The Aredia/Zometa case of Guenther v. Novartis Pharmaceuticals Inc., 2013 U.S. Dist. LEXIS 50945 (M.D. Fl. Apr. 9, 2013), produced another interesting decision last week.  Not necessarily good, but interesting.  The defense moved for summary judgment on plaintiffs’ failure-to-warn-based claims for failure to satisfy the proximate causation element of the learned intermediary doctrine.  Id. at *5.  There was no evidence that a different warning about osteonecrosis of the jaw would have changed the prescribers’ decisions to prescribe Zometa to the injured plaintiff.  Id. at *6.  In fact, the evidence seems to show that the two prescribers continue to prescribe Zometa today, even knowing the risk.  Id.  The opinion offers little to no other evidence about the prescribers.  So this argument seemed like a good one.  It is, after all, the plaintiffs’ burden to produce evidence tending to show that an adequate warning would have caused the prescribers not to prescribe. 

Yet the court rejected this argument, not based on anything the prescribers said or did, but based on the injured plaintiff’s claim that she would have refused Zometa if her doctor had told her about the risk.  Id.  That was enough for the court:

[T]he learned intermediary doctrine is based in part on a presumption that, once informed by the manufacturer, physicians will share the pertinent risks with his or her patient. [Plaintiff] has testified that if she had been warned by her oncologists about the risk of ONJ, she would have refused to take Zometa, and that she did stop taking the drug once she was told of that risk. . . .  [Plaintiff’s] testimony is enough to create a genuine issue of material fact as to whether the allegedly insufficient warning was a proximate cause of her injury.

Id. at *6-7. 

The problem with this reasoning, however, is that it walks right on by the lack of affirmative proximate cause evidence related to the prescribing doctor and sends the case to trial based on generic testimony that is routinely given by plaintiffs in product liability drug cases.  It’s hard to imagine many scenarios in which, if this type of evidence was sufficient, a plaintiff couldn’t just avoid summary judgment by saying something like, “I wouldn’t have taken the drug if I’d known of the risk,” or “No, my doctor didn’t tell me about the risk (even if the doctor says she did), and if she had I wouldn’t have taken the drug.”  It shouldn’t help the plaintiff either to argue, as the plaintiff did in this case, that she stopped taking the drug once the potential risk became a reality.  Id. at *6.  That type of 20/20 hindsight testimony comes with most product liability drug cases too.  This type of self-serving testimony just doesn’t seem near enough.  To satisfy proximate causation testimony as to the learned intermediary doctrine, some of the plaintiffs’ evidence should at least address . . .  learned intermediary. 

Additionally, although the court didn’t base its decision on it, the court noted that the plaintiff had produced expert testimony claiming that physicians – not the plaintiff’s prescribers – changed prescribing habits after learning of Zometa’s alleged osteonecrosis risk.  Id. at *6-7.  But the case is about the injured plaintiff and her prescribers, not other doctors or an expert’s opinion about what other doctors did.  And, frankly, the expert’s testimony seems to be contradicted by the only evidence we saw in the court’s opinion about the prescribers, which is that they continued to prescribe Zometa after learning of the risk.  Id. at *6.   

Now, there may be more to the facts to this case than are set out in the opinion.  Or maybe not.  But based on the facts in the opinion, we’re not sure we see a basis for the plaintiffs’ warnings-based claims to move forward. 

Now, the court did dismiss plaintiffs’ warranty claims.  Florida requires privity between the defendant and the plaintiff for warranty claims, and there was none between Novartis and the patient.   Id. at *11-12.   Good.  Also, while the court allowed plaintiffs’ design defect claim to proceed, it recognized that under comment k it could not proceed under a theory that the product was somehow improperly designed, but rather, in essence, only if the warning was inadequate:   

Comment k . . .  encompasses products whose benefits generally outweigh their (unavoidably high) risks but are “incapable of being made safe for their intended and ordinary use.”  Such products are neither defective nor unreasonably dangerous, and sellers of such products cannot be held strictly liable, so long as the products are properly prepared and “accompanied by proper directions and warning.”  In this case, the sufficiency of the directions and warning accompanying Zometa are clearly in dispute. As such, Novartis is not entitled to summary judgment on this issue.

Id. at *10-11.

So there is some good in this decision.  But the learned intermediary analysis leaves us unsatisfied, primarily because it focuses on things other than the learned intermediary.  On the positive side, though, the opinion may have little precedential value given that it discusses so few facts about the prescribers’ decisions.