Lok Sabha Question No. 2908 (UNSTARRED), answered on 2018-12-28
Subject: Faulty Hip Implants
Ministry: HEALTH AND FAMILY WELFARE
Asked by: NAGARAJAN P., MUTHAMSETTI SRINIVASA RAO (AVNTHI), RAJESH KUMAR DIWAKAR, GOPALAKRISHNAN CHINNARAJ, KIRTI VARDHAN SINGH

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 2908 TO BE ANSWERED ON 28 TH DECEMBER, 2018

## FAULTY HIP IMPLANTS

SHRI MUTHAMSETTI SRINIVASA RAO (AVANTHI):

2908. SHRI P. NAGARAJAN: SHRI RAJESH KUMAR DIWAKER: DR. C. GOPALAKRISHNAN: SHRI KIRTI VARDHAN SINGH:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a)  whether  the  Government  is  aware of  the  faulty  Hip - im lants  cases  which has  led  to unbearable suffering to the patients;
- (b) if so, the details thereof indicating the name of the company which supplied this faulty hip - implants in India;
- (c) the total number of patients affected/suffered by the faulty hip implants, State/UT - wise;
- (d) whether the Government hasconstituted an expert group/Committee to investigate the matter  in  this  regard  and  if so, the details and findings thereof along with  the  amount  of compensations proposed to be given to each patient; nd
- (e) whether the Government has imposed any penalty on the company who produced faulty hip implants and if so,

the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

## (SHRI ASHWINI KUMAR CHOUBEY)

- (a) & (b): Yes.  The  issue  of  adverse  effects  of  the  product  requiring  higher  rat revision surgeries in patients implanted with the Articular Surface Replacement (ASR implant imported by M/s DePuy Medical Private Limited (Now Johnson & Johnson) was reported t o Central Drugs Standard Control Organisation (CDSCO) ,Ministry of Health and Family Welfare by the said firm.
- (c): As per the information provided by the firm, 1058 patients were registered on Johnson & Johnson Helpline, out of which, 277 patients had undergone revision surgeries. Among 277 patients, 250 were Indian patients. The State/UT - wise data of these patients is attached as Annexure.
- (d) & (e): The Government had constituted a committee to e xamine the issues relating to faulty ASR Hip Implants.  The committee, after detailed examination of the issue, subm its report to the Government, which accepted the recommendations with some modificatio Based  on  the  accepted  recommendations,  the  G overnment  constituted  a  Central  Expert Committee under the Chairmanship of Dr. R.K. Arya, Director, Sports Injury Centre in -alia to determine the quantum of compensation.

The Ministry of Health & Family Welfare has also requested all the States/UTs to form State Level Committees to examine the affected patients within their jurisdiction the process is less arduous for the patients.

A  formula  for  determining  compensation  for  the  affected  patients  has  also  b formulated and placed in public domain. The affected patients can approach either the Central Expert Committee or State Level Committee as per their convenience.

M/s Johnson & Johnson Pvt. Ltd. has been asked to comply with the recommendations of the Committee and to pay the compensation as per the formula approve by the Government in the interest of the patients. However, M/sJohnson & Johnson Pvt. Ltd. haschallenge d the expert committee report on payment of compensation before the Hon'ble High Court of Delhi.

Further, in response to the reports of adverse events and recalls, the Import li M/s.  DePuy  Medical  Private  Limited  (Now  Johnson  &  Johnson) was  cancelled  under  the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 thereunder.

## ANNEXURE

|   S.NO. | State Wise Numbers   |   State Wise Numbers |
|---------|----------------------|----------------------|
|       1 | Andhra Pradesh       |                    9 |
|       2 | Assam                |                    1 |
|       3 | Arunachal Pradesh    |                    1 |
|       4 | Chattisgarh          |                    1 |
|       5 | Gujarat              |                   17 |
|       6 | Haryana              |                   11 |
|       7 | Himachal Pradesh     |                    2 |
|       8 | Jammu and Kashmir    |                    1 |
|       9 | Jharkhand            |                    4 |
|      10 | Karnataka            |                   14 |
|      11 | Kerala               |                   13 |
|      12 | Madhya Pradesh       |                    4 |
|      13 | Maharashtra          |                   65 |
|      14 | Manipur              |                    1 |
|      15 | Meghalaya            |                    1 |
|      16 | New Delhi            |                    7 |
|      17 | Orissa               |                    2 |
|      18 | Punjab               |                    8 |
|      19 | Rajasthan            |                    6 |
|      20 | Sri Lanka            |                    1 |
|      21 | Tamil Nadu           |                   39 |
|      22 | Telangana            |                    5 |
|      23 | Tripura              |                    1 |
|      24 | Uttar Pradesh        |                   24 |
|      25 | Uttarakhand          |                    2 |
|      26 | Uttranchal Pradesh   |                    1 |
|      27 | West Bengal          |                    9 |