As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims with indirect third-party warning claims where the third party is a governmental agency – that is, the FDA. Validating such allegations could have much broader implications – on everything from statements made to insurance regulators to child abuse reporting requirements – but, even limited to the FDA, it creates precisely the same perverse incentive “to submit a deluge of information that the [FDA] neither wants nor needs” that supported preemption of other tort claims challenging the accuracy/completeness of FDA submissions in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 351 (2001). But the Supreme Court denied certiorari in Stengel, so life goes on.

To the extent that Stengel had any redeeming feature, it is found in the 7-judge concurrence (a majority opinion, really, since 11 judges were sitting for the en banc decision), which recognizes that causation is particularly problematic where a federal agency with preemptive power is a middle-man in state-law litigation:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist. To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries. But at this juncture − a request for leave to amend their complaint – [plaintiffs’] allegations of causation are adequate.

Stengel, 704 F.3d at 1234-35 (concurring opinion). Stengel cited to the causation theory described in Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011):

[Plaintiff’s] primary causation theory is that if [defendant] had reported the true number of injuries and malfunctions related to [the risk] caused by the [device], this information would have appeared on the FDA’s MAUDE internet database [of adverse events reported about medical devices] and in medical journals, and with this information [the prescriber] would not have recommended the [device] to [plaintiff] for treatment.

Id. at 776.

Again, this is not much different conceptually from fraud on the FDA, in that it depends on the FDA doing something that it in fact did not do in reliance on information it did not have. In defending our clients going forward, however, defense counsel have to adjust their strategies to deal with whatever mud the courts allow the plaintiffs to throw at the wall.

So causation in failure-to-report claims is necessarily roundabout because “any attempt to predicate the [] claim on an alleged state law duty to warn doctors directly would have been expressly preempted.” Stengel,704 F.3d at 1234; accord Perez v. Nidek Co., 711 F.3d 1109, 1118 (9th Cir. 2013) (“had the plaintiffs predicated their claim on a failure to warn doctors directly − an action not required by FDA regulations − that claim would have been preempted”). The causal chain requires, first, that FDA would do something differently (such as make the adverse events public), and, second, that the hypothetical action by the FDA would have caused the prescriber, in turn, to change his/her prescribing decision in some way that would have prevented the claimed injuries. See McAfee v. Medtronic, Inc., 2016 WL 2588807, at *2 (N.D. Ind. May 5, 2016) (“[plaintiff] still hasn’t suggested how any delay in filing a report (or reports) with the FDA caused or contributed to his injuries, i.e., that had [defendant] filed the report of the . . . adverse event before his surgery, his physician would have received notice of that filing, and would have considered and used a different [device]”). In large part, defending these claims post-Stengel means focusing on this attenuated causal chain, which is what this post is about.

Before we start, a disclaimer − almost all of the cases that have addressed causation in failure-to-report cases have been on the pleadings. Thus, almost all these decisions have been taking the plaintiffs’ word for it with respect to causation issues.

For example, the availability of adverse events on the FDA’s public databases (such as “Manufacturer and User Facility Device Experience” (MAUDE) system, even after they are reported, is hardly a certainty. See 21 C.F.R. §803.9 (“[the FDA] may disclose to the public any report . . . submitted under this part”). “[B]ecause of the FDA’s independence and bureaucratic process, defendants hardly would have had any ‘reasonable assurance’ that the reported information would have reached plaintiff.” Norman v. Bayer Corp., 2016 WL 4007547, at *4 (D. Conn. July 26, 2016).

    • Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). If a report contains trade secret or confidential business information, that text is replaced by “(b)(4)”. If a report contains personnel or medical files information, that text is replaced by “(b)(6)”.
    • Variations in trade, product, and company names affect search results. Searches only retrieve records that contain the search term(s) provided by the requester.
    • MAUDE is updated monthly and the search page reflects the date of the most recent update. The FDA seeks to include all reports received prior to the update but the inclusion of some reports may be delayed.

FDA Manufacturer and User Facility Device Experience Description. Therefore:

[T]he FDA’s disclosure of [adverse events] to the public is not guaranteed. Indeed, Plaintiffs’ allegations do not explain if or how the FDA would disclose Defendant’s [reports]. . . . [T]here is no guarantee that the FDA would have disclosed [adverse events] that were timely filed by Defendant,

Cline v. Advanced Neuromodulation Systems, Inc., 17 F. Supp.3d 1275, 1286 & n.1 (N.D. Ga. 2014) (regulatory citation omitted).

Plaintiff has not alleged that the FDA’s disclosure of Defendant’s timely filed [reports] would necessarily provide Plaintiff with specific, actionable information. In addition to disclosing information at its discretion, the FDA withholds trade secret or confidential information.

Id. at 1286 (citations omitted).

Nor is it likely that MAUDE results connote causation, or that one device is safer than another. Should a prescriber ever actually use this database – which they practically never do, but that is a summary judgment issue − s/he is warned by the FDA against drawing such conclusions because the Agency recognizes that MAUDE has many drawbacks that detract from its reliability:

    • MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
    • Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Establishing a cause-and-effect relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated.
    • MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions.
    • Submission of a medical device report and the FDA’s release of that information is not necessarily an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.

FDA Manufacturer and User Facility Device Experience Description. For all of these reasons, prescribing physicians simply don’t look at MAUDE, which should eventually defeat causation in failure-to-report cases on grounds of failure to read, but only on summary judgment − after the defense has spent a fortune on discovery.

At the pleading stage, due to all this uncertainty, many cases have recognized that TwIqbal “plausibility” (or an equivalent state law requirement) demands the pleading of sufficient facts to establish the causation element. For a failure-to-report claim to be plausible, it must allege “a causal connection between [plaintiffs’] injuries and the alleged failure to report.” Hawkins v. Medtronic, Inc., 2014 WL 346622, at *8 (E.D. Cal. Jan. 30, 2014).

Plaintiffs still have not alleged how defendants’ alleged failure to warn the FDA about adverse events contributed to their injuries. What is missing from [this] adverse events claims is any connection between defendants’ alleged failure to report adverse events and her surgery. Plaintiffs also have not alleged any factual support for these claims, such as any details (the date, nature of injuries, or method of implant) about any adverse events that should have been reported. Without such factual detail, it is not possible to tell if timely reporting would have affected the [prescriber’s] use of the [] device during [plaintiff’s] surgery.

Martin v. Medtronic, Inc., 63 F. Supp.3d 1050, 1058 (D. Ariz. 2014).

“[N]umerous district court decisions have also recognized that a causal link between a manufacturer’s failure to warn the FDA and a plaintiff’s injury is a necessary element of such a claim.” De La Paz v. Bayer Healthcare LLC, 159 F. Supp.3d 1085, 1093 (N.D. Cal. 2016) (collecting cases). One such fact, of course, would be that the allegedly unreported events later actually showed up on MAUDE. Only one case that we know of, however, has made that rather basic allegation. That claim survived. Rosen v. St. Jude Medical, Inc., 41 F. Supp.3d 170, 187 (N.D.N.Y. 2014). Other plaintiffs have not been so lucky. See Martin v. Medtronic, Inc., 32 F. Supp.3d 1026, 1043 (D. Ariz. 2014) (plaintiffs “have not alleged how that failure to warn caused or contributed to their damages or injuries”); Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp.3d 1021, 1040 (D. Haw. 2014) (“Plaintiffs provide no facts or argument tying the failure to submit reports of adverse events to the FDA to a failure to warn”); Simoneau v. Stryker Corp., 2014 WL 1289426, at *10 (D. Conn. March 31, 2014) (“scant pleadings” “do[] not link [plaintiff’s] injury to a violation, nor can the court reasonably infer such a link”); Hawkins, 2014 WL 346622, at *8 (“[w]hat is not alleged is any factual content that would support the causal nexus” to plaintiff’s surgery); Eidson v. Medtronic, Inc., 981 F. Supp.2d 868, 889 (N.D. Cal. 2013) (“although [plaintiff] generally asserts that the Defendants’ failure to report to the FDA ‘caused’ his injuries, he does not state with any specificity how it caused them”) (emphasis original); Angeles v. Medtronic, Inc., 863 N.W.2d 404, 419 (Minn. App. 2015) (“to sufficiently plead this claim, we do believe that appellants must show how [defendant’s] alleged failure to warn the FDA about adverse events . . . contributed to their injuries”); Lutz-Cummings v. Medtronic, Inc., 2016 WL 3082314, at *6 (Minn. Dist. May 31, 2016) (“Plaintiffs have not pled sufficient facts to establish that Defendants’ alleged failure to report to the FDA adverse events contributed to Plaintiff’s injuries”); Latimer v. Medtronic, Inc., 2015 WL 5222644, at *9 n.5 (Ga. Super. Sept. 4, 2015) (“Plaintiff’s claim necessarily fails because the complaint does not allege a causal connection between any purported failure to report adverse events and Plaintiff’s alleged injury”); Cales v. Medtronic, Inc., 2014 WL 6600018, at *14 (Ky. Cir. Nov. 21, 2014) (“The problem with Plaintiffs’ claims is that although they have alleged that [defendant] failed to warn the FDA about adverse events, they have not alleged how that failure to warn caused or contributed to their damages or injuries”), reconsideration denied, 2015 WL 4081908 (July 1, 2015).

Timing is important. To be causal, any alleged failure to report must occur before the plaintiff was treated with the device in question. A plaintiff “will ultimately have to prove that if [the defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the plaintiff’s] doctors in time to prevent” the alleged injuries. Coleman v. Medtronic, Inc., 167 Cal. Rptr.3d 300, 312 (Cal. App. 2014). Thus, plaintiffs alleging only that the defendant failed to report the particular adverse event that injured them do not state a claim.

Plaintiff must show that she was injured from the failure to report. Although she conjectures that Defendant failed to report similar injuries with other patients, she has no facts to support this assumption. At this point, the only failure to report she argues about is with respect to the [device] implanted in her. Any failure to report her injuries or any defects with her implants could not have caused her injury.

Malonzo v. Mentor Worldwide, LLC, 2014 WL 2212235, at *3 (N.D. Cal. May 28, 2014) (emphasis original). Accord Johnson v. Hologic, Inc., 2015 WL 75240, at *4 (Mag. E.D. Cal. Jan. 5, 2015) (“[a]ny failure to report this particular adverse event to the FDA could not have caused the injuries alleged . . . because it was necessary for plaintiff’s injuries to have occurred before defendant’s duty to report that event could arise”), adopted, 2015 WL 4745264 (March 6, 2015); Simmons v. Boston Scientific. Corp., 2013 WL 1207421, at *5 (C.D. Cal. March 25, 2013) (“a failure to notify the FDA of [plaintiff’s] injury could have no causal relationship to the injury she suffered”).

Another form of timing defense to failure-to-report claims is available when the events in question were, in fact, reported – albeit late – and still the FDA did not view them as significant enough to warrant any change in the device’s labeling, or anything else. In such a situation, causation is not plausibly pleaded:

[T]he FDA already required [defendant] to warn physicians and patients about the [risk at issue]. Moreover, although the Form 483 did not indicate when the unreported [events] occurred, it did establish that the FDA became aware of these adverse events more than a year before [plaintiff] underwent the procedure. . . . The FDA did not require [defendant] to take any action to further warn physicians or patients . . ., beyond the warnings already in place.

Thus, [plaintiff] has failed to plausibly show that her injuries would have been prevented if [defendant] had properly reported the [] events—a necessary element of her failure-to-warn-the-FDA claim.

De La Paz, 159 F. Supp.3d at 1097 (eight allegedly late reported events).

But the FDA was aware of these reporting issues years before plaintiff’s device was implanted, and the new type of warning did not change any of the warnings’ substance. . . . Therefore, plaintiff “has failed to plausibly show that her injuries would have been prevented if [defendant] had properly reported the [] events.”

Norman v. Bayer Corp., 2016 WL 4007547, at *4 (D. Conn. July 26, 2016) (quoting Del La Paz, supra). Accord Caton v. Stryker Sustainability Solutions, Inc., 2015 WL 12426110, at *6 (C.D. Cal. May 12, 2015) (alleged non-disclosure of studies; “these documents demonstrate that the FDA already considered the risks presented by the . . . Study”); Cline, 17 F. Supp.3d at 1287 (“it is implausible that either the FDA’s or Plaintiff’s medical providers’ opinion of the [product] would be affected by the failure of one device”).

Thus, the pleading of a plausible time period for the lack of reporting to have caused the plaintiff’s injury is necessary to avoid dismissal.

Appellants must allege factual support for their claims, such as details about adverse events that should have been reported in order to determine if timely reporting would have affected . . . their surgeries. Without such detail, it strikes us that it would be difficult if not impossible to determine whether timely reporting would have affected . . . appellants’ surgeries.

Angeles, 863 N.W.2d at 419 (citations omitted). Accord Brandt v. Medtronic, Inc., ___ F. Supp.3d ___, 2016 WL 1270993, at *4 (D. Nev. March 31, 2016) (“Plaintiff does not specify when [defendant] learned of those safety risks − if they arose after the Device’s PMA, then Plaintiff may be able to make out a claim”); Caton, 2015 WL 12426110, at *6 (failure to report studies; “the report could not have been completed until, at the earliest, two months after Plaintiff’s surgery, it could not have influenced [the prescriber’s] decision to surgically implant the [device]”); Michajlun v. Bausch & Lomb, Inc., 2015 WL 1119733, at *8 (S.D. Cal. Mar. 11, 2015) (“Plaintiffs have alleged relevant date ranges for the allegedly unreported adverse events”); Johnson, 2015 WL 75240, at *5 (“no mention by plaintiff . . . that defendant failed to report to the FDA the occurrence of similar adverse incidents that occurred prior to her use”); Cline, 17 F. Supp.3d at 1286 (“Plaintiffs claim ultimately must allege that if Defendant had properly filed [adverse events] in accordance with FDA regulations, this information would have reached Plaintiff or her physician in time to prevent her injury”); Hawkins, 2014 WL 346622, at *8 (E.D. Cal. Jan. 30, 2014) (“[n]o dates are provided that might allow the inference that timely reporting could have affected” plaintiff’s surgery) (emphasis original); Eidson, 981 F. Supp. 2d at 889 (the “complaint does not specify the date on which the [event occurred] or the date on which Defendants reported [it] to the FDA. Thus, the Court has no basis to evaluate whether the failure to report may have had a causal effect”).

Finally, we came across a couple of pleading points for failure-to-report claims beyond causation that are worth mentioning. First, a plaintiff must plausibly allege that the FDA actually did require that the information in question be reported. See Caton, 2015 WL 12426110, at *5-7 (alleged non-disclosure of studies; “Plaintiff fails to show that Defendants were required by federal regulations to disclose information”; one study was already considered, another did not involve the version of the device sold in the United States); Id. at *8 (“untethered assertions fail to identify the information that Defendants were required to provide to the FDA . . . Plaintiff fails to show that Defendants violated a federal regulation”). In Funke v. Sorin Group USA, Inc., 147 F. Supp.3d 1017, 1024 (C.D. Cal. 2015), the allegedly unreported events occurred either prior to approval or outside of the country, and thus were not subject to the immediate (as opposed to annual) reporting requirements that the plaintiff claimed were violated.

Thus, while a plaintiff might survive dismissal by alleging failures to report based on statistical inference, e.g. Hawkins v. Medtronic, Inc., 62 F. Supp.3d 1144, 1166 (E.D. Cal. 2014); Eidson v. Medtronic, Inc., 40 F. Supp.3d 1202, 1233-34 (N.D. Cal. 2014), such claims should not escape summary judgment where the defendant can show that actual FDA requirements are other than what the plaintiff claims they are. Walker v. Medtronic, Inc., 670 F.3d 569, 579-80 (4th Cir. 2012); Kemp v. Medtronic, Inc., 231 F.3d 216, 230 (6th Cir. 2001). The FDA’s reporting obligations are limited to specific events “that you receive or otherwise become aware of . . . from any source.” 21 C.F.R. §803.50. This is an FDA-defined term, meaning:

. . .We consider the following information to be reasonably known to you:

(i) Any information that you can obtain by contacting a user facility, importer, or other initial reporter;

(ii) Any information in your possession; or

(iii) Any information that you can obtain by analysis, testing, or other evaluation of the device.

Id. §803.50(b)(1). See Stengel, 704 F.3d at 1234 (finding parallel claim where defendant allegedly “fail[ed] to do what federal law [citing §803.50] mandated – nothing more”). Statistical speculation that there must have been unreported events, without proof of a defendant actually being “aware of” those events within the meaning of §803.50 would not be “genuinely equivalent” to the federal reporting requirements, and thus would be preempted. McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005) (“for a state requirement to be parallel to a federal requirement … , the plaintiff must show that the requirements are ‘genuinely equivalent.’”) (quoting Bates v. Dow Agrosciences LLC, 544 U.S. 431, 454 (2005) (emphasis original in Bates)). “To hold a defendant to a standard that does not track the federal requirement creates a duty that is ‘different from, or in addition to’ the federal requirements and is preempted.” Pearsall v. Medtronics, Inc., 147 F. Supp.3d 188, 199 (E.D.N.Y. 2015).

Second, the plaintiff must allege that the defendant actually had information that it did not report.

Plaintiff does not clearly allege that Defendant outright failed to file an [adverse event report] for these events; only that they were not timely filed. Defendant may have subsequently reported each incident to the FDA outside of the 30-day [reporting] deadline with enough time for the FDA to publicly disclose this information and inform Plaintiff.

Cline, 17 F. Supp.3d at 1286. See Nagel v. Smith & Nephew, 2016 WL 4098715, at *7 (D. Conn. July 28, 2016) (“Plaintiff does not allege facts indicating that defendant knew of adverse events and did not report them to the FDA”); Grant, 2016 WL 4447523, at *7 (S.D. Cal. Jan. 15, 2016) (the complaint “must include allegations of actual adverse events that Defendants did not report”); Caton, 2015 WL 12426110, at *8 (“Plaintiff has not pled that Defendants had any reports”); Johnson, 2015 WL 75240, at *5 (complaint failed where plaintiff alleged no unreported incidents alleged other than her own).

So in this fashion the litigation arms race continues to evolve. If the courts are going to let the plaintiffs make up novel causes of action that no state has ever adopted in order to avoid preemption, it’s our job as defense counsel to construct the defenses to these new claims.