Plaintiff\u2019s counsel began \u00a0the day by playing an excerpt from the video deposition of a DePuy compliance manager, Jimmy Smith. \u00a0Mr. Smith has worked at DePuy for 13 years. \u00a0During that time, his job performing internal audits included an audit of the ASR. \u00a0He also worked \u00a0as manager of those engineers who supported the design and manufacture of DePuy products. \u00a0Mr. Smith explained that when there is a health hazard evaluation for something such as cup loosening in the ASR, it is not considered a routine audit, but triggered by something out of the ordinary occurring.<\/p>\n
Plaintiff\u2019s counsel walked Mr. Smith through the design failure modes effect analysis, or \u201cDFMEA,\u201d \u00a0which allows a design team to document what is known and suspected about a product\u2019s failure modes before completing the design, and then allows that team to design out or mitigate against potential causes of failure. When asked if this was done with the objective for patient safety, Mr. Smith responded that it was simply a risk management exercise. \u00a0When asked again if the purpose was to identify these failure modes before the product is ever put into people he responded, \u201cthe purpose is to identify risks and identify detection methods.\u201d<\/p>\n
Describing the employees that failed in their duties in this respect, Plaintiff\u2019s counsel directly asked Mr. Smith, \u201cAnd so in your review you found that Magnus Flett had committed a number of errors in his design failure modes effects analysis, \u00a0the work he had done before the ASR was launched; right?\u201d to which Mr. Smith answered, \u201cThere are a number of inadequacies in the design FMEA that was performed.\u201d<\/p>\n
Plaintiff\u2019s counsel then called to the stand Graham Isaac, a development manager for the ASR XL. \u00a0Mr. Isaac admitted that when DePuy marketed the ASR in 2006, the company did not know what a \u201csafe\u201d level of metal debris was in a human being. \u00a0Mr. Isaac also admitted that if DePuy had written in the brochure that the company didn\u2019t know what a safe level was, that would have been the truth. \u00a0That information was not published in DePuy\u2019s brochure.<\/p>\n
Plaintiff\u2019s counsel then discussed testing of the ASR with Mr. Issac. \u00a0Only one cup size was tested (55). \u00a0The method was that of simulator laboratory testing. \u00a0The ASR was only tested at the \u201coptimum\u201d implantation angle, 45 degrees. \u00a0It was not tested at any other degree of implantation.<\/p>\n
Mr. Issac admitted that it was DePuy\u2019s job to look for all of the ways the product could fail, and to test for those ways. \u00a0He also admitted that DePuy had never made a device with these precise features. \u00a0The ASR was the first monoblock, cobalt and chromium cup that included an inserted ring. \u00a0Mr. Isaac acknowledged that DePuy had never made a cup like this before and that because of this, it was critical to identify all the ways in which it could hurt people.<\/p>\n
Please see the link below for articles related to the trial:<\/strong><\/p>\n J&J Had \u2018Inappropriate\u2019 Risk Controls for Hip, Jury Told<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":" Plaintiff\u2019s counsel began \u00a0the day by playing an excerpt from the video deposition of a DePuy compliance manager, Jimmy Smith. \u00a0Mr. Smith has worked at DePuy for 13 years. \u00a0During that time, his job performing internal audits included an audit of the ASR. \u00a0He also worked \u00a0as manager of those engineers who supported the design … Continue reading “Kransky v. DePuy Trial \u2013 Day Five 1\/31\/13”<\/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-1602","post","type-post","status-publish","format-standard","hentry","category-depuy-trial"],"_links":{"self":[{"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/posts\/1602","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=1602"}],"version-history":[{"count":0,"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/posts\/1602\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/media?parent=1602"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/categories?post=1602"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.sandiegopersonalinjuryattorney.pro\/law\/wp-json\/wp\/v2\/tags?post=1602"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}