In a proposed class action proceeding in federal court against a pharmaceutical company, in what circumstances will the class be certified where the allegations are that the company’s pharmaceuticals cause addiction?
A class actions lawyer is considering bringing a class action against a manufacturer of prescription opioids on behalf of people who developed addictions after being prescribed the medications by their treating physicians.
Fed. R. Civ. P. 23 sets out the requirements for certification of a class action in federal court. The class must satisfy the four prerequisites in Rule 23(a) and the action must fall into one of the categories of class action in Rule 23(b). (Fed. R. Civ. P. 23)
Under Rule 23(a), a class must satisfy four conditions: (1) the class must be so numerous that joinder of all members is impracticable; (2) there must be questions of law or fact common to the class; (3) the claims of the representative parties must be typical of the claims of the class; and, (4) the representative parties must fairly and adequately protect the interests of the class. (Fed. R. Civ. P. 23)
If these requirements are satisfied, the case must also fall within one of the categories specified in Rule 23(b). The first category is when separate actions by or against individual class members would risk establishing incompatible standards of conduct for the party opposing the class, would be dispositive of the interests of nonparty class members, or would substantially impair the ability of nonparty class members to protect their interests. The second category is if final relief of an injunctive nature is appropriate. Lastly, a class may be certified if common questions predominate over any questions affecting only individual class members and that resolution of these questions in a class action would be a superior method for the fair and efficient adjudication of the controversy. (Fed. R. Civ. P. 23)
The plaintiffs bear the burden of showing that the Rule 23 requirements have been met. (Campbell v. Purdue Pharma, L.P.)
The United States Court of Appeals for the Ninth Circuit has demonstrated some hesitation in regards to certifying mass tort or personal injury actions as class actions, particularly where they involve product liability, because cases involving injuries to numerous persons often involve more individual issues than common issues. (Northern Dist. of California, Dalkon Shield IUD Products Liability Litigation, In re)
A number of prescription opioid cases were identified in which the proposed classes were denied class certification because the class representatives were unable to satisfy one or more requirements of Rule 23. (Campbell v. Purdue Pharma, L.P., Wethington v. Purdue Pharma LP, Gevedon v. Purdue Pharma, Valentino v. Carter-Wallace, Inc.)
Fed. R. Civ. P. 23 sets out the requirements for certification of a class action in federal court. The class must satisfy the four prerequisites in Rule 23(a) and the action must fall into one of the categories of class action in Rule 23(b).
Under Fed. R. Civ. P. 23(a), a class must satisfy four conditions. First, the class must be so numerous that joinder is impracticable. Second, the litigation must involve questions of law or fact that are common to members of the class. Third, the claims of the class members must be similar, though not necessarily identical, to the claims of the representative party. Finally, the representative parties must fairly and adequately protect the interests of the class:
(a) Prerequisites. One or more members of a class may sue or be sued as representative parties on behalf of all members only if:
(1) the class is so numerous that joinder of all members is impracticable;
(2) there are questions of law or fact common to the class;
(3) the claims or defenses of the representative parties are typical of the claims or defenses of the class; and
(4) the representative parties will fairly and adequately protect the interests of the class.
If these requirements are satisfied, the case must also fall within one of the categories specified in Rule 23(b). The first category is when separate actions by or against individual class members would risk establishing incompatible standards of conduct for the party opposing the class, would be dispositive of the interests of nonparty class members, or would substantially impair the ability of nonparty class members to protect their interests. The second category is if final relief of an injunctive nature is appropriate. Lastly, a class may be certified if common questions predominate over any questions affecting only individual class members and that resolution of these questions in a class action would be a superior method for the fair and efficient adjudication of the controversy:
(b) Types of Class Actions. A class action may be maintained if Rule 23(a) is satisfied and if:
(1) prosecuting separate actions by or against individual class members would create a risk of:
(A) inconsistent or varying adjudications with respect to individual class members that would establish incompatible standards of conduct for the party opposing the class; or
(B) adjudications with respect to individual class members that, as a practical matter, would be dispositive of the interests of the other members not parties to the individual adjudications or would substantially impair or impede their ability to protect their interests;
(2) the party opposing the class has acted or refused to act on grounds that apply generally to the class, so that final injunctive relief or corresponding declaratory relief is appropriate respecting the class as a whole; or
(3) the court finds that the questions of law or fact common to class members predominate over any questions affecting only individual members, and that a class action is superior to other available methods for fairly and efficiently adjudicating the controversy. The matters pertinent to these findings include:
(A) the class members’ interests in individually controlling the prosecution or defense of separate actions;
(B) the extent and nature of any litigation concerning the controversy already begun by or against class members;
(C) the desirability or undesirability of concentrating the litigation of the claims in the particular forum; and
(D) the likely difficulties in managing a class action.
The United States Court of Appeals for the Ninth Circuit has voiced some hesitation in regards to certifying mass tort or personal injury actions as class actions, particularly where they involve product liability. Cases involving injuries to numerous persons often involve more individual issues than common issues. In Northern Dist. of California, Dalkon Shield IUD Products Liability Litigation, In re, 693 F.2d 847 (9th Cir. 1982), the Court stated (at 852-853):
The Advisory Committee Note to the 1966 Revision of Rule 23(b)(3) (39 F.R.D. 69, 103) states:
"A 'mass accident' resulting in injuries to numerous persons is ordinarily not appropriate for a class action because of the likelihood that significant questions, not only of damages but of liability and defenses to liability, would be present, affecting the individuals in different ways. In these circumstances an action conducted nominally as a class action would degenerate in practice into multiple lawsuits separately tried...."
Relying in part on that note and on the inherent obstacles to personal injury class actions, many courts have denied plaintiffs' motions for class certification in mass tort or personal injury actions, especially those alleging negligence by one or more defendants over extended periods. See Ryan v. Eli Lilly and Co., 84 F.R.D. 230 (D.S.C.1979) ("DES" action); Mink v. University of Chicago, 460 F.Supp. 713 (N.D.Ill.1978) ("DES" action); Harrigan v. United States, 63 F.R.D. 402 (E.D.Penn.1974) (action for negligent surgery in veterans' hospital); Snyder v. Hooker Chemicals & Plastics Corp., 104 Misc.2d 735, 429 N.Y.S.2d 153 (1980) (Love Canal toxic waste action); Rosenfeld v. A.H. Robins Co., 63 A.D.2d 11, 407 N.Y.S.2d 196 (1978) (Dalkon Shield case) (discussed below); Hobbs v. Northeast Airlines, Inc., 50 F.R.D. 76 (E.D.Penn.1970) (Rule 23(b)(3) certification of airplane crash cases denied because individual plaintiffs in tort actions have an interest in controlling their own lawsuits; many other suits already were pending in other states; and Pennsylvania causes of action, under which prospective named plaintiffs were suing, might not be available to out-of-state claimants); Daye v. Commonwealth of Pennsylvania, 344 F.Supp. 1337, 1342-43 (E.D.Penn. 1972),
cert. denied, 416 U.S. 946, 94 S.Ct. 1956, 40 L.Ed.2d 298 (1974) (Rule 23(b)(3) certification of school bus accident cases denied because some plaintiffs would bring personal injury claims while other plaintiffs would bring wrongful death claims); Marchesi v. Eastern Airlines, Inc., 68 F.R.D. 500, 501 (E.D.N.Y.1975) (class certification under any Rule 23 subsection denied).
In the typical mass tort situation, such as an airplane crash or a cruise ship food poisoning, proximate cause can be determined on a class-wide basis because the cause of the common disaster is the same for each of the plaintiffs.
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 facts peculiar to each plaintiff's case. See Rosenfeld v. A.H. Robins Co., 104 Misc.2d 735, 407 N.Y.S.2d 196, (1978) (class certification denied under New York statute patterned after Rule 23(b)(3)).
In Valentino v. Carter-Wallace, Inc., 97 F.3d 1227 (9th Cir. 1996) ("Valentino"), the plaintiffs in a product liability action against the manufacturers of an epilepsy drug sought class certification. The United States District Court for the Northern District of California entered the order conditionally certifying a nationwide plaintiff class and subclass, and the manufacturers appealed. The United States Court of Appeals for the Ninth Circuit held that the class representatives did not establish that their claims met the requirements of typicality and adequacy of representation in Rules 23(a)(3) and (4) because no named plaintiff had experienced aplastic anemia as result of taking the drug, even though that condition was one of the most serious of alleged adverse consequences (at 1233-1234):
This court reviews a district court's decision to grant class certification for abuse
of discretion. See Six (6) Mexican Workers v. Arizona Citrus Growers, 904 F.2d 1301, 1304 (9th Cir.1990). In order for a class action to be certified, the plaintiffs must establish the four prerequisites of Fed.R.Civ.P. 23(a) and at least one of the alternative requirements of Fed.R.Civ.P. 23(b). See Fed.R.Civ.P. 23(b). An action may be maintained as a class action if the court finds that: (1) common questions of law and fact predominate over questions affecting individual members, and (2) a class action is superior to other available methods for the fair and efficient adjudication of the controversy. Fed.R.Civ.P. 23(b)(3); Dalkon Shield, 693 F.2d at 855-56.
It is not clear that Plaintiffs have met either the typicality or adequacy of representation requirement. See Fed.R.Civ.P. 23(a)(3) and (4). The plaintiff-class representatives include two individuals who have had difficulty withdrawing from Felbatol and returning to prior medications, one alleging liver failure and one some unspecified type of liver damage. No named plaintiff has experienced aplastic anemia as a result of taking the drug, even though this condition is one of the most serious of the alleged adverse consequences. The named plaintiffs thus may not be able to provide adequate representation for those who have suffered different injuries. See Dalkon Shield, 693 F.2d at 854-55.
A number of prescription opioid cases were identified in which the proposed classes were denied class certification because the class representatives were unable to satisfy one or more requirements of Rule 23(a).
In Campbell v. Purdue Pharma, L.P., 2004 U.S. Dist. LEXIS 31173, 2004 WL 5840206 (E.D. Mo. June 25, 2004), the United States District Court for the Eastern District of Missouri refused to certify a proposed class because the plaintiffs were unable to satisfy the numerosity requirement of Rule 23(a)(1). The named plaintiffs, David and Belinda Campbell, sought to represent a class consisting of all persons residing in the state of Missouri who were prescribed OxyContin for any condition other than moderate to severe pain caused by a terminal illness or non-chronic condition and who suffered harm as a result, including dependence, addiction, or withdrawal symptoms. The Court observed that the plaintiffs did not have to prove that it would be impossible to join all members of the proposed class; they merely had to show that joinder would be difficult and inconvenient. Nor would they have to establish that the precise number of class members could be determined as long as it was possible to make a reasonable estimate of their numbers (at 11-12):
Plaintiffs bear the burden of showing that the Rule 23 requirements have been met, Coleman v. Watt, 40 F.3d 255, 258 (8th Cir. 1994); thus, Plaintiffs' "[f]ailure to meet any one of the prerequisites precludes certification of [their] proposed class," Dhamer v. Bristol- Myers Squibb Co., 183 F.R.D. 520, 525 (N.D. Ill. 1998) (alterations added). See also Gevedon v. Purdue Pharma, 212 F.R.D. 333, 335 (E.D. Ky. 2002) (requiring an adequate basis for the prerequisites of Rule 23(a) to be pled and supported by facts). A determination whether Plaintiffs have satisfied these requirements should be made only after a "'rigorous analysis.'" In re Baycol Products Litigation, 218 F.R.D. 197, 203 (D. Minn. 2003) (quoting General Telephone Co. of Southwest v. Falcon, 457 U.S. 147, 155, 102 S. Ct. 2364, 72 L. Ed. 2d 740 (1982)).
Rule 23(a)(1): Numerosity. Plaintiffs "need not demonstrate that it would be impossible to join all the class members" to satisfy Rule 23(a)'s first requirement that the putative class be so numerous that joinder of all members is impracticable. Wethington v. Purdue Pharma, L.P., 218 F.R.D. 577, 585 (S.D. Ohio 2003). [*12] "[R]ather, [they] need simply show that joinder . . . would be difficult and inconvenient." Id. (alterations added). Plaintiffs also need not show that the precise number of proposed class members can be determined - "a reasonable estimate will suffice." Id. Conflicting factual allegations about the number of class members should be construed in favor of the class. In re Copley Pharmaceutical, Inc., 158 F.R.D. 485, 488-89 (D. Wyo. 1994).
Plaintiffs estimate only that there are "thousands of persons in the Class." (Am. Compl. P 60.) This is not a reasonable estimate.
Although the Court rejected class certification on commonality grounds, it also determined that the plaintiffs had not satisfied Rule 23(a)(3)'s typicality requirement (at 22-23):
Rule 23(a)(3): Typicality. Plaintiffs must also show that their claims or defenses "are typical of the claims or defenses of the class." Fed.R.Civ.P. 23(a). "The typicality requirement primarily focuses on whether the named plaintiff's claims have the same essential characteristics as the claims of the class at large and is designed to prevent an instance where the legal theories of the named plaintiff may potentially conflict [*23] with those of absent plaintiffs." Dhamer, 183 F.R.D. at 526. Thus, "[t]he physical, emotional, or monetary damages sustained by Plaintiffs need not be identical or even similar, so long as those differences do not negatively affect the viability of the legal theories under which they proceed." In re Paxil Litigation, 218 F.R.D. 242, 246 (C.D. Cal. 2003) (alteration added). See also DeBoer, 64 F.3d at 1174 ("The burden of demonstrating typically is fairly easily met so long as other class members have claims similar to the named plaintiff[s]." (alteration added)).
The Court then declared that it must examine the named plaintiff's medical history in order to determine whether his claims were essentially the same as the claims of other class members. These records revealed that Campbell had both a varied and unusual dosage history compared to other putative class members. Consequently, the propriety of OxyContin being prescribed for Campbell would necessarily require consideration of his other medications. The other named plaintiff, Campbell's spouse, had a similar medical history. During the same period, she obtained prescriptions, including OxyContin and other opioids (at 26-27):
The above recitation of Mr. and Mrs. Campbell's pharmaceutical records illustrates the individual nature of any inquiry into the essential element of causation, even as to the "typical" claims of the putative class representatives. In In re Baycol Products Litigation, 218 F.R.D. at 205-06, the court concluded that typicality was not present in a class action filed against the manufacturers of Baycol, a prescription drug, for negligent marketing, failure to warn, and defective design. Noting that the putative class would be comprised of a "vast number of persons who took different dosages of Baycol, [*27] at different times, and possibly took Baycol concomitantly with other prescription drugs[,]" and that the class representatives' claims were subject to unique defenses, the court found that factual differences precluded a finding of typicality. See also Kurczi, 160 F.R.D. at 678 (finding no typicality in class action against manufacturers and distributers of diethylstilbestrol (DES) because resolution as to representations about DES to named plaintiff would not resolve anything with respect to other plaintiffs and proof of causation by one plaintiff would have no impact on other plaintiffs' burdens of proving causation).
In Wethington v. Purdue Pharma LP, 218 F.R.D. 577, 2003 U.S. Dist. LEXIS 20099 (S.D. Ohio September 30, 2003), the United States District Court for the Southern District of Ohio refused to certify a class whose members resided in multiple states, in part because the named plaintiff had failed to establish commonality as required by Rule 23(a)(2). The plaintiffs alleged that Purdue should be held liable for failing to properly warn consumers about OxyContin's side effects and for continuing to market it after the company became aware of them. The plaintiffs also claimed that the company concealed facts about the harmful nature of OxyContin from the medical community and from the public. According to the plaintiffs, these allegations raised issues of law and fact that were common to the class. Purdue maintained that no common issues existed because all of the plaintiffs' allegations related to the defendant's conduct and ignored the individualized medical histories of the various class members. Further, because many of the class members crushed or otherwise misused OxyContin, the resolution of their cases would depend on the applicability of the product misuse defense in the various states where they resided (at 586-587):
Plaintiffs argue that there are a number of [**25] questions of law and fact common to the individuals comprising the class (doc. 54). They argue that the drug was marketed and promoted in a misleading manner, and that Defendants knew or should have known of the harmful effects of such promotion and marketing (Id.). They argue that the Purdue Defendants are liable for manufacturing a defective, highly addictive product that lacks an antagonist agent to prevent its euphoric [*587] effects when crushed and ingested (Id.). Plaintiffs further allege Defendants are liable for failure to properly warn consumers, and for continuing to promote and market the drug notwithstanding their knowledge of its harmful side effects (Id.). Plaintiffs allege that Defendants knowingly concealed facts about the harmful nature of the drug from the medical community and/or the public (Id.). They state that there exists beneficial monitoring and testing procedures for which certain class members share the right to reimbursement (Id.). They argue that all class members received nearly identical information about the drug, and all suffer from the same defect (Id.). Finally, Plaintiffs argue that Defendants are liable for punitive damages--a [**26] common legal determination applicable to the claims of the putative class (Id.).
Purdue argues that Plaintiffs fail to demonstrate that common issues exist, because all of their professed common issues focus on Defendants' conduct rather than on the individualized medical histories of the putative class members (doc. 68). Defendants argue that marketing and promotional activities are not "common" because they are relevant only if individualized exposure, reliance, and proximate cause can be shown (Id.). Defendants argue that because they do not engage in direct-to-consumer advertising, but rather marketing to doctors, Plaintiffs will need to show that each doctor was exposed to misleading marketing and was misled, thus resulting in a decision to prescribe the drug (Id.). Defendants further argue that the OxyContin package insert highlights the individuality in patient treatment, and the effect of its warnings cannot be evaluated absent a determination of what the patient already knew about the drug (Id.). Defendants argue that the package insert clearly indicates the potency of the drug, so that Plaintiffs' allegation that Defendants misled the medical community has [**27] no basis in fact and is therefore not a common issue (Id.). Finally, Defendants argue that Plaintiffs' theory that the drug is defective for lack of an antagonist is relevant only to those class members who misused the product by crushing it (Id.). Moreover, Defendants argue, the claims of those people who intentionally crushed the drug would likely be barred by Ohio, West Virginia, or Indiana law as intentional product misuse (Id.).
The Court concluded that the factual circumstances of addiction are highly individualized and that the existence of the learned intermediary doctrine might affect the validity of the claims of individual class members. Consequently, the Court held that the plaintiffs failed to meet the commonality requirement of Rule 23(a)(2) (at 589-590):
The Court finds that Plaintiffs in this case have not come forward with a common issue, [*590] the resolution of which will advance this litigation. Plaintiffs' claims are inherently individualized, requiring an inquiry into questions of fact and law peculiar to each class member. Plaintiffs' claims based on Defendants' actions in manufacturing and/or marketing OxyContin cannot constitute a common issue because of the existence of individual learned intermediaries, physicians, who [**36] prescribed the drug to their patients.
There is no question that OxyContin, like many other powerful prescription drugs, can be dangerous when it is not used as directed, or when it makes it to the street. Testimony before Congress, on behalf of the FDA, however, indicates that the benefits of the drug outweighed its risk when used according to the approved labeling, and that the FDA believes the drug is a valuable product for the treatment of moderate to severe pain when properly used. As defined in their Motion, Plaintiffs' proposed class includes people who have a valid prescription, and who may very well have a new lease on life.
In summary, the Court finds too many problems with Plaintiffs' proposed class definition, and there are too many individual factual issues dealing with strict liability, negligence, failure to warn, and the host of affirmative defenses raised by the Defendants.
Rule 23(a)(4) requires that the representative parties fairly and adequately protect the claims or defenses of the class. In Gevedon v. Purdue Pharma, 212 F.R.D. 333, 2002 U.S. Dist. LEXIS 25977 (E.D. Ky. October 17, 2002), the plaintiffs sought to certify a class that included all persons in the Commonwealth of Kentucky who had obtained OxyContin and/or who would obtain OxyContin in the future. The United States District Court for the Eastern District of Kentucky construed this to mean that the proposed class would consist of persons who "obtained" OxyContin legally or otherwise and who suffered addiction or other medical conditions. After concluding that the plaintiff failed to establish numerosity, commonality and typicality, the Court turned to the issue of adequacy (at 336-337):
After examining the limited number of references to the proposed class definition in the complaint, the Court finds that this proposed "class" is similar in kind to that sought to be certified in Koen, 302 F. Supp. 1383, Newton, 163 F.R.D. 625, and American Medical Sys., 75 F.3d 1069. The Plaintiffs seek to certify a class based on medical problems, addiction, and [**10] damages resulting to those who "obtain" OxyContin(R) and suffer addiction and other adverse conditions. In order determine the Defendant's liability under these allegations, the Court or jury would be faced with a number of questions that are highly individualized in nature and call for plaintiff-specific information. Such an inquiry would include where the putative class member obtained the drug, whether possession of the drug was legal, and whether each member was, in fact, injured as a result of obtaining the drug. Further inquiries would include the assurances each Plaintiff received [*337] from his treating physician, individual medical histories, dosage and length of prescriptions and method of taking the drug. Basically, this Court would need to determine, consider and resolve a number of highly subjective facts, many of which are dependent on the state of mind of particular individuals, in order to ascertain whether any given individual is within or outside the alleged class.
Consequently, the Court concluded that the plaintiffs had failed to meet the adequacy requirement and refused to certify the class (at 337):
As a result, the Court concludes that this definition is vague and calls for subjective medical conclusions. The present case is unsuitable for certification because each putative class member's state of [**11] mind requires litigating each individual case. Even limiting the class to those individuals who legally obtained the drug does not remedy the large number of individual issues that still remain. The proposed class is so highly diverse and so difficult to ascertain that it is not adequately defined. Thus, this Court concludes that an initial, inherent element of class certification fails for lack of a definable, identifiable class.
In Valentino, supra, the Court of Appeals for the Ninth Circuit was hesitant to find that the proposed class action qualified under one of the categories in Rule 23(b). The Court discussed only the category of permissible class actions in Rule 23(b)(3), which is actions where the questions of law or fact common to class members predominate over any questions affecting only individual members and a class action is superior to other available methods for fairly and efficiently adjudicating the controversy. The Court held that there was no evidence that the common issues predominated over individual issues or that a class proceeding was the superior procedure (at 1234-1235):
The first requirement of Rule 23(b)(3) is predominance of common questions over individual ones. Implicit in the satisfaction of the predominance test is the notion that the adjudication of common issues will help achieve judicial economy. See 1 Newberg & Conte, supra, § 4.25 at 4-86. Even if the common questions do not predominate over the individual questions so that class certification of the entire action is warranted, Rule 23 authorizes the district court in appropriate cases to isolate the common issues under Rule 23(c)(4)(A) and proceed with class treatment of these particular issues. See Dalkon Shield, 693 F.2d at 856; see also Copley, 158 F.R.D. at 491, 7B Charles Alan Wright, Arthur R. Miller & Mary Kay Kane, supra, § 1790 at 276; 1 Newberg & Conte, supra, § 4.25 at 4-81.
Here, the certification order merely reiterates Rule 23(b)(3)'s predominance requirement and is otherwise silent as to any reason why common issues predominate over individual issues certified under Rule 23(c)(4)(A). There has been no showing by Plaintiffs of how the class trial could be conducted. See e.g., Castano, 84 F.3d at 741-44. The district court abused its discretion by not adequately considering the predominance requirement before certifying the class. See Dalkon Shield, 693 F.2d at 856; cf. Agent Orange, 818 F.2d at 163-67; School Asbestos, 789 F.2d at 1010-11.
Last, but certainly not least, the district court must find that a class action is superior to other methods of adjudication. Fed.R.Civ.P. 23(b). Where classwide litigation of common issues will reduce litigation costs and promote greater efficiency, a class action may be superior to other methods of litigation. See Dalkon Shield, 693 F.2d at 856. A class action is the superior method
for managing litigation if no realistic alternative exists. See Fed.R.Civ.P. 23(b)(3); 7A Charles Alan Wright, Arthur R. Miller & Mary Kay Kane, supra, § 1779 at 552. But here, as in Dalkon Shield, there has been no showing why the class mechanism is superior to alternative methods of adjudication, particularly when coupled with the discovery coordination that is made possible by the JPML consolidation. See Dalkon Shield, 693 F.2d at 856. Again, the certification order merely reiterates Rule 23(b)(3)'s superiority requirement but contains no discussion of alternatives or why class adjudication is superior.