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| HIP IMPLANT DEVICE |
J&J’s DePuy recalled its Hip
implant device (ASR Hip System) on 26th August 2010 due to reports
of faults in its devices. However, by that time DePuy sold and fixed the device
among 4700 patients from 2004 to 2010. Till date, they could trace only 1080
patients and still stated to be finding it difficult to trace around 3600 patients
in order to compensate for the damages already done to the patients due to faulty
devices.
Is Johnson & Johnson doing
enough to reach out to patients?
J&J in its one of the
advertisement claims that “Your safety and health are important to DePuy
International Ltd and we are assisting the Government to address concerns of
ASR patients.” However, the fact it does not have information of patients
to whom it has sold its medical device, which was to work for (shelf life) at
least 15 years is itself shows that the company does not have concern for its
patients or consumers. And even now the company failed to take serious steps to
reach out to the remaining patients. If they were to market their product, they
would have happily spent lakhs and crores in the expectation of reaching
potential customers.
I am not able to understand how
the company of J&J’s stature is getting difficult to reach out to its
4700 consumers, who might be suffering through various complications due to
faulty device. In spite of having strong networking, how come they are unable
to reach out to their old consumers? What is stopping them to reach out to the
Hospitals in order to get the details of the patients? The company was not able
to address all these questions. J&J cannot wash away its responsibility by
simply opening the helpline number to address the calls of a few patients. It has
to do something concrete. It should not have the luxury to say that “we
tried but could not reach 3600 patients”. After all, it has the duty to
maintain the data or information regarding the life-saving device which were sold
to its consumers.
What about Hospitals?
At the least, the hospital which
conducted surgery to fit the DePuy’s Hip implant device on the patient should
have the details about what device has been put by them in a patient’s body.
They cannot absolve responsibility by stating that under the Professional Ethics Code,
2002 they are supposed to maintain the records of patients only till three
years in the cases of surgical treatment. After all, the normal shelf life of
the Hip implant device is 15 years, and therefore, it is the hospital’s duty to
maintain medical records of such patients till that time.
Moreover, even as per the
Profession Ethics Code, 2002, whenever the patients request his medical
records with the hospital, it has to provide it within 72 hours of making a
request.
Hospitals should also realize
that refusal to give information about what device has been put in the body of the patient amounts to negligence as well as a deficiency in services.
Is the Government doing enough to
find the patients affected by the ASR hip system?
To its part the Central
Government also failed in its duty to protect its citizens from the MNC, which
sold faulty medical devices. It took more than 8 years to decide that Rs.35
lakh to 1.20 crores to be paid by the company to the affected patients. All
these years, the government did not press the company to find out the remaining
patients neither the government did anything concrete to reach out to the
affected patients except announcing Central Level Committee & State Level
Committees to address patients' queries. Even those committees also not working
actively to reach out to the patients. They address only those patients who
reach them. Besides that, no effort is put by them to reach out to the
patients.
I am wondering why the Central
Government is not taking assistance from the Customs Department in checking the
imported details of those 4700 medical
devices, which will be having the name of the patients/hospitals to whom the devices were sold. I am sure this
task can be done within a few days if the Customs Department and Central Drugs
Standard Control Organisation in respective states given the task of checking
imported details. After all medical devices (DePuy’s ASR Hip System) were
supposed to have been imported as per the guidelines provided in Drugs and
Cosmetics Act Rules, 1945.
So, reaching out to the remaining
3600 affected patients not at all that tough task to do. The only thing
required is the intention to search. Johnson & Johnson, concerned
hospitals, and the Government have to take some serious steps in order to save
the life of the patients affected due to faulty HIP implant devices.
Note: If you or your loved one has been implanted
with an artificial hip instrument device during the year between 2004 to 2010,
then it might be DePuy’s ASR System. In such cases, kindly contact your state’s
Drugs Controllers’ Zonal Office or Legal Cell, Central Drugs Standard Control
Organization, FDA Bhavan, Kotla Road, New Delhi or call on 011-23216367
(Ext.315) or email: legalcell@cdsco.nic.in to seek further assistance.
About Author: C.Prabhu is a practicing Advocate based in
Chennai. He is also assisting one of the affected patient due to faulty Hip
implant.
