Opinion
Civil Action No. 9:99-2280-18RB
March 30, 2001
ORDER
Plaintiff's Motion for Conditional Class Certification for his medical monitoring claim is before me for resolution. Both Plaintiff and Defendant have briefed their positions. Thus, the matter is ripe for disposition.
This case concerns Plaintiff's allegations that he contracted hepatitis as a result of his use of oral Trovan, a prescription antibiotic designed by Defendant. Plaintiff's Complaint alleges that Defendant failed to adequately warn of the antibiotic's risk of liver toxicity and improperly designed the drug to be sold through retail pharmacies to a class of persons in non-limb and non-life threatening circumstances. Plaintiff further asserts that those who used the antibiotic have incurred and will incur the cost of obtaining periodic medical screening to diagnose and monitor their health. As a remedy, Plaintiff seeks, in part, that Defendant be ordered to contribute to a facility to be operated under court supervision to defray the costs of future medical monitoring services for the members of the putative class. Accordingly, Plaintiff asks the court to conditionally certify a Federal Rule of Civil Procedure 23(b)(2) class limited to Plaintiff's claim for injunctive relief in the form of a medical monitoring facility. Defendant opposes the motion.
Rule 23(a) sets forth the threshold requirements applicable to all class actions: 1) that the class is so large that joinder of all members is impracticable (known as the numerosity" factor); 2) that there exists questions of law or fact common to the class (or commonality"); 3) that the named party's claims or defenses are typical of the class ("typicality"); and 4) that the named representative will fairly and adequately protect the interests of the class ("adequacy"). Anchem Products, Inc. v. Windsor, 521 U.S. 591, 613 (1997). In addition to satisfying the Rule 23(a) prerequisites, a party seeking class certification must also show that the action may be maintained under the provisions of Rule 23(b). Rule 23(b)(2) permits class actions for declaratory or injunctive relief where "the party opposing the class has acted or refused to act on grounds generally applicable to the class." Plaintiff, as the moving party, bears the burden of proving that the requirements of certification have been met. Windham v. American Brands, Inc., 565 F.2d 59, 65 n. 6 (4th Cir. 1977). See also In Re American Medical Systems, Inc., 75 F.3d 1069, 1079 (6th Cir. 1996). Unless all of the foregoing have been satisfied, the court should not certify the class. In Re American Medical Systems, 75 F.3d at 1079.
As Plaintiff here has expressly limited his motion to Rule 23(b)(2), I shall not address the provisions under subsections (1) or (3).
In evaluating Plaintiff's motion, the court should accept the putative class representatives allegations as true but should also go beyond the pleadings to the extent necessary to understand the claims, defenses, relevant facts, and applicable substantive law in order to make a meaningful determination of the certification issues. General Tel. Co. of the Southwest v. Falcon, 457 U.S. 147, 160 (1982). In other words, the court must give "serious consideration" to each factor before concluding that a particular requirement has been met, including looking beyond the pleadings where necessary. In re American Medical Systems, 75 F.3d at 1082. Here, the parties were permitted to engage in discovery on class issues and have supplied the court with portions of deposition testimony, as well as documentary evidence in support of their respective positions, all of which have been taken into consideration. The ultimate decision as to whether class certification is appropriate, however, may not be based on an evaluation of the merits of the case. Eisen v. Carlisle Jacquelin, 417 U.S. 156, 178 (1974). Rather, the court should also consider that under Rule 23(c)(1), class certification may be conditional (as is the request for certification here) and must be revisited as the litigation progresses to determine whether, in light of the emerging facts, Plaintiff continues to sustain his burden.
Prior to engaging in any analysis, however, the first step in the process is to define the nature of the class Plaintiff seeks to certify. Plaintiff identifies the class members as those persons whose use of Trovan was not warranted" according to the FDA. Presumably, this means that the purported class would consist of those persons who were prescribed the drug during the time period in which Plaintiff contends Defendant failed to adequately warn of the risk of liver toxicity and when the drug was being sold through retail pharmacies to persons with non-limb and non-life threatening circumstances. It appears that Defendant first started marketing Trovan for sale in United States pharmacies in February of 1998. Thereafter, on June 9, 1999, the Food and Drug Administration (FDA) issued a Public Health Advisory finding that the drug should be reserved for use in patients with serious, life or limb threatening infections who receive their initial therapy in an in-patient care facility. On July 20, Defendant issued an "Important Drug Warning" notifying health care professionals of an increased drug warning consistent with the FDA assessment. Thus, the class should reasonably be structured around this February 1998 to July 1999 time period. (The actual parameters will, of course, remain a question of fact based on issues such as when the warnings were received and when it is reasonable to find that heath care professionals acted in accordance with the warnings.) The ultimate point for our purposes here is that the class is expected to address persons who were prescribed the drug during a finite time period. If Plaintiff is seeking a broader class, he does not set forth any argument supporting this assertion. In addition, I must assume that this class is meant to encompass all users of the medication within the United States, as Plaintiff makes no mention of limiting the class to South Carolinians or those who were prescribed or purchased the medication in this state. Therefore, my analysis will assume that the nationwide class Plaintiff seeks to have certified concerns a limited time period and involves not every person who consumed the drug but rather only those for whom its prescription was "not warranted."
Before moving on next to an evaluation of the individual factors to be proven to support class certification, it is perhaps best to discuss Plaintiff's chief complaint which overshadows the analysis of several of the elements. Plaintiff has cried foul concerning his perception that Defendant has switched horses midstream on some of the issues relevant to class certification on which it took an opposing view in seeking to maintain federal diversity jurisdiction. In defending against Plaintiff's motion to remand, Defendant put forth several factual assertions and legal arguments pertaining to the class claim, some of which were accepted by Judge Blatt in his July 6th Order denying Plaintiff's motion. Specifically, in order to support its assertion that the putative class member's claims should be aggregated in order to satisfy the amount-in-controversy, Judge Blatt adopted Defendant's assertions that the medical monitoring relief sought was injunctive in nature and that the class member's interest therein was a "common and undivided" one. Plaintiff argues that Defendant should be judicially estopped from changing its position on these issues.
"Judicial estoppel precludes a party from adopting a position that is inconsistent with a stance taken in prior litigation. The purpose of the doctrine is to prevent a party from playing fast and loose with the courts, and to protect the essential integrity of the judicial process."Lowery v. Stovall, 92 F.3d 219, 223 (4th Cir. 1996) (quoting John S. Clark Co. v. Faggert Frieden, P.C., 65 F.3d 26, 28-29 (4th Cir. 1995)). Certain elements must be met before courts will apply judicial estoppel. Id. First, the party sought to be estopped must be seeking to adopt a position that is inconsistent with a stance taken in prior litigation and the position sought to be estopped must be one of fact rather than of law or legal theory. Lowery, 92 F.3d. at 224. Next, the prior inconsistent position must have been accepted by the court as part of a final disposition. Id. Finally, the party must be found to have "intentionally misled the court to gain unfair advantage." Id. (quotingTenneco Chemicals, Inc. v. William T. Burnett Co., Inc., 691 F.2d 658, 665 (4th Cir. 1982)). Plaintiff does not begin to undertake this analysis; rather, Plaintiff proposes what is more akin to the "law of the case" doctrine, which applies to maintain a consistent ruling of law throughout subsequent stages in the same case. United States v. Aramony, 166 F.3d 655, 661 (4th Cir. 1999). The law of the case doctrine is not an absolute bar but rather is a discretionary limit or rule of practice. United States v. Carson, 793 F.2d 1141, 1147 (10th Cir. 1986). This is so because as a matter progresses the natural developments of continued discovery "often provide a much improved foundation for deciding the same issue." 18 Wright, Miller Cooper, FEDERAL PRACTICE AND PROCEDURE 2d: Jurisdiction § 1478, at 794 (1981). Plaintiff has not provided any discussion of this doctrine either.
Nonetheless, a thorough analysis under either doctrine is unnecessary at this point because there is no need to disturb Judge Blatt's findings that the relief sought by the class is primarily injunctive in nature and that there can be found to exist a common, undivided interest among members of the putative class in a medical monitoring facility. The parameters of "common" and "undivided" as found by Judge Blatt while examining jurisdiction, however, as compared to the more detailed analysis required now are different, even if some of the terminology is the same. Although the parties' earlier discourse touched upon some issues pertaining to the nature of the class, Judge Blatt was not undertaking the ultimate determination of whether class certification was proper. Rather, while considering the jurisdictional issues, Judge Blatt was, as a matter of course, required to assume that a class was properly certifiable. See Gilman v. Wheat, First Securities. Inc., 896 F. Supp. 507, 509 (D.Md. 1995) (cited in Plaintiff's Reply in Support of Motion to Remand at 4). His findings then cannot be said to be based on the merits of class certification any more than my decision here shall be based on an evaluation concerning the merits of the case, although I must consider facts which may touch on the merits.
The court nonetheless empathizes with Plaintiff's frustration with the seemingly suspect nature of a party proceeding with a quasi-factual position when it suits its desire to keep the case in the federal court's jurisdiction and then promoting the opposite claim when attempting to defeat class certification. Should I find that a legal position is being advanced in this manner, the law of the case doctrine would aid in preventing this inherent fraud upon the court. Plaintiff must be cautioned, however, that some of the positions he took in opposing jurisdiction are in some degree incongruous with his current position as well. Ultimately, the very nature of advocacy coupled with the limits of the language often result in such a seemly apparent conflict. Fundamentally, however, Judge Blatt's ultimate finding that federal jurisdiction in this matter is appropriate has had no impact on this court's decision with regard to class certification.
In attempting to hold Defendant to its "previous position," Plaintiff paints with a too broad brush. A determination made at such an early stage should be considered narrowly rather than liberally interpreted to encompass matters (both legal and factual) not actually before the court during its initial determination. Judge Blatt found a common, undivided interest; he did not make findings as to numerosity, typicality, adequacy or cohesiveness to the extent required under Rule 23(a) and (b). To hold otherwise at this stage would be to shirk this court's duty to give "serious consideration" to each factor before concluding that a particular requirement has been met. In re American Medical Systems, Inc., 75 F.3d at 1082. Therefore, with this in mind, I will look now to the Rule 23(a) factors relevant to my decision.
Plaintiff must first demonstrate that the purported class is so large that joinder of all members is impracticable. Whether the numerosity prong is met depends on the court's practical judgment, given the facts of the particular case. See General Tel. Co. of the Northwest, Inc. v. E.E.O.C., 446 U.S. 318, 330 (1980). Plaintiff need not state a number with specificity; a good faith estimate is ordinarily sufficient. 7A Wright, Miller Kane, FEDERAL PRACTICE AND PROCEDURE 2d § 1762, at 153. In the Fourth Circuit this requirement has been found to have been met with as few as 18 class members. See Cypress v. Newport News General and Nonsectarian Hospital Ass'n, 375 F.2d 648, 653 (4th Cir. 1967).
Here, Plaintiff asserts that an estimated 2.5 million prescriptions were written for Trovan from the time Defendant began marketing the drug in the United States in February 1998 until the FDA limited the antibiotic's use in June of 1999. of these, Plaintiff asserts approximately 140 cases of hepatic adverse events such as his have been documented. In addition, Plaintiff contends that around 300,000 prescriptions are currently written each month for the drug. Within this recitation of numbers, however, Plaintiff does not make any attempt to estimate how many of these prescriptions were written for persons whose use of the drug was "not warranted." Plaintiff maintains nonetheless that at least 2.5 million people were "potentially affected" during the pre-FDA warning time period and that this number is sufficient to meet the numerosity prong.
This assertion, however, is simply not adequate. As Defendant points out, the important number for our purposes here is the number of those who could have been injured by the challenged practices. Halsey v. Armour Co., 743 F.2d 199, 217 (4th Cir. 1984). Thus while Plaintiff need not identify the number of persons whose injuries have been detected, he should provide a reasonable estimate of the number of those who are believed to have been affected by the "challenged practices," or, in other words, received the medication under conditions in which it was "not warranted." After all, Plaintiff's Complaint cannot be read to say that the distribution of the medication was legally improper under any and all circumstances. Rather the claim is limited to those situations in which it was administered to persons with non-life and non-limb threatening infections or who were prescribed the drug without physician supervision. One who suffered an adverse effect after taking the drug for a life-threatening infection while under in-patient observation by his physician would not, presumably, be a member of the putative class as defined by the Complaint. Accordingly, as Plaintiff has supplied no information in this regard, I cannot find that he has sustained his burden concerning the numerosity factor.
In addition, although each person whose use of the drug was "not warranted' may have a common, undivided interest in a medical monitoring facility, determining from the onset who would properly be included in that class presents major hurdles. As far as I can determine, some type of evidentiary hearing will be required in order to untangle the subjective issues as to whether each potential member of the class was threatened with a life or limb-threatening infection at the time of his prescription and whether he was being monitored by his physician in a manner consistent with the FDA's warnings. In the court's view, given Plaintiff's estimate that the class potentially involves 2.5 million people, this situation presents a logistical chimera for which Plaintiff has not provided a workable solution.
In addition, Plaintiff has also failed to sustain his burden to demonstrate that he will adequately represent the class. In order to be an adequate class representative, a named plaintiff must not have claims which are antagonistic to or in conflict with those of the other class members and must have sufficient interest in the outcome of the case to ensure vigorous advocacy. See Dhamer v. Bristol-Myers Squibb Co., 183 F.R.D. 520, 527 (N.D. Ill. 1998). A fundamental flaw with Plaintiff proceeding to represent a medical monitoring class is the fact that South Carolina has not recognized a cause of action for medical monitoring. Plaintiff blithely waives off any challenge on this point by stating that to the extent variations exist in the state laws concerning this claim they can be addressed with subclasses. Reply Brief at 14. Plaintiff, however, has failed to undertake the detailed analysis of the differences among the various jurisdictions to aid the court in determining what these subclasses might be. See Castano v. American Tobacco Co., 84 F.3d 734, 742 (5th Cir. 1996) (finding that court erred in failing to consider state law variations and their effects on class concerns); Walsh v. Ford Motor Co., 807 F.2d 1000, 1017 (U.S.App.D.C. 1986) (holding that nationwide class action movants must credibly demonstrate, through extensive analysis of state law variances, that class certification does not present insuperable obstacles.). See also, Ball v. Joy Technologies, 958 F.2d 36, 39 (4th Cir. 1991) and Bower v. Westinghouse Elec. Corp., 522 S.E.2d 424 (W.Va. 1999) (illustrating the variations of the interpretation of the cause of action simply within the Fourth Circuit). I cannot simply rely on counsel's assurances that any problems on this point can be overcome. See Castano, 84 F.3d at 741.
Even if I were to reserve decision as to subclasses until a later time, however, the fundamental flaw with Plaintiff's representation of the class is the fact that Plaintiff could not himself be eligible for the recovery sought. As such, he cannot be said to have sufficient interest in the outcome; neither he nor any of his neighbors in South Carolina, for that matter, could benefit from the monitoring facility. Simply put, he has failed to demonstrate that he has a legal interest sufficient to proceed on this cause of action. Nor can Plaintiff cure this infirmity by arguing that his inadequacy is immaterial because the court can allow an alternate plaintiff to serve as the class representative. While a "different case would be presented if the District Court has certified a class and only later had it appeared that the named plaintiffs were not class members or were otherwise inappropriate class representatives," to even conditionally certify a class when the named party's inadequacies are apparent from the onset would constitute plain error. Falcon, 457 U.S. at 156; East Texas Motor Freight, 431 U.S. at 403.
Accordingly, IT IS ORDERED that Plaintiff's motion to certify a medical monitoring class be DENIED.