Full opinion text
ORDER CLAY D. LAND, District Judge. This multidistrict litigation proceeding includes various product liability actions against Mentor Worldwide LLC (“Mentor”) arising from the implantation of Mentor’s suburethral sling product, ObTape Transobturator Tape (“ObTape”), to treat Plaintiffs for stress urinary incontinence. In these actions, claims for design and manufacturing defect, warranty, and failure to warn. ObTape allegedly caused complications, including infection and erosion of ObTape through Plaintiffs’ bodily tissues. In support of their claims, Plaintiffs rely upon the opinion testimony of several expert witnesses, who opine that ObTape had a design and/or manufacturing defect that proximately caused the injuries suffered by these Plaintiffs. These experts also opine that Mentor did not adequately warn Plaintiffs’ physicians about the risks associated with ObTape. Mentor argues that the testimony of Plaintiffs’ experts on these issues is unreliable under Federal Rule of Evidence 702 and must be excluded (Doc. 156). Mentor maintains that without that expert testimony, Plaintiffs are unable to create genuine issues of material fact on design defect, manufacturing defect, failure to warn, and causation. Mentor also contends that Plaintiffs’ claims for breach of implied warranty fail. Therefore, Mentor moves for summary judgment on all Phase I Georgia Plaintiffs’ design defect claims (Doc. 154), as well as their manufacturing defect claims, failure to warn claims, and implied warranty claims (Doc. 140 in 3:07-cv-88 (Parker Plaintiffs); Doc. 142 in 3:07-cv-88 (Olson Plaintiffs); Doc. 114 in 3:07-cv-101 (Plaintiffs Stafford and Pinkney); Doc. 110 in 3:07-ev-102 (Crowther Plaintiffs); Doc. 111 in 3:07-cv-102 (Booth Plaintiffs); Doc. 112 in 3:07-cv-102 (Tucker Plaintiffs); Doc. 105 in 3:07-ev-130 (Plaintiff Mills); Doc. 106 in 3:07-cv-130 (Dover Plaintiffs); Doc. 108 in 3:07-cv-130 (Merritt Plaintiffs); Doc. 109 in 3:07-cv-130 (Looper Plaintiffs); and Doc. 110 in 3:07-ev-130 (Turner Plaintiffs)). Mentor also argues that the claims of Plaintiffs Dover, Merritt, and Olson are time-barred. For the following reasons, the Court finds that Plaintiffs have produced sufficiently reliable expert testimony to create genuine issues of material fact as to design defect, manufacturing defect, failure to warn, and causation, but the Court finds that Plaintiffs’ claims for breach of implied warranty fail. Mentor’s motion to exclude the expert testimony is denied except as noted below. Mentor’s motions for summary judgment as to the design defect, manufacturing defect, and failure to warn claims are denied. Mentor’s motions for summary judgment as to the implied warranty claims are granted. SUMMARY JUDGMENT STANDARD Summary judgment may be granted only “if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(c)(2). In determining whether a genuine issue of material fact exists to defeat a motion for summary judgment, the evidence is viewed in the light most favorable to the party opposing summary judgment, drawing all justifiable inferences in the opposing party’s favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A fact is material if it is relevant or necessary to the outcome of the suit. Id. at 248, 106 S.Ct. 2505. A factual dispute is genuine if the evidence would allow a reasonable jury to return a verdict for the nonmoving party. Id. FACTUAL BACKGROUND The evidence relevant to the pending motions for summary judgment can be divided into two categories-evidence that relates to all Plaintiffs’ claims and individualized evidence that relates with specific particularity to one or more Plaintiffs. The Court will discuss each category of evidence separately, starting with the evidence that is relevant to all Plaintiffs’ claims. The record, with all reasonable inferences construed in favor of Plaintiffs, establishes the following. I. Evidence Relevant to All Plaintiffs’ Claims Mentor developed a suburethral sling called ObTape Transobturator Tape (“Ob-Tape”), which was used to treat women with stress urinary incontinence (“SUI”). ObTape was cleared for sale by the U.S. Food and Drug Administration (“FDA”) via the FDA’s 510(k) regulatory process. ObTape was a Class II medical device, available only through a prescription from a physician. It was sold to hospitals and physicians, not directly to patients. Every ObTape package included a Product Insert Data Sheet (“PIDS”) which contained the following statement regarding “Adverse Reactions”: No undesirable effects that could be directly attributed to the polypropylene fibers have been reported in the literature. As with all foreign bodies, the ObTape is likely to trigger any existing infection, which can result in fistular formation and/or expulsion of the device. The following events have been reported very rarely: Vaginal Erosion Urethral Erosion Infection Patients should be monitored regularly after the device has been implanted. No undesirable effects directly attributed to materials used in the Introducer Needles have been reported in the literature. (Ex. 1 to Mentor’s Mot. for Summ. J. as to Design Defect Claims (Doc. 154), Wyatt Deck, Jan. 12, 2010 [hereinafter Wyatt Deck], Ex. A, ObTape Product Insert Data Sheet 2 (emphasis added) [hereinafter Ob-Tape PIDS].) The PIDS also instructs that patients “should immediately report any onset of bleeding or dysuria.” (Id.) In addition, the PIDS states: “If explantation is necessary, Mentor will analyze the ex-planted device[.]” (Id.) As discussed in more detail below, Plaintiffs were implanted with ObTape to treat SUI. Plaintiffs contend that the defective design and/or manufacture of ObTape caused complications that resulted in significant injuries, including serious infections and erosion of the tape through their bodily tissues. In support of their claims, Plaintiffs rely primarily upon the testimony of various expert witnesses who have had direct clinical experience with ObTape, as well as the expert testimony of a former Mentor employee, Dr. Catherine Ortuno. Dr. Ortuno is a former employee of Mentor-Porges. She is a medical doctor who received her medical degree from CHU Cochin Port-Royal (University of Paris V). (Attach. A to Ex. 4 to Pis.’ Separate Statement of Material Facts, Ortuno Curriculum Vitae.) She began working for Porges in 1996 as a junior project manager for clinical trials, and she was also responsible for device vigilance. (Id.) In 2001, she became Senior Project Manager for Women’s Health Products, and she also served as Device Vigilance and Clinical Research Officer. In that role, she was in charge of the vigilance database for Mentor-Porges products, including Ob-Tape, and she was also in charge of clinical trials. She received complaints from the field about Mentor’s products, including ObTape and its predecessor, Uratape. Her job duties required her to evaluate, investigate, and report adverse events reported to Mentor-Porges regarding Ob-Tape. (Ortuno Dep. 73:24-74:3, Oct. 19, 2009.) With Uratape, Dr. Ortuno “observed an increased rate of vaginal erosions.” (Ex. 4 to Pis.’ Separate Statement of Material Facts, Ortuno Rule 26 Report 4 [hereinafter Ortuno Rule 26 Report].) Dr. Ortuno believed that the increased rate of erosions was caused either by Uratape’s silicone patch or by the structure of the Uratape mesh. (Id.) According to Dr. Ortuno, ObTape has the same mesh structure as Uratape, but it lacks the silicone patch. (Id.; see also Ortuno Dep. 29:12-14.) After ObTape was launched, Mentor received reports of serious complications, and Dr. Ortuno concluded: “The cause could no longer be the silicone patch which had been removed from the product. The cause was the structure of ObTape.” (Ortuno Rule 26 Report 4; accord Ortuno Dep. 300:6-20; see also id. at 233:6-25 (noting that ObTape complications were more severe than complications associated with competing product).) In addition to the opinions of Dr. Ortuno, Plaintiffs also rely upon the opinions of several medical experts. These experts include: Dr. Linda Brubaker, a board-certified obstetrician and gynecologist (“OB/GYN”) specializing in urogynecologie surgery; Dr. Suzanne Bush, a surgeon who performs urogynecologie surgery; Dr. Michel Cosson, a professor of gynecology and obstetrics at the Medical University Lille; Dr. John Davis, a physician who treats patients with stress urinary incontinence; Dr. Paul Dueheyne, a bioengineering professor at the University of Pennsylvania; Dr. Ahmed El-Ghannam, a professor of mechanical, biomaterials, and tissue engineering at the University of North Carolina at Charlotte; Dr. James Hiller, a surgeon who performs urogynecologic surgery; Dr. Mickey Karram, a board-certified OB/GYN; Dr. Kenneth Mitchell, a surgeon who performs urogynecologic surgery; Dr. Donald Ostergard, a board-certified OB/GYN specializing in urogynecologie surgery; Dr. William Porter, a board-certified OB/GYN specializing in urogynecologie surgery; Dr. Andrew Siegel, a board-certified urologist; and Dr. Mark Slack, a urogynecologist who has a urogynecology practice and also a faculty appointment at Cambridge University. These experts opine that the ObTape design is defective and that this defective design caused the medical complications complained of by the individual Plaintiffs. While each expert’s testimony is unique, their scientific and/or medical methodologies used to reach their opinions share common themes. The bioengineering experts-Dr. Ducheyne and Dr. El-Ghannam-examined ObTape samples and performed various tests on the samples. They base their opinions on these tests; their knowledge, skill, training, and experience as bioengineers; and on their review of the relevant scientific literature. The physician experts-Dr. Brubaker, Dr. Bush, Dr. Cosson, Dr. Davis, Dr. Hiller, Dr. Karram, Dr. Mitchell, Dr. Ostergard, Dr. Porter, Dr. Siegel, and Dr. Slack-rely upon their knowledge, experience, training, and skill as physicians; their specific experiences with ObTape and other suburethral sling products; their understanding of the differences between the structure of the ObTape polypropylene mesh and the structure of other polypropylene mesh products; and a review of relevant medical literature. In addition, at least two of the physicians-Dr. Siegel and Dr. Slack-published articles in peer-reviewed medical journals regarding ObTape complications. Viewed in the light most favorable to Plaintiffs, the evidence demonstrates that ObTape is a “non-woven, thermally bonded white polypropylene mesh tape” that contains non-uniform pores, some of which are closed-ended pores and the vast majority of which are smaller than 40 microns. (Ex. 11 to Mentor’s Mot. to Exclude Experts, Ducheyne Rule 26 Report 2, 9-10, 13 [hereinafter Ducheyne Rule 26 Report].) The evidence viewed in the light most favorable to Plaintiffs further shows that ObTape’s product specifications called for pores measuring between 40 and 100 microns. (Ex. 13 to Pis.’ Resps. to Mentor’s Mots, for Summ. J. as to Individual Ga. Pis., Mentor’s 510(k) Notification to the U.S. Food and Drug Administration at MENTOR/OBTAPE CONFIDEN-TIAL_00019-20 [hereinafter 510(k) Notification].) The evidence also shows that ObTape degrades under certain circumstances. (See generally Exs. 12 & 13 to Mentor’s Mot. to Exclude Experts, El-Ghannam Rule 26 Report & Supp.) According to Plaintiffs’ experts, these characteristics of ObTape cause ObTape to admit bacteria, hinder immune cells, and fail to achieve tissue in-growth, which causes complications such as erosion and infection. (E.g., Ducheyne Rule 26 Report 10-11,15; Ex. 15 to Mentor’s Mot. to Exclude Experts, Hiller Rule 26 Report 4 [hereinafter Hiller Rule 26 Report]; Ex. 35 to Mentor’s Mot. to Exclude Experts, Mitchell Rule 26 Report 2-3 [hereinafter Mitchell Rule 26 Report]; Ex. 39 to Mentor’s Mot. to Exclude Experts, Porter Rule 26 Report 3-4 [hereinafter Porter Rule 26 Report], Ex. 41 to Mentor’s Mot. to Exclude Experts, Siegel Rule 26 Report 4-5 [hereinafter Siegel Rule 26 Report].) In contrast, woven, macroporous mesh products (“Type I mesh products”), such as Gynecare TVT and Mentor’s own ARIS product, have a uniform distribution of pores that are generally larger than 75 microns. (Ducheyne Rule 26 Report 13-14.) Plaintiffs assert that Type I mesh products are a safer alternative to ObTape and that two of Mentor’s competitors offered Type I mesh products while ObTape was on the market. Eventually, Mentor introduced its own Type I mesh product. Mentor ultimately withdrew ObTape from the market. Mentor’s Type I mesh product, along with those of its competitors, are still on the market. While erosion and infection risks exist with Type I mesh products, Plaintiffs’ experts maintain that the design of ObTape creates more frequent complications that are more serious than those caused by the Type I mesh products. (E.g., Mitchell Rule 26 Report 3; Porter Rule 26 Report 3; Siegel Rule 26 Report 4-5.) To corroborate their findings, Plaintiffs’ experts point to case reports and case series that show a connection between ObTape and the complications. They also reviewed the medical records of the individual Plaintiffs. (E.g., Siegel Rule 26 Report 5-6.) Finally, Plaintiffs’ experts opine that ObTape is capable of causing Plaintiffs’ injuries and that ObTape actually did cause those injuries. (E.g., Hiller Rule 26 Report 4, 8-9 (opining that ObTape caused Plaintiff Booth’s injuries); Ex. 17 to Mentor’s Mot. to Exclude Experts, Karram Rule 26 Report 2-3 (same as to Plaintiff Crowther); Ex. 2 to Mentor’s Mot. to Exclude Experts, Brubaker Rule 26 Report re Dover 2, 6-7 (same as to Plaintiff Dover); Ex. 3 to Mentor’s Mot. to Exclude Experts, Brubaker Rule 26 Report re Looper 2, 6-7 (same as to Plaintiff Looper); Mitchell Rule 26 Report 4, 8 (same as to Plaintiff Merritt); Ex. 4 to Mentor’s Mot. to Exclude Experts, Brubaker Rule 26 Report re Mills 2, 5-6 (same as to Plaintiff Mills); Hiller Rule 26 Report 4, 8-9 (same as to Plaintiff Olson); Ex. 10 to Mentor’s Mot. to Exclude Experts, Davis Rule 26 Report re Parker 2 (same as to Plaintiff Parker); Mitchell Rule 26 Report 4, 8 (same as to Plaintiff Stafford); Bush Dep. 186:15-189:5, Nov. 18, 2009 (ruling out doctor errors and contributory factors as alternative causes of Plaintiff Tucker’s injuries); Mitchell Rule 26 Report 4, 8 (opining that ObTape caused Plaintiff Turner’s injuries).) Plaintiffs have certainly covered their bases with their proffered expert testimony. That testimony includes the opinion of a former employee of Mentor who opines that the product was defective and that the defective design was capable of causing the complications complained of by Plaintiffs, as confirmed by reports accepted by Mentor’s own employees as reliable. They have produced opinions of biomedical scientists who have examined the actual product and its design and explained how the design and/or manufacture is defective and is capable of causing the reported complications to an unreasonable degree. Finally, they rely upon medical doctors who have actual experience with these types of products and who have examined the individual Plaintiffs’ medical complications and opine that the most likely cause is the defectively designed and/or manufactured ObTape; these medical doctors also opine that the warnings Mentor gave regarding ObTape did not adequately disclose ObTape’s risks. If this testimony is admissible, Plaintiffs have created genuine issues of material fact as to whether Ob-Tape is defectively designed and/or manufactured, whether Mentor’s warnings regarding ObTape were adequate, and whether ObTape proximately caused Plaintiffs’ injuries. Thus, Mentor’s pending motions for summary judgment depend substantially upon the admissibility of these opinions. II. Evidence Regarding Individual Plaintiffs To address fully Mentor’s motions for summary judgment, it is also necessary to consider certain evidence that pertains to the individual Plaintiffs separately. The record, when construed in favor of Plaintiffs, establishes the following. A. Plaintiffs Treated by Dr. Thomas Oliver Dr. Thomas Oliver treated Plaintiffs Valerie Booth, Janice Crowther, Cheryl Olson, Barbara Parker, and Jeannie Tucker for SUI; he implanted each of them with ObTape and treated them for subsequent complications. The parties do not dispute that it was Dr. Oliver’s standard practice to review product insert data sheets prior to using an implantable medical device; though he could not specifically recall reading the ObTape PIDS, he would have done so in accordance with his standard practice. Independent of the ObTape PIDS, Dr. Oliver knew that infection and erosions were complications associated with ObTape and that there is a risk that a patient’s body may reject an implantable medical device. However, he also stated that neither the PIDS nor anyone from Mentor told him that ObTape had a higher risk of erosion and infection than other tapes and that, in his experience, such complications with ObTape were not “rare.” (Oliver Dep. 430:7-433:15, 434:16-436:11, Apr. 20 & 30, 2009, May 29, 2009.) He also stated that he would not have implanted ObTape in his patients if he had known of its increased risks. (Id. at 435:9-22.) 1. Valerie Booth In December 2004, Plaintiff Valerie Booth (“Mrs. Booth”) consulted with her physician about her SUI symptoms. Mrs. Booth was referred to Dr. Oliver, who diagnosed Mrs. Booth with SUI. After discussing the benefits of the suburethral sling implantation procedure compared with the risks as Dr. Oliver understood them, Mrs. Booth decided to undergo suburethral sling implantation surgery to treat her SUI. The surgery took place on December 22, 2004, and Dr. Oliver used the ObTape sling. After the surgery, Mrs. Booth was continent for between four and six months, but her incontinence returned, accompanied by discharge and odor. In January of 2006, Dr. Oliver diagnosed an erosion of the ObTape, along with an infection. (Id. at 339:13-15, 340:14-341:6.) Dr. Oliver removed a portion of Mrs. Booth’s ObTape. Mrs. Booth continued to experience complications, and her symptoms worsened. She underwent three additional surgeries to correct complications she contends were caused by ObTape. Mrs. Booth filed her product liability suit against Mentor on August 14, 2007. Her husband, Phil Booth, asserts a derivative claim for loss of consortium. 2. Janice Crowther In December of 2004, Plaintiff Janice Crowther (“Mrs. Crowther”) consulted her primary care physician about her SUI symptoms. The primary care physician referred Mrs. Crowther to Dr. Oliver. After discussing the benefits of the suburethral sling implantation procedure compared with the risks as Dr. Oliver understood them, Mrs. Crowther decided to undergo suburethral sling implantation surgery to treat her SUI. Dr. Oliver implanted the ObTape in Mrs. Crowther on March 7, 2005. About five months after the surgery, Mrs. Crowther began to have “really, really bad discharge” with a “terrible odor,” as well as a “horrific” pain in her right leg. (Crowther Dep. 149:21-150:5, Mar. 10, 2009.) On August 22, 2005, Mrs. Crowther saw her primary care physician, who diagnosed an abscess and sent Mrs. Crowther to the hospital, where Dr. Oliver removed the right half of the ObTape sling. (Id. at 159:2-4.) After that, Mrs. Crowther had two additional surgeries to treat complications she contends were caused by ObTape and to remove the remaining portion of ObTape. Mrs. Crowther filed her product liability suit against Mentor on August 14, 2007. Her husband, Terry Crowther, asserts a derivative claim for loss of consortium. 3. Cheryl Olson Plaintiff Cheryl Olson (“Mrs. Olson”) was diagnosed with SUI in 1995. In April 2004, Mrs. Olson’s physician referred her to Dr. Oliver to discuss the possibility of suburethral sling surgery. Mrs. Olson consulted with Dr. Oliver regarding the risks and benefits of the procedure as Dr. Oliver understood them, and Dr. Oliver warned her that there was no guarantee of success and that there was a risk of erosion and infection. Mrs. Olson elected to go forward with suburethral sling surgery, and Dr. Oliver implanted her with ObTape on September 21, 2004. After the surgery, Mrs. Olson was continent for a while but began to experience leakage of urine, and she also had pelvic discomfort during intercourse; in December of 2004, Dr. Oliver treated her symptoms by giving her a collagen injection. (Olson Dep. 148:6-149:17, Mar. 11, 2009.) At that point, Mrs. Olson believed her sling was not working. (Id. at 150:4-151:3.) In February 2005, Mrs. Olson went back to see Dr. Oliver because she “felt something,” which Dr. Oliver’s physician assistant discovered was a piece of exposed ObTape. (Id. at 151:17-152:2.) The physician assistant told Mrs. Olson that the ObTape had eroded. (Lavelle Dep. 139:5-141:19, Sept. 11, 2009.) Dr. Oliver also explained to Mrs. Olson that her ObTape had eroded and explained that it was possible that her body was rejecting the sling or that trauma from intercourse could have thinned the tissue. (Oliver Dep. 305:12-21.) Mrs. Olson realized at that time that the sling “wasn’t working like it should” (Olson Dep. 157:6-7), though she also stated she did not realize at that time that there was a problem with the sling (id. at 156:6-19). In March of 2005, Dr. Oliver removed a portion of Mrs. Olson’s ObTape. After the March 2005 excision procedure, Mrs. Olson continued to have problems, including brown, bloody discharge and pain during sexual intercourse. (Id. at 158:6-161-15, 168:13-18.) Mrs. Olson went to her gynecologist in June of 2005, and he prescribed a medicated cream for her. (Id. at 163:5-164:11.) Between then and November 2006, Mrs. Olson had “constant discharge and bleeding, sometimes worse than others, [and] the horrible smell[, b]ut it didn’t seem like anything was actually wrong.” (Id. at 161:25-162:3.) In November of 2006, however, Mrs. piece of ObTape hanging out of her vagina. (Id. at 161:23-162:11.) She returned to Dr. Oliver, who performed an excision procedure and gave Mrs. Olson another collagen injection in January 2007. (Id. at 173:4-20.) During that procedure, Dr. Oliver found “active infection on the mesh,” and he attributed it to the sling erosion. (Oliver Dep. 319:5-12.) After that procedure, Mrs. Olson experienced less discharge and was more continent, but she still experienced pain during intercourse. (Olson Dep. 178:16-179:23.) Finally, in September 2007, Mrs. Olson felt more exposed ObTape, and she had a third excision procedure. After that procedure, she stopped having discharge and bleeding, and the infection has not returned. (Id. at 182:23-183:5.) At some point after the January 2007 excision but before the final excision, Mrs. Olson had a conversation with Dr. Oliver’s physician assistant, who told her there was a problem with the sling; at that time, Mrs. Olson came to believe that her ObTape might be defective. (Id. at 134:4-17, 211:1-25.) Mrs. Olson filed her product liability action against Mentor on July 24, 2007. Her husband, Edwin Olson, asserts a derivative claim for loss of consortium. 4. Barbara Parker Plaintiff Barbara Parker (“Mrs. Parker”) was diagnosed with SUI in 1999. In February 2004, she consulted Dr. Oliver regarding her SUI. After discussing the benefits of the suburethral sling implantation procedure compared with the risks as Dr. Oliver understood them, Mrs. Parker decided to undergo suburethral sling implantation surgery to treat her SUI. The surgery took place on May 12, 2004, and Dr. Oliver used the ObTape sling. After the surgery, Mrs. Parker was pain-free and continent for nine months, but she began to experience heavy bleeding during intercourse. (Parker Dep. 135:16-136:10, Mar. 5, 2009.) She went to her gynecologist in March 2005, and the gynecologist told Mrs. Parker that it appeared the incision from her ObTape surgery had not healed properly. (Id. at 137:9-13, 138:12-14.) After receiving treatment from Dr. Oliver and another doctor during March, June, and July 2005, Mrs. Parker’s complications improved, but they returned later that year. Dr. Oliver performed surgery on Mrs. Parker in September 2005, and he discovered a piece of exposed ObTape, which he excised. (Oliver Dep. 233:2-9.) Her symptoms worsened, and she saw Dr. John Blankenship, who ultimately performed two additional excision surgeries. Mrs. Parker filed her product liability action against Mentor on July 24, 2007. Her husband, Richard Parker, asserts a derivative claim for loss of consortium. 5. Jeannie Tucker Plaintiff Jeannie Tucker’s (“Mrs. Tucker”) doctor diagnosed her with SUI and referred her to Dr. Oliver, who confirmed the SUI diagnosis. After consulting with Dr. Oliver regarding the risks and benefits of the procedure as Dr. Oliver understood them, Mrs. Tucker elected to go forward with suburethral sling surgery, and Dr. Oliver implanted her with ObTape on March 7, 2005. Although the ObTape surgery cured Mrs. Tucker’s SUI, she began to experience complications, including abdominal pressure and vaginal discharge, about a month after the surgery. (Tucker Dep. 192:3-193:5, Feb. 25, 2009.) Mrs. Tucker was treated with antibiotics, though she still experienced intermittent flare-ups of pain and malodorous discharge. (Id. at 197:7-17.) She had her first repair surgery in January 2006. Dr. Oliver discovered an erosion of the Ob-Tape, and he excised a portion of the tape. (Oliver Dep. 385:10-19.) In all, Mrs. Tucker has had seven repair surgeries to remove ObTape and treat infections she contends were caused by ObTape. (Tucker Dep. 202:23-203:1.) Mrs. Tucker filed her product liability action against Mentor on August 14, 2007. Her husband, Kenneth Tucker, asserts a derivative claim for loss of consortium. B. Plaintiffs Treated by Dr. Bruce Kyburz Dr. Bruce Kyburz, a urologist, treated Plaintiffs Maris Merritt and Cheryl Turner for SUI; he implanted each of them with ObTape and treated them for subsequent complications. It is undisputed that Dr. Kyburz never read the PIDS for Ob-Tape. Dr. Kyburz was in regular contact with a Mentor sales representative, and he believes he received written materials regarding ObTape. (Kyburz Dep. 121:3-124:2, Apr. 21, 2009, May 26, 2009.) It is undisputed that Dr. Kyburz knew that infection and erosions were complications associated with ObTape and that there is a risk that a patient’s body may reject an implantable medical device. However, Dr. Kyburz also stated that no Mentor sales representative or written materials from Mentor informed him that ObTape had a higher risk of erosion and infection than other tapes. (Id. at 363:2-365:20.) Dr. Kyburz also testified that he would not have recommended ObTape to his patients had he known of its increased risks. (Id. at 369:6-17.) 1. Maris Merritt Plaintiff Maris Merritt (“Mrs. Merritt”) was diagnosed with SUI by her urologist, Dr. Kyburz. Dr. Kyburz told Mrs. Merritt about the suburethral sling implantation procedure. He explained that there was a chance the procedure would not work and that there was a risk of infection and a need for additional surgeries to treat complications. After discussing the benefits of the suburethral sling implantation procedure compared with the risks as Dr. Kyburz understood them, Mrs. Merritt decided to undergo suburethral sling implantation surgery to treat her SUI. The surgery took place on September 19, 2003, and Dr. Kyburz used the ObTape sling. After the surgery, Mrs. Merritt’s SUI improved, but she began to suffer from vaginal discharge. At the time, Dr. Kyburz could not determine the cause of the discharge. (Merritt Dep. 189:16-22, Feb. 27, 2009, Apr. 8, 2009.) In January 2005, Mrs. Merritt returned to Dr. Kyburz, complaining of bloody discharge and pain during intercourse. Dr. Kyburz diagnosed “[probable excoriation of anterior vaginal wall.” (Kyburz Dep. 237:23-238:7.) Dr. Kyburz performed an excision procedure in February 2005, during which he found and removed some exposed ObTape; Dr. Kyburz told Mrs. Merritt that the excision should get rid of her symptoms. (Id. at 245:6-246:2.) Mrs. Merritt continued to have bloody discharge. She went back to Dr. Kyburz in May 2005, and Dr. Kyburz did not see or feel any more tape; he told Mrs. Merritt that they could either wait to see if the situation resolved on its own or excise the remainder of the sling. (Id. at 258:1-262:15.) In June 2005, however, Dr. Kyburz felt more tape and told Plaintiff it would have to be removed. (E.g., id. at 267:19-20.) After Dr. Kyburz performed the excision, Mrs. Merritt’s discharge and her SUI symptoms improved. (Id. at 276:25-280:9.) The discharge returned in August 2005, and Mrs. Merritt’s primary care physician found polyps on her vaginal wall. (Merritt Dep. 213:3-214:10.) Mrs. Merritt then saw a gynecologist regarding the polyps; she underwent two surgeries to remove the polyps, one in October 2005 and one in January 2006. (Id. at 215:18-21, 219:11-13.) The doctors did not give her any theories on what caused the polyps. (Id. at 214:2-4, 215:25-216:21, 219:14-17.) In the fall of 2006, Mrs. Merritt developed severe groin pain and was referred to another doctor, who performed a sling excision surgery on January 12, 2007. (Id. at 232:2-233:21.) Since that last surgery, Mrs. Merritt has not suffered from bleeding or discharge. (Id. at 234:2-3.) Dr. Kyburz never told Mrs. Merritt that the ObTape may have been defective. (Kyburz Dep. 402:19-403:14.) However, in the summer of 2007, Mrs. Merritt’s husband read a newspaper article about product liability suits against Mentor brought by women who experienced problems similar to Mrs. Merritt’s. (Merritt Dep. 249:8-21.) Mrs. Merritt filed her product liability action against Mentor on October 19, 2007. Her husband, Glenn Merritt, asserts a derivative claim for loss of consortium. 2. Cheryl Turner Plaintiff Cheryl Turner (“Mrs. Turner”) was diagnosed with SUI in 1995, and in 2003, Plaintiff saw Dr. Kyburz to discuss her SUI symptoms. After consulting with Dr. Kyburz regarding the risks and benefits of the procedure as Dr. Kyburz understood them, Mrs. Turner elected to go forward with suburethral sling surgery, and Dr. Kyburz implanted her with Ob-Tape on November 18, 2003. In March of 2006, Mrs. Turner began suffering from infections. She had an abscess, and she has undergone three excision procedures to remove eroded ObTape. (Turner Dep. 109:1-115:8, 116:24-117:2, 121:1-6, 125:5-9, Mar. 6, 2009.) Mrs. Turner filed her product liability action against Mentor on October 19, 2007. Her husband, Tommy Turner, asserts a derivative claim for loss of consortium. C. Gail Dover In 2002, Plaintiff Gail Dover (“Mrs. Dover”) was diagnosed with SUI by her OB/ GYN, and she was referred to Dr. Bruce Green, a urologist. Dr. Green does not specifically recall reading the ObTape PIDS, but he testified that he “must have” done so. It is undisputed that Dr. Green knew that infection and erosion are risks of suburethral slings and that he told Mrs. Dover about these risks. However, Dr. Green stated that no one from Mentor ever told him that ObTape had a higher risk of erosion and infection than other tapes. (Green Dep. 184:6-185:14, July 31, 2009.) Dr. Green further testified that he would not have used ObTape if he had known of the increased risks. (Id. at 185:15-186:7.) After consulting with Dr. Green regarding the risks and benefits of the procedure as Dr. Green understood them, Mrs. Dover elected to go forward with suburethral sling surgery, and Dr. Green implanted her with ObTape on February 11, 2004. Mrs. Dover was continent and pain-free for five months after the implantation surgery. (Dover Dep. 120:25-121:7, Mar. 17, 2009.) She began developing infections by September of 2004, and her doctors performed ultrasounds of her kidneys; at the time, they could not determine the cause of the infections. (Id. at 123:8-124:9.) On December 28, 2004, Dr. Green determined that Mrs. Dover’s ObTape had eroded through her vagina, and he told her that the tape needed to be removed. (Green Dep. 111:14-112:9; see also Dover Dep. 126:1-8.) At the time, Mrs. Dover “was having a lot of infections, a lot of bad odors coming out of [her] body.” (Dover Dep. 126:13-15.) She stated, “I understood it might be coming from the sling and that’s why he was going to have to remove it.” (Id. at 126:15-18; see also Green Dep. 231:21-232:19 (testifying that he told Mrs. Dover that erosion and infection would be alleviated by removing the ObTape).) It is undisputed that Dr. Green removed a portion of the ObTape on February 4, 2005, and he implanted a SPARC device at that time. The next month, Mrs. Dover presented with a severe infection and an abscess, and she was hospitalized. Dr. Green attributed these complications to the February 2005 procedure, and he removed additional portions of the ObTape. (Green Dep. 123:15-24.) Mrs. Dover’s wound closed by July 2005, and she returned to work in the fall of 2005. Mrs. Dover stated that she did not suspect that her ObTape was defective until sometime in 2006, when she read a newspaper article about a lawsuit regarding ObTape. (Dover Dep. 27:13-28:3, 165:10-167:9.) Mrs. Dover filed her product liability action against Mentor on October 19, 2007. Her husband, Hugh Dover, asserts a derivative claim for loss of consortium. D. Kellie Looper In November 2004, Plaintiff Kellie Loop-er (“Mrs. Looper”) consulted with Dr. Thomas Chun regarding her SUI symptoms. It is undisputed that Dr. Chun did not read the ObTape PIDS, but Dr. Chun did receive a brochure regarding ObTape that contained some language regarding potential adverse reactions, and he had a conversation with a Mentor sales representative regarding complication rates associated with ObTape; based on all of this information, Dr. Chun believed that the risks of ObTape were comparable to the risks associated with other suburethral sling products. (Chun Dep. 82:9-84:17, 93:18-94:24, 140:3-11, Apr. 23, 2009, July 15, 2009.) It is undisputed that Dr. Chun knew that infection and erosions were complications associated with ObTape and that there is a risk that a patient’s body may reject an implantable medical device. However, he also stated that neither the brochure nor anyone from Mentor told him that ObTape had a higher risk of erosion and infection than other tapes. (E.g., id. at 299:3-18.) Dr. Chun further testified that he would not have used ObTape if he had known of the increased risks. (Id. at 302:15-20.) After discussing the benefits of the suburethral sling implantation procedure compared with the risks as Dr. Chun understood them, Mrs. Looper decided to undergo suburethral sling implantation surgery to treat her SUI. The surgery took place on January 10, 2005, and Dr. Chun used the ObTape sling. Mrs. Loop-er lived pain-free and continent for about a year, but in early 2006 she and her husband determined that “something wasn’t right down there.” (Looper Dep. 143:1-5, Apr. 9, 2009.) Dr. Chun performed an excision procedure on March 17, 2006; after that, Mrs. Looper had three additional excision procedures and was treated for an abscess. Mrs. Looper filed her product liability action against Mentor on October 19, 2007. Her husband, Larry Looper, asserts a derivative claim for loss of consortium. E. Linda Mills Plaintiff Linda Mills (“Ms. Mills”) consulted with her physician regarding her SUI symptoms, and she was referred to Dr. Nikolas Symbas to discuss the possibility of suburethral sling surgery. It is undisputed that Dr. Symbas does not recall whether he read the ObTape PIDS. Dr. Symbas did discuss ObTape with a Mentor sales representative, who represented to Dr. Symbas that the tape was a good material; Dr. Symbas also received an instructional video on how to implant ObTape, along with materials regarding the safety and efficacy of the procedure, though he did not recall the specifics of those materials. (Symbas Dep. 135:1-17, 142:10-143:22, Apr. 27, 2009, June 4, 2009.) It is undisputed that Dr. Symbas knew that infection and erosions were complications associated with ObTape and that there is a risk that a patient’s body may reject an implantable medical device. However, Dr. Symbas stated that no one from Mentor told him that ObTape had a higher risk of erosion and infection than other tapes. (E.g., id. at 399:16-402:5.) Dr. Symbas further testified that he would not have used ObTape if he had known of the increased risks. (Id. at 403:21-23.) After consulting with Dr. Symbas regarding the risks and benefits of the procedure as Dr. Symbas understood them, Ms. Mills elected to go forward with suburethral sling surgery, and Dr. Symbas implanted her with ObTape on November 16, 2004. After the surgery, Ms. Mills underwent three excision procedures due to Ob-Tape erosion, and she has suffered from infections. Ms. Mills filed her product liability action against Mentor on October 19, 2007. F. Shirley Stafford Plaintiff Shirley Stafford (“Mrs. Stafford”) was diagnosed with SUI in 1999. She consulted with a urologist, Dr. John Blankenship, regarding her SUI symptoms in 2004. It is undisputed that Dr. Blankenship reviewed the PIDS for ObTape before he performed any ObTape surgeries. It is also undisputed that Dr. Blankenship knew that infection and erosions were complications associated with ObTape and that there is a risk that a patient’s body may reject an implantable medical device. However, Dr. Blankenship also stated that neither the PIDS nor anyone from Mentor told him that ObTape had a higher risk of erosion and infection than other tapes and the “degree of infections, erosions, and abscess formation was far greater than [he] would have interpreted the [PIDS] as indicating possible.” (Blankenship Dep. 359:17-362:8, 369:19-370:5, Apr. 22, 2009, May 1 & 28, 2009.) In fact, the Mentor sales representative told Dr. Blankenship that ObTape had a complication rate equal to that of another suburethral sling product, TVT. (Id. at 343:17-25.) Dr. Blankenship stated that he would not have prescribed ObTape for his patients if he had known it was associated with increased risks. (Id. at 365:15-366:4.) After discussing the benefits of the suburethral sling implantation procedure compared with the risks as Dr. Blankenship understood them, Mrs. Stafford decided to undergo suburethral sling implantation surgery to treat her SUI. The surgery took place on September 28, 2004, and Dr. Blankenship used the ObTape sling. After the surgery, Mrs. Stafford was pain-free and continent for six months, but she began to develop complications, including an infection for which Dr. Blankenship could not pinpoint the cause. Ultimately, Mrs. Stafford underwent several excision surgeries and suffered from severe infections, and Dr. Blankenship stated that “she almost died from complications of the sling.” (Id. at 284:5-6.) In addition, Mrs. Stafford’s husband, Torrence Pinkney, was cut on the penis several times during sexual intercourse with Mrs. Stafford, and he attributes these injuries to ObTape. (Stafford Dep. 147:24-148:6, Mar. 18, 2009.) Mrs. Stafford filed her product liability action against Mentor on August 3, 2007. Her husband, Mr. Pinkney, asserts a claim for personal injury and a claim for loss of consortium. DISCUSSION Plaintiffs rely upon four separate legal theories in support of their claims: 1) design defect; 2) manufacturing defect; 3) breach of implied warranty; and 4) failure to warn. Although the evidence relating to these claims overlaps, the Court will address each claim separately. I. Plaintiffs’ Legal Theories and Causes of Action As previously mentioned, the admissibility of the opinion testimony of Plaintiffs’ experts is critical in determining whether sufficient evidence exists to create genuine issues of material fact. Before turning to the admissibility of the opinions of Plaintiffs’ experts, it is necessary to understand what Plaintiffs must prove to recover on their various claims. A. Design Defect To recover on their design defect claims against Mentor, Plaintiffs must establish that (1) ObTape’s design is defective and (2) the defective design caused Plaintiffs’ injuries. Under Georgia law, a product design is defective if “the risks inherent in a product design [outweigh] the utility or benefit derived from the product.” E.g., Dean v. Toyota Indus. Equip. Mfg., Inc., 246 Ga.App. 255, 259, 540 S.E.2d 233, 237 (2000). The factors relevant to the risk-utility analysis include: the usefulness of the product; the gravity and severity of the danger posed by the design; the likelihood of that danger; the avoidability of the danger, i.e., the user’s knowledge of the product, publicity surrounding the danger, or the efficacy of warnings, as well as common knowledge and the expectation of danger, and the user’s ability to avoid danger; the state of the art at the time the product is manufactured; the manufacturer’s ability to eliminate the danger without impairing the product’s usefulness or making it too expensive; and the feasibility of spreading the loss in the price or by purchasing insurance. Id. (footnote omitted). “A manufacturer’s proof of compliance with federal regulations is also a factor to be considered. These factors are not exhaustive and do not apply in all cases.” Id. (footnotes omitted). The most important factor, however, is “whether the design chosen was a reasonable one from among the feasible choices of which the manufacturer was aware or should have been aware”-this factor is the “heart” of design defect cases. Banks v. ICI Ams., Inc., 264 Ga. 732, 736, 450 S.E.2d 671, 674 (1994) (internal quotation marks omitted). In general, weighing the risk-utility factors is left to the jury. E.g., Dean, 246 Ga.App. at 259, 540 S.E.2d at 237. Judgment as a matter of law “will rarely be granted in design defect cases when any of [the] elements is disputed.” Ogletree v. Navistar Int’l Transp. Corp., 271 Ga. 644, 646, 522 S.E.2d 467, 470 (1999) (internal quotation marks omitted). To prevail at summary judgment, a defendant must “show plainly and indisputably an absence of any evidence that a product as designed is defective.” Id. When faced with a summary judgment motion, Plaintiffs have the burden to demonstrate a genuine issue of material fact that ObTape is defectively designed; to do this, they must produce evidence from an expert who is qualified to conduct the risk-utility analysis and to opine that the risks inherent in ObTape’s design outweigh the utility or benefit derived from the product. E.g., Dean, 246 Ga.App. at 259, 540 S.E.2d at 237. Once it is established that a product has a defect, the plaintiff must show causation. The parties agree that to prevail on their claims, Plaintiffs must establish both general causation and specific causation. Guinn v. AstraZeneca Pharms. LP, 602 F.3d 1245, 1249 n. 1 (11th Cir.2010) (per curiam). In other words, Plaintiffs must prove that ObTape can cause the type of injury suffered by Plaintiffs (general causation) and that Ob-Tape did in fact cause Plaintiffs’ injuries (specific causation). Id. B. Manufacturing Defect In addition to their design defect theory, Plaintiffs contend that each of their ObTapes had a manufacturing defect. While a design defect claim posits that there is a problem with the entire product line, a “manufacturing defect is a defect that is ‘measurable against a built-in objective standard or norm of proper manufacture.’ ” Jones v. Amazing Prods., Inc., 231 F.Supp.2d 1228, 1239 (N.D.Ga.2002) (quoting Banks, 264 Ga. at 734 n. 2, 450 S.E.2d at 673 n. 2); see also id. at 1236 n. 7 (“In manufacturing defect cases ... the standard of comparison is supplied by the designer of the perfectly executed product that is in complete accordance with the intended design.”). Therefore, in a manufacturing defect case, the “product’s defectiveness is determined by measuring the product in question against the benchmark of the manufacturer’s designs.” ACE Fire Underwriters Ins. Co. v. ALC Controls, Inc., Civil Action No. 1:07-CV-606-TWT, 2008 WL 2229121, at *2 (N.D.Ga. May 28, 2008). C. Failure to Warn In addition to their design and manufacturing defect claims, Plaintiffs contend that Mentor failed to provide adequate warnings regarding the risks associated with ObTape and that Plaintiffs were injured as a result of the inadequate warnings. To establish their failure to warn claims, Plaintiffs must show that (1) Mentor had a duty to warn, (2) Mentor breached that duty, and (3) the breach was the proximate cause of Plaintiffs’ injuries. E.g., Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 815 (11th Cir.2010) (applying Georgia law). Under Georgia’s learned intermediary doctrine, a medical device manufacturer “does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient’s doctor, who acts as a learned intermediary between the patient and the manufacturer.” McCombs v. Synthes (U.S.A.), 277 Ga. 252, 253, 587 S.E.2d 594, 595 (2003). “The rationale for the doctrine is that the treating physician is in a better position to warn the patient than the manufacturer, in that the decision to employ [a medical device] involves professional assessment of medical risks in light of the physician’s knowledge of a patient’s particular need and susceptibilities.” Id. (internal quotation marks omitted). The warnings to the doctor “must be adequate or reasonable under the circumstances of the case.” Id. In general, the first step of the inquiry is whether the manufacturer provided the learned intermediary with an adequate warning. Dietz, 598 F.3d at 816; see also Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1277-78, 1281 (11th Cir.2002) (per curiam) (finding that manufacturer adequately warned doctors and nurses of risks of third-party activation of morphine pump because evidence demonstrated they all had actual knowledge of risk). If the warning is inadequate, the plaintiff must show that the deficient warning proximately caused the alleged injury to prevail; if the learned intermediary “has actual knowledge of the substance of the alleged warning and would have taken the same course of action even with the information the plaintiff contends should have been provided,” then the plaintiff cannot establish causation. Ellis, 311 F.3d at 1283 n. 8 (internal quotation marks omitted). D. Implied War>"anty Plaintiffs’ breach of implied warranty claims can be disposed of summarily. Under Georgia law, a plaintiff must have privity with the seller to recover under a theory of breach of implied warranty of merchantability. E.g., Gowen v. Cady, 189 Ga.App. 473, 476, 376 S.E.2d 390, 393 (1988) (finding that lack of privity between patient and medical device manufacturer warranted summary judgment in favor of manufacturer on breach of warranty claim). Plaintiffs Booth, Looper, Merritt, Mills, and Turner concede that them breach of warranty claims fail for lack of privity. (Pis.’ Resp. to Mot. for Summ. J. as to Booth 13 n. 3; Pis.’ Resp. to Mot. for Summ. J. as to Looper 11 n. 2; Pis.’ Resp. to Mot. for Summ. J. as to Merritt 16 n. 3; Pis.’ Resp. to Mot. for Summ. J. as to Mills 12 n. 2; Pis.’ Resp. to Mot. for Summ. J. as to Turner 11 n. 2.) Plaintiffs Crowther, Dover, Olson, Parker, Stafford, and Tucker did not respond to this argument. It is undisputed that Mentor did not sell ObTape directly to any patient; therefore, there is a lack of privity between Mentor and Plaintiffs. Accordingly, Mentor is entitled to summary judgment on all Plaintiffs’ implied warranty claims. With this background in mind, the Court now turns to the expert testimony relied upon by Plaintiffs to prove design defect, manufacturing defect, failure to warn, and causation. II. Admissibility of Opinions from Plaintiffs’ Experts A. Expert Witness Standards Under Federal Rule of Evidence 702, “a witness qualified as an expert by knowledge, skill, experience, training, or education” may testify in the form of an opinion “if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods^ and (3) the witness has applied the principles and methods reliably to the facts of the case.” The trial court must act as a gatekeeper to ensure the reliability and relevancy of expert testimony; for an expert’s testimony to be admitted, the proffered expert must be qualified to render a reliable opinion based on sufficient facts or data and the application of accepted methodologies. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999); Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 592-93, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The purpose of this gatekeeping function is “to ensure that speculative, unreliable expert testimony does not reach the jury under the mantle of reliability that accompanies the appellation ‘expert testimony.’ ” Rink v. Cheminova, Inc., 400 F.3d 1286, 1291 (11th Cir.2005) (internal quotation marks omitted). Scientific expert testimony is admissible when (1) the expert is qualified to testify competently regarding the matters he intends to address; (2) the methodology by which the expert reaches his conclusion is sufficiently reliable as determined by the sort of inquiry mandated in Daubert; and (3) the testimony assists the trier of fact, through the application of scientific, technical, or specialized expertise, to understand the evidence or to determine a fact in issue. Allison v. McGhan Med. Corp., 184 F.3d 1300, 1309 (11th Cir.1999) (internal quotation marks omitted). “The party offering the expert has the burden of satisfying each of these three requirements by a preponderance of the evidence.” Rink, 400 F.3d at 1292. A district court “may not exclude an expert because it believes one expert is more persuasive than another expert.” Id. at 1293 n. 7. Rule 702 further provides that a witness “may be qualified as an expert by virtue of his or her ‘knowledge, skill, experience, training, or education.’ ” Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326 F.3d 1333, 1342 (11th Cir.2003) (quoting Fed.R.Evid. 702). Accordingly, in determining whether a proffered expert is “qualified” to offer an opinion, courts generally look to evidence of the witness’s education and experience and ask whether the subject matter of the witness’s proposed testimony is sufficiently within the expert’s expertise. E.g., Maiz v. Virani, 253 F.3d 641, 665 (11th Cir.2001). To ascertain whether proposed expert testimony is “reliable,” the courts consider several factors: “(1) whether the expert’s methodology can be tested; (2) whether the expert’s scientific technique has been subjected to peer review and publication; (3) whether the method has a known rate of error; (4) whether the technique is generally accepted by the scientific community.” Rink, 400 F.3d at 1292 (citing Quiet Tech., 326 F.3d at 1341). These four factors are not exhaustive, and the district court’s primary focus should be “‘solely on principles and methodology, not on the conclusions that they generate.’ ” Allison, 184 F.3d at 1312 (quoting Daubert, 509 U.S. at 595, 113 S.Ct. 2786). For an expert’s testimony to “assist” the trier of fact, “the evidence must have a valid scientific connection to the disputed facts in the case.” Id. A court “may exclude expert testimony that is imprecise and unspecific, or whose factual basis is not adequately explained.” Cook ex rel. Tessier v. Sheriff of Monroe County, Fla., 402 F.3d 1092, 1111 (11th Cir.2005) (internal quotation marks omitted). Also, expert testimony is generally only admissible “if it concerns matters that are beyond the understanding of the average lay person.” Id. (internal quotation marks omitted). “Proffered expert testimony generally will not help the trier of fact when it offers nothing more than what lawyers for the parties can argue in closing arguments.” Id. (internal quotation marks omitted). B. Preliminary Matters Before turning to an analysis of the qualifications of Plaintiffs’ experts and the reliability of their opinions, the Court addresses Mentor’s argument that the Court should not consider Plaintiffs’ submissions of unsworn expert reports, Mentor’s internal documents, and journal articles. As to the unsworn expert reports, Mentor contends that they are inadmissible because they are unsworn, and that Plaintiffs should have opposed summary judgment with declarations by the experts. Mentor does not appear to dispute that each of Plaintiffs’ experts was examined about his or her report and verified the opinions therein during a deposition. Mentor also does not dispute that the expert reports were exhibits to the experts’ depositions. With one exception, Mentor does not contend that any of Plaintiffs’ experts retracted or disavowed their opinions. Under these circumstances, the Court concludes that it may properly consider the unsworn expert reports. E.g., Maytag Corp. v. Electrolux Home Prods., Inc., 448 F.Supp.2d 1034, 1064-65 (N.D.Iowa 2006) (finding that unsworn expert reports are properly considered at summary judgment if expert reaffirmed opinions stated in unsworn report during deposition), aff'd w/o op., 224 Fed.Appx. 972 (Fed.Cir.2007) (per curiam); see also Medtronic Xomed, Inc. v. Gyrus ENT LLC, 440 F.Supp.2d 1300, 1310 n. 6 (M.D.Fla.2006) (concluding that unsworn expert report was properly before court because it was marked as exhibit to expert’s deposition and identified by the expert). As to Mentor’s internal documents and the journal articles, the Court finds that those items may be relied upon by Plaintiffs’ experts in reaching their opinions. See Fed.R.Evid. 703; see also United States v. Steed, 548 F.3d 961, 975 (11th Cir.2008) (per curiam) (noting that expert may rely on hearsay if such information is of a type reasonably relied upon by experts in the field). Accordingly, the experts’ reliance on the journal articles and Mentor’s internal documents does not diminish the weight that the Court gives to the experts’ opinions, assuming that the opinions are otherwise sufficiently reliable. C. Plaintiffs’Experts The first step in the Court’s expert testimony gatekeeping function is to evaluate the qualifications of Plaintiffs’ experts. Since Mentor does not seriously challenge those qualifications, the Court moves to the second step and evaluates the reliability of the expert testimony. 1. Dr. Ortuno Although the Court finds it unnecessary to examine seriously Dr. Ortuno’s professional qualifications, the Court does make the following observations regarding her capacity as an expert in this case. She is not the typical retained litigation expert. Instead, she is a former employee of Mentor. Moreover, her testimony relates to the areas that she oversaw as an employee of Mentor. Her opinions are not based on what others have told her happened, but they are based at least in part on what she actually observed. While these factors do not excuse her from supporting her opinions with reliable scientific methodology, they do give her testimony added credibility- Dr. Ortuno opines that ObTape caused higher rates of vaginal erosions than a competitor’s suburethral sling product did and that the complications associated with ObTape were more severe than those associated with the competing product; according to Dr. Ortuno, ObTape’s design structure caused these problems. (Ortuno Rule 26 Report 4; Ortuno Dep. 300:6-20; see also id. at 233:6-25 (noting that ObTape complications were more severe than complications associated with competing product).) The bases for Dr. Ortuno’s opinions are her experience evaluating, investigating, and reporting adverse events regarding ObTape (and its predecessor, Uratape), her knowledge of the relevant scientific and medical literature, and her experience as the person in charge of clinical trials for products such as ObTape. Dr. Ortuno’s job at MentorPorges was to get to the bottom of any reports that ObTape caused complications and to provide Mentor with a suggested course of action. To do that, she collected and studied all of the adverse event reports Mentor received about ObTape; she reviewed clinical studies, animal studies, and case reports regarding ObTape; and she communicated with physicians whose patients experienced complications with ObTape. Based on her prior experience evaluating problems associated with Ob-Tape’s predecessor product, Uratape, Dr. Ortuno ruled out Uratape’s silicone patch as the cause of the increased risks of the product and concluded that the increased risks were caused by the structure of the polypropylene mesh, which was identical in Uratape and ObTape. The Court finds that Dr. Ortuno’s methodology in arriving at those opinions is sufficiently reliable to be considered by a jury. Therefore, her testimony shall be considered in deciding Mentor’s summary judgment motions. 2. Doctors with Adverse Clinical Experiences To support their claims of defect and general causation, Plaintiffs also seek to introduce the opinions of several doctors who had adverse clinical experiences with ObTape: Dr. Linda Brubaker; Dr. Suzanne Bush; Dr. Michel Cosson; Dr. John Davis; Dr. James Hiller; Dr. Mickey Karram; Dr. Kenneth Mitchell; Dr. Donald Ostergard; Dr. William Porter; and Dr. Andrew Siegel. These doctors opine, among other things, that the degree and frequency of complications caused by ObTape is greater than the degree and frequency of complications caused by other suburethral sling products, Type I mesh products. They opine that ObTape’s design accounts for the difference-there is evidence that ObTape is a non-woven, thermally bonded polypropylene mesh tape with non-uniform pores, the majority of which are smaller than 40 microns, while Type I mesh products are woven and have pores larger than 75 microns. They base their opinions on their personal adverse clinical experiences with ObTape, and they maintain that these adverse experiences are confirmed by published scientific literature about ObTape, including case reports and case series. Mentor contends that the doctors’ personal clinical experiences, combined with their literature reviews, are insufficient to enable these doctors to opine reliably that ObTape has greater risks than other suburethral slings. Essentially, Plaintiffs’ experts seek to show a connection between Ob-Tape and increased risks of complications by pointing mainly to adverse event data. Adverse event data is generally regarded with caution, particularly in the context of a drug or device that is alleged to cause an injury that might otherwise occur for another reason. See McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1253 (11th Cir.2005) (noting that causal attribution based on case studies must be regarded with caution in context of case regarding herbal supplement that allegedly caused injuries that also occur without exposure to the product). However, these experts are not simply parroting published adverse event data. They use that data as confirmation of their own experience using ObTape or treating ObTape patients. It is beyond dispute that experience in a field may provide a sufficient foundation for expert testimony. United States v. Frazier, 387 F.3d 1244, 1260-61 (11th Cir.2004) (en banc). If a witness relies upon experience as a primary qualification for the opinion, the witness must still explain how that experience is reliably applied to the facts. Id. at 1261. The Court cannot simply take the expert’s “word for it,” but must ensure that the opinion rests on a reliable foundation. Id. (int