Last week, we were reminded that Eliot wrote that April was the “cruellest month.” This week, the Elliott case reminds us of the wasteland that can result when vague complaints meet device preemption. Elliott v. Smith & Nephew, Inc., No. 1:12-CV-0070-EJL-MHW, 2013 WL 1290812 (D. Idaho Mar. 28, 2013), involves fairly standard allegations about
2013
When Is Off-Label Use Not Off Label?
We’ve read Phelps v. Wyeth Inc., No. 09-6168, slip op. (D.Or. April 2, 2013) (also at 2013 WL 1403060). In general, Phelps is another rather dismal Fulgenzi-type decision holding involving metoclopramide and holding both that failure-to-update claims are not preempted (expressly or impliedly) and state a state-law cause of action. It’s not good…
Thumbs Down on Dopson-Troutt Aredia/Zometa Case
The geezers in our family have been busy recently ululating over the rule of three celebrity deaths. We are not sure we have ever before witnessed a trilogy quite like Roger Ebert, Margaret Thatcher, and Annette Funicello. An aunt insists that it is actually a trilogy of three celebrity women, with fashion designer Lily Pulitzer…
Website Not Considered Labeling in Food Case
If you are a regular reader of this blog, and we hope you are, you know that we have been paying close attention to when the FDA will issue its guidance on internet and social media promotion of drugs and devices. You can find our latest update here. As we’ve said before, we, and more importantly our clients, want and need word from the FDA as to what it will consider proper and what it will not. We know the rules for print and broadcast promotion, but those media continue to lose readers/viewers to the internet, and in particular to social media. And, in that marketplace – there remain too many unanswered questions for our clients to have any comfort in using the internet as a means of communicating information about their products.
The single biggest question for which we don’t have an answer is what actually constitutes promotion. Is it providing a link to a scientific article? Is it “liking” a Facebook post? Or “re-tweeting” someone else’s comments? We just don’t know. So, while we sit and wait for the FDA to decide the answer, we thought we’d bring you a recent decision from a food labeling case that grappled with the internet issue. The rules about food labeling are different from those for drugs and devices, but in the absence of formal FDA guidance, it behooves us to be aware of what courts are saying about our cousins in the food industry.
We doubt you’ll be surprised to learn that the issue arose in the context of a putative class action brought in California alleging violations of California’s Unfair Competition Law’s (“UCL”), False Advertising Law (“FAL”), and Consumers Legal Remedies Act (“CLRA”); as well as unjust enrichment and breach of warranty. Wilson v. Frito-Lay North America, Inc., 2013 U.S. Dist. LEXIS 47126, at *4-5 (N.D. Cal. Apr. 1, 2013). Perhaps you’ll be slightly more surprised, as we were, that anyone was claiming they were misled about the nutritional content and value of such products as “Lay’s Classic Potato Chips, Lay’s Honey Barbeque Potato Chips, Lay’s Kettle Cooked Mesquite BBQ Potato Chips, Cheetos Puffs, and Fritos Original Corn Chips.” Id. at *2. Can anyone claim — with a straight face – that they both purchased these products and that “they care about the nutritional content of food and seek to maintain a healthy diet”? This is the food of juvenile ignorance, youthful metabolism, and the occasional late night, perhaps alcohol-influenced, binge. It’s called junk food for a reason! But, back to the case.
There is a lot going on this decision, including a finding that several of plaintiffs’ claims are not preempted because the requirements they seek to impose mirror those imposed by the FDA – in drug and device parlance, they are allowable parallel violation claims. Not a result we’d champion and since we blogged about a similar result last week in Brazil v. Dole Food Company, 2013 WL 1209955 (C.D. Cal. Mar. 25, 2013), we won’t re-hash the issue here. See Wilson, 2013 U.S. Dist. LEXIS 47126 at *19-29. There is also an interesting discussion of the deference to be afforded to an agency’s informal, non-binding interpretation of its own regulations. In this case, the court found that because the regulation in question (on MSG labeling) was subject to different possible interpretations, it would give deference to the FDA’s statement on its website which “appears to be its own interpretation of an ambiguous regulatory scheme.” Id. at *26-29. Again, not a ground breaking ruling, but noteworthy.Continue Reading Website Not Considered Labeling in Food Case
A Decent Rule 702 Decision: Expert Can’t Give Legal Conclusions or Claim That He Knows What the Company Was Thinking
In one sense, the decision in Sadler v. Advanced Bionics, LLC, 2013 U.S. Dist. LEXIS 47964, (W.D. Ky. Apr. 3, 2013), is a mixed bag (we said that last week about the court’s in limine decisions as well). The defense moved to exclude the testimony of the plaintiff’s FDA expert in many areas…
That Was The Week That Was
The Rights of Spring: A Vernal Trio on Mensing/Conte, FDA Evidence, and Hack Experts
Maybe it is the hopeful anticipation of the cherry blossoms or the long-awaited spring thaw, but we were feeling generous as we read three recent decisions that touched on some recurring issues in drug cases these days. So, in part to save Bexis from having to address these with many others in his roundup, we…
Mud, Flowers, and Dismissals
Ediscovery For Defendants Cheat Sheet Updated
We update most of our Scorecards and Cheat Sheets on a real-time basis, because we have a good handle on the new decisions as they arise. Some of them, however, are updated more sporadically, mostly because they involve issues that go beyond purely drug/device matters. Our cheat sheet listing favorable e-discovery decisions involving plaintiffs’ social…
BAAA . . . . We’re Not Talking About Sheep
Maybe it was a recent couple of days spent in the Lancaster, Pennsylvania area, but when we saw a case about the BAAA – our first thoughts were along the lines of Old McDonald’s Farm. But today’s BAAA is significantly less known than either Dolly (the first cloned mammal) or Lamb Chop (the sock puppet) …