On Jan. 27, 2012, plaintiff Florence Kuhlmann, 59, underwent elective out-patient stapled hemorrhoidopexy surgery, which was performed by Dr. Rakhee Shah at Pleasanton Surgery Center, in Pleasanton. The procedure was to address symptomatic grade III hemorrhoids and included the use of a Proximate PPH Procedure Set (PPH03) hemorrhoid stapler, manufactured by Ethicon Endo-Surgery, LLC, Inc., a subsidiary of Johnson & Johnson. The PPH03 stapler was used to excise excess tissue and return hemorrhoids to their anatomically correct position, and it was supposed to fire 28 staples and excise tissue. During the course of Kuhlmann’s procedure, the PPH03 stapler fired an incomplete stroke on the first firing attempt made by Shah, causing the staples to partially deploy. As a result, the staples did not form into the correct closed shape. In addition, the stapler’s knife did not cut the tissue, causing the stapler to become stuck in Kuhlmann. Unable to remove the stapler from Kuhlmann’s rectum, Shah fired the stapler a second time and was then able to remove it. Since the stapler was opened and fired blindly the second time, it incorporated excess tissue, causing Kuhlmann’s upper rectum to be stapled to the lower rectum. The PPH03 stapler was later recalled in 2012, after the subject procedure. Kuhlmann claimed of her rectum, anus, intestines, and necessitated the use of colostomy bags. She also claimed emotional distress. Kuhlmann sued Ethicon Inc.; Ethicon Endo-Surgery Inc.; Ethicon Endo-Surgery, LLC; Johnson & Johnson; and Johnson & Johnson Health Care Systems Inc. She also sued Dr. Shah and the surgery center where the procedure was performed, Pleasanton Surgery Center, LLC. Kuhlmann alleged that the stapler was defectively manufactured. She also alleged that Shah failed to diagnose the rectal occlusion and that this failure constituted medical malpractice. Pleasanton Surgery Center was ultimately dismissed from the case. Kuhlmann’s counsel contended that the PPH03 stapler had a manufacturing defect in that the force needed to fire the stapler exceeded the product’s specifications due to a change in the lubrication manufacturing process. Counsel argued that Ethicon knew the PPH03 stapler had defects — which included misfiring, incomplete firing strokes, and incomplete staple formation — and that the stapler was being inadequately tested. Counsel also argued that Ethicon knew the defects were causing serious , including sphincter dysfunction, rectal wall damage, sepsis, and bleeding, but that Ethicon continued to manufacture, sell and market the product. Plaintiff’s counsel contended that between 2003 and 2012, Ethicon measured the pounds of force exerted by its individual PPH03 staplers, but that the test measurements were ignored, and Ethicon failed to make sure the force to fire matched its own specifications. Counsel also contended that the inspection and testing of the returned and allegedly defective staplers were itself defective and inadequate in that Ethicon failed to measure the firing force of the returned staplers, and merely reloaded the stapler, fired it, and concluded user error. Plaintiff’s counsel noted that in April 2011, Ethicon changed the process by which the staplers were manufactured by brushing the stapler with lubricant, rather than submerging it into lubricant. Counsel contended that this process caused a lack of lubrication, increased friction, and increased the force needed to fire the stapler, causing an increase in complaints by doctors using the product. In addition, plaintiff’s counsel argued that Shah departed from the standard of care by failing to diagnose the rectal occlusion, since the doctor knew there was an issue with the stapler. Counsel contended that had Shah inspected the stapler line, she would have discovered that the upper rectum was stapled to the lower rectum. Thus, counsel argued that when the stapler became stuck, Shah should have exercised extra caution in inspecting the stapler line. The plaintiff’s expert medical device engineer testified that the misfire Shah experienced using the stapler on Jan. 17, 2012, was a defect in the force of fire of the stapler. He further testified that the defect was the same reason the PPH03 was recalled six months later. Thus, plaintiff’s counsel argued that Ethicon was 90 percent to 100 percent liable, while Shah was only 0 to 10 percent liable. Counsel for Ethicon and Johnson & Johnson contended that Shah did not fire the stapler properly on the first attempt due to Shah’s failure to take the safety off before firing the stapler and a subsequent failure to align the stapler correctly within the anal canal. Counsel also contended that the subject stapler could not be proven to be part of a recalled lot of staplers and that Shah did not mention that an elevated use of force was needed to fire the subject stapler during depositions. In addition, counsel contended that Ethicon adequately warned of the possible risks of firing the stapler twice. Ethicon’s counsel’s medical supplies industry expert testified that Ethicon’s quality control system was of excellent quality and within the U.S. Food and Drug Administration’s standards. In addition, Ethicon’s counsel’s expert colorectal surgeon testified that it was below the standard of care, and against the instruction of use for the PPH03 stapler, for Shah to fire the stapler a second time. Shah claimed that she was supplied a defective stapler and that there were no instructions for what to do in the event that the stapler became stuck due to a misfire. She further claimed that after firing the stapler a second time, she did in fact adequately inspect the site, but did not find a rectal occlusion., Kuhlmann suffered a rectal occlusion due to the upper rectum being stapled to the lower rectum. She claimed that as a result, she suffered severe constipation, increasing pain, and an inability to make a bowel movement over the weekend that followed her surgery. On Tuesday, Jan. 31, 2012, Kuhlmann presented to the emergency room at ValleyCare Medical Center, in Pleasanton, with complaints of severe pain, distention of the abdomen, and an inability to move her bowels. She was ultimately diagnosed with a perforated bowel and sepsis, as well as an occlusion of the rectum. As a result, Kuhlmann underwent a laparotomy and remained in the hospital’s Intensive Care Unit for approximately three weeks. Due to the growth of scar tissue, medical personnel were unable to locate and remove the staples from the initial surgery performed by Shah. As a result, a diverting colostomy was performed, and a balloon dilation of the anal canal was also performed over the course of 60 days. Kuhlmann then underwent additional dilation procedures at Stanford University Medical Center, in Stanford, and two subsequent transanal endoscopic microsurgeries, which were performed at the University of California, San Francisco Medical Center, in San Francisco. Kuhlmann claimed that her only two medical choices are to live with a permanent colostomy, or endure a full rectal removal and/or a coloanal anastomosis, which would result in her never again regaining full bowel function. She also claimed she would need a second surgery to repair a prolapsed stoma. In addition, Kuhlmann alleged that her caused emotional distress. She claimed the colostomy hampered her ability to have a normal social life and affected every aspect of her daily life, such as eating in public, traveling, dressing and showering, being intimate, or participating in sexual and physical activity. Thus, Kuhlmann sought recovery of compensatory damages for her past and future medical expenses, and past and future pain and suffering. She also sought recovery of punitive damages. Kuhlmann’s husband, plaintiff John Perkins, a physicist in his 50s, presented a derivative claim seeking recovery of damages for his loss of consortium.