This is our second post in as many months about Dr. Blond and the Trasylol MDL, and he’s not faring any better in April than he did in March. Of course, with a name like Blond, we thought of all the “blondisms” in our culture. We opted to take the high road and go
We don’t know how to mind our own business.
‘Cause the whole world’s got to be just like us.
Now we are fighting a war over there
No matter who wins, you know we can’t pay the cost.
Steppenwolf, “Monster.”
Some might say that John Kay’s musical biopic of American history is as true today
In our day job, we generally rely on final decisions of FDA about things like drug approvals, device clearances, and rules and guidances. We also rely on the general integrity of the FDA’s processes. Even when there are things we do not like on the merits, like observations in form 483s or warnings letters—each is not a final determination of anything according to FDA—we often look to the process itself, which can include a number of steps after the offending statement or action is final.
We also find ourselves calling to the Congressional charge of FDA to protect public health and its various powers of enforcement as counters to the plaintiff charges that FDA’s actions or actions do not amount to condoning our client’s conduct. Even when we read reports like IOM’s panning aspects of FDA, we still find ourselves looking at the process for the product in our case, with (we hope) thorough evaluation of evidence, layers of review, and consistency in reasoning.
The underlying facts in Ivy Sports Medicine, LLC v. Sebelius, No. 11-cv-1006 (RLW), 2013 U.S. Dist. LEXIS 51763 (D.D.C. April 10, 2013), test even our somewhat slanted view of things. The case came up on dueling summary judgment motions on an Administrative Procedures Act (APA) review of an FDA decision on a medical device. We have posted on cases in a similar posture before and noted the tension we, as a drug and device products defense lawyers, feel when FDA screws up. In Ivy, the court is asked to decide whether FDA has inherent authority to correct what it considered a massive screw-up and whether it behaved rationally—as opposed to arbitrarily and capriciously—in its correction. In other words, as a big-boned Colorado kid would demand respect for his authority in any situation, is FDA’s inherent authority to be respected when it takes unusual steps to correct a prior abuse of its authority?Continue Reading Respecting FDA’s (Inherent) Authority
One of the avowed purposes of the blog is to make available to all defense lawyers the kind of extremely detailed legal research that that we large firm lawyers frequently end up doing. After all, a win anywhere helps defendants everywhere. Sometimes we’ve done this research ourselves; sometimes we’ve come across research done by others.
The Aredia/Zometa case of Guenther v. Novartis Pharmaceuticals Inc., 2013 U.S. Dist. LEXIS 50945 (M.D. Fl. Apr. 9, 2013), produced another interesting decision last week. Not necessarily good, but interesting. The defense moved for summary judgment on plaintiffs’ failure-to-warn-based claims for failure to satisfy the proximate causation element of the learned intermediary doctrine. Id
Huggins v. Stryker Corp., 2013 WL 1191058 (D. Minn. March 25, 2013), is another opinion that puts the “pain” in “pain pump litigation.” It’s also another example of a court putting the cart before the horse, a theme raised in Eric’s post yesterday. The opinion addresses three motions: Plaintiff’s motion to transfer the
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
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
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
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