One, Two ... Three?

by Dechert LLP

A couple of weeks ago we posted about the one-two punch of generic preemption and product identification disposing of most of the claims in the Darvocet MDL.  Well, that combination has since landed a third punch that sent still more plaintiffs reeling.

It seems that the original branded manufacturer of the product was also embroiled in the litigation.  That defendant had sold all its rights to the NDA in 2002 – long before the litigation began – to independent successor corporations.  In In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 767595 (E.D. Ky. Feb. 5, 2012), the court dismissed those claims as well.  The same rule – that the branded manufacturer owes no duty to generic-only plaintiffs – applies.  Id. at *2, 8.  Given the length of time that has passed, none of the plaintiffs could plausibly plead that they, in fact, took the original manufacturer’s product prior to 2002.  Id. at *4.

There are a couple of factual twists that make this latest Darvocet decision particularly interesting, given the manner in which drug companies can divest themselves of NDAs.  First, due to the learning curve in manufacturing drugs, it’s not unusual for the original NDA holder to continue producing the drug for a purchasing company for some time after the sale is effectuated.  In Darvocet that period was two years and some months.  2012 WL 767595, at *6.  Second, after selling off the NDA, it’s not unheard of for former branded manufacturers to keep their facilities operating by manufacturing drugs for sale by generic manufacturers.  That also was alleged in DarvocetId. at *5-6.

Neither fact pattern helped plaintiffs, however.  As for the first, the former brand name manufacturer did not make all of its successor’s product, but only a declining fraction of it.  Id. at *7.  No plaintiff could allege ingestion of of product from one source versus the other.  Thus, the claim still failed product identification requirements – thanks to TwIqbal:

"The plaintiffs have failed to state a plausible claim against [defendant] as a manufacturer of brand-name drugs after 2002.  Accepting the allegations as true, at most they establish a mere possibility that the medicine used could have been made by [defendant]. . . .  This is simply insufficient under Iqbal or Twombly because the allegations are too speculative to state a plausible claim. . . .  The statement that “[The NDA purchaser] may have sold” products manufactured by [defendant] is too vague to establish that this plaintiff ingested a [defendant] drug on those specific dates."

2012 WL 767595, at *7 (emphasis added).  Liability in this sort of indefinite manufacturer situation would require something along the lines of market share, but no market share theory applies where a manufacturer (here, the NDA purchaser) is in fact known.  Thus, there cannot be a viable theory of liability – even in market share states.

Nor did plaintiffs get any further with allegations that the former branded manufacturer might have produced generically-marketed drugs.  First, those claims suffered from the same fatal “maybe is not enough” product identification problems just discussed.  Id. at *6 (“nothing more than a “sheer possibility” that [defendant] is liable”).  Even more interesting, once a non-NDA manufacturer is involved, preemption comes into play.  None of the plaintiffs alleged that the product made by the former brand name manufacturer had a manufacturing defect – only warning claims were made – and we all know that warning claims are preempted under Mensing when it's impossible for the particular defendant to change warnings unilaterally:

"The plaintiffs have not brought a manufacturing defect claim against [defendant] because their allegations do not assert that [it], at any time, manufactured products that were adulterated, outside of specifications, or used defective ingredients.  Additionally, any state failure-to-warn claims would be preempted by federal law because, as the plaintiffs concede, [defendant] had no power to change the labels for generic drugs, or for brand-name drugs that were made and sold by others.  Thus, it is not immediately apparent what purpose would be served by establishing that [defendant] manufactured propoxyphene products for other companies."

Id. (citations and quotation marks omitted) (emphasis added).  Once a manufacturer surrenders its NDA, it loses the ability to make warning changes.  Thus, Mensing impossibility preemption applies once the NDA is sold.  Mensing thus cuts off claims of successor liability – whether or not the end product is generic or branded.  That's a point to remember.

These plaintiffs, as well, were thus down for the count.  “[U]nder Iqbal, plaintiffs should not be permitted to conduct discovery in order to fix factually deficient complaints, even where the necessary information is within the defendant's exclusive possession.” 2012 WL 767595, at *9 (denying leave to amend).

Written by:

Dechert LLP

Dechert LLP on:

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