By Kurt R. Karst –
A series of decisions handed down earlier this week by Judge Mary Jane Bowes of the Superior Court of Pennsylvania arising from mass tort litigation in Philadelphia County involving REGLAN (metoclopramide) and its generic versions can only be drescibed as brutal. In four separate decisions – here, here, here, and here – the court largely affirmed Orders entered in November 2011 in the Court of Common Pleas of Philadelphia County against brand-name and generic drug manufacturers concerning liability for harm alleged by plaintiffs who consumed various versions of metoclopramide, and considered whether such claims are preempted by the FDC Act and the U.S. Supreme Court’s decisions in Mutual Pharmaceutical Co. v. Bartlett (2013), PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), and Wyeth v. Levine, 555 U.S. 555 (2009). The court also quashed appeals lodged by several defendant drug manufacturers.
In each of the four decsions, Judge Bowes took a rather narrow view of preemption, holding, for example, in two cases that “only [pre-FDA Amendments Act of 2007] failure-to-warn claims based solely on a label that was in conformity with the RLD label are pre-empted under Mensing,” and that all remaining claims, such as strict liability and negligence for defective design claims, breach of warranty (express and implied) claims, and fraud and misrepresentation in drug advertising and promotion claims, are not preempted. We’re not going to delve into three of the decisions in any great detail, including dissents from Senior Judge William H. Platt (see here, here, and here). Perhaps our colleagues over at Drug & Device Law Blog will do so. But one decision in particular caught our attention, because it involves is an issue we have been following for quite some time now: the RLD theory of liability.
As we discussed in November 2011 (see here), the RLD theory 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drug product is unilaterally designated by FDA as an RLD once the brand-name RLD NDA drug product is discontinued and withdrawn from the market.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 Mensing decision is inapplicable to the generic drug manufacturer because it has stepped into the role of an NDA sponsor. Rather, a court should employ the impossibility preemption analysis utilized by the Court in Wyeth applicable to brand-name drug products approved under an NDA. Over the past few years, both state and federal courts have rejected the RLD theory of liability (see here, here, and here). As one court noted, regardless of whether FDA unilaterally has designated a manufacturer’s ANDA drug product as the RLD, “[t]he bottom line is that they are an ANDA manufacturer and that’s the whole distinction here.” Judge Bowes, however, in a decision involving ANDA sponsor and RLD designate Morton Grove Pharmaceitucals, Inc. (“Morton Grove”), is, to our knowledge, the first judge to give any merit to the RLD theory of liability.
Morton Grove argued that despite its FDA-assigned status as the RLD holder for liquid syrup metoclopramide, the company remained a generic manufacturer of an ANDA-approved product. As such, Morton Grove had no ability to use the Changes Being Effected (“CBE”) process to modify labeled warnings for the drug product, and cannot be liable under state tort law for failure to change its label. Plaintiffs argued otherwise, saying that FDA’s designation of Morton Grove as a successor RLD places the company “in the ‘shoes of the pioneer manufacturer,’ with the authority and the duty to update warnings on the drug’s label,” and that to hold otherwise, “would result in a finding that no entity had the ability to use the CBE process to change the RLD label.”
Delving into Wyeth, Judge Bowes commented that “the name-brand manufacturer was both the NDA applicant and the RLD holder, and the Court held that it had the power to utilize the CBE process to change its label. The Wyeth Court did not specifically state, however, whether that authority stemmed from Wyeth’s status as a brand-name manufacturer that filed the NDA or as the RLD holder.” Turning to Mensing, Judge Bowes commented that “none of the generic defendants was also the RLD holder,” and that “[i]n concluding that the generic defendants did not have the power to unilaterally change the label, the Court did not address the issue before us: whether a generic holder which is subsequently designated as the RLD can unilaterally change its label.” Judge Bowes does note, however, that the Court in Mensing “referred to RLD holders and brand-name manufacturers interchangeably in its opinion.” Moving on to FDA, Judge Bowes did not find clarity in FDA’s regulations, saying that the CBE regulations do not distinguish between brand-name and generic holders, but only use the general term “applicant.”
Dismissing as “suspect” and unsupportive, Judge Bowes was not swayed by federal district court decisions in Cooper v. Wyeth, Inc., 2010 U.S. Dist. LEXIS 29209 (M.D. La. 2012) and Esposito v. Xanodyne Pharm., Inc. (In re Darvocet, Darvon and Propoxyphene Prods. Liability Litig.), 2012 U.S. Dist. LEXIS 30593 (E.D. Ky. Mar. 5, 2012), rejecting the RLD theory of liability. Those cases, did not, said Judge Bowes, answer the question of whether a successor generic RLD can utilize the CBE process. Instead, Judge Bowes devised her own rationale, apparently totally ignoring the status of Morton grove as an ANDA holder:
In our examination of the regulations regarding the CBE process, we find no indication that only brand-name manufacturers that obtained NDA approval, rather than RLDs generally, can utilize the process. If the CBE process is available only to the original NDA/RLD holder, there would be no need to designate a successor RLD in a situation where the original RLD withdraws its drug. Generic manufacturers could continue to file ANDAs demonstrating that their proposed generic drugs are equivalent to that of the obsolete NDA/RLD, but no manufacturer would bear any responsibility for the content of the label or the continued safety and efficacy of the drug. The purpose for designating a successor RLD is to have a standard to which subsequent ANDAs must correspond. This includes labeling.
Herein, we have a generic RLD seeking to avoid liability under the Mensing rationale. The burden of proving the basis for the pre-emption defense rests with Morton Grove, and it has not established with the requisite certainty that it was impossible to modify its label.
Of course, all the court had to do was look at FDA guidance the Agency issued in draft form in April 2011 (see here, Docket No. FDA-2011-D-0164) concerning drug product labeling changes to know that FDA draws a distinction between RLD NDAs and "ANDAs marketed without an NDA RLD." That guidance, titled "Safety Labeling Changes — Implementation of Section 505(o)(4) of the FD&C Act," was released in final form earlier this week (see here). Among other things, both the draft and final guidance clarify that:
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 (with some exceptions, as described in 21 CFR 314.94(a)(8)(iv)). 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.
In a dissenting opinion on the RLD issue, Senior Judge Platt clearly understood the import of the caselaw and the holes in the court’s rationale for accepting the RLD theory of liability:
I would conclude that [Morton Grove] had no additional duties or liability under state law as the FDA designated holder of the RLD (Reference Listed Drug) for liquid syrup metoclopramide, precluding any separate basis for the overrule of the preliminary objections as to these Appellants.
I find no support for the Majority’s conclusion that Morton Grove failed to meet its burden of proof to establish pre-emption. (See Majority, at *12-*13). Further, I find the Majority’s conclusions unsupported by pertinent caselaw. The Majority’s mere identification of inconsistent use of terminology in the caselaw or FDA regulations is, in my view, insufficient to establish the imposition of additional affirmative duties on a successor RLD holder.
Whether rehearing will be sought in the case or an eventual appeal to the Supreme Court of Pennsylvania is not currently clear. Plaintiffs’ attorneys throughout the country will undoubtedly latch on to Judge Bowes’ deicison to support thier own cases. FDA’s planned rulemaking to “create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements” (see our previous post here) may also come into play in pending and future litigation on the RLD issue.
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