Catherine Issac, et au. v. Jameson Memorial Hospital

1 In this appeal, we are asked to determine, in an action alleging lack of
informed consent, the relevance of Medicaid regulations which set forth the
parameters of informed consent to sterilization procedures required for
federal reimbursement of those procedures. For the reasons that follow, we
hold that they are not relevant, and thus affirm the judgment entered
against Catherine Isaac and John Isaac, wife and husband, and in favor of
Appellees Jameson Memorial Hospital and Rifaatt Bassaly, M.D.

2 The factual background of this case was set forth by the trial court as
follows:

[Ms. Isaac] came under the care of [Appellee] Rifaatt
Bassaly, M.D., on October 21, 1997. At this time, Ms. Isaac was
in the eighth month of her fourth pregnancy. At that initial
appointment in Dr. Bassaly's office, Dr. Bassaly determined that
Ms. Isaac's due date was November 12, 1997. Also, at that
initial office visit on October 21, 1997, Ms. Isaac executed an
"Authorization for Surgery or Special Procedures" for a bi-lateral
partial salpingectomy (the tubal litigation procedure to

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permanently prevent pregnancy) and a "[S]terilization Consent
Form."

On November 21, 1997, Ms. Isaac was admitted to
Jameson Memorial Hospital so that labor could be induced.
During the course of labor, it was determined that it was
medically necessary to deliver the unborn child by cesarean
section. The cesarean section was accomplished on November
22, 1997, as the result of which, Ms. Isaac gave birth to a baby
boy. Immediately following the cesarean section, Dr. Bassaly
performed a bi-lateral salpingectomy (the tubal litigation).
(Trial Court Opinion, 7/26/06, at 2.)

3 At trial, held on March 21 to March 27, 2006, the Isaacs contended
that the tubal ligation procedure was performed without Ms. Isaac's consent,
and, specifically, that she had withdrawn any previous consent given at the
time of her initial appointment with Dr. Bassaly on October 21, 1997. They
filed a motion for directed verdict, asserting that the evidence was
conclusive that she had withdrawn any previous consent given by her for the
tubal ligation procedure upon her admission to the hospital on November 21,
1997, and that any subsequent consent obtained from her by Appellees,
during labor and childbirth, was in violation of Medicaid regulations and thus
ineffectual to constitute her informed consent to the tubal ligation procedure.

4 The trial court denied the Isaacs' motion for directed verdict,
concluding that, under Pennsylvania law, Jameson Memorial Hospital could
not be liable for any lack of informed consent. With respect to Dr. Bassaly,
the court concluded that the Medicaid regulations had no relevance to an
action for lack of informed consent.

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5 Thereafter, the case was submitted to the jury on a theory of
negligence as to Jameson Memorial Hospital, in allegedly failing, through its
personnel, to communicate Ms. Isaac's withdrawal of her consent to the
doctor, and on the theory of lack of informed consent as to Dr. Bassaly
based on Ms. Isaac's testimony that she continuously advised Dr. Bassaly
throughout the period of labor and prior to the performance of the cesarean
section that she did not want to have the tubal ligation procedure.

6 On March 27, 2006, the jury entered a verdict in favor of Appellees,
finding that Jameson Memorial Hospital was not negligent, and that Dr.
Bassaly did not perform the tubal ligation without Ms. Isaac's informed
consent. The Isaacs filed post-trial motions seeking judgment
notwithstanding the verdict, and a new trial on damages. The trial court
denied the motions, and this appeal followed, in which the Isaacs ask:

1. Did the Trial Court err in refusing to grant [the Isaacs']
Motion for Directed Verdict in favor of [the Isaacs] and
against [Appellees] as a matter of law, because
[Appellees] failed to follow the state and federally
mandated "informed consent" procedures required by [55]
Pa. Code. 1101.11 et seq. and 42 C.F.R. 441.25[0] et
seq.?

2. [Are the Isaacs] entitled to a new trial on damages only
due to the trial Court's refusal to direct a verdict against
[Appellees] as a matter of law?
(Appellants' Brief at 4.)

7 Our standard of review with respect to the denial of a directed verdict
is as follows:

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[W]e may only ask whether the trial court's decision was an
abuse of discretion or an error of law that controlled the
outcome of the case. The trial judge, however, may only grant a
directed verdict motion where "the facts are clear and there is no
room for doubt." In so determining, the trial court "must
consider the facts in the light most favorable to the nonmoving
party and must accept as true all evidence which supports that
party's contention and reject all adverse testimony."
Faherty v. Gracias, 874 A.2d 1239, 1246 (Pa. Super. 2005) (citations
omitted).

8 The crux of the Isaacs' appeal is their contention that Appellees failed
to obtain Ms. Isaac's informed consent to the tubal ligation because
Appellees violated federal Medicaid regulations setting forth the parameters
for obtaining that consent. Specifically, she asserts that she withdrew her
prior written consent to the procedure, made in accordance with the
regulations, upon her admission to Jameson Memorial Hospital and that,
once her labor began, any further consent was invalid under the regulations
which invalidate consent given during labor. Thus, the Isaacs assert that
her consent was invalid as a matter of law. We need not address the factual
issue of compliance with the regulations, as, for the following reasons, we
reject the Isaacs' contention that the regulations were relevant to their lack
of informed consent action against Appellees.

9 The Isaacs cite Medicaid regulations which indisputably govern
sterilization procedures such as the tubal ligation performed on Ms. Isaac,
and which applied to her as a participant in Pennsylvania's Medical

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Assistance Program.1 See 42 C.F.R. § 441.250 et seq.2 These regulations
specify the requirements that must be met in order for a health care
provider to receive reimbursement for a sterilization procedure. See 42
C.F.R. § 441.252 ("A State plan must provide that the Medicaid agency will
make payment under the plan for sterilization procedures and
hysterectomies only if all the requirements of this subpart were met."); id. §
441.253 (federal financial participation "is available in expenditures for the

1 The federal Medicaid Act, 42 U.S.C. §§ 1396 et seq., provides for
federal-state collaboration in the provision of medical assistance.
Specifically, the Act provides that states may elect to participate in the
federal Medicaid program, as Pennsylvania has done, by preparing and
submitting for federal approval a state Medicaid plan that complies
with the Act and the regulations promulgated by the federal
Department of Health and Human Services. See 42 U.S.C. § 1396a;
42 C.F.R. §§ 430-456. If the state plan is approved, the state will
qualify for federal funding, which will cover part of the costs of the
state's medical assistance program. See 42 U.S.C. § 1396b(a); id. §
1396d(b). Although "states are given considerable latitude in
formulating the terms of their own medical assistance plans," their
discretion is limited by the requirement that they must "fully comply
with the federal statutes and regulations governing the program."
Addis v. Whitburn, 153 F.3d 836, 840 (7th Cir.1998).
Dep't of Pub. Welfare v. Devereux Hosp. Texas Treatment Network, 579 Pa.
313, 320 n.7, 855 A.2d 842, 846 n.7 (2004). Pennsylvania's Medical Assistance
Program was designed to provide medical assistance to those that cannot afford it
and was created pursuant to the Public Welfare Code, 62 P.S. §§ 441.1 to 449, and
in accordance with the Medicaid Act. 579 Pa. at 320-21, 855 A.2d at 846; see also
55 Pa. Code. § 1101.11(b) ("The [Medical Assistance] Program is authorized under
Article IV of the Public Welfare Code (62 P. S. §§ 401--488) and is administered in
conformity with Title XIX of the Social Security Act (42 U.S.C.A. §§ 1396-- 1396q)
and regulations issued under it."). Ms. Isaac was enrolled in Pennsylvania's Medical
Assistance Program. Jameson Memorial Hospital asserts, however, that there is no
evidence that the hospital was ever reimbursed by Medicaid for Ms. Isaac's tubal
ligation.

2 Although the Isaacs rely on these Medicaid regulations, we note that the trial
court, in its analysis, mistakenly cites the regulations for federal financial assistance
programs administered by the Public Health Service. See 42 C.F.R. §§ 50.201 et
seq. For purposes of our review of the trial court's determination, this error is
immaterial as the two sets of regulations are substantially the same.

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sterilization of an individual only if" certain requirements are met).
Specifically, Section 441.253 provides:

§ 441.253 Sterilization of a mentally competent individual
aged 21 or older.
FFP [(Federal financial participation)] is available in expenditures
for the sterilization of an individual only if -

(a) The individual is at least 21 years old at the time
consent is obtained;

(b) The individual is not a mentally incompetent
individual;

(c) The individual has voluntarily given informed
consent in accordance with all the requirements
prescribed in §§ 441.257 through 441.258; and
(d) At least 30 days, but not more than 180 days,
have passed between the date of informed consent
and the date of the sterilization, except in the case of
premature delivery or emergency abdominal surgery.
An individual may consent to be sterilized at the time
of a premature delivery or emergency abdominal
surgery, if at least 72 hours have passed since he or
she gave informed consent for the sterilization. In
the case of premature delivery, the informed consent
must have been given at least 30 days before the
expected date of delivery.
42 C.F.R. § 441.253. Furthermore, Section 441.257 specifies the content of
any consent form, 42 C.F.R. § 441.257(a), and specifically states that
informed consent may not be obtained when the individual to be sterilized
is: "(1) In labor or childbirth; (2) Seeking to obtain or obtaining an abortion;
or (3) Under the influence of alcohol or other substances that affect the
individual's state of awareness," id. § 441.257(b) (emphasis added).3

3 These regulations were adopted in 1979 following protracted litigation and several
cases of sterilization abuse involving minors and mentally incompetent individuals

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10 As noted above, the Isaacs contend that these regulations were not
adhered to in Ms. Isaac's case. Thus, they contend, as a matter of law, her
tubal ligation was performed without her informed consent. We begin with a
review of the legal principles underlying a cause of action for lack of
informed consent.

11 In a claim alleging lack of informed consent,
it is the conduct of the unauthorized procedure that constitutes
the tort. Moure v. Raeuchle, 529 Pa. 394, 604 A.2d 1003,
1008 (1992). A claim of a lack of informed consent sounds in the
intentional tort of battery because an operation performed
without the patient's consent is deemed to be the equivalent to a
technical assault. Smith v. Yohe, 412 Pa. 94, 194 A.2d 167,
174 (1963). To obtain a patient's informed consent, doctors
must provide patients with "material information necessary to
determine whether to proceed with the surgical or operative
procedure or to remain in the present condition." Duttry v.
Patterson, 565 Pa. 130, 771 A.2d 1255, 1258 (2001) (quoting
Sinclair by Sinclair v. Block, 534 Pa. 563, 633 A.2d 1137,
1140 (1993)). This information must give the patient "a true
understanding of the nature of the operation to be performed,
the seriousness of it, the organs of the body involved, the
disease or incapacity sought to be cured, and the possible
results." Id. (quoting Gray v. Grunnagle, 423 Pa. 144, 223
A.2d 663, 674 (1966)). While doctors are not required to
disclose "all known information," they are required to "advise the
patient of those material facts, risks, complications and
alternatives to surgery that a reasonable person in the patient's
situation would consider significant in deciding whether to have
the operation." Gouse v. Cassel, 532 Pa. 197, 615 A.2d 331,
334 (1992) (emphasis omitted).

in the early 1970s under prior regulations which merely required that the procedure
be deemed "voluntary." See generally Haverhill Mun. Hosp. v. Comm'r of Div.
of Med. Assistance, 699 N.E.2d 1, 3 (Mass. App. 1998); Relf v. Weinberger,
372 F. Supp. 1196, 1199-1200 (D.D.C. 1974), vacated as moot, 565 F.2d 722
(D.C. Cir. 1977).

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Valles v. Albert Einstein Med. Ctr., 569 Pa. 542, 551, 805 A.2d 1232,
1237 (2002). Moreover, since the tort founded upon lack of informed
consent is an intentional tort, i.e. a battery, negligence principles generally
do not apply. Montgomery v. Bazaz-Sehgal, 568 Pa. 574, 585, 798 A.2d
742, 748-49 (2002); Moure, 529 Pa. at 404 n.8, 604 A.2d at 1008 n.8.4
12 We first address the Isaacs' lack of informed consent claim against
Jameson Memorial Hospital. As the above discussion suggests, the informed
consent doctrine principally concerns the actions of the physician performing
the surgical procedure. Given the unique nature of the doctrine and its
origins as a technical battery, hospitals cannot be held vicariously liable for a
physician's failure to obtain informed consent because "a medical facility
cannot maintain control over this aspect of the physician-patient
relationship." Valles, 569 Pa. at 554, 805 A.2d at 1239. The Isaacs,
however, rely on an exception to this general rule enunciated by this Court
in Friter v. Iolab Corp., 414 Pa. Super. 622, 607 A.2d 1111 (1992). We
find their reliance on Friter to be misplaced.

13 In Friter, we addressed whether the defendant hospital was liable for
lack of informed consent where the hospital was involved in a clinical
investigation for the federal Food and Drug Administration to determine the

4 The General Assembly codified the law of informed consent in 2002. See 40 P.S.
§ 1303.504; see generally Valles, 569 Pa. at 551 n.10, 805 A.2d at 1237 n.10.
This statute is inapplicable to the instant matter, however, as it became effective
after the procedure at issue herein took place.

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safety of an ocular lens implant. Federal regulations required the hospital,
as an approved institution for conducting experimental studies, to obtain the
informed consent of any patient participating in the study. Finding an
exception to the general rule that health care institutions are not liable for
lack of informed consent, we concluded that the hospital, "as a participant in
a clinical investigation for the FDA," specifically assumed a duty to ensure
that an informed consent was obtained by any patient participating in the
study. Id. at 628, 607 A.2d at 1113.

14 By contrast, herein, the Medicaid regulations cannot be read to place
an independent duty on Jameson Memorial Hospital to obtain Ms. Isaac's
informed consent. Rather, the regulations set forth preconditions for federal
reimbursement of the costs of a sterilization procedure. See 42 C.F.R. §
441.252 ("A State plan must provide that the Medicaid agency will make
payment under the plan for sterilization procedures and hysterectomies only
if all the requirements of this subpart were met." (emphasis added)); id. §
441.253 ("FFP is available in expenditures for the sterilization of an
individual only if" the consent requirements are met. (emphasis added)).
Thus, if a health care provider fails to ensure that the regulations are
adhered to, it forfeits any right to reimbursement under Medicaid; only in
this way is the hospital obliged to follow the regulations. See Rosson v.
Coburn, 876 P.2d 731, 736 (Okla. App. 1994) (holding that the Medicaid
regulations do not impose a policy "prohibiting sterilization of those under

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the age of 21 years," but "ensure that federal funding is not used to do
so."). Accordingly, the exception announced in Friter to the general rule
that hospitals cannot be held vicariously liable for a physician's failure to
obtain informed consent is inapplicable, and the trial court correctly denied
the Isaacs' motion for directed verdict against Jameson Memorial Hospital on
this basis.

15 We now turn to the relevance of the Medicaid regulations to the
Isaacs' lack of informed consent claim against Dr. Bassaly. The trial court
concluded that the regulations "relate to a procedure for payment for
medical services, and the subject matter of the regulations does not address
a legal standard relative to a cause of action against the doctor on the
Doctrine of Informed Consent," adding that the regulations have "no
application to the law as it currently exists in Pennsylvania relative to the
Doctrine of Informed Consent." (Trial Court Opinion, 7/26/06, at 12.) We
agree.

16 We first stress what the Isaacs do not argue. The Isaacs do not
proffer the Medicaid regulations in support of a claim that Dr. Bassaly (or the
hospital) was negligent or negligent per se. Their arguments are strictly tied
to lack of informed consent, the intentional tort of battery. (See Appellants'
Brief at 10 ("As [consent was improperly obtained], [Appellees] are liable to
[the Isaacs] for battery."), 22 (asserting that contributory negligence is not
an issue in this case because Appellees liability is premised on battery; "the

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battery that occurred was a result of the [Appellees'] failure to adhere to
state and federal regulations [regarding Ms. Isaac's] informed consent to a
sterilization procedure").) Accordingly, we need not and do not reach the
question of whether these regulations may be asserted in support of a cause
of action for negligence.

17 Instead, we are asked to assess the import of the regulations in the
context of an informed consent claim. There are no decisions from the
courts of this Commonwealth addressing these Medicaid regulations.
Moreover, looking to other jurisdictions, we have located no decisions that
address the application of these regulations to an informed consent action.
While the Isaacs cite decisions from the trial courts of our sister states, the
cited decisions concern negligence actions, not lack of informed consent.
See, e.g., Hare v. Parsley, 596 N.Y.S.2d 313 (N.Y. Sup. 1993) (violation of
regulations constituted negligence); Butler v. Med. Ctr. of Delaware,
Inc., 1993 WL 80616 (Del. Super. 1993) (unpublished decision) (in
negligence action for failure to perform requested tubal ligation, court held
that hospital was contractually prohibited from performing procedure where
to do so in violation of Medicaid regulations would have rendered patient
financially liable).

18 Upon review of the regulations, we agree with the trial court that they
relate primarily to "a procedure for payment for medical services" and do not
impose a legal standard relevant to an action for lack of informed consent.

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(Trial Court Opinion, 7/26/06, at 12.) As discussed above, the regulations
ostensibly impose prerequisites for federal reimbursement of a sterilization
procedure. See 42 C.F.R. § 441.252; id. § 441.253. As the Oklahoma
Court of Appeals reasoned in Rosson, supra, in determining that the
regulations could not support a negligence per se claim:
The Medicaid Act is an administrative scheme providing medical
assistance benefits to qualified recipients through states,
implying no private right of action. Chalfin v. Beverly
Enterprises, Inc., 741 F.Supp. 1162 (E.D.Pa.1990). Also see,
Stewart v. Bernstein, 769 F.2d 1088 (5th Cir.1985).
The Medicaid regulations themselves reveal that their purpose is
not to impose a national policy prohibiting sterilization of those
under the age of 21 years, but to ensure that federal funding is
not used to do so.

Rosson, 876 P.2d at 736; but see Morinaga v. Vue, 935 P.2d 637,
643 (Wash. App. 1997) (the regulations protect Medicaid patients "from
being sterilized without being fully aware of the consequences and
alternatives" and thus support negligence per se claim). Thus,
fundamentally, the regulations impose administrative, not legal, obligations.

19 We recognize the Isaacs' contention that the regulations, by setting
forth preconditions for reimbursement, indirectly benefit patients by
ensuring that they are able to fully consider a sterilization procedure, and
thus reducing the risk of coercion. See Morinaga, supra.5 Nevertheless,
in proffering the Medicaid regulations, the Isaacs seek to expand the
doctrine of informed consent beyond that recognized in Pennsylvania. In

5 See also supra note 3.

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this Commonwealth, doctors obtain a patient's informed consent when they
provide "material information" necessary for the patient to determine
whether to proceed with a procedure; they are not required to disclose "all
known information," but only to "advise the patient of those material facts,
risks, complications and alternatives to surgery that a reasonable person in
the patient's situation would consider significant in deciding whether to have
the operation." Valles, 569 Pa. at 551, 805 A.2d at 1237 (internal
quotation marks omitted).6 The Isaacs do not argue, however, that the
alleged violation of Medicaid regulations had any bearing on the type or
quality of information Ms. Isaac received from Appellees regarding her
procedure - they argue only that the timing of the consent rendered it
invalid under the regulations. The additional responsibilities the Isaacs seek
to impose on physicians in obtaining a patient's informed consent exceed the
exchange of "material information" our caselaw requires. The Isaacs seek
the imposition of new duties more in line with a negligence claim, not a
cause of action for lack of informed consent. See Montgomery, 568 Pa. at
585, 798 A.2d at 748-49 (negligence principles generally do not apply to the
intentional tort of lack of informed consent); Pollock v. Feinstein, 917 A.2d
875, 878 (Pa. Super. 2007) ("Appellant correctly asserts that the established

6 We note that Pennsylvania's informed consent statute, see supra note 4, retains
these same basic requirements for a valid informed consent. See 40 P.S. §
1303.504(b) ("Consent is informed if the patient has been given a description of a
procedure set forth in subsection (a) and the risks and alternatives that a

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law of our Commonwealth considers a claim for a lack of informed consent to
be a technical battery, and that negligence principles do not apply to this
claim.").

20 Although the standard of care due a patient - ostensibly a negligence
concept - may be relevant in a narrow class of informed consent cases
where the type or quality of information provided is at issue, see Pollock,
917 A.2d at 878-79 (holding that certificate of merit was required in
informed consent case, as claim was based upon the failure of the
defendant-doctors to adhere to an acceptable professional standard in
providing patient with a full explanation of the medical risks involved in the
procedure she was to undergo), here, the Isaacs' contention is not that Ms.
Isaac's consent was not fully informed. Again, their argument is that, given
the timing of her consent, it was invalid under the Medicaid regulations.

21 Finally, we agree with the concern expressed by the trial court that
adopting the regulations as a legal standard in informed consent cases would
lead to a perverse inequity. The court reasoned, and we agree, that if such
a legal standard was adopted,
then patients whose services are to be paid by Medica[id] would
be treated differently than patients whose medical services
would be paid by other forms of private or public insurance or
self pay. It would be absurd to find that the standard for
medical care should be determined by the method of payment
reasonably prudent patient would require to make an informed decision as to that
procedure." (emphasis added)).

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for the services as opposed to a legal standard applicable to all
person[s] who receive medical care from a doctor or hospital."
(Trial Court Opinion, 7/26/06, at 12.) We will not expand the doctrine of
informed consent where it would lead to this inequitable result.

22 Accordingly, we hold that the proffered Medicaid regulations pertaining
to informed consent for sterilization procedures have no relevance to a lack
of informed consent cause of action in Pennsylvania. As a result, we find
that the trial court properly denied the Isaacs' motion for directed verdict
against Dr. Bassaly on that basis.7

23 For all the foregoing reasons, we affirm the judgment entered below.

24 Judgment AFFIRMED.

7 As a result of our determination that the trial court properly denied the Isaacs'
motion for directed verdict, we need not address their contention that any remand
should direct a new trial on damages alone.