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observing that any fault on the part of defendant is immaterial if an individual class member is unable to prove that the defendant's conduct caused the injury in fact and concluding that individual issues of causation and comparative fault will predominate over the proposed common issues regarding product defect
Summary of this case from In re American Commercial Lines, LLCOpinion
No. 1:00-CV-00569, Consolidated with No. 1:01-CV-37, No. 1:01-CV-38
August 15, 2001
MEMORANDUM OPINION AND ORDER DENYING REPRESENTATIVE PLAINTIFFS' MOTION FOR CLASS CERTIFICATION
Before the Court is Plaintiffs' Opposed Motion for Class Certification (Doc. No. 91), Representative Plaintiffs' Memorandum of Points and Authorities in Support of Class Certification (Doc. No. 74), Defendants' Opposition to Plaintiffs' Motion for Class Certfication (Doc. No. 92), Representative Plaintifs' Reply to Memorandum in Opposition to Plaintiffs' Motion for Class Certification Under Federal Rule 23(c)(4)(A) (Doc. No. 94), and Defendants' Surreply to Plaintiffs' Motion for Class Certification (Doc. No. 102). The Court heard arguments on Plaintiffs' motion for class certification on July 23 and 24, 2001. Having considered the arguments of counsel, the papers submitted, the applicable law and the record in this case, the Court finds that Plaintiffs' proposed class does not meet the standards for certification under Federal Rule of Civil Procedure 23(b)(3). For the reasons set forth below, Plaintiffs' Opposed Motion for Class Certification (Doc. No. 91) is DENIED.
I. BACKGROUND AND PROCEDURAL HISTORY
Pursuant to the Federal Rules of Civil Procedure 23(a), 23(b)(3), and 23(c)(4)(A), the Representative Plaintiffs bring this class action lawsuit on behalf of themselves and all similarly situated individuals. Plaintiffs' proposed class consists of individuals who were allegedly injured by contaminated Vicryl sutures designed, manufactured, marketed, distributed, and sold by Defendants Ethicon, Inc., Johnson Johnson, and Johnson Johnson Health Care Systems, Inc. (collectively, "Defendants"). Defendants are the nation's largest manufacturers of medical sutures, producing in excess of 80% of all sutures used in this country. The millions of Vicryl sutures that are the subject of this action were all produced in San Angelo, Texas, between January 1, 1994 and September 8, 1994. These sutures are the allegedly defective products that caused injuries to Plaintiffs and putative class members when they were implanted in their bodies during medical procedures.
Class representatives include Iris Mazaroff, Rivers Theriot, Mary Jane Neely, Mary DeGarmo, Sandra Lawrence, Marshall Dougharty, and Ossie Mesker.
The class is defined as: All persons in the United States who had vicryl sutures manufactured by Ethicon, Inc. between January 1, 1994 and January 1, 1995 placed into their person during surgery or other medical procedure between January 1, 1994 and December 31, 1999 and who thereafter developed an infection proximate to their surgical site within twelve (12) months of that surgery. (Doc. No. 94 at 13.)
In the early nineties, Defendants began exploring a new sterilization process for sutures to replace the traditional ethylene oxide sterilizers. According to Defendants, the major reason for the replacement was to create a process that eliminated the use of chlorofluorocarbons ("cfc's") ultimately prohibited by the Montreal Protocol directed at environmental concerns. In early 1992, Defendants began to design and construct a new, Non-CFC sterilization process at its San Angelo, Texas facility to comply with environmental regulations. Defendants' first Non-CFC sterilizer, the "SP-1", went into production during the first quarter of 1994.
Plaintiffs allege that this new sterilization system failed to meet good manufacturing practices (GMP) under Title 21 of the Code of Federal Regulations (C.F.R.) and that Defendants were forced to shut the SP-1 down on May 23, 1994, a little over a month after they claimed it was properly validated. Plaintiffs further allege that due to Defendants' failure to properly validate the SP-1, in 1994, they sterilized and distributed more than 8 million adulterated and potentially contaminated Vicryl sutures.
Between July 19, 1994 and July 26, 1994, the Food and Drug Administration ("FDA") instituted an unannounced audit of the San Angelo facility. Following the audit, the FDA sent a warning letter to Defendants concerning the alleged problems with the SP-1 sterilizer. Thereafter, Defendants began to advise its distributors and hospitals of the recall of Vicryl sutures due to a low probability of adverse health consequences. Defendants officially conducted the recall from September 6, 1994 to April 17, 1995. Plaintiffs contend that Defendants' recall was not timely, was ineffective and failed to include millions of sutures that should have been recalled. Finally, Plaintiffs assert that Defendants destroyed all of the product that was returned from the recall.
The case presently before this Court is a consolidation of three class action complaints — Neely, et al. v. Ethicon, Inc., et al.; Morgan, et al. v. Ethicon, Inc., et al.; and Lawrence, et al. v. Ethicon, Inc. The lead plaintiff in Neely, Mary Jane Neely, filed her suit in Jefferson County, Texas on May 30, 2000. After filing her suit as an individual action in state court, Ms. Neely and her counsel reached an agreement with putative class counsel in Lawrence, to represent the national class against Ethicon. Thereafter, Ms. Neely amended her action to include class allegations on June 14, 2000. Defendants removed this action on August 21, 2000, and the case was assigned to this Court.
Lawrence, et al. v. Ethicon, the first class action filed in these proceedings, was originally filed in New Jersey on June 29, 1999. Shortly after Lawrence was filed, Ethicon filed a motion to dismiss the class allegations and to transfer the case from the District of New Jersey to the Northern District of California. On October 22, 1999, the Honorable Anne E. Thompson denied Ethicon' s motion to dismiss the class allegations and transferred the case to the Northern District of California. On December 10, 1999, Judge Breyer in the Northern District of California determined that Ethicon's renewed motion to dismiss the class allegations was premature. Thereafter, Defendant Ethicon filed its answer in Lawrence raising various affirmative defenses, including applicable statutes of limitations, laches, the learned intermediary doctrine, preemption, and the doctrine of superseding or intervening cause. Plaintiffs, after completing limited discovery related to distribution of the contaminated sutures, determined that the Distributor Defendants and the JJ Entities were proper parties and sought leave to amend their class complaint.
Plaintiffs' motion to amend in Lawrence sought to add additional defendants, some of whom were non-diverse, and therefore, would have required dismissal. Although Judge Breyer agreed that the potential new defendants could be properly joined, he expressed concern that the dismissal and re-filing of this case could pose statute of limitations problems for the putative nationwide class. Consequently, on June 9, 2000, Judge Breyer transferred Lawrence to the Northern District of Texas where the putative class action Morgan, et al. v. Ethicon. et al., was pending. Judge Breyer concluded that transfer was appropriate so that both cases could be considered by a single Judge who could evaluate whether the dismissal and re-filing of Lawrence might have any deleterious effect on class tolling. Morgan — the second class action filed in this matter — was filed in the Dallas County District Court on December 9, 1999. The Morgan action mirrored many of the allegations contained in Lawrence and was filed on behalf of an alternative class — either national or statewide — depending on which class was most ascertainable. Ethicon immediately removed Morgan to the Northern District of Texas where an initial remand motion was heard and denied without prejudice by the Honorable Sam A. Lindsay.
On December 29, 2000, Judge Lindsay transferred both the Lawrence and Morgan actions to this Court. Pursuant to this Court's docket control order, Plaintiffs filed a model complaint consolidating the three pending class actions captioned Neely, et al v. Ethicon, Inc., et al. on February 6, 2001. ( See Doc. No. 89.) On July 23, 2001, this Court granted Plaintiffs unopposed motion to dismiss Baxter, Owens Minor, and McKesson General Medical Corp. ( See Doc. No. 115.) Plaintiffs' motion to dismiss these distributor defendants was based on discovery showing no basis for individual liability and the fact that Ethicon is indemnifying these defendants. The hearing on Plaintiffs' motion for class certification was held on July 23-24, 2001.
II. LEGAL STANDARD — FED. R. Civ. P. 23
The Court is directed by Federal Rule of Civil Procedure 23 in making its decision whether to certify a class action. The Court is given broad discretion in deciding the issue of class certification, but that discretion must be exercised within the framework of Rule 23. Castano v. American Tobacco Co., 84 F.3d 734, 740 (5th Cir. 1996) (citing Gulf Oil Co. v. Bernard, 452 U.S. 89, 100, 101 S.Ct. 2193, 2200, 68 L.Ed.2d 693 (1981)); see also Allison v. Citgo Petroleum Corp., 151 F.3d 402, 408 (5th Cir. 1998) (noting that "[i]mplicit in this deferential standard is a recognition of the essentially factual basis of the certification inquiry and of the district court's inherent power to manage and control pending litigation"). Furthermore, the Court is mandated by Rule 23(c)(1) to decide class certification "[a]s soon as is practicable." FED. R. Civ. P. 23(c)(1). The decision to certify a class will be reversed only upon a showing that the Court abused its discretion, see Jenkins v. Raymark Industries, 782 F.2d 468, 471-72 (5th Cir. 1986), or that it applied incorrect legal standards in reaching its decision, see Forbush v. J. C. Penny Co., 994 F.2d 1101, 1104-05 (5th Cir. 1993). Therefore, the Court must conduct a "rigorous analysis" of the rule 23 requirements before certifying a class. General Tel. Co. v. Falcon, 457 U.S. 147, 161, 102 S.Ct. 2364, 2372, 72 L.Ed.2d 740 (1982); Castano, 84 F.3d at 740. This is particularly true with respect to questions of predominance and superiority under subdivision 23(b)(3) which necessitates a close look at "the difficulties likely to be encountered in the management of a class action." Amchem Prods., Inc. v. Windsor, 521 U.S. 591, 117 S.Ct. 2231, 2246, 138 L.Ed.2d 689 (1997); MANUAL FOR COMPLEX LITIGATION § 30.11 (3d ed. 1995). Finally, while th Court may not consider the merits of plaintiffs' claims at the certification stage, see Eisen v. Carlisle Jacquelin, 417 U.S. 156, 177-78, 94 S.Ct. 2140, 40 L.Ed.2d 732 (1974), it may look past the pleadings to the record and any other completed discovery to make the certification decision. See General Tel. Co. of Southwest v. Falcon, 457 U.S. 147, 160, 102 S.Ct. 2364, 72 L.Ed.2d 740 (1982) (holding that a decision on class certification remains a fact specific determination); Castano, 84 F.3d at 744. Mindful of these considerations, the Court now turns to the substantive arguments of Plaintiffs' motion, and the requirements of Rule 23.
III. DISCUSSION
"A class action is not maintainable as a class action by virtue of it designation as such in the pleadings." In re American Med. Sys., Inc., 75 F.3d 1069, 1079 (6th Cir. 1996). Thus, the proposed class must satisfy the requirements for certification outlined in Rule 23(a) and (b). To begin, "every proposed class action must satisfy the four, well-known prerequisites of Rule 23(a)." Shaw v. Toshiba Am. Info. Sys., Inc., 91 F. Supp.2d 942, 955 (E.D. Tex. 2000). The 23(a) prerequisites include:
(1) numerosity (a class so large that joinder of all members is impracticable); (2) commonality (questions of law or fact common to the class); (3) typicality (named parties' claims or defenses are typical of the class); and (4) adequacy of representation (representatives will fairly and adequately protect the interests of the class).Amchem, 521 U.S. at 614, 117 S.Ct. at 2245 Once the prerequisites of Rule 23(a) are met, a party must show that class treatment is appropriate under one of the alternative, class categories outlined in Rule 23(b). See id. In this instance, Plaintiffs seek class certification under subsection 23(b)(3), which sets out two requirements — predominance and superiority. FED. R. Civ. P. 23(b)(3). Furthermore, as the party seeking certification, Plaintiffs bear the burden of establishing all of the requirements for class certification under Rule 23(a) and (b)(3). See Castano, 84 F.3d at 743 (holding that a court cannot rely on assurances of counsel that any problems with predominance or superiority can be overcome).
Plaintiffs, however, do not seek certification of their entire action for class treatment. Instead, Plaintiffs propose to severe certain common issues under Rule 23(e)(4)(A), and proceed with two phases of litigation. Phase I of the litigation, on behalf of the class representatives and a national class, would focus on Defendants' liability for a defective product and punitive damages. Specifically, Phase I would seek to establish Defendants' liability for knowingly or negligently placing a defective product into the stream of commerce; for the design, manufacture, marketing, distribution, or sale of a defective product; for failure to warn of the product defect; for breach of warranties; and for fraudulent and negligent misrepresentations about the product. In addition, Phase I would determine class members' eligibility for punitive damages. The first phase would fully litigate and resolve these claims, including causation and damages, for the named Plaintiffs. Assuming the proposed class is successful in establishing liability in Phase I of the litigation, absent class members would take these findings to their respective home states and initiate the second phase of litigation. Through individual trials, Phase II of the litigation would seek to prove that Defendants' conduct proximately caused the harm suffered by individual class members and the amount of compensatory and punitive damages.
Interestingly, Plaintiffs abandon their fraud claims and proceed with the product liability theory of failure to warn or non-obvious defects. ( See Doc. No. 112 at 64.)
A. The Standard for Certification Under Rule 23(c)(4)(A)
In general, the Federal Rules of Civil Procedure provide a district court with the authority to bifurcate certain issues and claims for trial. See FED. R. Civ. P. 42(b). With respect to class certification, Rule 23(c)(4)(A) states that: "When appropriate an action may be brought or maintained as a class action with respect to particular issues." FED. R. Civ. P. 23(c)(4)(A). Commentators have observed that Rule 23(c)(4)(A) "is particulary helpful in enabling courts to restructure complex cases to meet the other requirements for maintaining a class action." 7A CHARLES ALAN WRIGHT, ARTHUR R. MILLER MARY KAY KANE, FEDERAL PRACTICE AND PROCEDURE § 1780 at 562 (2d ed. 1986). "The theory of Rule 23(c)(4)(A) is that the advantage and economies of adjudicating issues that are common to the entire class on a representative basis should be secured even though other issues in the case may have to be litigated separately by each class member." Id.
However, the Fifth Circuit prohibits courts from using Rule 23(c)(4)(A) to circumvent the predominance requirement in Rule 23(b)(3):
A district court cannot manufacture predominance through the nimble use of subdivision (c)(4). The proper interpretation of the interaction between subdivisions (b)(3) and (c)(4) is that a cause of action, as a whole, must satisfy the predominance requirement of (b)(3) and that (c)(4) is a housekeeping rule that allows courts to sever the common issues for a class trial. Reading rule 23(c)(4) as allowing a court to sever issues until the remaining common issue predominates over the remaining individual issues would eviscerate the predominance requirement of rule 23(b)(3); the result would be automatic certification in every case where there is a common issue, a result that could not have been intended.Castano v. American Tobacco Company, 84 F.3d 734, 745 n. 21 (5th Cir. 1996). This prohibition was reaffirmed by the Fifth Circuit in Allison v. Citgo Petroleum Corp., 151 F.3d 402, 422 (5th Cir. 1998). In Mullen v. Treasure Chest Casino, the Fifth Circuit was careful to distinguish the bifurcated class action in that case from the "`Frankenstein's monster' feared in Castano, 84 F.3d at 745, n. 19." 186 F.3d 620 (5th Cir. 1999). Thus, Fifth Circuit case law clearly mandates that Rule 23(c)(4)(A) does not operate independently from the rule of predominance found in Rule 23(b)(3). Guided by this precedent, the Court examines Plaintiffs' proposed "issues class" in conjunction with the requirements of Rule 23(b)(3).
Because the Court finds that Plaintiffs' class fails the necessary requirements of subsection 23(b)(3), it does not address the prerequisites set forth in Rule 23(a) ( i.e., numerosity, commonality, typicality, and adequacy of representation).
B. FED. R. Civ. P. 23(b)(3) — Predominance and Superiority
Plaintiffs move this Court to certify a nationwide, products liability/personal injury class under Rule 23(b)(3). Accordingly, Plaintiffs bear the burden of establishing the elements of Rule 23(b)(3). The two requirements of Rule 23(b)(3) are "predominance" and "superiority": "Common questions must `predominate over any questions affecting only individual members'; and class resolution must be `superior to other available methods for the fair and efficient adjudication of the controversy.'" Amchem, 521 U.S. at 615, 117 S.Ct. at 2246 (quoting FED. R. Civ. P. 23(b)(3)). Subdivision (b)(3) parallels subdivision (a)(2) in that both require that common questions exist, but subdivision (b)(3) contains the more stringent requirement that common issues "predominate" over individual issues. 1 HEBERT B. NEWBERG ALBA CONTE, NEWBERG ON CLASS ACTIONS § 3.10, at 3-56 (3d ed. 1992). Rule 23(b)(3) applies to cases for which "a class action would achieve economies of time, effort, and expense, and promote uniformity of decision as to persons similarly situated, without sacrificing procedural fairness or bringing about other undesirable results." Amchem, 521 U.S. at 615, 117 S.Ct. at 2246. Whether common issues predominate and the class action is superior requires an understanding of the relevant claims, defenses, facts, and substantive law presented in the case. See Castano, 84 F.3d at 744.
1. Variations in State Law
"In order to make the findings required to certify a class action under Rule 23(b)(3) . . . one must initially identify the substantive law issues which will control the outcome of the litigation." Alabama v. Blue Bird Body Co., 573 F.2d 309, 316 (5th Cir. 1978). In Castano v. American Tobacco Company, the Fifth Circuit made it absolutely clear that the trial court must determine "which law will apply before making a predominance determination" and that determining the applicable law "is especially important when there may be differences in state law." 84 F.3d at 741 (warning that the "proliferation of disparate factual and legal issues is compounded exponentially" when the law of multiple jurisdictions apply). The Court of Appeals reaffirmed this obligation in Spence v. Glock, holding that "[t]he district court's predominance finding depends on its choice of law analysis." 227 F.3d 308, 311 (5th Cir. 2000). A court's failure to conduct a proper choice of law analysis by itself is an abuse of discretion and precludes certification. See id. at 310 n. 3 (reversing the district court's certification for failure to conduct a proper choice of law analysis). Because Plaintiffs bear the burden of satisfying all Rule 23 requirements, they must present a sufficient choice of law analysis and demonstrate that common questions of law predominate. See id. at 313 (citing Castano, 84 F.3d at 741).
A federal court sitting in diversity must look to the forum state's choice of law rules to determine the controlling substantive law. See Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487, 496, 61 S.Ct. 1020, 85 L.Ed. 1477 (1941); see also W.R. Grace Co. v. Continental Gas Co., 896 F.2d 865, 873 (5th Cir. 1990) (holding that the choice of law rules used to determine the substantive law in a diversity case depends on where "the district court sits"). Texas, the forum state here, applies the "most significant relationship test", which is guided by the principles outlined in Sections 6 and 145 of the Restatement (Second) of Conflicts. See Duncan v. Cessna Aircraft Co., 665 S.W.2d 414, 421 (Tex. 1984); Gutierrez v. Collins, 583 S.W.2d 312, 318 (Tex. 1979) (adopting the most significant relationship test for tort choice of law issues). Texas choice of law rules under Section 6 of the Restatement (Second) of Conflict of Laws are as follows:
(1) A court, subject to constitutional restrictions, will follow a statutory directive of its own state on choice of law.
(2) When there is no such directive, the factors relevant to the choice of the applicable rule of law include
(a) the needs of the interstate and international systems,
(b) the relevant policies of the forum,
(c) the relevant policies of other interested states and the relative interests of those states in the determination of the particular issue,
(d) the protection of justified expectations,
(e) the basic policies underlying the particular field of law,
(f) certainty, predictability and uniformity of result, and
(g) ease in the determination and application of the law to be applied.
Section 145 concerns choice of law for issues in tort, and states that:
(1) The rights and liabilities of the parties with respect to an issue in tort are determined by the local law of the state, which, with respect to that issue, has the most significant relationship to the occurrence and the parties under the principles stated in § 6.
(2) Contacts to be taken into account in applying the principles of § 6 to determine the law applicable to an issue include:
(a) the place where the injury occurred,
(b) the place where the conduct causing the injury occurred,
(c) the domicile, residence, nationality, place of incorporation and place of business of the parties, and
(d) the place where the relationship, if any, between the parties is centered. These contacts are to be evaluated according to their relative importance with respect to the particular issue.
Restatement (Second) of Conflict of Laws § 145. The trial court should evaluate these contacts for their quality, not their quantity when conducting its choice-of-law analysis. See Gutierrez, 528 S.W.2d at 319. Texas also requires that a choice of law determination be conducted on an issue by issue basis. See Spence, 227 F.3d at 311, n. 6. In addition, the Court must examine the relevant interest and policies of each state with contacts. See id. at 313 (quoting In re Ford Motor Co. Bronco II Product Liability Litigation, 177 F.R.D. 360, 370-71 (E.D. La. 1997)). Thus, this Court's choice of law analysis necessarily involves the potential interests and relevant policies of all 50 states, the District of Columbia, and Puerto Rico.
See Restatement (Second) of Conflict of Laws § 6 cmt.f ("In determining a question of choice of law, the forum should give consideration not only to its own relevant policies . . . but also to the relevant policies of all other interested states."); Restatement (Second) Conflict of Laws § 145 cmt.e ("[T]he forum should give consideration to the relevant policies of all potentially interested states.").
The difficulties associated with conducting a choice-of-law analysis in this case can be summarized with one word — nationwide. The Fifth Circuit warned that conflict-of-law issues can be torturous where class members come from many states: "In a multi-state class action, variations in state law may swamp any common issues and defeat predominance." Castano, 84 F.3d at 741. The Fifth Circuit's reasoning is multiplied in the context of a nationwide class action. As one commentator explained:
Beyond the difficult task of correctly determining foreign law, the nationwide class action may present an even greater problem because of the sheer burden of organizing and following fifty or more different bodies of complex substantive principles. Although the comparison obviously is inexact, one can appreciate the magnitude of the trial judge's task by imagining a first-year law student who, instead of a course in contracts, is required simultaneously to enroll in fifty courses, each covering the contract law of a single state, and to apply each body of law correctly on the final examination. Another way to appreciate the dimension of the task is to consider that fifty opinions are more than most appellate judges write in a year.
Arthur R. Miller David Crump, Jurisdiction And Choice Of Law In Multistate Class Actions After Phillips Petroleum Co. v. Shutts, 96 YALE L.J. 1, 64 (1986). In fact, no appellate court has approved the certification of a nationwide products liability/personal injury class. See e.g., Castano, 84 F.3d 734, 745 n. 21 (5th Cir. 1996); Spence, 227 F.3d 308, 311 (5th Cir. 2000); In re American Medical Systems, 75 F.3d 1069, 1085 (6th Cir. 1996) (stating that there is "a national trend to deny class certification in drug or medical product liability/personal injury cases"); In re Rhone-Poulenc Rorer, Inc., 51 F.3d 1293, 1300 (7th Cir. 1995); Valentino v. Carter-Wallace, Inc., 97 F.3d 1227 (9th Cir. 1996); Zinser v. Accufix Research Institute, Inc., 2001 WL 668939 (9th. Cir. (Cal.)).
Subsequent decisions by the Federal Circuit Courts indicate that they agree with Professor Miller on this point. See, e.g., Castano, 84 F.3d at 741-42, In re American Medical Systems, 75 F.3d 1069, 1085 (6th Cir. 1996); In re Rhone-Poulenc Rorer, Inc., 51 F.3d 1293, 1300 (7th Cir. 1995).
The cases cited in Plaintiffs' brief supporting certification of a products liability/personal injury class are easily distinguishable from this case because they lack the insurmountable obstacle of a national class. The court in In re Copley Pharmaceutical I never made the choice of law analysis this Court is required to make under Spence. 158 F.R.D. 485 (D. Wy. 1994). In In re Telectronics Pacing Systems, the plaintiffs' first attempt at a general nationwide certification failed because they could not manage the variations in state law. Their second attempt at certification was approved only after plaintiffs developed an elaborate subclass proposal. See In re Telectronics Pacing Sys, Inc., 172 F.R.D. at 278. More importantly, there is no case in the Fifth Circuit certifying a national class action. Jenkins v. Raymark Indus. Inc., did not involve a nationwide or even statewide class, no choice-of-law issues were present, and all proceedings were to take place in the same district court. 782 F.2d 468, 473 (5th Cir., 1986). In Castano, the Fifth Circuit highlighted the distinctions in Jenkins:
Jenkins involved only 893 personal injury asbestos cases, the law of only one state, and the prospect of trial occurring in only one district. Accordingly, for purposes of the instant case, Jenkins is largely inapposite.Castano, 84 F.3d at 744. Likewise, Mullen was not a nationwide class requiring the laws of multiple jurisdictions to be applied. The class in Mullen was 100-150 plaintiffs, all allegedly injured on a single boat at a single location in Louisiana, with the same body of federal Jones Act and maritime law to be applied to all the claims. It was precisely these facts that the Mullen court used to distinguish the case before it from Castano:
The district court based its superiority finding on the fact that the class litigation in this case would not present the degree of managerial complexities that prompted this Court to decertify the putative class in Castano. Specifically, the district court mentioned the lack of any complex choice-of-law or Erie problems, and that the class would consist of only hundreds, instead of millions, of members.Mullen, 186 F.3d at 627.
Even Plaintiffs acknowledge that the products liability laws of the 52 jurisdictions vary, and that "each jurisdiction has articulated and asserted a policy interest in protecting their citizens against injury caused by negligence and fraud and almost every jurisdiction has adopted specific products liability tort theories." (Doc. No. 74 at 32.) Nevertheless, Plaintiffs contend that Texas has the "most significant relationship" to the issues to be decided on behalf of the proposed national class. ( See id. at 33.) Based on the supposed distinction between the different choice-of-law considerations that apply to the first phase class issues and the second phase issues of causation and damages, Plaintiffs conclude that:
"[A]n important factor in determining the law that should apply — `the place where the conduct causing the injury occurred' — points to Texas. The epicenter of disputed contacts causing injury is in Texas and fully supports a determination that Texas law should be applied on behalf of the national class."
( Id.) However, the Fifth Circuit rejected a similar "attempt to finesse the choice of law by omitting comparison of law" other than the forum state in Spence v. Glock. 227 F.3d at 313 (noting that: " Castano is predicated squarely on the court's duty to determine whether the plaintiffs have borne their burden where a class will involve multiple jurisdictions and variations in state law."). In Spence, the district court concluded that Georgia law could be applied to all the class members because the guns in question were imported, assembled, tested, and distributed from Georgia. See id. The Fifth Circuit disagreed with the trial court's choice-of-law analysis, and stated:
[W]hile the actual contacts with Georgia are certainly enough to suggest that Georgia has more than a negligible relationship to the tort issues in this case, they are not so overwhelming that it is clear that Georgia has the most significant relationship to those issues. To answer that question, one must compare Georgia's contacts and the state policies those contacts implicate with those of the 50 other interested jurisdictions.
The central problem with the district court's opinion is its failure to make this comparison. . . . Critically, the court did not examine the relationship of other interested states — for example, the states where class members bought their guns — to the tort issues, as Section 6 [of the RESTATEMENT] requires. If it had, it would have recognized that this case implicates the tort policies of all 51 jurisdictions of the United States, where proposed class members live and bought Glock pistols.Id. at 312-13.
Similarly, Plaintiffs' choice-of-law analysis ignores the difficulties associate with their proposed "nationwide" class: (1) members of the putative class live in 52 jurisdictions; (2) class members' surgeries were likely performed in 52 jurisdictions; (3) sales of the sutures used in class members' surgeries likely occurred in 52 jurisdictions; and (4) class members' alleged injuries occurred in 52 jurisdictions. Furthermore, Plaintiffs' analysis "understates the importance that place of injury plays in a tort choice of law analysis." Spence, 227 F.3d at 315. Section 145, comment e, of the Restatement emphasizes that "[i]n the case of personal injuries. . . . the place where the injury occurred is a contact that, as to most issues, plays an important role in the selection of the state of the applicable law." Restatement (Second) of Conflict of Laws § 145 cmt. e. Section 145 further states that "[c]hoice of the applicable law becomes more difficult in situations where the defendant's conduct and the resulting injury occurred in different states." Id. Thus, even if the Court accepts Plaintiffs' contention that the conduct causing their injury occurred only in Texas, the Restatement requires this Court, for purposes of the strict liability claims, to examine the products liability laws of each jurisdiction in which a putative class member developed an infection because each such jurisdiction is a place where an injury occurred. Again, the reasons for such an analysis are clearly outlined in Spence. Each state's approach to products liability represents the way in which that state deals with a variety of issues, including the protection of its citizens from defective products, regulating commerce within the state, and regulating the state's tort system. This Court must know what purposes are at work in each jurisdiction's product liability laws in order to make its choice of law analysis. The description of varying state laws offered by Plaintiffs fails to consider the purposes behind the products liability laws of the other jurisdiction with contacts to this case. If the Court is required to know which law will apply before it makes its predominance determination, then Plaintiffs must supply adequate information on the policies of other interested states relevant to the choice of law. Under the watchful eyes of Castano and Spence, this Court cannot conduct a choice of law analysis that fails to carefully consider the potential interests and relevant policies of the other 51 jurisdictions.
2. Predominance
In order for common issues to predominate they must constitute "a significant part of the individual cases." Mullen, 186 F.3d at 626 (quoting Jenkins, 782 F.2d at 472). "The predominance requirement serves two functions. It assures a court that adjudicating related claims in a single proceeding will conserve resources and yield economies of scale. It also protects absent plaintiffs' rights to due process by showing that a class is cohesive." Shaw, 91 F. Supp.2d at 955, However, when individual rather than common issues predominate, the "economy and efficiency of class action treatment are lost and the need for judicial supervision and the risk of confusion are magnified." 7A CHARLES ALAN WRIGHT, ARTHUR A. MILLER MARY KAY KANE, FEDERAL PRACTICE AND PROCEDURE § 1778 at 535-39 (2d. ed. 1986).
In Shaw, this Court certified a nationwide, settlement class brought against a computer manufacturer by purchasers of allegedly defective computers. In certifying the Shaw class, the Court noted the lack of personal injuries and choice of law problems, and concluded that Shaw was "an even better candidate for certification than Treasure Chest." Id. at 957-58.
In medical devise products liability litigation, individual factual and legal issues often differ dramatically because there is no common cause of injury. In re American Medical Sys., Inc., 75 F.3d 1069, 1084 (6th Cir. 1996) (distinguishing a mass tort action arising out of a single accident).
In products liability actions, however, individual issues may outnumber common issues. No single happening or accident occurs to cause similar types of physical harm or property damage. No one set of operative facts establishes liability. No single proximate cause applies equally to each potential class member and each defendant. Furthermore, the alleged tortfeasor's affirmative defenses (such as failure to follow directions, assumption of the risk, contributory negligence, and the statute of limitations) may depend on fact peculiar to each plaintiff's case.In re American Medical Sys., Inc., 75 F.3d at 1084-84 (quoting In re Northern Dist. of Calif, Dalkon Shield IUD Prods. Liab. Litig., 693 F.2d 847, 853 (9th Cir. 1982). It is fair to assume that despite the efforts of the medical profession and hospitals, there is a "normal" background rate of post-surgery infections. In the United States this background rate is approximately one to three million post-surgical site infections each year. (R.R. p. 208-09.) Infections can be caused by different species of bacteria, with different abilities to cause infection, different growth and survival characteristics, and different environmental sources. Some species are more likely to cause infections at one surgical cite rather than another. See, e.g., Alicia J. Mangram, et al., Guideline for Prevention of Surgical Site Infection, 1999,20 INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY 247 (1999). The numerous individual issues in this case illustrate the difficulty in certifying a medical device/products liability class.
Here, the evidence presented at the certification hearing indicated a number of potential sources for nosocomial surgical site infections, including the plaintiffs' own microbioflora, the surgical team, the instruments used during surgery, hospital dressing changes, the personal wound care by the plaintiffs, and blood-borne infections from a distant site. (R.R. p. 262-263; R.R. p. 222-26.) Indeed, it is well-documented that a post-surgical infection can be caused by a wide variety of factors other than the sutures used in Plaintiffs' surgeries, including contamination from the surgical team, from the operating room, from post-surgical care, or from patients themself. See, e.g., Elizabeth Norman, For Want of Soap and Water, N.Y. TIMES, May 27, 2000; Alicia J. Mangrarn, et al., Guideline for Prevention of Surgical Site Infection, 1999,20 INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY 247 (1999). Furthermore, evidence shows that Plaintiffs' infections were not caused by the same micro-organism, and cannot be attributed to a single bacterial agent. (R.R. p. 276). Moreover, Plaintiffs concede that not all Vicryl sutures processed by the SP-1 were contaminated. As long as the evidence provides that some of the Vicryl sutures were sterile, the Phase I jury cannot make the global determination that all the sutures were defective. Instead, the issue of whether a given suture was defective is an individual one to be determined on a plaintiff by plaintiff basis. Likewise, the Phase I jury cannot determine Defendants' liability without considering the liability of potentially responsible third parties.
A nosocomial infection is a hospital-acquired infection. (R.R. Testimony of Dr. Rhame, p. 280.)
In reaching a finding of Rule 23(b)(3) predominance, both the Copley and Telectronics courts concluded that there was no possibility that the contributory or comparative negligence of plaintiffs or third parties caused or contributed to plaintiffs' injuries under the facts presented in each case. In Telectronics, the court rejected the "possibility that external forces such as doctor error are the reasons for the fractures" of the leads of the implant devices at issue there. 172 F.R.D. at 289; see also Copley II 161, F.R.D. 456, 461 (D.Wy. 1995) (rejecting possibility of claims that plaintiffs' own contributory negligence caused injury in light of nature of infection). By contrast, here there is a nationwide background rate of 1-3 million post-operative infections each year and a likelihood that contributory negligence on the part of class members and third persons caused Plaintiffs' infections. A trier of fact cannot evaluate the liability of Defendants without conducting a separate analysis of how each of these facts relate to Plaintiffs.
Ultimately, the battle in Plaintiffs' individual lawsuits will be fought over causation. Whether Plaintiffs received a contaminated suture and whether that suture caused the infection complained of is the crux of whether Plaintiffs will be able to recover. An essential element of negligence, even under Plaintiffs' analysis, is cause in fact. Thus, any negligence of any Defendant found in the proposed Phase I trial is immaterial if an individual plaintiff is unable to establish that negligence caused an actual injury. See, e.g., El Chico v. Poole, 732 S.W.2d 306, 313 (Tex. 1987) (restating the concept that "[p]roximate cause consists of cause in fact and forseeability"). Based on the evidence provided to date the Court concludes that the individual issues of causation and comparative fault will predominate over Plaintiffs' proposed common issues.
Representative Plaintiffs cannot even be sure at this stage they received sutures subject to the recall and that they are members of the class they purport to represent. ( See, e.g., R.R. 82, 180, 207.)
3. Superiority
"When a dispute could conceivably be handled in any of several ways, the superiority requirement allows a trial court to certify a (b)(3) class when this is reasonably thought to be the most practical and sensible manner of proceeding." Shaw, 91 F. Supp.2d at 958. There are four primary, but non-exhaustive, factors this Court must consider in determining whether a class action is superior pursuant to Rule 23(b)(3):(1) the interests of the class members in individually controlling separate actions; (2) the extent and nature of any litigation already commenced by the class; (3) the desirability of concentrating the litigation of the claims in the particular forum in which the class action is pending; and (4) the difficulties likely to be encountered in the management of the class action. See id. "A consideration of these factors requires the court to focus on the efficiency and economy elements of the class action so that cases allowed under subdivision (b)(3) are those that can be adjudicated most profitably on a representative basis." 7A CHARLES ALAN WRIGHT, ARTHUR R. MILLER MARY KAY KANE, FEDERAL PRACTICE AND PROCEDURE § 1780 at 562 (2d ed. 1986). Thus, the Court's inquiry into superiority again "requires an understanding of the relevant claims, defenses, facts, and substantive law presented in the case." Allison v. Citgo Petroleum Corp., 151 F.3d 402, 419 (5th Cir. 1998); see also FED. R. CIV. P. 23(b)(3) (requiring a court to consider "the difficulties likely to be encountered in the management of a class action"). In fact, it is an abuse of discretion to certify a class without adequately considering "how a trial on the alleged causes of action would be tried." Castano, 84 F.3d at 751.
"In most class actions — and those the ones in which the rationale for the procedure is most compelling — individual suits are infeasible because the claim of each class member is tiny relative to the expense of litigation." In re Rhone-Poulenc Rorer Incorporated, 51 F.3d 1293, 1299 (7th Cir. 1995). Under the facts of this case, the individual class members have a significant economic interest in "individually controlling the prosecution" of their own claims. FED. R. CIV. P. 23(b)(3)(A). The evidence offered at the certification hearing regarding the severity of Plaintiffs' injuries establishes that their claims are not negative value claims. Indeed, Plaintiffs expressly plead that "[w]ithout reference to punitive damages, the amount in controversy in compensatory damages for each Plaintiff and Class Member exceeds the sum of $75,000, exclusive of interest and costs." (Doc. No. 89.) The likelihood of significant recovery is obvious if Plaintiffs establish liability and injury in fact. In Phone-Poulenc, the Seventh Circuit indicated that when individual claims have significant independent value, individual suits do not waste judicial resources and provide a diverse and fairer sample of verdicts for use in evaluating the claims. Rhone-Poulenc, 51 F.3d at 1300. The Court concludes that the members of the class have a significant interest in "individually controlling the prosecution or defense of separate actions." Rule 23(b)(3)(A).
The Rule 23(b)(3)(B) inquiry serves two purposes. First, it informs the court as to the status of other pending litigation. Second, it informs the court as to how other trials have been conducted so it can determine "whether the [alleged] common issues would be a `significant' portion of the individual trials." Castano, 84 F.3d at 745. The second factor is more important here — both in assessing whether common issues of fact predominate and whether the class device would be superior. With respect to individual cases, including claims brought by one of the putative class counsel, some have been negotiated and settled. Some have been dismissed or otherwise resolved based on individual limitations questions. Some have been disposed of by summary judgment or other pretrial procedure due to lack of proof of causation. Moreover, the majority of litigation is not currently concentrated in the Eastern District of Texas. To the contrary, the claims of over one-hundred twenty-five plaintiffs are in California and coordinated in Judicial Council Coordination Proceeding ("JCCP") No. 4148. The claims of thirty test plaintiffs in California state court are set to commence trial in July, 2002.
Class counsel presently before this Court represent the vast majority of Plaintiffs (by the Court's estimate over 90% of the actions filed) throughout the nation.
At this stage, with the limited litigation history available, this Court cannot know which view accurately reflects how individual trials would proceed, and therein lies the problem:
[A] mass tort cannot be properly certified without a prior track record of trials from which the district court can draw the information necessary to make the predominance and superiority analysis required by rule 23. This is because certification of an immature tort results in a higher than normal risk that the class action may not be superior to individual adjudication.Castano, 84 F.3d at 747. True, products liability/personal injury is not the type of immature tort theory contemplated by the Fifth Circuit in Castano. However, "[i]n the context of Rule 23(b)(3), the immature tort theory has a much broader meaning then its mere name would suggest. The immature tort can refer to a new cause of action, or an old cause of action applied to a new situation." Arch v. American Tobacco Co., 175 F.R.D. 469, 494 (E.D. Pa. 1997). See also In re Norplant Contraceptive Prods. Liab. Litig., 168 F.R.D. 577, 578 (E.D. Tex. 1996) (denying certification in a medical/products liability action because "individual trials are necessary in order to allow the court to make an informed decision regarding whether common issues predominate and whether certification of a class is superior to other methods for handling this litigation"). Before certifying any "common issues" class, this Court must be certain that Plaintiffs' Phase I issues are not only common, but predominate as well. Plaintiffs cannot establish such predominance at this stage, nor demonstrate from prior litigation that such an approach would be the superior method of adjudication.
The Rule 23(b)(3)(D) inquiry into "the difficulties likely to be encountered in the management of a class action" requires this Court to determine how this case will actually be tried and submitted to a jury. Plaintiffs' proposed "issues class" and bifurcated trial plan pose threats to the Court's Art. III powers and the "re-examination clause" of the Seventh Amendment.
To begin, this Court's judicial power is limited to deciding cases and controversies. U.S. CONST. art. III. That power does not include the issuance of advisory opinions or the determination of abstract issues, even when the parties are in an adversary posture to one another. See Muskrat v. United States, 219 U.S. 346 (1911). Therefore, Rule 23's requirements must be interpreted in keeping with Article III constraints. Amchem Prods., Inc., 521 U.S at 613; Ortiz v. Fibreboard Corp., 527 U.S. 815, 845 (1999). Accordingly, in each case there must be the possibility of a "definitive determination of the legal rights of the parties." Aetna Life Ins. Co. v. Haworth, 300 U.S. 227, 241 (1937).
Although Plaintiffs state that the proposed Phase I trials "will seek to establish the liability of the defendants" (Doc. No. 74 at 1), this is not an accurate description of what the first phase will involve. Essentially, Plaintiffs ask this Court to preside over a trial in which the Phase I jury makes certain factual findings preliminary to a finding of liability. The Phase I trial will not establish Defendants' liability to any absent class member. The Phase I trial will not provide absent members with an enforceable, final judgment to take to their home courts. Still, Plaintiffs assume that findings from the Phase I litigation will be afforded full faith and credit and would be binding on Defendants and on all potential plaintiffs who did not opt out after reasonable notice. Plaintiffs offer no assurance that such findings would be respected in another jurisdiction. Moreover, unlike the trial judge in Mullen, this Court will have no control over the second phase of litigation. There, the judge clearly intended that all Phase II trials would take place in his court so he could control the second trials and give consistent guidance to the subsequent juries about the proper scope of their responsibilities. Here, all the Court can do is cross its fingers and hope that the second phase judge and jury get it right. This leap-of-faith approach to litigation is neither manageable nor superior.
Furthermore, before certifying the proposed issues class, this Court must satisfy itself that the bifurcated trial plan will not run afoul of the "re-examination clause" of the Seventh Amendment. The Seventh Amendment "re-examination clause" provides that "[n]o fact tried by jury, shall be otherwise reexamined in any Court of the United States . . ." U.S. CONST. Amend. VII. There is broad agreement that "[b]ifurcation and even finer divisions of lawsuits into separate trials are authorized in federal district. . . . . . . [a]nd a decision to employ the procedure is reviewed deferentially." See, e.g., In re Rhone-Poulenc Rorer Inc., 51 F.3d 1293, 1302 (7th Cir. 1995). Disagreement, where it exists, centers on the standard by which a potential violation of the Seventh Amendment should be judged and whether a given bifurcation plan violates that standard. The standard for determining Seventh Amendment violations is set forth by the Supreme Court in Gasoline Prods. Co. v. Champlin Ref Co., 283 U.S. 494 (1931). "The prohibition is not against having two juries review the same evidence, but rather against having two juries decide the same essential issues." Paine, Webber, Jackson Curtis, Inc. v. Merrill Lynch, Pierce, Fenner Smith, 587 F. Supp. 1112, 1117 (D. Del. 1984) (emphasis in original). As the court put it in Castano "[t]he Seventh Amendment entitles parties to have fact issues decided by one jury, and prohibits a second jury from reexamining those facts and issues. Castano 84 F.3d at 750.
The Court is not wholly convinced that Plaintiffs' proposed trial plan would not violate the Seventh Amendment. At the very least, the potential for a violation exists. Plaintiffs contend that "[a]bsent any real nexus between the Defendants' alleged conduct in this case, and the subsequent conduct of a class member that Defendants may offer as a defense, a natural separation exists between the proposed Phase I and Phase II trials." There are two obvious problems with Plaintiffs' argument. First it ignores the possible role third persons may play in causing a class members' infection and the comparative fault issues raised by the acts of third persons. That is, Plaintiffs' argument fails to consider the contributory negligence of the plaintiff and the comparative fault of yet unidentified parties such as doctors, nurses, hospitals, family care givers, etc. Second, Plaintiffs' argument acknowledges a nexus between Defendants' alleged conduct and the subsequent conduct of a class member. That nexus exists every time the conduct of a class member causes or enhances the effects of the infection allegedly caused by Defendants. Until this Court can be certain that no class member caused or enhanced his own infection, and that the infection was not caused or enhanced by third persons, Plaintiff's proposed class action and trial plan come too close to the edge of a Seventh Amendment violation.
The Court concludes, as have the appellate courts which have considered proposed nationwide personal injury class actions, that "the difficulties likely to be encountered in the management of [such] a class action" clearly indicate that a class action is not a superior method of adjudicating the plaintiffs' claims. Rule 23(b)(3)(D).
IV. CONCLUSION
It is difficult for the Court to disagree with the justness and logic of what Plaintiffs seek to accomplish by certifying a Rule 23(c)(4)(A) class of common issues. Nevertheless, as appealing as Plaintiffs' proposed "issues class" sounds, the arguments for certification are not compelling. Having conducted a "rigorous analysis" of the Rule 23 requirements and Fifth Circuit precedent, the Court concludes that there are too many individual issues in Plaintiffs' proposed class that defeat predominance and superiority, even though there is a common nucleus of facts concerning Defendants' conducts. Consequently, the requirements of Federal Rule of Civil Procedure 23(b)(3) have not been satisfied.
IT IS THEREFORE ORDERED that Plaintiffs' Opposed Motion for Class Certification (Doc. No. 91) is DENIED.