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Trial Begins in Suit to Determine Whether VA Prostate Surgery Constituted 'Medical Experiment'

May 13, 2005

Trial in a case involving a 63 year-old patient with permanent nerve damage began recently in U.S. District Court in Tacoma. Plaintiff Bruce Banks' malpractice alleges that University of Washington urologist Dr. James Porter performed a surgery that involved Banks being strapped to the operating table with knees apart, feet together, hips tilted up and head tilted down for 11 hours and 14 minutes, and resulted in Banks' inability to walk well anymore and constant pain, probably because the nerves in his legs and one arm were damaged from being fixed in such a position for so long, according to interviews and court documents.

The surgeon, who removed Banks' prostate, was trying to learn a new and difficult technique, laparoscopic prostatectomy. What will be hotly disputed in the suit is whether what was done to Banks - and nine other veterans at the Seattle Veterans Administration Medical Center between October 2000 and November 2001 - constituted a human experiment that the university should have been told about and given more attention to.

The case raises a fact that anyone facing surgery should know: The line between innovative surgery and surgical experimentation is thin but it's an important distinction, because what patients are told about an operation can depend on which side of the line surgeons think they are on. "I (didn't) need to be part of someone's learning curve," said Banks, a Portland-area resident who was a patient at the American Lake VA hospital in Lakewood when he was referred for the surgery in Seattle. "If someone had told me about a learning curve, I would have said stop."

Patient No. 10, Richard Hodges, 59, of Fairbanks, Alaska, agreed. "If I had known then what I know now, I would have said no way," said Hodges, who has settled his suit for hundreds of thousands of dollars, though he would not reveal the exact amount. Hodges' suit, like Banks', was brought against the federal government because his operation was done at a VA hospital.

In depositions in the case, the surgeons say assistant surgeon Dr. David Penson told Banks that he was one of the first in line for the new prostate surgery and that put him at a greater risk. Regardless, said the doctors' lawyer, Assistant U.S. Attorney Philip Lynch, the operation was not experimental. "It was a new procedure, but it was done in medical centers all over the U.S.," Lynch said.

Penson said in his deposition he told Banks he could expect a shorter recovery time and better outcome than from a traditional procedure, based on the results French surgeons reported in 1999 after their first 65 laparoscopic prostatectomies. If the court decides Porter and Penson experimented on Banks, the doctors are in trouble because, according to records, they did not report the surgery to the UW safety board so that the school could take the extra, and time-consuming, safety steps.

The outcome of the case will hinge in part on how the court applies the legal definition of research, "the systematic gathering of information to develop general knowledge." Using that language to divide experimental procedures from merely innovative ones has vexed the medical community for years. There is a tradition in surgery that classifies even significant changes in techniques as simple modifications, not research.

That Porter compiled data on his initial series of laparoscopic prostatectomies and presented his results to peers in 2003 suggests that's what he was up to, Banks' lawyer is expected to argue. She also will point to the fact that Porter said the series of procedures helped him learn the best way to stitch the urinary tract back together and when to remove the catheter, and that he presented that information in the 2003 meeting. That meeting was recorded for sharing with other doctors.

The lawyers will likely debate other topics besides the research question, including whether the surgeons adequately tended to Banks to make sure he wasn't being hurt. But the bigger issue in the case will be whether Banks knew what he was getting into. He said Penson told him, "'if you were my father, I would tell you to have the laparoscopic surgery.' " "I trusted that," Banks said. "It sounded down-home."

A 2002 study in the Journal of the American College of Surgeons found wide differences of opinion among surgeons about when the line is crossed. "Surgeons have a duty to adapt and improve their techniques," and that is not necessarily experimentation, said Dr. Jonathan Moreno, an expert in bioethics from the University of Virginia who helps draft federal policy on stem cell experiments and other research topics. What makes a procedure research is when actions taken aren't solely in a patient's best interest, but are also meant to gather information to apply to others.

In the traditional method for removing a cancerous prostate, surgeons draw the walnut-shaped organ from the base of a man's pelvis through a slit in his abdomen or from a slit between his legs just below the buttocks. The procedure takes about three hours. On Jan. 18, 2001, Porter did the same thing, but through tubes inserted around Banks' navel. The surgeon slid cutting and grasping instruments into the tubes, along with a tiny lamp and a camera. Porter and Penson followed their movements on a TV screen.

Surgeries done this way - laparoscopically - usually result in less bleeding, less pain, fewer scars and a quicker recovery. However, laparoscopic surgery is difficult, much like trying to sew on a button with knitting needles inserted through a keyhole.

Banks' surgery was Porter's third attempt at laparoscopic prostatectomy at the Seattle hospital. The procedure was discontinued there after Hodges' November 2001 surgery because of the injuries, according to Penson's deposition. "It takes most surgeons anywhere from 25 to 50 cases to become anywhere near facile with the operation," Penson said. A friend of Porter's and a VA urologist at the time, Penson referred patients for the procedure.

In August 2003, Porter described difficulties he'd experienced with the procedure when he told peers at a meeting that it is "a challenging procedure with an extended learning curve." By that time, Porter had performed about 70 laparoscopic prostatectomies, including those at the VA, at hospitals around the area.

Banks' case is not about the merits of the new surgery, but about who might have been harmed while developing it in the Puget Sound area. Four years after Banks' operation, the University of Washington promotes laparoscopic prostatectomy to men with prostate cancer and Porter as the region's expert. His operating times are much shorter now, according to court documents.

Many federal safety laws apply if a new kind of operation is deemed experimental. They include a mandated review and approval by a safety board, whose sole purpose is to protect people from being exploited in medical experiments. These boards would have required "complete revelation" to Banks of what was going on, said Dr. John Mather, head of the federal VA's human research safety office until 2003. Those details would have included the fact that all but one of the laparoscopic prostatectomies Porter had tried had failed and that each had lasted up to nearly 14 hours, Mather said.

However, if a procedure is deemed just innovative, what follows is largely between the surgeon and the patient. In that case, there is no legal obligation to say that a patient is first in line. And when surgeons tell patients what to expect, they can quote the results of the most experienced doctors, not what might happen in their hands.