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I am writing on behalf of my client, (b)(6), a member of (b)(6).A brief bullet-point history is the best way for us to bring the gravity of harm caused left leg amputation - by the (b)(6) podiatrist who ignored the contraindication against implanting the star, in a pt who had severe avascular necrosis of his talus.Sbi, stryker and the fca identify "avascular necrosis of the talus" as a "contraindication" for implanting a star ankle."contraindication" means "dont use the star," according to the fda definition of the term.The podiatrist, (b)(6) dpm, ignored the "contraindication" prohibiting him from implanting the star in mr.(b)(6), a pt he had diagnosed with "severe" avascular necrosis of the talus.The chronology is as follows: (b)(6) 2010: mr.(b)(6) fractures his left ankle in a motorcycle accident.On (b)(6) 2010: dr.(b)(6) notes that the pt has a "100% chance" of developing avascular necrosis of his talus.On (b)(6) 2010 - (b)(6) 2012: dr.(b)(6) notes that mr.(b)(6) has developed severe avascular necrosis of his halus.On (b)(6) 2013: dr.(b)(6) performs a star total ankle replacement on mfr.(b)(6) left foot and ankle, despite "contraindications" (defined by the fda as "don't do it"), promulgated by the fda, small business innovations, stryker and the "pivotal study" conducted by (b)(6) md, to obtain the conditional approval to market the star total ankle replacement system conditionally approved on may 27, 2007.On (b)(6) 2013: early signs that the star implanted by dr.(b)(6) had failed, persuading the podiatrist to perform a subtalar fusion.Prior to (b)(6) 2013: dr.(b)(6) did not consider mr.(b)(6) even a remote candidate for amputation.On (b)(6) 2013: the pt's left leg must be amputated, according to dr.(b)(6).Any attempt to perform a total ankle fusion at this time would be doomed to catastrophic failure.On (b)(6) 2014: (b)(6) md, disregards dr.(b)(6) opinion and performs a total ankle fusion; however, dr.(b)(6) allows dr.(b)(6), without the pt's knowledge or consent to make a "cameo" appearance in the total ankle fusion to remove the hardware he installed on (b)(6) 2013, and on (b)(6) 2013.Dr.(b)(6) operative report finds that the star has completely subsided into the talus and that the talus is completely necrotic.On (b)(6) 2014: dr.(b)(6) performs a below-knee amputation of the pt's leg because of infection at the surgical site.On (b)(6) 2013 - (b)(6) 2016: mr.(b)(6) undergoes several revisions and numerous d&cs because of unrelenting infections and pain in his left stump.(b)(6) retained experts who testified that severe avascular necrosis of the talus was not a contraindication to implanting a star total ankle replacement, despite the specific prohibition from the mfr, the "pivotal" study headed by (b)(6) md, the fda conditional approval of the star ankle replacement (specifically prohibiting the implantation of the star total ankle replacement in pts with avascular necrosis of the talus) and surgery of the foot and ankle, 9th edition, mann, et.Al.Under (b)(6) law, dr.(b)(6) is a "learned intermediary," obligated to convey the mfr's warning and/or prohibition against implanting the star total ankle replacement system in any pt with avascular necrosis of the talus.Dr.(b)(6) admitted he did not inform mr.(b)(6) that he was not a candidate for a star total ankle replacement because he had severe avascular necrosis of his talus.According to the definition of "contraindication" promulgated by the fda, dr.(b)(6) was not permitted to even offer the star to mr.(b)(6).The issue in mr.(b)(6) arbitration was not whether "a" total ankle replacement could have been performed, but rather, whether a "star total ankle replacement" should have been implanted, given the severe avascular necrosis of the pt's talus.As expected, dr.(b)(6) total ankle replacement was a total failure.Mr.(b)(6) left leg was amputated because the star was implanted against the unequivocal contraindications and prohibitions against implanting a star because mr.(b)(6) has severe avascular necrosis of the talus at the time of the surgery.Mr.(b)(6) is outraged that dr.(b)(6) performed the surgical procedure to remove the implants without mr.(b)(6) knowledge or consent.Doctors (b)(6) then sent three pieces of unidentified surgical explants to pathology while failing to send the surgical screw dr.(b)(6) used in the subtalar fusion.Suppression of the screw, was intentional deception on the part of (b)(6) and its surgeons to conceal the fact that mr.(b)(6) talus had subsided, softened and was incapable of supporting the star total ankle replacement.Despite repeated requests, (b)(6) has refused to product the pathology report relating to the explant of the surgical screw.Expert testimony indicated that the bone tissue remaining on the explanted surgical screw would have objectively revealed the severe avascular necrosis of his talus at the time dr.(b)(6) implanted the star.From reading the letter and supporting documents for the fda conditional approval of the star, it is clear that (b)(6) was obligated to report this failure not only to sbl, but also to the fda.(b)(6) has not produced any records showing that it complied with the reporting requirements or the identification of medical implant requirements when it removed the hardware from mr.(b)(6) left ankle.Mr.(b)(6) wants to know whether or not (b)(6) reported the failure of the star to sbi and/or the fda.Mr.(b)(6) also wants to know whether or not (b)(6) produced a pathology report regarding the surgical screw that dr.(b)(6) implanted when he performed the subtalar fusion in (b)(6) 2013.Above, all mr.(b)(6) hopes that your investigation will both protect and prevent other pts from suffering a similar fate because (b)(6) ignores the considered warnings and contraindications by medical device mfrs and the fda.
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