lack of safety/higher failure rates plausibly meant products weren’t “compatible”

Straumann USA, LLC v. TruAbutment Inc., No.
8:19-cv-00878-JLS-DFM, 2019 WL 6887173 (C.D. Cal. Oct. 1, 2019)
The parties compete in the market for dental implants, which
are medical devices surgically implanted into the patient’s jaw bone to replace
natural teeth and function as artificial tooth roots. A connector, called an
abutment, is placed on the inside; it holds
and supports dental restorations, such as crowns or bridges. TruAbutment markets abutments as
“compatible” with implants produced by various manufacturers, including Straumann’s. I’ll
ignore the patent claims.
Abutments for use in dental implants are classified as Class
II medical devices, “medium to moderate risk.” 510(k) preclearance is required, but Straumann alleged
that TruAbutment hadn’t obtained 510(k) clearance for many of its abutments,
including for dozens of devices marketed as Straumann-compatible. Straumann further
alleged that TruAbutment products fail at an unusually high rate and that
non-adherence to the exact specifications of the original product or use of
different materials increase the chance that some combination of the implant,
abutment, or connecting screw will break. Device failure “typically requires
emergency surgery.” The failure of a non-Straumann abutment would allegedly unfairly
cast doubt on the reliability and safety of the implant with which it was
The court found the Lanham Act claim sufficiently pled.
Although the FDCA provides no private right of action, the Lanham Act claim was
not dependent on lack of preclearance. Straumann alleged false statements about
compatibility, which could succeed without litigating any alleged underlying
FDCA violation. The complaint also satisfied Rule 9(b) by alleging that TruAbutment’s
products weren’t actually Straumann-compatible because they are unsafe and fail
at an unacceptably high rate, along with other allegations about the other
elements, including, for harm, that dental labs are likely to select and supply
cheaper third-party abutments to dentists if they are falsely advertised as
equivalent to Straumann’s. The California UCL claim therefore also survived.

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