Southard v. Temple University Hosp.

• Court: United States State Supreme Court of Pennsylvania
• Writing for the Court: Before FLAHERTY, C.J., and ZAPPALA, CAPPY, CASTILLE, NIGRO, and SAYLOR, JJ.
• Citation: 781 A.2d 101,566 Pa. 335
• Decision Date: 26 September 2001
• Parties: Branes N. SOUTHARD and Deborah Southard, Appellees, v. TEMPLE UNIVERSITY HOSPITAL and David H. Clements, III, M.D., and William F. Young, M.D., John Reed, Intervenor. Appeal of David H. Clements, III, M.D. and William F. Young, M.D.

781 A.2d 101
566 Pa. 335

Branes N. SOUTHARD and Deborah Southard, Appellees,
v.
TEMPLE UNIVERSITY HOSPITAL and David H. Clements, III, M.D., and William F. Young, M.D.,
John Reed, Intervenor.
Appeal of David H. Clements, III, M.D. and William F. Young, M.D

Supreme Court of Pennsylvania.

Argued January 29, 2001.

Decided September 26, 2001.

781 A.2d 102

J. Kurt Straub, Philadelphia, for Temple University Hosp., David H. Clements, III, M.D., and William F. Young, M.D

Robert B. Hoffman, Harrisburg, for amicus curiae American Medical Assn.

Murray S. Levin, James Michael Beck, Philadelphia, for Medtronic Sofamor Danek, Inc.

Christine Anne Hodson, Daniel F. Ryan, Plymouth Meeting, for amicus curiae Pennsylvania Medical Society.

John P. Kopesky for Barnes and Deborah Southard.

Richard L. Orwig, Reading, for amicus curiae Pennsylvania Trial Lawyers Assn.

Paul E. Peel, Daniel F. Ryan, Plymouth Meeting, for John Reed.

Before FLAHERTY, C.J., and ZAPPALA, CAPPY, CASTILLE, NIGRO, and SAYLOR, JJ.

OPINION

Justice CAPPY

We granted allocatur limited to the issue of whether the doctrine of informed consent requires surgeons to advise their patients of the Food and Drug Administration ("FDA") regulatory status of a medical device. We conclude that there is no

781 A.2d 103

such requirement, and therefore we reverse that portion of the Superior Court's order that held otherwise

Appellee Branes Southard injured his back at work in 1987 and again in 1989. In October 1992, in an attempt to alleviate Appellee's back pain, Appellants Dr. Clements and Dr. Young at Temple University Hospital implanted a spinal fixation device in order to aid in spinal fusion. As a part of the surgery, the physicians implanted bone screws in the pedicles (i.e., portions of the vertebrae) of Appellee's spine. In May 1994, Appellee underwent explantation¹ surgery to remove the bone screws.

In June 1995, Appellee and his wife, Deborah Southard (collectively "Appellees"), filed a complaint against Appellants, asserting, inter alia, that Appellants failed to obtain informed consent from Appellee prior to the surgery. This claim was premised, inter alia, on the fact that Appellee was not advised of the FDA regulatory status of the bone screws. Deborah Southard's claim was based on loss of consortium.

Because Appellee's informed consent claim was premised on the device's FDA regulatory status, a brief overview of that classification scheme is necessary. The marketing, labeling and promotion of medical devices for commercial distribution such as the spinal fixation system at issue here are regulated by the FDA pursuant to its authority under the Medical Device Amendments ("MDA") of 1976 to the Federal Food Drug and Cosmetic Act ("FDCA"). 21 U.S.C. § 301 (1994 & Supp. V). The MDA classifies devices in three categories depending on, inter alia, the controls deemed necessary to provide reasonable assurance of their safety and effectiveness. Class I devices are those which pose no unreasonable risk of illness or injury and therefore require only general controls. 21 U.S.C. § 360c(a)(1)(A). Class II devices are those with a greater potential dangerousness and thus warrant more stringent controls. 21 U.S.C. § 360c(a)(1)(B). Class III devices are those which are "for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health" or "present[] a potential unreasonable risk of illness or injury", and for which there is not sufficient information to provide reasonable assurance of the device's safety and effectiveness under the general or special controls under Class I or II. 21 U.S.C. § 360c(a)(1)(C).

Class III devices warrant the FDA's heaviest regulation and must undergo a premarket approval ("PMA") process before they may be commercially distributed. Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 1015, 148 L.Ed.2d 854 (2001).² The PMA process entails a thorough review in which the manufacturer must demonstrate a "reasonable assurance" that the device is "safe ... [and] effective under the conditions of use prescribed, recommended or suggested in the proposed labeling thereof." Id. (citing 21 U.S.C. §§ 360e(d)(2)(A), (B)). Two exceptions exist to the PMA process. First, "predicate" devices (i.e., those which were on the market prior to the MDA's enactment in 1976) may remain available until the FDA initiates and completes the PMA

781 A.2d 104

process. Buckman, 121 S.Ct. at 1015-16. Second, "[I]n order to avoid the potentially monopolistic consequences of this predicate-device exception, the MDA allows other manufacturers to distribute (also pending completion of the predicate device's PMA review) devices that are shown to be `substantially equivalent' to a predicate device." Id. at 1016 (citing § 360e(b)(1)(B))

Apart from the FDA's labeling requirements, doctors sometimes employ medical devices for an "off-label" use, i.e., for a purpose other than those which appear in the labeling and which have been approved by the FDA. See Notice, 59 Fed.Reg. 59820, 59820 (1994). The FDA does not preclude off-label use of medical devices. To the contrary, while the FDA regulates the marketing and labeling of medical devices, it does not purport to interfere with the practice of medicine. See 21 U.S.C. § 396 (1994 ed. & Supp. V) ("Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship."). The United States Supreme Court recently recognized that offlabel use "is an accepted and necessary corollary of the FDA's mission to regulate in this area without directly interfering with the practice of medicine." Buckman, 121 S.Ct. at 1018 (citing James. M. Beck and Elizabeth D. Azari, FDA, Off Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 FOOD AND DRUG L.J. 71, 76-77 (1998)). In the case of bone screws, "[b]y mid 1992, [the] FDA discovered that the use of pedicle screw spinal systems outside of approved [investigational device exemption] studies was widespread, and that pedicle screw fixation was considered to be the standard of care by the surgical community." Proposed Rule, 60 Fed.Reg. 51946, 51947 (proposed Oct. 4, 1995).³

In 1996, Appellees' case was transferred to the Court of Common Pleas of Philadelphia County, where it became part of Pennsylvania's coordinated orthopedic bone screw litigation. Similar coordinated litigation was ongoing in the United States District Court for the Eastern District of Pennsylvania.

On March 8, 1996, in a Memorandum and Order issued jointly by the courts in both the federal and state coordinated litigations, the courts granted partial summary judgment to the physician defendants and dismissed with prejudice all informed consent claims alleging that the physicians were obligated to advise patients

781 A.2d 105

of the FDA regulatory status of the pedicle screw devices. In re Orthopedic Bone Screw Products Liability Litigation, 1996 WL 107556 (E.D.Pa. March 8, 1996), reconsideration denied, 1996 WL 900351 (E.D.Pa. May 21, 1996) ("Bone Screw Litigation"). The courts found that examples of "risks" included "internal bleeding, paralysis, or neurological damage." Id. at *3. The courts further recognized that the FDA does not regulate the practice of medicine, and therefore the "decision whether or not to use a drug for an off-label purpose is a matter of medical judgment[,] not of regulatory approval." Id. (quoting Klein v. Biscup, 109 Ohio App.3d 855, 673 N.E.2d 225 (1996), appeal denied, 76 Ohio St.3d 1438, 667 N.E.2d 987 (1996)). The courts reasoned that the FDA labels given to a medical device do not speak directly to the medical issues surrounding a particular surgery. Id. The courts concluded that the terms "Class III", "investigational" and "significant risk" device were terms used by the FDA for administrative or regulatory purposes, and were not "risks" of a surgical procedure. Id. at *5, 667 N.E.2d 987. By virtue of the inclusion of Appellees' case in the consolidated litigation, the March 8, 1996 order applied to Appellees' informed consent claims against Appellants.

Thereafter, the trial court precluded Appellees from introducing evidence that Appellants never informed Branes Southard of the FDA regulatory status of the bone screws and rods. A jury trial commenced on Appellees' negligence claims and a remaining informed consent claim. The jury returned a verdict in favor of Temple University Hospital and Appellants as to the negligence claims, and to Appellants as to the informed consent claim. The trial court denied Appellees' post-trial motions.

On appeal, the Superior Court reversed the order granting partial summary judgment in favor of all physicians and vacated the judgment in favor of Appellants on the informed consent claim regarding the FDA regulatory status. The court remanded the matter for a new trial on that claim.⁴ Appellants' application for reargument/reconsideration was denied, and this appeal followed.

Our review on an appeal from the grant of a motion for summary judgment is well-settled. A reviewing court may disturb the order of the trial court only where it is established that the court...