[Drug and Device Law] Warnings Causation Sinks "Failure to Update" Claim
This post is not from the Dechert side of the blog.
“Failure to update” claims have multiple problems. You probably already know what we are referring to. Federal law requires that generic drug manufacturers distribute their products with drug labeling that is the same as their innovator counterparts—the so-called “duty of sameness.” A “failure to update” claim is where a plaintiff alleges that a generic manufacturer did not update its labeling to match the most current FDA-approved changes to innovator labeling and that the failure caused an injury. Because that involves an FDA-imposed duty, it is easy to conclude that it looks a lot like a disguised form of FDCA enforcement barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), as we pointed out here.
In addition to the preemption issues, “failure to update” claims are highly contrived. We never saw them before the Supreme Court found most claims against generic drug manufacturers preempted by federal law, and the key principle under tort law is whether drug labeling adequately warns of known and reasonably knowable risks. Sameness might be relevant to adequacy, but it also might not. In this regard, “failure to update” claims are nothing more than plaintiffs’ lawyers trying to thread the eye of a needle after Mensing and Bartlett.
True, the duty of sameness does not seem all that onerous to our uneducated eyes: Just follow the leader. And it is not like we are talking about absolute liability. As we have discussed, the plaintiffs still have to prove all the elements of their claims, including (but not limited to) causation. On days when we are in this generous frame of mind, “failure to update” claims are something we can live with.
A recent case in the Northern District of Ohio graphically demonstrates how “failure to update” claims come about—and how they go away. You may remember the Fulgenzi litigation. We discussed it here, back in 2013, when the Sixth Circuit became one of the first appellate courts to rule that these update-based claims survived preemption. That meant the plaintiff actually had to go about proving the claim. On remand, in Fulgenzi v. Pliva, Inc., No. 5:09-cv-1767, 2015 U.S. Dist. LEXIS 144283 (N.D. Ohio Oct. 23, 2015), the district court ruled that she failed. In Fulgenzi, plaintiff took generic metoclopramide prescribed by three different physicians and allegedly experienced a neurological movement disorder. All three physicians prescribed the branded drug, Reglan, but the pharmacies dispensed generic versions from various manufacturers, which is a typical scenario. Id. at **7-16. As luck would have it, one of the generic manufacturers had not updated its labeling to match the innovator: Whereas the generic label said that therapy beyond 12 weeks had “not been evaluated and cannot be recommended,” the innovator label had been changed to say that therapy “should not exceed 12 weeks.” Id. at **6-7, 26.
The problem for the plaintiff is that none of the doctors read the generic manufacturer’s labeling. All were familiar with the branded drug, which has been around for many years, and all expressed an understanding of its risks and benefits. Id. Notably, all three physicians testified that if they had known about the updated information at the time, they may have altered their prescribing practices.
The death knell, however, was their admitted non-reading of the generic label, which could have said anything and everything about the drug and its risks, and it still would have had zero impact on this particular plaintiff. No causation, therefore summary judgment granted. Thus, we’ve added this decision to our collection of cases turning on failure to read warnings.
With such a slam-dunk case on warnings causation, you may be asking yourself, why is this case interesting? Well, there are three reasons why the order caught our interest. First, the case confirms the Sixth Circuit’s prediction, back when it first allowed “failure to update” claims (see our prior post), that causation in a “failure to update” claim would be difficult to prove, owing to the fact that the plaintiffs will often be arguing that the updated warning itself was not adequate. Id. at *25. Plaintiffs thus might have a claim, but it is a narrow one on which they will not likely prevail.
Second, the district court applied what it understood to be a heeding presumption under Ohio law. Id. at *29. You know our opinions on heeding presumptions, which we view as needlessly complicating the issue of warnings causation and even shifting the burden of proof unfairly to defendants in some instances. Here, our recent experience tells us that Ohio law actually does not apply a heeding presumption, at least not for several years. Regardless, the Fulgenzi order demonstrates that whatever presumption applies, testimony from the prescribing physicians that they did not read the warnings rebuts it. Id. at **29-31. This quote is very useful on this point:
Still, all three doctors stated that they did not read the [generic manufacturer’s] warning. This un-contradicted testimony demonstrates that an adequate warning would have made no difference and sufficiently rebuts the presumption that the inadequacy of the warning was the proximate cause of plaintiff’s injuries.
Id. at *31. We will bank this one away for future use.
Third, the physicians all said that had they known about the updated information, they may have changed their prescribing practices and that they, in fact, had altered the way they prescribed Reglan in recent years. Id. at **7-16, 38-42. We imagine this testimony came in response to questions from the plaintiffs’ lawyers that began with “Doctor, would you like to have known . . .” or “Doctor, would it have been important to you if someone had told you . . . .” Whatever prompted the testimony, the district court had no difficulty brushing it aside. The fact of the matter was that these doctors did not read the generic labeling, and the generic manufacturers had no duty to communicate the information to physicians in any other way. Id. at **38-42. In other words, plaintiffs may have a “failure to update” claim against generic manufacturers, but “failure to communicate” claims are forbidden under the law.
At the end of the day, only one thing is for sure. These are lousy claims. Plaintiffs and their advocates will continue to search for ways to evade the preemptive effect of federal laws governing generic drugs and their warnings, but the pickings are slim. One narrow avenue is a claim for failure to update. Let’s hope plaintiffs realize how truly limited their chances are.
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Posted By Steven Boranian to Drug and Device Law at 11/06/2015 12:02:00 PM --
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