A federal judge largely denied a motion to dismiss a proposed class-action lawsuit against Dentsply Sirona for its Byte aligners, A&O Shearman reported in a Jan. 27 JD Supra article.
Five notes:
1. Dentsply Sirona voluntarily suspended the sale and marketing of its Byte clear aligners and impression kits in October 2024 while reviewing regulatory requirements. The company also paused shipment and processing of new and recently placed orders for the products.
2. Byte disclosed in a notice on its website that its patient onboarding workflow “may not provide adequate assurance that certain contraindicated patients do not enter treatment with Byte aligners.” This conclusion followed a review of medical device reports related to its aligners and discussions with the FDA.
3. A class-action lawsuit was filed on behalf of those who purchased or acquired Dentsply Sirona securities, alleging that Dentsply Sirona made misleading statements and omissions regarding its business, financial condition and prospects.
4. The lawsuit also alleges that Dentsply Sirona sold Byte aligners to contraindicated patients knowing that the aligners were injuring patients.
5. The court held that plaintiffs adequately alleged misrepresentations and scienter in several ways, while ruling that they failed to allege scienter in other areas, including with claims made against the dental technology company’s former CFO.
