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Kaiser v. Johnson & Johnson

United States District Court, N.D. Indiana, Hammond Division

August 8, 2018




         This is 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 husband.

         Defendants 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.

         The 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 damage award.


         Defendants 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 substantial pain.

         Mrs. 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. [DE 160.]

         A jury 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 awards.

         Legal Standard

         It is 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).

         In 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).

         The 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) (citation omitted).

         Once 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).


         This 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 Ethicon.

         A. Judgment as a Matter of Law as to Failure to Warn

         Defendants' 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 (Ind.Ct.App. 1997).

         In 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 19:23-20:09.]

         On the 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.

         In sum, 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.

         Defendants 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.

         Defendants 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.”).

         In sum, 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.

         B. Judgment as a Matter of Law as to Design Defect

         On the 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.

         1. State of the Art Presumption under Indiana Law

         The 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.

         On this 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.”).

         I was 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. 367:7-368:5.]

         Likewise, 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.

         2. Lack of Design Defect

         Defendants 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.

         Defendants' 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.

         What's 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 Corp. ...

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