JOHNSON & JOHNSON

What kinds are the hip implants at the center of the current controversy?
These are metal on metal, with cobalt, chromium and molybdenum as major constituents. Called
ASR (Articular Surface Replacement) XL Acetabular System and ASR Hip Resurfacing System,
these were being manufactured and sold for several years by Deputy International Limited
(DePuy), UK, a subsidiary of Johnson & Johnson.

2003- J & J subsidiary De Puy Orthopaedics begins marketing ASR Hip Resurfacing System only
outside the US.

2004- DePuy launches ASR XL Acetabular System worldwide.

2005- USFDA gives ASR XL marketing clearance following pre-market submission to

demonstrate it’s at least as safe and effective as an already-present device

DECEMBER 6, 2006 - DePuy International registers ASR XL Acetabular and ASR Hip
Resurfacing systems for import and marketing in India.

DECEMBER 15, 2006: DuPuy International granted import license in India.

2007- The Australian Registry warned Johnson & Johnson about high numbers of revision
surgeries- or surgeries to fix a problem that surfaces after the first hip replacement is implanted.
However, Johnson & Johnson continues worldwide sales of the DePuy ASR and XL hip implant
despite this evidence.

2009- FDA decides not to approve a version of the ASR for sales in the United States, but Johnson
& Johnson continues to sell a similar version to US patients, which made it to market through a
loophole in the FDA’s approval process.

DEC 2009- DePuy removes products from Australia upon its regulator’s intervention (J&J
spokesperson claims it decided to discontinue the systems due to declining demand).

2010- The National Joint Registry of England presents evidence that at least 12% of all the ASR
hip implants were being revised (replaced in a second surgery) after only 5 years.

2010- On August 24th, Johnson & Johnson finally pulled the ASR off the market in the United
States. Johnson & Johnson sold more than 93,000 ASR hips worldwide before finally shutting
down sales of this defective product.
Why Johnson & Johnson recalled the product? What problems arose with those hip
implants?
When the prosthetic ball and socket rub against each other, it causes wear. If the implant is metal
on metal, this can sometimes release metallic debris into the bloodstream. This can lead to
complications, sometimes requiring revision surgery. Of the 93,000 patients implanted with ASR
worldwide, many experienced serious adverse reactions, some requiring revision surgery to
replace the ASR implant with another kind. Because of this, the company recalled the product on
August 24, 2010.

FEB 2010: India’s central drug regulator (CDSCO) gives DePuy’s fresh imports license for
implants on the basis of renewed registration.
At the time of application of its renewal certificate and import licence, Johnson and Johnson failed
to inform the Drugs Controller-General India (DCGI) of the intervention by the Therapeutic Goods
Administration, Australia. This omission amounted to a violation of the conditions of the
Registration Certificate under Form 41 of the Drugs and Cosmetics Rules, 1945, which requires
the manufacturer or authorized agent to inform the DCGI of restrictions imposed by regulatory
authorities of other countries where the drug or device is marketed.
It could be argued that the device was being marketed without a valid licence given that it was
obtained by misrepresentation. This should attract a minimum term of imprisonment of three years
under the Drugs and Cosmetics Act. Although the Act also allows fines imposed to be paid as
compensation to victims, this applies only to adulterated and spurious drugs; these terms cannot
be applied meaningfully to medical devices.
2010: When was this problem first examined in India?
This issue was first raised in 2010, when the Maharashtra Food & Drug Administration
(FDA) got an anonymous complaint about a patient suffering a serious adverse reaction, leading
to an FDA investigation and an FIR with Mahim police.

DEC 2010: In response to a query on the recall, DePuy tells CDSCO that 1,295 of 15,829 implants
are successfully recalled, while 4,700 are already used in patients.

SEPT 2011: CDSCO asks DePuy to share details such as recall procedure, reason and
compensation details.

DEC 2011: CDSCO asks DePuy for details of patients paid compensation again. DePuy says
information is confidential and only with surgeons and hospitals
2012: The state FDA asked the regulator CDSCO to cancel the firm’s import license for not taking
proper remedial measures or creating awareness about the “defective”.

JULY 2012: CDSCO cancels import and marketing permissions “in public interest” and tells
DePuy it failed to take proper measures to make patients aware implants were recalled due to
“defectiveness”.

NOVEMBER 2013: J&J announces $2.5-billion ASR settlement for around 8,000 patients in the
US.
Under the agreement, the Johnson & Johnson paid nearly $2.5 billion in compensation
to an estimated 8,000 patients who have been forced to have the all-metal artificial hip removed
and replaced with another device. The company has agreed to pay all medical costs related to such
procedures, expenses that could have raised the deal’s cost to Johnson & Johnson to $3 billion.
The compensation got reduced due to certain factors Under the plan, plaintiffs who smoke, were
overweight or older got reduced compensation. In addition, the plaintiff who had the device
implanted for a longer period of time got reduced compensation.
Only two law suits went to trial in US: In March 2013, a Los Angeles jury ordered DePuy to pay
$8 million in damages to a Montana man after finding that the A.S.R. was defectively designed.
In August 2013, a Chicago jury sided with DePuy and rejected claims that it had inappropriately
marketed the implant.

2013: CDSCO issued a medical device alert on ASR implants three years after the global recall of
the device.

JULY 2014: DePuy informs CDSCO of “certain” patients who had undergone revision surgeries
and reports deaths of four who had ASR implants.

JULY 2014: Following news reports, CDSCO asks DePuy for details on action taken to identify
patients implanted with ASR, related hospitals and compensation paid.

DEC 2014: CDSCO and health ministry receive grievances on ASR implants and take it up with
DePuy.

FEBRUARY 2017: Health ministry constitutes an expert committee to look into the issue.
Headed by Dr Arun Kumar Agarwal, former Dean and Professor of ENT at Maulana Azad Medical
College, the committee reviewed action taken by the company to replace faulty ASR implants, and
reviewed compensation provided to those who had suffered.

FEB 2018: Expert committee submits its report.

Findings of the committee:
 While more than 3,600 of the 4,700 patients could not be traced, the committee sent letters
to 101, of whom 22 responded. The committee concluded that not only did patients undergo
revision after first surgery, but in some cases, more than one revision surgeries have been
performed.
 Some of the patients had reported that they had to undergo excoriating pain during all these
and more particularly after the implant. Many patients reported general fatigue or local
issues such pseudo tumour, pain walking, metallosis (increase in Cobalt and Chromium
levels, Asthenozoospermia (reduced sperm motility), cyst in kidney,claudication pain.
Recommendation:
 The company should be made liable to pay at least Rs 20 lakh to each patient with such
complications, and the reimbursement programme be extended until August 2025.
 A central expert committee and a regional expert committee should be constituted by the
Ministry for evaluation of patients’ claims in “respect of disability and suffering caused
due to use of faulty ASR”. The regional committee will determine whether there is
permanent disability, and whether such disability has affected or will affect the patient’s
earning capacity, and then submit its report to the central expert committee.
 The central expert committee will determine the quantum of compensation. According to
the committee that examined ASR implants, the base amount should be Rs 20 lakh, and in
addition to this, the patient should be given compensation on the basis of suffering on
“account of monetary loss due to wages and other loss” and percentage of disability. It has
recommended that the maximum amount be at par with the maximum granted for clinical
trial-related death and permanent disability as per rules and guidelines of the Drug
Controller General of India.
 With 3,600 patients yet to traced, the “firm has to give due diligence to trace those
remaining patients who have received ASR but have not registered with the helpline”.
 Health assessment of patients should be reported once a year till 2025 and compliance
report periodically, preferably six-monthly, submitted to the Ministry. Follow-up should
be done regularly.
 An independent registry should be established for tracking usage of high-risk medical
devices. Provisions for compensation should be included in Medical Device Rules if any
serious adverse event or death is caused due to the sole use of a medical device.

AUG 2018: Expert committee’s report is made public. Officials say ministry has accepted
recommendations and is reaching out to states to trace affected patients.

OCTOBER 2018: PIL filed by Arun Kumar Goenka, a Delhi based social activist, under Article
32 in the Supreme Court of India.
Some key points in the petition:
 Neither the health ministry nor the Mumbai police, which had registered an FIR in
 November 2011, has taken any civil or criminal action against the US-based company or
its officials.
 The company has tracked 1,080 patients in India and reimbursed the cost of revision
surgery to 275 eligible patients, a Johnson & Johnson spokesperson had said last month.
 Quoting the Mumbai FIR, the petition says that around 15,820 “DePuy ASR hip implants”
were imported to India till 2010 but only around 1,295 devices were recalled.
It says the balance of nearly 10,000 units after deducting the 4,700 units actually implanted
is still untraced.
 Petitioner requested that an “SIT comprising of Senior Medical Officers and Indian Police
Services” be appointed “to oversee the effective measures for implementation of swift and
immediate actions to save the lives of all the patients of DePuy ASR implants.

OCTOBER 5, 2108: Supreme seeks Center’s response on a plea alleging faulty implants by Arun
Kumar Goenka.
A bench comprising Chief Justice Ranjan Gogoi and Justices S K Kaul and K M Joseph asked
the Union Ministry of Health and Family Welfare to apprise it within two months about the
actions, if any, taken after an expert committee found the pharma firms guilty of “medical
negligence”. SC also asked the Centre to furnish an expert probe committee’s report on
allegations that Johnson & Johnson subsidiary DePuy had supplied faulty hip implants to
hundreds of patients in India.

OCTOBER/ NOVEMBER –Recent Developments:

A new expert committee has been formed by government. The new central committee will be
chaired by RK Acharya, director of Safdarjung Hospital's sports injury center, and will consist of
five members, according to an order dated August 30.

According to a second notification sent to states on the same date, the committee has to calculate
the compensation amount on a case-by-case basis, using details like degree of disability and
suffering on account of monetary loss due to reasons like loss of wages.

This committee has been formed upon recommendations of another expert group set up last year
to look into the issue of these implants.

According to news sources, Indian victims of faulty hip implants sold by Johnson &Johnson may
get as much as Rs 1.2 crore each in compensation, according to a formula devised by a government
panel of experts. The formula though has to be approved by the health ministry. The compensation
amount is expected to vary from Rs 33 lakh to Rs 1.2 crore.If a person underwent a surgery when
he/she was 60 years or above and the disability is measured at the scale of 10%, he/she will be
entitled to get a minimum of Rs 33 lakh.

Patients will be eligible to claim recall related expenses like travel, hotel, and food from the time
of admission until discharge from the hospital for the patient and one attendant. Expenses for
follow up tests conducted in the year following revision surgery will also be reimbursed.