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In re Bard IVC Filters Products Liability Litigation

United States District Court, D. Arizona

March 12, 2018

IN RE Bard IVC Filters Products Liability Litigation,
v.
C. R. Bard, Inc., a New Jersey corporation; and Bard Peripheral Vascular, Inc., an Arizona corporation, Defendants. Doris Jones and Alfred Jones, Sr., a married couple, Plaintiffs,

          ORDER

          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.

         The case brought by Doris and Alfred Jones has been selected as one of several bellwether cases and is set for trial in May 2018. Defendants have filed a motion for partial summary judgment. Doc. 7351. The motion is fully briefed, and the parties agree that oral argument is not necessary. For reasons set forth below, the Court will grant the motion in part and deny it in part.[1]

         I. Background.

         The IVC is a large vein that returns blood to the heart from the lower body. An IVC filter is a small metal device implanted in the IVC to catch blood clots before they reach the heart and lungs. This MDL involves seven different versions of Bard IVC filters - the Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali. They are spider-like 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 curved arms that serve to catch or break up blood clots. Each of these filters is a variation of its predecessor.

         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 physicians and patients about these higher risks. Plaintiffs assert a host of state law claims and seek both compensatory and punitive damages. Defendants dispute Plaintiffs' 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. Plaintiffs Doris and Alfred Jones.

         In August 2010, before gastrointestinal surgery, Doris Jones was implanted with an Eclipse filter due to recurrent deep vein thrombosis. Dr. Anthony Avino implanted the filter without incident. In April 2015, Mrs. Jones went to the emergency room with complaints of lightheadedness and arm pain. A chest scan revealed a fractured filter limb that had embolized in the right pulmonary artery. The filter was removed but the fractured limb remains in place.

         Mrs. Jones and her husband assert various claims under Georgia law, some of which have been withdrawn. The following claims remain: failure to warn (Counts II and VII), design defects (Counts III and IV), misrepresentation (Counts VIII and XII), negligence per se (Count IX), fraudulent concealment (Count XIII), consumer fraud and unfair trade practices (Count XIV), loss of consortium (Count XV), and punitive damages. See Doc. 364 (master complaint); Doc. 1, CV-16-00782-PHX-DGC (short-form complaint).[2]

         Defendants seek summary judgment on the failure to warn, misrepresentation, negligence per se, consumer fraud and unfair trade practices, and punitive damages claims. Doc. 7351 at 3. Plaintiffs concede that summary judgment is proper on the consumer fraud and unfair trade practices claim. Doc. 7943 at 2 n.1. The Court will grant summary judgment on that claim and the misrepresentation and negligence per se claims. The Court will deny summary judgment on the failure to warn and punitive damages claims.[3]

         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 must be viewed in the light most favorable to the nonmoving party, Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986), 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, ” Anderson, 477 U.S. at 255.

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

         Georgia law applies in this case because the alleged injuries occurred in Georgia and Plaintiffs lived there when their complaint was filed. Doc. 7351 at 5; Doc. 1 ¶¶ 4-6, CV-16-00782-PHX-DGC. To establish a failure to warn claim under Georgia law, “the plaintiff must show that 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). 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 may be breached in two ways: “(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 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, Plaintiffs allege that Bard failed to adequately warn physicians about the known defects and higher complication rates associated with Bard filters. Doc. 364 ¶¶ 174-78, 211-16. Plaintiffs claim that this failure constitutes a breach of Bard's duty to warn and proximately caused their injuries. Id. ¶¶ 177-81, 215-17. Plaintiffs assert strict liability and negligence claims for the alleged failure to warn. Id. ¶¶ 171-81, 202-09; see Doc. 1 at 3, CV-16-00782-PHX-DGC.

         Defendants contend that proximate cause is lacking because Dr. Avino did not read the Eclipse filter's instructions for use (“IFU”) and had actual knowledge of the risk of fracture. Doc. 7351 at 6-7. Defendants further contend that the warnings provided with the Eclipse filter were adequate because they included the complication experienced by Mrs. Jones. Id. at 8-11. The Court will address each argument.

         A. Causation.

         1. Failure to Read the Eclipse IFU.

         Defendants rely on Wilson Foods Corp. v. Turner, 460 S.E.2d 532, 534 (Ga.Ct.App. 1995), for the proposition that “failure to read product instructions . . . will prevent a plaintiff from recovering on a claim grounded on failure to provide adequate warning of the products' potential risk.” Doc. 7351 at 6. Defendants contend that Dr. Avino did not read the Eclipse IFU before implanting the device in Mrs. Jones, and Plaintiffs therefore cannot show that any warning inadequacy proximately caused their injuries. Id.

         But the duty to warn is breached not only by having a deficient warning, but also by “failing to adequately communicate the warning to the ultimate user.” Thornton, 22 F.3d at 289. Indeed, Wilson makes clear that failure to read instructions “‘does not bar recovery where the plaintiff is challenging the adequacy of the efforts of the manufacturer or seller to communicate the dangers of the product to the buyer or user.'” 460 S.E.2d at 534 (quoting Thornton, 22 F.3d at 290). Plaintiffs bring such a challenge in this case.

         Plaintiffs claim that the instructions contained in the IFU were inadequate, and that Bard otherwise failed to communicate sufficient warnings to physicians. Specifically, Plaintiffs allege that Bard breached its duty to warn by not “providing instructions for safe use” or “communicating the information and dangers” about Bard filters to physicians. Doc. 364 ¶¶ 181, 216. Plaintiffs note that medical device warnings are provided in various ways, including “dear doctor” letters, product pamphlets, and statements by the company sales representatives. Doc. 7943 at 14 (citing Allen v. Belinfante, 458 S.E.2d 867, 869 (Ga.Ct.App. 1995) (assessing doctor's awareness of “dear doctor” letters and other sources of information about potential risks in determining liability for failure to warn claim)); see PLIVA, Inc. v. Mensing, 564 U.S. 604, 615 (2011) (noting that manufacturers provide warnings through dear doctor letters).

         Given Plaintiffs' claim that Bard breached its duty to warn by failing to adequately communicate warnings to physicians through means other than IFUs, the fact that Dr. Avino may not have read the Eclipse IFU is not dispositive on causation. See Jones v. Amazing Prods., Inc., 231 F.Supp.2d 1228, 1247 (N.D.Ga. 2002) (“A plaintiff's failure to read a warning will not . . . bar recovery as to the first prong of the test: namely, where the plaintiff is challenging the adequacy of the defendant's efforts to communicate the dangers of the product to the user[.]” (citing Wilson, 460 S.E.2d at 534)); In re Stand ‘n Seal Prods. Liab. Litig., No. 1:07MD1804-TWT, 2009 WL 2145911, at *6 (N.D.Ga. July 15, 2009) (denying summary judgment where the plaintiffs did not read the warning label but claimed that the manufacturer's efforts to communicate the dangers were inadequate (citing Wilson)); Mizell v. Pilgrim's Pride Corp., No. CV 509-064, 2012 WL 130056600, at *5 (S.D. Ga. Mar. 14, 2012) (finding the failure to read a warning not dispositive where the plaintiff challenged the manufacturer's communication of the warning (citing Wilson)); In re Seroquel Prods. Liab. Litig., No. 6:06-md-1769-Orl-22DAB, 2007 WL 4117201, at *2 (M.D. Fla. Nov. 6, 2007) (denying summary judgment where the plaintiffs alleged that the ...


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