1. Plaintiffs Eileen Guckin and Stephen Guckin are husband and wife,
with a residence at 934 Herbert Street, Philadelphia, PA 19124.
2. Defendant Deborah A. Nagle, M.D., is an individual and employee of
Tenet Healthcare Corporation and Graduate Hospital, Inc.where she practices
surgery. Her business address is Graduate Hospital, Inc., 1800 Lombard
Avenue, Philadelphia, PA 19146.
3. At all times relevant hereto, Dr. Nagle was the principal investigator
in a clinical trial studying the safety and efficacy of a device known
as the Secca System, designed to remedy problems associated with fecal
incontinence.
4. Defendant Tenet Healthcare Corporation is believed to be a California
corporation with an address at 3820 State Street, Santa Barbara, CA
93105 and is believed to be the owner of the Graduate Hospital, located
at 1800 Lombard Ave., Philadelphia, PA 19146.
5. Defendant Graduate Hospital, Inc. ("Graduate Hospital")
is believed to be a Pennsylvania corporation with an address at 1800
Lombard Ave., Philadelphia, PA 19146.
6. Defendant, Curon Medical, Inc., ("Curon") is believed to
be a California corporation with an address at 735 Palomar Avenue, Sunnyvale,
CA 94085. Curon Medical, Inc. is the manufacturer of the Secca System.
7. Defendants John Does 1 through 12 are individual members of the Institutional
Review Board of Graduate Hospital ("IRB Defendants") whose
name and address are currently unknown at this time.
8. In the winter of 2000, Eileen Guckin met with her urologist and complained
that she had been experiencing episodes of fecal incontinence for many
years. Accidents stemming from her inability to properly control her
bowels, however, were only occasional, and she was able to maintain
enough control so that she could rush to the bathroom in order to avoid
an accident. She was not dependent on adult diapers, nor was she restricted
to a lifestyle that required her to be in a state of constant fear over
her condition.
9. The urologist recommended Ms. Guckin visit with defendant Dr. Nagle,
a colorectal surgeon practicing at Graduate Hospital.
10. In the spring of 2000, Dr. Nagle advised Ms. Guckin of a new procedure
she said she was studying at Graduate Hospital, involving the Secca
System, a device manufactured by Curon and intended to alleviate or
decrease the symptoms of fecal incontinence by delivering radiofrequency
energy to the muscles of the anal canal.
11. Dr. Nagle represented that the procedure was performed in a 10-person
study in California which proved its success.
12. Dr. Nagle further represented the procedure was the best therapeutic
alternative for Ms. Guckin and that, even if unsuccessful, her condition
would not deteriorate as a result of the procedure.
13. In August of 2000, Dr. Nagle represented that Ms. Guckin had qualified
to be included in the study at Graduate Hospital and that she would
receive $300 for participating.
14. On August 18, 2000, Ms. Guckin was presented with an informed consent
document, a copy of which is attached as Exhibit "A." Neither
Dr. Nagle, the principal investigator, nor any other qualified member
of the clinical trial team participated in the consent process. Instead,
no one other than a registered nurse presented the document to Ms. Guckin.
15. The informed consent document was materially deficient and misleading
in several respects. For one, it did not include the term "experiment"
or the phrase "clinical trial," thus masking the fact that
this was a human subject experiment on a device still in its initial
stage of development for the indicated use. In addition, the document
did not accurately set forth the history of the prior experiments with
the device, the risks associated with a malfunction of the device, or
the alternatives available to human subjects.
16. Ms. Guckin did not fully understand the document because of the
absence of the participation from qualified members of the clinical
trial team, and because of what researchers call "the therapeutic
misconception." Mr. and Ms. Guckin signed the document believing
it was in her best therapeutic interest to undergo the procedure.
17. On September 12, 2000, Ms. Guckin underwent the procedure at Graduate
Hospital. During the surgery, the device malfunctioned when it failed
to automatically shut off when it reached a dangerous temperature, permanently
damaging the sphincter muscle of Ms. Guckin.
18. After the surgery, Dr. Nagle willfully and falsely represented to
Ms. Guckin that "everything went well," and that the surgery
had been successful.
19. Immediately following surgery, Ms. Guckin began to experience excruciating
pain and bleeding as a result of a gaping perianal wound caused by the
device failure. Furthermore, she experienced an intensification of her
earlier problems, including a total lack of sensation of or control
over her bowel movements.
20. Dr. Nagle failed to treat the injuries suffered by Ms. Guckin in
a prompt, candid, and professional manner; such failure caused additional
and irreversible damage to Ms. Guckin.
21. Sixteen days after the original surgery, Dr. Nagle admitted Ms.
Guckin to the hospital where she stayed for three weeks. During this
time, Ms. Guckin underwent procedures involving the debridement of the
necrotic tissue, causing her extreme pain and suffering.
22. Following the second surgery, Dr. Nagle finally admitted to Ms.
Guckin that a mishap had in fact occurred in the initial procedure.
She told Ms. Guckin, "I am not going to do this procedure again
until I find out what happened."
23. Also during this period, an intern at the hospital, after treating
Ms. Guckin, told her, "I hope you are seeking legal advice because
your sphincter muscle had been almost completely destroyed." The
Director of Surgery at Graduate Hospital, upon learning of the intern's
comments to Ms. Guckin, tried to convince Ms. Guckin that the intern
had been wrong and told her, "you are healing nicely." By
information and belief, the intern was terminated by Graduate Hospital
for telling Ms. Guckin the truth about what happened to her.
24. At some time during this period, Dr. Nagle finally admitted that
the device, which was supposed to create scars in the sphincter and
automatically shut down if it got too hot, failed to shut off properly.
Dr. Nagle tried to excuse this malfunction by explaining that the reason
for the malfunction in the device was that Ms. Guckin's "global
tissue temperature was too high." Dr. Nagle knew this excuse was
false and that the device simply failed to operate properly.
25. According to Curon, a computer controlling system in the device
is supposed to modulate the area set for operation to a precise, desired
temperature.
26. The informed consent document also states: "temperature of
the thermal treatment [is regulated] with a computer controlled system."
27. As a result of the negligence, recklessness, and intentional misconduct
of defendants, Ms. Guckin has little or no sphincter muscle and is completely
dependent on diapers because of her total lack of control over her bowel
movements. Accidents, which in the past occurred only occasionally,
are now an everyday reality that she must suffer through. In addition,
she suffers pain and discomfort and humiliation on a daily basis.
28. As a result of the physical injuries caused by the action and failures
of defendants, Ms. Guckin has undergone severe emotional and psychological
distress caused by the humiliation and fear of her present condition.
29. As a result of the physical injury caused by the initial procedure,
Ms. Guckin has undergone and will undergo medical treatment to ease
the pain and discomfort from which she suffers and will suffer in the
future.
30. Ms. Guckin's quality of life, because of defendants' wrongful acts,
is miserable.
31. 45 CFR '46, part of the Code of Federal Regulations, establishes
the law of the United States with respect to the protection of human
research subjects at institutions such as Graduate Hospital.
32. These regulations require:
Risks to subjects are minimized: (i) By using procedures
which are consistent with sound research design and which do not unnecessarily
expose subjects to risk.
. . .
Risks to subjects are reasonable in relation to anticipated benefits.
. . .
Selection of subjects is equitable.
. . .
Informed consent will be sought from each prospective subject or the
subject's legally authorized representative, in accordance with, and
to the extent required by '46.116.
. . .
Informed consent will be appropriately documented, in accordance with,
and to the extent required by '46.117.
. . .
Where appropriate, the research plan makes adequate provision for monitoring
the data collected to insure the safety of subjects.
. . .
Where appropriate, there are adequate provisions to protect the privacy
of subjects and to maintain the confidentiality of data.
. . .
Where some or all of the subjects are likely to be vulnerable to coercion
or undue influence, such as persons with acute or severe physical or
mental illness, or persons who are economically or educationally disadvantaged,
appropriate additional safeguards have been included in the study to
protect the rights and welfare of these subjects.
33. As set forth above, defendants have violated these regulations
to the great damage and detriment of Ms. Guckin.
FIRST CAUSE OF ACTION
NEGLIGENCE
34. Plaintiffs incorporate by reference all other paragraphs of this
complaint as if fully set forth herein.
35. Defendants, as set forth above, were negligent in that they failed
to treat Ms. Guckin in accordance with the standards governing the medical
and research professions, failed to conduct the clinical trial in a
careful and professional manner, failed to treat Ms. Guckin properly
once she suffered injury in the experiment, failed to abide by 45 C.F.R.
§46 and other regulations and standards governing the conduct of
clinical trials, and otherwise acted negligently as a matter of law.
36. As a direct and proximate result of defendants' actions, as set
forth above, Ms. Guckin was caused to sustain serious, disabling and
permanent personal and psychological injuries. She has in the past been
required and may in the future continue to be required to submit to
medical examinations; she sustained other injuries to her internal system;
she sustained other psychological injuries, the full extent of which
have yet to be determined; she has in the past required and may in the
future continue to require medicines, medical care and treatment; she
has in the past and may in the future continue to be compelled to expend
monies and incur obligations for such medical care and treatment; she
has in the past suffered and may in the future continue to suffer agonizing
aches, pains and mental anguish; she has in the past been and may in
the future continue to be disabled from performing her usual duties,
occupations and avocations, all to her great detriment and loss; and
she has suffered a breach of her right to essential human dignity as
a result of the failure of defendants to conduct a clinical trial in
accordance with standards governing human subject protection.
37. As a direct and proximate result of defendants' actions, as set
forth above, plaintiffs have in the past been and may in the future
continue to be compelled to expend monies and incur obligations for
Ms. Guckin's medical care and treatment; plaintiffs have also incurred
and may hereafter continue to incur other financial expenses or losses
which do or may exceed amounts which they may otherwise be entitled
to recover.
38. Plaintiff has sustained and makes claims for pain and suffering,
loss of physical function, permanent physical, mental, dignitary and
psychological injuries, humiliation and embarrassment, loss of life's
pleasures, loss of earning capacity, and any and all the damages to
which she is or may be entitled under the law of the Commonwealth of
Pennsylvania.
WHEREFORE, Eileen Guckin claims of defendants,
and each of them respectively, jointly and severally, compensatory damages
in excess of One Million Dollars ($1,000,000.00), delay damages pursuant
to Pa. R.C.P. 238, punitive damages and interest and allowable costs
of suit.
SECOND CAUSE OF ACTION
INTENTIONAL ASSAULT AND BATTERY, LACK OF INFORMED CONSENT
39. Plaintiffs incorporate by reference all other paragraphs of this
complaint as if fully set forth herein.
40. As set forth above, the informed consent process engaging the defendants
was materially deficient, misleading and contrary to the regulations
and standards
41. As a direct and proximate result of defendants' actions, as set
forth above, plaintiff, Eileen Guckin, was caused to sustain serious,
disabling and permanent personal and psychological injuries. She has
in the past been required and may in the future continue to be required
to submit to medical examinations; she sustained other injuries to internal
system; she sustained other psychological injuries, the full extent
of which have yet to be determined; she has in the past required and
may in the future continue to require medicines, medical care and treatment;
she has in the past and may in the future continue to be compelled to
expend monies and incur obligations for such medical care and treatment;
she has in the past suffered and may in the future continue to suffer
agonizing aches, pains and mental anguish; she has in the past been
and may in the future continue to be disabled from performing her usual
duties, occupations and avocations, all to her great detriment and loss;
and she has suffered a breach of her right to essential human dignity
as a result of the failure of defendants to conduct a clinical trial
in accordance with standards governing human subject protection.
42. As a direct and proximate result of defendants' actions, as set
forth above, plaintiffs have in the past been and may in the future
continue to be compelled to expend monies and incur obligations for
Ms. Guckin's medical care and treatment; plaintiffs have also incurred
and may hereafter continue to incur other financial expenses or losses
which do or may exceed amounts which plaintiff may otherwise be entitled
to recover.
43. Plaintiff has sustained and makes claims for pain and suffering,
loss of physical function, permanent physical, mental, dignitary and
psychological injuries, humiliation and embarrassment, loss of life's
pleasures, loss of earning capacity, and any and all the damages to
which she is or may be entitled under the law of the Commonwealth of
Pennsylvania.
WHEREFORE, Eileen Guckin claims of defendants, and
each of them respectively, jointly and severally, compensatory damages
in excess of One Million Dollars ($1,000,000.00), delay damages pursuant
to Pa. R.C.P. 238, punitive damages and interest and allowable costs
of suit.
THIRD CAUSE OF ACTION
INTENTIONAL AND NEGLIGENT INFLICTION
OF EMOTIONAL DISTREST
44. Plaintiffs incorporate by reference all other paragraphs of this
complaint as if fully set forth herein.
45. Defendants engaged in the conduct described above willfully, recklessly
and/or negligently causing Eileen Guckin severe emotional distress.
46. As a direct and proximate result of defendants' actions, as set
forth above, plaintiff Eileen Guckin was caused to sustain serious,
disabling and permanent personal and psychological injuries. She has
in the past been required and may in the future continue to be required
to submit to medical examinations; she sustained other injuries to her
internal system; she sustained other psychological injuries, the full
extent of which have yet to be determined; she has in the past required
and may in the future continue to require medicines, medical care and
treatment; she has in the past and may in the future continue to be
compelled to expend monies and incur obligations for such medical care
and treatment; she has in the past suffered and may in the future continue
to suffer agonizing aches, pains and mental anguish; she has in the
past been and may in the future continue to be disabled from performing
her usual duties, occupations and avocations, all to her great detriment
and loss; and she has suffered a breach of her right to essential human
dignity as a result of the failure of defendants to conduct a clinical
trial in accordance with standards governing human subject protection.
47. As a direct and proximate result of defendants' actions, as set
forth above, plaintiffs have in the past been and may in the future
continue to be compelled to expend monies and incur obligations for
Ms. Guckin's medical care and treatment; plaintiffs have also incurred
and may hereafter continue to incur other financial expenses or losses
which do or may exceed amounts which plaintiff may otherwise be entitled
to recover.
48. Plaintiff has sustained and makes claims for pain and suffering,
loss of physical function, permanent physical, mental, dignitary and
psychological injuries, humiliation and embarrassment, loss of life's
pleasures, loss of earning capacity, and any and all the damages to
which she is or may be entitled under the law of the Commonwealth of
Pennsylvania.
WHEREFORE, Eileen Guckin claims of defendants,
and each of them respectively, jointly and severally, compensatory damages
in excess of One Million Dollars ($1,000,000.00), delay damages pursuant
to Pa. R.C.P. 238, punitive damages and interest and allowable costs
of suit.
FOURTH CAUSE OF ACTION
COMMON LAW FRAUD/INTENTIONAL MISREPRESENTATION
49. Plaintiffs incorporate by reference all other paragraphs of this
complaint as if fully set forth herein.
50. Defendants made the following intentional misrepresentations and
committed common law fraud in:
a. intentionally misrepresenting the nature and history of the clinical
trial; and
b. intentionally misrepresenting facts relating to the adverse event
which occurred during the course of the clinical trial.
51. The intentional misrepresentations set forth above were done to
induce plaintiff to participate in the clinical trial and in defendants'
attempts to remedy the adverse results.
52. The misrepresentations set forth above were done with the knowledge
that the misrepresentations were false when made.
53. Plaintiff justifiably relied upon the misrepresentations set forth
above in making the decision as to whether to participate.
54. As a direct and proximate result of defendants' actions, as set
forth above, plaintiff Eileen Guckin was caused to sustain serious,
disabling and permanent personal and psychological injuries. She has
in the past been required and may in the future continue to be required
to submit to medical examinations; she sustained other injuries to her
internal system; she sustained other psychological injuries, the full
extent of which have yet to be determined; she has in the past required
and may in the future continue to require medicines, medical care and
treatment; she has in the past and may in the future continue to be
compelled to expend monies and incur obligations for such medical care
and treatment; she has in the past suffered and may in the future continue
to suffer agonizing aches, pains and mental anguish; she has in the
past been and may in the future continue to be disabled from performing
her usual duties, occupations and avocations, all to her great detriment
and loss, and she has suffered a breach of her essential human dignity.
55. As a direct and proximate result of defendants' actions, as set
forth above, plaintiffs have in the past been and may in the future
continue to be compelled to expend monies and incur obligations for
Ms. Guckin's medical care and treatment; plaintiffs have also incurred
and may hereafter continue to incur other financial expenses or losses
which do or may exceed amounts which plaintiff may otherwise be entitled
to recover.
56. Plaintiff has sustained and makes claims for pain and suffering,
loss of physical function, permanent physical, mental, dignitary and
psychological injuries, humiliation and embarrassment, loss of life's
pleasures, loss of earning capacity, and any and all the damages to
which she is or may be entitled under the law of the Commonwealth of
Pennsylvania. As a direct and proximate result of defendants' intentional
and material misrepresentations as set forth above, plaintiff has suffered
severe emotional, psychological and personal injuries.
WHEREFORE, Eileen Guckin claims of defendants,
and each of them respectively, jointly and severally, compensatory damages
in excess of One Million Dollars ($1,000,000.00), delay damages pursuant
to Pa. R.C.P. 238, punitive damages and interest and allowable costs
of suit.
FIFTH CAUSE OF ACTION
STRICT LIABILITY IN TORT
57. Plaintiffs incorporate by reference all other paragraphs of this
complaint as if fully set forth herein.
58. At all times relevant hereto, defendants were in the business of
developing, testing, marketing, promoting and utilizing the Secca System.
59. At sometime prior to September 9, 2000, Curon tested, marketed,
promoted and/or sold the Secca System utilized by Graduate Hospital
during the surgery on Eileen Guckin.
60. Upon information and belief, the device utilized in surgery by Graduate
Hospital was expected to, and did, reach the facility in the condition
in which it was intended and/or sold by Curon.
61. At the time the Secca System was tested, marketed, promoted and/or
sold for the use by Graduate Hospital on Eileen Guckin, the device was
in a defective condition and unreasonably dangerous in at least the
following particulars:
a. The device was defective and/or unreasonably dangerous when used
under the conditions contained in the product information literature;
b. The device was not accompanied by adequate or explicit labeling;
c. The device contained inadequate labeling;
d. The device was not accompanied by adequate directions for its safe
use;
e. The device was improperly marketed;
f. The device's advertising and promotional materials contained misrepresentations
of material facts and/or failed to contain sufficient material facts
necessary for physicians and/or consumers to make informed decisions
regarding its selection and use;
g. The device's labeling contained misrepresentations of material
fact and/or failed to contain sufficient material facts necessary
for physicians and/or consumers to make informed decisions regarding
its selection and use;
h. Information necessary for the Food and Drug administration to make
informed judgments regarding the safety and efficacy of the device
was withheld, improperly reported and/or insufficient;
i. The device was dangerous to one's health when used as recommended
or suggested in the labeling, advertising and promotional materials
promulgated to both the medical community and the plaintiff by the
defendants;
j. The dangers associated with the use of the device exceeded the
expectations of the average consumer; and
k. The device was over-promoted.
62. Curon placed the Secca System into the stream of commerce in a
defective condition that was unreasonably dangerous to persons such
as Eileen Guckin in that the device lacked adequate warnings and instructions
about dangers that were known, or should have been known, by Curon.
63. As a direct and proximate result of the placement of the Secca System
into the stream of commerce in a defective condition by Curon and its
use by Dr. Nagle and Graduate Hospital, Eileen Guckin was deprived of
the information necessary to decide whether or not to utilize the device
and was injured by the device's failure to operate properly.
64. By reason of the wanton, willful and outrageous conduct of defendants,
as aforesaid, plaintiff was caused to sustain severe emotional, psychological
and personal injuries.
65. As a direct and proximate result of defendants' actions, as set
forth above, plaintiffs have in the past been and may in the future
continue to be compelled to expend monies and incur obligations for
Ms. Guckin's medical care and treatment; plaintiffs have also incurred
and may hereafter continue to incur other financial expenses or losses
which do or may exceed amounts which they may otherwise be entitled
to recover.
66. Plaintiff has sustained and makes claims for pain and suffering,
loss of physical function, permanent physical, mental, dignitary and
psychological injuries, humiliation and embarrassment, loss of life's
pleasures, loss of earning capacity, and any and all the damages to
which she is or may be entitled under the law of the Commonwealth of
Pennsylvania.
WHEREFORE, Eileen Guckin claims of defendants,
and each of them respectively, jointly and severally, compensatory damages
in excess of One Million Dollars ($1,000,000.00), delay damages pursuant
to Pa. R.C.P. 238, punitive damages and interest and allowable costs
of suit.
SIXTH CAUSE OF ACTION
NEGLIGENCE
Eileen Guckin vs. IRB Defendants
67. Plaintiffs incorporate by reference all other paragraphs of this
complaint as if fully set forth herein.
68. The IRB defendants who approved the experiment had a duty to protect
Eileen Guckin and other subjects from unethical research practices.
69. The IRB defendants were negligent in approving the design of the
study, in approving the informed consent document, and in not monitoring
appropriately the informed consent process and the conduct of the trial.
70. As a direct and proximate result of defendants' actions, as set
forth above, Eileen Guckin was caused to sustain serious, disabling
and permanent personal and psychological injuries. She has in the past
been required and may in the future continue to be required to submit
to medical examinations; she sustained other injuries to her internal
system; she sustained other psychological injuries, the full extent
of which have yet to be determined; she has in the past required and
may in the future continue to require medicines, medical care and treatment;
she has in the past and may in the future continue to be compelled to
expend monies and incur obligations for such medical care and treatment;
she has in the past suffered and may in the future continue to suffer
agonizing aches, pains and mental anguish; she has in the past been
and may in the future continue to be disabled from performing her usual
duties, occupations and avocations, all to her great detriment and loss;
and she has suffered a breach of her right to essential human dignity.
71. As a direct and proximate result of defendants' actions, as set
forth above, plaintiffs have in the past been and may in the future
continue to be compelled to expend monies and incur obligations for
Ms. Guckin's medical care and treatment; plaintiffs have has also incurred
and may hereafter continue to incur other financial expenses or losses
which do or may exceed amounts which plaintiff may otherwise be entitled
to recover.
72. Plaintiff has sustained and makes claims for pain and suffering,
loss of physical function, permanent physical, mental and psychological
injuries, humiliation and embarrassment, loss of life's pleasures, loss
of earning capacity, and any and all the damages to which she is or
may be entitled under the law of the Commonwealth of Pennsylvania. As
a direct and proximate result of defendants' intentional and material
misrepresentations as set forth above, plaintiff has suffered severe
emotional, psychological and personal injuries.
WHEREFORE, Eileen Guckin claims of defendants,
and each of them respectively, jointly and severally, compensatory damages
in excess of One Million Dollars ($1,000,000.00), delay damages pursuant
to Pa. R.C.P. 238, punitive damages and interest and allowable costs
of suit.
SEVENTH CAUSE OF ACTION
LOSS OF CONSORTIUM
Stephen Guckin vs. All Defendants
73. Plaintiffs incorporate by reference all other paragraphs of this
complaint as if fully set forth herein.
74. As a result of the injuries sustained by Eileen Guckin, plaintiff
Stephen Guckin has been and will continue to be deprived of the assistance,
companionship, consortium and society of his wife, all to his loss and
detriment.
WHEREFORE, Stephen Guckin claims of defendants,
and each of them respectively, jointly and severally, compensatory damages
in excess of One Million Dollars ($1,000,000.00), delay damages pursuant
to Pa. R.C.P. 238, punitive damages and interest and allowable costs
of suit.
