{"id":1592,"date":"2013-03-08T23:44:36","date_gmt":"2013-03-08T23:44:36","guid":{"rendered":"http:\/\/sandiegopersonalinjuryattorney.pro\/law\/?p=1592"},"modified":"2018-07-30T20:59:39","modified_gmt":"2018-07-31T03:59:39","slug":"kransky-v-depuy-trial-day-two-1282013","status":"publish","type":"post","link":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/kransky-v-depuy-trial-day-two-1282013\/","title":{"rendered":"Kransky v. DePuy Trial \u2013 Day Two 1\/28\/2013"},"content":{"rendered":"<p><strong>January 28, Morning Session:<\/strong><\/p>\n<p>Plaintiff continued with the video depositions excerpts from Magnus Flett, a former DePuy employee in the marketing department who headed the failure mode and effect analyses performed on the ASR.<\/p>\n<p>An email was introduced from Chris Hunt, a bioengineer, regarding health hazard evaluations of the ASR.<\/p>\n<ul>\n<li>Q.\u00a0 And he indicates here in this email that a health hazard evaluation is outstanding with respect to the ASR; is that correct? \u2026<\/li>\n<li>A.\u00a0 Yes.<\/li>\n<li>Q. \u00a0If you read the entire e-mail, it indicates that the health hazard evaluation relates to ASR loosening; true?<\/li>\n<li>A.\u00a0 I think that you\u2019re right, yes, ASR loosening rationale.<\/li>\n<li>Q.\u00a0 In 2008, you oversaw the committee that was responsible for getting the message to the surgeons about the ASR, were you not?<\/li>\n<li>A.\u00a0 That was part of my \u2013 that was part of my role, yeah.<\/li>\n<li>Q.\u00a0 And if a health hazard evaluation makes a determination that there is a health hazard with respect to a product, certainly you would have some responsibility in getting that message to the surgeons; correct?<\/li>\n<li>A.\u00a0 I expect to see the output of that.<\/li>\n<\/ul>\n<p>Plaintiff\u2019s attorneys then went on to introduce Mr. Flett\u2019s deposition testimony regarding Project ALPHA, the secret code name for a redesign project of the ASR, intended to make safety changes.\u00a0 Mr. Flett admitted in an email that he believed by October of 2008, that DePuy was \u201cunder pressure\u201d from the Australian Joint Registry and stated, \u201c\u2026showing a higher than normal failure rate for Corail and XL heads (and we can respond to this) and also the data from Tony Nargol looks bad for ASR, especially the small sizes.\u00a0 Here we have significantly inferior performance to that of the BHR \u2026 And Graham agrees we are starting to look weak in smaller sizes\u2026Based on the projected costs, E&amp;O instrument costs, it\u2019s likely \u2013 it\u2019s looking like it will not stand up.\u201d\u00a0 It was noted by Plaintiff\u2019s counsel that there was no mention of anything other than costs and business reasons for why the redesign might not go forward.<\/p>\n<p>Mr. Flett also admitted that in Fall of 2009, DePuy had already announced commercial rationalization of the ASR, which was simply a euphemism for slowly taking a product off the market, and was done so, in Magnus Flett\u2019s words, \u201cfor business reasons.\u201d<\/p>\n<p>Plaintiff then\u00a0 called Dr. George Samaras, a medical device engineer and testifying expert, to discuss the design effects mode analysis of the ASR and how DePuy did not do so appropriately.<\/p>\n<p>During Dr. Samaras\u2019 direct examination, Plaintiffs introduced an exhibit showing DePuy failed its own safety test and then rather that fix the device, changed the test.\u00a0 In his explanation, Dr. Samaras stated, \u201cWell, \u2018at least as good\u2019 means that it is identical to \u2013 it\u2019s less than or equal to.\u00a0 \u2018Similar\u2019 allows it to be close to the same, but it could be more\u2026[t]hat violates the international standard on medical device quality management systems.\u00a0 It\u2019s \u2013 their design input was ambiguous and incomplete\u2026it\u2019s horrible practice.\u00a0 That\u2019s not what good engineers do.\u201d<\/p>\n<p>Dr.\u00a0 Samaras further testified that the initial results of the ASR overall performed something on the order of 16 or 17 times worse, meaning the amount of metal that wore off during that testing process was 16 or 17 times more than their previous product.\u00a0 When asked what DePuy should have done upon receiving these results was the following, \u201c[w]hat I tell my medical device manufacturing consultants when they encounter something like this is stop and go fix the design because, obviously it\u2019s no good.\u201d<\/p>\n<p>In wrapping up whether DePuy was acceptable in their risk analyses performed on the ASR, Dr. Samaras stated they violated every fundamental engineering principle regarding risk management.<\/p>\n<p>Michael Zellers, of Tucker Ellis then cross-examined Dr. Samaras. \u00a0Mr. Zellers\u2019 argued on cross that DePuy compared\u00a0 the 63mm size ASR to other DePuy hip products on the market that had good clinical studies. \u00a0He further argued that because those other sizes had a decent clinical study it was a reasonable conclusion that the ASR 63mm was not any worse than the other devices.\u00a0 Zellers also questioned the fact that Dr. Samaras essentially determined that his expertise was better than the DePuy individuals.<\/p>\n<p>Next, Plaintiff\u2019s counsel called to the stand, Dr. Brooke, Mr. Kransky\u2019s medical doctor for a period of time.\u00a0 Dr. Brooke practices general orthopedic surgery.<\/p>\n<p>One main issue related to Dr. Brooke\u2019s testimony was whether he believed Mr. Kransky had an infection, which could in turn support DePuy\u2019s argument that they are not liable for Mr. Kransky\u2019s damages.\u00a0 When asked why Dr. Brooke and another physician, Dr. Linderman, tested for infection, Dr. Brooke stated that he tested Mr. Kransky not because he believed he actually had an infection, but rather to disprove any theory of its existence.<\/p>\n<p>Dr. Brooke also stated that he believed Mr. Kransky needed to have a revision given his left hip pain and elevated cobalt serum level. When asked why Dr. Brooke himself did not elect to perform the revision surgery he responded, \u201c[i]t was my opinion that this hip revision was going to be difficult, a lot of blood loss. \u00a0We weren\u2019t sure what we were going to find, and that with his co-morbidity, that is, you know his cancers and whatnot, that he was at high risk to have repeat surgery.\u00a0 I think he told me that was his concern also.\u00a0 I think I mention in my note he was reticent to have something done.\u00a0 He was afraid of dying.\u201d\u00a0 Dr. Brooke also mentioned several times in his deposition excerpt that Mr. Kransky had very high levels of cobalt, and believed the revision surgery was absolutely necessary.<\/p>\n<p>Following the direct examination of Dr. Brooke, Plaintiff\u2019s counsel called Dr. John Baron to the stand.<\/p>\n<p>Dr. Baron is an epidemiologist, someone who studies disease patterns in humans.\u00a0 He testified as to his opinion on whether the ASR XL exhibited a higher revision rate than a typical him implant from 2003-2010.\u00a0 He found that the ASR XL did in fact fail at a higher rate.<\/p>\n<p>On defendants\u2019 cross-examination, Mr. Zellers pointed out that while Dr. Baron\u2019s studies looked at the ASR\u2019s higher revision rate, there are several reasons for a revision surgery.\u00a0 Mr. Zellers also questioned Dr. Baron on his expertise in epidemiology, rather than general orthopedic practice.<\/p>\n<p><strong>To read articles related to the trial please click the links below:<\/strong><\/p>\n<p><strong><a title=\"When J&amp;J Learned of Implant Problems\" href=\"http:\/\/online.wsj.com\/article\/SB10001424127887323940004578258503673382928.html\" target=\"_blank\">When J&amp;J Learned of Implant Problems<\/a><\/strong><\/p>\n<p><strong><a title=\"Documents Show J&amp;J Concealed 40% Hip Implant Failure Rate\" href=\"http:\/\/www.drugwatch.com\/2013\/01\/28\/documents-show-jj-concealed-40-hip-implant-failure-rate\/\" target=\"_blank\">Documents Show J&amp;J Concealed 40% Hip Implant Failure Rate<\/a><\/strong><\/p>\n<p id=\"article_headline\"><strong><a title=\"J&amp;J's Hip Device Not Defective, Designer Testifies\" href=\"http:\/\/www.businessweek.com\/news\/2013-01-29\/j-and-j-failed-own-safety-test-in-hip-design-witness-says\" target=\"_blank\">J&amp;J\u2019s Hip Device Not Defective, Designer Testifies<\/a><\/strong><\/p>\n<p><strong><a title=\"Court Documents Show DePuy Knew Nearly 40 Percent Of Its Hip Implants Failed Within 5 Years\" href=\"http:\/\/www.rightinginjustice.com\/news\/2013\/01\/28\/court-documents-show-depuy-knew-nearly-40-percent-of-its-hip-implants-failed-within-5-years\/\" target=\"_blank\">Court Documents Show DePuy Knew Nearly 40 Percent Of Its Hip Implants Failed Within 5 Years<\/a><\/strong><\/p>\n<p><a href=\"https:\/\/www.consumersafetyguide.com\/\" rel=\"noopener\" target=\"_blank\"><strong>Consumer Safety Guide<\/strong><\/a> was created to keep the public informed about consumer dangers and safety issues associated with numerous products that can cause the public harm. Yhis website is constantly being updated with the most recent information on the most popular prescription medications and FDA-approved medical devices that could be endangering your health or putting your loved ones at risk. The mission of this website is to keep you informed and help you make the most educated decisions about your health care!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>January 28, Morning Session: Plaintiff continued with the video depositions excerpts from Magnus Flett, a former DePuy employee in the marketing department who headed the failure mode and effect analyses performed on the ASR. An email was introduced from Chris Hunt, a bioengineer, regarding health hazard evaluations of the ASR. Q.\u00a0 And he indicates here &hellip; <a href=\"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/kransky-v-depuy-trial-day-two-1282013\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Kransky v. DePuy Trial \u2013 Day Two 1\/28\/2013&#8221;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[19],"tags":[],"class_list":["post-1592","post","type-post","status-publish","format-standard","hentry","category-depuy-trial"],"_links":{"self":[{"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/posts\/1592","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/comments?post=1592"}],"version-history":[{"count":2,"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/posts\/1592\/revisions"}],"predecessor-version":[{"id":3309,"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/posts\/1592\/revisions\/3309"}],"wp:attachment":[{"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/media?parent=1592"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/categories?post=1592"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/tags?post=1592"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}