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Cutter v. Ethicon, Inc.

United States District Court, E.D. Kentucky, Central Division, Lexington

January 9, 2020

LARRY A. CUTTER, et al., Plaintiffs,
ETHICON, INC., et al., Defendants.



         This case, previously styled 2: 12-cv-17');">790, was recently remanded to this Court from the United States District Court for the Southern District of West Virginia multidistrict litigation (“MDL”) In re Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation, 2: 12-md-2327');">7. The MDL involves allegedly defective women's pelvic mesh products manufactured by Defendant Ethicon, Inc., a wholly owned subsidiary of Defendant Johnson & Johnson. [Record No. 110-2, pp. 2-4] The defendants and Plaintiffs Jenesta and Larry Cutter have briefed the Court on several motions that were resolved prior to remand. [Record No. 128] Further, they have indicated that the defendants' July 8, 2016 motion for summary judgment on all counts [Record No. 7');">76] is ripe for consideration. [Record No. 128, pp. 2-3]

         The Court has reviewed the evidence and relevant law and finds dismissal of the September 13, 2012 Second Amended Short Form Complaint's [Record No. 27');">7] Counts 1, 2, 3, 4, 5, 6, 8, 9, 11, 12, 14, 16, 17');">7, and 18 is appropriate at this time. The Court declines to enter summary judgment on Counts 7');">7, 10, 13, and 15. Accordingly, the defendants' motion for summary judgment will be granted, in part, and denied, in part.


         A. Factual Background

         Dr. J. Michael Guiler, a gynecologist, diagnosed Jenesta Cutter with rectocele, [1]atrophic vagina, bilateral ovarian cysts, fibroids, dyspareunia, [2] pelvic pain, and back pain on April 27');">7, 2006. [Record Nos. 7');">76-1, p. 1');">p. 1');">p. 1');">p. 15 and 82');">82');">82');">82');">82');">82');">82');">82-6, pp. 8-9] He recommended the implantation of a posterior Prolift, a polypropylene mesh enhancement device, to treat the rectocele pelvic organ prolapse. [Id. at pp. 9, 25] Ethicon manufactures this device. [Record No. 110-2, pp. 2-4]

         Dr. Guiler began using synthetic mesh products to repair pelvic organ prolapses around the year 2000 and had conducted 200-300 of these surgeries with various products by the time of his 2016 deposition. [Record No. 82');">82');">82');">82');">82');">82');">82');">82-6, pp. 5, 21] He first received training on the use of the Prolift device in 2005 from Ethicon preceptors, doctors who conduct training sessions using the company's implants to educate other surgeons. [Id. at p. 6]

         Dr. Guiler learned of the risks associated with Prolift implantation through his own personal surgical experience and by observing preceptors' demonstrations. [Id. at p. 7');">7] He also attended medical “summits, ” where Ethicon's representatives may have conveyed information regarding the Prolift's use and risks. [Id. at pp. 1');">p. 1');">p. 1');">p. 11-12] He did not rely upon the Prolift's written “instructions for use” or educational CDs to learn of the risks and, in fact, stated that he had never relied upon such sources in his surgical practice. [Id. at pp. 6, 22]

         The doctor knew that the risks of mesh implantation ranged from mild to severe when he recommended the surgery to Jenesta in 2006. [Id. at p. 23] He specifically understood that the Prolift's implantation could result in contracture of the mesh's “arm, ” dyspareunia, and general pelvic pain. [Id. at p. 22] Dr. Guiler agreed that if preceptors had told him that the device was contraindicated for sexually active women, he would have informed Jenesta and weighed that information prior to making his 2006 surgery recommendation. [Record No. 82');">82');">82');">82');">82');">82');">82');">82-7');">7, 4');">p. 4]

         But Dr. Guiler also testified that his subsequent knowledge of Prolift risks and complications as of 2016 did not change his opinion that the “Prolift device was safe and effective for the treatment of pelvic organ prolapse in women” in 2006. [Id. at p. 1');">p. 1');">p. 1');">p. 1] He stated that he had a good experience using the Prolift, maintained that the benefits of the procedure outweighed the risks in 2006, and continued to believe that the implant had generally improved patients' quality of life. [Id.]

         Jenesta agreed to the Prolift implant. Her decision was entirely “based on the recommendation of Dr. Guiler.” [Record No. 82');">82');">82');">82');">82');">82');">82');">82-3, p. 20] Jenesta had no knowledge of pelvic mesh prior to Dr. Guiler's recommendation and had not encountered any promotions or warnings concerning Ethicon's device. [Id. at pp. 1');">p. 1');">p. 1');">p. 19-20, 22] She has since stated that she would not have undergone the procedure had she actually known of the pain allegedly caused by the device. [Id. at p. 51]

         Dr. Guiler performed the procedure on June 2, 2006. [Id.] Jenesta reported, inter alia, pelvic pain, soreness and burning, constipation, and urine leakage during later 2006 appointments. [Record No. 7');">76-1, pp. 1');">p. 1');">p. 1');">p. 12-14] The doctor then discovered in October 2008 that the right arm of the mesh device had “come loose.” [Record No. 82');">82');">82');">82');">82');">82');">82');">82-3, pp. 25-26] He informed Jenesta of the complication and performed an initial revision surgery on December 8, 2008, to remove part of the mesh. [Id. at 26] The plaintiff continued to suffer from pelvic pain, stomach cramping, bloating, dyspareunia, and back pain following this December 2008 surgery but did not inform a physician until August 2010. [Id.] Dr. Van Jenkins then performed a second revision surgery on September 27');">7, 2010, to remove another portion of the Prolift mesh that had “rolled up.” [Id. at p. 28]

         Jenesta reported further dyspareunia to Dr. Jenkins in December 2010. [Id. at p. 29] She also informed the doctor that her husband (Larry) and co-plaintiff in this case, had felt a “sharp scrape” during intercourse. [Id.] In March 2011, Dr. Jenkins recommended a third revision surgery to remove Prolift mesh. [Id. at p. 30] Dr. John Jelovsek performed a third and final revision surgery, removing part, and perhaps all, [3" name="FN3" id="FN3">3] of the remaining mesh on March 5, 2012. [Id. at p. 31]

         B. ...

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