Wood, et al v. Phillips et al
Filing
73
ORDER denying 43 Motion for Summary Judgment. So Ordered by Judge Landya B. McCafferty.(gla)
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW HAMPSHIRE
Celeste Wood and Thomas Wood
v.
Civil No. 13-cv-090-LM
Opinion No. 2015 DNH 099
Medtronic Xomed Inc.
O R D E R
The plaintiff, Celeste Wood, suffers from a condition known
as pseudotumor cerebri (“PC”), which results in elevated
intracranial pressure.
To alleviate her symptoms, Mrs. Wood has
undergone several surgeries to implant devices known as
“shunts,” which are designed to drain fluid away from her brain.
During one of these surgeries, in 2009, Mrs. Wood’s surgeon
implanted a catheter manufactured by the defendant, Medtronic
Xomed Inc. (“Medtronic”).
Later, the catheter broke, and a
piece became lodged in Mrs. Wood’s heart.
Subsequently, Mrs.
Wood required surgery, and she endured a series of infections
and an extended hospital stay.
Mrs. Wood and her husband, Thomas Wood, brought suit
against two medical facilities at which Mrs. Wood was treated,
several of her doctors, and Medtronic.
The Woods have since
dismissed all of the defendants with the exception of Medtronic,
against which they assert claims for strict liability and loss
of consortium.
Medtronic has moved for summary judgment and the
Woods have objected.
The court held a hearing on Medtronic’s
motion on May 11, 2015.
For the reasons that follow, the court
denies the motion for summary judgment.
Background
I.
Statement of Facts1
Mrs. Wood has suffered from PC since 1994.
The disorder is
characterized by intracranial hypertension, which results in
headache and vision loss, among other symptoms.
PC is often
treated by using shunts to divert cerebrospinal fluid (“CSF”)
away from the brain to another part of the body.
A shunt is
typically comprised of a valve with an attached catheter on
either end.
One catheter is surgically placed near the brain to
collect CSF, and the other is placed elsewhere in the body,
often in the abdomen.
The draining of CSF away from the brain
acts to relieve the buildup of pressure within the skull.
Mrs. Wood first underwent surgery to implant a shunt system
in 1998.
Due to ongoing symptoms, the shunt system was modified
in 2000.
Mrs. Wood underwent a further surgery to modify the
shunt system on June 4, 2009.
The purpose of this surgery was
These facts are summarized from the summary judgment
record and are not in dispute.
1
2
to convert Mrs. Wood’s existing shunt system to a so-called
“ventricular-atrial shunt.”
To complete the procedure, Mrs.
Wood’s surgeon attached a catheter manufactured by Medtronic,
and ran the catheter from the existing shunt to Mrs. Wood’s
right atrium, one of the chambers of the heart.
This catheter
was made of silicone, and was part of a batch of Medtronic
catheters bearing the lot number C37608, and the reference
number 43103.
Several months after the surgery, Mrs. Wood experienced
further symptoms, and surgery was scheduled to examine the
modified shunt system.
This surgery occurred on March 4, 2010,
and it determined that the newly-installed catheter had broken
into two pieces.
Mrs. Wood’s surgeon removed a segment
measuring approximately two centimeters, but he could not locate
the remaining portion of the catheter.
Mrs. Wood was transferred to the Dartmouth-Hitchcock
Medical Center in Lebanon, New Hampshire, where she underwent
further surgery.
During this procedure, her surgeons removed a
14-centimeter portion of the catheter, which, after breaking,
had migrated through a valve in Mrs. Wood’s heart from the right
atrium to the right ventricle.
Mrs. Wood underwent yet another
surgery on March 18, 2010, to address ongoing problems related
to the broken catheter.
3
After her release from Dartmouth-Hitchcock, Mrs. Wood
developed an infection in the area of the surgical incisions.
Combating the infection required two surgical procedures and an
extensive antibiotics regimen.
Ultimately, Mrs. Wood was
hospitalized for a total of 28 days, and then suffered a series
of severe rashes requiring extensive dermatological treatment.
II.
The Summary Judgment Record
The Woods allege that the catheter was defectively
manufactured and that Mrs. Wood suffered injury as a result.
The parties have each offered evidence on these issues.
The
Woods proffer the testimony of two witnesses whom they seek to
offer as experts: Dr. Richard Sutton, and Professor John G.
Webster, Ph.D.
Dr. Sutton serves as Acting Chief of the Section of
Infectious Diseases at the Veterans Affairs Connecticut
Healthcare System.
Dr. Sutton proposes to testify regarding the
infection that Mrs. Wood developed following her surgeries.
He
does not, however, offer any testimony regarding the manner in
which the catheter broke, or whether the catheter was
defectively manufactured.
Professor Webster is not a medical doctor, but has a long
background in engineering and fluid mechanics.
Professor
Webster began his career in the 1950s in the aerospace industry,
4
and since 1967 has worked as a professor at the University of
Wisconsin, where he studies and teaches in the field of medical
devices and instrumentation.
He is currently conducting funded
research on the use of shunt systems to drain CSF.
Professor Webster proposes to testify regarding the manner
in which the catheter malfunctioned.
In Professor Webster’s
expert report, he concludes, without a great deal of
elaboration, that the shunt system broke due to “excessive
flexing.”
Separately, in a more detailed declaration, Professor
Webster opines that “more probably than not, the subject
catheter was defective . . . [and] could not withstand normal
flexion stress and separated.”
See Decl. of John G. Webster,
Ph.D. (doc. no. 69-4) ¶ 9.
The Woods have also offered in evidence a declaration by
Mrs. Wood’s surgeon, Dr. Joseph Phillips, who originally
implanted the Medtronic catheter, and who discovered during the
March 2010 exploratory surgery that the catheter had broken.2
In
relevant part, Dr. Phillips states that the catheter was not
abnormally stretched during surgery, and that he is aware of one
other incident involving a different patient in which a
Medtronic catheter similarly malfunctioned.
See Decl. of Joseph
M. Phillips, M.D. (doc. no. 69-5) ¶¶ 4, 6.
2
The Woods do not offer Dr. Phillips as an expert witness.
5
Medtronic has offered two experts of its own: Dr. Michael
Pollay and Dr. Joseph Polak.
Both Drs. Pollay and Polak would
testify regarding whether the catheter was defectively
manufactured.
Each concludes that a malfunction due to a
manufacturing defect is highly improbable, and Dr. Polak
suggests that a more likely cause of the break was an error by
Mrs. Wood’s surgeon in implanting the catheter.
In addition, Medtronic offers the declarations of four of
its employees, each of whom concludes that a manufacturing
defect was highly unlikely.
Jeffrey Bertrand, a Principal
Scientist in Product Development, suggests based on his
assessment of the two broken ends of the catheter that it was
manually torn or cut, and did not fail as a result of normal
stretching or flexing.
Another Principal Scientist in Product
Development, Drew Amery, suggests that the catheter’s silicone
material was strong enough to withstand extreme stretching, and
that therefore a manufacturing defect would have been highly
unlikely to result in a malfunction.
Jason McElroy, a Senior
Principal Quality Engineer, states that the catheter was
manufactured in accordance with company specifications and
passed a quality assurance test.
Finally, Leanne Lintula, a
Product Manager, states that she found no evidence of a
manufacturing defect.
6
Standard of Review
A movant is entitled to summary judgment where he “shows
that there is no genuine dispute as to any material fact and
[that he] is entitled to judgment as a matter of law.”
Fed. R.
Civ. P. 56(a); see also Ponte v. Steelcase Inc., 741 F.3d 310,
319 (1st Cir. 2014).
In reviewing the record, the court
construes all facts and reasonable inferences in the light most
favorable to the nonmovant.
Kelley v. Corr. Med. Servs., Inc.,
707 F.3d 108, 115 (1st Cir. 2013).
Discussion
Medtronic seeks summary judgment on the grounds that: (1)
the expert witnesses offered by the Woods are not qualified
under the standards articulated in Daubert v. Merrell Dow
Pharm., Inc., 509 U.S. 579 (1993); and that (2) even if the
experts were qualified, the Woods have failed to proffer
sufficient evidence to maintain a strict liability claim.
Because it is entitled to judgment on the strict liability
claim, Medtronic suggests, the ancillary loss of consortium
claim must be dismissed as well.
I.
Expert Qualification Under Daubert
The admissibility of expert testimony is governed by
Federal Rule of Evidence 702:
7
A witness who is qualified as an expert by knowledge,
skill, experience, training, or education may testify
in the form of an opinion or otherwise if:
(a)
the expert’s scientific, technical, or other
specialized knowledge will help the trier of fact
to understand the evidence or to determine a fact
in issue;
(b)
the testimony is based on sufficient facts or
data;
(c)
the testimony is the product of reliable
principles and methods; and
(d)
the expert has reliably applied the principles
and methods to the facts of the case.
Fed. R. Evid. 702.
“[T]his rule requires district courts to act
as gatekeepers, ensuring that an expert’s proffered testimony
‘both rests on a reliable foundation and is relevant to the task
at hand.’”
Samaan v. St. Joseph Hosp., 670 F.3d 21, 31 (1st
Cir. 2012) (quoting Daubert, 509 U.S. at 597).
In other words,
in addition to ensuring that the witness has the requisite
expertise, the trial judge must “evaluate an expert’s proposed
testimony for both reliability and relevance prior to admitting
it.”
Ruiz-Troche v. Pepsi Cola of P.R. Bottling Co., 161 F.3d
77, 80 (1st Cir. 1998) (citing Daubert, 509 U.S. at 589-95).
“The requisite review for reliability includes
consideration of several factors: the verifiability of the
expert’s theory or technique, the error rate inherent therein,
whether the theory or technique has been published and/or
8
subjected to peer review, and its level of acceptance within the
scientific community.”
Ruiz-Troche, 161 F.3d at 80-81 (1st Cir.
1998) (citing Daubert, 509 U.S. at 593-95).
These factors do
not amount to a “definitive checklist or test,” but they do
“form the basis for a flexible inquiry into the overall
reliability of a proffered expert’s methodology.”
Ruiz-Troche,
161 F.3d at 81 (citations omitted) (internal quotation marks
omitted).
The relevancy requirement “seeks to ensure that there is an
adequate fit between the expert’s methods and his conclusions.”
Samaan, 670 F.3d at 32 (citing Daubert, 509 U.S. at 591).
This
“fit requirement refers to the necessity of a connection between
the expert’s testimony and the facts of the case.”
Grimes v.
Hoffmann-LaRoche, Inc., 907 F. Supp. 33, 35 (D.N.H. 1995).
“Thus, the results of a scientifically reliable experiment or
study will fail Daubert’s fit requirement and be excluded unless
the results can be linked through scientifically reliable means
to the expert opinion it purports to support.”
Id.
“The Daubert regime can play a role during the summary
judgment phase of civil litigation.
If proffered expert
testimony fails to cross Daubert’s threshold for admissibility,
a district court may exclude that evidence from consideration
when passing upon a motion for summary judgment.”
9
Cortes-
Irizarry v. Corp. Insular de Seguros, 111 F.3d 184, 188 (1st
Cir. 1997).
Nevertheless, the First Circuit has urged a
cautious approach:
The fact that Daubert can be used in connection with
summary judgment motions does not mean that it should
be used profligately. A trial setting normally will
provide the best operating environment for the triage
which Daubert demands. Voir dire is an extremely
helpful device in evaluating proffered expert
testimony and this device is not readily available in
the course of summary judgment proceedings. Moreover,
given the complex factual inquiry required by Daubert,
courts will be hard-pressed in all but the most
clearcut cases to gauge the reliability of expert
proof on a truncated record. Because the summary
judgment process does not conform well to the
discipline that Daubert imposes, the Daubert regime
should be employed only with great care and
circumspection at the summary judgment stage.
We conclude, therefore, that at the junction where
Daubert intersects with summary judgment practice,
Daubert is accessible, but courts must be cautious except when defects are obvious on the face of a
proffer - not to exclude debatable scientific evidence
without affording the proponent of the evidence
adequate opportunity to defend its admissibility.
Id. (citations omitted).
Medtronic contends that both of the Woods’ proffered expert
witnesses, Dr. Sutton and Professor Webster, are subject to
exclusion under Daubert.
A.
Dr. Richard Sutton
Medtronic seeks to exclude Dr. Sutton’s testimony on the
grounds that it does not meet the relevancy, or “fit”
10
requirement under Daubert.
Based on the record, it appears that
Dr. Sutton’s testimony would be confined solely to the manner in
which Mrs. Wood acquired the bacterial infection that required
her extended hospital stay.
Dr. Sutton would opine that the
infection resulted from Mrs. Wood’s surgery on March 18, 2010,
which was made necessary by complications resulting from the
broken catheter.
Dr. Sutton apparently will not opine on the
manner in which the catheter malfunctioned, or whether any such
malfunction was the result of a manufacturing defect.
The Woods do not appear to dispute that Dr. Sutton’s
testimony is irrelevant to the issue raised in Medtronic’s
motion for summary judgment: whether there is adequate evidence
that the catheter was defectively manufactured.
Dr. Sutton’s
testimony is relevant, however, to causation and damages should
these proceedings reach those issues.
See Pridham v. Cash &
Carry Bldg. Ctr., Inc., 116 N.H. 292, 297 (1976) (recognizing
that a tortfeasor is liable for damages resulting from
negligently-performed medical services that are necessitated by
the tortfeasor’s original act of negligence).
Thus, the court
will not consider Dr. Sutton’s testimony for purposes of the
motion for summary judgment, but declines to eliminate him as a
prospective expert witness at this early juncture.
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B.
Professor John Webster, Ph.D.
Medtronic challenges Professor Webster’s testimony on the
grounds that Professor Webster is unqualified, and that his
opinions are unreliable and do not meet the relevancy (or fit)
requirements under Daubert.
The court will consider each
challenge in turn.
i.
Qualifications
To testify as an expert, a witness must be qualified by
virtue of his “knowledge, skill, experience, training, or
education . . . .”
Fed. R. Evid. 702.
The district courts are
afforded a measure of discretion in qualifying expert witnesses,
and the First Circuit has recognized that not all experts will
be “blue-ribbon practitioner[s].”
United States v. Mahone, 453
F.3d 68, 71 (1st Cir. 2006).
Medtronic contends that Professor Webster is unqualified to
serve as an expert witness in this case because, among other
reasons, he is not a medical doctor and has no experience with
the surgical implantation of catheters.
What is more, Medtronic
contends, Professor Webster’s training was largely in the field
of electrical engineering.
All of this is true.
Nevertheless, a review of Professor
Webster’s qualifications reveals that he has spent several
12
decades studying and designing medical devices, including
shunts.
He also has extensive experience in the field of fluid
mechanics, and he is presently working on funded research into
the use of shunts to divert CSF and relieve intracranial
pressure.
Professor Webster’s curriculum vitae contains many
examples of his work (past and present) on topics directly
relevant to the issues in this case.
At this preliminary stage
of the case, Professor Webster appears eminently qualified to
opine on the proper manufacture and use of shunts and catheters,
and on the manner in which the catheter in this case
malfunctioned.
For this reason, the court declines to enter
summary judgment for Medtronic on grounds that Professor Webster
is unqualified to serve as an expert witness.
ii.
Reliability
Medtronic argues that Professor Webster’s opinion that the
catheter was defective is unreliable because he did not
adequately describe the methodology that he used to arrive at
this conclusion.
See Ruiz-Troche, 161 F.3d at 80-81 (describing
that an expert’s theory or technique should be, inter alia,
verifiable and subjected to peer review).
Based on Professor
Webster’s expert report and his declaration, it appears that he
13
analyzed the catheter by taking pictures of it with a cameraenabled microscope.3
The subject on which Professor Webster proposes to testify
is the manner in which the catheter broke while inside of Mrs.
Wood’s body.
To the court, a careful examination of the
catheter by a qualified expert seems to be a reasonable
methodology to use in order to arrive at a conclusion as to the
cause of the malfunction.
See id. at 85 (“As long as an
expert’s scientific testimony rests upon good grounds, based on
what is known, it should be tested by the adversary process
. . . rather than excluded from jurors’ scrutiny . . . .”)
(citations omitted) (internal quotation marks omitted).
Indeed,
in his declaration, Professor Webster explains that despite
several decades of relevant experience, he is unaware of any
test other than visual examination that would be useful in
determining the cause of a catheter’s failure.
For these
reasons, the court finds that, for purposes of summary judgment,
Professor Webster’s testimony meets the reliability requirements
under Daubert.
These pictures accompanied Professor Webster’s expert
report.
3
14
iii. Relevancy (Fit)
Finally, Medtronic suggests that Professor Webster’s
testimony is inadmissible under Daubert because he does not
adequately explain how his theory that the catheter broke due to
“excessive flexing” is related to a purported manufacturing
defect.
Of the three Daubert grounds on which Medtronic
challenges Professor Webster’s testimony (qualifications,
reliability, and relevancy), this is the closest call.
Ultimately, the question before the court is whether there
exist genuine issues of material fact with regard to the manner
in which the catheter malfunctioned.
The Woods suggest that the
malfunction was due to a manufacturing defect.
Medtronic denies
this allegation, and suggests that the malfunction must have
been due to an error by Mrs. Wood’s surgeon.
Professor
Webster’s testimony pertains directly to this key issue.
In his declaration, Professor Webster opines that the
catheter was defective because of the shape and texture of the
edge of the catheter at the point of the breakage.
According to
Professor Webster, the shape and texture indicated that the
catheter was subjected to more stress than it could withstand,
which caused it to break while inside of Mrs. Wood’s body.
While it would have been preferable for Professor Webster
to more fully explain his conclusion that a manufacturing defect
15
led to the catheter’s failure, the court is mindful that, at the
summary judgment stage, Professor Webster has not yet had an
opportunity to fully explain the methodology underlying his
conclusions.
This factor counsels against prematurely
discounting his testimony.
Cortes-Irizarry, 111 F.3d at 188.
Thus, for summary judgment purposes, the court finds that
Professor Webster’s testimony meets the Daubert relevancy
requirements.
C.
Conclusion
For the reasons described, the court declines to grant
summary judgment to Medtronic on the grounds that the Woods’
proffered expert witnesses are unqualified under the standards
articulated in Daubert.
To be clear, however, this order should
not be construed as certifying Dr. Sutton and Professor Webster
as expert witnesses.
Medtronic may, through motions in limine,
seek to exclude their testimony in later proceedings.
II.
Strict Liability and Loss of Consortium
Medtronic maintains that even if the court were to admit
the Woods’ proffered expert testimony in full, the Woods have
nonetheless failed to adequately allege a strict liability
claim.
Because a loss of consortium claim is ancillary to the
underlying tort claim, Medtronic argues that it is entitled to
16
summary judgment on both claims.
See Guilfoy v. United Servs.
Auto. Ass’n, 153 N.H. 461, 463 (2006) (“It is well settled that
loss of consortium is a consequential damage derivative of the
underlying bodily injury claim.”).
“Under the doctrine of strict liability, ‘one who sells any
product in a defective condition unreasonably dangerous to the
user or consumer . . . is subject to liability for physical harm
thereby caused to the ultimate user or consumer.’”
Kelleher v.
Marvin Lumber & Cedar Co., 152 N.H. 813, 824 (2006) (quoting
Restatement (Second) of Torts § 402A(1) (further citations
omitted)).
A strict liability claim may allege that the product
in question was defectively designed, that it lacked adequate
warnings to consumers, or, as here, that it was defectively
manufactured.
See Gianitsis v. Am. Brands, Inc., 685 F. Supp.
853, 856 (D.N.H. 1988).
Medtronic takes the position that there is no evidence in
the record that the catheter was defectively manufactured.
Medtronic points to the evidence offered by Drs. Pollay and
Polak that a manufacturing defect was a highly improbable cause
of the catheter’s failure, and also points to the declarations
offered by the four Medtronic employees which reach similar
conclusions.
17
In opposing summary judgment, the Woods point to Professor
Webster’s expert report, in which he concludes that the catheter
broke due to “excessive flexing,” as well as to his declaration,
in which he states his opinion that the catheter was defective
because it “could not withstand normal flexion stress.”4
The
Woods also point to Dr. Phillips’s declaration, in which he
offers evidence that the catheter was not abnormally stretched
during surgery, and that another one of his patients experienced
the similar malfunction of a Medtronic catheter.
The court finds that the evidence offered by Professor
Webster and Dr. Phillips is adequate to raise a genuine issue of
material fact regarding the cause of the catheter’s malfunction.
As noted above, it would have been preferable for Professor
Medtronic urges the court to disregard Professor Webster’s
declaration on the grounds that it is inconsistent with his
expert report. See Colantuoni v. Alfred Calcagni & Sons, Inc.,
44 F.3d 1, 4-5 (1st Cir. 1994) (explaining what has become known
as the “sham affidavit rule” by noting that “[w]hen an
interested witness has given clear answers to unambiguous
questions, he cannot create a conflict and resist summary
judgment with an affidavit that is clearly contradictory, but
does not give a satisfactory explanation of why the testimony is
changed”). The court has carefully reviewed Professor Webster’s
expert report and his declaration, and finds that they are not
materially inconsistent. In relevant part, Professor Webster’s
declaration states that the catheter broke because it was
subjected to “more flexion than it could withstand,” and that
the catheter “could not withstand normal flexion stress.” The
court does not view these statements as fundamentally
inconsistent with Professor Webster’s expert report in which he
states that the catheter malfunctioned due to “excessive
flexing.”
4
18
Webster to more thoroughly articulate the basis for his
conclusion that, based on his visual examination of the
catheter, a manufacturing defect was to blame for its failure.
The court finds, however, that Professor Webster’s testimony
credibly calls into question the conclusion offered by Medtronic
that its catheter was highly unlikely to have a manufacturing
defect.
The court’s conclusion that there exist genuine issues of
material fact regarding the cause of the catheter’s malfunction
is also supported by Dr. Phillips’s declaration.
There, Dr.
Phillips states that he is “quite sure” that the catheter was
not abnormally stretched during the implantation procedure, and
he notes a similar occurrence involving the spontaneous
fracturing of a Medtronic catheter in another one of his
patients.
At this stage, the weight of the evidence likely favors
Medtronic’s position that the catheter failed for some reason
other than a manufacturing defect.
Nevertheless, viewing the
record in the light most favorable to the Woods, as the court
must, Kelley, 707 F.3d at 115, the evidence that Professor
Webster and Dr. Phillips offer is adequate to raise a genuine
dispute of material fact regarding the cause of the catheter’s
malfunction.
See Noonan v. Staples, Inc., 556 F.3d 20, 25 (1st
19
Cir. 2009) (quoting Anderson v. Liberty Lobby, Inc., 477 U.S.
242, 250 (1986) (further citations omitted)) (“[T]he court’s
task is not ‘to weigh the evidence and determine the truth of
the matter but to determine whether there is a genuine issue for
trial.’”).
Thus, Medtronic is not entitled to summary judgment.
Conclusion
For the foregoing reasons, Medtronic’s motion for summary
judgment (doc. no. 43) is denied.
SO ORDERED.
__________________________
Landya McCafferty
United States District Judge
May 14, 2015
cc:
Kenneth M. Brown, Esq.
Kevin M. Fitzgerald, Esq.
Melissa M. Hanlon, Esq.
Bradley D. Holt, Esq.
Michael P. Lehman, Esq.
Morgan C. Nighan, Esq.
Michael A. Pignatelli, Esq.
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