United States: Illinois And Colorado Courts Reject Stengel/Hughes Failure To Warn Claims

Last Updated: October 3 2017
Article by Michelle Yeary

In our post earlier this week " No Causation, No 'Parallel Claim'" we examined the enormous causation hurdle plaintiffs face in trying to prove a Stengel or Hughes type failure to warn claim in those jurisdictions where such a claim has been found not to be preempted. In that post, we commented that we "would have preferred an order finding the failure-to-warn claims preempted." Well today, we bring you two that do just that. The first a complete preemption win, the other only a partial, but we'll start with the good news.

Both Golden v. Brown, Case # 17CV30568, slip op. (Colo. Dist. Ct. Sep. 24, 2017) and Norabuena v. Medtronic, Inc., 2017 Ill. App. LEXIS 593 (Ill. App. Sep. 20, 2017) refused to recognize a failure to warn claim premised on a failure to report adverse events to the FDA – a Stengel claim if you're in the Ninth Circuit and a Hughes claim if you're in the Fifth. Now neither Colorado nor Illinois is in those circuits, but we'd like to think that regardless these state courts would have reached the same conclusion they did – neither Colorado nor Illinois law recognizes a claim for failure to warn the FDA. So, plaintiff can allege defendant violated a federal regulation by failing provide information to the FDA – but it isn't "parallel" to any state law claim because there is no such state law claim. The Illinois appellate court summed it up nicely:

[A]lthough plaintiffs have identified a federal requirement that their complaint alleges Medtronic violated, there is no Illinois requirement that parallels it. Plaintiffs asserted claims for failure to warn. Although Illinois recognizes that a manufacturer may satisfy its duty to warn by conveying information to third-party learned intermediaries, this is not synonymous with an affirmative duty to warn a federal regulatory body. The learned intermediary doctrine states that a manufacturer has a duty to warn prescribing physicians of a drug's known dangerous propensities" under the understanding that those physicians will use their expert knowledge in adequately warning the patient. We cannot find that this duty is parallel to the federal requirement.

Norabuena, 2017 Ill. App. LEXIS 593 at **14. The Colorado court not only found that allegations of failure to report adverse events to the FDA don't state a parallel claim, but also concluded that Stengel and Hughes "cannot be reconciled with 21 U.S.C. §360k(a) as interpreted in Riegel or 21 U.S.C. §337(a) as interpreted in Buckman." Golden, slip op. at 3. In other words, failure to warn a learned intermediary is different from and in addition to federal requirements regarding reporting of adverse events and a claim for failure to provide information to the FDA is an improper attempt at private enforcement of the FDCA. Just what we've been saying since these two awful decisions came down.

Both decisions have a little more to discuss.

In Golden, plaintiff also attempted to base a parallel claim on alleged violations of Current Good Manufacturing Processes ("CGMPs"). Noting that it was joining the majority of courts to have considered the issue, the court ruled that the CGMPs are too "vague" and "open-ended" to serve as a basis for a parallel claim. Id. at 2. The court also found plaintiff's breach of implied warranty of merchantability claim preempted as essentially an allegation that the device was not safe and effective which would directly contradict the FDA's PMA decision that "there is a reasonable assurance of . . . safety and effectiveness" and therefore expressly preempted. Id. at 3. And finally, the court found plaintiff's claims impliedly preempted because plaintiff failed to explain "how Defendant's conduct violated state law duties absent the FDCA." Id. Simply stating that her claims were premised on Colorado common law was insufficient – "true merely in title, not substance." Id. Instead, plaintiff's claim exist solely under the FDCA which is not allowed.

The Golden case also suffered from some pleadings defects, such as failure to allege facts to support either a defect or causation. Id. at 2. But even if those pleading deficiencies could be cured, none of plaintiff's claims survived preemption, so the case was dismissed in its entirety.

Switching gears to Illinois – unfortunately the court ruled that one of the bases for plaintiff's failure to warn claim was not preempted. The FDCA contains regulations against device misbranding, which includes advertising that is false and misleading. Norabuena, 2017 Ill. App. LEXIS 593 at **15. Plaintiff alleged that defendant's advertising was false and misleading in that it concealed known risks of using the device in an off-label manner. Id. at **16. In reaching its conclusion, the court distinguished plaintiff's claim as not an attack on the device's label which would be preempted as having been specifically approved by the FDA during the PMA process. But rather, plaintiff was challenging allegedly deceptive marketing practices post pre-market approval. Id. at **17. But that is a distinction without a difference where plaintiff's allegation is that in its advertising defendant should have included a warning different from or in addition to the warning the FDA approved. The FDA-approved warning is what must accompany product advertising. Think about what the court is saying – if the warning is in the product label it must adhere to the FDA-approved language. If the warning accompanies an advertisement for the product it does not. We do not believe that is something the FDA would allow. While we can understand how a court can find that a false statement made in product promotion may be both a violation of state law and FDCA misbranding regulations, where that falsity is alleged to be a failure to include a warning not approved by the FDA, we respectfully disagree.

But, all is not lost in Norabuena. The appellate court found that plaintiff's claims were properly dismissed on another ground – failure to plead causation. The complaint apparently was replete with allegations of "omitted" risks, "[h]owever, there are no specific factual allegations in the complaint asserting that [plaintiff's] surgeon encountered or relied on any of the asserted promotional marketing." Id. at **21. If a tree falls in the woods. . . . It's not enough to plead the act or omission, the complaint was also allege facts supporting proximate cause. This pleading deficiency wasn't enough for a dismissal with prejudice, so the case is heading back to the trial court and plaintiff will have to re-plead her remaining failure to warn claim.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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