Kottayam District Commission Dismisses Complaint Against Karithas Hospital Based On Conflicting Medical Literature For Certain Chemotherapy Processes

Brief Facts:

Miss Ansamma Varghese (“Complainant”) was admitted to Karithas Hospital (“Hospital”) for breast cancer treatment. Following investigations and examinations, a mastectomy was performed by Dr. Jojo V Joseph (“Doctor”), and the Complainant was discharged subsequently. Post-surgery, a drainage tube was affixed to her breast for the collection of seroma and other fluid materials. The drainage tube was detached prematurely by the doctor, before the stoppage of seroma collection, leading to the accumulation of waste materials and subsequent infection. Consequently, the Complainant had to be readmitted to the hospital, experiencing vomiting, fever, and severe pain. She was admitted to the hospital for 14 days and was eventually discharged with extensive antibiotic treatment to combat the infection.

Further issues arose during the administration of chemotherapy through a chemo port. Despite an initial successful therapy session, subsequent attempts failed as the port was found to be blocked. Seeking resolution, the Complainant visited the Hospital to consult the Doctor. Examination revealed a blockage in the chemo port, hindering proper flushing. The situation worsened during the removal of the embolished chemo port by the Doctor, resulting in the breaking of the port's tip. Efforts to extract the broken tip from the Complainant's chest proved futile and she was later admitted to the cardiology ICU. The broken tip was eventually removed through angiography conducted by a Cardiologist. However, inadequate wound stitching post-angiography led to broken sutures and infection. Later, the Complainant was discharged, with a prescription for antibiotics to address the wound infection.

Feeling aggrieved by the negligence on the part of the Hospital and the Doctor, the Complainant filed a consumer complaint in the District Consumer Disputes Redressal Commission, Kottayam, Kerala (“District Commission”).

In response, the Hospital denied any negligence or deficiency in service, asserting that the Complainant's treatment followed universally accepted medical protocols. The Hospital contended that the surgery and subsequent treatments were conducted with utmost care, and any complications, such as infection, were addressed promptly. The Doctor argued that complications, such as infection and chemoport issues, are known risks associated with the procedures and do not indicate negligence.

Observations by the Commission:

The District Commission noted that the Complainant cited Bailey and Love's Short Practice of Surgery, which emphasized that drains should be removed as soon as possible, particularly when drainage has ceased or reduced to less than 25 ml/day. The Complainant also cited a methodological mini-review from Cureus on drainage after modified radical mastectomy, stating that early removal of drainage systems might limit injuries and infections while possibly increasing the incidence of seromas. However, the District Commission noted that there was no unanimous opinion on the optimal time for drain removal, with suggestions that the best patient outcomes occur when drains are removed on the second or third postoperative day or when the drained fluid in the last 24 hours falls below 50 millilitres. The District Commission further referred to another medical literature which discussed the duration of suction drains after breast surgery, noting that although suction drainage reduces the incidence of seroma formation, keeping drains 'in situ' (in their natural surroundings) for an extra day does not prevent seroma formation.

In light of the medical literature and the absence of substantial complaints during the consultation with the Doctor, the District Commission opined that the Complainant's claim that the infection resulted from the earlier detachment of the drain tube by the doctor wasn't accepted.

Addressing another contention of the Complainant that the inserted chemo port was later found blocked, the District Commission held that the breakage of the chemo port was a medically reported and accepted complication in chemotherapy treatment. Referring to an expert opinion, the District Commission noted that over the expert's ten-year career, he had attended four other cases of a similar nature. Importantly, the expert opined that the breakage of the chemo port was not due to negligence on the part of the Doctor. Further, the District Commission highlighted that the Complainant did not make efforts to present expert testimony from Surgical Oncology or Interventional Cardiology to support her case. Therefore, the District Commission dismissed the complaint.

Case Title: Ansamma Varghese vs Karithas Hospital and Anr.

Case No.: CC/43/2019

Advocate for the Complainant: K. Karjet

Advocate for the Respondent: Preetha John K. and M.C. Suresh

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