The district court’s order dismissing claims in Ebrahimi v. Mentor Worldwide LLC, No. CV 16-7316, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017), is a good antidote to the Ninth Circuit’s wrongly decided opinion in Stengel v. Medtronic. Stengel is where the Ninth Circuit held that the plaintiff avoided express preemption by alleging that a pre-market approved medical device manufacturer failed to report adverse events to the FDA, thus violating FDCA regulations and a “parallel” state-law duty to warn. We have criticized Stengel any number of times, but you can read this and this to get the gist. The most obviously questionable aspect of Stengel is its application of a California state-law duty to warn the FDA, which we are not convinced exists in the first place.
Another befuddling aspect of Stengel is causation: How can a plaintiff plead and prove that an alleged failure to report events to the FDA actually affected his or her physician’s treating decisions or the treatment outcome? The district court’s order in Ebrahimi v. Mentor dismissing claims against a breast implant manufacturer shows that most plaintiffs can’t do it.
Here is what happened. When the FDA approved the defendant’s silicone-gel breast implants through the pre-market approval process, it required six-post approval studies “to further assess the safety and effectiveness” of the implants. This presumably was because of the ultimately unfounded concerns about silicone-gel breast implants that led to their absence from the U.S. market for a period of years. The plaintiff in Ebrahimi was treated with the defendant’s silicone-gel implants and later experienced complications leading to the implants being removed.
Her lawsuit alleged failure to warn, strict liability manufacturing defect (presumably because California does not recognize strict liability for design defect), and negligence per se—all of which failed. On failure to warn, the district court distilled two theories from the complaint: “a claim based on [the manufacturer’s] failure to report to the FDA ‘adverse events’ regarding certain dangers with the Implants’ use, and (2) a claim based on [the manufacturer’s] failure to issue sufficient warnings to consumers and doctors.” Id.
There are a number of issues here—express and implied preemption paramount among them—but the failure-to-warn claim failed at this juncture because of causation. The plaintiff opposed the manufacturer’s motion to dismiss by arguing that the manufacturer knew about “reported systemic ailments which can only be attributed to gel bleed . . . but failed to report that to the FDA.” (emphasis supplied by court). Those failure-to-report allegations were impossibly vague and failed to allege causation. The following quote is kind of long, but it’s the core of the order:
The problem with Ebrahimi’s allegations concerning the flawed post-approval studies is that she has not sufficiently alleged facts to support her assertion that the unreported “systemic ailments” or negative health effects that patients experienced during the post-approval studies “can only be attributed to gel bleed” or some other actual “adverse event.” . . . . Ebrahimi fails to sufficiently allege what the “systemic ailments” are that the post-approval studies revealed and merely surmises, in conclusory fashion, that they “can only be attributed to gel bleed.”
Furthermore, Ebrahimi has not sufficiently alleged a causal nexus between her injuries and [the manufacturer’s] failure to report adverse events to the FDA. She does not allege, for instance, how any “gel bleed” issue would have caused the FDA to require different labeling, especially given the FDA—and Ebrahmi herself for that matter—was aware of the risk of gel bleeding. Ebrahimi states she suffered injuries “[a]s a direct and proximate results of [the manufacturer’s] foregoing acts and omissions.” . . . . Yet, she fails to allege how any reporting by Mentor to the FDA would have caused her surgeon to stop using Implants or her to refrain from having the breast-implant surgery with the devices at issues, considering the potential health consequences of which she was already aware.
Id. Let’s unpack that a little bit. The plaintiff’s theory was the alleged failure to report events from post-approval studies caused her complications. But in trying to get from point A to point B, the allegations fall apart. It is awfully easy to allege “unreported systemic ailments,” but which ones? What other actual “adverse events” did the defendant allegedly fail to report? And how do any of them have anything to do with what the plaintiff allegedly experienced. It is similarly easy to write on paper that such “ailments” can “only be attributed to gel bleed,” but how? If there could be link, what else could cause the “ailments” and how can we exclude them? We don’t know, and neither did the plaintiff, who “merely surmised” these facts, in conclusory fashion.
All that is before we even get directly to proximate causation. Sure, the plaintiff alleged injuries “as a direct and proximate result” of the defendant’s alleged conduct, as all plaintiffs do. But when the FDA already knew about gel bleed, and the plaintiff’s doctor already knew about gel bleed, and the plaintiff herself already knew about gel bleed, how could the alleged failure to report adverse events (whatever those events were) possibly have made any difference. Would the FDA have required a different warning? Would the physician have reviewed the adverse reports? If so, would anything have added to the physician’s knowledge, or to the plaintiff’s own knowledge? Would it have changed anything? Again we don’t know—and, again, neither did the plaintiff.
Recall what we said about Stengel at the outset. That opinion’s Achilles heel is causation, owing to the Ninth Circuit’s result-oriented acrobatics to find a claim that avoided express preemption. It purported to find one, but one that requires a causal chain that is extraordinarily attenuated. We offer kudos to the district judge in Ebrahimi for recognizing the plaintiff’s burden to plead causation as part of her “parallel claim” and correctly finding that the plaintiff had not met it. Of course, we would have preferred an order finding the failure-to-warn claims preempted, but this is not bad.
The district court also dismissed the strict liability manufacturing defect claim and the negligence per se claim. The former was implied preempted under Buckman because “it hinges entirely on conduct [the plaintiff] claims violates the FDCA as well as the FDA’s Current Good Manufacturing Practices.” Id. In other words, she was suing because the alleged conduct violated the FDCA, which is the sine qua non of implied preemption. The negligence per se claim fell because negligence per se is not a separate cause of action under California law. Id.
Alas, the district court granted leave to amend. But given that this plaintiff alleged a known and warned-of complication of a pre-market approved medical device, she has a tough row to hoe.