A Pennsylvania federal court recently refused to certify a proposed class action accusing a drugmaker of off-label marketing. See  In re: Actiq Sales and Marketing Practices Litigation, No. 2:07-cv-04492 E.D. Pa. March 23, 2015).

Plaintiffs were various entities who pay for employee's prescription drugs.  They alleged that defendant promoted its drug Actiq for uses not approved by the FDA.  As readers know, it is legal for doctors in their judgment to prescribe medications for uses other than those approved by the FDA, i.e., off-label uses. Plaintiffs argued that Cephalon’s conduct somehow caused Plaintiffs to make excessive off-label prescription payments for Actiq to treat conditions not approved by the FDA and for whom less expensive pain management drugs were appropriate. They asserted that under the circumscriptions of Actiq’s approved label, off-label marketing is not permissible since most forms of off-label use were for contraindicated conditions.

Plaintiffs moved for certification of one Nationwide Class defined as follows: All Third Party Payors (“TPP”) in the United States who paid and/or reimbursed, in whole or in part, for the cost of Actiq prescribed for indications other than cancer and for consumption by their members, employees, plan participants, beneficiaries or insureds during the period from January 1, 2002 through December 31, 2006. Plaintiffs also suggested multi-state classes. 

The class action is an exception to the usual rule that litigation is conducted by and on behalf of the individual named parties only. Comcast Corp. v. Behrend, 133 S. Ct. 1426, 1432 (2013) (quoting Califano v. Yamasaki, 422 U.S. 682, 700-01 (1979)).  Class certification is proper only if the trial court is satisfied, after a rigorous analysis, that the prerequisites’ of Rule 23 are met. In re Hydrogen Peroxide Antitrust Litig., 552 F.3d 305, 309 (3d Cir. 2008) (quoting Gen. Tel. Co. of Sw. v. Falcon, 457 U.S. 147, 161 (1982)).

A decision to certify a class requires findings by the court, not merely a threshold showing by a party, that each requirement of Rule 23 is met.  In re Hydrogen Peroxide, 552 F.3d at 306; see Wal-Mart Stores, Inc., 131 S. Ct. at 2551. In conducting its analysis, a court is to resolve factual disputes by a preponderance of the evidence and to consider all relevant evidence and arguments by the parties. In re Hydrogen Peroxide, 552 F.3d at 306, 320. “Frequently [the court’s] ‘rigorous analysis’ will entail some overlap with the merits of the plaintiff’s underlying claim.” Wal-Mart Stores, Inc., 131 S. Ct. at 2551. Merits questions may be considered to the extent that they are relevant to determining whether the Rule 23 prerequisites for class certification are satisfied.  Amgen Inc. v. Conn. Ret. Plans and Trust Funds, 133 S. Ct. 1184, 1195 (2013). Plaintiffs’ burden is to show that the elements of their claims are capable of proof through evidence that is common to the class. See In re Hydrogen Peroxide, 552 F.3d at 311-12. In opposing class certification here, Cephalon argued that individualized factual issues would predominate over their common claims, and the class action would be impossible to manage if certified. The Court agreed. Nationwide and multi-state classes raise the issue of applicable substantive law.  Because choice of law is thus relevant to a determination under Rule 23, the Court first had to determine what law applied to Plaintiffs’ claim of unjust enrichment. 22 Powers v. Lycoming Engines, 328 F. App’x 121, 124 (3d Cir. 2009). Irreconcilable conflicts among state laws may defeat class certification. Federal courts sitting in diversity are to use conflict of laws rules of the forum state to determine which substantive law applies. Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487, 496-97 (1941); Kaneff v. Del. Title Loans, Inc., 587 F.3d 616, 621 (3d Cir. 2009). This Court therefore used Pennsylvania rules on conflict of laws.

“[U]njust enrichment is a tricky type of claim that can have varying interpretations even by courts within the same state, let alone amongst the fifty states.” In re Sears, Roebuck & Co. Tools Mktg. and Sales Practices Litig., Nos. 05 C 4742, 05 C 2623, 2006 WL 3754823, at *1 n.3 (N.D. Ill. Dec. 18, 2006).  Here, Cephalon presented several bases upon which states’ laws conflict. For example, states apply various statutes of limitations to unjust enrichment claims. These differences meant that Plaintiffs’ claim for unjust enrichment  could withstand a statute of limitations defense in some jurisdictions but not in others, depending on the applicable law. A statute of limitations evidences a state’s policy interest in preventing litigation of delayed claims and preventing injustice by affording a defendant a fair opportunity to defend.

Additional variances in states’ unjust enrichment jurisprudence existed, including the availability of unjust enrichment as an independent cause of action, the need to show an absence of an adequate remedy at law, the requirement that a benefit be obtained at the direct expense of the plaintiff, the level of misconduct a plaintiff must prove, and the availability of defenses such as unclean hands and laches.  

Applying Pennsylvania's choice of law rules,most of the relevant factors weighed in favor of applying the laws of TPPs’ various home states, including the most important factors. See Restatement (Second) of Conflict of Laws § 221 cmt. d. Policy considerations also led to the same conclusion. Plaintiffs’ home states had a regulatory interest in providing redress to its citizens for acts of wrongdoing.

For the same reasons why an actual conflict existed among the unjust enrichment laws of the fifty states, individual issues of law predominated with regard to a nationwide class. In addition to proving different elements for all class members to establish unjust enrichment at trial, other individual issues that may predictably arise included the level of misconduct required to be proven and whether defendant might avail itself of particular defenses. 

Plaintiffs argued their smaller multi-state classes addressed this issue. Plaintiffs’ notable grouping efforts, however, still did not account for individual fact issues such that common issues predominated. “The polestar of the unjust enrichment inquiry is whether the defendant has been unjustly enriched[.]” Limbach Co., LLC v. City of Phila., 905 A.2d 567, 577 (Pa. Cmmw. Ct. 2006). Resolution to this question is, by nature, fact-sensitive. Id. Even if some common proof regarding equitable circumstances was present here, Plaintiff’s proposal to make a class-wide showing of whether Cephalon’s enrichment was unjust failed. Under an unjust enrichment theory, all facts and circumstances are considered to determine whether, without a remedy, inequity would result or persist. It is a physician’s prerogative whether to prescribe Actiq for any medical purpose, on-label or off. Physicians may have accounted for a number of factors in making their Actiq prescriptions, including their experiences with patients and their experiences with prescribing Actiq. See Ironworkers Local Union 68 v. AstraZeneca Pharm., LP, 634 F.3d 1352, 1362 (11th Cir. 2011) (“Several considerations shape the physician’s medical judgment, including both individual patient concerns and drug-specific information regarding the propriety of a drug’s use for treatment of a patient’s given condition . . . The physician learns about a drug through multiple sources, only one of which might be the drug manufacturer’s promotions and literature.”  It was also uncontested that Actiq provided the benefit of effective pain relief to many who used it. If doctors would have written Actiq prescriptions regardless of the defendant's alleged acts, then payment for prescriptions beyond would not be unjust.  In sum, whether  payments for Actiq prescriptions resulted in "unjust" enrichment is a question resolved by examination into the actions not only of Cephalon, but also of individual payers  and prescribing doctors. See Marcus v. BMW of N. Am., LLC, 687 F.3d 583, 611 (3d Cir. 2012).

The class also failed the superiority prong. Together with predominance, the superiority criterion is designed to “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 Prods., Inc., 521 U.S. at 615 (quoting Fed. R. Civ. P. 23 advisory committee’s note). The Court here considered the factors enumerated in Rule 23(b)(3) for determining superiority: (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.

Here, the largest impediment to a finding of superiority was the difficulty of managing a class action in which the laws of plaintiffs' various home states applied and individual questions of fact predominated. Also, plaintiffs here were sophisticated institutional entities with an interest in controlling litigation when relatively large amounts of money are at stake.  Indeed, some putative absent class members had already filed suit based on Cephalon’s distribution of Actiq.

Motion for class certification denied.