Complaint process

I filed a complaint with the Patient Advocate at the Hospital. She was very supportive on the phone and asked me to send the letter. This is what I sent her

Dear Ms Eller,

Pls refer to our telephonic conversation. I am attaching my story as talked with you. I chose to deliver at Edward because of the excellent reputation I had heard about the hospital. Infact i chose my doctor based on edwards referral program. So I was naturally stunned when this happened to me. I believe that when this can happen to an educated, logical girl like me , there are many more who are subjected to unnecessary pain and trauma.

At the request of the Food and Drug Administration (FDA), Bristol-Myers Squibb has strengthened its US label for warfarin (Coumadin) to include a black-box warning about the risk for major or fatal bleeding. It says that bleeding is more likely to occur during the starting period. Among others, the risk factors for bleeding include trauma, anemia and concomitant drugs

Warfarin label also reads that warfarin is contraindicated with recent traumatic surgery resulting in large open surfaces. Potential adverse reactions to COUMADIN may include: Fatal or nonfatal hemorrhage from any tissue or organ. This is a consequence of the anticoagulant effect. Therefore, the possibility of hemorrhage should be considered in evaluating the condition of any anticoagulated patient with complaints which do not indicate an obvious diagnosis. (Source: http://www.fda.gov/medwatch/safety/2006/coumadin_PI_april2006.pdf)

And yet I was given Coumadin following recent abdominal surgery (C section), in absence of any symptoms and inconclusive CT scan reports. And these were continued for next 5 days in spite of my repeated denial of all symptoms (Pls see hematologist initial report saying that patient says she feels fine ) bleeding from surgical site, drainage from c section incision, increasing anemia in spite of thrice a day oral iron, increasing WBC count on antibiotics, fever and complete wound separation. After 5 days, clarification CTA and other required tests like VQ Scan and Ultrasound of lower extremities were ordered to conclusively rule out PE and DVT. It was determined I had no PE\DVT and I was not required to be on anticoagulation ever. I had several thousands in medical bills, severe anemia, weakness and anxiety and a 13 cm long and 2.5 cm deep abdominal wound for 14 weeks.

The FDA Med watch announcement also notes that warfarin prescriptions will also be issued with a new patient medication guide warning about potentially serious bleeding with the drug. FDA regulations state that such medication guides are to be provided with each prescription that is dispensed for products that the FDA determines pose a serious and significant public health concern. I was also not made aware of the possibility of bleeding on Coumadin.

This incident happened under the treatment of Dr Vimi Bajaj following my C section on January 10, 2008. I was hospitalized from Jan 10 - Jan 18, first in the OB ward and then at the Heart Hospital. I strongly urge you, to take necessary action against the doctor so that no more patients like me are subjected to unnecessary trauma, pain and suffering. Such doctors should not be allowed to practice especially at big hospitals like Edward. At the very least they should be asked to undergo special continuing education classes before they are allowed to practice at Edward.

The other doctors involved in my care were Dr Ann Davis and Dr Stanley Clark from the cardiology department and Dr Maria Quejada from the Hematology department.
Thank you



Attached:
My incidence of what happened Before, during and after my delivery