Plaintiff’s counsel began the day by playing an excerpt from the video deposition of a DePuy compliance manager, Jimmy Smith. Mr. Smith has worked at DePuy for 13 years. During that time, his job performing internal audits included an audit of the ASR. He also worked as manager of those engineers who supported the design and manufacture of DePuy products. Mr. 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.
Plaintiff’s counsel walked Mr. Smith through the design failure modes effect analysis, or “DFMEA,” which allows a design team to document what is known and suspected about a product’s 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. When asked again if the purpose was to identify these failure modes before the product is ever put into people he responded, “the purpose is to identify risks and identify detection methods.”
Describing the employees that failed in their duties in this respect, Plaintiff’s counsel directly asked Mr. Smith, “And so in your review you found that Magnus Flett had committed a number of errors in his design failure modes effects analysis, the work he had done before the ASR was launched; right?” to which Mr. Smith answered, “There are a number of inadequacies in the design FMEA that was performed.”
Plaintiff’s counsel then called to the stand Graham Isaac, a development manager for the ASR XL. Mr. Isaac admitted that when DePuy marketed the ASR in 2006, the company did not know what a “safe” level of metal debris was in a human being. Mr. Isaac also admitted that if DePuy had written in the brochure that the company didn’t know what a safe level was, that would have been the truth. That information was not published in DePuy’s brochure.
Plaintiff’s counsel then discussed testing of the ASR with Mr. Issac. Only one cup size was tested (55). The method was that of simulator laboratory testing. The ASR was only tested at the “optimum” implantation angle, 45 degrees. It was not tested at any other degree of implantation.
Mr. Issac admitted that it was DePuy’s job to look for all of the ways the product could fail, and to test for those ways. He also admitted that DePuy had never made a device with these precise features. The ASR was the first monoblock, cobalt and chromium cup that included an inserted ring. Mr. 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.
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