Over five years ago, the Maharashtra Food and Drug Administration (FDA) commissioner asked the state government to seek a CBI investigation into complaints by patients against the ASR hip implants sold by the Indian arm of Johnson & Johnson. Three years later, Vijay Anant Vojhala, a patient who underwent a hip replacement surgery using this device, asked the central government for a CBI probe into the “faulty” implants.
But the Centre decided in July 2015 against such a probe on the grounds that “referring the case to CBI may not help the compensation claim” of patients.
Speaking to The Indian Express, Mahesh Zagade, the Maharashtra FDA Commissioner in 2013, said there was a “whole thought process” behind his recommendation and it is the “failure of the government machinery that leads to this type of thing”.
Zagade alleged that his “officials were hand in glove and they did not pay any heed to the complaint (of patients)… and this was a case of failure of FDA machinery.”
Union Health Secretary Preeti Sudan did not respond to the queries sent by The Indian Express. Johnson & Johnson did not respond to requests for comment on the Maharashtra FDA’s recommendation.
On July 8, 2015, the Union Health Ministry noted in an internal file: “Regarding CBI enquiry, CBI is a police organisation and it looks into criminal liability of a company, individual or government organisation in terms of CrPC; the issues of civil liability/compensation are not looked into by it. Secondly, with respect to criminal liability as well there can not be two simultaneous investigations into a case. Thus, if a CBI enquiry is to be ordered, the investigation by Mahim police station, Mumbai, has to cease and it has to be transferred to CBI. In view of this, referring the case to CBI may not help the compensation claim of the applicant (Vojhala).”
On June 4, 2013, Zagade wrote a letter to the Maharashtra Chief Secretary requesting a CBI enquiry against DePuy, a Johnson & Johnson subsidiary that sold the hip implants. On January 5, 2015, Vojhala wrote an email to G N Singh, the then Drug Controller General of India (DCGI), asking for a CBI enquiry. The Mumbai-based patient quoted the letter written by Zagade.
Zagade, who retired on May 31 this year as Principal Secretary of Administrative Reforms in the Maharashtra government, said: “I don’t know what happened later on. They should have taken (the matter of CBI enquiry) up with the central government.”
Zagade said: “I did not recommend CBI investigation just like an off-the-cuff kind of thing. There was a whole thought process. In this particular case, about 4,600-4,700 of these hip implants were sold, which later turned to be faulty. It is not the private party (company) that alone is responsible. It is the government machinery which is supposed to supervise this thing under the statute. And it is the failure of this government machinery that leads to this type of thing. The patients are left high and dry at the mercy of the corporate sector.”
The DCGI told the Union Health Ministry in 2015 that 4,700 hip implant surgeries were carried out in India prior to the voluntary recall of the product in August 2010.
“When I joined in August 2011. I was told about the complaints that stated that because of these implants, many patients are in pain and therefore, the FDA should enquire into this thing. Till that time, these complaints were not attended to. I found that these implants were faulty and they were recalled in many countries by the company. I found that apart from bearing the expenses of corrective surgeries, the company also provided compensation to the patients that ran into millions and millions of dollars,” Zagade said.
“I called the company representatives and they told me that they have contracted one NGO and this NGO will go around and find out all the patients. I told them that all over the world you are recalling it and here you are playing this kind of prank saying that we have contracted an NGO. So, they said that we will go to management and we will appraise you of the thing. They did not do anything. Patients were dying,” he said.
“The second time I called them, I told them that this is not some Nokia handset that has been sold and then no one knows where has it gone. Under Drugs and Cosmetics Act, this is one product that is statutorily controlled. Also, I told them this is not an automobile product that goes into some car or motorcycle. It is implanted into patients by hospitals through major surgeries. And hospitals are supplied these implants by distributors or retailers. So, I told them that entire chain from company to distributor to retailer to hospital to patient is recorded. You can find out about all the patients within two-three days. They dilly-dallied,” the retired official said.
Zagade said that it is at this time that he decided to file an FIR in the Mahim police station. “This was not a regular criminal case under IPC (Indian Penal Code) or other criminal laws. The company went to High Court to get this FIR quashed, the FIR was against the company management itself because they are responsible for the compensation. But the high court said that the investigation should continue.Then I realised that it is not just Maharashtra but this faulty product was sold all across the country,” he said.
“The officials of Maharasthra FDA, the Central govt departments all are responsible towards safeguarding of the patient’s interests. I knew that my officials were hand in glove. They did not pay any heed to the complaint…This was a case of failure of FDA machinery.and since it was all-India case that is why I recommended CBI investigation,” Zagade said.
According to Zagade, the CBI probe was also necessary because the headquarters of Johnson & Johnson was not in India.
“Any investigation that has to be carried out beyond the borders of the country has to be done by a central government agency. Even the state police has to approach the central government if they want to carry out such investigation. Therefore, I thought that CBI is the right agency for any international investigation. If you want to pressurise the international company to provide compensation to the patients affected by these implants, then the CBI is a more appropriate agency then the state police,” Zagade said.