J&J faulty hip transplant: CIC directs RTI disclosure of crucial documents

A Johnson & Johnson subsidiary caught in a controversy over faulty hip replacement systems has opposed RTI disclosure of crucial documents it submitted to the country's drug regulator for seeking import clearance for these devices, the CIC has said.

The commission, however, said it has found no impediment in directing disclosure of these compliance documents.

Among the records whose disclosure the DePuy Medical Private Limited, the Johnson and Johnson subsidiary, has opposed was an indemnity clause, said Mukesh Jain, the RTI applicant who had sought the information from Central Drugs Standard Control Organisation (CDSCO).

The indemnity clause makes companies liable for compensation to patients globally in case equipment are found faulty.

The CDSCO, the drug regulator, did not apply the RTI clause of "larger public interest" to provide the documents, Jain told PTI.

Instead, he said, it sought the consent of DePuy Medical Private Limited applying the "third party" clause of the Act and the company rejected the request.

The company claimed that the information sought attracts exemption clauses of the RTI Act related to commercial confidence.

Even exempted information can be furnished by a public authority if it finds that the disclosure is in larger public interest, according to the RTI Act.

When the matter came before the Central Information Commission, the top appellate authority on RTI matters in the country, the objections raised by DePuy were rejected by Information Commissioner Yashovardhan Azad, who heard the matter.

Through his RTI application, Jain had sought documents submitted by DePuy Medical Private Limited Ltd, a subsidiary of Johnson and Johnson, for import and marketing clearance of "ASR XL Acetabular System" and "DePuy ASR Hip Resurfacing system" manufactured by DePuy International Ltd.

These replacements were marketed by Johnson and Johnson.

When the matter was challenged by Jain, a pharmacist himself, before the CIC, the CDSCO tried to justify its stand, saying these medical implants manufactured by foreign firms are imported and marketed by Johnson and Johnson Ltd.

Accordingly, the manufacturer and marketing company Johnson and Johnson sign various agreements including the Power of Attorney by which the onus and responsibility of marketing the product and consequences thereof accrue on the marketing company, the CDSCO officials argued.

Jain challenged the contention of the CDSCO, saying the matter pertains to a large number of patients who had to suffer because of faulty products which were recalled by the United States.

On being tested and found defective these implants have been banned from usage worldwide. But patients, mostly senior citizens in India, are being freely recommended and implanted with these allegedly cancer-causing devices with far-reaching complications, Information Commissioner noted in the order, citing Jain's submissions.

Azad said none of the documents submitted by the CDSCO contains information of commercial confidence, trade secrets or intellectual property of the Drug manufacturer -- DePuy International.

"Neither the company nor the respondent has made out a case as to which portion of these documents contain such information disclosure whereof is likely to adversely affect the competitive position of the company- the third party in question," he said.

Azad said Jain has successfully made out his case that he needs this information in larger public interest on behalf of thousands of patients suffering in India waiting to get relief in the form of monetary compensation against the parent company.

Jain has said the imports have been detrimentally affecting the senior citizens who have been administered such implants, he noted.

The documents are required for proving the liability and onus of the companies in the case of artificial hip implants imported by DePuy, Azad said.

"The exemption under Section 8(1)(d) (related to exemption of information pertaining to commercial confidence) of the RTI Act 2005 does not extend a blanket cover nor are such bald assertions legally tenable, unless tested on the touchstone of facts," he said.

Azad said the commission found no impediment in directing disclosure of these compliance documents as submitted before the commission and sought by Jain.

He, however, added a caveat that in case the CDSCO feels that any particular document attracts clause of commercial confidence that can be withheld by it.

Recently, the CDSCO, which works under the Health Ministry, put out a report on its website stating the Johnson and Johnson "suppressed" facts on the harm caused by surgeries which were conducted on patients in India using "faulty" hip replacement systems.

A group of patients, who suffered due to alleged faulty hip replacement surgeries by a multinational firm, have written to Union Health Minister J P Nadda, saying it is surprising that the media has been able to get the report yet the persons directly affected have been kept in the dark.

The group said that in the last eight years, since the recall of this product, they have endured pain and become disabled while some of them have lost family members who died awaiting redressal.

Reports quoting the expert committee findings say that over 3,600 patients with faulty implants remain untraceable, and that at least four deaths have been reported among these patients.