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In re Bard IVC Filters Products Liability Litigation

United States District Court, D. Arizona

June 19, 2018

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. Sherr-Una Booker, an individual, Plaintiff,


          David G. Campbell United States District Judge

         This multidistrict litigation proceeding involves thousands of personal injury cases related to inferior vena cava (“IVC”) filters manufactured and marketed by Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, “Bard”). The case brought by Plaintiff Sherr-Una Booker was selected for one of several bellwether trials. A jury trial was held in March 2018. The jury found in favor of Plaintiff Booker on one of four claims and awarded her $3.6 million in damages.

         Defendants have filed a renewed motion for judgment as a matter of law and a motion for a new trial. Docs. 10879, 10880. The requests for oral argument are denied because the issues have been fully briefed and oral argument will not aid in the Court's decision. For reasons stated below, the motions will be denied.

         I. Background.

         Before surgery in June 2007, Plaintiff was implanted with a Bard G2 IVC filter given her history of blood clots and the risk of experiencing a pulmonary embolism during or after surgery. Seven years later, it was discovered that the G2 filter had tilted, penetrated the IVC wall, and fractured, and that one strut of the filter had migrated to the right atrium of Plaintiff's heart. Subsequent x-rays revealed two other fractured struts and multiple legs perforating the IVC. Plaintiff underwent surgery in July 2014, and the G2 filter and one of the fractured struts in the IVC were removed. During attempts to remove the strut from the heart, however, Plaintiff's tricuspid valve was damaged. Plaintiff had open heart surgery to repair the tricuspid valve and remove the strut from the right atrium. One fractured strut remains embedded in Plaintiff's IVC wall.

         Plaintiff filed suit against Defendants in February 2016, alleging that Bard filters are more dangerous than other IVC filters because they have higher risks of complications, and that Bard failed to warn physicians and patients about these higher risks. Doc. 364; Doc. 1, CV-16-00474-PHX-DGC. She asserted various claims under Georgia law. Id. Four claims were presented to the jury at trial: strict liability design defect, negligent design, strict liability failure to warn, and negligent failure to warn. Id. The jury found Defendants liable on the negligent failure to warn claim and awarded Plaintiff $1.6 million in compensatory damages and $2 million in punitive damages. Docs. 10595, 10596.[1]

         Defendants seek judgment as a matter of law under Federal Rule of Civil Procedure 50, contending that the evidence was insufficient to support the verdict. Doc. 10879. Defendants alternatively seek a new trial pursuant to Rule 59 on the ground that the verdicts on the strict liability and negligent failure to warn claims are inconsistent. Doc. 10880. Plaintiff argues that substantial evidence supports the verdict in her favor. Doc. 11014. She further argues that the verdicts are not inconsistent, that Defendants have waived their challenge to the alleged inconsistency, and that the Court is without authority to order a new trial even if the verdicts are inconsistent. Doc. 1107.

         II. Motion for Judgment as a Matter of Law.

         Rule 50 provides that a court may grant judgment as a matter of law if a party has been fully heard on an issue and the court finds that “a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue[.]” Fed.R.Civ.P. 50(a)(1). The Rule 50 standard mirrors the standard for granting summary judgment under Rule 56 - “the inquiry under each is the same.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250 (1986). In deciding whether to grant a Rule 50 motion, “the court ‘may not make credibility determinations or weigh the evidence.'” E.E.O.C. v. Go Daddy Software, Inc., 581 F.3d 951, 961 (9th Cir. 2009) (quoting Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 149-50 (2000)). Rather, the court “must view the evidence in the light most favorable to the nonmoving party . . . and draw all reasonable inferences in that party's favor.” Reeves, 530 U.S. at 150. The test is “whether the evidence permits only one reasonable conclusion, and that conclusion is contrary to the jury's verdict.” Go Daddy, 581 F.3d at 961 (citation omitted).

         Defendants argue that the evidence presented at trial is insufficient to support the jury's verdict on the negligent failure to warn claim and punitive damages. Doc. 10879 at 2. The Court denied Defendants' initial request for judgment as a matter of law during trial, and denied their earlier motion for summary judgment. Docs. 8874, 10580. The Court continues to conclude that there is sufficient evidence to support a finding in favor of Plaintiff.

         A. Negligent Failure to Warn Claim.

         To establish a negligent failure to warn under Georgia law, “the plaintiff must show the defendant had a duty to warn, the defendant breached that duty and the breach was the proximate cause of the plaintiff's injury.” Wheat v. Sofamor, S. N.C. , 46 F.Supp.2d 1351, 1362 (N.D.Ga. 1999). The duty to warn arises “whenever the manufacturer knows or reasonably should know of the danger arising from the use of its product.” Chrysler Corp. v. Batten, 450 S.E.2d 208, 211 (Ga. 1994). The duty generally is “breached by (1) failing to adequately communicate the warning to the ultimate user or (2) failing to provide an adequate warning of the product's potential risks.” Wilson Foods Corp. v. Turner, 460 S.E.2d 532, 534 (Ga.Ct.App. 1995) (citation omitted).[2]

         Defendants contend that the negligent failure to warn claim fails as a matter of law for three reasons. First, Plaintiff presented no evidence to support the fundamental premise of the claim - that the G2 filter had higher risks of complications than other IVC filters. Doc. 10879 at 3-6. Second, she proposed no alternative warning. Id. at 5. Third, there is insufficient evidence of causation. Id. at 6-8. Plaintiff counters that the evidence presented at trial, when taken as a whole and construed in her favor, is more than sufficient to support the jury's finding that Bard failed to provide an adequate warning to her treating physicians and that this failure was a proximate cause of her injuries. Doc. 11014 at 2-12.

         1. Evidence of an Inadequate Warning.

         Plaintiff presented sufficient evidence for the jury reasonably to find that the G2 filter failed at higher rates than other filters, including Bard's own Simon Nitinol Filter (“SNF”), and that Bard failed to warn Plaintiff's treating physicians about these higher rates. As early as February 2006, less than two months after the G2's launch, Bard had received ten reports of G2 filter migration. Bard performed a health hazard evaluation and concluded that “unlike the literature reports, the migration events with the G2 filter have been associated with a high percentage of caudal migrations accompanied by significant filter tilting and limb displacement.” Doc. 11014-1 at 348 (Trial Ex. 8355). Bard further concluded that the G2's actual failure rate was probably higher than the rate suggested by ten migrations “due to the asymptomatic nature of some of the migration events and because the actual number of G2 filters implanted is very probably less than the number distributed.” Id. at 349. Bard's internal analysis showed that the G2 experienced caudal migration at rates higher than those for the SNF and the G2 filter's predicate device, the Recovery, and that Bard found the risks associated with caudal migration to be “unacceptable.” Id. at 93-119 (Trial Ex. 2248). Further analysis showed that the G2 filter tilted, perforated the IVC, and fractured more often than the Recovery. Id. at 327 (Trial Ex. 2052). The Everest clinical trial, which limited patient follow-up to only six months, showed a G2 filter migration rate of 12%, a tilt rate of 18%, and a penetration rate of 22%. Id. at 192 (Trial Ex. 5290). Bard's review of the Everest study and its internal complaint database showed that 80% of caudal migrations were associated with tilt and penetration, and 43% of fractures were associated with tilt. Id. at 132, 138 (Trial Ex. 1517). One of Bard's leading design engineers testified that the design features of the G2 made it less resistant to caudal migration and this complication could lead to tilting, perforation, and fracture. Id. at 5, 10-12. The jury reasonably could have concluded from this evidence that Bard knew the G2 filter experienced caudal migration at rates higher than other filters and that this type of failure could lead to other complications.

         There was also evidence that Bard failed to warn physicians about the G2 filter's higher complication rates, and that physicians generally would want to know this information when making treatment decisions. The G2 filter's instructions for use (“IFU”) and promotional materials did not warn about higher risk rates or that caudal migration was often associated with other complications. Doc. 11012-1 at 95-98 (Trial Ex. 5283); Doc. 11014-1 at 34 (testimony that the IFU set forth a “laundry list of complications” that did not disclose risk rates and diluted the warnings about the most common and severe complications). Nor did Bard provide this information to its sales force or to physicians directly through “dear doctor” letters. Doc. 11012-1 at 31-32. Two of Plaintiff's experts, Drs. Hurst and Muehrcke, testified that information about higher risks rates and the potential for a cascade of complications is information interventional radiologists generally would want to know when deciding to treat a patient with an IVC filter. Doc. 11014-1 at 22-23, 35-40.

         Defendants assert that they presented the unrebutted testimony of Dr. Grassi that establishes “the norm” for what the medical community knew about adverse events of IVC filters generally. Doc. 10879 at 6. But the jury was free to give little or no weight to Dr. Grassi's testimony (Doc. 10589 at 7), and the Court may not “substitute[] its judgment concerning the weight of the evidence for the jury's.” Reeves, 530 U.S. at 153. Moreover, when construed in Plaintiff's favor, Dr. Grassi's testimony about adverse event rates in the literature does not contradict the evidence that the G2 filter failed at rates higher than other filters and that Plaintiff's treating physicians were not warned about the higher rates.

         Contrary to Defendants' assertion, sufficient evidence supports the jury's finding that Bard failed to provide an adequate warning about the G2 filter's complications and risks.

         2. Alternative Warning.

         Defendants contend that Plaintiff proposed no alternative warnings for the jury to consider when deciding whether the warnings Bard provided about the G2 filter were adequate. Doc. 10879 at 5. Throughout trial, however, Plaintiff made clear that Bard should have warned physicians that the G2 filter failed at rates higher than other filters, and that its propensity to migrate caudally could lead to other complications such as tilt, perforation, and fracture. Both Dr. Hurst and Dr. Muehrcke testified that this information should have been included in the G2 filter's IFU or otherwise provided to physicians. Doc. 11014-1 at 22-23, 35-40.

         Defendants' reliance on Nolley v. Greenlee Textron, Inc., No. 1:06-CV-228-MHS, 2007 WL 5369405, at *7 (N.D.Ga. Dec. 6, 2007), is misplaced. Doc. 11078 at 2-3. The district court in that case concluded that, without expert testimony as to what alternative warnings should have been given, the jury would “have no means by which to adjudge whether the existing warnings were adequate.” Id. at 6 (citing Pineda v. Ford Motor Co., No. 04-3359, 2006 WL 3762015, at *2 (E.D. Pa. Dec.19, 2006)). That is not the situation in this ...

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