Integra Lifesciences Holdings Corporation (IART) Misled Investors Regarding the Remediation of Violations at its Boston Facility
A shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired Integra Lifesciences Holdings Corporation (NASDAQ: IART) common stock between March 11, 2019 and May 22, 2023. Integra develops regenerative tissue technologies and neurological solutions.
According to the complaint, during the class period, defendants assured investors it was making improvements to remediate violations in its Boston Facility as noted by the FDA and touted the progress of its SurgiMend product to be used in implant-based breast reconstruction.
In truth, Integra had failed to take sufficient measures to remediate the violations identified by the FDA. As a result, since March 2018, all products manufactured in the Boston Facility had the potential for higher-than-permitted levels of endotoxin and would need to be recalled. Moreover, the Company was not making progress towards obtaining its premarket approval (PMA) indication for SurgiMend, in part, because the Boston Facility was in continued violation of the FDA standards that Integra failed to rectify and as a result, the facility had to be shutdown to correct those ongoing deficiencies.
On April 26, 2023, Integra revealed it had paused production at the Boston Facility and disclosed declining operating margins for the quarter and flat revenue growth projections. On this news, the price of Integra common stock declined by $4.64 per share, or 8%.
Then, on May 23, 2023, the Company announced a “recall” of all products manufactured at the Boston Facility between March 1, 2018 and May 22, 2023, because the Boston Facility deviated from good manufacturing practices in testing for bacterial endotoxin and allowed the release of products with unsafe levels of endotoxins. The Company also extended the pause on all production at the Boston Facility. As a result, the price of Integra stock declined by an additional $10.24 per share, or 20%.
What Now: Similarly situated shareholders may be eligible to participate in the class action against Integra Lifesciences Holdings Corporation. Shareholders who want to act as lead plaintiff for the class must file their motion for lead plaintiff by November 13, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.