Wednesday, May 30, 2012

A Quick Mensing Note

            It has been almost one year since the Supreme Court decided PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and it is undeniable that it has dominated the world of pharmaceutical litigation for all eleven months – and likely will continue to do so for a while longer.  This is clearly evidenced by our ever-growing generic drug preemption scorecard.    While you can always find the latest Mensing decisions there, we like to separately point out those that add something new to the discussion – at least we don’t think we’ve seen these particular twists yet. 

            So, today we draw your attention to Johnson v. Teva Pharmaceuticals USA, Inc., 2012 U.S. Dist. LEXIS 71384 (W.D. La. May 21, 2012).  This is a metoclopramide case and as our regular readers know, Dechert is involved in this litigation and therefore, we can’t offer commentary.  But, we can report what this court had to say on two issues. 

            First, plaintiff made an argument that has become commonplace since Mensing:  Mensing doesn’t apply when a generic defendant doesn’t timely update its label to conform to the brand label.  The Johnson court, like the others to have considered this argument, agreed.  “[I]mpossibility preemption would not apply to any [state law] requirement . . . that the Generic Defendants update their product label to reflect changes made by the brand name manufacturer.”  Id. at *10.  However, it is what the court did next that we don’t think we’ve seen explicitly spelled out in any other Mensing decision:
     Nevertheless, the court finds that amendment would be futile because Ms. Johnson cannot state a plausible claim for relief based on the Generic Defendants' delay in adopting the 2004 labeling changes. The proposed amendment is wholly inconsistent with the allegations of Ms. Johnson's original complaint. The original complaint includes an allegation that the FDA-approved warning label for Reglan remained "inadequate" until the FDA issued a "boxed warning" in 2009. Essentially, therefore, Ms. Johnson seeks leave to amend her complaint to assert a claim that the Generic Defendants are liable for failing to update their label to one that was still inadequate.
Id. at *10-11.  In other words, failure to implement an inadequate warning is not a viable cause of action. 
            Second, plaintiff attempted to dodge Mensing’s preemption of failure to warn claims by couching her cause of action as a design defect.  Plaintiff alleged that “the Generic Defendants could have employed an alternative packaging design that would have mitigated the risks posed by metoclopramide.”  Id. at *12.  To which the court responded:
     This, however, is merely another way of stating that the Generic Defendants failed to provide adequate warnings about the risks associated with the long term-use metoclopramide. As explained above, Mensing forecloses any such claim. The FDCA prohibits generic manufacturers from employing any labeling that contains information that differs from that contained in the labeling used by brand-name manufacturers. Under the FDCA, "labeling" includes any written material accompanying the product. Accordingly, there was no alternative packaging design available to the Generic Defendants that could have conveyed stronger or different warnings about metoclopramide’s side effects.
Id.  In other words, any argument about “alternative packaging” is a preempted failure to warn claim.
            Plaintiff’s failure to warn, breach of warranty, and failure to withdraw from the market claims were likewise dismissed. 

1 comment:

Anne Roberts said...

That was indeed a grueling eleven months. We all watched how it ended. I am tired of all these legal issues, but of course, as always, I can't help watching out for verdict.