It seems that we have posted hundreds of times about attempts to impose liability on the manufacturer of a PMA device that a doctor chose to use off-label. Recently, a bunch of those have involved Infuse. Cales v. Baptist Healthcare Sys., Inc., No. 2015-CA-001103-MR, 2017 Ky. App. LEXIS 10 (Ky. Ct. App. Jan. 13, 2017), involves claims against a hospital over alleged off-label use of Infuse by a doctor there. (The decision gives no indication of a specific alleged injury from the use.) Why sue the hospital? Maybe to keep the case against the manufacturer in state court. Maybe to pursue someone else when the claims against the manufacturer are preempted. The problem for the plaintiff is that she needs a viable claim against the hospital, at least something that can get by a motion to dismiss. She offered three claims (two product liability and one medical negligence) premised on the hospital’s alleged knowledge of the possibility of off-label use, and the trial court dismissed them all.
Unfortunately for the hospital, the Kentucky Court of Appeals reversed as to one of the claims. Product liability claims against the manufacturer of this PMA device have, as the court noted, “been mostly unsuccessful based on federal pre-emption.” Id. at *10. Plaintiff claimed that preemption does not apply to such claims when made against a healthcare provider. “This distinction is of no avail.” Id. at *11. As the court analyzed it, consistent with the majority position, express preemption for PMA devices is based on the device, not how it is used or who uses it. It stands to reason that strict liability product liability claims about the design and warnings of a PMA device are expressly preempted too. This may seem obvious, but we think it is the first ruling of its kind in favor of a hospital. That may be because strict liability claims against hospitals are generally unavailable.
Framing those claims as negligence does not help under the Kentucky Product Liability Act. Among other things, a distributor or “middleman” is not liable simply based on knowing that there may be off-label use, which is not the same thing as knowing the product is in a defective condition. Id. at **12-13.
Medical negligence predicated on the hospital not telling the plaintiff that her doctor planned to use the device off-label is neither preempted by the MDA—FDA does not regulate the practice of medicine—nor covered by the Kentucky Product Liability Act. Kentucky law imposes a duty on hospitals to obtain informed consent from patients in connection with procedures to be performed. Id. at **15-16. In essence, the consent process is supposed to inform the patient of the “procedure[,] acceptable alternative procedures or treatments and substantial risks and hazards inherent in the proposed treatment or procedures.” Id. at *15. In the context of a motion to dismiss, the Cales appellate court viewed that whether there was a need to inform a patient of off-label us was a question of fact to be addressed as the case progresses and resurrected the medical negligence claim. Id. at *17. Not having the complaint in front of us, it is hard to say if there was any allegation of failing to inform the plaintiff of inherent substantial risks and hazards, it is hard to say whether this was a correct result. We can say, however, as the court acknowledged in its discussion of the product liability claims, that off-label use does not necessarily involve excess risks compared to on-label use. It may be possible to meet the state law requirements for proper consent without ever mentioning the loaded term “off-label.” That is why other courts have held that there is no duty to warn that a planned treatment is off-label.