Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca7-18-02944/USCOURTS-ca7-18-02944-0/pdf.json

Nature of Suit Code: 367
Nature of Suit: TORTS - Personal Injury - Health Care/Pharmaceutical Personal Injury/Product Liability
Cause of Action: 

---

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 implant 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 conditions to contractions in the mesh of the Prolift. Kaiser had

revision surgery to remove the device, but her surgeon could 

Case: 18-2944 Document: 47 Filed: 01/14/2020 Pages: 42
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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 awarded 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 judgment, starting with an argument about federal preemption

and moving through several issues of Indiana productliability 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 evidence 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.

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No. 18-2944 3

I. Background

A. Prolift

Barbara Kaiser suffers from pelvic-organ prolapse, a 

nonlife-threatening condition that occurs when pelvic muscles 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 patients 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 surgically implantable materials, including infection potentiation, 

inflammation, adhesion formation, fistula formation, erosion, extrusion and scarring that results in implant contraction.” 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 complications occurred. In these cases Prolift’s complications 

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frequently became permanent. Following years of complaints 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 controls” 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 controls” are regulations tailored to the device such as performance 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 ... 

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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 supporting or sustaining human life or for a use which is of substantial 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 promulgates 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. Almost 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 

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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 intended 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 device that receives what’s known as a “§ 510(k) clearance” 

from the FDA. To get this clearance, a device must be “substantially 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 manufacturer may petition the FDA that a device meets the criteria 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 substantially equivalent, the device must have “the same intended use as the predicate device” and either (1) have “the 

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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 assurance 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 reasonable 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) “substantial equivalence” process raises additional complications. 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 clearance 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 pertinent to Prolift—the FDA can clear a device if it has “the 

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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 distinction between safety and similarity of technological characteristics, 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 piggybacking, 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 notification regulations is misleading and constitutes misbranding.”); 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.”).

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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 Ethicon, Prolift had the same technological characteristics as 

these predicates.

The FDA cleared Prolift based on this submission, sending 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 number of patients by a sufficient number of medical practitioners 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). 

 1 Ethicon’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. 

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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 determination. 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 devices. Because the FDA’s records for the 17 second-order predicates 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 prolapse. Her doctor referred her to Dr. Gregory Bales, a pelvicfloor surgeon in her home state of Indiana. In January 2009 

Dr. Bales surgically implanted Prolift to treat Kaiser’s condiCase: 18-2944 Document: 47 Filed: 01/14/2020 Pages: 42
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 noncognizable 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. 

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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 compensatory 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 dangerous as required for liability. Regarding the failure-towarn 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 challenged the jury’s award of compensatory damages and 

attacked the award of punitive damages as both substantively unwarranted and excessive.

 2 Kaiser’s husband, Anton, brought a derivative claim for loss of consortium, but the jury found in favor of Ethicon. He did not appeal. 

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No. 18-2944 13

The judge denied the posttrial motions in all respects except one: he agreed that the jury’s award of punitive damages was excessive and granted a remittitur to $10 million, 

which Kaiser accepted. The judge then entered final judgment, 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 product.” Id. § 34-20-2-1.

Ethicon’s state-law challenges to the judgment center on 

whether Prolift was “defective” and “unreasonably dangerous.” 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 unreasonably dangerous ... when used in reasonably expectable

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ways.” IND. CODE § 34-20-4-1. “A product may be defective 

under the IPLA if it is defectively designed, if it has a manufacturing flaw, or if it lacks adequate warnings about dangers 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 liability in negligence: a plaintiff must “establish that the manufacturer 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 required. 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, perception, appreciation, circumstances, and behavior of expected 

users.” Koske v. Townsend Eng’g Co., 551 N.E.2d 437, 440–41 

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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 supreme 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, 

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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 (quotation marks omitted). Meanwhile, federal law required 

Ethicon to obtain FDA clearance before marketing or substantially 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 alreadycleared 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).

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Kaiser argues that Lohr forecloses Ethicon’s preemption 

defense without further inquiry. We disagree. Lohr addressed a question of express preemption; Ethicon argues 

here for implied preemption. An express-preemption provision “supports a reasonable inference[] that Congress did 

not intend to pre-empt other matters,” but it does not “entirely 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 preemption is not a reason to find no conflict pre-emption.”). 

The Court’s decision in Lohr turned on the particular language of the MDA’s preemption provision—more specifically, 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 instructive, 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 question 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 exercise 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 particuCase: 18-2944 Document: 47 Filed: 01/14/2020 Pages: 42
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 substantialequivalence 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 brandname 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 unilaterally 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.

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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 straightforward 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 prohibited 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 generic 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.”).

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Because of this inflexibility, the Court’s generic-drug rulings 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 manufacturer 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 “impossibility 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 obligations 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 safeharbor 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

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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 reasonable 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 meaning of the IPLA if it is sold “in a condition: (1) not contemplated 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 consumer 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 prevented his injury; indeed, the Act is silent on the subject.

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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 principles.” 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 crashworthiness 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 standpoint,” 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., 

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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 defective condition, must offer a more cost-effective design applies 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 product 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 negligence means failure to take precautions that are less expensive 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 plaintiffs 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 require evidence of a reasonable alternative design in all 

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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 “proceeded 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 manufacturers 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 alternative-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 standard 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 product 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 reCase: 18-2944 Document: 47 Filed: 01/14/2020 Pages: 42
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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 inconsistent with the IPLA as authoritatively construed by the 

state’s highest court.

“A decision by a state’s supreme court terminates the authoritative 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. Residential Funding Corp., 380 F.3d 1027, 1029 (7th Cir. 2004). The 

Indiana Supreme Court has spoken clearly and unequivocally: the IPLA does not require evidence of a reasonable alternative 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 

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Of course, a plaintiff proceeding under Indiana law remains free to establish design-defect liability through evidence 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) (quotation 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 reasonably 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 designdefect 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 improper 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.

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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 accidents.” 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 consumerexpectations test under Indiana law when ordinary consumers “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.

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CODE § 34-6-2-146 (mandating that 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”) (emphasis added). It was entirely 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 patients, 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 “impossible” for every surgeon to know about all of Prolift’s risks.

To be sure, the evidence wasn’t one-sided. Dr. Bales testified 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 evidence favored Ethicon establishes only that the case presented factual disputes for the jury to resolve. The jury was free 

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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 reasonable warnings of danger about the product ... when the seller, 

by exercising reasonable diligence, could have made such 

warnings or instructions available to the user or consumer.” 

IND. CODE § 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 manufacturer. 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.

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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 materials, including infection potentiation, inflammation, adhesion formation, fistula formation, erosion, extrusion and 

scarring that results in implant contraction.” The Instructions 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 warning was inadequate. For example, Dr. Bales pointed to the 

absence of any warning about Prolift’s potential for permanent 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 

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(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 consumers about the severity of burns that hot coffee can produce. 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 intermediaries” 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.

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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 “medicolegal 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 patients 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 testimony 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 warnings about complications would have led him to choose a 

different treatment plan.

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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 excluded 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 labeled.” § 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 sufficient evidentiary basis” to support the state-of-the-art presumption. FED. R. CIV. P. 50(a)(1). The presumption requires 

evidence that the product used “the best technology reasonably feasible at the time the defendant designed” it. Wade v. 

Terex-Telelect, Inc., 966 N.E.2d 186, 192 (Ind. Ct. App. 2012)

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(quotation marks omitted). Ethicon could satisfy this standard by providing “[e]vidence of the existing level of technology, 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 satisfying 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 establish that it “complied with applicable codes, standards, 

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regulations, or specifications established, adopted, promulgated, 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 evidence, see FED. R. CIV. P. 51(c)(1), so our review is limited to 

plain error, id. R. 51(d)(2). The regulatory-compliance presumption requires evidence of compliance with governmental 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 associated” 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 outweighed by the risk of confusing or misleading the jury and 

wasting time.

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36 No. 18-2944

That was not an abuse of discretion. To start, evidence of 

Prolift’s § 510(k) clearance faces the same categorical problem 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 predicates—the surgical meshes in the 1988 rulemaking—did not 

come with a reasonable assurance of safety. While incomplete, the § 510(k) history also shows that Prolift’s connection 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 concerns 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 

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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 

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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 underwent 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 comparisons 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 analysis” 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 province 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 considerations if the size of the award can be explained on any reasonable ground.”).

2. Punitive Damages

The judge granted Ethicon’s remittitur motion and reduced 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 

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No. 18-2944 39

and that the size of this award is excessive even after remittitur.

The parties agree that New Jersey law applies to this issue, so bear with us as we discuss one more statutory regime. New Jersey’s Punitive Damages Act establishes a twostep 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 serious harm would arise from the defendant’s 

conduct;

(2) The defendant’s awareness of reckless disregard 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 concealment 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 

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40 No. 18-2944

misconduct to the defendant,” “[w]hen the misconduct was 

terminated,” and “[t]he financial condition of the defendant.” Id. § 2A:15-5.12(c).

Finally, as relevant here, the Punitive Damages Act provides 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 punitive 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 framework; 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 

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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 egregiousness 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 record a reasonable jury could find that Ethicon acted recklessly 

when releasing Prolift and crafting its warnings. For example, 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 complications.

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 genericalCase: 18-2944 Document: 47 Filed: 01/14/2020 Pages: 42
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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 Instructions 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 conclude 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 sufficient evidence existed for punitive damages where a manufacturer 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 warranted punitive damages.

Finally, Ethicon objects that the punitive award is excessive 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

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