tag:blogger.com,1999:blog-5764290.post7897831247860266313..comments2024-03-22T08:01:16.236-04:00Comments on Rebecca Tushnet's 43(B)log: Does a purchaser of one flavor of ice cream have standing as to other flavors?Unknownnoreply@blogger.comBlogger7125tag:blogger.com,1999:blog-5764290.post-20675704653901688952012-07-31T13:11:22.485-04:002012-07-31T13:11:22.485-04:00Thanks. Sorry about my loose use of preclusion/pre...Thanks. Sorry about my loose use of preclusion/preemption. Now I'm worked up about the balkanization of the supposedly national economy, where the exact same behavior is or is not unlawful and actionable depending on which state, which circuit, and which court you are in. Maybe we should be like the European Union and try to harmonize our laws. Would a coherent national body of law be such a bad thing? It IS interstate commerce, after all. No Constitutional reason to let 1000 flowers-- or 50 weeds-- grow.Mark Edw. Andrewshttp://artsciencelaw.comnoreply@blogger.comtag:blogger.com,1999:blog-5764290.post-59895763094245161352012-07-31T11:21:01.113-04:002012-07-31T11:21:01.113-04:00A couple of doctrinal points, which I've negle...A couple of doctrinal points, which I've neglected but which are probably of most relevance to your questions: the FDCA preempts contrary <em>state</em> law. Technically, interaction with other federal statutes is a matter of preclusion, not preemption, and the analysis differs (in part because of the absence of federalism concerns). <br /><br />The Lanham Act does not make any violation of the FDCA actionable (whereas California has chosen to do so by adopting "identical" laws, as allowed by the FDCA's key preemption provision). Instead, the Lanham Act bars false advertising. It may be the case that a claim is false because it conflicts with FDA rules (e.g., if the FDA has defined an "active ingredient," maybe if you call an inactive ingredient active you're speaking falsely), or it may even be that FDA regulation has shaped consumers' expectations so they expect advertisers to adhere to FDA definitions (this has recently been litigated with respect to what pharmacists think about terms like "equivalent"). But you can't use mere violation of the FDCA/regs to establish a Lanham Act violation; you need the whole falsity/materiality package. In addition, some courts have refused to find falsity based on a mere failure to follow the FDA's definitions--though even then, if a plaintiff can show that consumers believe the advertiser is using a term the same way the FDA does, the possibility of false advertising should logically remain, and the pharmacist cases have generally come out that way.Rebecca Tushnethttps://www.blogger.com/profile/17344226000864611148noreply@blogger.comtag:blogger.com,1999:blog-5764290.post-47555824976929339642012-07-31T10:59:18.218-04:002012-07-31T10:59:18.218-04:00So the Lanham Act functions as a sort of Clayton A...So the Lanham Act functions as a sort of Clayton Act for the FDCA, and creates a "private attorney general" right of action? Everything you say about what the courts are allowing is true. (That's why I read your blog every day.) And what the courts are allowing is probably even necessary. But why are they allowing it in the absence of a statutory grant, and in the face of what certainly appears to be an exclusive grant to the FDA? Does the Lanham Act create a private right of action under the FDCA the same way it does under the FTCA? Has any court ever stepped up and said so directly? Or are attractive easy claims actionable and ugly complex claims preempted depending on the wh--, uh, sense of the court?Mark Edw. Andrewshttp://artsciencelaw.comnoreply@blogger.comtag:blogger.com,1999:blog-5764290.post-13904531685644296872012-07-31T10:23:45.091-04:002012-07-31T10:23:45.091-04:00It depends--there are cases about the meaning of &...It depends--there are cases about the meaning of "kosher," not to mention the class action against McDonald's for misleadingly touting that they didn't use beef to fry their french fries while in fact they added beef extract at another phase--which, among other things, caused Hindus to inadvertently violate an important taboo. <br /><br />Sometimes there isn't any need to interpret a regulation, even when it applies. There's another Pom case providing an easy example: a fraudster makes juice with mostly apple and grape and a hint of pomegranate and advertises it as pomegranate juice. The FDA regulates juice pretty closely, but there is no reason to leave enforcement against that fraudster to the highly overworked FDA, especially when legitimate competitors have an incentive to police the market. Plus, to say the FDA is "exclusively responsible" is to assume the answer to the question; it's not, where there are (1) violations of an independent law (and no conflict preemption) or (2) state laws "identical to" the FDCA/regs, which is what the key preemption provision says isn't preempted.<br /><br />Another hypo: a contract dispute in which the defendant promised to deliver product X, whose composition is regulated by the FDA. Plaintiff says that defendant didn't deliver X but a variant that doesn't have the same composition. Why would the FDCA preclude such a private action? True, the court might have to look at the regs to figure out if defendant delivered X, but so what?Rebecca Tushnethttps://www.blogger.com/profile/17344226000864611148noreply@blogger.comtag:blogger.com,1999:blog-5764290.post-22904291689697040232012-07-31T09:54:49.897-04:002012-07-31T09:54:49.897-04:00I do not doubt that the caselaw is all over the ma...I do not doubt that the caselaw is all over the map. Seems like false advertising ought to be actionable no matter whether it coincidentally violates the FDCA, FDA regs, religious taboos, dietary customs or restrictions, social mores, whatever. But can you make an interpretation of the religious taboos part of the claim? Part of the defense? Part of the proof? How can any claim of violating any FDA regulation not involve some kind of interpretation of the FDCA, starting with how to characterize the goods and which of the many FDA regulations-- and exceptions-- and special rules for bulk products and raw ingredients-- to apply? Isn't that what the FDA-- the federal agency exclusively responsible-- is for?Mark Edw. Andrewshttp://artsciencelaw.comnoreply@blogger.comtag:blogger.com,1999:blog-5764290.post-31099383991685479422012-07-30T19:46:45.226-04:002012-07-30T19:46:45.226-04:00Mark, that's not entirely true. The FDCA pree...Mark, that's not entirely true. The FDCA preempts non-identical state regulations, but to the extent the state merely provides a cause of action for violating the FDCA/governing regulations, that's ok. See, e.g., Delacruz v. Cytosport, Inc., 2012 WL 2563857 (N.D. Cal.). The Lanham Act caselaw gets a bit more complicated--there's a line of cases not allowing Lanham Act claims that would require interpretation of the FDCA/regs while allowing claims that merely require straightforward application--but even there, private causes of action survive. Pom Wonderful is a bit of an outlier in the circuits, but I don't think it cuts off Lanham Act claims entirely; it's perfectly possible for a food- or drug-related claim to be false and to violate the FDCA.Rebecca Tushnethttps://www.blogger.com/profile/17344226000864611148noreply@blogger.comtag:blogger.com,1999:blog-5764290.post-18622806384183770672012-07-30T17:02:40.950-04:002012-07-30T17:02:40.950-04:00Why is the court entertaining a private civil acti...Why is the court entertaining a private civil action over FDA regulations at all? The FDCA preempts, and only the FDA itself can act under the FDCA. See Pom Wonderful v. CocaCola.Mark Edw. Andrewshttp://artsciencelaw.comnoreply@blogger.com