Dianne Donaldson v. Johnson & Johnson

In the
United States Court of Appeals
For the Seventh Circuit
No. 21-2028
DIANNE M. DONALDSON and
DALE A. DONALDSON,
Plaintiffs-Appellants,
v.
JOHNSON & JOHNSON and
ETHICON, INC.,
Defendants-Appellees.
Appeal from the United States District Court for the
Southern District of Illinois.
No. 3:15-cv-00014 — Staci M. Yandle, Judge.
ARGUED DECEMBER 3, 2021 — DECIDED JUNE 15, 2022
Before ROVNER, HAMILTON, and JACKSON-AKIWUMI, Circuit
Judges.
ROVNER, Circuit Judge. Dianne M. Donaldson and her
husband appeal from the grant of summary judgment entered
in favor of the makers of surgically implanted medical devices
2 No. 21-2028
that she contended injured her due to non-specific defects.
Although there is no doubt that Donaldson suffered severe and
painful complications after these devices were implanted, she
failed to produce sufficient evidence to avoid summary
judgment in her case for non-specific defects under Illinois
product liability law, and we therefore affirm.
I.
Diane M. Donaldson (“Donaldson”) sought treatment for
stress urinary incontinence and anterior pelvic organ prolapse.1
On May 24, 2010, in an attempt to remedy these conditions, Dr.
Michael Schultheis surgically implanted in Donaldson two
transvaginal polypropylene mesh medical devices—a TVT-
Secur to treat her incontinence, and a Prosima to treat the
prolapse. Both devices were manufactured by Ethicon, Inc., a
subsidiary of Johnson & Johnson. In 2014, Donaldson sought
treatment for injuries resulting from erosion of the mesh into
her bladder, vagina and adjacent tissues, causing scarring,
bladder stones and abdominal pain, among other problems.2
1
We will refer to Dianne M. Donaldson, the primary plaintiff here, as
“Donaldson.” The loss of consortium claim of her husband, Dale A.
Donaldson, is derivative of Donaldson’s claims. We will refer to the
defendants jointly as “Ethicon.”
2
Vaginal mesh erosion “is the most common complication following the
use of surgical mesh devices to repair pelvic organ prolapse and stress
urinary incontinence. Non-absorbable synthetic surgical mesh, such as that
made of polypropylene or polyester, can break down or wear away over
time. Part of the mesh may become exposed or protrude through the
vagina. … Less commonly, the mesh may erode into the urethra, bladder or
(continued...)
No. 21-2028 3
Information sheets packaged with the devices warned of
the risks of erosion but Donaldson never saw the warnings and
contends that Dr. Schultheis did not inform her of these risks.
At his deposition, Dr. Schultheis testified that he was aware of
the possible complications, and that at the time of the opera-
tion, he believed that the benefits of the devices outweighed
the risks. He also testified that, in implanting the devices, he
followed all of the instructions that the manufacturer presented
in writing and in a course that he attended. He opined that the
devices were both safe and effective at the time of the surgery.
He had placed hundreds of the devices in other patients and
stood by his decision to recommend the devices to Donaldson.
Donaldson presented an affidavit and testimony from one
of her treating physicians, Dr. Pernankel Nayak, a urologist
whom Donaldson began seeing in 2014 for evaluation and
treatment of complications that she suffered after the implanta-
tion of the mesh devices. In his affidavit, Dr. Nayak asserted
that, within a reasonable degree of medical certainty, the
devices were defectively designed and unreasonably danger-
ous. He averred that the devices failed to perform as expected
in light of their nature and intended function in that the
products had eroded into Donaldson’s internal tissues,
including her vagina and bladder, causing bladder stones and
pelvic pain. He also stated that, based on his own care of
Donaldson and on his review of the records of her other
treating physicians, there was no abnormal use of the products
2
(...continued)
rectum.” See https://my.clevelandclinic.org/health/articles/16298-surgical-
mesh-use-and-complications-in-women (last visited May 20, 2022).
4 No. 21-2028
and no reasonable secondary cause of the failures of the
products or the injuries sustained. R. 40-1.
At his deposition, however, Dr. Nayak contradicted most
of the key statements in his affidavit. First, he indicated in his
deposition that his opinions related only to the Prosima mesh
and not to the TVT-Secur device. The erosion that he found in
the bladder occurred far from the TVT-Secur and he attributed
the mesh he found in Donaldson’s bladder to the Prosima
alone. He agreed that, after the surgery implanting the devices,
Donaldson’s prolapse was repaired and her stress incontinence
did not return. He inferred that the Prosima had been defec-
tively designed based on the erosion of the mesh into
Donaldson’s internal organs. Asked to clarify his opinion, he
stated that the Prosima “possibly caused the mesh to be eroded
into the bladder and caused stones.” R. 56-4, at 68–69. Contrary
to his affidavit, he declined to give an opinion to a reasonable
degree of medical certainty that the Prosima was defectively
designed, remarking that he did not know how the device was
designed, and that he had inferred the injuries were related to
the Prosima implantation because they occurred after the
surgery. He opined that the complication would not have
occurred but for the implantation. He characterized the
product as unreasonably dangerous because it caused compli-
cations that are not reasonable when compared with other
types of surgery such as “sling” surgery.3 Because of the
3
Dr. Nayak testified that he uses a smaller mesh device, a midurethral
sling or “Lynx,” to treat urinary stress incontinence. He does not treat
pelvic prolapse. Like the devices at issue here, the sling is composed of
(continued...)
No. 21-2028 5
presence of a large amount of material with mesh devices that
can erode into the bladder and vagina, he thought these
devices were dangerous and never chose to implant them. He
declined to give an opinion that there was something wrong
with the mesh in the Prosima, stating only that mesh can cause
complications of erosion into the bladder or vagina, “no matter
who makes it.” R. 56-4, at 75–76. He could not say whether
Donaldson would still have had these complications if a
different mesh had been used or if the Prosima had been
designed differently.
Dr. Nayak also testified that he did not evaluate whether
Dr. Schultheis incorrectly implanted the Prosima in too deep of
a plane, which can lead to bladder erosion.4 Dr. Nayak con-
firmed that he did not consider “abnormal use” of the Prosima
3
(...continued)
polypropylene. Dr. Nayak testified that he preferred the smaller sling
device because “the larger the mesh, of course the more chance of erosion.”
R. 56-4, at 133–34.
4
The phrases “abnormal use” and “secondary causes” refer to elements of
proof under a products liability doctrine in Illinois known as the Tweedy
doctrine, which we discuss below. In relation to abnormal use, the
defendants presented the affidavit of Dr. Douglas Grier. He opined that the
erosion of the Prosima into Donaldson’s bladder was, “more likely than not,
due to surgical technique – likely implanting the mesh in too deep a plane.”
R. 56-3, at 18. Because Dr. Schultheis testified that he correctly followed the
instructions and training provided, there is a classic genuine issue of
material fact on “abnormal use” due to surgical technique. Donaldson’s
claim nevertheless fails because, as we discuss below, she did not present
evidence creating a genuine issue of material fact on the absence of
secondary causes or whether the products failed to perform as expected,
two other Tweedy factors.
6 No. 21-2028
device at all, and could not offer any opinion regarding
whether the device was implanted correctly. Contrary to his
affidavit, Dr. Nayak also testified that he had not considered
potential secondary causes for the failure of the products or the
injuries that Donaldson suffered. He agreed that vaginal
atrophy increases a patient’s risk for vaginal erosion of the
mesh but was unaware that Donaldson had been diagnosed
with atrophy. When shown her medical records from another
treating physician who diagnosed atrophy, Dr. Nayak agreed
that her atrophy could be one of the causes for vaginal erosion
of the mesh and could not say whether the mesh itself or the
atrophy was the cause of the erosion. Dr. Nayak also con-
firmed that a posterior colporrhaphy, a surgical procedure that
a physician at the Mayo Clinic performed on Donaldson in
2014, could contribute to pelvic pain and pain during sexual
intercourse, two of her symptoms that she sought to attribute
to the Prosima and TVT-Secur. Dr. Nayak had not considered
and offered no opinion as to whether Donaldson’s pain was a
result of that surgery as opposed to either of the implanted
mesh products.
By the time the defendants moved for summary judgment,
Donaldson and her husband had narrowed their claims to
strict liability for a defective product predicated on a design
defect with the mesh devices, and loss of consortium. To
establish the existence of a non-specific defect in the products,
Donaldson relied exclusively on the Tweedy doctrine, named
for an Illinois case setting forth a manner of proof that resem-
bles the common law doctrine of res ipsa loquitor in products
liability cases. Tweedy v. Wright Ford Sales, Inc., 357 N.E.2d 449(Ill. 1976). When Donaldson submitted the affidavit of Dr.
No. 21-2028 7
Nayak in response to the defendants’ motion for summary
judgment, the defendants moved to strike portions of the
affidavit as inconsistent with the testimony that Dr. Nayak
gave at his deposition. In particular, they asked the court to
strike paragraphs six through eight, where Dr. Nayak pre-
sented the core of his opinions. After noting the inconsistencies
between the declarations made in those three paragraphs and
Dr. Nayak’s subsequent deposition testimony, the court
granted the motion to strike. Although the defendants asked
the court to disregard only the three designated paragraphs,
the court more generally ruled that it would “not consider Dr.
Nayak’s Declaration in ruling on Defendants’ motion for
summary judgment,” suggesting that the court was striking
the entire Declaration and its attached exhibits.5 Donaldson v.
Johnson & Johnson, 2021 WL 1754605, *3 (S.D. Ill. May 4, 2021).
The court also granted the defendants’ motion for summary
judgment. The court first concluded that the Tweedy doctrine
could not be applied in a complex medical device case because
the issues involved were beyond a jury’s common knowledge,
experience and understanding. The court found that expert
testimony was necessary in this case to assist the jury’s
understanding of whether the products were unreasonably
dangerous. In the alternative, the court concluded that
Donaldson failed to produce sufficient evidence to create a
genuine issue of material fact on two of the Tweedy factors,
namely, the absence of reasonable secondary causes or whether
the devices failed to perform as reasonably expected. Because
5
Dr. Nayak’s affidavit was titled, “Declaration.” We will refer to it as his
affidavit.
8 No. 21-2028
the loss of consortium claim was derivative of the product
liability claims, the court granted summary judgment in favor
of the defendants on all claims. The plaintiffs appeal.
II.
On appeal, Donaldson contends that the district court
abused its discretion in striking the entire affidavit of Dr.
Nayak rather than limiting the ruling to the parts of the three
offending paragraphs that directly contradict his deposition
testimony. Donaldson also maintains that the court erred in
granting summary judgment because she has raised genuine
disputes of material facts relevant to the elements of a strict
liability claim under the Tweedy doctrine. A district court’s
ruling on a motion to strike an affidavit is reviewed for an
abuse of discretion. Magyar v. St. Joseph Regional Medical Center,
544 F.3d 766, 770 (7th Cir. 2008). We review the district court’s
grant of summary judgment de novo, and we examine the
record in the light most favorable to the plaintiffs, construing
all reasonable inferences from the evidence in their favor.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986); Horne v.
Electric Eel Mfg. Co., 987 F.3d 704, 713 (7th Cir. 2021). Summary
judgment is appropriate when there are no genuine disputes
of material fact and the movant is entitled to judgment as a
matter of law. Fed.R.Civ.P. 56(a); Anderson, 477 U.S. at 247–48;
Horne, 987 F.3d at 713. “Although federal law governs proce-
dure in a case in which federal court jurisdiction is premised on
diversity of citizenship, state law applies to substantive issues.”
Skyrise Constr. Group, LLC v. Annex Constr., LLC, 956 F.3d 950,
956 (7th Cir. 2020). When neither party raises a conflict of law
issue in a diversity case, the applicable law is that of the state
No. 21-2028 9
in which the federal court sits, in this case, Illinois. RLI Ins. Co.
v. Conseco, Inc., 543 F.3d 384, 390 (7th Cir. 2008). No party
raised a conflict of law issue here, and Illinois law therefore
applies to the substantive issues. Id.A.
Donaldson first contends that the court abused its discre-
tion in striking the entirety of Dr. Nayak’s affidavit. She asserts
that paragraphs one through three, together with Exhibit A,
are consistent with his deposition testimony. These portions of
the affidavit identify Dr. Nayak and set forth his credentials.
She also maintains that paragraph four and Exhibit B, which
identify the medical records that Dr. Nayak maintained in his
treatment of Donaldson, are also consistent with his deposition
testimony. Finally, she argues that certain parts of paragraph
seven, which set forth Dr. Nayak’s opinion that the products
were defectively designed and unreasonably dangerous, were
consistent with his deposition. She contends that, on summary
judgment, the court should have credited any parts of the
affidavit that were consistent with Dr. Nayak’s deposition
testimony because the court is obligated in summary judgment
proceedings to construe the record in the light most favorable
to the non-moving party.
There was no abuse of discretion in the court’s decision
granting the motion to strike the affidavit. During the deposi-
tion, it became clear that Dr. Nayak did not agree with signifi-
cant parts of the key paragraphs (six through eight) setting
forth his purported opinions. Among other things, Dr. Nayak
testified in his deposition that he had no opinion at all about
the TVT-Secur device; that he was not offering an opinion to a
10 No. 21-2028
reasonable degree of medical certainty that the Prosima was
defectively designed, remarking that he did not know how the
device was designed; and critically, that he had not evaluated
whether there was abnormal use of the device or any reason-
able secondary cause for Donaldson’s injuries. A court is well
within its discretion to strike an affidavit that contradicts
deposition testimony unless the affiant has offered a plausible
explanation for the discrepancy. Beckel v. Wal-Mart Associates,
Inc., 301 F.3d 621, 623 (7th Cir. 2002). Affidavits offered to
contradict the affiant’s deposition testimony can be “so lacking
in credibility as to be entitled to zero weight in summary
judgment proceedings” unless there is a plausible explanation
for the discrepancy from the affiant. Beckel, 301 F.3d at 623. See
also Russell v. Acme-Evans Co., 51 F.3d 64, 67–68 (7th Cir. 1995)
(“Where deposition and affidavit are in conflict, the affidavit is
to be disregarded unless it is demonstrable that the statement
in the deposition was mistaken, perhaps because the question
was phrased in a confusing manner or because a lapse of
memory is in the circumstances a plausible explanation for the
discrepancy.”). Dr. Nayak offered no explanation for the
discrepancies that we described above. It is not unusual for
affidavits, which are signed under oath by the affiant, to have
been drafted by a lawyer for a party or for the affiant, and that
is the case here. R. 40-1, at 3 (indicating that the affidavit had
been prepared by the plaintiffs’ lawyer). We decline to specu-
late why Dr. Nayak signed under penalty of perjury a docu-
ment with which he substantially disagreed, or why counsel
was not prepared at Dr. Nayak’s deposition to address the
significant discrepancies between Dr. Nayak’s written and oral
No. 21-2028 11
evidence.6 Given the substantial inconsistencies between the
affidavit and the deposition testimony, and the complete
absence of any explanation for the discrepancies, the court
acted well within its discretion in striking the affidavit. As for
paragraphs one through four, the defendants did not specifi-
cally ask the court to strike those paragraphs, but as will
become clear in the summary judgment analysis, neither those
portions of the affidavit nor the attached exhibits and medical
records were sufficient to avoid summary judgment. Any error
in striking the additional paragraphs was therefore harmless.
B.
Donaldson relies exclusively on the Tweedy doctrine in
seeking to prove the existence of a non-specific design defect
in the mesh devices. We very recently had occasion to explore
in depth Illinois law on strict liability claims for defective
products:
A strict liability claim is premised on a defect that
renders a product dangerous because the product
fails to perform in the manner one reasonably
expects it to in light of its nature and intended
function. To prevail on such a claim, a plaintiff must
establish each of the following elements: (1) a condi-
6
Plaintiffs’ counsel remarked at oral argument that Dr. Nayak gave a
“horrible deposition on behalf of the plaintiff.” Oral Argument, at
3:15—3:25. But what rendered it “horrible” was that it conflicted with the
Declaration that counsel drafted for Dr. Nayak’s signature, and that Dr.
Nayak provided no explanation for the marked inconsistencies. This left the
plaintiffs with a gaping hole in the evidence they needed to provide to
survive summary judgment under the Tweedy doctrine.
12 No. 21-2028
tion of the product resulting from its manufacture or
design, (2) that made the product unreasonably
dangerous, (3) and that existed at the time the
product left the defendant's control, and (4) an
injury to the plaintiff, (5) that was proximately
caused by the condition. A product may be unrea-
sonably dangerous as a result of (1) a manufacturing
defect—that is, a physical defect in the individual
product itself, (2) a defect in the product's design, or
(3) the manufacturer's failure to warn of a known
danger associated with the product or to instruct the
consumer on the proper use of the product. A
“manufacturing defect occurs when one unit in a
product line is defective, whereas a design defect
occurs when the specific unit conforms to the in-
tended design but the intended design itself renders
the product unreasonably dangerous.”
Illinois courts employ two different approaches to
determining whether a product is unreasonably
dangerous: the consumer expectations test and the
risk-utility test. The consumer expectations test asks
whether the product is “dangerous to an extent
beyond that which would be contemplated by the
ordinary consumer who purchases it, with the
ordinary knowledge common to the community as
to its characteristics.” The risk-utility test balances
the magnitude of the danger against the utility of the
product, as designed.
Bensenberg v. FCA US LLC, 31 F.4th 529, 535 (7th Cir. 2022)
(citations omitted).
No. 21-2028 13
But Illinois law also sets forth an alternate means for
proving a strict liability claim for a defective product, a form of
the common law doctrine of res ipsa loquitor:
Illinois recognizes a claim for non-specific defect,
which, in the appropriate case, relieves the plaintiff
of the obligation to identify a particular defect in the
product in order to make a prima facie case of
product liability. Tweedy, 2 Ill.Dec. 282, 357 N.E.2d at
452; Horne v. Elec. Eel Mfg. Co., 987 F.3d 704, 726 (7th
Cir. 2021) (citing DiCosolo v. Janssen Pharm., Inc., 351
Ill.Dec. 574, 951 N.E.2d 1238, 1244 (Ill. App. Ct.
2011)); McKenzie v. S K Hand Tool Corp., 272
Ill.App.3d 1, 208 Ill.Dec. 918, 650 N.E.2d 612, 616
(1995); Varady v. Guardian Co., 153 Ill.App.3d 1062,
106 Ill.Dec. 908, 506 N.E.2d 708, 711–12 (1987). The
plaintiff may instead resort to circumstantial evi-
dence that supports an inference that the product
was defective, by showing that the product failed to
perform as expected, in light of its nature and
intended function, and that the product was not
being used abnormally and that there were no
reasonable secondary causes of failure. Tweedy, 2
Ill.Dec. 282, 357 N.E.2d at 452; Horne, 987 F.3d at 726.
Bensenberg, 31 F.4th at 535–36. See also Tweedy, 357 N.E.2d at
452 (a prima facie case that a product was defective and that
the defect existed when it left the manufacturer’s control is
made by proof that, in the absence of abnormal use or reason-
able secondary causes, the product failed to perform in the
14 No. 21-2028
manner reasonably to be expected in light of its nature and
intended function).
In assessing the defendants’ summary judgment motion,
the district court first remarked:
This Court does not believe that the Tweedy doctrine
can appropriately be applied in complex medical
device cases. These devices are not simple products
that lay jurors commonly use or see and their func-
tions are, therefore, beyond a jury’s common knowl-
edge, experience or understanding. That is why
expert testimony is needed to assist the jury’s under-
standing of whether a product is unreasonably
dangerous. Without the aid of expert testimony, the
jury can only speculate as to what inferences to
draw. … Thus, the question of whether the devices
in question were defective and caused Donaldson’s
injuries is a complex issue that requires expert
interpretation and proof.
Donaldson, 2021 WL 1754605, *5. But Illinois courts have
applied the Tweedy doctrine to medical devices that are
arguably as complex as the mesh products at issue here. See,
e.g., DiCosolo v. Janssen Pharmaceuticals, Inc., 951 N.E.2d 1238(Ill. App. Ct. 2011) (affirming jury verdict in favor of plaintiff
who proceeded under the Tweedy doctrine to prove that a
transdermal Duragesic skin patch defectively delivered more
fentanyl through its rate-controlled membrane than it was
designed to do, resulting in the plaintiff’s death due to over-
dose); Weedon v. Pfizer, Inc., 773 N.E.2d 720 (Ill. App. Ct. 2002)
(reversing summary judgment in favor of defendant manufac-
No. 21-2028 15
turer of a venous access device implanted in plaintiff’s body to
deliver chemotherapy because, although plaintiff produced no
experts in the manufacture or design of the device, under the
Tweedy doctrine, the plaintiff’s treating physicians and nurse
provided sufficient evidence that the device did not perform as
expected when it likely leaked chemotherapy drugs into
surrounding tissues, and also testified to the absence of
abnormal use and secondary causes).
Although Illinois courts appear to approve the use of the
Tweedy doctrine in cases involving medical devices, the
application of that doctrine does not automatically eliminate
the need for any sort of expert testimony.7 Under Tweedy, the
plaintiff must present evidence that, in the absence of abnormal
use or reasonable secondary causes, the product failed to
perform in the manner reasonably to be expected in light of its
nature and intended function. Tweedy, 357 N.E.2d at 452;
Bensenberg, 31 F.4th at 535–36. In a case involving a medical
device that is implanted in the body, proving the absence of
abnormal use or reasonable secondary causes will likely
require evidence from healthcare providers who have experi-
ence in the use of the device, in other words, expert testimony.
For an implanted device, for example, a plaintiff will likely
need medical testimony on the appropriate installation of the
device in the body in order to rule out abnormal use, or
7
Donaldson argues that Tweedy obviates the necessity of expert testimony
to prove a specific defect, citing DiCosolo, 951 N.E.2d at 1243 (“[a] plaintiff
is not required to present expert testimony that the product contained a
specific defect.”). Although that is true, expert testimony may be necessary
to establish the Tweedy factors.
16 No. 21-2028
evidence from a medical professional demonstrating the
absence of infection or other medical conditions that could
have caused the injury. This sort of evidence is outside the
knowledge, experience and understanding of jurors.
The Weedon case illustrates well that expert testimony is
sometimes necessary in Tweedy cases. Weedon sought to prove
that his implanted venous access device injured him by leaking
chemotherapy drugs into the tissues surrounding the device,
a process called extravasation:
Although there was no witness produced by the
plaintiff to testify as an expert regarding any specific
defect in the venous access device, Sarah Coveny,
the oncology nurse who administered the chemo-
therapy, testified that she used a specially designed
“Port–A–Cath needle” and that she did not remem-
ber having any problems with Weedon’s chemother-
apy injections. Dr. Talamanti testified that he in-
spected the device prior to and immediately after
implantation and testified that there was no indica-
tion of any defects. Although Dr. Dumanian, the
plastic surgeon, did not see the Port–A–Cath
through which the chemotherapy was given, he
testified to the difference between an infection and
an IV infiltration injury and, although he did not
know exactly what happened, he testified that
Weedon had an infiltration injury. The defendants’
expert, Mr. James Hagar, testified that a venous
access device should not leak absent external forces,
such as a medical mistake or use of an improper
needle.
No. 21-2028 17
Weedon, 773 N.E.2d at 731. Weedon methodically countered
each secondary cause that the defendant presented, demon-
strating that his injuries were not due to infection, a medical
mistake such as improper implantation of the device, or the use
of an improper needle by the person administering the drugs.
Although “the doctors that treated Weedon all testified that his
injury could have resulted from infection, malpositioning of
the device or extravasation … each doctor testified that it was
more likely that plaintiff had an extravasation injury than an
injury due to infection or malpositioning of the device.” 773
N.E.2d at 722. The court therefore concluded that the plaintiff’s
evidence was sufficient to preclude summary judgment under
Tweedy.
Unfortunately for Donaldson, this is a case that required
expert evidence. On the question of abnormal use, there was
conflicting medical evidence in the record on whether the
implanting surgeon placed the Prosima device in too deep a
plane. The implanting physician testified that he installed the
devices correctly, following all of the manufacturer’s instruc-
tions and his training. That testimony countered the claim by
the defendants’ expert that the Prosima device was likely
implanted in too deep of a plane, leading to the bladder
erosion. If that were the only Tweedy factor in dispute, sum-
mary judgment would have been inappropriate as to the
Prosima device.
But on the issue of reasonable secondary causes, the record
was entirely one-sided. The defendants presented expert
opinion regarding several possible secondary causes for
Donaldson’s injuries, factors independent of the design of the
devices. In particular, the defendants presented an affidavit
18 No. 21-2028
from Dr. Douglas Grier, who examined Donaldson’s extensive
medical records and concluded that there were several causes
of mesh erosion and pelvic pain in Donaldson’s case that had
nothing to do with the design of the mesh products. Among
these secondary causes, Dr. Grier cited vaginal atrophy as a
cause of vaginal erosion, and noted the posterior surgical
repair and pelvic floor muscle dysfunction as the causes of her
pelvic pain. R. 59-3, at 16. Donaldson’s own treating physician,
Dr. Nayak, agreed that vaginal atrophy could be a cause of her
vaginal erosion injury. Dr. Nayak also agreed that Donaldson’s
pelvic pain could have been caused by the surgical procedure
she had undergone at the Mayo Clinic. Donaldson did not
counter this evidence with any direct or circumstantial evi-
dence that would negate any of the reasonable secondary
causes that are supported by the record.
Instead, Dr. Nayak opined only that the Prosima “possibly
caused the mesh to be eroded into the bladder and caused
stones.” R. 56-4, at 68–69. Where “[t]he evidence presented by
plaintiff only raised possibilities for the cause of the accident,
not a probability,” the evidence is insufficient to make out a
Tweedy claim. Saieve v. Budget Rent-A-Car of Rockford, 591
N.E.2d 507, 515 (Ill. App. Ct. 1992). Dr. Nayak inferred that the
injuries were related to the Prosima implantation because they
occurred after the surgery. But as we noted recently in a case
involving another Ethicon mesh product:
The FDA had approved the use of mesh implants
knowing that they are not 100 percent effective. The
fact that a known complication or failure occurs
could reasonably be interpreted as a sign that such
No. 21-2028 19
product or procedure-related failures could occur
without anyone acting wrongfully.
Stark v. Johnson & Johnson, 10 F.4th 823, 830 (7th Cir. 2021). See
also Ralston v. Casanova, 473 N.E.2d 444, 451 (Ill. App. Ct. 1984)
(finding that a Tweedy claim failed where the only evidence
presented by plaintiff was his testimony that he was wearing
a seat belt while operating his vehicle and that he sustained
injuries during a collision, because “it cannot legally be
presumed from evidence of the mere occurrence of an accident
involving a product that the product was defective when it left
the manufacturer’s control”). Unlike the healthcare providers
in Weedon, Dr. Nayak declined to say that the design of the
Prosima was the likely cause of Donaldson’s injuries as
opposed to any other cause cited by the defendants’ expert.
Donaldson asserts that an examination of her medical
records, attached to Dr. Nayak’s affidavit, demonstrates the
absence of reasonable secondary causes. That is simply not the
case. First, there is no indication that these records are a
complete account of Donaldson’s treatment from her many
providers. In his affidavit, Dr. Nayak characterized the thirty
pages of attached medical records as “portions of the medical
records” that he maintained pertaining to Donaldson’s
treatment. R. 40-1, at 2. Dr. Grier averred that he reviewed
“several thousand pages of Mrs. Donaldson’s medical re-
cords,” and pointed out that Dr. Nayak’s records begin in 2014
and contain no record of the operation where the devices were
implanted. R. 56-3, at 29–30. Obviously, a statement that there
are no secondary causes apparent in a tiny portion of the
medical record does not exclude secondary causes. Second, the
records that Dr. Nayak attached confirm other conditions from
20 No. 21-2028
which Donaldson suffers such as vaginal atrophy and pelvic
floor dysfunction, conditions that the defendants’ expert
opined caused Donaldson’s injuries. Nothing in Dr. Nayak’s
records indicates that any physician considered or excluded
secondary causes for the erosion of the devices into either the
bladder or vagina, or for her painful pelvic symptoms. And as
we noted previously, Dr. Nayak expressly conceded that he
had not considered the issue of secondary causes. Third,
reviewing and deciphering Donaldson’s complex medical
records to eliminate secondary causes is simply not a task that
a jury is competent to conduct without the aid of a medical
expert.
Finally, on the question of whether the Prosima failed to
perform in the manner to be expected in light of its nature and
intended function, the record is again one-sided. Dr. Nayak
conceded that the Prosima repaired Donaldson’s prolapse. He
characterized the product as unreasonably dangerous because
it caused complications that are not reasonable when com-
pared with other types of surgery such as “sling” surgery. But
the “sling” to which he referred was a device he employed to
treat urinary incontinence, not pelvic prolapse, and that is the
purpose of the Prosima device. Dr. Nayak testified that he does
not treat pelvic prolapse, and he was not, therefore, in a
position to offer an opinion on the risk-benefit profile of using
the Prosima for that purpose. Dr. Grier, on the other hand,
testified that the Prosima performed as expected, and ex-
plained that erosion is a known risk factor for all types of
No. 21-2028 21
surgical repairs for prolapse, not only for mesh products such
as the Prosima.8 He stated that the fact of erosion does not
necessarily indicate that the product is defective and he agreed
with Dr. Schultheis that the benefits of the device outweighed
the risks. Donaldson presented no evidence to counter Dr.
Grier’s expert opinion on the risk profile of the Prosima
compared to other surgical options. She argued only that her
surgeon did not warn her of the risks. But her surgeon’s failure
to warn her does not counter Dr. Grier’s testimony.
III.
Because Dr. Nayak disclaimed any opinion on the TVT-
Secur device, there is no evidence in the record eliminating
abnormal use or secondary causes, and no evidence that the
device failed to perform as expected. As for the Prosima
device, Donaldson presented no medical evidence that the
secondary causes offered by the defendants’ experts were not
the likely source of her injuries, or that the device did not
perform as reasonably expected in light of its intended pur-
pose. Summary judgment was therefore appropriate under
Tweedy.
AFFIRMED.
8
According to Dr. Grier, other surgical options include the use of sutures
or cadaver parts, both of which present the risk of erosion.