Williams-Roberts et al v. Coloplast Corp. et al
OPINION AND ORDER: Because plaintiffs have failed to establish that they are entitled to judgment in their favor as a matter of law on Count IV, their motion for partial summary judgment is DENIED 48 . The court also directs the clerk to TERMINATE the pending nature of the subsequent redacted version of this motion 63 . Signed by Senior Judge James T Moody on 9/7/2021. (bas)
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UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
JOVASCEA WILLIAMS-ROBERTS, and
COLOPLAST CORP., et al.,
No. 2:19 CV 42
OPINION and ORDER
In 2017, plaintiff Jovascea Williams-Roberts was implanted with a pelvic mesh
device, “Restorelle,” which was manufactured by defendant Coloplast Corp. (DE # 14
¶ 72.) Plaintiff alleges she experienced severe and debilitating injuries as a result of the
implantation following a number of invasive surgeries. (Id. ¶ 84.) Plaintiff and her
husband Avishoov Roberts sued defendant, alleging, inter alia, failure to warn in
violation of the Indiana Products Liability Act (“IPLA”), Ind Code § 34-20-1-1 et seq. (DE
# 14, Count IV.)
Plaintiffs have moved for partial summary judgment on Count IV. (DE # 48.) A
redacted but otherwise identical version of this motion also appears on the docket. (DE
# 63.) Defendants opposed the motion (DE # 57), and plaintiffs replied (DE # 59). The
motion is now fully briefed and ripe for ruling.
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Summary judgment is governed by Federal Rule of Civil Procedure 56.
“[S]ummary judgment is appropriate — in fact, is mandated — where there are no
disputed issues of material fact and the movant must prevail as a matter of law.”
Dempsey v. Atchison, Topeka, & Santa Fe Ry. Co., 16 F.3d 832, 836 (7th Cir. 1994) (citations
and quotation marks omitted). The parties’ summary judgment burdens depend on
whether the movant would ultimately bear the burden of proof on a disputed issue at
trial. Where the movant does not bear the burden of proof at trial, the oft-quoted
burden-shifting framework of Celotex Corp. v. Catrett, 477 U.S. 317 (1986), applies.
However, in the relatively unusual instance (such as this one) where the movant
is the same party who would bear the burden of proof at trial, the movant “must show
that the evidence . . . is ‘so one-sided that . . . [the movant] must prevail as a matter of
law’” in order to obtain summary judgment in its favor. Reserve Supply Corp. v.
Owens-Corning Fiberglass Corp., 971 F.2d 37, 42 (7th Cir. 1992) (quoting Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 251-52 (1986)); Addicks Servs., Inc., v. GGP-Bridgeland, LP,
596 F.3d 286, 293 (5th Cir. 2010) (where movant also bears burden of proof, “movant
must establish beyond peradventure” all essential elements in order to warrant
judgment in his favor); Moore’s Fed. Practice 3d, § 56.13 (where party moves for
summary judgment and bears the burden of proof on the issue, it must show that the
evidence is so powerful that no reasonable jury would be free to disbelieve it).
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The court’s role in deciding a summary judgment motion is not to evaluate the
truth of the matter, but instead to determine whether there is a genuine issue of triable
fact. Anderson, 477 U.S. at 249-50; Doe v. R.R. Donnelley & Sons Co., 42 F.3d 439, 443 (7th
Cir. 1994). In viewing the facts presented on a motion for summary judgment, a court
must construe all facts in a light most favorable to the non-moving party and draw all
legitimate inferences and resolve all doubts in favor of that party. NLFC, Inc. v. Devcom
Mid-Am., Inc., 45 F.3d 231, 234 (7th Cir. 1995).
Plaintiffs’ motion for partial summary judgment concerns the IPLA’s failure-to-
warn liability provision. Under this part of the IPLA, a product is defective if a seller
does not “properly package or label the product to give reasonable warnings of danger
about the product . . . when the seller, by exercising reasonable diligence, could have
made such warnings or instructions available to the user or consumer.” Ind. Code § 3420-4-2. “Put another way, [a seller has] a ‘duty to warn with respect to latent dangerous
characteristics of the product, even though there is no “defect” in the product itself.’”
Kaiser v. Johnson & Johnson, 947 F.3d 996, 1015 (7th Cir. 2020) (quoting Nat. Gas Odorizing,
Inc. v. Downs, 685 N.E.2d 155, 161 (Ind. Ct. App. 1997)). “Under Indiana’s learnedintermediary doctrine, a medical-device manufacturer can discharge this duty by
providing adequate warnings to physicians.” Id.
As noted above, the present motion is unusual, as it is plaintiffs moving for
summary judgment, rather than defendant. The fact that plaintiffs ultimately have the
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burden of proof in this case means that plaintiffs have a daunting task: to convince the
court that the evidence is “so one-sided” that no reasonable jurors could disagree that
plaintiffs should prevail. Reserve Supply, 971 F.2d at 42. In this instance, plaintiffs’
motion must be denied because, as explained below, reasonable jurors could disagree
about at least two elements of a failure-to-warn claim in this case: breach and causation.
Defendant argues that, at the least, there exist genuine issues of material fact as
to whether defendant breached its duty to warn in this case. Defendant contends that
the “Instructions for Use” (IFU) applicable to Restorelle warned of “every single injury
alleged by plaintiffs.” (DE # 57 at 1.) To illustrate this point, defendant points out the
list of injuries alleged in this case as articulated by plaintiffs’ expert:
multiple pelvic abscesses, vaginal cuff and fascial dehiscences,
mesh erosion into the rectum and vagina, chronic
inflammation, foreign-body giant cell reaction, pelvic abscess,
fistula, dense adhesions, bowel obstruction, intractable
abdominal pain, dyspareunia, frequent urinary tract infections,
stress urinary incontinence, cutaneous abscess, acute
parametritis, pelvic cellulitis, and acute vaginitis.
(DE # 57 Ex. A, Blaivas Rep. at 19.) Defendant implores the court to compare this list of
injuries to the IFU’s list of “adverse effects,” which stated:
Adverse effects associated with the use of Restorelle Y Contour
include: transient local wound irritation, foreign body
inflammatory response, hematoma, seroma, adhesions, pain,
abscess, infection/potentiation of infection, wound dehiscence,
erosion, extrusion, exposure of mesh, puncture or laceration of
vessels, nerves, or viscera (bladder or bowel), fistula, nerve
damage, scarring/contracture, urinary incontinence, voiding
dysfunction, urinary retention/obstruction, defecatory
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dysfunction, ileus or small bowel obstruction, uretera
obstruction or laceration, dyspareunia and procedure failure
and/or recurrent prolapse may occur.
(DE # 57 Ex. B.) Defendant further notes that in its “Warnings and Precautions” section,
the IFU states that “[t]he implant procedure carries an inherent risk of infection and
bleeding, as do similar urological procedures.” (Id.) Defendant argues the IFU also
advises that “[p]atient counseling should include a discussion that the mesh to be
implanted is a permanent implant, and that some complications associated with the
implanted mesh may require additional surgery.” (Id.) Finally, defendant asserts that
the IFU states that “[s]erious adverse tissue responses or infection may require removal
of mesh.” (Id.) Defendants argues that, when cross-referenced, every alleged injury is
warned against in the IFU, negating any assertion that it breached a duty to warn.
Plaintiffs, on the other hand, argue that the IFU is deficient and does not warn of
every single injury. (DE # 59 at 3.) For example, according to plaintiffs, the IFU lists
“transient local wound irritation,” when defendants actually knew that “chronic local
wound irritation” could occur. (Id.) Further, plaintiffs argue, the IFU fails to detail the
extent and frequency of known complications. (Id.) Plaintiffs insist that the IFU does not
warn of all of the latent dangerous characteristics associated with the product, including
“deformation, shrinkage/contracture, and degradation.”(Id.)
Plaintiffs’ alleged discrepancies between the IFU and the injuries alleged simply
bolster what the court must conclude in this instance: that plaintiffs have not met their
burden on their own motion for summary judgment to establish that no reasonable jurors
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could disagree about whether plaintiff should prevail on this element. Indeed, a
reasonable juror could agree with plaintiffs. But, a reasonable juror could also side with
defendant, concluding that the IFU contained reasonable warnings of the injuries
alleged by plaintiffs. The Seventh Circuit has noted that “whether a warning is
‘reasonable’ is ‘generally a question of fact for the trier of fact to resolve.’” Kaiser, 947
F.3d at 1015 (quoting Cook v. Ford Motor Co., 913 N.E.2d 311, 319 (Ind. Ct. App. 2009)).
This case fits squarely into that general rule. Whether defendant breached its duty to
warn in this instance cannot be determined as a matter of law in plaintiffs’ favor.
Plaintiffs also cannot establish that reasonable jurors could only side for them on
the issue of causation. Like breach, “‘causation-in-fact is ordinarily a factual question
reserved for determination by the jury.’” Kaiser, 947 F.3d at 1016 (quoting Kovach v.
Caligor Midwest, 913 N.E.2d 193, 198 (Ind. 2009)). Only where “reasonable minds cannot
disagree” does the question of causation become a question of law for the court. Id.
The duty of a manufacturer to warn extends only to the medical profession, and
not the ultimate users. Ortho Pharm Corp. v. Chapman, 338 N.E.2d 541, 548-49 (Ind. Ct.
App. 1979). Thus, in the context of a medical device manufacturer’s warnings, the
causation question is “relatively straightforward: Would [the physician] have used the .
. . device to treat [the condition] if [the manufacturer] had provided additional
warnings?” Kaiser, 947 F.3d at 1016.
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Plaintiffs points to statements by the treating physician in this case, in which he
indicated that he could not say whether he would have prescribed Restorelle had he
been informed about, for example, the frequency and extent of mesh erosions and
extrusions. (DE # 59 at 3.) Though the IFU did include the terms “erosion” and
“extrusion” (DE # 57 Ex. B), a juror might nonetheless credit the physician’s testimony
and conclude that causation was established. But it is quite another matter to surmise
that all jurors would credit the physician’s testimony and ultimately come to such a
conclusion, and that none would disagree. Certainly, the court cannot make such a
determination on the present record; the issue of causation cannot be determined as a
matter of law in plaintiffs’ favor.
Because plaintiffs have failed to establish that they are entitled to judgment in
their favor as a matter of law on Count IV, their motion for partial summary judgment
is DENIED. (DE # 48.) The court also directs the clerk to TERMINATE the pending
nature of the subsequent redacted version of this motion. (DE # 63.)
Date: September 7, 2021
s/ James T. Moody
JUDGE JAMES T. MOODY
UNITED STATES DISTRICT COURT
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