Back in the bad old days (only a couple of years ago), the Philadelphia Court of Common Pleas had the dubious distinction of being labeled as the worst “hellhole jurisdiction” in the country. While there was some merit to this designation, we always thought that Philadelphia’s role was rather overstated.  There were times – more often than most people thought – when Philadelphia judges did the right thing, but when they did, all too often they found themselves reversed on appeal.  One problem, we explained, was Pennsylvania’s extremely pro-plaintiff intermediate appellate court, known (somewhat confusingly to non-Pennsylvanians) as the Superior Court.

Here we go again.

The Superior Court has just made a complete hash of generic drug preemption, in several instances taking positions that are unique in the country, and in opposition to a great deal of precedent. There are a number of decisions.  We’ll cover only the high(low)lights.

Hassett v. Dafoe, 2013 Pa. Super. Lexis 1683, slip op. (Pa. Super. July 29, 2013)

and

In re Reglan Metoclopramide Litigation, 2013 Pa. Super. Lexis 1688, slip op.
(Pa. Super. July 29, 2013).

Hassett and Reglan Metoclopramide (all citations are to the former followed by the latter) are two almost verbatim copies of the same rulings, with only the facts being different.  We consider them together.  In these decisions, contra (usually) to the overwhelming majority of decisions across the country (which the Superior court acknowledged and then ignored entirely, 2013 Pa. Super. Lexis 1683, at *18-19; 2013 Pa. Super. Lexis 1688, at *21), the court let a number of warning-related claims survive preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011).  The court started both decisions by recognizing a “presumption against preemption,” 2013 Pa. Super. Lexis 1683, at *14; 2013 Pa. Super. Lexis 1688, at *17, that is nowhere found in either Mensing orMutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), and as to which another Supreme Court decision we discussed here indicates the Supreme Court is on the verge of eliminating. This presumption is routine, indeed de rigueur for courts determined to avoid preemption.

The Superior Court then proceeded to complicate everything, referring to a variety of state-specific peculiarities, 2013 Pa. Super. Lexis 1683, at *18-20; 2013 Pa. Super. Lexis 1688, at *21-22, although the preemption questions, after Mensing and Bartlettare really quite simple:  (1) Can the defendant make any changes demanded by state law without first getting FDA permission?  If not, then impossibility preemption exists.  (2) Can the defendant do anything to comply with both federal statutory and state tort duties?  If the choice is only pay judgments or to go out of business, then impossibility preemption exists.

The opinions initially, and uniquely, refuse to find claims for “absolute liability” – “that the drug, even when used as recommended and with appropriate warnings, was defective and unreasonably dangerous” – preempted.  2013 Pa. Super. Lexis 1683, at *21; 2013 Pa. Super. Lexis 1688, at *24.  Calling this “strict liability” (which doesn’t exist in Pennsylvania, although it does in other states), the Superior Court held that Bartlett left this open.  2013 Pa. Super. Lexis 1683, at *22; 2013 Pa. Super. Lexis 1688, at *25.

That’s a jaw-dropping result – since Bartlett specifically held that any claim where the only way to comply with state law was to stop selling the product was preempted.

We reject this “stop-selling” rationale as incompatible with our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability.  Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be “all but meaningless.”

133 S. Ct. at 2477.

Equally surprising is the Superior Court’s footnote reaching out (a la Lance with post-sale duty to warn) with dictum on an issue not even before it – “It is undisputed that FDA approval of a name-brand drug . . . does not preclude a state law tort claim against that manufacturer based on defective design.”  2013 Pa. Super. Lexis 1683, at *22-23 n.7; 2013 Pa. Super. Lexis 1688, at *25-26 n.8 (citing Wyeth v. Levine, 555 U.S. 555 (2009)).  Levine, of course, had nothing to do with design defects (whereas Bartlettdoes), and the Supreme Court in Bartlett carefully extended its design defect holding to both generic and innovator drugs.  “Once a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the 'qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved applications’.”  133 S. Ct. at 2471 (quoting 21 C.F.R. §314.70(b)(2)(i)) (emphasis added).  We hope that this uninformed dictum will be received with the appropriate grain of salt.

Next the court relies on non-FDCA express preemption cases (CippoloneBates, and Goode) to draw distinctions between negligence, strict liability, and warranty that are nowhere to be found in the discussions of implied preemption in Bartlett andMensing.  2013 Pa. Super. Lexis 1683, at *23-27; 2013 Pa. Super. Lexis 1688, at *26-29.  Those cases turned on limitations of the express preemption clauses in other statutes that have nothing to do with the FDCA.  The upshot of that judicial frolic and detour was to allow numerous warnings based claims − “marketing,” “lack of due care in testing” (which does not even exist under even the Superior Court’s own decisions) and express/implied warranty − where the defendant could only comply with the state duty by changing its warning.  2013 Pa. Super. Lexis 1683, at *28-29; 2013 Pa. Super. Lexis 1688, at *30-31.  This holding flies in the face of not only Mensing and Bartlett but the Supreme Court’s oft repeated holdings that express and implied preemption operate independently (see BuckmanGeier, and Myrick, to name three off the tops of our heads).

To be fair, these opinions also contain some rulings that aren’t way out in left field.  The distinction drawn between “labeling” and “false advertising and promotion,” 2013 Pa. Super. Lexis 1683, at *29-30; 2013 Pa. Super. Lexis 1688, at *31-32, isn’t novel, but here it’s applied without a single allegation identifying anything that in fact falls outside of the FDA’s expansive definition of labeling (and Pennsylvania is a fact pleading state).  Nor is a “carve out” claim for failure to update unusual in avoiding preemption.  2013 Pa. Super. Lexis 1683, at *31-34; 2013 Pa. Super. Lexis 1688, at *33-36.  To the extent that an informational claim falls within these exceptions, we might not like it, but at least legal support exists.  The opinions’ broader assertions, however, like trying to distinguish between warnings and supposed “tortious business practices,” 2013 Pa. Super. Lexis 1683, at *31; 2013 Pa. Super. Lexis 1688, at *33, where the latter necessarily implicates the former, is (to us) on par with how the First Circuit willfully ignored Mensing in its now-reversed Bartlett opinion.

We do take issue with the opinions’ equating failure to update with negligence per se, since negligence per se is a dodge around congressional intent that the FDCA not be privately enforced.  The citation (2013 Pa. Super. Lexis 1683, at *33; 2013 Pa. Super. Lexis 1688, at *36) to Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804 (1986), for there being “no impediment” to negligence per se, ignores not only Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) − which unlike Thompsonactually was a preemption case − but also the Supreme Court’s clear warning in Thompson itself against using state-law negligence per se to “flout” congressional intent.

The significance of the necessary assumption that there is no federal private cause of action [under the FDCA] thus cannot be overstated.  For the ultimate import of such a conclusion, as we have repeatedly emphasized, is that it would flout congressional intent to provide a private federal remedy for the violation of the federal statute.  We think it would similarly flout, or at least undermine, congressional intent to conclude that the federal courts might nevertheless . . . provide remedies for violations of that federal statute solely because the violation of the federal statute is said to be a “rebuttable presumption” or a “proximate cause” under state law, rather than a federal action under federal law.

478 U.S. at 812 (emphasis added).  See id. at 817 (“alleging a violation of a federal statute as an element of a state cause of action, when Congress has determined that there should be no private, federal cause of action for the violation, does not state a claim”).  Evidently someone did not read Thompson very carefully.  Reliance on Thompson as validating an FDCA-based negligence per se cause of action would be supremely ironic, were the issue not so important.

In another unique holding, these opinions allowed post-FDAAA (that is, after 9/27/07) claims to survive preemption because … well for no reason at all.  Mensing expressed “no opinion” on the FDAAA because it was irrelevant to the claims before it.  131 S. Ct. at 2574 n.1.  However, in the more than two years sinceMensing, no plaintiff anywhere has been able to identify anything in the FDAAA that allows unilateral generic drug label changes. The Superior Court didn’t find anything either, but delayed the inevitable by punting the issue back to the trial court, requiring a “thorough preemption analysis” – although of what we frankly have no idea.  2013 Pa. Super. Lexis 1683, at *34; 2013 Pa. Super. Lexis 1688, at *36.
 
The footnote (2013 Pa. Super. Lexis 1683, at *34-35 n.13; 2013 Pa. Super. Lexis 1688, at *37 n.14) referencing 21 U.S.C. §355(o)(4) can’t possibly be sufficient to save post-FDAAA claims, since at most that section allows generic (or other) manufactures to “propose” label changes to the FDA, which then decides what to do with these proposals.  2013 Pa. Super. Lexis 1683, at *34; 2013 Pa. Super. Lexis 1688, at *37.  Indeed, the FDA issued new guidance about §355(o)(4) today, making clear the this section does not allow CBE-style unilateral action by ANDA holders:

Under existing FDA regulations, ANDA holders cannot make labeling changes through the formal supplement process under 21 CFR 314.70 [the CBE section] 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. ANDA holders, however, are obligated to provide FDA with information about labeling concerns, including a concern that new information should be added to a product’s labeling.  An ANDA holder may submit a prior approval supplement to request a change to product labeling, and FDA will determine whether the labeling for the generic and [reference] listed drugs should be revised.

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), available here (emphasis added).

The heart of Mensing is its rejection of the same “take steps” rationale, which bars as impossible anything short of a manufacturer’s unilateral ability to comply with purported state-law duties:

[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.

131 S. Ct. at 2581.  In short, there’s nothing about the FDAAA in general, and §505(o)(4) in particular, for a “thorough preemption analysis” to analyze with respect to Mensing preemption principles.

About the only thing we whole-heartedly agree with in these opinions is their last part – which we consider obvious – “failure-to-warn claims involving generic labels that conformed to those of the RLD [“reference listed drug”] are pre-empted.”  2013 Pa. Super. Lexis 1683, at *35; 2013 Pa. Super. Lexis 1688, at *38-39.  Otherwise, we have to agree with the dissent that the majority has essentially made up distinctions without differences to avoid having to comply with the Supreme Court’s mandate:

[A]ll of the supposed carve out claims still rest on, or derive from, failure-to-warn claims. . . .  [T]he Majority cites [plaintiff’s] allegations at length, and then concludes generically that his position has merit. . . .  It is fundamental that by virtue of the Supremacy Clause, the State courts are bound by the decisions of the Supreme Court with respect to the federal Constitution and bound by the decisions of the Supreme Court with respect to the federal Constitution and federal law, and must adhere to extant Supreme Court jurisprudence.

Dissent, at 1-2 (citation and quotation marks omitted).  We have the same reaction to this opinion that we did to the First Circuit’s erstwhile decision in Bartlett – that it is a blatant refusal to follow binding Supreme Court authority that (we hope) is doomed to reversal on further appeal.

In re Reglan Metoclopramide Litigation (Morton Grove), 2013 Pa. Super. Lexis 1685, slip op. (Pa. Super. July 29, 2013)

This is another opinion in which the Superior Court ignored all prior precedent on a post-Mensing preemption issue.  Unlike any other court to date, the court held that a generic drug manufacturer, designated by the FDA as the “reference listed drug” for notification purposes, after the original innovator manufacturer has left the market can change its label unilaterally and therefore is no longer protected by preemption after the FDA’s designation.  The FDA, in its new Guidance, refers to this as the (the “ANDA without a marketed NDA reference listed drug” scenario.

The Superior Court reached this result because Mensing (which did not involve any defendant that held an “ANDA without a marketed NDA reference listed drug”) “referred to RLD holders and brand-name manufacturers interchangeably.”  2013 Pa. Super. Lexis 1685, at *12.  Building on that – and rejecting all directly-on-point precedent – the court professed to find no “FDA interpretation” of its regulations precluding any RLD from unilaterally modifying its warnings:

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.

Id. at *14-15.  Finding nothing, the court held that the defendant had not proven a basis for preemption.  Id. at *15.

If that’s the case, then defendant Morton Grove may want to seek rehearing.  The FDA Guidance issued today draws precisely the distinction that the Superior Court couldn’t find, and also makes clear that the label modification procedure under §505(o)(4) – requiring prior notification by, and approval of, the Agency – is applicable to “[p]rescription drug products with an approved abbreviated new drug application (ANDA) . . . if the NDA reference listed drug (RLD) is not currently marketed.”  FDA Guidance at 1. Indeed, the FDA specifically distinguishes its notification and pre-approval process for non-marketed NDA RLDs (don’t you just love FDA jargon?) from the procedure by which ANDA holders are automatically expected to comply with updated labeling where there remains an innovator reference listed drug:

Holders of ANDAs with a marketed NDA RLD would usually be notified . . . of the required safety labeling changes after approval of the labeling supplement for the NDA RLD.  ANDA holders should submit the required labeling changes as a supplement-changes-being-effected (CBE-0) within 30 days of the date of the written notification from FDA.

FDA Guidance at 11.

So we think that the Superior Court also got the Morton Grove appeal wrong by ignoring the wisdom of every other court to address this fact pattern.  We’re not aware of any instance of the FDA ever allowing what the Superior Court postulated − a CBE originating with a reference listed drug that is not also an innovator manufacturer.  However, there were arguably extenuating circumstances, those being a lack of clear FDA guidance, as the court mentioned.  However, those extenuating circumstances no longer exist, as the FDA has clarified that ANDA holders can only change their labels via CBE to match label changes instituted by a “marketed NDA RLD” and must otherwise submit either a supplement requiring pre-approval (if they agree) or a “rebuttal statement” (if they don’t) after receiving notification of new information requiring a label change from the FDA.

In re Reglan Metoclopramide Litigation, 2013 Pa. Super. Lexis 1689, slip op.
(Pa. Super. July 29, 2013).

The issue in this appeal was whether claims against the innovator manufacturer were preempted because, after the innovator sold the NDA, it no longer had the ability to make unilateral changes to the drug’s labeling under FDA regulations, and thus post-sale claims against it were preempted as impossible under Mensing andBartlett.  The Superior Court dodged the issue, finding that the order was not appealable as either final or collateral, and quashing the appeal.

This one is a non-event, which in light of the other three opinions, may well be a good thing.

In sum, generic preemption is now a mess in not only Philadelphia but throughout Pennsylvania as a whole.  For once the Philadelphia Court of Common Pleas is not to blame.