neglect and a systematic
conspiracy played by all concerned
in this game who had willfully
ignored their responsibility towards
patients.
It was the commissioner of
Food and Drugs Administration of
Maharashtra (FDA) Mahesh
Zogade who first gave the alert
against ASR implant of J&J by
lodging an FIR for not making a
series effort to inform patients
about their defective implant. He
also reported the issue to the
central Drugs standered control
organization (CDSCO) asking to
take corrective action about this.
Even then, either the CDSCO
or the FDAs in other states have
not plunged into action against
errant company to make it liable for
its faulty devices. It took 2 years
for the CDSCO to put out a ‘medical
device alerts’ on its website. It took
more than six years to obtain an
‘expert committee report’ on the
faulty hip implants manufactured
by the subsidiary of Johnson and
Johnson. And though the expert
committee report was submitted in
February, 2018, it has been put up
only in public domain after 6
months in the last week of August
2018. This too had occurred after
the CDSCO has been under attack
for not being pro-active is seeking
compensation for patients who got
faulty hip implants.
Thus the government had
neglected the issue for around
eight years to take any concrete
stand in obtaining relief to the
aggrieved patients despite being
engaged with the company. The
affected patients allege that the
government presently is taking
steps to ‘eye-wash’ them, by making
the governmental panel of union
health and family welfare ministry
to asking the company to pay a
minimum of Rs.20 lakh each to
every patient as compensation.
Aggrieved and suffering patients
allege that the government panel
set up for the assessment process
18
was “non-transparent and biased
towards the pharma giant”. They
claim that the governments action
is too hasty and are distressed to
see the government continuing to
closely consult with J&J, while
patients who have suffered
grievous injuries have not been
consulted even a simgle time.’
The allegations of the patients
are not only just but are correct too.
Such a callous negligence of the
governments and rulers of their
responsibility towards the patients
(victims) is not new. Such a gross
callous negligence was exhibited
by our rulers and successive
governments are well known
towards the victims of Bhopal gas
disaster created by the union
carbide corporation of U.S.A.
While J&J has paid hefty
compensation to patients in other
parts of the world following a global
recall of ASR hip implant device in
2010, it did nothing to the patients
in India leaving them out. Even
after the advise of FDA of
Maharashtra to CDSCO to take
corrective action nobody stopped
the act through a class action suit
for example. The J&J has agreed
to pay $2.5 billion as compensation
to nearly 8,000 patients in the US.
But it has not taken the
responsibility to pay compensation
to the Indian patients.
It is argued that since in India
the drugs and cosmetics act. 1940,
which also regulates medical
devices has not expressly provide
for compensation of adverse and
serious reactions, such a legal
loophole has made the regulators
(both central and state) weak in
seeking compensation from the
errant company and to make it
liable for its faulty devices. Such
arguments hold no water. As a
sovereign
country
Indian
government can always work out a
mechanism to book J&J like
bringing out an ordinance for
instance and make it liable.
But such a course of action
was not taken by our rulers and
governments intentionally since
they are working with an unheard
zeal to make the country, the best
for the transnational corporations
to do easy benefits in India even
at the cost of lives of Indian people
including the sick patients.
On the other hand the J&J did
whatever it can to evade its
responsibility and avoid any help
to the grievously suffering patients.
It claims that it had sent an “urgent
field safety notice” dated August
24, 2010 to surgeons informing
them about the higher than
expected revision rates involving
ASR, directing them to stop
implanting the ASR devices and
provide for details about the
reimbursement process and the
ASR Help-line. But the surgeons
state that they were not in receipt
of any such notice either from J&J
or any such alert notice from
CDSCO. Some surgeons state that
the implant maker got in touch with
them about three to four years after
the global recall and when they
tried to get in touch with their
patients they were unable to reach
them to alert. The ASR helpline that
was supposed to have provided
Deputy was of no help in anyway
to the patients. The patients claim
that the company was not at all
cooperative and complain when
they reached out to the helpline the
response they get was “call back
when you have severe problem”
and they rudely said to the patients
contracted them that “nagging
problem was not a big enough
problem”. Thus the company
deliberately evaded from its liability
and responsibility.
Even after the exposure of its
heinous crime of concealing the
information about its totally faulty
ASR hip-implants and looting the
patients of India amply, J&J has
never attempted to redeem from its
crime and come to the aid of
patients affected by its faulty ASR
Class Struggle