United States: Aredia/Zometa Plaintiff Can't Avoid Learned Intermediaries

Last Updated: October 17 2016
Article by Michelle Yeary

Sometimes we take routine things for granted. We don't appreciate the taste of our morning coffee, it's just always there. We don't appreciate the softness of our favorite college sweatshirt, it's just always been that way. We don't appreciate that while watching an episode of The Walking Dead and seeing a familiar face we can IMDB and find out we recognize the actor from a 3-episode storyline on Law & Order from the late 1990s. That last one hasn't always been available, but it's getting harder to recall what it was like to not have that answer until it woke you from a sound sleep at three in the morning.

In the legal world we take things for granted too. We talk about things like breach, duty, causation, and on this blog, preemption, so routinely, we do start to gloss over them a bit. TwIqbal, Daubert, Buckman. Routine, routine, routine. And for sure, learned intermediary fits into this category of things we know about, we like, but maybe take a bit for granted. For many of us, it's been part of drug and device law our whole careers given that the term was first coined in 1966 by the Eighth Circuit in Sterling Drug Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). So sometimes, it's good to be reminded just how important it is.

That is what today's case is all about. In Bock v. Novartis Pharmaceuticals Corp., 2016 U.S. App. LEXIS 18042 at *1 (3d Cir. Oct. 5, 2016), decedent's family alleged that the defendant failed to adequately warn decedent's doctors that its drugs Aredia and Zometa contribute to the risk of developing osteonecrosis of the jaw ("ONJ"), which decedent developed following multiple tooth extractions and other dental procedures. The court's decision starts out with a recitation of the warnings that accompanied the drugs as well as additional warnings distributed by the defendant via "Dear Doctor" letters. Those warnings, which pre-dated decedent's prescription and use of the drugs, included information such as that ONJ had been reported in patients using the drugs, mostly associated with dental procedures like tooth extractions and that invasive dental procedures should be avoided. Id. at *2-3. We know we come at this from the skewed perspective of drug and device defense counsel, but the warning seems fairly clear to us.

But, if you don't want to take our word for it – let's see what the learned intermediaries had to say. Decedent's first prescriber testified that he was aware of the risk of ONJ when he prescribed for Mr. Bock and that it was his practice to discuss that risk with his patients. Id. at *5. Further, he testified that at the time he prescribed the drugs to Mr. Bock it was the standard of care to do so and that he continues to prescribe today. Id. Mr. Bock's second prescriber continued the drugs because it was the standard of care to do so. That doctor's records also reflect that Mr. Bock was told about the risks of dental surgery while taking Aredia/Zometa and told to advise the prescriber of any problems with his teeth right away. Id. at *5-6. The second prescriber also testified that the risk of ONJ is so small and non-life threatening that it is outweighed by the enormous benefit of treatment with Aredia/Zometa. Id. at *6. This doctor's records also reflect that Mr. Bock had his tooth extracted without informing his office as he was advised to do. Id. at *7. Finally, there is the dentist who performed decedent's tooth extractions. He testified that he was unfamiliar with Aredia/Zometa at the time, but per his usual practice, he would have looked them up and discussed any risks with Mr. Bock. Id. at *7-8. He also testified that regardless of the recommendation to avoid tooth extractions, he would have removed the tooth anyway because of the more serious risk of infection if left in. Id. at *8.

Sounds like the learned intermediaries also thought defendant's warnings were adequate. They were certainly well aware of the risk of ONJ when they prescribed and even made decedent aware of the need to be careful about dental procedures. There really is little else to discuss. Could plaintiff produce an expert to opine that to a reasonable degree of certainty Mr. Bock's use of Aredia/Zometa led to his development of ONJ? Probably. But what the learned intermediary evidence demonstrates is that there is no additional or different warning that defendant could have provided that would have altered the outcome. Under Pennsylvania law, "[p]roximate causation may be shown in learned intermediary cases through evidence that, if properly warned, the doctor either would have declined to prescribe a particular drug or would have detailed the known risks for the patient, who would then have declined the medication." Id. at *12. The doctors in this case were clear that they would not have changed their prescribing and/or treatment decisions and while Mr. Bock is deceased, the available evidence is that he was warned on multiple occasions by different doctors about the risk and opted to both use the drug and undergo dental procedures while using the drug despite the risk.  There is also no heeding presumption in Pennsylvania, not that it should have mattered in this case anyway.

Plaintiffs attempted to avoid summary judgment by arguing that the case should have gone to the expert testimony stage, at which time their expert would have testified that the risk of ONJ is actually greater than what is "presently known" and that if decedent's doctors knew that they would have changed their prescribing and treatment decisions. But this argument fails on two bases. Pennsylvania law does not permit a failure to warn claim to be based on "subsequent revelations." Id. at *16. And, speculation about the possibility of what expert testimony might reveal is too little, too late at summary judgment. Summary judgment is time for the non-moving party to "put up or shut up" with facts not allegations or argument. Id. at *17.

The facts are undisputed. They are the testimony and the records of the learned intermediaries who said — we knew, we prescribed, it was the standard of care, and we'd do it again.  Learned intermediaries are important. Don't take them for granted.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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