Consumer Court junks Rs 20 lakh claim in implant failure case, exonerates TN hospital

A few months later, the complainant experienced unbearable pain and consulted the NRK Hospital in Pudukkottai. After conducting an X-ray, the doctors immediately recommended surgical removal of the earlier plate and a re-surgery. Again, the complainant got admitted to Devadoss Hospital and underwent a second surgery. The previous plate was removed and a new one was fixed. For the first surgery, the complainant paid around Rs 3.5 lakh and for the second surgery, he paid Rs 2 lakh.

The Complainant alleged that due to the improper and negligent manner in which the initial surgery was conducted, he suffered serious complications. Resultantly, he had to undergo another surgery, face financial hardship, endure severe physical pain, mental agony, and lose valuable time. He alleged that owing to the negligence of the treating hospital, he had to endure the pain and consequences of two surgeries, as the plate initially inserted was found to be defective. 

Alleging that the hospital committed serious lapses in its professional duty and is liable to pay for the damages, the complainant filed the consumer complaint seeking Rs 20 lakh as compensation.

On the other hand, the hospital denied the allegations and claimed that the patient was given proper treatment. The complainant was diagnosed with "Closed Traumatic Left Stable IT Fracture + Ipsilateral Shaft of Femur Fracture (Distal)." This diagnosis was clearly explained to the complainant and his family members. Based on the nature and severity of the injury, necessary treatment, including surgical intervention, was advised and undertaken with the consent of the complainant and his family. According to the hospital, the surgery was conducted on 23.05.2023 and another one on 29.05.2023 and the complainant was discharged from the hospital on 03.06.2023. It was alleged that the complainant did not follow the post-op instructions carefully.

The hospital argued that if the complainant had strictly followed the advice regarding physiotherapy and regular reviews, there would have been no complications.

Regarding the implant, the hospital submitted that the plate used for the surgery was of global standard and it is authorised by the Directorate of Central of Health Services, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare.

While considering the matter, the consumer court took note of the discharge summary and noted that the patient underwent two orthopaedic fixation procedures on the same leg during the first admission. On 23.05.2023, an Open Reduction & Internal Fixation (ORIF) with Femur Plating (LCP) was done and on 29.05.2023, Left DHS Fixation (Dynamic Hip Screw) - 95mm, 3-hole plate was performed.

But the Commission noted that the summary did not contain the information about the implant plate. No implant manufacturer, serial number, or batch code is mentioned, which is crucial for traceability and determining defective implant liability.

The Commission also took note of a consultation note dated 22.11.2023 from NRK Speciality Hospital, authored by an independent orthopaedic specialist, which recorded that the complainant suffered implant failure and non-union, which necessitated revision surgery. The expert attributed such complications to one or more of the following: poor surgical technique, inferior implant, or inadequate post-operative care at the initial hospital.

"This opinion assumes evidentiary importance as it emanates from a qualified, neutral expert who had the opportunity to examine the complainant and his clinical records firsthand, particularly on the day of the second surgery. His remarks are not generic; rather, they identify plausible causes of failure based on medical indicators and clinical observation," noted the Commission.

"However, the document itself lists these as possible causes and does not categorically conclude that poor surgical technique alone was responsible," it further noted at this outset.

Even though the Commission noted that the medical record did not include essential traceability data, it observed that mere omission of such details did not by itself prove surgical negligence.

"Importantly, the complainant returned for follow-up in July 2023, nearly two months after the surgery. Ex. A1 (dated 31.07.2023) does not record any complaint of pain, swelling, or dysfunction that would ordinarily signal a botched surgical procedure. The absence of early post-operative complications weakens the inference that the plate broke due to faulty technique. Moreover, the complainant chose to undergo the second surgery again at the same hospital. This decision, while not conclusive, suggests residual trust in the competence of the surgical team. While poor surgical technique is a possible cause mentioned in the independent expert opinion, it is not conclusively proved in this case. The available records do not establish with certainty that the implant plate broke solely due to surgical error by the opposite party," observed the Commission.

"The independent expert opinion does mention inadequate post-op care as one of the possible causes for implant failure, but it does not isolate or confirm this as the actual cause in the present case. No evidence has been produced to show that the opposite party failed to provide adequate post-operative instructions, or that the complainant reported any complications that were neglected by the hospital during the critical healing period," it further noted.

Accordingly, the Commission held,

"Thus, neither contributory negligence by the complainant nor neglect by the opposite party in follow-up care is conclusively established. There is no concrete evidence to prove that the implant plate broke due to lack of post-operative management by the opposite party. The follow-up visits, absence of early complaints, and general compliance weaken the claim of deficient post-op care."

Regarding the opinion by the independent orthopaedic specialist, the Commission observed that the said doctor did not examine the failed implant or conduct any testing of its material properties.

"No metallurgical report or manufacturer trace was produced by the complainant. Therefore, no direct evidence exists to prove that the implant was physically defective or non-compliant with medical standards," the Commission observed.

"On the other hand, the opposite party relies on Dr. ***, an orthopaedic expert, who opines that the implant was of high quality and certified by CDSCO. Although his opinion is general and not specific to this patient, his claim is not rebutted by scientific proof from the complainant’s side," it noted.

Even though the Commission noted that not mentioning critical traceability information-such as implant brand, batch number, or serial ID, was undoubtedly a procedural lapse that goes against standard medical documentation practices, the consumer court held that this alone does not establish that the implant was defective or the cause of pain and resurgery.

"It is also critical to note that the complainant did not preserve or send the failed implant for testing, despite having undergone a second surgery. This omission weakens his claim, because in cases of suspected product defect, the burden lies with the complainant to prove such defect with cogent evidence, which in this case, is absent," the Commission further noted.

Accordingly, holding that there was a lack of evidence to hold the hospital guilty of medical negligence, the consumer court dismissed the complaint while noting,

"The absence of implant traceability in the discharge summary is a procedural lapse, but not enough on its own to constitute “deficiency of service” under the Act. Had the complainant preserved and tested the broken implant, it could have decisively supported his claim. In the absence of such direct evidence, and considering other plausible non-negligent causes (e.g., weight-bearing, reinjury, non-compliance), this Commission cannot impute liability solely on suspicion. The act of returning to the same hospital for the second surgery further weakens the inference of gross negligence or deficient care. It is not proved that the opposite party committed deficiency in service warranting compensation under the Consumer Protection Act, 2019. The complaint, while sympathetic, lacks legally sufficient evidence to justify relief."

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/tn-dcdrc-no-compensation--297702.pdf

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