O'Neil v. Texas Deparment of Criminal Justice

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

• finding preemption based on PAS submission, but recognizing the clear evidence standard is undefined
• holding conflict preemption is a demanding defense
• FDA’s denial of drug manufacturer’s requested change to “[precautions” section of label soon after plaintiff’s injury provided clear evidence FDA would have rejected change before injury occurred
• “Thus, since the FDA rejected Defendant’s PAS, it would not have approved a CBE seeking to add the same language to the label that it just rejected in the PAS.”
• “Thus, since the FDA rejected Defendant’s PAS, it would not have approved a CBE seeking to add the same language to the label that it just rejected in the PAS_”
• “Like a PAS, the ‘proposed change must be based on ‘reasonable evidence of an association between a hazard and the drug at issue; however, a causal relationship need not have been definitely established.’ ”

Source: CourtListener parenthetical corpus (CC0).