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Karnes v. C.R. Bard, Inc.

United States District Court, W.D. Wisconsin

April 16, 2019

C. R. BARD, INC., Defendant.


          WILLIAM M. CONLEY District Judge

         Defendant C. R. Bard (“Bard”) is the manufacturer of the Align-S Suprapubic Urethral Support System (the “Align-S”). Plaintiffs Delinda Karnes and her husband Randy Karnes brought this lawsuit following Delinda's 2015 surgeries, originally to implant and then to remove the Align-S. Plaintiffs allege products liability, negligence, breach of warranty, fraud, loss of consortium and other claims. Pending before this court is defendant's motion to dismiss under Rule 12(b)(6), arguing that all of plaintiffs' claims are time-barred or, alternatively, that some are deficient. For the reasons set forth below, that motion will be granted in part and denied in part.


         A. Background

         The Karneses reside in Wisconsin. Bard is incorporated in New Jersey, which is also where it has its principal place of business. (Compl. (dkt. #1) ¶¶ 2-3.) Bard develops, manufactures, produces and sells medical devices, which it promotes and markets “multinational[ly].” (Id. ¶ 3.) Bard allegedly controls the “largest share of the hernia mesh market.”[2] (Id.) Bard designed, manufactured, packaged, labeled, marketed and sold the Align-S that injured Delinda Karnes. (Id. ¶¶ 9-11, 22, 24-26, 28-31.)

         B. FDA Approval and Warnings about Mesh

         The FDA first approved mesh products -- including transvaginal mesh -- to treat stress urinary incontinence (“SUI”) in 1996. (Id. ¶ 40.) Sometime before 2005, Bard sought and obtained FDA approval to sell the Align-S under 21 U.S.C. § 510(k), because it was “substantially equivalent to a predicate device” marketed before May 29, 1976. (Id. ¶¶ 32-37.) However, the FDA issued a “Safety Communication” on July 13, 2011, warning that (1) “serious complications associated with surgical mesh for transvaginal repair of POP [pelvic organ prolapse] are not rare”; (2) “Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA”; (3) “literature associate[s] mesh contraction with vaginal shortening, vaginal tightening and vaginal pain”; and (4) “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” (Id. ¶¶ 41-44.)

         Contemporaneously with the “Safety Communication, ” the FDA also issued a white paper, titled Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse. (Id. ¶ 45.) The FDA noted in the white paper that it “has NOT seen conclusive evidence that using transvaginally placed mesh in POP repair improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risk, ” warning that mesh products “are associated with serious adverse events, ” which were compounded by “performance data that fail to demonstrate improved clinical benefit over traditional non-mesh repair.” (Id. ¶¶ 46-47.) As a result, the white paper reiterated that the FDA had “serious safety and effectiveness concerns over the use of surgical mesh for the transvaginal repair of pelvic organ prolapse” and advised doctors to “[r]ecognize that in most cases, POP can be treated successfully without mesh.” (Id. ¶¶ 48-49.)

         The complaint goes on to allege that “the FDA assigns a specific ‘device problem' code” to “degradation” and “fragmentation.” (Id. ¶ 54.) More specifically, the FDA allegedly defines: (1) “Material Fragmentation” as an “[i]ssue associated with small pieces of the device breaking off unexpectedly”; and (2) “degradation” as an “[i]ssue associated with a deleterious change in the chemical structure, physical properties, or appearance in the materials that are used in device construction.” (Id.) According to plaintiffs, “the material from which Defendant's products are made is biologically incompatible with human tissue and promotes a negative immune response in a large subset of the population implanted with the[se] products, ” which included Delinda Karnes. (Id. ¶ 52.)

         C. Alleged Defects

         Well before Delinda Karnes' surgery in 2015, plaintiffs further allege that Bard “knew or should have known” of the inherent dangers of the Align-S, including those warned about by the FDA. (Id. ¶¶ 38, 50-51.) Likewise, plaintiffs allege that Bard's “products were unreasonably susceptible to shrinkage and contraction, ” “degradation and fragmentation, ” and “gradual elongation and deformation when subjected to prolonged tension” inside the body. (Id. ¶¶ 54-56.) Despite these risks, plaintiffs allege these products are marketed as being “safe, effective, [and] reliable.” (Id. ¶¶ 57-59.) Plaintiffs go on to allege roughly a dozen, specific product defects: (1) “the use of polypropylene and collagen” that causes “adverse reactions and injuries”; (2) the product's design for insertion in a part of the body with high levels of mesh-adhering bacteria; (3) the product's propensity “to contract or shrink inside the body”; (4) the use of arms and anchors “that can injure major nerve routes”; (5) the product's inelasticity that causes pain with normal movement; (6) the likelihood that the product would degrade or fragment once implanted; (7) collagen-producing, hyper-inflammatory responses following implantation; (8) collagen's propensity to disintegrate after implementation; (9) collagen's adverse tissue reactions; (10) “the harshness of cross linked collagen upon the female pelvic tissue, and the hardening of the product in the body”; and (11) a “non-anatomical condition” causing “chronic pain and functional disabilities” following implantation. (Id. ¶ 60.)

         Finally, plaintiffs also allege that Bard failed to: (1) warn about these and other risks associated with the Align-S; (2) adequately test the effectiveness and safety of the product; (3) adequately train and warn doctors about the product; and (4) design an effective and safe procedure for removal of the mesh. (Id. ¶¶ 61-64, 67.)

         D. Delinda Karnes' Surgeries

         On September 18, 2015, in Eau Claire, Wisconsin, Dr. Michael Hirsh implanted an Align-S in Delinda Karnes to treat pelvic organ prolapse and other symptoms, which the Align-S is designed, marketed and sold to treat. (Id. ¶¶ 19, 23.) The Align-S implanted had the following identifying information: Catalog No. BRD200S, Lot No. HUY10031. (Id. ¶ 19.) At the time implanted, plaintiffs allege that the Align-S was “in the same or substantially similar condition” as when it left Bard's control. (Id. ¶ 68.)

         Following implantation, Delinda “experienced significant mental and physical pain, disability, [and] suffering, ” as well as “permanent injury, and permanent and substantial physical deformity.” (Id. ¶ 39.) Less than two months after implantation, on November 11, 2015, Delinda had the Align-S removed by Dr. Hirsh. (Id. ¶ 20.)

         After both implantation and removal of the Align-S, plaintiffs claim economic harm of lost income and medical expenses, as well as Delinda's need for further medical intervention. (Id. ¶¶ 39, 77.) In addition to those obvious damages from multiple surgeries and complications, plaintiffs claim that the mesh implant “promote[d] a negative immune response, ” which inflamed Delinda's pelvic tissue. (Id. ¶¶ 52-53.) Plaintiffs further claim to have suffered “impaired physical relations during intimacy, and other damages.” (Id. ¶ 39.)


         Defendant seeks dismissal of plaintiffs' claims for failure to state a claim. A motion to dismiss under Rule 12(b)(6) is designed to test the complaint's legal sufficiency. See Fed.R.Civ.P. 12(b)(6). Dismissal is warranted only if no recourse could be granted under any set of facts consistent with the allegations. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 563 (2007). “To survive a motion to dismiss under Rule 12(b)(6), ” a plaintiff must allege sufficient facts to “state a claim for relief that is plausible on its face.” Spierer v. Rossman, 798 F.3d 502, 510 (7th Cir. 2015) (citing Twombly, 550 U.S. at 570).

         As this court has emphasized on numerous occasions, the motion to dismiss phase of proceedings “is not an opportunity for the court to find facts or weigh evidence.” My Health, Inc. v. Gen. Elec. Co., No. 15-CV-80-JDP, 2015 WL 9474293, at *2 (W.D. Wis. Dec. 28, 2015). The court must “tak[e] all factual allegations as true and draw[] all reasonable inferences in favor of the plaintiffs.” Pugh v. Tribune Co., 521 F.3d 686, 692 (7th Cir. 2008). In addition to contending that all of plaintiffs' claims are time-barred, defendant claims the following eight pleading deficiencies: (1) the manufacturing defect claim fails to state a claim under Wisconsin law; (2) the fraudulent concealment claim fails to satisfy the heightened pleading standard of Federal Rule of Civil Procedure 9; (3) the negligent misrepresentation and failure-to-warn claims fail because defendant had no duty to warn under the learned-intermediary doctrine; (4) plaintiffs were not in privity with Bard and did not buy the Align-S directly from it, so their claims for breach of warranties fail to state a claim; (5) plaintiffs' breach of warranty claims are improper because they are asserted with tort claims; (6) plaintiffs cannot establish negligent infliction of emotional distress because there was no physical injury; (7) ...

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