One of the things we like to do here at MassTortDefense is keep an eye on the non-traditional claims plaintiffs concoct — to evade the requirements of traditional torts, or to expand the group of “injured” plaintiffs. Earlier this month the Third Circuit knocked down just such an attempt. See In Re: Schering Plough Corp. Intron/Temodar Consumer Class Action, Nos. 10-3046 and 10-3047 (3d Cir. May 16, 2012).
The issue here was an attempt by two groups of plaintiffs to hold a drug manufacturer liable for violating the federal Racketeer Influenced and Corrupt Organizations Act (RICO) by allegedly marketing drugs for off-label uses. The court of appeals affirmed that neither had standing to maintain this cause of action, primarily for failure to allege a plausible nexus between the assailed marketing campaign and the physicians‘ decisions to prescribe certain drugs for off-label use.
While off-label marketing is prohibited, prescription drugs frequently have therapeutic uses other than their FDA-approved indications. The FDCAct does not regulate the practice of medicine, and so physicians may lawfully prescribe drugs for off-label uses. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001) (recognizing off-label usage as an accepted and necessary corollary of the FDA‘s mission to regulate in this area without directly interfering with the practice of medicine); Wash. Legal Found. v. Henney, 202 F.3d 331, 333 (D.C. Cir. 2000) (physician may prescribe a legal drug to serve any purpose that he or she deems appropriate, regardless of whether the drug has been approved for that use by the FDA).
Plaintiffs’ claims, as is so common, attempted to piggy-back off of prior government investigations. They alleged that Schering‘s marketing practices caused physicians to prescribe the drugs for off-label uses instead of equally effective alternative treatments that were approved for the prescribed uses or no medication at all. They assert that these marketing techniques led to a significant increase in prescriptions of the drugs for off-label uses, and contend that this caused the plaintiffs an “ascertainable loss” (key concept) because they supposedly paid millions of dollars for the drugs that they otherwise would not have paid.
The district court granted a motion to dismiss, and the plaintiffs appealed.
A motion to dismiss for lack of standing implicates Rule 12(b)(1) because standing is a jurisdictional matter, and 12(b)(6) with the Twombly/Iqbal guidance. While the plausibility standard of those cases does not impose a probability requirement, it does demand more than a sheer possibility that a defendant has acted unlawfully. The plausibility determination is a context-specific task that requires the reviewing court to draw on its judicial experience and common sense; and some claims require more factual explication than others to state a plausible claim for relief.
The Constitution imposes a requirement that there be an actual case or controversy. Federal courts have developed several justiceability doctrines to enforce the case-or-controversy requirement, and perhaps the most important of these doctrines is the requirement that a litigant have standing to invoke the power of a federal court. The standing question is whether the plaintiff has alleged such a personal stake in the outcome of the controversy as to warrant his invocation of federal-court jurisdiction and to justify exercise of the court’s remedial powers on his behalf. The plaintiff bears the burden of meeting the irreducible constitutional minimum of Article III standing by establishing three elements: First, the plaintiff must have suffered an injury in fact—an invasion of a legally protected interest which is (a) concrete and particularized and (b) actual or imminent, not conjectural or hypothetical. Second, there must be a causal connection between the injury and the conduct complained of—the injury has to be fairly traceable to the challenged action of the defendant, and not the result of the independent action of some third party not before the court. Third, it must be likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision.
In addition to meeting the constitutional standing requirements, plaintiffs seeking recovery under RICO must satisfy additional standing criterion set forth in section 1964(c) of the statute: that the plaintiff suffered an injury to business or property; and that the plaintiff‘s injury was proximately caused by the defendant‘s violation.
The Union plaintiff on behalf of a proposed class of third-party payors alleged economic loss based on paying for ineffective drugs. Accordingly, to establish standing, it must allege facts showing a causal relationship between the alleged injury—payments for a specific drug that was ineffective or unsafe for the use for which it was prescribed—and Schering‘s alleged wrongful conduct. However, there were no averments that came close to satisfying this standard. It was pure conjecture to conclude that because Schering‘s misconduct supposedly caused other doctors to write prescriptions for ineffective off-label uses for other products, the Union ended up paying for prescriptions for a different drug due to the same kind of alleged misconduct. (Again, attempted piggy-backing on government allegations.)
The court of appeals spent considerable effort reviewing claims of a proposed class of plaintiff consumers, who tried to prove standing by incorporating materials from the government investigation and concocting a series of purported links between drug trials, marketing activities and prescribing doctors’ behavior. The district court rejected this, and plaintiffs’ focus on appeal on the pleading standards for each of these claims was secondary to the threshold issue that the consumers did not adequately allege an injury fairly traceable to Schering‘s alleged misconduct. Although the complaint was replete with factual allegations and indeed asserted them with somewhat greater specificity than the third-party payor complaint, they do not present a plausible allegation actually linking the injuries to any type of miscommunication or false claim about the drugs that were actually prescribed.
No standing. Dismissal affirmed.