The Long Road After Doing Right – A Medical Representative’s Heartfelt Plea After Four Years of Job Restriction
Reporting and consulting with one’s supervisor when one becomes aware of corporate wrongdoing, “whistle-blowing” ⇒ Power harassment and recommendation for resignation
Many people would like to live in a world where those who do the right thing are rewarded. However, in reality, this is not always the case.
One person who has filed a lawsuit is Maru Kobayashi, whose X (formerly Twitter) account name is “Kobayashi Maru.
Ms. Kobayashi joined Alexion Pharma LLC, a foreign pharmaceutical company, in 2001 as a medical representative (called “MCC” by the company because it requires advanced knowledge specialized in rare diseases).
The incident began shortly after Mr. Kobayashi joined the company when he noticed irregularities related to Soliris, a drug indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Mr. Kobayashi reported and consulted with his supervisor and reported the matter internally, but was subjected to power harassment and was recommended to resign. The situation worsened from there.
After September 2001, when Soliris was indicated for the treatment of atypical hemolytic uremic syndrome (aHUS), the company began to engage in inappropriate promotional activities to promote the use of its products to patients with off-label indications. Promoting off-label use is a violation of the Pharmaceutical Affairs Law, and in fact, there was a string of deaths of off-label patients.
Four medical societies, concerned about the situation, issued a warning against easy off-label use, but the company only temporarily refrained from using inappropriate materials, but soon resumed and reinforced the practice. (Mr. Kobayashi, hereafter referred to as “Mr. Kobayashi”)
Whistleblowing to Alexion Japan ⇒Required to sign an “Acknowledgement” which makes whistleblowing difficult ⇒Whistleblowing to U.S. parent company
Although there were complaints from customers, the company’s response remained the same, and Mr. Kobayashi filed an internal report with Alexion’s Japanese subsidiary in March ’16. However, the company requested Ms. Kobayashi to sign a confirmation form, which would have made it difficult for her to report the matter internally.
The U.S. company informed her that it would have Nagashima Ohno & Tsunematsu investigate the matter as a third-party organization, but “the investigation was in name only, and the findings were that serious irregularities were outside the scope of the investigation.
Escalating Power Harassment ⇒ “Whistleblower Report” to the Ministry of Health, Labor and Welfare
The power harassment escalated from there, and Mr. Kobayashi was unable to overlook the fact that off-label patients were dying without proper information, so he filed a public-interest report with the Ministry of Health, Labor, and Welfare in February 2005.
“I was interviewed several times by the Ministry of Health, Labor and Welfare, and at the last interview, an official told me, ‘If the government takes action, there is a possibility that you will be disadvantaged.
But I asked, ‘There is the Whistleblower Protection Act, and I will deal with the disadvantage myself, so please stop the injustice.'”
The company’s misconduct and power harassment of Mr. Kobayashi continued.
Filing for a “labor tribunal” and “administrative guidance” by the Ministry of Health, Labor, and Welfare => Job is hung out to dry
In August 2006, Mr. Kobayashi filed for a labor tribunal. The diary he submitted as evidence at that time clearly records the company’s misconduct and contains many harsh criticisms, and also describes an interview with a Ministry of Health, Labor, and Welfare official. From September 2006 onward, the trade newspaper Mixonline reported on Alexion’s fraud.
The following month, the MHLW issued written administrative guidance to Alexion. According to Kobayashi, this is a serious matter: “As far as I know, this is the second time a written administrative guidance has been issued to a pharmaceutical company regarding its advertising.
The Ministry of Health, Labor, and Welfare (MHLW) subsequently conducted an investigation at Alexion’s headquarters, and in February 2007, ordered Alexion to revise the package insert for Soliris.
Shortly thereafter, however, Mr. Kobayashi was reassigned.
I filed a lawsuit in July ’19 to invalidate the reassignment, but from ’20 my work dried up. Furthermore, in August ’20, a second reassignment left me without a job in a department of only one person.”
One would think that if one is assigned to a department with only one person and no work, there is no need for reassignment. However, Ms. Kobayashi lost the lawsuit to confirm the invalidity of her reassignment.
Ms. Kobayashi felt that “the Whistleblower Protection Act must be amended to truly protect whistleblowers, or the same thing will happen to me,” and so she started a petition drive to “amend the Whistleblower Protection Act. Meanwhile, the company completely eliminated Ms. Kobayashi’s responsibilities in May of last year.
He said, “Until now, I had less than one hour of work, but since mid-May, I have had no work at all.
I thought this was terrible at any cost, so I filed an internal report with the internal reporting office of AstraZeneca, which has been the parent company since ’21, that I had reported irregularities internally to Alexion Pharmaceuticals, but that no appropriate action had been taken, and that I was being hung out to dry at work. However, no action was taken.”
In January of this year, Ms. Kobayashi filed a lawsuit claiming damages for power harassment. In addition, she is also considering suing to have her managerial position (senior manager, grade 9) demoted to general position D (fourth from the bottom) and her base salary lowered due to the merger of the personnel systems with AstraZeneca.
In the second part of this interview, we will hear about the treatment of his colleagues who raised their voices along with Mr. Kobayashi, and their current situation, which has made it difficult for them to change jobs.
Interview and text by： Wakako Takou
