Boston Scientific announced a worldwide recall on November 17, 2020, of all unused inventory of the LOTUS Edge Aortic Valve System, a transcatheter aortic valve replacement product which had been approved by the U.S. Food and Drug Administration (“FDA”) in April 2019. Citing “complexities associated with the product delivery system” and the “additional time and investment required to develop and reintroduce an enhanced delivery system,” Boston Scientific stated that it had “chosen to retire the entire LOTUS product platform immediately.”
On November 17, 2020, Boston Scientific’s stock price fell $3.00 per share, or approximately 8%, on this news, to close at $35.03 per share, thereby injuring investors.
It is alleged in this lawsuit that throughout the Class Period, Boston Scientific made misleading and/or materially false statements, as well as failed to disclose material adverse facts about Boston Scientific’s prospects, operations, and business. Specifically, Boston Scientific failed to disclose to investors that: (1) It was clear that the LOTUS Edge Aortic Valve System’s product delivery system was dysfunctional, which threatened the entire product line’s continued viability; (2) Boston Scientific had materially overstated the continued commercial viability and profitability of the LOTUS Edge Aortic Valve System as a result; and (3) positive statements made by Boston Scientific about its business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.
Boston Scientific Corporation
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