United States District Court, District of Massachusetts
July 7, 2014
ROBERT ZEMAN and JULIA ZEMAN, Plaintiffs,
ZIV WILLIAMS, M.D., EMAD ESKANDAR, M.D., HINA ALAM, SARY F. ARANKI, M.D., RHONDA BENTLEY-LEWIS, M.D., SUSAN BURNSIDE, RICHARD D’AUGUSTA, ASHWIN DHARMADHIKARI, M.D., DEBORAH ECKER, MELISSA FRUMIN, M.D., ROBERT J. GLYNN, ELIZABETH L. HOHMANN, M.D., DAVID A. JONES, 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., SEAN R. WILSON, M.D., and NEUROLOGIX, INC., Defendants.
George A. O’Toole, Jr. United States District Judge.
The plaintiffs have moved to amend their Amended Complaint (dkt. no. 4) to add claims against a new party, Michael Kaplitt, M.D., and, as a result, a new count against Neurologix, Inc., for vicarious liability. The new complaint would also add some allegations to the existing counts.
The proposed allegations as to Dr. Kaplitt include the following: Dr. Kaplitt, a licensed physician in New York, acted as a representative and agent of Neurologix. Neurologix made representations to the Recombinant DNA Advisory Committee (“RAC”), a federal advisory committee that oversees gene transfer experiments, that Dr. Kaplitt would provide training to each participating surgeon as to surgical techniques and would be present at each site’s first surgery. Mr. Zeman believed that Dr. Kaplitt had been involved with devising the study, had trained Dr. Williams, and would be present at the surgery to oversee Dr. Williams.
♦ The plaintiffs wish to bring negligence and loss of consortium claims against Dr. Kaplitt. The negligence claim asserts Dr. Kaplitt’s negligent training of Dr. Williams, the neurosurgeon; negligent supervision of Dr. Williams during the surgery; and abandonment of Mr. Zeman midway through the surgery.
♦ To prevail on a claim for negligence, “a plaintiff must first establish that the defendant owed a legal duty of care” to the plaintiff Remy v. MacDonald, 801 N.E.2d 260, 262-63 (Mass. 2004) (citations omitted). Whether a duty exists is a matter of law, “to be determined by reference to existing social values and customs and appropriate social policy.” Wallace v. Wilson, 575 N.E.2d 1134, 1136 (Mass. 1991) (citations omitted).
The key question is whether Dr. Kaplitt owed a duty to Mr. Zeman the breach of which would give rise to a cause of action. The plaintiffs’ theory is based on the proposition that Dr. Kaplitt voluntarily undertook a duty to Mr. Zeman by undertaking to train the neurosurgeon in the clinical trial, Dr. Williams, and thus stood in a “special relationship” with Mr. Zeman under the doctrine of cases such as Mullins v. Pine Manor College, 449 N.E.2d 331, 336 (Mass. 1983) (“It is an established principle that a duty voluntarily assumed must be performed with due care.”). In Mullins, the Supreme Judicial Court found that a college had a duty to use care to protect the safety of its students.
It should be noted that the proposed claim against Dr. Kaplitt is not a claim of medical malpractice, nor could it be. The proposed amended complaint does not assert facts to support the existence of a doctor-patient relationship. The claim is rather predicated on Dr. Kaplitt’s acting on behalf of the sponsor of the clinical trial.
Under Massachusetts law, a “special relationship” sufficient to impose a duty of care may arise under a variety of factual circumstances. See Irwin v. Town of Ware, 467 N.E.2d 1292, 1300-1301 (Mass. 1984). A person’s statutory responsibilities may give rise to a “special relationship.” Id. at 1302. The plaintiffs have alleged that a special relationship arose between Dr. Kaplitt and the first human subject of the clinical trial because of Dr. Kaplitt’s obligations under the regulatory scheme applicable to such trials. Ultimately, whether such a relationship is supported in this case will be judged on the basis of the evidence at trial, but for now, the claim is plausible under Massachusetts law and pled with adequate detail.
The proposed vicarious liability claim against Neurologix may also proceed.
For these reasons, the plaintiffs’ Motion to Amend (dkt. no. 27) is GRANTED, subject, however, to the ruling, separately announced, that the claims against the IRB members are to be DISMISSED. Accordingly, the plaintiffs shall prepare a form of complaint that reflects that ruling. Any appeal rights regarding the dismissal of the claims against IRB members are saved.
It is SO ORDERED.