This case study based in hip implant which was done by johnson and johnson company ,controversy on hip implant, compensation, adverse effect, and many more
4. 1886- 3 brothers founded Johnson & Johnson in New
Jersey.
1888- The first commercial First Aid Kit
1894- Launches first maternity kit to make child birth
safer
1898- First to mass produce dental floss
1921- An employee invents the first BAND-AID
1954- Baby products enter the market
2008- Introduction of medical devices into market
HISTORY
7. PROFILE:
In 1988, he began his career as sales representatives with Janssen
pharmaceutical
In 2001, Alex was appointed president of Janssen
In 2003, he was named company group Chairman J & J
In 2004, he left J & J to join Novartis pharmaceutical
In 2008, he returned to Johnson & Johnson
8. In 2009, he was appointed a chairman of medical devices
segment
In 2011, he was named vice chairman of J and J
In 2012, He became CEO of J and J
In 2013, he became chairman and Board of director
Alex has been named one of the “100 most inspiring leaders ”
by Pharma voice
9. CORPORATE STRUCTURE
J&J formed a divisional organization structure for better control
and coordination
J&J consist of 180 operating units
Meet with customer demand
A good strategy is maintained due to customer feedback
J&J coordinated with local people around the world
10. HIP REPLACEMENT SURGERY
It is a surgical procedure which involves removal of
painful hip joint and replacing it with artificial joint.
General age is 60 to 80 years.
Occasionally performed in teens and early twenties.
93000 patients globally have been implanted by
devices manufactured by J & J.
J & J imported and sold ASR XL Acetabular Hip System
in India.
11. OVERVIEW
DePuy ASR XL Acetabular System was first available in 2005 in US.
J & J was given special clearance from FDA clinical trials.
Higher than normal failure rate was reported.
EVENTS
TOTAL NUMBER OF
IMPLANTS
TOTAL NUMBER OF
PEOPLE
Sold 15829 --
Fitted 4700 --
Untraceable -- 3600
Died -- 4
Revision surgery -- 254
Recalled 1295 --
13. HIP IMPLANT PROBLEM IN NUMBERS
In India, the company got the license to import the device in 2006
An estimated 4,700 ASR implant had been done in the country
93,000 patients implanted with ASR worldwide
While more then 3,600 of the 4,700 patients could not be traced
The company recalled the product on August 24, 2010
14. COMPENSATION & ADVERSE EFFECTS
License approval in 2006
4,700 implantation
Expert committee by health ministry in 2017
Report & Recommendations :
Compensation of 20L to each patients & reimbursement continues till 2025
Constitution of Central & regional expert committee
Additional to 20L under excessive conditions
Diligence to trace the patients
Reports submissions
Independent registry for tracking high risk medical devices
15. Was it the first time government has examined the problem?
How have other countries addressed the issues?
Waved a clean chit?
Section 328
FIR specificity
No release of toxics
No medical reference
Recalling in US