Summary
distinguishing between cases where plaintiffs seek " the establishment of a medical monitoring fund, rather than the establishment of a medical monitoring program"
Summary of this case from In re Welding Fume Prods. Liab. Litig.Opinion
No. C 01-20395 RMW
August 28, 2002
ORDER DENYING PLAINTIFFS' MOTION TO CERTIFY CLASS
Plaintiffs have moved for an order of class certification. Defendants oppose the motion. Having considered the papers submitted by the parties and the arguments of counsel at oral argument, for the reasons set forth below, plaintiffs' motion is denied.
The class action complaints purports to bring claims on behalf of all persons who have been implanted with an AneuRx stent graft, a medical device manufactured and sold by the Medtronic defendants for the treatment of abdominal aortic aneurysms. The complaint seeks to allege claims for strict liability (failure to wam), strict products liability, negligence (defective product design), breach of implied warranty, breach of express warranty, fraud, negligent misrepresentation, fraud by concealment, and finally, for "medical monitoring." Plaintiffs seek relief in the form of monetary damages in an amount sufficient to compensate plaintiffs and each member of the class for all damages, punitive damages, and the creation of a trust fund to provide for a medical monitoring program "including but not limited to, preventative screening, monitoring, examination and surveillance of conditions resulting form the placement of defective ANEIJRX stents, as well as the funding of a medical registry research and education fund concerning this product." Complaint at 33, ¶ 3. Notably, plaintiffs do not seek the creation of a medical monitoring program, but instead merely the creation of a trust fund to cover the cost of such a program.
Plaintiffs now seek class certification, but only on the medical monitoring claim and on the fraud/punitive damages claims. Not included in the purported class are any claims for personal injury or claims by persons who have actually suffered injury as a result of the AneuRx device. Plaintiffs confirmed at oral argument that any member of the class who suffers injury from the device during the course of these proceedings will be dropped from the class to pursue his or her own individual claims.
Defendants argue that because none of the named plaintiffs or class members have yet been injured, plaintiffs have no standing to bring suit. If plaintiffs do not have standing, the court does not have jurisdiction to entertain this action. Defendants have not, however, filed a motion challenging the court's jurisdiction. Accordingly, the court declines to address this argument at this time. The court notes, however, that on its face, the complaint asserts various torts, including fraud and misrepresentation, and seeks recovery for the resulting damages.
This had already happened with regard to one of the named plaintiffs. In addition, more than twenty separate individual actions are now pending in this court brought by persons claiming to have been injured by an AneuRx device.
Plaintiffs propose two class certification alternatives. First, plaintiffs propose two subclasses, one each for medical monitoring under Rule 23(b)(2) and for the fraud causes of action and punitive damages claims under Rule 23(b)(3), with each subclass further divided into two subclasses so that the plaintiffs are divided into groups depending upon when the implantation occurred (either before or after the device received FDA approval). Alternatively, plaintiffs propose a single medical monitoring and fraud class under Rule 23(b)(3), with a subclass of persons who were implanted during the clinical trials prior to FDA approval. All classes are nationwide. As the party seeking class certification, plaintiffs bear the burden of demonstrating that they have met each of the four requirements of Rule 23(a) and at least one of the requirements of Rule 23(b). Zinser v. Accufix Research Institute, 253 F.3d 1180, 1186 (9th Cir. 2001), as amended and superceded by Zinser v. Accufix Research Institute, 273 F.3d 1266 (9th Cir. 2001). For the reasons discussed below, the court concludes that even if the requirements of Rule 23(a) are met, plaintiffs have not established any of the requirements under Rule 23(b). Class certification is therefore not appropriate.
In amending and superceding the initial Zinser opinion, the Ninth Circuit added one sentence to the opinion. For ease of citation, the court will cite to the relevant portions of the initial opinion.
1. Rule 23(a)
The four requirements of Rule 23(a) are: 1) numerosity, the class must be so numerous that joinder of all members is impracticable; 2) commonality, that is, there must be questions of law or fact common to the class; 3) typicality, the claims and defenses of the class representatives must be typical of the claims and defenses of the class; and 4) adequacy of representation to ensure that the person representing the class is able to fairly and adequately protect the interests of all class members.
There are close to 15,000 persons in the United States who have had the AneuRx implanted, more than 1,000 of them clinical trial participants. All of the prospective class members have been implanted with the AneuRx and there will be common questions relating to Medtronic's conduct applicable to each class member: plaintiffs allege that Medtronic withheld adverse events to convince physicians and patients that AneuRx was safe; marketed the product as safe; directed, trained, supervised and approved each physician; identified patient selection criteria and instructed physicians in patient selection; and created the instructions for use and a patient information booklet for the devices. With regard to typicality, there are only two named class members: Mr. Lewallen who was implanted with the AneuRx after FDA approval by a physician trained by Medtronic and pursuant to Medtronic's training manual; Mr. Hansen who was part of the clinical trials. Both are asserted to have claims that are typical of their respective sub-classes. Finally, with regard to the adequacy of representation, plaintiffs' counsel appears to be experienced in complex litigation, including medical consumer litigation, and are not laboring under any disabling conflicts of interest. Defendants offer only token opposition regarding the requirements of Rule 23(a). Nevertheless, the court is somewhat concerned with the adequacy of the representation, not from the standpoint of whether counsel is qualified, but rather from the standpoint of whether the class representatives are adequate. In particular, the court is concerned with the apparent conflict that arises between the named plaintiffs and members of the class who, though presently uninjured, may suffer injury in the future. Members of the class may be forced to split their claims, if suit is brought now, which may preclude them from later suing to recover for injuries. It is not clear that presently uninjured members of the class would be permitted to bring a subsequent lawsuit if physical injury later resulted from the AneuRx device. But, it is not necessary to resolve the question of whether or not Rule 23(a) is satisfied, because the court finds that plaintiffs have failed to meet the requirements of Rule 23(b).
2. Rule 23(b)
Plaintiffs seek to satisfy Rules 23(b)(2) and (3). Plaintiffs have failed to satisfy either rule.
a. Rule 23(b)(2)
Plaintiffs first seek a proposed class for medical monitoring under Rule 23(b)(2). Class certification under Rule 23(b)(2) is appropriate where the party opposing the class has acted or refused to act on a ground 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). Plaintiffs argue that "numerous federal courts have recognized that medical monitoring is a form of injunctive relief, and have certified classes under Rule 23(b)(2) to monitor health risks due to exposure to harmful medical devices and substances." Motion at 17-18. None of the authorities cited by plaintiffs, however, are from the Ninth Circuit. Moreover, plaintiffs overlook the fact that "medical monitoring" is not universally recognized as a separate claim for relief. Califomia, for example, treats medical monitoring as a form of remedy available to a plaintiff who has otherwise established defendant's tort liability. Potter v. Firestone Tire Rubber Co., 6 Cal.4th 965, 1006-07 (1993); see also Day v. NLO. Inc., 851 F. Supp. 869, 879-80 (S.D. Ohio 1992) (noting that medical monitoring is not a separate tort but is instead a compensable item of damage when liability is established under traditional tort theories of recovery). Thus, with regard to medical monitoring, plaintiffs seek to certify a class for the remedy but not for the underlying tort. More importantly, however, Zinser, 253 F.3d 1180, is controlling and is not meaningfully distinguishable from the present case. The Ninth Circuit in Zinser affirmed the denial of class certification for medical monitoring under Rule 23(b)(2) on the basis that class certification is not appropriate where the primary relief sought is monetary. Zinser, 253 F.3d at 1195. The court noted that:
Courts have split on whether medical monitoring relief is primarily compensatory or injunctive. Depending on the nature of the precise relief sought and the circumstances of the particular case, many courts have declined to certify medical monitoring classes when joined with requests for funding and compensation. [¶] We conclude that Zinser's proposed medical monitoring subclass is not appropriate for class certification pursuant to Rule 23(b)(2). 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/member, " this injunctive relief is merely incidental to the primary claim for money damages.253 F.3d at 1196 (citations omitted). The present case is not meaningfully distinguishable. It too seeks the establishment of a medical monitoring fund, rather than the establishment of a medical monitoring program. It too seeks recovery of compensatory and punitive damages. Accordingly, the complaint seeks primarily monetary relief and certification under Rule 23(b)(2) is not appropriate. Additionally, to be certified under Rule 23(b)(2), the class claims must be cohesive. Even though the rule does not contain a predominance and superiority requirement, the requisite cohesiveness is lacking where individual issues predominate. See Barnes v. American Tobacco Co., 161 F.3d 127, 142-43 (3d Cir. 1998) (rejecting Rule 23(b)(2) certification of medical monitoring claim); Dhamer v. Bristol-Myers Squibb Co., 183 F.R.D. 520, 529 (N.D. Ill. 1998) (same). As discussed in the section below, the individual questions predominate over the common questions, and therefore the cohesiveness requirement for Rule 23(b)(2) class certification is not met here.
Under Rule 23(b)(3), an action may be maintained as a class action if the common questions of law or fact predominate over questions affecting only individual members and the class action is superior to other available methods for the fair and efficient adjudication of the controversy. Plaintiffs seek to certify a class for the fraud claims, for punitive damages, and again, medical monitoring. Plaintiffs have failed to carry their burden and have not established either prong of the test.
Plaintiffs argue that common questions of law and fact predominate. Specifically, according to plaintiffs, the overriding questions in this case involve defendants' conduct and the appropriate remedy for defendants' wrongdoing, which are common throughout the class. Plaintiffs identify the following common questions of fact:
1. Whether Medtronic failed to warn of the dangers associated with the use of AneuRx;
2. Whether defendants fraudulently concealed information and made affirmative misrepresentations to the Physicians and patients; and,
3. Reliance, which plaintiffs contend can be resolved on a class-wide basis.
Plaintiffs argue that under Vasquez v. Superior Court, 4 Cal.3d 800 (1971), reliance may be presumed on a class-wide basis where a defendant communicates the same or substantially similar material misrepresentations to the class as a whole.
Plaintiffs further argue that a class action is superior to any other method of adjudication because the individual claims are so small in comparison to the costs of litigating against Medtronic that they will be left with no recovery. See Phillips Petroleum v. Shutts, 472 U.S. 797, 780 (1985) (class actions "permit plaintiffs to pool claims which would be uneconomical to litigation individually").
The court is not persuaded by plaintiffs' arguments. While there are undoubtedly some common questions of fact, the court is not persuaded that those common questions predominate. Undoubtedly, there will be substantial questions of fact common to all AneuRx stent graft recipients. Issues regarding the design and manufacture of the device, as well as Medtronic's marketing of the device, may be common throughout the claimants. Certain of Medtronic's representations regarding the safety of the device and the risks associated with it may also be common. Nevertheless, the court concludes that individual questions of fact will predominate. Even if the only representations at issue are ones that defendant included in product promotional and treatment materials, there are still individual questions regarding what each treating physician knew and relied upon, and what information was conveyed to each patient. Each patient who received an AneuRx stent was treated by a physician who made the decision that the AneuRx was an appropriate alternative to other possible treatments for abdominal aortic aneurysm. Each patient's medical history is different, as are each patient's risk factors. Each treating physician's determination is different. What each doctor told each patient, the risks assumed by each patient, and the anticipated course of treatment for each patient are all highly individualized inquiries. So too, causation will require individualized proof. Moreover, the court is not persuaded that reliance may be established on a class-wide basis. See Brown v. Regents of Univ. of Cal., 151 Cal.App.3d 982, 990 (1984) (class-wide reliance is inappropriate where the alleged fraud relates to the decision to obtain surgery or medical treatment). In addition, various affirmative defenses require individualized proof, including the statutes of limitation, consent, assumption of risk, and comparative fault. Finally, assuming that there has been an increased need for medical monitoring, each individual plaintiff would only be able to recover to the extent of that increase. Whatever monitoring was expected as an part of the anticipated course of treatment would not be recoverable, again a particularly individualized inquiry. The court concludes that the individual factual issues predominate over the common issues of fact.
Additionally, plaintiffs have failed to establish that common questions of law will predominate. Plaintiffs presume that California law will apply to all members' claims merely because the defendants are located in California. Plaintiffs apparently presume that defendants will be precluded from seeking to invoke the law of another interested forum. That presumption is erroneous. As noted in Zinser, California applies the governmental interest approach to conflict of law questions. To determine which state's law applies, the court must compare the interest of each relevant non-forum state with the law of California in order to determine first if there is a conflict, and then if so, which state has a greater interest in having its law apply to the dispute. Zinser 253 F.3d at 1187-88. The choice of law analysis must be applied to each claim upon which certification is sought. Id. at 1188. Here, the proposed class is nationwide, and therefore, each of the fifty states may have an interest in seeing that its law is applied in an action involving one of its own injured citizens. Particularly where plaintiffs are asserting a relatively novel claim for relief — such as medical monitoring — the differences in state law are likely to be substantial. Plaintiffs have failed to establish that there are predominant common questions of law.
Finally, plaintiffs have failed to establish that a class action is a superior method of adjudicating the dispute. Plaintiffs have largely ignored the factors for assessing superiority which are set forth in Rule 23(b)(3) and which the court is required to consider: A) the interests of members of the class in individually controlling the prosecution or defense of separate actions; B) the extent and nature of any litigation concerning the controversy already commenced by or against members of the class; C) the desirability or undesirability of concentrating the litigation of the claims in the particular forum; and D) the difficulties likely to be encountered in the management of a class action. Fed.R.Civ.P. 23(b)(3). The court must consider these four factors in order to determine superiority, with a focus on the efficiency and economy elements so that appropriate cases may be adjudicated most profitably on a representative basis. Zinser, 253 F.3d at 1190, citing 7A Wright, Miller Kane, Federal Practice and Procedure, § 1780 at 562 (2d ed. 1986). Instead of addressing these factors, however, plaintiffs have argued that class treatment is the superior method of adjudicating the controversy because if the court "does not certify the class, individual members of the class will be left with no remedy because the individual claims of class members are so small in comparison to the costs of litigating against a large corporation like Medtronic." Motion at 23.
The first factor is the interest of each class member in controlling the prosecution or defense of separate actions. Fed.R.Civ.P. 23(b)(3)(A). Where the damages suffered by each class member are not large, this weighs in favor of class certification. Zinser, 253 F.3d at 1190. The complaint alleges that the court has subject matter jurisdiction under the diversity statute, 28 U.S.C. § 1332, and that the amount in controversy exceeds $75,000. It is sufficient for jurisdictional purposes that at least one class member satisfy the amount in controversy requirement. Gibson v. Chrysler Corp., 261 F.3d 1517 [ 261 F.3d 927] (9th Cir. 2001). There are no allegations regarding the amount in controversy with regard to the specific claims of the two named class representatives, but assuming that two class representatives are sufficiently similar, and that prospective members of the class are also similarly situated, the court may assume for present purposes that each class member's claim exceeds $75,000. As noted by the court in Zinser, to some degree this undermines the plaintiffs' assertion that the claims have relatively small value and justify class certification. 253 F.3d at 1191 and n 7. In any event, while it is true that it may be more efficient to aggregate all claimants, particularly when each individual claim is relatively modest, it is also true that class certification could serve to breathe life into marginal cases that might never be pursued as individual actions. This factor, then, is not dispositive.
The second factor is the extent and nature of any litigation concerning the controversy already commenced by or against members of the class. Fed.R.Civ.P. 23(b)(3)(B). Here, the court has been made aware of no other litigation involving the AneuRx device and which involves any member of the class, but that results only because the class has been defined to exclude persons who have actually suffered injury. There are at least twenty individual actions brought by injured persons pending in this district alone. There may well be other lawsuits pending in other jurisdictions. A class action will not serve to reduce the possibility of multiple lawsuits; instead, a class action will be merely one additional lawsuit, a factor weighing against class certification. Zinser, 253 F.3d at 1191.
Third, the court must consider the desirability or undesirability of concentrating the litigation in a particular forum. Fed.R.Civ.P. 23(b)(3)(C). As in Zinser, this case involves potential plaintiffs located across the country, with witnesses and evidence found nationwide. 253 F.3d at 1191-92. Plaintiffs have failed to demonstrate why it would be especially efficient for this court to hear an action involving thousands of class members.
Finally, the court is to consider the difficulties likely to be encountered in the management of a class action. Fed.R.Civ.P. 23(b)(3)(D). "[W]hen the complexities of class action treatment outweigh the benefits of considering common issues in one trial, class action treatment is not the `superior' method of adjudication." Zinser, 253 F.3d at 1192. If each class member has to litigate numerous and substantial separate issues to establish his or her right to recover individually, a class action is not superior. Id. Moreover, in view of the potential application of the laws of multiple states and the individual questions regarding each individual class member's entitlement to relief class treatment is not superior to individual adjudications. See Zinser, 253 F.3d at 1192. Overall, the factors weigh against a determination that class treatment is superior to individual actions. Accordingly, the court finds that it is not appropriate to certify classes for the medical monitoring, fraud, and punitive damages claims.
ORDER
For the foregoing reasons, plaintiffs' motion for class certification is denied.