Vickery & Shepherd is currently investigating the connection between OCALIVA, its 2016 and 2018 labels, and liver injuries and death in patients. This investigation was initiated by the FDA’s recent January 2018 safety communication to healthcare providers and pharmacies based, in part, on reports of incorrect dosing in some OCALIVA patients that resulted in liver injuries or death. The fundamental reason for this incorrect dosing and liver injuries or death is unknown at this point. What is apparent is that the 2016 and 2018 OCALIVA labels are fundamentally different. Not only does the 2018 OCALIVA label has a BLACK BOX WARNING related to incorrect dosing and injuries, it also includes a very detailed section on the first page related to how health care providers determine the severity of a patient’s liver damage. The 2018 OCALIVA label also includes a detailed table to help prescribing physicians determine the appropriate OCALIVA dosing for patients based on the severity of their liver damage. This information does not appear to be in the 2016 OVALIVA label. One of the fundamental questions in any pharmaceutical case is whether a pharmaceutical company like Intercept Pharmaceuticals, Inc. who manufactures OCALIVA, failed to warn prescribing physicians and patients of known or foreseeable risks of the drug. The answers to this question, as well as many other questions, needs to be investigated.
The lawyers at Vickery & Shepherd have more than two decades of experience in helping clients that have been injured by pharmaceuticals. We have a national practice, and have represented clients in almost every state. If you or a loved one have suffered liver injury or death that you believe is related to OCALIVA, call the national pharmaceutical attorneys of Vickery & Shepherd at 713-526-1100.