St. Thomas Aquinas wrote in the Summa Theologica that "justice is a certain rectitude of mind whereby a man does what he ought to do in the circumstances confronting him."
With the circumstances it confronted, St. Joseph Medical Center did the right thing. After investigating questions about Dr. Mark Midei's use of cardiac stents, St. Joseph sent letters to 585 of his patients, as well as their primary-care physicians and cardiologists, informing them that patients may have received stents not supported by their angiograms.
These patients were encouraged to see their primary care physicians and/or treating cardiologists to determine what impact the placement of the stents had or may have on their condition and future treatment. This was the "clinical" basis for the notification: to ensure that treating physicians had accurate information as they formulated continuing treatment plans. Sending this notification was acting in the best interests of its patients.
To the best of our knowledge, there have been "medical" complications in only three patients as a result of the stent procedures. The greatest risk of complications is within the first six to 12 months. However, St. Joseph does not have access to all 585 patients' past and current medical records. Without complete medical records, it is impossible to determine with finality the "necessity" of the stent.
The external peer review of Dr. Midei's practice that was conducted at St. Joseph's request included the complete medical records of the patients up to and including the time of the stent placement. Of these cases, the hospital concluded with certainty that 40 patients received stents that were not necessary. However, even in these cases, there were no complications or deaths. In one of these cases, St. Joseph and the patient have reached a monetary settlement. There is another case that was not part of this group, in which St. Joseph has also settled.
St. Joseph first became aware of an issue with Dr. Midei's practice in April 2009 and took action in a timely manner. It decided to review all patients treated over a two-year period and to notify only those patients where a subsequent review determined that Dr. Midei's reported percentage of stenosis differed significantly from the independent expert's review based only on the cardiac catheterization report and the angiogram.
The review went back to January 2007 based on careful consideration as to the well-being of the affected patients. That is, St. Joseph needed to determine the time frame where there was a clinical basis for informing patients. The literature and the experts that St. Joseph consulted in determining the appropriate "look-back" period indicate that the risk of clotting, and perhaps any complication, is greatly diminished, and is in the realm of 1 percent to 2 percent after two years.
St. Joseph's main concerns in dealing with Dr. Midei's medical practice were twofold. First, St. Joseph needed to determine, based on an independent, expert review of Dr. Midei's practice, whether he was competent to continue practice at St. Joseph. Dr. Midei's privileges were suspended in July 2009. Second, St. Joseph undertook a clinical review of all patients over a two-year period in order to determine those patients who needed to be provided this clinical information so that current treatment decisions could be made with this information in mind.
The Maryland Board of Physicians was notified of problems with Dr. Midei's practice in November 2008 and April 2009.
To date, 14 cases have been filed. Different attorneys and different insurers represent Dr. Midei and St. Joseph.
The fact that St. Joseph sent a letter to certain patients is not proof of liability. The plaintiff is required to establish liability prior to receiving compensation. St. Joseph will continue to execute its responsibility to patients who received an unnecessary stent or stents, but determination of liability requires access to all the facts.
St. Joseph has encouraged the plaintiffs' attorneys to submit supporting medical information so that each claim can be properly and fairly evaluated. The hospital has only received that information in a few cases.
St. Joseph has completed expert reviews on all cases identified by plaintiffs' attorneys. There are cases where liability has been established. But there are also cases where liability is questionable or non-existent.
St. Joseph's insurance carrier has worked collaboratively with St. Joseph in making the decision to send notification letters to patients in the first place. St. Joseph's insurers are ready and willing to settle all legitimate claims for fair and reasonable compensation. The biggest barrier is not the insurers but rather the plaintiffs' bar, which refuses to provide requested medical information upon which a determination of liability and an assessment of damages can be made.
Ellen Barton is vice president of governance and administrative services for St. Joseph Medical Center. Her e-mail is email@example.com.