Monday, December 30, 2019

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 coupled.

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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