New Delhi: There seems to be no end to the woes of pharmaceutical and consumer healthcare company Johnson and Johnson (J&J) Pvt. Ltd.
On Monday, it challenged a central government order to pay a compensation of ₹65 lakh and ₹74 lakh respectively to two patients affected by its faulty hip implants. The company told the Delhi high court it was willing to pay only ₹25 lakh each to the patients.
In addition, the US giant is now facing the heat over one of its orthopaedic knee implants.
India’s drug pricing regulator has rejected the company’s proposal to increase the price of its knee implants, citing safety concerns about the product.
J&J’s total knee replacement system, ATTUNE S+, has come under the scanner of authorities, with the National Pharmaceutical Pricing Authority (NPPA) now asking the Drug Controller General of India (DCGI) to examine safety concerns regarding the product, minutes of NPPA’s meeting held on 27 March suggest. “The product has also been hit with several recalls," the minutes reveal. Mint has reviewed a copy of the minutes.
Earlier, the matter was examined by subject experts who pointed to various publications that mentioned quality and safety concerns regarding the product. “The authority deliberated upon the matter in detail and decided to accept the recommendation of the multidisciplinary committee of experts." The committee recommended that no price revision be allowed to ATTUNE S+ orthopaedic knee implant of J&J and hence the proposal was rejected, according to the minutes of the meeting.
DePuy Synthes, the J&J subsidiary that deals with ATTUNE S+, claims on its website that the artificial knee system has shown statistically significant improvement in PROMs (patient reported outcome measures) compared to certain other leading knee implants.
ATTUNE S+ is a new version of the ATTUNE knee tibial base plate. It was introduced in 2017 after the original ATTUNE knee implant was recalled following a flaw in its design that led to it failing prematurely, resulting in complications in patients.
J&J has already sparked a controversy over its faulty acetabular surface replacement (ASR) hip implants in India.
On Monday, the company agreed to pay ₹25 lakh as compensation even as it opposed the direction issued by the government saying that there was no legal provision to support the same.
The Delhi High court has now issued a notice to the central government on the petition filed by J&J. Justice Vibhu Bakru said that “the court has been relying on a rule of thumb formula. What is the non-pecuniary compensation arrived at? Where is the provision in which you will enforce? We need to ensure that it is done in accordance with law."
On its part, J&J said that it was committed to providing assistance, including appropriate compensation within an “established framework", to ASR patients in India who have undergone revision surgery.