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
http://www.sskrplaw.com/gene/guckin.html.
Copyright 2002, The Bureau of National Affairs, Inc., Washington, D.C.
