Patricia Stark v. Johnson & Johnson

10 F.4th 823
CourtCourt of Appeals for the Seventh Circuit
DecidedAugust 24, 2021
Docket20-1837
StatusPublished
Cited by25 cases

This text of 10 F.4th 823 (Patricia Stark v. Johnson & Johnson) is published on Counsel Stack Legal Research, covering Court of Appeals for the Seventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Patricia Stark v. Johnson & Johnson, 10 F.4th 823 (7th Cir. 2021).

Opinion

In the

United States Court of Appeals For the Seventh Circuit ____________________ No. 20-1837 PATRICIA A. STARK, Plaintiff-Appellant, v.

JOHNSON & JOHNSON and ETHICON, INC., Defendants-Appellees. ____________________

Appeal from the United States District Court for the Northern District of Illinois, Eastern Division. No. 1:18-cv-06609 — Mary M. Rowland, Judge. ____________________

ARGUED NOVEMBER 30, 2020 — DECIDED AUGUST 24, 2021 ____________________

Before EASTERBROOK, WOOD, and HAMILTON, Circuit Judges. HAMILTON, Circuit Judge. This appeal turns on the Illinois discovery rule for applying the statute of limitations to prod- uct liability claims. Plaintiff Patricia Stark had surgery in 2007 to implant a pelvic mesh device. The surgery was not success- ful, and she had follow-up surgeries that also were not suc- cessful. In 2018, she learned for the first time that her prob- lems with the pelvic mesh device might have resulted from a 2 No. 20-1837

defect in the product itself. She consulted a lawyer and later that year filed this suit against the manufacturer. The district court concluded that Ms. Stark should have realized much earlier that the product might have been defective. The court granted summary judgment based on the two-year statute of limitations. We reverse. The statute of limitations began to run only when Ms. Stark should have realized that her mesh-related complications might have been wrongfully caused by another person. As a general rule, the failure of a medical procedure or product to cure a patient does not necessarily signal that anyone acted wrongfully, particularly when the patient experiences known complications that do not necessarily result from tortious actions. In addition here, plaintiff’s medical history included Ehlers-Danlos syndrome, which two of her doctors told her could explain her continued problems. The combination of that general principle and plaintiff’s specific circumstances could allow a reasonable jury to decide that this suit was timely. I. Factual and Procedural Background A. Facts for Purposes of Summary Judgment Because plaintiff Stark appeals from a grant of summary judgment, we must view the evidence in the light reasonably most favorable to her and give her the benefit of conflicts in the evidence. Greengrass v. Int’l Monetary Sys. Ltd., 776 F.3d 481, 485 (7th Cir. 2015). We do not vouch for the objective truth of every fact that we must assume to be true for pur- poses of the appeal. KDC Foods, Inc. v. Gray, Plant, Mooty, Mooty & Bennett, P.A., 763 F.3d 743, 746 (7th Cir. 2014). No. 20-1837 3

1. Plaintiff’s Relevant Medical History In 1999, Ms. Stark began seeing Andrew Roth, M.D., as her primary care physician and obstetrician-gynecologist. During a December 2006 appointment, Dr. Roth diagnosed Ms. Stark with stress urinary incontinence, which is the unintentional loss of urine as a result of an increase in intra-abdominal pressure, such as that caused by coughing or sneezing. Dr. Roth provided Ms. Stark with information about a possible treatment for her incontinence, the surgical implantation of a mesh TVT-Obturator (“TVT-O”) sling device manufactured by defendant Ethicon, Inc., a subsidiary of defendant Johnson & Johnson. Dr. Roth testified that, as of his deposition in 2019, he had implanted approximately 400 TVT-O slings. On February 5, 2007, Ms. Stark returned to Dr. Roth for a consultation about the TVT-O sling. Dr. Roth also offered Ms. Stark a non-surgical treatment option, but she opted for sur- gery because she wanted a more permanent solution with a higher likelihood of success. Dr. Roth described the surgery to Ms. Stark in the follow- ing terms: “We would make a small incision in the vagina. I would thread a tape [the TVT-O sling] underneath her blad- der. It would wrap around the pubic bone and come out the inner thigh on both sides.” Dr. Roth testified that they dis- cussed potential risks associated with the procedure, includ- ing “death, injury to bowel or bladder, possible nephrostomy, colostomy, exploratory laparotomy, hysterectomy, blood re- placement, infection and prolonged catheterization.” They did not specifically discuss the risk of mesh from the sling eroding into her urethra. Dr. Roth believed that the potential benefits of the TVT-O sling outweighed the risks in Ms. Stark’s case. 4 No. 20-1837

Ten days later, on February 15, Dr. Roth performed surgery to implant the TVT-O sling. After the surgery, Ms. Stark had a general feeling that it had not worked. She continued to experience urinary incontinence, leakage, and subsequent odor.1 After the surgery, Dr. Roth explained to Ms. Stark that her Ehlers-Danlos syndrome (“EDS”) might be contributing to her poor wound healing and post- implantation complications. EDS refers to a group of inherited disorders that affect the body’s connective tissues. Ehlers-Danlos syndrome, Mayo Clinic, https://www.mayoclinic.org/diseases-conditions/ehlers- danlos-syndrome/symptoms-causes/syc-20362125 (last visited Aug. 23, 2021). People with EDS generally experience symptoms such as hyperflexible joints and extremely stretchy, fragile skin. Id. Skin fragility can lead to post- surgical issues, including increased bleeding and poor wound healing. Dr. Roth did not tell Ms. Stark that mesh from the sling might be the cause of her pain—that the mesh itself might be defective. For her part, Ms. Stark believed then that her EDS was to blame. In early 2008, Ms. Stark sought a second opinion to ad- dress her continued incontinence. On March 5, 2008, Denise Elser, M.D., a urogynecologist, determined that she was still experiencing tenderness in her pelvic floor muscles, stress in- continence, and cystocele. Cystocele, sometimes referred to as a dropped or fallen bladder, occurs when the bladder drops into the vagina. Cystocele (Fallen Bladder), Cleveland Clinic,

1Dr. Roth testified that urge incontinence can also be a complication of TVT-O sling implantation. No. 20-1837 5

https://my.clevelandclinic.org/health/diseases/15468-cysto- cele-fallen-bladder (last visited Aug. 23, 2021). Dr. Elser also found that Ms. Stark’s TVT-O sling had shifted. Dr. Elser recommended, and Ms. Stark agreed to, implan- tation of a mesh TVT retropubic sling, also manufactured by Ethicon, to treat her continued incontinence. Both the TVT-O and TVT retropubic slings are made of synthetic mesh. Midurethral sling surgery for stress incontinence, Harvard Women’s Health Watch (Sep. 2010), https://www.health.har- vard.edu/newsletter_article/midurethral-sling-surgery-for- stress-incontinence (last visited Aug. 23, 2021). The retropubic method positions the mesh under the urethra in a U shape. The ends of the sling are brought up behind the pubic bone and out through incisions above the pubic bone. The TVT-O approach passes the mesh under the urethra and out through incisions in the groin. As part of the informed consent process, Dr. Elser dis- cussed with Ms. Stark the risks of mesh erosion and the need for additional operations to excise any eroded mesh, as well as recurrent stress incontinence, urge incontinence, and void- ing difficulty. Dr. Elser scheduled the surgery for May 21, 2008. During the surgery, Dr. Elser discovered fibers of eroded mesh from the TVT-O sling implanted by Dr. Roth that had become embedded in Ms. Stark’s urethral wall. After implant- ing the new TVT retropubic sling, Dr. Elser removed the eroded mesh and repaired the urethra. However, Dr. Elser was unable to remove all the eroded mesh. Following the surgery, Dr. Elser explained to Ms. Stark that mesh from the previously implanted TVT-O sling had 6 No. 20-1837

eroded into her urethra. Dr.

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Bluebook (online)
10 F.4th 823, Counsel Stack Legal Research, https://law.counselstack.com/opinion/patricia-stark-v-johnson-johnson-ca7-2021.