May 21, 2019
from the United States District Court for the Northern
District of Indiana, Hammond Division. No. 2:17-cv-00114 -
Phillip P. Simon, Judge.
Flaum, Kanne, and Sykes, Circuit Judges.
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 not completely extract it. He
informed her that the painful complications she was
experiencing were likely permanent.
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.
appeal is a broad-spectrum attack on the judgment, 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.
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.
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.
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
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
"[transient leg pain may occur and can usually be
managed with mild analgesics."
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
frequently became permanent. Following years of complaints
and FDA scrutiny Ethicon took Prolift off the market in 2012.
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.
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.
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.
a Class III device is one for which "insufficient
information exists to determine" that either general or
special controls "would provide reasonable assurance of
... 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).
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).
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).
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 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
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).
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.
§ 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 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).
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.
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 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).
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.
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
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
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. According to Ethicon, Prolift had the same
technological characteristics as these predicates.
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). Due to "insufficient evidence of
safety and effectiveness/' the FDA assigned these
surgical meshes to Class II. Id.
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
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.
Kaiser's Surgery and Lawsuit
suffered from a severe anterior pelvic-organ prolapse. 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
condition. She was then 60 years old. The parties agree that
Dr. Bales properly implanted Prolift and otherwise met the
appropriate standard of care.
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.
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.
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. 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.
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 ...