We’ve heard about a new plaintiffs’ informed consent theory that’s making the rounds. It’s similar to, if even goofier than, the FDA regulatory status (that is, off-label use) theory that the plaintiffs tried with notable lack of success in the Bone Screw litigation (which we’ve discussed here and here).
As with all informed consent theories in product liability cases, this new theory is fundamentally an attempt by plaintiffs to stir up trouble between device manufacturers and the doctors who use their products. Thus, we’d like to offer our thoughts on how to beat it.
The ultimate target – not a great surprise – of this new theory is federal preemption as applied to so-called “IDE” (investigational device exemption) devices being tested in FDA-regulated clinical trials. As we’ve applauded earlier, most courts since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (and even before) have found tort claims involving investigational devices to be preempted. E.g., Robinson v. Endovascular Technologies, Inc., 119 Cal. Rptr.3d 158, 164-65 (Cal. App. 2010); Burgos v. Satiety, Inc., 2010 WL 4907764, at *2 (E.D.N.Y. Nov. 30, 2010); Williams v. Allergan USA, Inc., 2009 WL 3294873, at *2-5 (D. Ariz. Oct. 14, 2009); Dorsey v. Allergan, 2009 WL 703290, at *5-7 (M.D. Tenn. Mar. 11, 2009).
Justifiably worried that they’ll lose against IDE device manufacturers on preemption grounds, plaintiffs have started to allege that it’s somehow fraudulent, a misrepresentation or a violation of informed consent for (usually) the doctors who are serving as IDE investigators not to tell their patients about, of all things, preemption.
The new theory is particularly obnoxious because its damned-if-you-do-damned-if-you-don’t reasoning seeks to use doctors’ compliance with federal IDE informed consent regulations against them. Specifically, the doctors (“investigators” in FDA parlance) are obligated by regulation (in addition to whatever state informed consent parameters they operate under) to provide informed consent to patients who volunteer to be subjects in clinical trials. See 21 C.F.R. §812.100 (investigators are “responsible for seeing that informed consent is obtained in accordance with Part 50 of this Chapter”). Part 50, in turn specifies that investigational informed consent forms cannot seek waivers of patients’ legal rights:
No informed consent . . . may include any exculpatory language through which the subject [patient] . . . is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor [the device manufacturer], the institution [the hospital], or its agents from liability for negligence.
To comply with §50.20, from what we know, most investigating doctors simply make sure that their informed consent forms contain language that paraphrases the regulation, reciting something like “This informed consent does not waive any of your legal rights or release [list study investigator, institution, and sponsor] or any of their agents from liability for negligence.”
Plaintiffs – purporting to equate federal preemption under the Medical Device Amendments (“MDA”) with “waiver” or “release” under §50.20 – now claim that such compliant language is either fraudulent or failed to provide informed consent because it didn’t mention...
