Attorney(s) appearing for the Case
Eugene G. Iredale, Bethany O'Neill, San Diego, CA, for the defendant-appellant.
Patrick K. O'Toole, United States Attorney, Melanie K. Pierson, Assistant United States Attorney, United States Attorney's Office, San Diego, CA, for the plaintiff-appellee.
Before: FERNANDEZ, KLEINFELD, and McKEOWN, Circuit Judges.
United States Court of Appeals, Ninth Circuit.
Opinion by Judge McKEOWN; Dissent by Judge FERNANDEZ.
McKEOWN, Circuit Judge.
Section 303 of the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 333(a)(2), imposes felony liability for misbranding "with the intent to defraud or mislead." The question presented is whether this provision requires proof of materiality. We hold that materiality must be proven as an element of the offense under either a theory of intent to defraud or a theory of intent...
NEVER MISS A DECISION. START YOUR SUBSCRIPTION.
Uncompromising quality. Enduring impact.
Your support ensures a bright future for independent legal reporting.
As you are aware we have offered this as a free subscription over the past years and we have now made it a paid service.Look forward to your continued patronage.