Collateral Damage: A Patient, a New Procedure and the Learning Curve

Carol Palmer
Maryland Department of Health and Mental Hygiene
Board of Physicians
4201 Patterson Ave.
Baltimore, MD 21215-2222
January 4, 2007

Dear Ms. Palmer,

I have written to you before about Dr. Hugh Calkins at Johns Hopkins Hospital and the injuries suffered there by my wife, Pam Walter, on March 25th, 2002. I recently acquired medical records that had been concealed by Hugh Calkins and I am writing to file a complaint of that concealment – and the information that had been illegally withheld from my wife and me.

Hugh Calkins has violated the following provisions of the Health Occupations Article, Section 14- 404 in that: Hugh Calkins abandoned a patient; (11)Hugh Calkins made and filed a false report or record in the practice of medicine; (12) Hugh Calkins willfully failed to file or record a medical report as required under law, willfully impeded and obstructed the filing or recording of the report., or induced another to fail to file or record the report;Hugh Calkins failed to provide details of a patient’s medical record to the patient on proper request, and in accordance with the provisions of Title 4, Subtitle 3 of the Health – General Article; (17) Hugh Calkins made a willful misrepresentation in treatment.

As follows: Hugh Calkins was engaged by Pamela J. Walter to personally perform a cardiac catheter ablation procedure which took place on March 25, 2002. Without the knowledge or consent of Pamela J. Walter, Hugh Calkins delegated vital aspects of the procedure to a trainee. Hugh Calkins failed to inform Pamela J. Walter that he observed the practice in teaching hospitals wherein “the actual attending shows up to be there during the burn.”

“A doctor who partially abandons his or her patient by improperly delegating to others professional tasks that the doctor was engaged personally to do and agreed personally to do may be liable for traditional professional negligence, lack of informed consent, and breach of contract, depending in part on the nature of the consequences that flow from that abandonment.” Md. Court of Appeals

Johns Hopkins has produced a consent form bearing the signatures of Pamela Walter and myself claiming that Richard Wu met with us before the procedure and explained all the risks of the procedure to us. Regardless of the provenance or contents of that document my wife has never met Richard Wu, and never consented to his use of her body as a training instrument. We did sign a form that said that “Dr. Hugh Calkins/Staff” could operate, and made the ordinary assumption that “staff” meant nurses, technicians and the like. Hugh Calkins was aware that Pamela Walter specifically chose him to personally perform all vital aspects of the procedure. At no time did Hugh Calkins make any expressions that anyone but he would be the prime operator.

Hugh Calkins made and filed a false report or record in the practice of medicine.

Hugh Calkins willfully failed to file or record a medical report as required under law, willfully impeded and obstructed the filing or recording of the report, or induced another to fail to file or record the report; (13) Hugh Calkins failed to provide details of a patient’s medical record to the patient on proper request. On the afternoon of March 25 2002, Hugh Calkins told two family members that a complication had occurred because he – Hugh Calkins – had turned away from the procedure in order to switch catheter sheaths.Hugh Calkins repeated this story to at least three more relatives over the next few days.

On the evening of March 29th, 2002, Hugh Calkins signed the official procedure report stating – for the record – that he, Hugh Calkins,had performed the procedure. On July 28th, 2006, I inadvertently received a new set of Pamela Walter’s medical records from Johns Hopkins Hospital. Two years previous, the hospital had produced an affidavit from the head of the records department swearing that all records had been produced. However, among the records received in July 2006 was a memorandum from Hugh Calkins in which he states that “Richard Wuwas manipulating the catheter at the time that the catheter became entrapped in the mitral valve.” The memorandum is dated May 23rd, 2002. My wife and I made no fewer than six requests for the full record. Documentation will show that largest set of what was sworn under affidavit to be the complete medical record was received in June of 2004 and was comprised of 742 pages. The set of records received in July of 2006 was comprised of 749 pages. There can be no dispute that sometime between June of 2004 and July of 2006, the medical record was tampered with.

Hugh Calkins made a willful misrepresentation in treatment. While seeking her informed consent in 2001 and 2002, Hugh Calkins failed to convey to Pamela J. Walter that he really didn’t know what the risks of the procedure were. Prior to, during, and after the consultation period and the procedure, Hugh Calkins wrote in medical journals: (in 2001) “It is important to note that the techniques used for catheter ablation of atrial fibrillation continue to evolve rapidly. To date, no published prospective, multi-center reports have described the results and complications of catheter ablation of atrial fibrillation. Until such data are available, catheter ablation of atrial fibrillation should be considered as an experimental procedure…” and (in 2003) “it is likely that the complications … probably are actually higher when we finally start to do multi-center prospective trials ,” and (in 2003), “data regarding the efficacy and safety of these techniques are not available.”

Within months of his expressions of assurance to Pamela J. Walter that the procedure carried ordinary risk, and that he himself felt confident and competent in performing the procedure, Hugh Calkins wrote in medical journals that in fact he did not know if the procedure was safe, and that he did not know if the procedure was effective and that he thought the procedure to be “technically challenging” to him. In words apparently not meant for – and definitely not conveyed to Pamela J. Walter as he sought her informed consent – Hugh Calkins said in 2003 — a year after his disastrous experiment on Pamela J. Walter — that the techniques used to treat atrial fibrillation are still in a development stage,” and “data regarding the efficacy and safety of these techniques are not available,” and that “the risk: benefit ratio of these techniques remains to be determined,” and that “a reliable estimate of risk is not yet available,” and Hugh Calkins recommended to his peers that catheter ablation of atrial fibrillation be classified as a Class IIb procedure, meaning that “its usefulness and efficacy is less well established by evidence or opinion,” because “the accumulated evidence is insufficient to determine the complications.”

After conveying to Pamela J. Walter in 2001 and 2002 that pulmonary vein isolation for atrial fibrillation by catheter ablation was a procedure which he felt confident and comfortable in performing in a reasonably safe manner with a reasonable chance of success, Hugh Calkins told representatives of the Food and Drug Administration in 2003 – more than a year after his failed and disastrous experiment on Pamela J. Walter – that “the safety and efficacy of pulmonary vein isolation was unknown then and it is unknown now,” and that he considered it to be “a high risk procedure,” and “associated with a risk of serious complications,” and that “anyone who is doing this procedure realizes there is a learning curve and the learning curve is very rocky as you go up on it and the complications are like no other procedure that’s ever been done in an EP lab…. We don’t know where this procedure is going. It’s evolving rapidly, a procedure with high(er) risks that’s in evolution.” Hugh Calkins never told Pamela J. Walter – who suffered a stroke as a direct result of undergoing this procedure – that “pulmonary stenosis or stroke are clear risks.” No one would consent to a procedure if a doctor told them that it was was experimental, that he did not know of the procedure was safe, that he did not know if the procedure worked, that the procedure techniques were still in a developmental stage, that the procedure was technically challenging and associated with a risk of serious complications – and further, that he intended to let a trainee be the prime operator during the most dangerous part of the procedure because at Johns Hopkins, “the actual attending shows up to be there during the burn.”

Hugh Calkins failed to be candid with us from the start. Hugh Calkins
tampered with the medical record. All of the above is fully documented. To retain the public trust, the Board of Physicians needs to act.

Dan Walter