When All Else Fails, Follow the Instructions

The creativity of physicians in using existing drugs and products to treat illness and injuries not even contemplated by the manufacturer plays an important role in the advancement of medicine. Sometimes, however, the advice given by the manufacturer on the product's use is not something that a physician may ignore without peril.

A 48-year-old office worker with bilateral avascular hip necrosis underwent a successful left total hip replacement by Dr. OS, an orthopedic surgeon, with no complications. Ten months later, Dr. OS scheduled the gentleman for the same surgery on the right hip.

After insertion of the artificial cup into the superacetabular region, Dr. OS's team turned to reaming the femur. As an 18 mm reamer was being removed, however, the "bullet head tip" became separated and lodged in the distal femoral canal. Though visible, Dr. OS could not retrieve the device after several attempts using hooks and other methods.

Dr. OS then decided to create an anterolateral "window" in the femoral cortex at the level of the lost reamer. Upon the creation of the window, Dr. OS passed a wire through the guide hole of the bullet tip reamer, brought it out to the window, made a knot with the wire, and then extracted the reamer through the end of the femur.

The surgical team then packed the window with graft, sutured the accompanying muscle, and returned to reaming the femur. The artificial head was placed, with good flexion and extension noted.

Postoperatively, Dr. OS advised the patient to not bear weight during the healing period. Two weeks later, however, the patient suffered a fracture of the femoral shaft just below the stem and directly through the femoral window. Though Dr. OS immediately took the patient to surgery for plate fixation and cables, the patient developed a varus deformity. After surgery eight months later for partial removal of the hardware, the patient developed a wound infection.

Following the patient's suit for medical malpractice, an expert review of Dr. OS's care revealed significant criticisms. Some of the concerns centered on Dr. OS's decision not to apply reinforcements and a prosthesis around the window area. Others dealt with Dr. OS's lack of explicit instructions to the patient on the dangers inherent in the window and with his surgical technique in repairing the fracture.

Such judgment calls notwithstanding, Dr. OS's decision to not use a "ball tip guide wire" was the most significant. The use of the guide wire would have prevented the reamer from separating from the drill shaft.

According to the reamer system's manufacturer, the ball tip guide wire is supposed to be used at all times in order to prevent tip separation. In fact, Dr. OS had disregarded the specific advice of manufacturer's representative on use of the guide wire and instead chose to never use the wires. Dr. OS's pre-surgery instruction to the hospital staff was to assemble the surgical tool without the guide wire.

Faced with an indefensible position, Dr. OS's attorney negotiated a resolution with the patient very early in the litigation.

This probably avoided a slew of closing-argument circus metaphors by the plaintiff's attorney regarding the doctor's "high-wire act" that he performed "without a safety net."