SDNY Sacks Treanda Failure to Warn Claim

by Reed Smith

Failure to warn cases remind us of sports talk radio and paleontology.  Especially on Monday mornings in the Fall, Philly sports talk radio is a festival of woe and recrimination.  The Iggles are terrible, their deficiencies are many and obvious, and the people running the team are dunderheads.  Mind you, the callers and radio hosts are the same people who a few short weeks ago anticipated Super Bowl glory.  But there is a reason for the phrase “Monday morning quarterback.”  There is also a reason why we DDL defense hacks worry about hindsight bias.  At first blush (though what plaintiff lawyer has ever blushed?) a failure to warn claim seems so reasonable and modest.  It does not ask for scientific innovation.  It asks only that the company tell the truth about its product.  Ah, but what truth?  The truth is that the company probably believed (and the FDA concurred) that the relevant risks had been adequately disclosed.  Sadly, reality in the form of an unfortunate, sympathetic plaintiff seems to disclose a new risk, or a risk that calls for a louder, brighter warning.  The reality also is that nobody hid anything.  Stuff happens.  Looking back, we all always wish we had done more and done better. 
Hindsight is 20-20.  What it sees is corporate omniscience.  What it demands is perfection.  That’s when we start reflecting on paleontology – or, to be more precise, the debate between paleontology and creationism.  Creationist critics point to “gaps in the fossil evidence” as refutation of evolution.  Where is the missing link?  That ploy creates no end of frustration among actual scientists.  Produce a new piece fossil in the evolutionary chain, and the critics will now gleefully point to two new gaps in the evidence.  You cannot win, because you are dealing with people who care much more about the end result than the integrity of the process.   The same is true with drug or device warnings.  Whatever is warned about, it is all too easy after the fact to find something that was not warned about, or was not warned about with enough fury and poetry. It gets worse when the court admits evidence of subsequent warnings.  Not only is the perfect the enemy of the good, but so is the better.  What we wish courts (or legislators or regulators) would do is establish a bright line rule that when a label warns of the injury suffered in the case, the failure to warn claim (and all of the parasitic claims essentially alleging the selfsame thing) must be dismissed.  The court should not pass along to the jury as a bogus, hindsight fact-issue whether the warning could have been more robust.
Something like what we want – a rigorous, disciplined approach to warning adequacy – happened in Becker v. Cephalon, Inc., 2015 U.S. Dist. LEXIS 123670 (SDNY Sept.15, 2015).  The court’s clear-headedness is particularly impressive because it was a wrongful death case, and the claim was that the decedent had come down with the horrific burning and peeling skin condition known as Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrosis (TEN).  That dreadful injury would provoke sympathy in anyone.  The decedent had been diagnosed with leukemia in 2000.  He was treated with allopurinol in late 2010, and was also treated with the medicine at issue, Treanda, on multiple dates in late 2010 and early 2011.  Then came the SJS/TEN.
The plaintiff alleged that the defendant had known for many years that intravenous treatment with Treanda carried the risk of SJS/TEN, and had also known of additional risks associated specifically with the administration of Treanda in conjunction with, or shortly after, the administration of allopurinol.  The plaintiff pointed out that the defendant’s website for Treanda had been modified several times, alternatively showing a warning that “a mild rash or itching may occur during treatment with TREANDA” on some dates and displaying a warning about the more serious risk of SJS/TEN on others. 
The plaintiff sued on theories of strict liability and negligence based on failure in its marketing and promotion of Treanda to warn, and for its misrepresentation of risks.  There were other claims as well, and we will get to them, but they are premised on the same facts, theories, and grievances.  The biggest hurdle for the plaintiff is that the Treanda label explicitly listed, under “Skin Reactions,” cases of  SJS/TEN, including fatal cases.  Further, under “Adverse Reactions,” there was a note that skin reactions are one form of serious adverse reaction observed in clinical trials, then referring physicians to the “Skin Reactions” section for further detail.  Another section of the label specifically warned of the risk of SJS/TEN when Treanda was administered concomitantly with allopurinol.  In short, everything that the plaintiff could reasonably ask for in a warning was there.  The court had no trouble concluding that, “[b]ecause all of the alleged side effects described by Plaintiff are specifically indicated as potential side effects in the drug’s package insert, the warning is adequate as a matter of law.”
But now the plaintiff pointed to gaps in the fossil record.  The plaintiff attempted to circumvent the label by alleging that the product liability claims were based not only on a failure-to-warn theory, but also on the defendant’s  affirmatively misleading statements to both the decedent and his doctor regarding the risk of a  mild rash versus more serious skin conditions like SJS/TEN.  The “Patient Counselling” section of the Treanda label advises doctors to “[a]dvise patients that a mild rash or itching may occur during treatment with TREANDA.  Advise patients to immediately report severe or worsening rash or itching.”  According to the plaintiff, this provision was so tepid as to render the other warnings ineffective.  It is as if this provision went back and whited out the previous SJS/TEN warnings.  Except it did not.  The court was unpersuaded by the plaintiff’s argument, finding it “illogical and contradicted by the label, however, as not only do several sections of the TREANDA label explicitly warn of the risk of SJS/TEN and other severe skin reactions, but Section 17 itself tells doctors to advise their patients that they should report ‘severe or worsening rash or itching.’”  Moreover, it is not as if the “Patient Counselling” reference to a risk of mild rash was false.  Boiled down to its essence, the plaintiff’s theory was more about sound than sense.  The theory must be that the label, or a certain portion of the label, was misleading because it failed “to emphasize the more serious risks—making Plaintiff’s claim, in essence, simply a failure-to-warn claim, not a distinct type of claim or theory as Plaintiff asserts.”  Because the label did, in fact, warn about SJS/TEN, the claim had to be dismissed.   
The plaintiff also included claims for breaches of express and implied warranties.  The former requires some affirmative statement of fact that is so definite as “to induce the buyer to purchase” while also being false.  But the label’s reference to “mild rash or itching” is neither particularly attractive nor false.  Again, the express warranty claim is merely a failure-to-warn claim moonlighting, and it is defeated by the adequacy of the label’s warning.  For the same reason, the implied warranty claim fails:  the “drug’s label is adequate as a matter of law because it clearly and adequately warns the prescribing physician of the very malady suffered by Decedent.” 
And then there is the inevitable claim for consumer fraud under the available statute, in this case New York General Business Law § 350 (“false advertising in the conduct of any business, trade or commerce or in the furnishing of any service in this state is hereby declared unlawful”).  Different legal claim, but same result.  Only here the learned intermediary doctrine surfaces with a beneficent effect.  The “consumer protection statute forbids deceptive acts or practices likely to mislead a reasonable consumer, specifically requiring proof that the defendant’s acts are directed at consumers.”  By contrast, a drug label “is directed at physicians, not consumer-patients.”

Finally, the plaintiff could not satisfy the elements of a claim for negligent misrepresentation because she and/or the decedent were not in privity of contract with the defendant, and there were no allegations that either the plaintiff  or the decedent was a “known party” to the defendant or that the defendant undertook special conduct directed to them.  There was, in short, a missing link.   The plaintiff’s only effort at conjuring up privity was that the decedent’s insurance company purchased Treanda from the defendant, acting as the decedent’s agent.  But there is no authority that insurers can create such privity, and if they could it would blow a huge hole in the general rule that “privity does not exist between manufacturers and patients when the medication is only available by prescription.” 

There it is.  The Becker case offers an analysis that is straightforward and inescapable.  The label says what it says. It reminds us of the highest piece of sports wisdom we have ever heard, football coach Bill Parcells’s pronouncement that “You are your record.”  A win is a win.  A loss is a loss.  No excuses.  Becker is a win for the good guys.

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Reed Smith

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