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.
 

21 C.F.R. §50.20.

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 preemption.

That’s hogwash.

Under the law of, we suspect, every state, both waiver and release involve the relinquishment of existing rights. We’re in Pennsylvania so we took a quick look, and sure enough “Waiver is an intentional and voluntary relinquishment of a known right.” Commonwealth v. Lucarelli, 971 A.2d 1173, 1179 (Pa. 2009). “[A] release is the giving up or the abandoning of a claim or right to the person against whom the claim exists or the right is to be enforced.” Tindall v. Friedman, 970 A.2d 1159, 1165 (Pa. Super. 2009).

That’s nothing like preemption. Where preemption applies, it extinguishes legal rights as a matter of law. The doctrine is in no way dependent upon “exculpatory language” of any sort. And the regulatory history of §50.20 deals only with attempts to insert such language in informed consent forms:


Fourth, the HEW regulations forbid use of exculpatory language through which the subject is made to waive, or appear to waive, any legal rights, including a release of the investigator from liability for negligence. FDA has no comparable regulation, although actual agency policy has been similar to the HEW rule.


44 Fed. Reg. 47713, 47716 (FDA Aug. 14, 1979). With preemption, there’s no right left, let alone a “known” right, left to be waived. There's nothing "voluntary" about the operation of the Supremacy Clause. Nor is preemption any form of release, since any affected rights were simply abolished by act of Congress, not signed over to anyone else.

Case law interpreting §50.20 is even more explicit in distinguishing between claims that are and aren’t preempted. The regulation’s waiver/release provisions apply only to unpreempted claims:


[Section] 50.20 preserves the patient’s common law rights outside of the limited scope of the preemption provision. It does not repeal the preemption provision itself. . . . [T]he consent regulation should be read to prevent patients from waiving legal rights which are not preempted under federal law. That is, those common law rights which are retained by a patient and not preempted by the federal scheme may not be waived by the patient.


Gile v. Optical Radiation Corp., 22 F.3d 540, 543 (3d Cir. 1994) (emphasis original). See also Slater v. Optical Radiation Corp., 961 F.2d 1330, 1334 (7th Cir. 1992); Hunsaker v. Surgidev Corp., 818 F.Supp. 744, 750 (M.D. Pa. 1992), both of which are discussed in Gile.

Since preemption has nothing whatever to do with waiver or release, there’s no way that an informed consent document discussing only the latter could be “fraudulent” – an intentional tort – for not mentioning the former. Even so, lawsuits are expensive to litigate, so going forward investigators might want to check with the FDA to see if the Agency would permit some sort of additional language in informed consent documents such as “Some rights or remedies may, however, be preempted by operation of federal law,” or something similar. We have no idea whether the FDA would permit such language, or not, but all in all litigation is better avoided than defended.

The second theory, that informed consent somehow has to discuss the legal, as well as the medical ramifications of investigational medical treatments, is also hooey. Doctors simply aren’t lawyers, and they have no professional obligation to advise patients of legal – as opposed to medical – risks. We litigated a similar issue, whether the FDA regulatory status of a device, that is it’s being used off-label, was a medical “risk” that had to be disclosed as part of informed consent. Fortunately, the courts pretty unanimously said “no.” Again, we’ll stick to Pennsylvania, which we know best, but our prior posts collect all those cases. In Pennsylvania, legal issues are not “risks” that have to be disclosed under the rubric of informed consent:


We see no reason to expand the information that surgeons traditionally impart to their patients to encompass a device’s FDA regulatory status. . . . FDA labels given to a medical device do not speak directly to the medical issues surrounding a particular surgery . . . . [They] do[] not enlighten the patient as to the nature or seriousness of the proposed operation, the organs of the body involved, the disease sought to be cured, or the possible results. The FDA administrative label does not constitute a material fact, risk, complication or alternative to a surgical procedure. It follows that a physician need not disclose a device's FDA classification to the patient in order to ensure that the patient has been fully informed regarding the procedure.


Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001) (emphasis added). Thus, a “risk” for purposes of informed consent means a “medical issue” not a legal one.

Trying to shoehorn preemption into informed consent is even worse than the FDA regulatory status rejected in Southard and the other Bone Screw cases. The FDA regulatory status of a device was at least something determinable at the time the device was used. Preemption is simply one of many possible defenses to a lawsuit that may or may not ever happen, and in most cases won’t. There are lots of equivalent legal issues. For example, in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), the court killed off a bunch of legal theories, holding that only negligent failure to warn is allowed in prescription drug cases. Id. at 891 (“the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer’s negligence, is the only recognized basis of liability”). Hahn applies to medical devices. E.g., Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006). MDA preemption only knocked out the one theory that was left. Is a doctor supposed to tell a patient that Pennsylvania law wipes out far more “rights” than preemption? The absurdity of expanding informed consent to legal matters is obvious – as doctors cannot be expected to act as lawyers and advise patients of legal rights.

Thus, there is not even a colorable claim under the law of any state that medical informed consent somehow has to encompass a purely legal doctrine such as preemption. It’s just another example of plaintiffs blowing smoke. But the thicket of FDA regulations is something that most medmal defense attorneys (thankfully) don’t have to deal with regularly. We’re used to it here, so we hope our colleagues can use these pointers to prevent such a colorable claim from ever arising.