Darke v. Isner, Estate Of
| Decision Date | 22 November 2005 |
| Docket Number | 022194E |
| Citation | 2005 MBAR 647 |
| Parties | Susan Darke, individually and as Executrix of the Estate of Roger J. Darke v. Estate of Dr. Jeffrey M. Isner, M.D. et al. |
| Court | Massachusetts Superior Court |
Judge (with first initial, no space for Sullivan, Dorsey, and Walsh): Troy, Paul E., J.
Following the death of her husband, Roger J. Darke, Susan Darke individually, and as executrix of Mr. Darke's estate filed an action for medical malpractice against the defendants, the Estate of Jeffrey M. Isner, M.D., Jeffrey M. Isner, M.D., James Symes, M.D., Douglas Losordo, M.D., Caritas St. Elizabeth's Medical Center of Boston, Inc. ("St. Elizabeth's"), and Vascular Genetics, Inc. ("VGI"). The defendants now move for partial or complete summary judgment pursuant to Mass.R.Civ.P. 56. For the reasons discussed hereafter, the Estate of Dr. Isner's motion for summary judgment as to Counts II, III, IV, and VII is DENIED and as to Counts I, VI, and X is ALLOWED. Dr. Symes' motion as to Count III is DENIED and as to Counts I, VI, and VII is ALLOWED. Dr. Losordo's motion as to Count II is ALLOWED. St. Elizabeth's motion as to Count X is ALLOWED. VGI's motion based on the absence of vicarious liability for the acts of Dr. Isner only is DENIED and as to Count II is ALLOWED.
The undisputed facts, and any disputed facts viewed in a light most favorable to the non-movant, are presented as follows:
In light of the prevalence of cardiovascular disease and cardiovascular-related deaths in the United States, Dr. Isner, now deceased, who was chief of cardiovascular research at St. Elizabeth's, developed a vascular therapy program involving the injection of a certain human gene, which produces a substance called VEGF2, into bodily tissue to promote the formation and differentiation of blood vessels. In nonclinical studies, this "gene therapy" demonstrated increased blood flow to obstructed or constricted body parts, including the heart, which implicated the effectiveness of such therapy in treating patients with advanced coronary artery disease (CAD).
In 1997, in connection with Dr. Isner's research, St. Elizabeth's, which owned certain patents relating to Dr. Isner's work, Cato Holding Company, Human Genome Sciences, Inc. and Dr. Isner formed VGI to develop and commercialize gene therapy products for the treatment of vascular disease. Both Dr. Isner and St. Elizabeth's held a twenty percent ownership interest in VGI and were represented on the Board of Directors.
In 1999, VGI submitted to the United States Food and Drug Administration (FDA) an application to sponsor VEGF2 treatment for CAD on a human clinical basis. Because the use of VEGF2 to treat CAD was investigational and experimental in nature, the protocol for the clinical study was subject to regulation and approval by the FDA.
According to FDA regulations, if the FDA finds a problem with the clinical protocol, it can order a "clinical hold" to suspend an investigation, or interrupt a clinical trial if problems arise during the study. Before allowing a clinical protocol to continue, the FDA frequently requires modifications to the protocol to ensure that all known problems or safety issues have been addressed.
On March 11, 1999, the FDA insisted on the modification of the admission criteria for VGI's gene therapy program to exclude from the study patients who were candidates for coronary artery bypass surgery or other revascularization procedures. After this revision, the clinical trial in which Mr. Darke participated commenced at St. Elizabeth's.
As sponsor of the clinical study, VGI provided the VEGF2-producing gene to the clinical investigators to administer to patients participating in the study by direct injection into the heart. Dr. Isner was the principal investigator for the clinical study and Drs. Symes and Losordo, among other medical practitioners at St. Elizabeth's, were subinvestigators involved in the CAD clinical trial at the time Mr. Darke participated in the program.
Mr. Darke suffered from chronic cardiovascular disease, including CAD. In November 1993, Mr. Darke underwent triple bypass surgery, after which his condition remained stable and treatable. However, in 1999, Mr. Darke again began to experience chest pains. On January 25, 1999, Mr. Darke presented at the Beth Israel Deaconess Medical Center ("Beth Israel") complaining of chest pain and was referred for cardiac catheterization. The catheterization revealed that the vein grafts in his heart had occluded.
In a letter dated February 24, 1999, Dr. Robert Johnson, a surgeon at Beth Israel, offered to Dr. Lance Larsen, Mr. Darke's treating cardiologist, the possibility of repeat coronary revascularization surgery for Mr. Darke's persistent angina, about which Mr. Darke expressed concern because his vein grafts occluded so quickly after his last surgery. In light of Mr. Darke's concern and Dr. Larsen's belief that Mr. Darke was not a good candidate for percutaneous coronary intervention, Dr. Larsen suggested that Mr. Darke consider the gene therapy program at St. Elizabeth's headed by Dr. Isner.
Dr. Larsen referred Mr. Darke to Dr. Losordo by letter dated March 12, 1999, in response to which the coordinator of the gene therapy program sent Mr. Darke information describing the gene therapy treatment. On May 3, 1999, Dr. Joel Shelkrot, Mr. Darke's primary care physician, wrote Dr. Losordo stating that Mr. Darke had exhausted all other medical options and indicated Mr. Darke's continued interest in the gene therapy treatment.
After consulting members of the gene therapy program at St. Elizabeth's, Mr. Darke and his wife agreed to his participation in the clinical trial. As part of the patient screening phase for the trial, Mr. Darke underwent several diagnostic tests, including an endocardial mapping test and coronary angiography performed by Dr. Isner and Dr. Peter Vale at St. Elizabeth's. Based on his test results and medical history, Dr. Isner referred Mr. Darke to Dr. Symes for a consultation, after which Dr. Symes determined that Mr. Darke qualified for the gene therapy program.
On May 24, 1999, Mr. Darke was admitted to St. Elizabeth's to undergo the gene therapy treatment. This same day, Mr. Darke signed an "Informed Consent for Experimental Procedures" in the presence of Dr. Vale, which disclosed the investigational nature of the clinical study and enumerated the potential risks associated with gene therapy treatment. The consent form did not disclose that a patient had died during her participation in the initial phase of the gene therapy program. Nor did the form disclose St. Elizabeth's or Dr. Isner's financial interest in VGI.
On May 25, 1999, Mr. Darke underwent surgery in which Dr. Symes injected VEGF2 into Mr. Darke's heart. Dr. Symes did not review the consent form with Mr. Darke prior to surgery. The following day, approximately twenty hours after the surgery, Mr. Darke died.
On May 17, 2002, Ms. Darke, individually, and as executrix of the estate of Mr. Darke, filed the instant action for medical malpractice and wrongful death. An amended complaint was filed on August 7, 2002. In her amended complaint, Mrs. Darke claims that her husband's death was the result of his participation in the experimental gene therapy program sponsored by VGI and under the direction and care of Drs. Isner, Symes, Losordo and St. Elizabeth's.
On June 26, 2003, pursuant to G.L.c. 231, §60B, a Medical Malpractice Tribunal was convened. The Tribunal ruled in favor of Drs. Isner, Symes, and Losordo as well as St. Elizabeth's, finding Mr. Darke's death to be an unfortunate medical result.[1] Subsequently, Mrs. Darke appealed the Tribunal's ruling and filed the requisite bond of $6,000 in accordance with G.L.c. 231, §60B to pursue her medical malpractice and wrongful death claims in this court.
Summary judgment shall be granted only where there are no issues of material facts in dispute and where the summary judgment record entitles the moving party to judgment as a matter of law. Cassesso v. Comm'r of Corr., 390 Mass. 419, 422 (1983); Cmty. Nat'l Bank v. Dawes, 369 Mass. 550, 553 (1976); Mass.R.Civ.P 56(c). In deciding a motion for summary judgment, the court views the facts in the light most favorable to the non-moving party. G.S. Enters, Inc. v. Falmouth Marine, Inc., 410 Mass. 262, 263 (1991). The moving party bears the burden of affirmatively demonstrating the absence of a triable factual issue and of showing that it is entitled to judgment as a matter of law. Pederson v. Time, Inc., 404 Mass. 14, 16-17 (1989). Once the moving party demonstrates the absence of a triable issue, the non-moving party must set forth specific facts establishing the existence of a genuine dispute as to a material fact. Correllas v. Viveiros, 410 Mass. 314, 317 (1991). "A complete failure of proof concerning an essential element of the non-moving party's case renders all other facts immaterial" and requires summary judgment in favor of the moving party. Kourouvacilis v. General Motors Corp., 410 Mass. 706, 711 (1991). Even if the facts of the case are disputed, "summary judgment is still available if the party with the burden of proof at trial... fails to present in the summary judgment record, taking everything it says as true and drawing all reasonable inferences in its favor, sufficient facts to warrant a finding in its favor." NG Bros. Constr., Inc. v. Cranney, 436 Mass. 638, 644 (2002).
The Estate of Dr. Isner has moved for summary judgment on Mrs Darke's claims...
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