Natalie Johnson v. C. R. Bard, Inc. ( 2023 )

In the
United States Court of Appeals
For the Seventh Circuit
____________________
No. 22-2610
NATALIE JOHNSON,
Plaintiff-Appellee,
v.
C. R. BARD, INC., and BARD PERIPHERAL VASCULAR, INC.,
Defendants-Appellants.
____________________
Appeal from the United States District Court for the
Western District of Wisconsin.
No. 19-cv-760-wmc — William M. Conley, Judge.
____________________
ARGUED JUNE 1, 2023 — DECIDED AUGUST 11, 2023
____________________
Before EASTERBROOK, WOOD, and PRYOR, Circuit Judges.
WOOD, Circuit Judge. Hoping to minimize her risk of suf-
fering serious complications from future blood clots, plaintiff
Natalie Johnson underwent surgery to implant a retrievable
intravascular filter. Intravascular filters are medical devices
that are placed in the inferior vena cava (the major lower vein
that carries blood to the heart) to prevent blood clots that de-
velop in the lower body from flowing into the heart and lungs.
Johnson’s doctor selected the Meridian filter, which was
2 No. 22-2610
supposed to be temporary and easily removeable. It was not.
Instead, Johnson’s filter migrated and fractured, leaving
shards embedded in the wall of her heart and elsewhere. Her
surgeon was unable to remove the device safely and fully. She
now faces an ongoing risk of infection, pain, and other com-
plications as a result of the broken filter.
Johnson sued the manufacturers of the Meridian filter—
C.R. Bard, Inc., and Bard Peripheral, Inc. (together, “Bard”)—
claiming that they defectively designed the Meridian filter
and failed to warn medical providers about the device’s risks,
in violation of Wisconsin law. A jury cleared Bard on most of
Johnson’s theories, but it returned a $3.3 million verdict in her
favor on her strict liability failure-to-warn count. Bard moved
for a new trial on a host of issues, but the district court denied
the motion. We affirm.
I
Johnson’s case is one of several that were remanded for
further proceedings following the conclusion of multidistrict
litigation related to alleged defects in Bard’s intravascular fil-
ters. See In re Bard IVC Filters Prod. Liab. Litig., No. MDL 15-
02641, 2019 WL 3928657 (D. Ariz. Aug. 20, 2019). At trial, she
argued that Bard was liable for her injuries under several Wis-
consin-law theories: negligent defective-design, strict liability
defective-design, negligent failure-to-warn, and strict liability
failure-to-warn. Johnson’s main contention was that Bard’s
Meridian filter was defectively designed because it had an un-
acceptably high risk of migration or fracture, or both, and that
Bard failed properly to warn users about these risks. Bard’s
central defense (as relevant to this appeal) was that Johnson’s
problems came about because her surgeon, Dr. Irina Goncha-
rova, had placed the filter too high (i.e. toward the heart) in
No. 22-2610 3
the wall of the vein. Bard contended that Johnson’s injuries
were caused by that improper placement, not any problem
with the device.
Among Johnson’s witnesses was Dr. Darren Hurst, a vas-
cular and interventional radiologist. In his expert report and
deposition testimony, Hurst stated that CT scans taken a few
days after Goncharova implanted Johnson’s filter showed
that the filter had migrated down by 3 millimeters. At trial,
however, he testified that the scans showed that the filter had
migrated upward by 2.5 or 2.3 centimeters. This led Bard to ob-
ject at various times on nondisclosure grounds, an issue that
we discuss in more depth in Part II.A, infra.
Johnson also called Goncharova to testify, but securing her
appearance turned out to be difficult. On day one of the trial,
Johnson informed the court that she was “concerned that the
two physicians that have been subpoenaed have not re-
sponded.” The district court replied that the trial would pro-
ceed, but that it might be possible “to take them out of turn”
or “have them appear by videoconferencing.” The district
court also stated that “if you want some relief in an effort to
get them to appear in some way … you need to let me know
and I’ll do what I can.”
As Johnson suspected, Goncharova failed to appear as re-
quired by the subpoena at the scheduled time on day two of
the trial. On day four, Johnson rested her case. But on the
morning of day five of the trial, Johnson informed the court
that she intended to file a motion to request that the marshals
escort Goncharova to court on Monday, day six of the trial.
The motion turned out to be unnecessary. That same day, the
court e-mailed the attorney representing the hospital group
that employed Goncharova in an effort to enforce the
4 No. 22-2610
subpoena. So prompted, Goncharova agreed to testify on day
six. Bard objected to the court’s decision to re-open the plain-
tiff’s case-in-chief to permit Goncharova to testify, but the
court overruled the objection. It made clear, however, that
Bard would have an opportunity to respond to her testimony:
“If there’s something else or other testimony you wanted to
submit, you could do that.”
One final aspect of the trial requires a word. Bard sought
a jury instruction stating that it was entitled to a rebuttable
presumption that the Meridian filter was not defective. Under
Wisconsin law, manufacturers are entitled to such a presump-
tion if the product “complied in material respects with rele-
vant standards, conditions, or specifications adopted or ap-
proved by a federal or state law or agency.” Wis. Stat.
§ 895.047(3)(b). Bard argued that it qualified for the presump-
tion because its filter received “510(k) clearance” from the fed-
eral Food and Drug Administration (FDA). As we explain at
greater length in Part II.C, 510(k) clearance authorizes a man-
ufacturer to sell a medical device without undergoing the
FDA’s rigorous premarket review process. See Kaiser v. John-
son & Johnson, 947 F.3d 996, 1003–04 (7th Cir. 2020). The dis-
trict court refused to give the jury instruction, holding that
Bard’s 510(k) clearance did not qualify as a relevant safety
standard for purposes of the statutory presumption.
The jury returned a verdict for Bard on both of the defec-
tive-design theories and on the negligent failure-to-warn the-
ory, but it returned a $3.3 million verdict for Johnson on the
strict liability failure-to-warn theory. For the latter, it con-
cluded that the “foreseeable risks of harm posed by the [Me-
ridian filter] could have been reduced or avoided by the pro-
vision of reasonable instructions or warnings by [Bard] and
No. 22-2610 5
the omission of the instructions or warnings render[ed] the
[Meridian filter] not reasonably safe.” Wis. Stat. § 895.047(a).
Bard moved for a new trial on a host of issues, but the dis-
trict court denied the motion in its entirety. On appeal, Bard
renews three of its post-trial arguments. First, it asserts that
Hurst’s flip-flop violated the expert witness disclosure re-
quirements of Federal Rule of Civil Procedure 26. Second,
Bard argues that the district court erred by permitting Gon-
charova to testify belatedly and without submitting an expert
report. Third, Bard contends that the court should have in-
structed the jury on the presumption of non-defectiveness.
We examine the first two points only for abuse of discretion;
to the extent the third involves issues of law, our review is de
novo.
II
A
1
Bard asserts that we must grant a new trial “because of Dr.
Hurst’s undisclosed and contradictory expert opinions of-
fered for the first time at trial.” Although Hurst’s expert re-
port and deposition testimony stated that the filter migrated
down by 3 millimeters, he testified at trial that the filter mi-
grated upward by 2.5 centimeters or so. This change in opin-
ion was significant, according to Bard, because one of its de-
fenses was that Johnson’s injuries were caused by Goncha-
rova’s placement of the filter in a spot that was too high. It
would have needed an entirely different defense if the evi-
dence showed that the placement was at the right spot and
the device drifted up. On the stand, Hurst admitted that he
had arrived at his new opinion only after Johnson asked him
6 No. 22-2610
to reevaluate her CT scans. On appeal, Johnson does not dis-
pute that Hurst changed his opinion regarding the filter’s mi-
gration, that she knew of the change, and that she failed to
disclose the change to Bard.
Before we delve into this part of the appeal, we need to
assure ourselves that Bard’s objections to Hurst’s testimony
have something to do with Johnson’s failure-to-warn theory.
If they pertain only to her defective-design theories, there is
nothing left to say—Bard prevailed on all of those theories be-
fore the jury, and Johnson did not file a cross-appeal. Hurst’s
testimony addressed the flaws in the device rather than any
warnings that went along with it, and so at first glance one
might think that any errors in admitting or denying it were
harmless for purposes of the failure-to-warn theory. On the
other hand, the Supreme Court of Wisconsin has held that
“the likelihood of an accident’s taking place and the serious-
ness of the consequences are always pertinent matters to be
considered with respect to the duty to provide a sufficient
warning label, and … there is a particular need for a sufficient
warning where there is a representation that the product in
question is not dangerous.” Schuh v. Fox River Tractor Co., 63
Wis. 2d 728, 739 (1974); Tanner v. Shoupe, 228 Wis. 2d 357, 368
(Wis. Ct. App. 1999). The jury might well have relied on
Hurst’s testimony in its consideration of the seriousness of the
consequences that attended the alleged failure to warn. That
is enough, we think, to support the continued relevance of
Bard’s arguments about him.
2
Several provisions of the Federal Rules of Civil Procedure
govern the pretrial disclosure of expert opinions. Under Rule
26(a)(2)(B), witnesses who are “retained or specially
No. 22-2610 7
employed to provide expert testimony in the case” must pro-
vide a written report that includes, among other disclosures,
“a complete statement of all opinions the witness will express
and the basis and reasons for them.” Rule 26(e)(2) imposes on
parties a “duty to supplement” their initial disclosures: “Any
additions or changes to [information in an expert’s report or
deposition] must be disclosed by the time the party’s pretrial
disclosures under Rule 26(a)(3) are due.” The consequences
for violating these rules can be dire. Under Rule 37(c)(1), “[i]f
a party fails to provide information or identify a witness as
required by Rule 26(a) or (e), the party is not allowed to use
that information or witness … at a trial, unless the failure was
substantially justified or is harmless.”
We have held in the context of Rule 26(a)—which governs
initial disclosures, not the duty to supplement—that Rule
37(c)(1)’s “sanction of exclusion is automatic and mandatory
unless the sanctioned party can show that its violation of Rule
26(a) was either justified or harmless.” David v. Caterpillar,
Inc., 324 F.3d 851, 857 (7th Cir. 2003) (quoting Salgado v. Gen.
Motors Corp., 150 F.3d 735, 742 (7th Cir. 1998)). At the same
time, we have emphasized that “[t]he determination of
whether a Rule 26(a) violation is justified or harmless is en-
trusted to the broad discretion of the district court.” Id. (quot-
ing Mid-America Tablewares, Inc. v. Mogi Trading Co., Ltd., 100
F.3d 1353, 1363 (7th Cir. 1996)). Given that the text of Rule
37(c)(1) treats violations of 26(a) and 26(e) equally, we apply
the same standards to a party’s failure to supplement.
We agree with Bard that Johnson’s failure to disclose
Hurst’s new opinion regarding the direction and magnitude
of the filter’s migration appears to violate Rule 26(e). From
Bard’s standpoint, that is the end of the discussion: a new trial
8 No. 22-2610
should be automatic. But Bard is trying to sweep a critical
problem under the rug: It did not raise in the trial court the
broader argument it presses here. Its objections to Hurst’s tes-
timony were narrow, and the court addressed and ruled in its
favor each time. That raises the specter of waiver; we nor-
mally do not criticize a district judge for refraining from more
drastic measures when no one asked for them.
Hurst initially testified at some length about the place-
ment of the filter, with no objection from Bard regarding non-
disclosure. Bard’s first objection came when Johnson’s law-
yer, James Johnson, attempted to present a demonstrative aid
that Bard had not received in advance and that Bard believed
was inconsistent with Hurst’s previous disclosures. The court
sustained Bard’s objection, admonishing Attorney Johnson
that “you should have cleared this in advance. And you’ve
put yourself in this position, so he’ll have to testify without it,
Counsel.” The demonstrative was not shown to the jury, and
Bard did not request any further remedial action from the
court.
Bard’s next objection was also sustained. When Attorney
Johnson attempted to show an exhibit to Hurst (though not to
the jury), Bard objected. A lengthy sidebar ensued, during
which the parties disputed whether Hurst’s intended testi-
mony about the filter’s location and its upward movement
was consistent with his expert report and deposition. Given
the uncertainty about whether Hurst’s intended testimony
had previously been disclosed, the court told Attorney John-
son that he was “going to have to lay a foundation then, be-
fore you ask him about any movement, as to the placement of
the apex of the filter after three days in relation to the inferior
cortical margin.” Counsel’s questioning immediately
No. 22-2610 9
following the sidebar respected that limitation. And when At-
torney Johnson requested permission to publish the exhibit at
issue, the court refused: “No. You didn’t disclose it in ad-
vance. There’s problems with it and you’re not going to be
showing it to the jury.”
Bard’s last nondisclosure objection during Hurst’s testi-
mony came shortly thereafter, when Hurst stated that the fil-
ter had moved 2.3 centimeters. Bard objected, citing Hurst’s
deposition testimony that the filter had moved only 3 milli-
meters. The district court asked Hurst about the discrepancy,
and Hurst replied that he “was asked to reevaluate” one of
the images by the plaintiff. At that point, the following ex-
change took place:
Court: There’s a procedure for someone to correct their
deposition transcript. Did you do that, did you review
your transcript and change it?
Hurst: I did not review my transcript, but I did not make
the change because this change—I was asked to review
the IVC venacavogram later.
Court: And was this change ever disclosed to the defend-
ants?
Attorney Johnson: No, sir.
Court: I’m sorry?
Attorney Johnson: No, sir.
Court: Then we are where we are, Counsel.
Attorney Johnson: I’ll ask about other features that were
disclosed.
Court: Fine.
Bard did not make any further relevant objections during
Hurst’s testimony. At the conclusion of the testimony, Bard
filed a motion “seeking the exclusion of plaintiff’s expert Dr.
Hurst’s undisclosed opinions.” On appeal, Bard claims that
“the district court never ruled on that request.” True enough,
10 No. 22-2610
but a closer look at the motion and subsequent developments
during the trial explains why.
Bard’s motion did not focus on the damage that had al-
ready been done by Hurst’s trial testimony during the plain-
tiff’s case-in-chief. Instead, the motion requested that the
court exclude Hurst’s prospective testimony as a rebuttal wit-
ness. For example, Bard explained:
[T]he Court, sua sponte, stated that Dr. Hurst
could return as a rebuttal witness to testify
about his new opinion … . If Dr. Hurst was al-
lowed to offer his entirely new opinion about
where the filter was placed and how far and in
what direction it moved following the place-
ment, he would not be rebutting anyone except
himself … . Furthermore, Plaintiff did not offer
a rebuttal expert report for Dr. Hurst by the
Court mandated August 11, 2020 deadline.
After Bard filed its motion, the court asked Attorney John-
son if he intended to call any rebuttal witnesses. He expressly
declined: “We are not planning on calling Dr. Hurst in rebut-
tal, and, therefore, we have no rebuttal expected, Your
Honor.” Thus, Bard’s motion to exclude Hurst’s rebuttal tes-
timony was moot and there was no need for a ruling by the
court.
Nowhere in the motion did Bard ask the court to recon-
sider rulings it had made on Bard’s objections during Hurst’s
testimony. Never did Bard suggest that it was seeking addi-
tional curative measures to remedy the harm done by Hurst’s
testimony in the case-in-chief. To the contrary, the motion
stated that “[f]ollowing Bard’s objection, the Court sustained
No. 22-2610 11
Bard’s objection to the introduction of this new opinion and
excluded it,” and that this “refusal to allow” the testimony
was “proper.” This stands in stark contrast to Bard’s position
on appeal to the effect that the district court “did not squarely
address Bard’s myriad objections.” We decline to accept this
revisionist account.
The record shows that the nondisclosure-related objec-
tions Bard made to Hurst’s testimony were all addressed to
its satisfaction by the district court. We appreciate the chal-
lenges that parties face when attempting to respond to unan-
ticipated issues arising in the heat of trial. For this reason, we
have explained that “an objection [need not] be perfectly con-
temporaneous with the challenged testimony in order to …
be considered ‘timely.’” Jones v. Lincoln Elec. Co., 188 F.3d 709,
727 (7th Cir. 1999). But objections still must be “raised within
a sufficient time after the proffer of testimony so as to allow
the district court an adequate opportunity to correct any er-
ror.” Id. Although Bard could have asked the court for a
stronger sanction, such as striking Hurst’s testimony from the
record, a curative instruction, or even a mistrial, it chose not
to do so. Bard cannot, only after losing a jury verdict, repack-
age its earlier acquiescence as a bid for much stronger
measures.
B
Bard also argues that it is entitled to a new trial because
the district court mishandled Dr. Goncharova’s appearance.
It accuses the court of abusing its discretion by “sua sponte”
reopening the plaintiff’s case-in-chief to allow Goncharova to
testify, and of similarly erring by permitting her to opine on
matters outside her role as Johnson’s treating physician with-
out providing an expert report. Once again, we can see the
12 No. 22-2610
potential relevance of this testimony to the failure-to-warn
theory of liability. As the treating physician, Goncharova was
just the person who needed to see an adequate warning, and
her testimony was capable of shedding light on this issue.
The biggest problem we see with Bard’s current argu-
ments is that they do not reflect what happened at the trial.
We begin with Bard’s contention that Goncharova should not
have been allowed to testify at all, because Johnson rested her
case without securing Goncharova’s appearance. We review
a district court’s decision to reopen a party’s case-in-chief for
abuse of discretion. See Nanda v. Ford Motor Co., 509 F.2d 213,
223 (7th Cir. 1974). Federal Rule of Evidence 611(a)(1) in-
structs that courts “should exercise reasonable control over
the mode and order of examining witnesses and presenting
evidence so as to[ ] … make those procedures effective for de-
termining the truth.” This authority includes the discretion to
permit (or deny) a party’s request to reopen its case after it
has rested. See United States v. Green, 757 F.2d 116, 119 (7th
Cir. 1985) (“[T]he district court is invested with broad, discre-
tionary powers in allowing a party to reopen its case.”).
Bard first accuses the district court of abusing its discre-
tion because (according to Bard) it acted on its own initiative
to secure Goncharova’s attendance. But that is a misleading
portrayal of what happened. Johnson informed the court dur-
ing the trial that she was attempting to secure Goncharova’s
testimony after Goncharova disregarded a trial subpoena and
failed to appear on day two of the trial. On the morning of day
five of the trial, Johnson stated that she intended to file a mo-
tion to request that the U.S. marshals escort Goncharova to
testify on the next trial date. At that point, the court e-mailed
the hospital group’s attorney in an attempt to enforce its
No. 22-2610 13
subpoena. This effort was successful; Goncharova indicated
that same afternoon that she would appear to testify on day
six. The most one could say is that the court anticipated John-
son’s motion and sought to avoid dispatching U.S. marshals
by sending a warning first. That does not amount to un-
prompted or inappropriate activism.
Bard also argues that the district court abused its discre-
tion in permitting Goncharova’s belated testimony because
Johnson did not act “diligently” to secure her presence. The
court was willing to say that Johnson “should have done a
better job of pursuing [Goncharova].” But it nevertheless con-
cluded that the “various steps” Johnson had taken were suf-
ficient, and so it declined to exclude Goncharova’s testimony
for lack of diligence. The district court was well-situated to
make this determination, and Bard has not shown that the
court’s conclusion amounted to an abuse of discretion.
Bard also argues that allowing Goncharova to testify “on
the last day of all evidence” was prejudicial because it upset
Bard’s case strategy and gave “her testimony out-sized im-
portance … without any meaningful ability to respond.” This
too is a matter that lies squarely within the district court’s dis-
cretion, and we see nothing amiss here. The court was satis-
fied that Bard was not unfairly prejudiced by the timing of
Goncharova’s testimony. Bard was on notice from the outset
that Johnson intended to call Goncharova as a witness. John-
son attempted to depose Goncharova (albeit unsuccessfully)
and listed her as a witness on her pretrial submissions. In ad-
dition, Bard knew that the court had expressed a willingness
to permit Goncharova to testify “out of turn” after Johnson
shared concerns about Goncharova’s responsiveness. If Bard
decided to rest its trial strategy on the hope that a key witness
14 No. 22-2610
would successfully ignore a subpoena, that was a risk it ac-
cepted voluntarily.
We reject Bard’s argument that the timing of Goncha-
rova’s testimony deprived it of a meaningful opportunity to
respond to her. The trial court stated that it would accommo-
date Bard’s needs in response to Goncharova’s testimony: “If
there’s something else or other testimony you wanted to sub-
mit, you could do that.” Nor did Goncharova get the last
word before the case was sent to the jury; Bard called its own
witness after her testimony and before deliberations began. In
sum, the court’s decision to permit Goncharova’s belated tes-
timony was not an abuse of discretion.
Alternatively, Bard argues that Goncharova’s testimony
should have been excluded because she impermissibly of-
fered “opinions on a variety of issues that went far beyond
describing her care and treatment of Plaintiff.” Typically,
“[a]n expert witness must submit a written report ‘if the wit-
ness is one retained or specially employed to provide expert
testimony in the case or one whose duties as the party’s em-
ployee regularly involve giving expert testimony.’” E.E.O.C.
v. AutoZone, Inc., 707 F.3d 824, 833 (7th Cir. 2013) (quoting
Fed. R. Civ. P. 26(a)(2)(B)). “However, a treating physician can
provide an expert opinion without submitting a written re-
port if the physician’s opinion was formed during the course
of the physician’s treatment, and not in preparation for litiga-
tion.” Id.; see also 1993 Committee Note to Fed. R. Civ. P. 26
(“A treating physician, for example, can be deposed or called
to testify at trial without any requirement for a written re-
port.”).
As we discussed above with respect to Hurst, we review a
district court’s decision to admit or exclude expert testimony
No. 22-2610 15
after a nondisclosure violation for abuse of discretion. See Da-
vid, 324 F.3d at 857. Here, however, the underlying question
is whether Goncharova’s testimony was within the scope of
her role as Johnson’s treating physician. We have treated sim-
ilar issues as legal questions that are evaluated de novo. See,
e.g., Echo, Inc. v. Timberland Machs. & Irrigation, Inc., 661 F.3d
959, 963 (7th Cir. 2011) (“We review the district court’s classi-
fication of a witness as lay or expert de novo.”).
Bard highlights three exchanges during Attorney John-
son’s examination of Goncharova as impermissibly veering
outside the scope of her treatment of Johnson and into the
realm of an expert retained for litigation purposes. It failed to
lodge relevant objections to Attorney Johnson’s questions
during two of these exchanges. But in any event, counsel’s
questions to Goncharova appropriately focused on her treat-
ment of Johnson.
The three exchanges that Bard now criticizes follow a sim-
ilar pattern. First, Attorney Johnson asked Goncharova
whether she knew certain information regarding Meridian fil-
ters at the time she chose a Meridian filter for Johnson’s sur-
gery. Next, counsel asked Goncharova whether that infor-
mation “would … have been important” to her. Finally, he
asked why the information would have been important, or
what she would “likely have done had [she] been made aware
of that information[.]”
These questions were directed at what Goncharova knew
about the Meridian filter at the time she decided to implant
that device in one particular patient—Johnson—and how that
knowledge (or lack thereof) affected the doctor’s decisions
with respect to her treatment of that patient. This is not a case
where the plaintiff attempted to back-door undisclosed
16 No. 22-2610
expert testimony through the testimony of the plaintiff’s treat-
ing physician. Goncharova did not, for example, offer a gen-
eral opinion on industry standards, what other surgeons
might do, or conclusions based on studies or research she con-
ducted after Johnson’s surgery. Nor did she engage in special
preparation leading up to the litigation. To the contrary, the
events leading up to her testimony show that Goncharova
was an uncooperative witness. Goncharova testified about
her personal knowledge and decision-making process with
respect to a particular patient at the time she treated that pa-
tient. This is precisely the type of testimony that the treating-
physician exception to the expert-report requirement permits.
C
Finally, Bard argues that the district court should have in-
structed the jury that Bard was entitled to a rebuttable pre-
sumption that the Meridian filter was not defective. Again,
we need to ensure that these arguments continue to be rele-
vant to the appeal. It appears to us that they are. Wisconsin
law considers a manufacturer to be strictly liable for a product
that “is defective because of inadequate instructions or warn-
ings.” Wis. Stat. § 895.047(1)(a). “A product is defective be-
cause of inadequate instructions or warnings only if the fore-
seeable risks of harm posed by the product could have been
reduced or avoided by the provision of reasonable instruc-
tions or warnings by the manufacturer and the omission of
the instructions or warnings renders the product not reason-
ably safe.” Wis. Stat. § 895.047(1)(a). If, however, there is “ev-
idence that the product, at the time of sale, complied in mate-
rial respects with relevant standards, conditions, or specifica-
tions adopted or approved by a federal or state law or
agency,” then the manufacturer is entitled to “a rebuttable
No. 22-2610 17
presumption that the product is not defective.” Wis. Stat.
§ 895.047(3)(b). This presumption applies not only to alleged
defects in a product’s design, but also to alleged defects that
flow from inadequate instructions or warnings.
Bard argues that the fact that the Meridian filter received
“510(k) clearance” from the FDA means that it “complied in
material respects with relevant standards, conditions, or spec-
ifications adopted or approved by a federal … agency,” Wis.
Stat. § 895.047(3)(b), and thus as a matter of state law it is pre-
sumed not to be defective. But Bard overstates the impact of
510(k) clearance for present purposes.
To see why, a brief look at that process is in order. We de-
scribed it in detail in Kaiser v. Johnson & Johnson, 947 F.3d 996,
1003–05 (7th Cir. 2020), a case dealing with an analogous In-
diana presumption of non-defectiveness. The FDA catego-
rizes medical devices as Class I, Class II, or Class III. See 21
U.S.C. § 360c(a). New devices are considered Class III devices
by default and therefore must go through “a rigorous regime
of premarket approval.” Kaiser, 947 F.3d at 1003 (quoting Rie-
gel v. Medtronic, Inc., 552 U.S. 312, 317 (2008)). One exception,
however, is key. A new device need not undergo premarket
approval if it is “substantially equivalent” to a Class I or Class
II device already on the market or a device that is otherwise
exempt from premarket review. Id. at 1004 (citing
§ 360c(f)(1)(A)).
There are two ways to show substantial equivalence, if the
new device has the same intended use as the predicate device:
the new device may “(1) have ‘the same technological charac-
teristics’ as the predicate device or (2) be ‘as safe and effective’
as the predicate and ‘not raise different questions of safety
and effectiveness.’” Id. (quoting § 360c(i)(1)(A)). Critically for
18 No. 22-2610
our purposes, this means that a device can receive 510(k)
clearance based on its technological similarity to another de-
vice without an inquiry into the safety of the new device. In
addition, the statutory scheme authorizes “piggybacking”—
i.e., “clearing a device based on its substantial equivalence to
a predicate device that itself received clearance through sub-
stantial equivalence.” Id. at 1005.
In lay terms, this means that 510(k) clearance is possible
without any examination of the safety of a particular medical
device if the company uses the first path. The FDA has admit-
ted as much, noting that 510(k) clearance “does not in any
way denote official approval of the device” and “it’s unlawful
for a device manufacturer to make such a representation.” Id.
(quoting 21 C.F.R. § 807.97).
In Kaiser, we held that the defendants were not entitled to
the Indiana presumption of non-defectiveness because there
was no assurance that product safety had factored into the
FDA’s clearance decision, which was based on the substan-
tial-equivalence exception. Id. at 1018. We also found that the
district court did not abuse its discretion in refusing to allow
the defendant to present evidence of the product’s 510(k)
clearance to the jury. Id. The Fourth and Eleventh Circuits
have come to similar conclusions in cases dealing with 510(k)
clearance. See In re C.R. Bard, Inc., Pelvic Repair Sys. Prod. Liab.
Litig., 810 F.3d 913 (4th Cir. 2016); Eghnayem v. Boston Sci.
Corp., 873 F.3d 1304 (11th Cir. 2017).
The district court in the present case concluded that the
line of substantial-equivalence findings that Bard’s filter de-
pended on did not demonstrate compliance with relevant fed-
eral safety standards. We agree with this reasoning. Bard did
not show that the 510(k) clearance of its Meridian filter was
No. 22-2610 19
based on the FDA’s determination that it complied with any
specific safety standards, rather than its similarity to previ-
ously approved devices.
Bard finally argues that the district court failed to consider
that apart from the substantial-equivalence showing, the FDA
requires it to comply with three “special controls.” These
“special controls,” it asserts, are sufficient to invoke the pre-
sumption. But it was vague about what these “special con-
trols” actually were, other than referring generically to “three
mandatory guidance documents … delineat[ing] the testing,
labeling, etc. that must be done when developing a [sic] intra-
vascular filter.” This is not good enough. Recall that the Wis-
consin presumption applies only if Bard shows that it “com-
plied in material respects with relevant standards.” Wis. Stat.
§ 895.047(3)(b) (emphasis added). Bard does not explain what
within these guidance documents establishes “relevant”
standards regarding risks of filter migration or fracture.
Even if we were to overlook Bard’s failure to develop this
argument fully (and we are not inclined to do so), we are
skeptical that the special controls currently applicable to in-
travascular filters qualify as relevant standards as contem-
plated by Wisconsin law. The special controls consist of three
guidance documents: (1) “Use of International Standards Or-
ganization’s ISO 10933 ‘Biological Evaluation of Medical De-
vices Part I: Evaluation and Testing,” (2) “510(k) Sterility Re-
view Guidance and Revision of 2/12/90 (K90-1),” and (3)
“Guidance for Cardiovascular Intravascular Filter 510(k) Sub-
missions.” 21 C.F.R. § 870.3375.
Bard does not discuss these documents in any detail, prob-
ably because they are far too general to qualify as relevant
20 No. 22-2610
safety standards. One document enumerates “the criteria for
an ideal filter,” but only at a high level of generality:
 Nonthrombogenic
 High filter efficiency without impedance of blood
flow
 Secure fixation within the vena cava
 Rapid and safe percutaneous insertion
 Low rate of associated morbidity
 Magnetic resonance imaging (MRI) compatibility
U.S. Food & Drug Admin., FDA-2020-D-0957, Guidance for
Cardiovascular Intravascular Filter 510(k) Submissions – Guidance
for Industry and FDA Staff (1999). The guidance does not at-
tempt to measure, quantify, or describe these criteria. What,
for example, constitutes “secure” fixation? Or a “low rate” of
morbidity? The guidance does not say. Similarly, the guid-
ance provides broad suggestions for categories of tests that
manufacturers should conduct, but it does not prescribe any
particular methodology, metrics, or criteria regarding how
these tests should be performed or what results must be at-
tained. It states, for example, that “an adequate number of
samples should be tested,” that the “[t]est protocols and ac-
ceptance criteria for these tests are the responsibility of the
submitter,” and that “the objectives, test methodologies, re-
sults, and conclusions should be clearly defined for each test
performed.” Id. We are not willing to say that an agency’s rec-
ommendation that manufacturers conduct tests using the
methodologies and criteria of the manufacturer’s choosing
are enough to establish “relevant standards, conditions, or
specifications” regarding the product’s safety. See also In re
No. 22-2610 21
Bard IVC Filters Prod. Liab. Litig., 969 F.3d 1067 (9th Cir. 2020)
(holding that the three special controls at issue here did not
constitute “specific FDA requirements applicable to a partic-
ular device” for preemption purposes).
We conclude that the district court did not err in holding
that the evidence that Bard proffered regarding its 510(k)
clearance was insufficient to show that it materially complied
with relevant federal safety standards. Therefore, the district
court did not err by refusing to instruct the jury that there was
a rebuttable presumption that the Meridian filter was not de-
fective for failure to warn.
III
Our decision in this appeal should not be misinterpreted
as our endorsement of some of Johnson’s counsel’s trial tac-
tics. But ours is an adversary system, and parties in civil liti-
gation are held to the decisions they make. From that perspec-
tive, we find no reversible error, and we AFFIRM the district
court’s denial of defendants’ motion for a new trial.