Engleka v. Boston Scientific Corporation

Opinion

1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA

9 Frances Engleka, No. CV-20-00925-PHX-DLR

10 Plaintiff, ORDER

11 v.

12 Boston Scientific Corporation,

13 Defendant. 14 15 16 Defendant Boston Scientific Corporation moves for partial summary judgment on 17 the following of Plaintiff Frances Engleka’s claims: (1) punitive damages (Count IX), (2) 18 breach of implied warranty (Count VI), (3) breach of express warranty (Count V), (4) 19 negligence (Count I), (5) strict products liability-defective design (Count II), and (6) strict 20 products liability-manufacturing defect (Count III). (Doc. 59.) During an October 13, 21 2021 telephonic conference, counsel informed the Court that a decision on the punitive 22 damages question could facilitate settlement. Accordingly, to assist the parties in their 23 settlement negotiations, this order will address only the punitive damages question. The 24 Court will rule on the remaining portions of Boston Scientific’s motion in due course. 25 This case concerns two medical devices manufactured and sold by Boston 26 Scientific: (1) the Obtryx, a mid-urethral polypropylene mesh sling that is surgically 27 implanted to treat stress urinary incontinence, and (2) the Uphold, a polypropylene mesh 28 device that is surgically implanted to treat pelvic organ prolapse. Engleka was implanted 1 with both devices in 2009. At that time, the Obtryx and Uphold each were cleared for 2 marketing by the Food and Drug Administration (“FDA”). Engleka subsequently 3 experienced a host of complications and brought this lawsuit against Boston Scientific. 4 Boston Scientific argues that Engleka cannot recover punitive damages because 5 the Obtryx and Uphold were cleared by the FDA at the time they were implanted. 6 Boston Scientific is correct. Under Arizona law, “[a] manufacturer . . . is not liable for 7 exemplary or punitive damages if,” as relevant here, “[t]he product alleged to have 8 caused the harm was designed, manufactured, packaged, labeled, sold or represented in 9 relevant and material respects according to the terms of an approval, conditional 10 approval, clearance, license or similar determination of a government agency.” A.R.S. § 11 12-689(A)(1). It is undisputed that the Obtryx and Uphold were FDA cleared during the 12 relevant time period. 13 In arguing against summary judgment, Engleka relies on an exception to this rule; 14 this statutory limitation on punitive damages does not apply if “the manufacturer . . . at 15 any time before the activity or event that allegedly caused the harm, . . . [i]ntentionally, 16 and in violation of applicable regulations as determined by final action of the government 17 agency, withheld from or misrepresented to the government agency information material 18 to the approval or maintaining of approval of the product . . . and the information is 19 relevant to the harm that the claimant allegedly suffered.” Id. at (B)(2). “However, to 20 meet this exception, there must not only be an intentional withholding or misrepresenting 21 of information, but there must also be a determination ‘by final action of the government 22 agency,’ in this case the FDA, that such conduct occurred.” Taylor v. Boston Scientific 23 Corp., No. CV-19-05499-PHX-DJH, 2020 WL 4592923, at *5 (D. Ariz. Aug. 5, 2020). 24 Engleka cites no final FDA action determining that Boston Scientific intentionally 25 withheld or misrepresented material information. The only final FDA action Engleka 26 cites is the FDA’s April 16, 2019 order that manufacturers halt the sale and distribution 27 of surgical mesh intended for transvaginal repair. (Doc. 80-1 at 93.) This agency action 28 occurred ten years after Engleka received her surgical implants and, although the FDA || determined that it had “not recetved sufficient evidence to assure that the probable 2|| benefits of these devices outweigh their probable risks,” (id.) the FDA did not determine || that Boston Scientific had withheld or misrepresented material information. Engleka 4|| therefore cannot recover punitive damages in this case. See Taylor, 2020 WL 4592923, 5|| at *4-5; Hix v. Boston Scientific Corp., No. CV-19-00422-PHX-DJH, 2019 WL 6003456, at *8 (D. Ariz. Nov. 14, 2019); McMahill v. C_R. Bard, Inc., 2019 WL 4899720, at *4-5 7\| (Ariz. Sup. Ct. July 23, 2019). 8 IT IS ORDERED that Boston Scientific’s motion for partial summary judgment 9|| (Doc. 59) is GRANTED as to Engleka’s claim for punitive damages (Count IX). The Court will rule on the remainder of Boston Scientific’s motion in due course. 11 Dated this 14th day of October, 2021. 12 - 13 J □□ a 14 Do . Rayes 5 United States District Judge 16 17 18 19 20 21 22 23 24 25 26 27 28

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