A Fourth Department Court of Appeals case against Strong Memorial Hospital was decided in June of 2015., in which the plaintiff alleged that, while conducting a heart surgery to correct a congenital malformation, defendants negligently left a foreign object in his heart which caused him to suffer serious and permanent injuries.
The plaintiff underwent the heart surgery when he was three years old and polyvinyl catheters were placed inside the plaintiff's heart during the surgery to record and monitor atrial pressure. A follow-up procedure to remove the catheters was performed three days later. In the hospital records, a nursing note indicates that a catheter "possibly broke off with a portion remaining in ."
When the patient was 25 years old, a 13-centimeter loop of plastic tubing was removed from the patient's heart during a subsequent surgery.
Defendants moved to dismiss the complaint, contending that the action should have been filed ten years after they allegedly failed to remove the entire catheter and that the foreign object exception for medical malpractice actions did not apply. Although the plaintiff sued within one year of discovering the tubing, defendants contended that the catheter was a fixation device, not a foreign object.
The Supreme Court held that this was not a fixation device because it serves no fixative or fixation purpose. Its nature is not one which closes or fixates anything within a patient's body. Based on the Court of Appeals decision in LaBarera, the Court was compelled to conclude that the catheter was not a foreign object because it was left in the plaintiff's body deliberately with a continuing medical purpose.
The Fourth Department Appellate Division affirmed the Supreme Court decision, but for different reasons. Based on Rockefeller v. Moront and LaBarera, it was concluded that the catheter, which was deliberately inserted into plaintiff's heart to monitor arterial pressure, was a fixation device within the statute.
The Court of Appeals reversed the decision, holding that the fragment in question in this case qualified as a foreign object.
In order to come to this decision, the Court of Appeals went through the history of the Foreign Object Rule. The cases of Flanagan v. Mount Eden General Hospital (1969), Rodriguez v. Manhattan Med. Group, Rockefeller v. Moront, and LaBarbera were looked at.
Several general principles may be distilled from these cases considering the foreign object exception:
- Tangible items (clamps, scalpels, sponges, etc.) introduced into a patient's body solely to carry out or facilitate a surgical procedure are foreign objects if left behind (Flanagan and dicta in Rockefeller and LaBarbera);
- the alleged failure to timely remove a fixation device does not transform it into a foreign object (Rodriguez and LaBarbera);
- nor does a fixation device become a foreign object if inserted in the wrong place in the body (Rockefeller);
- failure to timely remove a fixation device is generally akin to misdiagnosis (Rodriguez), and
- improper placement of a fixation device is most readily characterized as negligent medical treatment (Rockefeller); and
- the legislature directed the courts not to exploit the rationale supporting Flanagan to expand the discovery exception for foreign objects beyond the rare Flanagan fact pattern, and explicitly commanded that chemical compounds, fixation devices and prosthetic aids or devices are never to be classified as foreign objects.
In determining whether an object which remains in a patient constitutes a foreign object, courts should consider the nature of the materials implanted as well as their intended function.
Every fixation device is intentionally placed for a continuing (even if temporary) treatment purpose, but it does not follow that everything that is intentionally placed for a continuing treatment purpose is a fixation device.
Considering the intended function of the catheter, which was to permit monitoring of arterial and venous pressures for management of fluid replacement, blood pressure and to prevent congestive heart failure during surgery, it can be concluded that it simply served as a conduit of information from the cardiovascular system
Therefore, even though intentionally placed, the catheter is not a fixation device because its function is not a securing or supporting role during the surgery.