AFFY would be liable of course for negligence if it failed to adequately warn about the risks of Omontys. But as a retired health care lawyer, I was wondering if a case for puntive damages could be submitted to the jury. For AFFY to be liable for punitive damages, it must have been grossly negligent or reckless about warning patients of the risks involved with taking Omontys. Interestingly, the PEARL studies reported essentially that Omontys was unsafe for nondialysis CKD patients, such that one AFFY physician reviewer stated that it would be "suicide" for AFFY to seek approval of Omontys generally. AFFY obtained FDA approval for Omontys to be administered to the "sicker" dialysis CKD patients on the basis of the EMERALD study that indicated Omontys safety was within established safety endpoints. First question, is whether the EMERALD study's safety data was corrupted or manipulated somehow by AFFY. If so, then yes puntive damages would be likely. Second question, the FDA approved Omontys in the clinical setting of dialysis treatment, but also required continuous monitoring of patient results and ongoing FDA cooperation and reporting of serious adverse events in its pilot program. Was AFFY under a legal duty to disclose the reasons (higher risk or unproven risk) to dialysis patients why continuous monitoring and reporting to the FDA was required so as to obtain valid consent to treatment? Did AFFY's legal duty become more imperative as patient deaths occurred and did AFFY notify new patients of those patient deaths prior to Omontys administration? Should Omontys be liable in punitive damages, then it may be game over for AFFY.