Townsend v. Ethicon, Inc.

• Court: District Court, D. Nevada
• Decided: August 1, 2023
• Docket: 2:20-cv-01984
• Status: Unknown

Opinion

2 UNITED STATES DISTRICT COURT 3 DISTRICT OF NEVADA 4 TAMARA J. TOWNSEND, Case No. 2:20-cv-01984-ART-DJA 5 Plaintiff, ORDER 6 v.

7 ETHICON, INC. and JOHNSON & JOHNSON, 8 Defendants.

9 10 Plaintiff Tamara Townsend brings this action for injuries sustained 11 following surgical implantation of a pelvic mesh product, the TVT-Abbrevo, 12 manufactured by Defendants. This case is one of many that were joined in 13 multidistrict litigation (“MDL”) in the Southern District of West Virginia. (MDL No. 14 2327.) Before the Court are: (1) Defendants’ motion for summary judgment (ECF 15 No. 111); and (2) six motions brought by Defendants to limit the testimony or 16 opinions of Plaintiff’s experts, namely: (i) Dr. Paul J. Michaels (ECF No. 112); (ii) 17 Dr. Med. Uwe Klinge (ECF No. 113); (iii) Dr. Jeremy Blaivas (ECF No. 114); (iv) 18 Dr. Bruce Rosenzweig (ECF No. 115); (v) John Cary, MA (ECF No. 116); and (vi) 19 Scott Guelcher, Ph.D. (ECF No. 117). 20 For the reasons set forth in this order, the Court denies Defendants’ motion 21 for summary judgment as to Plaintiff’s failure to warn strict liability claim, grants 22 summary judgment as to Plaintiff’s fraud and negligence-based claims as 23 duplicative of the strict liability claims, and grants summary judgment as to 24 Plaintiff’s defective product and unjust enrichment claims by virtue of Plaintiff’s 25 consent to withdrawal of those claims. (ECF No. 111.) The Court further: (1) 26 denies Defendants’ motions to limit the testimony of Dr. Michaels (ECF No. 112) 27 and Mr. Cary (ECF No. 116); (2) denies as moot Defendants’ motion to limit the 28 testimony of Dr. Blaivas (ECF No. 114) due to Plaintiff’s withdrawal of Dr. Blaivas 1 as an expert; and (3) grants in part and denies in part Defendants’ motions to 2 limit the testimony of Dr. Klinge (ECF No. 113), Dr. Rosenzweig (ECF No. 115), 3 and Dr. Guelcher (ECF No. 117). 4 I. BACKGROUND 5 Plaintiff received a TVT-Abbrevo implant on January 17, 2012, at St. Rose 6 Dominican Hospital in Henderson, Nevada. (ECF No. 111-1 at 5.) Dr. Paula 7 Schwartz performed the implantation surgery and Dr. James Oliver assisted. 8 (ECF No. 111-3 at 7:20–8:14.) In February of 2012, shortly after receiving the 9 implant, Plaintiff began to experience severe pelvic pain, vaginal pain, recurrent 10 urinary tract infections, severe pain with intercourse, disabling prudential 11 neuropathy, severe labial and perineal neuropathy, increased urinary frequency, 12 urge incontinence, bowel dysfunction, groin pain, and vaginal wall damage. (ECF 13 No. 111-1 at 6; ECF No. 131-9 at 28:18–30:14, 34:11–21.) Dr. Gregory Hseih 14 performed a mesh revision surgery on March 16, 2012, which removed a portion 15 of the mesh (ECF No. 131-3 at 34:4–35:22; ECF No. 111-1 at 10–11), and after 16 continued complaints from Plaintiff, Dr. Hseih performed another surgery on July 17 19, 2012 (ECF No. 131-3 at 50:25–53:19). On February 8, 2013, Dr. Ja-Hong Kim 18 surgically removed additional mesh and performed vaginal reconstruction and 19 bladder neck suspension. (ECF No. 131-9 at 35:18–36:2.) Plaintiff’s case-specific 20 expert, Dr. Bruce Rosenzweig, opines that Plaintiff will likely experience 21 permanent conditions of mesh erosion, urinary incontinence, recurrent stress 22 urinary incontinence, bladder spasms, overactive bladder, increased urinary 23 frequency and nocturia, pelvic pain, vaginal pain, groin pain, obstructed voiding, 24 recurrent urinary tract infections, dyspareunia and hyspareunia, and that 25 Plaintiff may need further mesh excision procedures. (ECF No. 131-12 at 68–69.) 26 Dr. Schwartz testified that she had some awareness of risks of vaginal 27 scarring and mesh erosion from the use of surgically implanted mesh products 28 prior to January of 2012, as she was aware of FDA public health notifications 1 from October of 2008 and December of 2011. (ECF No. 131-5 at 58:10–62:11.) 2 Dr. Schwartz also testified that her knowledge of mesh-related risks has grown 3 over the course of her practice and that she is aware of data from after January 4 of 2012 that has shown increased concern about complications after mesh 5 implantation procedures. (Id. at 131:20–132:6.) She testified that before she 6 counseled and performed the surgical procedure on Plaintiff, she did not have the 7 awareness of the increased risks associated with shorter mesh slings that she 8 later came to have. (Id. at 132:8–133:1.) She also testified that prior to Plaintiff’s 9 surgery, she did not know the percentage of people who would have complications 10 that would not improve over time. (Id. at 144:23–145:1.) Dr. Oliver testified that 11 he was not told by Ethicon nor otherwise aware of increased risks associated with 12 laser-cut mesh slings. (ECF No. 131-8 at 99:14–101:15.) 13 Dr. Schwartz testified that she would have changed her patient consenting 14 process with respect to Plaintiff if she had known of the risks of shorter slings. 15 (Id. at 134:16–23.) Dr. Oliver testified that awareness of the increased risks of 16 shorter and laser-cut meshes such as the TVT-Abbrevo would have led him to 17 use an alternative product if available. (ECF No. 131-8 at 102:6–103:6.) Plaintiff 18 also testified that she would not have elected to have the mesh sling implanted if 19 she had known of the true risks. (ECF No. 131-7 at 176:22–178:7.) 20 II. MOTION FOR SUMMARY JUDGMENT 21 Following a stipulated dismissal of certain claims (ECF No. 95), Plaintiff 22 brings eight claims: (1) negligence; (2) strict liability failure to warn; (3) strict 23 liability defective product; (4) strict liability design defect; (5) fraud; (6) negligent 24 infliction of emotional distress; (7) gross negligence; and (8) unjust enrichment. 25 Defendants moved for summary judgment on all claims, however in the course of 26 the briefing Defendants agreed to withdraw their summary judgment challenge 27 to Plaintiff’s design defect claim. (ECF No. 134 at 6.) Likewise, Plaintiff agreed to 28 dismissal of her defective product and unjust enrichment claims. (ECF No. 131 1 at 15, 23.) 2 “The purpose of summary judgment is to avoid unnecessary trials when 3 there is no dispute as to the facts before the court.” Nw. Motorcycle Ass’n v. U.S. 4 Dep’t of Agric., 18 F.3d 1468, 1471 (9th Cir. 1994). Summary judgment is 5 appropriate when the pleadings, the discovery and disclosure materials on file, 6 and any affidavits “show there is no genuine issue as to any material fact and 7 that the movant is entitled to judgment as a matter of law.” Celotex Corp. v. 8 Catrett, 477 U.S. 317, 322 (1986). An issue is “genuine” if there is a sufficient 9 evidentiary basis on which a reasonable fact-finder could find for the nonmoving 10 party and a dispute is “material” if it could affect the outcome of the suit under 11 the governing law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248–49 (1986). 12 The court must view the facts in the light most favorable to the non-moving party 13 and give it the benefit of all reasonable inferences to be drawn from those facts. 14 Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). 15 The party seeking summary judgment bears the initial burden of informing 16 the court of the basis for its motion and identifying those portions of the record 17 that demonstrate the absence of a genuine issue of material fact. Celotex, 477 18 U.S. at 323. Once the moving party satisfies Rule 56’s requirements, the burden 19 shifts to the non-moving party to “set forth specific facts showing that there is a 20 genuine issue for trial.” Anderson, 477 U.S. at 256. The nonmoving party “may 21 not rely on denials in the pleadings but must produce specific evidence, through 22 affidavits or admissible discovery material, to show that the dispute exists[.]” 23 Bhan v. NME Hosps., Inc., 929 F.2d 1404, 1409 (9th Cir. 1991). 24 A. FAILURE TO WARN 25 Under Nevada law, strict liability for failure to warn has the same elements 26 as in other strict products liability cases, namely that the plaintiff must show 27 that: (1) the product had a defect which rendered it unreasonably dangerous, (2) 28 the defect existed at the time the product left the manufacturer, and (3) the defect 1 caused the plaintiffs injury. Motor Coach Indus., Inc. v. Khiabani by & through 2 Rigaud, 137 Nev. 416, 419, 493 P.3d 1007, 1011 (2021). The lack of a warning 3 functions as the relevant “defect.” Id. The burden of proving causation can be 4 satisfied in failure to warn cases by demonstrating that a different warning would 5 have altered the way the plaintiff used the product or would have prompted the 6 plaintiff to take precautions to avoid the injury. Id. (citing Rivera v. Philip Morris, 7 Inc., 125 Nev. 185, 191, 209 P.3d 271, 275 (2009)). 8 The parties agree that the “learned intermediary doctrine” applies (ECF No. 9 131 at 9), which means that the adequacy of Defendants’ warnings is analyzed 10 with respect to the information provided to Plaintiff’s implanting surgeons, 11 namely Dr. Schwartz and Dr. Oliver, not with respect to information provided 12 directly to Plaintiff by Defendants. Defendants argue that Plaintiff’s failure to 13 warn claim fails on two grounds: (1) Dr. Schwartz and Dr. Oliver were aware of 14 the risks associated with pelvic mesh products such as the TVT-Abbrevo, which 15 means Defendants cannot be liable since there is no duty to warn of known 16 dangers; and (2) Plaintiff lacks evidence that Dr. Schwartz and Dr. Oliver would 17 have changed their decision to recommend the TVT-Abbrevo had further 18 warnings been provided. 19 On the former, the Court finds that a genuine issue of fact exists as to 20 whether Dr. Schwartz and Dr. Oliver were provided with warnings sufficient to 21 convey the risks associated with the TVT-Abbrevo. The manufacturer’s duty is 22 not merely to provide notice of general dangers, but instead to provide more 23 specific information such as the relative frequency with which serious 24 complications occur. See Allison v. Merck & Co., 110 Nev. 762, 774–75, 878 P.2d 25 948, 956–57 (1994). Here, although Dr. Schwartz and Dr. Oliver testified in their 26 depositions that they had some prior knowledge of the risks associated with pelvic 27 mesh products, they also testified that they were unaware of the increased risks 28 associated with shorter, laser-cut products such as the TVT-Abbrevo. (ECF No. 1 131-5 at 132:8–133:1; ECF No. 131-8 at 99:14–101:15.) Dr. Schwartz testified 2 that she was unaware of the percentage of patients who would develop 3 irreversible complications from devices like the TVT-Abbrevo. (ECF No. 131-5 at 4 144:23–145:1.) 5 On the latter issue, the Court likewise finds that a genuine issue of fact 6 exists as to whether Dr. Schwartz and Dr. Oliver would have changed their 7 decision to recommend the TVT-Abbrevo to Plaintiff had adequate warnings been 8 provided. Dr. Schwartz testified that she would have changed her patient 9 consenting process if she had known of the risks of shorter slings (ECF No. 131- 10 5 at 134:16–23), and Dr. Oliver testified that awareness of the increased risks of 11 shorter and laser-cut meshes would have led him to use an alternative product 12 if available (ECF No. 131-8 at 102:6–103:6). Defendants’ motion for summary 13 judgment is denied with respect to Plaintiff’s strict liability failure to warn claim. 14 B. DUPLICATIVE CLAIMS 15 Defendants move for summary judgment on Plaintiff’s fraud claim as 16 duplicative of Plaintiff’s failure to warn claim. Defendants argue that Plaintiff 17 cannot employ a fraud claim as a means to circumvent the learned intermediary 18 doctrine and that Plaintiff cannot identify any particular fraudulent statement 19 that Plaintiff detrimentally relied upon. Plaintiff responds that fraud is a valid 20 claim in the learned intermediary context since Defendants knew of risks and 21 failed to disclose them, causing Plaintiff to detrimentally rely on the statements 22 of the learned intermediary. The Court agrees with Plaintiff that the learned 23 intermediary doctrine does not generally bar fraud claims, however the Court also 24 finds that in this case, Plaintiff does not advance any unique facts or allegations 25 specific to her fraud claim that are not present in the failure to warn claim. 26 Plaintiff’s fraud claim is therefore entirely duplicative of her strict liability failure 27 to warn claim and therefore dismissal is appropriate. See Carter v. Ethicon, Inc., 28 2021 WL 1226531, at *4 (D. Nev. Mar. 31, 2021). 1 Defendants move for summary judgment on Plaintiff's negligence-based 2 claims—negligence, negligent infliction of emotional distress, and gross 3 negligence—as duplicative of Plaintiff’s strict liability claims. In response Plaintiff 4 cites Forest v. E.I. DuPont de Nemours & Co., 791 F. Supp. 1460, 1464 (D. Nev. 5 1992), in which the Court described “the task of distinguishing between 6 negligence and strict liability” as akin to “count[ing] angels on the heads of pins[,]” 7 but nonetheless noted that the claims may differ as to common law defenses such 8 as contributory negligence and therefore “preserved for trial” the “formal 9 dichotomy between the two causes of action[.]” Id. at 1464 n.6. The Court 10 disagrees that formally preserving the separate causes of action for trial is 11 necessary. Introduction of common law defenses to negligence-based claims 12 when those defenses do not apply to the analogous strict liability claims founded 13 on entirely the same allegations would waste judicial resources and confuse the 14 issues. Dismissal of Plaintiff’s negligence-based claims is appropriate. 15 III. MOTIONS TO LIMIT TESTIMONY AND OPINIONS 16 Defendants bring six motions to limit the testimony or opinions of Plaintiff’s 17 experts, namely: (1) Dr. Paul J. Michaels (ECF No. 112); (2) Dr. Med. Uwe Klinge 18 (ECF No. 113); (3) Dr. Jeremy Blaivas (ECF No. 114); (4) Dr. Bruce Rosenzweig 19 (ECF No. 115); (5) John Cary, MA (ECF No. 116); and (6) Scott Guelcher, Ph.D. 20 (ECF No. 117). In response to Defendants’ motion, Plaintiff withdrew Dr. Blaivas 21 as an expert (ECF No. 118), therefore Defendants’ motion will be denied as moot. 22 Fed. R. Evid. 702 permits a witness who is qualified as an expert by 23 knowledge, skill, experience, training, or education to testify in the form of an 24 opinion or otherwise if: (a) the expert's scientific, technical, or other specialized 25 knowledge will help the trier of fact to understand the evidence or to determine a 26 fact in issue; (b) the testimony is based on sufficient facts or data; (c) the 27 testimony is the product of reliable principles and methods; and (d) the expert 28 has reliably applied the principles and methods to the facts of the case. As 1 explained in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), 2 five factors have traditionally been used to determine if the principles and 3 methods utilized by the proposed expert are reliable: (1) whether a theory or 4 technique can be tested; (2) whether it has been subjected to peer review and 5 publication; (3) the known or potential error rate of the theory or technique; (4) 6 whether there are standards controlling the technique's operation; and (5) 7 whether the theory or technique enjoys general acceptance within the relevant 8 scientific community. 9 A. DR. MICHAELS 10 Defendants seek to exclude Dr. Michaels’ opinions regarding proposed 11 alternative mesh materials and designs that he claims would be safer than the 12 polypropylene TVT-Abbrevo mesh, such as absorbable mesh materials and 13 designs with larger pores. Defendants argue that, although Dr. Michaels cites to 14 several scientific studies discussing, for example, the relative incidence of 15 inflammation and foreign body reactions with polypropylene versus other 16 materials, Dr. Michaels has not and cannot cite to any testing of an alternative 17 mesh product as a treatment for the conditions Plaintiff used the TVT-Abbrevo 18 for, namely stress urinary incontinence and pelvic organ prolapse. 19 In order for a scientific technique to be reliable, there must be evidence in 20 the record indicating the methodology “can be or has been tested.” City of Pomona 21 v. SQM N. Am. Corp., 750 F.3d 1036, 1046 (9th Cir. 2014) (citing Cooper v. Brown, 22 510 F.3d 870, 880–81 (9th Cir.2007)). The question is whether an expert's 23 methodology can be “challenged in some objective sense, or whether it is instead 24 simply a subjective, conclusory approach that cannot reasonably be assessed for 25 reliability.” Id. (citing Fed. R. Evid. 702 Advisory Committee's Note to 2000 26 Amendments). Shaky but admissible evidence is to be attacked by cross 27 examination, contrary evidence, and attention to the burden of proof, not 28 exclusion. Primiano v. Cook, 598 F.3d 558, 564 (9th Cir. 2010), as amended (Apr. 1 27, 2010). 2 The Court agrees with Plaintiff’s characterization that the scope of the 3 testing inquiry concerns whether the proposed expert’s opinions have been 4 subject to scientific testing in a more general sense and is not limited to whether 5 the proposed expert’s opinions have been tested precisely within the application 6 at issue in the case. The precise point at which scientific support becomes too 7 general to bear on the specific case is a matter for the Court to decide in each 8 particular case. Overly narrowing the testing requirement would risk precluding 9 opinions for reasons that would be properly the subject of cross examination and 10 impeachment, and such narrowing of the testing requirement would essentially 11 require studies that are perhaps impossible or infeasible to carry out, especially 12 in the medical context. See Primiano, 598 F.3d at 565–66 (“The human body is 13 complex, etiology is often uncertain, and ethical concerns often prevent double- 14 blind studies calculated to establish statistical proof.”). 15 Here, the Court finds that the scientific literature cited by Dr. Michaels for 16 the effects of differing materials and pore sizes is sufficiently related to the issues 17 in Plaintiff’s case to be generally admitted. See Carter v. Johnson & Johnson, No. 18 2:20-cv-01232-KJD-VCF, 2022 WL 4589583, at *2–3 (D. Nev. Sept. 28, 2022). As 19 explained in Carter, it does not appear that Dr. Michaels intends to opine on what 20 specific material a surgeon should use. (ECF No. 112-1 at 7 (listing summary of 21 opinions).) The Court agrees that opining on what specific material a surgeon 22 should use goes beyond the scope of Dr. Michaels’ expert role, however, this does 23 not preclude Dr. Michaels from opining on the likelihood of alternative materials 24 and designs causing, for example, different rates of inflammatory reactions. 25 Defendants’ motion is denied. 26 B. DR. KLINGE 27 Defendants seek to exclude Dr. Klinge’s opinion that an alternative design 28 with less mesh material and larger distance between the mesh fibers, specifically 1 including Ethicon’s Ultrapro mesh (which Defendants point out is a product 2 made to treat hernias), would be safer in a woman’s pelvic tissues than the TVT- 3 Abbrevo. Defendants argue that Dr. Klinge’s Ultrapro opinion should be excluded 4 as unreliable for lack of testing or scientific literature demonstrating that it is 5 safer than the TVT-Abbrevo. Defendants further assert that Dr. Klinge should not 6 be permitted to support the Ultrapro opinion in his expert report by referencing 7 in his deposition a study—the Okulu et al. study—that was not cited in his expert 8 report and also that this study cannot support his Ultrapro opinions because it 9 involved different surgical implantation techniques than were used in Plaintiff’s 10 case for the TVT-Abbrevo. 11 The Court agrees with Defendants that under Fed. R. Civ. P. 26(a)(2)(B)(i) 12 and (ii), Dr. Klinge cannot support the opinions in his expert report with a study 13 not disclosed in the report. Nonetheless, even excluding the Okulu et al. study, 14 the Court agrees with Plaintiff that Dr. Klinge’s Ultrapro alternative design 15 opinion is supported by scientific literature and should be admitted. Similar to 16 the above reasoning regarding Dr. Michaels, just because there are not studies 17 testing Ultrapro in vivo for the precise application at issue does not mean that 18 Dr. Klinge’s opinions are not founded on rigorous scientific literature. Rather, as 19 noted in Carter v. Johnson & Johnson, No. 2:20-cv-01232-KJD-VCF, 2022 WL 20 4700570, at *3 (D. Nev. Sept. 30, 2022), Dr. Klinge cites numerous scientific 21 studies to support his opinions regarding mesh weight and pore size. (ECF No. 22 113-1 at 9–15.) Defendants’ motion is granted with respect to the Okulu et al. 23 study and denied in all other aspects. 24 C. DR. ROSENZWEIG 25 Defendants bring three challenges1 to Dr. Rosenzweig’s expert testimony. 26 1 Defendants also challenged as unreliable Dr. Rosenzweig’s opinions concerning degradation and 27 the manner in which the mesh in the TVT-Abbrevo was cut, however in reply Defendants withdrew their challenges on these topics. (ECF No. 127 at 3, 5.) Defendants also challenge Dr. Rosenzweig’s 28 1 First, Defendants assert that Dr. Rosenzweig’s supplemental report improperly 2 includes additional opinions based on information available before the close of 3 MDL discovery in contravention of the Court’s limitation of the re-opening of 4 discovery to occurrences after the close of the MDL discovery. Second, Defendants 5 argue that Dr. Rosenzweig should be prohibited from testifying that non-mesh 6 surgical procedures, such as those which use biological slings, are safer 7 alternatives to surgeries using mesh products. Third, Defendants argue that Dr. 8 Rosenzweig should be precluded from testifying that a different type of mesh 9 would be a safer alternative. 10 1. Supplemental Report 11 As explained in the parties’ joint motion to reopen discovery (ECF No. 104), 12 discovery in the MDL case closed on October 25, 2019. The Court granted the 13 parties’ joint motion to reopen discovery “for the limited purpose of addressing 14 changes in Plaintiff’s damages” and set a deadline for supplemental case-specific 15 expert reports “limited to occurrences after the close of MDL discovery[.]” (ECF 16 No. 108 at 2, 3.) Dr. Rosenzweig submitted a supplemental report dated August 17 8, 2022. (ECF No. 115-2.) 18 Defendants’ challenge Dr. Rosenzweig’s reference to the deposition 19 testimony of Dr. Ja-Hong Kim, which Dr. Rosenzweig cites when discussing his 20 revised opinion that Plaintiff suffers from obturator neuralgia and pudendal 21 neuralgia. Defendants point out that the deposition of Dr. Kim occurred on 22 September 30, 2019, before the close of discovery in the MDL. Thus, Defendants 23 argue that Dr. Rosenzweig cannot rely on Dr. Kim’s deposition since that 24 deposition does not fall within the limited scope for which discovery was 25 reopened, namely for post-MDL occurrences. Plaintiff responds that although Dr. 26 opinions concerning warnings “for the reasons set forth in Ethicon’s concurrently filed summary 27 judgment motion[.]” (ECF No. 115 at 6.) Since the Court denies Defendants’ motion for summary judgment and Defendants provide no further argument on this topic, the Court rejects 28 Defendants’ challenge to Dr. Rosenzweig’s warning opinions. 1 Kim’s deposition occurred during the MDL discovery, the deposition occurred six 2 weeks after the deadline on which Dr. Rosenzweig submitted his original expert 3 report and therefore supplementation is warranted. Defendants reply that the 4 proper procedure would have been for Plaintiff to supplement Dr. Rosenzweig’s 5 expert report shortly after Dr. Kim’s deposition was taken pursuant to Fed. R. 6 Civ. P. 26. 7 The Court agrees that Dr. Rosenzweig’s use of Dr. Kim’s deposition is 8 improper given that it is not a post-MDL occurrence. However, Dr. Rosenzweig’s 9 opinions regarding obturator and pudendal neuralgia are not based only on Dr. 10 Kim’s deposition testimony but also upon Plaintiff’s medical records and 11 Plaintiff’s deposition. (ECF No. 115-2 at 16–19.) The Court grants Defendants’ 12 motion to preclude Dr. Rosenzweig from referring to Dr. Kim’s 2019 deposition 13 and denies Defendants’ motion in all other aspects on the subject of Dr. 14 Rosenzweig’s supplemental report. 15 2. Alternative Procedures 16 Defendants argue that Dr. Rosenzweig should be precluded from offering 17 testimony on alternative procedures that do not utilize a mesh implant, such as 18 the “Burch” surgical procedure which does not require implanting a device, or 19 the use of autologous or allograft slings, which are biological slings that use the 20 patient’s own tissues or donor tissues, respectively. Defendants assert that these 21 alternative procedures are not relevant to the issue of whether an alternative 22 design exists for the product at issue, which is a synthetic mesh product. Since 23 the decision to utilize a certain surgical approach over another involves patient- 24 specific medical considerations, Defendants reason that introduction of this 25 evidence would confuse the issues since the central issue in this case is the 26 design of the product for a mesh-based procedure. Plaintiff responds that under 27 Nevada law, an alternative design is not a required element of a strict liability 28 defective design claim, meaning alternative procedures are permissible as 1 alternatives, and that the jury should be allowed to hear about alternative 2 procedures to contextualize the risks associated with mesh products, especially 3 since Defendants’ experts assert that mesh products are the “gold standard” for 4 treating conditions such as stress urinary incontinence. 5 The Court agrees, following Carter v. Johnson & Johnson, 2022 WL 6 4700567, at *2–3 (D. Nev. Sept. 30, 2022), that alternative procedures are not 7 generally relevant to the issue in this case, which is the design of a mesh product, 8 and that the presence of patient-specific considerations in recommending the use 9 of a mesh over alternative procedures carries the risk of confusing the issues. 10 Therefore, Dr. Rosenzweig will not be permitted in the first instance to opine that 11 alternative procedures are safer alternatives to the TVT-Abbrevo. However, the 12 Court will permit Plaintiffs to rebut any representation by Defendants that mesh 13 products are safer alternatives to non-mesh procedures. Therefore, the Court will 14 permit Plaintiff to provide alternative procedure evidence should Defendants open 15 the door by introducing such evidence themselves. 16 3. Mesh Type 17 Defendants argue that Dr. Rosenzweig should be prohibited from opining 18 that a device with lighter weight and greater porosity, such as Defendants’ 19 Ultrapro product, would be a safer alternative to the TVT-Abbrevo because Dr. 20 Rosenzweig’s expert reports do not contain the specific assertion that Plaintiff’s 21 injuries would have been lessened if she had been implanted with such an 22 alternative. Plaintiff responds that: (1) the MDL Court already ruled that Dr. 23 Rosenzweig’s opinions about a lighter-weight, larger-pore mesh such as the 24 Ultrapro are admissible; (2) Dr. Rosenzweig does reference lighter-weight, larger- 25 pore mesh such as the Ultrapro in his reports; and (3) Dr. Rosenzweig testified in 26 his deposition that the Ultrapro would have reduced the risk of injury for Plaintiff. 27 The Court agrees with Plaintiff that Dr. Rosenzweig’s report sufficiently 28 discusses a lighter-weight, larger-pore mesh such as the Ultrapro to put 1 Defendants on notice of Dr. Rosenzweig’s opinion. The report states that “Ethicon 2 had lighter weight, larger pore meshes that were less stiff and rigid, and more 3 compliant with patients’ tissues that it marketed for use in the pelvis[,]” and the 4 report discusses Ultrapro by name. (ECF No. 124-1 at 41, 67.) Defendants’ 5 motion is denied on this point. 6 D. JOHN CARY 7 Defendants challenge the introduction of Plaintiff’s damages expert, John 8 Cary, who was disclosed by Plaintiff following the Court’s limited reopening of 9 discovery to address occurrences after the close of discovery in the MDL. 10 Defendants assert that Mr. Cary’s opinions are improper because they are based 11 on the totality of the evidence available, including evidence available before the 12 close of MDL discovery. Plaintiff responds that Mr. Cary’s retention as a damages 13 expert arose from the change in Dr. Rosenzweig’s opinion that occurred after the 14 close of MDL discovery: Dr. Rosenzweig first opined that Plaintiff’s required 15 medical care could range from 6 months to 5 years, then in his supplemental 16 report opined that treatments would likely need to be performed over the 17 remainder of Plaintiff's life, and Plaintiff notes Mr. Cary’s opinion that Plaintiff 18 has a life expectancy of an additional 31.8 years. (ECF No. 121 at 11–12.) Plaintiff 19 also points out that she lost her job after the close of MDL discovery and asserts 20 that Mr. Cary’s report is responsive to that occurrence. 21 The parties’ joint motion to reopen discovery states that “since the close of 22 discovery in the MDL, Plaintiff has continued to receive medical treatment for her 23 mesh-related injuries and has sustained a change in employment status as a 24 result of the progression of her injuries and job duties. These recent developments 25 could necessitate the need for vocational and/or damages expert(s) limited to 26 occurrences since the close of MDL discovery.” (ECF No. 104 at 9.) The Court 27 granted the motion and set forth a deadline for “disclosure of vocational and/or 28 damages expert(s) limited to occurrences after the close of MDL discovery, if 1 any[.]” (ECF No. 108 at 2.) Although Mr. Cary’s report canvasses Plaintiff’s 2 medical history prior to the close of MDL discovery, including depositions, Mr. 3 Cary’s vocational assessment and life care plan centers on calculating the impact 4 of Plaintiff’s injuries on a lifetime basis and on Plaintiff’s employment prospects. 5 Although Defendants are correct that Plaintiff could have and did not designate 6 a damages expert during MDL discovery, the permanent nature of Plaintiff’s 7 injuries was not known at that time, and, more concretely, the loss of Plaintiff’s 8 employment had not occurred. The language of the parties’ joint motion and the 9 Court’s order put Defendants on reasonable notice that Plaintiff would introduce 10 an expert to address those occurrences. Mr. Cary’s analysis must, as a matter of 11 logical necessity, acknowledge and build upon Plaintiff’s medical history from the 12 time of MDL discovery.2 Defendants’ motion is denied. 13 E. DR. GUELCHER 14 Defendants challenge: (1) the introduction of Dr. Guelcher’s alternative 15 procedure opinions, incorporating the arguments from the challenge to Dr. 16 Rosenzweig; and (2) the reliability of Dr. Guelcher’s alternative design and 17 degradation opinions. The Court grants Defendants’ motion on alternative 18 procedures consistent with § III.C.2, supra. 19 Regarding alternative design, Dr. Guelcher opines that a polyvinylidene 20 fluoride (“PVDF”) mesh or a less dense version of a polypropylene mesh would not 21 degrade in the same way as the TVT-Abbrevo. (ECF No. 117-1 at 3.) Defendants 22 assert that Dr. Guelcher is not qualified to give alternative design opinions, that 23 his proposals have not been tested, and that he fails to cite literature that 24 establishes that his proposals are safer. While the MDL Court held that Dr. 25 Guelcher, as a professor of chemical engineering, is not qualified to opine as to 26 2 The instant matter is distinct from Defendants’ challenge to Dr. Rosenzweig’s reliance upon the 27 deposition testimony of Dr. Kim, § III.C.1, supra. Dr. Rosenzweig was already disclosed as a case- specific expert on causation, and general updates to causation opinions based on MDL discovery 28 evidence were not within the scope of the limited reopening of discovery. 1 the medical complications that may be caused by polymer degradation (ECF No. 2 119-1), it does not appear at this stage that Dr. Guelcher intends to offer opinions 3 as to medical complications. Rather, Dr. Guelcher’s testimony will center on the 4 potential for polymer mesh implants to undergo oxidative degradation and what 5 that means as a matter of structural chemistry, which is within Dr. Guelcher’s 6 domain of expertise. Furthermore, as Plaintiff points out, Dr. Guelcher has 7 supported his opinions with citations to studies evaluating oxidative degradation 8 of PVDF, Prolene, and other materials in animal implantations. As discussed 9 above with respect to Dr. Michaels, § III.A, supra, the testing requirement cannot 10 be so narrow as to require recreation of nearly identical conditions as that which 11 allegedly injured Plaintiff. Here, the testing performed is reliable enough for 12 admissibility and its weaknesses may be properly attacked on cross examination. 13 Regarding degradation, Defendants assert that an article published by Dr. 14 Guelcher and others, Talley et al., Oxidation and Degradation of Polypropylene 15 Transvaginal Mesh, J. Biomater. Sci., Polymer Ed. (2017) (“Talley”), has been 16 discredited, yet Dr. Guelcher continues to rely upon it for his opinion that 17 polypropylene mesh oxidizes and degrades in the body. Defendants assert that 18 the Talley study authors failed to follow a methodological protocol for actions 19 such as scraping explanted samples, failed to use a sufficiently large sample size 20 or employ control samples, failed to explain their use of a 20% hydrogen peroxide 21 medium to simulate in vivo conditions, and came to a speculative conclusion that 22 oxygen found on samples was present due to oxidative degradation and not either 23 naturally present with pristine polypropylene or present as a result of other 24 naturally occurring processes. Defendants also point out that the study authors 25 noted the presence of silicon on nine of the fifteen samples and that silicon is a 26 common laboratory contaminant. Plaintiff responds both by defending the Talley 27 study as a peer-reviewed scientific paper and by pointing out that Dr. Guelcher’s 28 opinions on degradation are supported by more than the Talley study. 1 The Court finds that subject to certain specific exclusions, the Talley study 2 is sufficiently reliable for admissibility and that its weaknesses are proper 3 subjects for cross-examination. The authors discuss the choice to clean the 4 explanted samples by mechanical scraping versus other methods such as 5 ultrasonification and how previous studies likely destroyed their results using 6 those procedures. (ECF No. 119 at 12.) The method chosen here is not so 7 unfounded as to render the experiment inadmissible. Regarding control samples, 8 the authors describe analysis of the in vitro samples at zero weeks, which is 9 satisfactory for that part of the experiment. The in vivo sample was analyzed both 10 for surface presence of oxygen and for general visual evidence of degradation such 11 as fraying, etc. Although there is not a discussion of surface oxygen in a pristine 12 sample, the observations of general degradation are contextualized against the 13 control samples in the in vitro experiment. Therefore the Court will preclude Dr. 14 Guelcher from testifying that the presence of surface oxygen on the in vivo sample 15 is evidence of oxidative degradation, but Dr. Guelcher may testify as to the 16 observations of general degradation in the in vivo sample. Regarding the oxidative 17 medium for the in vitro samples, although Defendants point out that one of the 18 citations used to justify the 20% hydrogen peroxide oxidative medium, the Zhao 19 et al. study, used a 10% hydrogen peroxide medium, the Talley study cites more 20 than the Zhao et al. study and Defendants do not rebut these citations. (Id. at 4.) 21 Finally, the Court agrees with Defendants that the reported carboxylate 22 concentration found in samples 5 and 8 in the supplementary data does not 23 correspond to the spectra shown for those samples (ECF No. 117-11 at Supp. 2– 24 3) and therefore Dr. Guelcher may not offer conclusions which incorporate those 25 samples. 26 More generally, the Court agrees with Plaintiff that Dr. Guelcher supports 27 his degradation opinions with more than just the Talley study. Defendants’ 28 motion is granted in part and denied in part with respect to Dr. Guelcher’s 1 || discussion of the Talley study and is denied in all other aspects. 2|| IV. CONCLUSION 3 Based on the above and in light of the record as a whole, the Court grants 4 || Defendants’ motion for summary judgment (ECF No. 111) as to Plaintiffs fraud, 5 || negligence, negligent infliction of emotional distress, gross negligence, defective 6 || product, and unjust enrichment claims and denies Defendants’ motion for 7 || summary judgment in all other aspects. 8 The Court further denies Defendants’ motion to limit the testimony of Dr. 9 || Paul J. Michaels (ECF No. 112). 10 The Court further grants in part and denies in part Defendants’ motion to 11 || limit the testimony of Dr. Med. Uwe Klinge (ECF No. 113) as described herein. 12 The Court further denies as moot Defendants’ motion to limit the testimony 13 || of Dr. Jeremy Blaivas (ECF No. 114) in light of Plaintiffs withdrawal of Dr. Blaivas 14 || as an expert. 15 The Court further grants in part and denies in part Defendants’ motion to 16 || limit the opinions of Dr. Bruce Rosenzweig (ECF No. 115) as described herein. 17 The Court further denies Defendants’ motion to limit the opinions of John 18 || R. Cary, MA (ECF No. 116). 19 The Court further grants in part and denies in part Defendants’ motion to 20 || limit the testimony of Dr. Scott Guelcher, Ph.D (ECF No. 117) as described herein. 21 22 DATED THIS 1st day of August 2023. 23 24 i idan 26 ANNE R. TRAUM UNITED STATES DISTRICT JUDGE 27 28