Surgeon sues device maker for patient death
Surgeon sues device maker for patient death
Trocar cited as cause
A surgeon is suing a huge medical device manufacturer on the grounds that one of its surgical trocars led to the death of his patient, a case in which he was sued for malpractice and won.
Franklin Chow, MD, filed suit recently in federal court in Denver against Norwalk, CT-based U.S. Surgical Corp., alleging that one if its trocars contains a serious product defect. In the lawsuit, Chow, a board-certified obstetrician and gynecologist, claims that the disposable trocar he used to perform an elective laparoscopic-assisted vaginal hysterectomy in 1995 malfunctioned and ultimately caused his patient’s death. The lawsuit was filed by the Dallas law firm of Sayles, Lidji & Werbner.
Trocars are sharp-tipped tools used by surgeons to penetrate the body for insertion of endoscopic instruments. U.S. Surgical’s trocar has a pyramid-shaped, razor-sharp tip that is used to penetrate a patient’s abdominal wall during laparoscopic procedures.
Once inside the abdominal cavity, the trocar’s spring-operated plastic sleeve is supposed to slide down and cover the tip of the trocar to prevent internal injury. The device’s sleeve tip is not found on most trocars, and it is designed to avoid a common hazard of laparoscopy — jamming the sharp trocar tip into internal tissues and organs after it pops through the abdominal wall.
Undeserved damage’
Chow claims that, while performing the 1995 surgery, the plastic sleeve on the trocar failed to slide down and cover the blade, thereby causing the patient’s right internal iliac vein and artery to be severed. Chow converted to an open procedure immediately to repair the damage, but the patient died.
The patient’s family filed a wrongful death lawsuit against Chow in 1996. On May 11, 2000, an Eagle County, CO, jury vindicated his surgical performance, finding no negligence in his care of the patient, says Mark Werbner, Chow’s attorney.
"Despite the favorable jury verdict, the incident and subsequent lawsuit caused considerable undeserved damage to Dr. Chow’s reputation and his medical practice," Werbner says. "Dr. Chow hopes this lawsuit will bring public attention to the dangers of this defective surgical instrument. We believe the evidence will show that U.S. Surgical knew of the problems with its trocar, and while informing the FDA of some of the many serious incidents with defective trocars, concealed the information from doctors and hospitals."
U.S. Surgical did not return calls seeking comment on the lawsuit.
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