(a)Informed ConsentUnder MCARE, a physician is required to obtain the patient’s full, knowing, andvoluntary informed consent prior to the following procedures:1. Performing surgery, including the related administration ofanesthesia;2. Administering radiation or chemotherapy;3. Administering a blood transfusion;4. Inserting a surgical device or appliance;5. Administering an experimental medication, using anexperimental device or using an approved medication or device inan experimental manner.See 40 P.S. § 1303.504(a). Informed consent had been likewise required under the predecessorstatute, Act 135, now repealed, 40 Pa. Stat. Section 1301.811-A, since January 25, 1997 for thesame procedures.Under MCARE, as under the predecessor statute, informed consent results where thephysician gives the patient (1) a description of the procedure and (2) the risks and alternativesthat a reasonably prudent patient would need to consider to make an informed decision as to thatprocedure. The question of whether the physician obtained his patient’s informed consent is stillgoverned under the prudent patient standard. As to what constitutes the required informedconsent, it is not necessary for the physician to disclose to the patient all known risks of a givenprocedure. Rather, Pennsylvania law requires that the patient be advised of those material facts,risks, complications, and alternatives that a reasonable person in the patient’s situation wouldconsider significant in deciding whether to undergo the procedure.In defending against a claim of lack of informed consent, a physician may presentevidence of the description of the procedure at issue and those risks and alternatives that aphysician acting in accordance with the accepted medical standards of medical practice wouldprovide. See 40 P.S. § 1303.504(b). Expert testimony is also required to determine whether theprocedure at issue constituted the type of procedure which necessitates informed consent and toidentify the risks of that procedure, the alternatives to that procedure and the risks of thesealternatives. See 40 P.S. § 1303.504(c). Under MCARE, as under Act 135, a Plaintiff mustestablish the element of causation in order to set forth a viable claim for lack of informedconsent. Specifically, a physician is liable for failure to obtain informed consent of a patientonly if the patient proves that receiving such information would have been a substantial factor inhis decision whether to undergo that procedure. See 40 P.S. § 1303.504(d).MCARE, unlike Act 135, also contains a provision stating that a doctor can be held liablefor failure to obtain a patient’s informed consent if the doctor “knowingly misrepresents to thepatient his or her professional credentials, training or experience.” 40 Pa. Cons. Stat. §96
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
- Page 3 and 4:
EMTALA CASES ......................
- Page 5:
Filing an Affidavit of Non-Involvem
- Page 8 and 9:
II.PROFESSIONAL LIABILITY - AN OVER
- Page 10 and 11:
The Superior Court reversed the tri
- Page 12 and 13:
to a third party pursuant to the st
- Page 14 and 15:
After approximately five months, De
- Page 16 and 17:
learned the day after the surgery t
- Page 18 and 19:
conduct to the delay in colon cance
- Page 20 and 21:
court admitted the expert’s testi
- Page 22 and 23:
(b)(c)other reasonable causes, incl
- Page 24 and 25:
corroborated his testimony. The cou
- Page 26 and 27:
husband’s estate. Plaintiff alleg
- Page 28 and 29:
Other notable federal cases arising
- Page 30 and 31:
The Superior Court found that in re
- Page 32 and 33:
§ 1303.512(b). The court, however,
- Page 34 and 35:
In Neidig v. United States, No. 07-
- Page 36 and 37:
Additionally, the Supreme Court not
- Page 38 and 39:
were not indicated for her conditio
- Page 40 and 41:
surgeon is the same as it would be
- Page 42 and 43:
It should be noted that the Superio
- Page 44 and 45:
Finally, the court held that the tr
- Page 46 and 47:
The Supreme Court of Pennsylvania r
- Page 48 and 49:
nurses deviating from applicable st
- Page 50 and 51:
certainty, the court reviews expert
- Page 52 and 53: Under Pennsylvania law, the Court n
- Page 54 and 55: testimony, Defendant presented his
- Page 56 and 57: Following Cooper v. Roberts, 286 A.
- Page 58 and 59: Plaintiff developed chronic diarrhe
- Page 60 and 61: where payment is made by Medicaid w
- Page 62 and 63: accomplished. In Valles v. Albert E
- Page 64 and 65: In 1980, the Pennsylvania Superior
- Page 66 and 67: Plaintiff had a routine monitoring
- Page 68 and 69: Plaintiff’s Contract ClaimsThe Co
- Page 70 and 71: is a failure to report changes in a
- Page 72 and 73: unit to assure post-surgical patien
- Page 74 and 75: sliced his wrist and arm with a raz
- Page 76 and 77: licensed professionals for whom the
- Page 78 and 79: (c)Limitations of Corporate Neglige
- Page 80 and 81: Even more recently, our Superior Co
- Page 82 and 83: (a)HMO IssuesIn McClellan v. Health
- Page 84 and 85: affidavit submitted by Defendants o
- Page 86 and 87: treatments while at VA’s faciliti
- Page 88 and 89: [s]ubstantively, we believe that a
- Page 90 and 91: The party claiming the benefit of t
- Page 92 and 93: deprive (him) of civil rights guara
- Page 94 and 95: found that the District Court was w
- Page 96 and 97: With respect to fraudulent concealm
- Page 98 and 99: would be applied in situations wher
- Page 100 and 101: they had not raised them in the cou
- Page 104 and 105: civil enforcement provisions and ma
- Page 106 and 107: MCARE also changes the manner in wh
- Page 108 and 109: whose death, in 2005, was allegedly
- Page 110 and 111: vicariously liable if the plaintiff
- Page 112 and 113: health center or its equivalent or
- Page 114 and 115: In Pennsylvania Medical Society, th
- Page 116 and 117: to any professional who is alleged
- Page 118 and 119: Since the 2005 amendments, there ha
- Page 120 and 121: ule, but who intentionally ignores
- Page 122 and 123: the original Complaint was delivere
- Page 124 and 125: foreclose all challenges against th
- Page 126 and 127: number of boxes), which was support
- Page 128 and 129: questions of professional judgment
- Page 130 and 131: deviated from any professional stan
- Page 132 and 133: The Third Circuit affirmed the Dist
- Page 134 and 135: claims and cross-claims remain agai
- Page 136 and 137: By an Amendatory Order dated March
- Page 138 and 139: The court acknowledged that there i
- Page 140 and 141: apply and that the trial court misa
- Page 142 and 143: Barbados had enough litigation-spec
- Page 144 and 145: E. Preemption of Vaccine Design Def
- Page 146 and 147: 2. Pa. R. Civ. Pro. 1036.1 - Reinst
- Page 148 and 149: Barrick, at *34-35.Furthermore, the
- Page 150 and 151: (b) the utility of the defendant’
- Page 152 and 153:
2006). In this case, Plaintiffs bro
- Page 154 and 155:
B. Elements of a Cause of Action fo
- Page 156 and 157:
decision in Muhammad precluded Mr.
- Page 158 and 159:
considered speculative “only if t
- Page 160 and 161:
underlying cause of action involved
- Page 162 and 163:
In Capital Care Corp., the Superior
- Page 164 and 165:
The court found, however, to state
- Page 166 and 167:
of reasonable diligence. The standa
- Page 168 and 169:
not be set aside. On July 7, 2005,
- Page 170 and 171:
complete bar to recovery. Since a l
- Page 172 and 173:
On appeal, Plaintiffs claimed that
- Page 174 and 175:
In Liggon-Redding, 659 F.3d at 265,
- Page 176 and 177:
elieved of those minimum standards
- Page 178 and 179:
elevant to the proceedings, the com
- Page 180 and 181:
establish professional misconduct b
- Page 182 and 183:
Upholding the Superior Court’s Or
- Page 184 and 185:
Id.Rejecting revocation and suspens
- Page 186 and 187:
order as a sanction under Rule 4019
- Page 188:
{1009912]182