Claims predicating prescription medical product liability claims on purported failure to report adverse events to the FDA - á la Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), and Coleman v. Medtronic, Inc., 167 Cal. Rptr.3d 300 (App. 2014), were almost unheard of prior to the recognition of preemption in medical device cases in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). We know of only one decision, a prescription drug case at that, Axen v. American Home Products Corp., 974 P.2d 224, 235 (Or. App. 1999), that addressed such claims pre-Riegel.
Because failure-to-report claims are transparent attempts at common-law enforcement of FDA reporting requirements, our first reaction to such claims is that they should be impliedly preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and 21 U.S.C. § 337(a), as purely FDCA-based claims. Some courts have agreed, others (like the three cases cited above) - have been reluctant to put plaintiffs totally out of court on preemption grounds - so they have distorted the law by jamming the square peg of failure-to-report claims into the round hole of plain vanilla failure-to-warn product liability claims.
But what about that square peg? We've never (and we haven't seen it anywhere else, either) taken a look at the purely state-law issue of whether, in contexts beyond prescription medical products, the common law has ever given thumbs up - or thumbs down - to state-law tort claims actually predicated on failure to report something to some governmental body (excluding the FDA for these purposes).
Such laws do exist in a variety of areas. The most significant example are so-called "mandated reporting statutes" that obligate differing groups of statutorily designated persons to report child abuse (and more recently, elder abuse) to state or local authorities. The details differ, but from what we can tell, practically every state has a mandated reporting statute.
With plaintiffs being always on the lookout for extra deep pockets, no matter how bizarre the liability theory, surely somebody out there has tried to predicate liability on a purely state-law failure to report.
So we did some research that validated that gut feeling. Indeed, it turns out that state-law failure-to-report claims have been asserted fairly often.
Fortunately for the good guys, most states have rejected those claims, and even the minority of adverse decisions are mostly distinguishable.
Perhaps the leading case is Perry v. S.N., 973 S.W.2d 301 (Tex. 1998). In Perry, "[t]he sole issue [was] whether plaintiffs may maintain a cause of action for negligence per se based on the Family Code, which requires any person having cause to believe a child is being abused to report the abuse to state authorities." Id. at 302. Before the Texas Supreme Court, that dog didn't hunt. "[W]e will not apply the doctrine of negligence per se if the criminal statute does not provide an appropriate basis for civil liability." Id. at 304 (footnote omitted). That the injured plaintiff was a person within the scope of the statute's protection was not enough. Id. at 305. The claim being asserted "corresponds to no common law duty." Id. at 306.
[W]e have considered the following factors regarding the application of negligence per se to the . . . child abuse reporting provision: (1) whether the statute is the sole source of any tort duty from the defendant to the plaintiff or merely supplies a standard of conduct for an existing common law duty; (2) whether the statute puts the public on notice by clearly defining the required conduct; (3) whether the statute would impose liability without fault; (4) whether negligence per se would result in ruinous damages disproportionate to the seriousness of the statutory violation, particularly if the liability would fall on a broad and wide range of collateral wrongdoers; and (5) whether the plaintiff's injury is a direct or indirect result of the violation of the statute. Because a decision to impose negligence per se . . . would impose immense potential liability under an ill-defined standard on a broad class of individuals whose relationship to the abuse was extremely indirect, we hold that [liability] is not appropriate.
Id. at 309.
Another interesting case is Ward v. Greene, 839 A.2d 1259 (Conn. 2004), which held that, while a cause of action for failure to report might be brought on behalf of the "identified" abused child him or herself, the statute did not protect other "unidentified" abused children allegedly injured by the same pattern of failure to report child abuse:
[W]e conclude that the [statute] appears to be directed at the child, or children in the case of multiple children placed at risk in a singular incident, who should be the subject of a report of abuse or neglect under the statute and are, accordingly, in need of services. The policy statement thus suggests that the legislature intended to focus on children who already have been exposed to conduct that amounts to a reportable event, and we do not find merit in the plaintiff's argument that the statute creates a duty of care to every child who has been in the care of the defendant.
Id. at 1266-67. The limited claim in Ward can't translate to drug/device liability because a similar construction of the FDCA's reporting requirements would not do plaintiffs any good. Causation in product liability doesn't work the same way. In drug/device cases, every court to consider the issue has held that failure to report a plaintiff's own adverse event cannot possibly be causal, since any failure to report necessarily happens after the plaintiff was injured. See Johnson v. Hologic, Inc., 2015 WL 75240, at *4 (Mag. E.D. Cal. Jan. 5, 2015), adopted, 2015 WL 4745264 (E.D. Cal. March 6, 2015); Malonzo v. Mentor Worldwide, LLC, 2014 WL 2212235, at *3 (N.D. Cal. May 28, 2014); Simmons v. Boston Scientific. Corp., 2013 WL 1207421, at *5 (C.D. Cal. March 25, 2013).
Perry and Ward are examples of the distinct majority of precedent addressing similar claims of injury due to somebody's failure to report child abuse. Most states do not recognize any purely common-law, or negligence per se state-law, duty to report child abuse. "The vast majority of courts . . . have held that their reporting statutes do not create a civil cause of action." Becker v. Mayo Foundation, 737 N.W.2d 200, 208 (Minn. 2007).
Alabama: C.B. v. Bobo, 659 So.2d 98, 102 (Ala. 1995) ("there is no indication of any legislative intent to impose civil liability for failure to report").
Connecticut: Ward, supra, 839 A.2d...