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Most of the controversy in the recent decision, Hill v. Bayer Corp., 2020 WL 5367334 (E.D. Mich. Sept. 8, 2020), revolved around whether the plaintiff could assert a cause of action for failure to report adverse product events to the FDA.  Like the great majority of decisions (particularly since Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. Dec. 18, 2018), exposed Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. Jan. 10, 2013) (en banc), as an erroneous decision) Hill refused to allow such a claim.

Plaintiff’s chief problem in Hill was that the contraceptive device she was suing over was FDA pre-market approved, thus providing the defendant with a strong preemption defense.  As a purported “parallel” claim that could escape preemption, the plaintiff in Hill alleged failure-to-report as a “negligent failure-to-warn”:

Despite the heading “negligent failure-to-warn,” the Amended Complaint cites to a lengthy list of alleged federal regulatory violations, the vast majority of which do not involve warning requirements at all, but rather involve the alleged failure to make certain reports including adverse events to the FDA.

2020 WL 5367334, at *4.

Hill wasn’t buying what the plaintiff was selling.  “The law is well established that there is no parallel federal requirement that [defendant] had a duty to warn the general public or the medical community, and thus, those claims are expressly preempted because they are different from, or in addition to,’ the Medical Device Amendments (“MDA”) requirements.”  Id. (citations and quotation marks omitted).  Any duty to report was created solely by the Food, Drug & Cosmetic Act (“FDCA”):

[I]t is the Federal Government, not private litigants who are authorized to file suit for noncompliance with the medical device provisions. . . .  [A] state law tort claim that is “a disguised fraud on the FDA” claim is preempted. . . .  That is exactly what [plaintiff] seeks to do here: to hold [defendant] liable for alleged misrepresentations and withholding of information to the FDA.

Id. at *5 (citations and quotation marks omitted).

The learned intermediary rule is a traditional restriction on warning claims involving prescription medical products, and that rule means that the FDA is not a common-law learned intermediary.

Under the learned intermediary rule, the physician is the proper recipient of necessary information or warnings, not plaintiff.  Thus, under Michigan law, any duty in this case would be one owed to [plaintiff’s] physicians, not [plaintiff] herself, and not the FDA.

Id. at *7 (citations and quotation marks omitted).  Nice and simple – where the learned intermediary rule applies, there is no common-law duty to warn anyone else, including the FDA.  Because plaintiff “has not alleged any Michigan requirement that a manufacturer report adverse events to the FDA” but instead “relies solely on [defendant’s] alleged failure to warn the FDA of adverse events in support of her failure to warn claim,” the claim is preempted.  Id.

Hill is representative of most recent precedent (except for the case we discussed here).  Just since August, three other cases had held reporting-based warning claims preempted when asserted against manufacturers of PMA devices.  In Bayer Corp. v. Leach, ___ N.E.3d ___, 2020 WL 4811506 (Ind. App. Aug. 19, 2020) (discussed here), the court held:

[E]ven assuming that [defendant] failed to comply with federal reporting requirements, other federal law nevertheless required that [defendant] use the approved labeling and packaging.  Under the MDA, a state cannot impose a different or additional requirement.  Thus, the claims that [defendant] is liable for a failure to . . . are expressly preempted.

Id. at *10 (regulatory citations omitted).

Next, in Noel v. Bayer Corp., 2020 WL 5038782 (D. Mont. Aug. 26, 2020) (discussed here), failure-to-report claims failed under Montana law.  First, “no FDA requirement for Bayer to report consumer complaints directly to healthcare providers and consumers or to update its warnings and labeling.”  Id. at *4.  Second, “Montana law provides no such parallel duty” to the federal requirement that “device manufacturers must report any incident to the FDA where their device may have caused or contributed to a death or serious injury.”  Id. (citation and quotation marks omitted).  Under the learned intermediary rule:

A government regulator is not a foreseeable user or consumer of a product.  Nor is it a healthcare professional responsible for a patient’s care.  In neither case did the Montana Supreme Court hold that a manufacturer must warn the FDA (or government regulators generally) of known dangers.

Id. (emphasis original).

Likewise, Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020) (discussed here), joined the “[m]any courts [that] have found claims based on alleged reporting failures preempted.”  Id. at *7 (citations omitted).  Given the learned intermediary rule, Conley rejected the plaintiff’s argument and held that Pennsylvania common law imposed no “general[] . . . duty to warn third parties.”  Id. at *5-6 nn. 5-6.  Without any parallel common-law duty preemption could not be avoided.  Thus, the reporting claim in Conley “failed to state a parallel claim” and was “preempted.”  Id. at *7.

Depending on how a court chooses to view the issue, a failure-to-report claim against a PMA device manufacturer can be expressly preempted (Leach, Conley), impliedly preempted (Noel), or both (Hill).