A key to many drug or device law cases is the learned intermediary doctrine. It can powerful, and so we generally approach it with great care and from multiple angles. We meticulously develop labeling histories to establish when the label first mentioned the alleged side effect and how and where it was discussed over time. We do scientific research so that we can show the contemporaneous state of the science, when there was a signal to warn and, just as important, when there wasn’t, and we then match that to the contents of the label. We lay out the company’s internal and regulatory history to show that it understood and advanced the science and included it, when appropriate, in the label. And we take testimony of prescribers and treaters to show that they knew the potential side effects, were warned, and/or would’ve made the same decision even today. When we do this well in discovery, we often feel that we should win summary judgment.
But despite a good discovery record on the learned intermediary doctrine courts sometimes seem unwilling to end a case before trial. They gloss over which party has the burden of proof. They can misconstrue the doctrine as an affirmative defense. They can punt the decision on a seemingly adequate warning to the jury, or ask the jury to consider whether it should have been disseminated differently or better. We’re sure that many of you have had similar experiences on summary judgment.
With that background, we want to discuss D’Agnese v. Novartis Pharmaceuticals Corp., 2013 U.S. Dist. LEXIS 92757 (D. Az. July 2, 2013). It involves a plaintiff (and his wife suing for loss of consortium) who claimed to have suffered bisphosphonate-related osteonecrosis of the jaw as a result of using Aredia/Zometa. While he brought a number of claims, they were all, at bottom, based on failure to warn. And the learned intermediary doctrine played a vital role.
The defendant, Novartis, established its labeling history during discovery. It had placed osteonecrosis in the Adverse Reactions section in September 2003 and revised the language in February 2004 to say that causality could not be determined but it was prudent to avoid dental surgery while on the drug. In September 2004, Novartis added a three-paragraph discussion of osteonecrosis to the Precautions section. It sent a Dear Doctor Letter to doctors attaching the revised label. Id. at *15-18.
As for plaintiff, his original prescriber prescribed him Aredia in 1996. In March 2005 – after all these label changes were put into effect – a second prescriber informed plaintiff of the risk of osteonecrosis, plaintiff signed an informed consent form and, later that year, plaintiff made it clear that he wanted to continue on the drug. Plaintiff’s story was different in litigation. He claimed no memory of the risk discussion or of signing the informed consent. In 2005, Plaintiff was tentatively diagnosed with osteonecrosis of the jaw. Finally, plaintiff’s second prescriber testified that he still prescribes Zometa today and even suggested that plaintiff restart it in 2010. Id. at *18-19.
These facts make this is one of those cases that we feel should be a defense win on summary judgment. But, as we mentioned, we’ve seen courts find the smallest of holes through which to push a trial. Maybe the plaintiff’s different recollection about being told of the risk is enough for a jury to consider. . . . Or maybe a court could send it to a jury because there was no testimony from the original prescriber, like there was from the second prescriber, that he still prescribes Zometa and suggested that plaintiff restart it . . . . Or maybe there were some adverse events or animal studies that the doctor didn’t know about . . . . Let a jury decide.
Not here. This court started its analysis from the right place, stressing that the plaintiffs, not the defense, had the burden of proof:
To prove causation, it is Plaintiffs burden to present evidence that, if Defendant had issued a proper warning, Mr. D’Agnese would not have taken Aredia® or Zometa®.
Id. at *24-24. This means that plaintiffs had the burden of presenting sufficient evidence that the label was inadequate at the time the drug was prescribed and that this inadequacy proximately caused plaintiff’s injuries.
As to the label’s adequacy, the defense presented a labeling history showing that osteonecrosis was discussed in the Adverse Reactions section by 2003 and the Precautions sections by 2004, all before plaintiff was tentatively diagnosed in 2005. This history left plaintiffs trying to challenge an earlier label from 1996 when plaintiff was first prescribed Aredia. But at that point in time there was little to no meaningful science to support including a risk in the label. There were six adverse events and an animal study. The court saw this for what it was – not enough:
Plaintiffs have not pointed to any evidence, including any testimony, suggesting that based on one study and six possible cases of ONJ in a clinical trial, Defendant’s actions fell below the acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and warned about. Likewise, Plaintiffs have not pointed to any evidence or testimony that, in light of this article and six possible cases of ONJ in the clinical trial, ONJ was a knowable risk of using Aredia® in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution.
Id. at *28-29. In other words, the defense was entitled to summary judgment.
The court, however, found more holes in plaintiffs’ case. Even if the label were deficient (and the court found that it was not), plaintiffs hadn’t presented enough evidence to suggest that plaintiff’s prescribers would have made a different prescribing decision under a different warning. Plaintiffs again relied on the 1996 label. That’s when plaintiff’s original prescriber, Dr. Curley, first prescribed Aredia to plaintiff. In considering this argument, the court again emphasized that plaintiffs had the burden of proof:
Although Plaintiffs appear to suggest that it is Defendant’s burden to demonstrate that Dr. Curley’s prescription decisions would have been different, it is Plaintiffs’ burden to demonstrate proximate cause.
Id. at *30.
Plaintiffs could not meet the burden. In fact, they provided no evidence that Dr. Curley would have done anything differently. Id. at *27. If you have the burden and no evidence, you lose. Plaintiff tried to get around this by invoking the heeding presumption – that is, the legal presumption that Dr. Curley would’ve heeded a different warning and never prescribed.
But the heeding presumption is rebuttable.
Since plaintiffs had no evidence on what Dr. Curley would do, the only evidence that could shed any light on it was the evidence on what plaintiff’s second prescriber did. And he continued to prescribe the drug. He still prescribes Zometa today. In 2010, he recommended that Plaintiff restart Zometa. Moreover, plaintiff himself took Zometa after being warned of its risks. All of this evidence points one way. The heeding presumption was rebutted. And since plaintiffs had no evidence whatsoever indicating that the original prescriber would’ve changed his decision, plaintiffs lost on proximate causation as well. Id. at *29-31.
At first blush, this case may seem like an easy victory for the defense. But some of that may be due to how the court wrote its opinion. Experience tells us that courts have made trials out of a lot less than this. Not that they should have. But they did. All of this is to say that when a court understands the doctrine and the burden and views the evidence as it should on summary judgment, the learned intermediary doctrine can be a powerful tool.