We knew what the correct result ought to be in Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 57319 (N.D. Ohio Apr. 24, 2014), as soon as we read the following statement in the second paragraph of the district court’s order:
The record reflects that at the time [the plaintiff’s physician] prescribed the [birth control patch], he was aware that [the birth control patch] exposes users to increased levels of estrogen, and that such increased exposure increases the risk of blood clots. Moreover, [the plaintiff’s physician] testified that notwithstanding these risks, he believed the [birth control patch] was a reasonably safe method of birth control for Plaintiff, and further believed that the risks to Plaintiff were outweighed by the drug’s benefits.
Id. at **1-2. Case closed. Full stop. As our faithful readers know, there are generally three paths to defeating warnings-based claims for lack of causation. The drug labeling fully disclosed the risk that allegedly befell the plaintiff; the prescribing physician did not read the labeling; or the prescribing physician was already aware of the risk through his or her medical training and experience. Sometimes, it is all three. The upshot is that if the prescribing physician knew and understood the risks and decided that the benefits of the drug therapy outweighed those risks for that patient, then the plaintiff’s alleged injury did not result from any material failure to warn.
That is what happened in Brown, where the plaintiff used the Ortho Evra contraceptive patch, a contraception product that delivers estrogen and progestin hormones through a transdermal patch delivery system. The patient experienced blood clots in her lungs, which is a serious condition. Id. at *2. But doctors have been well aware of the risk of blood clotting in connection with combination hormone contraceptives for more than 50 years. Ask any doctor (and we have), and he or she will tell you exactly that. It is also true that labeling for combination hormone contraceptives has included comprehensive and prominent warnings against the risk of blood clots for almost as long as combination products have been prescribed—again for something like 50 years. As medical science has developed over the years, those warnings have become even more comprehensive and robust.
The prescribing physician’s testimony in Brown resulted in summary judgment on the warnings-based claims, as it well should have. Under Tennessee law, a warning can be adequate as a matter of law where the instructions are accurate and unambiguous, and the Ortho Evra package insert “provided specific warnings of the exact adverse events suffered by Plaintiff; namely, the package insert warned that . . . increased levels of estrogen can increase the risk of developing blood clots that may travel to the lungs.” Id. at *8. Moreover, in light of the prescribing physician’s testimony that he was aware of the increased risk of blood clots and that he nevertheless believed the benefits of the drug outweighed the risks, the warnings claims failed on causation as well. As the district court concluded, “the learned intermediary doctrine bars Plaintiff’s failure to warn claims.” Id. at **8-9. Sometimes we call this a double whammy: Summary judgment granted because (1) the warnings were adequate as a matter of law and (2) also because of a lack of causation.
This is the correct result, and it makes us wonder why substantial litigation over combination hormone contraceptives even exists. (For our commentary on previous, similar orders involving the same product, see here and here.) We are not insensitive to women who experience complications with contraceptive drugs. But the risks of unintended pregnancy and postpartum care (including the risk of blood clots) are much worse. In this day and age, it simply is not possible that any physician prescribing combination hormone contraceptives is not fully aware of the risk of blood clots, and it is equally implausible that any prescribing physicians failed to take that risk into account when making his or her prescribing decisions. Under those circumstances, there is no way that any inadequacy in the warnings caused the patient harm. What is more, it should not take years of litigation with all the trappings of multidistrict and coordinated proceedings to come to that conclusion.
There is more to the Brown order than just warnings. The defendants also moved for judgment on the pleadings on the plaintiff’s claims for manufacturing defect, negligence, breach of warranty, and fraud claims. Their success was limited: Because the plaintiff did not allege privity of contract between herself and the defendant, the district court granted judgment as a matter of law on the warranty claim. Id. at **11-12. Otherwise the motion was denied.
Moving for judgment on the pleadings was an unconventional choice. It is not entirely clear from the order whether the motion for summary judgment took aim at all of the plaintiff’s claims, but it would not surprise us if it did. An argument that “warnings cover everything” recognizes that claims arising from the use of prescription drugs almost always come down to the warnings, and the defendants would have been more than justified in asserting their warnings arguments as broadly as they could. Unfortunately, the district court ruled that the defendants raised their omnibus warnings argument improperly in reply, which allowed the court to brush it off as an “unsupported, passing assertion.” Id. at **9-10.
In the end we don’t think the denial of judgment on the pleadings will matter much. The core failure-to-warn claims are gone, and 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 leads straight back to the physician’s testimony cited at the outset of this post. It does not get any better than that.