Med­i­cal boon or bust?

Suits raise al­le­ga­tions of de­fects in da Vinci ro­bot

Modern Healthcare - - THE WEEK IN HEALTHCARE - Joe Carl­son and Jaimy Lee

When the Sil­i­con Val­ley startup In­tu­itive Sur­gi­cal went pub­lic 13 years ago, the com­pany was post­ing $10 mil­lion in an­nual sales, and its lit­tle-known sur­gi­cal ro­bot had been used on just 600 pa­tients world­wide.

In­tu­itive has since ex­pe­ri­enced the kind of me­te­oric growth cher­ished in the na­tion’s high-tech hot­bed, blos­som­ing into a cor­po­ra­tion with $610 mil­lion in sales of a prod­uct, the da Vinci Sur­gi­cal Sys­tem, which is con­sid­ered one of the most cov­eted sta­tus sym­bols of 21st-cen­tury medicine. But along the way, scores of crit­ics say, the com­pany ex­hib­ited a baf­fling dis­re­gard for pa­tient safety as it ag­gres­sively mar­keted ma­chines that can cost up to $2.3 mil­lion each.

In­tu­itive is now fac­ing at least 25 prod­uct li­a­bil­ity law­suits, and one at­tor­ney in the field con­firmed that he per­son­ally has more than 1,000 po­ten­tial clients who are claim­ing in­juries from the de­vice. While a Wash­ing­ton state jury cleared the com­pany of li­a­bil­ity last week in an ini­tial case in­volv­ing al­le­ga­tions that the com­pany failed to prop­erly train sur­geons, scores of other cases are wait­ing in state and fed­eral courts that con­tain wider al­le­ga­tions about de­fects in the sur­gi­cal ro­bots them­selves.

“This com­pany grew at a tremen­dous rate, and they were able to suc­cess­fully cre­ate this aura of the ro­bot that ev­ery­one fell in line with,” said mal­prac­tice at­tor­ney and ob­ste­tri­cian Dr. Fran­cois Blaudeau. “We can’t let a com­pany from Sun­ny­vale, Calif., just walk in and change medicine that eas­ily. There will be a lot of lit­i­ga­tion, and some of it is go­ing to carry over to the hos­pi­tals and the doc­tors. … They are not go­ing to es­cape the blow­back as more and more in­for­ma­tion comes out.”

Reg­u­la­tors have al­ready taken note of the com­plaints. The Food and Drug Ad­min­is­tra­tion opened an in­quiry this year into the safety of the da Vinci sys­tem fol­low­ing nu­mer­ous ad­verse event re­ports. Mas­sachusetts and New Hamp­shire are also in­ves­ti­gat­ing safety con­cerns stem­ming from an in­creas­ing num­ber of pa­tient com­pli­ca­tions.

This month the com­pany pub­lished an ur­gent med­i­cal de­vice warn­ing of a po­ten­tial flaw in one of the com­po­nents of the sys­tem that can cause tis­sue burns in­side pa­tients. Hos­pi­tal of­fi­cials across the coun­try are now re­con­sid­er­ing their rules for which pa­tients are right for robotic surgery.

The da Vinci sys­tem is branded as a min­i­mally in­va­sive al­ter­na­tive to many forms of la­paro­scopic and tra­di­tional ab­dom­i­nal and pelvic surgery. To use it, a sur­geon watches a com­puter mon­i­tor dis­play­ing im­ages from in­side the body and ma­nip­u­lates the ro­bot’s arms through a con­sole of hand con­trols and foot ped­als.

Al­though lawyers and physi­cians fault the com­pany for ex­ploit­ing hos­pi­tal ex­ec­u­tives’ in­se­cu­ri­ties about fall­ing be­hind their com­peti­tors in the tech­nol­ogy arms race, none say that robotic surgery is in­her­ently prob­lem­atic or that it won’t be used in the fu­ture. In fact, some of the strong­est crit­ics, in­clud­ing Blaudeau, credit In­tu­itive ex­ec­u­tives with fi­nally lis­ten­ing to pa­tient con­cerns in re­cent months.

That won’t nec­es­sar­ily ab­solve the com­pany from li­a­bil­ity if the prod­uct it­self is found at fault for in­juries and deaths.

The jury con­cluded last week that the com­pany’s brief train­ing reg­i­men for two uro­logic sur­geons in Sil­ver­lake, Wash., did not make In­tu­itive li­able for any dam­ages when Fred E. Tay­lor died in 2012 af­ter robotic surgery. Though Tay­lor died four years af­ter the pro­ce­dure, his widow Josette Tay­lor claimed the death was di­rectly caused by com­pli­ca­tions from a botched op­er­a­tion to re­move his prostate.

“We are pleased with the jury’s ver­dict,” com­pany spokesman Ge­off Cur­tis said in an e-mail. “In­tu­itive Sur­gi­cal’s tech­nolo­gies have ex­tended the ben­e­fits of min­i­mally in­va­sive surgery to over 1.5 mil­lion pa­tients around the world. We will con­tinue our com­mit­ment to pa­tients, sur­geons and hos­pi­tals to up­hold the high­est stan­dards of safety.”

Tay­lor also sued Har­ri­son Med­i­cal Cen­ter, Bre­mer­ton, and the two in­de­pen­dent sur­geons who per­formed the pro­ce­dure. Records on file with the Kit­sap County Su­pe­rior Court say the hos­pi­tal and sur­geons set­tled those claims with­out go­ing to trial.

“If I was an at­tor­ney work­ing in a hos­pi­tal risk-anal­y­sis depart­ment, I would be con­cerned. I would def­i­nitely be in­ter­ested in re­view­ing the train­ing pro­to­col that da Vinci is pro­vid­ing my physi­cians. I would be in­ter­ested in look­ing at the prod­uct re­call closer. I would be in­ter­ested in talk­ing to the man­u­fac­turer fur­ther,” said Wil­liam Dubanevich, a New York at­tor­ney with Parker Waich­man, which is in­ves­ti­gat­ing po­ten­tial claims in­volv­ing robotic surg­eries. “They may be a po­ten­tial tar­get.”

Nu­mer­ous hos­pi­tals with da Vinci ma­chines de­clined or did not re­turn calls for comment, in­clud­ing Har­ri­son Med­i­cal Cen­ter.

Next year, In­tu­itive is sched­uled to de­fend a $200 mil­lion law­suit filed by Gwen­dolyn and Amos Jones of Ethelsville, Ala.—a case seen as a po­ten­tial “bell­wether” trial be­cause it presents al­le­ga­tions that are wider than the Tay­lor case, and that are al­leged by many of the other peo­ple claim­ing to have been harmed.

Gwen­dolyn Jones, 44, sued the ro­bot manu-

fac­turer in fed­eral court April 10 af­ter she said a flawed hys­terec­tomy left her with se­vere pelvic pain, a dam­aged blad­der and on­go­ing vagi­nal leak­age of urine, along with emo­tional dis­tress and loss of nor­mal bod­ily func­tions.

The law­suit says the de­vice is “de­fec­tive” be­cause it re­lies on a tech­nol­ogy known as monopo­lar en­ergy, which uses a sin­gle elec­trode to de­liver elec­tric cur­rent to cau­ter­ize wounds, in­stead of safer meth­ods such as bipo­lar or ul­tra­sonic en­ergy. The de­vice lacks in­su­la­tion to pre­vent elec­tric cur­rents from af­fect­ing nearby tis­sues, ac­cord­ing to the law­suit, and the com­pany doesn’t pro­vide the sur­gi­cal train­ing or sup­port that it prom­ises or no­tify health­care providers of known de­fects.

Jones’ suit also takes aim at the com­pany’s mar­ket­ing prac­tices, which it called “a cal­cu­lated pro­gram of in­tim­i­da­tion … forc­ing hos­pi­tals and physi­cians to pur­chase it in or­der to ap­pear com­pet­i­tive. (In­tu­itive) creat(ed) a fear in their minds that if they did not have this tech­nol­ogy they would lose busi­ness to com­peti­tors,” the suit said.

Com­pany lawyers de­nied the Jone­ses’ al­le­ga­tions, as­sert­ing that the da Vinci sys­tem was not re­spon­si­ble for the in­juries. “The risks, if any, as­so­ci­ated with the use of the da Vinci Sur­gi­cal Sys­tem are out­weighed by the de­vice’s util­ity” and any in­juries may have been caused by “mis­use or un­in­tended use” of the sys­tem, the com­pany re­sponse said.

The con­tro­ver­sies put hos­pi­tals in a tough po­si­tion. Af­ter spend­ing about $2 mil­lion to ac­quire the tech­nol­ogy, and then from $100,000 to $170,000 on a ser­vice con­tract each year, hos­pi­tals now have to con­tend with con­cerns that the de­vice isn’t liv­ing up to its fi­nan­cial prom­ise or the clin­i­cal claims.

Few providers turn a profit on robotic pro­ce­dures, which are, on aver­age, 15 to 30 min­utes longer and cost about $3,000 more than la­paro­scopic surg­eries, many physi­cians said. Pay­ers gen­er­ally re­im­burse robotic and la­paro­scopic pro­ce­dures at the same rate. On the other hand, they have what Dr. Martin Makary, a sur­geon at Johns Hop­kins Medicine in Bal­ti­more, calls an “in­tan­gi­ble mar­ket­ing ben­e­fit.” A study pub­lished in 2011 found that more than a third of 400 ran­domly se­lected U.S. hos­pi­tals pro­moted robotic surgery on their web­site home­pages. None of the 400 hos­pi­tals pro­vided any risk in­for­ma­tion on the web­sites. Many hos­pi­tals with in­stalled sys­tems have pur­chased bill­board ads tout­ing their ro­bots, launched “name the ro­bot” games within their com­mu­ni­ties, or dis­played the robotic sys­tems at lo­cal high school football games.

Pa­tients are now choos­ing hos­pi­tals be­cause they of­fer robotic surgery, which makes them come across as more tech­no­log­i­cally ad­vanced even though some crit­ics say there’s no ev­i­dence to sug­gest the ro­bots or the hos­pi­tals have bet­ter out­comes than their com­peti­tors. “The broad ap­pli­ca­tion of robotic surgery in the U.S. with- out the proper eval­u­a­tion … is the story of what’s wrong with health­care to­day,” Makary said.

Some hos­pi­tals are re­fus­ing to ad­ver­tise robotic surgery for this rea­son. Ex­ec­u­tives at Beth Is­rael Dea­coness Med­i­cal Cen­ter in Bos­ton and the Univer­sity of Illi­nois Hos­pi­tal and Health Sciences Sys­tem, Chicago, for in­stance, said the re­cent con­tro­ver­sies sur­round­ing robotic surgery will likely lead to fur­ther as­sess­ments of how the providers talk to pa­tients about sur­gi­cal op­tions, as well as what kind of train­ing and op­er­a­tional stan­dards are in place.

“The re­al­ity is that it’s a case-by-case unique de­ci­sion” for each pa­tient, said Dr. Jae­won Ryu, as­so­ciate vice pres­i­dent for pro­fes­sional prac­tice and chief med­i­cal of­fi­cer at the Univer­sity of Illi­nois hos­pi­tal. “We just don’t want to cre­ate those pre­con­ceived no­tions.”

In­tu­itive Sur­gi­cal re­cently in­curred a set­back when the Amer­i­can Congress of Ob­ste­tri­cians and Gyne­col­o­gists re­peated its con­cern that “ag­gres­sive di­rect-to-con­sumer mar­ket­ing” of new med­i­cal tech­nolo­gies was mis­lead­ing the pub­lic. The trade group cited a study pub­lished in the Jour­nal of the Amer­i­can Med­i­cal As­so­ci­a­tion that found that clin­i­cal out­comes were no bet­ter for pa­tients who un­der­went robotic hys­terec­tomies for be­nign gyne­co­logic dis­or­ders than those who had la­paro­scopic pro­ce­dures. In ad­di­tion, the costs of the robotic pro­ce­dures were sub­stan­tially higher.

Dr. James Bree­den, the ob­ste­tri­cian group’s pres­i­dent, said there may be clin­i­cal ben­e­fits to robotic surgery, but the lack of good data and “un­prece­dented ad­ver­tis­ing to con­sumers and hos­pi­tals” has raised con­cerns.

AP PHOTO

In­tu­itive is fac­ing mul­ti­ple law­suits as well as an in­quiry from the FDA into the safety of its da Vinci Sur­gi­cal Sys­tem.

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