you are both there and we will hear st i'm afraid i don't know how to pronounce your name but not a georgia but your honor thank you you may don't understand how that is in any way independent of the federal law because that's the same rule the feds have you're not supposed to sell a drug if we haven't approved it and here you say yeah we agree don't makes there be some kind of independent requirement but when i looked at your complaint and maybe this goes to what you stated a claim rather than what it is whether it's preempted but did you allege in her complaint that this was not approved by the state because when i look at the only claim that plaintiff is advancing cheer for why the lotion is supposed to be unlawful is that it wasn't subjected to the f d a is federal new drug application process just as you observed judge miller the complaint a state regulatory process that was required to proceed through that would not be preempted under bachmann but that just isn't this case and is not the theory that summers has ever advanced  we already talked about the complaint the twenty two paragraphs in that complaint but summers has been completely consistent about that throughout the case for example in the citizen position that she filed with the f fifteen the district court stayed this litigation so that the plaintiff then franz could pursue a regulatory solution she went to the f d a and in her petition she wrote well there is no private right of actions or private right of action created by california law to pursue an alleged violation of the f t c a plaintiff made the same statement same similar statement in her briefing in her prior appeal to this court she said that the firestorm unlawful conduct triggering liability was its failure to seek the requisite f d a approval and when she opposed the summary judgment in the district court in this case she argued failed to comply with the required state regulatory process i don't think that would be preempted under buckman as you observed there would be other issues with a claim like that for example there might be an express preemption problem y front complained in a different suit such to enforce only state law no bachmann preemption but you know i do think it's very important that in this case we haven't seen any arguments that would apply to a claim like that just as you observed those aren't present here we haven't discussed express preemption counsel mentioned earlier that the state regulatory process she understands is defunct i frankly don't know a lot about the state regulatory process because it's never been raised it's not part of plaintiff's theory which solely seeks to have firestorm of compelled or penalized for not compelled to participate in the federal where one competitor allergan stude another competitor athena under the u c l for selling an unapproved drugs so the harm alleged in that case was harm from a competitors unfair competition which is an actual economic injury that's recognized in traditional state law separate and apart from the f t c a summer spear has alleged no harm of any kind no physical injury no misrepresentation another critical difference is that unlike the plaintiff in this case allegan claimed that the defendants product did violate state regulatory requirements for prescription drugs that's discussed in the supreme court  g which plaintiff cites in her brief and it's also clear from the federal circuit's decision to reverse the district courts or to modify the injunction put in place by the district court in that case the district court had imposed a nationwide injunction on the grounds that you know the defendants products had not been approved and the federal circuit said it's got to be california only because the plaintiff alleges only violation of california's health code other states may not have chosen to implement state regulatory requirements that mirror the f t c day so if we imposed using this decision barred you know from selling their products in those other states that would essentially be imposing california's health code on them it would have a quote here violate their sovereignty and usurp the discretion discretionary enforcement of the f d a so that decision with respect to the injunction shows you that the federal circuit understood that is a state law case a parallel state law that's exactly the theory that summers has not advanced in this lawsuit a similar st similar reason the other cases that summers relies on like trader joe's to know what a geisha in which counsel mentioned here in the argument are completely consistent with a finding of preemption in this case so in trader joe's claim was that the defendant had violated a state law substantive standard on misbranding of food products that mirrored the f t c a missed branding provision and that truly was a parallel claim that is permitted under the saving clause that summers summer cited that claim wasn't like like summers claim here that trader joe's needed to submit cans of tuna fish to f d a for some kind of approval process but instead it was that the tuna cans misrepresented the amount of tuna that was contained when measured according to the state law standards which mirrored federal law standards but the trader joe's court also held in connection with a different claim brought under a different state's law that didn't have mirroring state law provisions it held that a claim seeking to enforce the f t c a version of of through what some of the case law says about how you identify whether a claim is a parallel claim versus preempted efforts to enforce the f c c a so the cases point very far from independent of the f d a is approval process since that is exactly and the only reason why the plaintiff says that the that the well lucian is unlawful by focusing on the regulatory process also it's completely clear that summers is not attempting to enforce a mirror or parallel substantive provision it's true that states can incorporate federal standards state can make the state substantive standards the same as a federal substantive standard certainly that's permitted and that's a parallel claim but that is just not what summers claim is here given that she says what is about with comparable discrimination statutes just not the case with this claim here  and as i mentioned before that's been completely consistent theory this isn't a matter of plucking you know one in artful comment out of one brief here or there for a theory has been repeated and consistent through the so a claim seeking a ruling that would penalize fire store for or caused fire storify not to be able to sell its product solely because it hadn't gone through the f d a new drug approval process that is a