Barbara Kaiser v. Johnson & Johnson ( 2020 )

In the
United States Court of Appeals
For the Seventh Circuit
____________________
No. 18-2944
BARBARA KAISER,
Plaintiff-Appellee,
v.
JOHNSON & JOHNSON and ETHICON, INC.,
Defendants-Appellants.
____________________
Appeal from the United States District Court for the
Northern District of Indiana, Hammond Division.
No. 2:17-cv-00114 — Phillip P. Simon, Judge.
____________________
ARGUED MAY 21, 2019 — DECIDED JANUARY 14, 2020
____________________
Before FLAUM, KANNE, and SYKES, Circuit Judges.
SYKES, Circuit Judge. Barbara Kaiser had surgery to im-
plant the Prolift Anterior Pelvic Floor Repair System, a
transvaginal mesh medical device that supports the pelvic
muscles. Within a few years of her surgery, Kaiser began
experiencing severe pelvic pain, bladder spasms, and pain
during intercourse. Her physician attributed these condi-
tions to contractions in the mesh of the Prolift. Kaiser had
revision surgery to remove the device, but her surgeon could
2 No. 18-2944
not completely extract it. He informed her that the painful
complications she was experiencing were likely permanent.
Kaiser sued Ethicon, Inc., Prolift’s manufacturer, and
Johnson & Johnson, its parent company, seeking damages
under the Indiana Products Liability Act, IND. CODE §§ 34-
20-1-1 to 34-20-9-1. (Johnson & Johnson has no distinct role
in this litigation, so we refer to the defendants collectively as
“Ethicon.”) After a two-week trial, a jury found Ethicon
liable for defectively designing the Prolift device and failing
to adequately warn about its complications. The jury award-
ed a hefty sum: $10 million in compensatory damages and
$25 million in punitive damages, though the judge granted
Ethicon’s motion for remittitur and reduced the punitive
award to $10 million.
Ethicon’s appeal is a broad-spectrum attack on the judg-
ment, starting with an argument about federal preemption
and moving through several issues of Indiana product-
liability law, a claimed evidentiary error, and challenges to
the compensatory and punitive damages. We reject these
arguments and affirm.
One issue in particular warrants special mention upfront.
Our caselaw interprets the Indiana Product Liability Act to
require a plaintiff in a design-defect case to produce evi-
dence of a reasonable alternative design for the product. The
Indiana Supreme Court disagrees. See TRW Vehicle Safety
Sys., Inc. v. Moore, 936 N.E.2d 201, 209 (Ind. 2010). The state
supreme court’s decision controls on a matter of state law, so
we apply TRW rather than our own contrary precedent.
No. 18-2944 3
I. Background
A. Prolift
Barbara Kaiser suffers from pelvic-organ prolapse, a
nonlife-threatening condition that occurs when pelvic mus-
cles loosen, causing nearby organs to press into the vagina.
This condition can lead to several medical complications like
uncomfortable pelvic pressure and incontinence.
Ethicon developed Prolift as a treatment option for pa-
tients with this condition, and in 2009 Kaiser had surgery to
implant the device. Some detail about Prolift is necessary to
understand her case and the arguments raised on appeal.
The device is essentially a precut section of polypropylene
mesh connected to six mesh arms. A surgeon inserts it
through the vagina, pulls it through the vaginal wall, and
anchors the arms to muscles in the hip, thigh, and groin. The
device was designed to reinforce the pelvic muscles and
prevent further organ displacement.
Ethicon began marketing Prolift in 2005. It included an
“Instructions for Use” package insert that warned: “Potential
adverse reactions are those typically associated with surgi-
cally implantable materials, including infection potentiation,
inflammation, adhesion formation, fistula formation, ero-
sion, extrusion and scarring that results in implant contrac-
tion.” It also cautioned that “[t]ransient leg pain may occur
and can usually be managed with mild analgesics.”
Patients soon reported serious problems with the Prolift.
Relevant here, the mesh would often contract, causing severe
pain and bladder problems. Scar tissue could also form
around the device, preventing a complete removal if compli-
cations occurred. In these cases Prolift’s complications
4 No. 18-2944
frequently became permanent. Following years of com-
plaints and FDA scrutiny, Ethicon took Prolift off the market
in 2012.
B. Regulatory Background
The FDA cleared Prolift for sale in 2007. The clearance
process features prominently in this appeal, so we take a
moment to describe the FDA’s role in regulating medical
devices. The Medical Device Amendments of 1976 (“MDA”),
21 U.S.C. §§ 360c–360k, 379–379a, establishes the framework
for federal regulation of medical devices. As amended, the
MDA requires the FDA to place a device into one of three
classes reflecting different levels of regulation.
Class I covers devices for which the MDA’s “general con-
trols” that apply to all medical devices “are sufficient to
provide reasonable assurance of the safety and effectiveness
of the device.” 21 U.S.C. § 360c(a)(1)(A)(i). These general
controls include measures like the MDA’s prohibition on
misbranding a device. The FDA typically places low risk
devices like bandages and tongue depressors in Class I.
The FDA places a device in Class II when the MDA’s
“general controls by themselves are insufficient to provide
reasonable assurance of … safety and effectiveness” but
enough information exists “to establish special controls to
provide such assurance.” Id. § 360c(a)(1)(B). “Special con-
trols” are regulations tailored to the device such as perfor-
mance standards and postmarket surveillance. See id. Most
medical devices fall into Class II.
Finally, a Class III device is one for which “insufficient
information exists to determine” that either general or
special controls “would provide reasonable assurance of …
No. 18-2944 5
safety and effectiveness.” Id. § 360c(a)(1)(C)(i). These devices
“present[] a potential unreasonable risk of illness or injury”
or are “purported or represented to be for a use in support-
ing or sustaining human life or for a use which is of substan-
tial importance in preventing impairment of human health.”
Id. § 360c(a)(1)(C)(ii). Before marketing, a Class III device
undergoes “a rigorous regime of premarket approval.”
Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008).
The particulars of the premarket approval process aren’t
important here; it’s enough to note that it requires extensive
submissions by the device manufacturer and a thorough
review by the FDA. See generally 21 U.S.C. §§ 360c, 360e. The
FDA has broad discretion to withhold approval throughout
the process. See 21 C.F.R. § 861.1(b) (permitting the FDA to
set performance standards for Class II and III devices); see
also Nicholas R. Parrillo, Federal Agency Guidance and the
Power to Bind: An Empirical Study of Agencies and Industries,
36 YALE J. ON REG. 165, 186–87 (2019).
The MDA automatically places a new medical device in
Class III. 21 U.S.C. § 360c(f)(1). But three broad exceptions
largely overshadow this rule. To start, medical devices on
the market before the MDA’s enactment in 1976 are subject
only to the MDA’s general controls until the FDA promul-
gates device-specific regulations to classify and regulate
them. Id. § 360e(b).
Post-1976 devices can escape rigorous premarket review
through the MDA’s “premarket notification” process. Al-
most every manufacturer of a new device must submit a
notification to the FDA at least 90 days before marketing the
device. See 21 C.F.R. § 807.81(a); see also id. § 807.81(a)(3)
(requiring a manufacturer to file a premarket notification
6 No. 18-2944
when it alters an existing device if the alteration “could
significantly affect the safety or effectiveness of the device”
or if it creates a “major change or modification in the intend-
ed use of the device”). The FDA may clear a device for sale
without premarket approval based on this notification if it is
satisfied the device falls into one of the two other exceptions.
First, the MDA exempts from premarket review any de-
vice that receives what’s known as a “§ 510(k) clearance”
from the FDA. To get this clearance, a device must be “sub-
stantially equivalent” to either a pre-1976 device that the
FDA hasn’t yet classified or a Class I or II device already on
the market. § 360c(f)(1). Most medical devices enter the
market through this exception. See 2 JAMES T. O’REILLY &
KATHARINE A. VAN TASSEL, FOOD AND DRUG ADMINISTRATION
§ 18.22, at 464 (4th ed. 2019).
Second, if a device isn’t substantially equivalent to an
unclassified pre-1976 device or a Class I or II device, it can
still avoid premarket review through “de novo” § 510(k)
clearance. See 21 U.S.C. § 360c(f)(2)(A). Specifically, a manu-
facturer may petition the FDA that a device meets the crite-
ria for Class I or II. If the FDA agrees, the device is exempted
from premarket review. Id.; O’REILLY & VAN TASSEL, supra,
§ 18.26, at 470–71.
The § 510(k) clearance process is central to several issues
raised in this appeal. If the FDA is satisfied that a new device
is substantially equivalent to a device that is already in
Class I or II or meets the standards for these classes through
“de novo” § 510(k) review, then it will clear the device for
marketing without stringent premarket review. To be sub-
stantially equivalent, the device must have “the same in-
tended use as the predicate device” and either (1) have “the
No. 18-2944 7
same technological characteristics” as the predicate device or
(2) be “as safe and effective” as the predicate and “not raise
different questions of safety and effectiveness.” 21 U.S.C.
§ 360c(i)(1)(A).
The relevance to safety of the § 510(k) clearance process
varies based on context. That’s due in part to the MDA’s
three-tiered system for classifying medical devices. If the
FDA places a device in Class I after a de novo § 510(k)
review, we know the agency has concluded that the MDA’s
minimal general controls are enough to “provide reasonable
assurance of … safety.” § 360c(a)(1)(A). Likewise, when the
FDA places a device in Class III following full premarket
review, we know that the agency lacks a reasonable assur-
ance of the device’s safety. But the FDA’s decision to place a
device in Class II tells us only that it had enough information
about the device to design special controls to provide rea-
sonable assurance of safety. It’s hard to draw inferences
about a device’s safety without knowing what concerns
triggered its Class II designation and what special controls
the FDA thought were necessary.
A device cleared for market through the § 510(k) “sub-
stantial equivalence” process raises additional complica-
tions. To start, two of the three ways for a new device to be
substantially equivalent to a predicate device have nothing
to do with product safety. First, a device can receive clear-
ance if it is substantially equivalent to a pre-1976 device that
the FDA hasn’t yet classified “regardless of how unsafe or
ineffective the grandfathered device happens to be.”
Eghnayem v. Bos. Sci. Corp., 873 F.3d 1304, 1318 (11th Cir.
2017) (quotation marks omitted). Second—and more perti-
nent to Prolift—the FDA can clear a device if it has “the
8 No. 18-2944
same technological characteristics as [a] predicate device.”
§ 360c(i)(1)(A)(i). This comparison does not consider safety.
The MDA defines “different technological characteristics” as
“a significant change in the materials, design, energy source,
or other features of the device from those of the predicate
device.” 21 U.S.C. § 360c(i)(1)(B). Underscoring the distinc-
tion between safety and similarity of technological character-
istics, the FDA does not generally require safety information
in a § 510(k) substantial-equivalence premarket notification.
See 21 C.F.R. § 807.92(a).
Finally, the MDA’s authorization of “piggybacking”—
clearing a device based on its substantial equivalence to a
predicate device that itself received clearance through
substantial equivalence—increases the gulf between § 510(k)
clearance and comprehensive safety review. Through piggy-
backing, a medical device moves incrementally further and
further away from the “original” predicate device that the
FDA actually classified.
In light of these features of the system, it’s no surprise
that the FDA has promulgated a disclaimer that § 510(k)
clearance “does not in any way denote official approval of
the device.” Id. § 807.97. In fact, it’s unlawful for a device
manufacturer to make such a representation. See id. (“Any
representation that creates an impression of official approval
of a device because of complying with the premarket notifi-
cation regulations is misleading and constitutes misbrand-
ing.”); see also O’REILLY & VAN TASSEL, supra, § 18.22, at 464
(“It is important to note that in the § 510(k) process, the
device is not officially approved by the FDA as being safe
and effective.”).
No. 18-2944 9
C. Prolift
Prolift did not weather the full premarket review process.
Quite the contrary: Ethicon started marketing Prolift in 2005
without submitting any premarket notification to the FDA,
reasoning that the device didn’t depart materially from a
transvaginal mesh product that the agency had previously
cleared. In fact, Ethicon did not submit a § 510(k) premarket
notification for Prolift until 2007 when the FDA demanded
one.
Its 2007 submission asserted that Prolift was substantially
equivalent to three devices: the Gynecare Gynamesh PS
Prolene Soft Mesh, the AMS Apogee Vault Suspension
System, and the AMS Perigee System. 1 According to Ethi-
con, Prolift had the same technological characteristics as
these predicates.
The FDA cleared Prolift based on this submission, send-
ing a form letter that did not identify which particular
predicate device it accepted for the substantial-equivalence
determination. But the agency did indicate that Prolift’s
“original” predicates were a group of surgical meshes the
FDA classified in a 1988 rulemaking. See 21 C.F.R. § 878.3300.
When it promulgated that rule, the FDA cautioned that the
“surgical mesh has not been implanted in a sufficient num-
ber of patients by a sufficient number of medical practition-
ers to provide adequate evidence on the long-term
biocompatibility of these devices.” General and Plastic
Surgery Devices, 53 Fed. Reg. 23856, 23862 (June 24, 1988).
1Ethicon’s premarket notification for Prolift listed a fourth predicate, the
Ultrapro Mesh, but it used that device only to clear the Prolift +M Pelvic
Floor Repair System, a different device than the Prolift at issue here.
10 No. 18-2944
Due to “insufficient evidence of safety and effectiveness,”
the FDA assigned these surgical meshes to Class II. Id.
Because the FDA did not specify the predicate device it
used for Prolift’s § 510(k) clearance, the chain connecting the
1988 surgical meshes to Prolift is not clear. We do know that
Prolift used the piggybacking method to achieve clearance;
that is, each of Prolift’s three proposed predicates received
FDA clearance through a substantial-equivalence determina-
tion. The manufacturers of those three predicates collectively
proposed 17 predicates. And again, the FDA did not indicate
which of the 17 predicates it used to clear these three devic-
es. Because the FDA’s records for the 17 second-order predi-
cates are incomplete, we cannot make out a clear picture of
the next layer. But the available records reveal an additional
degree of piggybacking—all received FDA clearance
through a substantial-equivalence determination.
Based on Ethicon’s 2007 § 510(k) premarket notification,
the FDA cleared Prolift as a Class II device after finding that
it was substantially equivalent to existing Class II devices.
But in 2011 the FDA ordered Ethicon and other transvaginal
mesh manufacturers to submit plans for postmarket studies
of the devices. When the FDA rejected Ethicon’s plan for
Prolift in 2012, Ethicon discontinued the device. In 2016 the
FDA reclassified all transvaginal mesh into Class III. See
21 C.F.R. § 884.5980.
D. Kaiser’s Surgery and Lawsuit
Kaiser suffered from a severe anterior pelvic-organ pro-
lapse. Her doctor referred her to Dr. Gregory Bales, a pelvic-
floor surgeon in her home state of Indiana. In January 2009
Dr. Bales surgically implanted Prolift to treat Kaiser’s condi-
No. 18-2944 11
tion. She was then 60 years old. The parties agree that
Dr. Bales properly implanted Prolift and otherwise met the
appropriate standard of care.
In September 2011 Kaiser reported pelvic pain to her
physician, who attributed the problem to Prolift “bunching.”
Kaiser’s complications gradually worsened. In October 2013
she complained of severe pelvic pain and bladder spasms.
After determining that the Prolift was the likely source of
these problems, Kaiser’s physician recommended surgery to
remove the device. In November Dr. Bales performed a
corrective procedure by using clamps and scissors to remove
the vaginal tissue surrounding the mesh. But he was only
able to remove part of the device. He informed Kaiser that
her pain was likely permanent.
Kaiser sued Ethicon in the Southern District of West
Virginia, the venue of a 28,000-case multidistrict litigation
(“MDL”) against Ethicon. Kaiser and Ethicon agreed that
Indiana law applied, and the MDL judge construed two
counts in Kaiser’s complaint as alleging design-defect and
failure-to-warn claims under the Indiana Product Liability
Act (“IPLA” or “the Act”). The judge rejected Ethicon’s
argument that the federal regulatory scheme preempted
Indiana law. He then dismissed Kaiser’s other claims as non-
cognizable under the Act and transferred the case to the
Northern District of Indiana.
Two of Kaiser’s posttransfer motions are relevant here.
First, the Indiana district judge granted Kaiser’s motion to
exclude evidence related to the FDA’s clearance of Prolift,
reasoning that the § 510(k) process was only minimally
probative of safety and that introducing evidence about the
regulatory process posed a significant risk of jury confusion.
12 No. 18-2944
Second, the judge ruled that Prolift did not qualify as “state
of the art” under Indiana law, which blocked Ethicon from
relying on a rebuttable presumption that the device was not
defective. See IND. CODE § 34-20-5-1.
The case proceeded to trial. The jury returned a verdict
for Kaiser on both the design-defect and failure-to-warn
theories of liability and awarded $10 million in compensato-
ry damages and $25 million in punitive damages. 2
Ethicon moved for judgment as a matter of law under
Rule 50 of the Federal Rules of Civil Procedure, reiterating
the argument it raised in the MDL court that the § 510(k)
process preempts a design-defect claim under state law.
Ethicon also argued that the IPLA required Kaiser to present
evidence of a reasonable alternative design for the device
(she had none), and that the evidence otherwise failed to
establish that Prolift was defective and unreasonably dan-
gerous as required for liability. Regarding the failure-to-
warn theory, Ethicon argued that Prolift’s warnings were
adequate as a matter of law and that Kaiser’s evidence of
causation was insufficient. Ethicon also moved for a new
trial based on the judge’s exclusion of evidence of Prolift’s
§ 510(k) clearance and his refusal to instruct the jury on a
pair of rebuttable presumptions under the IPLA, including
the “state of the art” presumption. Finally, Ethicon chal-
lenged the jury’s award of compensatory damages and
attacked the award of punitive damages as both substantive-
ly unwarranted and excessive.
2 Kaiser’s husband, Anton, brought a derivative claim for loss of consor-
tium, but the jury found in favor of Ethicon. He did not appeal.
No. 18-2944 13
The judge denied the posttrial motions in all respects ex-
cept one: he agreed that the jury’s award of punitive damag-
es was excessive and granted a remittitur to $10 million,
which Kaiser accepted. The judge then entered final judg-
ment, setting up this multifaceted appeal.
II. Discussion
Ethicon’s first attack on the judgment rests on federal
preemption. Alternatively, Ethicon argues that Kaiser’s
claims fall short under Indiana law in multiple respects, or at
the very least a new trial is warranted based on evidentiary
and instructional errors by the district judge. Lastly, Ethicon
challenges the compensatory and punitive damages.
Before addressing this flurry of arguments, we pause to
sketch the law of product liability in Indiana. The Indiana
Products Liability Act governs all claims brought by a
consumer against a manufacturer for physical harm caused
by its product, regardless of legal theory. IND. CODE § 34-20-
1-1. Under the Act a manufacturer who places “into the
stream of commerce any product in a defective condition
unreasonably dangerous to any user or consumer … is
subject to liability for physical harm caused by that prod-
uct.” Id. § 34-20-2-1.
Ethicon’s state-law challenges to the judgment center on
whether Prolift was “defective” and “unreasonably danger-
ous.” Defectiveness “focuses on the product itself.” Gresser v.
Dow Chem. Co., 989 N.E.2d 339, 345 (Ind. Ct. App. 2013). A
product is defective if it is in a condition “not contemplated
by reasonable persons among those considered expected
users or consumers of the product” and “will be unreasona-
bly dangerous … when used in reasonably expectable
14 No. 18-2944
ways.” IND. CODE § 34-20-4-1. “A product may be defective
under the IPLA if it is defectively designed, if it has a manu-
facturing flaw, or if it lacks adequate warnings about dan-
gers associated with its use.” Brewer v. PACCAR, Inc.,
124 N.E.3d 616, 621 (Ind. 2019).
The Act grounds design-defect and failure-to-warn liabil-
ity in negligence: a plaintiff must “establish that the manu-
facturer or seller failed to exercise reasonable care under the
circumstances in designing the product or in providing the
warnings or instructions.” IND. CODE § 34-20-2-2. Under
either theory, a plaintiff must prove that the defendant
breached the duty of reasonable care owed to him—whether
in the product’s design or in its warnings—and the breach
proximately caused his injury. See Brewer, 124 N.E.3d at 621.
(In cases involving a manufacturing defect, the statute
imposes strict liability; a showing of negligence is not re-
quired. See IND. CODE § 34-20-2-2.)
The “unreasonably dangerous” standard incorporates the
“consumer expectations” test set forth in the Restatement
(Second) of Torts: A product is unreasonably dangerous when
it “exposes the user or consumer to a risk of physical harm
to an extent beyond that contemplated by the ordinary
consumer who purchases the product with the ordinary
knowledge about the product’s characteristics common to
the community of consumers.” IND. CODE § 34-6-2-146; accord
RESTATEMENT (SECOND) OF TORTS § 402A cmt. i (AM. LAW
INST. 1965). To decide whether a product is unreasonably
dangerous, the fact-finder may consider several factors,
including “the reasonably anticipated knowledge, percep-
tion, appreciation, circumstances, and behavior of expected
users.” Koske v. Townsend Eng’g Co., 551 N.E.2d 437, 440–41
No. 18-2944 15
(Ind. 1990). Whether a product is unreasonably dangerous is
a distinct inquiry and must be established whether the claim
is based on a manufacturing defect, a design defect, or a
defective warning.
A. Design-Defect Liability
Ethicon reprises several of its arguments for judgment as
a matter of law on Kaiser’s design-defect claim. Our review
is de novo; judgment as a matter of law is warranted “only if
on the basis of the admissible evidence, no rational jury
could have found for the prevailing party.” Stragapede v. City
of Evanston, 865 F.3d 861, 865 (7th Cir. 2017) (quotation
marks omitted). A threshold legal issue, however, is federal
preemption.
1. Preemption
Under the Supremacy Clause, federal law is “the su-
preme Law of the Land … , any Thing in the Constitution or
Laws of any State to the Contrary notwithstanding.” U.S.
CONST. art. VI cl. 2. When “state and federal law ‘directly
conflict,’ state law must give way.” PLIVA, Inc. v. Mensing,
564 U.S. 604, 617 (2011). A direct conflict exists where “it is
impossible for a private party to comply with both state and
federal requirements.” Id. at 618 (quotation marks omitted).
Ethicon maintains that it is impossible for it to comply with
both the federal regulatory scheme for medical devices—
here, the § 510(k) clearance process—and the requirements
of the IPLA.
We begin by recapping Ethicon’s duties under state and
federal law. As relevant here, under Indiana tort law,
Ethicon was required to “exercise reasonable care under the
circumstances in designing” Prolift. § 34-20-2-2. That is,
16 No. 18-2944
Ethicon had a state-law duty to ensure that Prolift’s design
made the device “reasonably fit and safe for the purpose for
which [it was] intended.” Brewer, 124 N.E.3d at 623 (quota-
tion marks omitted). Meanwhile, federal law required
Ethicon to obtain FDA clearance before marketing or sub-
stantially modifying Prolift. § 360c(f)(2)(A); 21 C.F.R.
§ 807.81(a)(3)(ii). To obtain FDA clearance under the § 510(k)
process, it had to file a premarket notification establishing
that Prolift was substantially equivalent to an already-
cleared device or otherwise met the requirements for a
Class I or II device.
Ethicon argues that these state and federal duties directly
conflict: it could not independently redesign Prolift to satisfy
its duties under the IPLA because the § 510(k) regulatory
scheme required it to seek FDA clearance before making any
substantive changes to the device.
This argument does not come to us on a blank slate. In
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Supreme
Court addressed the § 510(k) clearance process in relation to
the MDA’s express preemption provision, which preempts
state regulations that are “different from, or in addition to,
any [MDA] requirement applicable … to the device.”
21 U.S.C. § 360k(a)(1). The Court held that the § 510(k)
regulatory regime does not preempt state tort liability
through this provision. Lohr, 518 U.S. at 501. The Court
explained that the § 510(k) substantial-equivalence standard
does not impose any requirements on a medical device but is
simply an exception to the premarket approval process. Id. at
492–94; cf. Riegel, 552 U.S. at 323 (holding that the MDA
premarket approval process does preempt state law under
the express-preemption provision).
No. 18-2944 17
Kaiser argues that Lohr forecloses Ethicon’s preemption
defense without further inquiry. We disagree. Lohr ad-
dressed a question of express preemption; Ethicon argues
here for implied preemption. An express-preemption provi-
sion “supports a reasonable inference[] that Congress did
not intend to pre-empt other matters,” but it does not “en-
tirely foreclose[] any possibility of implied pre-emption.”
Freightliner Corp. v. Myrick, 514 U.S. 280, 288 (1995); see also
PLIVA, 564 U.S. at 618 n.5 (“[T]he absence of express pre-
emption is not a reason to find no conflict pre-emption.”).
The Court’s decision in Lohr turned on the particular lan-
guage of the MDA’s preemption provision—more specifical-
ly, whether the § 510(k) process imposes “any
requirement[s] applicable … to the device.” 518 U.S. at 486
(quoting § 360k(a)(1)). Lohr’s reasoning is certainly instruc-
tive, but it does not tell us whether it was impossible for
Ethicon to comply with its duties under both federal and
state law.
Still, implied preemption does not arise here. “The ques-
tion for ‘impossibility’ is whether the private party could
independently do under federal law what state law requires
of it.” PLIVA, 564 U.S. at 620. “[W]hen a party cannot satisfy
its state duties without the Federal Government’s special
permission and assistance, which is dependent on the exer-
cise of judgment by a federal agency, that party cannot
independently satisfy those state duties for pre-emption
purposes.” Id. at 623–24.
Nothing in the § 510(k) regulatory scheme prevented
Ethicon from complying with the IPLA’s standard of care
before seeking § 510(k) clearance for Prolift. Indeed, the
§ 510(k) process did not require Prolift “to take any particu-
18 No. 18-2944
lar form for any particular reason.” Lohr, 518 U.S. at 493. As
we’ve explained, the § 510(k) process simply asks whether a
device is substantially equivalent to an approved device or
otherwise meets the MDA’s broad standards for Class I or II
devices. See § 360c(f). Federal law did not stop Ethicon from
satisfying its state-law duties regarding Prolift’s design before
it filed its premarket notification seeking substantial-
equivalence clearance. It lost independent control over
Prolift’s design only after it received § 510(k) clearance from
the FDA.
Ethicon’s situation is loosely analogous to that of a
brand-name drug manufacturer faced with state-law tort
duties regarding the adequacy of its warnings. A brand-
name manufacturer can strengthen a warning label without
waiting for FDA approval. See 21 C.F.R. § 314.70(c)(6)(iii).
The FDA requires brand-name manufacturers to file a
supplement explaining a change in warnings and reserves
the right to reject a labeling change after it is made. Id.
§ 314.70(c)(7).
In Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court
considered whether it was impossible for a brand-name
drug manufacturer to comply with this federal labeling
regime and its duties under state tort law. The Court rejected
the manufacturer’s claim of impossibility preemption,
noting that the FDA permitted a manufacturer “to unilater-
ally strengthen its warning” to comply with state law. Id. at
573. The Court recognized that the FDA could veto such a
change, but “absent clear evidence that the FDA would not
have approved a [warning] change,” no direct conflict
between federal and state duties could be said to exist. Id. at
571.
No. 18-2944 19
The same reasoning applies here. The federal regulatory
regime did not make it impossible for Ethicon to comply
with its state-law duties before it sought § 510(k) clearance
for Prolift in 2007. Ethicon does not claim that the FDA
would have rejected a different design, so on a straightfor-
ward application of Wyeth, Ethicon hasn’t established a
direct conflict between its duties under federal and state law.
See id. at 573 (“[T]he mere fact that the FDA approved [a
different] label does not establish that it would have prohib-
ited such a change.”).
Ethicon’s response rests largely on an analogy to the
FDA’s framework for generic drugs, which the Supreme
Court has held preempts failure-to-warn liability under state
tort law. See Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 486–87
(2013); PLIVA, 564 U.S. at 618. There is some similarity
between the § 510(k) process for clearing a medical device
and the FDA’s clearance of generic drugs. A manufacturer
can receive FDA clearance for a generic drug “by showing
equivalence to a reference listed drug that has already been
approved by the FDA.” PLIVA, 564 U.S. at 612 (citing
21 U.S.C. § 355(j)(2)(A)).
But there is a crucial difference: A manufacturer of gener-
ic drugs has no flexibility when it initially creates a warning
label. Instead, federal law imposes the “duty of sameness,”
which requires a generic drug manufacturer to “ensur[e]
that its warning label is the same as the brand name’s” label.
Id. at 613. So if a brand-name warning is insufficient under
state law, it’s impossible for a generic drug manufacturer to
simultaneously comply with federal and state law. See
Bartlett, 570 U.S. at 490 (“Federal law requires a very specific
label … , and state law forbids the use of that label.”).
20 No. 18-2944
Because of this inflexibility, the Court’s generic-drug rul-
ings turn on whether a “generic manufacturer[] may change
[its] label[] after initial FDA approval.” PLIVA, 564 U.S. at
613. The important point for this case, however, is that
Ethicon had complete and independent control over Prolift’s
design before it sought § 510(k) clearance for the device. It
was not impossible to simultaneously comply with federal
and state law.
Ethicon also relies on the Supreme Court’s rejection of
the “stop selling” theory in Bartlett. The plaintiffs in Bartlett
resisted federal preemption by asserting that the manufac-
turer could comply with both federal and state law by
simply ceasing to manufacture the generic drug at issue. The
Court explained that this argument would make “impossi-
bility pre-emption … all but meaningless.” Bartlett, 570 U.S.
at 488 (quotation marks omitted). The Court held that “an
actor seeking to satisfy both his federal- and state-law obli-
gations is not required to cease acting altogether in order to
avoid liability.” Id. At least one circuit has relied on Bartlett
to reject an “exit the market” argument in a case raising a
preemption defense against a design-defect claim involving
a pharmaceutical product. Yates v. Ortho-McNeil-Janssen
Pharm., Inc., 808 F.3d 281, 300 (6th Cir. 2015).
Ethicon’s reliance on this aspect of Bartlett is misplaced.
Bartlett, 570 U.S. at 490 (“[F]ederal law establishes no safe-
harbor for drug companies … .”); see also Merck Sharp &
Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1678 (2019) (“[W]e
have refused to find clear evidence of … impossibility where
the laws of one sovereign permit an activity that the laws of
the other sovereign restrict or even prohibit.”). The Court
held only that a plaintiff cannot use the stop-selling rationale
No. 18-2944 21
to harmonize otherwise conflicting federal and state laws.
Bartlett, 570 U.S. at 488. That holding is of little help where,
as here, no direct conflict between federal and state law
exists. As we’ve explained, the requirements of the § 510(k)
premarket-notification process do not directly conflict with
Indiana law under the principles announced in Wyeth. The
design-defect claim is not preempted.
2. Reasonable Alternative Design
Moving on to state-law arguments, Ethicon contends that
the IPLA requires a plaintiff to produce evidence of a rea-
sonable alternative design for the product in order to prevail
on a design-defect claim. If this reading of Indiana law is
correct, Ethicon is entitled to judgment as a matter of law.
Kaiser did not present evidence of a reasonable alternative
design for transvaginal mesh.
As we’ve noted, a product is defective within the mean-
ing of the IPLA if it is sold “in a condition: (1) not contem-
plated by reasonable persons among those considered
expected users or consumers of the product; and (2) that will
be unreasonably dangerous to the expected user or consum-
er when used in reasonably expectable ways of handling or
consumption.” IND. CODE § 34-20-4-1. Put in terms of the
Act’s negligence standard for design-defect claims, Ethicon
had a duty to ensure that Prolift’s design made the device
“reasonably fit and safe for the purpose for which [it was]
intended.” Brewer, 124 N.E.3d at 623 (quotation marks
omitted).
Nothing in the IPLA expressly requires a plaintiff to
prove that an alternative product design would have pre-
vented his injury; indeed, the Act is silent on the subject.
22 No. 18-2944
Nevertheless, we have long held that “[t]o demonstrate a
design defect under Indiana law, the plaintiff must … show
that another design not only could have prevented the injury
but also was cost-effective under general negligence princi-
ples.” Aregood v. Givaudan Flavors Corp., 904 F.3d 475, 488
(7th Cir. 2018) (quotation marks omitted). Ethicon invokes
this line of circuit precedent. Kaiser, in turn, points to the
Indiana Supreme Court’s decision in TRW Vehicle Safety
Systems, Inc. v. Moore, 936 N.E.2d 201, 209 (Ind. 2010), which
specifically rejected an alternative-design requirement as
inconsistent with the IPLA standards for design-defect
liability.
To understand this split in authority, it’s helpful to trace
its origin. The story begins with the Indiana Supreme
Court’s decision in Miller v. Todd, 551 N.E.2d 1139 (Ind.
1990), which considered the appropriate standard for crash-
worthiness cases, also known as “enhanced injury” cases.
These claims seek to hold manufacturers liable “for injuries
sustained in a motor vehicle accident where a manufacturing
or design defect, though not the cause of the accident,
caused or enhanced the injuries.” Id. at 1140. Miller held that
to prove “‘[d]efectiveness’ from a crashworthiness stand-
point,” a plaintiff must “demonstrate that a feasible, safer,
more practicable product design would have afforded better
protection.” Id. at 1143.
Following Miller’s instructions, we have applied an
alternative-design requirement in crashworthiness cases
under Indiana law. See Piltch v. Ford Motor Co., 778 F.3d 628,
632 (7th Cir. 2015); Whitted v. Gen. Motors Corp., 58 F.3d 1200,
1204–05 (7th Cir. 1995); Pries v. Honda Motor Co., 31 F.3d 543,
545 (7th Cir. 1994); Bammerlin v. Navistar Int’l Transp. Corp.,
No. 18-2944 23
30 F.3d 898, 902 (7th Cir. 1994). But we limited Miller to that
specific context—at least initially. See Anderson v. P.A. Radocy
& Sons, Inc., 67 F.3d 619, 625 n.5 (7th Cir. 1995) (“[T]he
requirement that the plaintiff, in order to establish a defec-
tive condition, must offer a more cost-effective design ap-
plies to enhanced injury cases only.”); see also Welch v.
Scripto-Tokai Corp., 651 N.E.2d 810, 815 n.5 (Ind. Ct. App.
1995) (“Although the feasibility of a safer design of a prod-
uct may be relevant to the ordinary consumer’s expectations
about that product, such feasibility is not controlling.”).
We later applied an alternative-design requirement in a
design-defect case outside the crashworthiness context,
albeit through the IPLA’s negligence provision. See § 34-20-
2-2. In McMahon v. Bunn-O-Matic Corp., we cited Miller for
the proposition that “a design-defect claim in Indiana is a
negligence claim, subject to the understanding that negli-
gence means failure to take precautions that are less expen-
sive than the net costs of accidents.” 150 F.3d 651, 657 (7th
Cir. 1998). In the design-defect context, the “failure to take
[cost-effective] precautions” is another way of saying that
the manufacturer did not adopt a reasonable alternative
design. Id.; see 1 DAVID G. OWEN & MARY J. DAVIS, OWEN &
DAVIS ON PRODUCTS LIABILITY § 8:11, at 746 (4th ed. 2014).
McMahon involved burn injuries from hot coffee; the plain-
tiffs sued the manufacturer of the coffee maker alleging that
the device was unreasonably dangerous because it held the
coffee temperature too high. 150 F.3d at 653. Based on the
foregoing understanding of the requirements of Indiana law,
we affirmed a summary judgment for the manufacturer.
Since McMahon we have generally read the IPLA to re-
quire evidence of a reasonable alternative design in all
24 No. 18-2944
design-defect cases. See, e.g., Aregood, 904 F.3d at 489; see also
Mesman v. Crane Pro Servs., 409 F.3d 846, 849 (7th Cir. 2005)
(holding that a product is negligently designed “only if the
product could have been redesigned at a reasonable cost to
avoid the risk of injury”).
The Indiana Supreme Court rejected that interpretation
of the Act in its 2010 decision in TRW Vehicle Safety Systems.
The plaintiff in TRW brought a crashworthiness claim
against several vehicle and component-part manufacturers,
including a seat belt manufacturer. Applying Miller, the
Indiana Court of Appeals held that because the claim “pro-
ceeded in negligence … , [the plaintiff] was required to
provide proof of an alternative design.” Ford Motor Co. v.
Moore, 905 N.E.2d 418, 427 (Ind. Ct. App. 2009). The manu-
facturers defended this conclusion in the state supreme
court, contending that the plaintiff had to provide evidence
of “a safer, more practicable product design” and “rebut
evidence that its proposed alternative design … presented
safety concerns.” TRW, 936 N.E.2d at 209.
The Indiana Supreme Court disagreed, explaining that
although the Restatement (Third) of Torts proposes an alterna-
tive-design requirement, the 1998 version of the IPLA “did
not adopt this analytical framework.” Id. at 209 n.2. The
Indiana legislature “instead enacted … a negligence stand-
ard for product liability claims based on defective design.”
Id. And because the Act “prescribes the applicable standard
of care,” the court explicitly declined “to require proof of
any additional or more particular standard of care in prod-
uct liability actions alleging a design defect.” Id. at 209.
Our circuit caselaw cannot be reconciled with TRW. Our
view that Indiana law imposes an alternative-design re-
No. 18-2944 25
quirement rests on an understanding that “negligence means
failure to take precautions that are less expensive than the
net cost[] of accidents.” McMahon, 150 F.3d at 657; see also
Bammerlin, 30 F.3d at 902 (endorsing this approach and
stating that there is “no reason to think that [Indiana] would
see things otherwise”). The Indiana Supreme Court has
unambiguously rejected that reading of state law, clarifying
that the IPLA’s negligence provision does not incorporate
the standard proposed by the American Law Institute in the
Restatement (Third) of Torts and thus does not “require proof
of any additional or more particular standard of care.” TRW,
936 N.E.2d at 209. Requiring a design-defect plaintiff to
produce evidence of a cost-effective, safer design imposes a
“more particular standard of care” and is therefore incon-
sistent with the IPLA as authoritatively construed by the
state’s highest court.
“A decision by a state’s supreme court terminates the au-
thoritative force of our decisions interpreting state law, for
under Erie our task in diversity litigation is to predict what
the state’s highest court will do. Once the state’s highest
court acts, the need for prediction is past.” Reiser v. Residen-
tial Funding Corp., 380 F.3d 1027, 1029 (7th Cir. 2004). The
Indiana Supreme Court has spoken clearly and unequivocal-
ly: the IPLA does not require evidence of a reasonable alter-
native design to establish design-defect liability. TRW,
936 N.E.2d at 209. Sitting in diversity, we are required to
follow TRW rather than our own cases to the contrary, which
are not accurate interpretations of state law. 3
3 This opinion declines to follow circuit precedent, which must give way
to an authoritative decision of the Indiana Supreme Court on a matter of
26 No. 18-2944
Of course, a plaintiff proceeding under Indiana law re-
mains free to establish design-defect liability through evi-
dence of a reasonable alternative design. TRW left this
method of proof open to plaintiffs, while not requiring it as
an element of the claim. Id. at 210; accord FMC Corp. v. Brown,
551 N.E.2d 444, 446 (Ind. 1990). Reasonable alternative
designs are also “relevant to the issue of whether the design
in question is unreasonably dangerous.” Marshall v. Clark
Equip. Co., 680 N.E.2d 1102, 1106 (Ind. Ct. App. 1997) (quota-
tion marks and emphasis omitted); see also Gilbert v. Stone
City Constr. Co., 357 N.E.2d 738, 744 (Ind. Ct. App. 1976)
(“Those who come into contact with a product may reasona-
bly expect its supplier to provide feasible safety devices in
order to protect them from dangers created by its design.”).
Although evidence of a cost-effective alternative design can
be relevant to design-defect liability, TRW holds that the
IPLA does not require such evidence to prevail on a design-
defect claim.
3. Unreasonably Dangerous
As we’ve explained, the Act’s “unreasonably dangerous”
standard “focuses on the reasonable expectations of the
consumer.” Gresser, 989 N.E.2d at 345. The parties agree that
the relevant consumers here are pelvic-floor surgeons.
Ethicon contends that the jury based its verdict on an im-
proper understanding of consumer expectations in this
context. Quoting our decision in Bourne v. Marty Gilman, Inc.,
Ethicon argues that “a user’s knowledge of a general risk
precludes recovery even if he did not know the extent or
state law. Accordingly, we circulated the opinion under Circuit Rule 40(e)
to all judges in active service. No judge wished to hear this case en banc.
No. 18-2944 27
specific degree of that risk.” 452 F.3d 632, 636 (7th Cir. 2006);
see also Moss v. Crosman Corp., 136 F.3d 1169, 1173 (7th Cir.
1998) (rejecting a claim that a BB gun was unreasonably
dangerous in a case involving a fatal injury when ordinary
consumers would know the device could cause serious
injury). By the same logic, Ethicon reasons that Prolift wasn’t
unreasonably dangerous if an ordinary pelvic-floor surgeon
would be aware of the possibility of all relevant risks, even if
he would be unaware of the precise likelihood or severity of
those risks. As Ethicon sees it, that describes this case.
This argument overreads our decision in Bourne. We did
not hold that “a user’s knowledge of a general risk precludes
recovery”; that statement came from our description of the
district court’s decision. Bourne, 452 F.3d at 636. Bourne
explained that under the consumer-expectations test, some
cases involving obvious risks are “so one-sided that there is
no possibility of the plaintiff’s recovery.” Id. at 637. Even so,
“a product may be designed with a feature that, although
obvious, is nonetheless unreasonably prone to cause acci-
dents.” Id. at 636. Bourne does not help Ethicon.
Nor does Moss advance Ethicon’s position. As we later
explained in McMahon, our decision in Moss rejected a claim
that a consumer’s “failure to appreciate the gravity of the
damage a product could do” could satisfy the consumer-
expectations test under Indiana law when ordinary consum-
ers “understood that the product could cause a serious
injury.” McMahon, 150 F.3d at 657. Moss does not, however,
stand for the proposition that the severity or frequency of a
product’s risks are irrelevant. Indeed, Ethicon’s argument on
this point actually contradicts the IPLA, which contemplates
an inquiry into probability and severity of risk. See IND.
28 No. 18-2944
CODE § 34-6-2-146 (mandating that a product is unreasona-
bly dangerous when it “exposes the user or consumer to a
risk of physical harm to an extent beyond that contemplated
by the ordinary consumer”) (emphasis added). It was entire-
ly proper for the jury to consider evidence of the frequency
and severity of Prolift’s complications when applying the
consumer-expectations test.
And on this understanding of Indiana law, a reasonable
jury could conclude that Prolift created risks beyond the
expectations of ordinary pelvic-floor surgeons. Dr. Bales
testified that “none of the surgeons originally implanting the
Prolift probably were quite as appraised of all the possible
risks and some of the subsequent problems” associated with
the device. For example, he testified that he was not aware
that Prolift was impossible to remove safely in some pa-
tients, making its complications permanent. Similarly,
Dr. Bruce Rosenzweig, an expert witness for Kaiser, testified
that he “did not know of [the] risks that were associated
with the Prolift device[,] and once [he] found out about
them, [he] stopped using it.” Finally, Dr. Daniel Elliott,
another plaintiff’s expert, testified that it would be “impos-
sible” for every surgeon to know about all of Prolift’s risks.
To be sure, the evidence wasn’t one-sided. Dr. Bales testi-
fied that he was aware of many of Prolift’s risks. The jury
also heard testimony that surgeons could have learned more
about Prolift’s risks from medical literature. But “whether a
product is unreasonably dangerous is usually a question of
fact that must be resolved by the jury.” Baker v. Heye-Am.,
799 N.E.2d 1135, 1140 (Ind. Ct. App. 2003). That some evi-
dence favored Ethicon establishes only that the case present-
ed factual disputes for the jury to resolve. The jury was free
No. 18-2944 29
to infer, for example, that an ordinary pelvic-floor surgeon
does not have exhaustive knowledge of medical literature.
On this record a reasonable jury could conclude that Prolift
was unreasonably dangerous.
B. Failure-to-Warn Liability
A product is also defective under the IPLA if a seller does
not “properly package or label the product to give reasona-
ble 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 § 34-20-4-2. Put another way, Ethicon had “a duty
to warn with respect to latent dangerous characteristics of
the product, even though there is no ‘defect’ in the product
itself.” Nat. Gas Odorizing, Inc. v. Downs, 685 N.E.2d 155, 161
(Ind. Ct. App. 1997). Under Indiana’s learned-intermediary
doctrine, a medical-device manufacturer can discharge this
duty by providing adequate warnings to physicians. See id.
at 162 n.10; Phelps v. Sherwood Med. Indus., 836 F.2d 296, 303
(7th Cir. 1987). 4
Ethicon argues that Kaiser’s failure-to-warn claim was
deficient as a matter of law. More specifically, Ethicon
contends that no reasonable jury could have found that it
breached its duty or that any failure to warn caused Kaiser’s
4 Kaiser asserts that the learned-intermediary doctrine applies only when
an intermediary has equal knowledge and sophistication as the manufac-
turer. That’s true only of the “sophisticated intermediary” defense, a
“related but distinct” doctrine. Nat. Gas Odorizing, Inc. v. Downs,
685 N.E.2d 155, 162 n.10 (Ind. Ct. App. 1997). Both doctrines permit a
manufacturer to warn an intermediary instead of the end consumer, but
the learned-intermediary doctrine, which “is limited to prescription
drugs and medical devices,” applies without this qualification. Id.
30 No. 18-2944
injuries. It faces an uphill battle on both fronts. Looking first
to breach, whether a warning is “reasonable” is “generally a
question of fact for the trier of fact to resolve.” Cook v. Ford
Motor Co., 913 N.E.2d 311, 319 (Ind. Ct. App. 2009). It only
becomes “a question of law when the facts are undisputed
and only a single inference can be drawn from those facts.”
Id. at 327.
The warnings in Prolift’s Instructions for Use were brief,
so we’ll repeat them in full: “Potential adverse reactions are
those typically associated with surgically implantable mate-
rials, including infection potentiation, inflammation, adhe-
sion formation, fistula formation, erosion, extrusion and
scarring that results in implant contraction.” The Instruc-
tions also warned that “[t]ransient leg pain may occur and
can usually be managed with mild analgesics.” Much of the
evidence at trial supported the jury’s finding that this warn-
ing was inadequate. For example, Dr. Bales pointed to the
absence of any warning about Prolift’s potential for perma-
nent pelvic pain and sexual dysfunction. Similarly,
Dr. Elliott testified that the Instructions did not provide
warnings about the frequency, severity, or permanence of
Prolift’s side effects. Given the limited scope of the warnings
in Prolift’s Instructions for Use, a reasonable jury could
conclude that Ethicon breached its duty to warn surgeons of
its risks.
Ethicon challenges this conclusion on two grounds. It
first contends that the “Surgeons’ Resource Monograph”—a
document it distributed to surgeons only at training
events—contained more comprehensive warnings about
Prolift’s risks. But even if we assume that Ethicon can satisfy
its duty to warn through a limited-distribution monograph
No. 18-2944 31
(an open question), Kaiser successfully undermined this
evidence through effective cross-examination. For example,
Dr. Salil Khandwala, one of Ethicon’s experts, conceded that
Ethicon failed to update the monograph when it received
information regarding heightened complication rates. A
reasonable jury could conclude that the monograph did not
tip the scales in Ethicon’s favor.
Ethicon also argues that its duty to warn did not extend
to providing information about the frequency, severity, or
permanence of Prolift’s side effects. This argument relies on
a different aspect of McMahon. Recall that the claims in
McMahon arose out of burn injuries from hot coffee; in
addition to a design-defect claim, the plaintiff argued that
the manufacturer of the coffee maker failed to warn con-
sumers about the severity of burns that hot coffee can pro-
duce. 150 F.3d at 654. We affirmed the summary judgment
for the manufacturer, reasoning that the IPLA “expects
consumers to educate themselves about the hazards of daily
life … by general reading and experience.” Id. at 656.
This case is far removed from “the hazards of daily life.”
Ethicon asks us to rule as a matter of law on the contents of a
reasonable warning for a specialized medical device. The
question raises technical and highly fact-bound inquiries.
We have held in the related context of “sophisticated inter-
mediaries” that “[w]hether a manufacturer has discharged
its duty … is almost always a question for the trier of fact.”
Id. (quotation marks omitted). That principle applies with
equal force to the learned-intermediary doctrine. Whether
Ethicon breached its duty to warn was a question for the
jury, and we see no reason to disturb its determination on
this element of the claim.
32 No. 18-2944
Ethicon’s causation argument is a closer question. As
with breach, “[c]ausation-in-fact is ordinarily a factual
question reserved for determination by the jury.” Kovach v.
Caligor Midwest, 913 N.E.2d 193, 198 (Ind. 2009). But “where
reasonable minds cannot disagree as to causation-in-fact, the
issue may become a question of law for the court.” Id.
The causation question here is relatively straightforward:
Would Dr. Bales have used the Prolift device to treat Kaiser’s
condition if Ethicon had provided additional warnings? The
answer is more complicated. When asked: “Is there anything
you would have done differently with respect to
Ms. Kaiser’s January 2009[] surgery?” Dr. Bales responded:
“No, not looking back, I don’t think I would have done
anything differently.” He also admitted that the “medi-
colegal climate” surrounding Prolift “probably was a factor”
in his ultimate decision to discontinue using it. And he
conceded that after discontinuing Prolift, he returned to a
procedure he felt had “virtually the same complication risks,
except for … extrusion and erosion.” But when asked if he
would “have wanted to use Prolift if told about [its] risks,”
Dr. Bales offered a different response: “My sense is that had
I had all the subsequent information about how some pa-
tients fared and how some complications occurred, it’s
probably safe to say that I may not have started using the
Prolift.”
Reasonable minds could read Dr. Bales’s mixed testimo-
ny and disagree about causation. Again, however, that just
means the question was one for the jury—and a reasonable
jury could credit Dr. Bales’s assertion that additional warn-
ings about complications would have led him to choose a
different treatment plan.
No. 18-2944 33
C. Motion for a New Trial
As a fallback, Ethicon asks us to reverse for a new trial,
arguing that the judge failed to instruct the jury on two of
the IPLA’s evidentiary presumptions and improperly ex-
cluded evidence of Prolift’s § 510(k) clearance. Different
standards of review apply. “We review jury instructions de
novo to determine whether, taken as a whole, they correctly
and completely informed the jury of the applicable law.”
Javier v. City of Milwaukee, 670 F.3d 823, 828 (7th Cir. 2012)
(quotation marks omitted). We review the district court’s
evidentiary decisions for abuse of discretion. Smith v. Hunt,
707 F.3d 803, 807 (7th Cir. 2013). Under either standard, an
error warrants a new trial only if it is prejudicial. See id. at
808; Javier, 670 F.3d at 828.
1. State-of-the-Art Presumption
The IPLA provides a rebuttable presumption that “the
product that caused the physical harm was not defective”
and “the manufacturer … was not negligent” if the product
“was in conformity with the generally recognized state of
the art applicable to the safety of the product at the time the
product was designed, manufactured, packaged, and la-
beled.” § 34-20-5-1. The judge declined to instruct the jury on
this presumption. Ethicon challenged this ruling in its
posttrial motions and does so again on appeal.
To justify the instruction, Ethicon needed a “legally suffi-
cient evidentiary basis” to support the state-of-the-art pre-
sumption. FED. R. CIV. P. 50(a)(1). The presumption requires
evidence that the product used “the best technology reason-
ably feasible at the time the defendant designed” it. Wade v.
Terex-Telelect, Inc., 966 N.E.2d 186, 192 (Ind. Ct. App. 2012)
34 No. 18-2944
(quotation marks omitted). Ethicon could satisfy this stand-
ard by providing “[e]vidence of the existing level of technol-
ogy, industry standards, the lack of other advanced
technology, the product’s safety record, and the lack of prior
accidents.” Id.
Ethicon’s evidence in support of the presumption was
thin at best. It presented no expert testimony on the issue,
nor did it produce evidence of existing industry standards.
Ethicon conceded that it hadn’t conducted any human trials
before releasing Prolift, so it couldn’t present a safety record.
Instead, it offered testimony that Prolift was generally an
improvement over its predecessor. It also provided a lay
witness’s statement that those who designed Prolift were
“working to get something out there that’s better … than
anything that has been out there before.”
These highly generalized statements fall far short of satis-
fying the legal standard for the presumption. “State of the
art evidence must be relevant to the risk at issue.” Id. at 193.
In Wade, for example, the Indiana Court of Appeals held that
the presumption did not apply even when the manufacturer
offered “anecdotal evidence that the same technology had
been used for almost thirty years and that it … had not
heard of a report of anyone” being injured by the design
risk. Id. at 194. Ethicon’s evidence is no more specific to the
risks at issue here. The judge was right to decline to instruct
the jury on the presumption.
2. Regulatory-Compliance Presumption
The IPLA also provides a rebuttable presumption that
the product was not defective if the manufacturer can estab-
lish that it “complied with applicable codes, standards,
No. 18-2944 35
regulations, or specifications established, adopted, promul-
gated, or approved … by an agency of the United States or
Indiana.” § 34-20-5-1. Based on Prolift’s § 510(k) clearance,
Ethicon faults the judge for not instructing the jury on this
presumption.
Ethicon did not request this instruction at the close of ev-
idence, see FED. R. CIV. P. 51(c)(1), so our review is limited to
plain error, id. R. 51(d)(2). The regulatory-compliance pre-
sumption requires evidence of compliance with governmen-
tal standards that “relate to the risk or product defect at
issue.” Wade, 966 N.E.2d at 195; see also id. (holding that a
regulation wasn’t relevant to the presumption because it was
“silent” regarding the particular defect at issue, even when it
had a “primary objective of … prevent[ing] accidents associ-
ated” with the product). We’ve explained at length that the
§ 510(k) process does not require a medical device “to take
any particular form for any particular reason.” Lohr, 518 U.S.
at 493. Prolift’s § 510(k) clearance is insufficient to support
the presumption. We find no error.
3. FDA Evidence
Ethicon also wanted to present evidence of Prolift’s
§ 510(k) clearance for the more general purpose of inviting
the jury to draw an inference that the device was safe. The
judge excluded this evidence under Rule 403 of the Federal
Rules of Evidence, reasoning that because the § 510(k)
process “speaks to equivalency, not safety,” the probative
value of this evidence was minimal and substantially out-
weighed by the risk of confusing or misleading the jury and
wasting time.
36 No. 18-2944
That was not an abuse of discretion. To start, evidence of
Prolift’s § 510(k) clearance faces the same categorical prob-
lem as any device cleared to market through substantial
equivalence: The FDA expressly disclaims any intent of
“approving” devices through the § 510(k) process. See
21 C.F.R. § 807.97. Prolift’s clearance also contains several
red flags. The FDA warned that Prolift’s original predi-
cates—the surgical meshes in the 1988 rulemaking—did not
come with a reasonable assurance of safety. While incom-
plete, the § 510(k) history also shows that Prolift’s connec-
tion to these meshes is attenuated—both it and its three
possible immediate predicates all piggybacked off of other
§ 510(k)-cleared devices. And importantly, Ethicon’s § 510(k)
premarket notification never claimed that Prolift was as safe
as its proposed predicates. Instead, it asserted that Prolift
had the same technological characteristics.
Simply put, Prolift’s § 510(k) clearance is remote from
FDA safety review. The available records indicate only that
Prolift lies at the end of an undefined chain of devices that
each received FDA clearance through a process that does not
necessarily consider product safety. And at the origin of this
chain is a group of devices that raised serious safety con-
cerns at the FDA. It was reasonable to conclude that the
probative value of this evidence was minimal at best and
that admitting it would precipitate a confusing sideshow
over the details of the § 510(k) process.
D. Damages
1. Compensatory Damages
Ethicon sought remittitur of the jury’s $10 million award
of compensatory damages. Applying the federal standard
No. 18-2944 37
for reviewing damages awards, the judge denied the motion,
reasoning that the damages were rationally connected to the
evidence, not “monstrously excessive,” and comparable to
awards in other personal-injury cases involving vaginal
mesh. Marion Cty. Coroner’s Office v. EEOC, 612 F.3d 924,
930–31 (7th Cir. 2010). Ethicon challenges that ruling, which
we review for abuse of discretion. EEOC v. AutoZone, Inc.,
707 F.3d 824, 833 (7th Cir. 2013).
We note at the outset that it was a mistake to review the
jury’s award under the federal standard. The Supreme Court
has held that state standards for reviewing damages awards
are substantive law for Erie purposes. Gasperini v. Ctr. for
Humanities, Inc., 518 U.S. 415, 430–31 (1996). Accordingly,
“when a federal jury awards compensatory damages in a
state-law claim, state law determines whether that award is
excessive.” Rainey v. Taylor, 941 F.3d 243, 253 (7th Cir. 2019);
see also Smart Mktg. Grp., Inc. v. Publ’ns Int’l Ltd., 624 F.3d
824, 832 (7th Cir. 2010); Naeem v. McKesson Drug Co., 444 F.3d
593, 611 (7th Cir. 2006). So the judge’s use of the federal
standard was legal error. In fairness, the judge relied on our
suggestion in Jutzi-Johnson v. United States that portions of
the federal standard remain viable when a court reviews a
state-law damages award. 263 F.3d 753, 760 (7th Cir. 2001);
accord Arpin v. United States, 521 F.3d 769, 777 (7th Cir. 2008).
We take this opportunity to clarify that federal law has no
place in reviewing a damages award in a state-law claim.
Rainey, 941 F.3d at 252–53 (acknowledging the lack of clarity
in our cases on this point).
That said, the error was harmless. The damages award
was not excessive under Indiana law. Indiana courts will not
disturb a compensatory-damages award “[i]f there is any
38 No. 18-2944
evidence in the record which supports the amount of the
award, even if it is variable or conflicting.” Sears Roebuck &
Co. v. Manuilov, 742 N.E.2d 453, 462 (Ind. 2001) (quotation
marks omitted). The evidence here satisfies this deferential
standard. For example, the jury learned that Kaiser under-
went painful corrective surgery that removed large portions
of vaginal tissue. And Kaiser suffers from permanent pelvic
pain, bladder spasms, and pain during intercourse—all
Prolift-related conditions. This evidence was enough to
justify the jury’s $10 million compensatory award.
Ethicon’s counterargument largely focuses on compari-
sons to other damages awards. While these comparisons are
relevant to the federal standard, see, e.g., AutoZone, 707 F.3d
at 834, Indiana courts heavily disfavor “comparative analy-
sis” when reviewing a damages award, Weinberger v. Boyer,
956 N.E.2d 1095, 1114 (Ind. Ct. App. 2011). The state courts
instead adopt a “historical regard for the uniqueness of
every tort claim and … the belief that compensatory damage
assessments should be individualized and within the prov-
ince of the factfinder.” Id. Because the jury had a reasonable
evidentiary basis for its decision, we will not disturb the
compensatory award. See id. at 1112 (“The jury’s damage
award will not be deemed the result of improper considera-
tions if the size of the award can be explained on any rea-
sonable ground.”).
2. Punitive Damages
The judge granted Ethicon’s remittitur motion and re-
duced the punitive award from $25 million to $10 million,
which Kaiser accepted. Ethicon argues that an award of
punitive damages is unwarranted as a substantive matter
No. 18-2944 39
and that the size of this award is excessive even after remit-
titur.
The parties agree that New Jersey law applies to this is-
sue, so bear with us as we discuss one more statutory re-
gime. New Jersey’s Punitive Damages Act establishes a two-
step process for awarding punitive damages. First, the jury
must decide whether the defendant’s conduct warrants
punitive damages, which requires the plaintiff to prove “by
clear and convincing evidence” that the defendant’s acts or
omissions caused the harm and were “actuated by actual
malice or accompanied by a wanton and willful disregard of
persons who foreseeably might be harmed.” N.J. STAT. ANN.
§ 2A:15-5.12(a). When making this determination, the jury
must consider four factors:
(1) The likelihood, at the relevant time, that se-
rious harm would arise from the defendant’s
conduct;
(2) The defendant’s awareness of reckless dis-
regard of the likelihood that the serious harm
at issue would arise … ;
(3) The conduct of the defendant upon learning
that its initial conduct would likely cause
harm; and
(4) The duration of the conduct or any con-
cealment of it by the defendant.
Id. § 2A:15-5.12(b).
If the jury finds that punitive damages are warranted, it
next sets the amount of damages. Besides the four factors
listed above, the jury must consider “[t]he profitability of the
40 No. 18-2944
misconduct to the defendant,” “[w]hen the misconduct was
terminated,” and “[t]he financial condition of the defend-
ant.” Id. § 2A:15-5.12(c).
Finally, as relevant here, the Punitive Damages Act pro-
vides an affirmative “FDA defense” that applies in two
situations: (1) when the medical device at issue is “subject to
premarket approval or licensure” by the FDA or (2) when
the device “is generally recognized as safe and effective
pursuant to conditions established” by the FDA. Id.
§ 2A:58C-5.
Ethicon raises three arguments in opposition to the puni-
tive award: the FDA defense precludes punitive damages
altogether; the evidence is insufficient to support an award
of punitive damages at step one of the New Jersey frame-
work; and the remitted award is excessive under step two.
To the first point, the FDA defense does not apply. The
§ 510(k) process cannot be considered “premarket approval
or licensure” when the FDA itself cautions that § 510(k)
clearance “does not in any way denote official approval of
the device.” 21 C.F.R. § 807.97; see also Lohr, 518 U.S. at 492–
94 (holding that the § 510(k) process is an exception from the
MDA licensing process). And we reiterate one last time that
the § 510(k) process is not designed to designate devices as
“safe and effective.”
To the second point, as we’ve noted, to justify an award
of punitive damages under the New Jersey framework,
Kaiser had to prove that Ethicon’s conduct evinced “wanton
and willful disregard” of those who might foreseeably be
harmed by its conduct. N.J. STAT. ANN. § 2A:15-5.12(a). That
is, Ethicon must have acted or failed to act “with knowledge
of a high degree of probability of harm to another and
No. 18-2944 41
reckless indifference to the consequences of such act or
omission.” Id. § 2A:15-5.10. Although a plaintiff must prove
the required degree of culpability “by clear and convincing
evidence,” id. § 2A:15-5.12(a), the New Jersey Supreme Court
has recognized that “determinations about whether there is
sufficient evidence of egregiousness to permit or to support
a punitive award are necessarily fact-sensitive,” Quinlan v.
Curtiss-Wright Corp., 8 A.3d 209, 230 (N.J. 2010). Thus, “the
appropriate focus” for legal challenges to punitive-damages
claims is “whether there was too little evidence of egre-
giousness presented by plaintiff to get to the jury on the
issue at all.” Id. at 231.
Even under the heightened burden of proof, on this rec-
ord a reasonable jury could find that Ethicon acted recklessly
when releasing Prolift and crafting its warnings. For exam-
ple, the jury saw e-mails from Prolift’s inventors alerting
Ethicon that problems could occur from mesh shrinkage,
including permanent pain and sexual dysfunction. Dr. Peter
Hinoul, one of Ethicon’s medical directors, admitted that
Ethicon knew from the outset that Prolift had a high risk of
these side effects. He also conceded that Ethicon knew that if
the device contracted, it could lead to invasive remedial
surgeries. Dr. Hinoul also testified that Ethicon understood
when Prolift was released that it would eventually need to
replace its mesh with a safer material due to these complica-
tions.
Notably, an Ethicon medical director proposed updating
Prolift’s Instructions for Use to account for the risk of sexual
dysfunction. The jury heard testimony that Ethicon denied
this request in order to reduce printing costs and avoid
delaying Prolift’s release. The Instructions instead generical-
42 No. 18-2944
ly described Prolift’s “[p]otential adverse reactions” as those
“typically associated with surgically implantable materials.”
Ethicon did not warn of Prolift’s risks of sexual dysfunction,
permanent pain, and other complications. Indeed, the In-
structions mentioned the risk of postsurgical pain only once,
in its warning that “[t]ransient leg pain may occur and can
usually be managed with mild analgesics.”
A reasonable jury could credit this evidence and con-
clude that Ethicon knew of the risk of serious complications
and acted with reckless indifference by failing to warn
surgeons. See Ripa v. Owens-Corning Fiberglas Corp., 660 A.2d
521, 532 (N.J. Super. Ct. App. Div. 1995) (holding that suffi-
cient evidence existed for punitive damages where a manu-
facturer knew about a serious product risk but failed to warn
consumers of the danger). Accordingly, we see no basis to
disturb the jury’s conclusion that Ethicon’s conduct warrant-
ed punitive damages.
Finally, Ethicon objects that the punitive award is exces-
sive even after remittitur. But it raised this objection only in
its reply brief and even then the argument is undeveloped.
That’s a waiver. See Harris v. Warrick Cty. Sheriff’s Dep’t,
666 F.3d 444, 448 (7th Cir. 2012).
AFFIRMED