Lok Sabha Question No. 1110 (UNSTARRED), answered on 2019-02-08
Subject: CDSCO Report on Faulty Hip Implants
Ministry: HEALTH AND FAMILY WELFARE
Asked by: JAGDAMBIKA PAL

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

LOK SABHA UNSTARRED QUESTION NO. 1110 TO BE ANSWERED ON 08 TH FEBRUARY, 2019

## CDSCO REPORT ON FAUL TY HIP IMPLANTS

## 1110. SHRI JAGDAMBIKA PAL:

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

- (a) whether the Government has received any report from the Central Drugs Standard Control Organisation (CDSCO) on the issue of faulty ASR Hip Implants and if so, the salient findings and recommendations thereof;
- (b) whether the Government has accepted and acted upon the recommendations of the said report and if so, the details thereof and if not, the reasons therefor;
- (c) whether all of the affected patients in India have received compensation from Johnson & Johnsonand if so, the details thereof and if not, the reasons therefor;
- (d) whether consultations were held with patients while deciding the formula, if so, the details thereof along with the basis of deciding on a formula for payment of compensation; and
- (e) whether the Government is proposing to take criminal action against Johnson & Johnson and if so, the details thereof and if not, the reasons therefor?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a) to (e): The Government had constituted a committee to examine the issues relating t faulty  Articular  Surface  Replacement  (ASR)  Hip  Implants. The  committee,  after  detailed examination  of  the  issue,  submitted  its  re port.  Specific  recommendations  of  the  Committee include:
- I. Compensation to ASR patients by the firm.
- II. Constitution of Central Expert Committee and Regional Expert Committees.
- III. Extension of ASR Reimbursement Program by the firm.
- IV. Health assessment of the patien ts.
- V. Patient awareness.
- VI. Medical Management to patients by the firm.

The Government accepted the recommendations with some modifications. Based on the accepted recommendations, the Government constituted a Central Expert Committee under th Chairmanship  of  Dr.  R.K.  Arya,  Director,  Sports  Injury  Centre  inter -alia  to  determi ne  the quantum of compensation.

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

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

Subsequently,  the  Central  Expert  Committee  has  invited  the  affected  patients/ representatives/stakeholders in the meeting and given audience to those present in the mee

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 approved by the Governme in the interest of the patients. How ver, M/sJohnson & Johnson Pvt. Ltd. has c llenged the exp ert 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  cancell ed  under  the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 thereunder.

## Formula for determining compensation for the affected patients.

<!-- formula-not-decoded -->

## Risk Factor (R)

| Percentage Disability   |   Risk factor to be assigned |
|-------------------------|------------------------------|
| 20% - 30%               |                          1   |
| 30% - 40%               |                          1.5 |
| 40% - 50%               |                          2   |
| 50% & above             |                          2.5 |

## Age Factor (F)

|   Age |   Factor |
|-------|----------|
|    16 |   228.54 |
|    17 |   227.49 |
|    18 |   226.38 |
|    19 |   225.22 |
|    20 |   224    |
|    21 |   222.71 |
|    22 |   221.37 |
|    23 |   219.95 |
|    24 |   218.47 |
|    25 |   216.91 |
|    26 |   215.28 |
|    27 |   213.57 |
|    28 |   211.79 |
|    29 |   209.92 |

|   30 |   207.98 |
|------|----------|
|   31 |   205.95 |
|   32 |   203.85 |
|   33 |   201.66 |
|   34 |   199.4  |
|   35 |   197.06 |
|   36 |   194.64 |
|   37 |   192.14 |
|   38 |   189.56 |
|   39 |   186.9  |
|   40 |   184.17 |
|   41 |   181.37 |
|   42 |   178.49 |
|   43 |   175.54 |
|   44 |   172.52 |
|   45 |   169.44 |
|   46 |   166.29 |
|   47 |   163.07 |
|   48 |   159.8  |
|   49 |   156.47 |
|   50 |   153.09 |
|   51 |   149.67 |
|   52 |   146.2  |
|   53 |   142.68 |
|   54 |   139.13 |
|   55 |   135.56 |
|   56 |   131.95 |

| 57        |   128.33 |
|-----------|----------|
| 58        |   124.7  |
| 59        |   121.05 |
| 60        |   117.41 |
| 61        |   113.77 |
| 62        |   110.14 |
| 63        |   106.52 |
| 64        |   102.93 |
| 65 & more |    99.37 |

For easy understanding of the patients, illustrative cases of the amount of compensation payable to the patients with ASR Hip implant with disability in relation to their Age and Percentage Disability would work out as below:

| Age        |   Age Factor as per Clinical Trial Formula |   Compensation Amount (in lakhs) for Disability 20- 30% (Risk Factor 1) |   Compensation Amount (in lakhs) for Disability 30- 40% (Risk Factor 1.5) |   Compensation Amount (in lakhs) for Disability 40- 50% (Risk Factor 2) |   Compensation Amount (in lakhs) for Disability50% above (Risk Factor 2.5) |
|------------|--------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 20         |                                     224    |                                                                   55.08 |                                                                     77.63 |                                                                  100.17 |                                                                     122.71 |
| 25         |                                     216.91 |                                                                   53.66 |                                                                     75.49 |                                                                   97.31 |                                                                     119.14 |
| 30         |                                     207.98 |                                                                   51.86 |                                                                     72.79 |                                                                   93.72 |                                                                     114.65 |
| 35         |                                     197.06 |                                                                   49.66 |                                                                     69.49 |                                                                   89.32 |                                                                     109.15 |
| 40         |                                     184.17 |                                                                   47.07 |                                                                     65.6  |                                                                   84.14 |                                                                     102.67 |
| 45         |                                     169.44 |                                                                   44.1  |                                                                     61.15 |                                                                   78.21 |                                                                      95.26 |
| 50         |                                     153.09 |                                                                   40.81 |                                                                     56.22 |                                                                   71.62 |                                                                      87.03 |
| 55         |                                     135.56 |                                                                   37.28 |                                                                     50.93 |                                                                   64.57 |                                                                      78.21 |
| 60         |                                     117.41 |                                                                   33.63 |                                                                     45.45 |                                                                   57.26 |                                                                      69.08 |
| 65 & above |                                      99.37 |                                                                   30    |                                                                     40    |                                                                   50    |                                                                      60    |