The key to appreciating the latest order granting summary judgment for the defense in the Ortho-Evra birth control patch MDL is to start with the order’s last paragraph:
The Court has found that the Defendants provided adequate warnings sufficient to discharge their duty to warn. Because the Defendants exercised reasonable care by communicating the risks involved with the Ortho Evra® patch to [the plaintiff’s] physician, and those warnings were not faulty, [the plaintiff] has not established a claim of negligent misrepresentation under Tennessee law.
Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 145415 (N.D. Ohio Oct. 10, 2014). Ah, the familiar ring of the learned intermediary doctrine, the beat to which the Drug and Device Law Blog most often marches. But what’s this? The doctrine applied to negligent misrepresentation? Some background is in order: The plaintiff in Brown alleged that her use of hormonal contraceptives caused blood clots, which is one of the most widely known drug risks ever known to medical science. As we said when we first reported on this case, every doctor and medical student knows about the risk—so do most women—and the labeling for hormonal contraceptives has fully disclosed the risk of clots for decades.
The defendants therefore moved for judgment on the pleadings, which the district court granted on the failure-to-warn claims back in April 2014. See Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 57319 (N.D. Ohio Apr. 24, 2014). This was absolutely the correct result as far as it went, but there were still several claims left over—manufacturing defect, negligence, and fraud.
We were not all that concerned. With the failure-to-warn claims gone, we at the DDL observed that
. . . a plaintiff left with manufacturing defect, negligence, and fraud does not have much to work with going forward. Manufacturing defects are extremely rare in pharmaceutical cases, and fraud is usually disposed of with one question posed to the plaintiff in written discovery or a deposition. Question: “Have you ever had any contact or communication with the drug manufacturer? Answer: “No.” Of course, negligence can raise a host of issues, but we would not be surprised if further exploration of negligence beats a path straight back to the adequacy of the warnings . . . .
Which brings us to the court’s latest order, which granted summary judgment and put an end to the case. Brown, 2014 U.S. Dist. LEXIS 145415. It turns out the plaintiffs had even less to work with that we thought. On manufacturing defect and negligence, the plaintiffs merely cited the allegations in their own complaint, which obviously is not evidence. The court saw it that way too, and summarily granted the defendant’s motion on those claims. Id. at **5-7. The plaintiffs converted their fraud claim into “deceit by concealment” and negligent misrepresentation, but they offered little to nothing in support of those claims either. They based their concealment claim on a statute that did not apply. The negligent misrepresentation claim failed because the plaintiff never communicated with the defendants, and there was no identifiable misrepresentation made to anyone else—such as the prescribing physician. Id. at **9-10.
The court’s order granting summary judgment therefore played out pretty much as we expected it might. One of our mantras is that claims arising from the use of prescription drugs almost always come down to the adequacy of the warnings and their impact (or lack of impact) on prescribing physicians. Thus, once warnings-based claims are knocked out of a case, everything else tends to collapse. That is what we foresaw with the Brown case, and that is what in fact came to pass, although it was predictable enough that we will not break our arms patting ourselves on the back for our prodigious prognostication.
The citation to the learned intermediary doctrine in connection with negligent misrepresentation is still interesting. Where the plaintiff has had no contact or communication with the defendant—which is almost always the case in prescription drug and medical device cases—he or she may try to base fraud and misrepresentation claims on communications with a physician. We suppose you might call it misrepresentation by proxy. We are not sure that should ever work, but even giving credence to such a concept, what representation has a drug manufacturer made to prescribing physicians? At the risk of sounding like a broken record, claims arising from the use of prescription drugs almost always come down to the adequacy of the warnings.
So the court’s application of Tennessee’s learned intermediary doctrine to cut off alleged negligent misrepresentation is not as far-fetched as it seemed at the outset, but it still goes to show that defendants are in good stead when asserting warnings-based defenses as broadly as they can and across as many causes of action as conceptually possible. The defendants in Brown appear to have done that, and with the help of the incredibly well developed blood-clot warnings that accompany hormonal contraceptives, they won.