Fisher v. Winding Waters Clinic, PC et al
Filing
53
OPINION AND ORDER: Defendants have failed to carry their burden to meet Fed. R. Civ. P. 35s in controversy and good cause requirements with regard to WES testing of X.S.F. Accordingly, defendants Motion to Compel Genetic Testing (Docket No. 33 ) and Amended Motion to Compel Genetic Testing (Docket No. 35 ) are DENIED. (See 18 page opinion for more information) Signed on 2/13/17 by Magistrate Judge Patricia Sullivan. (dsg)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF OREGON
PENDLETON DIVISION
CASSI C. FISHER as Guardian ad Litem for
X.S.F., a minor,
Plaintiff,
Case No. 2:15-cv-01957-SU
OPINION AND ORDER
v.
WINDING WATERS CLINIC, PC, an Oregon
corporation; ELIZABETH POWERS, M.D.;
KEITH DeYOUNG, M.D.; and RENEE
GRANDI, M.D.,
Defendants.
_______________________________________
SULLIVAN, United States Magistrate Judge:
Plaintiff Cassi C. Fisher, a resident of the State of Washington and mother of and
guardian ad litem for X.S.F., a minor, brings this medical malpractice action against defendants
Winding Waters Clinic, Dr. Elizabeth Powers, Dr. Keith DeYoung, and Dr. Renee Grandi, all
residents of Oregon and providers of medical services in Enterprise, Oregon. Plaintiff’s claim
arises from the obstetric care that defendants provided Fisher during her pregnancy with X.S.F.,
and from the brain damage and other injuries that X.S.F. suffered at or before birth, allegedly due
Page 1 – OPINION AND ORDER
to defendants’ negligent care. Plaintiff asserts one cause of action, for negligence under Oregon
state law. The Court has diversity jurisdiction under 28 U.S.C. § 1332(a)(1).
Defendants move to compel plaintiff to make X.S.F.’s blood available for genetic testing
under Fed. R. Civ. P. 35(a). (Docket Nos. 33 (original Motion), 35 (Amended Motion)).
Plaintiff opposes the Motions. (Docket No. 39). For the following reasons, the Court DENIES
defendants’ Motion and Amended Motion to Compel.
FACTUAL BACKGROUND
I.
Plaintiff and X.S.F.’s Medical Background
For the purposes of providing factual background, the Court takes the following
allegations from plaintiff’s Amended Complaint. (Docket No. 21). Defendant Winding Waters
Clinic is an Oregon medical clinic providing family medical care, including obstetric care. Id.
¶ 2. Defendants Powers, DeYoung, and Grandi are medical doctors who each practiced at
Winding Waters Clinic. Id. ¶¶ 3-5. Plaintiff, a Washington state resident, received obstetric care
for her pregnancy with, and delivery of, X.S.F., beginning in May 2010. Id. ¶¶ 1 & 8. At
plaintiff’s initial office visit, defendants identified her pregnancy as “high-risk.” Id. ¶ 9. Various
warning signs presented themselves during plaintiff’s pregnancy, including pregnancy-induced
hypertension,1 id. ¶ 10, and an abnormal fundal height,2 id. ¶¶ 11 & 23. Defendants did not take
certain steps to assess X.S.F.’s well-being in utero late in plaintiff’s pregnancy, for example,
through ultrasonography. Id. ¶ 12. On December 25, 2010, one day before her due date,
1
“[H]ypertension [i.e., abnormally high blood pressure] during pregnancy in a previously
normotensive woman or aggravation of hypertension during pregnancy in a hypertensive
woman.” Gestational hypertension, Stedman’s Medical Dictionary 426290 (2014) (synonymous
with “pregnancy-induced hypertension”).
2
“Fundal height is the distance from the pubic bone to the top of the uterus. This distance,
measured in centimeters, is nearly equivalent to the weeks of gestation . . . .” 40 Am. Jur. Trials
1 § 41 (2017).
Page 2 – OPINION AND ORDER
plaintiff presented to defendants with leaking fluid and the possibility of a ruptured membrane;
defendants conducted certain tests of X.S.F. and sent plaintiff home. Id. ¶ 13. On December 29,
2010, plaintiff followed up with defendants and although her “membranes were stripped,”
defendants again sent her home. Id. ¶ 14. On January 4, 2011, plaintiff again presented with
leaking fluid and, following certain tests of X.S.F., defendants performed a Caesarian section
delivery of X.S.F. Id. ¶¶ 15 & 16. X.S.F. “was delivered in a severely depressed state with
significant brain damage that has continued without improvement, and is permanent.” Id. ¶ 17.
Specifically, X.S.F. suffered “Partial Prolonged Hypoxic Ischemia3 resulting in brain damage . . .
with significant developmental delay, cognitive delay, learning disabilities, [and] physical
disabilities . . . all of which are permanent.” Id. ¶ 23.
II.
Defendants’ Proposed Genetic Testing
Defendants argue that it was not defendants’ alleged negligence that caused X.S.F.’s
brain damage, but rather that “some or all of X.S.F.’s impairments are more likely than not the
result of a genetic condition unrelated to prenatal care.” Defs.’ Am. Mot. Compel (Docket No.
35), at 4. Defendants seek to perform genetic testing on X.S.F. to confirm this, including by
conducting whole exome sequencing (“WES”).
Defendants rely on perinatology and genetics expert Kenneth Ward, M.D. to support their
Motion. Ward Decl. (Docket No. 34) ¶ 1; see also Defs.’ Am. Mot. Compel. (Docket No. 35),
Ex. 1 (Docket No. 35-1) (Dr. Ward’s curriculum vitae). Dr. Ward testifies that, based on his
review of X.S.F.’s medical records, he “believe[s] to a reasonable medical probability that
[X.S.F.] has a genetic syndrome which is the cause of or a significant contributing factor of his
3
“[G]enerally permanent brain injury resulting from a lack of oxygen or inadequate blood flow
to the brain . . . .” Hypoxic ischemic encephalopathy, Stedman’s Medical Dictionary 289320
(2014).
Page 3 – OPINION AND ORDER
impairments in the records including neonatal seizures, urethral stenosis,4 hypospadias,5
developmental delay and possible neurological damage.” Ward Decl. (Docket No. 34) ¶ 4
(footnotes added).
X.S.F. has already undergone one round of genetic testing: comparative
genomic hybridization (also called chromosomal microarray testing), which is the “first line”
genetic testing for children with developmental disabilities or congenital abnormalities. Id. ¶ 7;
see also Pl.’s Resp. (Docket No. 39), Raff Decl. ¶ 5 (“X.S.F. has had appropriate genetic testing
to address the possibility of a genetic syndrome . . . .”). Dr. Ward states that “Whole Exome
Sequencing and Comparative Genomic Hybridization are scientifically reliable genetic tests,
which can be utilized to identify certain known genetic syndromes.” Ward Decl. (Docket No.
34) ¶ 5. Dr. Ward testifies that “[m]ost medical geneticists,” including himself, “would advise
parents as well as litigants” to undergo further genetic testing, namely, WES, “in an attempt to
establish a full and correct diagnosis.” Id. ¶ 8. WES “examines the protein coding signals in . . .
genes. . . . More specifically, 30 million DNA bases [are] analyzed and compared to reference
(normal) gene sequences. Any abnormalities detected are compared to databases describing
known genetic syndromes and diseases.” Id. ¶ 9. Dr. Ward claims that “[t]here are several
diagnosable syndromes which match [X.S.F.’s] finding quite closely . . . .” Id. He concludes his
declaration by repeating his “professional opinion” that “in similar cases with children like
[X.S.F.] that there is a greater than 50% probability that valuable information concerning the
medical diagnosis and what caused it will be uncovered through the proposed testing.” Id. ¶ 10.
4
“[A] narrowing of [the] urinary tract.” Yarborough v. United States, No. ED CV 10-346-VAP
PLA, 2014 WL 1255945, at *4 (C.D. Cal. Mar. 5, 2014), report and recommendation adopted,
No. ED CV 10-346-VAP PLA, 2014 WL 1255957 (C.D. Cal. Mar. 20, 2014).
5
“A developmental anomaly characterized by a defect on the ventral surface of the penis so that
the urethral meatus is proximal to its normal location . . . .” Hypospadias, Stedman’s Medical
Dictionary 430330 (2014).
Page 4 – OPINION AND ORDER
III.
Plaintiff’s Opposition
Plaintiff argues that defendants’ Motion to Compel is legally and factually insufficient.
Pl.’s Resp. (Docket No. 39). She argues that Dr. Ward’s testimony is deficient for failing to
identify specific genetic syndromes or conditions for which defendants seek testing.
She
observes that one type of genetic testing—comparative genomic hybridization (chromosomal
microarray)—has already been performed on X.S.F., with normal results, and that these test
results have been provided to defendants. See Ward Decl. (Docket No. 34) ¶ 7; Pl.’s Resp.
(Docket No. 39), Exs. 5 & 7.6
At eight days of life, X.S.F. underwent a brain magnetic resonance imaging (MRI) scan
that showed “anoxic ischemic encephalopathy.” Pl.’s Resp. (Docket No. 39), Ex. 1. X.S.F.’s
treating neurologist, Erika Finanger, M.D., attributes X.S.F.’s brain injury to hypoxia (low
oxygen). Pl.’s Resp. (Docket No. 39), Ex. 4, Finanger Dep. 17:5-19:4 & 56:3-13.
Plaintiff’s expert, Michael Raff, M.D., offers testimony that diverges from Dr. Ward’s.
Pl.’s Resp. (Docket No. 39), Ex. 2, Raff Decl. Dr. Raff testifies that, based on his review of the
medical records, he “believe[s] it is unlikely that there is a genetic etiology that underlies X.S.F’s
encephalopathy (abnormal brain findings and cognitive delays). In other words, [he] believe[s] it
is unlikely that X.S.F.’s brain damage has a genetic cause.” Id. ¶ 4. He states that “X.S.F. has
had appropriate genetic testing to address the possibility of a genetic syndrome as an explanation
for his . . . congenital abnormalities. Such testing included a chromosomal microarray analysis
using up-to-date technology. . . . [N]o other genetic testing is medically indicated.” Id. ¶ 5. He
testifies that X.S.F.’s brain MRI and electroencephalogram (EEG) scans are “consistent with
6
Certain of the exhibits to plaintiff’s Response are not authenticated. See Pl.’s Resp. (Docket
No. 39), Exs. 1, 3-7. These include deposition excerpts and test results. However, defendants
have not objected to this evidence, and so the Court considers it herein; nonetheless, even if it
were to exclude this evidence, the Court would not change its analysis or conclusion.
Page 5 – OPINION AND ORDER
hypoxic-ischemic brain damage rather than a genetic syndrome.” Id. ¶ 6. Moreover, “[o]f the
known genetic syndromes that include X.S.F.’s . . . congenital abnormalities—but have no other
major anomalies—none are associated with head MRI findings such as those seen in X.S.F.’s
head MRI.” Id. ¶ 7.
Dr. Raff also opines on the proposed WES testing. He asserts that it “uncovers vast
amounts of genetic information that has nothing to do with the potential genetic syndrome.”
Pl.’s Resp. (Docket No. 39), Ex. 2, Raff Decl. ¶ 8. He characterizes WES technology as “so new
and the experience so limited” that many insurers consider it “investigational and experimental”
and so do not cover it. Id. He states that WES is “not considered standard-of-care genetic
testing in children for whom the remote possibility of a genetic diagnosis has been raised.” Id.
¶ 9. “Accordingly, whole exome sequencing (WES) is unlikely to determine the cause of
[X.S.F.’s] brain damage.” Id.
PROCEDURAL BACKGROUND
Defendants originally filed their Motion to Compel Genetic Testing on October 3, 2016
(Docket No. 33); they then filed their substantially similar Amended Motion to Compel Genetic
Testing (Docket No. 35) the next day, on October 4, 2016.
The Court heard oral argument in this matter on December 6, 2016. (Docket No. 46). At
that hearing, the Court ordered defendants to submit supplemental briefing to address specific
questions, and plaintiff to submit supplemental briefing in response. The Court’s questions
were: (1) what specific syndromes do defendants seek to identify in X.S.F. with WES testing; (2)
with what frequency does Dr. Ward perform WES on infants with impairments similar to
X.S.F.’s; (3) what additional case law or legal authority supports defendants’ position that WES
Page 6 – OPINION AND ORDER
testing has been ordered in cases like the one before the Court, and that such orders comply with
Rule 35. The parties have submitted their supplemental briefing (Docket Nos. 48-50).
LEGAL STANDARD
Under Fed. R. Civ. P. 35, a court “may order a party whose mental or physical condition .
. . is in controversy to submit to a physical or mental examination.” Fed. R. Civ. P. 35(a)(1).
Such an order “may be made only on motion for good cause.” Fed. R. Civ. P. 35(a)(2)(A). This
rule establishes two requirements: that the mental or physical condition be “in controversy,” and
that “good cause” be shown. Schlagenhauf v. Holder, 379 U.S. 104, 111 (1964). The Supreme
Court has instructed that “good cause” requires a showing of more than mere relevance; “there
must be greater showing of need under [Rule 35] than under the other discovery rules.” Id. at
118 (“The specific requirement of good cause would be meaningless if good cause could be
sufficiently established by merely showing that the desired materials are relevant . . . .”). Neither
the “in controversy” nor the “good cause” requirement can be “met by mere conclusory
allegations of the pleadings.” Id. “Rule 35, therefore, requires discriminating application by the
trial judge.” Id. Rule 35 examinations must not be “ordered routinely”; “[t]he plain language of
Rule 35 precludes such an untoward result.” Id. at 122.
“‘Good cause’ generally requires a showing of specific facts justifying discovery.”
Franco v. Bos. Sci. Corp., No. 05-CV-1774 RS, 2006 WL 3065580, at *1 (N.D. Cal. Oct. 27,
2006). “Factors that courts have considered include, but are not limited to, the possibility of
obtaining desired information by other means, whether plaintiff plans to prove her claim through
testimony of expert witnesses, whether the desired materials are relevant, and whether plaintiff is
claiming ongoing emotional distress.” Id.; see Ayat v. Sociètè Air France, No. C 06-1574 JSW
Page 7 – OPINION AND ORDER
(JL), 2007 WL 1120358, at *5 (N.D. Cal. Apr. 16, 2007) (citing Franco factors); Mandujano v.
Geithner, No. C 10-01226 LB, 2011 WL 825728, at *3 (N.D. Cal. Mar. 7, 2011) (same).
“Even if good cause is shown, it is still within the court’s discretion to determine whether
to order an examination.” Franco, 2006 WL 3065580 at *1; Nguyen v. Qualcomm Inc., No.
CIV. 09-1925-MMA WVG, 2013 WL 3353840, at *4 (S.D. Cal. July 3, 2013) (same).
“Although the rule is to be construed liberally to allow the examination, the court must still
balance the right of the party to be examined to avoid personal invasion against the moving
party’s right to a fair trial.” Franco, 2006 WL 3065580 at *1. The court should also ensure the
parties have a “balanced opportunity” to assess plaintiff’s allegations and proof. Nguyen, 2013
WL 3353840, at *7 (quotation omitted). A court must inquire into the appropriateness of the
tests for determining the contested physical or mental state. Ayat, 2007 WL 1120358, at *8-9.
DISCUSSION
I.
Rule 35’s “In Controversy” Requirement
In this medical malpractice action, plaintiff claims that defendants’ negligent care
resulted in X.S.F.’s brain damage. X.S.F.’s mental and physical condition is generally at issue.
Defendants are entitled to attempt to show that their medical care was not negligent and did not
cause or contribute to X.S.F.’s injuries. However, defendants have not shown that the near
entirety of X.S.F.’s genome, as WES would assay, is in controversy. WES has the potential to
uncover genetic predispositions to numerous conditions unrelated to X.S.F.’s known injuries,
such as cancer, cardiac arrhythmias, neurologic disorders, and metabolic disorders. Pl.’s Resp.
(Docket No. 39), Ex. 2, Raff Decl. ¶ 8. The testimony of defendants’ expert, Dr. Ward, that
some unidentified and unspecified genetic condition may be a cause or contributing factor to
X.S.F.’s condition is insufficient to place the near entirety of X.S.F.’s genetic information at
Page 8 – OPINION AND ORDER
issue, especially in the face of competing testimony by Dr. Raff that it is unlikely that X.S.F.’s
brain damage has a genetic cause. Dr. Ward’s testimony is even less persuasive given that the
genetic testing X.S.F. has already been subject to—chromosomal microarray—did not indicate
any genetic abnormality, and that the non-genetic testing performed (MRI, EEG) indicate that
hypoxia caused his injuries. See Rogers-Duell v. Ying-Jen Chen, 974 N.Y.S. 2d 769, 775-76
(Sup. Ct. 2013) (finding, in medical malpractice action for infant’s hydrocephalus, that
“unspecified genetic testing” would reveal “vast amount of personal and private information”
and so would “impose[] a special burden on” plaintiff; that “[a]lthough Plaintiff put his physical
and mental condition at issue, the information to be gleaned from unspecified genetic testing
goes far beyond the relevant issues” in the action; and concluding that “[w]hile DNA testing for
identification purposes is ubiquitous, Defendants’ proposed testing, to determine the genetic
cause of a disability is uniquely novel”).
Accordingly, defendants have not met their burden to show that the vast amount of
X.S.F.’s genetic information, as WES would gather, is “in controversy.”
II.
Rule 35’s “Good Cause” Requirement
Courts have emphasized the serious nature of physical examinations and blood draws. In
Union Pacific Railway Co. v. Botsford, 141 U.S. 250, 251 (1891), the Supreme Court held that
the lower court had no power to order the plaintiff to submit to a medical examination: “No right
is held more sacred, or is more carefully guarded by the common law, than the right of every
individual to the possession and control of his own person . . . unless by clear and unquestionable
authority of the law.” “The right to one’s person may be said to be a right of complete
immunity; to be let alone.” Id. (quotation omitted). “The inviolability of the person is as much
invaded by a compulsory stripping and exposure as by a blow.” Id. at 252.
Page 9 – OPINION AND ORDER
Following Botsford, the Ninth Circuit, in holding that Rule 35 did not permit the court to
compel blood testing of a party’s parent to confirm paternity, declared, “it is apparent that Rule
35 diminishing that sacred right should be strictly construed.” Fong Sik Leung v. Dulles, 226
F.2d 74, 77 (9th Cir. 1955). In a similar case, the Ninth Circuit observed that it had “no
jurisdiction to compel a person not a party to the action to yield his body to the invasion of a
physician’s instruments.” Dulles v. Quan Yoke Fong, 237 F.2d 496, 499 (9th Cir. 1956). Nor
does Rule 35 permit a court to order a physical examination of a non-party. Scharf v. U.S. Att’y
Gen., 597 F.2d 1240, 1243 (9th Cir. 1979).
Schlagenhauf v. Holder, 379 U.S. 104 (1964), provides leading guidance regarding the
application of Rule 35; there, the Supreme Court analyzed Rule 35 in a negligence action
involving the collision of a bus with a tractor-trailer. Defendant tractor-trailer owner crossclaimed against defendant Schlagenhauf, the bus driver, alleging that he was negligent and not
physically or mentally capable of driving a bus at the time of the accident. Id. at 107. The
tractor-trailer owner petitioned for medical examinations of Schlagenhauf, and the district court
ordered nine physical and mental examinations. Id. at 108-09. The Supreme Court found this
was in error. The tractor-trailer company relied solely on a “general conclusory statement” that
Schlagenhauf was not physically or mentally capable of operating the bus. Id. at 120. This did
not justify the “wide-ranging psychiatric or neurological examinations” nor “the broad internal
medicine examination” ordered. Id. at 120-21 & 121 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 theory of the case.”).
Defendants have failed to show “good cause” to compel a blood draw to conduct WES
testing on X.S.F. The Franco factors weigh against a finding of good cause: genetic information
Page 10 – OPINION AND ORDER
has already been examined through chromosomal microarray testing, and the other tests
performed indicate that WES would not reveal any additional relevant genetic conditions, given
the strength of plaintiff’s evidence of hypoxia as a likely cause of X.S.F’s injuries.
The Court finds Dr. Ward’s vague testimony regarding a possible, though unidentified,
genetic cause of X.S.F.’s condition particularly troubling, and finds that such testimony does not
support defendants’ “good cause” argument. At least one court, in a medical malpractice action
concerning an infant’s brain damage, has balked at ordering sweeping genetic testing to search
for an unspecified genetic cause. See Rogers-Duell, 974 N.Y.S. 2d at 775. Where courts have
ordered genetic testing, the moving parties have specified particular conditions that they believe
underlie the controverted injuries and that testing would confirm or deny. See, e.g., Cruz v.
Super. Ct., 121 Cal. App. 4th 646, 648-49 (2004) (ordering blood draw and genetic testing to
ascertain whether “genetic alterations in blood clotting factors” may have caused or contributed
to the child’s brain injuries); Harris v. Mercy Hosp., 231 Ill. App. 3d 105, 106 (1992) (holding
that district court did not abuse its discretion in ordering a blood draw to determine if a specific
genetic condition, Angelman Syndrome, caused the child’s brain damage); Kaous v. Lutheran
Med. Ctr., 30 N.Y.S.3d 663, 665 (App. Div. 2016) (ordering genetic testing to confirm diagnosis
of Fraser Syndrome as cause of infant’s brain damage); Kriloff v. Providence Health & Servs.,
No. 14CV11115 (Or. Multnomah Cty. Cir. Ct. Jan 12, 2016) (ordering genetic testing to test for
Nance-Horan Syndrome and Warburg Micro Syndrome, which only WES could detect).7 But
see Cutting v. United States, No. 07-CV-02053-PAB-MEH, 2008 WL 5064267, at *1 (D. Colo.
Nov. 24, 2008) (ordering genetic testing to determine whether allegedly negligent medical care
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 order
compelling genetic testing).
Page 11 – OPINION AND ORDER
during delivery resulted in infant’s brain injury, especially where independent medical
examination of the infant was already scheduled: “this is a good faith dispute that supports the
requested, minimally invasive, one-time blood and urine draw at the time of the [independent
medical examination]”).8
Other considerations weigh against a finding of “good cause.” Dr. Raff’s testimony
regarding the reliability and appropriateness of WES is more persuasive than Dr. Ward’s. Dr.
Raff testifies that WES is “new,” “investigational,” and “experimental,” Pl.’s Resp. (Docket No.
39), Ex. 2, Raff Decl. ¶ 8, and that it is not considered standard-of-care genetic testing, id. ¶ 9.
The genetic testing already done buttresses this testimony. Although Dr. Ward testifies that he
would “advise” parties to conduct WES, Ward Decl. (Docket No. 34) ¶ 8, and describes its
“value,” id. ¶ 9, unlike Dr. Raff he does not state whether it is routinely administered or is the
standard of care; this contrasts with already-performed chromosomal array testing, which Dr.
Ward himself specifically says is “first line” testing and is recommended by the American
8
The other cases defendants cite regarding good cause for ordering blood draws from minors are
inapposite. Two of those cases consider blood draws to establish citizenship, and do not
consider broader genetic testing. See Scharf v. U.S. Att’y Gen., 597 F.2d 1240, 1242 (9th Cir.
1979); Fong Sik Leung v. Dulles, 226 F.2d 74, 75 (9th Cir. 1955). Another considered a blood
draw to perform chromosomal analysis where the sample from an earlier blood draw had spoiled.
Otis v. Hyde Hosp. Ass’n, 520 N.Y.S. 2d 884, 885 (App. Div. 1987). And in another the
appellate court found that the district court abused its discretion in ordering a blood draw for
genetic testing, because good cause did not exist where defendants, in support of their motion to
compel, relied on the conclusory and “bare assertion” that “the relationship between genetic
disturbances and brain damage is well documented and commonly accepted.” Thompson v.
Palos Cmty. Hosp., 254 Ill. App. 3d 836, 841 (1993) (quotation omitted). The parties also cite an
Oregon Circuit Court case denying a motion to compel genetic testing, Cloutier v. St. Anthony
Hosp., No. CV150474 (Or. Umatilla Cty. Cir. Ct. July 26, 2016); however, this is a two-page
order issued without explaining its reasoning, and so does not lend any support to the parties’
arguments.
Page 12 – OPINION AND ORDER
Academy of Pediatrics, id. ¶ 7.
The Court finds Dr. Raff’s testimony more specific and
supported by the record.9
Additionally, while a blood draw may not appear particularly burdensome or intrusive,
the Supreme Court and Ninth Circuit have emphasized that any such invasion of the person is a
serious procedure. See Botsford, 141 U.S. at 251 (describing the right to control one’s person as
“sacred”); Fong Sik Leung, 226 F.2d at 77 (repeating Botsford’s “sacred” language); Dulles, 237
F.2d at 499 (describing “the invasion of a physician’s instruments”). That WES may uncover
numerous other and very serious genetic predispositions multiplies the burden on X.S.F., and on
X.S.F.’s family members, who share much of X.S.F.’s genetic material. Pl.’s Resp. (Docket No.
39), Ex. 2, Raff Decl. ¶ 10. This sweeping invasion of personal integrity and privacy strongly
weighs against a finding of good cause. See Schlagenhauf, 379 U.S. at 120 (criticizing proposed
examinations for being excessively “wide-ranging”).
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 thousands of DNA sequence variants, and in order to determine whether a
9
Defendants also cite the deposition of Dr. Joseph Gilhooly, one of X.S.F.’s treating physicians
at Oregon Health & Science University, as evidence that any cause of X.S.F.’s injuries must
have been before birth. O’Kasey Decl. (Docket No. 42), Ex., Gilhooly Dep. But the cited
testimony is vague and inconclusive at best, and does not contradict Dr. Raff’s testimony or
support Dr. Ward’s. Defendants rely on this statement: “if there was an injury, or whatever was
causing his neurologic problems, whether it was from birth defects or lack of oxygen injury,
happened prior to the time around delivery” id. 12:8-11, and “[b]ut for there to already be
abnormalities indicates that something happened before delivery,” id. 14:3-4. Dr. Gilhooly did
not testify that a cause of X.S.F.’s condition was genetic. Moreover, Dr. Gilhooly testified
immediately after the cited portions as to his uncertainty about the cause of X.S.F.’s injuries,
thus undermining whatever support his testimony might give defendants: “I don’t have any
expertise to sort of date those findings and tell you how long it would have taken to see those
changes develop,” id. 14:5-7, and in response to a question regarding whether certain birth
defects were “often genetically caused,” he said “I’m not sure,” id. 14:17-18. Dr. Gilhooly also
testified that he “didn’t have a very high suspicion for a chromosomal abnormality” underlying
X.S.F.’s conditions. Pl.’s Resp. (Docket No. 39), Ex. 6, Gilhooly Dep. 39:5-6.
Page 13 – OPINION AND ORDER
particular variant has caused a potential genetic syndrome, WES “inevitably requires whole
exome sequencing of the parents of the individual as part of the testing process” for comparison.
Id.10 The Court finds this additionally troubling as such a requirement could force further
physical intrusions of X.S.F.’s parents, for instance, and because it could disclose the highly
personal and revealing genetic information of these individuals. Serious legal concerns are also
presented. Under Rule 35 the Court cannot order a blood draw of non-parties, such as X.S.F.’s
parents. Scharf, 597 F.2d at 1243. The Court’s inability to order blood draws of X.S.F.’s
relatives, and defendants’ claim that they would not seek such draws, Defs.’ Reply (Docket No.
41), at 7-8, undercut the purported value of WES, and thus weigh against the Court’s compelling
plaintiff to submit X.S.F. to it.
Thus, defendants have also failed to show that good cause exists to compel plaintiff to
submit X.S.F. to a blood draw for WES genetic testing.
III.
The Parties’ Supplemental Briefing
The parties’ supplemental briefing does not alter the Court’s foregoing analysis;
specifically, defendants have failed to cite persuasive legal authority regarding the
appropriateness of WES under Rule 35 in these circumstances, or to provide sufficient concrete
detail regarding the genetic conditions in X.S.F. that they seek to identify using WES.11
10
That WES additionally requires testing of family members is supported by the case defendants
rely on in their Supplemental Briefing, Meyers v. Intel Corp., No. CV N11C-07-009 JRJ, 2015
WL 3643470, at *1 (Del. Super. Ct. June 11, 2015), where defendant sought WES testing of the
injured child’s parents in order to establish that a “genetic structure [plaintiff] inherited from his
parents caused his birth defects—not the alleged chemical exposures” at defendant’s facility, as
plaintiffs alleged.
11
Dr. Ward only vaguely answered the Court’s specific question regarding “the frequency that
Dr. Ward does [WES] testing on infants with impairments.” Minute Order (Docket No. 46). Dr.
Ward testifies that:
In recent years, I have performed or requested whole exome sequencing tests at
least a thousand times a year, both in cases in which it is medically indicated due
Page 14 – OPINION AND ORDER
The case defendants have cited regarding WES, Meyers v. Intel Corp., No. CV N11C-07009 JRJ, 2015 WL 3643470 (Del. Super. Ct. June 11, 2015), concerns whether the court had
jurisdiction to order genetic testing of the injured child’s parents (the court concluded that it did
not). This case does not address the issues before this Court. In Meyers, for reasons the court’s
order does not make clear, the plaintiffs did not dispute defendant’s entitlement to genetic testing
of the plaintiff child. Id. at *1.12 Other cases defendants cite are not helpful; they were either
already cited to the Court and concern testing to confirm or rule out specific syndromes (unlike
the broad search defendants propose here), or contain extremely brief and uninformative
analyses.13 Thus, the Court finds no authority defendants have identified, nor any the Court has
been able to locate in its own research, that justifies genetic testing of the scope involved with
WES where, as here, a defendant has not specified a particular genetic condition to identify and
confirm.
Dr. Ward testifies, “[b]ased upon [his] review of the medical records, [his] education,
training, and medical study,” that there is “a reasonable certainty that X.S.F.’s medical
[conditions] are not due to a birth injury,” but rather, that there is a “a medical probab[i]lity that
X.S.F[.] has an as-yet undiagnosed genetic syndrome.” Suppl. Ward Decl. (Docket No. 49) ¶ 3
to a child’s presentation at birth and in situations in which the other types of
genetic testing have not been diagnostic of potential syndromes.
Suppl. Ward Decl. (Docket No. 49) ¶ 2.
12
In Meyers, the court, in concluding it would not order genetic testing of the parents, cited
defendant Intel’s concession that there was “at least a 35% probability” that the genetic testing
would identify a genetic cause for the child’s birth defects. 2015 WL 3643470, at *3. The
Meyers court criticized this as a “low probability of success” that weighed against ordering the
genetic testing. Id.
13
These cases are: Kaous v. Lutheran Medical Center, 30 N.Y.S.3d 663 (App. Div. 2016);
McVay v. Johns Hopkins Hospital, No. 24-C-14-005568, 2015 WL 10642695 (Md. Cir. Ct. Nov.
9, 2015); Bennett v. Fieser, No. 93-1004-MLB, 1994 WL 542089 (D. Kan. Feb. 25, 1994);
Dodd-Anderson v. Stevens, No. 92-1015-MLB, 1993 WL 273373 (D. Kan. May 4, 1993); and
Harris v. Mercy Hospital, 231 Ill. App. 3d 105 (1992).
Page 15 – OPINION AND ORDER
(emphases added). However, Dr. Ward does not provide specific evidence for these opinions.
Likewise, Dr. Raff testifies in his supplemental briefing that the “likelihood of a genetic
diagnosis that includes X.S.F.’s brain injuries is highly remote.” Pl.’s Reply to Defs.’ Suppl. Br.
(Docket No. 50), Ex. 2, Raff Decl. ¶ 4 (emphasis added). This conclusion lacks supporting
evidence, and at most simply contradicts Dr. Ward’s conclusions. Neither expert opinion is
helpful in providing the specifics the Court requested.
In response to the Court’s request that defendants identify specific genetic conditions that
WES testing would reveal given X.S.F.’s symptoms, Dr. Ward submits:
[T]here are over 1,300 diseases associated with neonatal seizures that can be
detected using whole exome sequencing. There are hundreds of conditions that
can be diagnosed using exome sequencing which can have hypospadias, anal
atresia,14 seizures, and intrauterine growth restriction15 . . . . Examples include:
Contiguous or single gene disruptions on chromosome 13 (particularly
13q33.2qter)
Familial hypospadias (MAMLD1 gene)
VACTERL association (HOXD13 gene)
Suppl. Ward. Decl. (Docket No. 49) ¶ 3 (footnotes added).
The Court finds this cursory
explanation unpersuasive and deficient as a response to the concerns the Court raised at oral
argument and in its Minute Order (Docket No. 46).
The Court is not satisfied that these
“conditions” correspond to X.S.F.’s symptoms. Although Dr. Ward specifically denies that
WES constitutes a “fishing expedition,” defendants’ submissions, especially in light of the
serious concerns the Court expressed regarding defendants’ apparent lack of specificity,
14
“[C]ongenital absence of an anal opening due to the persistence of epithelial plug (persistence
of the anal membrane) or to complete absence of the anal canal.” Anal atresia, Stedman’s
Medical Dictionary 83510 (2014).
15
“[F]etal weight ≤5th percentile for gestational age.” Fetal growth restriction, Stedman’s
Medical Dictionary 777520 (2014) (synonymous with “intrauterine growth retardation”); see
also 2 American Law of Medical Malpractice § 13:12 (2016) (discussing “symmetric intrauterine
growth restriction” and “asymmetric growth retardation”).
Page 16 – OPINION AND ORDER
reinforce plaintiff’s argument that defendants’ Motions may well amount to little more than such
an expedition.
Dr. Raff’s reply testimony further exposes the deficiencies in Dr. Ward’s testimony. Dr.
Raff testifies that the first of Dr. Ward’s listed genetic conditions, disruptions on chromosome
13, would in the “vast majority” of cases have been diagnosed by the already-conducted
chromosomal microarray testing. Pl.’s Reply to Defs.’ Suppl. Br. (Docket No. 50), Ex. 2, Raff
Decl. ¶ 4. He also testifies that the second and third listed conditions, as to the MAMLD1 and
HOXD13 genes, are not associated with the brain abnormalities seen in X.S.F.; that the
MAMLD1 genetic condition is not typically associated with anything other than hypospadias;
and that the HOXD13 genetic condition usually presents with digital congenital anomalies,
which X.S.F. lacks. Id. The Court finds that the specificity of Dr. Raff’s rebuttal testimony
makes it more persuasive than Dr. Ward’s testimony, and supports the conclusion that
defendants have not made it sufficiently clear to the Court what they think they will find by
having plaintiff submit X.S.F. to WES testing.
Finally, Dr. Ward testifies that defendants can interpret WES “in a very targeted fashion
so that only conditions relevant to this lawsuit are disclosed. The family does not need to learn
about other genetic conditions that X.S.F. or other family members may carry if they do not want
this information . . . .” Suppl. Ward. Decl. (Docket No. 49) ¶ 4. As plaintiff persuasively argues,
however, this potentially targeted disclosure of information does not satisfy plaintiff’s, or the
Court’s, privacy concerns. Even if this genetic information is kept from X.S.F. and his family
members for the time being, there is an invasion of privacy in the information having been
gathered, and harm in the information simply existing. This information could well be disclosed
against the family’s wishes in the future, for instance, in conjunction with an insurance
Page 17 – OPINION AND ORDER
application, or as the result of a court proceeding or court order, or from a computer hack of
electronic medical records. As Dr. Raff observes,
Such privacy concerns are addressed in the clinical setting by giving patients and
their families the right to refuse whole exome sequencing given the invasive
nature of the data generated. That right should not be discarded in order to pursue
testing that is highly unlikely to provide the information 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 potentially sweeping genetic revelations can successfully be limited
through selective disclosure.
CONCLUSION
For the foregoing reasons, defendants have failed to carry their burden to meet Fed. R.
Civ. P. 35’s “in controversy” and “good cause” requirements with regard to WES testing of
X.S.F. Accordingly, defendants’ Motion to Compel Genetic Testing (Docket No. 33) and
Amended Motion to Compel Genetic Testing (Docket No. 35) are DENIED.
IT IS SO ORDERED.
DATED this 13 date of February2017.
__
______,
/s/ Patricia Sullivan
PATRICIA SULLIVAN
United States Magistrate Judge
Page 18 – OPINION AND ORDER
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