Happy birthday to Al Roker, who makes even a rainy day forecast seem jolly.  Happy birthday to Amy Adams, who enchanted audiences in movies as diverse as Drop Dead GorgeousThe Fighter, and American Hustle.  Happy birthday to the late Jacqueline Susann, who authored one of the key documents of the Mad Men era, Valley of the Dolls (1966).  That novel is what the English majors call aroman a clef – literally, a novel/romance with a ‘key.’  The key is the correspondence to real life.  Valley of the Dollschronicled show biz women and their adventures in Hollywood, in bed, and in the medicine cabinet.  Some of the characters allegedly are based on real starlets, such as Judy Garland and Ethel Merman.  Most readers of this post are too young to remember what a big deal Valley of the Dolls was in the late 1960’s.  It was a huge success and a huge scandal.  Almost every adult of a certain age read it.  Almost every one of them denied reading it.  Both Susann and her book were subjected to scathing reviews from the literati.  More than one critic said, “That’s not writing, that’s typing.”  If it was typing, it was typing on a cash register.  It rained money all over Ms. Susann.

The film version of Valley of the Dolls came out only a year later.  The plaintiff lawyers would probably call it a rush-to-market.  It starred Patty Duke, Barbara Perkins, and Susan Hayward.  Hayward played a part originally slated for Judy Garland, but Garland turned out to be more of a method actress than was expected, as her dissipations prevented her from doing little things like showing up on the set.  If you haven't yet had your daily dose of trash, take a peek at the movie's trailer.  Sharon Tate was another lead in the movie.  Only a couple of years later, she would become, at the hands of the Manson Family, perhaps the single most iconic victim of 1960's craziness.   

Valley of the Dolls is not wholly extraneous to this blog.  The “Dolls” in the title referred both to the female protagonists and the pills that … helped them.  However much you might sniff about the literary deficiencies of Valley of the Dolls, it still reads better than some of the judicial opinions we’ve discussed this month.

And now for a little case analysis.  (At least one of you will send us a rejoinder along the lines of, “That’s not analysis, that’s typing.”)   

Thomas v. Abbott Laboratories, 2014 U.S. Dist. LEXIS 109905 (C.D. Cal. July 29, 2014) is about causation – both warning causation and medical causation.  The plaintiff sued two companies that made the anti-cholesterol medications Trilipix and Zetia. The plaintiff claimed  that he developed pancreatitis as a result of ingesting those drugs.  More specifically, the plaintiff alleged that the defendants failed to warn him and his primary care physician that Trilipix and Zetia, when taken together or alone: (1) would not reduce the risk of having heart problems or a stroke; (2) could cause gallstones; and (3) could cause the blockage of common bile duct, severe acute pancreatitis, diabetes, and other ailments.  The defendants filed for summary judgment. 

Warning Causation

One hurdle in the plaintiff’s way was the learned intermediary doctrine.  He attacked the learned intermediary rule for being outdated and unpersuasive because prescription drugs are now advertised directly to the consumers.  There are some courts that have smiled upon such nonsense, but no California court has, and the federal judge declined to blaze a path to imbecility.  Thus, the plaintiff was stuck with the learned intermediary rule, and stuck with some rather inconvenient testimony by his treating physicians. Dr. Lake testified that when he first prescribed Trilipix to the plaintiff,  he was aware of Trilipix’s association with pancreatitis (including acute pancreatitis) and gallstones. Dr. Lake testified that had he been aware in 2008 that Trilipix did not reduce the risk of coronary heart disease, he still would have prescribed it to the plaintiff because he believed that Trilipix was “still barking up the right trail” in helping the plaintiff lower cholesterol. Thomas v. Abbott Laboratories, 2014 U.S. Dist LEXIS 109905 at *17. So far so good.

But Dr. Lake’s testimony regarding Zetia was different.  He  testified that he did not believe that Zetia’s warnings adequately apprised him of the potential risk for gallstones.  So far so bad.  The plaintiff managed to conjure up a genuine issue on warning adequacy.  But that is not enough to create a genuine issue as to warning causation.  The plaintiff presented no evidence that Dr. Lake’s conduct would have differed if he had been adequately warned.

At this point in the Thomas opinion, the court embarks on a discussion of an issue that vexes both plaintiff and defense hacks on an almost daily basis. During the all-important deposition of the prescriber, which side has the obligation – and, more important, the guts -- to ask the doctor the ultimate question of whether a different warning would have changed the prescribing decision? Both sides tend to nibble at the edges of this question. Nobody wants to lose the case in one fell swoop, with ocular proof of the folly in the form of a deathless transcript. Plaintiff lawyers, in particular, are wary, because they like to keep open their options– maybe right up to closing argument – as to what exactly the warning should have said. This juncture in the prescriber deposition is a messy, scary moment. In theThomas case, the plaintiff never asked what the court called “the key question.” We would say that on that basis alone, the plaintiff should lose. After all, the plaintiff bears the burden of proving causation. Could anything be clearer? No. Does the Thomas court say that? No. Instead, the Thomascourt says that if the warning causation issue was necessary to dispose of this case, the court“would invite further briefing on this point or perhaps even authorize a further deposition of Dr. Lake.” Id. at *20. Yikes. That strikes us as a bit soft-headed. It certainly provides no guidance for our future hackery. It also strikes us as a bit … wrong. But for now, we’ll also say that it strikes us as a bit of dicta. That is because the court goes on to say that “even if a genuine issue exists as to whether Dr. Lake would have prescribed Zetia with proper warnings, there is still insufficient evidence of medical causation for both drugs.” Id. at *21.

Talk about burying the lead!

Medical Causation

If there is a key guidance to be seized from the Thomascase, it is this: line up experts who will say what you need them to say. The plaintiff in Thomas introduced zero expert testimony in support of his oppositions to the defendants’ motions for summary judgment. He did not designate any expert during discovery. Instead, he relied on the diagnosis and notes of his treating physicians. That decision might have saved the plaintiff and his lawyers money, but it certainly could not save their case. The treating physicians’ notes and testimony were insufficient to demonstrate that Trilipix and Zetia were a probable cause, not simply a possible cause, of the plaintiff’s pancreatitis.

For instance, Dr. Kerekes’s report stated that the plaintiff presented “with acute pancreatitis of unclear etiology, but it is quite possible this may be related to Trilipix which as known to cause pancreatitis.”  Id. at *24.  Dr. Kerekes acknowledged two possible causes of the pancreatitis:  the medications and gallstones.  While he opined that gallstones were the less likely cause, he did not rule them out.  Thus, Dr. Kerekes’s report did not demonstrate that Trilipix and Zetia caused the plaintiff’s pancreatitis within a reasonable medical probability.  Id.

There were three other doctors who similarly identified the medications as a possible cause of the pancreatitis, but also could not rule out an alternative cause.  The plaintiff’s counsel argued that based on the notes and reports of the treating physicians, the fact-finder could eliminate all the other possible causes of the plaintiff’s pancreatitis except for his medications.  After all, none of the doctors’ reports stated that the plaintiff had a gallstone.  Thus, the plaintiff's lawyer wanted to argue by inference that the plaintiff’s medications were left as the probable cause of his pancreatitis.  The court did not buy this argument.  The plaintiff’s counsel was essentially asking for the jury to perform a differential etiology that the actual treating doctors could not do.  But “leaving it to the jury to conduct this process of elimination would not establish causation ‘within a reasonable medical probability.’”  Id. at *29.  There was no evidence demonstrating that the plaintiff’s treating physicians completed this process of elimination, and it would be judicial malpractice to entrust that process to a jury. 

The lack of warning and medical causation caused the plaintiff’s case to go away.  

(Believe us, this is a much better ending than either the book or movie versions of Valley of the Dolls.)

The reason we started off with birthday greetings is because today is the birthday of the DDL Son, and we like him even more than Al Roker, Amy Adams, or Jacqueline Susann.  Our kids are miracles, and they dazzle us daily with the ways in which they are like us and unlike us, and then they ultimately dazzle us by emerging into their own unique personality.  The DDL Son is ready to head back to college, where he is focusing on Marketing and Russian Studies.  (Don’t ask.)  He probably knows that a few other things happened on August 20 besides his birth.  Tchaikovsky’s1812 Overture premiered on this date in 1882.  On August 20, 1953, Stalin acknowledged that the Soviet Union had detonated a hydrogen bomb.  Fifteen years later, Warsaw Pact tanks rolled into Czechoslovakia and said ‘nyet’ to the Prague Spring.  So even picking out one date in Russian history, we see the vicissitudes of the human story.  It’s clear enough that we cannot count on music and freedom every day.  But we are counting on music and freedom today.  And we are counting on more.  Today and for all of his days, we hope the DDL Son gets plenty of what he has given to us: love, astonishment, and laughter.  (And, yeah, you can count on getting those garish, ludicrously expensive soccer cleats you wanted.)