Hip replacement with faulty hip implant : Consumer Court directs Rs 12 lakh compensation
New Delhi: Holding deficiency and negligence, District Consumer Disputes Redressal Forum has directed and ASR tm & ASR tm XL Hip Systems (Johnson and Johnson hip implant) to pay a compensation of over Rs 12 lakh to a patient on account of hip replacement surgery using DePuy ASR and AML Femoral Stem Implants which was later found to be broken.
The case dates back to 2006 when a 21-year-old was diagnosed with Juvenile Spondyloarthropathy with bilateral AVN of Hip joint and required the primary surgery. The patient underwent surgery at Krishna Institute of Medical Sciences for replacement of right Hip on 5th July 2006 and left Hip on 8th July 2006. However, after a few years he started suffering from severe pain in the left Hip while walking.
In 2016, he visited Maxcure Hospital where he was advised to undergo a revision Hip replacement as the X-ray showed a broken implant. The hospital informed the patient that the implants used were DePuy ASR and AML femoral stem which was recalled for a high incidence of failure.
The patient then approached ASR tm asking them to reimburse his second surgery expenditure. However, in 2017 the firm denied the claim. The patient moved a complaint with the consumer forum against the hospital as well as the implant manufacturer claiming a relevant refund.
The hospital in its submission, agreed that the said surgery was performed by them using the said implant. However, it stated that in so far as the second surgery the complainant underwent and recall and high incidence of failures in the implants used –these are not cogent and tenable allegations. The surgery done by them almost eleven years back was performed with the quality implants available then and does not imply that it was substandard.
The supplier of the implant - (implant marketed by DePuy Medical Private Limited which later merged with Johnson and Johnson Limited w.e.f. August 2014 and hence the answering opponent herein,
The company raised the objections that the complainant has failed to prove the inherent manufacturing defect in the ASR Hip implants and the onus lies heavily on him to do so. Not all patients who received the ASR implants have had revision surgery to allege manufacturing defect. In this instant case, the complainant is only complaining about pain in the left Hip – which further establishes that there were no defects in the implants.
In their submissions, they stated that they obtained import license from Drugs Controller General of India (DCGI) on 15thDecember, 2006 and subsequent renewal was valid till 31-10-2012. All artificial implants will have some wear and tear as they interact. They also submitted a background of ASR recall adding that after issue of recall notice, they did not sell any ASR products to the dealer or Hospital. The recall notice also explicitly stated the action points for surgeons, as well as patients follow up.
Based on their statistics – 4700 ASR surgeries were estimated to be conducted in India till the voluntary recall. Not all registered patients may require revision surgery.
The complainant was suffering from Juvenile Spondyloarthropathy with bilateral AVN of Hip joint. Thus the complainant’s medical condition required the primary surgery. The ASR reimbursement program was only for patients who were required to undergo revision surgery within a period of 7 years, from date of primary Hip surgery. Later it was extended to 10 years. In the instant case, since the complainant’s revision surgery is required after 10 years – he is not eligible. With these submissions, they sought the complaint be dismissed.
The forum noted that the following point needed to be analysed
Have the Opposite parties No.1 and 2 been deficient in using the said implants and not intimating the complainant regarding the voluntary recall?
Going through the full details of the case the court noted
The Opposite party No.2 (Company) has not taken proper remedial measures to inform the patients who had undergone implant surgery. The Hospital i.e., opposite party No.1 (hospital and Opposite party No.2 had the information on the complainant. By their own admission approximately 4700 ASR surgeries were carried out in India - where all the patients traced out? Is the important question to be answered. The period of 10 years is not the valid ground to dispute and repudiate.
They had to reach out to patients who underwent surgery using their faulty implants. The evasive attitude in providing information on the faulty device only shows that opposite party No.2 cares very less about the patients and proves their deficiency in service.
A “remedial and reimbursement process” was put in place as per the evidence adduced by Opposite party No.2. They engaged the services of M/s. Puri Crawford and Associates India Private Limited to handle all claims related to recall. Obviously this was initiated since the implants were found faulty. The complainant did not receive any information from them. Due diligence was certainly lacking and not intimating the complainant about the recall amounts so grave deficiency and negligence on the part of Opposite party No.1 and opposite party No.2.
Have the Opposite parties No.1 & 2 been deficient and negligent in not reimbursing the 2nd surgery expenses incurred by the complainant?
On this point the court again noted
In August 2010, the company – Opposite party No.2 voluntarily recalled ASR implants world wide - Ex. B6 to B10 is filed as evidence for this. The 10 years period then does not apply since the complainant had undergone the primary surgery in 2006 only. The suffering of the complainant cannot be limited by the 10 years period but that he needs revision surgery and he was not examined before this for the damage he suffered. For the extent of damage suffered he has filed....
Obviously Opposite party No.2 has established a helpline and if it is an ongoing process and they are aware that patients will reach out seeking their claim management services. Given this scenario, rejecting the complainant’s case certainly lacks the dignity and care he deserves.
The forum then held the company responsible
On view of the reasoning given in point no. 1 & 2, we opine that the complainant has proved his case beyond doubt and opposite party No.2 are well aware of their role and responsibility. Their act of evading speaks volumes for deficiency in service and gross negligence and is against the essence of the C. P. Act 1986, based on the principles of natural justice.
The complainant ought to be compensated reasonably for the delay and trauma he has had to suffer, especially given his health condition.
The forum then directed the company to pay compensation
1. To pay Rs.5,03,930/- towards medical expenses incurred for revision surgery.
2. A sum of Rs.5,00,000/- is deemed reasonable and necessary as compensation and incidental expenses.
3. Rs.15,000/- towards costs of litigation.
The forum did not issue any directions against the hospital