As Cappy explained, doctors sometimes utilize medical devices for an “off-label” use, meaning for a purpose other than what appears on the label or what the FDA has approved. Such use is not precluded by the FDA, and the U.S. Supreme Court in 1998 recognized that off-label use is acceptable.
In May 1994, Southard underwent surgery to remove the bone screws. In 1995, he and his wife filed a complaint against the hospital and his doctors alleging the defendants did not get his informed consent before the surgery.
Southard’s case was transferred to the Philadelphia Common Pleas Court in 1996, where it became part of Pennsylvania’s coordinated bone screw litigation. At the same time, similar litigation was ongoing in the Eastern District Court.
On March 8, 1996, the state and federal courts issued a joint memorandum and order granting partial summary judgment to the physician-defendants and dismissed with prejudice all informed consent claims alleging a duty to inform patients of the FDA status of the bone screw devices.
FDA labels given to a medical device do not directly address the medical factors of surgery, the courts said, and the label “Class III” said nothing about the risks of a surgery.
The order applied to Southard’s case, as it had been consolidated with the cases in Philadelphia Common Pleas Court.
The trial court therefore precluded Southard from offering at trial any evidence that the doctors should have informed him of the Class III status. A jury returned a verdict in favor of the defendants on all claims.
On appeal, the Superior Court reversed and remanded for a new trial on the informed consent claim. The defendants appealed to the Supreme Court.
The informed consent doctrine requires doctors to provide their patients with “material information necessary to determine whether to proceed with the surgical or operative procedure or to remain in the present condition.” The high court reaffirmed that standard in Duttry v. Patterson, PICS Case No. 01-1039 (Pa. May 23, 2001) Cappy, J.; Nigro, J., dissenting (9 pages), earlier this year.
The doctrine mandates only that doctors provide their patients with the factors that any reasonable person would consider significant in the decision of whether to have surgery.
According to the Superior Court’s rationale, Cappy said, a Class III certification denotes the FDA’s knowledge that there are “unknowns” of the device, which constitute risks. Even if risks don’t exist, the Superior Court said, these are clearly facts that address the medical issues of a particular surgery.
But the high court did not find that reasoning sound.
“The category into which the FDA places the device for marketing and labeling purposes simply does not enlighten the patient as to the nature or seriousness of the proposed operation, the organs of the body involved, the disease sought to be cured or the possible results,” Cappy said.
“The FDA label does not constitute a material fact, risk, complication or alternative to a surgical procedure. It follows that a physician need not disclose a device’s FDA classification to the patient in order to ensure that the patient has been fully informed regarding the procedure.”
Cappy said the justices did not agree with the Superior Court that the devices’ unknowns could be equated with risks.
“The fact that the FDA had not yet garnered sufficient information in its review process to conclude that there is a reasonable assurance of safety to classify the screws for a particular use is not a qualitative determination that the device is risky or unsafe,” Cappy said.
Experimental Device Statute
The justices also said Southard mistakenly relied on the experimental device statute, 40 P.S. Section 1301-811-A. The statute requires a physician to obtain a patient’s consent before “administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner.”
Southard claimed the statute was consistent with the informed consent requirements he advocated, but Cappy said the statute was inapplicable to his case because it was enacted after his surgery.
