“RLD Theory of Liability” Continues to Fall Flat; Multiple Court Decisions Build Momentum in Generic Drug Failure-to-Warn Preemption Litigation

By Kurt R. Karst –      

As myriad failure-to-warn cases against generic drug manufacturers work through the judicial system in light of the U.S. Supreme Court’s June 23, 2011, 5-4 landmark decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), as well as a recent petition to the Court concerning Kentucky common law, plaintiffs’ attorneys have increasingly attempted to design around Mensing with new theories of liability.  (In Mensing, the Court ruled that FDA’s regulations preventing generic drug manufacturers from changing their labeling except to mirror the label of the brand-name, Reference Listed Drug (“RLD”) manufacturer whose drug product is approved under an NDA preempt state-law failure-to-warn claims against generic drug manufacturers, because generic drug manufacturers are unable to comply with both federal and state duties to warn.)  One such “design around” theory we’ve prevously discussed is the so-called “RLD theory of liability,” which posits that FDA’s regulations impose new or additional responsibilities on an ANDA sponsor whose drug product is unilaterally designated by FDA as an RLD in the Orange Book when the brand-name NDA RLD is no longer marketed.  Under this theory, plaintiffs’ attorneys argue that the Court’s Mensing decision is inapplicable and that a court should employ the impossibility preemption analysis utilized in the U.S. Supreme Court’s March 2009 decision in Wyeth v. Levine, 555 U.S. 555 (2009), applicable to brand-name drug products approved under an NDA.

Earlier this year, the U.S. District Court for the Northern District of Georgia (Atlanta Division) handed down the first federal court ruling on the RLD theory of liability in Moore v. Mylan, Inc., No. 11:1-cv-03037-MHS (N.D. Ga. Jan. 5, 2012).  As we reported, Judge Marvin H. Shoob shot down RLD theory arguments concerning Mylan’s RLD version of DILANTIN KAPSEALS (extended phenytoin sodium) Capsules approved pursuant to an ANDA suitability petition, stating in his opinion that the plaintiff failed to show “how Mylan acquired all of the same rights as a brand name drug manufacturer simply by manufacturing one drug that was an RLD” and how “Mylan’s manufacture of one RLD converted Mylan into a brand name drug manufacturer with the right to use the [Changes Being Effected (‘CBE’)] process to change the label of any of its drugs . . . .”

A trio of recent federal court decisions have followed Moore.  In each case, the courts rejected plaintiffs’ RLD theories of liability. 

In Cooper v. Wyeth, Inc., No. 09-cv-929-JJB (M.D. La. Mar. 6, 2012), which concerns metoclopramide, plaintiffs argued that “becoming an RLD at some point for metoclopramide oral solution imbues Teva with NDA duties and liability for metoclopramide tablets,” a pharmaceutically inequivalent drug allegedly ingested by plaintiffs.  Giving great weight to FDA statements on RLD status (see, e.g., 72 Fed. Reg 39,629 (July 19, 2007)), the court found ruled that “Teva does not hold NDA status by virtue of becoming an RLD and thus does not bear the burden of its brand name counterpart.  It is the FDA that is responsible for mandating changes in labeling, and as Mensing recognized, NDA-approved drug makers alone retain duties above and beyond those of generic drug makers.”  That’s some pretty nice language for generic drug manufactures!

In another Louisiana decision also concerning metoclopramide – Morris v. Wyeth, Inc., No. 09-cv-0854 (W.D. La. Feb. 21, 2012) – the court denied plaintiff’s motion to alter and/or amend the court’s October 19, 2011 judgment dismissing the generic drug manufacturers from the case.  Plaintiffs asserted that “a generic manufacturer, which has a product classified as an RLD, has the same discretion as a brand name manufacturer to unilaterally change the product’s warning label,” and as such, FDA’s “regulations do not preempt a failure to warn claim against a generic drug manufacturer if its drug is classified as an RLD.”  Citing Moore, the court rejected ths argument saying that “it assumes, without authority, that the FDA considered TEVA to be a brand name manufacturer with the requisite duty to unilaterally change its product’s labeling simply because FDA designated TEVA’s metoclopramide as the RLD.”

Finally, in In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, MDL Docket No. 2226 (E.D. Ky. Mar. 5, 2012), the court dismissed myriad claims against manufacurers of generic versions of DARVON (propoxyphene), including plaintiffs’ RLD theory of liability.  (Our friends over at Drug and Device Law Blog previously discussed the decision – see here.)  Citing both the Moore decision and the same Federal Register notice relied on by the court in Cooper, the court stated in its decision that plaintiffs provided “no authority to support their contention that when a generic drug manufacturer becomes an RLD holder, it is thereby empowered to independently change the drug’s warning label,” and that “is unpersuaded that Mylan and Watson are subject to liability based on their status as RLD holders.”

In addition to the four federal court decisions dismissing RLD theory of liability claims, there is a growing number of state courts that have also considered and rejected this theory. 

• Sincoskie v. West-Ward Pharms., No. MER-L-2643-10 (N.J. Super. Ct. Law Div. Nov. 4, 2011) (Transcript of Motions):  In a ruling from the bench, the court held that warnings-based claims against a generic drug designated by FDA as the RLD are equally preempted as those against any other generic drug manufacturer.  The court, accordingly, held that the claims against the manufacturer whose generic drug had been designated as the RLD must be dismissed.
• Yamane v. Wyeth, No. 08-1-349K (Cir. Ct. Haw. Jan. 3, 2012):  The court held that claims against generic drug manufacturers for failure to warn are barred by Mensing.  The court found that FDA’s designation of a generic drug as the RLD does not change that result, and that manufacturers of the RLD are entitled to the full protections of Mensing. 
• Robinson v. Mylan Pharms., Inc., No. 0247 (Phil. Ct. Comm. Pleas. Dec. 2, 2011):  The Philadelphia Court of Common Pleas, in consolidated litigation over generic phenytoin, dismissed all claims brought by certain plaintiffs against the generic drug manufacturers as preempted.  Among other things, the plaintiffs argued that FDA’s RLD designation of the defendants’ product precluded preemption.  Despite these arguments, the court ordered that all claims brought by the plaintiffs at issue against the generic drug manufacturers be dismissed.