Thacker v. Ethicon, Inc.

47 F.4th 451

Connie J. THACKER, Plaintiff-Appellant,

v.ETHICON, INC. ; Johnson & Johnson, Defendants-Appellees.

No. 21-6193

United States Court of Appeals, Sixth Circuit.

Argued: June 9, 2022

Decided and Filed: August 26, 2022

ARGUED: G. Sean Jez, FLEMING, NOLEN & JEZ, LLP, Houston, Texas, for Appellant. Amy M. Pepke, BUTLER SNOW LLP, Memphis, Tennessee, for Appellees. ON BRIEF: G. Sean Jez, Gregory D. Brown, Sylvia Davidow, FLEMING, NOLEN & JEZ, LLP, Houston, Texas, for Appellant. Amy M. Pepke, Susanna M. Moldoveanu, BUTLER SNOW LLP, Memphis, Tennessee, Charles A. Byrd, BUTLER SNOW LLP, Ridgeland, Mississippi, for Appellees.

Before: CLAY, ROGERS, and KETHLEDGE, Circuit Judges.

CLAY, Circuit Judge.

Plaintiff Connie Thacker sued Defendants Ethicon Inc. and its parent company Johnson & Johnson (collectively "Ethicon") alleging that two medical devices that Ethicon manufactured caused Thacker to suffer several injuries. She brought strict liability and negligence claims under the Kentucky Product Liability Act ("KPLA") alleging design defect and failure to warn. See Ky. Rev. Stat. § 411.300 – 411.340. After the close of discovery, Ethicon moved for summary judgment. The district court granted Ethicon's motion for summary judgment on Thacker's KPLA claims. See Thacker v. Ethicon, Inc. , 571 F. Supp. 3d 691, 695 (E.D. Ky. 2021). For the reasons set forth below, we REVERSE the district court's order and REMAND for further proceedings.

I. BACKGROUND

A. Factual Background

1. Ethicon's Pelvic Mesh Devices

This litigation involves two medical devices (the "Pelvic Mesh Devices") manufactured by Ethicon. The first is a mesh sling called TVT-Secur. Ethicon introduced the TVT line of devices in 1998. It developed the TVT-Secur to treat stress urinary incontinence ("SUI"). SUI "is the involuntary leakage of urine during moments of physical activity that increases abdominal pressure, such as coughing, sneezing, laughing, or exercise." (Rosenzweig General Rep., R. 225-9, Page ID #10597.) Ethicon launched the second device, a posterior mesh called Prolift, in March 2005. Prolift was designed to treat pelvic organ prolapse ("POP"). POP "is a condition in which one or more of the female pelvic organs (bladder, rectum, uterus, and/or intestines) drop into the vagina to varying degrees ... to form a bulge or fullness in the vagina." (Elliot Rep., R. 225-12, Page ID #12228.) Both devices must be surgically implanted into a woman's pelvic walls. When Ethicon distributed the devices, it included a packet of Instructions for Use ("IFU") that gave various warnings and disclosures about the devices.

Both devices use a type of mesh called Prolene. Prolene mesh is made of a material called polypropylene. It was developed in 1974 for use in hernia repairs. Prolene is considered a "small pore, heavyweight mesh[ ]." (Rosenzweig General Rep., R. 225-9, Page ID #10616.) Eventually, Ethicon stopped using Prolene mesh for hernia repairs, but it continued to use it in its Pelvic Mesh Devices. For the hernia repairs, Ethicon switched to a "large pore, lighter weight mesh[ ]" called Ultrapro, which was shown to "minimize the complications seen with heavyweight meshes like the Prolene" found in the Pelvic Mesh Devices. (Id. at Page ID #10606, #10616.) Lighter weight meshes with larger pores were known to be a "superior mesh design to prevent" certain severe side effects associated with smaller pore meshes like Prolene. (Id. at Page ID #10623–24.) Ultrapro also contained less polypropylene than the Prolene mesh used in TVT-Secur and Prolift. Over the years, studies have shown that using polypropylene mesh in a permanent implant in a woman's pelvic walls can cause additional side effects "because of the chemical composition and structure of the mesh." (Id. at Page ID #10606–07.)

2. Thacker's Medical History and Treatment

Plaintiff Connie Thacker is approximately 60 years old. In early 2009, Thacker began seeing a board-certified obstetrician-gynecologist named Dr. Michael Guiler. She reported symptoms including pelvic pressure, discomfort during intercourse, and frequent and urgent urination (particularly at night). Dr. Guiler diagnosed her with rectocele¹ (a type of POP) and mild SUI. He recommended surgery to implant the TVT-Secur to treat Thacker's SUI and Prolift to treat her rectocele. Dr. Guiler told Thacker that the devices were "something new" and that they were the "gold standard" and a "good product." (Thacker Dep., R. 159-4, Page ID #2891.) On May 8, 2009, Dr. Guiler surgically implanted both devices. Before the surgery, Thacker reviewed and signed an informed consent form. The form listed several risks of surgery including: "infections and/or erosions of the mesh" which could require additional follow-up surgeries; "urinary retention" meaning "the inability to empty the bladder fully;" "[p]ainful intercourse and vaginal shortening," although this side effect was said to be "uncommon" and was rarely permanent; and treatment failure (meaning continued POP and SUI). (Informed Consent Form, R. 225-8, Page ID #10591.)

After the surgery, Thacker's incontinence worsened, and she suffered from shooting pain in her groin area and severe abdominal swelling and bloating. In 2010, Thacker started experiencing severe and unbearable pain during intercourse (known as dyspareunia ). Thacker reported these problems to Dr. Guiler in a 2012 follow-up appointment, and she also told her primary physician and a therapist whom she was seeing at the time. Her primary physician sent her to a specialist, who examined her and told her that some of the mesh from the implanted Pelvic Mesh Devices "was all bunched up on the left side." (Thacker Dep., R. 159-4, Page ID #2897.) The specialist sent her to Dr. Marie Fidela Paraiso at the Cleveland Clinic. Dr. Paraiso diagnosed Thacker with "[d]ebilitating pelvic pain due to vaginal mesh, severe dyspareunia, urinary frequency, and urinary dysfunction." (Rosenzweig Specific Rep., R. 225-4, Page ID #10421.) On September 27, 2012, Dr. Paraiso revised Thacker's TVT-Secur sling and removed a portion of the Prolift device. Without the Prolift, Thacker risked recurrent POP, so Dr. Paraiso performed a different procedure to correct Thacker's rectocele. Thacker reported that her pain and side effects from the Pelvic Mesh Devices worsened after the 2012 surgery. Over the next several years, Thacker continued to report severe dyspareunia, pelvic pressure, and urinary and fecal incontinence to her primary physician. Sometime in 2016, she discovered a piece of the mesh from one of the devices in her urine.

On January 27, 2019, Thacker began seeing Dr. Dionysios Veronikis, who specializes in female pelvic medicine and reconstructive surgery. Dr. Veronikis recommended surgery to remove the remaining mesh arms of both the TVT-Secur and Prolift devices. He operated on Thacker on March 1, 2019, but he was only able to locate and remove the TVT-Secur. He was unable to locate and remove the mesh arms of the Prolift device. Thacker said that her pelvic pain decreased after this surgery, but she was still in pain. She continued to struggle with urinary and fecal incontinence. All said, Thacker claims that the 2009 surgical implantation of the Pelvic Mesh Devices caused her several injuries including:

Mesh erosion into pelvic floor muscles, pelvic pain, suprapubic pain, vaginal pain, dyspareunia, recurrent urinary tract infections, voiding [urinary] dysfunction, incomplete bladder emptying, mixed urinary incontinence, bowel dysfunction, rectal pain, levator [rectal] spasm[,] and leg pain.

(Rosenzweig Dep., R. 225-3, Page ID #10365.)

3. Dr. Guiler's Deposition Testimony

Dr. Guiler was deposed more than eleven years after Thacker's surgery. While most of his deposition gave details about Thacker's surgery, he was also asked about his experience with Ethicon's Pelvic Mesh Devices. By May 2009, he had performed about 300 surgeries using the TVT-Secur and 75 to 100 surgeries using the Prolift. Before surgically implanting those devices into Thacker, Dr. Guiler did a risk-benefit analysis and concluded that the devices were the best option for treating her SUI and POP.

Dr. Guiler had learned about the devices through his education, training, and experience; his personal familiarity with the devices; medical journals and conferences; the IFUs; and input from other physicians who were doing similar procedures. He testified that he would expect Ethicon to disclose the severity and probability of certain complications in the IFUs. Had Ethicon disclosed certain risks, that additional information would have impacted his risk-benefit assessment for Thacker's treatment plan. However, he said that he continued to believe that the TVT-Secur and Prolift were safe and effective treatment options back in 2009, even with the knowledge he had at the time of his deposition. He did not explain what he had since learned about the Pelvic Mesh Devices in the years after Thacker's surgery.

4. Expert Witness Reports and Testimony

The summary judgment briefing included expert reports from two of Plaintiff's witnesses: Dr. Bruce Rosenzweig and Dr. Daniel Elliot. Dr. Rosenzweig submitted two expert reports, one that he created for Thacker's case (the "specific report") and one that he produced for the multidistrict litigation ("MDL") related to Ethicon's Pelvic Mesh Devices (the "general report"). In his specific report, Dr. Rosenzweig opined on both TVT-Secur and Prolift and offered several conclusions. He opined that: (1) the devices were defectively designed because the Prolene mesh in both devices created a high risk of severe and permanent injuries; (2) Ethicon could have used a feasible alternative design by using Ultrapro instead of Prolene mesh; (3) the devices’ IFUs did not adequately disclose the risks of Prolene mesh; (4) failure to disclose these risks caused Thacker's injuries. His specific report incorporated the findings from his general report, which was about TVT-Secur,...