Would you have bet on the Red Sox to win the 1986 World Series? Would you have booked passage on the Titanic?  Would you have bought a ticket to see the movie Ishtar?  If someone asked us these questions today, we all would answer in the negative because we already know the outcomes.  The 1986 Red Sox won 95 games that year and were riding the arms of their two young stars, Bruce Hurst and Roger Clemens.  They may have been a good bet at the time, but Bostonians can still see that ground ball wiggling its way between the legs of a certain first baseman.  The Titanic was a modern marvel and highly sought after ticket, but that voyage ended in tragedy (a real tragedy, not a faux tragedy like losing a baseball game).  We actually did buy a ticket to the movie Ishtar when it debuted in 1987 (forgive us, we were young).  It was a big-budget vehicle for two A-list movie stars, Dustin Hoffman and Warren Beatty, but the film was an epic flop.  

We know now how these events in history turned out, yet millions of people placed that bet, booked that passage, or bought that ticket—and they all had good reasons to do so.  Hindsight is 20/20, and if those people said today that they would not have acted that way “if they had known,” they would be met with a smirk and a raised eyebrow.  If you add in a profit motive—such as when a plaintiff stands to recover damages in a lawsuit—a convenient change in position would be more than just irrational, it would be a farce.  When you further add a dire downside—such as leaving cancer untreated (you can see now where we are going with this)—a post hoc claim of different behavior becomes an obvious counterfactual construct aimed at recovering dollars and entitled to no consideration.  

That is why the district court was correct and the Sixth Circuit is wrong in Payne v. Novartis Pharmaceuticals Corp., No. 13-6266, 2014 WL 4056889 (6th Cir. Aug. 18, 2014).  The case is an Aredia and Zometa case in which the plaintiff alleged that the drug manufacturer’s failure to warn regarding the risk of osteonecrosis of the jaw (“ONJ”) resulted in onset of ONJ several years after she first used one of the drugs.  Id. at *2.  The prescribing physician testified that he was not aware of the risk of ONJ when he first prescribed one of the drugs for breast cancer in 1999, but by the time the plaintiff shows jaw-related symptoms in 2005, he was aware of the risk and suspended treatment.  Id.  The plaintiff was later diagnosed with ONJ.  Id.

The district court granted summary judgment on the plaintiff’s failure to warn claims because the plaintiff produced no substantial evidence that a warning regarding ONJ in 1999 would have changed the physician’s decision to prescribe the drug.  Id. at *3.  This of course is a textbook application of the learned intermediary doctrine, under which the manufacturer’s duty to warn runs only to the prescribing physician and under which proximate causation is judged by the impact that a stronger warning would have had on the prescriber’s treatment decisions.

In Payne, there was no evidence that a warning regarding ONJ would have changed anything for this plaintiff, at least no evidence that would justify sending the case to a jury.  The prescribing physician testified that he now warns patients about the risk of ONJ and recommends that they see a dentist before taking bisphosphonates.  Id. at *5.  Fair enough, but there was no evidence that a dental exam would have shown anything noteworthy for this plaintiff, let alone anything that might have prevented the plaintiff’s injury, either in 1999 when the plaintiff started one drug or in 2001 when she switched to the other.

In other words, nothing would have changed in the prescribing physician’s decision making process, which is why the district court was correct to grant summary judgment on the warnings.  

So why did the Sixth Circuit reverse?  It reversed because the doctor said he now instructs patients re ONJ and because the plaintiff filed an affidavit stating that she would not have taken the products if she had been warned.  Id. at *3.  The Sixth Circuit found this to be a “straightforward” argument, under which the plaintiffs had raised a jury issue on whether the lack of a warning on ONJ in 1999 or 2001 caused her injury.

We have two problems with the Sixth Circuit’s analysis.  First, we do not agree with the Sixth Circuit’s gloss on learned intermediary doctrine under the applicable Tennessee law.  According the Sixth Circuit, the learned intermediary rule is a liability-shifting doctrine that can place a duty to warn on the prescribing physician.  As the court explained, “At base, the doctrine can shift liability from drug companies to doctors:  If the drug company adequately warned and instructed the doctor but the doctor did not adequately warn the patient, the patient’s quarrel is with the doctor rather than the drug company.”  Id. at *4.  

This statement misapprehends the law, which probably explains why the Sixth Circuit cited no real support.  (The Sixth Circuit cited only a concurring opinion and a law review article.)  The learned intermediary doctrine imposes no duty on prescribing physicians, nor does it provide patients any basis upon which to “shift liability to” or “quarrel” with doctors.  A healthcare provider’s potential liability to a patient is governed by state law on medical malpractice, which generally requires proof of a breach of a standard of care.  That standard may encompass a duty to provide patients with certain treatment-related information—or it might not.  The learned intermediary doctrine says nothing on that score.  It defines a drug or medical device manufacturer’s duty to warn and the manufacturer’s potential liability, and nothing further.  

Our second problem with the Sixth Circuit’s analysis is more profound.  The district court was absolutely correct in ruling that the plaintiff’s affidavit stating that she would not have used the products if she had been warned of ONJ was not evidence sufficient to defeat summary judgment.  It was very easy for the plaintiff to say that she would not have used the drug after she already knew the outcome, i.e., that she experienced the exact condition about which she claims she should have been warned. When bearing in mind that this plaintiff was being treated for a potentially fatal disease (breast cancer) and that she now stands to gain financially by saying that she would have refused cancer treatment, her statement is entitled to no weight, even if admissible.  We have commented on plaintiffs' attempts to do an "end run" on warnings causation before, including within the last few days, and we consider such attempts to be idle conjecture based on "evidence" that does not prove anything.  

States define the sufficiency of the evidence differently, but the law typically requires substantial evidence, something more than a mere scintilla or speculation.  The Sixth Circuit glossed past this point too, first by stating that there was no authority “that supports the proposition that this testimony is insufficient to forestall summary judgment.”  Id. at *6.  The problem with this conclusion is that there is no authority supporting the Sixth Circuit’s position either.  The Sixth Circuit therefore again inappropriately blended medical malpractice and product liability and analogized to cases involving informed consent, observing that “we can find no indication that the Tennessee Supreme Court would adopt a different standard.”  Id. at *6.  This is problematic too, because a patient’s consent—or lack thereof—is not an element of a product defect claim, even one based on allegedly inadequate warnings.  The Sixth Circuit again could find no legal support for this extension of Tennessee law, citing another law review article, this time with the telltale “cf.” signal, code for “here's something that is not totally off the wall.”  

We have thought long and hard about whether a plaintiff’s retrospective change of heart can ever be substantial evidence sufficient to reach a jury.  If there is a scenario under which this can be true, we can’t think of it.  We understand that juries hear this sort of evidence somewhat regularly, and maybe there is corroborating evidence from time to time.  But that was not the case in Payne, which came to wrong result.  Now if only we can get a refund for our ticket to Ishtar.  Does anyone know a lawyer?