The defendant in Parkinson v. Novartis Pharmaceuticals Corp., No. 3:12-cv-02089, 2014 U.S. Dist. LEXIS 36677 (D. Or. Mar. 20, 2014), won summary judgment on warnings causation because the alleged inadequacy in the drug warnings didn’t make a lick of a difference. That is the right result and is why we think warnings causation is such a useful concept. Bexis likes to remind us that preemption is the king of all defenses because it eliminates entire cases, and in some instances entire MDLs, or an entire category of claims within an MDL. But if preemption is king, then warnings causation is a crown prince. For one thing, warnings causation is not a defense. Every plaintiff bringing a claim based on allegedly inadequate warnings bears the burden of proving that the alleged inadequacy proximately caused his or her injury. That is to say, the plaintiff must prove that additional or “more adequate” warnings would have altered the physician’s decision to prescribe the drug or select the medical device. For another thing, unlike preemption, causation is present and potentially a winning argument in most every drug and medical device case, depending on the case-specific evidence. Sure, there are presumptions in certain states that doctors would have heeded stronger warnings if given, but presumptions can be overcome, and they often are.
In Parkinson, the patient was taking the defendant’s bisphosphonates to treat cancer. Bisphosphonates were the subject of an FDA Safety Alert explaining that osteonecrosis of the jaw (ONJ) was observed in cancer patients receiving treatment with intravenous bisphosphonates and that dental surgery may aggravate the condition in cancer patients who develop ONJ while on bisphosphonate therapy. Although the order in Parkinson does not explain it, that seems to be the basis for the claims against the drug manufacturer. The patient had two teeth extracted, which evidently resulted in ONJ or worsened ONJ. At least that is what the order seems to say, and the plaintiff claimed that the defendant failed to warn adequately about that risk.
The problem for the plaintiff—the survivor of the patient, who sadly died—is that the doctor who prescribed bisphosphonates “knew of thousands of scientific articles . . . that set out and described the various risks associated with [bisphosphonates] (including ONJ).” Id. at *11. Moreover, the evidence was undisputed that the doctor chose to prescribe the drugs “because the benefits to Plaintiff . . . outweighed the risk of ONJ.” Id. The district court further noted that the prescribing physician continues to prescribe bisphosphonates despite the risk of ONJ because the benefits “greatly outweigh” the risks. Id. at *12.
This is ironclad, and when we depose prescribing physicians, this is what we hope (and usually expect) them to say. Such testimony cuts off causation because additional information about a risk about which the prescriber already knows cannot have had an impact on the prescribing decision.
The plaintiff had a few responses to this, but none held water. First, the plaintiff argued that Oregon law provided a heeding presumption, but the only authority she cited was an unpublished (and thus uncitable) Ninth Circuit opinion applying Alaska law. Maybe plaintiffs in Alaska can see Russia from their houses, but this Oregon plaintiff clearly could not see a heeding presumption in Oregon law. Neither could the district court, because one does not exist. Id. at **9-10. To the contrary, “the burden is on the plaintiff ‘to establish that [the alleged inadequate warning] proximately caused [her] injures or damages.” Id. at *10 (citing Oregon authority).
Second, the plaintiff argued that her late daughter (the patient) would not have consented to treatment with these bisphosphonates if she had known about the risk of ONJ. But there was no competent evidence of that, and even if there were, the learned intermediary doctrine makes it beside the point. As the district court explained,
[T]he Ninth Circuit has made clear that the relevant inquiry is not whether Plaintiff would have taken [the medicine], but whether Dr. Seligman would have prescribed [the medicine] if he had received a different warning related to the possibility of ONJ.
Id. at **12-13 (emphasis in original). This is ironclad too, and we wish every court were as vigilant in shutting down plaintiffs who claim after the fact they would not have used the product “if they had known.” We take with a grain of salt any plaintiff’s statement that he or she would have rejected a doctor’s advice “if they had known,” especially a cancer patient for whom rejecting treatment could have had grave consequences. But even if crediting those self-serving statements as true, they are immaterial where the learned intermediary doctrine applies, which the district court correctly found.
Third, the plaintiff claimed that the dentists who pulled the teeth “changed their practices with regards to going over treatment with patients” since the time they treated the decedent. Id. at *15. We’re not sure where the plaintiff was going with this argument. She cited no authority for the idea that these “changed practices” made any difference, and the actual facts of the case demonstrated that they would not have made any difference: The dentists agreed that there were no alternatives to extracting the teeth, which means that even if they had known more about bisphosphonates and ONJ, they would have treated the patient the same anyway. Id. at *17. To remove any doubt, it was undisputed that the patient did not tell her dentists that she had cancer or that she was using bisphosphonates until after they pulled her teeth. Id. at **18-19. Unless the plaintiff had a time machine, what impact could additional information regarding bisphosphonates have had on her treatment when her dentists were unaware?
We have to admit, we have always considered warnings causation mainly in the context of the impact of warnings on prescribing physicians. (See for example Bexis’s recent “little list” of authorities dismissing warning claims for lack of causation where the prescribers were unavailable.) This plaintiff questioned the warnings and their impact (or lack thereof) both on prescribing physicians and treating physicians. Hmm. Maybe the next time we depose a treating physician, we will give that line of questioning some additional thought.
So, we like warnings causation. The argument may not always be there, and it may require marshaling evidence for a defendant to assert it (or perhaps not since, after all, proving causation is the plaintiff’s burden). Parkinson is a good example of a defendant presenting the argument, the court understanding it, and the correct resulting following.