684206.

1
UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS

_______________________________________________
)
ROBERT ZEMAN and JULIA ZEMAN, )
Plaintiffs, )
) Civil Action No. 11-10204-MLW
)
v. )
)
ZIV WILLIAMS, M.D., EMAD ESKANDAR, M.D., )
INDIVIDUAL MEMBERS OF THE INSTITUTIONAL )
REVIEW BOARD: MELISSA FRUMIN, M.D., HINA )
ALAM, SARY F. ARANKI, M.D., RHONDA )
BENTLEY-LEWIS, M.D., SUSAN BURNSIDE, )
RICHARD DAUGUSTA, ASHWIN )
DHARMADHIKARI, M.D., DAVIDA. JONES, M.D., )
DEBORAH ECKER, ROBERT J. GLYNN, )
ELIZABETH L.HOHMANN, M.D.,THOMAS )
KOLOKOTRONES, KEITH A. MARCOTTE, )
FRANCISCO MARTY, M.D., ELINOR A. MODY, M.D., )
JOAN RILEY,ANDREW P. SELWYN, ARTHUR )
C. WALTMAN, M.D., SJIRK WESTRA, M.D., )
and SEAN R. WILSON, M.D., MEDTRONIC, INC. )
and NEUROLOGIX, INC. )
Defendants )
_______________________________________________ )

DEFENDANTS, THE INDIVIDUAL MEMBERS OF THE INSTITUTIONAL REVIEW
BOARD: MELISSA FRUMIN, M.D., HINA ALAM, SARY F. ARANKI, M.D., RHONDA
BENTLEY-LEWIS, M.D., SUSAN BURNSIDE,RICHARD DAUGUSTA, ASHWIN
DHARMADHIKARI, M.D., DAVID A. JONES, M.D., DEBORAH ECKER, ROBERT J.
GLYNN, ELIZABETH L. HOHMANN, M.D.,THOMAS KOLOKOTRONES, KEITH A.
MARCOTTE, FRANCISCO MARTY, M.D., ELINOR A. MODY, M.D., JOAN RILEY,
ANDREW P. SELWYN, ARTHUR C. WALTMAN, M.D., SJIRK WESTRA, M.D., AND
SEAN R. WILSON, M.D., MOTION TO DISMISS THE PLAINTIFFSFIRST
AMENDED COMPLAINT

Now come the Individual Members of the Institutional Review Board: Melissa Frumin,
M.D., Hina Alam, Sary F. Aranki, M.D., Rhonda Bentley-Lewis, M.D., Susan Burnside, Richard
DAugusta, Ashwin Dharmadhikari, M.D., David A. Jones, M.D., Deborah Ecker, Robert J.
Glynn, Elizabeth L. Hohmann, M.D., Thomas Kolokotrones, Keith A. Marcotte, Francisco
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684206.1
Marty, M.D., Elinor A. Mody, M.D., Joan Riley, Andrew P. Selwyn, Arthur C. Waltman, M.D.,
Sjirk Westra, M.D., and Sean R. Wilson, M.D., (hereinafter the IRB), and request that the
claims against them in the Plaintiffs First Amended Complaint be dismissed. In brief, the
Plaintiffs have failed to state a claim upon which relief can be granted because, as a matter of
law, there is no private cause of action under the applicable federal statutes and regulations and
even assuming a cause of action exists, the IRB has no duty to individual plaintiffs. Further, the
Defendants are immune from liability under both the state peer review statute, M.G.L. ch. 111,
203(c), and the federal Health Care Quality Improvement Act of 1986, 42 U.S.C. 11101(a).
Specifically, the Plaintiffs Complaint must be dismissed for the following reasons:
1) There are no federal statutes or regulations that create a private cause of action against
the IRB for the Plaintiffs;

a. Federal regulations regarding Institutional Review Boards do not provide a
private right of action nor do they evidence the intent to do so;

b. The legislatures decision not to create a private right of action is supported by
public policy as exposing the volunteer members of an IRB to liability would
undermine the purpose of assuring the protection of the rights and welfare of
human subjects by disincentivizing people from volunteering for IRB
membership and disincentivizing Institutional Review Boards from approving and
candidly discussing potentially beneficial research projects;

2) The plaintiffs cannot establish that the Defendants owed the Plaintiffs a legally
cognizable duty, as is required for their negligence claim;

a. There was an insufficient relationship between the IRB members and the plaintiff
for a duty to exist from the defendants to the plaintiff.

b. Even assuming the existence of a sufficient relationship, the plaintiffs claims for
negligence against the IRB must fail as Massachusetts law is clear that it is the
attending physicians duty to obtain informed consent.

c. Under federal law it is the clinical study's investigator who owes the duty to warn
a patient-subject of risks.

3) The Individual Members of the IRB are immune from liability under both the state
peer review statute, M.G.L. ch. 111, 203(c), and the federal Health Care Quality
Improvement Act of 1986, 42 U.S.C. 11101(a).
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684206.1

4) In the alternative, should the court disagree with the Defendant IRBs argument that
there is controlling Massachusetts and Federal law which requires dismissal, the IRB
requests that this Court certify questions on this matter to the Massachusetts Supreme
Judicial Court pursuant to SJC Rule 1:03.

As further grounds in support of this Motion, the Individual Members of the IRB rely on the
accompanying Memorandum of Law.
For all of the foregoing reasons, and those in the accompanying Memorandum of Law,
the Defendants, the Individual Members of the Institutional Review Board, respectfully request
that this Honorable Court grant their Motion to Dismiss the Plaintiffs First Amended Complaint.


Respectfully submitted,

THE INDIVIDUAL MEMBERS OF THE
INSTITUTIONAL REVIEW BOARD,

By Their Attorneys

/s/ John P. Ryan
______________________________
John P. Ryan, B.B.O. 435660
jryan@sloanewalsh.com
Marcia K. Divoll, B.B.O. 544481
mdivoll@sloanewalsh.com
Sloane & Walsh, LLP
Three Center Plaza
Boston, MA 02108
(617) 523-6010










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684206.1
LR 7.1(A)(2) CERTIFICATE
Pursuant to Locale Rule 7.1(A)(2) Defendants counsel hereby certifies that they have
conferred with Plaintiffs counsel on July 25, 2011 and have attempted in good faith to resolve or
narrow the issues that are the subject of this motion.

/s/ Christopher M. Reilly

Christopher M. Reilly



CERTIFICATE OF SERVICE

I, Christopher M. Reilly, hereby certify that this document filed through the ECF system will be
sent electronically to the registered participants as identified on the Notice of Electronic Filing
and paper copies will be sent to those indicated as non-registered participants.

/s/ Christopher M. Reilly

Christopher M. Reilly

Case 1:11-cv-10204-GAO Document 33 Filed 07/25/11 Page 4 of 4