|Court:||United States District Court for the District of Massachusetts|
|Case Number:||No. 1:20-cv-12225-DPW|
|Class Period:||04/24/2019 - 11/16/2020|
|Case Leaders:||Salvatore J. Graziano, Michael D. Blatchley|
|Case Team:||James M. Fee, Alexander T. Payne|
This is a securities class action filed on behalf of all persons who purchased shares of Boston Scientific Corporation (“Boston Scientific” or the “Company”) securities from April 24, 2019 through November 16, 2020, inclusive (the “Class Period”). The action is brought against Boston Scientific and certain of the Company’s senior executives and asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
On March 30, 2021, the Honorable Douglas P. Woodlock appointed BLB&G client Union Asset Management AG as Lead Plaintiff and BLB&G as Lead Counsel for the class.
Background on the Alleged Fraud
Based in Marlborough, Massachusetts, Boston Scientific manufactures medical devices and is one of the largest medical device manufacturers in the world. The action against Boston Scientific arises out of the Company’s representations concerning one such device, the LOTUS Edge, a transcatheter aortic valve replacement—or “TAVR”—device. A TAVR is used in patients whose aortic heart valve is diseased due to calcium build up, which causes the valve to narrow and restricts blood flow through the valve. As the heart works harder to pump enough blood through the smaller opening, the heart eventually becomes weak—which can lead to life-threatening heart problems such as fainting, chest pain, or abrupt loss of heart function (cardiac arrest).
After the close of trading on April 23, 2019, Boston Scientific announced that the U.S. Food and Drug Administration had approved the LOTUS Edge device for TAVR procedures in the United States. Boston Scientific touted the LOTUS Edge as the only re-deployable and repositionable TAVR device on the market—meaning that, unlike other TAVR devices, the LOTUS Edge could be repositioned and “recaptured” once deployed. According to Boston Scientific, this increased level of control over the delivery and deployment of the device ensured optimal patient outcomes, and represented a significant advantage over the two primary TAVR devices already on the market. Following the FDA’s approval, Boston Scientific and its senior executives made numerous statements touting the device’s purportedly successful commercial launch, its adoption by heart surgeons, and the device’s advantages over its two competitor products. For example, the Company told investors that the “Lotus Edge launch is going extremely well,” that many surgical centers were signing up for the device, and that the Company had already met its goal to open 150 accounts in the United States.
In reality, the LOTUS Edge delivery system—the feature that supposedly separated the device from competitors—was severely flawed and, as a result, the launch of the device never got off the ground. Investors learned the truth about the LOTUS Edge when, on November 17, 2020, Boston Scientific abruptly announced the recall of all unused LOTUS Edge inventory and the immediate discontinuation of the LOTUS Edge family of products. In response to this disclosure, Boston Shares declined dramatically and in a statistically significant manner, causing substantial damage to investors.
On April 21, 2021, the Court approved the parties’ proposed briefing schedule. The Amended Complaint is due on June 4, 2021. Defendants’ motion to dismiss is due on July 19, 2021, with the Lead Plaintiff’s opposition to the motion dismiss due on August 30, 2021. Defendants’ reply in further support of the motion to dismiss is due on September 20, 2021.
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