Costa et al v. Johnson & Johnson et al
Filing
46
MEMORANDUM AND ORDER: Defendants' Motion for Summary Judgment, ECF No. 38 , is GRANTED as to Counts II, IV and V of the Complaint and DENIED as to Counts I, III, VI, and VII of the Complaint. So Ordered by District Judge William E. Smith on 3/28/2023. (Urizandi, Nissheneyra)
Case 1:17-cv-00452-WES-PAS Document 46 Filed 03/28/23 Page 1 of 20 PageID #: 1883
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF RHODE ISLAND
___________________________________
)
)
)
)
Plaintiffs,
)
)
v.
)
)
JOHNSON & JOHNSON and
)
ETHICON, INC.,
)
)
Defendants.
)
___________________________________)
BIANCA COSTA and
JOHN COSTA,
C.A. No. 17-452 WES
MEMORANDUM AND ORDER
WILLIAM E. SMITH, District Judge.
Before
the
Court
is
Defendants
Johnson
&
Johnson’s
and
Ethicon, Inc.’s Motion for Summary Judgment (“Defs.’ MSJ”), ECF
No. 38. For the reasons that follow, Defendants’ Motion is GRANTED
as to Counts II, IV and V of the Complaint, ECF No. 1, and DENIED
as to Counts I, III, VI, and VII.
I.
Background
A. Facts
The following facts are either undisputed or viewed in the
light most favorable to Plaintiffs.
See Cadle Co. v. Hayes, 116
F.3d 957, 959 (1st Cir. 1997).
On October 10, 2014, Plaintiff Bianca Costa underwent surgery
at Women and Infants Hospital Division of Gynecology in Providence,
Case 1:17-cv-00452-WES-PAS Document 46 Filed 03/28/23 Page 2 of 20 PageID #: 1884
Rhode Island, performed by Dr. Kyle Wohlrab.
Defs.’ Statement
Undisp. Facts (“Defs.’ SUF”) ¶¶ 1, 2 , ECF No. 39; Pls.’ Statement
Undisp. Facts (“Pls.’ SUF”) ¶ 7, ECF No. 43.
The surgery was to
correct stress urinary incontinence and uterovaginal prolapse and
involved implantation of TVT-Exact, a pelvic mesh manufactured by
Defendants.
Defs.’ SUF ¶ 1; Pls.’ SUF ¶ 7.
Dr. Wohlrab was aware
of Ms. Costa’s comorbidities at the time of the surgery, which
included a stroke in 2005, histories of deep vein thrombosis and
hypertension,
systemic
lupus
erythematosus,
and
chronic
immunosuppression due to the use of Prednisone and Imuran to treat
the
lupus.
He
concluded
that
there
were
no
absolute
contraindications for Ms. Costa to have the TVT-Exact implanted.
Defs.’ SUF ¶ 4; Pls.’ SUF ¶¶ 2, 3.
Dr. Wohlrab had knowledge of the risks associated with the
TVT-Exact from the Instructions for Use (“IFU”) that Defendants
provided with the product.
Defs.’ SUF ¶ 5; Pls.’ SUF ¶ 4.
IFU listed the following risks:
The
retropubic bleeding; dysuria;
detrusor instability; punctures or lacerations of vessels, nerves,
bladder,
or
irritation
bowel
at
the
that
wound
may
require
site;
surgical
extrusion;
repair;
erosion;
local
fistula
formation; inflammation; potentiation of existing infection; and
temporary or permanent lower urinary tract infection (“UTI”).
Pls.’ SUF ¶ 4.
not
listed
in
Dr. Wohlrab was also aware of additional risks,
the
IFU,
from
his
2
own
training
and
research,
Case 1:17-cv-00452-WES-PAS Document 46 Filed 03/28/23 Page 3 of 20 PageID #: 1885
including:
acute or chronic pain with intercourse; acute or
chronic pain; vaginal scarring; infection; urinary problems such
as
urinary
obstruction,
frequency,
or
urgency,
incontinence;
organ
dyspareunia,
or
nerve
retention,
damage;
wound
complications; neuromuscular problems in the pelvic floor muscles,
lower extremities, or abdominal area; the need for additional
surgeries to treat an adverse event; recurrent failure of the TVT
or mesh; foreign body response; and contraction or shrinkage of
the tissues.
Defs.’ SUF ¶¶ 5, 7.
In 2015, Defendants revised the IFU to add additional risks
that were not included in the previous version.
Pls.’ SUF ¶ 23.
These added risks are: foreign body response; acute and/or chronic
pain; voiding dysfunction; pain with intercourse which, in some
patients, may not resolve; neuromuscular problems including acute
and/or chronic pain in the groin, thigh, leg, pelvic, and/or
abdominal area; recurrence of incontinence; bleeding, including
hemorrhage or hematoma; need for one or more revision surgeries;
seroma; urge incontinence; urinary frequency; urinary retention;
adhesion formation; atypical vaginal discharge; pain or discomfort
to patient’s partner during intercourse from exposed mesh; and
death.
See Pls.’ SUF ¶ 24.
Following
her
surgery
in
2014,
Ms.
Costa
experienced
recurrent UTIs, pelvic pain, painful voiding, dyspareunia, and
incomplete sensation of bladder emptying.
3
Defs.’ SUF ¶ 12; see
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Pls.’ SUF ¶ 11.
Cystoscopies performed in 2016 revealed foreign
material that eroded into the urethra and narrowing of the lumen.
Pls.’ SUF ¶ 12.
On June 13, 2016, Ms. Costa underwent surgery to
remove the TVT-Exact and repair the urethra.
Pls.’ SUF ¶ 15.
experience
Defs.’ SUF ¶ 11;
Following this surgery, Ms. Costa continued to
urinary
incontinence
urethrovaginal fistula.
with
urethral
erosion
and
Defs.’ SUF ¶ 12; Pls.’ SUF ¶ 16.
a
Ms.
Costa underwent a third surgery on May 30, 2017, after a small
fistula was discovered mid-urethra.
On
October
19,
2018,
Ms.
Pls.’ SUF ¶ 20.
Costa
underwent
an
additional
procedure to have an autologous rectus fascial sling placed at the
bladder neck to address recurrent urinary stress incontinence.
Pls.’ SUF ¶ 22.
According to the doctor’s notes in January 2019,
the sling worked well for forty-five days before Ms. Costa’s
original stress incontinence returned.
Pls.’ SUF ¶ 21.
As a result of the implantation of the TVT-Exact and its
ensuing
complications,
Ms.
Costa
continues
to
suffer
from
incontinence, UTIs, pain in the pelvis and abdomen, and permanent
damage to the urethra.
Defs.’ SUF ¶ 12; Pls.’ SUF ¶ 25.
B. Procedural History
Plaintiffs filed this lawsuit on September 29, 2017.
1.
Compl.
On October 23, 2017, the action was conditionally transferred
to the Southern District of West Virginia pursuant to 28 U.S.C.
§ 1407 to be consolidated with other actions involving common
4
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questions of fact as part of a multi-district litigation (“MDL”)
against Defendants.
5.
Conditional Transfer Order (CTO-235), ECF No.
On June 5, 2020, the action was conditionally remanded to this
Court pursuant to 28 U.S.C. § 1407(a) following the completion of
coordinated or consolidated pretrial proceedings in the Southern
District of West Virginia.
Conditional Remand Order, ECF No. 9.
Following discovery, Defendants filed this Motion for Summary
Judgment.
II.
Defs.’ MSJ 1.
Legal Standard
Summary judgment is appropriate when “there is no genuine
dispute as to any material fact and the movant is entitled to
judgment as a matter of law.”
Fed. R. Civ. P. 56(a).
In deciding
a motion for summary judgment, the Court views the record in the
light
most
favorable
to
the
non-moving
inferences in that party’s favor.
party
and
draws
Cadle Co., 116 F.3d at 959.
all
It
is the Court’s function “to determine whether there is a genuine
issue for trial,” not to weigh evidence or assess credibility.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252 (1986).
The burden is on the movant to demonstrate an “absence of any
genuine issue of material fact.”
Borges ex rel. S.M.B.W. v.
Seranno-Isern, 605 F.3d 1, 5 (1st Cir. 2010) (citing Celotex Corp.
v. Catrett, 477 U.S. 317, 323 (1986)).
this
burden,
the
nonmovant
must
If the movant satisfies
produce
“significant[ly]
probative” evidence “demonstrat[ing] that a trier of fact could
5
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reasonably resolve that issue in her favor.”
Id.
fails to do so, summary judgment is appropriate.
If the nonmovant
Id.
The parties agree that Rhode Island law applies to Plaintiffs’
substantive claims under the most significant relationship test.
See Harodite Indus., Inc. v. Warren Elec. Corp., 24 A.3d 514, 526
(R.I. 2011); Defs.’ Mem. Supp. Mot. Summ. J. (“Defs.’ Mem.”) 3,
ECF No. 38-1; Pls.’ Mem. Supp. Opp’n Defs.’ Mot. Summ. J. (“Pls.’
Opp’n”) 3 n.1, ECF No. 40-1.
III. Discussion
A. Strict Liability
Under Rhode Island law, a plaintiff may pursue a strict
product liability claim under three theories: failure to warn,
design defect, and manufacturing defect.
Castrignano v. E.R.
Squibb & Sons, Inc., 546 A.2d 775, 779 (R.I. 1988); see Guilbeault
v. R.J. Reynolds Tobacco Co., 84 F. Supp. 2d 263 (D.R.I. 2000)
(summarizing Rhode Island law of strict product liability). “If
one of these three types of defects appears in the product and
that defect renders the product unreasonably dangerous in spite of
all
reasonable
care
exercised
by
the
manufacturer is liable for that defect.”
manufacturer,
then
the
Castrignano, 546 A.2d at
779 (citing Ritter v. Narragansett Elec. Co., 283 A.2d 255, 262
6
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(R.I. 1997)).
Here, Plaintiffs pursue claims on the theories of
failure to warn and design defect.1
1. Failure to Warn (Count II)
Under a failure-to-warn theory of strict product liability,
a plaintiff must prove that the failure to warn of the product’s
dangers “that are reasonably foreseeable and knowable at the time
of marketing” “render[ed] the product unreasonably dangerous in
spite of all reasonable care exercised by the manufacturer.”
Castrignano, 546 A.2d at 779, 782.2
“The plaintiff has the burden
of proving a defect in the product and that his or her injury was
proximately caused by this defect.”
Austin v. Lincoln Equip.
Assocs., Inc., 888 F.2d 934, 936 (1st Cir. 1989).
The Rhode Island
Supreme Court has described the standard as “equivalent to the
standard for negligence.”
Castrignano, 546 A.2d at 782; accord
DiPalma v. Westinghouse Elec. Corp., 938 F.2d 1463, 1466 (1st Cir.
Plaintiffs initially asserted a manufacturing defect claim
in their Complaint.
See Compl. Count IV, ¶¶ 58-63.
They have
since opted not to pursue this claim. See Pls.’ Mem. Supp. Opp’n
Defs.’ Mot. Summ. J. (“Pls.’ Opp’n”) 5 n.2, ECF No. 40-1.
In
addition, they have opted to abandon their claim of breach of
express warranty that they initially asserted. See Compl. Count
V, ¶¶ 64-69; Pls.’ Opp’n 20 n.4. Accordingly, Defendants’ Motion
for Summary Judgment is GRANTED as to Counts IV and V of the
Complaint.
1
In addition, a manufacturer has no duty “to warn of dangers
that, given the present state of scientific knowledge, are
unknowable.” Castrignano, 546 A.2d at 779, 782. Here, Defendants
do not contend that the risk complained of by Plaintiffs was
unknowable at the time of the surgery.
2
7
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1991) (“It is clear under Rhode Island law that the duty to warn
. . . is measured, in all respects material to this case, by the
same standard as the duty to warn that is enforceable in a
negligence cause of action.”).
Plaintiffs must establish the
standard of care with expert testimony.
See Mills v. State Sales,
Inc., 824 A.2d 461, 468 (R.I. 2003); Raimbeault v. Takeuchi Mfg.
(U.S.), Ltd., 772 A.2d 1056, 1063 (R.I. 2001).
Defendants
argue
that
the
learned
applies to absolve them of liability.
intermediary
Defs.’ MSJ 4-5.
doctrine
Under the
doctrine, a manufacturer of a medical device can discharge its
liability by providing an adequate warning of the risks of the
device to “prescribing and other health-care providers who are in
a position to reduce the risks of harm in accordance with the
instructions or warnings,” even if the manufacturer did not provide
an adequate warning to the patient directly.
of Torts: Products Liability § 6(d)(1).
this
‘learned
intermediary’
rule
is
Restatement (Third)
“The rationale supporting
that
only
health-care
professionals are in a position to understand the significance of
the risks involved and to assess the relative advantages and
disadvantages . . . .
The duty then devolves on the health-care
provider to supply to the patient such information as is deemed
appropriate under the circumstances so that the patient can make
an informed choice.”
Id. cmt. b.
In addition, if the specific
risk was known to the physician, a manufacturer’s alleged failure
8
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to warn of that risk cannot be considered a defect.
See In re
Zyprexa Products Liab. Litig., 277 F.R.D. 243, 250 (E.D.N.Y. 2011)
aff’d sub nom Greaves v. Eli Lilly & Co., 503 F. App’x 70, 71 (2d
Cir. 2012).
The Rhode Island Supreme Court has not expressly adopted the
learned intermediary doctrine, and Plaintiffs urge the Court to
certify the question to the Rhode Island Supreme Court.
Opp’n 6.
The Court declines this invitation.
Pls.’
“Even in the absence
of controlling precedent, certification would be inappropriate
where state law is sufficiently clear to allow us to predict its
course.”
In re Engage, Inc., 544 F.3d 50, 53 (1st Cir. 2008); see
Hugel v. Milberg, Weiss, Bershad, Hynes & Lerach, LLP, 175 F.3d
14, 18 (1st Cir. 1999) (“[W]hen state law is sufficiently clear to
allow [a federal court] to predict its course, certification is
both inappropriate and an unwarranted burden on the state court.”).
Here, a number of factors counsel in favor of predicting that the
Rhode Island Supreme Court would adopt the learned intermediary
doctrine.
First, the Rhode Island Supreme Court has implicitly
referenced
the
doctrine
when
describing
element of a failure to warn claim.
A.2d 1225, 1227-28 (R.I. 1998).
Supreme
Court
frequently
relies
the
proximate
cause
See Hodges v. Brannon, 707
In addition, the Rhode Island
on
the
Second
and
Third
Restatements of Torts as a basis for the state’s product liability
law.
The learned intermediary doctrine is defined in § 388 of the
9
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Second Restatement, which the Rhode Island Supreme Court has cited
with approval in other contexts.
See Maggi v. De Fusco, 267 A.2d
424, 427 (R.I. 1970) (citing § 388(b)).
defined
in
§ 6
of
the
Third
Restatement
The doctrine is also
of
Torts:
Products
Liability, other provisions of which the Rhode Island Supreme Court
has cited with approval.
See, e.g., Calise v. Hidden Valley Condo
Ass’n, 773 A.2d 834, 846 n.13 (R.I. 2001) (citing Restatement
(Third) Torts).
Thus, the Rhode Island Supreme Court’s treatment
of the Second and Third Restatements leaves this Court with “no
reason to expect Rhode Island, if it were to adopt the learned
intermediary doctrine, to offer an unusual interpretation of it,
thereby rejecting the current edition of the Restatement.”
Hogan
v. Novartis Pharms. Corp., No. 06 Civ. 0260(BMC)(RER), 2011 WL
1533467, at *10 (E.D.N.Y. Apr. 24, 2011).
Finally, the Court
follows the lead of other federal courts that have predicted that
“the Rhode Island Supreme Court would likely adopt the learned
intermediary doctrine.”
Greaves v. Eli Lilly & Co., 503 F. App’x
70, 71 (2d Cir. 2012); see Hogan, 2011 WL 1533467, at *10.
Turning to the merits of the claim, Plaintiffs argue that the
warning provided in the TVT-Exact IFU by Defendants was inadequate
because it (1) failed to contraindicate the use of the device in
patients, like Ms. Costa, with preexisting medical conditions,
specifically a compromised immune system from chronic steroid use
to treat lupus, (2) failed to warn of certain adverse reactions
10
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that were later added to the IFU,3 and (3) failed to warn of the
risk of erosion and degradation of the polypropylene mesh of which
the TVT Exact is constructed.
Pls.’ Opp. 11-12.
Plaintiffs point
to the expert report of Dr. Robert Gutman, Defendants’ expert
witness, to support the suggestion that the complications Ms. Costa
experienced were due to problems with her immune response caused
by immunosuppressant use.
Id. at 10.
Dr. Gutman states in his
report that Ms. Costa’s recurrent UTIs, retention issues, and
urethral erosion following the initial surgery were “unlikely to
be a problem with the sling material/construction or the alleged
defects, and more likely than not to be a problem with her immune
response and poor wound healing with chronic immunosuppressant
use.”
Ex. 7, Case Specific Expert Rep. of Robert E. Gutman, MD,
Mar. 28, 2019, ECF No. 40-7.
As to the first alleged inadequacy –- failure to warn of the
risk of poor wound healing associated with immunosuppression from
chronic steroid use -- Defendants have presented evidence that Dr.
Wohlrab was aware of the specific risk that Plaintiffs complain
of.
In his deposition, Dr. Wohlrab stated generally that Ms.
These risks are acute and/or chronic pain, voiding
dysfunction, pain with intercourse which in some patients may not
resolve, neuromuscular problems including acute and/or chronic
pain in the groin, thigh, leg, pelvic, and/or abdominal area,
recurrence of incontinence, bleeding including hemorrhage or
hematoma, one or more revision surgeries to treat adverse
reactions, and significant dissection to remove the mesh in part
or in whole. Pls.’ Opp’n 11-12.
3
11
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Costa’s preexisting medical conditions “did raise the risk of her
procedure, which we had discussed,” and specifically that he was
aware at the time of the surgery that “[w]ith chronic steroid use,
there is a decrease in overall healing.”
Ex. 5, Wohlrab Dep. at
90:11-22 (“Wohlrab Dep.”), ECF No. 40-6.
Because the risk was
known to the Plaintiff’s physician, the alleged failure to warn of
that risk cannot be considered a defect.
See In re Zyprexa
Products Liab. Litig., 277 F.R.D. at 250.
As to the alleged failure to warn of certain adverse reactions
that were later added to the IFU, Dr. Wohlrab also testified to
his knowledge of these risks.
Wohlrab Dep. at 47:3-51:20.
And,
he specifically testified that he was aware of the risk of erosion
of the mesh, the third inadequacy that Plaintiffs allege.
Id. at
51:15-17.
Finally, Plaintiffs make much of Dr. Wohlrab’s testimony
that, had he been aware of any “absolute contraindications for Ms.
Costa” based on her medical history, he “wouldn’t have done” the
procedure. Wohlrab Dep. at 90:5-21. Plaintiffs have not, however,
demonstrated that an absolute contraindication was present here.
Dr.
Wohlrab
testified
specifically
that
Ms.
Costa’s
medical
history did not make her an inappropriate candidate for the TVT
Exact, see id., and Plaintiffs have not identified any facts or
expert testimony to the contrary.
(plaintiffs
must
establish
the
12
See Mills, 824 A.2d at 468
standard
of
care
with
expert
Case 1:17-cv-00452-WES-PAS Document 46 Filed 03/28/23 Page 13 of 20 PageID #: 1895
testimony).
Therefore, Defendants’ Motion for Summary Judgment is
GRANTED as to Count II of the Complaint.
2. Design Defect (Count III)
A claim for design defect consists of five elements:
(1) that there was a defect in the design or construction
of the product in question; (2) that the defect existed
at the time the product left the hands of * * *
defendant; (3) that the defect rendered the product
unreasonably dangerous, and by unreasonably dangerous it
is meant that there was a strong likelihood of injury to
a user who was unaware of the danger in utilizing the
product in a normal manner; (4) that the product was
being used in a way in which it was intended at the time
of the accident; and (5) that the defect was the
proximate cause of the accident and plaintiff's
injuries.
Raimbeault, 772 A.2d at 1063 (quoting Crawford v. Cooper/T. Smith
Stevedoring Co., 14 F. Supp. 2d 202, 211 (D.R.I. 1998)).
Here,
Defendants
identify
the
fifth
factor
as
where
Plaintiffs’ claim falls short. See Defs.’ Mot. 12-13. A plaintiff
must show not only that the use of the product resulted in injury,
but must also show “the necessary proximate relationship between
. . . the defect and the injury.”
Thomas v. Amway Corp., 488 A.2d
716, 722 (R.I. 1985); see DiPalma, 938 F.2d at 1466 (“absence of
any evidence to support a finding that there was a . . . defect in
the [product], is the exact sort of conjecture and speculation
that the Rhode Island Supreme Court has specifically forbidden
juries to consider in strict liability cases”); Salk v. Alpine Ski
Shop, Inc., 342 A.2d 622, 625 (R.I. 1975) (“mere happening of an
13
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accident”
expert,
does
Dr.
not
establish
proximate
Steven
Berliner,
identified
cause).
a
causal
Plaintiffs’
connection
between the TVT-Exact and Ms. Costa’s injuries in his report.
See
Ex. 5, Berliner Apr. 15, 2019 Rep. 9, ECF No. 39-5 (“Plaintiff’s
injuries would not have occurred but for the TVT Exact mesh
sling.”).
However, Dr. Berliner did not opine as to any defect in
the mesh that caused Ms. Costa’s injuries.
However, Plaintiffs point to the statements of two other
experts
to
establish
this
missing
causal
link.
First,
the
affidavit of Scott Guelcher, Ph.D., identifies the defect in the
mesh.
Dr. Guelcher attested that the material that the mesh is
made out of, polypropylene, reacts upon implantation in the human
body to cause an inflammatory response resulting in oxidation,
chain scission, mesh embrittlement degradation, flaking, pitting,
and cracking.
Ex. 3, Guelcher Aff. ¶¶ 8(b)-(c), ECF No. 40-4.
The defect, therefore, is the material from which the mesh is
constructed.4
The MDL court and others have concluded that, because he is
a chemical engineer and not a medical doctor, “Dr. Guelcher is
simply not qualified to offer opinions on medical complications
that may be caused by polymer degradation.” In re Ethicon, Inc.
Pelvic Repair Sys. Prod. Liab. Litig., MDL No. 2327, 2016 WL
4547055, at *3 (S.D. W. Va. Aug. 31, 2016); see also Salinero v.
Johnson & Johnson, No. 1:18-cv-23643-UU, 2019 WL 7753453, at *15
(S.D. Fla. Sept. 5, 2019) (“Dr. Guelcher is not qualified to opine
about clinical manifestations of the body’s response to implanted
polypropylene mesh.”); Enborg v. Ethicon, Inc., No. 2:20-cv-02477AWI-BAK, 2022 WL 800879, at *5 (E.D. Cal. Mar. 16, 2022) (“[T]he
Court agrees with the finding in Salinero that since Dr. Guelcher
4
14
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Second, Plaintiffs cite the affidavit and report of Dr.
Vladimir Iakovlev, a licensed pathologist.
18.
See Pls.’ Opp’n 17-
Dr. Iakovlev opined that “polypropylene of the mesh device
degraded while in the body of Ms. Costa and that this process
contributed to the development of the mesh related complications,”
causing
“urethral
damage
symptoms for Ms. Costa.”
and
the
associated
de-novo
urinary
Ex. 6, Iakovlev Aff. ¶¶ 11(a), (d), ECF
No. 41.
Taken together, these affidavits establish the defect of the
mesh – the material from which it was constructed – and the causal
connection between that defect and Ms. Costa’s injuries – the
degradation caused urethral damage and urinary symptoms.
Thus,
Plaintiffs have put sufficient facts in dispute as to the proximate
relationship between the defect and the injury to survive summary
judgment on this claim.
Accordingly, Defendants’ Motion for
Summary Judgment is DENIED as to Count III of the Complaint.5
is not a physician, he is not in a position to observe and assess
patient outcomes and that, consequently, his opinions as to patient
complications are not reliable.”). Here, however, Plaintiffs rely
on Dr. Guelcher’s affidavit only for the proposition that
polypropylene reacts upon implantation in the human body and
degrades, not to establish any medical consequences that may arise
from such degradation.
Defendants do not challenge the other four requirements of
a design defect claim.
5
15
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B. Negligence (Count I)
Under Rhode Island law, product liability claims based on
theories
of
strict
liability
and
overlapping standards of proof.
negligence
are
subject
to
See DiPalma, 938 F.2d at 1466
(“It is clear under Rhode Island law that the duty to warn, the
violation of which is actionable by means of the so-called strict
liability cause of action, is measured, in all respects material
to this case, by the same standard as the duty to warn that is
enforceable in a negligence cause of action.”); Raimbeault, 772
A.2d at 1063 (equating standards for negligence and design defect).
Here, because Plaintiffs’ strict liability claim on the theory of
design defect survives summary judgment, as discussed supra, so
too does their negligence claim, and Defendants’ Motion for Summary
Judgment is DENIED as to Count I of the Complaint.
C. Breach of Implied Warranty of Merchantability (Count VI)
Rhode
injuries
Island
based
recognizes
on
breach
a
of
cause
the
of
action
implied
for
personal
warranty
of
merchantability. Castrignano, 546 A.2d at 783. A claim for breach
of the implied warranty of merchantability requires a plaintiff to
demonstrate that the product is defective, that it was in defective
condition at the time it left the hands of the manufacturer, and
that the defect was a proximate cause of the injury.
Dent v. PRRC,
Inc., 184 A.3d 649, 656 (R.I. 2018) (quoting Lariviere v. Dayton
Safety Ladder Co., 525 A.2d 892, 896 (R.I. 1987)).
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1. Notice
Defendants first argue that Plaintiffs’ claim fails because
they did not provide the requisite notice to Defendants of any
alleged breach of the warranty.
Defs.’ Mem. 16.
Under R.I. Gen.
Laws § 6A-2-607(3)(a), a “buyer must within a reasonable time after
he or she discovers or should have discovered any breach notify
the seller of breach or be barred from any remedy.”
of the notice requirement is threefold:
The purpose
to “provide[] the seller
a chance to correct any defect,” to “afford[] the seller an
opportunity to prepare for negotiation and litigation,” and to
“provide[] the seller a safeguard against stale claims being
asserted after it is too late for the manufacturer or seller to
investigate them.”
DiPetrillo v. Dow Chemical Co., 729 A.2d 677,
682 (R.I. 1999) (quoting Prutch v. Ford Motor Co., 618 P.2d 657,
661 (Colo. 1980)).
“The question of what constitutes a reasonable
time in which to give notice of breach is ordinarily a question of
fact; when the facts are undisputed and only one inference can be
drawn from those facts, the question becomes one for the courts.”
Parrillo v. Giroux Co., Inc., 426 A.2d 1313, 1317 (R.I. 1981).
Plaintiffs’ first notice of breach to Defendants in this case
was in the Complaint.
See Pls.’ Opp’n 21.
In some instances,
filing a complaint “constitute[s] sufficient notice of the breach
of the implied warranty.”
DiPetrillo, 729 A.2d at 683.
In
DiPetrillo, the Rhode Island Supreme Court concluded that although
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Case 1:17-cv-00452-WES-PAS Document 46 Filed 03/28/23 Page 18 of 20 PageID #: 1900
the
product
that
the
plaintiff
alleged
was
defective
was
manufactured and sold only between 1968 and 1972, the plaintiff
“could not reasonably have discovered any putative effect” until
1990, when he was diagnosed with cancer.
Id.
“By that time, there
was nothing that defendant could have done to reverse the effects
of
[plaintiff’s]
exposure
between 1968 and 1972.”
to
the
allegedly
defective
product
On those facts, the court concluded, “the
filing of the complaint,” which occurred in 1993, “constituted
sufficient notice of the breach of implied warranty.”
Id.
Here, Ms. Costa testified that she was not aware that her
symptoms were caused by the TVT-Exact until 2016.
Pls.’ Opp’n 21;
Ex.
ECF
3,
Bianca
Costa
Depo.
Tr.
36:17-38:17,
No.
39-3.
Defendants have not identified any evidence demonstrating that she
could have become aware sooner, and as in DePetrillo, there was
nothing Defendants could have done at that time to “reverse the
effects
of
product.”
[Plaintiff’s]
exposure
to
DePetrillo, 729 A.2d at 683.
complaint on September 29, 2017.
the
allegedly
defective
Plaintiffs filed their
See Compl. 1.
This is in line
with the timing approved by the Rhode Island Supreme Court in
DePetrillo, in which the complaint, filed three years after the
plaintiff
could
reasonably
constituted sufficient notice.
Therefore,
lack
of
have
known
about
the
breach,
See DePetrillo, 729 A.2d at 683.
compliance
18
with
the
statutory
notice
Case 1:17-cv-00452-WES-PAS Document 46 Filed 03/28/23 Page 19 of 20 PageID #: 1901
requirement is not a basis on which to grant summary judgment for
this claim.
2. Causation
Defendants also argue that Plaintiffs cannot demonstrate that
the defect was the proximate cause of Ms. Costa’s injury.
Rhode
Island
law,
“strict
liability
and
implied
Under
warranty
of
merchantability are parallel theories of recovery, one in contract
and the other in tort.”
Castrignano, 546 A.2d at 783.
Thus, for
the reasons discussed supra in regard to Plaintiffs’ design defect
claim, Defendant’ request for summary judgment as to Count VI of
the Complaint is DENIED.
D. Loss of Consortium (Count VII)
Loss of consortium
“is not an independent action but a
derivative one that is attached to the claim of the injured
spouse.”
Fiorenzano v. Lima, 982 A.2d 585, 591 (R.I. 2009)
(quoting Sama v. Cardi Corp., 569 A.2d 432, 433 (R.I. 1990)).
Defendants
argue
that
because
Ms.
Costa’s
substantive
claims
cannot survive summary judgment, her husband’s loss of consortium
claim must also fail.
However, as the Court has determined that
Plaintiffs’ claims of design defect, negligence, and breach of
implied warranty of merchantability survive summary judgment,
discussed supra, so too must Mr. Costa’s loss of consortium claim.
Accordingly, Defendants’ request for summary judgment as to Count
VII of the Complaint is DENIED.
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IV.
Conclusion
For the foregoing reasons, Defendants’ Motion for Summary
Judgment, ECF No. 38, is GRANTED as to Counts II, IV and V of the
Complaint and DENIED as to Counts I, III, VI, and VII of the
Complaint.
IT IS SO ORDERED.
William E. Smith
District Judge
Date: March 28, 2023
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