What? You were expecting another of our insensitive blogpost headlines?
Nope, we’re playing this one straight down the middle. In In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286 (N.D. Ill. Nov. 9, 2015) (“TRT”), the court ruled that all claims against all makers of generic testosterone replacement drugs were preempted. Indeed, except for those generic manufacturers who were also designated by the FDA as “reference listed drugs,” the plaintiffs did not even contest dismissal. Id. at *1.
Maybe the word is getting through to the other side that the Supreme Court meant what it said in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).
The main issue in TRT was whether a generic manufacturer somehow lost the protection of impossibility preemption because the FDA designated that manufacturer’s product as a “reference listed drug” (“RLD”) after the original branded drug left the market. This issue has been out there for some time, and we discussed in detail in our post on the aberrant Pennsylvania Superior Court metoclopramide-related decisions. Indeed, we noted that that the FDA had confirmed – on the very day that we wrote that post – that designated generic RLDs remained generic drug manufacturers and were unable to use the preemption-destroying “changes being effected” process to modify their labels. Id. (citing and quoting “FDA, Guidance for Industry, Safety Labeling Changes − Implementation of Section 505(o)(4) of the FD&C Act, at 7 n.10 (FDA July 30, 2013)).
Fortunately, the MDL judge in TRT did not have much more patience for Pennsylvania Superior Court’s rationale than we did – and the FDA guidance we cited in our post figured in that result. The MDL plaintiffs’ simplistic argument is basically, once any drug is designated an RLD by the FDA, then that drug’s manufacturer can change its label using the CBE process, because the regulations “do not actually use the terms ‘generic‘ or ‘brand-name,‘” but “only require the [generic] drug’s label to be the same as the RLD upon which its application is based.” TRT, 2015 WL 6859286, at *4.
Nice try, but as we mentioned above, that’s not how the FDA interprets its own regulations – and in Mensing, “[t]he Supreme Court deferred to the agency’s interpretation.” Id. at *3. The first FDA interpretation was the Guidance Document we mentioned, stating that generic manufacturers can only use the CBE process “to match the RLD labeling or to respond to FDA’s specific request to submit a labeling change.” Id. at *5 (quoting Guidance). Moreover, plaintiffs’ “strained reading” of that language was inconsistent with a second FDA statement, made as part of the Agency’s attempt to change its regulations to gutpreemption. In describing that proposal, the FDA reiterated that generic RLDs can’t make unilateral CBE changes to labeling. “‘Currently, these [RLD] ANDA holders must contact FDA if they believe that new safety information should be added to their product labeling unless a labeling change already has been requested by FDA.” Id. at *5 (quoting this FDA document at 9). The court summed up the FDA’s position as: “According to FDA, therefore, ANDA RLD holders have no more authority than other ANDA holders to change their labeling unilaterally through the CBE process.” Id.
Not surprisingly, “[e]very federal court to consider plaintiffs’ argument has rejected it.” Id. at *4 & n.4 (citing In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 934 (6th Cir. 2014); Moore v. Mylan Inc., 840 F. Supp. 2d 1337, 1348 (N.D. Ga. 2012); Hogue v. Pfizer, Inc., 2012 WL 11944897, at *4 (S.D. Ohio Sept. 27, 2012); Cooper v. Wyeth, Inc., 2012 WL 733846, at *9 (M.D. La. March 6, 2012); Morris v. Wyeth, Inc., 2012 WL 601455, at *6 (W.D. La. Feb. 23, 2012), aff’d, 713 F.3d 774 (5th Cir. 2013)). Checking that list against our generic preemption scorecard, it appears that TRT cited every pertinent federal case – we would add only In re Reglan Litigation, 2012 WL 1617417 (N.J. Super. Law Div. May 4, 2012), to the set of cases rejecting the plaintiffs’ position on RLDs and generic preemption.
The only case supporting the plaintiffs’ position was the Pennsylvania Superior Court case that we roundly excoriated at the time – In re Reglan Litigation, 74 A.3d 221 (Pa. Super. 2013) − and recommended that they reconsider, given the FDA’s subsequent clarification of its regulatory position. That court didn’t, of course (who listens to us?), but the court in TNTindicated that would have been the wiser course:
With the benefit of FDA’s interpretation of its own regulations, which the court in Reglan lacked, this Court agrees with the Sixth Circuit in Darvocet and all the other federal courts to address this issue in concluding that RLD ANDA holders are prohibited under federal law from unilaterally changing their drugs’ warning labels. . . . Future ANDA applicants must have a drug against which to compare their active ingredient, route of administration, dosage form, strength, and bioequivalence, and to match their current labeling. . . . [A] successor RLD designation ensures that future ANDA applicants will be able to base their applications on a non-obsolete drug; FDA need not alter the ANDA RLD holder's labeling rights or duties to serve this purpose.
2015 WL 6859286, at *6.
We’ve said repeatedly that, where available, preemption is the strongest defense that drug and device defendants have. TRTdemonstrates that this is so. With one motion to dismiss, and avoiding costly discovery, id. at *6 (denying discovery), all of the generic defendants are now out of this multi-district litigation.