THE Supreme Court Friday sought to know whether a committee appointed by the Union Health Ministry had submitted a report on hip implants marketed and sold by pharma major Johnson & Johnson and asked the government to furnish a copy of the same.
THE Supreme Court Friday sought to know whether a committee appointed by the Union Health Ministry had submitted a report on hip implants marketed and sold by pharma major Johnson & Johnson and asked the government to furnish a copy of the same.
“Copy of the writ petition be served on the Central Agency whereafter the Additional Solicitor General who may be nominated shall inform the Court whether the report of the Committee headed by Dr Arun Agarwal, Professor of ENT, Maulana Azad Medical College has been submitted and if so a copy of the said report along with the recommendations/suggestions contained therein be furnished to the Court”, a bench of Chief Justice of India Ranjan Gogoi and Justices S K Kaul and K M Joseph ordered.
As reported by The Indian Express, the committee’s report concluded that the Indian arm of Johnson & Johnson “suppressed” key facts on the harmful aftermath of surgeries conducted on hundreds of patients in the country using “faulty” hip replacement systems it imported and sold.
And that in a “clear abdication of responsibility”, it did not inform the national regulator about the exact number of patients who used these devices, the adverse reports following such surgeries and the corrective operations subsequently conducted. It also “did not provide any compensation” to those affected. Friday’s direction from the apex court came on a PIL filed by Delhi-based Arun Kumar Goenka.
Appearing for him, senior advocate Salman Khurshid pointed out that Goenka’s mother was a victim of faulty hip implants. A consumer complaint filed in this regard against US-based Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc and Indian arm Johnson & Johnson Limited was pending before the National Consumer Disputes Redressal Commission, he added.
Goenka, whose case was first reported by The Indian Express, claimed that similar “faulty, deadly and poisonous” implants had been done on thousands of patients in India but it was not still known who these patients were. The PIL said “the ‘DePuy ASR Hip Implants’ were introduced in the USA in the year 2005 without any clinical trials and FDA approval, because it resembled devices already in the market. Testing was required for DePuy’s ASR hip resurfacing system, but DePuy dropped its request for approval when problems were revealed.
Even without FDA approval, DePuy recommended the hip resurfacing system to the US doctors and continued selling it outside the U.S”. Goenka said that “around the same time, in the year 2005 these implants were unofficially & without approvals introduced and sold in Indian market as well, without obtaining necessary and mandatory Import License under the Drugs Act, 1940 and Rules made thereunder”.
He said his mother’s surgery was on March 3, 2006 whereas the licence to import them into India was granted only on December 15, 2006 on an application dated December 6, 2006. Despite the violation, no legal action was taken against the firms by the authorities, he said, and pointed out that the hip implants were recalled worldwide by the company in August 2010.
Arguing that awareness in India has been “negligible.” Goenka said that since the recall in August 2010, only 1500 patients have been identified by the firm in the last more than 4 years of whom 275 have had revision surgery. If this data is taken as true, the petitioner said, more than 12000 patients are still untraceable. “Who are they? What difficulties they would be facing? Etc. etc.” there are numerous such questions which have no answers even after four years of recall”, the PIL said.
An FIR was filed on the matter with Mumbai Police in November 2011 by Drug Inspector Rakesh Narayan Rao Tirpude, it said adding “however, no action has been taken” by the concerned authorities on this. “As per the figures available and also reflected in the FIR dated 19.11.2011; from the year 2005 to year 2010 (recall date), around 15,820 ‘DePuy ASR Hip Implants’ were imported in India, out of which around 4,700 Implants were officially implanted in patients in India.
After the recall of Implants, around 1295 Implant units only were returned / recalled from the Indian Market by the manufacturing company. The balance Implant units i.e. 9825 DePuy ASR Hip Implants are untraceable, as per records”, the petition said.
Goenka pointed out that in February 2017, the Ministry of Health had constituted a committee under the Chairmanship of Mr. Arun Agarwal “to look into the aftermath of the disaster caused by the faulty” hip Implants. Thought the committee had submitted its report, “till date nothing has been done to discover vast number of patients who had undergone hip transplant”, the PIL said and sought urgent steps to identify the victims.
It also 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”.
“Copy of the writ petition be served on the Central Agency whereafter the Additional Solicitor General who may be nominated shall inform the Court whether the report of the Committee headed by Dr Arun Agarwal, Professor of ENT, Maulana Azad Medical College has been submitted and if so a copy of the said report along with the recommendations/suggestions contained therein be furnished to the Court”, a bench of Chief Justice of India Ranjan Gogoi and Justices S K Kaul and K M Joseph ordered.
As reported by The Indian Express, the committee’s report concluded that the Indian arm of Johnson & Johnson “suppressed” key facts on the harmful aftermath of surgeries conducted on hundreds of patients in the country using “faulty” hip replacement systems it imported and sold.
And that in a “clear abdication of responsibility”, it did not inform the national regulator about the exact number of patients who used these devices, the adverse reports following such surgeries and the corrective operations subsequently conducted. It also “did not provide any compensation” to those affected. Friday’s direction from the apex court came on a PIL filed by Delhi-based Arun Kumar Goenka.
Appearing for him, senior advocate Salman Khurshid pointed out that Goenka’s mother was a victim of faulty hip implants. A consumer complaint filed in this regard against US-based Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc and Indian arm Johnson & Johnson Limited was pending before the National Consumer Disputes Redressal Commission, he added.
Goenka, whose case was first reported by The Indian Express, claimed that similar “faulty, deadly and poisonous” implants had been done on thousands of patients in India but it was not still known who these patients were. The PIL said “the ‘DePuy ASR Hip Implants’ were introduced in the USA in the year 2005 without any clinical trials and FDA approval, because it resembled devices already in the market. Testing was required for DePuy’s ASR hip resurfacing system, but DePuy dropped its request for approval when problems were revealed.
Even without FDA approval, DePuy recommended the hip resurfacing system to the US doctors and continued selling it outside the U.S”. Goenka said that “around the same time, in the year 2005 these implants were unofficially & without approvals introduced and sold in Indian market as well, without obtaining necessary and mandatory Import License under the Drugs Act, 1940 and Rules made thereunder”.
He said his mother’s surgery was on March 3, 2006 whereas the licence to import them into India was granted only on December 15, 2006 on an application dated December 6, 2006. Despite the violation, no legal action was taken against the firms by the authorities, he said, and pointed out that the hip implants were recalled worldwide by the company in August 2010.
Arguing that awareness in India has been “negligible.” Goenka said that since the recall in August 2010, only 1500 patients have been identified by the firm in the last more than 4 years of whom 275 have had revision surgery. If this data is taken as true, the petitioner said, more than 12000 patients are still untraceable. “Who are they? What difficulties they would be facing? Etc. etc.” there are numerous such questions which have no answers even after four years of recall”, the PIL said.
An FIR was filed on the matter with Mumbai Police in November 2011 by Drug Inspector Rakesh Narayan Rao Tirpude, it said adding “however, no action has been taken” by the concerned authorities on this. “As per the figures available and also reflected in the FIR dated 19.11.2011; from the year 2005 to year 2010 (recall date), around 15,820 ‘DePuy ASR Hip Implants’ were imported in India, out of which around 4,700 Implants were officially implanted in patients in India.
After the recall of Implants, around 1295 Implant units only were returned / recalled from the Indian Market by the manufacturing company. The balance Implant units i.e. 9825 DePuy ASR Hip Implants are untraceable, as per records”, the petition said.
Goenka pointed out that in February 2017, the Ministry of Health had constituted a committee under the Chairmanship of Mr. Arun Agarwal “to look into the aftermath of the disaster caused by the faulty” hip Implants. Thought the committee had submitted its report, “till date nothing has been done to discover vast number of patients who had undergone hip transplant”, the PIL said and sought urgent steps to identify the victims.
It also 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”.