United States District Court, N.D. Indiana, Hammond Division
OPINION AND ORDER
P. SIMON, UNITED STATES DISTRICT COURT JUDGE
a products liability case where Barbara Kaiser claimed to
have been substantially and permanently injured by a mesh
product that was implanted in her vagina to treat her pelvic
organ prolapse. The mesh product was designed and
manufactured by defendants Johnson & Johnson and Ethicon,
Inc. After a two week trial, the jury agreed with Mrs. Kaiser
and found in her favor on her failure to warn and design
defect claims. The jury awarded Mrs. Kaiser $10 million in
compensatory damages and $25 million in punitive damages. The
jury found in the defendants' favor on the claim of loss
of consortium brought by Anton Kaiser, Mrs. Kaiser's
have filed a motion contesting the verdict, seeking judgment
as a matter of law on both the failure to warn and design
defect claims, or in the alternative a new trial, or in the
alternative to that, a remittitur of the jury's damages
award. [DE 416.] Because there was sufficient evidence for a
reasonable jury to find in favor of Mrs. Kaiser, I will deny
defendants' motion for a judgment as matter of law and
likewise deny defendants' motion for a new trial.
Similarly, because I find the jury's compensatory damages
award was neither monstrously excessive nor the product of
passion or prejudice, I will deny Ethicon's request for a
remittitur of the jury's compensatory damages award.
jury's punitive damage award, however, is another story.
I find the punitive damages award excessive and unreasonable
under controlling law. As such, I will grant defendants'
motion for remittitur of the jury's $25 million punitive
Ethicon and Johnson & Johnson are corporations which,
among other lines of business, design, market, and sell
medical devices. Ethicon is a wholly owned subsidiary of
Johnson & Johnson. For ease of reference I will refer to
both defendants as “Ethicon.” One of the devices
sold by Ethicon was the Prolift Pelvic Floor Repair System.
Prolift is a vaginal mesh which was implanted in Mrs.
Kaiser's pelvis in January 2009 to treat her pelvic organ
prolapse condition. Mrs. Kaiser subsequently experienced
various issues including vaginal pain, pelvic pain, pain
during intercourse, bladder spasms, and bowel issues. All of
these problems associated with the mesh necessitated a second
surgical procedure to have the mesh removed from Mrs.
Kaiser's vagina, or at least as much of it as could be
removed. There was evidence that once the mesh is implanted
it becomes very difficult, if not impossible, to have it all
removed; it grows into the tissue, hardens and causes
Kaiser alleged in her complaint that her injuries were the
result of Prolift's defective design and that Ethicon did
not adequately warn Mrs. Kaiser's surgeon (Dr. Bales) of
the risks associated with Prolift. The case was originally
filed in the United States District Court for the Southern
District of West Virginia, where a consolidated
Multi-District Litigation related to Prolift and other
vaginal mesh products is pending. [DE 1.] On March 28, 2017
the case was transferred here because all pretrial
proceedings had concluded, and the case was ready for trial.
trial began on February 26, 2018 and each side put on
extensive evidence, including multiple witnesses, both fact
and expert, both live and through videotaped deposition
testimony. Trial concluded on March 8, 2018 and after several
hours of deliberations, the jury returned a verdict in favor
of Mrs. Kaiser, awarding her $10 million in compensatory
damages and $25 million in punitive damages. [DE 405.]
Ethicon timely filed the present motion seeking judgment as a
matter of law, or in the alternative a new trial, or in the
alternative of that, a remittitur of the jury's damages
important to note at the outset the posture and standard
applicable to defendants' motions. Federal Rule of Civil
Procedure 50 governs motions for judgments as a matter of
law. Defendants are entitled to a judgment as a matter of law
only if I find “that a reasonable jury would not have a
legally sufficient evidentiary basis to find” in favor
of Mrs. Kaisser. Fed.R.Civ.P. 50(a)(1). In making this
determination, I do not approach the case with new eyes,
examining the evidence and the jury's verdict as though I
am the fact finder receiving the evidence for the first time.
Instead, I may only disregard the jury's verdict
“if no reasonable jury could have found in [Mrs.
Kaiser's] favor.” Erickson v. Wisc. Dept. of
Corrections, 469 F.3d 600, 601, (7th Cir. 2006).
“This is obviously a difficult standard to meet.”
Waite v. Bd. of Trustees of Ill. Cmty. Coll. Dist. No.
508, 408 F.3d 339, 343 (7th Cir. 2005). What makes it
such a daunting standard is that the Supreme Court has
instructed that I “must disregard all evidence
favorable to the moving party that the jury is not required
to believe.” Reeves v. Sanderson Plumbing Prod.,
Inc., 530 U.S. 133, 150-51 (2000).
considering the present motion for judgment as a matter of
law, it is not my role to “re-weigh the evidence
presented at trial or make credibility determinations.”
Black & Decker Inc. v. Robert Bosch Tool Corp.,
No. 04 C 7955, 2007 WL 108412, at *1 (N.D. Ill. Jan. 12,
2007) (citation omitted). As the Supreme Court has succinctly
put it, “[c]redibility determinations, the weighing of
the evidence, and the drawing of legitimate inferences from
the facts are jury functions, not those of a judge, whether
he is ruling on a motion for summary judgment or for a
directed verdict.” Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 255 (1986).
standard applicable to Ethicon's motion for a new trial
is similar but distinct. Federal Rule of Civil Procedure
59(a) governs a motion for a new trial and states that a new
trial may be granted “for any reason for which a new
trial has heretofore been granted in an action at law in
federal court.” Fed. R. Civ. Proc. 59(a)(1)(A). The
Seventh Circuit has explained, “‘[a] motion for a
new trial should succeed ‘only if the verdict is
against the manifest weight of the evidence.'”
ABM Marking, Inc. v. Zanasi Fratelli, S.R.L., 353
F.3d 541, 545 (7th Cir. 2003) (quoting Lowe v. Consol.
Freightways of Del., Inc., 177 F.3d 640, 641 (7th Cir.
1999); Latino v. Kaizer, 58 F.3d 310, 315 (7th Cir.
1995) (“[N]ew trials granted because the verdict is
against the weight of the evidence are proper only when the
record shows that the jury's verdict resulted in a
miscarriage of justice or where the verdict, on the record,
cries out to be overturned or shocks our conscience.”).
Defendants “must demonstrate that no rational jury
could have rendered a verdict against them.” King
v. Harrington, 447 F.3d 531, 534 (7th Cir. 2006)
again, in making this determination, I “must view the
evidence in a light most favorable to [Mrs. Kaiser], leaving
issues of credibility and weight of evidence to the
jury.” Id. “[I]t is an invasion of the
jury's province to grant a new trial merely because the
evidence was sharply in conflict.” Latino, 58
F.3d at 315. “Even when evidence is contradictory,
‘[i]t's the jury's job-not the district
court's job or the job of a panel of appellate judges-to
figure out who's telling the truth.'”
United States v. Hassebrock, 663 F.3d 906, 920 (7th
Cir. 2011) (citation omitted).
was a close case with conflicting expert testimony. On the
one hand, it is certainly true that defendants put forth
evidence which supported their theory of the case: that
Prolift was a safe product, that all necessary warnings were
fully disclosed to the necessary individuals, and that Mrs.
Kaiser's injuries could not be traced to any harm caused
by the vaginal mesh. But it is equally clear the jury did not
believe or find defendants' evidence persuasive enough to
render a verdict in their favor. On the contrary, the jury
obviously believed Mrs. Kaiser and the witnesses who
testified that Prolift was a defective product, that Ethicon
knew of the risks associated with Prolift but chose not to
disclose them to surgeons using the product, and that Mrs.
Kaiser's injuries were the result of her having Prolift
surgically implanted in her. Given the substantial evidence
on both sides of the ledger, it was up to the jury to decide
whose story was more believable. With these general thoughts
in mind, I will now turn to the various motions brought by
Judgment as a Matter of Law as to Failure to Warn
central argument concerning why Mrs. Kaiser's failure to
warn claim must fail is one of causation. Ethicon argues that
Kaiser failed to offer sufficient evidence at trial that Dr.
Bales, the surgeon who implanted the Prolift device into her,
was not adequately warned of risks related to Prolift. [DE
416 at 10-16.] It is the sufficiency of the warnings to Dr.
Bales - not Mrs. Kaiser - that is at issue here. This is
because under the so-called “sophisticated or learned
intermediary doctrine” warnings for prescription drugs
and medical devices “need only be directed to doctors,
not patients who are the ultimate users.” Ortho
Pharm. Corp. v. Chapman, 388 N.E.2d 541, 549
(Ind.Ct.App. 1979). Typically, this is a question of fact for
the jury to determine because “the intermediary's
alleged sophistication may be more or less reasonable given
the product's nature, complexity and associated dangers,
the likelihood that the intermediary will communicate
warnings to the ultimate consumer, the dangers posed to the
ultimate consumer by an inadequate or nonexistent warning,
and the feasibility of requiring the manufacturer to directly
warn the product's ultimate consumers.” Nat.
Gas Odorizing, Inc. v. Downs, 685 N.E.2d 155, 164
support of their argument, defendants rely primarily upon Dr.
Bales's testimony. But Dr. Bales' testimony was in
flux; he said different things at different times in his
deposition. It's worth pointing out that Dr. Bales was
not subpoenaed to testify at the trial despite the fact that
he was within the subpoena power of the Court. I found this
curious, but both parties chose instead to simply rely on his
deposition testimony, a portion of which was read to the
jury. It is true, as the defendants correctly note, that Dr.
Bales's testimony was not entirely favorable to Mrs.
Kaiser. For example, he testified that he did not read the
Instructions for Use (“IFU”) before every
surgery. [DE 395, Ex. H, Bales Tr. at 116:19-118:1.] But Dr.
Bales also testified that he read the IFU for Prolift
multiple times, followed it when implanting Prolift, and that
the IFU influenced his decision to implant Prolift in Mrs.
Kaiser. [Id. at 19:05-19:21; id. at
issue of whether he would have done anything differently had
he known at the time of Mrs. Kaiser's surgery what he
later found out, Dr. Bales' testimony waxed and waned. On
the one hand, when asked generally if he “would have
done anything differently with respect to Ms. Kaiser's .
. . surgery” he responded, “No, not looking back,
I don't think I would have done anything
differently.” [Id. at 84:9-1, 85:6-10.] On the
other hand Dr. Bales specifically testified that once he
realized that the complications from Prolift were happening a
“little too frequently” and the “risks
started to become a little more than you would like and the
benefits are not abundantly clear, ” he started
recommending against the continued use of vaginal mesh.
[Id. at 51:15-52:6.] It was in this context that Dr.
Bales provided the following critical piece of testimony: he
concluded that it was “fair to say that in hindsight,
had I seen potential problems that occurred, I may not have
started employing the Prolift.” [Id. at
22:16-23.] This was the clinching testimony relating to
causation that allowed the failure to warn claim to go to the
jury. So while Dr. Bales said some things that were
contradictory, it was ultimately for the jury to evaluate his
testimony and decide what weight, if any, to put on any
particular piece of evidence.
there was evidence showing that Dr. Bales read and reviewed
the Prolift IFU many times prior to Mrs. Kaiser's
surgery. There was also evidence that Dr. Bales was familiar
with some of the risks associated with Prolift prior to Mrs.
Kaiser's surgery, but not all of them. In that regard,
the most damning testimony from Dr. Bales was his statement
that if he knew at the time of Mrs. Kaiser's surgery what
he later found out about the problems associated with
Prolift, he would not have used the device. In other words,
after learning more about the Prolift after implanting it in
Mrs. Kaiser, he began to have doubts concerning the efficacy
of the product compared to its risks. This was compelling
testimony from an experienced surgeon that the jury was
entitled to credit.
likewise argue that Prolift's warnings were sufficient as
a matter of law because risks associated with Prolift were
fully disclosed in literature and commonly known to pelvic
floor surgeons like Dr. Bales. [DE 416 at 11-12.] But Dr.
Bales and Kaiser's expert Dr. Elliott testified to the
contrary - that they were not aware of every risk claimed in
January 2009 or that such risks were necessarily generally
known amongst pelvic floor surgeons. [DE 395, Ex. H, Bales
Tr. at 22:16-19; Trial Tr. 610:3-15 (testimony of Dr.
Elliott).] The jury heard testimony from Dr. Elliott that the
frequency, severity and permanence of certain complications
were not disclosed within the IFU. [Trial Tr. at 398:4-399:6;
id. at 388:7-390:19.] It was the role of the jury,
as the fact finder, to determine whether the warning was
adequate under the sophisticated intermediary doctrine.
Downs, 685 N.E.2d at 163 (“Whether a
manufacturer has discharged its duty under the sophisticated
intermediary doctrine is almost always a question for the
trier of fact.”). And the jury decided that the warning
was inadequate in this case.
further criticize the testimony of Mrs. Kaiser's experts,
Dr. Elliott and Dr. Rozenzweig, for testifying that they
expect all risks related to a medical device to be disclosed
within the IFU. [DE 416 at 11.] Defendants argue that this
testimony put forth an impermissibly high standard- higher
than what is required under the law. But defendants'
arguments suffer from a fatal flaw; plaintiffs' experts
did not testify as to the legal standard applicable to a
failure to warn or opine on the law. The jury instructions
stated the correct legal standard, namely that a manufacturer
need only disclose “reasonable warnings about the
dangers of the product when the seller, by exercising
reasonable diligence, could have made those warnings
available to the user or consumer.” [Trial Tr.
1744:15-19.] There is no reason to believe that the jury
disregarded those instructions in reaching its verdict.
See Schandelmeier-Bartels v. Chicago Park Dist., 634
F.3d 372, 387 (7th Cir. 2011) (“We assume that the jury
followed the instructions as they were provided.”).
there was sufficient evidence for a reasonable jury to
conclude that Ethicon failed to warn Dr. Bales of the
necessary risks related to Prolift. The law does not require
a plaintiff to offer unequivocal evidence at a trial or proof
beyond a reasonable doubt, only sufficient evidence that a
reasonable jury could find in its favor. See Fed. R.
Civ. P. 50(a)(1). For the reasons I have just stated, Mrs.
Kaiser met that standard here on the failure to warn claim.
Judgment as a Matter of Law as to Design Defect
design defect claim, defendants raise four arguments as to
why they are entitled to a judgment as a matter of law:
First, that they were entitled to a state of the art
presumption under Indiana law; second, that the evidence
offered by Kaiser failed to establish that Prolift was in
fact defective; third, that Kaiser failed to establish that
her injuries were caused by Prolift; and fourth, for the
first time before me, Ethicon raises a conflict preemption
defense, arguing that the FDA's requirements that new or
altered products receive some form of FDA clearance before
they can be marketed conflicts with Mrs. Kaiser's state
law claim. I am not persuaded by any of these arguments.
State of the Art Presumption under Indiana Law
Indiana Products Liability Act (IPLA) allows for a defendant
to avail itself of a rebuttal presumption that its product
was not defective if it was designed and manufactured
“in conformity with the generally recognized state of
the art applicable to the safety of the product at the time
the produce was designed, manufactured, packaged, and
labeled.” Ind. Code § 34-20-5-1. The statute does
not define “state of the art” but courts have
defined it to mean “the best technology reasonably
feasible.” Indianapolis Athletic Club, Inc. v. Alco
Standard Corp., 709 N.E.2d 1070, 1074 (Ind.Ct.App.
1999). In order to avail itself of the presumption, a
defendant must put forth “[e]vidence of the existing
level of technology, industry standards, the lack of other
advanced technology, the product's safety record, [or]
the lack of prior accidents . . . in order to prove that a
product is state of the art.” Wade v.
Terex-Telelect, Inc. 966 N.E.2d 186, 192 (Ind.Ct.App.
2012) (citing Weller v. Mack Trucks, Inc., 570
N.E.2d 1341, 1343 (Ind.Ct.App. 1991). A defendant must make a
showing that no other similarly advanced technology existed
at the time the product was designed and manufactured.
Wade, 966 N.E.2d at 193-194.
issue, this case is similar, albeit the inverse, to the facts
before the Indiana Court of Appeals in Wade. In that
case, the trial court actually gave the “state of the
art” jury instruction but the Court of Appeals found
that to be improper and reversible error because the
defendants failed to offer sufficient evidence at trial which
would meet their burden to make use of the rebuttable
presumption. The court in Wade held that the
defendant was not entitled to the rebuttable presumption in
part because they manufactured products which both had and
did not have the design defect in question (a lack of
interior step in a “bucket” attached to a vehicle
used by electrical workers to repair power lines).
Wade, 966 N.E.2d at 194-195 (“The fact that
Terez manufactured a liner with an interior step at the time
that the liner at issue was manufactured shows that there was
other advanced technology available.”).
guided by Wade in my decision not to give a state
the art instruction. At the time Prolift was launched,
defendants manufactured another vaginal mesh material, known
as Ultrapro. This existence of an alternative belies any
notion that Prolift was truly the
state of the art at the time. It is true that certain
witnesses did testify that Prolift was in their opinion a
good product and “better than anything that has been
out there before.” [DE 387 Hinoul Tr. 1282:22-1283:1.]
But there was competing testimony that even at the time
Prolift was launched, it was contemplated that the mesh
material used in Prolift would be replaced, and potentially
by Ultrapro, another mesh product produced by Ethicon. [DE
395, Ex. E, Hinoul Tr. 891:2-892:3; DE 395, Ex. I, Arnaud Tr.
there was evidence that at the time Prolift first began to be
marketed, defendants had not conducted any clinical trials of
Prolift in humans. [DE 395, Ex. E, Hinoul Tr. 200:9-200:12;
id. at 726:21-726:25; id. at 727:1-727:4.]
Thus, there was no evidence which Ethicon did or could have
introduced showing Prolift's specific safety track record
at the time it was brought to market. See Wade, 966
N.E.2d at 194 (“Terex introduced no evidence regarding
the product's safety record and the lack of prior
accidents pertaining to the buckets . . .”). Given that
defendants did not present sufficient evidence to warrant the
rebuttal presumption and jury instruction on state of the
art, they cannot sufficiently show that they were entitled to
judgment as a matter of law on this same issue.
Lack of Design Defect
next argue that all of Mrs. Kaiser's complications
“were well known to pelvic floor surgeons, including
Dr. Bales.” [DE 416 at 19.] Without any unknown or
undisclosed risk, a product cannot have been unreasonably
dangerous. Id. But as I did above, I must reject
this argument relating to Dr. Bale's knowledge because,
while there was testimony indicating that Dr. Bales
appreciated many risks associated with Prolift, there was
additional testimony, both from Dr. Bales himself and Dr.
Elliott that both he and the pelvic floor surgeon community
were not fully apprised of every risk associated with
Prolift. [DE 395, Ex. H, Bales Tr. at 22:16-19; Trial Tr.
610:3-15.] Thus it was not unreasonable as a matter of law
for the jury to find for Kaiser on this element of her claim.
main argument on this element, however, is that I reconsider
my prior ruling on whether proof of a safer alternative
design is an element of a design defect claim under Indiana
law. [DE 416 at 19-20.] My prior ruling [DE 329 at 6-14],
that such proof is not an element of a design defect claim
under Indiana law, was dictated by the Indiana Supreme
Court's decision in TRW Vehicle Safety Systems, Inc.
v. Moore, 936 N.E.2d 201 (Ind. 2010). In TRW,
the Indiana Supreme Court squarely rejected any such
requirement based upon the language of the IPLA.
TRW, 936 N.E.2d at 209 (“Thus the statute
itself prescribes the applicable standard of care. We decline
to require proof of any additional or more particular
standard of care in product liability actions alleging a
design defect.”); id. at 209, n.2 (noting that
Indiana legislature declined to adopt the America Law
Institute's “different approach” which
requires proof of safer alternative design as an element of a
design defects claim). Notwithstanding some loose language in
several cases to the contrary, it remains my view the
TRW settles the issue of whether evidence of a safer
alternative design is necessary in a design defect case
brought under Indiana. The Indiana Supreme Court has stated
explicitly that such proof is not required. That's the
end of the matter from my point of view.
more, defendants have not offered any additional basis for me
to reconsider my ruling but instead state that they have done
so only “to preserve the issue” while repeating
their prior arguments. [DE 416 at 19.] Nor have they provided
any persuasive reason as to why I should depart from Indiana
law as decided by Indiana's highest court. Since this
issue was squarely decided in TRW and there has been
no intervening change in the law or other manifest error, I
decline to reconsider this issue or find it a basis for a
judgment as a matter of law in defendants' favor.
Cain v. Grams, No. 09-CV-145-BBC, 2009 WL 2408342,
at *1 (W.D. Wis. July 31, 2009) (“[A] motion to
reconsider should not be used to rehash previous
arguments.”) (citing Oto v. Metro Life Insurance
Co.,224 F.3d 601, 606 (7th Cir. 2000)); Lock Realty