There has been a lot of good news coming out of the Darvocet MDL recently (see here, here and here). In particular, the use of  the one-two punch of product identification (can’t sue non-manufacturers (i.e. brand manufacturers)) and generic preemption (can't sue generic manufacturers) to dispose of meritless generic pharmaceutical litigation.  But what if the brand name manufacturer also manufactured the generic drug?  In that case, the one-two becomes a two-fisted hammer punch like that so often used by Captain James T. Kirk.   

The latest decision picks up where the court left off on February 5, 2012, see 2012 WL 767595,  considering the liability of a brand name manufacturer who manufactures generic drugs for sale by a generic manufacturer.  In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 U.S. Dist. LEXIS 107388 (E.D. Ken. Jul. 31, 2012) (addressing complaints filed by two plaintiffs Chavez v. Eli Lilly and Company, et al., Civil Action No. 2:12-62 and Marston v. Eli Lilly and Company, et al., Civil Action No. 2:12-66).   With respect to Darvocet, the original NDA Holder (brand manufacturer) entered into an agreement in 1994 to also manufacturer generic product and supply it to one of the generic manufacturers for sale.  After the original NDA Holder sold off the NDA in 2002, it continued to manufacture and supply generic product to the generic manufacturer.  2012 U.S. Dist. LEXIS 107388, at *47.  When the court examined this issue back in February, based on the alleged dates of usage, the court held “it is not reasonable to infer that a product ingested in 2010 was manufactured by [the original brand name manufacturer],” id. at *48, and therfore dismissed the claims.

In the current cases, plaintiffs Marston and Chavez alleged they used generic propoxyphene no later than 2004, removing the “attenuated time line” problem of the early case and allowing the court to find that these complaints “create more than a sheer possibility that at least some of the [generic] products ingested were manufactured by [the original brand name manufacturer].”  Id. at *49.  So this time, the court had to go beyond the temporal allegations and look at the substance of the claims.  The result was the same – claims dismissed.

Starting with plaintiff Marston – she alleged she ingested the drug between 2003 and 2004 – after the defendant had sold the NDA.  Id. at * 47.    The court found that by that time, the original NDA Holder was in no different position than a generic manufacturer and therefore applied its prior decisions dismissing all claims as preempted under MensingId. at *48-50 (plaintiff’s “claims against [the original brand manufacturer] are preempted under Mensing, because [it] had no more power to change the label than did [a generic manufacturer]”). 

Moving on to plaintiff Chavez – who alleged product usage during the time defendant was the NDA Holder – the court acknowledged that this was a closer question, but still too drawn-out to allow the claim to stand.  Plaintiff’s argument goes something like this:  because the brand name manufacturer could change the brand label, “thereby triggering a required change in the generic label . . . [it] indirectly controlled the label for generic propoxyphene.”  Id. at *52.  Putting aside whether the brand manufacturer was supplying the generic product – isn’t this really the same “innovator liability” argument that has been shot down by virtually every court to consider it?  The Darvocet MDL court picked up on that too:

[I]mputing a duty to [the brand name manufacturer] in this situation might have problematic consequences. Allowing the plaintiff in Chavez to assert failure-to-warn claims against [the brand name manufacturer] would be tantamount to finding that [the brand name manufacturer] is responsible for the labels of all generic propoxyphene, rather than only the label of the propoxyphene product it sells or manufactures. Using this reasoning, an NDA-holder could be held liable to the consumers of the corresponding generic product for failure to warn (regardless of which company manufactured the drug), simply because it had the power to change the label and chose not to do so. As the Court has repeatedly found, a threshold requirement of any products-liability claim is that the plaintiff assert that the defendant's product caused the plaintiff's injury.

Id. at *53 (citation and quotation marks omitted).

And as to the specific situation presented here – brand manufacturing for generic – the court did not see that as a game changer:

[T]he inherent argument in Chavez is that [the brand name manufacturer], as the NDA-holder for propoxyphene, owed a duty to the consumers of another company’s product because it had a supply agreement with that company. In other words, Chavez seeks to hold a brand-name company responsible as a generic manufacturer based on the powers it held as a brand-name company. This convoluted theory of liability is insufficient to state a viable claim against [the brand name manufacturer]. The claims would be dismissed under Mensing if they were asserted against a generic manufacturer; they would be dismissed on product identification grounds if they were asserted against [defendant] as a brand-name manufacturer. Chavez cannot create a viable claim by combining two other, untenable claims. Therefore, the claims asserted against [the brand defendant] in Chavez will be dismissed.

Id. at *52-53.  That’s the one-two punch we’ve been talking about – product identification and preemption.  When aimed at the same defendant – you get the Kirk hammer fist. 

Switching analogies and tipping our cap to the Olympics -- the court was unwilling to go through the legal and analytical gymnastics equivalent to a Yurchenko with 2.5 twist required to adopt plaintiff’s reasoning: 

the Court would have to find that [the brand name manufacturer] owed the plaintiffs a duty to change the label as a brand-name defendant and that its failure to do so rendered it liable as a generic manufacturer.  The Court refuses to adopt the line of reasoning that would render [the brand defendant] liable under these circumstances.

Id. at *54-55.

            Another good decision. Another strong use of the one-two (or two-fisted) punch. Begs the question, how many more blows can the Darvocet plaintiffs withstand?