Schlagenhauf was not physically or
disability is uniquely novel"). mentally capable of operating the bus. Id. at 120. This
did not justify the "wide-ranging psychiatric or
Accordingly, defendants have not met their burden to neurological examinations" nor "the broad internal
show that the vast amount of X.S.F.'s genetic medicine examination" ordered. Id. at 120-21 & 121
information, as WES would gather, is "in controversy." n.16 ("Here the examinations were ordered in very
broad, general areas. . . . It is hard to conceive how
some of these could be relevant under any possible
II. Rule 35's "Good Cause" Requirement theory of the case.").
Courts have emphasized the serious nature of Defendants have failed to show "good cause" to compel
physical [*13] examinations and blood draws. In Union a blood draw to conduct WES testing on X.S.F. The
Pacific Railway Co. v. Botsford, 141 U.S. 250, 251, 11 Franco factors weigh against a finding of good cause:
S. Ct. 1000, 35 L. Ed. 734 (1891), the Supreme Court genetic information has already been examined through
held that the lower court had no power to order the chromosomal microarray testing, and [*15] the other
plaintiff to submit to a medical examination: "No right is tests performed indicate that WES would not reveal any
held more sacred, or is more carefully guarded by the additional relevant genetic conditions, given the strength
common law, than the right of every individual to the of plaintiff's evidence of hypoxia as a likely cause of
possession and control of his own person . . . unless by X.S.F's injuries.
clear and unquestionable authority of the law." "The
right to one's person may be said to be a right of The Court finds Dr. Ward's vague testimony regarding a
complete immunity; to be let alone." Id. (quotation possible, though unidentified, genetic cause of X.S.F.'s
omitted). "The inviolability of the person is as much condition particularly troubling, and finds that such
invaded by a compulsory stripping and exposure as by a testimony does not support defendants' "good cause"
blow." Id. at 252. argument. At least one court, in a medical malpractice
action concerning an infant's brain damage, has balked
Following Botsford, the Ninth Circuit, in holding that at ordering sweeping genetic testing to search for an
Rule 35 did not permit the court to compel blood testing unspecified genetic cause. See Rogers-Duell, 974
of a party's parent to confirm paternity, declared, "it is N.Y.S. 2d at 775. Where courts have ordered genetic
apparent that Rule 35 diminishing that sacred right testing, the moving parties have specified particular
should be strictly construed." Fong Sik Leung v. Dulles, conditions that they believe underlie the controverted
226 F.2d 74, 77 (9th Cir. 1955). In a similar case, the injuries and that testing would confirm or deny. See,
Ninth Circuit observed that it had "no jurisdiction to e.g., Cruz v. Super. Ct., 121 Cal. App. 4th 646, 648-49,
compel a person not a party to the action to yield his 17 Cal. Rptr. 3d 368 (2004) (ordering blood draw and
body to the invasion of a physician's instruments." genetic testing to ascertain whether "genetic alterations
Dulles v. Quan Yoke Fong, 237 F.2d 496, 499 (9th Cir. in blood clotting factors" may have caused or
1956). Nor does Rule 35 permit a court to order a contributed to the child's brain injuries); Harris v. Mercy
physical examination of a non-party. Scharf v. U.S. Att'y Hosp., 231 Ill. App. 3d 105, 106, 596 N.E.2d 160, 172
Gen., 597 F.2d 1240, 1243 (9th Cir. 1979). Ill. Dec. 881 (1992) (holding that district court did not
abuse its discretion in ordering a blood draw to
Schlagenhauf v. Holder, 379 U.S. 104, 85 S. Ct. 234, 13
determine if a specific genetic condition, Angelman
L. Ed. 2d 152 (1964), provides leading guidance
Syndrome, caused the child's brain damage); Kaous v.
regarding the application of Rule 35; there, the Supreme
Lutheran Med. Ctr., 138 A.D.3d 1065, 30 N.Y.S.3d 663,
Court analyzed Rule 35 in [*14] a negligence action
665 (App. Div. 2016) (ordering genetic testing to [*16]
involving the collision of a bus with a tractor-trailer.
confirm diagnosis of Fraser Syndrome as cause of
Defendant tractor-trailer owner cross-claimed against
infant's brain damage); Kriloff v. Providence Health &
defendant Schlagenhauf, the bus driver, alleging that he
Servs., No. 14CV11115 (Or. Multnomah Cty. Cir. Ct.
was negligent and not physically or mentally capable of
Jan 12, 2016) (ordering genetic testing to test for
driving a bus at the time of the accident. Id. at 107. The
Nance-Horan Syndrome and Warburg Micro Syndrome,
tractor-trailer owner petitioned for medical examinations
of Schlagenhauf, and the district court ordered nine
physical and mental examinations. Id. at 108-09. The
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Fisher v. Winding Waters Clinic
which only WES could detect).7 But see Cutting v. performed chromosomal array testing, which Dr. Ward
United States, No. 07-CV-02053-PAB-MEH, 2008 U.S. himself specifically says is "first line" testing and is
Dist. LEXIS 100723, 2008 WL 5064267, at *1 (D. Colo. recommended by the American Academy of Pediatrics,
Nov. 24, 2008) (ordering genetic testing to determine id. ¶ 7. The Court finds Dr. Raff's testimony more
whether allegedly negligent medical care during delivery specific and supported by the record.9
resulted in infant's brain injury, especially where
independent medical examination of the infant was Additionally, while a blood draw may not appear
already scheduled: "this is a good faith dispute that particularly burdensome or intrusive, the Supreme Court
supports the requested, minimally invasive, one-time and Ninth Circuit have emphasized that any such
blood and urine draw at the time of the [independent invasion of the person is a serious procedure. See
medical examination]").8 Botsford, 141 U.S. at 251 (describing the right to control
one's person as "sacred"); Fong Sik Leung, 226 F.2d at
Other considerations weigh against a finding of "good 77 (repeating Botsford's "sacred" language); Dulles, 237
cause." Dr. Raff's testimony regarding the reliability and F.2d at 499 (describing "the invasion of a physician's
appropriateness of WES is more persuasive than Dr. instruments"). That WES may uncover numerous other
Ward's. Dr. Raff testifies that WES is "new," and very serious genetic predispositions multiplies the
"investigational," and "experimental," Pl.'s Resp. burden on X.S.F., and on X.S.F.'s family members, who
(Docket No. 39), Ex. 2, Raff Decl. ¶ 8, and that it is not share much of X.S.F.'s genetic material. Pl.'s Resp.
considered standard-of-care genetic testing, id. ¶ 9. The (Docket No. 39), Ex. 2, Raff Decl. ¶ 10. This sweeping
genetic testing already done buttresses this testimony. invasion of personal integrity and privacy strongly
Although [*17] Dr. Ward testifies that he would "advise" weighs [*18] against a finding of good cause. See
parties to conduct WES, Ward Decl. (Docket No. 34) ¶ Schlagenhauf, 379 U.S. at 120 (criticizing proposed
8, and describes its "value," id. ¶ 9, unlike Dr. Raff he examinations for being excessively "wide-ranging").
does not state whether it is routinely administered or is
the standard of care; this contrasts with already- This potential burden on X.S.F.'s family members is
exacerbated because WES testing of X.S.F. may
require testing of his relatives as well. Pl.'s Resp.
(Docket No. 39), Ex. 2, Raff Decl. ¶ 10. WES uncovers
7 See Pl.'s Reply to Defs.' Suppl. Br. (Docket No. 50), Ex. 1,
Tsai Dep. 72:18-19 (deposition transcript from Kriloff case
providing background information absent from the court's
9 Defendants
order compelling genetic testing). also cite the deposition of Dr. Joseph Gilhooly,
one of X.S.F.'s treating physicians at Oregon Health & Science
8 The other cases defendants cite regarding good cause for University, as evidence that any cause of X.S.F.'s injuries
ordering blood draws from minors are inapposite. Two of those must have been before birth. O'Kasey Decl. (Docket No. 42),
cases consider blood draws to establish citizenship, and do Ex., Gilhooly Dep. But the cited testimony is vague and
not consider broader genetic testing. See Scharf v. U.S. Att'y inconclusive at best, and does not contradict Dr. Raff's
Gen., 597 F.2d 1240, 1242 (9th Cir. 1979); Fong Sik Leung v. testimony or support Dr. Ward's. Defendants rely on this
Dulles, 226 F.2d 74, 75 (9th Cir. 1955). Another considered a statement: "if there was an injury, or whatever was causing his
blood draw to perform chromosomal analysis where the neurologic problems, whether it was from birth defects or lack
sample from an earlier blood draw had spoiled. Otis v. Hyde of oxygen injury, happened prior to the time around delivery"
Hosp. Ass'n, 134 A.D.2d 711, 520 N.Y.S. 2d 884, 885 (App. id. 12:8-11, and "[b]ut for there to already be abnormalities
Div. 1987). And in another the appellate court found that the indicates that something happened before delivery," id. 14:3-4.
district court abused its discretion in ordering a blood draw for Dr. Gilhooly did not testify that a cause of X.S.F.'s condition
genetic testing, because good cause did not exist where was genetic. Moreover, Dr. Gilhooly testified immediately after
defendants, in support of their motion to compel, relied on the the cited portions as to his uncertainty about the cause of
conclusory and "bare assertion" that "the relationship between X.S.F.'s injuries, thus undermining whatever support his
genetic disturbances and brain damage is well documented testimony might give defendants: "I don't have any expertise to
and commonly accepted." Thompson v. Palos Cmty. Hosp., sort of date those findings and tell you how long it would have
254 Ill. App. 3d 836, 841, 627 N.E.2d 239, 194 Ill. Dec. 123 taken to see those changes develop," id. 14:5-7, and in
(1993) (quotation omitted). The parties also cite an Oregon response to a question regarding whether certain birth defects
Circuit Court case denying a motion to compel genetic testing, were "often genetically caused," he said "I'm not sure," id.
Cloutier v. St. Anthony Hosp., No. CV150474 (Or. Umatilla 14:17-18. Dr. Gilhooly also testified that he "didn't have a very
Cty. Cir. Ct. July 26, 2016); however, this is a two-page order high suspicion for a chromosomal abnormality" underlying
issued without explaining its reasoning, and so does not lend X.S.F.'s conditions. Pl.'s Resp. (Docket No. 39), Ex. 6,
any support to the parties' arguments. Gilhooly Dep. 39:5-6.
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Fisher v. Winding Waters Clinic
thousands of DNA sequence variants, and in order to The case defendants have cited regarding WES,
determine whether a particular variant has caused a Meyers v. Intel Corp., No. CV N11C-07-009 JRJ, 2015
potential genetic syndrome, WES "inevitably requires Del. Super. LEXIS 285, 2015 WL 3643470 (Del. Super.
whole exome sequencing of the parents of the individual Ct. June 11, 2015), concerns whether the court had
as part of the testing process" for comparison. Id. 10 The jurisdiction to order genetic testing of the injured child's
Court finds this additionally troubling as such a parents (the court concluded that it did not). This case
requirement could force further physical intrusions of does not address the issues before this Court. In
X.S.F.'s parents, for instance, and because it could Meyers, for reasons the court's [*20] order does not
disclose the highly personal and revealing genetic make clear, the plaintiffs did not dispute defendant's
information of these individuals. Serious legal concerns entitlement to genetic testing of the plaintiff child. 2015
are also presented. Under Rule 35 the Court cannot Del. Super. LEXIS 285, [WL] at *1.12 Other cases
order a blood draw of non-parties, such as X.S.F.'s defendants cite are not helpful; they were either already
parents. Scharf, 597 F.2d at 1243. The Court's inability cited to the Court and concern testing to confirm or rule
to order blood draws of X.S.F.'s relatives, and out specific syndromes (unlike the broad search
defendants' claim that they would not seek such draws, defendants propose here), or contain extremely brief
Defs.' Reply (Docket No. 41), at 7-8, undercut the and uninformative analyses.13 Thus, the Court finds no
purported value of WES, and thus weigh against the authority defendants have identified, nor any the Court
Court's compelling [*19] plaintiff to submit X.S.F. to it. hasbeen able to locate in its own research, that justifies
genetic testing of the scope involved with WES where,
Thus, defendants have also failed to show that good as here, a defendant has not specified a particular
cause exists to compel plaintiff to submit X.S.F. to a genetic condition to identify and confirm.
blood draw for WES genetic testing.
Dr. Ward testifies, "[b]ased upon [his] review of the
III. The Parties' Supplemental Briefing medical records, [his] education, training, and medical
study," that there is "a reasonable certainty that X.S.F.'s
The parties' supplemental briefing does not alter the
medical [conditions] are not due to a birth injury," but
Court's foregoing analysis; specifically, defendants have
rather, that there is a "a medical probab[i]lity that
failed to cite persuasive legal authority regarding the
X.S.F[.] has an as-yet undiagnosed genetic syndrome."
appropriateness of WES under Rule 35 in these
Suppl. Ward Decl. (Docket No. 49) ¶ 3 (emphases
circumstances, or to provide sufficient concrete detail
added). However, Dr. Ward does not provide specific
regarding the genetic conditions in X.S.F. that they seek
evidence for these opinions. Likewise, Dr. Raff
to identify using WES.11
testifies [*21] in his supplemental briefing that the
"likelihood of a genetic diagnosis that includes X.S.F.'s
10 That brain injuries is highly remote." Pl.'s Reply to Defs.'
WES additionally requires testing of family members is
supported by the case defendants rely on in their
Suppl. Br. (Docket No. 50), Ex. 2, Raff Decl. ¶ 4
Supplemental Briefing, Meyers v. Intel Corp., No. CV N11C-
07-009 JRJ, 2015 Del. Super. LEXIS 285, 2015 WL 3643470,
at *1 (Del. Super. Ct. June 11, 2015), where defendant sought
12 In
WES testing of the injured child's parents in order to establish Meyers, the court, in concluding it would not order genetic
that a "genetic structure [plaintiff] inherited from his parents testing of the parents, cited defendant Intel's concession that
caused his birth defects—not the alleged chemical exposures" there was "at least a 35% probability" that the genetic testing
at defendant's facility, as plaintiffs alleged. would identify a genetic cause for the child's birth defects.
2015 Del. Super. LEXIS 285, 2015 WL 3643470, at *3. The
11 Dr. Ward only vaguely answered the Court's specific Meyers court criticized this as a "low probability of success"
question regarding "the frequency that Dr. Ward does [WES] that weighed against ordering the genetic testing. Id.
testing on infants with impairments." Minute Order (Docket No.
13 These
46). Dr. Ward testifies that: cases are: Kaous v. Lutheran Medical Center, 138
A.D.3d 1065, 30 N.Y.S.3d 663 (App. Div. 2016); McVay v.
In recent years, I have performed or requested whole
Johns Hopkins Hospital, No. 24-C-14-005568, 2015 WL
exome sequencing tests at least a thousand times a year,
10642695 (Md. Cir. Ct. Nov. 9, 2015); Bennett v. Fieser, No.
both in cases in which it is medically indicated due to a
93-1004-MLB, 1994 U.S. Dist. LEXIS 4050, 1994 WL 542089
child's presentation at birth and in situations in which the
(D. Kan. Feb. 25, 1994); Dodd-Anderson v. Stevens, No. 92-
other types of genetic testing have not been diagnostic of
1015-MLB, 1993 U.S. Dist. LEXIS 8270, 1993 WL 273373 (D.
potential syndromes.
Kan. May 4, 1993); and Harris v. Mercy Hospital, 231 Ill. App.
Suppl. Ward Decl. (Docket No. 49) ¶ 2. 3d 105, 596 N.E.2d 160, 172 Ill. Dec. 881 (1992).
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Fisher v. Winding Waters Clinic
(emphasis added). This conclusion lacks supporting to Defs.' Suppl. Br. (Docket No. 50), Ex. 2, Raff Decl. ¶
evidence, and at most simply contradicts Dr. Ward's 4. He also testifies that the second and third listed
conclusions. Neither expert opinion is helpful in conditions, as to the MAMLD1 and HOXD13 genes, are
providing the specifics the Court requested. not associated with the brain abnormalities seen in
X.S.F.; that the MAMLD1 genetic condition is not
In response to the Court's request that defendants typically associated with anything other than
identify specific genetic conditions that WES testing hypospadias; and that the HOXD13 genetic [*23]
would reveal given X.S.F.'s symptoms, Dr. Ward condition usually presents with digital congenital
submits: anomalies, which X.S.F. lacks. Id. The Court finds that
[T]here are over 1,300 diseases associated with the specificity of Dr. Raff's rebuttal testimony makes it
neonatal seizures that can be detected using whole more persuasive than Dr. Ward's testimony, and
exome sequencing. There are hundreds of supports the conclusion that defendants have not made
conditions that can be diagnosed using exome it sufficiently clear to the Court what they think they will
sequencing which can have hypospadias, anal find by having plaintiff submit X.S.F. to WES testing.
atresia,14 seizures, and intrauterine growth
restriction15 . . . . Examples include: Finally, Dr. Ward testifies that defendants can interpret
Contiguous or single gene disruptions on WES "in a very targeted fashion so that only conditions
chromosome 13 (particularly 13q33.2qter) relevant to this lawsuit are disclosed. The family does
Familial hypospadias (MAMLD1 gene) not need to learn about other genetic conditions that
VACTERL association (HOXD13 gene) X.S.F. or other family members may carry if they do not
want this information . . . ." Suppl. Ward. Decl. (Docket
Suppl. Ward. Decl. (Docket No. 49) ¶ 3 (footnotes No. 49) ¶ 4. As plaintiff persuasively argues, however,
added). The Court finds this cursory explanation this potentially targeted disclosure of information does
unpersuasive and deficient as a response to the not satisfy plaintiff's, or the Court's, privacy concerns.
concerns the Court raised at oral argument and [*22] in Even if this genetic information is kept from X.S.F. and
its Minute Order (Docket No. 46). The Court is not his family members for the time being, there is an
satisfied that these "conditions" correspond to X.S.F.'s invasion of privacy in the information having been
symptoms. Although Dr. Ward specifically denies that gathered, and harm in the information simply existing.
WES constitutes a "fishing expedition," defendants' This information could well be disclosed against the
submissions, especially in light of the serious concerns family's wishes in the future, for instance, [*24] in
the Court expressed regarding defendants' apparent conjunction with an insurance application, or as the
lack of specificity, reinforce plaintiff's argument that result of a court proceeding or court order, or from a
defendants' Motions may well amount to little more than computer hack of electronic medical records. As Dr.
such an expedition. Raff observes,
Such privacy concerns are addressed in the clinical
Dr. Raff's reply testimony further exposes the setting by giving patients and their families the right
deficiencies in Dr. Ward's testimony. Dr. Raff testifies to refuse whole exome sequencing given the
that the first of Dr. Ward's listed genetic conditions, invasive nature of the data generated. That right
disruptions on chromosome 13, would in the "vast should not be discarded in order to pursue testing
majority" of cases have been diagnosed by the already- that is highly unlikely to provide the information
conducted chromosomal microarray testing. Pl.'s Reply being sought.
Pl.'s Reply to Defs.' Suppl. Br. (Docket No. 50), Ex. 2,
Raff Decl. ¶ 6. The Court is not persuaded that WES's
14 "[C]ongenital potentially sweeping genetic revelations can
absence of an anal opening due to the
persistence of epithelial plug (persistence of the anal successfully be limited through selective disclosure.
membrane) or to complete absence of the anal canal." Anal
atresia, Stedman's Medical Dictionary 83510 (2014).
CONCLUSION
15
"[F]etal weight ≤5th percentile for gestational age." Fetal
growth restriction, Stedman's Medical Dictionary 777520 For the foregoing reasons, defendants have failed to
(2014) (synonymous with "intrauterine growth retardation"); carry their burden to meet Fed. R. Civ. P. 35's "in
see also 2 American Law of Medical Malpractice § 13:12 controversy" and "good cause" requirements with regard
(2016) (discussing "symmetric intrauterine growth restriction" to WES testing of X.S.F. Accordingly, defendants'
and "asymmetric growth retardation").
Page 10 of 10
Fisher v. Winding Waters Clinic
IT IS SO ORDERED.
PATRICIA SULLIVAN
End of Document