Estate of Baker v. Univ. of Vt. ( 2005 )

Estate of Baker v. University of Vermont, No. 233-10-03 Oscv (Morris, Jr., J., May 5, 2005)
[The text of this Vermont trial court opinion is unofficial. It has been reformatted from the
original. The accuracy of the text and the accompanying data included in the Vermont trial court
opinion database is not guaranteed.]
STATE OF VERMONT
ORLEANS COUNTY, SS.
ESTATE of KEVIN BAKER.
Ann Baker, Administrator,
Plaintiff
V. Docket No. 233-10-03 Oscv
UNIVERSITY of VERMONT,
FLETCHER ALLEN HEALTH CARE,
WARREN BICKEL, JOHN BROOKLYN,
LISA MARSH, LOUIS GIORDIANO, and
JOHN or JANE DOE aka “staff member,”
Defendants.
Orleans Superior Court
Docket No. 233-10-03 Oscv
DECISION AND ORDER-MOTION FOR SUMMARY JUDGMENT
The case is before the Court on Defendant Fletcher Allen Health Care’s (“FAHC”)
Motion for Summary Judgment, pursuant to V.R.C.P. 56. FAHC seeks judgment in its favor on
all of Plaintiff’s claims against it. Summary judgment is “appropriate only when there are no
genuine issues of material fact and a party is entitled to judgment as a matter of law.” LoPresti
v. Rutland Regional Health Services, Inc., 2004 VT 105, ¶ 14. Summary judgment “shall be
rendered forthwith if the pleadings, depositions, answers to interrogatories, and admissions on
file, together with the affidavits ... show that there is no genuine issue as to any material fact and
that any party is entitled to a judgment as a matter of law.” V.R.C.P. 56 (c)(3). In making such a
determination, the Court “will take as true the facts alleged by the nonmoving party, and give the
nonmoving party the benefit of all reasonable doubts and inferences.” Fireman’s Fund Ins. Co.
V. CNA Ins. Co., 2004 VT 93, ¶ 8 (citation omitted). Further, “[i]t is not the function of the trial
court to resolve disputed facts when ruling on a motion for summary judgment.” Quinn v.
Grimes, 2004 VT 89, ¶ 7.
Undisputed Facts
1
1. Warren K. Bickel, Ph.D., a professor of psychiatry at the University of Vermont
(“UVM”) and the “principal investigator,” and Lisa Marsch, M.A. submitted a
grant application to the United States Department of Health and Human Services
(“DHHS”) National Institute on Drug Abuse (“NIDA”) for a research project
entitled “Improving Combined Buprenorphine-Behavioral Treatment” (“research
project”), naming Regina H. White, Director of UVM’s Office of Sponsored
Programs, as the “official” for the “applicant organization” and UVM’s Office of
Sponsored Programs as the “applicant organization.”
2. The other key personnel noted on the grant application were Stephen T. Higgins,
Ph.D., co-investigator, Alan Budney, Ph.D, co-investigator, a TBD Resident
Assistant Professor, co-investigator, Gary J. Badger, M.S., biostatistician, and
John R. Brooklyn, M.D. All these individuals work for UVM, with the exception
of Dr. Brooklyn who works for the Community Health Center. None of these
individuals are employed by Fletcher Allen Health Care.
3. The “performance sites” designated on the grant application are the Human
Behavioral Pharmacology Lab at UVM and UVM’s Substance Abuse Treatment
Center (“SATC”).
4. Project personnel’s salaries followed UVM policy, with UVM covering the
difference in salary coverage for Drs. Bickel and Higgins, as necessitated by the
National Institute of Health’s salary cap.
5. UVM operates the SATC in Burlington, Vermont, on the FAHC campus under
the terms of a lease agreement for use of the designated space.
6. Buprenorphine is a narcotic analgesic and also an opioid antagonist, displacing
heroin opioids from the mu-opioid receptors when administered to persons using
heroin. Buprenorphine is commonly dispensed under the trade names, “Subutex”
and “Suboxone”.
7. Buprenorphine also acts as a partial agonist, easing withdrawal symptoms
experienced by heroin addicts.
8. Federal law requires that an Institutional Review Board ("IRB”) review, approve,
and supervise research projects involving human subjects.
2
9. Federal law requires that all IRBs “include at least one member who is not
otherwise affiliated with the institution....” 45 C.F.R. § 46.107(d).1
10. The University of Vermont’s IRB is referred to as the “Committees on Human
Research”. These are the “Committee on Human Research in the Medical
Sciences” (“CHRMS”), and the “Committee on Human Research in the
Behavioral Sciences” (“CHRBS”). The work of the latter committee is not in
issue in this case. FAHC maintains its own IRB, designated the “Fletcher Allen
Health Care Committee on Human Studies”. From time to time, FAHC has used
UVM’s CHRMS as its own IRB, consistent with the by laws of the Committees
on Human Research and CHRMS, which authorize such. The by-laws of the
UVM CHRMS provide that FAHC’s Committee on Human Studies meets
“jointly” with the CHRMS only to consider human research protocols that will be
carried out in FAHC facilities. The said by-laws also reference the FAHC
Committee on Human Studies as “functioning under the by-laws of the Fletcher
Allen Health Care Medical Staff”. The said by-laws also provide in pertinent part
that “To the extent that it is feasible, members of the Fletcher Allen Health Care
Committee on Human Studies will also be members of CHRMS…..”.
11. The IRB seeks to ensure compliance with DHHS regulations for research projects
“that are sponsored by the University of Vermont (UVM) or Fletcher Allen health
Care (FAHC).” IRB Policy and Procedure Handbook at 2 (emphasis added).
Further, all research projects involving human subjects “conducted by University
[of Vermont] and/or Fletcher Allen Health Care personnel, including students, or
done under the auspices or sponsorship of either institution must be reviewed by”
the appropriate IRB or review committee. Investigator Guidelines for Human
Subjects Research, Committees on Human Research, September 27, 2001, at 3
(emphasis added).
12. Members of the CHRMS receive no compensation for their service on the
1
The referenced regulation clearly mandates a diversity of membership reflecting a variety of interests, and
expertise as relates to the work of IRBs. In pertinent part, the regulation provides that: “Each IRB shall have at
least five members, with varying backgrounds to promote complete and adequate review of research activities
commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise
of its members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as
community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
subjects. In addition to possessing the professional competence necessary to review specific research activities, the
IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and
regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include
persons knowledgeable in these areas.” “No IRB may consist entirely of members of one profession.” “Each IRB
shall include at least one member whose primary concerns are in scientific areas and at least one member whose
primary concerns are in nonscientific areas.” “No IRB may have a member participate in the IRB’s initial or
continuing review of any project in which the member has a conflicting interest, except to provide information
requested by the IRB.” 45 CFR Part 46, § 46.107 (a)—(e).
3
Committee. Actions by members of the CHRMS carried out as a function of
Committee appointments are as provided in the by-laws to be included under the
University’s general liability insurance coverage. Members of the CHRMS are
appointed by the Vice Provost of UVM. Members of UVM’s CHRMS are not
appointed by FAHC. Meetings of the CHRMS are held on UVM premises. All
meetings of the CHRMS pertinent to review of the research project in issue in this
case were convened at 5:00 PM.
13. Both FAHC and UVM personnel serve on the twenty-two member CHRMS. At
the time of initial approval of the buprenorphine study in issue in this case, the
CHRMS included nine physicians who were employed both as professors at
UVM and as physicians at FAHC. In addition, two members--Marcia Dunham, a
research pharmacist and Michealanne Rowen, cardiology research nurse, both
solely employees of FAHC served on the Committee. Nine additional members
of the CHRMS were employed solely by UVM. The twenty-first member of the
CHRMS was an attorney in private practice, and the twenty-second member a
priest employed by St. Michael’s College. Excepting the nine physicians who
were employed both by UVM and FAHC, only two other members of the
CHRMS are employees of FAHC. The by laws applicable to CHRMS provide
that the chair of the CHRMS must be a UVM faculty member.
14. The project in issue in this case was assigned number “99-207” for reference by
the CHRMS. The CHRMS reviewed, approved, and supervised the research
project, including its protocol and informed consent form. From May 19, 1999
through October 17, 2001, the CHRMS met a total of seven times to consider and
take action with respect to the research project protocols in issue in this case. The
CHRMS engaged in active and objective review of the project and its protocols,
including the informed consent, as reflected in the minutes of CHRMS meetings
and suggestions made from time to time as to content of protocols and informed
consent. The chair of the CHRMS at each of these meetings was a physician,
employed both as a professor at UVM and a physician at FAHC (Dr. Bernstein,
3/19/99-6/20/01; Dr. Homans thereafter).
15. Under the terms of the project design, UVM/SATC contracted with FAHC to
provide pharmacy-related services required for the research project. Specifically,
the contract provided for the services of a “full time pharmacy technician”. This
individual was to “prepare all medications, monitor the inventory and paper trail
of all medications. S/he will insure compliance with FDA regulations and assist
in the preparation of INDs”. The sum payable to FAHC under the contract was to
be $23,000.00. See grant proposal, Defendant FAHC’s Exhibit A, p. 10.
16. FAHC pharmacy technicians and pharmacists prepared doses of buprenorphine
4
for individuals enrolled in the research project. These FAHC employees acted
under the direction of UVM employees and pursuant to the referenced contract
with UVM.
17. All buprenorphine required for the research project was ordered by and shipped to
Dr. Bickel, a UVM employee. A member of Dr. Bickel’s staff delivered the
buprenorphine to the Investigational Drug Services Division of FAHC’s
Pharmacy Services. Required individual doses were then prepared and packaged
by FAHC-IDS at the direction of Dr. Brooklyn of the SATC, delivered to the
SATC and stored in a safe within the SATC to be later dispensed to individual
patients by SATC staff, per Dr. Brooklyn’s instructions, in accordance with the
research project’s protocol.
18. FAHC personnel were not involved with and did not engage in determining
eligibility of individuals for the research project, determining when to administer
buprenorphine, the size or frequency of any administered dose, actually
administering a dose to an individual enrolled in the research project, monitoring
an individual before or after getting a buprenorphine dose, or evaluating whether
any individual participating in the project should be released and permitted to
drive home after having received a dose of buprenorphine.
19. On November 29, 2001, Theodore Pecor enrolled in the UVM study and received
doses of Buprenorphine—three 2 milligram-dose Subutex tablets, as prescribed
for the so-called “induction phase” of Buprenorphine treatment. This medication
was provided to Mr. Pecor by SATC staff, from a stock of induction doses
maintained in a safe at the SATC. Mr. Pecor had previously been in treatment as
a patient at the SATC, for a period of approximately ten months beginning in
April, 1999. During that period of time, Mr. Pecor drove himself to the SATC
three days per week to receive doses of buprenorphine, driving home afterward
without any apparent adverse incident.
20. At time of his enrollment in the study, Mr. Pecor reviewed and signed an
Informed Consent form stating “you must agree to limit your activities, especially
driving and operation of machinery, according to the advice of the investigators
while participating in this study.... Please understand that you are free not to
participate in this study or to withdraw from it at any time.” The Informed
Consent form also provided Mr. Pecor with warning of potential adverse side
effects of administration of buprenorphine, and indicated that buprenorphine may
produce temporary sedation and coordination difficulties which could increase the
risk of accident. Informed Consent, signed by Mr. Pecor on November 29, 2001,
at 7.
5
21. Pursuant to the research project’s protocol, certain sobriety tests were
administered by SATC personnel prior to allowing an enrolled individual to leave
the SATC.
22. No FAHC personnel were involved in administering the buprenorphine or
monitoring and releasing Mr. Pecor from the SATC on November 29, 2001.
There is no evidentiary showing that any FAHC personnel or employees were
aware of Mr. Pecor’s treatment, personal status, or circumstances of his departure
from the SATC on November 29, 2001.
23. The Project’s protocol and underlying agreements did not assign to FAHC
personnel any functional responsibilities for actual administration of the
buprenorphine or the monitoring of and the circumstances of release of patients
from the program.
24. On November 19, 2001, buprenorphine, in its forms of Suboxone or Subutex, were
“investigational drugs”. They were not approved by the Food and Drug
Administration (“FDA”) until October, 2002. As such, the FDA had not
generated any patient information literature, or counseling materials/guidelines or
“warnings” recommended for use in conjunction with the dispensing or
administration of these drugs. No such literature or documents accompanied the
drugs provided to the FAHC pharmacy in conjunction with its preparation and
provision of buprenorphine doses to the SATC.
25. As a research pharmacist employed in the Investigational Drug Service Division of
FAHC’s Department of Pharmacy Services, Marcia Dunham, is, and was on
November 29, 2001, familiar with the properties of buprenorphine, and its effects
upon patients following administration of the drug. Ms. Dunham had worked
with Dr. Bickel on buprenorphine studies for a number of years preceding the
events in issue in this case. As noted, Ms. Dunham also served as a member of
the CHRMS during the period in issue, and participated in Committee review and
approval of the Project #99-207 and its protocols.
26. Participation in the SATC research project was a voluntary undertaking on the
patient’s part. If an individual enrolled in the SATC research project chose to
disregard or otherwise not follow either the terms of informed consent related to
treatment, or a research project investigator’s recommendation not to leave the
SATC or operate a motor vehicle, research project personnel did not have the
6
authority to prevent an enrolled individual from doing so.2
27. On November 29, 2001, Mr. Pecor “passed” the protocol’s sobriety tests in the
assessment of the SATC screener, and SATC staff permitted him to leave SATC.
Mr. Pecor left and began driving towards his home in Johnson. The state of Mr.
Pecor’s sobriety upon departure from the SATC is a matter of factual dispute
among the parties.3
28. While Mr. Pecor was driving home, the vehicle that he was operating crossed the
center line and struck Mr. Baker’s car. The collision resulted in the deaths of Mr.
Baker and his two passengers.4
Discussion
The parties have provided the Court with a compelling view into the world of issues
associated with the state of federally-supported therapeutic medical studies involving human
subjects. Along the way, the Court is well reminded of the historic evils that have been
recognized in the annals of human medical experimentation, as well as the virtually miraculous
discoveries that have inured to the benefit of all in consequence of scientific studies involving
human subjects. With respect and care owing to such profound concerns and interests, we
venture to determine the present Motion.5
The key to Plaintiff’s claims against FAHC is the well-recognized doctrine of respondeat
superior, under the terms of which an employer is vicariously liable for the actions of employees
committed “within the scope of their employment”. Poplaski v. Lamphere, 152 Vt. 251, 257
(1989). Thus, it is critical to the maintenance of Plaintiff’s claims against FAHC that it be
shown that FAHC employees, acting within the scope of their employment, breached specific
cognizable duties resulting in harm to Plaintiff’s deceased, and thus Plaintiff.6 Plaintiff has
stated its claims as to FAHC essentially as consisting of four components: (1) respondeat
superior/vicarious liability; (2) negligent review/approval/supervision of SATC activities by
FAHC employees as members of the CHRMS; (3) breach of duty by FAHC employees serving
2
“Authority” being of course distinct from the issue of any duty or responsibility flowing from patient declination of
SATC recommendation.
3
Resolution of this dispute is not essential to disposition of the present Motion.
4
Two other cases related to this incident are pending before the Court: Fountain v. University of Vermont, Docket
No. 256-10-03 Oscv, and Dezotelle v. University of Vermont, et. al., Docket No. 275-11-03 Oscv.
5
As noted in Grimes v. Kennedy Krieger Institute, Inc., 366 Md. 29, 782 A.2d 807, 835 (2001), cited by Plaintiff,
“There have been very few court decisions involving human experimentation. It is therefore very difficult for a
“common law” of human experimentation to develop.” Federal statutes and regulations of pertinence do of course
apply broadly to the conduct of medical research involving human subjects.
6
This formulation of the “test” on the Court’s part of course omits certain other elements of the negligence calculus;
the issue presented for determination is institutional culpability under the theory of respondeat superior.
7
on the CHRMS to control the conduct of patient Pecor; and (4) actual control of patient Pecor’s
operation of a motor vehicle by FAHC employees serving on the CHRMS. A related claim is
discerned from the pleadings that sounds in pharmaceutical malpractice, addressed to the
conduct of FAHC pharmacy staff in dispensing buprenorphine to the SATC. This claim is
addressed separately herein.
The determinative criterion as to the primary claims clearly lies in the respondeat
superior claim and the sufficiency of evidence related thereto. In the Court’s assessment,
Plaintiff’s claims against FAHC fail because FAHC owed no actionable duty to Mr. Pecor or Mr.
Baker, and FAHC connections to the UVM study are, in the Court’s assessment, otherwise too
tenuous to attach institutional liability.
Were FAHC Employees Serving on the CHRMS Acting “Within the Scope of Their
Employment”?
It is necessary to review FAHC’s connections to the research project and the November
19, 2001 accident. It is undisputed that FAHC employees were members of the CHRMS that
reviewed and approved the research project, including the informed consent form. Further,
under contract, FAHC pharmacy technicians and pharmacists stored and provided the doses of
buprenorphine to UVM-SATC employees and research project investigators, who in turn
administered the dose to Mr. Pecor. The SATC, while located on the FAHC campus, is, in all
respects, operated by UVM.
Plaintiff maintains that FAHC employees serving on the CHRMS acted within their
scope of employment when the CHRMS reviewed, approved, and supervised the research
project. Further, Plaintiff points out that one FAHC employee serving on the CHRMS, Marcia
Dunham, may have provided some contracted pharmaceutical services to UVM. Indeed, the
credible record establishes that Ms. Dunham possessed considerable expertise as to
buprenorphine and its trade versions, and impacts of the drug upon administration to patients.
Ms. Dunham had participated in work and studies related to buprenorphine for a period of years
preceding approval and conduct of the project in issue. Plaintiff contends that FAHC is
vicariously liable for the actions of its employees who serve on the CHRMS. Notwithstanding
these contentions, in the Court’s assessment it is clear on the state of the record that FAHC
personnel were not acting within the scope of their employment while serving on the CHRMS.
The test to determine whether certain conduct falls within the scope of employment is set
forth in Doe v. Forrest, 2004 VT 37, ¶ 15. While a determination of the scope of employment is
often a question of fact, it may be decided as a matter of law where “facts and the inferences to
be drawn there from are not in dispute,” as is the case here. Sweet v. Roy, 173 Vt. 418, 433
(2002)(internal marks omitted), quoting Ploof v. Putnam, 83 Vt. 252, 259 (1910).
8
To establish that a servant’s conduct falls within the scope of his or her employment, a
plaintiff must demonstrate that the conduct: (a) is the kind the servant is employed to
perform; (b) occurs substantially within the authorized time and space limits; [and] (c) is
actuated, at least in part, by a purpose to serve the master.
Doe, 2004 VT 37, ¶ 15 (internal marks omitted); see also Brueckner v. Norwich Univ., 169 Vt.
118, 123 (1999); Restatement (second) of Agency § 228(2). Even assigning a broad
interpretation to these criteria, the nature and extent of the activities of FAHC personnel serving
on the CHRMS in reviewing the UVM-SATC project and protocols in this case plainly fall short
of conduct “within the scope of employment” at FAHC.
FAHC employees serving on the CHRMS were not providing the services for which
FAHC had employed them, thus failing the first prong of the test. The primary functions of
FAHC personnel as FAHC employees were to serve FAHC’s needs in providing health care and
services to FAHC clients, medical professionals, and patients. Service on the CHRMS was an
entirely voluntary undertaking; on this record, there was neither an expectation of service on the
CHRMS as a condition of FAHC employment, nor any apparent consequence of an individual’s
election not to serve. FAHC employees serving on the CHRMS may have been asked to serve
on the CHRMS based upon the same expertise and credentials that led to FAHC employment;
however, this does not equate to a conclusion that their service on the CHRMS was the kind of
service FAHC employed them to do. Indeed, CHRMS members were asked to serve by and
worked at the discretion of UVM’s Vice Provost for Research and acted under the direction and
control of the Chair of the Committee, a physician employed by both UVM and FAHC. The by
laws provide that the Chair of the Committee must be a UVM faculty member. As to the nine
physician members of the CHRMS who were employed both by UVM as medical faculty and
FAHC as staff physicians, a stronger case might be made as to “scope of employment” of the
physicians, as UVM faculty employees. That is, as medical faculty members rather than staff
physicians, medical research and related activities might be considered to be not an unexpected
consequence of employment as a medical faculty member. However, as relates to FAHC
employment, it is clear on this record that the staff physician’s responsibility with regard to
FAHC is to provide patient care and directly related treatment services.
FAHC from time to time presented its own research projects to the CHRMS for review,
utilizing the CHRMS as its IRB. However, it was not required to do so, and apparently FAHC
maintained its own IRB, the FAHC Committee on Human Studies, which could be utilized. The
project in issue in this case was generated and implemented entirely by UVM through its SATC.
The sole exception being the contract with FAHC for pharmacy services, a relatively
insignificant component monetarily of the project and the grant providing the financing. There is
no genuine issue that as related to CHRMS review of Project/Protocols # 99-207, the CHRMS
was functioning as UVM’s IRB, and not FAHC’s IRB.
UVM in its by laws for the CHRMS provided that actions of the members of the CHRMS
9
were to be included in the University’s general liability insurance coverage. Certainly, this latter
action on the part of UVM does not equate to a legal conclusion; however, it serves as a
declaration on the part of UVM that the institution considers the work of the members of the
CHRMS to be University work for which the institution may be liable.
CHRMS members were not paid for their service on the board, which met at UVM. The
meetings at which the project and protocols in issue in this case were the subject of CHRMS
review and action all were convened at or shortly after 5:00 PM. On this record, and giving due
consideration to the fact that the employees here were in professional service, there is no
evidence fairly and reasonably tending to establish that FAHC employee service on the CHRMS
occurred “substantially within the authorized time and space limits” customarily expected in
performance of job functions at FAHC.
Was CHRMS service by FAHC employees “actuated, at least in part, by a purpose to
serve the interests” of FAHC? Probably, at least from the perspective of the employee. It would
be quite ingenuous to ignore the motivations and professional interests of the individuals
involved, as concerns the decision to engage in volunteer service on the CHRMS. As health care
professionals, the individuals would no doubt have professional interest in remaining abreast of
developments in medical research, being exposed to the various research proposals presented to
the CHRMS for review. Information gained in course of service on the CHRMS certainly might
enable the individual to perform his/her assigned duties more effectively. Service on the
CHRMS might be perceived as helpful in provision of knowledge as to CHRMS procedures, as
relates to preparation of FAHC research projects that might go before the CHRMS for review,
even if the particular member/employee might be obliged to recuse from the review. Of more
immediate impact, an individual volunteering to serve on the CHRMS might view such service
as an important asset in career progression or employment competition. For bad or good, such
motivations and purposes cannot be ignored. They would certainly extend as well to a wide
variety of activities engaged in as a volunteer and related to profession, such as participation in
professional societies or community service efforts related directly or indirectly to professional
role. Standing alone though, they do not serve to establish that CHRMS service was within the
“scope of employment” at FAHC.
The conclusion urged by Plaintiff—that FAHC employees serving as volunteers on the
CHRMS were acting within the scope of their employment at FAHC—is just not sustainable on
the record presented. The “threads” are just too tenuous. While it is tempting to engage in
speculation as to institutional interests that might play out, or be invoked in consequence of the
decisions of any institution’s IRB, we must be governed by the competent record in our
determinations, and not speculation. There is in our assessment no genuine issue of fact
presented as to scope of employment.
Since FAHC employees serving on the CHRMS were not acting within the scope of their
employment, Plaintiff’s claims asserting institutional culpability on the part of FAHC for
10
CHRMS’ actions are unsustainable.7
FAHC Pharmacy Negligence
Plaintiff’s other claims involve alleged negligence in the pharmaceutical services
provided to the research project by FAHC. As the undisputed facts demonstrate, FAHC
pharmacists and pharmacy technicians acted pursuant to the requests of research project
investigators and the research project’s protocol. There is no claim here to the effect that FAHC
provided medications other than as specified; that is, that there was negligence associated with
erroneous dosage or quantity or quality of the medication prescribed. There is no claim of
pharmaceutical malpractice premised upon erroneous “filling” of a prescription. FAHC
pharmaceutical services prepared the dose of buprenorphine and gave it to a research project
investigator to administer, and never interacted in any way with Mr. Pecor or others enrolled in
the research project. The actions of those pharmaceutical employees cannot, as a matter of law,
be viewed as negligent.
Plaintiff’s negligence claim rests on the theory that FAHC pharmacy employees made no
effort to ensure that proper release procedures were being used by SATC, or that they otherwise
failed to provide proper warnings related to the consequences of administration of
buprenorphine during the so-called “induction” phase. In the present case, FAHC pharmacy
employees were acting within their scope of employment with FAHC in dispensing the
buprenorphine to research project investigators; however, their actions, as a matter of law, were
not negligent.
It is well established that liability for negligence must be predicated upon a duty of care,
the existence of which is primarily a question of law to be determined by the Court. Duty may
be viewed as an expression of the sum total of those considerations of policy which lead the law
to say that the plaintiff is entitled to protection. Denis Bail Bonds Inc. v. State of Vermont, 159
Vt. 481, 487 (1993) (internal marks and citations omitted); Sorge v. State, 171 Vt. 171, 174
(2000); W. Prosser & W. Keeton, The Law of Torts § 53, at 538 (5th ed. 1984). Plaintiff in this
case asks the Court to extend a duty of care from a pharmacist or pharmacy to a patient and a
third person for what amounts to the lawful filling of a prescription given directly to the
prescribing doctor. We decline, as a matter of law in this case, to recognize such a duty on the
7
Is an IRB ever to be considered an entity separate from its parent institution for purposes of claims arising in the
conduct of research projects that have been reviewed and approved by the IRB? Are individual IRB members liable
in their individual capacities for actions undertaken as IRB members in reviewing and approving research projects?
Plaintiff has provided some authority which suggests that liability might attach to IRBs under certain circumstances,
noting one Oklahoma case in which IRB members were sued in their individual capacities. See, Anderlik and
Elster, Lawsuits Against IRBs: Accountability or Incongruity?, 29 Journal of Law, Medicine and Ethics 220 (2001).
As the authors note, there is very little authority on the questions, and distinct and persuasive contentions both
favoring and opposing extension of liability to IRBs and members. Neither of the referenced scenarios is in issue as
relates to the parties and their capacities presented in this case.
11
part of the FAHC pharmacy as relates to the interests of Mr. Pecor, Mr. Baker, or to SATC
research project personnel.
While apparently never explicitly treated by our Supreme Court, we consider the so-
called “learned intermediary doctrine” adopted in a majority of jurisdictions to be of significant
dispositive effect in determining the present claims. The learned intermediary doctrine, first
recognized in 1966, initially stood for the proposition that a prescription drug manufacturer had a
duty to warn of possible side effects in some patients only to a purchasing doctor, the learned
intermediary between the manufacturer and patient, and not directly to the patient. Sterling
Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). The majority of jurisdictions have
expanded this approach to cover pharmacists as well. Cottam v. CVS Pharmacy, 764 N.E.2d
814, 819 (Mass. 2002) (“[T]he overwhelming majority [of jurisdictions addressing this issue]
hold that, in general, a pharmacy has no duty to warn its customers of side effects.”); McKee v.
American Home Products, Corp., 782 P.2d 1045, 1048-49 (Wash. 1989)(joining the majority of
states that hold a pharmacist has no duty to warn). Some jurisdictions have reached this
conclusion through expanding the learned intermediary doctrine, while others have used an
independent analysis. See, e.g., Kirk v. Michael Reese Hosp. & Med. Ctr., 513 N.E.2d 387, 395
(Ill. 1987), cert. denied, 485 U.S. 905 (1988)(expanding the scope of the learned intermediary
doctrine to pharmacists), compare with McKee, 782 P.2d at 1048-49(finding no duty to warn on
the part of pharmacists, independent of the learned intermediary doctrine). In either case, the
majority of jurisdictions have apparently concluded that pharmacists have no duty to warn
patients of the dangers of a drug provided pursuant to a physician’s lawful prescription. See e.g.,
Tardy v. Eli Lilly & Co., 2004 WL 1925536 (Me.Super. 2004); Walls v. Alpharma USPD, Inc.,
887 So.2d 881, *4 (Ala. 2004); Cottam, 764 N.E.2d at 819; Brooks v. Walmart Stores, Inc., 535
S.E.2d 55 (N.C. App. 2000), review denied, 547 S.E.2d 2 (N.C. 2001); Walker v. Jack Eckerd
Corp., 434 S.E.2d 63, 67-68 (Ga. 1993); McKee, 782 P.2d at 1048-49; Adkins v. Mong, 425
N.W.2d 151, 152 (Mich.App. 1988); Eldridge v. Eli Lilly & Co., 485 N.E.551, 552-53 (Ill.App.
1985); Pysz v. Henry’s Drug Store, 457 So.2d 561, 562 (Fla. Dist.Ct.App. 1984).
A number of policy considerations underpin the rationale of these cases. “[R]equiring the
pharmacist to warn of potential risks associated with a drug would interject the pharmacist into
the physician-patient relationship and interfere with ongoing treatment.... [T]he physician is in
the best position to determine the proper drug therapy and to decide how and when to inform a
patient of its risks and benefits.” Silves v. King, 970 P.2d 790, 794 (Wash.App. 1999). Further,
the “pharmacist owes his customers a duty to properly fill lawful prescriptions,” and not to
second guess or otherwise investigate a prescription that a physician has already determined is
proper for his or her patient. Adkins, 425 N.W.2d at 152. Finally, a “pharmacist presented with
a prescription ordered by a duly licensed physician is not at liberty to substitute his judgment of
the product’s safety for the patient for that of the physician.” Coyle v. Richardson-Merrel, Inc.,
584 A.2d 1383, 1387 (Pa. 1991).
We note that in construing whether a duty owes under the particular circumstances
presented here, the existence of “warnings” or patient counseling and advisory literature
12
prescribed by the Food and Drug Administration and accompanying medication packaging
would bear relevance. Here, the undisputed evidence is that at time of administration of the
dosage of buprenorphine to Mr. Pecor, the drug was still in “investigational” status, and had not
been approved by the FDA. Thus, there was no warning or patient advisory literature that had
been mandated or even recommended by the FDA. No such FDA mandated or recommended
literature existed, and certainly had not been provided with the drugs provided by Dr. Bickel’s
office to the FAHC pharmacy.
The instant case presents facts that differ from those of the majority of cases addressing
the issue. This case does not involve the more typical scenario in which a physician prescribes a
medication to a patient, who in turn takes it to be filled by a pharmacist. Rather, in this case,
FAHC pharmacy services acted pursuant to the research project investigators’ directions, who
received the buprenorphine dose themselves, and in turn administered the dose to the enrolled
individual. These factual differences serve in the Court’s assessment to reinforce the logic and
rationale underlying a conclusion that a pharmacist has no duty to warn patients or doctors under
the circumstances presented here.
Accordingly, the actions of the FAHC pharmacists and pharmacy technicians cannot lead
to FAHC liability under the facts of this case. FAHC pharmacy services provided the
buprenorphine dose that eventually was administered to Mr. Pecor under the orders and
supervision of Dr. Brooklyn and SATC professional staff. The pharmacists and pharmacy
technicians provided only intermediary pharmaceutical services, and at no time played a role in
carrying out or otherwise participating in the research project beyond providing contracted
pharmaceutical services. They owed no duty to warn, monitor or control Mr. Pecor or to provide
warning to any investigator in the research project, and indeed never even came into contact with
Mr. Pecor. There is no suggestion, and certainly no evidentiary showing, that the FAHC
pharmacy personnel provided anything other than medication that was precisely as indicated in
the orders for its dispensation. Nor do the pleadings, much less competent evidence, serve to
identify any specific employee of FAHC pharmacy who engaged in conduct that would serve as
basis for assigning culpability to FAHC as alleged. No breach of applicable standard of care; no
breach of obligation of cognizable informed consent obligation. Therefore, no culpability as a
matter of law, entitling FAHC to summary judgment herein.8
8
Plaintiff maintains that, consistent with Peck v. The Counseling Service of Addison County, Inc., 146 Vt. 61(1985), FAHC was entrusted with a duty of care, to monitor and control the activities of Mr. Pecor, owing to a
“special relationship” which existed under the terms of the project design and protocols approved by the CHRMS,
and the participation of FAHC employees in both the CHRMS review and the dispensing of buprenorphine by the
FAHC pharmacy. Peck is in our assessment inapposite. There, reviewing the provisions of the Restatement of Torts
(2d) § 315, the Court held that notwithstanding patient privilege, a clinical therapist who knows, or should know
consistent with professional standards, that the patient poses a serious risk of danger to an identifiable victim has a
duty to exercise reasonable care to protect him or her from that danger. In Peck, a long standing therapeutic
relationship existed between patient and therapist. Patient had revealed to therapist that he intended to burn down
his parents’ barn, and then did so. Under the circumstances, the therapist was privy to very specific information as
to an intended harm that patient had declared that he would commit to specific victims. Quite logically, the holding
imposes a duty to exercise reasonable care to avert the harm. In Peck, the Court also notes the general rule that
13
Conclusion
Plaintiff asserts that FAHC owed Mr. Baker a duty. Absent a duty of care owed to a
plaintiff by a defendant, an action for negligence fails. Farnham v. Inland Sea Resort Properties,
Inc., 175 Vt. 500, 501 (2003). Based on the analysis above, and viewing the facts in the light
most favorable to Plaintiff, neither FAHC employees nor FAHC as an entity owed a duty to Mr.
Baker as related to the specific claims raised in this case.
Plaintiff claims that the CHRMS-approved informed consent form created a special
relationship between CHRMS and Mr. Pecor, leading to a duty on the part of CHRMS to control
Mr. Pecor. Plaintiff extends this contention to a claim that CHRMS had actual control over Mr.
Pecor on November 29, 2001. As we conclude above, FAHC employees were not acting within
their scope of employment in their service on the CHRMS. The entity responsible for the
conduct of the research study in issue in this case was, and remains, the University of Vermont
acting through its SATC. The Institutional Review Board’s exercise of oversight with respect to
the project and its protocols does not, on this record, serve to draw FAHC into the circle of
liability even though certain individuals, who happened to be employed by FAHC, also
happened to serve on the IRB. It is clear, and not in the Court’s assessment subject to genuine
factual dispute, that in all instances of CHRMS review of Project/Protocol # 99-207, the
ordinarily, there is no duty to control the conduct of another to protect third persons from harm. The key thread
associated with attachment of duty is one’s ability, consistent with the nature of the special relationship, to exercise
control over the conduct of the actor. The principles detailed in Peck are certainly of application in our assessment
here. However, here, it was UVM-SATC that developed and designed the project, maintained a specific treatment
relationship with Mr. Pecor, and administered day to day details of Mr. Pecor’s treatment, extending to
administration of buprenorphine and assessment of its effects upon him. FAHC, either institutionally or through the
incidental service of certain of its employees on the CHRMS, had no direct involvement in Mr. Pecor’s treatment.
No patient relationship existed. In the Court’s assessment, review and approval of the protocols generally applicable
to the conduct of the UVM-SATC buprenorphine project does not fairly and reasonably serve to establish the
“special relationship” contemplated by Peck and the Restatement between Mr. Pecor, and FAHC and its employees
serving as volunteers on the CHRMS, from which specific duty to control and warn might otherwise be derived. It
is logical and reasonable to extend a duty to control and/or warn in a therapeutic relationship where there is a
specific, current knowledge base as to a patient’s status and specifically identifiable risks; no duty would otherwise
extend though, consistent with Peck and related authority cited by the parties. Grimes v. Kennedy Krieger Institute,
Inc., 366 Md. 29, 782 A.2d 807 (2001), referenced by Plaintiff in its contention that duty, and liability on the part of
FAHC derive from a “special relationship” created by approval of the project protocols and Informed Consent, is not
to the contrary. In the Grimes case, which involved a non-therapeutic research program studying effects of exposure
to lead paint by children, the issue was the sponsoring institution’s liability for injuries sustained in the program
after the IRB’s approval of an informed consent which failed to disclose known risks to the otherwise healthy
children involved, whose “consent” to participation in the project was given by their parents, accompanied with
certain financial and other economic benefits. In the Court’s assessment, the Grimes decision, not surprisingly,
holds essentially that a “special relationship” commonly exists between medical researchers and their subjects from
which duties derive the breach of which may result in civil liability. The circumstances of the Grimes case would
appear to have been particularly egregious: non-therapeutic study of exposure of otherwise healthy children to lead
paint, without full and reasonable disclosure of known risks, with consent being given by parents under
circumstances found by the Court not to have been in the children’s best interests. We have determined under the
circumstance presented here that no duty attaches to FAHC as an institution; that there is no genuine issue of fact
pertinent to the same. While the principles of Grimes and other authority cited by Plaintiff may feature in the
resolution of other claims presented in the case, they do not dictate the extension of liability as a matter of law to
FAHC as an institution.
14
CHRMS was serving as the IRB for UVM, and not FAHC. FAHC as an institution did not
participate in any significant manner in the design, monitoring, or implementation of UVM-
SATC’s research study. The particular circumstance of service of FAHC employees on the IRB
reviewing the project here and its protocols is not reasonably shown to be within the scope of
these individuals’ employment by FAHC. There is in the Court’s assessment no genuine issue of
fact as to this point. Further, FAHC pharmacists and pharmacy technicians, while certainly
bearing distinct professional responsibilities generally speaking, owed no duty to either Mr.
Pecor or Mr. Baker as related to the specific claims presented here.
We grant that certain aspects of the CHRMS, its organization, procedures, lines of
authority and thus accountability, may appear to some to be as in the ironic phrase not
uncommonly used by Vermonters—“Plain as Mud!”. However, our sworn obligation is to assess
the merit of the Plaintiff’s claims against FAHC upon the evidentiary showing presently made
and the arguments advanced on this record. We have previously granted Plaintiff’s request for
extension of time to engage in further discovery and preparation to respond to the present Motion
for Summary Judgment, so that Plaintiff would not be required to prematurely respond, given the
complex issues in the case. In our assessment, Plaintiff has failed to present sufficient evidence
to establish genuine issue on any of the theories advanced as relates to the Defendant FAHC’s
Motion.9
Construing the facts in a light most favorable to Plaintiff we conclude that there is no
genuine issue as to material fact and that Defendant is entitled to summary judgment as a matter
of law. Defendant FAHC’s Motion for Summary Judgment is GRANTED.10
So Ordered at Newport, Vermont, this ____th day of May, 2005.
__________________
Walter M. Morris, Jr.
Presiding Judge
9
We have not expressly discussed an alternative theory discerned from the pleadings of the Plaintiff, that FAHC is
accountable here in that the research study was in effect a joint venture of the two institutions. There is no genuine
issue on this record that UVM-SATC was the sole entity directing, and in control of the conduct of the project.
FAHC did not possess or exercise co-equal authority to direct and control. As noted, FAHC exercised a relatively
minor role here, dispensing the required drug as directed, and in manner directed by, SATC. Participation of certain
employees of FAHC as members of the IRB does not serve to convert UVM-SATC’s project into a joint venture.
10
In consequence of the Court’s determination of the Motion for Summary Judgment, FAHC’s Motion to Dismiss,
filed on or about September 7, 2004, and the pending Motion to Compel Discovery, filed on or about September 27,
2004, are considered moot.
15