With Spring Training well underway, we took notice of the solid base hit delivered last month by the Northern District of California in La Paz v. Bayer Healthcare LLC, No. C 15-03995, 2016 U.S. Dist. LEXIS 13058 (N.D. Cal. Feb. 2, 2016). The district court dismissed all the plaintiff’s claims, mainly on preemption grounds, but the more interesting part of the order is the district court’s treatment of causation.
Here is what we mean. In La Paz, the plaintiff was treated with a permanent contraceptive device that works by inserting one device into each fallopian tube. Significantly, the FDA had approved the product as a Class III device under the rigorous scrutiny of the premarket approval process, which of course signals the application of express preemption under Riegel v. Medtronic. We’ll get to that in a minute. Following implantation, the plaintiff allegedly experienced complications, including bleeding and pain. She therefore sued the manufacturer and alleged a full raft of claims: Manufacturing defect, design defect, negligence, failure to warn, strict liability, implied warranty, express warranty, and a variety of fraud claims. Id. at *7.
The defendants moved to dismiss based on preemption, both express and implied. One noteworthy aspect of the district court’s order is the court’s thorough analysis of express preemption under Section 360k(a) and Riegel, including discussion of the much-misunderstood “parallel claim” exception. Id. at *10-*12. The district court also described implied preemption under Buckman and its impact on claims that exist “solely by virtue” of federal requirements. Id. at *12-*13. Echoing other courts that have viewed these concepts together, the district court recognized the “narrow gap through which a state-law claim must fit to escape preemption by the [Medical Device Amendments].” Id. at *13.
In other words, the plaintiff must be suing for conduct that violates federal law, or else the claims would be expressly preempted by Section 360k(a). But the plaintiff also must not be suing because the conduct violates federal requirements under the MDA, as such claims would be impliedly preempted under Buckman. Id. (quoting Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th Cir. 2013)). To sustain an action, the plaintiff must allege a viable claim under state law that parallels federal requirements.
This is where it gets interesting (as if the exposition of express and implied preemption is not already interesting enough!). The Plaintiff in La Paz argued that her claims fit into the “narrow gap,” and while the district court was willing to consider the possibility, it defined the gap about as narrowly as could be. To start with, the plaintiff’sdesign defect and implied warranty claims were expressly preempted and were dismissed without leave to amend.
The other claims were not so simple. For manufacturing defect, the district court took judicial notice of Form 483 observations that the FDA issued to the product’s manufacturer, noting manufacturing issues requiring correction. The plaintiff argued that the 483 observations meant that the product was “adulterated” under federal law, making their state-law manufacturing defect claim “parallel” to a federal requirement. The district court entertained the idea, but dismissed the manufacturing claim anyway because the plaintiff had not alleged that the manufacturing issues actually caused a manufacturing defect in any device or caused her alleged injuries. Id. at *18-*22. This is a very good ruling because it recognizes, as we have said many times, that an alleged wrong in the abstract does not a lawsuit make. The alleged breach of duty has to actually have a consequence, which the plaintiff did not allege here.
The plaintiff’s negligence claim was based on alleged negligent training, but the court dismissed that claim on similar reasoning. Because the FDA had reviewed and approved the manufacturer’s training manual, the manufacturer argued express preemption. Citing California’s apparent recognition of a negligence-in-training claim (which we disagree with), the district court noted that the plaintiff had not alleged any deviation from the FDA-approved training, but that the manufacturer had provided training outside the scope its PMA submission, which somehow would avoid preemption. But again, the plaintiff did not allege a plausible causal link between any alleged negligence and the plaintiff’s injuries, so the claim failed regardless. Id. at *22-*25. We have read this part of the order multiple times, and to be honest, we cannot see how a “negligent training” claim involving a PMA device can ever escape express preemption. If the FDA has erected requirements governing training, then a state-law claim purporting to hold the manufacturer liable for additional training would be “different from” what the FDA required. If the FDA has not, then preemption flows from the statute’s “in addition to” language. So either way there would be preemption by Section 360k(a). But a dismissal is a dismissal, so we will move on.
With regard to failure-to-warn, the plaintiff attempted to track a post-Stengel failure-to-warn-the-FDA claim (which is another theory we think is dead wrong). The district court dismissed this claim along the same pattern: Even accepting the allegation that the manufacturer did not timely report similar adverse events to the FDA, and even accepting that California recognizes a negligence claim based on a failure to report, the plaintiff did not allege that her physician would have learned of the events even if they had been reported. Indeed, the manufacturer already warned physicians about the exact risks at issue anyway. Id. at *25-*27. In other words, timely reporting would not have changed the physician’s treating decision. This again is a failure of causation.
Finally, the express warranty and the various fraud claims. Apparently the product manufacturer had a blog (perish the thought) where a blogger wrote under the pseudonym “Judy.” As it turns out, “Judy” was not the blogger’s real name, and she never used the product. Aha, said the plaintiff. Meh, said the district court. The plaintiff did not allege that the product failed to conform to statements made in the blog, and she did not allege with any particularity the “who, what, when, where, and how” that Rule 9(b) requires for fraud-based claims. All she alleged was that the blog was “ghostwritten,” which “is not a ‘promise’ or a ‘description’ of the . . . product” in any sense. Id. at *27-*32.
So why is this complete dismissal a base hit, and not a homerun? The district court granted leave to amend on many of the claims, which causes us to sigh. But the court’s stated intention to hold plaintiff to her pleading burden—and particularly her burden to plead causationfor each of the non-preempted claims—certainly gave her a tough row to hoe. As we were writing this post, we were wondering to ourselves how the plaintiff could possibly plead viable claims. Apparently, the plaintiff was wondering the same thing: She voluntarily dismissed her complaint two days after the order was filed.