[Drug and Device Law] Lack of Warning Causation Dooms Aredia-Zometa Case
Warning: You have heard all this before.
Still reading? Okay. But please don't tell us later that our warning was inadequate and that you would have clicked over to Scotus or Grantland or TMZ if we had been more forthcoming. As we have mentioned/kvetched what seems like 2814 times before (according to Blogger, that is how many posts we have put up -- you're welcome), most of the drug and device cases we encounter center around an allegation of failure to warn. And most of those cases are weak and/or incoherent. Yet most of those cases cost our clients a lot of money, if only because of the dysfunctional, asymmetrical meat-grinder called "discovery".
Instead of ushering nuisance cases to the exit, too many courts are too inclined to find a purported issue of fact as to whether a warning is inadequate or whether a better warning would have made a difference. Again, we've said it before and will doubtless say it again in the face of judicial obstinacy or lassitude, but courts should insist that plaintiffs state exactly what the warning should have been and show that such a warning would have prompted the doctor to make a different prescribing decision.
What happens in reality is rather different. Plaintiffs are permitted to dodge the issue, changing on the fly as to what was allegedly missing from the warning. More often than not, the alleged inadequacy stems from an editing quibble too arcane for even a New Yorker proofreader to consider. Recent mass torts have been propelled by allegations that warnings of pain with implanted devices should have specified that the pain would occur during some specific activity, or that the pain would be "chronic." Some of the most enormous recent verdicts against drug manufacturers came from jurors who had been convinced that a drug label’s reference to a rash side effect was insufficiently scary – that it should have disclosed that such a rash could be deadly or at least really bad. Courts should be able to rule as a matter of law that warnings that mention the condition complained of are adequate as a matter of law. As in securities cases, materiality need not automatically become an issue worthy of factual dispute. We wrote a couple of weeks ago about a court that took a careful look at warning adequacy and rejected a plaintiff’s effort to red pencil his way to a multimillion dollar verdict. Such decisions, though, are like Vermeers: rare, precious, and a little bit haunting.
Let's face it, when courts muster the gumption to dismiss failure to warn claims, it is usually not on the warning adequacy prong but, rather, on the warning causation prong. Such was the case in Bock v. Novartis Pharmaceuticals Corp., 2015 U.S. Dist. LEXIS 136920 (W.D. Pa. Oct. 7, 2015). Bock was an Aredia-Zometa case, a category that occupies a pretty big chunk of the DDL blog oeuvre. As usual, the claim was that the label did not adequately warn that Aredia-Zometa - drugs used to treat cancer - could conceivably lead to osteonecrosis of the jaw (ONJ). The fact is that most doctors already know of such a risk and, given the relatively slight magnitude of that risk versus the profound cancer treatment benefits, would still have prescribed those drugs no matter how decorous the label might be. That was true in the Bock case, where the treating doctor (aka the learned intermediary) testified that he was aware that ONJ was a potential side effect of A-Z, and that it was his practice to discuss such a risk with patients. The patient subsequently died, so the case was actually brought by the estate. That should not matter, except perhaps it did, because the case was bereft of the usual self-serving plaintiff testimony that if the doctor had said anything at all additional about the risk then the plaintiff would certainly have said no. There are, sadly, Pennsylvania cases where that warning-causation-two-step escorted a case past summary judgment, and the Bock opinion discusses those cases. But Bock was an easier case because there simply was no evidence adduced that a different warning would have changed prescribing practices and thereby avoided the injury. The treating doctors already knew of the risk, they continue to prescribe A-Z, and there is no hint that a warning would have changed anything. Pennsylvania makes life considerably easier for defendants making this argument, because our enlightened Commonwealth provides no heeding presumption -- which, by the way, we do not think would have made any difference on the facts of this case anyway.
There was more to the case. There always is. But, like the much hoped for new warning, it made no difference. The plaintiff in Bock argued that the court should not grant summary judgment without first hearing from plaintiff's experts concerning what information the A-Z labels should have provided, but that is confusing warning adequacy with warning causation. It is the latter that ends the case, because the treating doctors' testimony was so clear that a different warning would have changed nothing. Interestingly, the plaintiff then argued that such testimony lacked credibility, but it "is axiomatic that a plaintiff cannot survive a well-supported summary judgment motion by simply asserting that the opposing witnesses lack credibility." Indeed, if plaintiffs could get away with that maneuver, summary judgment would be well nigh impossible. We would certainly warn you of that.
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Posted By Steve McConnell to Drug and Device Law at 10/14/2015 07:30:00 AM --
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