Monday, February 04, 2013

The Learned Intermediary Doctrine Applied Learnedly

In our business, it’s good to have intermediaries, particularly learned ones.  They add a dose of reality to cases that are otherwise conjecture.  They shift the focus from dramatic accusations about profits and hidden risks to tangible realities such as science and medicine and the professionals who know a thing or two about both.  Hidden risks become standard knowledge, and statements in labeling sections with titles such as Warnings or Precautions actually become, you know, warnings and precautions. 

So, while we’ve at times railed against courts that have failed to recognize the importance of what these learned intermediaries say or don’t say, it’s also important – maybe more important – that we highlight courts that do recognize it.  One of them is the court in Carr-Davis v. Bristol—Myers Squibb Co., No. 07-1098 (FLW), 2013 U.S. Dist. LEXIS 10914 (D.N.J. Jan. 28, 2013.  It’s one thing to apply the learned intermediary doctrine.  It’s a whole other thing to apply it correctly.  Here’s how that’s done.

The decedent in Carr-Davis had a quadruple bypass and other heart problems and procedures.  His cardiac surgeon placed him on Plavix and aspirin.  Id. at *6-8.  The Plavix label discussed an increased risk of bleeding in its Precautions, Adverse Reactions and Information For The Patient sections.  Id. at *4-7.  Three days after his last heart-related procedure, the decedent had a cerebral hemorrhage (bleeding in the brain) and died.  Id. at *9.  He had stopped taking Plavix five days before the procedure, and his cardiac surgeon had instructed him not to resume Plavix after the procedure.  Id.  Moreover, the neurosurgeon who treated the cerebral hemorrhage testified that the hemorrhage could have resulted from the procedure itself and the decedent’s platelet levels and bleeding did not point to Plavix.  Id. at *10.  Nonetheless, the decedent’s spouse brought failure to warn, defect and other claims, pointing the finger at Plavix and the alleged inadequacy of the warnings about its risk of increased bleeding. 

From this point onward, the court – applying Missouri law – crafts an opinion that reads like an instruction manual on how to properly apply the learned intermediary doctrine.  As an important starting point, it addressed two things that many courts conflate or simply miss.  The plaintiff’s failure to warn claim would fail if the manufacturers satisfied their duty to warn or there was no proximate cause – say, because the doctor knew of the risk:

The learned intermediary doctrine is a corollary to the rule that a manufacturer of prescription drugs or products discharges its duty to warn by providing the physician with information about risks associated with those products. . . . The physician acts as a “learned intermediary” between the manufacturer and the patient and any warning given to the physician is deemed a warning to the patient. . . . The learned intermediary doctrine provides that the failure of a drug manufacturer to provide the physician with an adequate warning of the risks associated with a prescription product is not the proximate cause of a patient's injury if the prescribing physician had independent knowledge of the risk that the adequate warnings should have communicated.

Id. at *14. 

Plaintiff’s claims had both problems.  First, the statements in the label about an increased risk of bleeding were adequate.  Moreover, the studies that plaintiff used to argue that they weren’t had nothing to do with the decedent: “virtually none of these studies are relevant to Decedent’s medical situation.”  Id. at 16.  Better yet, in a juicy bit of spot-on reasoning, the court explained that even the study that might actually have been relevant to the decedent’s medical situation didn’t matter because it addressed Plavix’s “efficacy,” not its “risk.”  The claim is about a failure to warn of a risk of increased bleeding, not an efficacy claim: 

Plaintiff's efficacy arguments are not relevant in the context of a failure-to-warn analysis. Plaintiff's claim is essentially premised on the fact that [the decedent] suffered substantial bleeding as a result of taking both Plavix and aspirin at the same time - not that Plavix did not work. As the Court has previously noted, in Missouri, a drug manufacturer is required to provide an adequate warning of its product if it knows of any potential harm that may result from the use of its product. In other words, a proper warning should adequately alert any danger or harm that may result from ingesting the drug.  Permitting Plaintiff to pursue her failure-to-warn claim on an efficacy theory would, as has been found in other jurisdictions with similar laws, impermissibly expand liability . . . .

Id. at 19-20.  (This isn’t the first time that the court in the Plavix litigation has explained the futility of arguing efficacy studies in a failure to warn case.) 

Second, the court addressed proximate cause.  The prescriber knew about the risk of increased bleeding.  How could he know?  This is where hidden risks become standard knowledge.  He knew because he was a learned intermediary.  He knew because he followed the “medical literature and other available information regarding his prescription decisions” and looked to “guidelines from the medical community and his colleagues’ opinions.”  Id. at 24.  That’s what learned intermediaries do.  That’s why they’re learned.  That’s also why they’re intermediaries.  And given this knowledge, “any alleged failure to warn could not be the proximate cause of [the decedent’s] injuries.”  Id. at *24-25.

The plaintiff, undaunted, pointed to the heeding presumption.  Surely the case must go forward because the court must presume that the prescriber would have heeded a proper warning if one was given.  We’re sure you see the problem with this argument.  The court did.  The manufacturers had given an adequate warning.  There was no “other” proper warning containing the supposedly missing information for a prescriber to heed: “the Court has already concluded that Plaintiff has failed to demonstrate the inadequacy of the current warning, and therefore that Plaintiff has not demonstrated that the warning failed to impart the necessary information.”  Id. at 27.  The court granted defendants judgment on the failure to warn claim and all other claims, which simply restated the failure to warn claim. 

That’s how it’s done.  That’s how the learned intermediary doctrine is applied learnedly. 

No comments: