Wednesday, January 16, 2013

Does the "N.D." in N.D. Mississippi Stand For No Doubt? A Good Decision on Branded and Generic Liability


We were recently talking with the Drug and Device Law Heirs about going to a movie. There was a suggestion to see Les Miserables, but we declined. We had sat through the theatrical version 20 years ago and did not like it a bit. Why? Well, it was too … miserable. And as we get older and crankier, we have less tolerance for things that make us feel sad. We’d rather stay at home and catch up on tv piffle like Cougartown or It’s Always Sunny in Philadelphia than endure a bummer film, no matter how artfully done.

 

By the way, it is not always sunny in Philadelphia. In fact, right now, it is dreary and drizzly and gray. Is there no end to this grimness? We’re feeling like that old country song, where mom got out of prison on a rainy day, only to be run over by a train. Or something like that. And now 2013 has opened up with some terrible cases. How do we wash off the stench of Stengel and the wretchedness of Weeks? Those opinions revived doctrines that we find even more distasteful than Brussels sprouts or Middlemarch.  And they did so with all the coherence of Jodie Foster’s Golden Globes speech or the ongoing debt-ceiling debate. We’re looking around for some relief, like a crocus poking through the frost.

 

Yesterday, we found some relief in Abicht, a metoclopramide case where a court rejected a claim that the defendant failed to update its label. Whether via preemption or the lack of a private right of action to enforce FDA rules, the plaintiff was out of court. Today’s metoclopramide case, Gardley-Starks v. Pfizer, Inc., 2013 U.S. Dist. LEXIS 3966 (N.D. Mississippi Jan. 10, 2013), is even better, because it offers a one-two punch knocking out claims against both branded and generic defendants, and because it disposes of a variety of purported exceptions to Mensing preemption.

 

We’ll admit to being badly scarred by our high school reading of William Faulkner. Honestly, can you really make head or tail out of Absalom! Absalom!? And when we heard that Hollywood is coming out with a film of As I Lay Dying, all we could think was, how? Okay, we also had another thought: why? Anyway, our encounters with the bard of Yoknapatawpha County made us think that all prose coming out of Mississippi must be florid and opaque. Not so. Here is how the Gardley-Starks court begins its discussion of the Conte issue (whether a branded manufacturer can be held liable by a consumer of only the generic drug): “The Brand Defendants argue that, because it is undisputed that the Plaintiff never ingested their product (brand name Reglan), they are entitled to summary judgment. The Court agrees.” 2013 U.S. Dist. LEXIS 3966 at *5. The plaintiff cited no Mississippi authority supporting liability for a manufacturer whose product was not used, and there were two federal cases applying Mississippi law that rejected the plaintiff’s theory. Moreover, the “overwhelming majority of courts to consider the issue” rejected that theory. Id. at *15.   Accordingly, the Gardley-Starks court concluded that “Mississippi law, consistent with the vast majority of courts to consider this issue, would not recognize a cause of action- however styled – against a brand manufacturer for injuries caused by use of its competitors’ generic product.” Id.  Nice and straightforward. Here’s something we find especially cute about the Gardley-Starks opinion: in rejecting the theory that most of us call by the name of the California case that invented it, Conte, the Gardley-Starks opinion never mentions Conte (unless we missed it somewhere in the small Lexis printing). Perhaps ignoring something is the ultimate sign of disrespect.  Hmmmmm – maybe if we refuse to say “Conte” or “Weeks” they will disappear in the mists of time.

 

The generic defendants in Gardley-Starks also got out. They moved to dismiss on the ground of Mensing preemption. The Gardley-Starks court begins its Mensing analysis in a good place when it correctly observes that “the majority of courts have continued to hold that state law tort claims asserted against generic drug manufacturers, no matter how styled, are ultimately based on a failure to warn.” Id. at *20-21. And yet, the plaintiff tried to do some serious styling. No matter – the court batted away all the efforts to circumvent Mensing:

 

1. Failure to Withdraw

 

The plaintiff argued that Mensing did not address a manufacturer's liability for continuing to sell a bad product.  This argument is, of course, what is at issue in the Bartlett case that is now before the U.S. Supreme Court.  But, in fact, that failure to withdraw theory "was embraced by the Eighth Circuit in its original Mensing opinion which was later reversed by the Supreme Court."  Id. at *26.  Plus, every court that has considered that theory has spurned it for the nonsense that it is.  The Gardley-Starks court devotes all of one paragraph to depositing the failure-to-withdraw theory in the trashcan.  Are you listening Justice Kennedy?  This is a simple issue.  There really is no need to consult foreign law or wonder how the case implicates a person's confrontation with the meaning of the universe and the mystery of human life. 

 

2. Failure to Communicate Warnings (Dear Doctor letters)

 

"A Dear Doctor letter that contained substantial new warning information would not be consistent with the drug's labeling."  Id. at *28.  As Cousin Vinny would say, "I'm troo wit dis guy!"

 

3. Failure to Conduct Post-Marketing Surveillance and Reporting

 

This misbegotten theory was dealt with nicely in an earlier N.D. Mississippi case called Truddle (which we blogged about here), and the reasoning cannot be improved upon even a little.  "To the extent any investigation, testing or marketing surveillance would have revealed the dangers of the drug, that knowledge would have been helpful only to the extent it was communicated through labeling - which would not have made any difference as long as the Generic Defendants were following the FDA's labeling regulations."  Id. at *30.  It ends up in the heartland of Mensing preemption of failure to warn claims. 

 

4. Failure to Update Label

 

This theory is precisely what the Abicht court rejected in the opinion we discussed yesterday.   In Abicht, the court rejected the theory out of hand as an improper attempt by a private litigant to enforce FDA regulations.  The Gardley-Starks court was not so sure, but finessed the issue by finding that the Complaint never plausibly alleged that the plaintiff's physician ever relied on the label when prescribing metoclopramide.  Indeed, the Complaint states that "PLIVA never provided a copy of its label ... to ANY physician."  Id. at *35.  Poor plaintiffs - they either plead nothing, or they plead something that clobbers themselves.  You probably cannot tell as you are reading this, but we are actually dabbing at our eyes with a silk hankie.  Who needs to watch a head-shaved Ann Hathaway wail away as poor Fantine when the law gives you pathos such as this?

 

5. Defective Design

 

The court gives this theory all the dignity it deserves: three sentences.  The "duty of sameness" requires a generic drug to be bioequivalent to its name brand counterpart.   A different design would be a violation of federal law.  Next?

 

Oh, there is no next.  That's it for the Gardley-Starks claims.  We love happy endings.         

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