Hospital sanctioned for death during hysteroscopy
Incident led to sentinel event investigation
The current problems at Beth Israel Medical Center in New York City come close on the heels of another incident at the hospital that also was remarkable for the extreme nature of the alleged malpractice. The incident involved a woman who died during what should have been a routine procedure. Investigators claim that the woman died because two gynecological surgeons made gross medical errors and that an equipment salesman actually performed part of the procedure. As in the Allan Zarkin case, there was evidence of long-known complaints against the doctors. One doctor’s privileges to deliver babies had even been revoked.
Even though the salesman’s alleged participation in the procedure apparently was not the cause of the woman’s death, observers say it greatly complicates the defense of the malpractice cases and creates extremely bad publicity for the medical center. The immediate fallout from the incident was a $30,000 fine imposed by state health officials. They concluded that a salesman of hysteroscopy equipment participated in the procedure, actually manipulating the new electrosurgery system because the doctors and nurses did not know how to operate it.
The woman’s husband also filed suit against the hospital, both surgeons, the anesthesiologist, and Ethicon, the company whose salesman allegedly participated in the procedure. Ethicon is a division of Johnson & Johnson.
The incident also was investigated as a sentinel event by the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL. Sam Bishop, ARM, vice president of compliance and insurance services for Wellstar Health System in Marietta, GA, called the allegations "a nightmare, a massive failure of the system that is supposed to protect the patient. There’s no way to make an excuse for this, to make this sound like anything better than what it is. You’d think these things just couldn’t happen, but then they seem to pop up every once in a while."
The incident began in October 1997, according to a report from the State Department of Health. Ethicon salesman David Myers reportedly met with Allan Jacobs, MD, chairman of the hospital’s department of obstetrics and gynecology, to introduce an Ethicon product used for hysteroscopies, a minimally invasive procedure. The product, the Versa point Bipolar Hysteroscopy Electrosurgery System, allows the surgeon to cut and ablate with electrosurgery probes.
Jacobs made no commitment to buy the product but did not dissuade Myers from seeking the support of surgeons and other administrators, the report says. Myers arranged to have the product used in surgery about a month later with OB-GYN partners Marc Solar, MD, and Robert Linger, MD. The patient, Lisa Smart, 30, was a healthy accountant and financial analyst undergoing hyster oscopy for the removal of a benign fibroid tumor — a routine procedure with relatively little risk.
State health investigators say the OR nurses told the surgeons they were not familiar with the new electrosurgery system, but that the surgeons dismissed their concerns and said Myers would operate it. The salesman was scrubbed and did operate the electrosurgery system during the procedure, according to the health department report.
However, the report does not claim the salesman’s actions led to the woman’s death. In fact, it appears that he may have performed his task better than the actual surgeons. As a normal part of the procedure, the patient’s uterus was filled with saline, and nurses monitored the fluid output closely to make sure that the patient was not overloaded with fluids. The salesman reportedly was operating the electrosurgery equipment and had no involvement in the fluid administration. The state report says that a nurse told the doctors several times during the surgery that the fluid output was too low, but her concerns were dismissed.
But immediately after the surgery, the patient appeared bloated from excess fluid. According to the state report, one of the OR nurses claims that Linger admitted to shutting off the fluid outflow so he could get a better view of the uterus, an action that could lead to fluid overload if not corrected quickly. Linger denied shutting off the flow or making the statement afterward, according to the report.
As a result of the fluid overload, the woman went into cardiac arrest soon after surgery and died in the emergency department. The autopsy determined she had died of "excessive infusion and absorption of normal saline."