“implied gov’t approval” claims don’t work

ImPACT Applications, Inc. v. Concussion Management, LLC, 2021
WL 978823, No. GJH-19-3108 (D. Md. Mar. 16, 2021)

ImPACT provides training and software, including a proprietary
evaluation system. Immediate Post-concussion Assessment and Cognitive Testing “provides
a neurocognitive test battery that offers healthcare professionals objective
measures of neurocognitive functioning.” Healthcare professionals, including in
schools, teams, and the military, use it to aid assessment and management of
concussions in individuals between the ages of 12 and 59. ImPACT Pediatric is
for patients ages 5-11. They are “the only software-based neurocognitive tests
that have been cleared and designated … as Class II medical devices for use as
an aid in the assessment and management of concussions.”

XLNTbrain seeks to “assess[] neurological activity in
athletes in order to enhance their performance,”  and sells its products to schools, medical professionals,
and sports teams in direct competition with ImPACT.

There are 1.6 to 3.8 million concussions in sports and
recreational activities annually. Traumatic brain injuries account for more
than 2 million emergency room visits per year in the US and contribute to the
deaths of more than 50,000 Americans. In 2019, the FDA issued a safety
, recommending that “people who may be tested for a head
injury, parents and caregivers of people who may be tested, coaches and
athletic administrators, sports medicine specialists and athletic trainers, and
health care providers who assess or diagnose head injuries” should “use only
cleared or approved medical devices to help assess or diagnose a head injury,
including a concussion.” It warned that uncleared products marketed for “assessment,
diagnosis, or management of a head injury, including concussion” violate the

While ImPACT’s products are on the FDA’s list of approved
medical devises for assessing head injury, XLNTbrain’s products are not.

Nonetheless, it allegedly falsely advertised with claims
such as:

• XLNTbrain offers “The First Complete Online Concussion
Test and Management Program for All Sports and Levels.”

• “[C]linical-caliber post-concussion evaluations to monitor
severity and the recovery progress.”

• “XLNTbrain Sport provides clinical-caliber concussion care
giving subscribers a complete solution that’s easy to use, affordable and adds
a ‘virtual neurologist’ for the team.”

• “XLNTbrain offers a complete feature set when compared to
other solutions.”

• XLNTbrain “helps answer the most common question, ‘when
can I play again?’ Dr. Kerasidis created a tool that guides the decision-making
process, giving all-involved individuals a recovery care plan that includes
daily monitoring of symptoms, progressive physical and cognitive exertion
exercises and a timeline to safely return to gameplay.”

Perhaps surprisingly given the seriousness of the claims,
the court found that ImPACT didn’t allege any actionable statements. It grouped
the statements into three categories: (1) false implications of FDA approval;
(2) misleading suggestions that XLNTbrain products possess the qualities of
FDA-approved devices; and (3) statements of superiority. But these were “exactly
the type of claims that are non-actionable under the Lanham Act.”

Courts do not recognize implied government approval
claims in the absence of explicit claims. ImPACT didn’t identify anything
explicit about FDA review or approval in the statements. The Lanham Act can’t be
used to enforce the FDCA.

What about suggestions that XLNTbrain’s products have
qualities that only exist in medical devices cleared by the FDA in providing
screening, return-to-play assessments, diagnosis, and care? Unfortunately,
ImPACT failed to specify what qualities unapproved products can’t have. “Is it
impossible for XLNTbrain’s post-concussion evaluations to be clinical-caliber?
Can only FDA-approved devices provide a Daily Symptom Checklist?” The court
didn’t see why an unapproved product could have the qualities of an
FDA-approved device, especially since ImPACT admitted that FDA approval wasn’t
necessary to compete in the parties’ field. The court could not interpret and
apply the FDCA as part of a Lanham Act case.

Finally, the statements of superiority, e.g. “Beyond
Baseline Concussion Tests” and “The First Complete Online Concussion Test and
Management Program for All Sports and Levels,” weren’t sufficiently alleged to
be false. ImPACT didn’t allege that XLNTbrain wasn’t “beyond” baseline
testing, or that it wasn’t complete. Instead, the argument was that these
statements necessarily implied superiority to ImPACT, which couldn’t be true
because the latter was FDA-cleared. The court didn’t think that followed. “Moreover,
XLNTbrain has not been denied approval by the FDA—rather it never sought
approval—so the FDA has not declared XLNTbrain inferior in some measurable way.”
Also, it was likely that these statements were puffery.

State-law claims therefore failed too.

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