Lawsuit Claims Investigator, IRB Liability - In Study of Fecal Incontinence Control Device


An investigator, institutional review board members, a hospital, and a medical device manufacturer all are liable for the injury of a patient who underwent unsuccessful experimental surgery to control mild fecal incontinence, according to a lawsuit filed June 7 in the Pennsylvania Court of Common Pleas, Philadelphia County (Guckin v. Nagle, Pa. Ct. Com. Pl., No. 1425, complaint filed 6/11/02).

The experimental procedure, performed with a device called the Secca System, involved delivery of radiofrequency energy to the muscles of the anal canal in order to improve its barrier function by causing the formation of scar tissue. The suit claims a 35-year-old woman agreed to the procedure after she was told falsely that, even if unsuccessful, it could not worsen her condition.

In fact, the device used to target the sphincter muscle malfunctioned and failed to shut off automatically when it reached a dangerous temperature. Plaintiff Eileen Guckin's sphincter muscle was almost completely destroyed and she was left with a gaping perianal wound that required additional surgery for the debridement of dead tissue, the suit alleges. The result was an intensification of her earlier problems to the extent that she now has a total lack of sensation of or control over her bowel movements, according to the complaint.

The suit charges the investigator, hospital, IRB members, and device manufacturer with negligence, intentional assault and battery, lack of informed consent, intentional and negligent infliction of emotional distress, common law fraud/intentional misrepresentation, and strict liability in tort. It also separately charges the members of the hospital's IRB with negligence and seeks damages for loss of consortium for the plaintiff's husband, Stephen Guckin.

"In many injury cases, a jury can sympathize with a plaintiff but cannot really identify with him or her," plaintiff's attorney Alan C. Milstein told BNA June 18. "This case is just awful and I believe everyone will be able to identify with the plaintiff's suffering. What is almost worse and completely inexcusable is that after the device failed, for whatever reason, so much time elapsed before Ms. Guckin learned the truth of what happened to her," Milstein said. Milstein is with the law firm of Sherman, Silverstein, Kohl, Rose & Podolsky in Pennsauken, N.J.

IRB Members Sued for Negligence.

The complaint names as John Does one through 12 the individual members of the IRB at Graduate Hospital Inc. in Philadelphia. In addition to being included as defendants on the main counts in the complaint, the IRB members are charged with an additional count of negligence.

The IRB defendants who approved the experiment had a duty to protect clinical trial subjects from unethical research practices, the complaint says. However, they were negligent both in approving the design of the study and the informed consent document and in not monitoring appropriately both the informed consent process and the conduct of the trial, the complaint said.

"These investigators intentionally avoided describing the true nature of this experiment," Milstein told BNA. Although each patient informed consent document is stamped with an IRB approval, none of them mentioned the words "experiment" or "clinical trial," he said. "All they say is 'study.' Well, you can study something that has been FDA-approved. You can study aspirin to see how quickly it cures headaches. That doesn't make it a clinical trial."

Informed Consent Critical.

Lawsuits where the essential grievance is that the patient was not fully informed of the risks of an experimental procedure are legally and historically different from medical malpractice cases, the attorney said.

"It is difficult for people to understand this, including judges, but when we talk about the informed consent process in a clinical trial setting that is not the same animal as informed consent in a medical malpractice case. They are totally different," Milstein told BNA.

A major difference is that the informed consent process is regulated by the federal government, he said. "But more importantly, in the medical malpractice arena the purpose of informed consent is simply to relieve the doctor of liability for assault."

Before consent documents were in use, assault charges were routinely brought against physicians in tort suits even if their treatment consisted only of what any reasonable physician would do for the patient's benefit in similar circumstances, Milstein said. "So the whole source and purpose of the document was different.

"In the clinical trial setting, the purpose of the consent is to ensure that someone understands that they are choosing to participate in an experiment not only for their own benefit but for society's benefit. They are being asked to make a moral choice, not simply a medical decision."

Furthermore, unlike medical malpractice cases where courts treat consent documents like mortgages or insurance contracts and generally hold a patient bound by his or her agreement even if the person signs the document without reading it, in the clinical trial arena the signed document is "irrelevant," Milstein said.

"Signing the document itself is virtually meaningless because the document is just evidence that a process has taken place--the process of ensuring that the subject is fully informed and that the investigator has made sure the patient understands the risks," he said.

Maker Charged With Assault, Battery.

Milstein explained the charge of assault and battery against Curon Medical Inc. of Sunnyvale, Calif., maker of the medical device used on Guckin.

"The manufacturer is sponsoring the clinical trial in a very direct way," he said. In a typical malpractice case, if a doctor inserts a device in someone without their consent, the manufacturer could not be said to have committed a battery, he said. "But when you are talking about a clinical trial sponsored by a manufacturer, the doctor is acting at that manufacturer's behest and, in my view, also can be liable for assault and battery."

According to Curon spokeswoman Rachel Croft, since the experience testing the radiofrequency device in Graduate Hospital, it has been redesigned and approved by the FDA and "has helped 45 people" with fecal incontinence problems who have failed more conservative therapies such as changing their diets and practicing biofeedback. At the time of Guckin's surgery, Croft said, the radiofrequency generator was approved by FDA as an investigational device exempt from that agency's premarket approval process under the Medical Device Amendments to the Food, Drug, and Cosmetic Act.

Also named as a defendant in the suit is Tenet Healthcare Corp., headquartered in Santa Barbara, Calif., which Milstein said owns the hospital. Guckin seeks punitive damages in addition to compensatory damages in excess of $1 million, delay damages, interest, and the costs of suit.

By Susan Carhart

The complaint is available on the Web at

Copyright 2002, The Bureau of National Affairs, Inc., Washington, D.C.