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In re Bard IVC Filters Products Liability Litigation

United States District Court, D. Arizona

November 22, 2017

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 (“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 have received implants of Bard IVC filters and claim that they are defective and have caused Plaintiffs to suffer serious injury or death. Plaintiffs assert numerous state law claims and seek both compensatory and punitive damages.

         One of the MDL cases is brought by Plaintiff Sherr-Una Booker, who had a Bard filter implanted ten years ago. Plaintiff's case has been selected as one of several bellwether cases and is set for trial in March 2018. Defendants have filed a motion for partial summary judgment on Plaintiff's claims. Doc. 7456. The motion is fully briefed, and the Court heard oral arguments on November 17, 2017. For reasons set forth below, the Court will grant the motion in part and deny it in part.[1]

         I. Factual Background.

         [The factual background section of this order has been redacted because it sets forth Plaintiff's personal medical information protected from public disclosure under the provisions of HIPPA and orders sealing documents in this case. See Doc. 7787. An unredacted version of this order has been filed under seal. See Doc. 8873.]

         II. Plaintiff's Claims.

         The Court was assigned this MDL in August 2015. Doc. 1. Three months later, the MDL Plaintiffs filed a long-form master complaint that asserts seventeen causes of action. Doc. 303-1. The master complaint alleges that Bard filters, including the G2, were negligently designed and manufactured and are more dangerous than other IVC filters. The complaint further alleges that Defendants concealed adverse information and otherwise failed to warn about increased risks posed by Bard filters. Defendants dispute the allegations of concealment and high risk levels, contending that complication rates associated with Bard filters are low and comparable to those of other IVC filters.

         In her short-form individual complaint filed on February 22, 2016, Plaintiff asserts the following claims under Georgia law: manufacturing defects (Master Complaint Counts I and V), failure to warn (Counts II and VII), design defects (Counts III and IV), failure to recall or retrofit (Count VI), misrepresentation (Counts VIII and XII), negligence per se (Count IX), breach of warranties (Counts X and XI), and punitive damages. Doc. 1, CV-16-00474-PHX-DGC. Plaintiff agreed not to pursue the breach of warranty claims before the present motion was filed. Doc. 7460 at 2 n.1.[2]

         Defendants seek summary judgment on all claims other than design defects. Id. at 1. In her response to Defendants' motion, Plaintiff concedes the insufficiency of her manufacturing defect and failure to recall or retrofit claims. Doc. 8167 at 2 n.1. The Court will grant summary judgment on these claims and the breach of warranty claims.

         The remaining claims on which Defendants seek summary judgment are failure to warn, misrepresentation, negligence per se, and punitive damages. The Court will deny summary judgment on the failure to warn and punitive damages claims and grant summary judgment on the claims for misrepresentation and negligence per se.

         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 appropriate if 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). Only disputes over facts that might affect the outcome of the suit will preclude the entry of 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 of the nonmoving party, however, is to be believed, and all justifiable inferences 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.

         IV. Failure to Warn (Counts II and VII).

         The parties agree that Georgia law applies because the alleged injuries occurred in Georgia and Plaintiff lived there when the complaint was filed. Doc. 7460 at 6. To establish a failure to warn claim 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). “[A] manufacturer has a duty to warn of nonobvious foreseeable dangers from the normal use of its product.” Thornton v. E.I Du Pont de Nemours & Co., 22 F.3d 284, 289 (11th Cir. 1994) (citations omitted). 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.” Thornton, 22 F.3d at 289.

         In cases involving prescription drugs and medical devices, Georgia applies the “learned intermediary” doctrine. Under this doctrine, the manufacturer has no “duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient's doctor, who acts as a learned intermediary between the patient and manufacturer.” McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003) (citing Ellis v. C. R. Bard, Inc., 311 F.3d 1272, 1279-80 (11th Cir. 2002)). The manufacturer's warnings to the physician, however, “must be adequate or reasonable under the circumstances of the case.” Id.

         In this case, the G2 filter's Instructions for Use (“IFU”) were available to Dr. D'Ayala when he decided to implant the filter in Plaintiff, but he did not have information about any increased risks associated with Bard filters. Doc. 7462-2 at 5-6. Plaintiff alleges that the instructions Bard provided failed to adequately warn about the device's known defects and high complication rates, including the filter's propensity to tilt, fracture, and perforate the IVC. See Doc. 303-1 ¶¶ 174-78, 211-16. Plaintiff claims that this failure to warn constitutes a breach of Bard's duty to adequately warn of the dangers presented by its IVC filters, and proximately caused her injuries. Id. ¶¶ 177-81, 215-17. Plaintiff asserts strict liability and negligence claims for the alleged failure to warn. Id. ¶¶ 171-81, 202-09; see Doc. 1 at 3, CV-16-00474-PHX-DGC.

         Defendants contend that the warnings contained in the IFU were adequate as a matter of law because they included the risks of filter movement, fracture, and perforation - the very complications Plaintiff experienced. Doc. 7460 at 9-11. Defendants further contend that proximate cause is lacking because Dr. D'Ayala implanted the G2 filter with knowledge of its potential risks, and there is no evidence that additional warnings would have made him choose a different filter or treatment. Id. at 11-12. For purposes of summary judgment, Defendants do not dispute that Plaintiff has presented evidence that Bard knew its IVC filters had complication rates higher than other filters at the time Plaintiff was implanted with the G2 filter. See Doc. 8167 at 4-7.

         A. Adequacy of the Warnings.

         The IFU for the G2 filter included the following warnings under the bold heading of “Potential Complications”:

. Movement or migration of the filter is a known complication of vena cava filters. This may be caused by placement in IVCs with diameters exceeding the appropriate labeled dimensions specified in the IFU. Migration of filters to the heart or lungs have also been reported in association with improper deployment, deployment into clots and/or dislodgment due to large clot burdens.
. Filter fracture is a known complication of vena cava filters. There have been reports of embolization of vena cava filter fragments resulting in retrieval of the fragment using endovascular and/or surgical techniques. Most cases of filter fracture, however, have been reported without any adverse clinical sequelae.
. Perforation or other acute or chronic damage of the IVC wall.
. All of the above complications have been associated with serious adverse events such as medical intervention and/or death. There have been reports of complications, including death, associated with the use of vena cava filters in morbidly obese patients. The risk/benefit ratio of any of these complications should be weighed against the inherent risk/benefit ratio for a patient who is at risk of pulmonary embolism without intervention.

Doc. 7457-1 at 2.

         Plaintiff concedes that the IFU warned about G2 filters tilting, fracturing, and perforating the IVC, but notes that these complications exist for all IVC filters. Doc. 8167 at 13. Plaintiff argues that the warnings were inadequate because they did not include risk rates or disclose that the risks associated with the G2 filter were higher than those ...

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