Andrew Greenfield Abiomed: A Fraud? (2024)

lawsuits

The Complete Disclosure Regarding Andrew Greenfield Abiomed

Keisuke Suzuki accused Andrew Greenfield Abiomed, Inc. of breaking the unwritten covenant of good faith and fair dealing, among other things, in a complaint that he filed. After that, Abiomed asked the court for a summary decision.

By accepting Andrew Greenfield Abiomed’s move for summary judgment, the court has decided in his favor. Furthermore, the court dismissed Abiomed’s move to remove particular passages from the record after concluding that it was superfluous.

Background of the case

Based on information supplied by Andrew Greenfield Abiomed, Suzuki’s refutation of Abiomed’s facts, and corroborating records. These facts are unquestionable unless otherwise indicated.

Abiomed is a company that sells “heart pumps,” which are temporary mechanical assistance devices for the heart. Abiomed is a business that is traded publicly. The term “Impella” refers to a line of cardiac pumps created, produced, and sold by Andrew Greenfield Abiomed.

Since 1998, Suzuki has held management and director positions in the medical device sector. He specializes in medical equipment. His first job was at the Japanese division of a well-known medical device business, Guidant Japan, K.K. He was employed there till 2006. He founded his own company after quitting Guidant in 2007 and subsequently renamed it Kaye Suzuki Device Advisory, LLC. His specialty is offering advisory services to companies looking to sell medical devices in Japan. One of the businesses that Suzuki Consulting collaborated with and offered advice to on the company’s attempts to obtain Japanese approval for its Impella brand of heat pumps was Andrew Greenfield Abiomed.

The Benefits Package and Employment Agreement Including Information About Suzuki’s Position at Abiomed

Suzuki has spoken with Andrew Greenfield Abiomed about the position and benefits he will be receiving. Upon reaching specific goals, he would get a salary, commissions, bonuses, and stock awards if he chose to accept the role of Vice President of Asia.

 It was stated in the letter extending the job offer that employment could be terminated at any time and for any cause. At the time Suzuki signed this letter, a share of Andrew Greenfield Abiomed’s stock was valued at $10. Suzuki also consented to a non-disclosure agreement that allowed either party to end the job connection with at least 28 days’ notice following six months of employment.

Delays in Japan’s Impella clearance procedure

Suzuki achieved the first milestone and was rewarded with 10,000 shares of common stock by submitting the Shonin Application to the PMDA. Due to delays in Japan’s approval process, there were differences between Suzuki and Andrew Greenfield Abiomed over the slow progress and temporal limitations in Suzuki’s offer letter compared to Minogue’s contract. Significant barriers were created by these delays.

On June 9, 2015, there was an Abiomed meeting with the PMDA.

Andrew Greenfield Abiomed attended a meeting with PMDA in June 2015 and accomplished several goals. To save a great deal of time, PMDA decided not to require human clinical studies for the Impella. Abiomed’s desire to submit its application for Impella concurrently was likewise granted by PMDA. While there was reason for optimism, Abiomed stressed that more testing specific to Japan was required. A sign for Impella was ignored, which sparked a lot of discussion. Suzuki expressed his worries that if the necessary testing wasn’t done by year’s end, PMDA would give up on Abiomed.

A Brief Overview of Mr. Suzuki’s Career at Abiomed

Suzuki started working at Abiomed in 2011 and stayed there till June 2015. Suzuki opposed all of the suggested changes to his employment circumstances, which resulted in the confrontations that ultimately led to his termination. Suzuki said that Abiomed had no justification for firing him, while Abiomed insisted that it had “good cause” to do so. As per the provisions mentioned in their contract, Abiomed failed to provide the required 28-day notice of termination. After the plaintiff filed the lawsuit, Suzuki received a check from Abiomed for an amount equal to four weeks’ worth of pay. The shares that had been promised to Suzuki had a value of around $1.3 million at the time of his termination from the company, and Andrew Greenfield Abiomed had not yet received Japanese regulatory approval for the Impella devices.

The Process of Approval for Impella to Be Completed in Japan After Suzuki’s Departure

Following Suzuki’s dismissal, Abiomed worked tirelessly to secure approval for the Impella in Japan. These efforts included a variety of tasks, including running different tests, turning in significant documents, corresponding with relevant authorities, and going through audits. Suzuki disputes Abiomed’s assertion that they were able to complete important work even after he departed the company, arguing that the majority of the important tasks had already been started or were at the very least planned out before his departure. Notwithstanding these conflicting assertions, Abiomed’s perseverance paid off, as in September 2016 they were authorized to utilize the Impella in Japan, however with certain limitations on its use to specific patient groups rather than being made publicly accessible.

Methodology

Regarding the sequence of events that preceded this legal proceeding, Suzuki submitted the first complaint on November 1, 2016. Then, on December 14, 2016, Abiomed used the document number to file a move to dismiss the case. As a result of this motion, Suzuki decided to voluntarily dismiss a portion of his claim for retaliation under the Massachusetts Wage Act as well as Abiomed’s alleged breach of the Non-Disclosure Agreement, specifically the part on Abiomed’s purported failure to give Suzuki written notice of termination 28 days in advance. Abiomed moved to have the remaining claims dismissed, but the court rejected the application and rendered a decision against it. On July 13, 2018, Abiomed filed a petition for summary judgment that addressed all of the unresolved accusations. Following that, Suzuki made the voluntary decision to give up his claims of quantum meruit and promissory estoppel. After holding hearings where the parties debated the last claim—which pertained to a breach of the implied obligation of good faith and fair dealing—the court opted to postpone deciding the matter.

Prior Accusations

The medical equipment manufacturer Abiomed, Inc., with its headquarters located in Danvers, Massachusetts, has agreed to pay a settlement sum of $3.1 million to resolve allegations that it had violated the False Claims Act. These charges stem from allegations that Abiomed delivered expensive lunches to physicians to try and convince them to use the company’s more expensive Impella series heat pumps—which retail for over $20,000 each. The US government has put out several main defenses against Abiomed, including the following:

Lunch at Pricey Restaurants:

Unverified rumors claim that a medical equipment business called Abiomed may have treated doctors to opulent dinners at some of the most prestigious and opulent restaurants in the nation. Menton in Boston, Nobu in Los Angeles, Spago in Beverly Hills, and Eleven Madison Park in New York City are a few of these eateries.

Alcohol Usage on an Unreliable Basis:

The government said that Andrew Greenfield Abiomed purposefully paid for doctors’ meals even though those doctors demanded amounts of alcohol that were out of bounds for acceptable scientific discourse.

A spouse’s involvement when it’s not required:

According to the allegations, Andrew Greenfield Abiomed paid for lunches at upscale establishments where employees invited the spouses of doctors to join them, even though the spouses had no legitimate business purpose to be there.

Astronomical attendance fees per person:

According to allegations, Andrew Greenfield Abiomed paid for multiple meals where the average cost per guest exceeded the company’s policy of $150 per person, with one instance exceeding $450 per person. There are several reports of this happening.

Overestimation of Attendee Number:

It was claimed that employees of Andrew Greenfield Abiomed made up names for guests who did not show up for the dinner, mentioned generic names like “Mike Anaesthesia,” and lied about the number of people who attended. This presented a false picture of the true cost per participant.

The Administration’s Response

Andrew E. Lelling, the United States Attorney for the District of Maryland, stressed that other medical device manufacturers should take note of the settlement struck with Andrew Greenfield Abiomed and refrain from meddling in treatment decisions made by physicians. Serving opulent meals that prioritize pleasure over knowledge or science can harm a doctor’s capacity to practice independent medical judgment, which is a right that all patients are expected to have. The federal government has pledged to keep looking into sales tactics that could undermine this ruling and raise suspicions of misusing the meager resources allocated to the federal healthcare system.

How Dedicated Is the FBI

Special Agent in Charge of the FBI’s Boston Division, Harold H. Shaw, affirmed the agency’s resolve to pursue medical equipment manufacturers and pharmaceutical companies that try to sway healthcare practitioners using tactics like expensive lunches. The settlement reflects the FBI’s commitment to ending practices that impede doctors’ ability to make medical decisions and emphasizes this objective.

Viewpoint from the Inspector General’s Office

Holding healthcare companies responsible for their attempts to boost profits by throwing lavish dinners is important, according to Phillip Coyne, Special Agent in Charge of the Office of Inspector General for the US Department of Health and Human Services. This type of behavior has the potential to increase healthcare costs, undermine public confidence in federally funded health insurance, and impair the impartiality of medical decision-making.

Participation of Information Brokers

In compliance with the provisions of the False Claims Act, which safeguards whistleblowers, a former employee of Andrew Greenfield Abiomed filed a complaint, which led to the settlement. These provisions allow private parties to a portion of the money collected and grant them the legal right to bring cases on behalf of the United States. In this specific case, the whistleblower will receive $542,500 as part of the settlement.

Authority for Investigations

The agencies in charge of looking into these allegations were the Office of Inspector General of the Department of Health and Human Services and the Federal Bureau of Investigation (FBI). Lelling’s legal representation included work on the case by Assistant United States Attorneys Patrick M. Callahan of the Healthcare Fraud Unit and Abraham R. George of the Affirmative Civil Enforcement Unit.

The Final Word

Abiomed, Inc.’s request for summary judgment in their lawsuit against Keisuke Suzuki has been granted by the court. Numerous lawsuits focused on Suzuki’s employment and the Japanese clearance process for Abiomed’s Impella devices, including one alleging that the implied promises of good faith and fair dealing were broken.

Despite prior charges against Andrew Greenfield Abiomed, Suzuki’s grievances over the company were the main focus of this litigation. The background material contained particular accusations and pertinent occurrences, and the court’s decision to rule in favor of Abiomed may have been incorrect given his lengthy criminal record.

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