Professional Documents
Culture Documents
One of the Non-conformities involved another sterility technician who could have caused
an explosion by having and talking on a cell phone, while entering the restricted
sterilization chamber area. In this instance, he also entered the chamber alone, which is
another instance of Non-conformity. This was important to correct, because, I am often
this employees partner, in the chamber. However, no Non-conformity Report was
generated for either matter. Both of these Non-conformities are regulatory violations, per
TUV and the FDA. Managements response to these issues, and the decision to not
generate the reports was because it did not have anything to with patient safety.
This may not sound like a big deal to you, or even to the average person who is
unfamiliar with the strict compliance with regulatory guidelines. My practice is to follow
the rules, and adhere to the guidelines, especially, when safety or potential for injury is
involved.
On the same date, September 19, 2014, and in the same conversation, with Mrs. Lynn
Purst, Director of Employee Relations, I asked her what about the defective Simulator
Leads. I told Mrs. Prust that during the development of the Leads, when I was designing
the cycle, in 2005, there was an issue with the Simulator Leads that still exists, today. She
documented my statements about the defective Simulator Leads. (Statements that I made
to Mrs. Prust were based on my fourteen (14) years of experience in Quality Management
for Medical Device Manufacturing and Sterilization, from inception to completion of
medical devices, which includes research and testing.)
Also, on the same day as my conversation with Mrs. Prust, regarding Nonconformities, regulatory violations, and defective Simulator Leads, I was placed on a
Leave of Absence.
On October 17, 2014, Mrs. Prust, Director of Employee Relations, and Mr. Thomas
Landon, Regional Security Manager (Western Region), summoned me to meet with
them. I was still on a Leave of Absence, while Mrs. Prust conducted an Investigation
regarding my concerns.
I was hoping and praying that Mrs. Prusts Investigation would reveal the TRUTH
one of the aspects of the Boston Scientific Corporations CODE OF CONDUCT, which
is strongly emphasized, and used to keep employees under control, and in fear of losing
their jobs.
HOWEVER..
Having already been on a Leave of Absence from September 19 to October 17, 2014, I
already had the strong feeling that I was going to be terminated, because of my inquiries
especially, about the defective Simulator Leads.
In that regard, knowing that I was going to receive the traditional Boston Scientific
Corporation Separation Package, I prepared my own Separation Package. (See
attached Document, dated October 17, 2014.)
As I correctly supposed, at the October 17, 2014, meeting with Mrs. Prust, Director of
Employee Relations, and Mr. Thomas Landon, Regional Security Manager (Western
Region), I was told that Mrs. Prust found no evidence of concern during her
Investigation, and that she could not talk about the Investigation. She said that if I
was unhappy about working with my Supervisor, she had already prepared a
Separation Package for me. As Mrs. Prust handed me her Separation Package, in the
amount of Twenty-six Thousand One Hundred Sixteen Dollars and Ninety-two Cents,
($26,116.92) I handed her my already prepared Separation Package, in the amount of
One Billion Dollars ($1,000,000,000.00).
PLEASE NOTE: In the interview, on September 19, 2014, Mrs. Prust asked me my
expectations, regarding the concerns that I raised. I responded by telling her that the
persons who were responsible for violating the CODE OF CONDUCT, by performing
certain Non-conformities (I identified the Parties by name) should be relieved from their
duties, per the Corporate CODE OF CONDUCT. Mrs. Prust and Management did not
respond to my request, for this change in Management. Please be advised that one of the
persons whom I suggested needed to be replaced is the same person, the Vice President
of Quality, who knowingly and deliberately omitted the Non-conformity from the TUV
Audit of August 19-22, 2014, which is a regulatory violation as well a violation of the
Boston Scientific Corporation Code of Conduct.
When the issue was raised again about my expectations, I already knew that persons
who assisted in the decision-making process to continue manufacturing the defective
product would not be removed from their positions. It was at that point that I stated in
my October 17, 2014, Separation Package -- my even more SERIOUS
EXPECTATION is to settle this matter with Boston Scientific in the amount of ONE
BILLION DOLLARS, USD ($1,000,000,000.00). This settlement request is not
negotiable.
(The point that I was making is that Patient Safety and the development of quality
product are not negotiable! A patient who loses his life, because of a defectively
manufactured product does not have the opportunity to negotiate his position in the
matter.)
I requested that the Boston Scientific Corporation Management respond to my
Separation Package or Settlement Offer, by Tuesday, October 21, 2014. Mrs. Prust,
Director of Employee Relations, acting on the behalf of Boston Scientific Corporation,
and Management, promptly replied with a rejection of my Separation Package or
Settlement Offer, on Monday, October 20, 2014.
Frankly, by October 17, 2014, I had to raise my expectation from ever thinking that the
Boston Scientific Corporation Management would ever discharge one of its own, in favor
of saving a patient from injury, or even the loss of life. My real expectation was that
Boston Scientific Corporation would show me, by example, that its Mission Statement
and the Code of Conduct, regarding quality product and patient safety as first priorities
were really what they were purported as being. I really wanted to believe that to the
very extent of offering every opportunity for Management to fix the patient safety
issue, and show that the patient was more important than profit. As time went by, and
nothing was being done to resolve the defective product issue, I never really got the
feeling that Patient safety was always the first priority.
I did not set the amount of my Separation Package at One Billion Dollars, because
Boston Scientific is a multi-billion Dollar Company, but because I assessed the value of a
healthy body or a human life as being GREATER than a Billion Dollars as Priceless!
THE CHARGER AND THE UNIT ARE DEFECTIVE. The only hardware related
to the Unit that does not have an issue is the remote. (The remote is NOT
manufactured by Boston Scientific Corporation.)
In my prior conversation, and October 17, 2014, Letter to Mrs. Prust and Mr. Landon, I
tried to the best of my ability or to the extent to which they would allow me, as well as, in
subsequent communications, to emphasize the quality product/patient responsibility of
Boston Scientific Corporation, and JUST HOW MUCH IT WOULD COST, if the matter
to continue to manufacture defective product continued.
I emphasized over and over, in in-person interviews, telephone conversation as well as in
written communications that the costs should not always be measured in dollars and cents
to Boston Scientific Corporation, but rather what it will cost the patient/consumer, with
his health, long-term disability, and life. I emphasized my desire to feel good about what
I do, as I participate in the operation of a medical device company that develops quality
products that enhance the life of the patients/consumers.
Again, I hoped that Senior Management would get wise in making the comparison that
when I raised the issue of One Billion Dollars in my Separation Package that it would
show just how much, much more the magnitude and gravity of the economic situation
really is, and will continue to be, if the Boston Scientific Corporation does not get this
defective product/ patient safety issue resolved.
The following excerpt is taken from the November 16, 2014 Letter: Costs include:
PRODUCT RECALL, FACILITY SHUTDOWN, THE COSTS TO
CORRECT
THE
DEFECTIVE
PRODUCT,
PENALITIES
TO
REGULATORY AGENCIES, FOR KNOWINGLY MANUFACTURING
AND INTRODUCING A DEFECTIVE PRODUCT TO THE PUBLIC;
COSTS ASSOCIATED WITH PATIENT INJURY OR A FATALITY; LOSS
OF MARKET SHARE, WHICH MORE THAN LIKELY WILL NEVER BE
RECOVERED, LOSS OF PATIENT AND HEALTHCARE PROVIDER
CONFIDENCE; AND LOSS OF INVESTOR CONFIDENCE AND
DEVALUATION OF THE STOCK. HOWEVER, THERE IS NO PRICE
THAT CAN BE PLACED ON A HUMAN LIFE!
If Mrs. Lynn Prust, Director, Employee Relations, acting on the behalf of Boston
Scientific Corporation and Management wanted to know the TRUTH, she would have
conducted an Investigation into my concerns, which would definitely have revealed
that the SPINAL CORD SIMULATOR (SCS) AND DEEP BRAIN SIMULATOR
(DBS) UNITS ARE DEFECTIVE.
In fact, on October 23, 2014, the same day that I submitted a questionnaire
regarding my concerns to Mrs. Lynn Prust, Director of Employee Relations, Mr.
Michael Mahoney, CEO and President of Boston Scientific Corporation, sent me an
E-mail stating: Please stop E-mailing me.
As a result of the October 23, 2014, Letter in the form of a questionnaire to Mrs. Lynn
Prust, Director, Employee Relations, requesting an explanation of the statement that she
made to me regarding the Investigation and her findings, her response was as follows:
The Company has taken your concerns and allegations very seriously, and has
carefully reviewed them. We did not find information or evidence to validate your
concerns, nor did we find violations of our (Boston Scientific) Code of Conduct or
Company policies.
The first question that I asked Mrs. Lynn Prust, Director, Employee Relations is:
*QUESTION:
WHAT DID YOU INVESTIGATE? PLEASE EXPLAIN.
Other Questions that I asked Mrs. Lynn Prust, Director of Employee Relations, included
the following: Taken from Letter of October 23, 2014
*QUESTION:
HOW, AND IN WHAT MANNER
HANDLED? PLEASE EXPLAIN.
WAS
THE
INVESTIGATION
*QUESTION:
DID YOU, MS. LYNN PRUST, DIRECTOR OF EMPLOYEE RELATIONS,
CONDUCT THE INVESTIGATION? YES _ or NO_?
*QUESTION:
WHAT WERE THE INDIVIDUAL OR SEPARATE FINDINGS FROM
YOUR INVESTIGATION, WITH REGARD TO THE FOLLOWING
ISSUES? PLEASE PROVIDE AN EXPLANATION, FOR EACH ISSUE.
A. The same person who is in charge of calibration is in charge of validation. This can
pose a conflict of interest. (QUALITY-RELATED ISSUE)
PLEASE EXPLAIN.
B. An employee was permitted to enter into a clearly marked restricted area where
electronics are prohibited, with a cell phone. Not only did the employee have the
cell phone in his possession, he was talking on the phone, while in front of the EtO
Sterilization Chamber Door, while the door was opening, which is clearly more
serious than a mere violation of the Code of Conduct. (NON-CONFORMITYBREACH OF CODE OF CONDUCT, and TUV/FDA VIOLATION, WITH
REGARD TO AUDITING REPORTING, AND SAFETY ISSUE)
PLEASE EXPLAIN.
C. The employee also violated protocol, by entering the Sterilization Chamber
unaccompanied. Where was the other sterilization technician, at that time? (NONCONFORMITY-BREACH OF CODE OF CONDUCT, and TUV/FDA
VIOLATION, WITH REGARD TO AUDITING REPORTING, AND
SAFETY ISSUE)
D. Why were these questions not asked or answered, by Management, with regard to
its responsibility of accountability, per the Code of Conduct? (MANAGEMENT
ISSUE, WITH REGARD TO THE FACT THAT ALL EMPLOYEES,
INCLUDING MANAGERS, ARE TO ADHERE TO THE CODE OF
CONDUCT, AT ALL TIMES)PLEASE EXPLAIN.
E. *IF THESE QUESTIONS WERE ASKED, WHAT ANSWERS DID
MANAGEMENT PROVIDE? PLEASE EXPLAIN.
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F. The likelihood of a similar incident happening is more probable, because a Nonconformity Report was not generated. The absence of a Non-conformity Report
allowed this matter to go unnoticed and uncorrected. (NON-CONFORMITYBREACH OF CODE OF CONDUCT, and TUV/FDA VIOLATION, WITH
REGARD TO AUDITING REPORTING) PLEASE EXPLAIN.
G. The absence of generating a Non-conformity Report is a violation of the Code of
Conduct. The matter is an even more serious violation, when other registration
bodies, such as: TUV/FDA Auditors, are not informed of the infraction. (NONCONFORMITY-BREACH OF CODE OF CONDUCT, and TUV/FDA
VIOLATION, WITH REGARD TO AUDITING REPORTING) PLEASE
EXPLAIN.
H. The absence of generating a Non-conformity Report is a violation of the Code of
Conduct; and deprived other employees of the opportunity to be reminded of the
seriousness of this infraction, because of the high risk of endangerment to others,
including loss of life; property damage, and loss of Corporate profit, especially
had there been an explosion. (NON-CONFORMITY-BREACH OF CODE OF
CONDUCT AND SAFETY ISSUE) PLEASE EXPLAIN.
*QUESTION:
WHAT IS MANAGEMENTS POSITION AND PROPOSED RESOLUTION
FOR EACH OF THE FOLLOWING ISSUES? PLEASE EXPLAIN
MANAGEMENTS POSITION TAKEN.
*QUESTION:
IS BOSTON SCIENTIFIC CORPORATION IN AGREEMENT WITH THE
WAY OR MANNER IN WHICH THE INVESTIGATION FOR BOSTON
SCIENTIFIC
CORPORATION,
EMPLOYEE,
BENJAMIN
H.
GHANOONGOOI, WAS HANDLED OR CONDUCTED?
YES _ or NO _?
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*QUESTION:
IS BOSTON SCIENTIFIC CORPORATION, IN AGREEMENT WITH
YOUR FINDINGS OF THE INVESTIGATION CONDUCTED RELATIVE
TO EACH ISSUE AND CONCERN OF BOSTON SCIENTIFIC
EMPLOYEE, BENJAMIN H. GHANOONGOOI?
YES ___ or NO ____?
*QUESTION:
IS BOSTON SCIENTIFIC CORPORATION IN AGREEMENT, WITHOUT
RESERVATION, WITH THE SPECIFIC DECISIONS, FINDINGS,
RESOLUTIONS AND CONCLUSIONS REACHED BY YOU, AND
MANAGEMENT, REGARDING THE FACT THAT EACH ISSUE, AND
CONCERN RAISED BY BENJAMIN H. GHANOONGOOI, HAS NO
VALIDITY, PER THE RESULTS OF YOUR INVESTIGATION, AND
CAREFUL REVIEW, MADE BY YOU AND MANAGEMENT; AND
THEREFORE, BOSTON SCIENTIFIC CORPORATION FURTHER
AGREES AND CONCLUDES THAT SUCH ISSUES AND CONCERNS
RAISED BY BENJAMIN H. GHANOONGOOI, DO NOT VIOLATE THE
BOSTON SCIENTIFIC CODE OF CONDUCT OR COMPANY POLICIES?
YES_ or NO _?
*PLEASE NOTE (1): MRS. LYNN PRUST, DIRECTOR, EMPLOYEE
RELATIONS, REFUSED TO ANSWER THESE AND ANY OF THE QUESTIONS
THAT I RAISED. MRS. PRUST WOULD NEVER DISCUSS OR COMMENT
ABOUT THE DEFECTIVE SIMULATOR LEADS ISSUE IN WRITING. SHE
WOULD ONLY MAKE REFERENCE TO THE SIMULATOR LEADS,
VERBALLY. EACH CONVERSATION OR LACK OF CONVERSATION WAS
NEVER REDUCED TO WRITING, BY MRS. LYNN PRUST, DIRECTOR,
EMPLOYEE RELATIONS. I ASKED MRS. PRUST SEVERAL TIMES TO
DISCUSS THE DEFECTIVE LEADS ISSUE.
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Respectfully submitted,
Benjamin H. Ghanoongooi