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REPORTED IN THE COURT OF SPECIAL APPEALS OF MARYLAND No. 2623 September Term, 2006

REBECCA MARIE WALDT, ET AL. v. UNIVERSITY OF MARYLAND MEDICAL SYSTEM CORPORATION, et al.

*

Krauser, C.J., Eyler, Deborah S., Murphy, Joseph F., Jr. (Specially Assigned), JJ.

Opinion by Eyler, Deborah S., J.

Filed: September 5, 2008 * Joseph F. Murphy, Jr., Associate Judge of the Court of Appeals, participated in the hearing and conference of this case while an active member of this Court; he participated in the adoption of this opinion as a specially assigned member of this Court.

In the Circuit Court for Baltimore City, Rebecca Marie Waldt and her husband, Roy Waldt, sued Gregg Zoarski, M.D., and the University of Maryland Medical System ("UMMS") for medical malpractice. Using a device called the "Neuroform Microdelivery Stent System" ("neuroform stent"), Dr. Zoarski, the Chief of Interventional Radiology at UMMS, had performed a procedure to treat an aneurysm in a blood vessel in Mrs. Waldt's brain. During the procedure, an artery was perforated, which caused bleeding into the brain and a stroke. The stroke left Mrs. Waldt with significant physical and mental deficits. In their complaint, the Waldts alleged two types of negligence: 1) ordinary medical negligence, i.e., failure by Dr. Zoarski to adhere to the standard of care in the actual performance of the procedure; and 2) informed consent negligence, i.e., failure by Dr. Zoarski to obtain the patient's informed consent to the procedure. The Waldts' sole claim against UMMS was for vicarious liability for the alleged malpractice of Dr. Zoarski. The case went to trial beginning on November 30, 2006. Ultimately, at the close of the Waldts' case, on December 21, 2006, the court granted judgment in favor of UMMS and Dr. Zoarski on both counts. The Waldts noted this appeal, raising seven questions for review, which we have reordered, consolidated, and reworded: I. Did the trial court err in ruling that Gerard Debrun, M.D., the Waldts' expert witness, could not testify on the issue of whether Dr. Zoarski breached the standard of care in treating Mrs. Waldt? Did the trial court err in ruling that Dr. Debrun could not testify as an expert witness on the medical issues that were part of the Waldts' informed consent claim? Did the trial court err by granting judgment in favor of UMMS and Dr. Zoarski at the end of the Waldts' informed consent case?

II.

III.

IV.

Did the trial court err by ruling inadmissible certain documentary evidence?

For the following reasons, we answer "Yes" to the first question and "No" to the second and third questions. Our disposition makes it unnecessary to address the fourth question. Accordingly, we shall affirm the judgment in favor of the appellees on the informed consent claim, reverse the judgment in favor of the appellees on the ordinary negligence claim, and remand the case to the circuit court for further proceedings on that claim. FACTS AND PROCEEDINGS In August 2002, Mrs. Waldt, then 52, went to see her primary care physician, Amy Jones, M.D., because for four months she had been experiencing headaches that were not improving with medication. Dr. Jones ordered an MRI of Mrs. Waldt's head, which revealed an unruptured intracranial "right paraopthalmic brain aneurysm." An aneurysm is a weak spot on a blood vessel that produces a bubble-like bulge, which can rupture. In Mrs. Waldt's case, the bubble had not yet burst. Mrs. Waldt had some knowledge of brain aneurysms because both her mother and aunt had died of them. Dr. Jones referred Mrs. Waldt to Dennis Winters, M.D., a local neurosurgeon. Dr. Winters reviewed the MRI and arranged for a cerebral angiogram, a procedure that uses dye to mark the blood vessels in the brain so they can be seen and evaluated. The angiogram confirmed the presence of the aneurysm in Mrs. Waldt's middle cerebral artery ("MCA"), near its junction with the opthalmic artery. The area is deep inside the brain, at its base, on the right side, near the optic nerve and behind the eyes. The angiogram showed the aneurysm to be 8 millimeters in size with a wide "neck," that is, the point on the artery at which the bubble protrudes.

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Due to the size and location of the aneurysm, Dr. Winters referred Mrs. Waldt to Francois Aldrich, M.D., a neurosurgeon at UMMS. Dr. Aldrich specializes in repairing damaged blood vessels in the brain by "open brain surgery," i.e., surgery that involves the temporary removal of a section of the skull (a "craniotomy") to gain access to the damaged vessel in the brain. The aneurysm is repaired by the surgical placement of titanium "clips" across the weakened area of the vessel, closing it off. The procedure is called surgical "clipping." On October 18, 2002, the Waldts met with Dr. Aldrich, at UMMS. He reviewed the various test results with them and discussed three treatment avenues. The first was to do nothing except to monitor the status of the aneurysm. The second was to perform open brain surgery with surgical clipping. The last avenue, which is the one that was taken, was a non-surgical procedure known as endovascular coiling ("coiling"). Coiling procedures are performed by interventional radiologists. The radiologist inserts a catheter in a large blood vessel in the patient's groin, into which he threads a "stent" and a guide wire through other blood vessels until they reach the aneurysm site. The stent is a hollow tube made of metal mesh, that serves as a scaffold. Using the guide wire, the radiologist moves the stent into place against the neck of the aneurysm. Then another catheter, containing tiny metal coils of various sizes, in the shape of pig tails, is inserted and deposited in the stented area. Again using the guide wire, the radiologist moves the metal coils, one by one, from inside the stent to inside the aneurysm sac. In doing so, he or she guides each coil through one of the mesh openings in the stent, into the sac. When the coils are in place in the sac, the catheter and guide wire are withdrawn. The stent remains, propping the artery open and covering the coil-filled sac. Blood coagulates around the coils, walling off the sac and thereby repairing the aneurysm. 3

On the same day as their consultation with Dr. Aldrich, the Waldts met with Dr. Zoarski, at Dr. Aldrich's suggestion. Dr. Zoarski agreed with Dr. Aldrich about the three treatment options. He and Dr. Aldrich strongly recommended against the "do nothing except monitor" approach, given Mrs. Waldt's family history. It is undisputed that the do nothing approach was not acceptable for Mrs. Waldt's condition. During their October 18 meeting, Dr. Zoarski spent an hour discussing the coiling procedure with the Waldts. He explained how it is done and told the Waldts that, ordinarily, the stent that is used in the procedure is a cardiac stent, that is, one that is used in the blood vessels of the heart in heart surgery. He told the Waldts that a new stent, more supple than a cardiac stent, was in the process of being developed but was not yet available for use in the United States. As a consequence of the meeting with Dr. Zoarski on October 18, Mrs. Waldt was scheduled to undergo the coiling procedure, with a cardiac stent, on November 20, 2002. Before that date, Dr. Zoarski learned that the new neuroform stent had become available for use in this country. He called the Waldts and informed them of that development. On November 13, 2002, when the Waldts came to UMMS for the pre-procedure preparation for the cardiac stent coiling procedure, they and Dr. Zoarski again met. Dr. Zoarski told the Waldts that although the neuroform stent was available for use, he would have to receive training from Boston Scientific, the manufacturer, before he could use it. Thus, if the Waldts wanted the coiling procedure to be performed using the neuroform stent, instead of the cardiac stent, the procedure date would have to be postponed. The Waldts decided in favor of that approach, and the procedure date was moved to December 19, 2002. Dr. Zoarski in fact received training in the use of the neuroform stent at a Boston Scientific training session in Chicago on December 10, 2002. 4

The neuroform stent coiling procedure is essentially the same as the cardiac stent coiling procedure, except that the stent that is used is made of more flexible and less rigid metal mesh. Dr. Zoarski performed the neuroform stent coiling procedure on Mrs. Waldt as rescheduled, on December 19, 2002. He inserted a catheter into a large artery in Mrs. Waldt's groin and moved it through the other arteries into the artery in her brain in which the aneurysm was located. (Just as in the cardiac stent coiling, contrast material inside the catheter allowed Dr. Zoarski to use radiological studies to visualize inside the blood vessels and brain.) Dr. Zoarski threaded the guide wire and the neuroform stent through the catheter; placed the neuroform stent in the artery in which the aneurysm was located; and fixed it in place so as to cover the neck of the aneurysm. When the neuroform stent was in place, he removed the guide wire and catheter. He then inserted a micro-catheter, containing the tiny metal coils, and threaded it and the guide wire through the arteries, to the location of the neuroform stent, next to the aneurysm. He began using the guide wire to move the coils, one by one, from inside the neuroform stent, through its wire mesh openings, into the aneurysm sac. He successfully moved two coils from inside the neuroform stent to inside the aneurysm sac. The procedure went as planned until Dr. Zoarski was in the process of moving the third pigtail-shaped coil from inside the neuroform stent to inside the aneurysm sac. As he moved the third coil through the wire mesh, it became ensnared. For over two hours, Dr. Zoarski maneuvered the guide wire back and forth in an effort to free the tangled coil from the mesh. Ultimately, the coil broke. During that maneuvering period, the MCA was perforated, and blood and dye extravasated into the brain. Dr. Zoarski called for the assistance of a neurosurgeon. Dr. Aldrich responded, performed a craniotomy, and brought the bleeding under control. The bleeding inside the brain had 5

caused a stroke, however; and ultimately, and allegedly, the stroke caused injuries to Mrs. Waldt in the form of loss of use of her left hand, impaired cognition, loss of vision, confinement to a wheelchair, and severe depression. Throughout the ensuing litigation, the Waldts' theory of the case was that the MCA was perforated at a location far beyond the site of the aneurysm, and the perforation was caused by Dr. Zoarski's repeatedly moving the guide wire back and forth ("fishing") through the catheter in an effort to unsnare the tangled coil. The Waldts' theory of the case was not that the neuroform stent failed, or was defective, or was itself the reason for the perforation. Dr. Zoarski's theory of defense was that the artery did not perforate at a site away from the aneurysm; rather, it perforated near the aneurysm, which is a known and usual risk of any coiling procedure. Alternatively, if the artery did perforate distant from the aneurysm site, it did not perforate due to a breach of the standard of care by him or by any other health care provider involved in Mrs. Waldt's treatment. We shall include additional facts as pertinent to our discussion of the issues. DISCUSSION I. Ordinary Medical Negligence Claim In Maryland, the procedures in medical malpractice litigation are established by the Health Claims Arbitration Act, codified at Md. Code (1976, 2006 Repl. Vol., 2007 Supp.), section 3-2A-01 et seq. of the Courts and Judicial Proceedings Article ("CJ") ("the Act"). The Act requires that all malpractice claims against health care providers in which damages in excess of the jurisdictional limit of the District Court are sought be initiated by filing a statement of claim in the Health Claims

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Alternative Dispute Resolution Office ("HCADRO"), formerly called the Health Claims Arbitration Office. See CJ

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