Im­plant­ing cor­rect mea­sures

BioSpectrum (India) - - BIO EDIT - Milind Kokje Chief Ed­i­tor milind.kokje@mmac­

The de­tails com­ing out of the John­son & John­son (J&J)’s Ac­etab­u­lar sur­face re­place­ment (ASR) hip im­plant con­tro­versy raise more ques­tions than an­swers. This met­alon-me­tal type hip joint re­place­ment de­vice is man­u­fac­tured by J&J’s fully-owned sub­sidiary DePuy Or­tho­pe­dics Inc. It was with­drawn glob­ally by the com­pany in Au­gust 2010 fol­low­ing com­pli­ca­tions de­vel­oped among some pa­tients fit­ted with the im­plant re­quir­ing many pa­tients to un­dergo re­vi­sion surgery. As against the per­mis­si­ble limit of 5% al­most dou­ble the num­ber of pa­tients de­vel­oped the com­pli­ca­tions re­quir­ing the prod­uct re­call.

Like in case of many other faulty drugs and med­i­cal de­vices ASR hip im­plant too has be­come a big le­gal is­sue in the US with the com­pany fac­ing lot many court cases and end­ing in pay­ing mil­lions of dol­lars as com­pen­sa­tion . The com­pany agreed to pay ap­prox­i­mately $2.5 bil­lion in 2013 cov­er­ing 8,000 pa­tients to set­tle thou­sands of law suits emerg­ing out of the faulty hip joint. But in In­dia the pa­tients with post-op­er­a­tion com­pli­ca­tions have not been paid any com­pen­sa­tion. The rea­son re­ported be­ing that there is no pro­vi­sion for com­pen­sa­tion in case of ap­proved prod­ucts as per the Act.

The hip joint was im­planted in about 4700 pa­tients in In­dia be­fore it was glob­ally re­called in 2010. No ASR hip joint was im­planted there­after in In­dia. But it took two years to can­cel the im­port li­cense of the com­pany. Later a med­i­cal de­vice alert was is­sued to hos­pi­tals, sur­geons and pa­tients. Then in 2014 the reg­u­la­tor started seek­ing in­for­ma­tion on pa­tients fit­ted with the im­plant. Two MPs, San­jay Jaiswal of BJP and Brinda Karat of CPM, have se­verely crit­i­cised the reg­u­la­tor for fail­ing in its duty of safe­guard­ing the pa­tients.

A suf­fer­ing pa­tient in­formed me­dia that he was not aware of the alert. Only when a doc­tor saw him limp­ing in a con­fer­ence which he at­tended as he was work­ing as med­i­cal rep­re­sen­ta­tive and asked him about his con­di­tion he came to know from that doc­tor that such an alert was is­sued. If that is the case with ed­u­cated peo­ple and that too from med­i­cal field one can imag­ine the sit­u­a­tion of un­e­d­u­cated pa­tients and those from re­mote ar­eas.

The gov­ern­ment formed an 11-mem­ber com­mit­tee in Fe­bru­ary 2017 to go into the is­sue which gave its re­port in Fe­bru­ary 2018. The com­mit­tee has in­dicted the com­pany for “sup­press­ing” key facts on the harm­ful ef­fects of the im­plant. The com­mit­tee could track only 1080 of the 4700 pa­tients fit­ted with the im­plant. Re­vi­sion surgery was con­ducted only on 275 of them. Over 3,600 pa­tients re­main­ing un­trace­able even after 8 years is a se­ri­ous is­sue ex­pos­ing the short­com­ing of the na­tional joint registry, a com­mon data­base of all joint re­place­ment surg­eries.

The com­mit­tee has rec­om­mended among other things ap­point­ment of cen­tral and re­gional com­mit­tees for eval­u­at­ing pa­tients’ claims, the com­pany should be made li­able to pay at least Rs 20 lakh to each pa­tient, an in­de­pen­dent registry should be set up to track us­age of med­i­cal de­vices and pro­vi­sion for com­pen­sa­tion should be in­cluded in med­i­cal de­vices rules. Com­pared to US, min­i­mum com­pen­sa­tion of Rs 20 lakh is too low.

It is a good de­vel­op­ment that the gov­ern­ment is us­ing this op­por­tu­nity to send a strong sig­nal to med­i­cal de­vices pro­duc­ing com­pa­nies that they can­not es­cape from pay­ing dam­ages to the In­dian pa­tients. It has al­ready ini­ti­ated the process to make a le­gal pro­vi­sion mak­ing com­pa­nies pay the com­pen­sa­tion to pa­tients. This in­ci­dence can also be used to cor­rect the short­com­ings within its reg­u­la­tory sys­tem to ini­ti­ate quick ac­tions in fu­ture.

The gov­ern­ment has launched Ayush­man Bharat for pro­vid­ing medicines, health­care fa­cil­i­ties, health in­sur­ance at rea­son­able rates to the masses. But at the same time, tack­ling such is­sues ef­fec­tively with quick ac­tions to safe­guard the in­ter­ests of pa­tients should also be con­sid­ered as an in­te­gral part of Ayush­man Bharat.

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