We talk a lot about the learned intermediary doctrine on this blog. Rightfully so. It is a powerful tool for drug and medical device defendants. In a nutshell, the learned intermediary doctrine says that pharmaceutical companies’ duty is to warn doctors, not patients, about the risks of prescription drugs.It is a recognition of the essential role the physician plays when it comes to prescription drugs and devices. And, while the doctrine inures to the benefit of defendants, it is not an affirmative defense. That is, the plaintiff still bears the burden to prove proximate causation. The plaintiff must prove that the doctor would have made a different prescribing decision if he had the information that plaintiff claims he should have had. And, as an essential element of plaintiff’s case, plaintiff must plead sufficient facts to support his claim that his physician would have acted differently.
That’s where plaintiff in today’s case ran into some trouble. Plaintiff brought a purported class action seeking a refund of what he spent on Avandia alleging that defendant violated Pennsylvania’s Unfair Trade Practices and Consumer Protection Law (“UTPCPL”). In re Avandia Marketing, Sales and Products Liab. Litig., MDL 1871 (Morgan v. Smithkline Beecham Corp.), 2013 U.S. Dist. LEXIS 96774 (E.D. Pa. Jul. 10, 2013). There was no personal injury alleged. Rather, the crux of plaintiff’s claim is that even though Avandia is effective in reducing blood-sugar, because it allegedly carries an increased risk for heart-related disease, the drug “has no health benefit.”Id. at *2-3. The court did not have to get into the substance of the claim, however, because plaintiff failed to allege any facts that would get him around the learned intermediary doctrine. The court also refused to recognize a direct-to-consumer exception to the learned intermediary doctrine. Once again, New Jersey remains a party of one on that issue.
It is worth noting that this was plaintiff’s second attempt to state his claim. The original complaint was dismissed because plaintiff failed to allege, among other things, “what materials or information his physician relied upon.” Id. at *1. Plaintiff tried to fix that deficiency by alleging that his physician reviewed defendant’s “marketing and statements.” Id. at *2. But that wasn’t enough to cure the fatal inadequacies of plaintiff’s pleading. Fatal because this time, the court dismissed the case with prejudice.
The court starts off by acknowledging that the learned intermediary doctrine applies to consumer protection claims – and in Pennsylvania almost always bars them. Pennsylvania’s consumer protection statute requires reliance and under the learned intermediary doctrine it is the prescribing physician upon whom plaintiff relies – not the manufacturer:
Under the learned intermediary doctrine, the drug manufacturer owes a duty of disclosure to the prescribing physician, but it is then the duty of the prescribing physician to communicate any risks or other information about the drug to the patient. As courts have held, the existence of the learned intermediary doctrine in Pennsylvania makes it difficult, if not impossible, for plaintiffs to successfully bring a UTPCPL claim based on a prescription drug.
Id. at *5 (quotation marks and citations omitted). And as to reliance, plaintiff failed to plead anything beyond “generalized allegations that his (unidentified) physician viewed Avandia marketing materials.”
Id. at *6.
Plaintiff attempted to fit into the “almost impossible” category of viable prescription drug UTPCPL claims by alleging that defendant marketed Avandia directly to consumers. Id. at *5. Fortunately, like almost every court to consider the issue, this court found that DTC advertising doesn’t alter the role of the physician in prescribing medications to his patients:
Media dissemination of information concerning the existence of these drugs does not enhance the public’s ability to acquire them, as the skill and knowledge of the physician still must be brought to bear in a determination of whether the pharmaceutical is appropriate for the patient. Because Plaintiff could not obtain Avandia without a physician’s prescription, and the allegations with regard to the prescribing physician’s exposure to, and justified reliance on, misleading information from Defendant are insufficient to state a cause of action, the learned intermediary doctrine bars Plaintiffs claim.
Id. at *6. In other words, even if plaintiff saw an ad for Avandia and asked his physician about it – it was still up to the physician to use his medical training and knowledge of his patient to decide whether to prescribe it. His role as the learned intermediary is unchanged. Furthermore, that role remains essential. Plaintiff still could not obtain the drug without a prescription. So, we come full circle. The very reason for adopting the learned intermediary doctrine is a recognition of the patient-physician relationship, a relationship that it not altered by marketing to the general public.
With this decision shutting down yet another attempt by plaintiffs to sidestep the learned intermediary doctrine, it just became even more difficult to bring a consumer protection claim for a drug or medical device in Pennsylvania. We won’t go so far as to say impossible, but it’s getting close.