Oester v. Wright Medical Technology Incorporated

Opinion

1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA 8

Greg Oester, et al., ) No. CV-19-04763-PHX-SPL ) 9 ) 10 Plaintiffs, ) ORDER vs. ) ) 11 ) Wright Medical Technology, ) 12 Incorporated, ) 13 ) ) 14 Defendant. ) 15 Before the Court is Defendant Wright Medical Technology Incorporated (“WM”)’s 16 Motion for Summary Judgment (Doc. 49) and Motion to Partially Exclude the Opinions of 17 Mari Truman. (Doc. 51) Both Motions are fully briefed and ready for review. (Docs. 52, 18 53, 54, 55) Defendants seek summary judgment on Plaintiff Greg Oester’s failure to warn 19 and punitive damage claims. (Doc. 49 at 5–6) They also seek to exclude part of Plaintiffs’ 20 expert Mari Truman’s opinion. (Doc. 51 at 4) The motion to partially exclude the expert 21 testimony will be denied and the motion for summary judgment will be granted, as set forth 22 below.1 23 I. INTRODUCTION 24 This is a products liability case involving medical hip replacement systems 25 manufactured by Defendant WM. On December 20, 2006, Plaintiff had a hip replacement 26

27 1 Because it would not assist in resolution of the instant issues, the Court finds the pending motion is suitable for decision without oral argument. See Fed. R. Civ. P. 78(b); Partridge 28 v. Reich, 141 F.3d 920, 926 (9th Cir. 1998). 1 system implanted, specifically the Profemur Total Hip System, which included “a metal 2 Conserve2 acetabular cup, a cobalt chrome Conserve femoral head, a Profemur modular 3 neck, and a Profemur femoral stem.” (Doc. 1 at ¶¶9,48) The implants allegedly failed 4 because the metal-on-metal design of the components allegedly resulted in excessive wear, 5 corrosion, and debris. (Doc. 1 at ¶¶9,20) The implant had to be replaced with “hip revision 6 surgery” after the hip failed and there were “elevated metal ions” and “metallosis”3 found 7 in the hip area. (Doc. 1 at ¶¶9,52)4 8 Plaintiff filed a complaint against Defendant WM on July 19, 2019, with five counts. 9 (Doc. 1) The remaining claims left for the Court to resolve are: Count I, negligence, Count 10 II, strict liability-design defect, Count IV, strict liability-failure to warn, and Count V, 11 punitive damages. (Doc. 49 at 5) Plaintiff retained expert Mari Truman. In her expert 12 report, she offers opinions regarding “alleged fretting, wear and corrosion of Plaintiff’s 13 CONSERVE® femoral head component.” (Doc. 51 at 4) 14 Defendants ask the Court to exclude Ms. Truman’s opinions regarding corrosion 15 and metal wear because they are “speculative and not reliable.” (Doc. 51 at 4) Defendants 16 also ask the Court to grant summary judgment in their favor on Counts IV and V — strict 17 liability failure to warn and punitive damages. (Doc. 49 at 5–6) 18 /// 19 ///

20 2 The Conserve components have also been referred to by Defendants as the 21 “CONSERVE®” components. When not quoting the pleadings or referencing a case name, the Court will refer to them by their registered trademark name, that is, CONSERVE®. 22 3 Metallosis is a type of metal poisoning involving a build-up of metal debris in soft tissue. 23 See Catarina A. Oliveira, Metallosis: A diagnosis not only in patients with metal-on-metal 24 prostheses, 2 EUR. J. OF RADIOLOGY OPEN, 3, 3 (2015). 4 This case involves the same subject-matter as an earlier multidistrict litigation action 25 against Defendant, assigned to the Northern District of Georgia. In re: Wright Med. Tech., Inc., Conserve Hip Implant Prod. Liab. Litig., 844 F. Supp. 2d 1371 (U.S. Jud. Pan. Mult. 26 Lit. 2012). There was a bellwether trial, and the jury found in favor of the plaintiffs. See In re Wright Med. Tech. Inc., Conserve Hip Implant Prod. Liab. Litig., 178 F. Supp. 3d 1321 27 (N.D. Ga. 2016), aff’d in part sub nom. Christiansen v. Wright Med. Tech., Inc., 851 F.3d 1203 (11th Cir. 2017). The MDL was closed to new claims in 2017 and terminated in 2018. 28 Id. 1 II. LEGAL STANDARDS 2 A. Daubert Motions 3 Federal Rule of Evidence (“FRE”) 702 permits parties to file motions to strike to 4 ensure relevance and reliability of expert testimony. See Kumho Tire Co. v. Carmichael, 5 526 U.S. 137, 152–53 (1999). Courts have a “gatekeeping” function when it comes to 6 expert testimony. Primiano v. Cook, 598 F.3d 558, 565 (9th Cir. 2010), as amended (Apr. 7 27, 2010). “When an expert meets the threshold established by Rule 702 as explained in 8 Daubert, the expert may testify and the jury decides how much weight to give that 9 testimony.” Id. When the expert does not meet the threshold, the Court may prevent her 10 from providing testimony. See Alaska Rent-A-Car, Inc. v. Avis Budget Grp., Inc., 738 F.3d 11 960, 969 (9th Cir. 2013) (“Basically, the judge is supposed to screen the jury from 12 unreliable nonsense opinions, but not exclude opinions merely because they are 13 impeachable.”). 14 “Evidence is relevant if it has any tendency to make a fact more or less probable 15 than it would be without the evidence and the fact is of consequence in determining the 16 action.” Fed. R. Evid. 401. Reliability is determined separately. “The trial court must first 17 assess whether the testimony is valid and whether the reasoning or methodology can 18 properly be applied to the facts in issue.” Puente v. City of Phoenix, No. CV-18-02778- 19 PHX-JJT, 2021 WL 1186611, at *1 (D. Ariz. Mar. 30, 2021) (citing Daubert v. Merrell 20 Dow Pharm., Inc., 509 U.S. 579, 592–93 (1993)). “The focus ... must be solely on [the 21 expert’s] principles and methodology, not on the conclusions that they generate.” Id. (citing 22 Daubert, 509 U.S. at 594). 23 B. Summary Judgment 24 A court must grant summary judgment “if the movant shows that there is no genuine 25 dispute as to any material fact and the movant is entitled to judgment as a matter of law.” 26 Rule 56(a); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322–23 (1986). Material facts 27 are those facts “that might affect the outcome of the suit under the governing law.” 28 Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A genuine dispute of material 1 fact arises if “the evidence is such that a reasonable jury could return a verdict for the 2 nonmoving party.” Id. 3 The party moving for summary judgment bears the initial burden of informing the 4 court of the basis for its motion and identifying those portions of the record, together with 5 affidavits, which it believes demonstrate the absence of a genuine issue of material fact. 6 Celotex, 477 U.S. at 323. If the movant can do so, the burden then shifts to the non-movant 7 who “must do more than simply show that there is some metaphysical doubt as to the 8 material facts,” and, instead, must “come forward with ‘specific facts showing that there is 9 a genuine issue for trial.’” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 10 574, 586-87 (1986). When considering a motion for summary judgment, a court must view 11 the factual record and draw all reasonable inferences in a light most favorably to the 12 nonmoving party. Leisek v. Brightwood Corp., 278 F.3d 895, 898 (9th Cir. 2002). 13 III. DISCUSSION 14 The Court will address the Daubert motion first, then the motion for summary 15 judgment. 16 A. Daubert Analysis of Plaintiffs’ Expert Mari Truman 17 Truman is a “biomechanical and biomedical engineering expert.” (Doc. 51 at 5) 18 Truman created her expert report without seeing the components of the hip replacement 19 system that Plaintiff had removed from his body, or pictures or x-rays of the device or hip. 20 (Docs. 51 at 5, 7; 51-1 at 12) Because Truman failed to examine Plaintiff’s specific hip 21 replacement, Defendant seeks to exclude her opinions regarding corrosion and metal wear 22 “because they are speculative and not reliable.” (Doc. 51 at 4) It also seeks to exclude her 23 opinions regarding the general design defect because they do not fit the facts of the case, 24 due to her failure to examine the specific component. (Doc. 51 at 4–5) Finally, Defendant 25 seeks to exclude the medical causation opinions because they are outside the scope of 26 Truman’s expertise. (Doc. 51 at 5) 27 i. Reliability 28 “An expert’s testimony may [be] excluded where it is based on subjective beliefs 1 or unsupported speculation which is no more than unreliable ipse dixit guesswork.” Friend 2 v. Time Mfg. Co., 422 F. Supp. 2d 1079, 1081 (D. Ariz. 2005) (citing General Electric Co. 3 v. Joiner, 522 U.S. 136, 146 (1997) (holding that trial court may properly exclude ipse dixit 4 opinions where “there is simply too great an analytical gap between the data and the 5 opinion proffered”)). This determination is up to the district court’s discretion. Sementilli 6 v. Trinidad Corp., 155 F.3d 1130, 1134 (9th Cir. 1998), as amended (Nov. 12, 1998). 7 “Unlike an ordinary witness… an expert is permitted wide latitude to offer opinions, 8 including those that are not based on firsthand knowledge or observation.” Sementilli, 155 9 F.3d at 1134 (citing Daubert, 509 U.S. at 592). When an expert opinion is based on 10 information such as medical records and the expert’s knowledge, training, and education, 11 it is sufficient under FRE 703. Id. (“Federal Rule of Evidence 703 allows an expert to base 12 his or her opinions and inferences on facts and/or data ‘perceived by or made known to the 13 expert at or before the hearing.’”) Experts are not required by the Federal Rules of Evidence 14 to examine the subject of the case firsthand. In Sementilli, the defense’s causation expert 15 witness did not examine the plaintiff, was not present at the scene of the pertinent slip and 16 fall accident, and was unaware of plaintiff’s thought process prior to the accident, but the 17 panel found his opinion was able to be considered at summary judgment, based on 18 examination of the medical records and his personal knowledge, training, and experience. 19 Id. 20 Here, Truman’s opinion regarding the device’s corrosion was based on medical 21 records and deposition testimony from the revision surgeon. (Doc. 52 at 4) Plaintiffs argue 22 these materials are sufficient to support her opinion regarding the corrosion. (Doc. 52 at 4– 23 7) Defendant argues this methodology was insufficient because Truman offers opinions 24 about the specific device’s corrosion and wear yet did not examine the device to see 25 whether it actually demonstrated such damage. (Docs. 51 at 6–8, 53 at 6) Defendant offers 26 examples from other cases in which Truman’s opinions on other medical devices were 27 excluded because she relied too much on her training, background, and prior experience 28 and not on the device itself. (Doc. 51 at 7–8, 53 at 6) Plaintiffs argue the reliance on the 1 observations of the surgeon’s observations during the procedure was sufficient. (Doc. 52 2 at 8) 3 The cases involving Ms. Truman that Defendant offers as examples are either not 4 factually aligned with the case here or are from outside the District of Arizona and Ninth 5 Circuit. In re: Zimmer M/L Taper Hip Prosthesis or M/L Taper Hip Prosthesis With 6 Kinectiv Tech. and Versys Femoral Head Prod. Liab. Litig. v. Zimmer, Inc., et al., Nos. 18- 7 MD-2859, 18-MC-2859, 19-CV-699 (PAC), 2021 WL 3475681 (S.D.N.Y. Aug. 6, 2021); 8 Hardison v Biomet, Inc., No. 5:19-cv-00069-TES, 2020 WL 4334108 (M.D. Ga. July 27, 9 2020); Fitzsimmons v. Biomet Orthopedics, Inc., No. 2:19-cv-182-FTM-29NPM, 2020 WL 10 6784236, at *4 (M.D. Fla. Nov. 18, 2020). Defendant also offers Ninth Circuit case Triton 11 Energy Corp. v. Square D Co. for the proposition that when a single expert is testifying in 12 a products liability case, she must examine the product in question for her opinion to be 13 reliable. Doc. 51 at 8 (citing 68 F.3d 1216, 1222 (9th Cir. 1995)). In Triton, the expert was 14 evaluating the effectiveness of a particular circuit breaker that he never examined because 15 it had been destroyed. Id. at 1219–20. Under Nevada law, the opinion was found to be 16 unreliable because the expert could not base his opinion on specific facts, since he could 17 not view the circuit breaker Id. A later Ninth Circuit case distinguished Triton because 18 under California law (applicable in that case), a product design defect can be proven 19 through circumstantial evidence, and there the plaintiff had alleged a design defect of all 20 1999 Ford Expeditions, and not just the one involved in the accident. Michery v. Ford 21 Motor Co., 650 F. App’x 338, 342 (9th Cir. 2016). Therefore, the panel held the expert did 22 not need to look at the specific 1999 Ford Expedition. Id. Here, Plaintiff alleges all WM 23 hip implant systems on the market at the time were defective, not just the one placed within 24 his hip. (Doc. 1 at ¶4,9,36) Truman noted in her expert report that she has examined devices 25 explanted from other patients with similar injuries. (Doc. 51-1 at 12) She also relied on the 26 records from the treating surgeon. (Doc. 51-1 at 12) She has been an expert witness in 27 many hip replacement design defect cases, including cases involving the CONSERVE® 28 system at issue here. (Docs. 51 at 9; 51-1 at 13; 52 at 57) The Court now looks to see what 1 is necessary under Arizona law to prove the remaining claims in this case, which will 2 determine whether it was necessary for Truman to look at this specific system. 3 In Arizona, “[a] negligence design defect claim begins with the assertion that a 4 manufacturer produced a product that fails to meet ‘the purpose for which it is designed.’” 5 Jones v. Medtronic Inc., 411 F. Supp. 3d 521, 531 (D. Ariz. 2019), aff’d sub nom. Jones v. 6 Medtronic, 830 F. App’x 925 (9th Cir. 2020) (quoting Stilwell v. Smith & Nephew, Inc., 7 482 F.3d 1187, 1194 (9th Cir. 2007)). “A negligent design case focuses on whether the 8 defendant’s conduct was reasonable in view of a foreseeable risk at the time of design of 9 the product.” Jones v. Medtronic, 411 F. Supp. 3d at 531 (citing St. Clair v. Nellcor Puritan 10 Bennett LLC, 2011 WL 5331674, at 5 (D. Ariz. Nov. 7, 2011)) (emphasis added). 11 For strict liability design defect claims, Arizona courts use the consumer expectation 12 test or a risk/benefit analysis. Id. Neither test requires consideration of the specific product 13 at issue; one focuses on the expectations of the consumer, the other focuses on what the 14 manufacturer knew at the time the product was placed on the market. Id. Furthermore, 15 “[n]o expert testimony is necessary to establish a design defect under the consumer 16 expectation test because the test focuses on the safety expectations of an ordinary consumer 17 rather than those of an expert.” Long v. TRW Vehicle Safety Sys., Inc., 796 F. Supp. 2d 18 1005, 1010 (D. Ariz. 2011) (internal quotations omitted). 19 Here, the failure to warn claim is focused on the warning with the device and not 20 the device itself. See infra III.B. The two relevant claims5 require Plaintiffs to show 21 Defendant had some sort of general knowledge about the product at issue. Defendant’s 22 concerns about the materials Truman relied upon in making her opinion go to the credibility 23 of her testimony, but not its admissibility. See Friend, 422 F. Supp. 2d at 1081 (“The jury 24 is entitled to hear expert testimony and decide whether to accept or reject it after 25 considering whether predicate facts on which the expert relied were accurate.”) (internal 26 27 5 Summary judgment has been granted in favor of Defendant on the punitive damages claim, as will be discussed below. See infra III.B. Therefore, the Court will not discuss it 28 in the Daubert context. 1 citation omitted). The Court will not find Truman’s opinion unreliable solely based on the 2 failure to examine the specific hip replacement component. 3 ii. Relevancy and Fit 4 “The scientific knowledge must be connected to the question at issue.” Friend, 422 5 F. Supp. 2d at 1081. The standard for fit is higher than the relevance standard, and “federal 6 judges must exclude proffered scientific evidence under Rule 702 unless they are 7 convinced that it speaks clearly and directly to an issue in dispute in the case, and that it 8 will not mislead the jury.” Id. (citing Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311 9 (9th Cir. 1995) (“Daubert II”). 10 Defendant alleges Truman’s general design defect opinion that metal-on-metal hip 11 implants are subject to excessive wear that causes injury like the one allegedly present in 12 Plaintiff are unreasonably applied to the facts of this case because Truman failed to 13 examine Plaintiff’s specific implant. (Doc. 51 at 9) Defendant argues this creates a “gap” 14 between the opinion and the underlying facts. (Doc. 51 at 9–10) Defendant’s gap argument 15 is based on a Middle District of Florida holding that excluded expert testimony for lack of 16 fit because the expert (not Truman, though she involved in the case) did not view the metal- 17 on-metal hip implant at issue and opined that the injury was due to “mixed-metal coupling,” 18 where the hip implant did not contain mixed metals. Doc. 53 at 7, citing Fitzsimmons., 19 2020 WL 6784236 at *4. Obviously, that expert was making an analytical leap because the 20 hip implant at issue was not of the same makeup as the others examined. Id. That opinion 21 was based on facts that are not present in the instant case. Defendant makes no such 22 arguments here. Defendant notes Truman’s opinion was based on her experience with other 23 “explanted CONSERVE® MoM bearings,” which were the same kind Plaintiff had 24 implanted, then explanted. (Docs. 1 at ¶9, 51 at 9) Therefore, although Truman did not 25 examine Plaintiff’s implant, her opinion was based in part on others just like it. Therefore, 26 the Court finds Truman’s testimony sufficiently fits the facts at hand. 27 iii. Scope of Expertise 28 Defendant argues Truman’s opinions on the cause of Plaintiff’s injuries should be 1 excluded because she is not a medical doctor and should not be allowed to offer medical 2 causation opinions. (Doc. 51 at 10) Plaintiffs argue the causation opinion is proper because 3 Truman relied on the treating surgeon’s report and deposition testimony in forming her 4 opinion. (Doc. 52 at 6–10) An Eastern District of Missouri court and a Middle District of 5 Georgia court have both excluded Truman’s medical causation testimony because she is 6 an engineer and not a medical doctor. Bayes v. Biomet, Inc., No. 4:13-cv-00800-SRC, 2020 7 WL 5594059, at *6 (E.D. Mo. Sept. 18, 2020); Hardison v Biomet, Inc., No. 5:19-cv- 8 00069-TES, 2020 WL 4334108, at *12 (M.D. Ga. July 27, 2020). This district does not 9 have a blanket prohibition on engineers opining on medical causation; rather, if the 10 engineer has “extensive experience and expertise in engaging in primary research on the 11 effects of the relevant mechanism at issue” she may testify as to medical causation. 12 Compare Allen v. Am. Cap. Ltd., 287 F. Supp. 3d 763, 805 (D. Ariz. 2017), with Rascon v. 13 Brookins, No. CV-14-00749-PHX-JJT, 2018 WL 739696, at *2 (D. Ariz. Feb. 7, 2018) 14 (finding a toxicologist unqualified to offer medical causation opinions on law enforcement 15 restraints, TASER usage, or cardiorespiratory compromise). 16 Having reviewed the parties’ arguments and Truman’s expert report and 17 qualifications, the Court finds she is sufficiently qualified to opine on medical causation 18 because of her extensive experience with metal-on-metal hip implants and their effects on 19 recipients, the provided Georgia and Missouri cases notwithstanding. 20 B. Summary Judgment Analysis 21 First, Plaintiffs have said they do not oppose dismissal of the punitive damages 22 claim. (Doc. 54 at 14) Defendant agreed to dismissal. (Doc. 55 at 5) Therefore, the Court 23 will dismiss the punitive damages claim. 24 Turning to the failure to warn claim, Defendant states that it is grounded in 25 negligence (Count I) and strict liability (Count IV) and that it fails as a matter of law. (Doc. 26 49 at 9) The Complaint states Count I as a general negligence claim and Count IV as “Strict 27 Liability – Failure to Warn.” (Doc. 1 at ¶¶81–84,95–100) Plaintiffs do not address the 28 negligence arguments in their response to the motion for summary judgment, focusing 1 entirely on strict liability. (Doc. 54) To the extent Plaintiffs bring the negligence claim 2 under a failure to warn theory, summary judgment will be granted in favor of Defendants 3 due to the lack of response. “Failure to respond to the merits of one party’s argument 4 constitutes a concession of that argument.” Panaccione v. Aldonex Inc., No. CV-19-04483- 5 PHX-DLR, 2021 WL 268781, at *3 (D. Ariz. Jan. 27, 2021) (citing M.S. v. Cty of Ventura, 6 No. CV 16-03084-BRO (RAOx), 2017 WL 10434015, at *24 n. 20 (C.D. Cal. Mar. 7, 7 2017) and Mendoza v. City of Peoria, No. CV-13-00258-PHX-DJH, 2015 WL 13239816, 8 at *4 (D. Ariz. July 31, 2015)). 9 To grant summary judgment in favor of a plaintiff on a strict liability failure to warn 10 claim, the plaintiff must prove “that the defendant did not adequately warn of a particular 11 risk that was known or knowable in light of the generally recognized and prevailing best 12 scientific and medical knowledge available at the time of manufacture and distribution.” 13 D’Agnese, 952 F. Supp. 2d 880, 890 (D. Ariz. 2013) (citing Powers, 217 Ariz. at 404). 14 In strict liability failure to warn cases, Arizona law has a heeding presumption that 15 allows “the fact-finder to presume that the person injured by product use would have 16 heeded an adequate warning, if given.” Id. (citing Golonka v. General Motors Corp., 204 17 Ariz. 575, 586 (Ariz. Ct. App. 2003)). However, the presumption is rebuttable, meaning 18 “if the manufacturer introduces evidence that would permit reasonable minds to conclude 19 that the injured party would not have heeded an adequate warning” the presumption is 20 destroyed “and the existence or non-existence of the presumed fact must be determined as 21 if the presumption had never operated in the case.” Id. at 890–91. Furthermore, in such 22 cases, Arizona courts also follow the learned intermediary doctrine (“LID”). Id. at 891. The 23 Arizona Supreme Court has held that in strict liability cases, “if the manufacturer provides 24 complete, accurate, and appropriate warnings about the product to the learned 25 intermediary, it fulfills its duty to warn the consumer.” Watts v. Medicis Pharm. Corp., 239 26 Ariz. 19, 24 (2016). Arizona has adopted the Third Restatement of Torts definition of the 27 LID, as follows: 28 A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable 1 instructions or warnings regarding foreseeable risks of harm are not provided to: 2 (1) prescribing and other health-care providers who are in a 3 position to reduce the risks of harm in accordance with the instructions or warnings; or 4 (2) the patient when the manufacturer knows or has reason to 5 know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or 6 warnings. 7 Id. (citing RESTATEMENT (THIRD) OF TORTS: PROD. LIAB. § 6(d) (1998)). The LID does 8 not apply, “if the manufacturer fails to provide adequate warnings to the learned 9 intermediary.” Id. The heeding presumption and the LID work together; rather than 10 determining whether the injured party would have heeded the warning, courts look at 11 whether the treating physician would have heeded it. Paseka v. Ethicon Inc., No. CV-20- 12 00100, 2020 WL 8175427, at *4 (D. Ariz. Nov. 9, 2020). 13 Defendant first argues it had no duty to warn Plaintiff directly. (Doc. 49 at 9–10) 14 Plaintiffs do not contest that argument. Defendant next argues Dr. Firestone did not read 15 the warnings provided, thus, the claim must fail. (Doc. 49 at 10–11) Plaintiff responds that 16 although Dr. Firestone did not read the warning that came on the box of the implant, first, 17 most doctors do not see medical device product boxes prior to surgery and second, he had 18 “received informational brochures from Defendants and had multiple conversations with 19 Defendant’s sales representatives, engineers, marketing staff, and executives” and at no 20 point was he told of the risk associated with the implant. (Doc. 54 at 12–13) 21 It is not a disputed fact that Dr. Firestone did not read the warning that came with 22 the implant. (Doc. 50 at 3, 70) This Court has found that when it is undisputed that the 23 treating medical provider did not read warnings that came with the medical device before 24 using it on or implanting it in the plaintiff, the heeding presumption is rebutted, and the 25 plaintiff will be unable to prove causation for a failure to warn claim. Paseka, 2020 WL 26 8175427 at *4. Furthermore, in Paseka, the treating physician had spoken to 27 representatives from the defendant manufacturer and had reviewed warning materials at 28 1 some point, but not those for the specific product at issue. These facts are similar to the 2 instant case, and the Court still found the failure to read the specific warnings rebutted the 3 presumption. Id. at *5. The Court finds the same in the instant case. 4 Additionally, courts should not impose additional requirements on manufacturers 5 than those already levied by the FDA. See Eidson v. Medtronic, Inc., 981 F. Supp. 2d 868, 6 887 (N.D. Cal. 2013) (citing Houston v. Medtronic, Inc., 957 F. Supp 2d 1166, 1176–78 7 (C.D. Cal. 2013)). A state law tort claim is not the proper vehicle to impose further 8 obligations on FDA-compliant medical device manufacturers. Id. 9 Therefore, there is no way a reasonable jury could find that an inadequate warning 10 or warnings were the proximate cause of Plaintiff’s injuries, and grants summary judgment 11 on the strict liability failure to warn claim. 12 IV. CONCLUSION 13 As to the Daubert motion, the Court finds Mari Truman’s expert testimony is 14 admissible under the standards set forth in the Federal Rules of Evidence, Daubert, and its 15 progeny. See supra III.A. 16 As to the motion for summary judgment, the parties agreed to dismiss the punitive 17 damages claim. See supra III.B. The Court further found there to be no genuine dispute of 18 material fact on the failure to warn claim, both for negligence and strict liability purposes. 19 Id. 20 Therefore, 21 IT IS ORDERED that Defendant Wright Medical Technology, Incorporated’s 22 Motion to Partially Exclude the Opinions of Mari Truman (Doc. 51) is denied. 23 /// 24 /// 25 /// 26 /// 27 /// 28 /// 1 IT IS FURTHER ORDERED that Defendant’s Motion for Summary Judgment 2| (Doc. 49) is granted as follows: 3 1. Count V — Punitive Damages is dismissed with prejudice. 4 2. Summary judgment is granted in favor of Defendant Wright Medical 5 Technology on Count IV — Strict Liability — Failure to Warn. 6 3. Summary judgment is granted in part in favor of Defendant Wright Medical 7 Technology on Count I — Negligence, only to the extent Plaintiffs intended to 8 base the negligence claim on a failure to warn theory. 9 Dated this 24th day of August, 2021. 10

United States District Judge 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28