Southard v. Temple University Hosp.
| Decision Date | 27 April 1999 |
| Citation | 731 A.2d 603 |
| Parties | Branes N. SOUTHARD and Deborah Southard, Husband and Wife, Appellants, v. TEMPLE UNIVERSITY HOSPITAL, David H. Clements, III, M.D., and William F. Young, M.D., Appellees. |
| Court | Pennsylvania Superior Court |
John P. Kopesky, Philadelphia, for appellants.
J. Kurt Straub, Philadelphia, for appellees.
Mark W. Tanner, Philadelphia, amicus curiae.
Before McEWEN, President Judge, MUSMANNO and BROSKY, JJ.
¶ 1 Appellants Branes N. Southard ("Branes Southard") and Deborah Southard ("Deborah Southard" and, together with Branes Southard, "Southards")1 appeal from a judgment entered in favor of Appellees Temple University Hospital ("Temple"), David H. Clements, III, M.D. ("Clements"), and William F. Young, M.D. ("Young" and, together with Clements, "Physicians") in this medical malpractice action.2 We affirm in part, vacate in part, and remand for a new trial.
¶ 2 The relevant facts of this case are as follows. In October 1992, at Temple, Clements, a neurosurgeon, and Young, an orthopedic surgeon, performed spinal fusion surgery upon Branes Southard to alleviate his severe back pain. During the surgery, Physicians implanted into the pedicles of Branes Southard's spine orthopedic bone rods and screws ("bone screws" or "screws") to aid in the fusion process.3
¶ 3 Bone screws, if intended for use in the spine, are classified by the United States Food and Drug Administration ("FDA") as a Class III device pursuant to the Medical Device Amendments to the Food, Drug, and Cosmetic Act ("Medical Device Amendments").4 A Class III classification means that the FDA has determined that manufacturers have not provided sufficient information to provide reasonable assurance of the safety and effectiveness of bone screws for use in the spine. Therefore, manufacturers cannot market, label or promote bone screws for commercial distribution or sale for use in the spine unless they obtain premarket approval from the FDA.5 21 U.S.C. § 360e; 21 C.F.R. Part 814.
¶ 4 Manufacturers of bone screws are permitted, however, to investigate the safety and effectiveness of bone screws for use in the spine, but only in FDA-monitored clinical investigations. See 21 U.S.C. § 360j(g); 21 C.F.R. Part 812. In such clinical investigations, qualified experts conducting the investigations are required to follow procedures and abide by conditions mandated by the FDA, including informing patients who are subjects of the investigations about the experimental nature of the screws. 21 U.S.C. § 360j(g)(3)(D); 21 C.F.R. Part 50.
¶ 5 Manufacturers are permitted to market, label and promote bone screws for commercial distribution or sale if they are intended for use in long bones (such as a tibia or a femur) rather than in the spine. If used in long bones, bone screws are classified by the FDA as a Class II device, meaning that the FDA has determined that, for that intended use only, there is sufficient information to provide reasonable assurance that bone screws are safe and effective.
¶ 6 The manufacturer of the bone screws that were implanted into Branes Southard's spine provided FDA-approved literature in the screws' packaging. That literature indicated that bone screws, in most cases, eventually must be explanted because, otherwise, a variety of complications could occur.
¶ 7 Neither Temple nor Physicians informed Branes Southard, prior to his surgery, that bones screws had been classified by the FDA as a Class III device for use in the spine and, therefore, that the FDA had not approved them as safe and effective. Nor did Temple or Physicians inform Branes Southard before the surgery that the bone screws eventually would need to be explanted. In May 1994, Branes Southard underwent surgery to explant the bone screws.
¶ 8 In June 1995, Southards filed a Complaint against Temple and Physicians6 asserting, inter alia, that Temple and Physicians were negligent in performing Branes Southard's spinal fusion surgery. Southards claimed that Physicians were negligent in their decision to perform the spinal fusion surgery when a laminectomy would have sufficed and that Temple was vicariously liable therefor as the employer of Physicians. Southards also asserted claims against Temple and Physicians based on their failure to obtain Branes Southard's informed consent prior to the surgery. Southards argued that Temple and Physicians did not advise Branes Southard that the FDA had classified bone screws as a Class III device if used in the spine. Also, Southards contended that Temple and Physicians failed to inform Branes Southard that the bone screws might loosen or require explantation as stated in the manufacturer's literature. Deborah Southard asserted claims of loss of consortium against Temple and Physicians.
¶ 9 Southards' case became part of Pennsylvania's coordinated orthopedic bone screw litigation in the Court of Common Pleas of Philadelphia County. See In re: Orthopedic Bone Screw Litigation, No. 0002, August Term, 1994 (C.C.P. Philadelphia).7 Similar coordinated litigation is ongoing in the United States District Court for the Eastern District of Pennsylvania. See In re: Orthopedic Bone Screw Products Liability Litigation, MDL Docket No. 1014 (E.D.Pa.).8
¶ 10 In August 1995, certain physicians, who were defendants in other cases that were part of either the federal or state coordinated orthopedic bone screw litigations, moved for partial summary judgment in those cases claiming that they were not required under the doctrine of informed consent to inform their patients of the FDA classification of bone screws used in the spine. In a Memorandum and Order issued jointly by the courts in both the federal and state coordinated litigations and made applicable to all cases that were a part thereof, the courts granted partial summary judgment to the physicians as to that issue. The courts therefore dismissed with prejudice all claims in the coordinated litigations alleging that physicians are required under the doctrine of informed consent to disclose to patients the FDA classification of bone screws used in the spine. See Memorandum and Order, 3/8/96, at 11.
¶ 11 Additionally, certain hospitals, who were defendants in the state coordinated orthopedic bone screw litigation, also moved for partial summary judgment contending that they were not liable under any doctrine of informed consent because only physicians, and not hospitals, are responsible for obtaining informed consent. In an Order applicable to all cases that were a part of the state coordinated litigation, the trial court granted partial summary judgment to the hospitals as to that issue, thereby dismissing with prejudice all claims in that litigation alleging that hospitals are liable based on informed consent theories. See Order dated 4/16/96.
¶ 12 Southards' jury trial commenced as to the negligence claims against Temple and Physicians and as to the one surviving informed consent claim against Physicians based on a failure to advise Branes Southard of the possibility that the bone screws might loosen or need explantation. At trial, Physicians and their expert testified that the risks of the bone screws loosening or needing explantation were so remote that it was not necessary to inform Branes Southard of those risks. They also testified that they did not read the manufacturer's literature concerning the bone screws. The trial court refused to allow Southards to cross-examine Clements regarding the contents of the manufacturer's literature, including the statements therein regarding the need for explantation.
¶ 13 At the conclusion of trial, the jury returned a verdict in favor of Temple and Physicians as to the negligence claims and in favor of Physicians as to the informed consent claim. Southards filed a post-trial Motion, which the trial court denied. Judgment was entered in favor of Temple and Physicians. Southards then filed this timely appeal.
¶ 14 On appeal, Southards contend that trial court erred as follows:
(1) by granting partial summary judgment in favor of all physicians regarding informed consent claims based on a failure to inform patients of the FDA classification of bone screws;
(2) by granting partial summary judgment in favor of all hospitals regarding all informed consent claims;
(3) by prohibiting cross-examination of Clements regarding the contents of the manufacturer's literature indicating the need for explantation of bone screws;
(4) by failing to instruct the jury that proof of causation is not required to prove damages in an informed consent claim;
(5) by failing to instruct the jury that Physicians' failure to read available information about the risks of bone screws and consequent failure to inform Branes Southard of those risks could establish Physicians' failure to obtain Branes Southard's informed consent; and
(6) by failing to instruct the jury that Physicians could have breached the standard of care by not educating themselves as to the proper use of bone screws and by not investigating the screws' side effects.
¶ 15 In their first two issues on appeal, Southards challenge the granting of summary judgment in favor of Temple and Physicians. In reviewing a grant of summary judgment, our scope of review is plenary. Albright v. Abington Mem. Hosp., 548 Pa. 268, 280, 696 A.2d 1159, 1165 (1997). We apply the same legal standard for the granting of summary judgment as the trial court:
A grant of summary judgment is proper [when] "the pleadings, depositions, answers to interrogatories, and admissions on file, together with affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." The record is to be viewed in the light most favorable to the nonmoving party, and all doubts as to the presence of a genuine issue of material fact must be resolved against the...
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