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In re Bard IVC Filters Products Liability Litigation

United States District Court, D. Arizona

April 16, 2019

IN RE Bard IVC Filters Products Liability Litigation,
C. R. Bard, Inc., a New Jersey corporation; and Bard Peripheral Vascular, Inc., an Arizona corporation, Defendants. Debra and James Tinlin, a married couple, Plaintiffs,


          David G. Campbell Senior United States District Judge.

         This multidistrict litigation proceeding (“MDL”) involves thousands of personal injury cases brought against Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, “Bard”). Bard manufactures and markets medical devices, including inferior vena cava (“IVC”) filters. The MDL Plaintiffs received implants of Bard IVC filters and claim they are defective and have caused serious injury or death.

         One of the MDL cases is brought by Plaintiff Debra Tinlin. She received a Bard filter fourteen years ago. Her case has been chosen as one of several bellwether cases and is set for trial in May 2019. Defendants have filed a motion for summary judgment. Doc. 15071. The motion is fully briefed. Docs. 15696, 16011. The parties request oral argument, but it will not aid the Court's decision. See Fed. R. Civ. P. 78(b); LRCiv 7.2(f). For reasons stated below, the Court will grant the motion in part and deny it in part.

         I. Background.

         The IVC is a large vein that returns blood to the heart from the lower body. An IVC filter is a device implanted in the IVC to catch blood clots before they reach the heart and lungs. This MDL involves multiple versions of Bard IVC filters - the Recovery, G2, G2X, Eclipse, Meridian, and Denali. They are spider-shaped devices that have multiple limbs fanning out from a cone-shaped head. The limbs consist of legs with elastic hooks that attach to the IVC wall, and bent arms to catch or break up blood clots.

         The MDL Plaintiffs allege that Bard filters are more dangerous than other IVC filters because they have higher risks of tilting, perforating the IVC, or fracturing and migrating to vital organs. Plaintiffs further allege that Bard failed to warn patients and physicians about these higher risks. Defendants dispute these allegations, contending that Bard filters are safe and effective, that their complication rates are low and comparable to those of other IVC filters, and that the medical community is aware of the risks associated with IVC filters.

         II. The Tinlin Plaintiffs.

         Plaintiff Debra Tinlin has a history of deep vein thrombosis and pulmonary emboli. She received a Bard Recovery filter on May 7, 2005. Dr. Joshua Riebe implanted the filter.

         On June 10, 2013, Ms. Tinlin experienced cardiac tamponade after the filter fractured and two struts embolized in the right ventricle of her heart. She had emergency surgery to drain a pericardial effusion. No fractured strut was found during the procedure. She was discharged ten days later.

         On July 31, 2013, a fractured strut was removed through open heart surgery. A chest scan showed several other struts perforating the IVC wall. Subsequent scans revealed multiple fractured struts in the pulmonary arteries. These struts and the filter have not been removed.

         Ms. Tinlin and her husband assert various claims against Bard under Wisconsin law, some of which have been withdrawn.[1] The following claims remain: failure to warn (Counts II and VII), design defect (Counts III and IV), misrepresentation (Counts VIII and XII), concealment (Count XIII), deceptive trade practices (Count XIV), and loss of consortium (Count XV). See Doc. 364 (master complaint); Doc. 1, Case No. CV-16-00263 (short-form complaint).[2]

         Defendants seek summary judgment on the remaining claims and future damages, but not on Plaintiff's request for punitive damages. Doc. 15071 at 2-4. The Court will grant summary judgment on the misrepresentation and deceptive trade practices claims, deny summary judgment on the claims for failure to warn, design defect, concealment, and loss of consortium, and grant summary judgment in part with respect to future damages.

         III. Summary Judgment Standard.

         A party seeking summary judgment “bears the initial responsibility of informing the court of the basis for its motion and identifying those portions of [the record] which it believes demonstrate the absence of a genuine issue of material fact.” Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). Summary judgment is warranted where the moving party “shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). Summary judgment is also appropriate against a party who “fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial.” Celotex, 477 U.S. at 322.

         Only disputes over facts that might affect the outcome of the suit will preclude summary judgment, and the disputed evidence must be “such that a reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). The evidence must be viewed in the light most favorable to the nonmoving party, and all justifiable inferences are drawn in that party's favor because “[c]redibility determinations, the weighing of evidence, and the drawing of inferences from the facts are jury functions[.]” Id. at 255; see Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986)

         III. Failure to Warn Claims (Counts II and VII).

         Plaintiffs assert strict liability and negligent failure to warn claims. See Doc. 364 ¶¶ 171-81, 210-17; Doc. 1 at 3, Case No. CV-16-00263. To establish each claim, Plaintiffs must show, among other things, that the lack of an adequate warning was a cause of their injuries. See Wis. Stat. § 895.047(1)(e) (a plaintiff asserting a strict liability claim must prove that “the defective condition was a cause” of her injuries); Kessel v. Stansfield Vending, Inc., 714 N.W.2d 206, 211 (Wis. Ct. App. 2006) (a plaintiff claiming negligent failure to warn must prove a “causal connection between the defendant's breach of the duty of care and the plaintiff's injury”). “Under Wisconsin law, negligence or defect ‘caused' an injury if it was a substantial factor in producing the injury.” Burton v. Am. Cyanamid, No. 07-CV-0303, 2019 WL 325318, at *2 (E.D. Wis. Jan. 25, 2019); see Sumnicht v. Toyota Motor Sales, U.S.A., 360 N.W.2d 2, 11 (Wis. 1984) (“The long-standing test for cause in Wisconsin is whether the defect was a substantial factor in producing the injury.”); Morgan v. Pa. Gen. Ins., 275 N.W.2d 660, 666 (Wis. 1979) (“The test of cause-in-fact is whether the negligence was a ‘substantial factor' in producing the injury.”); Fandrey v. Am. Family Mut. Ins., 680 N.W.2d 345, 353 (Wis. 2004) (“When Wisconsin courts currently speak of ‘cause,' they do so in the context of the substantial factor test for cause-in-fact.”); see also Wis JI-Civil 1500 (general causation standard).

         Defendants contend that the failure to warn claims fail because Plaintiffs cannot show that an adequate warning would have changed Dr. Riebe's decision to use a Recovery filter for Ms. Tinlin. Doc. 15071 at 3, 7-9. The Court does not agree.[3]

         Defendants note that Dr. Riebe does not recall seeing the Recovery's instructions for use (“IFU”) and does not routinely read IFUs or “dear doctor” letters. Doc. 15071 at 8-9. But “it does not follow that he would have ignored any warnings provided by [D]efendants.” Stevens v. Stryker Corp., No. 12-CV-63-BBC, 2013 WL 12109101, at *6 (W.D. Wis. May 9, 2013). Defendants do not contend that IFUs and “dear doctor” letters are the only avenues by which Bard can provide warnings to physicians. See Doc. 15071 at 9. Dr. Riebe testified that sales representatives for IVC filter manufacturers, including Bard, visited the hospital where he performed surgery and called on him as a customer throughout his practice. Doc. 15702 ¶ 10; see Doc. 15702-1 at 3, 10. Because Bard sales representatives could have personally provided warnings about the Recovery to Dr. Riebe, the fact that he did not read IFUs or “dear doctor” letters does not establish a lack of causation.

         Dr. Riebe testified that he needed complete and accurate information from medical device manufacturers to help him conduct a proper risk-benefit analysis. Doc. 15702-1 at 5. He stated that he would have wanted to know about the Recovery's alleged higher risks of failure, and that Bard did not understand the root causes, did not have a good understanding of the long-term performance of its retrievable filters or the dynamics of the IVC, had placed the Recovery on hold due to migration problems, and internally found the Recovery to have unacceptable risks. Id. at 6-8, 14. This information would have been important for understanding the Recovery's safety and conducting a proper risk-benefit analysis. Id. at 8-9, 19; see Doc. 15701 ¶¶ 17-22. Bard's knowledge that overweight patients tend to have large expansions of their IVCs, if shared with Dr. Riebe, would have helped him select a filter that would have remained in place in Ms. Tinlin. Doc. 15702-1 at 22; see Doc. 15702 ¶ 5.

         A jury reasonably could infer from this evidence that Bard's failure to warn Dr. Riebe about the Recovery's higher risks of failure, Bard's lack of knowledge about the root causes, and the Recovery's known migration problems in overweight patients was a substantial factor in Dr. Riebe's decision to choose a Recovery for Ms. Tinlin. See Burton v. Am. Cyanamid, 334 F.Supp.3d 949, 967 (E.D. Wis. 2018) (denying summary judgment where the jury could draw “the permissible inference . . . that the persons responsible for selecting [the product] would have heeded warnings regarding the risk . . . if such warnings had been issued”); Stevens, 2013 WL 12109101, at *6 (finding a triable issue with respect to causation even though the physician generally did not rely on information he received from the defendants when he decided to use their medical device); Forst, 602 F.Supp.2d at 969 (a jury could rely on the prescribing physician's testimony that the lack of warning about the drug's increased risk for suicide prevented him from doing a proper risk-benefit analysis in concluding that his decision to prescribe would have changed); Michaels v. Mr. Heater, Inc., 411 F.Supp. 992, 1007 (W.D. Wis. 2006) (denying summary judgment where the jury reasonably could find that the failure to provide adequate warnings was a substantial factor in causing the plaintiff's injuries).[4]

         Defendants contend that because Dr. Riebe had no involvement in selecting the IVC filters used at his hospital, and never suggested that any filter other than a Recovery could have been used for Ms. Tinlin, no reasonable inference can be drawn that he would have selected a different filter regardless of what warning Bard provided. Doc. 15071 at 9. But Dr. Riebe testified that he often would switch to a Cook Bird's Nest filter for patients with large IVCs. Doc. 15702-1 at 25; see Doc. 15702 ¶ 5.

         Defendants have not shown, as a matter of undisputed fact, that their alleged failure to warn was not a cause of Plaintiffs' injuries. The Court will deny ...

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