This post is from the non-Reed Smith side of the blog.
When we say Nebraska, what comes to mind? Cornhusker football? Warren Buffet, the Wizard of Omaha? Buffalo Bill’s Wild West Show? Mutual of Omaha’s Wild Kingdom? An amazingly haunting album by Bruce Springsteen? As the Jersey Girl blogger on this site, it should be no surprise that those ten songs go right to the top of the list. And, if you too are a true fan you’ll already know that Nebraska is actually mostly demos that Springsteen recorded as an experiment on a four-track cassette recorder. When the songs were tried later with the full power of the E Street Band behind them – most of them didn’t work. Born in the USA, Downbound Train, Pink Cadillac, and Working on the Highway found a home on later albums. But for songs like Atlantic City, Highway Patrolman, and My Father’s House – a guitar and a harmonic sold those songs more than a heavy back beat. Nebraska isn’t Springsteen’s only stripped-down album (The Ghost of Tom Joad and Devils & Dust), but for this Jersey Girl, it’s the one with the power. And it was recorded in a New Jersey bedroom one day in January 1982.
Nowhere in any of that did we connect Nebraska to preemption. That is until now. Until Ideus v. Teva Pharmaceuticals USA, Inc., 2017 WL 6389630 (D. Neb. Dec. 12, 2017). Based on our review, and please correct us if we’ve missed something, this is the first case to find a complaint was deficient for failure to plead any facts to establish why the warning claim involved “newly acquired evidence” that would allow it to escape preemption under Wyeth v. Levine, 555 U.S. 555 (2009).
Plaintiff alleged that defendant failed to warn about the risks of an intrauterine device. While the device was being removed, a piece of it broke off and embedded in plaintiff’s uterus. The broken piece later had to be surgically removed. Ideus, at *1. To support her claim, plaintiff alleged that the device’s brochure and package insert, lacked any warning that the device “could break during removal, or that smaller pieces of the device (as opposed to the device as a whole) could separate and become embedded.” Id. A quick aside. This distinction between the device as a whole and a piece of the device made us look at the device’s label. As a disclaimer, we simply looked at the available label on line, but it appears that product contains a warning that the device can become embedded and require surgery to remove. So, in essence, plaintiff’s claim is that while the manufacturer did warn of embedding and surgery as to the whole device, it didn’t warn about those things with a piece of the device. And plaintiff’s other claim is that the manufacturer didn’t warn the device could break. From our perspective, that’s a claim for something that was warned about and something that is a general risk of every product in the world. We don’t think much of plaintiff’s claims.
But we told you this was about preemption, so let’s get back to that. Defendant challenged plaintiff’s claims on the grounds of preemption. The warnings were FDA approved and therefore, plaintiff’s claims don’t survive conflict preemption. Id. As non-surprising as a Jersey Girl loving Springsteen, is a plaintiff raising the FDA’s Changes Being Effected (“CBE”) regulations in response to a failure to warn preemption challenge. Because CBE regulations allow a manufacturer to change the device’s warning without prior FDA approval, per Wyeth, it is possible for a manufacturer to change its warning and not run afoul of federal law. Hence, no preemption. But, what the court said in Ideus is that CBE isn’t a “magic” word that gets plaintiff around preemption even at the pleadings stage. More is required.
A CBE is only allowed based upon “newly acquired information,” not previously submitted to the FDA. “In the absence of such information, the [manufacturer] cannot alter its product’s labeling, and any state regulation or law requiring it to do so is necessarily preempted.” Id. at *2. The court in Ideus, therefore concluded that because “newly acquired information” is a pre-requisite for a valid CBE, facts to support the existence of such new information must be affirmatively pleaded in the complaint. The court cites three cases in support of its finding. We’ve discussed all three on this blog here, here, and here. The difference between those cases and Ideus is that in the prior cases the plaintiff had alleged some facts regarding “new” evidence. The courts were able to examine those allegations and reach conclusions regarding whether they demonstrated new information sufficient to support a CBE. They did not address the specific question of “whether the plaintiff must affirmatively plead the existence of “newly acquired information” to state a cognizable claim for relief.” Id. The closest earlier case was Utts v. BMS, 251 F.Supp.3d 644, 661 (S.D.N.Y 2017) which said:
In sum, if the plaintiff can point to the existence of “newly acquired information” to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by “clear evidence” that the FDA would not have approved the labeling change made on the basis of this newly acquired information.
Sounds like a pleading requirement to us. Even construing the allegations in a light most favorable to plaintiff, “dismissal is nonetheless appropriate . . . if the facts alleged in the complaint do not plausibly give rise to a claim that is not preempted.” Ideus, at *3 (citations omitted). Because “some indication of newly acquired information [is required] to trigger the applicability of the CBE regulation,” those allegations are required to be in the complaint. Id.
And, of course, they must then meet the requirements of TwIqbal. So, while plaintiff is being given an opportunity to amend her complaint, she “must plead with specificity any newly acquired evidence which may have warranted a change” in the device’s warning after the device was approved but before it was implanted in plaintiff.” Id. Given our earlier aside about the substance of the claims, we wonder if there was nothing in plaintiff’s complaint because there is nothing. We’ll wait and see, but in the meantime Nebraska, in addition to lending its name to a classic rock album, has given us a significant ruling in our preemption arsenal.