1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 EASTERN DISTRICT OF CALIFORNIA 10 11 MICHELLE KLINKER and DAVID No. 2:21-cv-00817-TLN-KJN KLINKER, 12 Plaintiffs, 13 ORDER v. 14 JOHNSON & JOHNSON and ETHICON, 15 INC., 16 Defendants. 17 18 This matter is before the Court on Defendants Johnson & Johnson and Ethicon, Inc.’s 19 (collectively, “Defendants” or “Ethicon”1) Motion for Summary Judgment. (ECF No. 10.) 20 Plaintiffs Michelle Klinker (“Ms. Klinker”) and David Klinker (collectively, “Plaintiffs”) have 21 filed an opposition. (ECF No. 18.) Defendant filed a reply. (ECF No. 23.) Also before the 22 Court is Defendants’ Motion to Exclude Case-Specific Testimony and Opinions. (ECF No. 11.) 23 This motion is also fully briefed. (ECF Nos. 19, 24.) For the reasons set forth below, 24 Defendants’ Motion for Summary Judgment is GRANTED and Motion to Exclude is DENIED as 25 moot. 26 /// 27 1 Defendants refer to themselves collectively as “Ethicon” in the instant motion. (ECF No. 28 10 at 1.) 1 I. FACTUAL AND PROCEDURAL BACKGROUND2 2 The instant action is a personal injury action premised on claims of defective warnings 3 and defective design with respect to an Ethicon TVT3 device to treat stress urinary incontinence. 4 (See ECF No. 18.) 5 A. Plaintiff’s Background and Dr. Hilger’s Testimony 6 On June 20, 2007, Ms. Klinker underwent an anterior colporrhaphy and implantation of 7 two mesh devices — the Monarc Subfascial Hammock sling and the Perigee prolapse mesh — for 8 the treatment of her stress urinary incontinence and a grade-4 cystocele. (DSUF ¶ 1.) American 9 Medical System (“AMS”), not Defendants, manufactured the Monarc and Perigee devices. (Id.) 10 Prior to filing this suit, Plaintiffs settled their claims against AMS. (Id. at ¶ 2.) From April to 11 June 2010, Ms. Klinker presented to Dr. Wesley Scott Hilger (“Dr. Hilger”) with complaints of 12 pelvic pain, urinary urgency, dyspareunia (pain with intercourse), and recurring urinary tract 13 infections and yeast infections, all of which she had been experiencing since implantation of the 14 Monarc and Perigee meshes. (Id. at ¶ 3.) 15 In 2010, Dr. Hilger determined that Ms. Klinker’s dyspareunia was likely caused by her 16 AMS mesh implants.4 (Id. at ¶ 4.) On June 8, 2010, Dr. Hilger surgically removed Ms. Klinker’s 17 AMS mesh implants and implanted Ethicon’s TVT to treat her recurrent urinary stress 18 incontinence.5 (Id. at ¶ 5.) Prior to recommending the TVT to Ms. Klinker, Dr. Hilger took into 19 2 The following facts are undisputed unless otherwise noted and are taken largely verbatim 20 from Defendants’ Statement of Uncontroverted Material Facts (“DSUF,” ECF No. 10-1.)
21 3 None of the parties identify in their briefing what TVT stands for. (ECF Nos. 10, 18, 23.) However, the Court finds this is immaterial to resolution of the instant motion. 22
23 4 Plaintiffs dispute this point, noting that Dr. Hilger determined the 2007 implant might be causing Ms. Klinker some discomfort and the 2007 implant was not the Ethicon TVT implant. 24 (Plaintiffs’ Response to Defendants’ Statement of Uncontroverted Material Facts (“PR”), ECF No. 18-7 ¶ 4.) The Court agrees with Defendants that Plaintiffs do not actually contradict this 25 fact, but rather “Dr. Hilger’s testimony cited by Plaintiffs further demonstrates that the complication experienced by Ms. Klinker during the 2010 exam could not have been the TVT 26 because it had not yet been implanted.” (Defendants’ Reply to Plaintiffs’ Response to 27 Defendants’ Statement of Uncontroverted Material Facts (“DR”), ECF No. 23-1 ¶ 4.)
28 5 Plaintiffs dispute this point, but only repeat the facts stated and add that the goal of the 1 consideration the fact that she had already been implanted with two other mesh devices and was 2 already complaining of pain, dyspareunia, and urinary urgency. (Id. at ¶ 6.) Dr. Hilger testified 3 in his deposition that he did not recall having ever read the Instructions for Use (“IFU”) for TVT 4 prior to implanting the device in Ms. Klinker.6 (Id. at ¶ 7.) Dr. Hilger did not rely on Ethicon’s 5 warnings for the device when implanting Ms. Klinker’s TVT, stating: “By that time, I had been 6 through fellowship and had been in practice for four years . . . So I was really relying on my own 7 training and research that I had done and the research that I had heard at those meetings . . . I 8 hadn’t really relied on the manufacturer, by that time, for anything.” (Id. at ¶ 8.) Instead, Dr. 9 Hilger learned of the potential risks “associated with the use of mesh” during his fellowship. (Id. 10 at ¶ 9.) He became familiar with various potential risks, including acute or chronic pain with 11 intercourse, acute or chronic pain, vaginal scarring, infection, urinary problems (including 12 frequency, urgency, dysuria, retention, or obstruction and incontinence), organ or nerve bleeding, 13 wound complications, inflammation, fistula formation, neuromuscular problems, one or more 14 surgeries required to treat adverse events, recurrence or failure, foreign body response to mesh, 15 erosion, exposure, or extrusion of mesh, and contraction or shrinkage issues. (Id.) Dr. Hilger 16 also reviewed literature and studies to understand the rates of these potential risks, and he did not 17 rely on Ethicon to inform him of the rates. (Id. at ¶ 10.) 18 On June 28, 2013, Dr. Hilger performed another surgery on Ms. Klinker to revise a 19 portion of the TVT and remove a urethral diverticulum.7 (Id. at ¶ 11.) The symptoms of a 20 procedure was also to reduce her dyspareunia and pelvic pain. (PR ¶ 5.) The Court will therefore 21 consider this fact undisputed for the purpose of the instant motion.
22 6 Plaintiffs dispute this point, noting Dr. Hilger stated he was familiar with TVT’s IFU and 23 he was trained at the Mayo Clinic to use the product. (PR ¶ 7.) Plaintiffs also dispute the facts set forth in paragraphs 8 through 10 on the same basis, arguing Dr. Hilger was familiar with the 24 TVT’s IFU. (Id. at ¶¶ 8–10.) Regarding paragraphs 7 through 10, the Court agrees with Defendants that the testimony to which Plaintiffs cite in support of this point “describes Dr. 25 Hilger’s general response to manufacturers and their warnings” and “[t]hese general observations and preferences do not change the fact that Dr. Hilger testified repeatedly that he did not 26 remember reading TVT’s IFU.” (DR ¶ 7.) The Court also agrees that this alleged dispute does 27 not contradict the facts asserted. (Id. at ¶¶ 8–10.)
28 7 Plaintiffs dispute this point, but only repeat the facts stated and add that Dr. Hilger also 1 urethral diverticulum include pain, urinary tract infections, and urinary leakage. (Id.) Dr. Hilger 2 testified he had no reason to believe the TVT caused the urethral diverticulum. (Id.) On February 3 2, 2017, Dr. Hilger performed a third surgery on Ms. Klinker to lyse pelvic adhesions, excise a 4 portion of the TVT, and remove a Prolene suture likely associated with Ms. Klinker’s AMS mesh 5 implants.8 (Id. at ¶ 12.) 6 Dr. Hilger stands by his decision to implant Ms. Klinker’s TVT in 2010, and even 7 knowing that she was suffering from chronic pain in 2010, he still thinks TVT was “the best 8 option” for her treatment.9 (Id. at ¶ 13.) To this day, Dr. Hilger still uses TVT, as he stated: 9 “[f]or urinary stress incontinence, I think TVT is the most helpful for treating that condition 10 surgically.” (Id. at ¶ 14.) Dr. Hilger regards TVT as the “current” “gold standard” treatment. 11 (Id.) Plaintiffs allege Ms. Klinker sustained the following injuries from her TVT: yeast 12 infections, pain, painful intercourse, infections, bleeding, depression, urinary dysfunction and 13 incontinence, and anxiety.10 (Id. at ¶ 15.) Dr. Hilger does not believe TVT is causing Ms. 14 Klinker’s current pain, including her pelvic pain or her urinary urgency.11 (Id. at ¶ 16.) 15 performed a repair of urethral diverticulum and cystourethroscopy. (PR ¶ 11.) The Court will 16 therefore consider this fact undisputed for the purpose of the instant motion.
17 8 Plaintiffs dispute this point, but only repeat the facts stated and add that Dr. Hilger also performed a removal of right vaginal mesh, cystoscopy, and repair of vaginal exploration. (PR ¶ 18 12.) The Court will therefore consider this fact undisputed for the purpose of the instant motion. 19 9 Plaintiffs dispute this point as well as the point made in paragraph 14, stating that Dr. 20 Hilger made this statement in 2019, so it is unclear what might have transpired in the past three years. (PR ¶¶ 13–14.) The Court agrees with Defendants that Plaintiffs offer no evidence to 21 dispute this fact and it is their burden to establish all the elements of their claims. (DR ¶¶ 13–14.) Accordingly, the Court will consider this fact undisputed for the purpose of the instant motion. 22
23 10 Plaintiffs dispute this point, but only repeat the facts stated and add that Ms. Klinker sustained other injuries, such as diverticulum, bowel problems/spasms, and no muscle control. 24 (PR ¶ 11.) The Court will therefore consider this fact undisputed for the purpose of the instant motion. 25
11 Plaintiff disputes this point, stating that their expert Dr. Bruce Patsner (“Dr. Patsner”) 26 does not agree. (PR ¶ 16.) The Court finds that Plaintiff’s argument does not contradict Dr. 27 Hilger’s opinion, but is instead simply the opinion of another expert. (DR ¶ 16.) The Court will therefore consider this fact undisputed for the purpose of the instant motion. 28 1 B. Plaintiff’s Expert Opinions 2 Plaintiffs’ sole expert, Dr. Patsner, does not identify any specific defects in TVT’s design, 3 nor does he opine that any specific defect caused Ms. Klinker’s alleged injuries. (Id. at ¶ 17.) 4 Instead, Dr. Patsner testified that he was “not offering the opinion that a specific defect in TVT is 5 what caused [Ms. Klinker’s] complications” and he is “not attributing a specific design[] defect in 6 the mesh to her complications.”12 (Id.) Moreover, Dr. Patsner has no opinions to offer about 7 “specific mesh properties or characteristics,” including no critique of the “choice of mesh, its 8 weave, its pore size, its fiber size, its diameter or any mesh properties generally about the TVT.” 9 (Id. at ¶ 18.) Dr. Patsner is not familiar with the specific mesh characteristics of TVT.13 (Id.) 10 Instead, Dr. Patsner opines only that “the injuries sustained by Ms. Klinker — vaginal 11 pain, dyspareunia, and mesh exposure are all the direct result of the implanted mesh” and 12 “pain/dyspareunia the patient [sic] developed by Ms. Klinker were the direct result of mesh 13 placement, and required a second, and later a third operation.” (Id. at ¶ 19.) When asked in 14 deposition what he meant in opining “the implanted mesh” caused Ms. Klinker’s injuries, Dr. 15 Patsner admitted, “I say implanted mesh, and that’s a very broad non-specific statement, and it 16 was written that way because it is not clear what caused what in this patient.” (Id. at ¶ 20.) When 17 specifically asked about evidence linking Ms. Klinker’s claimed complications to TVT, Dr. 18
19 12 Plaintiffs dispute the point made in paragraph 17, stating that Dr. Patsner attributed Ms. Klinker’s injuries to the implantation of mesh, meaning both the AMS mesh and the Ethicon TVT 20 mesh. (PR ¶ 17.) Plaintiffs further note that Dr. Patsner based his report, within a reasonable degree of medical certainty, on review of Ms. Klinker’s medical records, including surgical 21 reports, history of complaints, laboratory and pathology reports, and his education and experience in the field. (Id.) Plaintiffs state Dr. Patsner’s opinion was based on a differential diagnosis. 22 (Id.) The Court agrees with Defendants that Plaintiffs’ argument does not contradict Dr. 23 Patsner’s testimony and they have not stated anything about what Dr. Patsner reviewed or how he performed his review. (DR ¶ 17.) Defendants also note that Plaintiffs’ expert is unable to 24 contradict this testimony. The Court will therefore consider this fact undisputed for the purpose of the instant motion. 25
13 Plaintiffs dispute the point made in paragraphs 18 and 19, stating that Dr. Patsner 26 identified the defect that he believes caused each of Ms. Klinker’s injuries: exposure to the 27 Ethicon TVT Sling. (PR ¶ 18–19.) The Court agrees with Defendants that Plaintiffs’ argument does not actually contradict Dr. Patsner’s testimony. (DR ¶ 18–19.) The Court will therefore 28 consider this fact undisputed for the purpose of the instant motion. 1 Patsner replied, “[I]t’s not really clear from her last operative report and the surgery that was done 2 exactly what symptomatology she might or might not have had that could be attributed to her 3 TVT.”14 (Id.) 4 Dr. Patsner cannot state to a reasonable degree of medical certainty that Ms. Klinker’s 5 pain, including vaginal pain and dyspareunia, or urethral diverticulum were caused by her TVT 6 — as opposed to her AMS mesh products. (Id. at ¶ 21.) He does not attribute recurrent urinary 7 tract infections or mesh exposure to TVT. (Id.) Further, Dr. Patsner found no objective evidence 8 in Ms. Klinker’s medical records of: mesh degradation; cytotoxicity; abnormal chronic 9 inflammatory reaction or foreign body reaction; mesh roping, fraying, or curling; or mesh 10 shrinkage or contraction. (Id.) Generally, Dr. Patsner agrees that “there’s at least a moderate 11 consensus in the medical literature that the use of synthetic retropubic slings at present is an 12 acceptable treatment for stress urinary incontinence . . . both in terms of efficacy and safety.”15 13 (Id. at ¶ 22.) 14 C. Procedural History 15 Plaintiffs filed the instant action on May 4, 2021. (ECF No. 1.) Plaintiffs allege three 16 claims: (1) negligence for failure to warn and design defect; (2) strict liability for failure to warn; 17 and (3) loss of consortium. (Id.) Defendants filed the instant motion for summary judgment and 18 the instant motion to exclude on October 22, 2021. (ECF Nos. 10, 11.) Because the Court 19 14 Plaintiffs dispute the points made in paragraphs 20 and 21, stating that Dr. Patsner 20 identified the defect that he believes caused each of Ms. Klinker’s injuries: exposure to the Ethicon TVT Sling. (PR ¶¶ 20–21.) Plaintiffs notes that Dr. Patsner testified regarding his 21 review of the records of the 2017 surgery that the doctor “clearly found what he thought was part of the TVT which was stuck to something which was scarred down which he removed, and based 22 on the description of that and the location and the way he described excising it, it would at least 23 strongly suggest that that was a contributory thing towards causing discomfort.” (Id. (citing ECF No. 18-5 at 27).) 24 15 Plaintiffs dispute this point, stating that Dr. Patsner also mentioned that there is a great 25 deal of controversy over the use of synthetic mesh kits for pelvic organ prolapse. (PR ¶ 22.) Defendants contend this fact does not contradict its stated fact, adds irrelevant information, and 26 the mesh device implanted to treat Ms. Klinker’s prolapse was not manufactured by Defendants 27 but by AMS. (DR ¶ 22.) The Court agrees with Defendants that Plaintiffs do not contradict this point. The Court will therefore consider this fact undisputed for the purpose of the instant 28 motion. 1 concludes Defendants’ motion for summary judgment should be granted even considering the 2 evidence Defendants seek to exclude, the Court need not and does not address the motion to 3 exclude. 4 II. STANDARD OF LAW 5 Summary judgment is appropriate when the moving party demonstrates no genuine issue 6 of any material fact exists and the moving party is entitled to judgment as a matter of law. Fed. 7 R. Civ. P. 56(a); Adickes v. S.H. Kress & Co., 398 U.S. 144, 157 (1970). Under summary 8 judgment practice, the moving party always bears the initial responsibility of informing the 9 district court of the basis of its motion, and identifying those portions of “the pleadings, 10 depositions, answers to interrogatories, and admissions on file together with affidavits, if any,” 11 which it believes demonstrate the absence of a genuine issue of material fact. Celotex Corp. v. 12 Catrett, 477 U.S. 317, 323 (1986). “[W]here the nonmoving party will bear the burden of proof 13 at trial on a dispositive issue, a summary judgment motion may properly be made in reliance 14 solely on the pleadings, depositions, answers to interrogatories, and admissions on file.” Id. at 15 324 (internal quotation marks omitted). Indeed, summary judgment should be entered against a 16 party who does not make a showing sufficient to establish the existence of an element essential to 17 that party’s case, and on which that party will bear the burden of proof at trial. 18 If the moving party meets its initial responsibility, the burden then shifts to the opposing 19 party to establish that a genuine issue as to any material fact does exist. Matsushita Elec. Indus. 20 Co. v. Zenith Radio Corp. (Matsushita), 475 U.S. 574, 585–87 (1986); First Nat’l Bank of Ariz. v. 21 Cities Serv. Co., 391 U.S. 253, 288–89 (1968). In attempting to establish the existence of this 22 factual dispute, the opposing party may not rely upon the denials of its pleadings, but is required 23 to tender evidence of specific facts in the form of affidavits, and/or admissible discovery material, 24 in support of its contention that the dispute exists. Fed. R. Civ. P. 56(c). The opposing party 25 must demonstrate that the fact in contention is material, i.e., a fact that might affect the outcome 26 of the suit under the governing law, Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986), 27 and that the dispute is genuine, i.e., the evidence is such that a reasonable jury could return a 28 verdict for the nonmoving party. Id. at 251–52. 1 In the endeavor to establish the existence of a factual dispute, the opposing party need not 2 establish a material issue of fact conclusively in its favor. It is sufficient that “the claimed factual 3 dispute be shown to require a jury or judge to resolve the parties’ differing versions of the truth at 4 trial.” First Nat’l Bank of Ariz., 391 U.S. at 288–89. Thus, the “purpose of summary judgment is 5 to ‘pierce the pleadings and to assess the proof in order to see whether there is a genuine need for 6 trial.’” Matsushita, 475 U.S. at 587 (quoting Rule 56(e) advisory committee’s note on 1963 7 amendments). 8 In resolving the summary judgment motion, the court examines the pleadings, depositions, 9 answers to interrogatories, and admissions on file, together with any applicable affidavits. Fed. 10 R. Civ. P. 56(c); SEC v. Seaboard Corp., 677 F.2d 1301, 1305–06 (9th Cir. 1982). The evidence 11 of the opposing party is to be believed and all reasonable inferences that may be drawn from the 12 facts pleaded before the court must be drawn in favor of the opposing party. Anderson, 477 U.S. 13 at 255. Nevertheless, inferences are not drawn out of the air, and it is the opposing party’s 14 obligation to produce a factual predicate from which the inference may be drawn. Richards v. 15 Nielsen Freight Lines, 602 F. Supp. 1224, 1244–45 (E.D. Cal. 1985), aff’d, 810 F.2d 898 (9th Cir. 16 1987). Finally, to demonstrate a genuine issue that necessitates a jury trial, the opposing party 17 “must do more than simply show that there is some metaphysical doubt as to the material facts.” 18 Matsushita, 475 U.S. at 586. “Where the record taken as a whole could not lead a rational trier of 19 fact to find for the nonmoving party, there is no ‘genuine issue for trial.’” Id. at 587. 20 III. ANALYSIS 21 Defendants move for summary judgment as to all of Plaintiff’s claims. (ECF No. 10.) 22 The Court will address Plaintiffs’ failure to warn claims, design defect claim, and loss of 23 consortium claim in turn. 24 A. Failure to Warn Claims 25 Defendants move for summary judgment as to Plaintiffs’ failure to warn claims because 26 there is insufficient evidence showing causation. (ECF No. 10 at 7.) More specifically, 27 Defendants argue Plaintiffs cannot show that Dr. Hilger, the implanting physician, read or relied 28 on Defendants’ warnings. (Id. at 8.) Defendants also argue Plaintiffs cannot prove that different 1 warnings would have changed Dr. Hilger’s prescribing decision. (Id. at 10.) 2 The parties agree that California’s learned intermediary doctrine applies to Plaintiffs’ 3 failure to warn claims.16 (ECF No. 10 at 7; ECF No. 18 at 10.) “California’s learned 4 intermediary doctrine holds that a manufacturer of prescription drugs or medical devices satisfies 5 its duty to warn when it provides adequate warnings to the prescribing physician, as opposed to 6 the patient.” Enborg v. Ethicon, Inc., No. 2:20-CV-02477-AWI-BAK, 2022 WL 800879, at *19 7 (E.D. Cal. Mar. 16, 2022) (citations omitted). “Under the learned intermediary doctrine, a 8 plaintiff must prove ‘not only that no warning was provided or that the warning was inadequate, 9 but also that the inadequacy or absence of the warning caused the [plaintiff’s] injury.’” Id. 10 (quoting Motus v. Pfizer Inc., 196 F. Supp. 2d 984, 991 (C.D. Cal. 2001), aff’d sub nom. Motus v. 11 Pfizer Inc., 358 F.3d 659 (9th Cir. 2004)). “A product defect claim based on insufficient 12 warnings cannot survive summary judgment if stronger warnings would not have altered the 13 conduct of the prescribing physician.” Motus, 358 F.3d at 661. 14 In arguing there is no evidence Dr. Hilger read or relied on Defendants’ warnings, 15 Defendants cite the following excerpts of Dr. Hilger’s deposition testimony: 16 1. Dr. Hilger did not remember reading the IFU prior to implanting the TVT in Ms. 17 Klinker (ECF No. 10-4 at 25); 18 2. When asked how he knew about the manufacturer’s warnings for the TVT, he stated, 19 “By that time, I had been through fellowship and been in practice for four years, been 20 to several meetings. So I was really relying on my training and the research I had 21 done and the research I had heard at those meetings . . . and the articles I had read. I 22 hadn’t really relied on the manufacturer, by that time, for anything” (id. at 25, 28); 23 3. Dr. Hilger learned of potential risks “associated with the use of mesh” during his 24 fellowship (id. at 14); and
25 16 Plaintiffs allege a strict liability claim for failure to warn (Claim One) and a negligence claim for failure to warn (Claim Two). (ECF No. 1.) The learned intermediary doctrine applies 26 to both. See Enborg v. Ethicon, Inc., No. 2:20-CV-02477-AWI-BAK, 2022 WL 800879, at *20 27 (E.D. Cal. Mar. 16, 2022) (“The learned intermediary doctrine applies to implanted medical devices, and it covers failure to warn claims under both the strict liability theory and the 28 negligence theory.”) (internal citations omitted). 1 4. Dr. Hilger also reviewed literature and studies to understand the rate of the potential 2 risks, and he did not rely on Ethicon to inform him of the rates (id.). 3 In arguing there is no evidence that different warnings would have changed Dr. Hilger’s 4 prescribing decision, Defendants point to multiple excerpts from Dr. Hilger’s deposition, where 5 he testified that: 6 1. He understood Ms. Klinker was suffering from chronic pain in June 2010 and still 7 believed TVT was the best option for Ms. Klinker (ECF No. 10-4 at 20); 8 2. He stood by his decision to use the TVT with Ms. Klinker, continued to use TVT after 9 Ms. Klinker’s surgery, and still believed TVT to be the best as far as surgical options 10 to treat Ms. Klinker’s condition (id. at 21); 11 3. He still held the opinion that even though sometimes mesh must be explanted or taken 12 out, TVT was the best option for Ms. Klinker (id. at 28); and 13 4. He believed TVT was the most helpful for treating urinary stress incontinence 14 surgically and regarded TVT as the gold standard treatment (id. at 11, 16). 15 Based on the foregoing evidence, the Court concludes Defendants have met their initial 16 burden of showing there is an absence of evidence as to causation. See Celotex, 477 U.S. at 324– 17 25 (where the non-moving party will have the burden of proof at trial, the movant can satisfy its 18 initial burden by pointing out that there is an absence of evidence to support the non-moving 19 party’s case). Accordingly, the burden shifts to Plaintiff to establish a genuine issue of material 20 fact as to causation. 21 Plaintiffs argue Dr. Hilger’s testimony creates an issue of fact as to whether he “relied on 22 accurate information from the manufacturer to make correct risk-benefit decisions for his 23 patients.” (ECF No. 18 at 10.) Plaintiffs cite the following excerpts from Dr. Hilger’s deposition: 24 1. Dr. Hilger met with Defendants’ sale representatives regarding the TVT product (ECF 25 No. 10-4 at 23); 26 2. When Dr. Hilger is not trained on a device, he would read the IFU (id. at 25); 27 3. Dr. Hilger could not remember if he ever received an IFU from Ethicon sales 28 representatives (id.); 1 4. When he was implanting the TVT in Plaintiff in June 2010, Dr. Hilger “hadn’t really 2 relied on the manufacturer, by that time, for anything” (id. (emphasis added)); 3 5. Dr. Hilger never received any warning from Ethicon regarding the risks of smoking 4 and complications with TVT implants (id. at 24); and 5 6. Dr. Hilger “relies on the manufacturer to provide him with adequate warnings 6 regarding known risks, he expects a manufacturer to put all relevant information in a 7 warning, and he wants as much information about a product before implanting it into a 8 patient” (id. at 25). 9 Construing the evidence in the light most favorable to Plaintiffs, there is perhaps a 10 reasonable inference that Dr. Hilger generally relied on manufacturer warnings and was at some 11 point aware of Defendants’ warnings regarding the TVT. However, as to Ms. Klinker’s case 12 specifically, Plaintiffs’ evidence is insufficient to raise a triable issue as to whether Dr. Hilger 13 relied on Defendants’ warnings and whether different warnings would have changed Dr. Hilger’s 14 prescribing decision. Dr. Hilger clearly testified he did not rely on Defendants’ warnings in 2010 15 and instead relied on his own training and research. Moreover, as Defendants correctly point out, 16 Plaintiffs have not presented testimony that any different warning would have changed Dr. 17 Hilger’s prescribing decision. 18 For these reasons, Plaintiffs fail to meet their shifted burden to show there is a triable issue 19 of fact as to causation. See Latiolais v. Merck & Co., Inc., 302 F. App’x. 756, 757 (9th Cir. 2008) 20 (affirming summary judgment for defendant where deposition testimony of prescribing physician 21 indicated that drug warnings “did not play a role in his decision to prescribe” the drug); Brennan 22 v. Johnson & Johnson, No. 5:20-CV-01954-FWS-KK, 2022 WL 17219513, at *13 (C.D. Cal. 23 Nov. 18, 2022) (“Here, as in Motus, the court finds that there is no affirmative testimony from Dr. 24 Winesburg that she would have acted differently given a different warning from Defendants.”); 25 Enborg, 2022 WL 800879, at *21 (holding that plaintiff did not establish causation where her 26 physician testified that he relied “minimally” on the manufacturer for information about the 27 product, continued to use the product, and stood by his decision to recommend and use the 28 product for plaintiff). 1 Accordingly, the Court GRANTS Defendants’ motion for summary judgment as to 2 Plaintiffs’ failure to warn claims. 3 B. Design Defect Claim 4 Defendants argue Plaintiffs’ design defect claim fails on the element of causation because 5 Plaintiffs’ sole expert — Dr. Patsner — cannot connect any of Plaintiffs’ injuries to TVT itself, 6 much less to a specific defect in TVT.17 (ECF No. 10 at 11.) 7 “A product liability case must be based on substantial evidence establishing both the 8 defect and causation (a substantial probability that the design defect, and not something else, 9 caused the plaintiff’s injury) and where . . . the complexity of the causation issue is beyond 10 common experience, expert testimony is required to establish causation.” Marmont v. 11 Bernzomatic Corp., 2018 WL 6252500, at *14 (C.D. Cal. July 31, 2018) (quoting Stephen v. Ford 12 Motor Co., 134 Cal. App. 4th 1363, 1373 (2005) (internal quotation marks omitted)). 13 In arguing there is an absence of evidence that a design defect in the TVT caused 14 Plaintiffs’ injury, Defendants cite the following evidence: 15 1. In his report, Dr. Patsner does not identify any specific defects in TVT’s design, nor 16 does he opine that any specific defect caused Ms. Klinker’s alleged injuries (ECF No. 17 18-2); 18 2. Dr. Patsner opines only that, “the injuries sustained by Ms. Klinker — vaginal pain, 19 dyspareunia, and mesh exposure are all the direct result of the implanted mesh,” and 20 “pain/dyspareunia the patient [sic] developed by Ms. Klinker were the direct result of 21 mesh placement, and required a second, and later a third operation” (id.); 22 3. When asked what he meant in opining “the implanted mesh” caused Ms. Klinker’s 23 injuries, Dr. Patsner admitted, “I say implanted mesh, and that’s a very broad non- 24 specific statement, and it was written that way because it is not clear what caused what 25 in this patient” (ECF No. 18-5 at 13, 40–41); 26
27 17 Defendants move to exclude Dr. Patsner’s report and testimony. (ECF No. 11.) Because the Court finds Dr. Patsner’s report and testimony are insufficient to preclude summary judgment, 28 the Court need not and does not address whether his opinions are admissible. 1 4. During his deposition, Dr. Patsner testified that he was “not offering the opinion that a 2 specific defect in TVT is what caused [Ms. Klinker’s] complications,” and he is “not 3 attributing a specific design defect in the mesh to her complications” (id. at 5, 44); 4 5. Dr. Patsner offers no opinion as to “specific mesh properties or characteristics” (id. at 5 6–7, 21); 6 6. When specifically asked about evidence linking Ms. Klinker’s claimed complications 7 to TVT, Dr. Patsner replied, “[I]t’s not really clear from her last operative report and 8 the surgery that was done exactly what symptomatology she might or might not have 9 had that could be attributed to her TVT” (id. at 13); and 10 7. Dr. Patsner cannot state to a reasonable degree of medical certainty that Ms. Klinker’s 11 pain, including vaginal pain and dyspareunia, or urethral diverticulum were caused by 12 her TVT — as opposed to her AMS mesh products. He does not attribute recurrent 13 urinary tract infections or mesh exposure to TVT, and he found no objective evidence 14 in Ms. Klinker’s medical records of mesh degradation, cytotoxicity, abnormal chronic 15 inflammatory reaction or foreign body reaction, mesh roping, fraying, or curling, or 16 mesh shrinkage or contraction (id. at 12, 13, 20, 24, 27, 28, 31, 41). 17 Based on the foregoing evidence, the Court concludes Defendants have met their initial 18 burden of showing there is an absence of evidence as to causation. See Celotex, 477 U.S. at 324– 19 25. Accordingly, the burden shifts to Plaintiff to establish a genuine issue of material fact as to 20 causation. 21 Plaintiffs argue Dr. Patsner’s report and deposition testimony “provide sufficient evidence 22 that the design defects of the TVT caused Plaintiff’s injuries.” (ECF No. 18 at 14.) Plaintiffs cite 23 the following excerpts from Dr. Patsner’s report and deposition: 24 1. Dr. Patsner opined in his report, “It is my opinion that the injuries sustained by Ms. 25 Klinker — vaginal pain, dyspareunia, and mesh exposure are all the direct result of the 26 implanted mesh” (ECF No. 18-2 at 5); 27 2. Dr. Patsner opined in his report, “The pain/dyspareunia the patient developed were the 28 direct result of mesh placement” (id. at 6); 1 3. When asked during his deposition if it was “fair to say that the records available for 2 your review are somewhat confusing and contradictory and don’t really allow you to 3 say here’s the definitive source of her pelvic pain and dyspareunia,” Dr. Patsner 4 responded, “Well, I think what we can say is [Dr. Hilger] clearly found, as he states, 5 assuming he didn’t mistake one thing for something else, he clearly found what he 6 thought was part of the TVT which was stuck to something which was scarred down 7 which he removed, and based on the description of that and the location and the way 8 he described excising it, it would at least strongly suggest that was a contributory thing 9 towards causing discomfort” (ECF No. 18-5 at 27); and 10 4. When asked if “it would be speculation to say that [Ms. Klinker’s] urethral 11 diverticulum was caused by the TVT,” Dr. Patsner responded, “So the answer to that 12 actually is a little tricky because if you had . . . let’s say you had a Product No. 1 in, 13 and you removed Product No. 1 in toto, and then you do another operation and you 14 insert a second product, and you develop something in that surgical area, logically it 15 doesn’t make sense to say that it was caused by the first thing if the first thing no 16 longer existed” (id. at 13). 17 In arguing this is sufficient to preclude summary judgment, Plaintiffs cite Shahbaz v. 18 Johnson & Johnson, No. CV 13-07382-AB (SSX), 2020 WL 5894590 (C.D. Cal. July 31, 2020), 19 which was a case about injuries allegedly caused by an Ethicon soft mesh device. (ECF No. 18 at 20 15.) The Court finds Shahbaz to be distinguishable. In Shahbaz, the court held that the plaintiffs’ 21 expert report created a triable issue of fact as to whether the product had a design defect that 22 caused the plaintiffs’ injuries. Id. at *17. Unlike Dr. Patsner’s report, however, the expert report 23 in Shahbaz identified seven specific defects in the product and opined that those specific defects 24 caused the plaintiffs’ injuries. Id. In contrast, Dr. Patsner’s report does not identify any design 25 defects in the TVT and instead offers the conclusory opinion that Ms. Klinker’s injuries were 26 caused by “the implanted mesh” and “mesh placement” without even identifying a particular 27 product. 28 /// 1 Moreover, in Dr. Patsner’s deposition testimony, he offered no opinion as to whether any 2 specific design defect in the TVT caused Ms. Klinker’s injuries, offered no opinion about the 3 specific characteristics of the TVT, and repeatedly indicated he could not determine what caused 4 Ms. Klinker’s injuries. Although Plaintiffs rely on Dr. Patsner’s testimony that Dr. Hilger “found 5 what he thought was part of the TVT which was stuck to something which was scarred down” 6 that “would at least strongly suggest that [the TVT] was a contributory thing towards causing 7 discomfort,” Plaintiffs fail to explain how this vague testimony establishes a causal link between 8 a specific design defect in the TVT and Ms. Klinker’s injuries. Defendants also point out in reply 9 that Dr. Patsner’s further testimony on this subject revealed that he could not say whether mesh 10 being removed was from the TVT or from one of the AMS products. (ECF No. 18-5 at 27–28, 11 30–31.) Plaintiffs’ citation to Dr. Patsner’s response to being asked whether Ms. Klinker’s 12 urethral diverticulum was caused by the TVT is similarly unavailing, as Dr. Patsner subsequently 13 clarified that he did not know if the TVT caused the urethral diverticulum. (Id. at 13.) For these 14 reasons, the Court concludes Plaintiffs fail to present sufficient evidence to raise a triable issue of 15 fact as to whether a design defect in the TVT caused Ms. Klinker’s injuries. 16 Accordingly, the Court GRANTS Defendants’ motion for summary judgment as to 17 Plaintiffs’ design defect claim. 18 C. Loss of Consortium Claim 19 Defendants move for summary judgment as to Plaintiffs’ loss of consortium claim 20 because it is derivative of Plaintiffs’ other claims, which fail as a matter of law. (ECF No. 10 at 21 13.) Plaintiffs do not address this claim in their opposition. Because the loss of consortium is 22 derivative of Plaintiffs’ other claims, it too fails. (ECF No. 1 at 24.) 23 Therefore, the Court GRANTS Defendants’ motion for summary judgment as to 24 Plaintiffs’ loss of consortium claim. 25 /// 26 /// 27 /// 28 /// 1 IV. CONCLUSION 2 For the reasons set forth above, Defendants’ Motion for Summary Judgment is hereby 3 | GRANTED. (ECF No. 10.) Defendants’ Motion to Exclude is DENIED as moot. (ECF No. 11.) 4 | The Clerk of Court is directed to enter judgment in Defendants’ favor and close the case. 5 IT IS SO ORDERED. 6 | DATED: January 19, 2023 / “ / Vm 9 — ZW NS Z Troy L. Nunley } 10 United States District Judge 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28