We praised Brooks v. Mentor Worldwide, LLC, 2019 WL 4628264 (D. Kan. Sept. 23, 2019), when it was first decided, as “checking all the boxes.”  Last week the Tenth Circuit affirmed, and believe us, it rechecked all those boxes.

In Brooks v. Mentor Worldwide LLC, ___ F.3d ___, 2021 WL 245246 (10th Cir. Jan. 26, 2021), plaintiffs appealed dismissal of claims against an FDA pre-market approved (“PMA”) breast implant manufacturer “for failure to warn and manufacturing defect, sounding in ordinary negligence, negligence per se, and strict liability.”  Id. at *2.  They were shut out.  Dismissal of all claims affirmed.

Brooks viewed the FDCA as containing “two preemption provisions.”  Id.  Section 360k(a), provided for “express preemption,” and §337(a) is an “implied preemption provision” demonstrating that “Congress intended that the MDA be enforced exclusively by the Federal Government.”  Id. at *3 (quoting Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001)).  The express preemption provision “preempts a tort claim unless the federal requirements impose duties that are at least as broad as those” imposed by the state law,” whereas the other “preempts any state tort claim that exists solely by virtue of an FDCA violation.”  Id. (citations and quotation marks omitted).  Together, they:

Leave[] only a narrow gap of possible state tort claims.  Any such claim must be predicated on conduct that violates the FDCA but may not be brought solely because that conduct violates the FDCA − the conduct must also violate a parallel state-law requirement.

Id. (emphasis original).  Thus, to survive preemption:

a plaintiff must plead conduct that (1) violates the FDCA (because state law may not impose additional or different duties) and (2) would be actionable under state law independently of the FDCA (because a plaintiff may not seek to enforce the FDCA).

Id. at *4 (citations omitted).

“Negligence per se” failed these tests miserably.  There simply wasn’t any independent state-law claim.  “When we ask whether liability under negligence per se exists independently under state law, regardless of the FDCA or MDA, we must answer ‘no.’”  Id.  This is simply the inherent nature of what negligence per se is.

[N]egligence per se . . . relies on a federal requirement to supply the duty of care and looks to a violation of the requirement as the breach of that duty.  Any negligence per se action premised on an MDA violation necessarily seeks to enforce the MDA rather than a parallel state-law duty.  And only the United States may enforce the MDA.

Id. (Buckman citations omitted).

Not only that, but state-law negligence per se does not support FDCA-based allegations.  Congress expressly precluded private FDCA enforcement through §337(a).  A negligence per se claim predicated on this type of statute “lacks viability under the laws of either Kansas or Missouri,” the two relevant states.  Kansas “limits negligence per se to violations of a statute for which the legislature intended to create a private cause of action.”  Missouri “limits negligence per se to violations of a statute where the legislature intended to replace the ordinary negligence standard of care.”  Id. (state law citations omitted).  The FDCA, with its express prohibition of private enforcement, met neither state’s negligence per se criteria.  Id.

This aspect of Brooks is particularly gratifying to us, because the decision recognizes the importance of legislative intent – one of the state-law limits to negligence per se we’ve advocated on the Blog since day one.  Thus negligence per se was impliedly preempted because “[t]he MDA’s text tells us that Congress created no private cause of action in the MDA, and Buckman tells us that Congress did not intend the MDA to supplant state-law duties of care.”  2021 WL 245246, at *4 (citations omitted).

Next up was “ordinary negligence and strict liability for failure to warn.”  Id.  In scattershot fashion, plaintiffs in Brooks argued “that Defendant breached a duty to warn (1) patients, (2) physicians, and (3) the FDA about the implants’ health risks.”  Id.

One, two, three strikes yer out.

The purported duty to warn patients directly was a gimme.  “Plaintiffs identify no federal requirement that a Class III-device manufacturer provide a warning directly to a patient.”  Id.  Therefore, any such claim was “in addition to” federal requirements.  Id. (“any state-law duty to do so adds to the federal scheme as it is before us”).  Express preemption.

As for standard duty to warn physicians under the learned intermediary rule, there was no mandatory duty to “update” FDA approved labels.

Defendant could have changed its labeling without FDA approval by a permissive mechanism, but that mechanism is not mandatory.  21 C.F.R. §814.39.  It allows, but does not require, a change.  And absent a federal requirement that they do so, federal law expressly preempts any state-law duty requiring a manufacturer to update its labeling.

Brooks, 2021 WL 245246, at *5 (case citations omitted).  Express preemption.

The purported “duty to warn the FDA” involved allegations about both “post-approval, FDA-mandated testing” and failure to “report negative results.”  Id.  Implied preemption wiped out these purported duties, under either Kansas or Missouri law:

Plaintiffs have not identified a state-law duty to comply with FDA-imposed post-approval requirements such as testing and reporting.  Buckman made clear that only the federal government may enforce reporting requirements and investigate and respond to suspected fraud.  Similarly, the government retains the exclusive right to enforce post-approval requirements. . . .  Federal law thus impliedly preempts Plaintiffs’ claims based on alleged failures to properly conduct post-approval testing and reporting as attempts to enforce the MDA.

Id. (citations omitted).

Plaintiffs in Brooks made their final stand around their manufacturing defect claim.  In the abstract, at least, such a claim could plausibly exist – but plaintiffs didn’t come close to pleading one.  Once again, we love TwIqbal:

Labels, conclusions, formulaic recitations of elements, and naked assertions will not suffice. An allegation is conclusory where it states an inference without stating underlying facts or is devoid of any factual enhancement.

Brooks, 2021 WL 245246, at *5 (citations omitted).  “Conclusory allegations are “not entitled to the assumption of truth.”  Id. (citation and quotation marks omitted).

Plaintiffs “sp[un] a wide-reaching story of noncompliance with FDA regulations and requirements.”  Id.  But like most plaintiffs, their allegations were long on innuendo and short on facts.  There were plenty of “[b]ald accusations such as ‘defendant violated the law,’” and “largely historical facts” about “indiscretions in conducting studies and reporting results.”  Id.  They didn’t matter, since those allegations did “not touch on any specific flaw in the manufacturing process relevant to Plaintiffs’ own implants.”  Id.  But that’s precisely what a manufacturing defect is – some kind of “specific flaw” in a plaintiff’s “own” device.  Other allegations of noncompliance do not matter.

The manufacturing-related allegations failed because they were entirely boilerplate:

Plaintiffs conclude that the implants “differed from the specifications agreed to by the FDA” and “used materials and components which differed from those approved by the FDA,” without alleging any supporting facts.

Id.  They also alleged vaguely:

that Defendant (1) “fail[ed] to follow good manufacturing practices,” (2) had “not complied with applicable federal regulations” and “fail[ed] to adhere to manufacturing protocols approved by the FDA,” (3) “carelessly and negligently s[old] and distribut[ed]” the implants “in violation of” federal law, (4) “negligently incorporate[ed] components and/or materials” that were not “commercially reasonable” and “could not stand up to normal usage,” and (5) “fail[ed] to exercise reasonable care in inspecting and testing … manufacturing, quality control and quality assurance processes.”

Id.  Those aren’t facts; they’re legal conclusions.  And since “[p]laintiffs did not plead factual allegations to support these or any of their other conclusions, . . . they cannot sustain a claim for relief.”  Id.

The district court thus properly ruled the entire complaint preempted.

Plaintiffs’ final argument was procedural – that they should have had another shot at amending their complaint.  Their supposed “motion” to amend wasn’t worthy of the name.  “Because we do not recognize Plaintiffs’ single sentence as a cognizable motion, the district court did not abuse its discretion in denying that request.”  Id. at *7 (citations omitted).  Since “[p]laintiffs made a strategic choice” and “took none of the available avenues to amend their Complaint,” the court saw no reason to “protect them from their own inaction.”  Id.

Thus Brooks adds to the growing weight of precedent that none of the following can defeat preemption where a PMA medical device is at issue:

  • Negligence per se based on purported FDCA violations.
  • A mandatory state-law duty to update warnings where the FDA’s CBE regulation is merely voluntary.
  • Violation of alleged duties to conduct FDA-mandated post-manufacturing testing.
  • Violation of alleged duties to report adverse events to the FDA.
  • Vague manufacturing defect allegations of failure to comply with “specifications” and/or using noncompliant materials or components.
  • Vague manufacturing defect allegations about “good manufacturing practices,” regulatory violations, “reasonable care,” and lack of inspection or testing.

From what we’ve seen, plaintiffs in breast implant litigation don’t have anything else.