Bailey v. Ethicon Inc.
| Decision Date | 12 July 2021 |
| Docket Number | CV-20-00457-TUC-JAS (LCK) |
| Parties | Diane Michelle Bailey, Plaintiff, v. Ethicon Incorporated, et al., Defendants. |
| Court | U.S. District Court — District of Arizona |
REPORT AND RECOMMENDATION
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.
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).[1]
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.
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.
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.
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...
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