Barbara Kaiser v. Johnson & Johnson

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