Medical facilities and their rapid advancements in the modern world have been a boon for those
suffering from irreparable and unmanageable issues. The constant efforts of medical institutes and
pharmaceutical companies keep brining to limelight several innovations that attempt to advance
the medical sciences. However, these innovations do not always come as a boon. Sometimes, in
the greed of being first in the race of inventions or recovering all research and development costs,
companies do not shy away from introducing products into the market without going through the
proper channels of testing and approval, often leading to endangering innocent lives, and hefty
amounts of money.
Take the case of the ‘revolutionary’ articulate surface replacement that was introduced for hip-
replacement mechanisms by DePuy International Ltd, UK, a subsidiary of Johnson & Johnson
(J&J). More than a decade ago, in 2003, the hip replacement surface was introduced with the first
of its kind, metallic surface, with hopes of replacing the previously popular plastic material,
established and used widely across the world. DePuy’s claim was that the material used makes the
procedure long lasting and strong. The controversy arose, however, when without prior approval of
the US FDA, the product was introduced in India as early as the year 2004. Up until 2010, a total of
4,700 patients in India had undergone hip replacement surgeries using DePuy’s metallic cups. In
the year 2007, diabolically late for medical criticality, J&J filed with the US FDA, its clinical trial data
for approval. However, the problems did not end there. It was soon discovered that the metallic
cups had high chance of causing leakages of chromium and cobalt, leading to serious issues like
impairment, tinnitus and even heart palpitations!
It wasn’t a surprise then, that the products were globally recalled and the filing for approval from
the FDA was quietly withdrawn. What was conveniently ignored, however, was the unknown risks
that over four thousand patients in India were living in, without any acknowledgement or
compensation for the same. It was only in the year 2013, four years after the actual recall of the
product, that complaints of the faulty replacement surgeries were first flagged by the Maharashtra
FDA. It was then that the Union Health Ministry ordered medical practitioners across the country to
stop usage of the implant. And yet, there was a shameless silence maintained over the damage
that had been done, without any formal statement for compensation of the patients with a faulty
transplant. Thankfully, activists and patients took it upon themselves to break the silence with their
noise. It is both petrifying and somewhat relieving to know that a decade after the actual issue
surfacing, the Union Health Ministry finally stirred to the noise of the masses and brought about a
committee to examine and propose a solution for compensation.
Later this year, on November 29th, 2018, in the first of its kind judgement, the Union Health
Ministry has finally approved the compensation parameters, including a grant of Rs. 1.2 Crores to
each patient, with additional compensation for non-pecuniary losses, leading to an amount upto
Rs. 10 Lacs. Not only has this ruling brought a much delayed but relieving news for the patients
who had been battling for about a decade for their rights, but also helps to set a strong precedence
for the medical fraternity as well as for the central health authorities, for both, cases of this kind in
the future, as well as a forewarning for precautions that need to be taken before such critical
introductions.
Unfortunately, the Indian market has been consistently used as a guinea pig for global player, with
minimal qualification criteria for entry level filtering, easy or low bars for quality check and close to
no parameters for measures in case things go south. It is a well known fact that medicines or
practices that are illegal in other countries are in rampant use in our nation. I wish I could say that
the authorities are unaware of this, but it is closer to the truth to say that they are fast asleep. While
the ruling of Artificial Surface Replacement is an important one, it is important for us to learn our
lessons and priorities having stronger entry level policies than having to struggle for erratic fire
fighting measures, when the citizens’ life is at stake.