Cutter v. Ethicon, Inc.
| Decision Date | 25 August 2021 |
| Docket Number | 20-6040 |
| Court | U.S. Court of Appeals — Sixth Circuit |
| Parties | JENESTA CUTTER; LARRY A. CUTTER, Plaintiffs-Appellants, v. ETHICON, INC.; ETHICON WOMEN'S HEALTH AND UROLOGY, a Division of Ethicon, Inc.; GYNECARE; JOHNSON & JOHNSON, Defendants-Appellees. |
In 2006, Jenesta (Sue) Cutter underwent implantation of a Prolift-brand mesh device manufactured by Defendants to treat her pelvic prolapse and pelvic pain. But her symptoms soon returned. Over the course of the next several years, she sought relief from multiple doctors and underwent several revision surgeries. In May 2012, after Cutter came to believe that her problems were being caused by a defect in the Prolift itself, she and her husband, Larry Cutter, brought suit against Defendants. The district court granted summary judgment dismissing their complaint. The Cutters appeal the district court's dismissal of their product-liability negligence, and loss-of-consortium claims as barred by Kentucky's statute of limitations, and its dismissal of their failure to warn claim on the alternate ground that Defendants' warnings were not the proximate cause of the Cutters' harms. For the reasons stated below, we AFFIRM in part and REVERSE in part.
The facts are presented in the light most favorable to the Cutters. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986).
In April 2006, Sue Cutter sought treatment from Dr. Michael Guiler for a constellation of conditions and symptoms, including pelvic organ prolapse (an uncomfortable condition in which her uterus was pushing down into her vagina), ovarian cysts, fibroids, pain during sexual intercourse, pelvic pain, back pain, frequent urination, hot flashes, and moodiness. At Guiler's recommendation, Cutter agreed to undergo a hysterectomy and implantation of a Prolift brand pelvic mesh, manufactured by Ethicon, a subsidiary of Johnson &Johnson. At the time, Cutter believed the implant was something "natural" rather than a "synthetic" manufactured product. And her husband Larry had previously received a mesh implant for a fistula, with no adverse effects. Guiler performed the procedure in June 2006, and at first Cutter's symptoms improved. But by the end of 2007, she was again reporting pain and issues with urination.
Cutter returned to Guiler's office in the fall of 2008 to seek treatment for her continuing pelvic and back pain, pain with intercourse, and point tenderness near the implant. According to Cutter, after conducting a battery of tests, including a colonoscopy and a neurological exam, Guiler informed her that the right arm of the Prolift had come loose, causing the tenderness. Cutter recalled that Guiler proposed "go[ing] in and repair[ing]" the mesh, her husband believed Guiler was going to "put the arm back" because it "had come loose." Guiler testified that he believed Cutter's pain was associated with scar tissue that had developed on the loose arm of the implant, and so he removed the scar tissue as well as part of the mesh arm to provide "complete relief." That type of scarring, he explained to her, was a standard risk that could "occur with any surgery."
Guiler performed the revision surgery soon afterwards, removing the loose right arm. At a post-operative checkup, Guiler observed that Cutter was "healing well." But Cutter continued to experience pain with intercourse; her pelvic pain improved for a "short while" before it too returned. In August 2010, Cutter sought a second opinion from Dr. Charles Papp, who told her that the Prolift appeared to be "rolled up" in the area where she was having pain. Cutter did not remember Papp telling her that her pain was related to the mesh. And according to Papp's notes, he was unable to palpate the mesh, but thought it was "possible" that the mesh was "contributing to her symptoms." He referred Cutter to Dr. Van Jenkins for a second opinion.
Jenkins confirmed that the Prolift was rolled up and recommended removing a portion of the mesh. Cutter understood Jenkins' and Papp's statements to mean that her pain was being caused by "the way [the mesh] was rolled up and that, you know, my body wasn't accepting it." In September 2010, Jenkins removed certain pieces of the implant vaginally. He reported afterwards that everything looked good. During intercourse two months later, however, Cutter's husband felt a "sharp scrape" that caused "some pretty deep scratch marks on the head of [his] penis." Cutter went back to Jenkins to report that injury and her own continuing pain. Jenkins's notes did not attribute either of these issues to the implant; he observed that he was unable to palpate the mesh but noted separation of the vaginal tissue. He prescribed painkillers, silver nitrate, and an antibacterial gel to treat the separation and advised Cutter to use warming jelly and increase foreplay during intercourse.
Throughout the spring of 2011, Cutter returned to Jenkins for multiple follow-up appointments, continuing to report pain and discomfort. In February, Jenkins noted the continuing separation of her vaginal tissue and discussed with Cutter the possibility of "excising this area that seems to separate and actually suturing it back together." He wrote that "[t]here was no palpable mesh in that area." On March 9, Jenkins noted that the separation appeared to have improved and proposed monitoring the area, but if it continued to separate, suggested the possibility of excising that area. He continued to monitor her in April and May; on May 11, for example, Jenkins noted improvement to Cutter's pain and the separated area, as well as an asymptomatic granular excoriation near her cervix, which he treated with medication. Nowhere in his notes did Jenkins suggest that he thought the Prolift was causing Cutter's problems nor that it needed to be removed. Cutter recalled that Jenkins at some point recommended removing more of the implant but did not suggest that her symptoms were due to the implant itself.
According to Jenkins' notes, on June 22, 2011, Cutter told him that she believed her symptoms were "from [the] mesh," and they discussed removing the rest of it abdominally at that appointment and again in July. Jenkins did not express his view of Cutter's belief, but ultimately declined to perform the procedure himself for personal health reasons. Cutter then visited several other doctors and eventually underwent two additional revision surgeries to remove more of the mesh in March 2012 and January 2019. In November 2011, the Cutters saw an advertisement on television describing the Prolift's alleged defects.
The Cutters sued Ethicon in May 2012, asserting 18 claims under Kentucky law. The case was transferred into a multi-district litigation concerning the Prolift. The MDL master complaint, which the Cutters have incorporated by reference in a short-form complaint, alleged that the Prolift is made of a biologically incompatible material that causes adverse immune responses, is prone to contamination, degrades and deforms after implantation, degrades surrounding tissue, causes nerve damage, and more. Plaintiffs allege that Defendants knew of these problems and the risks of the Prolift and its implantation procedure but misrepresented and concealed them.
The Cutters' suit was remanded to the Eastern District of Kentucky on November 4, 2019. Ethicon moved for summary judgment, arguing in part that the Cutters' negligence, loss-of-consortium, and product-liability claims were barred by Kentucky's one-year statute of limitations. The district court granted the motion in January 2020, holding that as a matter of law, the Cutters' "injury" from the Prolift arose no later than March 2011, more than one year before they filed suit. It noted that the Cutters' failure to warn products liability claim also failed for lack of proximate cause. In April, the district court issued an order resolving various outstanding Daubert motions, noting that some of these motions had been rendered moot by its earlier summary judgment order. Ethicon then filed a second motion for summary judgment directed at the Cutters' negligent infliction of emotional distress and fraud by omission. The district court granted the motion and entered final judgment against the Cutters on August 14, 2020. The Cutters timely appealed the judgment, and challenge the district court's dismissal of their negligence, loss-of-consortium, and product-liability claims.
We review a grant of summary judgment de novo. See Kalich v. AT&T Mobility, LLC, 679 F.3d 464, 469 (6th Cir. 2012). Summary judgment is appropriate where "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c)). The moving party bears the burden of demonstrating there is no dispute of fact; if the movant succeeds, the nonmoving party "must set forth specific facts showing that there is a genuine issue for trial." Anderson v. Liberty Lobby, 477 U.S. 242, 250 (1986) (quoting Fed.R.Civ.P. 56(e)). And a genuine issue for trial exists where "there is sufficient evidence favoring the nonmoving party" that a reasonable jury could return a verdict in her favor. Id. In conducting this analysis, we do not judge credibility or weigh conflicting evidence; instead, we accept the evidence of the nonmoving party, and draw "all justifiable inferences" in her favor. Id. at 255.
Kentucky law provides...
To continue reading
Request your trial