WRSH Partner, Phil Russotti, represented a 55 year old woman who was taking Tamoxifen following a radical mastectomy for breast cancer and who suffered liver failure requiring a liver transplant. After approximately nine months on the Tamoxifen she reported to her doctor, who was prescribing the medication that she was noticing fatigue. We claimed that her doctor should have ordered a liver function study. Three months later a subsequent treating doctor ordered liver function tests which were elevated. This second doctor failed to follow up on the elevated liver function studies, one month afterward she became jaundiced and shortly thereafter suffered acute liver failure resulting in the liver transplant. We claimed that the Tamoxifen should have been immediately discontinued when the liver study was abnormal which would have prevented the liver failure. Defendant claimed that the New York equivalent of Dalbert namely, the Frye requirement of scientific proof on the issue of causation had not been established showing a relationship between Tamoxifen and liver failure. After an extensive Frye hearing the trial court held that we proved it was generally accepted within the medical community that Tamoxifen could cause liver failure despite the fact that there are no test which directly show liver damage from Tamoxifen but the diagnosis is only made by exclusion, i.e. by ruling out all other causes of liver failure.
The case settled after the Frye hearing. The client has not had any difficulties with her transplanted liver for the past ten years. The settlement was solely for the necessity to undergo a liver transplant.