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Duty to ensure quality, design and safety of IOL: Manufacturer, Dealer or Treating Doctor?

Duty to ensure quality, design and safety of IOL: Manufacturer, Dealer or Treating Doctor?

By: Prof. (Dr.) Mukesh Yadav Published Date: 17-09-2019 DOI : 10.13140/RG.2.2.18302.74560 Issue Date: 13-09-2019

Abstract

In a catena of judgements, the Hon’ble Supreme Court has laid down the essential components of ‘Negligence’ as follows:

  1. The existence of a duty to take care which the defendant owes to the plaintiff;
  2. The breach of that duty towards the plaintiff and
  3. Damage or injury by the complainant as a result of such breach.

            The ‘Duty of Care’ for a medical professional starts from the time the patient gives an implied consent for his treatment and the medical professional accepts him as a patient for treatment, irrespective of financial considerations. This duty starts from taking the history of the patient and covers all aspects of the treatment, like writing proper case notes, performing proper clinical examination, advising necessary tests and investigations, making a proper diagnosis, and carrying out careful treatment. [Para 17]

It is pleaded by the Treating Doctor that it is not possible to check the functional ability and the quality of the said lens by ordinary and physical examination; same has to be tested using specialised equipments which are available only with the manufacturers.

It is further stated that before the packing of the lens it is the Manufacturer’s duty to check the quality of the functional ability and certify their safety.

It is presumed that such lens supplied by a reputed company like the Manufacturer herein would confirm to the best possible quality design and safety. The box containing The lens are not opened till implantation as there is strong chance of them getting contaminated, hence the box containing the lens was intact and not opened till just prior to the surgery. [Para 5]

NCDRC relying on medical literature observed that from the aforenoted standard protocol it is clear that it is the surgeon, who has to verify the quality of the lens, which includes the power and the suitability. The quality of the lens includes checking the opaqueness, if any, in the subject lens. NCDRC concluded that therefore the contention of the Doctor that the quality/ opaqueness or otherwise can be examined only by the manufacturer alone cannot be sustained. [Para 20]

This paper deals with duties of various stake holders in a case of Cataract Surgery and discussed relevant issues of medical negligence.

Question for Consideration:

  1. Whether the lens were opaque or not can be verified if it is an open lens and that at the time of cause of action preloaded lenses were not ordinarily used?
  2. Whether the Treating Doctor could verify the opaqueness or otherwise of the lens, just prior to the surgery?
  3. Whose duty to ensure quality, design and safety of IOL (Lense)? Manufacturer, Dealer or Treating Doctor
  4. Whether the wrong IOL model or power has been pulled?
  5. Who has to verify the quality of the lens, which includes the power and the suitability?

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