Photo of Stephen McConnell

Happy birthday, Justice Sotamayor.  Her autobiography, My Beloved World, is now in paperback and the Justice has been all over the airwaves for the inevitable promotional push.  Every time we see Justice Sotamayor interviewed, we like her more.  We learned that she shops at Costco, where she recently ran into Secretary Clinton, who was signing copies of her own book.  That makes us think that Justice Sotomayor is a real, down-to-earth person.  She is also smart and direct.  She reminds us of the old adage that the most effective politicians are tough liberals and cuddly conservatives.  Sotamayor was a prosecutor for a while, so we confess to harboring an undeniable bias in her favor.  She also makes a point of admitting her fallibility up front.  She points to retired Justice Stevens and his acknowledgment that he regrets some of his opinions and would now write them differently.  She says she fully expects to feel the same way about her judicial oeuvre in 20 years.

We do not have to wait so long to regret Justice Sotamayor’s opinions in an area close to our heart, FDA preemption.  Those opinions make for unpleasant reading. Luckily, they are dissents.  Justice Sotamayor wrote lengthy dissents in the Mensing and Bartlett cases.  Those dissents seem to turn on two fundamental notions: (1) hostility to conflict preemption, with a conviction that there is a conflict only when compliance with both federal and state law is impossible not only in a practical sense, but in a complete, almost metaphysical sense.  One gets the distinct impression that in Justice Sotamayor’s world view, it would be pretty much impossible for a manufacturer to show impossibility preemption. (2) Justice Sotamayor is irked that purchasers of generic products might be ousted from court while purchasers of branded products could still buy a ticket to the litigation lottery.  Big surprise: we think she is wrong about that, too.  Such distinct treatment of consumers of distinct products is not inherently unfair or illogical.  One could come up with a rational system where consumers could trade lower prices for reduced litigation options. Maybe that is what we have.  We certainly have it with respect to limited tort auto insurance policies.

Perhaps we are dewy-eyed optimists in hoping that one day Justice Sotamayor will see her dissents in Mensing and Bartlett as erroneous.   Meanwhile, judges across the land continue to apply those decisions to preempt lawsuits against generic manufacturers.  When the decision also dismisses claims against the branded manufacturer, whose products were not used by the plaintiff,  we call that a judicial one-two punch.  Recently, the Ninth Circuit applied that one-two punch.  The opinion is not yet published (and we are not sure why that is so) but it is good to know that the overly-criticized Ninth Circuit is fully capable of following the Supreme Court preemption precedents that distress Justice Sotamayor.

The case is called Moretti v. Wyeth, Inc., No. 12-16334 (9th Cir. June 17, 2014).  Let’s start with the first part of the one-two punch, which dismissed the claims against the brand defendants.  The plaintiff had used only the generic version of the drug, but still sued both the brand and generic manufacturers.  In a spasm of magnanimity or realism, the plaintiff conceded entry of summary judgment on all of her claims against the brand defendants except for her claims based on misrepresentation by omission; constructive fraud; negligent misrepresentation; and fraud by concealment. That concession did not go far enough.  The district court concluded that Nevada law did not recognize any of the plaintiff’s claims against the brand defendants.  The Ninth Circuit agreed.  Under Nevada law, a misrepresentation by omission is actionable only if the defendant was under a duty to disclose the relevant information.  Such a “duty to disclose requires, at a minimum, some form of relationship between the parties.”  The best that plaintiff could do to try to establish some sort of relationship between her and the brand defendants was to argue that negligent performance of an undertaking provided a duty of disclosure.  What undertaking?  The problem for the plaintiff is that her complaint failed to allege that the brand defendants undertook “to render testing, advisory, laboratory and personnel services for the purpose of
promoting the safety of [PLIVA’S Metoclopramide] in order to benefit third persons and had significant control over [its] development.” Thus, while the Moretti opinion nowhere mentions Conte, it implicitly rejects that theory, at least under Nevada law.

The second part of the one-two punch is preemption of the claims against the generic manufacturer.  The Moretti court’s analysis of the Mensing and Bartlett decisions is about as pithy as it gets:

Mensing made clear that tort claims based on a generic manufacturer’s failure to unilaterally strengthen warning claims are preempted by the federal requirement that generic labels display exactly the same information as the federally approved brand-name label, and that tort claims based on a generic manufacturer’s failure to change the chemical composition of the drug are preempted by the federal duty of sameness.  Mensing also clarifies that claims based on a generic’s failure to report incident information to the FDA are preempted because the generic manufacturer could not independently comply with its state-law duties – strengthening the warning label in line with new evidence-because any label change was dependent on the FDA’s discretionary action.  Finally, Bartlett bars claims based on a manufacturer’s failure to exit the market for a particular drug.

The plaintiff in Moretti was unable to propose any action by which the generic manufacturers could comply with the state-law obligations asserted in the complaint without violating federal law.  What about the one theory that sometimes successfully circumvents Mensing, that the generic manufacturer did not timely update its label after the brand manufacturer added a warning?  The Moretti court allowed that such a claim might theoretically survive preemption, but the plaintiff had conceded at oral argument that she was no longer taking the medicine at the time of the label change.  Bazinga!

The Moretti decision adds the Ninth Circuit to the list of circuits that have applied the one-two punch.  By our count, that makes seven.  We are happy with that result, but we doubt that Justice Sotamayor would be.  We hope that she gets whatever she wishes for when she blows out the candles today – unless that wish has anything to do with the scope of preemption.