2012 PROFESSIONAL LIABILITY UPDATE - Eckert Seamans

504(d)(2). This provision apparently overrules the Supreme Court case, Duttry v. Patterson, 771A.2d 1255 (Pa. 2001), with respect to procedures performed after MCARE’s effective date.Federal informed consent law does not preempt 40 P.S. § 1303.504. In Mack v.Ventracor, Ltd., No. 10-cv-02142, 2011 WL 890795 (E.D. Pa. Mar. 9, 2011), the case arosewhen decedent, as part of his elective participation in an FDA study that evaluated thesafety of an implantable cardiac device that was in the early stages of FDA approval, waskilled when the device allegedly malfunctioned after implantation. Id. at *4. Plaintiffbought suit against defendant doctors for failure to obtain informed consent pursuant to 40P.S. § 1303.504. 2011 WL 890795 at *3.Defendants attempted to remove the case to federal court alleging that federaljurisdiction was appropriate because 1) federal courts have jurisdiction over state lawclaims that turn on substantial questions of federal law, and 2) plaintiff’s battery claimturned on a substantial question of federal law because it requires an interpretation offederal regulations 6 governing informed consent. Id. at *6, *11.Plaintiff contended that removal was inappropriate because her claim solelyinvolved state statutory and common law. Id. at *4. In particular, plaintiff argued that herinformed consent claim did not refer to or rely on federal law, but rather asserted a claim,alleging battery based on lack of informed consent, that was governed solely by MCARE.Id. at *5. Further, plaintiffs alleged that the relevant inquiry was whether Congressintended federal regulations to confer federal question jurisdiction. Id. Plaintiffs averredthat Congress had not intended to create a federal private right of action because they werenot phrased in terms of persons benefited and because the regulations vested the states withenforcement power over the regulations. 7 Id. at *6. Consequently, as Congress did notcreate a federal right of action, removal was inappropriate. Id. at *5.The court, in finding for plaintiff, began by noting that when applying MCARE, theonly potential significant federal issue was whether the topic of informed consent forhuman research subjects had been preempted by federal law. Id. at *12. If Congress hadintended to preempt this area of law, then, the court noted, it would be impermissible forMCARE to impose additional or different informed consent requirements for humanresearch subjects. Id. However, the court found that the federal regulations explicitlyindicated that they did not preempt MCARE and even went further to contemplate stateauthorities imposing additional informed consent requirements. 8 Id. More specifically,MCARE was not preempted because the federal informed consent statute did not include6 The federal regulations at issue were 21 C.F.R. § 50.1 through 21 C.F.R. § 50.27 and 45 C.F.R. § 46.101 through45 C.F.R. § 46.124. These regulations pertain to the protection and informed consent of human subjects duringclinical investigations like the study at issue in this case.7 More specifically, the regulations state, “This policy does not affect any state or local laws or regulations whichmay otherwise be applicable and which provide additional protections for human subjects.” 45 C.F.R. § 46.101(f).8 Indeed, the court reasoned, 21 C.F.R. § 50.25(d) of the regulations stipulates, “The informed consentrequirements in these regulations are not intended to preempt any applicable Federal, State, or local lawswhich require additional information to be disclosed for informed consent to be legally effective.” 2011WL 890795 at *12 (emphasis added).97