Don’t be afraid to go for the win, even if the outcome seems harsh. In Nowacki v Gilead, an elderly man was given remdesivir to treat COVID-19. Two of the doses came from lots of the drug that Gilead voluntarily recalled. The recalled lots contained glass particulates which could cause symptoms ranging from irritation and swelling to stroke and death. The plaintiff suffered two strokes and had his leg amputated. The plaintiff sued Gilead on a products liability theory.
Gilead argued that it was absolutely immune from suit under the federal PREP Act. Congress enacted the PREP Act in 2005. The PREP Act seeks to encourage fast development of medical countermeasures during a public health emergency by permitting the Secretary of Health and Human Services to limit liability for losses related to administration of approved medical countermeasures. Specifically, the Act provides that if the HHS Secretary approves a medical countermeasure, the immunity applies to
any claim for loss that has a causal relation with the administration … of a covered countermeasure, including a causal relationship with the … manufacture … of such countermeasure.
42 USC 247d-6d(a)(2)(B).
There was no dispute that the PREP Act applied to remdesivir and Gilead in the context of the COVID-19 pandemic. But the plaintiff argued that because the remdesivir contained foreign glass particles, it was not the “covered countermeasure” the HHS had approved—in effect it was some other substance. But the Court of Appeals rejected this argument. Instead, it adopted Gilead’s argument that under the plain language of the act, Gilead was immune for losses caused by the manufacture of the remdesivir, unless the defect was “willful.” Since it was undisputed that the glass particles were present because of a negligent manufacturing defect, the PREP Act applied to give Gilead immunity.
This is inarguably a correct, but harsh, result. As lawyers, we can at times be shy about asking for a harsh result even if it is legally correct, for fear that the court will reject what “feels” like an unjust outcome. Nowacki counsels boldness. If your client has a clear right under a statute or black-letter caselaw, you should not hesitate to argue it.
Short on time? Need help crafting your client’s appeal? We have years of experience in drafting and arguing appeals. Bringing in an outside attorney who specializes in appeals signals to your client that you are taking the case seriously and giving it the best shot at success. Contact us to see if we can help.
