Barraza et al v. C R Bard Incorporated et al

Filing 95

ORDER denying 54 Motion to Certify Class. FURTHER ORDERED granting 57 Motion to Amend. The Clerk is directed to accept for filing document lodged as Doc. 58 in this case. FURTHER ORDERED granting 68 Motion to Exclude. FURTHER ORDERED The Court will hold a telephone conference with counsel on 9/29/17 at 1:00 p.m., to discuss future proceedings in this case. Counsel for Plaintiffs shall initiate a conference call to include counsel for all parties and the Court. If a dial-in number is used, the dial-in information shall be provided to the Court and all parties no later than 9/28/17 at 4:00 PM. Signed by Judge David G Campbell on 9/11/17.(MAP)

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1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA 8 9 Maria E. Barraza, et al., 10 Plaintiffs, 11 ORDER v. 12 No. CV16-01374-PHX-DGC C. R. Bard Inc., and Bard Peripheral Vascular Inc., 13 Defendants. 14 15 16 Plaintiffs Maria E. Barraza and others bring this case against Defendants C.R. 17 Bard, Inc. and Bard Peripheral Vascular Inc. (collectively, “Bard”) seeking medical 18 monitoring. Plaintiffs sue on behalf of themselves and classes of individuals who have 19 been implanted with a Bard inferior vena cava filter, have not had that filter removed, and 20 have not filed a claim or lawsuit for personal injury related to the filter. Doc. 57-2 at 36- 21 41, ¶ 206. Plaintiffs have filed a motion for class certification. Doc. 54. The motion is 22 fully briefed, and the Court heard oral arguments on August 21, 2017. Docs. 54, 72, 78, 23 94.1 For reasons that follow, the Court will deny Plaintiffs’ motion. 24 I. Background. 25 The inferior vena cava (“IVC”) is a large vein that carries de-oxygenated blood 26 from the lower body to the heart. This case concerns seven of Defendants’ IVC blood 27 1 28 Some portions of these documents have been redacted. Unredacted versions have been filed under seal. In some places, this order cites to sealed documents without identifying the sensitive information that resulted in their being sealed. 1 filters that were manufactured and marketed starting in 2003 for either permanent or 2 temporary use. Doc. 54-1 at 9.2 IVC filters are small devices placed in the IVC to stop 3 blood clots from travelling to the lungs. The Bard IVC filters at issue in this case are the 4 Recovery®, G2®, G2® Express, G2®X, Eclipse®, Meridian®, and Denali® filters. 5 Doc. 72 at 9. 6 Plaintiffs allege that these filters have defects that put users at an unacceptable risk 7 of serious injury or death. Id. at 5-6. Plaintiffs contend that the Bard filters tilt, perforate 8 the IVC, and fracture and migrate to neighboring organs such as the heart and lungs. Id. 9 Fractures can occur without notice or symptoms until serious physical injury or death 10 occurs. Id. Plaintiffs cite a wide range of medical sources and Bard documents to 11 support their claim that Bard IVC filters are more dangerous than other kinds of IVC 12 filters. Doc. 54-1 at 5-20. 13 Defendants dispute Plaintiffs’ allegation of high risk levels, contending that the 14 overall complication rates associated with Bard IVC filters are low. Doc. 72 at 11. 15 Defendants note that there are many IVC blood filters on the market, that all of these 16 products involve risks that physicians and patients must consider when deciding whether 17 the patient’s medical condition warrants the implant of a blood filter, and that failure 18 rates for Bard filters are comparable to those of other IVC filters. Defendants contend 19 that the various warnings cited by Plaintiffs – issued by the FDA and other professional 20 groups – apply to all blood filters, not just Bard filters. Id. at 9-11. 21 Although the FDA and various medical organizations have recommended 22 monitoring of all patients with IVC filters, physicians follow-up with such patients at 23 relatively low rates. Doc. 54-1 at 16-19; Doc. 72 at 10. Removals of IVC filters, even 24 those intended to be temporary, also occur at low rates. Id. Each of the Plaintiffs and 25 proposed class members currently have Bard filters implanted in their IVC’s, and bring 26 this action to obtain medical monitoring to reduce the risk presented by such filters. This 27 28 2 Page citations are to numbers placed at the top of each page by the Court’s CM/ECF electronic filing system rather than the document’s original page numbers. -2- 1 Court currently is presiding over a multidistrict litigation proceeding (MDL) involving 2 more than 2,500 personal injury cases arising out of Bard filters. This class action 3 involves many of the same attorneys and has been following a coordinated litigation track 4 with the MDL, but is otherwise separate. 5 Plaintiffs filed their motion for class certification on June 5, 2017, after almost a 6 year of class-related discovery and expert disclosures. 7 recognized that only 16 states permit claims for medical monitoring, and sought 8 certification of a single class that includes filter recipients who reside in those states: 9 10 11 12 13 14 Docs. 22, 54. The motion 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. 15 16 Doc. 54-1 at 21. 17 The motion recognizes that this case includes only 11 named Plaintiffs from 11 of 18 the 16 states, but asserted that these individuals could represent persons from the five 19 states that have no named Plaintiff. Id. at 23 n.20. To demonstrate the feasibility of this 20 class and a trial that encompasses all 16 states, Plaintiffs presented a trial plan which 21 asserts that the elements of medical monitoring claims are the same in all 16 states. Id. at 22 37-69. Plaintiffs identify these common elements: (1) exposure, (2) to a toxic substance 23 or hazard, (3) which exposure was caused by Defendants’ negligence or tortious conduct, 24 (4) resulting in an increased risk of a serious illness or injury, (5) for which a medical test 25 for early detection exists, (6) is reasonably necessary, and (7) is beyond that which is 26 offered in the ordinary course. Id. at 27. 27 28 -3- 1 Defendants responded to this proposed class, noting significant differences among 2 the laws of the 16 states to be included in the proposed class. Doc. 72-8. Defendants 3 made other arguments regarding the suitability of the proposed class under Rule 23. 4 Things changed significantly at the class certification hearing. Plaintiffs’ counsel 5 stated that they were not seeking certification of a single class for all 16 states, but 6 instead were seeking certification of 16 separate classes, one for each state that allows 7 medical monitoring claims. Doc. 94 at 50-51. Plaintiffs stated that they had provided the 8 Court with a single trial plan because they seek a consolidated trial of all 16 classes, and 9 they believe the Court could give a single set of jury instructions that blended the laws of 10 the 16 states.3 When it was noted that 5 of the 16 states have no class representative, 11 Plaintiffs’ counsel argued that the Court could certify the classes for these 5 states 12 without a class representative. Id. at 74. When this proposition was challenged – the 13 Court noted that Rule 23(a) cannot be satisfied without a class representative – Plaintiffs’ 14 counsel changed tack again, stating that “[w]e are only asking that you certify the states 15 at this time where we have identified a rep. If the Court does certify those states, we 16 would ask for leave to add additional reps in the states that don’t have reps at the 17 moment.” Id. at 74-75. This was Plaintiff’s final position, and the one the Court will 18 address in this order.4 19 20 21 22 23 24 25 26 27 28 3 This proposal, although not important in light of the Court’s ruling in this order, makes no sense. If a class is governed by California law (setting aside individual class member choice of law issues, as discussed below), the Court must instruct the jury using California law, not some hybrid version of the law that the Court develops by combining California with the laws of other states. See Matter of Rhone-Poulenc Rorer, Inc., 51 F.3d 1293, 1300 (7th Cir. 1995) (“If one instruction on negligence will serve to instruct the jury on the legal standard of every state of the United States applicable to a novel claim, . . . one wonders what the Supreme Court thought it was doing in the Erie case when it held that it was unconstitutional for federal courts in diversity cases to apply general common law rather than the common law of the state whose law would apply if the case were being tried in state rather than federal court.”) (emphasis in original). 4 The Court will not allow Plaintiffs to amend their complaint to name class representatives for the five proposed classes that lack named plaintiffs. Plaintiffs had months to seek such amendments, and did in fact change named Plaintiffs several times. Adding new Plaintiffs now would require the class discovery period (see Doc. 22) to start over, would prejudice Defendants, and would thwart the schedule the Court has sought to follow in this case and the related MDL. -4- 1 Thus, Plaintiffs seek certification of classes consisting of persons with Bard filters 2 in the following 11 states: Arizona, California, Colorado, Florida, Illinois, Maryland, 3 Massachusetts, Missouri, Ohio, Pennsylvania, and West Virginia. Each of these classes 4 is represented by a single named Plaintiff.5 5 II. Class Certification. 6 Under Rule 23(a), a district court may certify a class only if (1) it is so numerous 7 that joinder of all members is impractical, (2) there are questions of law or fact common 8 to the class, (3) the claims of the representative parties are typical of the claims of the 9 class, and (4) the representatives will fairly and adequately protect the interests of the 10 class. Fed. R. Civ. P. 23(a)(1)-(4). For reasons explained later in this order, the Court 11 finds that the named Plaintiffs are not typical of the class members. 12 requirements of Rule 23(a) are satisfied. The other 13 The Court must also find that one of the requirements of Rule 23(b) has been met. 14 Plaintiffs seek class certification under both Rule 23(b)(2) and 23(b)(3). Doc. 54. Rule 15 23(b)(2) permits certification if “the party opposing the class has acted or refused to act 16 on grounds generally applicable to the class, thereby making appropriate final injunctive 17 relief or corresponding declaratory relief with respect to the class as a whole.” Fed. R. 18 Civ. P 23(b)(2). Rule 23(b)(3) provides that class certification is appropriate if questions 19 of law or fact common to the class predominate over questions affecting only individual 20 class members, and if a class action would be superior to other available methods for 21 resolving the controversy. Fed. R. Civ. P. 23(b)(3). 22 23 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). 24 25 5 26 27 28 At the end of this order, the Court addresses and grants a motion to amend the complaint to modify the relief sought by Plaintiffs, and to make other modest changes to the class definition. Doc. 57. The Court will address the motion for class certification in light of these amendments. The Court also grants a motion to exclude two of Plaintiffs’ expert reports. Doc. 68. The Court enters this order without considering those experts reports, but the Court would not have reached a different conclusion even if they were considered. -5- 1 A. 2 Rule 23(b)(3). 1. Predominance. 3 “The Rule 23(b)(3) predominance inquiry tests whether proposed classes are 4 sufficiently cohesive to warrant adjudication by representation.” Amchem Prods., Inc. v. 5 Windsor, 521 U.S. 591, 623 (1997); accord In re Wells Fargo Home Mortg. Overtime 6 Pay Litig., 571 F.3d 953, 957 (9th Cir. 2009). “This calls upon courts to give careful 7 scrutiny to the relation between common and individual questions in a case.” Tyson 8 Foods, Inc. v. Bouaphakeo, 136 S. Ct. 1036, 1045 (2016). 9 “Considering whether ‘questions of law or fact common to class members 10 predominate’ begins, of course, with the elements of the underlying cause of action.” 11 Erica P. John Fund, Inc. v. Halliburton Co., 563 U.S. 804, 809 (2011). Plaintiffs argue 12 that medical monitoring claims in all the relevant jurisdictions have the following 13 elements: (1) exposure, (2) to a toxic substance or hazard, (3) which exposure was caused 14 by the defendant’s negligence or tortious conduct, (4) resulting in an increased risk of a 15 serious illness or injury, (5) for which a medical test for early detection exists, (6) is 16 reasonably necessary, and (7) is beyond that which is offered in the ordinary course. 17 Doc. 54-1 at 27. The Court will focus on these elements in deciding whether common or 18 individual issues predominate in the proposed classes.6 19 a. Elements One & Two: Exposure to a Toxicity or Hazard. 20 The first two elements of the medical monitoring claim – exposure to a toxic 21 substance or hazard – will not produce significant individual issues. Defendants do not 22 dispute that the named Plaintiffs each have been implanted with Bard IVC filters, nor that 23 thousands of additional individuals currently carry such filters. Thus, unlike a case where 24 6 25 26 27 28 Both parties dedicated significant portions of their briefing to whether these elements were truly representative of the law in all of the states, with Defendants arguing that there were significant differences among the various state laws that would defeat class certification. Because Plaintiffs took the position during oral argument that they do not seek to certify a single multi-state class, but instead seek eleven classes covering specific states, differences among state laws will not affect predominance. The Court normally would look to the law of each state to identify the elements of the claim and address predominance, but the Court concludes that such detail is unnecessary. Even using Plaintiffs’ seven elements, individual issues will predominate. -6- 1 exposure to toxic substances might require individualized proof, exposure to Bard filters 2 exists for each person who has received such a filter. Although proof that class members 3 received Bard filters would be required during the claim phase if the classes were 4 certified and successful, that fact could be established with relative ease in an 5 administrative process. 6 With respect to the alleged hazards of Bard filters, Plaintiffs intend to make their 7 case through generalized evidence of failure rates, FDA warnings, expert testimony, and 8 other common evidence. 9 Defendants do not contend that individual issues will predominate on this element. 10 b. Defendants will respond with similar general evidence. Element Three: Negligence and Causation. 11 To satisfy the third element, Plaintiffs must show that they face an increased risk 12 of injury and require monitoring because of Defendants’ negligence in designing the 13 filters and failing to warn of their risks. Doc. 54-1 at 28.7 Plaintiffs argue that they can 14 establish this element with class-wide law and evidence – whether Defendants owed a 15 duty to Plaintiffs is a question of law that will not vary among class members, and 16 whether Defendants were negligent in designing and marketing the filters will be decided 17 on the basis of Defendants’ actions, not individual issues. 18 Defendants disagree. They assert that Plaintiffs’ proof of negligence will raise a 19 wide range of issues. The classes include seven different Bard filters manufactured and 20 marketed at different times over the course of more than 15 years. Doc. 72 at 20-21. 21 Defendants contend that the design processes and warnings for these filters varied across 22 kinds of filters and over time, as did Defendants’ knowledge concerning the risks 23 associated with the filters. Id. (citing Doc. 74-4, Exhibit 11). 24 25 26 27 28 7 Plaintiffs’ counsel clarified during oral argument that they allege injury resulting only from Defendants’ negligence. Failure to warn and design defect are the alleged bases for Defendants’ negligence, but Plaintiffs are not asserting any separate failure to warn or design defect claims. -7- 1 i. Design and Testing Issues. 2 Each of Plaintiffs’ proposed state classes includes all seven of the Bard filters at 3 issue in this case. Plaintiffs allege that each of the filters was negligently designed. Trial 4 of each of the classes will therefore include the design history and risks of each of these 5 seven filters. And these facts must be evaluated in the context of what was reasonable at 6 the time each filter was designed and marketed. See, e.g., Muller v. Synthes Corp., No. 7 99 C 1492, 2002 WL 460827, at *7 (N.D. Ill. Mar. 26, 2002) (to prove negligent design 8 under Illinois law, the plaintiff must show that the defendant deviated from the standard 9 of care that other manufactures of similar products followed at the time the relevant 10 product was designed). In at least some of the states, proof of negligent design requires 11 consideration of safer alternatives or the state of the art at the time the filter was designed 12 or first sold.8 See, e.g., A.R.S. 12-683(1) (a defendant shall not be liable in a product 13 liability case if “[t]he defect in the product is alleged to result from inadequate design or 14 fabrication, and if the plans or designs for the product or the methods and techniques of 15 manufacturing, inspecting, testing and labeling the product conformed with the state of 16 the art at the time the product was first sold by the defendant.”). Thus, the Court and the 17 jury will need to consider the design of each filter. 18 The seven Bard IVC filters were introduced to the market in the following years: 19 Recovery® in 2002 for permanent use and 2003 for retrievable use; G2® in 2005 for 20 permanent use and 2008 for retrievable use; G2® Express and G2®X in 2008; Eclipse® 21 in 2010; Meridian® in 2011; and Denali® in 2013. Doc. 74-4. Each of these filters was 22 a variation of earlier generations, but with several changes. Id. For example, the G2® 23 filter had the following changes from the Recovery® filter: (1) increased hook wire 24 diameter of approximately 24%; (2) increased nominal leg span of 25%; (3) increased 25 nominal arm length of approximately 50%; (4) curved instead of straight arm tips; and 26 (5) increased radius of curvature on arms at the sleeve. Doc. 74-4 at 8. 27 8 28 For ease of explanation, the Court will discuss the required proof and affirmative defenses using only one or two jurisdictions as examples. Defendants provide a chart of the law in each of the relevant states. See Doc. 72-8. -8- 1 The G2® Express and G2®X filters had the following changes from earlier 2 versions: (1) modification of the filter tip to include a snare tip to allow retrievability 3 with commercially available snares; (2) the snarable tip was electropolished instead of 4 having a machine polished straight tip with no snare; and (3) the filter height was greater 5 with the addition of a snarable tip. Id. at 13. 6 The Eclipse® filter was introduced with these changes over prior versions: the 7 nitinol wire used to form the arms and legs was electropolished prior to filter assembly 8 and annealing. Id. at 14. The Meridian® filter added to alternating filter arms (1) a 9 “shoulder anchor” made out of titanium alloy tube with an in-line anchor tip to improve 10 caudal movement/migration resistance, and (2) a “wrist anchor” made out of titanium 11 alloy tube with an offset anchor tip to improve caudal movement/migration resistance. 12 Id. at 15. 13 The Denali® filter included these modifications: (1) fabricated differently; 14 (2) different leg spans; (3) different arm spans; (4) different unconstrained height; 15 (5) staggered leg lengths; (6) four instead of six legs with cranial anchors; (7) addition of 16 caudal anchors to two filter legs; (8) addition of penetration limiter on each filter leg; and 17 (9) electropolished following filter assembly. Id. at 17. 18 The various generations of Bard filters also underwent separate testing. 19 example, the Recovery® filter underwent bench testing of clot trapping efficiency, 20 migration resistance, hook strength, radial strength, weld integrity, creep study of filter 21 hooks, EnduraTEC fatigue testing, simulated use, rotating-beam corrosion fatigue testing, 22 optimum welding parameters, wire tensile test, and finite element analyses. Id. at 4. The 23 Recovery® filter also underwent the following animal studies: in-vivo evaluation for 24 permanent indication and early removal, and in-vivo evaluation for long-term removal 25 indication. 26 investigated the safety and effectiveness of the Recovery® filter in approximately 60 27 patients. Id. Other tests were performed for other generations of filters. See Doc. 74-4. Id. at 5. For A clinical study was conducted by Dr. Murray Asch, who 28 -9- 1 Plaintiffs allege that structural and manufacturing differences between the filters 2 are insignificant and that tests on the various filters were deficient. They note that the 3 filters were approved by the FDA through the § 510(k) clearance process, not the FDA’s 4 more onerous pre-market approval process for new devices. See 21 C.F.R. § 807.87, 5 807.92, 807.93 (2012). But even in the face of these arguments, there are still design, 6 manufacturing, and testing differences between the various generations of Bard filters 7 that would need to be addressed at trial. Whether the manufacturing changes and product 8 tests were sufficient to ensure the safety of the filters is hotly contested and would be 9 decided by the trier of fact, but only in the context of seven generations of filters with 10 differing specifications and testing histories. And for states that require a comparison to 11 the state of the art, the design and manufacturing standards for blood filters generally 12 would also have to be considered for each year. 13 ii. Failure to Warn Issues. 14 The Recovery® filter was approved by the FDA for permanent use in November 15 2002 and for retrievable use in July 2003. Doc. 74-4 at 5. Bard’s “instructions for use” 16 included the following warnings: 17 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. 18 19 Perforation of the vena cava wall. This may occur if improper insertion technique is not utilized. 20 21 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. 22 23 24 25 26 27 28 Id. 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. - 10 - 1 2 3 4 5 6 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. 7 8 9 10 11 12 13 14 15 16 17 18 19 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. 20 Id. at 6-8. Bard also sent letters to doctors in December 2004 or January 2005 alerting 21 them to these revised instructions for use. Id. at 8. 22 23 24 25 26 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. *** 27 28 NOTE: It is possible that complications such as those described in the ‘Warnings, Precautions, and Potential Complications’ section of this - 11 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Instructions for Use may affect the recoverability of the device and result in the clinician’s decision to have the device remain permanently implanted. Id. at 10. The instructions were revised in July 2009 to include the following statement, in bold type: Note: Standards and guidelines developed by the Society of Interventional Radiologists recommend that patients with filters (either permanent or retrievable) be tracked and receive “routine follow-up” subsequent to the placement of the device. See Reporting Standards for Inferior Vena Caval Filter Placement and Patient Follow-Up: Supplement for Temporary and Retrievable/Optional Filters. Millward, S., et al.: J. Vasc Interv Radiol 2005; 16:441-443; Recommend Reporting Standards for Vena Cava Filter Placement and Patient Followup. The Participants in the Vena Caval Filter Consensus Conference: J Vasc Inter Radiol 2003; 14:S427-S432; Guidelines for the Use of Retrievable and Convertible Vena Cava Filters: Report from the Society of Interventional Radiology Multidisciplinary Consensus Conference. Kaufman, J., et al.: J Vasc Interv Radiol 2006; 17:449-459. Id. at 11. Later versions of Bard filters at issue in this case contained additional warnings. For example, the Meridian® filter’s 2011 warnings included this language in bold type: FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from [pulmonary embolism] is no longer needed. FDA encourages all physicians involved in treatment and followup of IVC filter recipients to consider the risks and benefits of filter removal for each patient. Id. at 16-17. 24 Plaintiffs contend that Bard’s warnings were inadequate and incomplete. But 25 these examples show that the trial for each class would need to assess the warnings in 26 place at a particular time for the particular filter implanted in each class member. Trial of 27 a single class representative’s claim would not suffice because the representative would 28 have received a different filter with different warnings than many members of the class. - 12 - 1 iii. Affirmative Defenses. 2 Class members would also be subject to affirmative defenses that turn on 3 individual factual allegations. Plaintiffs contend that affirmative defenses should not be 4 considered when determining whether individual issues will predominate, but they cite no 5 authority for this assertion in their briefing or oral argument. While it is true that the 6 mere existence of affirmative defenses “does not compel a finding that individual issues 7 predominate over common ones,” Williams v. Sinclair, 529 F.2d 1383, 1388 (9th Cir. 8 1975), such defenses cannot be ignored when making a predominance decision. “[A] 9 class cannot be certified on the premise that [the defendant] will not be entitled to litigate 10 its . . . defenses to individual claims.” 11 individualized nature of affirmative defenses requires that courts consider such defenses 12 in undertaking the predominance analysis.” See Newberg on Class Actions § 4:55 (5th 13 ed. 2017); see also S. Gensler, Federal Rules of Civil Procedure, Rules and Commentary 14 at 533 (2016) (“The court must determine what impact, if any, the affirmative defenses 15 will have on the mix of common versus individualized issues[.]”); Myers v. Hertz Corp., 16 624 F.3d 537, 551 (2d Cir. 2010) (“[T]here is no reason the district court ought to have 17 given the ‘defense’ less weight in determining whether overall class certification would 18 serve the goals of the predominance requirement. [W]hile it is well established that the 19 existence of a defense potentially implicating different class members differently does 20 not necessarily defeat class certification, it is equally well established that courts must 21 consider potential defenses in assessing the predominance requirement.”) (citations 22 omitted; emphasis in original); Valenzuela v. Union Pac. R.R. Co., No. 15-1092-PHX- 23 DGC, 2016 WL 679095 at *14 (D. Ariz. 2016) (considering affirmative defenses in 24 predominance analysis); In re Orthopedic Bone Screw Prods. Liab. Litig., No. CIV. A. 25 93-7074, 1995 WL 273597, at *11 (E.D. Pa. Feb. 22, 1995) (acknowledging that Rule 26 23(b)(3) certification was not appropriate in part because defendants asserted defenses 27 that differ dramatically from one plaintiff to the next). Dukes, 564 U.S. at 367. 28 - 13 - “The potentially 1 Defendants assert various affirmative defenses. Doc. 9 at 20-35; Doc. 72 at 27-29. 2 For example, the eleven relevant states each recognize assumption of the risk, or 3 comparative or contributory negligence, as defenses to negligence that either negate or 4 reduce a defendant’s liability. Doc. 72-8; see, e.g., Franklin v. Clemett, 382 P.3d 802, 5 807 (Ariz. Ct. App. 2016) (recognizing assumption of the risk and contributory 6 negligence as defenses under Arizona law; the presence and effect of these defenses on 7 liability must be left to the jury). Additionally, most of the jurisdictions recognize the 8 learned intermediary defense, albeit with some differences. Compare Watts v. Medicis 9 Pharm. Corp., 365 P.3d 944, 948, 949 (Ariz. 2016) (“a learned intermediary (the 10 prescribing physician) who received an adequate warning regarding a drug’s side effects 11 or proper use but unforeseeably disregarded the warning constituted an intervening, 12 superseding event that broke the chain of causation between the manufacturer and the 13 patient[,]” but the doctrine does not apply “if the manufacturer fails to provide adequate 14 warning to the learned intermediary”), and Small v. Amgen, Inc., 134 F. Supp. 3d 1358, 15 1367 (M.D. Fla. 2015) (recognizing that the learned intermediary doctrine applies to 16 claims of negligent failure to warn under Florida law, and finding that “the failure of the 17 manufacturer to provide the physician with an adequate warning is not the proximate 18 cause of a patient’s injury if the prescribing physician had independent knowledge of the 19 risk that an adequate warning should have communicated”).9 20 As a result, to decide liability, the jury would need to consider what each class 21 member and her treating physicians knew about the risks associated with the relevant 22 Bard filters and when they knew it. Plaintiffs cite evidence showing that the FDA and 23 other organizations, as well as expert medical literature, have called for monitoring of 24 patients with embedded blood filters. Doc. 54-1 at 17-19. These sources advocate timely 25 removal of IVC filters. Id. But it is likely that at least some of the class members’ 26 27 28 9 Plaintiffs’ counsel contended during oral argument that “downstream” conduct by Plaintiffs and their physicians should not impact the “upstream” tortious conduct of Bard. But many of these affirmative defenses go to the question of liability, a plainly “upstream” consideration. Plaintiffs offered no support for their argument that principles of comparative and contributory negligence, assumption of risk, and the learned intermediary doctrine should not apply to their claims. - 14 - 1 treating physicians were aware of these warnings. Indeed, some class members were 2 aware of the risks as well. For example, testimony shows that at least one named plaintiff 3 was advised to have his filter removed in 2005, but declined to do so and did not follow 4 up with any medical providers. Doc. 74-1 at 9. A former named plaintiff allegedly 5 ignored no less than five letters from her implanting physician requesting clinical follow- 6 up regarding removal of her filter. Doc. 74-2 at 16. While this individual was replaced 7 as a class representative, she serves as an example of the individual circumstances of 8 each class member that would need to be considered in assessing issues of comparative or 9 contributory negligence and assumption of risk. Moreover, evidence suggests that other 10 named plaintiffs did not follow up with their physicians after being advised to do so or to 11 have their filters removed. Doc. 74-1 at 2-8; 74-2 at 16.10 12 Plaintiffs contend that these affirmative defenses “do not undercut the case-critical 13 predominant issues of risk and need for monitoring, as many of them only apply to either 14 failure to warn (learned intermediary) or negligent design (proof of safer alternative; 15 risk/benefit analysis) claims.” Doc. 78 at 15 n.12, 18. But there are two problems with 16 this argument. 17 First, Plaintiffs’ negligence claims are based on failure to warn and negligent 18 design. Although Plaintiffs’ say in their briefing that their claims are “not so limited” 19 (Doc. 78 at 15), they identify no other basis for their negligence claims.11 20 Second, the classes cannot be certified simply because Plaintiffs allegedly face a 21 common risk and need medical monitoring. Tortious conduct by Defendants is required 22 23 24 25 10 Defendants allege various other affirmative defenses, such as judicial estoppel. Doc. 72 at 28 & n.35 (contending that named plaintiff Barraza’s claim should be barred by judicial estoppel – an affirmative defense unique to Barraza’s claim – because she failed to disclose her lawsuit in her bankruptcy petition). 11 26 27 28 Plaintiffs’ reply brief provides this explanation of other grounds for their negligence claim: “Opening Br. at 7 (noting that Bard never shared with doctors or patients their internal assessment that their filters were associated with a significant increase in deaths compared to SNF) (citing Ex. 6 (Kessler Rep.)); and 8 (‘Bard conceded internally that “now that we have more experience with Recovery the position of tiltresistance should probably be down played”’) (citing Ex. 8)).” Doc. 78 at 15. But both of these examples appear to be failures to warn. - 15 - 1 for medical monitoring claims in all the relevant jurisdictions. The fact that Plaintiffs 2 face a common risk and require medical monitoring to reduce that risk is not sufficient to 3 state a claim for relief; Plaintiffs must also show that Defendants were negligent and 4 caused Plaintiffs’ increased risk. And it is in proving negligence that individual issues 5 will proliferate. Filter-by-filter inquiries into design and manufacturing defects will be 6 required; at each step, the state of the art must be examined; failures to disclose will vary 7 from year to year and filter to filter; the knowledge possessed by each class member’s 8 physician must be established to resolve the learned intermediary defense; and each class 9 member’s knowledge of the risk and response to suggestions of removal or medical 10 monitoring will be needed to resolve defenses of assumption of the risk and contributory 11 or comparative negligence. In short, common issues will not predominate on the third 12 element of medical monitoring. 13 c. Element Four: Increased Risk. 14 Plaintiffs contend that they will establish the fourth element – increased risk – for 15 all class members by “present[ing] common evidence, based on the medical literature and 16 expert opinion, on the common increased risks of each filter, the modest changes from 17 filter to filter, and how those modest changes do not mitigate those risks.” Doc. 78 at 19. 18 Plaintiffs cite heavily to medical literature and expert opinion concerning the heightened 19 health risks allegedly caused by all seven of the relevant Bard IVC filters. 20 21 Defendants contend that establishing increased risk will require individualized proof for two reasons. 22 First, Defendants contend that “[u]nlike medical monitoring for toxic exposure, 23 the increased risk in the medical device context is measured against the risks from 24 exposure to a non-defective filter, rather than exposure to no filter at all.” Doc. 72 at 26. 25 Defendants cite no authority for this proposition. And even if it is true, Defendants 26 present no reason to conclude that this comparison could not be made through common 27 evidence. 28 - 16 - 1 Second, Defendants argue that Plaintiffs “will actually need to quantify the 2 increased risk of injury for each individual class member to be entitled to medical 3 monitoring.” Id. at 27. But Defendants cite cases concerning levels of exposure to toxic 4 substances that are common in the environment. See, e.g., Exxon Mobil Corp. v. Ford, 5 71 A.3d 105, 132-33 (Md. 2013). 6 disputed – each class member is 100% exposed to the IVC filter in his or her body. 7 Plaintiffs contend that the filters create an increased risk of adverse health consequences, 8 a fact they intend to prove by common expert evidence. The Court does not find that 9 individual issues will predominate on this issue. 10 d. This case is different. The level of exposure is not Elements Five, Six, and Seven. 11 Defendants do not appear to dispute that Plaintiffs can show the fifth element with 12 common evidence – that a medical test exists for early detection of filter-related medical 13 problems. They do, however, contest that Plaintiffs can show by common evidence that 14 their proposed medical monitoring is necessary for all class members (element six) and 15 different from the ordinary course of treatment for those class members (element seven). 16 Cases have held that element six – the necessity of the proposed monitoring 17 scheme – raises individual issues. Plaintiffs cite no contrary authority. See In re St. Jude 18 Med., Inc., 425 F.3d 1116, 1122 (8th Cir. 2005) (“Every patient in the 17-state class who 19 has ever been implanted with a mechanical heart valve already requires future medical 20 monitoring as an ordinary part of his or her follow-up care. A patient who has been 21 implanted with the Silzone valve may or may not require additional monitoring, and 22 whether he or she does is an individualized inquiry depending on that patient’s medical 23 history, the condition of the patient’s heart valves at the time of implantation, the 24 patient’s risk factors for heart valve complications, the patient’s general health, the 25 patient’s personal choice, and other factors.”); Barnes v. Am. Tobacco Co., 161 F.3d 127, 26 146 (3d Cir. 1998) (“In order to state a claim for medical monitoring, each class member 27 must prove that the monitoring program he requires is ‘different from that normally 28 recommended in the absence of exposure.’ To satisfy this requirement, each plaintiff - 17 - 1 must prove the monitoring program that is prescribed for the general public and the 2 monitoring program that would be prescribed for him.”) (citation and footnote omitted). 3 Similarly, cases have held that element seven – whether a particular plaintiff’s 4 ordinary course of treatment would include the monitoring sought in this case – presents 5 individualized issues. See Lewallen v. Medtronic USA, Inc., No. C 01-20395 RMW, 6 2002 WL 31300899, at *4 (N.D. Cal. Aug. 28, 2002) (“[A]ssuming that there has been an 7 increased need for medical monitoring, each individual plaintiff would only be able to 8 recover to the extent of that increase. Whatever monitoring was expected as a[] part of 9 the anticipated course of treatment would not be recoverable, again a particularly 10 individualized inquiry.”); Lockheed Martin Corp. v. Super. Court, 63 P.3d 913, 924-25 11 (Cal. 2003) (“First, determining the extent of monitoring required by each class member 12 absent exposure poses a highly individualized inquiry. . . . Second, determining whether 13 each class member requires additional monitoring due to exposure requires individual 14 litigation of numerous and substantial questions. A class member’s need for additional 15 monitoring hinges on the particular traits or characteristics of each class member.”). 16 Here, the amount of monitoring a class member would require in the normal 17 course of her treatment and illness, without the monitoring sought in this case, is an 18 individualized inquiry into the medical needs and ongoing course of treatment for each 19 class member. For example, testimony from the named plaintiffs shows that not all class 20 members may need or would benefit from the proposed monitoring. One named plaintiff 21 was told that a CT scan would not be capable of showing the filter position due to his 22 size. Doc. 74-1 at 3. Another reported that her doctor monitored her filter position in 23 August 2016 using an x-ray and concluded that the filter was fine. Id. at 4. Yet another 24 named plaintiff stated that he regularly receives chest x-rays and CT scans for health 25 complications independent of his Bard filter, while a fourth claimed that she had received 26 a CT scan of her filter in October 2016 that showed that her filter was intact. Id. at 5, 11. 27 Plaintiffs argue that CT scans are needed for class members because most doctors 28 do not follow their patients carefully and monitor the condition of their filters. Even if - 18 - 1 that is true, can that failure be blamed on Defendants without an inquiry into whether the 2 doctor’s actions are due to the doctor’s own failings or a failure by Bard to adequately 3 advise the doctor? 4 implement a dedicated tracking protocol, monitor their patients carefully, and remove 5 IVC filters when warranted. Doc. 56 at 32. Class members under the care of such 6 diligent doctors likely could not show the need for additional tracking or that the relief 7 offered in this case would result in different monitoring than they already are receiving. 8 This further illustrates the member-by-member inquiry required for elements six and 9 seven. Further, Plaintiffs’ motion acknowledges that some doctors 10 What is more, as Defendants’ expert notes, there are risks associated with 11 exposing individuals to CT scans due to “ionizing radiation inherent in a CT scan[.]” 12 Doc. 74-2 at 19. Whether a class member and her doctor decide that these risks are worth 13 the potential benefits of a CT scan, especially where the class member has received 14 previous scans, is an individualized question not capable of proof by common evidence. 15 e. Choice of Law. 16 Plaintiffs emphasize that they selected states that recognize medical monitoring 17 claims. They seek certification of classes of persons with Bard filters who reside in these 18 states. But Plaintiffs have not shown that the place of residence of each class member 19 will control the law that applies to her case. 20 Choice-of-law issues are relevant to class certification under Rule 23(b)(3). 21 Where “‘class certification is sought in a case based on common law claims, the question 22 of which law governs is crucial in making a class certification determination. Not only 23 must the choice-of-law issue be addressed at the class certification stage – it must be 24 tackled at the front end since it pervades every element of [Rule] 23.’” In re Welding 25 Fume Prods. Liab. Litig., 245 F.R.D. 279, 291 (N.D. Ohio 2007) (quoting In re Prempro 26 Prods. Liab. Litig., 230 F.R.D. 555, 561 (E.D. Ark. 2005)). 27 In a diversity case such as this, “the district court must apply the choice-of-law 28 rules of the state in which it sits.” Abogados v. AT&T, Inc., 223 F.3d 932, 934 (9th Cir. - 19 - 1 2000). 2 (Second) of Conflict of Laws. See Bates v. Super. Ct., 749 P.2d 1367, 1369 (Ariz. 1988); 3 Magellan Real Estate Inv. Tr. v. Losch, 109 F. Supp. 2d 1144, 1155 (D. Ariz. 2000). 4 Under this test, the law of the state that has the most significant relationship to an issue 5 applies to that issue. 6 occurred, (b) the place where the conduct causing the injury occurred, (c) the domicile, 7 residence, nationality, place or incorporation and place of business of the parties, and 8 (d) the place where the relationship, if any, between the parties is centered.” Magellan, 9 109 F. Supp. 2d at 1155-56. “These contacts are to be evaluated according to their 10 Arizona follows the “most significant relationship” test of the Restatement Factors to consider include: “(a) the place where the injury relative importance with respect to the particular issue.” Id. at 1156. 11 Plaintiffs asserted during oral argument that medical monitoring cases always 12 apply the law of the place of residence of the plaintiff, but they provide no citation in 13 support. Even if this were true, the typical practice of medical monitoring cases does not 14 decide the choice-of-law issue in Arizona. The Court must determine the state with the 15 most significant relationship to the claim of each class member. This may be the place of 16 residence for some class members, but not for others. For example, named plaintiff 17 Flournay resides in Colorado, but his filter was implanted in Texas and his implanting 18 physician presumably practices there. Doc. 74-1 at 3. The Court must consider whether 19 Colorado, Texas, or some other state has the most significant relationship to the alleged 20 tort and the parties. 21 relationship, Texas does not recognize medical monitoring claims. Because other class 22 members, like Flournay, may have received their filters or their primary medical care in 23 states other than their current state of residence, a member-by-member inquiry would be 24 needed to decide what law governs their claims. 25 f. If the Court determines that Texas has the most significant Conclusion. 26 The Court concludes that individual issues would predominate if the classes were 27 certified. Individual issues would arise from several key elements of Plaintiffs’ claim: 28 (1) whether Defendants were negligent in the design of various generations of filters, - 20 - 1 considering not only the unique characteristics of the specific filters and the tests that 2 were or were not performed, but also whether the design met the then-available state of 3 the art; (2) whether Defendants were negligent in failing to disclose risks for various 4 kinds of filters at various points in time, given what was known about the risks at the 5 time; (3) whether the learned intermediary defense applies based on what the class 6 member’s doctor knew at the time of implant; (4) whether contributory or comparative 7 negligence or assumption of risk apply based on what the class member has been told 8 about the need for monitoring or removal of the filter; (5) whether the proposed medical 9 monitoring is necessary and distinct from the ordinary course of treatment the class 10 member is receiving; and (6) what state’s law should apply to each class member’s claim. 11 Defendants note that a California state court judge previously refused to certify a 12 California medical monitoring class of persons implanted with the same Bard IVC filters, 13 for the same reason. See Doc. 72-1. 14 2. Superiority. 15 The superiority inquiry asks whether “a class action is superior to other available 16 methods for fairly and efficiently adjudicating the controversy.” Fed. R. Civ. P. 23(b)(3). 17 This requirement must be met in addition to the predominance of common issues – it is 18 not an alternative means for certification under Rule 23(b)(3). 19 predominance “and” superiority). 20 present, superiority cannot save the day. Because the Court finds that individual issues 21 will predominate, it need not address superiority. See id. (requiring Thus, if predominance of common issues is not 22 B. 23 Rule 23(b)(2) permits certification of a class if the requirements of Rule 23(a) are 24 satisfied and “the party opposing the class has acted or refused to act on grounds that 25 apply generally to the class, so that injunctive relief or corresponding declaratory relief is 26 appropriate respecting the class as a whole.” Fed. R. Civ. P. 23(b)(2). Rule 23(b)(2). 27 28 - 21 - 1 1. Nature of the Relief Sought. 2 “Class certification under Rule 23(b)(2) is appropriate only where the primary 3 relief sought is declaratory or injunctive.” Zinser v. Accufix Research Inst., Inc., 253 4 F.3d 1180, 1195 (9th Cir. 2001). “A class seeking monetary damages may be certified 5 pursuant to Rule 23(b)(2) where such relief is merely incidental to the primary claim for 6 injunctive relief.” Id. (citation and quotations marks omitted, alterations incorporated). 7 The parties dispute whether the relief sought by Plaintiffs should be considered injunctive 8 or monetary in nature. 9 “Courts have split on whether medical monitoring relief is primarily compensatory 10 or injunctive[,]” and the Ninth Circuit has noted that “[a] request for medical monitoring 11 cannot be categorized as primarily equitable or injunctive per se.” 12 (compiling cases). Rather, the Court must examine “the precise relief sought and the 13 circumstances of the particular case.” Id. at 1196. Id. at 1195-96 14 In Zinser, the Ninth Circuit found that the complaint sought primarily monetary 15 relief and the proposed class therefore could not be certified under Rule 23(b)(2). Id. 16 The Ninth Circuit explained: 17 21 The amended class action complaint here seeks the establishment of a reserve fund for past and future damages, compensation for future medical treatment, plus other compensatory and punitive damages. Although the complaint also seeks “full and proper research into alternative methodologies for remedying the condition of each patient/class member,” this injunctive relief is merely incidental to the primary claim for money damages. 22 Id. at 1196. Defendants contend that Zinser controls this case, but the relief sought in this 23 case is distinguishable from the relief sought in Zinser. Plaintiffs do not seek direct 24 compensatory or punitive damages, nor do they seek compensation for medical treatment. 25 While Zinser does not control the outcome in this case, many other courts have 26 considered whether requests for medical monitoring constitute primarily injunctive or 27 monetary relief. An oft-cited decision from the Southern District of Ohio provides a 28 helpful discussion of the issue: 18 19 20 - 22 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Relief in the form of medical monitoring may be by a number of means. First, a court may simply order a defendant to pay a plaintiff a certain sum of money. The plaintiff may or may not choose to use that money to have his medical condition monitored. Second, a court may order the defendants to pay the plaintiffs’ medical expenses directly so that a plaintiff may be monitored by the physician of his choice. Neither of these forms of relief constitute injunctive relief as required by rule 23(b)(2). However, a court may also establish an elaborate medical monitoring program of its own, managed by court-appointed court-supervised trustees, pursuant to which a plaintiff is monitored by particular physicians and the medical data produced utilized for group studies. In this situation, a defendant, of course, would finance the program as well as being required by the court to address issues as they develop during program administration. Under these circumstances, the relief constitutes injunctive relief as required by rule 23(b)(2). Day v. NLO, Inc., 144 F.R.D. 330, 335-36 (S.D. Ohio 1992), vacated in part on other grounds sub nom. In re NLO, Inc., 5 F.3d 154 (6th Cir. 1993). Citing Day, the District Court for the Eastern District of Pennsylvania further elaborates on the distinction: 15 16 17 18 19 20 21 22 The dispositive factor that must be assessed to determine whether a medical monitoring claim can be certified as a Rule 23(b)(2) class is [] what type of relief do plaintiffs actually seek. If plaintiffs seek relief that is a disguised request for compensatory damages, then the medical monitoring claim can only be characterized as a claim for monetary damages. In contrast, if plaintiffs seek the establishment of a court-supervised medical monitoring program through which the class members will receive periodic examinations, then plaintiffs’ medical monitoring claim can be properly characterized as claim seeking injunctive relief. Arch v. Am. Tobacco Co., 175 F.R.D. 469, 483 (E.D. Pa. 1997). 23 Other courts considering the nature of medical monitoring relief have reached 24 various conclusions. Some courts have found requested relief to be injunctive in nature. 25 See, e.g., Donovan, 268 F.R.D. at 22 (finding a request for medical monitoring to be a 26 request for injunctive relief where “the plaintiffs seek a structured program, monitored by 27 and staffed with medical personnel, in which class members will receive regular medical 28 screenings . . . [and] would have to hire medical and administrative personnel, purchase - 23 - 1 equipment, and establish procedures for intake, informed consent, record keeping, and so 2 on”); In re Welding Fume Prods. Liab. Litig., 245 F.R.D. at 290 (finding injunctive relief 3 where the plaintiffs sought a court-supervised medical monitoring program rather than an 4 order that defendants pay their medical expenses directly so that they may be monitored 5 by the physician of their choice, or an order that defendants pay a certain sum of money 6 that plaintiffs may or may not choose to use to monitor their medical conditions); Cook v. 7 Rockwell Int’l Corp., 181 F.R.D. 473, 479 (D. Colo. 1998) (finding a request for 8 “diagnostic testing and medical screening necessary to facilitate the early detection and 9 permit the early treatment of disease, rather than damages for past, present or future 10 injury,” to be a request for injunctive relief); Barnes, 989 F. Supp. at 666 (finding it 11 “obvious that the use of a medical monitoring fund to administer medical surveillance 12 payments is an exercise of the Court’s equitable powers”); Craft v. Vanderbilt Univ., 174 13 F.R.D. 396, 406 (M.D. Tenn. 1996) (finding medical monitoring of exposed plaintiffs to 14 be injunctive relief); Yslava v. Hughes Aircraft Co., 845 F. Supp. 705, 713 (D. Ariz. 15 1993) (finding relief to be injunctive where it included the implementation of a “court- 16 supervised program requiring ongoing, elaborate medical monitoring”). 17 Other courts have found requests for medical monitoring to be monetary in nature. 18 See, e.g., Lewallen, 2002 WL 31300899, at *3 (finding primarily monetary relief where 19 the plaintiffs sought establishment of a medical monitoring fund, rather than the 20 establishment of a medical monitoring program, as well as compensatory and punitive 21 damages); Dhamer v. Bristol-Myers Squibb Co., 183 F.R.D. 520, 529 (N.D. Ill. 1998) 22 (finding request for funding of treatment and monitoring to be monetary relief); Arch, 23 175 F.R.D. at 483 (finding plaintiffs’ claim “identical to a traditional damage claim” 24 because the relief includes “not only a fund for the detection of disease but also a fund for 25 its treatment” and the “request for actual medical monitoring examinations is but a small 26 portion of the relief requested”); O’Connor v. Boeing N. Am., Inc., 180 F.R.D. 359, 379 27 (C.D. Cal. 1997) (finding relief primarily monetary where the plaintiffs sought 28 establishment of a fund to pay for medical monitoring, including treatment, as well as - 24 - 1 other compensatory and punitive damages); Thomas v. FAG Bearings Corp. Inc., 846 F. 2 Supp. 1400, 1404 (W.D. Mo. 1994) (finding a request for the “future costs of medical 3 monitoring” to be nothing more than a request for “compensation for necessary medical 4 expenses reasonably anticipated to be incurred in the future” because absent “anything 5 more than an exchange of money, as requested by plaintiffs, these damages cannot be 6 injunctive in nature”). 7 Several trends emerge from these cases. First, a request for medical monitoring 8 coupled with a request for compensatory or punitive damages is likely to be considered 9 primarily monetary. Donovan, 268 F.R.D. at 23 (collecting cases). Second, a request for 10 a fund for the treatment of injury, as opposed to detection of injury, is likely to be 11 considered monetary. See Arch., 175 F.R.D. at 484. Third, a request for a transmission 12 of money with little supervision from the court or further engagement by the defendants 13 is likely to be considered primarily monetary. See Duncan v. Nw. Airlines, Inc., 203 14 F.R.D. 601, 611 (W.D. Wash. 2001). Ultimately, whether requested relief is injunctive or 15 monetary in nature should be resolved by close scrutiny of the specific relief sought and 16 the circumstances of the case. 17 Plaintiffs’ amended complaint seeks an order requiring Defendants “to establish a 18 Court-supervised and Court-administered trust fund, in an amount to be determined, to 19 pay for the medical monitoring protocol for all Class members[.]” Doc. 57-2 at 45, 20 ¶ 228. During oral argument, Plaintiffs’ counsel explained that a class member who 21 elected to pursue this monitoring would see her own treating physician or another 22 physician of her choice to obtain a prescription for a CT scan. The fund would pay for 23 the doctor visit. If the physician prescribed the CT scan, the class member would obtain 24 the scan from a provider of her choice. The fund would pay for the scan. The scan 25 would be read at one of several already-existing centers around the country that 26 specialize in reading CT scans. The fund would pay the center for review of the scan and 27 issuance of a report. Defendants and the Court would not set up a structured medical 28 monitoring program staffed by medical personnel hired for that purpose, as in some - 25 - 1 medical monitoring cases. Nor would data generated by the monitoring be used for 2 research purposes or to benefit the class; it would be maintained only for fund 3 administrative purposes. 4 Although this proposed program is less clearly monetary than cases where 5 plaintiffs sought compensatory and punitive damages in addition to monitoring, the Court 6 concludes that the relief sought primarily constitutes monetary rather than injunctive 7 relief. Under Plaintiffs’ proposed remedy, Defendants would do nothing more than pay 8 money. The money would be used to pay for class members to see their own physicians, 9 receive a scan from a CT provider of their choice, and receive a report on the scan from a 10 designated reviewing radiologist. The Court has difficulty distinguishing this remedy 11 from a simple claim for money damages that a plaintiff will use to pay for a doctor visit, 12 a CT scan, and review of the scan. True, pure monetary recoveries generally do not come 13 with limitations on use of the funds – the plaintiff can just as readily buy a new sofa as a 14 doctor’s visit. But does that single distinction – that the funds in this case can be used 15 only for a doctor visit, a scan, and review of the scan – transform this from monetary to 16 injunctive relief? The Court does not think so. 17 Injunctions require defendants to take some action or refrain from acting. Black’s 18 Law Dictionary defines an injunction as “[a] court order commanding or preventing an 19 action.” Injunction, Black’s Law Dictionary (10th ed. 2014). It is “a judicial process or 20 mandate operating in personam by which, upon certain established principles of equity, a 21 party is required to do or refrain from doing a particular thing.” Id. 22 “Damages,” by contrast, are defined as “[m]oney claimed by, or ordered to be paid 23 to, a person as compensation for loss or injury.” Id. That is what Plaintiffs seek here – 24 an order that Defendants pay money to compensate them for an injury (the need for 25 medical monitoring created by Defendants’ negligence). Plaintiffs cannot transform a 26 claim for damages into injunctive relief simply by asking for an injunction that orders the 27 payment of money. As other courts have recognized, “[a]bsent anything more than an 28 exchange of money, as requested by plaintiffs, these damages cannot be injunctive in - 26 - 1 nature.” Thomas, 846 F. Supp. 2d at 1404; see also Werlein v. United States, 746 F. 2 Supp. 887, 895 (D. Minn. 1990), vacated in part on other grounds, 793 F. Supp. 898 (D. 3 Minn. 1992) (“Plaintiffs propose that defendants be forced to pay a lump sum of cash into 4 a fund, and that persons eligible for medical monitoring use that pot of cash to obtain 5 reimbursement costs incurred as the result of medical screening examinations. Payment 6 of cash by one party to reimburse other parties for costs incurred is not injunctive 7 relief.”). 8 9 Nor can Plaintiffs bring their claim within Rule 23(b)(2) simply by crafting it in way that looks like equitable relief. Rule 23(b)(2) “does not speak of ‘equitable’ 10 remedies generally but of injunctions and declaratory judgments.” Wal-Mart Stores, Inc. 11 v. Dukes, 564 U.S. 338, 365 (2011). The relief must be injunctive to come within the 12 rule, and the Court cannot conclude that a remedy requiring Defendants to do nothing 13 more than write a check can properly be viewed as an injunction. 14 2. Cohesiveness. 15 Defendants argue that Rule 23(b)(2) contains a “cohesiveness” requirement. 16 Doc. 72 at 19. Plaintiffs acknowledge this requirement, but appear to disagree on its 17 content. Doc. 54-1 at 25. A cohesiveness requirement has been widely applied by other 18 circuits and by district courts within the Ninth Circuit, but the Ninth Circuit has yet to 19 speak unequivocally regarding it. 20 The Third Circuit has explained that while Rule 23(b)(2) class actions “have no 21 predominance or superiority requirements, it is well established that the class claims must 22 be cohesive.” Barnes, 161 F.3d at 143. “This is so because in a (b)(2) action, unnamed 23 members are bound by the action without the opportunity to opt out.” Id. at 142-43; 24 accord Gates v. Rohm & Haas Co., 655 F.3d 255, 264 (3d Cir. 2011). Thus, a district 25 court “has the discretion to deny certification in Rule 23(b)(2) cases in the presence of 26 disparate factual circumstances.” Barnes, 161 F.3d at 143 (citation and quotation marks 27 omitted). 28 - 27 - 1 In addition to the Third Circuit in Barnes, at least five circuits have found a 2 cohesiveness requirement in Rule 23(b)(2). Some find the requirement in the text of the 3 rule, but all view cohesiveness as similar to a predominance test, asking whether 4 significant individual issues are present in the proposed class. See In re St. Jude Med., 5 425 F.3d at 1121-22 (“Although Rule 23(b)(2) contains no predominance or superiority 6 requirements, class claims thereunder still must be cohesive.”); In re Monumental Life 7 Ins. Co., 365 F.3d at 415 (Rule 23(b)(2) “presumes a class best described as a 8 homogenous and cohesive group with few conflicting interests among its members”) 9 (citation and quotation marks omitted)); Lemon v. Int’l Union of Operating Eng’rs, 216 10 F.3d 577, 580 (7th Cir. 2000) (“Rule 23(b)(2) operates under the presumption that the 11 interests of the class members are cohesive and homogeneous such that the case will not 12 depend on adjudication of facts particular to any subset of the class nor require a remedy 13 that differentiates materially among class members.”); Romberio v. Unumprovident 14 Corp., 385 F. App’x 423, 433 (6th Cir. 2009) (“Rule 23(b)(2) classes must be cohesive. 15 . . . Thus, the court must ensure that significant individual issues do not pervade the 16 entire action because it would be unjust to bind absent class members to a negative 17 decision where the class representative’s claims present different individual issues than 18 the claims of the absent members present.”) (emphasis in original); Shook v. Bd. of Cty. 19 Comm’rs of Cty. of El Paso, 543 F.3d 597, 604 (10th Cir. 2008) (the proposed class does 20 not satisfy the cohesiveness requirement of Rule 23(b)(2) “if redressing the class 21 members’ injuries requires time-consuming inquiry into individual circumstances or 22 characteristics of class members or groups of class members”); see also 1 McLaughlin on 23 Class Actions § 5:19 (13th ed. 2016) (“Courts addressing attempts to certify Rule 24 23(b)(2) medical monitoring classes have also analyzed whether ‘individual issues exist 25 among class members that would destroy the ‘cohesive nature’ of the class claims,’ a 26 requirement for certification of any (b)(2) class. 27 28 - 28 - A (b)(2) class must have more 1 cohesiveness than a (b)(3) class because in a (b)(2) action, unnamed members are bound 2 by the action without notice or the opportunity to opt out.”).12 3 District courts in the Ninth Circuit have also applied a cohesiveness requirement to 4 Rule 23(b)(2) class certification motions. See Connelly v. Hilton Grand Vacations Co., 5 LLC, 294 F.R.D. 574, 579 (S.D. Cal. 2013) (“Although Rule 23(b)(2) classes need not 6 meet the predominance and superiority requirements, ‘it is well established that the class 7 claims must be cohesive.’”) (citation and quotation marks omitted); Fosmire v. 8 Progressive Max Ins. Co., 277 F.R.D. 625, 635-36 (W.D. Wash. 2011) (“Because . . . the 9 individual issues contained within this proposed multistate class action overrun the 10 common issues, the cohesiveness requirement for class certification under Rule 23(b)(2) 11 is not met here.”); Grayson v. 7-Eleven, Inc., No. 09-CV-1353 MMA WMC, 2011 WL 12 2414378, at *2 (S.D. Cal. June 10, 2011) (recognizing that “[c]ourts have held that class 13 claims under Rule 23(b)(2) must be cohesive” and opining as to the meaning of this 14 requirement); Sweet v. Pfizer, 232 F.R.D. 360, 374 (C.D. Cal. 2005) (“Additionally, 15 courts have held that even though Rule 23(b)(2), unlike Rule 23(b)(3), does not 16 specifically contain predominance and superiority requirements, a class under Rule 17 23(b)(2) must not be overrun with individual issues.”); Lewallen, 2002 WL 31300899, at 18 *3 (“Additionally, to be certified under Rule 23(b)(2), the class claims must be cohesive. 19 Even though the rule does not contain a predominance and superiority requirement, the 20 requisite cohesiveness is lacking where individual issues predominate.”); but see 21 O’Connor, 197 F.R.D. at 411-12 (“Although common issues must predominate for class 22 23 24 25 26 27 28 12 In Shook, the Tenth Circuit found the cohesiveness requirement in Rule 23(b)(2) itself: “By its terms, then, Rule 23(b)(2) imposes two independent but related requirements. In the first place, the defendants’ actions or inactions must be based on grounds generally applicable to all class members. The second requirement is more restrictive, and it is on this aspect of the Rule that we affirm the district court’s ruling. The latter half of Rule 23(b)(2) requires that final injunctive relief be appropriate for the class as a whole. The rule therefore authorizes an inquiry into the relationship between the class, its injuries, and the relief sought, and we have interpreted the rule to require that a class must be ‘amenable to uniform group remedies.’ Put differently, Rule 23(b)(2) demands a certain cohesiveness among class members with respect to their injuries, the absence of which can preclude certification.” 543 F.3d at 604 (citation omitted; emphasis in original). - 29 - 1 certification under Rule 23(b)(3), no such requirement exists under 23(b)(2). 2 sufficient if class members complain of a pattern or practice that is generally applicable 3 to the class as a whole. Accordingly, for purposes of Rule 23(b)(2) certification, a class 4 is cohesive if plaintiffs meet the requirements of Rule 23(a).”) (citation omitted); Mad 5 Rhino, Inc. v. Best Buy Co., No. CV 03-5604 GPS AJWX, 2008 WL 8760854, at *6-7 6 (C.D. Cal. Jan. 14, 2008) (noting a lack of clarity as to the Ninth Circuit’s position on 7 cohesiveness). It is 8 The Ninth Circuit has not clearly determined whether Rule 23(b)(2) includes a 9 cohesiveness requirement. Plaintiffs cite the Walters case, which addressed a class action 10 alleging that nationwide administrative procedures used by the INS violated the class 11 members’ procedural due process rights. 12 injunction requiring the INS to revise their procedures and forms, engage in a notice 13 campaign, and reopen proceedings for class members who had been injured by the INS 14 policy. Id. at 1037. Upholding the district court’s certification of the class under Rule 15 23(b)(2), the Ninth Circuit explained: 16 The class sought an We note that with respect to 23(b)(2) in particular, the government’s dogged focus on the factual differences among the class members appears to demonstrate a fundamental misunderstanding of the rule. Although common issues must predominate for class certification under Rule 23(b)(3), no such requirement exists under 23(b)(2). It is sufficient if class members complain of a pattern or practice that is generally applicable to the class as a whole. 17 18 19 20 21 145 F.3d at 1036. Id. 22 Plaintiffs rely on this language to support their version of cohesiveness – a 23 “uniformity of both the defendant’s actions toward the class and the injunctive relief 24 applicable to the class.” Doc. 54-1 at 25 (citation omitted). But as the discussion above 25 demonstrates, this case fails even under this definition of cohesiveness. Defendants have 26 not engaged in uniform action toward all class members; they have produced different 27 filters at different times and accompanied them with different warnings. The claims in 28 Walters were different. All class members asserted the same claim based on the same - 30 - 1 conduct by the defendant: “In this case, each class member raises the same constitutional 2 question: whether the nationwide procedures used by INS in document fraud proceedings 3 sufficiently apprise aliens of their constitutional right to a hearing, thereby satisfying the 4 notice component of due process.” 145 F.3d at 1045. 5 For these reasons, the Court concludes that Walters is distinct from this case. The 6 Court also concludes that given the nature of the claim at issue in Walters, the brief 7 discussion in that case cannot be viewed as a rejection of the cohesiveness requirement 8 recognized by at least six other circuits and numerous district court cases in this circuit. 9 The Supreme Court in Dukes provided additional helpful clarification of Rule 10 23(b)(2). Dukes made clear that Rule 23(b)(2) class certification “applies only when a 11 single injunction or declaratory judgment would provide relief to each member of the 12 class. It does not authorize class certification when each individual class member would 13 be entitled to a different injunction or declaratory judgement against the defendant” or 14 “when each class member would be entitled to an individualized award of monetary 15 damages.” 564 U.S. at 360-61 (emphasis in original). The Supreme Court found that 16 “[t]he key to the (b)(2) class is the indivisible nature of the injunctive or declaratory 17 remedy warranted – the notion that the conduct is such that it can be enjoined or declared 18 unlawful only as to all of the class members or as to none of them.” Id. at 360 (quotation 19 marks and citation omitted). Thus, (b)(2) certification is proper where “the relief sought 20 must perforce affect the entire class at once.” Id. at 361-62. 21 Dukes emphasized that because Rule 23(b)(2) provides no mandatory notice or 22 opportunity to opt out, it allows certification in a much narrower set of circumstances 23 than Rule 23(b)(3), which requires notice and an opportunity to opt out for all potential 24 class members. Id. at 362. As the Supreme Court explained: 25 26 27 28 The procedural protections attending the (b)(3) class – predominance, superiority, mandatory notice, and the right to opt out – are missing from (b)(2) not because the Rule considers them unnecessary, but because it considers them unnecessary to a (b)(2) class. When a class seeks an indivisible injunction benefitting all its members at once, there is no reason to undertake a case-specific inquiry into whether class issues predominate - 31 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 or whether class action is a superior method of adjudicating the dispute. Predominance and superiority are self-evident. Id. at 362-63 (emphasis in original). This language makes clear that a predominance of common issues is indeed part of Rule 23(b)(2) classes – it is assumed, “self-evident.” This is not because the rule requires the trial court to examine the proposed class and find such predominance, but because the very nature of the relief available under (b)(2) – injunctive or declaratory relief obtained in a trial of the class representative’s claim and applicable to all members of the class – works only when common issues predominate. As the Seventh Circuit explained: “By virtue of its requirement that the plaintiffs seek to redress a common injury properly addressed by a class-wide injunctive or declaratory remedy, Rule 23(b)(2) operates under the presumption that the interests of the class members are cohesive and homogeneous such that the case will not depend on adjudication of facts particular to any subset of the class nor require a remedy that differentiates materially among class members.” Lemon, 216 F.3d at 580. This condition does not exist here. Trial of the class representative’s claims will not fairly adjudicate the claims of all class members because most of the class members have different filters, implanted at different times, with different warnings by Defendants, and are subject to different affirmative defenses. Stated differently, the named Plaintiffs cannot, by trying their claims, obtain “final injunctive relief or corresponding declaratory relief [that] is appropriate respecting the class as a whole.” Fed. R. Civ. P. 23(b)(2). Whether this defect is labelled a lack of cohesion or a simple failure to come within the requirements of Rule 23(b)(2), it defeats class certification. C. Typicality. The Court also concludes that Plaintiffs cannot show typicality under Rule 23(a)(3). This defect prevents certification under both 23(b)(2) and (b)(3). “The test of typicality is whether other members have the same or similar injury, whether the action is based on conduct which is not unique to the named plaintiffs, and whether other class members have been injured by the same course of conduct.” Hanon - 32 - 1 v. Dataproducts Corp., 976 F.2d 497, 508 (9th Cir. 1992) (quotation marks and citation 2 omitted); accord Rodriguez v. Hayes, 591 F.3d 1105, 1124 (9th Cir. 2010). In a general 3 sense in this case, it can be said that the named Plaintiffs and class members have been 4 subjected to the same course of conduct – Bard’s production of allegedly defective filters 5 and its dissemination of allegedly inadequate warnings. But as noted above, important 6 factual distinctions separate class members from the named Plaintiffs. These differences 7 include: (1) whether Defendants were negligent in the design of the filters implanted in 8 the class members, which often will be different from filters implanted in the named 9 Plaintiff; (2) whether Defendants were negligent in failing to disclose risks for various 10 kinds of filters at the point in time when the class members received their implants, as 11 opposed to when the named Plaintiff received theirs; (3) whether the learned intermediary 12 defense applies based on what the class member’s doctor knew at the time of implant, 13 versus what the named Plaintiff’s doctor knew; (4) whether contributory or comparative 14 negligence or assumption of risk apply based on what the class member has been told 15 about the need for monitoring or removal of the filter, as compared to what the named 16 Plaintiff has been told; (5) whether the proposed medical monitoring is necessary and 17 distinct from the ordinary course of treatment the class member is receiving, as opposed 18 to what the named plaintiff is receiving; and (6) what state’s law should apply to each 19 class member’s claim as opposed to the named Plaintiff’s claim. And these all go to the 20 elements of the claims that must be proved for liability to arise. 21 Defenses also affect typicality. Hanon concluded that typicality is not satisfied, 22 and class certification should not be granted, if “there is a danger that absent class 23 members will suffer if their representative is preoccupied with defenses unique to it.” Id. 24 (quotation marks and citation omitted); accord Ellis v. Costco Wholesale Corp., 657 F.3d 25 970, 984 (9th Cir. 2011) (relying on Hanon to overturn a district court’s holding that, “as 26 a general matter, individualized defenses do not defeat typicality”). As discussed above, 27 a number of affirmative defenses are likely to apply differently to the class members than 28 to the named Plaintiffs. - 33 - 1 Plaintiffs’ counsel asserted during oral argument that, at trial, the parties could 2 introduce facts, allegations, and defenses that pertain to individual class members and not 3 to the named Plaintiffs. 4 representative nature of class actions, under which the named Plaintiff’s claim is tried and 5 binds the absent class members. See Newberg on Class Actions § 1:5 (5th ed. 2017) 6 (“Class actions are representative suits on behalf of others similarly situated. Class 7 members are not named adversary parties before the court. They are absent, unnamed 8 parties who did not initiate the action but who will be bound by any class judgment, 9 whether favorable or adverse, assuming that they have been adequately represented with 10 respect to issues that they share in common with the class representative.”). Plaintiffs’ 11 proposed approach would also make the trial entirely unworkable. Evidence regarding 12 the unique issues related to hundreds of class members (or more) would overwhelm the 13 trial and make it confusing to the jury and otherwise unmanageable. This is because the 14 named Plaintiffs’ claims are not truly typical of those of all absent class members. 15 III. Doc. 94 at 65. But such an approach is contrary to the Leave to Amend. 16 Plaintiffs filed their original complaint on May 5, 2016. Doc. 1. Since that date, 17 they have amended the complaint several times to substitute plaintiffs. Docs. 24, 33, 36, 18 47. On June 5, 2017 – the same date Plaintiffs filed their motion for class certification – 19 Plaintiffs filed a motion to amend the complaint by altering the form of the medical 20 monitoring relief sought and the definition of the class. 21 specifically, the proposed amended complaint retains the original request for a court- 22 administered fund to pay for the proposed medical monitoring program and related notice 23 campaign, but seeks to alter the content of that program. Id. at 45, ¶ 228. See Doc. 57-2.13 More 24 The monitoring program set out in the original complaint would provide a 25 “catheter venography” by an interventional radiologist for every class member, followed 26 by a consultation with the class member’s treating physician to determine if removal of 27 13 28 The amended complaint also substitutes a former named plaintiff with plaintiff Ana Hernandez, a move already approved by the Court, and makes several typographical corrections. Defendants do not object to these changes. Doc. 64 at 2 n.1. - 34 - 1 the filter is appropriate. Id. The monitoring program set out in the amended complaint 2 does not include a “catheter venography,” but instead seeks to provide an abdominal CT 3 scan to assess the condition of the Bard filter. Id. 4 With respect to the scope of the class, the original complaint defined class 5 members as those who had been implanted with a Bard IVC filter between July 25, 2003 6 and the date of filing of the complaint. Id. at 37, ¶ 206. The amended complaint would 7 remove the second limit, expanding the class to anyone who had received a Bard IVC 8 filter after July 25, 2003. Id. 9 Leave to amend may be denied if the Court finds that the “amendment would 10 cause prejudice to the opposing party, is sought in bad faith, is futile, or creates undue 11 delay.” Madeja v. Olympic Packers, LLC, 310 F.3d 628, 636 (9th Cir. 2002) (citation 12 omitted). “The party opposing amendment bears the burden of showing prejudice,” 13 futility, or one of the other reasons for denying a motion to amend. DCD Programs, 833 14 F.2d at 187. 15 Defendants object to the proposed amendment on grounds of undue delay and 16 prejudice, contending that the amendment would “fundamentally alter the relief being 17 requested and would significantly expand the scope of the proposed class.” Doc. 64 at 2, 18 5-11. The Court is not persuaded. Defendants concede that Plaintiffs’ new remedy was 19 identified in Plaintiffs’ February 3, 2017 expert report as preferable to the venography 20 proposed in the class complaint, and that their own expert was able to address this new 21 medical monitoring approach in Defendants’ expert reports. 22 Defendants contend that they were “still denied the opportunity to pursue 23 discovery from the named plaintiffs/proposed class representatives on the new remedy.” 24 Id. But it is not clear why Defendants would need to depose the named plaintiffs about 25 the suitability of the new medical monitoring relief. That issue is properly determined by 26 experts, not by the testimony of lay Plaintiffs. 27 Defendants have not identified any specific discovery they would have sought 28 from the named plaintiffs with respect to the proposed CT scans. Defendants obtained all - 35 - 1 available medical records for the named plaintiffs and deposed them extensively about 2 their medical histories, including any scans they have had since their implants of the Bard 3 filters. Doc. 64 at 9 n.3; Doc. 71 at 6-7. Defendants suggest that they need to consider 4 taking depositions of Plaintiffs’ current treating radiologists concerning the new proposed 5 remedy, but Defendants have not explained why such depositions would be relevant or 6 necessary. 7 Defendants argue briefly that they are prejudiced by the change in class definition. 8 But the change does not alter the substance of the class, but only extends the cut-off date 9 from the filing of the class complaint to the date of class notice, a likely extension of 18 10 months or so if the class is certified. Defendants do not explain how this change affects 11 “the named plaintiffs’ ability to serve as class representatives under Rule 23[,]” what 12 additional discovery they would have conducted with such an extended class period, or 13 how they have otherwise been prejudiced. Doc. 64 at 9. 14 Defendants additionally argue that Plaintiffs do not offer any valid reason for 15 their delay in seeking to amend the class definition and remedy in their complaint. The 16 Ninth Circuit has made clear, however, that “[d]elay alone does not provide sufficient 17 grounds for denying leave to amend.” Hurn v. Ret. Fund Tr. of Plumbing, Heating & 18 Piping Indus. of S. Cal., 648 F.2d 1252, 1254 (9th Cir. 1981). “Where there is lack of 19 prejudice to the opposing party and the amended complaint is obviously not frivolous, or 20 made as a dilatory maneuver in bad faith, it is an abuse of discretion to deny such a 21 motion.” Id. (citation omitted). 22 The Court concludes that Defendants have not shown prejudice or bad faith. 23 Plaintiffs clearly should have been more diligent and sought to amend once they knew 24 that their expert recommended a remedy different than the remedy pleaded in their 25 complaint. But Plaintiffs did disclose their proposed new remedy in expert reports 26 months ago, Defendants’ experts were able to respond to the new remedy, and the experts 27 were deposed on the new remedy. The motion to amend will be granted. 28 - 36 - 1 IV. Motion to Exclude. 2 Defendants ask the Court to preclude Plaintiffs from relying on two papers: (1) a 3 “white paper” titled Background White Paper from a Medical Monitoring Program 4 Administrator: IVC Retrievable Filter Medical Monitoring Program Design, authored by 5 Garretson Resolution Group (specifically, Candace Young and Amy Gernon) (“the 6 “White Paper”); and (2) a supporting expert report titled Estimated Range Number of 7 People with Bard IVC Filters, authored by Dennis Tolley (the “Tolley Report”). 8 Defendants also ask the Court to exclude any testimony or opinions of Plaintiffs’ experts 9 that rely on the White Paper or the Tolley Report. Doc. 68 at 2. Defendants contend that 10 the White Paper and Tolley Report (collectively, the “Papers”) are expert reports that 11 were not timely disclosed under Federal Rule of Civil Procedure 26. Id. 12 The Court’s case management order required that expert disclosures related to 13 class certification be made by January 13, 2017. Doc. 22 at 1. Rebuttal expert reports 14 were due by March 24, 2017. Id. at 1-2. 15 Plaintiffs did not disclose the Papers or the identity of their authors by these 16 deadlines. 17 Plaintiffs’ other experts on May 9, 2017, well after the deadlines for expert disclosures 18 had passed. Doc. 68 at 2. Plaintiffs argue that they did not violate Rule 26 because the 19 Papers are not expert reports, but rather are counsel-generated reports intended to be used 20 solely for background information. The Court does not agree. Defendants first learned of the Papers during the deposition of one of 21 Expert testimony is based on “scientific, technical, or other specialized 22 knowledge[.]” Fed. R. Evid. 702(a). The White Paper sets forth such testimony. It is a 23 compilation of information and recommendations from persons who hold themselves out 24 as experts in creating and administering medical monitoring programs. The authors say it 25 is “based on our experience in this area,” and include a description of their specialized 26 qualifications. Doc. 68-1 at 2, 11. The Tolley report also sets forth expert opinions. Dr. 27 Tolley begins his report with a statement of his specialized qualifications, and then 28 provides “estimates” of the class size based on his expertise. Id. at 12. - 37 - 1 Plaintiffs argue that the Papers rely on public information, public cases, and 2 information from Defendants, but such reliance does not change the fact that their authors 3 are experts within the meaning of Rule 702 providing their compilations and evaluations 4 of that information. The Papers clearly contain expert evidence that should have been 5 disclosed under Rule 26(a)(2). 6 A party that fails to provide information required by Rule 26(a) or (e) “is not 7 allowed to use that information or witness to supply evidence on a motion, at a hearing, 8 or at a trial, unless the failure was substantially justified or is harmless.” Fed. R. Civ. P. 9 37(c)(1). Plaintiffs do not address the “substantially justified” prong of the Rule 37 10 standard. Instead, they argue that any failure to disclose was harmless. 11 Plaintiffs contend that “Bard’s own sales data, along with numerous documents 12 reflecting sales of thousands of Bard’s filters during the class period, readily establish the 13 minimal numerosity requirement.” Doc. 76 at 8 . But whether other evidence exists to 14 support the numerosity requirement for class certification is not the issue. Plaintiffs must 15 show that Defendants will not be prejudiced by their failure to disclose the Papers. See R 16 & R Sails, Inc. v. Ins. Co. of Pa., 673 F.3d 1240, 1246 (9th Cir. 2012). They have not 17 done so. The Papers include expert opinions bearing directly on class certification, and 18 Plaintiffs cite them several times in the briefing on class certification. Because the 19 Papers were not timely disclosed under the Court’s case management order, Defendants 20 were denied the opportunity to depose the authors, assess their qualifications, or provide 21 rebuttal expert reports. 22 Plaintiffs also contend that Defendants first received the Papers on May 9, 2017, 23 and then again on May 16, 2017, but failed to ask more than a few questions about them 24 at the expert depositions. But Defendants had no opportunity to depose the authors of the 25 Papers, and questioning experts in other fields who read the Papers is no substitute. Nor 26 do Plaintiffs dispute that Defendants had no chance to produce rebuttal expert reports. 27 28 - 38 - 1 Because Plaintiffs have not shown that their failure to disclose the Papers was 2 substantially justified or harmless, they cannot rely on the Papers in their motion for class 3 certification. Fed. R. Civ. P. 37(c).14 4 IT IS ORDERED: 5 1. Plaintiffs’ motion to certify (Doc. 54) is denied. 6 2. Plaintiffs’ motion to amend (Doc. 57) is granted. The Clerk is directed to 7 accept for filing document lodged as Doc. 58 in this case. 8 3. Defendants’ motion to exclude (Doc. 68) is granted. 9 4. The Court will hold a telephone conference with counsel on 10 September 29, 2017 at 1:00 p.m., to discuss future proceedings in this 11 case. 12 counsel for all parties and the Court. If a dial-in number is used, the dial-in 13 information shall be provided to the Court and all parties no later than 14 September 28, 2017 at 4:00 PM. 15 Counsel for Plaintiffs shall initiate a conference call to include Dated this 11th day of September, 2017. 16 17 18 19 20 21 22 23 24 25 26 27 14 28 Defendants ask the Court to strike the testimony or opinions of two of Plaintiffs’ experts – Drs. Hertz and Bates – that rely on the Papers, but do not identify any testimony or opinions that meets this description. - 39 -

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