Without test report, defect acceptable
Sudhakar Chowkekar had developed a cataract in the left eye. After conducting all the pre-operative investigations, he was admitted to Bombay Hospital for surgery by ophthalmic surgeon R C Patel. The intraocular lens (IOL) that had to be implanted was manufactured by Allergan Surgical (USA) and purchased for ~3,200 through dealer Shivnesh Phaco & Eye Micro Surgery.
During the post-operative examination, it was found that the lens was opaque and ineffective, due to which vision diminished from 90 per cent to 30 per cent. Chowkekar was advised to undergo corrective surgery.
The surgeon also informed Allergan USA'S Indian representative, who agreed to bear the cost of the second surgery for removal of the IOL and implant of a new one.
Chowkekar's vision deteriorated further after the second surgery. He had a legal notice issued to the doctor and the implant manufacturer. Patel replied, explaining that the IOL had become opaque, which necessitated a second surgery, resulting in the cornea getting damaged.
Chowkekar filed a complaint before the Maharashtra State Commission against the operating surgeon, the dealer, and the IOL manufacturer through its Indian representative. The manufacturer did not contest the case, but the dealer and the operating surgeon did so jointly. They stated that the IOL manufacturer had a duty to check the quality and functionality of the lens and certify it for safety. They noted that the box containing the lens had been kept sealed till the last minute to avoid contamination, and was opened just when the lens had to be implanted. They added that after the IOL was removed, it was sent to the manufacturer for testing, but the company hdid not respond despite reminders. Failure in improvement of vision even after the second surgery was attributed to corneal changes occurring during the second surgery. They admitted that Chowkekar had become blind, but denied that it was due to their negligence.
The State Commission held the doctor, the dealer and the manufacturer jointly and severally liable to reimburse the medical expenses of ~1,65,364 along with ~ 5 lakh as lump sum and ~20,000 towards costs. It was also ordered that these amounts would carry 9 per cent interest if payment was delayed beyond 45 days.
In the appeal, the manufacturer argued that an IOL could become opaque due to various reasons, and blamed the treating doctor of attempting to cover up his negligence by finding fault with the IOL by terming it to be defective.
The National Commission observed that the defect in the lens was immediately recorded during the postoperative examination. It pointed out that after its removal, the IOL was sent for testing, but the manufacturer had neglected to check it and submit a report despite repeated requests. It concluded that the manufacturer had rightly been held liable.
The National Commission held that the doctor should have examined the lens before implanting it. The failure to examine the IOL and check it for opaqueness was held to be contributory negligence on the part of the surgeon. So it confirmed the order holding Patel to be jointly and severally liable.
By its order of September 13, 2019, delivered by M Shreesha for the Bench headed by Justice R K Agrawal, the National Commission upheld the order passed by the State Commission and dismissed the appeals with further costs of ~25,000 payable by the manufacturer.
The failure to examine the IOL and check it for opaqueness was held to be contributory negligence on part of the surgeon. So it confirmed the order holding him liable