The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community.  Id. at 350.  Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.”  Id. at 351 n.5 (citation and quotation marks omitted). 

Plaintiffs tend to assert a bunch of different claims.  For prescription medical device cases, setting aside preemption, our experience is that plaintiffs do best—that is, avoid summary judgment and directed verdict—with design defect (strict liability or negligence) claims.  One reason for that is that it tends not to be hard to make up some theory,

I can make a hat, a brooch, or a pterodactyl.  Of course, that’s a famous line from the movie Airplane!  But, it seems to have taken on a new meaning now that we aren’t out and about like we use to be.  After work, weekends, before work, lunch hour.  All of these used to be

We all know that absent extraordinary circumstances, failure to warn claims against generic drug manufacturers are preempted under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  But as far as we are aware, no other court has been asked to decide whether that same preemption applies to cross-claims for contribution or indemnity.  Until now.

We are back in the trenches today after spending a wonderful day in New York with our lifelong best friend, in yet another of the blissfully endless celebrations of the milestone birthday we marked in December. We saw “The Band’s Visit,” a new musical based on a 2007 movie about eight members of an Egyptian

Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975).  Happy birthday also to Albert Brooks, writer/director/star of Modern Romance (1981), Lost in America (1985), Defending Your Life (1991), and a gaggle of other comedies.  Brooks also did fine work as an actor in several non-comedies, such as Taxi Driver (1976), Broadcast News (1987), and Drive (2011).  But for our money, his best performance is in Out of Sight (1998), where Brooks played a Michael Milken-esque financier-turned-prison-inmate.  By the way, Brooks’ birth name was Albert Einstein.  Brooks changed his name for obvious reasons.  He cracked that the great physicist had changed his name to Albert Einstein simply to sound smart.  Finally, happy birthday to Don Henley of The Eagles.  Henley sang and co-wrote “Hotel California” (1977), an allegory about SoCal showbiz excess.  The best line in the song is “We are all just prisoners here of our own device.”

Does that trio of birthdays suggest a theme?  Indeed, it does:  drugs and prisoners.  Today’s case is Flowers v. Eli Lilly & Co., 2015 U.S. Dist. LEXIS (D. Nevada July 10, 2015), in which a pro se plaintiff prisoner claimed that Zyprexa gave him diabetes.  The plaintiff had been prescribed Zyprexa at the beginning of his incarceration in 1997, went off it in 2003, and then back on it in 2009, continuing up through the filing of the lawsuit in 2014.  The plaintiff was diagnosed with diabetes in November 2012.  After learning of the diagnosis, the plaintiff requested that he be taken off Zyprexa.  The request was denied.  Remember, the plaintiff was a prisoner.  Patient choice seldom matters from a legal point of view in these cases (because of the learned intermediary doctrine, discussed below), but in this case it really, really does not matter. Zyprexa is an antipsychotic drug that can be used to treat very serious conditions such as schizophrenia and bipolar disorder.  The court’s opinion does not tell us why the prison wanted the plaintiff to be on an antipsychotic, but odds are there was a very good reason.

Continue Reading Little Reprieve for Prisoner Zyprexa Suit

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.

Continue Reading Ninth Circuit Applies One-Two Punch to Prevent Claims against Brandeds, and Preempt Claims against Generics