IN RE: Bard Implanted Port Catheter Products Liability Litigation

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WO
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
IN RE: Bard Implanted Port Catheter
Products Liability Litigation
–––––––––––––––––––––––––––––––––
Kimberly Divelbliss,
Individual Plaintiff,
v.
Becton Dickinson and Company, et al.,
Defendants.
MDL No. 3081
No. CV-23-01627-PHX-DGC
ORDER
Ralph Reichle, M.D.
This multidistrict litigation (“MDL”) involves thousands of personal injury cases
related to implanted port catheters (“IPCs” or “ports”) designed, manufactured, and
marketed by Defendants Becton Dickenson and Company, C. R. Bard, Inc., Bard Access
Systems, Inc., and Bard Peripheral Vascular, Inc. (collectively, “Defendants” or “Bard”).
Plaintiff has filed a motion to exclude the expert opinions of Ralph Reichle, M.D.
Doc. 7095. The motion is fully briefed and no party requests oral argument. See
Docs. 7095, 7412, 7668. The Court will grant the motion in part.
I. Background.
An IPC is a medical device surgically implanted under the skin to provide repeated
access to a patient’s vascular system without the need for multiple needlesticks into
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peripheral veins. IPCs are used to deliver chemotherapy and immunotherapy medication,
intravenous fluids, blood transfusions, and parenteral nutrition. IPCs can remain in place
for weeks, months, or even years until treatment is completed.
IPCs consist of a port and a catheter. The port is a small reservoir disc with a self-
sealing silicone center where a needle can be inserted to deliver medication. The port
typically is implanted beneath the chest skin and below the collarbone. Port bodies vary
in shape and size and are made of plastic, silicone, or titanium. The port is attached to a
catheter, which is a thin flexible tube for delivery of the medication to a vein. The catheter
is tunneled under the skin to an insertion point in a central vein. Catheters vary in width
and are made of silicone or polyurethane. IPCs typically are implanted by an interventional
radiologist or a vascular surgeon. A nurse or other medical professional then accesses the
IPC to inject the medication, which flows from the port to the catheter and into the vein.
This MDL involves multiple versions of Bard IPCs, each of which received
premarket clearance from the Food and Drug Administration (“FDA”). Bard IPCs contain
barium sulfate, a radiopaque substance that can be seen on diagnostic imaging such as
X-ray, CT, and MRI scans. Several Bard IPCs are manufactured using polyoxymethylene
(“POM”), an acetal thermoplastic polymer, in the construction of the port. Many Bard
IPCs have a port with raised palpation bumps on the silicone center, which help identify
these IPCs as power-injectable devices.
Each Plaintiff in this MDL had a Bard IPC implanted in his or her body, and claims
it was defective and caused serious injury. Plaintiffs allege that the barium sulfate in the
IPC degrades the mechanical integrity of the catheter, leading to surface irregularities that
cause catheter fracture, infection, and blood clots. Plaintiffs further allege that Bard’s
manufacturing process for the POM-containing IPCs lacks adequate measures to stabilize
the POM to prevent oxidative degradation, which causes cracks, fissures, and other
physical defects in the polymer and increases the risk of fracture, infection, and thrombosis.
Plaintiffs also allege that the palpation bumps on the power-injectable IPCs cause undue
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compression stress on the tissue surrounding the port, leading to ulceration and tissue
necrosis. See Docs. 23, 1889.
Plaintiffs claim that safer alternative designs and manufacturing processes were
available to Bard and that Bard IPCs are more dangerous than other available treatment
options. Plaintiffs assert a host of state law claims, including design and manufacturing
defects, failure to warn, breach of warranty, misrepresentation, concealment, and consumer
fraud and unfair trade practices. See Docs. 23, 1889.
Bard disputes Plaintiffs’ allegations and contends its IPCs are safe and effective and
that the medical community is aware of risks associated with IPCs. Bard further contends
that various factors impact the performance and wear of IPCs, including where the catheter
is inserted and how well the device is maintained by medical professionals and the patient.
See Docs. 23, 2023-1.
Plaintiff Divelbliss brings her lawsuit in this MDL. Doc. 26 (CV-23-01627-PHX-
DGC). On July 13, 2017, Plaintiff had a Bard port implanted. Id. ¶ 53. On December 13,
2019, Plaintiff discovered through an emergency room visit that a piece of the port catheter
had broken off and lodged in her heart. Id. ¶ 62. She underwent emergency surgery to
remove the port. Id. ¶ 63. Plaintiff raises claims typical of this MDL. Id. at 15-29.
Defendants have identified Ralph Reichle, M.D., as a medical expert. Dr. Reichle
is a board-certified interventional radiologist with over 30 years of practice. Doc. 7095-2
at 3. He is certified in Diagnostic Radiology by the American Board of Radiology and
maintains a Certificate in Interventional Radiology from the American Board of Radiology.
Id. Reichle has practiced interventional and diagnostic radiology at Mount Auburn
Hospital since 1994, and was Chief of Interventional Radiology from 2012 through 2023.
Id. Since 1994, Reichle has had a Faculty Academic Appointment at Harvard Medical
School and currently serves as an Assistant Professor of Radiology. Id. He also has held
a faculty appointment at Massachusetts General Hospital since 2007. Id. Plaintiff moves
to exclude Reichle’s opinions under Federal Rule of Evidence 702.
/ / /
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II. Legal Standard.
Rule 702 provides that “[a] witness who is qualified as an expert by knowledge,
skill, experience, training, or education may testify in the form of an opinion” if the
proponent of the expert’s testimony “demonstrates to the court that it is more likely than
not that” (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’s opinion reflects a reliable application of the principles
and methods to the facts of the case.” Fed. R. Evid. 702(a)-(d). The proponent of the
expert testimony must show by a preponderance of the evidence that the testimony satisfies
each of these requirements. Fed. R. Evid. 104(a); Fed. R. Evid. 702 advisory committee’s
note to 2023 amendment (“[T]he rule has been amended to clarify and emphasize that
expert testimony may not be admitted unless the proponent demonstrates to the court that
it is more likely than not that the proffered testimony meets the admissibility requirements
set forth in the rule.”); Engilis v. Monsanto Co., 151 F.4th 1040, 1050 (9th Cir. 2025)
(“Consistent with the 2023 amendment, our precedent establishes that Rule 702 requires a
proponent of expert testimony to demonstrate each of the requirements of Rule 702 by a
preponderance of the evidence.”).
The Court acts as a gatekeeper to ensure that expert testimony satisfies Rule 702.
Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597 (1993). The Court’s task is not
to decide whether the expert is right or wrong, but to ensure the proposed opinions satisfy
Rule 702. Alaska Rent-A-Car, Inc. v. Avis Budget Grp., 738 F.3d 960, 969-70 (9th Cir.
2013); Engilis, 151 F.4th at 1050. If the proponent does not meet its Rule 702 burden, the
expert testimony is not admissible. See Davis v. McKesson Corp., No. CV-18-1157-PHX-
DGC, 2019 WL 3532179, at *3 n.2 (D. Ariz. Aug. 2, 2019) (“[T]he Court may admit expert
opinions only if it can determine, under Rule 104(a), that Plaintiffs have shown each of the
Rule 702 requirements to be satisfied by a preponderance of the evidence.”).
/ / /
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III. Discussion.
Plaintiff moves to exclude several opinions of Reichle.
A. Causation and Defect Opinions.
Plaintiff argues Reichle’s “causation and defect opinions should be excluded
because he did not perform a reliable differential [etiology],” and his literature review
“simply ignored contradictory studies.” Doc. 7095 at 4.1 She refers to Reichle’s opinion
that her catheter fracture was caused by the placement of Vicryl “locking” sutures in the
soft tissue around the catheter, resulting in scar tissue that caused the catheter to kink and
fracture. Id. at 8. Reichle’s defect opinion flows from his causation opinion: because the
catheter fracture was caused by the placement of sutures, the port catheter was not
defective. Id.
Plaintiff argues that although Reichle repeatedly claims to have performed a
differential etiology (Doc. 7095-2 at 2, 5), he did not. Doc. 7095 at 4. “[A] reliable
differential [etiology] may form the basis of an expert’s causation testimony.” Messick v.
Novartis Pharms. Corp., 747 F.3d 1193, 1197 (9th Cir. 2014). The expert “first assumes
the pertinence of all potential causes, then rules out the ones as to which there is no
plausible evidence of causation, and then determines the most likely cause among those
that cannot be excluded.” Wendell v. GlaxoSmithKline LLC, 858 F.3d 1227, 1234 (9th Cir.
2017).
Defendants argue Reichle was not required to perform a differential etiology under
Rule 702. Doc. 7412 at 9. True, Millenkamp v. Davisco Foods Int'l, Inc., 562 F.3d 971,
979 (9th Cir. 2009), but when an expert bases his causation opinion on a differential
etiology, as Reichle clearly does (Doc. 7095-2 at 2), he must rule in potential causes and
rule out those without plausible evidence. Wendell, 858 F.3d at 1234.
Defendants’ cited cases support this distinction. In two of the cases, the expert did
not claim to perform a differential etiology and the courts were not required to decide its
1 Reichle uses the phrase “differential diagnosis” in his report, but the Court will use the
phrase “differential etiology,” which more accurately describes a search for the cause of a
medical condition. See Engilis, 151 F.4th at 1044 n.1.
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sufficiency. See Millenkamp, 562 F.3d at 979 (“Dr. Kertz did not purport to employ
differential [etiology.]”); Parenti v. Cnty. of Monterey, No. 14-CV-05481-BLF, 2017 WL
1709349, at *3 (N.D. Cal. May 3, 2017) (“Dr. Sheridan’s report does not indicate that he
utilized differential [etiology] methodology[.]”). Parenti did acknowledge, however, that
when an expert does claim to have performed a differential etiology, he must “consider
alternate causes.” 2017 WL 1709349, at *3 (explaining the Ninth Circuit has affirmed
decisions “excluding expert opinions that expressly relied on differential [etiology] but
failed to consider alternate causes.” (citations omitted)).
Defendants cite a third case for the proposition that “when a doctor offers a
reasonable medical opinion, grounded in their relevant experience, appropriate analysis,
and in the medical literature, their opinions should not be excluded.” Allen v. Am. Cap.
Ltd., 287 F. Supp. 3d 763, 790 (D. Ariz. 2017). This is an accurate statement, but Reichle
said at least three times that he arrived at his opinion by applying a differential etiology.
See Doc. 7095-2 at 2, 5. In Allen, the expert performed a satisfactory differential etiology
because he “clearly considered, and ruled out” the relevant possible causes. 287 F. Supp.
3d at 790-91.
Plaintiff argues Reichle “did not rule in or rule out multiple, obvious alternative
causes of the catheter fracture, including 1) pinch-off syndrome, 2) flex fatigue, and
3) degradation.” Doc. 7095 at 5. The Court agrees.
Plaintiff contends that “because Dr. Reichle opined that the catheter is in the pinch-
off zone, he must take the analysis a step further and rule out that pinch off occurred in this
case.” Doc. 7668 at 2. Reichle identified pinch-off syndrome as a contributing cause of
Plaintiff’s catheter fracture. See Doc. 7095-32 at 20 (“[T]hat kinking is a result of the
Vicryl suture and the catheter in the pinch-off zone getting stretched and causing this
kink.”), 33-34 (fracture caused in part by “the fact that [the catheter] was placed in the
pinch-off zone”). Defendants contend this is a sufficient treatment of pinch off as a
possible factor in this case, but Reichle never addresses whether pinch off could be the sole
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cause of Plaintiff’s fracture and if not, why not. He therefore fails to rule in or out a possible
alternative explanation for Plaintiff’s injury.
Reichle refers to “flex fatigue” as “repetitive bending, repetitive wear and tear.”
Doc. 7412 at 11. He opines that such repetitive bending of Plaintiff’s catheter was caused
by the sutures. See Docs. 7095-2 at 15-18, 7095-3 at 20. But as with pinch off, Reichle
never addresses whether repetitive bending was itself an independent cause of Plaintiff’s
catheter failure and therefore does not rule in or out a possible cause of her injury.
Defendants concede Reichle did not rule in degradation of the catheter as a possible
cause, but argue he is not qualified to opine on degradation because he is not a materials
scientist. Doc. 7412 at 12. That may be true, but Reichle nonetheless used differential
etiology to opine not only that suturing was the most likely cause of Plaintiff’s fracture,
but also that the catheter was not defective. See Doc. 7095-2 at 18 (“In my opinion, with
a reasonable degree of medical certainty, the Bard port catheter, used to replace the clotted
right subclavian port catheter, fractured due to the use of Vicryl sutures to stitch the soft
tissues around the catheter, and not to any defect in the port catheter.” (emphasis added)).
If Reichle is going to use differential etiology to arrive at an opinion that the catheter
was not defective, he must rule in all possible causes. He cannot ignore a possible cause –
indeed, a cause alleged in this case – simply because he does not have the expertise to
address it. That would be like saying a tire expert opining on the cause of an auto accident
need not address road conditions, driver behavior, weather, alcohol impairment, or a host
of additional possible causes because he is not an expert in any of them. Stated differently,
the central point of differential etiology – identifying and then systematically ruling out
possible causes – would be meaningless if the range of possible causes could be reduced
in every case to the retained expert’s field of expertise. If Defendants were going to retain
experts to apply differential etiology to determine the cause of Plaintiff’s fracture, they
could have used other, complimentary experts to rule out possible causes Reichle cannot
address. But Reichle does not identify any other expert he relied on to exclude degradation
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as a possible cause or to conclude that it is a less likely explanation of Plaintiff’s fracture
than his posited reason. Reichle simply leaves degradation entirely unaddressed.
The Court concludes that Reichle has not performed a reliable differential etiology.
The essence of that analytical approach is to rule in all plausible causes, then rule out those
that provide a less reliable explanation for the injury, thereby arriving at a final cause or
small group of causes which the expert can analyze to arrive at the most likely. “A
causation opinion arrived at by ruling out various possible causes is reliable only if the
expert first ‘ruled in’ only those potential causes that could have produced the injury in
question.” Jensen v. Camco Mfg., LLC, No. CV-23-00266-PHX DGC, 2024 WL 4566781,
at *3 (D. Ariz. Oct. 24, 2024), aff’d, No. 24-7092, 2026 WL 64295 (9th Cir. Jan. 8, 2026).
“The expert must provide reasons for rejecting alternative hypotheses ‘using scientific
methods and procedures’ and the elimination of those hypotheses must be founded on more
than ‘subjective beliefs or unsupported speculation.’” Clausen v. M/V New Carissa, 339
F.3d 1049, 1058 (9th Cir. 2003) (citation omitted). “A district court is justified in excluding
evidence if an expert utterly fails . . . to offer an explanation for why the proffered
alternative cause was ruled out” or why it was not ruled in at the start of the process. Id.
(citation modified).
Reichle failed to address pinch off, repetitive bending, and degradation as possible
causes of Plaintiff’s fracture. His analysis therefore failed to explain why each of them
was a less reliable explanation of Plaintiff’s injury than his espoused cause, Dr.
Richardson’s use of stitches. Although Reichle arguably could have reached his opinion
through a different approach, he did not do so. He used differential etiology, and his failure
to use it accurately renders his resulting opinion unreliable. The Court therefore will
exclude Reichle’s opinion on the cause of the catheter fracture in this case.2
2 Plaintiff additionally challenges Reichle’s causation opinion by arguing he “cherry picked
the literature” to support his opinion that “[t]here is no peer reviewed evidence that Bard
port catheters have a higher rate of fracture and embolization.” Docs. 7095 at 7, 7668 at 5
(quoting Doc. 7095-2 at 19). In light of the Court’s conclusion that his causation opinion
is not reliable, the Court need not address this issue.
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Turning to Reichle’s related defect opinion – that Plaintiff’s catheter fracture was
caused by the sutures and not by any catheter defect – Plaintiff argues that “[b]ecause his
defect opinion flows from the unreliable causation opinions . . . [,] it is also unreliable.”
Doc. 7095 at 8 (citing Doc. 7095-2 at 18). The Court agrees and will exclude his defect
opinion for reasons explained above.
B. Opinions on Sutures and Scar Tissue.
Plaintiff challenges several of Reichle’s opinions regarding the placement and effect
of Plaintiff’s sutures. Id. at 9.3 Plaintiff argues Reichle’s “opinion that Dr. Richardson[]
placed absorbable sutures around the port catheter is contradicted by the evidence” because
Dr. Richardson “testified unequivocally” that his locking stitch “does not contact the
catheter at all,” “only pinches the muscular tissue around the catheter,” “does not go around
the catheter,” and “was ‘nowhere near the fracture site.’” Docs. 7095 at 9, 7668 at 5
(citations omitted). Reichle’s opinion is that Dr. Richardson “placed a Vicryl absorbable
stitch in the soft tissues around the port catheter[.]” Doc. 7095-2 at 15. That opinion is not
inconsistent with Dr. Richardson’s testimony cited by Plaintiff.
Defendants argue there is more than one “plausible interpretation” of Dr.
Richardson’s testimony, and cite to testimony where he explains “the locking part has to
do with to snug the soft tissue around the catheter,” and he can place a stitch “so it encircles
the muscle and gently constricts it around the catheter[.]” Doc. 7412 at 17 (quoting Doc.
7095-17 at 37). Plaintiff contends “encircling muscle around the catheter is not the same
as encircling the catheter itself[.]” Doc. 7668 at 6. On this record, the Court cannot say
Reichle’s opinion is without support. See Doc. 7095-2 at 15. Plaintiff may cross-examine
Reichle if she believes he misrepresents Dr. Richardson’s testimony.
Plaintiff next argues Reichle’s “opinion that absorbable sutures caused scar tissue
is pure speculation with no basis in objective facts.” Doc. 7095 at 9. But during his
deposition, Reichle confirmed his opinion that “indentations” visible on a scan of
3 Plaintiff argues Reichle’s opinions “should all be excluded as the product of unreliable
methodology,” but her arguments challenge the factual basis of Reichle’s opinions and not
his methodology. Doc. 7095 at 9-10. The Court will address the factual basis.
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Plaintiff’s implanted catheter were scar tissue caused by the sutures. Doc. 7095-3 at 25
(“Q. So do you believe that these indentations that you believe are causing constriction are
scar tissue? A. Yes. Because the Vicryl sutures, whenever you put them in, . . . they cause
an inflammatory reaction. And that is going to lead to scar tissue.”).4 He later clarified that
he “cannot actually see scar tissue” on the scan but “can just see the effects of [scar tissue].”
Id. at 28. This observation of Reichle’s, coupled with his clinical experience that “[i]n every
port removal [he has] performed, where the port has been in place for at least a few months
and where Vicryl suture was used at the time of placement, there has been the development
of scar tissue at the site of the absorbed suture” (Doc. 7095-2 at 15), supports his opinion
that Plaintiff’s sutures caused scar tissue. 5 See Elosu v. Middlefork Ranch Inc., 26 F.4th
1017, 1024 (9th Cir. 2022) (“An expert’s specialized knowledge and experience can serve
as the requisite ‘facts or data’ on which they render an opinion.”).
Reichle’s opinion that the sutures and scar tissue “caused catheter constriction and
stress leading to fracture” (Doc. 7095 at 10) is his causation opinion, which is excluded as
discussed above. His more limited statement that sutures and scar tissue “caused catheter
constriction and stress” (id.) is essentially the same causation opinion and is also excluded.
Plaintiff’s final argument that Reichle “ignored years of [Plaintiff’s] normal port
infusion, apparently unimpeded by the constriction he alleges exists” (Doc. 7095 at 10),
relates to his excluded causation opinion and need not be addressed.
IT IS ORDERED Plaintiff’s motion to exclude the opinions of Ralph Reichle,
M.D. (Doc. 7095) is granted in part as set forth above.
Dated this 8th day of July, 2026.
4 Reichle gave this testimony in response to opposing counsel’s questioning, and it was
therefore sufficiently disclosed under the Court’s early instruction. Doc. 114 ¶ II.F.
5 The Court agrees with Plaintiff that Reichle’s experience alone, given the existence of
Plaintiff’s medical records, would not support his case-specific opinion about whether her
sutures caused scar tissue (Doc. 7668 at 6). But Reichle – a radiologist – also testified that
Plaintiff’s scan shows the effects of scar tissue. Doc. 7095-3 at 28. Plaintiff’s counsel did
not ask Reichle to clarify whether scar tissue is ever visible on a scan, or what he meant by
the “effects” of scar tissue. See id.
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