Sep 24, 2020
SEAN F. MCAVOY, CLERK
EASTERN DISTRICT OF WASHINGTON PAMELA LYNCH, No. 2:20-cv-00217-SMJ Plaintiff, ORDER GRANTING v. SUMMARY JUDGMENT ETHICON INC., ETHICON LLC, and
Defendants.
Before the Court, without oral argument, is Defendants’ Motion for Summary Judgment, ECF No. 37. Having reviewed the briefing and the record in this matter, the Court is fully informed and grants the motion. Pamela Lynch alleges that she suffered severe complications from the implantation of Defendants’ pelvic mesh product, the Gynecare Prolene Lot # CGB768, or Gynemesh PS (“Mesh Product”), during a surgery to treat her stress urinary incontinence and symptomatic rectocele. ECF No. 1 at 2; ECF No. 37-4 at 3. After implantation, she allegedly experienced urinary problems; dyspareunia; abdominal, pelvic, lower back, vaginal, and rectal pain; urinary tract and bladder infections; urinary and fecal incontinence, and related emotional distress and diminished quality of life. ECF No. 37-4 at 4–5. She sued in the Southern District of
West Virginia multi-district litigation (“the MDL”). ECF No. 1. On May 21, 2019, Scott Bailey, M.D., drafted an expert report, opining Defendants’ Mesh Product caused Lynch’s injuries. See ECF No. 41-7. Lynch has
presented other evidence, such as the expert opinion of Dionysios Veronikis, M.D. that generally addresses the alleged design defect. See ECF No. 41-9. Dr. Veronikis holds board certifications in female pelvic medicine and reconstructive surgery. Id. 41-9 at 2. His report discusses the defects of the Mesh Product, including its design,
material and properties, and method of surgical placement, and their correlation to symptoms in patients. See, e.g., id. at 4. Dr. Veronikis discusses an internal Ethicon email in which Ethicon states that “‘[p]olypropylene creates an intense
inflammatory response that results in rapid and dense incorporation into the surrounding tissue.’” Id. at 7. On May 29, 2020 Judge Goodwin in the Southern District of West Virginia transferred Lynch’s case to the Eastern District of Washington under 28 U.S.C. §
1404(a). ECF No. 53. The Court must grant summary judgment if “the movant shows that 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 fact is “material” if it “might affect the outcome of the suit under the governing law.” Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 248 (1986). A dispute about a material fact is “genuine” if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Id. On a summary judgment, the Court must view the evidence in the light most
favorable to the nonmoving party. See Tolan v. Cotton, 572 U.S. 650, 657 (2014) (quoting Adickes v. S.H. Kress & Co., 398 U.S. 144, 157 (1970)). Thus, the Court must accept the nonmoving party’s evidence as true and draw all reasonable inferences in its favor. See Anderson, 477 U.S. at 255. The Court may not assess
credibility or weigh evidence. See id. Nevertheless, the nonmoving party may not rest upon the mere allegations or denials of its pleading but must instead set forth specific facts, and point to substantial probative evidence, tending to support its
case and showing a genuine issue requires resolution by the finder of fact. See Anderson, 477 U.S. at 248–49. A. The Court grants summary judgment as to Counts I–IV and VI–XV
Defendants moved for summary judgment on August 13, 2019. ECF No. 37. In the intervening thirteen months, Lynch has had ample opportunity to seek leave from this Court or the MDL court to voluntarily dismiss those claims. Lynch has
failed to do so. Lynch has also failed to raise any argument as to why these claims should not be dismissed. This Court thus finds it appropriate to grant summary judgment as to Counts I through IV and VI through XV.
B. The Court grants summary judgment as to Count V The parties agree that Washington State substantive law applies in this case. ECF No. 38 at 7–8; ECF No. 42 at 5; see also Martin v. Humbert Constr., Inc., 61
P.3d 1196, 1199 (Wash. App. 2003). Under Washington State law, the Washington Products Liability Act (WPLA) preempts common law causes of action. See Wash. Water Power Co. v. Graybar Elec. Co., 774 P.2d 1199, 1203 (Wash. 1989). This Court construes Count V, strict liability for design defect, as stating a claim under
WPLA. See ECF No. 42 at 5. To prevail in a WPLA claim for design defect, a plaintiff must show that (1) a manufacturer’s product (2) not reasonably safe as designed (3) caused harm to the Plaintiff. See Pagnotta v. Beall Trailers of Oregon,
Inc., 991 P.2d 728, 732 (Wash. App. 2000); Wash. Rev. Code § 7.72.030(1). 1. Lynch has not established a genuine issue of material fact as to proximate cause
To establish a prima facie case of strict liability for design defect under the WPLA, a claimant must establish that the defect was the proximate cause of the injury. Wash. Rev. Code § 7.72.030(1). “Expert testimony is required to establish causation when,” as here, “an injury involves obscure medical factors that would require an ordinary lay person to speculate or conjecture in making a finding.” Bruns v. PACCAR, Inc., 890 P.2d 469, 477 (Wash. App. 1995). Lynch argues that several experts submitted reports that work in concert to
establish proximate cause. ECF No. 42 at 6–7. Dr. Veronikis opined generally on the design defects he observed in the Mesh Products, as described above. ECF No. 41-9. And Lynch’s case specific expert, Scott Bailey, M.D., opined that the Mesh
Product caused Plaintiff’s injuries. Using a differential diagnosis, Dr. Bailey ruled out other potential causes of Lynch’s injuries. ECF No. 41-7. Yet Defendants argue this is not enough. Because Dr. Bailey did not attribute Lynch’s injuries to the asserted defects in the Mesh Product, Defendants argue, Lynch has failed to
establish a genuine issue of material fact as to proximate cause. Defendants also rightly assert that because Dr. Veronikis’s expert report is unsworn, it is inadmissible for the purposes of summary judgment. See ECF No. 41-9; see also
Harris v. Extendicare Homes, Inc., 829 F.Supp.2d 1023, 1027 (W.D. Wash. 2011); Shuffle Master, Inc. v. MP Games LLC, 553 F. Supp.2d 1202, 1210–11 (D. Nev. 2008). Because the Court’s disposition here turns on the deficiencies in Dr. Bailey’s assertion of causation, Plaintiff fails to show that there is a genuine issue of material
fact even if Dr. Veronikis’s report were admissible. “[T]he manufacturer is liable for harm proximately caused by the design defect.” Ruiz-Guzman v. Amvac Chem. Corp., 7 P.3d 795, 800 (Wash. 2000)
(emphasis in original) (quoting Falk v. Keene Corp., 782 P.2d 974, 978 (Wash. 1989)). A plaintiff “must do more than ‘merely suggest the possibility that proximate cause exists.’” Paeschke v. General Motors LLC, No. 4:16-cv-5050-
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Sep 24, 2020
SEAN F. MCAVOY, CLERK
EASTERN DISTRICT OF WASHINGTON PAMELA LYNCH, No. 2:20-cv-00217-SMJ Plaintiff, ORDER GRANTING v. SUMMARY JUDGMENT ETHICON INC., ETHICON LLC, and
Defendants.
Before the Court, without oral argument, is Defendants’ Motion for Summary Judgment, ECF No. 37. Having reviewed the briefing and the record in this matter, the Court is fully informed and grants the motion. Pamela Lynch alleges that she suffered severe complications from the implantation of Defendants’ pelvic mesh product, the Gynecare Prolene Lot # CGB768, or Gynemesh PS (“Mesh Product”), during a surgery to treat her stress urinary incontinence and symptomatic rectocele. ECF No. 1 at 2; ECF No. 37-4 at 3. After implantation, she allegedly experienced urinary problems; dyspareunia; abdominal, pelvic, lower back, vaginal, and rectal pain; urinary tract and bladder infections; urinary and fecal incontinence, and related emotional distress and diminished quality of life. ECF No. 37-4 at 4–5. She sued in the Southern District of
West Virginia multi-district litigation (“the MDL”). ECF No. 1. On May 21, 2019, Scott Bailey, M.D., drafted an expert report, opining Defendants’ Mesh Product caused Lynch’s injuries. See ECF No. 41-7. Lynch has
presented other evidence, such as the expert opinion of Dionysios Veronikis, M.D. that generally addresses the alleged design defect. See ECF No. 41-9. Dr. Veronikis holds board certifications in female pelvic medicine and reconstructive surgery. Id. 41-9 at 2. His report discusses the defects of the Mesh Product, including its design,
material and properties, and method of surgical placement, and their correlation to symptoms in patients. See, e.g., id. at 4. Dr. Veronikis discusses an internal Ethicon email in which Ethicon states that “‘[p]olypropylene creates an intense
inflammatory response that results in rapid and dense incorporation into the surrounding tissue.’” Id. at 7. On May 29, 2020 Judge Goodwin in the Southern District of West Virginia transferred Lynch’s case to the Eastern District of Washington under 28 U.S.C. §
1404(a). ECF No. 53. The Court must grant summary judgment if “the movant shows that 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 fact is “material” if it “might affect the outcome of the suit under the governing law.” Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 248 (1986). A dispute about a material fact is “genuine” if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Id. On a summary judgment, the Court must view the evidence in the light most
favorable to the nonmoving party. See Tolan v. Cotton, 572 U.S. 650, 657 (2014) (quoting Adickes v. S.H. Kress & Co., 398 U.S. 144, 157 (1970)). Thus, the Court must accept the nonmoving party’s evidence as true and draw all reasonable inferences in its favor. See Anderson, 477 U.S. at 255. The Court may not assess
credibility or weigh evidence. See id. Nevertheless, the nonmoving party may not rest upon the mere allegations or denials of its pleading but must instead set forth specific facts, and point to substantial probative evidence, tending to support its
case and showing a genuine issue requires resolution by the finder of fact. See Anderson, 477 U.S. at 248–49. A. The Court grants summary judgment as to Counts I–IV and VI–XV
Defendants moved for summary judgment on August 13, 2019. ECF No. 37. In the intervening thirteen months, Lynch has had ample opportunity to seek leave from this Court or the MDL court to voluntarily dismiss those claims. Lynch has
failed to do so. Lynch has also failed to raise any argument as to why these claims should not be dismissed. This Court thus finds it appropriate to grant summary judgment as to Counts I through IV and VI through XV.
B. The Court grants summary judgment as to Count V The parties agree that Washington State substantive law applies in this case. ECF No. 38 at 7–8; ECF No. 42 at 5; see also Martin v. Humbert Constr., Inc., 61
P.3d 1196, 1199 (Wash. App. 2003). Under Washington State law, the Washington Products Liability Act (WPLA) preempts common law causes of action. See Wash. Water Power Co. v. Graybar Elec. Co., 774 P.2d 1199, 1203 (Wash. 1989). This Court construes Count V, strict liability for design defect, as stating a claim under
WPLA. See ECF No. 42 at 5. To prevail in a WPLA claim for design defect, a plaintiff must show that (1) a manufacturer’s product (2) not reasonably safe as designed (3) caused harm to the Plaintiff. See Pagnotta v. Beall Trailers of Oregon,
Inc., 991 P.2d 728, 732 (Wash. App. 2000); Wash. Rev. Code § 7.72.030(1). 1. Lynch has not established a genuine issue of material fact as to proximate cause
To establish a prima facie case of strict liability for design defect under the WPLA, a claimant must establish that the defect was the proximate cause of the injury. Wash. Rev. Code § 7.72.030(1). “Expert testimony is required to establish causation when,” as here, “an injury involves obscure medical factors that would require an ordinary lay person to speculate or conjecture in making a finding.” Bruns v. PACCAR, Inc., 890 P.2d 469, 477 (Wash. App. 1995). Lynch argues that several experts submitted reports that work in concert to
establish proximate cause. ECF No. 42 at 6–7. Dr. Veronikis opined generally on the design defects he observed in the Mesh Products, as described above. ECF No. 41-9. And Lynch’s case specific expert, Scott Bailey, M.D., opined that the Mesh
Product caused Plaintiff’s injuries. Using a differential diagnosis, Dr. Bailey ruled out other potential causes of Lynch’s injuries. ECF No. 41-7. Yet Defendants argue this is not enough. Because Dr. Bailey did not attribute Lynch’s injuries to the asserted defects in the Mesh Product, Defendants argue, Lynch has failed to
establish a genuine issue of material fact as to proximate cause. Defendants also rightly assert that because Dr. Veronikis’s expert report is unsworn, it is inadmissible for the purposes of summary judgment. See ECF No. 41-9; see also
Harris v. Extendicare Homes, Inc., 829 F.Supp.2d 1023, 1027 (W.D. Wash. 2011); Shuffle Master, Inc. v. MP Games LLC, 553 F. Supp.2d 1202, 1210–11 (D. Nev. 2008). Because the Court’s disposition here turns on the deficiencies in Dr. Bailey’s assertion of causation, Plaintiff fails to show that there is a genuine issue of material
fact even if Dr. Veronikis’s report were admissible. “[T]he manufacturer is liable for harm proximately caused by the design defect.” Ruiz-Guzman v. Amvac Chem. Corp., 7 P.3d 795, 800 (Wash. 2000)
(emphasis in original) (quoting Falk v. Keene Corp., 782 P.2d 974, 978 (Wash. 1989)). A plaintiff “must do more than ‘merely suggest the possibility that proximate cause exists.’” Paeschke v. General Motors LLC, No. 4:16-cv-5050-
LRS, 2017 WL 5632442 at *4 (E.D. Wash. Oct. 11, 2017) (quoting Browne v. McDonnell Douglas Corp., 698 F.2d 370, 371 (9th Cir. 1982). Lynch’s experts have not opined that a design defect in Defendants’ Mesh Products caused her injuries.
Dr. Veronikis has opined that the design defects in the Mesh Products can cause an “intense inflammatory response.” And Dr. Bailey opined that an inflammatory response was responsible for Lynch’s pain. But without an expert opinion asserting a causal link between the general design defects identified by Dr. Veronikis and
Lynch’s injuries, Lynch has not established a genuine issue of material fact. Courts in other circuits have also adopted this reasoning in similar cases involving plaintiffs allegedly harmed by comparable mesh products. In Abt v.
Ethicon, Inc., No. 1:20-cv-0047 SRC, 2020 WL 4887022 at *3–*4 (E.D. Mo. Aug. 20, 2020), the court found that where the case specific expert did not connect plaintiff’s injuries to a design defect in the TVT-O mesh product, or build off the general expert’s report about the design defects, plaintiff had not established a
genuine issue of material fact. And in Lewis v. Johnson & Johnson, 601 Fed. App’x 205, 211–212 (4th Cir. 2015), the Fourth Circuit upheld a directed verdict for defendants where plaintiff’s experts did not establish “a causal link between these
alleged defects . . . and [plaintiff’s] injuries.” In Howard v. Ethicon, Inc., __ F.Supp.3d __, No. CV-20-01137-PHX-MTL, 2020 WL 3971719 at *2–3 (D. Ariz. July 14, 2020), the court declined defendants’ Daubert motion to exclude the
opinions of Dr. Bailey in another case on similar facts. Despite defendants’ arguments, mirrored here, that Dr. Bailey did not opine on whether a design defect in the mesh product caused plaintiff’s injuries, the court concluded that Dr. Bailey’s
testimony was relevant. Id. Yet that conclusion is consistent with the instant Order. Determining relevance for the purposes of a Daubert motion is a different inquiry from determining if there is a genuine issue of material fact for a summary judgment motion. Because Plaintiff has failed to establish that there is a genuine issue of
material fact regarding causation, the Court must grant the Defendants’ Motion for Summary Judgment. Accordingly, IT IS HEREBY ORDERED:
1. Defendants’ Motion for Summary Judgment, ECF No. 37, is 2. Counts I–XV of Lynch’s Complaint, ECF No. 1, are DISMISSED
3. The Clerk’s Office is DIRECTED to enter judgment in favor of Defendants Johnson & Johnson, Ethicon, Inc., and Ethicon LLC, and CLOSE this file.
// 4. Defendants’ Motion to Exclude the Case-Specific Opinions of Scott Bailey, M.D., ECF No. 39, is DENIED AS MOOT. IT IS SO ORDERED. The Clerk’s Office is directed to enter this Order and provide copies to all counsel.
DATED this 24" day of September 2020. —~, rani SAJ_VADOR MENDS2)A, JR. United States District Juage
ORDER GRANTING DEFENDANTS’ MOTION FOR SUMMARY