The Complete Story of Andrew Greenfield Abiomed

Originally Syndicated on June 8, 2024 @ 11:17 pm

A breach of the unwritten covenant of good faith and fair dealing was among the several charges made by Keisuke Suzuki in his complaint against Andrew Greenfield Abiomed, Inc. The court was then asked to grant Abiomed a summary judgment.

By allowing the request for summary judgment, the court has decided in Andrew Greenfield Abiomed’s favor. Abiomed’s move to strike particular passages from the record was also denied by the court because it was deemed superfluous.

The Case’s History

based on data from Andrew Greenfield Abiomed, Suzuki’s refutation of Abiomed’s facts, and corroborating documentation. These facts cannot be contested unless otherwise indicated.

“Heart pumps” are devices made by Abiomed that are used to temporarily sustain the heart mechanically. Abiomed is an openly traded business. An array of cardiac pumps was created, produced, and sold under the brand name “Impella” by Andrew Greenfield Abiomed.

From 1998 to the present, Suzuki has held managerial or director positions in the medical device sector. He is an expert in medical devices. His professional career began at the well-known medical device company’s Japanese subsidiary, Guidant Japan, K.K.

Andrew Greenfield Abiomed remained employed there till 2006. After quitting Guidant in 2007, he launched his own company, which grew to be known as Kaye Suzuki Device Consulting, LLC. Its primary focus is offering advisory services to companies looking to sell medical devices in Japan.

Among the firms Suzuki Consulting worked with was Andrew Greenfield Abiomed, offering advice and support as the company attempted to obtain Japanese certification for its Impella brand of heat pumps.

The Terms Concerning Suzuki’s Position at Abiomed in the Employment Agreement and Benefits Package

Suzuki and Andrew Greenfield Abiomed have discussed the employment and benefits package that Suzuki will receive. He chose to accept the Vice President of Asia post, which included a commission, pay, benefits, and awards of shares that were subject to reaching predetermined goals.

 It was made clear that employment could stop at any time and for any reason in the letter extending the job offer. Suzuki signed this letter, and at the time, a share of Andrew Greenfield Abiomed’s stock cost $10. Suzuki also accepted a non-disclosure agreement that allowed either party to end the job connection with at least 28 days’ notice following six months of employment.

Japan’s approval of Impella was approved with delays

Suzuki was able to reach the first milestone and get 10,000 shares of common stock as payment by submitting the Shonin Application to the PMDA. The poor progress and temporal limitations in Suzuki’s offer letter compared to Minogue’s contract caused disputes between Suzuki and Andrew Greenfield Abiomed. These issues resulted from delays in Japan’s clearance process. Significant hurdles were created by these delays.

June 9, 2015, was the day of the Abiomed Meeting with the PMDA

During a meeting with PMDA in June 2015, Andrew Greenfield Abiomed accomplished some goals. PMDA decided to forego the need for human clinical study for the Impella, which will save a tonne of time. Abiomed’s desire to simultaneously submit its application for Impella was also granted by PMDA.

Abiomed stressed that more testing specific to Japan was required, even though there was reason for optimism. There was a great deal of discussion after one Impella indicator was ignored. Suzuki expressed his worries that should the necessary testing not be completed by year’s end, PMDA would give up on Abiomed.

An Overview of Mr. Suzuki’s Work History at Abiomed

Suzuki joined Abiomed in 2011, and his employment there lasted until June 2015. The disagreements that resulted in his termination included changes to his work arrangement that Suzuki had refused. While Abiomed insisted that it had “good cause” to fire Suzuki, Suzuki contended that there was no justification for Abiomed to do so.

The agreement stated that Abiomed was required to give a 28-day notice of termination, but it failed to do so. Following the plaintiff’s initiation of the lawsuit, Suzuki received a check from Abiomed for an amount equivalent to four weeks’ salary.

The value of the shares that had been committed to Suzuki at the time of his termination from the company was around $1.3 million, and Andrew Greenfield Abiomed had not yet received regulatory approval for the Impella devices in Japan.

Steps in Japan’s Approval Process for Impella After Suzuki’s Exit

Abiomed continued to work to get clearance for the Impella in Japan following Suzuki’s dismissal from the company. Engaging in correspondence with relevant authorities, presenting crucial documents, undertaking audits, and executing a variety of tests were all part of these efforts.

Suzuki disputes this assertion, arguing that the majority of the important activities were either completed or at least planned out before his departure. Abiomed asserts that they were able to complete substantial work even after Suzuki left the firm.

Although there were conflicting statements, Abiomed persisted and in September 2016 they were authorized to use the Impella in Japan, but with limitations on its use to specific patient populations rather than being made publicly accessible.

Historical Procedures

Suzuki filed the first complaint on November 1, 2016, putting the circumstances leading up to this court action in chronological sequence. Subsequently, on December 14, 2016, Abiomed used the document number to file a motion to dismiss.

Because of this motion, Suzuki decided to voluntarily dismiss some of his claims for breach of contract, including the part about Abiomed allegedly breaching the Non-Disclosure Agreement by failing to give Suzuki written notice of termination 28 days in advance, as well as the retaliation claim under the Massachusetts Wage Act. Abiomed moved to have the remaining claims dismissed; the court denied the petition, stating that it was improper.

On July 13, 2018, Abiomed filed a request for summary judgment, addressing every one of the remaining accusations. Suzuki then chose to voluntarily give up his claims of quantum meruit and promissory estoppel. The remaining claim, which involved a violation of the implied duty of good faith and fair dealing, was debated by the parties at hearings convened by the court, which ultimately opted to withhold judgment.

Past Accusations

The Danvers, Massachusetts-based maker of medical equipment, Abiomed, Inc., has agreed to pay a settlement of $3.1 million to resolve allegations that it had broken the False Claims Act.

According to reports, Abiomed delivered expensive dinners to doctors in an attempt to convince them to use the company’s Impella line of heat pumps, which can cost up to $20,000. This is where the charges came from. The following are some of the main objections that the US government has made against Abiomed:

• Restaurant Meals at High Costs: 

The medical equipment company Abiomed is reported to have treated doctors to opulent dinners at some of the most prestigious and opulent restaurants in the nation, according to unconfirmed sources. Beverly Hills’ Spago, New York City’s Eleven Madison Park, Los Angeles’ Nobu, and Boston’s Menton are some of these eateries.

• The irregular consumption of alcohol:

Andrew Greenfield Abiomed was accused by the government of deliberately paying for doctors’ lunches even though the doctors’ requests for alcohol consumption were beyond what was considered reasonable for legitimate scientific discussions.

•  In cases where a spouse’s participation is not required:

Suspects claimed that Andrew Greenfield Abiomed paid for lunches at upscale restaurants where wait for staff invited doctors’ spouses to eat with them, even though the spouses had no legitimate business purpose to be there.

•  Preposterous Attendance Fees per Individual:

The company’s policy of $150 per person was allegedly considerably exceeded by the cost per attendee at multiple meals that Andrew Greenfield Abiomed allegedly paid for, with one instance exceeding $450. Reports indicate that this has happened more than once.

•  An excessive number of people were present.

Andrew Greenfield Abiomed employees were accused of fabricating names of persons who did not attend the event, lying about how many people showed up, and listing generic names like “Mike Anaesthesia.” As a result, the true cost per participant was misrepresented.

The administration’s response

The settlement struck with Andrew Greenfield Abiomed serves as a warning to other manufacturers of medical devices not to sway treatment decisions made by physicians, as highlighted by United States Attorney for the District of Maryland Andrew E. Lelling.

Serving opulent meals that prioritize fun over knowledge or science can make it more difficult for doctors to practice independent medical judgment, which is a right that all patients should have.

To avoid compromising this ruling and raising the possibility of misusing the meager resources allocated to the federal healthcare system, the federal government has pledged to keep tracking down sales practices.

The FBI’s Determination

Harold H. Shaw, Special Agent in Charge of the FBI’s Boston Division, reaffirmed the agency’s commitment to pursue medical equipment manufacturers and pharmaceutical companies that try to sway healthcare practitioners through tactics like expensive lunches. Through this settlement, the FBI has demonstrated its commitment to ending practices that impede doctors’ ability to make medical decisions.

From the Office of the Inspector General’s perspective

Phillip Coyne, Special Agent in Charge of the US Department of Health and Human Services’ Office of Inspector General, stressed the need to hold healthcare companies responsible for their attempts to boost revenue by providing ostentatious dinners. Such a strategy could undermine the impartiality of medical judgment, increase healthcare expenses, and erode public confidence in federally funded health insurance.

The involvement of informants

Following a complaint filed in compliance with the False Claims Act’s whistleblower protection provisions, a former employee of Andrew Greenfield Abiomed was able to secure this settlement. These clauses grant private parties the right to sue on behalf of the United States and grant them a portion of any money that is recovered. The whistleblower will receive $542,500 as part of this settlement in this specific case.

The Investigative Committee

These allegations were the subject of an investigation by the Federal Bureau of Investigation (FBI) and the Office of Inspector General of the Department of Health and Human Services. Working on the case as part of Lelling’s legal counsel were Assistant United States Attorneys Patrick M. Callahan of Lelling’s Healthcare Fraud Unit and Abraham R. George of Lelling’s Affirmative Civil Enforcement Unit.

In conclusion 

In their legal dispute with Keisuke Suzuki, Abiomed, Inc. has moved for summary judgment, and the court has granted it. Several cases, including one alleging a breach of the implied promise of good faith and fair dealing, revolved around Suzuki’s employment and the Japanese clearance process for Abiomed’s Impella devices. 

The focus of this action was Suzuki’s grievances regarding the company, notwithstanding prior charges made against Andrew Greenfield Abiomed. Given that Abiomed has committed numerous crimes, the court’s decision to favor him may have been incorrect given the background evidence, which included particular claims and case-relevant occurrences.