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Barraza v. C. R. Bard Inc.

United States District Court, D. Arizona

September 11, 2017

Maria E. Barraza, et al., Plaintiffs,
C. R. Bard Inc., and Bard Peripheral Vascular Inc., Defendants.


          David G. Campbell United States District Judge.

         Plaintiffs Maria E. Barraza and others bring this case against Defendants C.R. Bard, Inc. and Bard Peripheral Vascular Inc. (collectively, “Bard”) seeking medical monitoring. Plaintiffs sue on behalf of themselves and classes of individuals who have been implanted with a Bard inferior vena cava filter, have not had that filter removed, and have not filed a claim or lawsuit for personal injury related to the filter. Doc. 57-2 at 36-41, ¶ 206. Plaintiffs have filed a motion for class certification. Doc. 54. The motion is fully briefed, and the Court heard oral arguments on August 21, 2017. Docs. 54, 72, 78, 94.[1] For reasons that follow, the Court will deny Plaintiffs' motion.

         I. Background.

         The inferior vena cava (“IVC”) is a large vein that carries de-oxygenated blood from the lower body to the heart. This case concerns seven of Defendants' IVC blood filters that were manufactured and marketed starting in 2003 for either permanent or temporary use. Doc. 54-1 at 9.[2] IVC filters are small devices placed in the IVC to stop blood clots from travelling to the lungs. The Bard IVC filters at issue in this case are the Recovery®, G2®, G2® Express, G2®X, Eclipse®, Meridian®, and Denali® filters. Doc. 72 at 9.

         Plaintiffs allege that these filters have defects that put users at an unacceptable risk of serious injury or death. Id. at 5-6. Plaintiffs contend that the Bard filters tilt, perforate the IVC, and fracture and migrate to neighboring organs such as the heart and lungs. Id. Fractures can occur without notice or symptoms until serious physical injury or death occurs. Id. Plaintiffs cite a wide range of medical sources and Bard documents to support their claim that Bard IVC filters are more dangerous than other kinds of IVC filters. Doc. 54-1 at 5-20.

         Defendants dispute Plaintiffs' allegation of high risk levels, contending that the overall complication rates associated with Bard IVC filters are low. Doc. 72 at 11. Defendants note that there are many IVC blood filters on the market, that all of these products involve risks that physicians and patients must consider when deciding whether the patient's medical condition warrants the implant of a blood filter, and that failure rates for Bard filters are comparable to those of other IVC filters. Defendants contend that the various warnings cited by Plaintiffs - issued by the FDA and other professional groups - apply to all blood filters, not just Bard filters. Id. at 9-11.

         Although the FDA and various medical organizations have recommended monitoring of all patients with IVC filters, physicians follow-up with such patients at relatively low rates. Doc. 54-1 at 16-19; Doc. 72 at 10. Removals of IVC filters, even those intended to be temporary, also occur at low rates. Id. Each of the Plaintiffs and proposed class members currently have Bard filters implanted in their IVC's, and bring this action to obtain medical monitoring to reduce the risk presented by such filters. This Court currently is presiding over a multidistrict litigation proceeding (MDL) involving more than 2, 500 personal injury cases arising out of Bard filters. This class action involves many of the same attorneys and has been following a coordinated litigation track with the MDL, but is otherwise separate.

         Plaintiffs filed their motion for class certification on June 5, 2017, after almost a year of class-related discovery and expert disclosures. Docs. 22, 54. The motion recognized that only 16 states permit claims for medical monitoring, and sought certification of a single class that includes filter recipients who reside in those states:

Plaintiffs move to certify a class covering each of the states that allow medical monitoring as a cause of action or remedy. The proposed class is defined to include all individuals in the sixteen jurisdictions that allow medical monitoring without manifest physical injury, who have been implanted with a Bard retrievable filter since July 25, 2003 (the date Bard received clearance to market the first of its filters as retrievable) to the present, who have not had their filters removed (and are at least ninety days post-implant), and who have not filed a personal injury lawsuit concerning their Bard filter.

Doc. 54-1 at 21.

         The motion recognizes that this case includes only 11 named Plaintiffs from 11 of the 16 states, but asserted that these individuals could represent persons from the five states that have no named Plaintiff. Id. at 23 n.20. To demonstrate the feasibility of this class and a trial that encompasses all 16 states, Plaintiffs presented a trial plan which asserts that the elements of medical monitoring claims are the same in all 16 states. Id. at 37-69. Plaintiffs identify these common elements: (1) exposure, (2) to a toxic substance or hazard, (3) which exposure was caused by Defendants' negligence or tortious conduct, (4) resulting in an increased risk of a serious illness or injury, (5) for which a medical test for early detection exists, (6) is reasonably necessary, and (7) is beyond that which is offered in the ordinary course. Id. at 27.

         Defendants responded to this proposed class, noting significant differences among the laws of the 16 states to be included in the proposed class. Doc. 72-8. Defendants made other arguments regarding the suitability of the proposed class under Rule 23.

         Things changed significantly at the class certification hearing. Plaintiffs' counsel stated that they were not seeking certification of a single class for all 16 states, but instead were seeking certification of 16 separate classes, one for each state that allows medical monitoring claims. Doc. 94 at 50-51. Plaintiffs stated that they had provided the Court with a single trial plan because they seek a consolidated trial of all 16 classes, and they believe the Court could give a single set of jury instructions that blended the laws of the 16 states.[3] When it was noted that 5 of the 16 states have no class representative, Plaintiffs' counsel argued that the Court could certify the classes for these 5 states without a class representative. Id. at 74. When this proposition was challenged - the Court noted that Rule 23(a) cannot be satisfied without a class representative - Plaintiffs' counsel changed tack again, stating that “[w]e are only asking that you certify the states at this time where we have identified a rep. If the Court does certify those states, we would ask for leave to add additional reps in the states that don't have reps at the moment.” Id. at 74-75. This was Plaintiff's final position, and the one the Court will address in this order.[4]

         Thus, Plaintiffs seek certification of classes consisting of persons with Bard filters in the following 11 states: Arizona, California, Colorado, Florida, Illinois, Maryland, Massachusetts, Missouri, Ohio, Pennsylvania, and West Virginia. Each of these classes is represented by a single named Plaintiff.[5]

         II. Class Certification.

         Under Rule 23(a), a district court may certify a class only if (1) it is so numerous that joinder of all members is impractical, (2) there are questions of law or fact common to the class, (3) the claims of the representative parties are typical of the claims of the class, and (4) the representatives will fairly and adequately protect the interests of the class. Fed.R.Civ.P. 23(a)(1)-(4). For reasons explained later in this order, the Court finds that the named Plaintiffs are not typical of the class members. The other requirements of Rule 23(a) are satisfied.

         The Court must also find that one of the requirements of Rule 23(b) has been met. Plaintiffs seek class certification under both Rule 23(b)(2) and 23(b)(3). Doc. 54. Rule 23(b)(2) permits certification if “the party opposing the class has acted or refused to act on grounds generally applicable to the class, thereby making appropriate final injunctive relief or corresponding declaratory relief with respect to the class as a whole.” Fed. R. Civ. P 23(b)(2). Rule 23(b)(3) provides that class certification is appropriate if questions of law or fact common to the class predominate over questions affecting only individual class members, and if a class action would be superior to other available methods for resolving the controversy. Fed.R.Civ.P. 23(b)(3).

         The Court must rigorously analyze the proposed classes to ensure they comport with Rule 23. See Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338, 351 (2011).

         A. Rule 23(b)(3).

         1. Predominance.

         “The Rule 23(b)(3) predominance inquiry tests whether proposed classes are sufficiently cohesive to warrant adjudication by representation.” Amchem Prods., Inc. v. Windsor, 521 U.S. 591, 623 (1997); accord In re Wells Fargo Home Mortg. Overtime Pay Litig., 571 F.3d 953, 957 (9th Cir. 2009). “This calls upon courts to give careful scrutiny to the relation between common and individual questions in a case.” Tyson Foods, Inc. v. Bouaphakeo, 136 S.Ct. 1036, 1045 (2016).

         “Considering whether ‘questions of law or fact common to class members predominate' begins, of course, with the elements of the underlying cause of action.” Erica P. John Fund, Inc. v. Halliburton Co., 563 U.S. 804, 809 (2011). Plaintiffs argue that medical monitoring claims in all the relevant jurisdictions have the following elements: (1) exposure, (2) to a toxic substance or hazard, (3) which exposure was caused by the defendant's negligence or tortious conduct, (4) resulting in an increased risk of a serious illness or injury, (5) for which a medical test for early detection exists, (6) is reasonably necessary, and (7) is beyond that which is offered in the ordinary course. Doc. 54-1 at 27. The Court will focus on these elements in deciding whether common or individual issues predominate in the proposed classes.[6]

         a. Elements One & Two: Exposure to a Toxicity or Hazard.

         The first two elements of the medical monitoring claim - exposure to a toxic substance or hazard - will not produce significant individual issues. Defendants do not dispute that the named Plaintiffs each have been implanted with Bard IVC filters, nor that thousands of additional individuals currently carry such filters. Thus, unlike a case where exposure to toxic substances might require individualized proof, exposure to Bard filters exists for each person who has received such a filter. Although proof that class members received Bard filters would be required during the claim phase if the classes were certified and successful, that fact could be established with relative ease in an administrative process.

         With respect to the alleged hazards of Bard filters, Plaintiffs intend to make their case through generalized evidence of failure rates, FDA warnings, expert testimony, and other common evidence. Defendants will respond with similar general evidence. Defendants do not contend that individual issues will predominate on this element.

         b. Element Three: Negligence and Causation.

         To satisfy the third element, Plaintiffs must show that they face an increased risk of injury and require monitoring because of Defendants' negligence in designing the filters and failing to warn of their risks. Doc. 54-1 at 28.[7] Plaintiffs argue that they can establish this element with class-wide law and evidence - whether Defendants owed a duty to Plaintiffs is a question of law that will not vary among class members, and whether Defendants were negligent in designing and marketing the filters will be decided on the basis of Defendants' actions, not individual issues.

         Defendants disagree. They assert that Plaintiffs' proof of negligence will raise a wide range of issues. The classes include seven different Bard filters manufactured and marketed at different times over the course of more than 15 years. Doc. 72 at 20-21. Defendants contend that the design processes and warnings for these filters varied across kinds of filters and over time, as did Defendants' knowledge concerning the risks associated with the filters. Id. (citing Doc. 74-4, Exhibit 11).

         i. Design and Testing Issues.

         Each of Plaintiffs' proposed state classes includes all seven of the Bard filters at issue in this case. Plaintiffs allege that each of the filters was negligently designed. Trial of each of the classes will therefore include the design history and risks of each of these seven filters. And these facts must be evaluated in the context of what was reasonable at the time each filter was designed and marketed. See, e.g., Muller v. Synthes Corp., No. 99 C 1492, 2002 WL 460827, at *7 (N.D. Ill. Mar. 26, 2002) (to prove negligent design under Illinois law, the plaintiff must show that the defendant deviated from the standard of care that other manufactures of similar products followed at the time the relevant product was designed). In at least some of the states, proof of negligent design requires consideration of safer alternatives or the state of the art at the time the filter was designed or first sold.[8] See, e.g., A.R.S. 12-683(1) (a defendant shall not be liable in a product liability case if “[t]he defect in the product is alleged to result from inadequate design or fabrication, and if the plans or designs for the product or the methods and techniques of manufacturing, inspecting, testing and labeling the product conformed with the state of the art at the time the product was first sold by the defendant.”). Thus, the Court and the jury will need to consider the design of each filter.

         The seven Bard IVC filters were introduced to the market in the following years: Recovery® in 2002 for permanent use and 2003 for retrievable use; G2® in 2005 for permanent use and 2008 for retrievable use; G2® Express and G2®X in 2008; Eclipse® in 2010; Meridian® in 2011; and Denali® in 2013. Doc. 74-4. Each of these filters was a variation of earlier generations, but with several changes. Id. For example, the G2® filter had the following changes from the Recovery® filter: (1) increased hook wire diameter of approximately 24%; (2) increased nominal leg span of 25%; (3) increased nominal arm length of approximately 50%; (4) curved instead of straight arm tips; and (5) increased radius of curvature on arms at the sleeve. Doc. 74-4 at 8.

         The G2® Express and G2®X filters had the following changes from earlier versions: (1) modification of the filter tip to include a snare tip to allow retrievability with commercially available snares; (2) the snarable tip was electropolished instead of having a machine polished straight tip with no snare; and (3) the filter height was greater with the addition of a snarable tip. Id. at 13.

         The Eclipse® filter was introduced with these changes over prior versions: the nitinol wire used to form the arms and legs was electropolished prior to filter assembly and annealing. Id. at 14. The Meridian® filter added to alternating filter arms (1) a “shoulder anchor” made out of titanium alloy tube with an in-line anchor tip to improve caudal movement/migration resistance, and (2) a “wrist anchor” made out of titanium alloy tube with an offset anchor tip to improve caudal movement/migration resistance. Id. at 15.

         The Denali® filter included these modifications: (1) fabricated differently; (2) different leg spans; (3) different arm spans; (4) different unconstrained height; (5) staggered leg lengths; (6) four instead of six legs with cranial anchors; (7) addition of caudal anchors to two filter legs; (8) addition of penetration limiter on each filter leg; and (9) electropolished following filter assembly. Id. at 17.

         The various generations of Bard filters also underwent separate testing. For example, the Recovery® filter underwent bench testing of clot trapping efficiency, migration resistance, hook strength, radial strength, weld integrity, creep study of filter hooks, EnduraTEC fatigue testing, simulated use, rotating-beam corrosion fatigue testing, optimum welding parameters, wire tensile test, and finite element analyses. Id. at 4. The Recovery® filter also underwent the following animal studies: in-vivo evaluation for permanent indication and early removal, and in-vivo evaluation for long-term removal indication. Id. at 5. A clinical study was conducted by Dr. Murray Asch, who investigated the safety and effectiveness of the Recovery® filter in approximately 60 patients. Id. Other tests were performed for other generations of filters. See Doc. 74-4.

         Plaintiffs allege that structural and manufacturing differences between the filters are insignificant and that tests on the various filters were deficient. They note that the filters were approved by the FDA through the § 510(k) clearance process, not the FDA's more onerous pre-market approval process for new devices. See 21 C.F.R. § 807.87, 807.92, 807.93 (2012). But even in the face of these arguments, there are still design, manufacturing, and testing differences between the various generations of Bard filters that would need to be addressed at trial. Whether the manufacturing changes and product tests were sufficient to ensure the safety of the filters is hotly contested and would be decided by the trier of fact, but only in the context of seven generations of filters with differing specifications and testing histories. And for states that require a comparison to the state of the art, the design and manufacturing standards for blood filters generally would also have to be considered for each year.

         ii. Failure to Warn Issues.

         The Recovery® filter was approved by the FDA for permanent use in November 2002 and for retrievable use in July 2003. Doc. 74-4 at 5. Bard's “instructions for use” included the following warnings:

Migration of the filter. This may be caused by placement in oversized vena cava diameters exceeding 28 mm or if proper anchoring techniques are not utilized.
Perforation of the vena cava wall. This may occur if improper insertion technique is not utilized.
Caval occlusion. The probability of this occurring should be weighed against the inherent risk/benefit ratio for a patient who is experiencing pulmonary embolism, or who is likely to do so without intervention.


         In October 2003, the warnings were revised to include this language:

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.
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 been reported in association with improper deployment, deployment into clots and/or dislodgment due to large clot burdens.
Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during or after the procedure. Possible complications include, but are not limited to, the following: Movement or migration of the filter is a known complication of vena cava filters. . . . Filter fracture is a known complication of vena cava filters. . . . Perforation or other acute or chronic damage of the IVCwall; Acute or recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombi passed through the filter, or originated from superior or collateral vessels; Caval thrombosis/occlusion; Extravasation of contrast material at time of venacavogram; Air embolism; Hematoma or nerve injury at the puncture site or subsequent retrieval site; Hemorrhage; Restriction of blood flow; Occlusion of small vessels; Distal embolization; Infection; Intimal tear; Stenosis at implant site. All these above complications have been associated with serious adverse events such as medical intervention and/or death. 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.

Id. at 6-8. Bard also sent letters to doctors in December 2004 or January 2005 alerting them to these revised instructions for use. Id. at 8.

         The G2® filter was approved by the FDA for retrievable use in 2008. The instructions for use included these warnings:

There have been reports of complications, including death, associated with the use of vena cava filters in morbidly obese patients.
* * *
NOTE: It is possible that complications such as those described in the ‘Warnings, Precautions, and Potential Complications' section of this Instructions for Use may affect the recoverability of the device and result in the ...

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