Consider this an addendum to the "Adequate Warnings Should be Enough" post that Bexis wrote back in February. What makes a warning "adequate"? Insistence on truth and completeness is of little help. One does not have to be one of history's all-time villains to ask what is truth, and it is just as legitimate to ask what is complete. Warnings do not and cannot say everything. It is all too easy for a plaintiff lawyer to identify a missing detail or modifier. We griped about the inadequate definition of inadequacy over five years ago, and it still plays a huge role in saving frail failure to warn claims from summary judgment. (Mind you, we are talking about warnings for prescription drugs and devices. Thus, the issue of adequacy is with respect to the learned intermediary doctors, not the enduser consumers.)
As the Bexis post points out, there are some good court decisions laying out categorical exclusions from what is needed to make a drug or device warning adequate. For example, warnings need not apprise doctors of how to diagnose the condition that renders the use potentially dangerous. Diagnosis is the practice of medicine, not the stuff of product warnings. Nor need labels warn about product-related storage problems. Also, a warning about possible infections is not defective because it did not specify fungal infections.
If Florida is once again the key battleground in next week's election, it is also a key battleground in product liability law. It is not a battleground from which the defense side usually emerges victorious. But if Florida tort law really is like a battleground, it is less like a Waterloo and more like an Antietam. Both sides get bloodied.
Dye v. Covidien LP, 2020 U.S. Dist. LEXIS 105676 (S.D. Fla. June 16, 2020), was a hernia mesh case that gave some wins to both sides. Today we are focusing on the Dye court's excellent discussion of warning adequacy. That part ended up being a win for the defense, and we are delighted to talk about it. For the parts that went the plaintiff's way, you'll have to read the case for yourself.
The plaintiff in Dye alleged that the Instructions for Use ("IFU") accompanying the hernia mesh did not warn of certain side-effects or their "duration, frequency, or severity" of complications, and did not warn of the defects linked to the mesh. The defendant filed a motion to dismiss, and the court granted that motion with respect to the failure to warn claim. Why?
The plaintiff did, indeed, list a number of side effects not included in the IFU. Maybe one could make a good case for inclusion of those side effects. But Dye was not that case because the plaintiff in Dye had not suffered from any of those side effects. The side effects that did affect the plaintiff (inflammatory response and infection) had been warned of in the IFU. As far as the plaintiff in Dye was concerned, the side effects warnings were adequate.
The plaintiff alleged that the IFU was inadequate because it did not warn of "the necessity for invasive surgical intervention in the event of complications." The Dye court held that such failure could not save the failure to warn claim, because "Defendant need only warn of complications stemming from the Product — not the subsequent measures medical professionals may employ to treat those complications." That is an important ruling. Plaintiffs often lob into their failure to warn claims a contention that the IFU should have listed the possibility of future surgical repairs or removals. Those claims should be gone.
Similarly, the Dye court ruled that the proper inquiry in a failure to warn claim "is not whether the manufacturer warned of defects, the question is whether the manufacturer warned of risks." More specifically, the defendant must warn of the risks of injury, but not the specific ways the alleged injury might occur. This ruling is also important.
Think of vaginal mesh cases, where plaintiffs allege that the IFU should not only have warned of possible pelvic pain, but also should have warned that such pain was possible because the raw material was not of medical grade (whatever that means) and was susceptible to degradation. Under the reasoning in Dye, the plaintiffs should not be allowed to argue to the jury that the defendant should have included any of the biomaterials or mechanistic discussion in the IFU.
The Dye case makes clear that it is not, ahem, adequate, for a court simply to send the issue of warning adequacy to the jury. Sometimes the issue of warning adequacy is a legal issue that can be decided by the court. Adequacy goes to warning of possible injuries that the plaintiff in the case claims to have suffered. Details, mechanisms, and sequelae are not proper considerations for adequacy.
This article is presented for informational purposes only and is not intended to constitute legal advice.