Harju v. Johnson & Johnson

[5] UNITED STATES DISTRICT COURT 6 WESTERN DISTRICT OF WASHINGTON AT TACOMA [7] YVONNE HARJU, et al. CASE NO. C20-6258 BHS-JRC [8] Plaintiffs, ORDER ADOPTING IN PART 9 v. REPORT & RECOMMENDATION 10 JOHNSON & JOHNSON, ETHICON, INC., [11] Defendants. [13] This matter comes before the Court on the Report and Recommendation (“R&R”) [14] of the Honorable J. Richard Creatura, United States Magistrate Judge, Dkt. 37, and [15] Plaintiffs Yvonne Harju, Doris Hosking, and Donald Hosking’s objections to the R&R, [16] Dkt. 39, and Defendants Johnson & Johnson and Ethicon, Inc.’s objections to the R&R, [17] Dkt. 40. [18] I. FACTUAL & PROCEDURAL HISTORY 19 This case arises out of Ms. Harju’s surgical implantation of Gynecare TVT20 Secur—a prolene mesh implant—to treat her stress urinary incontinence and out of Ms. 21 Hosking’s surgical implantation of Gynecare Prosima—another prolene mesh implant— 22 to treat her pelvic organ prolapse. Dkt. 29, ¶¶ 2, 6. Both the TVT-S and Prosima are 1 medical devices created by Defendants. Id. ¶¶ 11–13. Plaintiffs bring claims for 2 violations of the Washington Products Liability Act (“WPLA”), RCW 7.72, et seq., 3 breach of express warranty, breach of implied warranty, fraud, fraudulent concealment, 4 constructive fraud, violations of the Washington Consumer Protection Act (“CPA”), 5 RCW 19.86, et seq., unjust enrichment, and for Mr. Hosking’s loss of consortium. 6 Following Plaintiffs’ filing of their Second Amended Complaint, Dkt. 29, 7 Defendants moved to dismiss their claims, Dkt. 30. Judge Creatura issued the instant 8 R&R, recommending that the Court grant in part and deny in part Defendants’ motion. 9 Dkt. 37. Specifically, the R&R recommends that the Court dismiss Plaintiffs’ claim for 10 unjust enrichment without leave to amend and dismiss their claims for constructive fraud, 11 fraudulent inducement, and breach of implied warranty with leave to amend. The R&R 12 recommends that Defendants’ motion to dismiss be denied as to Plaintiffs’ remaining 13 claims. 14 On July 26, 2021, both Plaintiffs and Defendants filed their objections to the R&R. 15 Dkts. 39, 40. Plaintiffs object to the R&R’s recommendation to dismiss their claim for 16 unjust enrichment with prejudice. Dkt. 39. Defendants object to the R&R’s 17 recommendation to deny their motion to dismiss as to Plaintiffs’ claims for 18 manufacturing defect, breach of express warranty, common law fraud, and violations of 19 the CPA. Dkt. 40. On July 29, 2021, the parties responded to the opposing objections. 20 Dkts. 42, 43. On August 17, 2021, Defendants filed a notice of supplemental authority. 21 Dkt. 45. [22] 1 II. DISCUSSION 2 A. Standard 3 The district judge must determine de novo any part of the magistrate judge’s 4 disposition that has been properly objected to. The district judge may accept, reject, or 5 modify the recommended disposition; receive further evidence; or return the matter to the 6 magistrate judge with instructions. Fed. R. Civ. P. 72(b)(3). 7 B. Plaintiffs’ Objections 8 Plaintiffs object to the R&R’s recommendation that their unjust enrichment claim 9 be dismissed without leave to amend. Dkt. 39. The R&R concluded that Plaintiffs cannot 10 maintain their claim for unjust enrichment because the WPLA preempts all common law 11 remedies for product-related harms other than fraud, intentionally caused harm, or 12 violations of the CPA. Dkt. 37 at 24–25; see also RCW 7.72.010(4); Wash. Water Power 13 Co. v. Graybar Elec. Co., 112 Wn.2d 847, 860 (1989) (en banc) (holding that the WPLA 14 “creates a single cause of action for product-related harms that supplants previously 15 existing common law remedies”). 16 Plaintiffs argue they are entitled to advance separate claims as alternative theories 17 of liability. Dkt. 39 at 3–4. But they do not engage, as Defendants correctly highlight, 18 with the authority which conclusively holds that the WPLA preempts their claim for 19 unjust enrichment. See Dkt. 42. “The WPLA is the exclusive remedy for product liability 20 claims” and “supplants all common law claims or actions based on harm caused by a 21 product.” Macias v. Saberhagen Holdings, Inc., 175 Wn.2d 402, 409 (2012) (internal 22 citations omitted). While plaintiffs in general are entitled to advance competing theories 1 of liability, the statutory scheme of the WPLA does not permit Plaintiffs to advance an 2 alternate theory of unjust enrichment here. 3 The R&R correctly concluded that the WPLA preempts Plaintiffs’ claim for unjust 4 enrichment. The R&R is therefore ADOPTED as to this issue. 5 C. Defendants’ Objections 6 Defendants object to the R&R’s recommendation to deny their motion to dismiss 7 as to Plaintiffs’ claims for manufacturing defect, breach of express warranty, common 8 law fraud, and violations of the CPA. Dkt. 40. Plaintiffs, in response, argue that the R&R 9 reached the correct conclusions as to these claims and that the Court should adopt the 10 R&R. Dkt. 43. Defendants additionally filed a notice of supplemental authority to support 11 their objections. Dkt. 45. 12 1. Manufacturing Defect 13 Defendants first object to the R&R’s conclusion that Plaintiffs plausibly alleged a 14 manufacturing defect claim under the WPLA. Dkt. 40 at 5–12. “A design defect is a 15 defect that is present across an entire product line when some aspect of the product is 16 unsafe, while a manufacturing defect is due to factory departure from proper 17 specifications.” Moore v. Harley-Davidson Motor Grp., Inc., 158 Wn. App. 407 , 425 18 (2010); see also Bylsma v. Burger King Corp., 176 Wn.2d 555, 559 (2013). The R&R 19 concluded that there is a reasonable inference from the complaint that there was a 20 departure from proper specifications by Defendants in using non-medical grade materials 21 or manufacturing techniques that resulted in sharp product edges. Dkt. 37 at 11. The 22 Court respectfully disagrees with this conclusion. 1 Defendants argue persuasively that Plaintiffs have failed to plead a plausible 2 manufacturing defect claim because they do not allege how the TVT-S and Prosima 3 implants that were implanted in Ms. Harju and Ms. Hosking, respectively, deviated from 4 their intended designs. Plaintiffs do allege that the TVT-S and Prosima products in 5 general were defective due to, among others, the use of non-medical grade material. Dkt. 6 29, ¶¶ 128–132. These allegations sound in a design defect, not in a manufacturing 7 defect. 8 Rather than alleging that the products specific to Ms. Harju and Ms. Hosking are 9 defective “due to factory departure from proper specifications,” Moore, 158 Wn. App. at 10 425, Plaintiffs allege that the mesh implants are dangerous as designed. If, for example, 11 the TVT-S and Prosima products were defective due to inadequate specifications that 12 were not adhered to in the manufacturing of Plaintiffs’ products, see Dkt. 29, ¶ 128, then 13 the specifications were unsuitable as designed. Plaintiffs’ allegations do not support an 14 inference that their specific products departed from proper specifications; rather, 15 Plaintiffs allege that every mesh product was defective. 16 While not binding on this Court’s analysis, the Court does find persuasive that 17 other federal courts from around the country addressing manufacturing defect claims for 18 mesh products have reached this same conclusion. See, e.g., Drumheller v. Johnson & 19 Johnson, No. 20-6535, 2021 WL 1853407 , at *7–8 (E.D. Pa. May 10, 2021) (“As the 20 gravamen of Ms. Drumheller’s complaint is defect in the design of pelvic mesh, we find 21 she fails to plead a manufacturing defect.”); Payton v. Johnson & Johnson, No. 4:20-cv22 00257-JMS-DML, 2021 WL 1923799 , at *7 (S.D. Ind. May 13, 2021) (“First, the 1 Amended Complaint lacks any allegations explaining the intended proper design of the 2 TVT Product. Second, Ms. Payton does not allege facts showing how, in even the most 3 general sense, Ms. Payton’s Implant deviated from the intended design of the TVT 4 Product.”). 5 Defendants request that the Court dismiss Plaintiffs’ manufacturing defect claim 6 without leave to amend because there is no factual basis for their claim. Dkt. 40 at 12. 7 They do concede, though, that Plaintiffs may still pursue their manufacturing defect claim 8 if they obtain facts to support such a claim during discovery. Id. It is possible that 9 Plaintiffs may be able to plausibly plead at this stage a manufacturing defect claim that 10 specifies how their products were defective due to factory departure from proper 11 specifications. 12 Therefore, the Court DECLINES to adopt the R&R as to this issue. Defendants’ 13 motion to dismiss is GRANTED, and Plaintiffs’ claim for manufacturing defect is 14 DISMISSED with leave to amend. 15 2. Breach of Express Warranty 16 Defendants additionally object to the R&R’s conclusion that Plaintiffs adequately 17 alleged a breach of express warranty claim. Dkt. 40 at 12–18. They argue that the R&R 18 erred in concluding that the mesh implants’ Instructions for Use (“IFUs”) constituted an 19 express warranty and that a medical device’s warning label may not create an express 20 warranty. 21 The WPLA provides for strict liability if a “claimant’s harm was proximately 22 cause by the fact that the product was . . . not reasonably safe because it did not conform 1 to the manufacturer’s express warranty.” RCW 7.72.030(2). Washington law defines an 2 express warranty as “any affirmation of fact or promise.” RCW 62A.2-313(a). To state a 3 claim for breach of express warranty, a plaintiff must plausibly allege that (1) the 4 warranty was made part of the basis of the bargain; (2) the warranty relates to a material 5 fact concerning the product; and (3) the warranty turns out to be untrue. RCW 6 7.72.030(2)(b). 7 Defendants cite to, inter alia, Bryant v. Wyeth, 879 F. Supp. 2d 1214 (W.D. Wash. 8 2012), in support of their argument that a medical warning label cannot serve as an 9 express warranty of the product’s safety. In Bryant, the Court concluded that a 10 prescription medication’s warning label did not constitute an express warranty because 11 the warning provided only general risk information, not a promise or factual 12 representation. Id. at 1227 . However, the Court reached this conclusion when deciding a 13 motion for summary judgment—not a motion to dismiss. See id. at 1218 . The Court must 14 take the allegations as true, and Plaintiffs have alleged that the IFUs contained promises 15 that the mesh implants were not subject to degradation or weakening. See Dkt. 29, 16 ¶¶ 160–165. The Court agrees with the R&R’s conclusion that “whether the Instructions 17 for Use in fact contain such a claim and whether the context was such that it created an 18 express warranty [are] issues not before the Court at this time.” Dkt. 37 at 15. 19 Defendants additionally object to the fact that Plaintiffs did not attach the IFUs to 20 their complaint. This issue was not raised before Judge Creatura, however. The Court 21 declines to address this new argument because Plaintiffs have plausibly pled the express 22 warranties contained within the IFUs. See, e.g., Dkt. 29, ¶ 164; see also Brown v. Roe, [1] 279 F.3d 742 , 745–46 (9th Cir. 2002) (rejecting the Fourth Circuit’s holding that a 2 district court must consider new arguments raised for the first time in an objection to a 3 magistrate judge’s R&R); United States v. Howell, 231 F.3d 615, 622 (9th Cir. 2000) 4 (district courts have discretion to consider new evidence raised for the first time in an 5 objection to a magistrate judge’s R&R); Olmos v. Ryan, No. CV-11-00344-PHX-GMS, [6] 2013 WL 3199831 , at *8 (D. Ariz. June 24, 2013) (“Generally, a district court need not 7 consider new arguments raised for the first time in objections to an R & R.”). 8 Defendants’ remaining objections do not fare any better. Defendants again argue 9 that Plaintiffs’ allegations are not materially different than the allegations pled in 10 Hernandez v. Johnson & Johnson, No. 4:20-cv-05136-SMJ, 2021 WL 320612 (E.D. 11 Wash. Jan. 8, 2021), an Eastern District of Washington products liability case involving 12 Defendants’ mesh products. Compare Dkt. 30 at 13 with Dkt. 40 at 15. The R&R 13 considered Defendants’ arguments based on Hernandez and properly rejected those 14 arguments. See Dkt. 37 at 16. Defendants’ additional citations to non-binding case law 15 are not persuasive—the Court agrees with the R&R’s conclusion that Plaintiffs have 16 adequately alleged a breach of express warranty claim at this stage. 17 The R&R is therefore ADOPTED as to this issue. 18 3. Common Law Fraud & Consumer Protection Act 19 Finally, Defendants object to the R&R’s conclusion that Plaintiffs have adequately 20 pled their fraud-based claims, including common law fraud and violations of the CPA 21 (which sound in fraud). See Dkt. 40 at 18–21. While the R&R decided that Plaintiffs were 22 not entitled to a lenient application of Rule 9(b) pursuant to United States ex rel. Lee v. 1 SmithKline Beecham, Inc., 245 F.3d 1048 (9th Cir. 2001), it did conclude that the Rule 2 9(b) standard is somewhat relaxed because Plaintiffs’ fraud-based claims primarily sound 3 in the omission of information. Dkt. 37 at 19–20. The R&R relied in part on Falk v. 4 General Motors Corporation, 496 F. Supp. 2d 1088 (N.D. Cal. 2007), which held that “a 5 plaintiff in a fraud by omission suit will not be able to specify the time, place, and 6 specific content of an omission as precisely as would a plaintiff in a false representation 7 claim,” id. at 1098–99. 8 Defendants argue that “federal courts in Washington have not accepted the notion 9 that Rule 9(b) should be relaxed in a fraudulent omission claim.” Dkt. 40 at 19. Yet this 10 Court has in fact cited Falk with approval and has concluded that a fraud by omission 11 claim meets Rule 9(b)’s requirements when the claim is pled with particularity. See, e.g., 12 Short v. Hyundai Motor Co., No. C19-0318 JLR, 2020 WL 6132214 , at *5 (W.D. Wash. 13 Oct. 19, 2020); Floyd Blinksy Trucking, Inc. v. Navistar, Inc., No. C15-5467 BHS, 2020 14 WL 7043299 , at *2 (W.D. Wash. Dec. 1, 2020). Upon a review of Plaintiffs’ complaint, 15 the Court agrees with the R&R that Plaintiffs’ fraud-based claims are based on a theory 16 that Defendants failed to disclose material information. See, e.g., Dkt. 29, ¶ 194 17 (“Defendants had a duty to disclose and/or not conceal the true and material risks, 18 adverse events, and contraindications of the TVT-S and Prosima products to Plaintiffs, 19 their implanting medical providers, the medical community, the FDA, and/or the public 20 at large.”). The R&R, therefore, did not err in applying Falk to Plaintiffs’ claims. 21 Defendants additionally argue that Plaintiffs’ allegations are insufficient because 22 they are not specific enough. It is true that this Court has dismissed fraud-based claims in 1 similar mesh product cases on motions for summary judgment for a failure to identify 2 particular fraudulent statements relied upon; but those fraud claims were not fraud by 3 omission claims. See, e.g., Ellis v. Ethicon, Inc., No. C20-5692 BHS, 2021 WL 2949779 , 4 at *5 (W.D. Wash. July 14, 2021). Here, as the R&R noted, it is difficult to allege the 5 who, when, and where of the omissions. 6 Plaintiffs allege that Defendants were aware of the mesh products’ issues but did 7 not disclose the material information. See, e.g., Dkt. 29, ¶ 199 (“Defendants knowingly, 8 falsely, and actively misrepresented that the TVT-S and Prosima products did not cause 9 chronic injuries, degrade, harden, shrink or contract, fray, cord, curl, lose particles, 10 oxidize, corrode, and/or otherwise deform, with actual knowledge that these 11 representations were false.”). They have sufficiently alleged that Defendants knew that 12 their mesh products were defective and failed to disclose this information to Plaintiffs’ 13 detriment. The non-binding case law Defendants cite in their objections does not 14 convince the Court otherwise. The Court agrees with the R&R that Plaintiffs have 15 adequately pleaded their claims sounding in fraud by omission to meet Rule 9(b). 16 The R&R is therefore ADOPTED as to this issue. 17 III. ORDER 18 The Court having considered the R&R, the parties’ objections, and the remaining 19 record, does hereby find and order as follows: 20 (1) The R&R is ADOPTED in part; 21 (2) Defendants’ motion to dismiss, Dkt. 30, is GRANTED in part and 22 DENIED in part; 1 (3) Plaintiffs’ claim for unjust enrichment is DISMISSED without leave to 2 amend; 3 (4) Plaintiffs’ claims for manufacturing defect, constructive fraud, fraudulent 4 inducement, and breach of the implied warranty of merchantability are 5 DISMISSED with leave to amend; 6 (5) Plaintiffs are GRANTED leave to amend and shall file their amended 7 complaint within 30 days of this Order; and 8 (6) This matter is re-referred to Judge Creatura for further proceedings. 9 Dated this 2nd day of September, 2021. A [11] BENJAMIN H. SETTLE [12] United States District Judge