It is no secret that we are huge fans of the learned intermediary doctrine. So, when we see it being applied and upheld in modern medical situations, we can’t help but get a little excited. It is sort of like wondering how new additions to the casts of long-running sitcoms are going to play out (Ashton Kutcher on “Two and a Half Men”; James Spader on “The Office”; Martin Short on “How I Married Your Mother”). Will they rise to the occasion and challenge the veterans to up their game? Or, will it be like when Cousin Oliver joined the Brady Bunch – the beginning of the end?
So too we watch as courts grapple with the learned intermediary doctrine in the age of direct-to-consumer marketing, WebMD, and Yahoo! Answers. Yes, people do ask medical questions there too. What about when a drug manufacturer offers an educational class for patients taking its medication? That was the question asked of the court in Hernandez v. Schering Corporation, 2011 Ill. App. LEXIS 1055 (Sept. 30, 2011). The answer was a re-assuring affirmation of the learned intermediary doctrine – and a reminder about just how important the prescriber’s deposition can be.
Plaintiff was diagnosed with Hepatitis C (HCV) and his physician prescribed interferon. On his physician’s advice, plaintiff attended an educational class sponsored by the manufacturer. Hernandez, 2011 Ill. App. LEXIS 1055, *3-4. It was uncontested that as a result of the medication, plaintiff sustained optic nerve damage and permanent vision loss. Id. at *7. Neither the prescriber nor the nurse who taught the class discussed the risk of vision of loss, but the package insert did contain warnings about vision-related side effects. Plaintiff sued the drug manufacturer alleging both strict liability and product liability negligence and negligence in performing a voluntary undertaking. Id. at *2. In upholding summary judgment for defendants on all three claims, the court relied heavily on both what the prescribing physician said and what he did not. He testified that it was his duty to inform his patient of the side effects of the medication and that had he known of the risk of blindness he would have told the plaintiff. Id. at *4. And, he did not testify that had he known of the vision-related risk, he would have changed his prescribing decision. Id. at *7. Therefore, any alleged inadequacy of the manufacturer’s warning was not the proximate cause of plaintiff’s injury. Id.
In a case clearly governed by the learned intermediary doctrine – where the duty to warn is owed by the manufacturer to the physician, not the patient -- plaintiff attempted to create a voluntary undertaking exception. Plaintiff’s argument – by conducting classes on the medication, the manufacturer voluntarily undertook to warn patients of the side effects of the drug, thereby foregoing “the protection of the learned intermediary doctrine and assum[ing] the physician’s duty to warn.” Id. at *12. The court disagreed. To impose on the manufacturer a duty to warn the patient directly would “interfere with the physician-patient relationship.” Id. at *13. Again, the court cited to the prescriber’s testimony that “sending his patients to the [manufacturer sponsored] class did not relieve him of his duty to provide information on the side effects of the medication.” Id. at *15.
[The prescriber] recognized and accepted the responsibility for warning the plaintiffs about the side effects of [the drug]. In this case, to hold that the defendants voluntarily undertook to warn of the side effects of [the drug] would violate the learned intermediary doctrine.
Id. at *16. The court also rejected the comparison between the educational class attended after the medication was prescribed and direct-to-consumer marketing.
There was no evidence that prior to taking [the] class, [plaintiff] had ever heard of [the drug] until [his physician] prescribed it for him or that he requested that [his physician] prescribe [the drug] to treat his HCV.
So, there was no voluntary undertaking and with the learned intermediary firmly established, there was no proximate cause. While that was more than enough for summary judgment, the court also ruled that the defendant’s package insert – which “delineated the exact problems suffered by [plaintiff]” was adequate as a matter of law. Id. at *7. Under Illinois law, unless the insufficiency of the warning is “so obvious,” expert testimony is required to determine its adequacy. Id. at *19-20. Further, “the adequacy of the warning must be judged by whether it sufficiently apprises physicians of the risks.” Id. at *19. Therefore, the expert must be someone with specialized knowledge in “what a practicing physician . . . would consider an adequate warning” when making his prescribing decision.
Plaintiff here offered the testimony of a doctor who admittedly was a practicing anesthesiologist for one year in Sweden before becoming a marketing expert for drug companies (yes, you read that correctly, plaintiff’s turncoat expert spent years consulting with drug companies on the development of marketing materials and package inserts). Id. at *21. Therefore, the court found him not competent to testify as to the adequacy of the warning. No expert, no failure to warn claim.
So, while we wait to see whether some of our favorite TV shows withstand their makeovers, we celebrate the fact that the learned intermediary doctrine remains a favorite in courtrooms across the country, with no sign of “jumping the shark.”