One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year was that, virtually without discussion, it held that an FDA-approved black box
In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a branded prescription drug was preempted. Courts were chilled for a while, but eventually the right sort of cases found their way to judges who understood preemption. Now, we have a pretty big list of decisions finding preemption of such claims, along with decisions exhibiting supportive reasoning. We are not yet at the point where preemption of failure to warn claims with branded prescription drugs—for a long time, the core claim in the biggest litigations in our bailiwick—is no longer news. Preemption is still the exception—limited to cases with a strong regulatory history of FDA rejecting the warning plaintiff wanted—rather than the rule, particularly when it comes to favorable appellate decisions.
Rheinfrank v. Abbott Labs., Inc., __ Fed. Appx. __, 2017 WL 680349 (6th Cir. Feb. 21, 2017), is another favorable appellate decision on preemption. You may recognize the name—especially if you are a blog aficionado—from our prior posts on the case. We posted on partial summary judgment being granted as to part of the failure to warn claims being offered—on preemption—and the punitive damages claim—on lack of proof of relevant FDA fraud to meet the exception under the Ohio Product Liability Act provision generally precluding punitives for FDA-approved drugs. We posted on the expansion of the preemption ruling on motion to reconsider to include design defect. (These garnered an honorable mention in our list of the best decisions of 2015.) We even posted on motions in limine rulings. Even with all of those posts, a brief recap of the facts might help. The minor plaintiff’s mother took the prescription anti-seizure medication at issue for fifteen years, including through four pregnancies, before she became pregnant with plaintiff. She kept taking the medication at issue, along with another anti-seizure medication she had been taking, through the birth of plaintiff, who was diagnosed with “physical deformities and cognitive disabilities, including Fetal Valproate Syndrome.” 2017 WL 680349, *1. The label for the medication at issue had long featured a black box warning and other warnings about birth defects, focusing on neural tube defects like spina bifida and discouraging use during pregnancy unless use of the medications “are clearly shown to be essential in the management of their seizures.” Id. at *2. Over the course of seven years after plaintiff’s birth, FDA refused the manufacturer’s repeated efforts to revise the label to address developmental delays in offspring based on data from a study that was ultimately published in the New England Journal of Medicine. Id. at **2-4. A revision of the labeling was ultimately submitted by CBE and accepted by FDA in 2011. Id. at *4. The prescriber back in 2003 and 2004 testified that she was aware of the black box warning on birth defects, would have relayed it to plaintiff, and would not have relied on other materials outside the label. Id. at *2.
Somehow, on this record, the plaintiff got to trial. Under the logic of “all’s well that ends well,” we will limit our rant on this point. After all, we have discussed other birth defect cases that got to trial despite obvious issues, resulted in big verdicts, and got affirmed on appeal. Rheinfrank proceeded to trial under the portion of the strict liability failure to warn claim that was not preempted, a strict liability claim for failure to confirm to representations, the portion of a common law negligent failure to warn claim that was not preempted, and a common law negligent design claim. Among the reasons why the two failure to warn claims should not have seen a court are that 1) Ohio law requires the allegedly inadequate warning to relate to the injury plaintiff claims, 2) claims relating to developmental delays (including as part of Fetal Valproate Syndrome) were preempted, and 3) the prescriber was aware of black box warnings about really serious birth defects and the recommendation against prescription during pregnancy in most situations. It is hard to see how plaintiff mustered evidence of proximate cause—that is, that a proposed (non-preempted) alternative warning as to a risk of an injury the plaintiff had (based on evidence that existed when the prescription was written) would have changed the prescriber’s decision to prescribe—to survive summary judgment. Based on the jury instructions that plaintiff proposed at trial, it seems like a broader discussion of risks and the impact of different warnings about risks was permitted than maybe should have been, which is often a reason why failure to warn claims get past summary judgment. Given that the prescriber denied reliance on any representations outside the label, it is hard to see how that claim got to the jury. As for the negligent design claim, it is hard to see how the same reasoning for preempting the strict liability design claim would not have applied or how a design of the drug—without being a different drug—that lacked the same birth defect risk could have been offered. Anyway, the trial judge may have known what was coming, because the jury listened to the just about the best plaintiff could offer and returned a defense verdict on all counts after two weeks.
It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial. What’s left doesn’t strike us as a very good warnings case. Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects. Make no mistake about it, Depakote has a known association with such injuries. First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:
there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
21 C.F.R. §201.57(c)(9)(i)(A)(4). Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect. For details, see 2015 WL 4743056, at *2-3.
Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies. Id. at *1. On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it. Id. Her allegations did try to change the subject, however. In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.” Id. at *5.
In the index to this blog, we list 39 posts about the Aredia-Zometa litigation. After today it will be 40. And counting. That might actually be understating our coverage. (We’re not always so punctilious at affixing topical labels to our posts.) Sometimes it seems as if one could understand all of recent drug and device…
Our recent post on the outcome of the plaintiffs’ in limine motions in the Guenther Aredia/Zometa case prompted a volcanic retort from one of the plaintiffs’ counsel (who will remain anonymous) that “all was not beer and skittles” (yech – not an appetizing combination) for the defense, specifically listing the court’s rejection of a defense “paper storm” and “preemption based in limines.” Attached to counsel’s emails were an order striking an original set of defense in limines as too darn long and a second order resolving a choice of law dispute in favor of Florida, rather than Georgia, law. Why a plaintiff would prefer Florida law in prescription drug product liability litigation case escapes us; some of us remember the excellent Florida law on causation and the learned intermediary rule that led to huge defense wins in the Seroquel litigation.
At about the same time as that email, one of our automatic searches pulled up the opinion on the Guenther defense in limines, which counsel had referenced but did not attach. See Guenther v. Novartis Pharmaceutical Corp., 2013 WL 4648449 (M.D. Fla. Aug. 29, 2013). Because (as counsel noted) we are interested in preemption issues – even hard ones for our side, which certainly includes preemption in innovator drug cases post-Wyeth v. Levine, 555 U.S. 555 (2009) – we took a look. Hmmmm.
For a post-Levine decision, we actually don’t think the rulings are all that bad. In fact, since the opinion provides a road map for possible future preemption inroads, we think this Guenther decision is worthy of comment.
Continue Reading More On Aredia/Zometa – Innovator Drug Preemption
We occasionally blog about motion in limine rulings, but not nearly as often as we read this type of decision. Let’s face it, as blogging material (as opposed to their impact on a particular case) decisions on motions in limine can be pretty boring. You can talk about this; you can’t talk about that. In…
Everyone in the world – at least everyone who reads our blog – knows that the Supreme Court rejected preemption in Wyeth v. Levine, in large part because the regulatory history of Phenergan (as read by the majority) did not clearly establish a conflict between the plaintiff’s warning defect claim and the FDA’s regulatory…
One of the high-profile ways in which the FDA has been strengthening product warnings lately has been to require more “black box” labeling – the FDA’s strongest form of warnings. Among other consequences, products bearing black box warnings cannot be advertised directly to consumers. Thus, the Agency’s decision to require a black box warning on…