Photo of Bexis

Because it applied implied preemption, the decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) is powerful.  We’ve previously mentioned how we think Mensing’s principles might be invoked in some claims against non-PMA medical devices, where express preemption is precluded by Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

We haven’t seen anybody take us up on that idea (yet), but we’re not letting that stop us.  We’ve come across a case that’s given us more reason to think about how the implied preemption principle in Mensing may be gainfully employed on behalf of defendants who aren’t generic drug manufacturers.

First of all, the Mensing preemption principle – because it’s important to keep exactly what we’re talking about firmly in mind:

[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.

Mensing, 131 S. Ct. at 1281 (emphasis added).

Because Mensing involved implied preemption, this principle applies outside the specific context of Hatch-Waxman, ANDAs, and generic drugs.  Any interposing federal requirement that deprives the defendant of the ability to satisfy state tort duties “independently” should have the same preemptive effect under Mensing.

Now to the case.  As our continually updated post-Mensing generic preemption scorecard reflects, there’s already been a favorable generic preemption ruling in the Fosamax MDL.  See In re Fosamax Litigation, 2011 WL 5903623 (D.N.J. Nov. 21, 2011) (“Generic Fosamax I”).  Well, there’s just been a follow-up.  In In re Fosamax Products Liability Litigation, 2012 U.S. Dist. Lexis 5817 (D.N.J. Jan. 17, 2012) (“Generic Fosamax II”), the court had to deal with a generic straggler.  All the other generic manufacturers had been dismissed in Generic Fosamax I, but one of them (Watson) was alleged in one case (Welch) to have been more than simply a generic Fosamax manufacturer.

In this Welch case, the plaintiff also alleged:

Defendant Watson was what is known as the authorized distributor of branded Fosamax.  Upon information and belief, under the agreement between [the branded manufacturer] and Watson, [it] manufactured and supplied alendronate and Watson marketed and sold the drug under branded name Fosamax.

Generic Fosamax II, 2012 U.S. Dist. Lexis 5817, at *21 (quoting complaint).

On the basis of that one allegation (supported only by “information and belief” pleading), the Fosamax MDL plaintiffs tried to keep one peripheral defendant in one case.

The court said “no,” and that “no” has implications way beyond this one case.

Mensing implied preemption applies even where the defendant is a distributor of the branded product, as alleged in the Welch complaint.  Under the Mensing implied preemption principle, a mere distributor is no more able than a generic manufacturer to make unilateral changes in drug labeling:

[E]ven if the Plaintiffs in [other] cases made the allegation found in Welch – that Watson was an authorized distributor of Fosamax – Watson would still be entitled to judgment on the pleadings and dismissal from the MDL.  As a distributor of Fosamax, Watson has no power to change Fosamax labeling.  That power lies with the applicant who filed the New Drug Application (NDA) seeking approval to market Fosamax.  See 21 U.S.C. 355(b); 21 C.F.R. 314.70 (describing the Changes Being Effected or “CBE” regulation, which requires that “the applicant must notify FDA about each change in each condition established in an approved application.”) (emphasis added).  In this case, [the branded manufacturer] is the NDA applicant with the corresponding authority to change labeling.  Additionally, if FDA had “become aware of new safety information” in connection with Fosamax use that “it believe[d] should be included in the labeling,” FDA must notify the holder of the NDA to initiate the changes.  21 U.S.C. 355(o)(4)(A).  Neither of these procedures involves a distributor.

As a result of the scheme set forth by the FDCA, Watson has no authority to initiate a labeling change of Fosamax.  That authority lies with the FDA and/or with [the branded manufacturer].  Even taking the allegation in Welch as true, a contractual relationship between Watson and [the branded manufacturer] cannot change the fact that Watson is not the NDA holder.  Consequently, Watson has no power to unilaterally change Fosamax labeling.  Because Watson could not “independently do under federal law what state law requires of it,” the state law claims brought against it are preempted.

Generic Fosamax II, 2012 U.S. Dist. Lexis 5817, at *27-28 (most emphasis added).

Thus, under Mensing’s implied preemption principle, any distributor of any FDA-regulated prescription drug – branded or generic – has a preemption defense to warning claims based on the simple fact that non-manufacturing distributors aren’t manufacturers and thus aren’t “independently” able to change drug labeling through the CBE (or any other) process.  At most, distributors could pass information along to the branded manufacturer – but Mensing also held preempted pass-along claims that “depend[] on the actions of . . . the brand-name manufacturer.”  131 S. Ct. at 2578.

What Generic Fosamax II means is that anybody representing a non-manufacturing distributor of prescription drugs sued as an intermediate seller on a warning-related claim should give a serious look at Mensing impossibility preemption as a defense.  Similar arguments might be made on behalf of other non-manufacturing defendants – hospitals, pharmacists, sales reps, component part sellers, the list could be long – as long as their basis for liability is some deficiency in the FDA-approved label, as opposed to conduct specific to that defendant.

Since distributors are often joined as subterfuges to destroy diversity of citizenship, we note (but do not further discuss) the possible effects of the preemption theory in Generic Fosamax II on subject matter jurisdiction issues.

This is what we like to do best on this blog – pass along ideas for defending our clients that our readers might not have considered – so this is a good day for us.