Zim­mer’s le­gal chal­lenge

De­vice­maker faces mas­sive li­a­bil­ity case over knee re­place­ment sys­tems

Modern Healthcare - - THE WEEK IN HEALTHCARE - Joe Carl­son

Zim­mer Hold­ings, one of the world’s dom­i­nant ortho­pe­dic-de­vice mak­ers, of­ten touts its to­tal knee-re­place­ment sys­tems as the most widely used and depend­able de­vices for pa­tients with os­teoarthri­tis.

But more than 1,000 peo­ple walk­ing on Zim­mer knees to­day are dis­put­ing that claim of re­li­a­bil­ity.

The ortho­pe­dic surgery pa­tients are al­leg­ing in a mas­sive prod­uct-li­a­bil­ity case pend­ing in fed­eral court in Chicago that sev­eral com­po­nents of Zim­mer’s NexGen knee sys­tem have a ten­dency to loosen or fail pre­ma­turely, caus­ing pain and in many cases re­quir­ing fol­low-up “re­vi­sion” surg­eries.

Lawyers for the plain­tiffs say Zim­mer of­fi­cials val­ued quick prof­its over pa­tient safety, re­leas­ing and ag­gres­sively mar­ket­ing untested com­po­nents in a to­tal- knee re­place­ment kit via the Food and Drug Ad­min­is­tra­tion’s fast-track 510(k) de­vice ap­proval process.

The lit­i­ga­tion cen­ters on Zim­mer’s Flex knee tech­nol­ogy, which was sup­posed to give pa­tients a wider range of joint mo­tion, and a re­lated min­i­mally in­va­sive sur­gi­cal tech­nique.

Zim­mer, based in War­saw, Ind., has since launched a new knee sys­tem called Per­sona and in­formed its in­vestors that the NexGen lit­i­ga­tion holds so lit­tle merit that it hasn’t both­ered to es­ti­mate po­ten­tial losses.

“We be­lieve the plain­tiffs’ al­le­ga­tions are not con­sis­tent with the record of clin­i­cal suc­cess for th­ese prod­ucts,” the com­pany dis­closed to in­vestors last year in a Se­cu­ri­ties

“That some of th­ese im­plants have failed is just not all that sur­pris­ing, be­cause it’s new tech­nol­ogy. ... As long as you in­tro­duce new tech­nol­ogy, there is go­ing to be a fail­ure rate.”

—Dr. Mathias Bostrom, Hos­pi­tal for Spe­cial Surgery

and Ex­change Com­mis­sion fil­ing, adding that the first “bell­wether” tri­als for the NexGen law­suits are ex­pected in 2014.

As de­vice­mak­ers such as Zim­mer con­tinue mar­ket­ing newer and more ex­pen­sive prod­ucts, crit­ics say there may be good rea­son to be skep­ti­cal about new tech­niques and equip­ment in a quickly evolv­ing prod­uct mar­ket. The ab­sence of a com­pre­hen­sive national de­vice reg­istry used in coun­tries such as Aus­tralia, Swe­den and the United King­dom makes iden­ti­fy­ing faulty de­vices dif­fi­cult.

“That some of th­ese im­plants have failed is just not all that sur­pris­ing, be­cause it’s new tech­nol­ogy,” said Dr. Mathias Bostrom, a re­searcher and ortho­pe­dic sur­geon at the Hos­pi­tal for Spe­cial Surgery, New York, which is part of the New York-Pres­by­te­rian Health­care Sys­tem.

“As long as you in­tro­duce new tech­nol­ogy, there is go­ing to be a fail­ure rate,” said Bostrom, who is also a paid con­sul­tant for com­pet­ing de­vice­maker Smith & Nephew. “You may ar­gue whether it was in­tro­duced to the pub­lic too soon, and that’s a valid dis­cus­sion that you could have.”

In court records and pub­lic state­ments, Zim­mer of­fi­cials have ar­gued that the NexGen sys­tem is ac­tu­ally more re­li­able than other de­vice­mak­ers’ com­pa­ra­ble sys­tems for to­tal-knee re­place­ments, and they say reg­istries in other coun­tries sup­port their con­tention.

In Swe­den, a 2010 study found that Zim­mer’s NexGen was used in 14,440 pa­tients who were found to be at 0.5% risk of hav­ing a re­vi­sion surgery—the low­est rate for a widely used to­tal-knee de­vice in the reg­istry. In Eng­land and Wales, the NexGen sys­tem oc­cu­pied a mid­dle-of-the-pack po­si­tion, with its 29,730 de­vices show­ing a 1.9% re­vi­sion rate af­ter three years.

“NexGen knees record the best or among the best sur­vivor­ship rates in national joint re­place­ment reg­istries from around the world,” the com­pany says on zim­mer­facts.com, a web­site de­voted to re­but­ting al­le­ga­tions from the prod­uct­safety lawyers.

Dr. Richard Berger, for­merly a paid Zim­mer con­sul­tant who helped de­velop “min­i­mally in­va­sive” sur­gi­cal tech­niques for NexGen sys­tems, pub­licly crit­i­cized some NexGen com­po­nents for hav­ing what he said was an un­usu­ally high fail­ure rate—claims that prompted Sen. Chuck Grass­ley (R-Iowa) to pen a 2010 let­ter to Zim­mer CEO David Dvo­rak de­mand­ing an­swers.

It was not clear whether Zim­mer ever re­sponded to the se­na­tor’s let­ter, as nei­ther the com­pany nor Grass­ley’s of­fice would comment for this story.

But it can’t be dis­puted that the NexGen sys­tem has ex­pe­ri­enced prob­lems since its launch.

In Septem­ber 2010, the FDA is­sued a medium-sever­ity Class 2 re­call for the sur­gi­cal in­sti­tu­tions for 68,384 NexGen MIS tib­ial com­po­nents, which are one of the three types of equip­ment at is­sue in the on­go­ing prod­uct li­a­bil­ity case. The MIS tibia in­cluded a shorter bone-stem that was de­signed to al­low smaller sur­gi­cal in­ci­sions, but 114 pa­tients filed FDA com­plaints say­ing the de­vice came loose and re­quired re­vi­sion surgery.

In March 2012, the ECRI In­sti­tute sent a High Pri­or­ity Med­i­cal De­vice Alert to thou­sands of hos­pi­tals world­wide warn­ing that cer­tain NexGen tibia and fe­mur com­po­nents were caus­ing fail­ures be­cause sur­geons were us­ing in­com­pat­i­ble plas­tic ar­tic­u­lat­ing plates to sep­a­rate the bone-mounted ends of the de­vice.

And in Jan­uary, Mayo Clinic re­searchers pub­lished find­ings in the jour­nal Clin­i­cal Orthopaedics and Re­lated Re­search that said a NexGen com­po­nent called the LPS 3-de­gree tib­ial tray was fail­ing at an un­ex­pect­edly high rate be­cause the ce­ment used to se­cure the de­vice was “debond­ing” from the me­tal de­vice. Mayo has since stopped us­ing that par­tic­u­lar tib­ial com­po­nent.

“That is a rel­a­tively un­com­mon cause of fail­ure in the short term,” said Dr. Mark Pagnano, pro­fes­sor of ortho­pe­dic surgery at Mayo and one of the study au­thors. “It was a lit­tle bit sur­pris­ing and that is why we re­ported that. But to keep it in per­spec­tive, the vast ma­jor­ity of th­ese knee re­place­ments are still work­ing well at five years.”

Pagnano noted that Mayo doc­tors were able to in­ves­ti­gate the find­ing us­ing Mayo’s in­ter­nal reg­istry of ortho­pe­dic de­vices im­planted in pa­tients. Other health sys­tems have sim­i­lar in­ter­nal reg­istries, and in Fe­bru­ary 2012 a not-for­profit called the Amer­i­can Joint Re­place­ment Reg­istry hired a com­pany to build a national reg­istry with the goal of en­rolling 90% of U.S. hos­pi­tals by 2016. About 160 hos­pi­tals par­tic­i­pate to­day.

Such a data­base may one day help physi­cians and pa­tients learn how much risk is in­her­ent in us­ing new tech­nol­ogy, ver­sus los­ing out on the ben­e­fits of cut­ting-edge science—a con­flict high­lighted by the NexGen lit­i­ga­tion.

“There is al­ways in­com­plete in­for­ma­tion avail­able,” Pagnano said.

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