Opinion
3:20-cv-00380-AR
07-15-2022
LAURIE M. IMHOFF, and ROBERT IMHOFF, Plaintiffs, v. ETHICON, Inc., and JOHNSON & JOHNSON, Defendants.
FINDINGS AND RECOMMENDATION
FILED UNDER PROTECTIVE ORDER
JEFFREY ARMISTEAD UNITED STATES MAGISTRATE JUDGE
Plaintiffs Laurie M. Imhoff (Imhoff) and Robert Imhoff bring this product liability action against defendants Ethicon, Inc. and Johnson & Johnson, alleging that Imhoff was injured by the surgical implantation of defendants' Gynemesh PS mesh for treatment of her pelvic organ prolapse (POP). Defendants move for partial summary judgment. As the court explains, defendants' motion should be granted in part and denied in part.
Plaintiff Robert Imhoff brings a single claim for loss of consortium (Count XVI). Defendants did not move for summary judgment against the consortium claim. Because Mr. Imhoff's claim is not at issue in this motion and to avoid confusion, the court refers exclusively to plaintiff Laurie Imhoff throughout this F&R.
The court finds oral argument is not helpful to resolution of the issues. LOCAL RULE 7-1(d)(1).
FACTUAL BACKGROUND
Imhoff was diagnosed with POP (specifically, “incomplete uterovaginal pelvic relaxation” and “paravaginal defect”), which is relaxation or trauma of pelvic tissues resulting in their prolapse through the vaginal opening. Decl. Jeanne F. Loftis Supp. Mot. Partial Summ. J. (Loftis Decl.) Ex. 1 at 1, ECF No. 82-1; Ex. 3 at 12:15-17 (attaching Dep. Dr. John A. Murphy (Aug. 14, 2018) (Murphy Dep.)), ECF No. 82-3. On June 9, 2010, Dr. John A. Murphy performed surgery on Imhoff-a supracervical abdominal hysterectomy, a retropubic urethropexy using the Burch technique, and an abdominal sacral colpopexy. Id. For the abdominal sacral colpopexy, which involves suturing cervical tissues and the presacral ligament, Dr. Murphy used Ethicon's Gynemesh PS mesh. Ex. 1 at 2, ECF No. 82-1; see also Murphy Dep. at 8:5-9.
After surgery, Imhoff continued to experience chronic deep pain with intercourse, stress urinary incontinence (SUI), and abdominal wall pain. Loftis Decl. Ex. 1 at 3; Murphy Dep. 34:24-35:4. On March 7, 2012, Dr. James M. Carlson, assisted by Dr. Murphy, implanted a retropubic mesh sling manufactured by Bard and performed cystocele repair, rectocele repair, and a diagnostic laparoscopy. Id. at 4.
On June 11, 2014, Dr. Connie DiMarco examined Imhoff for progressive pain, which ranged from dull aches to severe stabbing pain two to three times a day. Resp. Mot. Summ. J. (Resp.) Ex. 3 at 13:2-12 (attaching Dep. Connie DiMarco (Sept. 24, 2018) (DiMarco Dep.)), ECF No. 84-3. Imhoff informed Dr. DiMarco that the pain was chiefly rectal and that manipulation of the cervix also reproduced the pain. DiMarco Dep. at 13:7-10. During Dr. DiMarco's vaginal examination of Imhoff, she could reproduce Imhoff's pain by manipulating the posterior mesh palpable below the vaginal mucosa, but not by palpating the cervix. DiMarco Dep. at 16:10-14. Dr. DiMarco diagnosed pelvic pain and sacral colpopexy mesh contracture. Loftis Decl. Ex. 1 at 17.
On August 20, 2014, Dr. DiMarco, assisted by Dr. Thomas Bascom, performed another surgery-an operation to excise and revise the posterior leaf of the sacral colpopexy Gynemesh PS mesh. Id. Drs. DiMarco and Bascom removed multiple adhesions to the mesh, including cul-de-sac adhesions creating peritoneal fluid filled cysts, a large enterocele sac, and sigmoid adhesions. Id. at 18. The removed portions of the mesh and tissue were sent to pathology for examination. Id. Dr. Bascom's surgery notes reflect that the “balled up segment” of posterior mesh was removed, “along with some permanent sutures.” Id. at 15. Postoperatively, Imhoff denied recurrence of sharp vaginal pain following excision of the mesh. DiMarco Dep. 44:13-19.
On September 14, 2018, Imhoff returned to Dr. DiMarco, complaining of “intermittent sharp pain and heaviness in the vagina, exacerbated by physical activity.” Loftis Decl. Ex. 1 at 21. Dr. DiMarco found no evidence of mesh erosion on the anterior or posterior walls, found the vagina and cervix “fairly well supported supine,” and a grade 2 cystocele and grade 1-2 cervical descensus while standing with tenderness to palpation. Id. at 23. Imhoff was encouraged to avoid heavy lifting, prevent constipation, and perform pelvic strengthening exercises. Id. at 24.
On February 26, 2020, Imhoff was referred for pelvic floor physical therapy. Loftis Decl. Ex. 6 at 3. On July 23, 2020, Imhoff saw Dr. Jones-Mitchell, reporting heaviness in her pelvic floor and pain in the rectal area that worsened with strenuous activity and prolonged standing. Id. at 8. Dr. Jones-Mitchell found no mesh exposure on examination, believed the pain was linked to scar tissue, and recommended Imhoff continue pelvic floor physical therapy, and prescribed vaginal estrogen and vaginal valium. Id.
PROCEDURAL BACKGROUND
On September 25, 2013, Imhoff filed this action in the Multi-District Litigation (MDL), In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation, in U.S. District Court for the Southern District of West Virginia, assigned to District Judge Joseph R. Goodwin. Short Form Compl., ECF No. 1. Imhoff alleges: negligence (Count I); strict liability - manufacturing defect (Count II); strict liability - failure to warn (Count III); strict liability - defective product (Count IV); strict liability - design-defect (Count V); common law fraud (Count VI); fraudulent concealment (Count VII); constructive fraud (Count VIII); negligent misrepresentation (Count IX); negligent infliction of emotional distress (Count X); breach of express warranty (Count XI); breach of implied warranty (Count XII); violation of consumer protection laws (Count XIII); gross negligence (Count XIV); unjust enrichment (Count XV); punitive damages (Count XVII); and discovery rule and tolling (Count XVIII). Id.
On March 3, 2020, this action was transferred from the MDL to the District Court of Oregon and assigned to Magistrate Judge John V. Acosta. ECF No. 50. On September 25, 2020, the parties stipulated to the dismissal of Counts II, IV, VIII, XI, XII, XIII, and XV, and agreed that Counts I, III, V, VI, VII, IX, X, XIV, XVI, XVII, and XVIII remain pending. Stip. Dismissal, ECF No. 71. On March 23, 2022, this action was reassigned to this court.
Defendants move for partial summary judgment on Imhoff's claims for strict liability design-defect and negligence premised on design-defect (Counts V and I); common law fraud and fraudulent concealment premised on omissions (Counts VI and VII); negligent misrepresentation (Count IX); punitive damages (Count XVII); and discovery rule and tolling (Count XVIII).
LEGAL STANDARDS
Summary judgment is appropriate when “there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” FED. R. CIV. P. 56(a). A party seeking summary judgment bears the burden of establishing the absence of a genuine issue of material fact. Celotex v. Catrett, 477 U.S. 317, 323 (1986). If the moving party shows no issue of material fact exists, the nonmoving party must go beyond the pleadings and identify facts which show a genuine issue for trial. Id. at 324. A party cannot defeat a summary judgment motion by relying on the allegations set forth in the complaint, on unsupported conjecture, or on conclusory statements. Hernandez v. Spacelabs Med., Inc., 343 F.3d 1107, 1112 (9th Cir. 2003). Summary judgment should be entered against “a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial.” Celotex, 477 U.S. at 322.
In determining whether to grant summary judgment, the court must view the evidence in the light most favorable to the nonmoving party. Curley v. City of N. Las Vegas, 772 F.3d 629, 631 (9th Cir. 2014); Hernandez, 343 F.3d at 1112. All reasonable doubt as to the existence of a genuine issue of fact should be resolved against the moving party. Hector v. Wiens, 533 F.2d 429, 432 (9th Cir. 1976). However, deference to the nonmoving party has limits. The nonmoving party must set forth “specific facts showing a genuine issue for trial.” FED. R. CIV. P. 56(e). The “mere existence of a scintilla of evidence in support of the plaintiff's position [is] insufficient.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252 (1986). Therefore, where “the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no genuine issue for trial.” Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (internal quotation marks omitted).
DISCUSSION
A. Design-Defect Claims (Counts I and V)
Defendants move for summary judgment on Imhoff's design-defect claims, arguing that Imhoff's specific-causation evidence fails to identify a specific defect in Gynemesh PS mesh linked to her injuries. Imhoff responds that, when viewed collectively, her evidence amply creates an issue of fact on specific causation. The court agrees with Imhoff.
1. Legal Standards
O.R.S. § 30.920 imposes strict liability on a manufacturer for injuries caused by its product if the product is “both defective and unreasonably dangerous.” Purdy v. Deere & Co., 311 Or.App. 244, 247 (2021), rev. denied, 369 Or. 110 (citing McCathern v. Toyota Motor Corp., 332 Or. 59, 77 (2001)). Under Oregon law, the necessary elements of a strict-liability design-defect case are:
(1) the sale or leasing of a product by one engaged in the business of selling or leasing such products; (2) a product that was expected to, and did, reach the user or consumer without substantial change in condition; (3) a product that, when sold, was in a defective condition unreasonably dangerous to the user or consumer; (4) injury to the user or consumer, or damage to his or her property; (5) that was caused by the product's defective condition.McCathern, 332 Or. at 77 n.15. Further, strict liability for a design-defect case is governed by the consumer-expectations test. McCathern, 332 Or. at 79; Bowden v. United Rentals (N.A.), Inc., Case No. 3:17-cv-1411-SI, 2020 WL 5507528, at *5; Chong v. STL Int'l, Inc., 152 F.Supp.3d 1305, 1317 (D. Or. 2016). This test requires a plaintiff to prove that, “when the product left the defendant's hands, the product was defective and dangerous to an extent beyond that which the ordinary consumer would have expected.” McCathern, 322 Or. at 79. “‘Whether a product is dangerous to an extent beyond that which would be contemplated by the ordinary consumer is a factual question to be determined by the jury.'” Purdy, 311 Or.App. at 248 (quoting McCathern, 332 Or. at 78).
Along with presenting evidence about the defective and unreasonably dangerous condition of the Gynemesh PS mesh, Imhoff must establish causation. “In Oregon, ‘[w]hen the element of causation involves a complex medical question,' a plaintiff must ‘present[ ] expert testimony that there is a reasonable medical probability' that her injuries were caused by defendant.” Smith v. Ethicon, Case No. 3:20-cv-00851-MO, 2022 WL 1909019, at *1 (D. Or. June 2, 2022) (quoting Hudjohn v. S&G Mach. Co., 200 Or.App. 340, 351 (2005)).“[A] plaintiff must present expert testimony to prove not only general causation (i.e. that the defendant's product could cause the injury), but also to prove specific causation (i.e. that there is a reasonable probability that defendant's product caused the plaintiff's particular injury).” Phelps v. Wyeth,Inc., 938 F.Supp.2d 1055, 1069 (2013). Oregon courts do not look for “magic words” to determine whether an expert's report, read as a whole, establishes a probability of causation. Id.; Smith, 2022 WL 1909019, at *1.
Oregon's causation standard demands that “a plaintiff need only show that ‘the defendant's conduct was . . . one of the causes of her injury.'” Smith, 2022 WL 1909019, at *1 (quoting Or. Steel Mills, Inc. v. Coopers & Lybrand, LLP, 336 Or. 322, 339 (2004)). “This requires that a plaintiff introduce evidence which affords a reasonable basis for the conclusion that it is more likely than not that the conduct of the defendant was a substantial factor in the result. A mere possibility of such causation is not enough[.]” Chong v. STL Int'l, Inc., 152 F.Supp.3d 1305, 1317 (D. Or. 2016) (simplified); see also Hudjohn, 200 Or.App. at 353 (holding that that expert's opinion must establish a probability of causation).
To establish products-liability negligence under Oregon law, “‘a plaintiff must show that the defendant owed the plaintiff a duty, that the duty was breached, and that the breach caused the plaintiff harm.'” Johnson v. Medtronic Inc., Case No. 6:20-cv-00599-MK, 2021 WL 2669560, at *5 (D. Or. June 10, 2021), adopted 2021 WL 2668793 (June 29, 2021) (quoting Clement v. Ecolab, Inc., 341 F.Supp.3d 1205, 1214 (D. Or. 2018)). “When a defendant's negligence is a factual cause of harm to the plaintiff, the defendant is subject to liability to the plaintiff as long as the harm that the plaintiff suffered was a reasonably foreseeable result of the defendant's negligence.” Lasley v. Combined Transp., Inc., 351 Or. 1, 7 (2011). See also Roach v. Kononen, 269 Or. 457, 465 (1974) (distinguishing defective-design and negligence claims, noting that negligence focuses on “the reasonableness of the manufacturer's actions in designing and selling the article” given the known risks at the time whereas strict liability design defect focuses on the “condition (dangerousness)” of the article).
2. Analysis
According to defendants, Imhoff fails to create a genuine issue of fact on “specific causation” because she fails to identify evidence that a specific defect in the Gynemesh PS mesh caused her injuries. Defendants contend that Imhoff needs to show more than that the mesh's presence caused her injuries, citing decisions from other jurisdictions. E.g., Lewis v. Johnson & Johnson, 601 Fed.Appx. 205, 211 (4th Cir. 2015) (affirming directed verdict for Ethicon where Lewis failed to proffer expert testimony that defect in TVT caused her pelvic pain); Lampron v. Johnson & Johnson, Case No. 20-cv-317-JD, 2020 WL 3452150, at *4 (D.N.H. June 24, 2020) (granting summary judgment on design-defect claim because there was no expert testimony about a specific defect in the mesh); Balura v. Ethicon, Inc., Case No. 3:19-cv-1372, 2020 WL 819293, at *9 (N.D.N.Y. Feb. 19, 2020) (excluding expert testimony because it did not explain how a defect in TVT caused her injuries, “as opposed to the mere presence of the TVT itself”).
Imhoff responds with deposition testimony and the surgical findings of her doctors as well as expert reports. According to Imhoff, this evidence collectively creates a genuine issue of material fact on specific causation to survive summary judgment.
Recently District Judge Michael W. Mosman examined this issue in another MDL pelvic mesh case, Smith v. Ethicon, 2022 WL 1909019, at *2. There, Ethicon moved to exclude the testimony from Smith's proffered expert, Dr. Daniel Elliott. Id. at *1. Ethicon argued that Dr. Elliott failed to opine on “specific causation” and consequently, his opinion was not relevant and must be excluded. Id. Judge Mosman remarked that Dr. Elliott opined generally that the polypropylene degrades and therefore intensifies the body's inflammatory response. Id. at *2. Dr. Elliott further opined that, based on his “expertise, review of Smith's medical history, and a physical examination of Smith,” he concluded “with a high degree of medical certainty” that Smith developed vaginal mesh erosion from implantation of Prolift. Id. Judge Mosman agreed with Ethicon that Dr. Elliott did “not directly connect Smith's injuries to polypropylene or any other defect he has identified in Prolift.” Id. However, Judge Mosman concluded that “Oregon law does not require experts to show that a specific product defect caused a plaintiff's injuries.” Id. (citing Hudjohn, 200 Or.App. at 353). “What matters is whether Dr. Elliott's report supports a reasonable inference that Prolift caused Smith's injuries.” Id. Judge Mosman determined that, although Dr. Elliott's report did not explicitly connect Prolift's alleged defects to Smith's injuries, a reasonable jury could infer that connection without additional expert testimony. Id. at *3.
Judge Acosta addressed similar issues in Pearson v. Ethicon, Inc., Case No. 3:20-cv-01905-AC, 2021 WL 4498562, at *3 (D. Or. Aug. 16, 2021), adopted in part and rejected in part, 2021 WL 4494188 (Sept. 30, 2021) (reversing F&R on gross negligence claim, otherwise adopted). There, Judge Acosta examined whether Dr. Ostergard's expert's opinion could be excluded because he failed to identify a specific defect in the TVT mesh that caused Pearson's injuries and was admissible. Pearson, 2021 WL 4498562, at *3. Distinguishing Lewis, the court found Dr. Ostergard's opinion identified more than the “mere presence” of the mesh as the cause of Pearson's injuries. Id. Judge Acosta noted Dr. Ostergard's opinion provided a differential diagnosis that there was no evidence of surgical or medical errors, identified that the TVT sling was made from polypropelene, and that “‘the mesh is heavy weight, with small pores, impure, not inert, degrades, shrinks, causes chronic inflammation, dense fibrosis and potentiates infection.'” Id. (quoting Dr. Ostergard's Supplemental Report). Additionally, Dr. Ostergard opined that Pearson's stress incontinence was due to the mesh migration coupled with marked inflammatory and dense fibrotic reaction to the device. Id. at *4. And, Judge Acosta discussed that Dr. Ostergard opined that Pearson's bladder outlet obstruction was likely caused by mesh shrinkage and the intense inflammatory and dense fibrotic reaction to the device, based on his differential diagnosis. Id.
After finding Dr. Ostergard's testimony admissible, Judge Acosta concluded that Pearson created a genuine dispute for trial on consumer expectations and rejected defendants' contention that proof of a tested, safer design was required. Id. at *12. “It is not Pearson's job to redesign the TVT mesh, but rather to demonstrate that the TVT, as designed, was unreasonably dangerous. Id. (citing Bowden, 2020 WL 5507528, at *5 (“It is not Plaintiff's burden to redesign the boom lift for Genie, but rather to demonstrate that the boom lift, as designed, was unreasonably dangerous.”)).
As in Smith and Pearson, the court finds that to survive summary judgment, Imhoff is not required to present expert testimony that a specific defect in the Gynemesh PS mesh caused her injuries. Smith, 2022 WL 1909019, at *2. Causation does not require absolute proof; it requires Imhoff to introduce evidence which supports a reasonable inference that that it is probable that defendants' Gynemesh PS mesh caused her injuries. Smith, 2022 WL 1909019, at *2; Chong, 152 F.Supp.3d at 1317; see also Kennedy v. Collagen Corp., 161 F.3d 1226, 1230 (9th Cir. 1998) (providing that, “given the difficulties in establishing a medical cause and effect relationship, causation can be proved even when we don't know precisely how the damage occurred, if there is sufficiently compelling proof that the agent must have caused the damage somehow”) (simplified); Enborg v. Ethicon, Inc., Case No. 2:20-cv-02477-AWI-BAK, 2022 WL 800879, at *11 (E.D. Cal. Mar. 16, 2022) (providing that experts may “satisfy the causation requirement in product liability cases by ruling out other causes of a patient's symptoms through a process of elimination known a ‘differential diagnosis'”) (citing Clausen v. M/V NEWCARISSA, 339 F.3d 1049, 1058 (9th Cir. 2003).
To support her design-defect claims, Imhoff offers the following: (1) the August 24, 2015 expert report of Dr. Bruce Rosenzweig; (2) the November 16, 2015 expert report of Dr. Uwe Klinge (Prof. Dr. med.); (3) the expert reports of Dr. Jorge Peacher, supplemented on November 22, 2020 and February 1, 2021; (4) the July 1, 2016 general causation and January 27, 2021 specific causation expert reports of Dr. Paul Michaels; and (5) the testimony, deposition, and medical records of Dr. DiMarco, Imhoff's treating physician. As detailed below, the evidence from Drs. Rosenzweig and Klinge fails to carry Imhoff's burden on specific causation, i.e., that there is a reasonable medical probability that the Gynemesh PS mesh caused Imhoff's injuries. But the testimony, surgical notes, and expert reports from Drs. DiMarco, Michaels, and Peacher, viewed in the light most favorable to Imhoff, readily creates a genuine issue for trial on specific causation.
a. Drs. Rosenzweig and Klinge
Dr. Rosenzweig is a urogynecologist and has been qualified as an expert in many MDL pelvic mesh cases. Pl. Ex. 2. However, Dr. Rosenzweig is not designated as an expert in this case. Loftis Decl. Ex. 4, ECF No. 82-4 (identifying as retained experts Dr. Dionysios Veronikis, general urogynecologist; Dr. Uwe Klinge; Dr. Michaels, pathologist; Dr. Peacher, case-specific urogynecolgist (specific causation); and Dr. DiMarco, specific causation and non-retained expert). Dr. Rosenzweig's expert report does not identify Imhoff's case as an action to which his report is related. See Pl. Ex. 2 at 1-2, ECF No. 84-2 (identifying cases, omitting any reference to Imhoff). And as defendants correctly emphasize, Dr. Rosenzweig's expert report discusses Ethicon's TVT mesh, a product not implanted in Imhoff. More troubling, Dr. Rosenzweig's expert report does not discuss Ethicon's Gynemesh PS mesh. Instead, Dr. Rosenzweig's report discusses his experience with TVT, TVT-O, and Prolift medical-device products. Pl. Ex. 2 at 2-3. Because Dr. Rosenzweig's expert report does not discuss defects in defendants' Gynemesh PS mesh generally or whether it was reasonably probably that Gynemesh PS mesh caused Imhoff's injuries, it fails to create an issue of fact that from which it can reasonably be inferred that defendants' product caused her injuries. Smith, 2022 WL 1909019, at *2; Chong, 152 F.Supp.3d at 1317.
Defendants contend that Dr. Klinge's expert report also fails to provide evidence of specific causation. See Pl. Ex. 5 (attaching expert report of Dr. Klinge), ECF No. 84-5. Dr. Klinge was designated as an expert in this case. See Loftis Decl. Ex. 4, ECF No. 82-4. But as defendants correctly clarify, Dr. Klinge's report focuses on Ethicon's Prolene meshes in TVT products, not Gynemesh PS. See id. at 2 (discussing that the “Prolene mesh in Ethicon's TVT products is unsuitable for use as a permanent implant for treatment of a woman's stress urinary incontinence”); Id. at 7 (“It is my opinion to a reasonable degree of medical and scientific certainty that the entire TVT line of products created and unnecessary risk of patient complications and injuries when implanted in pelvic tissue.”). Defendants submitted evidence providing that Gynemesh PS is “constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard Prolene mesh.” Loftis Decl. Ex. 9 at 40.
Although Imhoff asserts that “Prolene mesh is the same mesh utilized in the Gynemesh product,” the cited portions of Dr. Klinge's expert report fail to support the contention that the Prolene used in Ethicon's TVT products and the Gynemesh PS mesh implanted in Imhoff are the same. For example, Dr. Klinge opines that “the Prolene mesh in TVT” undergoes a chronic foreign body response, and that the weight of “the Prolene mesh in TVT unnecessarily increases the risk of patient injury.” Compare Pl. Ex. 5 at 1-2 with Pl. Resp. at 7-8. Dr. Klinge later provides that “all of Ethicon's TVT line of products, including TVT-R, TVT-O, TVT-A, TVT-E and TVT-S, are made of the same Prolene Old Construction 6 mil mesh” and “[t]herefore, all of my opinions in this report are the same as to all of the TVT devices.” Pl. Ex. 5 at 6-7. None of the pages cited by Imhoff in Dr. Klinge's report state that defendants' Gynemesh PS and TVT products are the same. The court refuses to review the remaining 500 pages of Dr. Klinge's expert report for Imhoff. The court has “no independent duty to scour the record in search of a genuine issue of triable fact, and may rely on the nonmoving party to identify with reasonable particularity the evidence that precludes summary judgment.” Simmons v. Navajo Cnty., Ariz., 609 F.3d 1011, 1017 (9th Cir. 2010) (internal quotation and citation omitted), overruled on other grounds by Castro v. Cnty. of L.A., 833 F.3d 1060 (9th Cir. 2016) (en banc).
Moreover, it is undisputed here that Imhoff's SUI device was manufactured by Bard; she was not implanted with an Ethicon TVT SUI device manufactured by defendants. Therefore, because Dr. Klinge's expert report does not discuss defects in defendants' Gynemesh PS mesh generally or how Gynemesh PS mesh caused Imhoff's injuries, it fails to create a reasonable inference that it is probable that defendants' product caused her injuries. Smith, 2022 WL 1909019, at *2; Chong, 152 F.Supp.3d at 1317.
b. Drs. DiMarco, Michaels, and Peacher
Imhoff points to the deposition testimony of Dr. DiMarco, the surgeon who excised a portion of her Gynemesh PS mesh implant. Pl. Ex. 3. Dr. DiMarco is board certified in obstetrics, gynecology, and pelvic reconstructive surgery. Id. at 9:14-17. Dr. DiMarco met with Imhoff to discuss complaints of progressive pain ranging from dull aches to stabbing pain, mostly in the rectal area. Id. at 13:2-9. On examination, Dr. DiMarco could reproduce the pain at the posterior wall of the vagina. Id. at 16:19-24. Dr. DiMarco referred Imhoff for an ultrasound and a cystoscopy to rule out other sources of her pain. Id. at 23-25. Drs. DiMarco and Bascom performed surgery on August 20, 2014. Id. at 29. Dr. DiMarco testified that “you could see the mesh was contracted and we felt like that was the area of tenderness that I was palpating through the wall of the vagina.” Id. at 33:1-5. Dr. Bascom's surgery report refers to the mesh as “balled up.” Id. at 33:23-34:1; Loftis Decl. Ex. 1 at 15. Dr. DiMarco's surgery notes reveal there was no evidence of active, visible endometriosis in Imhoff's lower pelvis or remaining left ovary. Loftis Decl. Ex. 1 at 18. Dr. Bascom's surgery notes reveal that there was no evidence of a defect in the rectal wall. Id. at 15. After the surgery, Imhoff reported post-operative tenderness, but “denied recurrence of sharp vaginal pain following excision of the mesh.” DiMarco Dep. at 44:15-19.
Imhoff also relies on the specific-causation and general-causation reports of Dr. Michaels. Dr. Michaels is board certified in anatomic pathology, clinical pathology, and cytopathology and he has been qualified as an expert in other pelvic mesh cases. See Godreau-Rivera v. Coloplast Corp., __ F.Supp.3d __, 2022 WL 1120371, at *9 (D. Del. Apr. 14, 2022) (denying defendants' motion to exclude Dr. Michaels' expert testimony that Restorelle mesh implant caused fibrotic reaction resulting in pelvic pain, irritative bladder symptoms, and dyspareunia); Townsend v. Ethicon, Inc., Case No. 2:20-cv-01984-APG-DJA, 2021 WL 304555, at *1 (D. Nev. Jan 29, 2021) (“Dr. Michaels is qualified as a pathologist to opine that there is no other pathological cause for Townsend's injuries following a review of her medical records and examination of specimens of the mesh and her tissue.”). Defendants state that they will move to exclude Dr. Michaels' opinions on various grounds. The court declines to speculate whether Dr. Michaels' opinions would be admissible at trial and considers Dr. Michaels' opinions for purposes of summary judgment only.
When this case was transferred from the MDL, several Daubert motions concerning the admissibility of certain expert witnesses were pending. ECF Nos. 42-48. Judge Acosta deferred ruling on those motions. Scheduling Order, ECF No. 80. Accordingly, this court expresses no opinion on the admissibility of any expert report for trial.
In his specific-causation expert report, Dr. Michaels provides that he reviewed Imhoff's medical records, slides of her explanted tissue, internal Ethicon documents, scientific literature, and deposition testimony of Imhoff, her husband, and her treating physicians. Pl. Ex. 4 at 1, ECF No. 84-4. Dr. Michaels opines that,
to a reasonable degree of medical and scientific certainty that her reported symptoms and exquisite pain to palpation, pelvic pain, and dyspareunia were the
direct result of a prominent inflammatory and fibrosing reaction secondary to the mesh, including scar plate formation, bridging fibrosis, chronic inflammation, vascular congestion with hemorrhage, nerve entrapment and distortion, polypropylene bark degradation, and granuloma formation. The histologic features demonstrating haphazardly arranged polypropylene filament bundles surrounded by dense fibrosis correlate with the clinical impression of “wadded up,” “balled up,” and “contracted” mesh appreciated by Drs. Bascom and DiMarco at the time of the mesh revision surgery in 2014. Of note, her symptoms of pain and dyspareunia reportedly differed in both quality and severity compared to any complaints of pain or dyspareunia that she experienced preoperatively and have continued subsequent to her initial synthetic mesh implantation, though initially dramatically improved following excision of the contracted pelvic mesh in 2014, supporting the fact that the degenerated mesh was a main etiology for Mrs. Imhoff's symptomology.Pl. Ex. 4 at 52, ECF No. 84-4.
In his general-causation report, incorporated by reference in his specific-causation report, Dr. Michaels discusses that defendants' meshes used to treat SUI and POP cause complications, and that studies have “uniformly supported the finding that larger mesh pore sizes have better incorporation,” that “smaller pore sizes significantly impair vessel and adipose tissue penetration secondary to prominent fibrosis,” and that the foreign body-type giant cell response and prominent fibrosis” forms a scar plate, “resulting in the mesh becoming stiff, contracted, and nonflexible.” Pl. Ex. 9 at 2. Dr. Michaels discusses how Ethicon's SUI and POP meshes degrade over time due to the inflammatory response which “causes an oxidative burst of free radicals and peroxides leading to embrittlement, crack formation, and loss of mechanical properties.” Id. at 6.
In his specific-causation expert report, Dr. Michaels noted that Imhoff's explanted mesh specimen contained “areas of nerve entrapment by mesh fibrosis.” Pl. Ex. 4 at 9. Dr. Michaels further indicated that by using polarization light microscopy, he could see cracked mesh fibers and that “the brittleness of this degraded polyprolene implant can impact the biocompatibility of the device and result in complications . . . including pain, dyspareunia, and scarring.” Id. Contrary to defendants' suggestion, the court finds that Dr. Michaels's opinion identifies specific defects in defendants' mesh - pore size, mesh contraction, and degradation - which support a reasonable inference that it is probable that defendants' product caused Imhoff's pain and dyspareunia. Loftis Decl. Ex. 2 at 7 (describing Imhoff's current symptoms include pain, pain during and after intercourse, and pain during bowel movements).
Imhoff also relies on several expert reports by Dr. Peacher as evidence of causation. Loftis Decl. Ex. 5 (attaching Peacher Expert Report), Ex. 6 (attaching Peacher Supplemental Report dated 11/22/2020), Ex. 7 (attaching Peacher Addendum dated 1/29/2021). Dr. Peacher is a urogynecologist with over 32 years of practice and has served as the Medical Director for the South Texas Women's Center for Incontinence and Pelvic Reconstructive Surgery from 1991 to the present. Loftis Decl. Ex. 5 at 1. In his January 29, 2021 Addendum, Dr. Peacher notes that Imhoff continues to suffer from chronic abdominal pain, pelvic pain, rectal pain, and dyspareunia. Loftis Decl. Ex. 7 at 2. Dr. Peacher discusses Dr. Michael's report, and opines that his findings of fibrotic bridging are consistent with mesh shrinkage that cause the tissue to contract, “pulling with it the synthetic mesh device” which can entrap nerves within the mesh or scar complex leading “to pain or other complications.” Id. at 2. Dr. Peacher opined that mesh contraction “can be in excess of 50” percent which can put undue tension on tissue anchoring the mesh, resulting in pain. Id. And Dr. Peacher opined that the “differential diagnosis of Mrs. Imhoff's chronic pain includes infection, endometriosis, and neoplasia,” that Dr. Michaels' findings “revealed no viral inclusions,” no “pathopneumonic microorganisms consistent with an infection,” no “fibrin thrombi or features to suggest primary vasculitis,” and that Dr. Michaels found no evidence of endometriosis, neoplasia, or malignancies. Id.
The court finds that viewing the evidence of Drs. DiMarco, Michaels, and Peacher in the light most favorable to Imhoff, she has introduced evidence creating a genuine issue for trial on causation. Dr. Michaels identified specific defects in the Gynemesh PS mesh and studied Imhoff's explanted tissue. Drs. Michaels and Peacher opined that chronic inflammation, fibrotic bridging, and mesh contracture can cause pain. Dr. Peacher conducted a differential diagnosis in which he ruled out other conditions as sources of Imhoff's chronic pain, including infection, endometriosis, neoplasia, or malignancies. Loftis Decl. Ex. 7 at 2-3. Additionally, Drs. DiMarco and Bascom's surgical reports reflect that there was no evidence of endometriosis or other defects, and that the mesh was visibly contracted and was excised during surgery, after which Imhoff reported improvement in her pain for several years. The court finds that, considering this evidence in the light most favorable to Imhoff, she has presented sufficient evidence supporting a reasonable inference that it is probable that defendants' Gynemesh PS mesh caused her persistent pain and dyspareunia. Smith, 2022 WL 1909019, at *2; Chong, 152 F.Supp.3d at 1317; Pearson, 2021 WL 4498562, at *12. Accordingly, defendants' motion for summary judgment on Imhoff's design-defect claims (Counts I and V) should be denied.
B. Omission-Based Fraud Claims (Common Law Fraud (Count VI) and Fraudulent Concealment (Count VII)), and Negligent Misrepresentation (Count IX)
Defendants argue that they are entitled to summary judgment on Imhoff's omission-based fraud claims and negligent misrepresentation claim because Imhoff has failed to establish that a “special relationship” exists between her and defendants. Defendants contend that, without a special relationship, there was no duty to disclose. Consequently, on Imhoff's omission-based claims, defendants argue that they are entitled to summary judgment. Defendants are correct.
1. Legal Standards
“Oregon law recognizes four theories of fraud: “(1) affirmative misrepresentations; (2) omission of a material fact when there is an independent duty to disclose; (3) omission of a material fact needed to make a “half-truth” not misleading; and (4) actual or active concealment.” Martell v. General Motors LLC, 492 F.Supp.3d 1131, 1142 (D. Or. 2020); Bixby v. KBR, Inc., 893 F.Supp.2d 1067, 1073 (D. Or. 2012); Unigestion Holdings, S.A. v. UPM Tech., Inc., 160 F.Supp.3d 1214, 1223-24 (D. Or. 2016). “When fraud is based on silence or nondisclosure of a material fact, a party first must demonstrate that the defendant either (1) remained silent when the defendant had a duty to speak, or (2) assumed the obligation to make a full and fair disclosure of the whole truth by making a representation in the nature of a halftruth.” Id. (internal quotation and citations omitted). “Where fraud is based on actual concealment, as opposed to simple nondisclosure, a duty to speak is not required.” Caldwell v. Pop's Homes, Inc., 54 Or.App. 104, 113 (1981); see also MAT, Inc. v. Am. Tower Asset Sub,LLC, 312 Or.App. 7, 17 (2021) (recognizing that evidence of active concealment with intent to deceive does not require finding special relationship with duty to disclose); Wieber v. FedEx Ground Package Sys., Inc., 231 Or.App. 469, 484 (2009) (“[I]n the absence of a duty to speak, actions by a defendant to actively conceal the truth can constitute fraud.”).
Under Oregon law, a duty to speak or disclose information exists when there is a special relationship between a plaintiff and a defendant. Unigestion Holdings, S.A. v. UPM Tech., Inc., __ F.Supp.3d __, 2022 WL 161491, at *11 n.15 (D. Or. Jan. 18, 2022) (citing Neel v. Lee, 316 Or.App. 159, 177 (2021) (“Typically, a duty to speak or disclose exists when there is a special relationship between the plaintiff and the defendant.”)). In Unigestion, District Judge Michael H. Simon noted that, when special relationships exist, “the defendant has a duty to disclose to the plaintiff all material matters of which the defendant had knowledge.” Id. (citing Gebrayel v. Transamerica Title Ins. Co., 132 Or.App. 271, 281 (1995) (citing RESTATEMENT (SECOND) OF TORTS § 551 (1976)).
“A special relationship exists when the plaintiff has authorized the defendant to exercise independent judgment on the plaintiff's behalf and the defendant has accepted this responsibility.” Unigestion, 2022 WL 161491, at *11 n.15 (citing Bennett v. Farmers Ins. Co. of Or., 332 Or. 138, 160-62, 26 P.3d 785 (2001)). “Certain professional relationships, such as lawyer-client, physician-patient, engineer-client, and agent-principal, have been recognized as special relationships.” Claus v. Columbia State Bank, Case No. 3:16-cv-01509-AC, 2019 WL 5624754, at *16 (D. Or. Oct. 30, 2019). “A special relationship does not exist if the parties were merely in an arm's-length commercial or business relationship where they were acting in their own economic interest.” Unigestion, 2022 WL 161491, at *11 n.15 (internal quotation omitted) (citing Conway v. Pac. Univ., 324 Or. 231, 239-41 (1996)); Claus, 2019 WL 5624754, at *16.
2. Analysis
Judge Acosta recently examined special relationships in Smith v. Ethicon, Inc., Case No. 3:20-cv-00851-AC, 2021 WL 3578681, at *5-6 (D. Or. May 13, 2021), adopted 2021 WL 3575099 (Aug. 12, 2021), and Placido v. Ethicon, Inc., Case No. 3:20-cv-01904-AC. In Smith, the court found that the relationship between defendants as a medical device manufacturer and Smith as a patient simply did not give rise to a “special relationship” under Oregon law, creating a duty to speak. Id. at *6. The court found “defendants were not acting to further [Smiths]' economic interests or acting on their behalf,” and granted summary judgment on Smith's constructive-fraud claim. Id. In Placido, Judge Acosta relied on the rationale in Smith to determine that Placido was not in a special relationship with defendants and granted defendants' summary judgment motion on her constructive-fraud and negligent-misrepresentation claims. F&R at 45-47, ECF No. 148.
As in Smith and Placido, defendants here were not acting to further Imhoff's economic interests and were not acting on Imhoff's behalf. Id. at *6. Hence, the relationship between Imhoff and defendants is simply not the type that “gives rise to a special relationship under Oregon law” and her fraud claims premised on omissions fail as a matter of law. Id.
Imhoff urges the court to revisit the rationale in Smith, arguing that the medical community relies on drug manufacturers to provide accurate statements about their products. The court declines to do so. Imhoff cites no controlling Oregon case law creating a special relationship and imposing a duty to disclose in similar circumstances and the court believes that the Oregon Supreme Court would not find one here. See Ave. Lofts Condo. Owners' Ass'n v. Victaulic Co., 24 F.Supp.3d 1010, 1018 (D. Or. 2014) (“The Oregon Supreme Court has held claims for negligent misrepresentation ‘must be predicated on some duty of the negligent actor to the injured party beyond the common law duty to exercise reasonable care to prevent foreseeable harm.'” (quoting Onita Pac. Corp. v. Trs. Of Bronson, 315 Or. 149, 166 (1992)).
Because Imhoff has not established a special relationship exists between her and defendants, or that defendants were acting to further her economic interests or were acting on her behalf, her negligent-misrepresentation claim likewise fails as a matter of law. Placido F&R at 47; see also Claus, 2019 WL 5624752, at *16 (stating elements of negligent misrepresentation claim, including a special relationship); Gillman v. Boston Sci. Corp., Case No. 11-cv-3067-CL, 2012 WL 892239, at *4 (D. Or. Jan. 27, 2012), adopted 2012 WL 882788, at *1 (Mar. 13, 2012) (dismissing negligent misrepresentation claim because there was no special relationship between plaintiff and Boston Scientific triggering a heightened duty of care).
In short, because no special relationship exists between Imhoff and defendants and defendants were not acting on Imhoff's behalf, the court recommends defendants' summary judgment motion on Count IX, and Counts VI and VII (premised on omissions of material fact only) be granted.
C. Punitive Damages (Count XVII) and Discovery Rule and Tolling (Count XVIII)
Defendants argue that Imhoff's claims for punitive damages and “discovery rule and tolling” should be dismissed with prejudice because they are not independent causes of action. While the court agrees these claims are not independent causes of action, defendants have not established that Imhoff may not rely on the discovery rule and tolling, or that punitive damages may not be awarded as an appropriate remedy. Therefore, defendants' motion for summary judgment on Counts XVII and XVIII should be denied.
CONCLUSION
As stated, defendants' Motion for Summary Judgment (ECF No. 81) should be GRANTED IN PART and DENIED IN PART. The district court should enter an Order dismissing with prejudice Counts II, IV, VIII, XI, XII, XIII, XV (as set forth in the Stipulation of Dismissal, ECF No. 71) and Counts IX and Counts VI-VII (premised on omissions) as detailed above.
SCHEDULING ORDER
The Findings and Recommendation will be referred to District Judge Michael W. Mosman. Objections, if any, are due within fourteen days. If no objections are filed, the Findings and Recommendation will go under advisement on that date. If objections are filed, a response is due within fourteen days. When the response is due or filed, whichever date is earlier, the Findings and Recommendation will go under advisement.