There’s been a lot of movement amongst the bloggers on this site over the last two years. And now there’s more. Sullivan – that’s me – has moved to Cozen O’Connor. I’ll miss my old firm, Dechert. But I’m excited about my move to Cozen, and I look forward to continuing to give you my thoughts on drug and device law, and sometimes pop culture, from within Cozen’s walls. And, for me, those walls will be in two Cozen offices, one in downtown Manhattan (where I practiced for years when I started my career) and the other in Cherry Hill, New Jersey. Now, Cherry Hill is a great town. I was in that office Friday when I began drafting this post. But today I’m in Manhattan. That’s different. If for no other reason than the views. It’s hard to beat the Freedom Tower as it’s being completed or ships sailing their way down the Hudson River into New York Harbor.
Frankly, if you’re in an office in just about any town other than New York City, “you lose that battle, you lose that battle nine times out of ten.” But that’s not the real advantage of spending much of my time in Cozen’s New York office. The most important benefit is that I now have the ultimate “bona fides” to counter what has been a distinctly Philadelphia voice on this blog. The New York-Philadelphia rivalry has now hit the legal blogosphere. If all else fails, I can just say, “fuhgeddaboudit.”Anyway, here’s my first Cozen post.
So where were we? Oh yes, the learned intermediary doctrine. On Friday, we reported on Calisi v. Abbott Labs., 2013 U.S. Dis. LEXIS 139257 (D. Mass. Sept. 27, 2013), a decision in which the court excluded plaintiff’s warnings expert thereby ending plaintiff’s failure to warn claim. Underlying that decision was the court’s refusal to adopt plaintiff’s argument that Abbott had “assumed a duty” to warn the plaintiff directly rather than warn her doctor because Abbott had earlier communicated directly with plaintiff via a patient video and direct-to-consumer (DTC) advertising.
Plaintiff’s argument sounded new, but it was really the same old, same old. As has been tried many times before, Plaintiff sought to use the fact that the manufacturer had directed educational and/or marketing materials directly to patients as a basis to bypass the duty to warn the prescribing doctor. But this argument has been rejected almost everywhere it’s been raised. In fact, the Calisi court rejected it earlier this year. See Calisi v. Abbott Labs, 2013 WL 5462274 (D. Mass. Feb. 25, 2013) (“Calisi I”).
In Calisi I, plaintiff phrased her argument in the way that we ordinarily hear it. She wanted the learned intermediary doctrine eliminated from the case because Abbott allegedly had either (1) engaged in DTC advertising or (2) compensated plaintiff’s prescribing doctor, presumably as an educational speaker. Id. at *1. Phrased traditionally, this argument was an obvious loser. The court put it simply: “Massachusetts law as it stands does not recognize these exceptions [to the learned intermediary doctrine] yet.” In fact, the court’s use of the word “yet” seemed generous, as only one jurisdiction has adopted this exception, and since then no other state has followed:
the direct-to-consumer exception was created in New Jersey in Perez v. Wyeth Labs., Inc., 161 N.J. 1, 734 A.2d 1245 (N.J.1999), many courts have declined to follow the New Jersey Supreme Court’s sweeping departure from the learned intermediary doctrine . . . .
Id. at *3. In other words, in 1999 New Jersey adopted its DTC exception to the learned intermediary doctrine, and since then no one else has signed on. Now, it’s true that West Virginia requires companies to warn patients directly. But that’s because West Virginia stands alone as the only state not to recognize the learned intermediary doctrine at all – under any circumstances.
Let’s stop here for a moment to linger on the court’s use of the word “yet.” Yes, Massachusetts hasn’t recognize the DTC exception to the learned intermediary doctrine “yet,” but maybe the Calisi I court could have predicted that it would. Maybe, but it didn’t. And it was right not to do so. As we’ve addressed many times before, federal courts sitting in diversity shouldn’t engage in guesswork by predicting expansions of state tort law. The Calisi I court understood this all too well: “It is not the province of the federal court to alter the boundaries of Massachusetts law.” Id. at *2 (quoting Hall v. FMR Corp., 559 F. Supp. 2d 120, 128 (D. Mass. 2008)).
We should also point out that there’s good reason for rejecting the DTC exception. Whether or not the manufacturer advertises directly to consumers, patients can’t get prescription drugs without doctors. If a doctor doesn’t prescribe it, the patient doesn’t get it. That relationship is the foundation of the learned intermediary doctrine, and it is why the law requires companies to direct their warnings to doctors. The doctors – that is, the learned intermediaries – bring their education and experience to their assessment of the scientific and medical information contained in warnings. They then choose how best to convey that information to their individual patients. This remains true whether the patient first learned of the particular drug from the doctor, DTC advertising, a friend, or a pharmacist. What also remains true is that if, for whatever reason, the company doesn’t provide a sufficient warning to the doctor, a plaintiff can sue the company for failure to warn. DTC advertising does nothing to change that either. The court also addressed plaintiff’s alleged “payment to doctors” exception to the learned intermediary doctrine. The court noted that, like with the claimed DTC exception, there is a line of cases rejecting this supposed exception. Id. at *3. So how do you think the court came out on this issue? . . . . Fuhgeddaboudit!