NCDRC holds no Medical Negligence while conducting transpedicular screw fixation, exonerates Neurosurgeon

New Delhi: Observing that the adopted treatment method was an accepted medical practice, the National Consumer Disputes Redressal Commission (NCDRC) recently exonerated a Neurosurgeon and hospital from charges of medical negligence while conducting transpedicular screw fixation between vertebrae on a patient suffering from Osteoporosis.

Referring to the MCI order, which had also exonerated the doctor, the top consumer court noted, "The OP-1 adopted the standard reasonable practice and also followed ethical principles to his professional colleague the anaesthetist, whose mother was operated by OP-1. We haven't expected, but surprised that the patient's son being an anaesthetist, how can raise frivolous allegation that pre anaesthetic check-up was not done. We find the doctors treated the patient reasonably and there was no deficiency or negligence during the treatment."

"In our view, the complaint was filed, simply to blame for untoward incident to get some compensation. The Complainant aims to turn the wheels of fortune in his favour by demanding such immense damages," it added.

Back in 2011, the complainant had approached Dr RC Mishra with complaints of severe backache. Therefore, her husband had informed the doctor about the Osteoporosis of the patient. After examination, the doctor had advised her for immediate admission to Kamayini Hospital. It was alleged that the physician's opinion and neurological evaluation was not done and no proper pre-anaesthetic check-up was done by the Anaesthetist.

After condicting MRI test, the report revealed collapse of D-10 vertebra and the X-Ray showed traumatic compression of D-11 vertebra and severe Osteoporosis. However, the complainant alleged that the doctor did not bother to reconfirm the report by repeat X-Ray or MRI, and operated on the patient. Following the completion of the operation, the doctor informed the husband of the complainant that due to very weak/fragile bones, he did not fasten the screws to its full extent.

It was alleged that the hospital forcefully discharged the patient on a critical condition. Following this, the patient received treatment at another facility in Agra and remained under the care of Dr. Singhal. Later, she had been diagnosed as tubercular infection (TB) at Indian Spinal Injuries Centre (ISIC) in New Delhi. Since, the backache continued at the site of surgery, she had been admitted to ISIC, where Dr. Deepak Raina examined the patient and informed about a wrong surgery performed at Agra. He mentioned that since the patient was suffering from Osteoporosis, such kind of surgery was not recommended. He also informed that even though 8 screws are necessary for fastening, the operating doctor had fastened just 4 screws.

At ISIC, X-Ray and CT Scan report revealed Osteoporosis and bilateral pleural collections, which was suggestive of consolidation/collapse of the lungs. The patient had been re-operated at ISIC on the same vertebra with bone cement augmentation under the supervision of Dr Raina and Dr Das. Later, post-operative check X-Rays and CT scan confirmed successful operation with intact screws.

Therefore, alleging negligence against Dr Mishra and Dr Gupta of Agra based Kamayani Hospital, the patient approached NCDRC and prayed for Rs. 1,02,01,000. It was the contention of the complainant that the doctors and the hospital ignored Osteoporosis and performed the operation unscientifically, which led to permanent disability of the patient.

On the other hand, the doctors and the hospital denied all kinds of allegations labelled against them- including negligence during treatment, forceful discharge of the patient in a critical condition and also the allegation that the operation had been performed despite the patient's weak and fragile bones with severe osteoporosis.

The doctor informed the NCDRC bench about the treatment record of the patient. he had conducted transpedicular screw fixation between vertebrae, which was followed by decompressive laminectomy of D-11 lamina. No Dural injury was found and no CSF leak was noticed. Suboptimal purchage of one screw at D10 was suspected and it was intimated to the attendants after surgery. Locally available bone was used as graft and put along screw-head.

It was further informed by the doctor that the patient's treatment had been modified from time to time and bedside x-ray of the chest showed problem with one screw, which needed fastening. The doctor further informed that it was her son, who sought discharge from the Hospital assuring that he would manage the antibiotics at home in consultation with a physician of his own choice. 

Dr Gupta at Rashmi Medicare Centre had also informed the patient's family about the need for a re-operation and resetting the loose screw. However, the patient got a discharge from there as well. 

The counsel for both the parties reiterated their versions and relied upon several medical and surgical articles. The commission noted that the contention of the Complainant was that such fractures have to be fixed at least two level above and two levels below to stable, or augment the fractured vertebrae with screw/ cage or cement.

In the concerned case, Dr. Mishra fixed four pedicle screws, two above (short segment fixation) and two below for a fracture of vertebra the spine. The doctor defended this by referring to an article from the year 2000 and he claimed that he had been carrying out the good old treatment method. As per the article short segment fixation could be employed in a very small subset of patients with simple fractures, and those who were willing to wear a brace for four months.

Taking note of this contention, the NCDRC bench observed, "In our view the method of treatment adopted by OP-1 was as an accepted medical practice. Pedicle screw fixation is widely used in spine surgery for numbers of indications, such as degenerative disease, trauma, tumor, infection, and deformity. It reduces the range of motion of the stabilized spine, increases the fusion rate, and is generally considered to be safe with relatively low complication rate associated with the device. Therefore, the decision to perform short or long fusion remains individualized to each patient, and depends on a multitude of factors as discussed. The current study results suggest that either approach can achieve sufficient correction if performed appropriately. Thus, the surgeon must balance the advantages and disadvantages of each fusion procedure when deciding which surgical procedure is most suitable for a patient."

Referring to the article 'Outcomes of Short Fusion versus Long Fusion for Adult Degenerative Scoliosis: A Systematic Review and Meta-analysis' the Commission noted, "The long segmented fusion is used to fix the mobility of vertebra. In the instant case D11 is a stable vertebra, it was damaged; therefore short segmented fusion was not a wrong method. Only 4 screws were used 2 at D10 and 2 at D12. Thus, cost of extra 4 screws was saved."

The top consumer court noted that the core question that concerned the case was whether the treatment adopted by Dr. Mishra had deficiency and if it was contrary to the reasonable practice in Neurosurgery.

Referring to concerned medical literature, the Commission noted, "cement augmentation has its own potential side-effects and irreversible neurological deficits or sometimes entails death. Moreover, sometimes re-absorption of screw chemicals of the augmented pedicle screw lead to loosening. Sometimes the broken screw can't be taken out. In the instant case, four screws were used as two in D-10 & two in D-12. One screw-problem may be classified as 'mal-positioned' due to obesity and excessive fat, which led to inadequate x-ray evaluation. It is pertinent to note that three screws were retained during 2 nd surgery at ISIC, thus meaning thereby Osteoporosis effect was not for the three screws..! In our view, the mistake of the patient's son that he took premature discharge from Kamayani Hospital, he took her home first and then, after about 9 hours, at 8 pm got her admitted in Rashmi Medicare Centre. The duty of care for the patient reflects as out of courtesy, the patient was regularly seen by colleague of OP-1 Dr. Sanjai Gupta at Rashmi Medicare Centre."

At this outset, the Commission referred to the letter issued by Dr. Tarun Singhal of Rashmi Medicare Centre. It mentioned, "Dr. Sanjay Gupta (MS. M.Ch. Neurosurgeon) was also looking after her, (who was in the operative team of patient Mrs. Manjulata Garg in Kamayani Hospital) till her discharge. He had visited her complimentary without any charge."

"The patient thereafter had developed hospital acquired respiratory infection with pleural effusion which has turned out to be TB at ISIC which cannot be attributed to the treatment given by OPs. We agree with the observations and the Order of MCI dated 19.0.2013 which exonerated the OP-1 with warning to maintain proper record and follow proper procedures before and after surgery in future. Such warning itself does not constitute medical negligence of the OPs," further noted the NCDRC.

Referring to the Supreme Court order in the case of Kusum Sharma Vs Batra Hospital & Ors., which discussed breach of duty of a doctor, the Commission noted, "In the instant case we do not find any breach of duty of care from the OP-1 who treated the patient, who was in-turn a mother of one anaesthetist."

The consumer court also referred to three discharge summaries of ISIC and noted,

"Therefore, collective reading of three discharge summaries, it is clear that the patient suffered neurological symptoms almost after one year of the surgery performed at ISIC. The MRI report dated 16.06.2012 showed mild atrophy of the cord at D8 to D11 suggesting myelomalacia. It is further to note that in the first two discharge summaries, there was no mention of TB or Anti Tubercular treatment (ATT) treatment. The third discharge summary was almost after one year and it revealed continuation of ATT treatment. Nothing is forthcoming about the AFB positive status or the diagnosis of TB. Moreover, nothing is on record to show when and where ATT with AKT4 started. All the discharge summaries of ISIC are silent on this issue. As per the medical literature, TB usually gets manifested 6 weeks after exposure of infection. Therefore, the Complainants arguments on this issue are unsustainable as we do not find any nexus between operation performed by OP-1 and further development of paraparesis and/or tuberculosis."

NCDRC further relied on Supreme Court order in the case of Bombay Hospital & Medical Research Centre vs. Asha Jaiswal & Ors., C.P. Sreekumar (Dr.), MS (Ortho) v. S. Ramanujam, and Dr. Harish Kumar Khurana v. Joginder Singh & Others.

To read the order, click on the link below.

https://medicaldialogues.in/pdf_upload/ncdrc-order-180444.pdf

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