Another Federal Court Rejects the ANDA RLD Theory of Liability: The Sixth Circuit Weighs InJuly 1, 2014
By Kurt R. Karst –
It’s been quite a while since we last posted on the so-called “RLD (Reference Listed Drug) Theory of Liability.” It’s the theory put forward by plaintiffs’ attorneys in a lot of failure-to-warn generic drug product liability cases 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drug product is unilaterally designated by FDA as an RLD once the brand-name RLD NDA drug product is discontinued and withdrawn from the market. Under this theory, the U.S. Supreme Court’s preemption analysis in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), essentially shielding generic drug manufacturers from liability because of the FDC Act’s same labeling requirement, is inapplicable to a generic drug manufacturer because it has stepped into the role of an NDA sponsor by virtue of FDA deisignating its drug as the RLD. Rather, say plaintiffs’ attorneys, a court should employ the impossibility preemption analysis utilized by the Court in Wyeth v. Levine, 555 U.S. 555 (2009), applicable to brand-name drug products approved under an NDA. Although a decision last summer by the Superior Court of Pennsylvania did say that there’s some merit to the RLD theory of liability (see our previous post here), that’s the only court (federal and state) that has thus far accepted the theory. Every other court to consider the issue has soundly rejected it (see here, here, and here). (And there’s still a chance that the Superior Court of Pennsylvania’s decision may be overturned on appeal.)
That leads us to the latest decision on the RLD theory of liability – and it’s a good one! Last week the U.S. Court of Appeals for the Sixth Circuit issued its decision in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, Case Nos. 12-5368, et al. (6th Cir. June 27, 2014). The Court affirmed in all respects relating to generic drug preemption the judgment of the Kentucky District Court that came out way back in March 2012. dismissing myriad claims against manufacurers of generic versions of DARVON (propoxyphene). The Plaintiffs in the case put forth several theories of generic drug manufacturer liability. We’re not going to get into most of them from the Court‘s 48-page decision (we’ll leave that to the folks over at the Drug & Device Law Blog for whom preemption is manna), but we do think the Circuit Court’s decision on RLD status and failure-to-warn liability is important to our readers (pages 18-20 of the decision).
Pointing to and quoting from a July 2013 FDA guidance document, titled Safety Labeling Changes–Implementation of Section 505(o)(4) of the FD&C Act, the Court says that RLD designation of an ANDA’d drug product does not equate to NDA status. That FDA guidance states, in relevant part, that while RLD designation generally means that the application sponsor must submit labeling changes when it becomes aware of new safety information, that obligation does not apply to ANDA sponsors:
Under existing FDA regulations, ANDA holders cannot make labeling changes through the formal supplement process under 21 CFR 314.70 in all circumstances in which NDA holders can because an ANDA’s labeling must be the same as the NDA RLD’s labeling. Accordingly the changes-being-effected supplement process under 21 CFR 314.70(c) is not expressly available to ANDA holders except to match the RLD labeling or to respond to FDA’s specific request to submit a labeling change under this provision.
Accordingly, the Sixth Circuit found that “the status of an ANDA holder’s product as the RLD for a given prescription drug product does not alter the ANDA holder’s obligations,” and affirmed the district court’s rejection of the RLD theory of liability. The decision also makes clear a point we’ve raised before: there’s the “big RLD,” which is the NDA-approved product relied on for safety and effectiveness findings, and the “little RLD,” which is the reference standard used for bioequivalence testing. Sometimes they’re the one and the same, but in the case of ANDA RLD designation, they’re different.
Regardless of how the various state and federal courts have addressed the RLD theory of liability, it could all be irrelevant if FDA ultimately adopts a November 2013 proposal – and successfully fends off any challenges to that rule – that would allow generic drug manufacturers to independently update product labeling (with respect to product safety) through the changes being effected supplement process that is currently only available to NDA sponsors. According to the Spring 2014 Department of Health and Human Services regulatory agenda, a final rule is scheduled to be published in December 2014.
The Generic Pharmaceutical Association has repeatedly blasted FDA’s November 2013 proposal as unworkable (see here), and recently released results of a survey showing a high preference among doctors, physician assistants, and pharmacists for FDA pre-approval of generic drug labeling changes. Congressional opposition to FDA’s proposal also seems to be building. Late last week, two lawmakers penned a letter to the Office of Management and Budget questioning FDA’s legal authority and cost-benefit analysis in issuing the proposed rule. That letter follows a hearing and several other letters, some of which have already drawn FDA responses (see, e.g, here and here).