boston scientific defects

14

Click here to load reader

Upload: medtechy

Post on 12-Dec-2015

90 views

Category:

Documents


3 download

DESCRIPTION

Boston Scientific

TRANSCRIPT

Page 1: Boston Scientific Defects

1

Monday, March 9, 2015

To: Honorable Joseph R. Goodwin, Judge

7009 Robert C. Byrd United States Courthouse

300 Virginia Street East

Charleston, WV 25301

From: Benjamin H. Ghanoongooi

Re: An Overview of the Situation and Sequence of Events that Led to Now Sharing

the Fact that Boston Scientific Corporation has history of Manufacturing Defective

Product

Dear Honorable Judge Goodwin,

My name is Benjamin H. Ghanoongooi. I was Quality Manager, at Parter Sterilization

Services, where I designed the original Boston Scientific/Advanced Bionics, Sterilization

Cycle Specification. I have been a Senior Sterilization Specialist for Medtronic,

Incorporation, from 2005-2011, and a Senior Sterility Engineer, Neuromodulation, for

Boston Scientific, Corporation, from 2011 through Friday, November 14, 2014.

In regards to recent posting in Reuters for EU court’s Ruling on Boston Scientific, I felt

that it was best for me to reduce my thoughts, and this unfortunate situation to writing,

which I am prepared to substantiate, if or when the need arises.

To help you to get a clearer understanding of the matter regarding Boston Scientific

Corporation’s manufacturing of defective product, and where this matter is today, I must

ask for your patience.

On September 19, 2014, during an investigative interview to discuss my concerns

regarding another “sensitive” subject matter, with Boston Scientific Corporation’s

Management, I discussed with Mrs. Lynn Prust, Director of Employee Relations, the fact

that there were Non-conformities that were being carried out, and that the customary way

to handle such matters, by opening a Non-conformity Report was being ignored. (I

apprised Mrs. Prust of the Non-conformities, who, and under what circumstances such

instances took place. I also told Mrs. Prust that omitting the Non-conformity from the

TUV Audit of August 19-22, 2014, was a regulatory violation. Mrs. Prust ignored that

statement as well.

Page 2: Boston Scientific Defects

2

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 employee’s 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. Management’s 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 Non-

conformities, 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. Prust’s “Investigation” would reveal the TRUTH –

one of the aspects of the Boston Scientific Corporation’s CODE OF CONDUCT, which

is strongly emphasized, and used to keep employees under control, and in fear of losing

their jobs.

Page 3: Boston Scientific Defects

3

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.

Page 4: Boston Scientific Defects

4

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!

Page 5: Boston Scientific Defects

5

I NEVER RAISED THE ISSUE OF A SEPARATION PACKAGE AGAIN.

ALTHOUGH, ON FRIDAY, NOVEMBER 14, 2014, MRS. LYNN PRUST,

DIRECTOR OF EMPLOYEE RELATIONS, TERMINATED MY EMPLOYMENT

WITH BOSTON SCIENTIFIC CORPORATION, BECAUSE I WOULD NOT STOP

SAYING TO HER AND TO SENIOR MANAGEMENT THAT

NEUROMODULATION WAS MANUFACTURING DEFECTIVE PRODUCT,

WHICH HAS THE POTENTIAL TO CAUSE PATIENT HARM OR INJURY, LONG-

TERM DISABILITY, AND POSSIBLY, A FATALITY. THIS TIME, MRS. PRUST,

DIRECTOR, EMPLOYEE RELATIONS, OFFERED ME A “SEPARATION

PACKAGE”, IN THE AMOUNT OF: FIFTY-TWO THOUSAND TWO HUNDRED

THIRTY-THREE DOLLARS AND EIGHTY-SEVEN CENTS ($52,233.87), WITH

“NO OPTION TO RETURN” TO MY EMPLOYMENT POSITION AS SENIOR

STERILIZATION ENGINEER, NEUROMODULATION.

Unfortunately, Mrs. Prust, nor Senior Management took my advice to seriously look into

the matter, and really “Investigate” the issue of manufacturing defective product, which

has the potential for patient injury or possibly a fatality. “TRUE INVESTIGATION”

BY BOSTON SCIENTIFIC CORPORATION MANAGEMENT WOULD HAVE

UNCOVERED THE “TRUTH”. It has been all too easy, for Boston Scientific

Corporation to state “we did not know” that the product was defective, or that the product

was “not manufactured with the intent” to be defective. However, whether the intent was

or was not to manufacture a defective product, it is the responsibility of the manufacturer

to produce a quality product, especially, if the issue of “defect” is even raised as a

possibility. When a product is manufactured under the conditions in which the

defective product in question is manufactured, one will ALWAYS get a defective

product. BOTTOM LINE! Again, unfortunately, a “different” Bottom line was

being considered – profit margin, market share, investor relations ….

The SPINAL CORD SIMULATOR (SCS) AND DEEP BRAIN SIMULATOR

(DBS) UNITS, which have been and are being manufactured by Boston Scientific

Corporation have the potential to cause patient injury, and possibly, a fatality – NO

DOUBT ABOUT IT!

Page 6: Boston Scientific Defects

6

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!

Page 7: Boston Scientific Defects

7

THE AMOUNT THAT BOSTON SCIENTIFIC CORPORATION WILL

SPEND, PAY OUT, AND LOSE FOR ANY SINGLE COST OR LOSS THAT

BOSTON SCIENTIFIC CORPORATION WILL INCUR AS A RESULT OF

THE DEFECTIVE SPINAL CORD SIMULATOR (SCS) AND DEEP BRAIN

SIMULATOR (DBS) UNITS THAT RESULT IN PATIENT INJURY OR

FATALITY, WILL BE AN ECONOMIC LOSS, AND A PUBLIC AND

INDUSTRY EMBARRASSMENT TO THE CORPORATION.

I realize that I have told you over and over that Boston Scientific Corporation is

manufacturing a defective Product. It can be proven as TRUTH, but Boston Scientific

Corporation does not want to discuss the matter. Boston Scientific Corporation would

rather manufacture defective product, and litigate any claim of injury or harm to the

patient, on a case-by-case, or even a class action basis. This certainly costs less than

“fixing” the defective product issue.

Logically, even, if not factually, it is more cost effective to increase the amount available

for litigation, as noted, by an increase in Boston Scientific Corporation’s amount

available for litigation – which for the most part is for either defense or settlement for

defective product or patient injury. In this regard, litigation on defective product cases

windup, bound up for years, in circular court proceedings, because this seemingly, is an

easier, less costly, long-term, but fast “fix” to solving a quality product/ patient safety

issue, which really needs to be fixed, right now, once and for all – no matter the

economic cost or the amount of time that it will take to do so. Patient safety is at stake.

The concern should be more than the fact that the Manufacturer hopes that no one is

injured or losses his life – but, is still willing to take the chance, anyway!

Subjectively speaking, the proposition is: Spend One Billion Dollars to keep matters tied

up in court for years, rather than spend Ten Billion Dollars to fix the defective

product/patient safety problem, and eliminate the defective product/patient safety matter,

from being a remote concern. Under the current circumstances, ALL of the product

manufactured by Boston Scientific Corporation, Neuromodulation, that is, The SPINAL

CORD SIMULATOR (SCS) AND DEEP BRAIN SIMULATOR (DBS) UNITS HAS

SOME TYPE DEFECT.

Page 8: Boston Scientific Defects

8

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 WAS THE INVESTIGATION

HANDLED? PLEASE EXPLAIN.

*QUESTION:

DID YOU, MS. LYNN PRUST, DIRECTOR OF EMPLOYEE RELATIONS,

CONDUCT THE INVESTIGATION? YES _ or NO_?

Page 9: Boston Scientific Defects

9

*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-CONFORMITY-

BREACH 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? (NON-

CONFORMITY-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.

Page 10: Boston Scientific Defects

10

F. The likelihood of a similar incident happening is more probable, because a Non-

conformity Report was not generated. The absence of a Non-conformity Report

allowed this matter to go unnoticed and uncorrected. (NON-CONFORMITY-

BREACH 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. (NON-

CONFORMITY-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 MANAGEMENT’S POSITION AND PROPOSED RESOLUTION

FOR EACH OF THE FOLLOWING ISSUES? PLEASE EXPLAIN

MANAGEMENT’S 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 _?

Page 11: Boston Scientific Defects

11

*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.

Page 12: Boston Scientific Defects

12

*NOTE (2): MY QUESTION IS: WHETHER MRS. LYNN PRUST, DIRECTOR

OF EMPLOYEE RELATIONS, WAS “QUALIFIED” TO CONDUCT THE

“INVESTIGATION” REGARDING THE DEFECTIVE SIMULATOR LEADS?

DOES SHE HAVE SUCH EXPERTISE OR KNOWLEDGE OF THE SUBJECT

MATTER?

*NOTE (3): DURING MY NOVEMBER 14, 2014, TELEPHONE

CONVERSATION WITH MRS. LYNN PRUST, DIRECTOR, EMPLOYEE

RELATIONS, AND MR. THOMAS LANDON, SECURITY (WESTERN REGION,

MRS. PRUST ASKED ME REPEATEDLY, WHETHER THERE WAS

ANYTHING SPECIFIC THAT I WANTED TO TELL HER ABOUT THE

DEFECTIVE SIMULATOR LEADS. MRS. PRUST CONDUCTED THE

“INVESTIGATION”; THEREFORE, SHE SHOULD HAVE BEEN ABLE TO

PROVIDE INFORMATION TO ME ABOUT THE DEFECTIVE LEADS,

RATHER THAN ASK ME WHAT I KNOW, SPECIFICALLY.

*NOTE (4): THE FACT OF THE MATTER IS, THE ENTIRE UNIT IS

DEFECTIVE!

*NOTE (5): EVEN IF MRS. PRUST WERE PROVIDED AN EXPLANATION

REGARDING THE DEFECTIVE LEADS, WOULD SHE REALLY KNOW

WHETHER THE INFORMATION PROVIDED TO HER WAS ACCURATE?

*NOTE (6): IN THIS REGARD, BY MRS. PRUST CONDUCTING THE

“INVESTIGATION”, ON THE BEHALF OF THE BOSTON SCIENTIFIC

CORPORATION, AND MANAGEMENT, NATURALLY, IT COULD BE

STATED THAT SHE/THE CORPORATION DID NOT KNOW THAT THE

SIMULATOR LEADS WERE DEFECTIVE, EVEN, THOUGH THEY ARE

DEFECTIVE. HOW COULD SHE KNOW, IF THIS IS AN AREA IN WHICH

SHE HAS NO EXPERTISE OR NO KNOWLEDGE, REGARDING THE

SUBJECT MATTER? THEREFORE, IT IS QUITE EASY TO ASSERT HAVING

NO KNOWLEDGE OF A DEFECT – AND, POSSIBLY, BE TRUTHFUL, WHEN

MAKING THAT STATEMENT.

Page 13: Boston Scientific Defects

13

*NOTE (7): THIS IS AN AREA IN WHICH I HAVE FOURTEEN (14) YEARS OF

EXPERIENCE. I HAVE EXPERIENCE IN STERILIZATION CYCLE

DEVELOPMENT, FROM THE INITIAL PRODUCT DEVELOPMENT STAGE

TO MANUFACTURING AND VALIDATION.

*CONCLUSIVE NOTE: I KNOW THAT THE SIMULATOR LEADS ARE

DEFECTIVE. I KNOW THAT IT CAN BE PROVEN THAT THE SIMULATOR

LEADS ARE DEFECTIVE. I KNOW THAT THE ENTIRE SPINAL CORD

SIMULATOR (SCS) AND DEEP BRAIN SIMULATOR (DBS) UNITS ARE

DEFECTIVE, EXCEPT FOR THE REMOTE.

on Friday, November 14, 2014, I was given a “Separation Package” to conclude my

employment with Boston Scientific Corporation. I NEVER VIOLATED THE

CODE OF CONDUCT; HOWEVER, I DID ASSERT OVER AND OVER AND

OVER TO MRS. LYNN PRUST, DIRECTOR OF EMPLOYEE RELATIONS, ON

THE BEHALF OF THE BOSTON SCIENTIFIC CORPORATION, AND

MANAGEMENT THAT THERE IS A “MAJOR” QUALITY PRODUCT AND

PATIENT SAFETY MANUFACTURING ISSUE AT NEUROMODULATION

THAT NEEDS TO BE RESOLVED, BEFORE THERE IS HARM OR INJURY TO

A PATIENT/CONSUMER, OR GOD FORBID, A FATALITY.

EVERY SINCE MY SEPARATION FROM BOSTON SCIENTIFIC

CORPORATION ON NOVEMBER 14, 2014, I HAVE BEEN RECEIVING

MESSAGES FROM A COMPANY THAT WAS RETAINED BY BOSTON

SCIENTIFIC CORPORATION ON MY BEHALF TO PROVIDE A STANDARD

OF PLACEMENT ASSISTANCE IN FINDING NEW EMPLOYMENT.

I STATED TO THE AGENT THAT I WOULD NOT LIE ON THE

APPLICATION ABOUT MY REASON FOR SEPARATION FROM BOSTON

SCIENTIFIC CORPORATION, AND THAT MY REASON FOR LEAVING WAS

BECAUSE I CONTINUED TO RAISE PATIENT SAFETY ISSUES. THE AGENT

CONFIDED MY CONCERNS REGARDING MY TRUTHFULNESS ON THE

APPLICATION TO MRS. LYNN PRUST, DIRECTOR OF EMPLOYEE

RELATIONS, BOSTON SCIENTIFIC CORPORATION.

Page 14: Boston Scientific Defects

14

THE AGENT CALLED BACK, AND LEFT A MESSAGE ON MY ANSWERING

MACHINE, AND STATED THAT SHE HAD SPOKEN TO LYNN PRUST,

DIRECTOR OF EMPLOYMENT, BOSTON SCIENTIFIC CORPORATION, AND

THAT THE AGENT HAD FIGURED OUT A WAY FOR ME TO FILL OUT MY

APPLICATION, SO THAT I WOULD NOT HAVE TO LIE, REGARDING MY

PATIENT SAFETY CONCERNS, AND STILL BE ABLE TO GIVE A REASON

FOR NEEDING NEW EMPLOYMENT – OTHER THAN STATING THAT MY

REASON FOR LEAVING BOSTON SCIENTIFIC CORPORATION HAD

ANYTHING TO DO WITH PATIENT SAFETY ISSUES.

THEN, NOW, AND ALWAYS, MY FIRST PRIORITY, AS LONG AS I AM

ASSOCIATED WITH THE MEDICAL DEVICE INDUSTRY, WILL ALWAYS

BE: TRUTH, PATIENT SAFETY/QUALITY PRODUCT FIRST AND

FOREMOST, NO MATTER THE COSTS.

Respectfully submitted,

Benjamin H. Ghanoongooi