FILED
IN THE SUPREME COURT OF TENNESSEE March 13, 2000
AT NASHVILLE
Cecil Crowson, Jr.
Appellate Court Clerk
FOR PUBLICATION
Filed: March 13, 2000
RHONDA S. BRYANT, and husband, )
NATHAN G. BRYANT, )
)
PLAINTIFFS/APPELLANTS, ) DAVIDSON CIRCUIT NO. 96C-1013
)
v. ) Hon. Walter C. Kurtz, Judge
)
HCA HEALTH SERVICES OF ) NO. M1998-00770-SC-R11-CV
TENNESSEE, INC., d/b/a )
CENTENNIAL MEDICAL CENTER, )
)
DEFENDANT/APPELLEE. )
FOR APPELLANTS: FOR APPELLEE:
CHARLES J. WILLIAMS C. J. GIDEON, JR.
JOHN B. CARLSON MARGARET MOORE
Nashville Nashville
G. THOMAS NEBEL
Nashville
OPINION
COURT OF APPEALS AFFIRMED HOLDER, J.
OPINION
We granted this appeal to address whether a hospital has a legal duty to
obtain the informed consent of a patient undergoing a surgical procedure
ordered and performed by a non-employee doctor. We hold that Tenn. Code
Ann. § 29-26-118 does not require a hospital to obtain the informed consent of a
patient. A hospital, however, may assume an independent legal duty to obtain
informed consent under certain circumstances not present in this case. The trial
court’s grant of the defendant’s motion for summary judgment is affirmed, and
the case is remanded.
FACTS
The plaintiff, Rhonda Bryant, sustained a back injury as the result of an
automobile accident in 1979. She was diagnosed as having four fractured
vertebrae. She returned to her normal activities without restrictions
approximately nine months after the accident. She later developed kyphosis, or
curvature of her spine. Doctors informed her that she might eventually need a
surgical procedure during the 1980s to correct the curvature.
Ms. Bryant was involved in another automobile accident in 1992. The
1992 accident aggravated her previous spinal injury. She suffered persistent
back pain and was referred to Dr. Stephen McLaughlin, an orthopedic surgeon.
Dr. McLaughlin diagnosed Ms. Bryant as having kyphosis. He then referred her
to Dr. David McCord.
Dr. McCord met with Ms. Bryant at his office and ordered studies on her
back. Both an MRI and a CT scan revealed a moderate compression fracture,
mild stenosis, and exaggerated kyphosis. Dr. McCord recommended to Ms.
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Bryant that she undergo surgery to correct her kyphosis. He proposed the
implantation of rods, screws, and plates.
The procedure proposed by Dr. McCord was apparently less invasive than
the surgical procedures discussed with Ms. Bryant during the 1980s. Dr. McCord
did not guarantee the results of the surgery. He informed Ms. Bryant that the
curvature could worsen should she elect not to have the surgery. He conveyed
to Ms. Bryant a high likelihood that the surgery would be successful and that she
would be able to return to work six months after the surgery. Dr. McCord also
informed Ms. Bryant that if the procedure were unsuccessful, she would have to
undergo a second, more invasive procedure.
Ms. Bryant elected to undergo surgery. Dr. McCord’s office provided her
a consent form entitled “What to Expect from Back Surgery.” The form outlined
numerous complications that could result from having back surgery. Ms. Bryant
signed and returned the form to Dr. McCord.
Dr. McCord admitted Ms. Bryant to the defendant hospital, Centennial
Medical Center, on May 2, 1993. Dr. McCord was not an employee of the
defendant. On May 3, he performed back surgery on Ms. Bryant. During this
surgery he implanted pedicle screws. Neither a Brantigan Cage nor a custom
carbon fiber cage was implanted in 1993.
Ms. Bryant’s condition worsened following the implantation of the pedicle
screws. Dr. McCord recommended a second, more invasive surgery to Ms.
Bryant. This procedure involved entering Ms. Bryant’s chest cavity, removing
rods, replacing screws, and implanting a bone cage. Ms. Bryant signed a
consent form which provided that she agreed to participate in a research study
involving the implantation of a Brantigan I/F cage.
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Dr. McCord admitted Ms. Bryant to the defendant hospital in February of
1994. On February 21, he installed both a carbon fiber cage and pedicle screws
into her spine. Ms. Bryant continued experiencing severe pain following the
second surgery. She eventually had to have a morphine pump installed into her
body, and she underwent additional surgery.
The plaintiffs, Rhonda S. Bryant and Nathan G. Bryant, filed an action
against a variety of defendants including the defendant hospital, Centennial
Medical Center. Pertinent to the issue now before us, the plaintiffs have alleged:
that the defendant hospital failed to “warn plaintiffs that the FDA had specifically
rejected the pedicle or back screws and/or plates (and other hardware) for
implantation in the spine;” that the defendant hospital failed to “warn plaintiff that
the pedicle screw devices, cages and hardware implanted in her spine . . . were
experimental . . . ;” that the defendant hospital failed to “supply the appropriate
information to the plaintiff in obtaining his [sic] informed consent;” and that the
defendant hospital failed “to insure that the doctor obtained the appropriate
informed consent from the plaintiff . . . .” The trial court granted the defendant
summary judgment on the issue of informed consent. The Court of Appeals held
that the hospital did not have a duty to obtain Ms. Bryant’s informed consent and
affirmed the grant of summary judgment with respect to the issue of informed
consent.
ANALYSIS
We granted review to address whether a hospital owes a general duty to
obtain the informed consent of a patient undergoing a surgical procedure
ordered and performed by a non-employee doctor. The issue is one of first
impression in Tennessee.1
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The va st ma jority of jurisdiction s having previous ly address ed this issu e have d eclined to
impo se upo n a hos pital the gen eral duty to ob tain inform ed con sent. Krane v. Saint Anthony
Hosp. Sys., 738 P.2d 75 (Co lo. App. 19 87); Petriello v. Kalman , 576 A.2d 474 (C onn. 199 0); Parr
(continue d...)
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The plaintiffs’ informed consent claim is predicated upon a theory of
battery. Blanchard v. Kellum, 975 S.W.2d 522, 524 (Tenn. 1998); see also
Cardwell v. Bechtol, 724 S.W.2d 739, 750 (Tenn. 1987) (holding that failure to
comply with standard of care when obtaining informed consent constitutes
battery). The existence of a legal basis upon which an actionable battery may be
predicated in the case now before us is both a question of law and a matter of
statutory interpretation. The plaintiffs have urged this Court to consider expert
testimony when defining the legal basis for their claim. The proffered expert
testimony opines that:
the recognized standard of care of acceptable professional practice
in Nashville for hospitals required [the defendant] to provide
appropriate information on material risks concerning spinal surgery
involving the use of pedicle screws.
This testimony, however, pertains only to an element of an informed consent
battery claim, the standard of care. While expert testimony may define the
standard of care, expert testimony neither defines nor creates a legal right to
pursue a remedy.
The plaintiffs first must allege a cognizable legal claim to which relief may
be granted. If a legal basis for the suit exists, the proffered expert testimony may
then be introduced to establish the elements of the claim. Our initial focus in this
appeal is whether the plaintiffs are entitled to legal protection if the defendant
had acted in a manner consistent with the plaintiffs’ allegations.
The claim against the defendant hospital involves matters of medical
science and requires specialized skills not ordinarily possessed by lay persons.
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(...continued)
v. Palmyra Park Hosp., 228 S.E .2d 596 ( Ga. Ap p. 1976) ; Pickle v. Curns, 435 N.E. 2d 87 7 (Ill.
App. 19 82); Pauscher v. Iowa M ethodist Med. Ctr., 408 N.W .2d 355 ( Iowa 19 87); Ackerm an v.
Lerwick, 676 S.W .2d 318 ( Mo. Ap p. 1984) ; Bing v. Th unig , 143 N.E .2d 3 (N.Y . 1957); Kershaw v.
Reichert, 445 N.W .2d 16 (N .D. 1989 ); Goss v. Oklah oma Blood Ins t., 856 P.2d 998 (Ok. App.
1990); Ritter v. Delaney, 790 S.W .2d 29 (T ex. App . 1990); Cross v. Trapp, 294 S.E.2d 446 (W .
Va. 1982).
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See generally Peete v. Shelby County Health Care Corp., 938 S.W.2d 693
(Tenn. Ct. App. 1996). Accordingly, the defendant is within the purview of the
Medical Malpractice Act (“Act”), and the plaintiffs’ claims are governed by that
Act. See Tenn. Code Ann. §§ 29-26-115 –120 (1980 & 1997 Supp.). The Act
provides for a medical malpractice cause of action based on the inadequacy of a
patient’s consent to a medical procedure. See Tenn. Code Ann. § 29-26-118.
The “informed consent” statute is codified at Tenn. Code Ann. § 29-26-118 and
provides:
In a malpractice action, the plaintiff shall prove by evidence as
required by § 29-26-115(b) that the defendant did not supply
appropriate information to the patient in obtaining his informed
consent (to the procedure out of which plaintiff’s claim allegedly
arose) in accordance with the recognized standard of acceptable
professional practice in the profession and in the speciality, if any,
that the defendant practices in the community in which he practices
and in similar communities.
We must now address whether § 29-26-118 may be applicable to a hospital
when a non-employee physician performs a surgical procedure.
The construction of a statute is a question of law that appellate courts
review de novo and without a presumption of correctness. Myint v. Allstate Ins.
Co., 970 S.W.2d 920, 924 (Tenn. 1998). The cardinal rule of statutory
construction is to effectuate legislative intent. Id.; Locust v. State, 912 S.W.2d
716, 718 (Tenn. Ct. App. 1995). Courts shall assume that the legislature
purposely inserted each word into a statute and that each word conveys intent,
has meaning, and has purpose. Id. Where words of the statute are clear and
fully express the legislature’s intent, there is no room to resort to auxiliary rules of
construction. Roberson v. University of Tennessee, 912 S.W.2d 746, 747 (Tenn.
Ct. App. 1995). Accordingly, the interpretation of an unambiguous statute shall
be restricted to the natural and ordinary meaning of the language employed by
the legislature. Austin v. Memphis Pub. Co., 655 S.W.2d 146, 148 (Tenn. 1983).
If, however, a statute is ambiguous, we must consider the language employed in
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context of the entire statute without any forced or subtle construction which
would extend or limit its meaning. Wilson v. Johnson County, 879 S.W.2d 807,
809 (Tenn. 1994). A statute is ambiguous if the statute is capable of conveying
more than one meaning. In re Conservatorship of Clayton, 914 S.W.2d 84, 90
(Tenn. Ct. App. 1995).
The informed consent statute does not clearly delineate whether hospitals
have a duty to procure informed consent to surgical procedures performed by
non-employee doctors. The statute employs the term “defendant” when defining
the elements of an informed consent cause of action. See Tenn. Code Ann.
§ 29-26-118 (“the defendant did not supply appropriate information to the
patient . . . .”). The term “defendant” would, at first blush, seemingly include a
hospital. The term “defendant” would also seem to include: pharmacists,
registered nurses, physician’s assistants, nurse anesthetists, anesthetists,
emergency medical technicians, or any other person or entity that may commit
an act of medical negligence.
The statute requires that the “defendant” provide “information” in
“accordance with the . . . specialty, if any, that the defendant practices . . . .”
Tenn. Code Ann. § 29- 26-118. A hospital does not practice the specialties of
non-employee physicians. Moreover, a hospital “shall not restrict or interfere
with medically appropriate diagnostic or treatment decisions.” Tenn. Code Ann.
§ 63-6-204(d)(1)(A). Accordingly, the language of the statute suggests that the
legal duty to obtain consent is imposed only on the physician who orders or
directs the surgical procedure. An interpretation requiring the hospital to provide
“information” in “accordance with the . . . specialty, if any, that the [surgeon]
practices . . . .” potentially renders absurd results. Such a broad interpretation
would seemingly impose a similar duty upon registered nurses, medical
technicians, or other health-care providers involved in the patient’s care to
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procure a patient’s consent prior to a surgical procedure. An overly broad
interpretation, therefore, could interfere with the physician-patient relationship.
Informed consent is predicated on a theory of battery. See generally
Cardwell v. Bechtol, 724 S.W.2d 739, 750-51 (Tenn. 1987). The statute protects
a patient from a physician who commits a battery when performing a procedure
without legally sufficient consent. See generally id. A hospital usually provides a
staffed facility in which a non-employee physician may perform a procedure. A
hospital, however, does not perform the surgical procedure merely as a by-
product of the non-employee physician’s use of the hospital facilities.
Accordingly, it is the non-employee physician and not the hospital who commits
the battery when a surgical procedure is performed without legally effective
consent.
We believe that Tenn. Code Ann. § 29-26-118 focuses on the physician
ordering the surgical procedure. Mere status as one involved in a patient’s care
is insufficient to trigger a statutory duty under the informed consent statute. We
hold that Tenn. Code Ann. § 29-26-118 generally does not require a hospital to
procure a patient’s informed consent to surgical procedures ordered and
performed by non-employee doctors.
In the case now before us, Dr. McCord was neither an agent nor an
employee of the defendant hospital during the time frame in question. He was
an independent medical practitioner utilizing the defendant’s facilities to perform
a surgical procedure on Ms. Bryant. Dr. McCord ordered and performed the
surgical procedure in question. Pursuant to Tenn. Code Ann. § 29-26-118, Dr.
McCord and not the defendant was required to obtain Ms. Bryant’s informed
consent for the surgical procedure.
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INDEPENDENT LEGAL DUTY
The plaintiff argues that the defendant assumed an independent duty to
procure her informed consent by participating in a monitored investigational
study involving implantation of pedicle screws. We disagree.
A hospital may assume “an independent duty which it would not ordinarily
bear” with regard to informed consent by participating in a clinical study
monitored by the Federal Drug Administration (“FDA”). Watkins v. Hospital of
the University of Penn., 737 A.2d 263, 268 (Pa. Super. Ct. 1999). In Friter v.
Iolab Corp., 607 A.2d 1111 (Pa. Super. Ct. 1992), the hospital was participating
in an investigational clinical study monitored by the FDA. As a participant in the
study, the hospital was required by federal regulations to obtain informed
consent from any patient undergoing the experimental treatment. The court in
Friter “found an exception to the general rule that there is no independent duty
for a non-physician to obtain a patient’s informed consent.” Watkins, 737 A.2d at
268.
Similarly, in Kus v. Sherman Hosp., 644 N.E.2d 1214 (Ill. App. 1995), the
hospital was involved in a monitored clinical study for the implantation of
intraocular lens. The implantation of intraocular lens into human subjects was
permitted only under the Medical Device Amendments (“MDA”) of 1976
exemption for experimental devices. See generally 21 U.S.C. § 301, et seq.
(1988). Pursuant to federal regulations, the internal review board of the
defendant hospital was charged with the responsibility of assuring that “legally
effective informed consent [was] obtained.” Kus, 644 N.E.2d at 1216. Moreover,
the federal regulations mandated that certain disclosures be provided to patients
involved in the study. In Kus, the court held that the hospital had an independent
duty to obtain the informed consent of patients receiving implantation of
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intraocular lens permitted under the federal investigational exemption. Id. at
1219-1222.
In the case now before us, Dr. McCord was involved in a clinical study
involving the use of pedicle screws in conjunction with an I/F Brantigan Cage.
This study was monitored by the defendant hospital’s Institutional Review Board.
Ms. Bryant, however, concedes that she was “never the subject to [sic] a
research study that was monitored and reviewed by [the defendant’s Institutional
Review Board] and a Brantigan I/F Cage was not utilized in her surgery.”
Unlike the implantation of the introcular lens in both Friter and Kus, the
pedicle screws were not implanted into Ms. Bryant under the MDA exemption for
experimental devices. Pedicle screws were approved for off-label uses prior to
Ms. Bryant’s surgery. See Femrite v. Abbott Northwestern Hosp., 568 N.W.2d
535, 541 (Minn. Ct. App. 1997) (noting pedicle screws approved for off-label use
in 1986). The plaintiff has not demonstrated that this off-label use was subject to
the federal study or mandatory monitoring. The defendant, therefore, was not
required by federal regulations to obtain Ms. Bryant’s informed consent.
CONCLUSION
We hold that a hospital generally is not required to procure a patient’s
informed consent to surgical procedures ordered and performed by non-
employee doctors. The hospital, however, may assume an independent legal
duty to obtain the informed consent of a patient undergoing a procedure that is a
part of an investigational study monitored by the FDA. The requisite
circumstances necessary to impose this independent legal duty upon the
hospital have not been met by the facts presented in this appeal. The trial
court’s grant of summary judgment for the defendant on this issue of informed
consent is affirmed. The case is remanded for further proceedings consistent
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with this opinion. The costs of this appeal shall be taxed against the plaintiffs for
which execution may issue if necessary.
JANICE M. HOLDER, JUSTICE
Concurring:
Anderson, C.J.
Birch, and Barker, J.J.
Drowota, J., Not Participating
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