Opinion
CV-20-00457-TUC-JAS (LCK)
07-12-2021
Diane Michelle Bailey, Plaintiff, v. Ethicon Incorporated, et al., Defendants.
REPORT AND RECOMMENDATION
HONORABLE LYNNETTE C. KIMMINS UNITED STATES MAGISTRATE JUDGE
Pending before the Court are Defendants Ethicon, Inc. and Johnson & Johnson's two partial Motions for Summary Judgment. (Docs. 55, 56, 117, 118.) Plaintiff filed responses to both (Docs. 62, 120, 121), and Defendants replied (Docs. 67, 123). Oral argument was heard on June 17, 2021. (Doc. 129.) The Magistrate Judge recommends the District Court, after its independent review of the record, grant summary judgment to Defendant, in part, as to the claims of manufacturing defect, breach of express warranty, breach of implied warranty, unjust enrichment, defective product, and design defect, and deny summary judgment on the remaining claims.
BACKGROUND
Plaintiff Diane Bailey filed a Short Form Complaint in January 2014 as part of the Ethicon, Inc., Pelvic Repair System Products Liability Litigation MDL No. 2327, presided over by District Judge Goodwin in the Southern District of West Virginia. (Doc. 1.) The Complaint alleges 16 claims against Defendants arising from Plaintiff being implanted with Defendants' Prolift +M device on September 20, 2010. (Doc. 1 at 3-5.) The case was transferred to this Court for trial on October 27, 2020. (Docs. 70, 86.) The First Amended Master Long Form Complaint was designated as part of the record for the MDL transfer. (Doc. 71-1.) At the time of transfer, a partial motion for summary judgment, filed by Defendants, was pending on the docket. Subsequently, the Court permitted Defendants to file a second motion for summary judgment addressing the remainder of Plaintiff's claims.
In response to Defendants' first Motion for Summary Judgment, Plaintiff withdrew four claims: Strict Liability - Manufacturing Defect (Count II), Breach of Express Warranty (Count XI), Breach of Implied Warranty (Count XII), and Unjust Enrichment (Count XV). (Doc. 62 at 2.) Therefore, the Court will grant summary judgment on those claims as requested by Defendants. Defendants seek summary judgment on the remaining 12 claims: Negligence (Count I); 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); Negligent Misrepresentation (Count IX); Negligent Infliction of Emotional Distress (Count X); Violation of Consumer Protection Laws (Count XIII); Gross Negligence (Count XIV); Punitive Damages (Count XVII); and Discovery Rule and Tolling (Count XVIII).
Plaintiff's Short Form Complaint does not allege two of the claims included in the Amended Master Long Form Complaint, Claim VIII (Constructive Fraud) and Claim XVI (Loss of Consortium). (Doc. 1 at 4-5.)
SUMMARY JUDGMENT STANDARD
In deciding a motion for summary judgment, the Court views the evidence and all reasonable inferences therefrom in the light most favorable to the party opposing the motion. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986); Eisenberg v. Ins. Co. of N. Am., 815 F.2d 1285, 1289 (9th Cir. 1987). Summary judgment is appropriate if the pleadings and supporting documents “show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). The moving party need not produce evidence of a genuine issue of material fact but may satisfy its burden by “pointing out . . . that there is an absence of evidence to support the nonmoving party's case.” Celotex Corp., 477 U.S. at 325. Material facts are those “that might affect the outcome of the suit under the governing law.” Anderson, 477 U.S. at 248. A genuine issue exists if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Id.
DISCUSSION
FAILURE TO WARN: Strict Liability (Count III); Negligence (Count I, in part); Negligent Misrepresentation (Count IX, in part); Negligent Infliction Of Emotional Distress (Count X, in part); Gross Negligence (Count XIV, in part)
Defendants argue that the failure to warn claims fail because (1) Plaintiff's physician did not rely on the medical device's Instructions for Use (IFU), and (2) her doctor continues to stand by his decision to prescribe the device. Therefore, Defendants contend a failure to warn did not cause Plaintiff harm.
Strict Liability
Under Arizona law, to prove a strict liability failure to warn claim, Plaintiff must establish: (1) a duty to warn; (2) the absence of a warning made the product “defective and unreasonably dangerous”; (3) the warnings were missing when the product left Defendants' control; and (4) Plaintiff's injuries were caused by the failure to adequately warn. Gosewisch v. Am. Honda Motor Co., 737 P.2d 376, 379, 153 Ariz. 400, 403 (1987) (superseded on other grounds by A.R.S. § 12-683); Sw. Pet Prods. v. Koch Indus., 273 F.Supp.2d 1041, 1060 (D. Ariz. 2003). A medical device manufacturer's duty to warn consumers of the foreseeable risks of harm from its product is satisfied if the manufacturer provides an adequate warning to a qualified intermediary, such as a healthcare provider. Watts v. Medicis Pharm. Corp., 365 P.3d 944, 948, 239 Ariz. 19, 23 (2016) (quoting Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 154 (Tex. 2012)); Conklin v. Medtronic, Inc., 431 P.3d 571, 577, 245 Ariz. 501, 507 (2018) (citing Restatement (Third) of Torts: Prods. Liab. § 6(d)(1)). This is known as the learned intermediary doctrine (LID). Watts, 365 P.3d at 948, 239 Ariz. at 23.
Defendants' arguments are based solely on the question of causation. Causation in a failure to warn case is ordinarily a question of fact for the jury. Gosewisch, 737 P.2d at 403, 153 Ariz. at 407; see also Golonka v. Gen. Motors Corp., 65 P.3d 956, 966, 204 Ariz. 575, 585 (Ct. App. 2003). Here, the Court must examine whether Plaintiff would not have had the Prolift +M implanted if the IFU had included different warnings.
Facts
Plaintiff chose to have surgery based on Dr. Shawn Tassone's recommendation and her own research. (Doc. 55, Ex. A at 57-59.) Prior to the surgery, she did not receive a patient brochure on the product to be used in the prolapse surgery. (Id. at 53.) She neither looked at the Defendants' websites nor had any conversations with Ethicon employees or representatives. (Id. at 60, 66.)
Dr. Tassone never had been trained on the Prolift +M and never used it; his partner, Dr. Kathryn Landherr, who had been trained, actually placed the device during Plaintiff's surgery. (Doc. 62, Ex. 1 at 93-95, 166, 183; Ex. 2 at 25.) Drs. Tassone and Landherr expected the IFU for the Prolift +M to be accurate, honest, complete, and to have a reasonably scientific basis, and that Ethicon would not mislead him/her or withhold important safety information. (Doc. 62, Ex. 1 at 82-83; Ex. 2 at 32.) Dr. Tassone generally read the Instructions for Use (IFU) for products used in his practice, had read the instructions for use for the Prolift +M, and was aware of the risks it posed. (Doc. 62, Ex. 1 at 51.) Dr. Tassone testified that IFUs disclose potential adverse events. (Id. at 87.) Dr. Landherr had reviewed the IFU for the Prolift +M prior to Plaintiff's implantation surgery. (Doc. 62, Ex. 2 at 31.) She reviewed the IFU because she wanted to be able to safely place the device in a patient's body and be familiar with the device's safety information. (Id. at 31-32.)
Dr. Tassone recommended the device to Plaintiff. (Doc. 62, Ex. 1 at 50-51.) He was unsure if he relied on the IFU in recommending the device to Plaintiff and wasn't aware of relying on any statements from Ethicon for his recommendation. (Id. at 165-66.) However, he stated that information on adverse risks is important to him and he uses the information he learns from IFUs as part of his informed consent with patients. (Id. at 88.) Dr. Landherr testified that she relied, in part, on information in Ethicon's IFU when selecting a device for a patient. (Doc. 62, Ex. 2 at 32, 126.) Similarly, Dr. Landherr testified that it was important for her to be aware of potential adverse reactions associated with a device because she communicates the risks and benefits to her patients prior to obtaining surgical consent. (Id. at 39-40.) Dr. Landherr relied on Ethicon to give her adequate information concerning their safety experience with the Prolift +M device, and any information she had from Ethicon related to potential adverse risks and events she would have explained to her patients. (Id. at 24-25.) Dr. Landherr did not recollect if she conducted a surgical consent discussion with Plaintiff but it would have been within her practice to have participated in a consent discussion with Dr. Tassone and Plaintiff. (Id. at 23, 86-87.)
Dr. Tassone testified that, at the time he recommended the Prolift +M to Plaintiff, he necessarily relied on the knowledge he possessed then and, based on that information, he stands by his decision to use Prolift +M for Plaintiff. (Doc. 55, Ex. B at 191-92.) He would not do so today because his practice has changed, and he no longer wants to use devices and would use solely sutures. (Id. at 92-94.) Dr. Tassone's understanding, in 2010, was that the Prolift +M would not cause chronic inflammation. (Doc. 62, Ex. 1 at 89.) Dr. Tassone testified that he would not put a device in a patient if he knew it would cause a chronic inflammatory response. (Id. at 67-68.) Dr. Daniel Elliott opined that Defendant Ethicon knew there was a risk that Prolift +M could cause a chronic inflammatory response but did not disclose this risk in the IFU prior to Plaintiff's implantation surgery. (Doc. 62, Ex. 3 at 17-19.)
If Ethicon had told Dr. Landherr (which they did not) that patients experienced certain complications - such as lifelong pain, chronic severe inflammatory reaction, or the mesh becoming rigid - she would have considered the data in determining whether to use the product. (Doc. 62, Ex. 2 at 39, 42-45, 50.) If some of the complications she believed to be rare were disclosed to occur frequently, she would not have used the device. (Id. at 51-52, 124.) Since Plaintiff's 2010 surgery, Dr. Landherr learned more about the risks and complications from the Prolift +M and based on that knowledge she would have chosen a treatment other than that device for Plaintiff. (Id. at 52-54.)
Analysis
Defendants argue, first, that Dr. Tassone did not rely on the Prolift +M IFU; therefore, any inadequacy in the warning was not the cause of Plaintiff's injury. Defendants rely on three cases in which the evidence was undisputed that the relevant physicians never read the manufacturer's warning label, therefore, a failure to warn claim failed for lack of causation. See Gebhardt v. Mentor Corp., 15 Fed.Appx. 540, 542 (9th Cir. 2001) (doctor never reviewed the medical device's warning label); Carter v. APP Pharm., LLC, No. CV-10-02573-PHX-ROS, 2013 WL 5532767, at *7 (D. Ariz. Aug. 13, 2013) (multiple physicians testified they had never reviewed the company's medication label); In re C.R. Bard, Inc., No. 2:11-CV-00114, 2013 WL 2949033, at *3 (S.D. W.Va. June 14, 2013) (applying Mississippi law and finding no proximate cause because the doctor never read the manufacturer's warning). These cases are inapposite to the facts presented in the briefing of Defendants' current motion for summary judgment.
Dr. Tassone testified that he had read the Prolift +M's IFU. Although he could not recall if he relied upon the IFU in recommending the device to Plaintiff, he testified that he relied on adverse risk information from IFUs when obtaining informed consent from his patients. Therefore, a jury could find that Plaintiff, through Dr. Tassone, relied upon the warnings provided in the IFU.
Further, because Dr. Tassone had not been trained on implanting the Prolift +M, he could not have performed Plaintiff's surgery without his partner, Dr. Landherr. By performing the surgery, Dr. Landherr implicitly recommended it to Plaintiff and she testified that she relied upon Ethicon's IFU when selecting a device for a patient. Because she conducted the surgical placement of the Prolift +M in Plaintiff's body, a jury could find her reliance on the IFU relevant to causation. Further, she testified that it would have been within her practice to meet Plaintiff at the office or prior to the surgery with Dr. Tassone for a consent procedure. Therefore, whether Dr. Landherr's reliance on the manufacturer's warnings influenced Plaintiff's decision is a question of fact.
Second, Defendants argue that because Dr. Tassone “stands by his decision” to use the Prolift +M for Plaintiff, causation for a failure to warn claim fails. “To establish proximate cause on a failure to warn claim under Arizona law, a plaintiff ‘needs to show that had a proper warning been given, the injury would not have happened.'” Murrell v. Wyeth, Inc., No. CV-13-0290-PHX-DGC, 2013 WL 1882193, at *6 (D. Ariz. May 3, 2013) (granting summary judgment on failure to warn claim in absence of any facts about what information plaintiff or doctor relied upon in making decision or whether alternative remedies were considered) (quoting Mills v. Bristol-Myers Squibb Co., No. CV 11-00968-PHX-FJM, 2011 WL 4708850, at *3 (D. Ariz. Oct. 7, 2011)). Dr. Tassone stated that he stands by his decision in 2010, based on the information he knew at that time. Both doctors testified that, if they had been informed about the frequency of certain possible outcomes, they would have chosen not to use the Prolift +M for Plaintiff. Because a change in warnings could have altered the surgeons' decisions, and in turn the Plaintiff's decision regarding surgery, Defendants are not entitled to summary judgment on this claim.
Negligence
Defendants argue that some of the negligence claims are based, in whole or part, on a failure to warn theory. Therefore, they argue those claims necessarily would fail if Plaintiff cannot establish the necessary causation for a strict liability failure to warn claim. Plaintiff conceded that, if her Count III failure to warn claim fails, her negligence claims premised on a failure to warn also would fail. Because the Court has determined that Defendants are not entitled to summary judgment on the strict liability failure to warn claim, they also fail to establish a right to summary judgment on the failure to warn claims premised on negligence.
FRAUD: Common Law Fraud (Count VI); Fraudulent Concealment (Count VII); Negligent Misrepresentation (Count IX); Consumer Fraud (Count XIII)
Defendants argue that the learned intermediary doctrine applies to these claims, which renders them duplicative of the Failure to Warn claim and not cognizable as independent claims. As discussed above, the LID provides that a manufacturer satisfies its duty to warn a person of the risks of harm from a medical device if adequate warning is given to the patient's doctor. Watts, 365 P.3d at 948, 239 Ariz. at 23.
Defendants rely upon a case decided in the MDL, in which the court granted summary judgment on a plaintiff's Arizona fraud claims based on the LID. See Bellew v. Ethicon, Inc., No. 2:13-CV-22473, 2014 WL 6886129, at *5 (S.D. W.Va. Nov. 24, 2014). In reaching that decision, the MDL court relied upon a prior ruling based on Illinois law. Id. (citing Huskey v. Ethicon, Inc., 29 F.Supp.3d 736, 743-45 (S.D. W.Va. 2014)). In Huskey, the MDL court noted that the plaintiff's fraud claims were premised on a failure to warn her, the patient, directly of the risks associated with the medical device rather than a failure to warn the plaintiff's physician. 29 F.Supp.3d at 744. For that reason, the court concluded that allowing the fraud claims would bypass the LID and render it meaningless. Id. at 745.
Neither Bellew nor any of the cases upon which it relied hold that a plaintiff cannot premise multiple different causes of action on a medical device manufacturer's inadequate warning. Rather, the cases hold that the LID applies to all claims premised on a failure to warn, regardless of the cause of action alleged. See Talley v. Danek Med., Inc., 179 F.3d 154, 164 (4th Cir. 1999) (applying LID to fraud claims); Lee v. Mylan Inc., 806 F.Supp.2d 1320, 1325 (M.D. Ga. 2011) (applying LID to negligent misrepresentation claim and finding it barred a claim based on representations to plaintiff's mother but not necessarily representations to plaintiff's doctor); Beale v. Biomet, Inc., 492 F.Supp.2d 1360, 1373 (S.D. Fla. 2007) (finding LID barred a claim of unfair trade practices because the manufacturer's warning was adequate); Southern v. Pfizer, Inc., 471 F.Supp.2d 1207, 1218 (N.D. Ala. 2006) (applying LID to negligent misrepresentation); In re Norplant Contraceptive Prod. Liab. Litig., 955 F.Supp. 700, 709-11 (E.D. Tex. 1997), aff'd sub nom., In re Norplant Contraceptive Prod. Litig., 165 F.3d 374 (5th Cir. 1999); Centocor, Inc., 372 S.W.3d at 143, 169-71 (applying the LID to fraud claim but finding claim failed for lack of causation). Following this law, the LID applies to causes of action based on a failure to warn; therefore, they are cognizable only if they challenge the adequacy of the warning to the prescribing doctor not the patient.
At oral argument, Plaintiff clarified that her fraud claims are premised on the adequacy of the warning given to her doctors by way of the IFU. By acknowledging that Plaintiff was required to prove the inadequacy of the warnings to her doctors, she essentially conceded the LID would apply to these claims. In contrast to Bellew, the LID does not bar Plaintiff's claims because they are based on the quality of the warning Defendants provided to her doctors. In the motion for summary judgment, Defendants did not establish, or attempt to establish, that they provided Plaintiff's doctor with a sufficient warning. Therefore, Defendants are not entitled to summary judgment on Plaintiff's fraud claims based on the LID.
COMMON LAW FRAUD (Count VI)
Defendants argue that Plaintiff cannot establish the elements of fraud because no representations were made to her by Defendants. Under Arizona law, a fraud claim requires proof of:
(1) a representation; (2) its falsity; (3) its materiality; (4) the speaker's knowledge of its falsity or ignorance of its truth; (5) the speaker's intent that it be acted upon by the recipient in the manner reasonably contemplated; (6) the hearer's ignorance of its falsity; (7) the hearer's reliance on its truth; (8) the right to rely on it; (9) his consequent and proximate injury.Echols v. Beauty Built Homes, Inc., 647 P.2d 629, 631, 132 Ariz. 498, 500 (1982) (citing Nielson v. Flashberg, 419 P.2d 514, 101 Ariz. 335 (1966)).
As urged by Defendants, and found above by the Court, the LID applies to this fraud claim. Therefore, the fraudulent representations must have been directed at Plaintiff's doctors to be actionable. Plaintiff argues that her expert, Dr. Elliott, has opined there were numerous material omissions in the warnings provided by Ethicon regarding the Prolift +M. She clarified at oral argument that this claim is premised on representations made to her doctors not directly to her. Defendants did not identify, and the Court did not locate, any case from this District or the state courts of Arizona dismissing a fraud claim because the alleged false representations were made to a physician and not directly to a patient. In contrast, fraud claims brought by patients, alleging that medical device manufacturers misrepresented information about their products to doctors, have survived motions to dismiss on other grounds. See Arvizu v. Medtronic Inc., 41 F.Supp.3d 783, 791 (D. Ariz. 2014); Ramirez v. Medtronic Inc., 961 F.Supp.2d 977, 997 (D. Ariz. 2013), clarified on denial of reconsideration (Oct. 24, 2013). Defendants have not established they are entitled to relief as a matter of law on Plaintiff's fraud claim premised on representations made by Defendants to Plaintiff's doctors.
FRAUDULENT CONCEALMENT (Count VII)
Defendants argue this claim fails because Plaintiff was not a party to a business transaction with them. Arizona law permits a claim for fraudulent concealment where “one party to a transaction who by concealment or other action intentionally prevents the other from acquiring material information.” Wells Fargo Bank v. Ariz. Laborers, Teamsters & Cement Masons Local No. 395 Pension Trust Fund, 38 P.3d 12, 34, 201 Ariz. 474, 596 (Ariz. 2002) (citing Restatement (Second) of Torts § 550 (1976)); King v. O'Rielly Motor Co., 494 P.2d 718, 721, 16 Ariz.App. 518, 521 (1972)). Arizona law requires that the plaintiff be a “party to a transaction” to maintain an independent claim for fraudulent concealment. Sullivan v. Pulte Home Corp., 290 P.3d 446, 454, 231 Ariz. 53, 61 (Ct. App. 2012), vacated in part on other grounds, 306 P.3d 1, 232 Ariz. 344 (2013), and disapproved of on other grounds by Sirrah Enterprises, LLC v. Wunderlich, 399 P.3d 89, 242 Ariz. 542 (2017).
Plaintiff relies upon the case of Watts, 365 P.3d at 953, 239 Ariz. at 28, in which the Arizona Supreme Court found that a pharmaceutical drug qualified as merchandise under the Consumer Fraud Act (CFA). The manufacturer had argued that the statute required a direct merchant-consumer transaction and that the sale of a prescription drug did not meet that criteria. Id. The court disagreed, finding the language of the statute did not require a direct transaction. Id. Watts is not applicable to Count VII because fraudulent concealment does require that the plaintiff be a party to the transaction.
As cited by Defendants, under Arizona law, a secondary purchaser of merchandise, such as the subsequent purchaser of a home, is not a party to a transaction with the builder and, therefore, cannot state a claim for fraudulent concealment. Id. at 454, 231 Ariz. at 61. Plaintiff did not obtain the Prolift +M directly from the manufacturer. However, it was obtained by the hospital for use in one specific patient.
Because a patient is the intended end consumer for a medical device, the Court finds she was a party to the transaction. If Defendants prevented Plaintiff's doctors from acquiring material information, they necessarily also prevented her from learning that same information. Again, because the LID applies to this claim, the only actionable conduct is that of Defendants' interactions with Plaintiff's doctors. Therefore, Defendants are not entitled to summary judgment on this claim.
DESIGN DEFECT: Strict Liability (Count V); Negligence (Count I, in part)
Defendants argue that Plaintiff's design defect claims, based on strict liability and negligence, fail for lack of adequate causation. Specifically, Defendants contend that Plaintiff's case-specific expert report is inadequate to establish causation because it concludes that the product caused Plaintiff's injuries, not an identified defect in the product.
Facts
Plaintiff averred that she has experienced the following injuries as a result of having the Prolift +M implanted (and excised in two subsequent surgeries): pain (vaginal and pelvic radiating into her leg), pelvic myalgia/spasms, adhesions, urinary problems (urinary loss, feeling of incomplete emptying, frequency, and urgency), recurrent prolapse and repair surgery, severe dyspareunia, vaginal scarring, inability to sit for long periods, pain on walking, use of chronic pain meds that prevent her from working, low back pain, sciatica, and pudendal nerve entrapment. (Doc. 118, Ex. 1 at 6; Doc. 121, Ex. 1 at 5.)
Dr. Joel Funk performed two surgeries in an effort to remove all of the mesh in Plaintiff's pelvis because he determined it was causing Plaintiff's vaginal and pelvic pain, and dyspareunia. (Doc. 121, Ex. 2 at 48, 50, 65-66.) Plaintiff experienced relief of symptoms after the second surgery but subsequently reported recurrent pelvic pain and dyspareunia. (Id. at 72, 77.)
Plaintiff has one case-specific expert, Dr. Daniel Elliot. In his report, Dr. Elliot diagnosed Plaintiff with severe pelvic pain, severe pelvic floor myalgia, severe vaginal pain resulting in severe dyspareunia, and vaginal scarring and narrowing (resulting in severe pain). (Doc. 118, Ex. 2 at 15.) Dr. Elliott concluded that these symptoms were a result of the implantation of the Prolift +M in Plaintiff's body and the reaction to the device. (Id. at 15, 17.) Dr. Elliott determined that Plaintiff's chronic pain was not due to a preexisting condition or a spinal issue. (Id. at 15.)
Dr. Elliott further opined that the Prolift +M product was defective due to its risks and complications including, in part:
a. The risk of the mesh causing a host versus implant immune response causing a chronic inflammation reaction resulting in pain and product failure;
b. Risk of chronic foreign body reaction due to the presence of the product;
c. The risk of permanent vaginal or pelvic scarring as a result of the products interaction with the host;
d. The risk of permanent vaginal shortening as a result of the product;
e. The risk of intractable pelvic, vaginal, urethral, and systemic pain and resulting from the products interaction with the body;
f. The severity of complications such as pelvic pain, vaginal pain, and dyspareunia;
g. That Prolift +M devices could cause permanent dyspareunia;
h. That Prolift +M devices could cause permanent vaginal pain; and i. That Prolift +M devices could cause narrowing of the vaginal vault.(Id. at 18-19.)
Dr. Brian Raybon's general expert report explains in detail why he determined that the Prolift +M was defectively designed and that its risks outweigh any benefits. (Doc. 121, Ex. 3 at 3-11.) Dr. Raybon further opined, to a reasonable degree of medical certainty, that the following injuries and complications, among others, are directly attributable to the defective design of the Prolift +M: chronic or permanent pelvic pain or inflammation of tissue surrounding the mesh; pelvic floor muscle spasm; dyspareunia; and vaginal shortening, tightening, stenosis and/or other deformation of the pelvic anatomy. (Id. at 16-17.)
Analysis
To succeed on a strict liability claim for design defect, the plaintiff must satisfy a three-part test: (1) the product is defective and unreasonably dangerous; (2) the defective condition existed at the time it left the defendant's control; and (3) the defective condition is the proximate cause of the plaintiff's injury. Dietz v. Waller, 685 P.2d 744, 747, 141 Ariz. 107, 110 (1984) (quoting Rocky Mountain Fire & Cas. Co. v. Biddulph Oldsmobile, 640 P.2d 851, 854, 131 Ariz. 289, 292 (1982)); Jimenez v. Sears, Roebuck & Co., 904 P.2d 861, 864, 183 Ariz. 399, 402 (1995). A negligence claim requires proof of the same, along with proof that the manufacturer acted unreasonably given a foreseeable risk at the time of design. Golonka, 65 P.3d at 962, 204 Ariz. at 581. Defendants' motion focuses solely on the third factor, causation. Defendants argue that Plaintiff is required to prove causation with expert testimony and that the testimony must establish that a defect, not the product generally, caused her harm.
The Court first examines Plaintiff's argument that she must prove only that the Prolift +M caused her injury, not that a specific defect did so. Plaintiff argues, based on a statement by the Arizona Court of Appeals, that the design defect test is broader than Defendants maintain: “A manufacturer is strictly liable for injuries caused by use of any product that was in a ‘defective condition unreasonably dangerous.'” Golonka, 65 P.3d at 962, 204 Ariz. at 581. Her reliance on Golonka is misplaced. The discussion in Golonka was focused on whether the product was defective and unreasonably dangerous, not the element of causation. Id. Further, the general language in Golonka cannot override the test for strict liability as set forth by the state's supreme court in Deitz and Jimenez, which requires that a plaintiff prove a defect caused her injury. See also Byrns v. Riddell, Inc., 550 P.2d 1065, 1069, 113 Ariz. 264, 268 (1976) (“Plaintiff must also prove the relationship between the defect and the injury.”). Concluding otherwise would allow a plaintiff to recover for a design defect even if her harm was unrelated to the defect; this is closer to imposing absolute liability rather than strict liability. See Brown v. Sears, Roebuck & Co., 136 Ariz. 556, 560, 667 P.2d 750, 754 (Ct. App. 1983) (“Strict liability, however, cannot be equated with absolute liability. . . . Before liability can be fixed, the plaintiff is required to prove . . . that plaintiff's injuries were proximately caused by the defect.”) (citing Morrow v. Trailmobile, Inc., 12 Ariz.App. 578, 473 P.2d 780 (1970)); Johnson v. United States Steel Corp., 192 Cal.Rptr.3d 158, 165 (Ct. App. 2015) (“A manufacturer is not an insurer for all injuries that may result from the use of its product; it is liable for injuries caused by a product defect.”). Following the standard established by the Arizona Supreme Court, Plaintiff must prove she was harmed by a defect in the Prolift +M.
Plaintiff cites several out-of-district cases to support her argument that she must establish only that she was harmed by the product not a specific defect. The law in these states is not identical to Arizona's causation standard. More critically, to the extent the cited cases support her argument, they do so only in dicta. In each case, the court made a general statement that a plaintiff need not identify a specific defect; however, an expert then tied the plaintiff's injury to at least one specific product defect. See Kaiser v. Johnson & Johnson, 334 F.Supp.3d 923, 935 (N.D. Ind. 2018), aff'd, 947 F.3d 996 (7th Cir. 2020); Huskey v. Ethicon, Inc., No. 2:12-CV-05201, 2015 WL 4944339, at *6 (S.D. W.Va. Aug. 19, 2015), aff'd, 848 F.3d 151 (4th Cir. 2017); Cisson v. C.R. Bard, Inc., No. 2:11-CV-00195, 2013 WL 5700513, at *5 (S.D. W.Va. Oct. 18, 2013), aff'd sub nom. In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Sys. Prod. Liab. Litig., 810 F.3d 913 (4th Cir. 2016); Campbell v. Bos. Sci. Corp., No. 2:12-CV-08633, 2016 WL 5796906, at *5 (S.D. W.Va. Oct. 3, 2016), aff'd, 882 F.3d 70 (4th Cir. 2018).
Determining proximate cause typically is a question of fact for a jury. Robertson v. Sixpence Inns Am., Inc., 789 P.2d 1040, 1047, 163 Ariz. 539, 546 (1990). However, Plaintiff must present sufficient evidence from which a juror could determine that causation is “probable” not “merely possible.” Kreisman v. Thomas, 469 P.2d 107, 110, 12 Ariz.App. 215, 218 (1970) (expert testimony that injury “could” or “may” have been caused by something is generally insufficient). Additionally, Arizona law requires expert evidence if “factual issues are outside the common understanding of jurors.” Rossell v. Volkswagen of Am., 167, 709 P.2d 517, 524, 147 Ariz. 160, 167 (1985). Proving causation in this case bears a similarity to a medical malpractice lawsuit, in which expert testimony of the causal connection between a doctor's conduct and the injury typically is required. See Benkendorf v. Advanced Cardiac Specialists Chartered, 269 P.3d 704, 706, 228 Ariz. 528, 530 (Ct. App. 2012) (“To establish the requisite causal connection, the plaintiff's expert is generally required to testify as to probable causes of the plaintiff's injury.”); Barrett v. Harris, 86 P.3d 954, 958, 207 Ariz. 374, 378 (Ct. App. 2004); see also Aguayo v. Indus. Comm'n of Arizona, 333 P.3d 31, 33, 235 Ariz. 413, 415 (Ct. App. 2014) (requiring expert medical testimony because the causal connection between a worker's compensation claimant's spinal condition and industrial injury was not readily apparent); Gentry v. Daugherity, No. CV-13-02136-PHX-ESW, 2015 WL 1346097, at *3 (Mar. 24, 2015) (finding expert testimony as to the “probable” cause of a physical injury arising after a car accident is generally required). Whether a defect in a medical device caused Plaintiff harm is a matter outside a layperson's common understanding. Therefore, expert testimony on this point is required.
Although Plaintiff relies primarily upon two expert reports to establish causation, she argues that she can rely solely upon circumstantial evidence to prove her claim. In support of that argument, she cites three cases, Dietz, 685 P.2d at 746-47, 141 Ariz. at 109-10, Philadelphia Indem. Ins. Co. v. BMW of N. Am. LLC, No. CV-13-01228-PHX-JZB, 2015 WL 5693525, at *16 (D. Ariz. Sept. 29, 2015), and Ruiz v. Otis Elevator, 703 P.2d 1247, 1251, 146 Ariz. 98, 102 (Ct. App. 1985). The discussion of circumstantial evidence in those cases related solely to proof of whether the product at issue was in a defective condition; they did not discuss the use of circumstantial evidence to prove causation, the only issue raised in Defendants' motion. Plaintiff also cites In re: Heparin Prod. Liab. Litig., No. 1953, 2016 WL 2868684, at *6 (N.D. Ohio May 17, 2016) for the proposition that a plaintiff may rely upon an inference in a product liability case. Again, the allowed inference in the Heparin case related solely to establishing a defect not causation. Id. Further, the inference of a defect applied only if the incident “was of a kind that ordinarily occurs as a result of a product defect.” Id. Plaintiff has not attempted to meet this standard.
Plaintiff presented general expert testimony identifying defects in the design of the Prolift +M and injuries those defects can cause, such as chronic pelvic pain, pelvic muscle spasm, dyspareunia, and vaginal stenosis. Further, she relies on specific expert testimony that she has experienced numerous symptoms identified as ones that can be caused by defects in the Prolift +M - severe pelvic pain, severe pelvic floor myalgia, severe vaginal pain resulting in severe dyspareunia, and vaginal scarring and narrowing - and that those symptoms were caused by the Prolift +M. Also, treating physician Dr. Funk testified that the mesh caused Plaintiff's symptoms. Interpreting this evidence in Plaintiff's favor and allowing for an inference of causation, a reasonable person could not find it probable that a defect caused Plaintiff's injury. The evidence that Plaintiff was injured by the mesh raises only the possibility that a defect of the mesh caused her harm. “[M]edical evidence of the possibility of the existence of the causal relationship” could be sufficient if Plaintiff presented “other evidence or circumstances indicating such relationship.” Kreisman, 469 P.2d at 110, 12 Ariz.App. at 218. However, Plaintiff has produced no other evidence upon which a juror could rely to find causation. Because the jury would be left to speculate on causation, summary judgment is warranted. See Robertson, 789 P.2d at 1047, 163 Ariz. at 546 (finding a directed verdict warranted because “reasonable persons could not differ on the inference derived from the evidence.”); see also Salica v. Tucson Heart Hosp.-Carondelet, L.L.C., 231 P.3d 946, 951, 224 Ariz. 414, 419 (Ct. App. 2010) (“A party may prove proximate causation by presenting facts from which a causal relationship may be inferred, but the party cannot leave causation to the jury's speculation.”); Barrett, 86 P.3d at 958, 207 Ariz. at 378.
Several courts recently have reached this same conclusion based on similar factual circumstances. See Lewis v. Johnson & Johnson, 601 Fed.Appx. 205, 210-12 (4th Cir. 2015) (affirming a directed verdict because expert testimony established only that the presence of the medical device, not a defect in the device, caused plaintiff's injury); Ream v. Ethicon, Inc., No. 1:20-CV-00922, 2020 WL 6889238, at *5 (M.D. Pa. Nov. 24, 2020) (granting summary judgment because the expert report did not link a product defect to plaintiff's injuries); Nix v. Ethicon, Inc., No. 1:19-CV-04896-SCJ, 2020 WL 5525172, at *4 (N.D.Ga. Sept. 14, 2020) (granting summary judgment because the case-specific expert did not connect plaintiff's injuries to a product defect); Abt v. Ethicon, Inc., No. 1:20-CV-0047 SRC, 2020 WL 4887022, at *3-4 (E.D. Mo. Aug. 20, 2020) (granting summary judgment because the case-specific expert's conclusion that the defective device caused the injuries was insufficient to link a design defect to the injuries as required for causation); Lampron v. Johnson & Johnson & Ethicon, Inc., No. 20-CV- 317-JD, 2020 WL 3452150, at *4 (D.N.H. June 24, 2020) (granting summary judgment because plaintiff's experts did not opine that a design defect caused her injuries).
In contrast, Plaintiff relies upon one district court case that determined a reasonable person could infer a defect was the probable cause of the plaintiff's harm based on a specific expert's testimony tying her injury to the mesh and a general expert's identification of defects that cause the type of injury she suffered. (Doc. 120 at 7, citing Huskey v. Ethicon, Inc., No. 2:12-CV-05201, 2015 WL 4944339, at *7 (S.D. W.Va. Aug. 19, 2015), aff'd, 848 F.3d 151 (4th Cir. 2017).) The Court does not determine whether the evidence presented in Huskey meets the Arizona causation standard, however, the evidence in that case is unquestionably more specific than that presented by Plaintiff here. In Huskey, the case-specific expert testified that the plaintiff had chronic inflammation and pain caused by her reaction to the mesh. 2015 WL 4944339 at *6. Two general experts testified that the body's response to the polypropylene mesh would be heightened the more of it present in the body. Id. Because the mesh used was heavyweight, the foreign body response, which causes pain and inflammation, would be greater. Id. Based on this evidence, the court concluded it was reasonable and probable to infer that the heavyweight nature of the mesh caused plaintiff's inflammation and pain. Id. at 7. Plaintiff also cites Eghnayem v. Bos. Sci. Corp., No. 1:14-CV-024061, 2016 WL 4051311, at *6-9 (S.D. Fla. Mar. 17, 2016), aff'd, 873 F.3d 1304 (11th Cir. 2017), arguing that the court found the causation evidence sufficient even though no expert identified how a specific design flaw harmed the plaintiff. Again, the evidence in that case was more specific than provided by Plaintiff here. In Eghnayem, the court cited two specific defects identified by experts and concluded that an expert had tied each plaintiffs' injuries to one of those defects. Id.
In contrast to Huskey and Eghnayem, based on the evidence cited by Plaintiff, the Court is unable to relate her injuries to any specific defects. Plaintiff relies on Dr. Raybon's broad testimony that the types of injuries she suffered can be caused by defects in the Prolift +M. As she offers no other evidence for the Court to consider, she fails to establish a defect was the probable cause of her harm. See Gentry, 2015 WL 1346097, at *3 (finding expert testimony of possible causation insufficient absent additional evidence to establish probable causation).
Because Plaintiff's evidence is insufficient for a reasonable juror to conclude that one or more defects in the Prolift +M proximately caused her injuries, Defendants are entitled to summary judgment on her strict liability and negligence design defect claims.
DEFECTIVE PRODUCT (Count IV)
Defendants argue this claim is not cognizable under Arizona law, which recognizes: “[t]hree types of defects can result in an unreasonably dangerous product: (1) design defects, (2) manufacturing defects, and (3) informational defects encompassing instructions and warnings.” Gosewisch, 737 P.2d at 379, 153 Ariz. at 403; Gebhardt v. Mentor Corp., 191 F.R.D. 180, 184 (D. Ariz. 1999), aff'd, 15 Fed.Appx. 540 (9th Cir. 2001). Plaintiff has alleged design defects (Count V) and informational defects (Count III) and does not contend she is raising a defective product claim based on other grounds. However, she argues it is not improper to assert a redundant claim based on the same theories. Because “defective product” is not an independent claim under Arizona law or as alleged by Plaintiff, the Court will grant Defendants summary judgment on Count IV.
NEGLIGENT INFLICTION OF EMOTIONAL DISTRESS (Count X) GROSS NEGLIGENCE (Count XIV)
Defendants argue that “Plaintiff cannot establish the higher burdens of proof to meet the standard for negligent infliction of emotional distress or gross negligence, which require proof of extreme and outrageous conduct.” (Doc. 56 at 7.) Defendant offered no further factual or legal support for their argument. (Id.)
At oral argument, Defendants argued, for the first time, that Plaintiff had no evidence of bodily harm as required for negligent infliction of emotional distress. Because this argument was not included in the motion for summary judgment and Plaintiff had no opportunity to respond to it, the Court will not grant Defendants' motion on this basis.
The Supreme Court has held that a party moving for summary judgment may meet its burden “by ‘showing'-that is, pointing out to the district court-that there is an absence of evidence to support the nonmoving party's case.” Celotex Corp., 477 U.S. at 320, 325 (“petitioner noted that respondent had failed to identify, in answering interrogatories specifically requesting such information, any witnesses who could testify about the decedent's exposure to petitioner's asbestos products.”) However, “a moving party may not require the nonmoving party to produce evidence supporting its claim or defense simply by saying that the nonmoving party has no such evidence.” Nissan Fire & Marine Ins. Co. v. Fritz Companies, Inc., 210 F.3d 1099, 1105 (9th Cir. 2000) (citing Clark v. Coats & Clark, Inc., 929 F.2d 604, 608 (11th Cir. 1991) (“Even after Celotex it is never enough simply to state that the non-moving party cannot meet its burden at trial.”)). Defendants' one sentence argument failed to show the Court that there was an absence of evidence for Plaintiff to prove the claims of gross negligence or negligent infliction of emotional distress.
Further, Defendants' argument - that Plaintiff's claims fails because she is unable to prove the element of extreme and outrageous conduct - is without merit under Arizona law. Extreme and outrageous conduct is a necessary element for intentional infliction of emotional distress. Ford v. Revlon, Inc., 734 P.2d 580, 585, 153 Ariz. 38, 43 (1987). But, it is not a stated element for either negligent infliction of emotional distress, Villareal v. State, Dep't of Transp., 774 P.2d 213, 220, 160 Ariz. 474, 481 (1989) (“Negligent infliction of emotional distress requires that the plaintiff witness an injury to a closely related person, suffer mental anguish that manifests itself as a physical injury, and be within the zone of danger so as to be subject to an unreasonable risk of bodily harm created by the defendant.”), or gross negligence, Badia v. City of Casa Grande, 988 P.2d 134, 141, 195 Ariz. 349, 356 (Ct. App. 1999) (“To establish gross negligence, the claimant essentially must show wanton misconduct that “is flagrant and evinces a lawless and destructive spirit.”). Cf. McBroom v. Ethicon, Inc., No. CV-20-02127-PHX-DGC, 2021 WL 824411, at *5 (D. Ariz. Mar. 4, 2021) (denying summary judgement on negligent infliction of emotional distress claim because the motion was based on an absence of extreme and outrageous conduct evidence).
For both of these reasons, Defendants have failed to establish entitlement to summary judgment on the claims of gross negligence and negligent infliction of emotional distress.
PUNITIVE DAMAGES (Count XVII)
Defendants argue that Arizona law applies to punitive damages but that they are barred in this case based on A.R.S. § 12-689. Because Defendants obtained FDA clearance to market the Prolift +M, they contend punitive damages are barred by statute:
[a] manufacturer, service provider or seller is not liable for exemplary or punitive damages if [t]he product alleged to have caused the harm was designed, manufactured, packaged, labeled, . . . sold, or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.A.R.S. § 12-689(A)(1). The statute's effective date was August 2, 2012. It is undisputed that Plaintiff had the Prolift +M implanted in September 2010, and she first underwent surgery to remove portions of the mesh in July 2012. She initiated this legal action in January 2014.
The statute is not retroactive because it contains no language declaring it to be. A.R.S. § 1-244 (“No statute is retroactive unless expressly declared therein.”). As the Arizona Supreme Court holds, accrual of a right and the filing of a legal action are not synonymous. Hall v. A.N.R. Freight Sys., Inc., 717 P.2d 434, 441, 149 Ariz. 130, 137 (1986). No. court has decided whether A.R.S. § 12-689 applies to a claim that accrued prior to the statute's effective date but was filed subsequent to it. A rule impacting the measure of damages is considered substantive and, once vested, “substantive rights may not be impaired.” Id. at 442-44, 149 Ariz. at 138-40 (citing Bouldin v. Turek, 607 P.2d 954, 955, 125 Ariz. 77, 78 (1979)).
In Hall, the court held, “[w]e believe that a right vests only when it is actually assertable as a legal cause of action or defense.” 717 P.2d at 444, 149 Ariz. at 140. That case addressed the time at which a defense of contributory negligence vested. Because contributory negligence cannot be asserted until a lawsuit is brought against a defendant, the court found it did not vest until the filing date. 717 P.2d at 444, 149 Ariz. at 140.
Plaintiff argues that her rights vested no later than her first mesh removal surgery, in July 2012, when they became assertable in a legal cause of action. Based on the plain language of Hall, the Court agrees with Plaintiff. Plaintiff's right to bring her action vested at the time it accrued, even though she did not file at that time. Defendants disagree, arguing that Plaintiff's rights did not vest until January 2014 when she filed her lawsuit. Their contention is based on the fact that “the right to an award of punitive damages must be grounded upon a cause of action for actual damages.” Quiroga v. Allstate Ins. Co., 726 P.2d 224, 226, 151 Ariz. 127, 129 (Ct. App. 1986). Because Plaintiff had a right to assert a legal action for actual damages by July 2012, her right to seek punitive damages vested at the same time. Thus, Plaintiff's claim for punitive damages vested prior to August 2012, the effective date of A.R.S. § 12-689. Because that statute would impair her right to seek punitive damages it does not apply to her case.
In arguing to the contrary, Defendants rely upon a case from this Court, Triant v. Am. Med. Sys. Inc., No. CV-12-00450-PHX-DGC, 2020 WL 4049844, at *15 (D. Ariz. July 20, 2020). Defendants argue that Triant held the action vested upon the date of filing. Triant did not discuss when a right vested and it did not decide the issue currently before the Court. In that case, the Court held that A.R.S. § 12-689 was not retroactive and, therefore, did not apply because the case was filed prior to the statute's effective date. There is no question that a plaintiff's right to punitive damages vests no later than the filing of her case, the question is whether it may vest prior to that date. This Court concludes that it does pursuant to Hall.
Defendants also cite Ocasio v. C.R. Bard, Inc., No. 8:13-cv-1962-T-36AEP, 2020 WL 3288026, at *2 n.1 (M.D. Fla. June 18, 2020). That decision relied upon an Arizona superior court case, in which the plaintiff suffered an injury and filed legal action after the effective date of A.R.S. § 12-689. See McMahill v. C R Bard Inc, No. CV 2017-000927, 2019 WL 4899720, at *4 (Ariz. Super. July 23, 2019). Based on Hall, that court mentioned that the plaintiff's rights did not vest until he filed the lawsuit. Id. However, because the date of that plaintiff's injury and filing of his lawsuit both occurred after the statute was in effect, the decision did not address the circumstances currently before the Court. Further, this Court disagrees that, under Hall, a plaintiff's rights always would vest upon the filing of a legal action.
The basis for Defendants' motion on punitive damages was that A.R.S. § 12-689 barred Plaintiff from seeking such relief. The Court has found otherwise, therefore, Defendants are not entitled to summary judgment as to punitive damages. In responding to the motion, Plaintiff argued that Defendants were judicially estopped from advocating for application of Arizona law, New Jersey law applied under Arizona's choice of law rules, and Arizona's statutory prohibition on punitive damages did not apply to the facts of her case. Because the Court finds that § 12-689 does not apply pursuant to Hall, it does not reach Plaintiff's other arguments.
This Court would conduct a choice of law analysis only if there were a conflict between Arizona and New Jersey law on punitive damages. See Bryant v. Silverman, 703 P.2d 1190, 1191-92, 146 Ariz. 41, 42-43 (Ariz. 1985) (determining that where interested states' punitive damages laws conflict, the Court must apply the Restatement principles to determine which State has the greater interest in that issue); Restatement (Second) of Conflict of Laws § 1 cmt. b (“If the local law of X and Y differ in relevant respects, the X court may be called upon to decide whether to apply the rules of one state rather than the rules of the other.”); State Farm Mut. Auto. Ins. Co. v. ANC Rental Corp., No. 1 CA-CV 07-0226, 2008 WL 4149006, at *5 (Ariz.Ct.App. Apr. 3, 2008) (declining to choose between two states' laws because they were the same). In their briefing, the parties argued for which state law each believed should be applied but did not identify a conflict between Arizona and New Jersey law on the issue of punitive damages. Implicit to the parties' arguments, however, was the suggestion that punitive damages would be available under New Jersey law but may not be available under Arizona law. At oral argument, Defendants' counsel raised the possibility that punitive damages may be barred by a New Jersey statute. Because it is not necessary to resolving Defendants' motion and this issue was not presented and briefed, the Court does not reach the conflict of law issues or address if punitive damages would be available under New Jersey law.
Finally, Defendants argue they are entitled to summary judgment on the separate count of punitive damages because it does not constitute an independent claim. While the Court agrees it is not a stand-alone cause of action, Defendants have not established that Plaintiff may not seek punitive damages. For that reason, the Court finds Defendants are not entitled to summary judgment on Count XVII.
DISCOVERY RULE AND TOLLING (Count XVIII)
Defendants argue they are entitled to summary judgment on this count because it is not an independent claim. While the Court agrees, Defendants have not established that Plaintiff may not rely upon the discovery rule and tolling. For that reason, the Court finds Defendants are not entitled to summary judgment as to Count XVIII.
RECOMMENDATION
Based on the foregoing, the Magistrate Judge recommends that the District Court enter an order Granting Defendants' Motion for Partial Summary Judgment in part as to Counts II, IV, XI, XII, and XV, and Denying in part as to Counts I (to the extent based on a failure to warn), III, VI, VII, IX, X, XIII, and XIV (Doc. 55). The Magistrate Judge further recommends that the District Court enter an order Granting Defendants' Supplemental Motion for Summary Judgment in part as to Counts I (to the extent based on design defect), and V, and Denying in part as to Counts XVII and XVIII (Doc. 117).
Pursuant to Federal Rule of Civil Procedure 72(b)(2), any party may serve and file written objections within fourteen days of being served with a copy of the Report and Recommendation. A party may respond to the other party's objections within fourteen days. No. reply brief shall be filed on objections unless leave is granted by the District Court. If objections are not timely filed, they may be deemed waived.