Informed consent ruling favors bone screw plaintiffs.

Plaintiffs who brought spinal surgery negligence cases involving controversial bone screw implants in Pennsylvania courts secured a victory that may have a ripple effect on similar informed consent cases in federal courts.

In a case noted for its unusual procedural characteristics, a Pennsylvania superior court ruled that plaintiffs injured by spinal bone screw implants may pursue informed consent claims against doctors who failed to tell them the screws have not been approved by the FDA for use in the spine. (Southard v. Temple University Hospital, No. 3660 Phila. 1997, 1999 WL 243324 (Pa. Super. Ct. Apr. 27, 1999).)

"This decision is certainly binding on all trial courts in Pennsylvania, and it will more than likely have substantial persuasive value in federal courts," said Mark Tanner, a Philadelphia attorney who argued the appeal on behalf of plaintiff Branes Southard and his wife. "Any responsible federal judge would have to take note of it."

John Kopesky, the Philadelphia attorney who represented the Southards at trial, said the ruling will affect not only bone screw cases in Pennsylvania but other state cases involving off-label use of any medical device and informed consent. "The patient is entitled to as much information as can be provided," Kopesky said. "The patient can then take all that information and make an informed decision."

In the case reviewed by the superior court, Branes Southard underwent spinal fusion surgery in 1992 at Temple University Hospital. The surgeons implanted rods and screws, which were made by Danek Medical, Inc. Southard later had them removed because they were causing him pain, Kopesky said.

Southard and his wife sued the hospital and the surgeons, claiming the doctors failed to inform them of the experimental nature of bonescrews in spinal surgery and of the potential need to remove them. The couple sued for negligent surgery and failure to obtain informed consent, among other claims.

Two months after the Southards filed their suit in state court, physicians who were defendants in federal or statewide bone screw litigation sought summary judgment in their cases with regard to the informed consent issue.

Tanner said he argued for the Southards against summary judgment before Pennsylvania Common Pleas Court Judge Sandra Mazer Moss and U.S. District Court Judge Louis Bechtle of the Eastern District of Pennsylvania.

"The judges sat side by side and heard the arguments," Tanner said. They issued a joint memo and order, finding the physicians did not have to tell the plaintiffs that the FDA categorized the bone screws as Class III devices, which means the manufacturers don't have enough information to say they are safe and effective when used in the spine. (In re: Orthopedic Bone Screw Products Liability Litigation, No. MDL 1014 (E.D. Pa. Mar. 8, 1996).)

The Southards went to trial on the negligence claims and on one remaining informed consent claim, which was based on the physicians' failure to inform them of the potential need to remove the screws. The jury returned a verdict for the physicians and the hospital, and the Southards appealed.

"This was an odd duck," Kopesky said of the unusual joint proceedings. "Moss and Bechtle issued an extraordinary order throwing out the claim. What the Pennsylvania Superior Court has done is to reverse that litigation-wide ruling with respect to the Pennsylvania state cases.

"Obviously, this does not result in overruling Judge Bechtle's cases, but ... I would strongly suspect that those attorneys representing plaintiffs in the multidistrict litigation will get reconsideration," Kopesky said.

Tanner praised the decision for the effect it will have on physicians and hospitals who perform spinal fusion surgery.

"There are two important things about this case," he said. "It sends a message to physicians that now they have to ask questions of the manufacturers about the use of the devices. They are not allowed to look the other way. And this decision obligates the manufacturers to disclose to the physicians what the status and testing of the development of the device are."