1

Estate of Baker v. University of Vermont, No. 233-1 0-03 Oscv (Morris, Jr., J., May 5, 2005)

[The text of this Vermont trial court opinion is un official. It has been reformatted from the original. The accuracy of the text and the accompan ying 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. 5 6. FAHC seeks judgment in its favor on all of Plaintiff’s claims against it. Summary judg ment is “appropriate only when there are no genuine issues of material fact and a party is enti tled 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, a nswers to interrogatories, and admissions on file, together with the affidavits ... show that th ere is no genuine issue as to any material fact and that any party is entitled to a judgment as a matte r of law.” V.R.C.P. 56 (c)(3). In making such a determination, the Court “will take as true the fac ts alleged by the nonmoving party, and give the nonmoving party the benefit of all reasonable doubt s 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 mo tion for summary judgment.” Quinn v.

Grimes , 2004 VT 89, ¶ 7.

Undisputed Facts2

1. Warren K. Bickel, Ph.D., a professor of psychia try at the University of Vermont

(“UVM”) and the “principal investigator,” and Lisa Marsch, M.A. submitted a grant application to the United States Department o f Health and Human Services (“DHHS”) National Institute on Drug Abuse (“NIDA”) for a research project entitled “Improving Combined Buprenorphine-Behavior al Treatment” (“research project”), naming Regina H. White, Director of UVM’ s Office of Sponsored Programs, as the “official” for the “applicant orga nization” and UVM’s Office of Sponsored Programs as the “applicant organization.”

2. The other key personnel noted on the grant appl ication were Stephen T. Higgins,

Ph.D., co-investigator, Alan Budney, Ph.D, co-inves tigator, a TBD Resident Assistant Professor, co-investigator, Gary J. Badge r, 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 C are.

3. The “performance sites” designated on the grant application are the Human

Behavioral Pharmacology Lab at UVM and UVM’s Substa nce Abuse Treatment Center (“SATC”).

4. Project personnel’s salaries followed UVM polic y, with UVM covering the

difference in salary coverage for Drs. Bickel and H iggins, as necessitated by the National Institute of Health’s salary cap.

5. UVM operates the SATC in Burlington, Vermont, o n the FAHC campus under

the terms of a lease agreement for use of the desig nated space.

6. Buprenorphine is a narcotic analgesic and also an opioid antagonist, displacing

heroin opioids from the mu-opioid receptors when ad ministered to persons using heroin. Buprenorphine is commonly dispensed under the trade names, “Subutex”

and “Suboxone”.

7. Buprenorphine also acts as a partial agonist, easin g withdrawal symptoms experienced by heroin addicts.

8. Federal law requires that an Institutional Revi ew Board ("IRB”) review, approve,

and supervise research projects involving human sub jects.3

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 Resea rch in the Medical Sciences” (“CHRMS”), and the “Committee on Human Re search in the Behavioral Sciences” (“CHRBS”). The work of the la tter committee is not in issue in this case. FAHC maintains its own IRB, de signated 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 St udies meets “jointly” with the CHRMS only to consider human res earch protocols that will be carried out in FAHC facilities. The said by-laws al so reference the FAHC Committee on Human Studies as “functioning under th e 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 r egulations for research projects

“that are sponsored by the University of Vermont (U VM) or Fletcher Allen health Care (FAHC).” IRB Policy and Procedure Handbook at 2 (emphasis added). Further, all research projects involving human subj ects “conducted by University [of Vermont] and/or

Fletcher Allen Health Care personnel, including st udents, or done under the auspices or sponsorship of either institution must be reviewed by” the appropriate IRB or review committee. Investiga tor Guidelines for Human Subjects Research, Committees on Human Research, Se ptember 27, 2001, at 3 (emphasis added).

12. Members of the CHRMS receive no compensation f or their service on the

1 The referenced regulation clearly mandates a diver sity of membership reflecting a variety of interest s, and expertise as relates to the work of IRBs. In perti nent part, the regulation provides that: “Each IRB shall have at least five members, with varying backgrounds to pro mote complete and adequate review of research activ ities commonly conducted by the institution. The IRB sha ll be sufficiently qualified through the experience and expertise of its members, including consideration of race, ge nder, and cultural backgrounds and sensitivity to s uch issues as community attitudes, to promote respect for its adv ice and counsel in safeguarding the rights and welf are of human subjects. In addition to possessing the profession al competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commit ments and regulations, applicable law, and standards of profe ssional conduct and practice. The IRB shall theref ore 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 con cerns are in scientific areas and at least one memb er whose primary concerns are in nonscientific areas.” “No IRB may have a member participate in the IRB’s init ial or continuing review of any project in which the membe r has a conflicting interest, except to provide inf ormation requested by the IRB.” 45 CFR Part 46, § 46.107 (a )—(e).4 Committee. Actions by members of the CHRMS carried out as a function of Committee appointments are as provided in the by-la ws 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 U VM’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 re search project in issue in this

case were convened at 5:00 PM.

13. Both FAHC and UVM personnel serve on the twent y-two member CHRMS. At

the time of initial approval of the buprenorphine s tudy in issue in this case, the CHRMS included nine physicians who were employed bo th as professors at UVM and as physicians at FAHC. In addition, two me mbers--Marcia Dunham, a research pharmacist and Michealanne Rowen, cardiolo gy research nurse, both solely employees of FAHC served on the Committee. Nine additional members of the CHRMS were employed solely by UVM. The twent y-first member of the CHRMS was an attorney in private practice, and the twenty-second member a priest employed by St. Michael’s College. Exceptin g 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 applicabl e to CHRMS provide that the chair of the CHRMS must be a UVM faculty m ember.

14. The project in issue in this case was assigned number “99-207” for reference by

the CHRMS. The CHRMS reviewed, approved, and super vised the research project, including its protocol and informed consen t 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 pr otocols 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 conten t of protocols and informed

consent. The chair of the CHRMS at each of these m eetings 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/SAT C contracted with FAHC to

provide pharmacy-related services required for the research project. Specifically, the contract provided for the services of a “full t ime pharmacy technician”. This individual was to “prepare all medications, monitor the inventory and paper trail of all medications. S/he will insure compliance wi th FDA regulations and assist in the preparation of INDs”. The sum payable to FA HC 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 prep ared doses of buprenorphine5 for individuals enrolled in the research project. These FAHC employees acted under the direction of UVM employees and pursuant t o the referenced contract

with UVM.

17. All buprenorphine required for the research pr oject 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 lat er dispensed to individual patients by SATC staff, per Dr. Brooklyn’s instruct ions, 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 adminis tered dose, actually administering a dose to an individual enrolled in t he research project, monitoring an individual before or after getting a buprenorphi ne dose, or evaluating whether any individual participating in the project should be released and permitted to drive home after having received a dose of buprenor phine.

19. On November 29, 2001, Theodore Pecor enrolled in the UVM study and received

doses of Buprenorphine—three 2 milligram-dose Subut ex tablets, as prescribed for the so-called “induction phase” of Buprenorphin e treatment. This medication was provided to Mr. Pecor by SATC staff, from a sto ck of induction doses maintained in a safe at the SATC. Mr. Pecor had pr eviously been in treatment as a patient at the SATC, for a period of approximatel y 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 buprenorphi ne, driving home afterward without any apparent adverse incident.

20. At time of his enrollment in the study, Mr. Pe cor reviewed and signed an

Informed Consent form stating “you must agree to li mit your activities, especially driving and operation of machinery, according to th e advice of the investigators while participating in this study.... Please unders tand 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 o f potential adverse side effects of administration of buprenorphine, and ind icated that buprenorphine may produce temporary sedation and coordination difficu lties which could increase the risk of accident. Informed Consent, signed by Mr. Pecor on November 29, 2001,

at 7.6

21. Pursuant to the research project’s protocol, c ertain sobriety tests were

administered by SATC personnel prior to allowing an enrolled individual to leave

the SATC.

22. No FAHC personnel were involved in administeri ng the buprenorphine or

monitoring and releasing Mr. Pecor from the SATC on November 29, 2001. There is no evidentiary showing that any FAHC perso nnel 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 agreemen ts did not assign to FAHC

personnel any functional responsibilities for actua l administration of the buprenorphine or the monitoring of and the circumst ances of release of patients from the program.

24. On November 19, 2001, buprenorphine, in i ts forms of Suboxone or Subutex, were

“investigational drugs”. They were not approved by the Food and Drug Administration (“FDA”) until October, 2002. As suc h, the FDA had not generated any patient information literature, or co unseling 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 Dunh am, 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 numb er 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 participa ted 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 S ATC research project chose to disregard or otherwise not follow either the terms of informed consent related to treatment, or a research project investigator’s re commendation not to leave the SATC or operate a motor vehicle, research project p ersonnel did not have the7 authority to prevent an enrolled individual from do ing so. 2

27. On November 29, 2001, Mr. Pecor “passed” the p rotocol’s sobriety tests in the

assessment of the SATC screener, and SATC staff pe rmitted him to leave SATC. Mr. Pecor left and began driving towards his home i n 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 collis ion resulted in the deaths of Mr. Baker and his two passengers. 4

Discussion

The parties have provided the Court with a compell ing view into the world of issues associated with the state of federally-supported th erapeutic medical studies involving human subjects. Along the way, the Court is well reminde d of the historic evils that have been recognized in the annals of human medical experimen tation, 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 suc h 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 consist ing of four components: (1) respondeat superior/vicarious liability; (2) negligent review/approval/supervisio n 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 issu e of any duty or responsibility flowing from patien t declination of

SATC recommendation.

3 Resolution of this dispute is not essential to dis position of the present Motion.

4 Two other cases related to this incident are pendi ng 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, I nc. , 366 Md. 29, 782 A.2d 807, 835 (2001), cited by Pl aintiff, “There have been very few court decisions involving human experimentation. It is therefore very diffi cult 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 in volving human subjects.

6 This formulation of the “test” on the Court’s part of course omits certain other elements of the negl igence calculus; the issue presented for determination is institutio nal culpability under the theory of respondeat superior.8

on the CHRMS to control the conduct of patient Peco r; and (4) actual control of patient Pecor’s operation of a motor vehicle by FAHC employees serv ing on the CHRMS. A related claim is discerned from the pleadings that sounds in pharmac eutical malpractice, addressed to the conduct of FAHC pharmacy staff in dispensing bupren orphine to the SATC. This claim is addressed separately herein.

The determinative criterion as to the primary claim s clearly lies in the respondeat superior claim and the sufficiency of evidence related there to. In the Court’s assessment, Plaintiff’s claims against FAHC fail because FAHC o wed no actionable duty to Mr. Pecor or Mr. Baker, and FAHC connections to the UVM study are, i n the Court’s assessment, otherwise too tenuous to attach institutional liability.

Were FAHC Employees Serving on the CHRMS Acting “Wi thin the Scope of Their Employment” ?

It is necessary to review FAHC’s connections to th e research project and the November 19, 2001 accident. It is undisputed that FAHC empl oyees were members of the CHRMS that reviewed and approved the research project, includi ng the informed consent form. Further, under contract, FAHC pharmacy technicians and pharm acists stored and provided the doses of buprenorphine to UVM-SATC employees and research pr oject investigators, who in turn administered the dose to Mr. Pecor. The SATC, whil e 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, approv ed, and supervised the research project. Further, Plaintiff points out that one FA HC employee serving on the CHRMS, Marcia Dunham, may have provided some contracted pharmaceu tical services to UVM. Indeed, the credible record establishes that Ms. Dunham possess ed considerable expertise as to buprenorphine and its trade versions, and impacts o f the drug upon administration to patients. Ms. Dunham had participated in work and studies rel ated to buprenorphine for a period of years preceding approval and conduct of the project in is sue. 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 fall s within the scope of employment is set

forth in Doe v. Forrest , 2004 VT 37, ¶ 15. While a determination of the s cope of employment is often a question of fact, it may be decided as a ma tter 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).9

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 author ized time and space limits; [and] (c) is actuated, at least in part, by a purpose to serve t he master.

Doe , 2004 VT 37, ¶ 15 (internal marks omitted); see also Brueckner v. Norwich Univ. , 169 Vt. 118, 123 (1999); Restatement (second) of Agency § 2 28(2). Even assigning a broad interpretation to these criteria, the nature and ex tent 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 provi ding the services for which FAHC had employed them, thus failing the first pron g 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, an d patients. Service on the CHRMS was an entirely voluntary undertaking; on this record, the re was neither an expectation of service on the CHRMS as a condition of FAHC employment, nor any ap parent consequence of an individual’s election not to serve. FAHC employees serving on t he CHRMS may have been asked to serve on the CHRMS based upon the same expertise and cred entials 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 me mbers 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 b e a UVM faculty member. As to the nine physician members of the CHRMS who were employed bo th 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 memb er. However, as relates to FAHC employment, it is clear on this record that the sta ff physician’s responsibility with regard to FAHC is to provide patient care and directly relate d treatment services.

FAHC from time to time presented its own research p rojects to the CHRMS for review, utilizing the CHRMS as its IRB. However, it was no t 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 imp lemented 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 a nd 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 acti ons of the members of the CHRMS10

were to be included in the University’s general lia bility insurance coverage. Certainly, this latter action on the part of UVM does not equate to a lega l 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 instituti on may be liable.

CHRMS members were not paid for their service on t he board, which met at UVM. The meetings at which the project and protocols in issu e in this case were the subject of CHRMS review and action all were convened at or shortly a fter 5:00 PM. On this record, and giving due consideration to the fact that the employees here w ere 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 l east in part, by a purpose to serve the interests” of FAHC? Probably, at least f rom the perspective of the employee. It would be quite ingenuous to ignore the motivations and pr ofessional interests of the individuals involved, as concerns the decision to engage in vol unteer 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 d uties 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 th at might go before the CHRMS for review, even if the particular member/employee might be obl iged to recuse from the review. Of more immediate impact, an individual volunteering to ser ve on the CHRMS might view such service as an important asset in career progression or empl oyment competition. For bad or good, such motivations and purposes cannot be ignored. They w ould 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 employe es serving as volunteers on the CHRMS were acting within the scope of their employm ent at FAHC—is just not sustainable on the record presented. The “threads” are just too t enuous. While it is tempting to engage in speculation as to institutional interests that migh t play out, or be invoked in consequence of the decisions of any institution’s IRB, we must be gove rned by the competent record in our determinations, and not speculation. There is in o ur 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 institutio nal culpability on the part of FAHC for11

CHRMS’ actions are unsustainable. 7

FAHC Pharmacy Negligence

Plaintiff’s other claims involve alleged negligenc e in the pharmaceutical services provided to the research project by FAHC. As the u ndisputed 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 medi cation prescribed. There is no claim of pharmaceutical malpractice premised upon erroneous “filling” of a prescription. FAHC pharmaceutical services prepared the dose of bupren orphine 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 pharmac eutical employees cannot, as a matter of law, be viewed as negligent.

Plaintiff’s negligence claim rests on the theory t hat FAHC pharmacy employees made no effort to ensure that proper release procedures wer e being used by SATC, or that they otherwise failed to provide proper warnings related to the co nsequences of administration of buprenorphine during the so-called “induction” phas e. In the present case, FAHC pharmacy employees were acting within their scope of employm ent with FAHC in dispensing the buprenorphine to research project investigators; ho wever, their actions, as a matter of law, were not negligent.

It is well established that liability for negligen ce must be predicated upon a duty of care, the existence of which is primarily a question of l aw to be determined by the Court. Duty may be viewed as an expression of the sum total of thos e 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 o mitted); Sorge v. State, 171 Vt. 171, 174 (2000); W. Prosser & W. Keeton, The Law of Torts § 53, at 538 (5 th 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 reviewe d and approved by the IRB? Are individual IRB memb ers liable in their individual capacities for actions undertak en as IRB members in reviewing and approving resear ch projects? Plaintiff has provided some authority which suggest s 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 Incongrui ty?, 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 cont entions both favoring and opposing extension of liability to IRB s and members. Neither of the referenced scenarios is in issue as relates to the parties and their capacities present ed in this case.12

part of the FAHC pharmacy as relates to the interes ts of Mr. Pecor, Mr. Baker, or to SATC research project personnel.

While apparently never explicitly treated by our S upreme Court, we consider the socalled “learned intermediary doctrine” adopted in a majority of jurisdictions to be of significant dispositive effect in determining the present claim s. The learned intermediary doctrine, first recognized in 1966, initially stood for the proposi tion that a prescription drug manufacturer had a duty to warn of possible side effects in some patie nts 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 (8 th 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 wa rn its customers of side effects.”); McKee v. American Home Products, Corp. , 782 P.2d 1045, 1048-49 (Wash. 1989)(joining the m ajority of states that hold a pharmacist has no duty to warn). Some jurisdictions have reached this conclusion through expanding the learned intermedia ry 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 le arned 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 L illy & 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 rat ionale of these cases. “[R]equiring the pharmacist to warn of potential risks associated wi th a drug would interject the pharmacist into the physician-patient relationship and interfere wi th ongoing treatment.... [T]he physician is in the best position to determine the proper drug ther apy 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 proper ly fill lawful prescriptions,” and not to second guess or otherwise investigate a prescriptio n that a physician has already determined is proper for his or her patient. Adkins , 425 N.W.2d at 152. Finally, a “pharmacist presen ted 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 th e physician.” Coyle v. Richardson-Merrel, Inc.

, 584 A.2d 1383, 1387 (Pa. 1991).

We note that in construing whether a duty owes und er the particular circumstances presented here, the existence of “warnings” or pati ent counseling and advisory literature13

prescribed by the Food and Drug Administration and accompanying medication packaging would bear relevance. Here, the undisputed evidenc e 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 warni ng or patient advisory literature that had been mandated or even recommended by the FDA. No s uch FDA mandated or recommended literature existed, and certainly had not been prov ided with the drugs provided by Dr. Bickel’s office to the FAHC pharmacy.

The instant case presents facts that differ from th ose of the majority of cases addressing the issue. This case does not involve the more typ ical 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 resear ch 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 a nd pharmacy technicians cannot lead to FAHC liability under the facts of this case. FA HC pharmacy services provided the buprenorphine dose that eventually was administered to Mr. Pecor under the orders and supervision of Dr. Brooklyn and SATC professional s taff. The pharmacists and pharmacy technicians provided only intermediary pharmaceutic al services, and at no time played a role in carrying out or otherwise participating in the rese arch 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 n o evidentiary showing, that the FAHC pharmacy personnel provided anything other than med ication that was precisely as indicated in the orders for its dispensation. Nor do the pleadi ngs, 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 h erein. 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, ow ing to a “special relationship” which existed under the term s of the project design and protocols approved by t he CHRMS, and the participation of FAHC employees in both the CHRMS review and the dispensing of buprenorphine b y 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 pat ient privilege, a clinical therapist who knows, or should know consistent with professional standards, that the pa tient poses a serious risk of danger to an identifi able 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 intende d to burn down his parents’ barn, and then did so. Under the circ umstances, 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 logical ly, the holding imposes a duty to exercise reasonable care to avert the harm. In Peck , the Court also notes the general rule that14 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 a bove, 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 t his case.

Plaintiff claims that the CHRMS-approved informed consent form created a special relationship between CHRMS and Mr. Pecor, leading t o 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 C HRMS. 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 rec ord, serve to draw FAHC into the circle of liability even though certain individuals, who happ ened 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 rev iew of Project/Protocol # 99-207, the

ordinarily, there is no duty to control the conduct of another to protect third persons from harm. Th e key thread associated with attachment of duty is one’s ability , consistent with the nature of the special relatio nship, to exercise control over the conduct of the actor. The princip les detailed in Peck are certainly of application in our assessment here. However, here, it was UVM-SATC that develope d and designed the project, maintained a specific t reatment relationship with Mr. Pecor, and administered day t o day details of Mr. Pecor’s treatment, extending t o administration of buprenorphine and assessment of i ts effects upon him. FAHC, either institutionally or through the incidental service of certain of its employees on t he CHRMS, had no direct involvement in Mr. Pecor’s treatment. No patient relationship existed. In the Court’s as sessment, review and approval of the protocols gene rally applicable to the conduct of the UVM-SATC buprenorphine projec t does not fairly and reasonably serve to establish the “special relationship” contemplated by Peck and the Restatement between Mr. Pecor, and FAHC an d its employees serving as volunteers on the CHRMS, from which spec ific duty to control and warn might otherwise be de rived. It is logical and reasonable to extend a duty to contr ol 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 Pl aintiff in its contention that duty, and liability on the part of FAHC derive from a “special relationship” created b y approval of the project protocols and Informed Co nsent, is not to the contrary. In the Grimes case, which involved a non-therapeutic research pr ogram studying effects of exposure to lead paint by children, the issue was the sponso ring institution’s liability for injuries sustained in the program after the IRB’s approval of an informed consent whi ch failed to disclose known risks to the otherwise healthy children involved, whose “consent” to participation in the project was given by their parents, accompa nied with

certain financial and other economic benefits. In the Court’s assessment, the Grimes decision, not surprisingly, holds essentially that a “special relationship” com monly exists between medical researchers and their subjects from which duties derive the breach of which may result in civil liability. The circumstances of the Grime s case would appear to have been particularly egregious: non-th erapeutic study of exposure of otherwise healthy ch ildren to lead paint, without full and reasonable disclosure of kn own risks, with consent being given by parents unde r circumstances found by the Court not to have been i n the children’s best interests. We have determine d under the circumstance presented here that no duty attaches t o FAHC as an institution; that there is no genuine issue of fact pertinent to the same. While the principles of Gri mes and other authority cited by Plaintiff may feature in the resolution of other claims presented in the case, t hey do not dictate the extension of liability as a matter of law to

FAHC as an institution.15

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 UVMSATC’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 a nd pharmacy technicians, while certainly bearing distinct professional responsibilities gene rally speaking, owed no duty to either Mr. Pecor or Mr. Baker as related to the specific claim s presented here.

We grant that certain aspects of the CHRMS, its or ganization, procedures, lines of authority and thus accountability, may appear to so me to be as in the ironic phrase not uncommonly used by Vermonters—“Plain as Mud!”. How ever, our sworn obligation is to assess the merit of the Plaintiff’s claims against FAHC up on 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 an d preparation to respond to the present Motion for Summary Judgment, so that Plaintiff would not b e required to prematurely respond, given the complex issues in the case. In our assessment, Pla intiff has failed to present sufficient evidence to establish genuine issue on any of the theories a dvanced 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 Defendan t is entitled to summary judgment as a matter of law. Defendant FAHC’s Motion for Summary Judgme nt 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 the ory 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. Th ere is no genuine

issue on this record that UVM-SATC was the sole ent ity 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 di rected, and in manner directed by, SATC. Participa tion of certain employees of FAHC as members of the IRB does not se rve to convert UVM-SATC’s project into a joint vent ure.

10 In consequence of the Court’s determination of the Motion for Summary Judgment, FAHC’s Motion to Dism iss, filed on or about September 7, 2004, and the pendin g Motion to Compel Discovery, filed on or about Sep tember 27, 2004, are considered moot.