FORMAL LEGAL COMPLAINT FOR FULL INVESTIGATION AND PROSECUTION OF CORPORATIONS that have made

MORCELLATION DEVICES,

Surgeons who have used it, the ACOG, and the marketing companies who helped them lie to the public to promote morcellation

Filed by: 
Dr. V.G. Hufnagel MD
Director of the Institute for Ethics Law, Science and Medicine. 
vikkihufnagel@gmail.com
PST 323–210–3371 vm, 
4244 Canoga Ave
Woodland Hills Ca 91364

To: The FTC, SEC, FINRA, BBB, FBI, OIG, CA Attorney General, Sen Boxer, Sen Feinstein, Ca Dept. of Insurance, Ca Dept. of Affairs, members of the US Congress and The Hague.

To The Hague: This crime of morcellation with a device that spreads disease and death is taking place around the globe. Poor women have been used as experimental animals without being educated or given informed consent. The WHO does many fine things. However WHO also promotes testing on women in underdeveloped nations who are taken advantage of. Money is given to WHO for the promotion of studies on these women for corporations’ research and development. There is a long history of these abuses. There are studies now taking place in which acid is being placed inside the uterus of women to sterilize them. In undeveloped nations women are experiment on and they have no follow up care. This is a major issue of human rights that needs to be exposed. We will be sending other crimes to be attached to this complaint on abuses of women around the globe that are not spoken of an accepted as routine conduct in the care of women.

We need The Hague to lead the action to educate and protect women around the world from medical abuse, harm and battery and to insure their health and welfare.

Please note:

On receipt of this document please email Dr. Hufnagel vikkihufnagel@gmail.com with the following information:

1/ Provide contact data as to who will be in charge of investigation and the prosecution.

Please note; No complaint is without factual evidence of abuses and crimes that are witnessed by multiple individuals as a rule. This case herein is no exception and hundreds of documents exist which you can find and we can provide for the investigation. We can provide witnesses.

To the members of the US Congress:
Please review for a Congressional Hearing.

2/Arrange for Skype Conference Call for intake so a formal video record can be made for press and Media. Dr. Hufnagel agrees to polygraph on all issues our institution files on.

3/Send document of standards and protocol of your investigations and full information on what Government organizations oversee your work.

4/Provide what actions you have the authority to take and implement in a case where a corporation has with premeditated thought lied to its investors and to the patients who are victims of the devices created by the corporation.

Please inform us of all Federal and State laws that are in place to prevent the abuses and crimes that have taken place. Please advise also of new law that is needed to prevent such crimes in the future.

5/Declaration of Truth 12/31/2015 by Dr. V.G. Hufnagel MD.

Dr. V.G. Hufnagel

12/31/2015 — The following statement is made under penalty of perjury in Los Angeles California on this date under the law of the State of California and Federal Law. I am over 18 years of age. I am making this action known to the National Enquire first in the hopes they will report it so that it is available in every grocery store in the nation.

The facts in my statement have not received adequate reporting by the media and press since 1993. If it had I would not need to be taking on this issue at this time. The people of this nation would of spoke out that enough is enough, and they are not going to take abuses and cover ups anymore. The killing of any women for money by the ACOG, AMA and the corporations making morcellator devices for an elective procedure lacking proper protocol, not providing informed consent, intentional fraud in the sales of morcellation operations to women, all add up to the fact at all times there was actions to commit intentional murder.

Further I am available to debate any agent for the ACOG, AMA etc. I will not stop this attack until the truth is known to all on the globe.

I am also providing this to medical physicians around the globe see: www.actamedicainternational.com. Physicians in other parts of the world do not get all the information that is need to assist them in learning about the politics of medicine in America. This is important because often organizations such as the WHO and others take on research projects in which poor uneducated women are subjugated to experimentation on for the benefit of corporations. This is also an area of investigation by enforcement. Who has been harmed in the development of the morcellation device on this earth? Should all know all the events that have taken place to commit mayhem on women.

My background as to why I am taking this action to ask all agencies of the government to stop these abuses by the physicians and the corporations which have killed and caused injury to women all over the globe. The reality is that I redesigned the device in 1995 which I showed and explained to the medical device committee of the FDA in 1995.

I am filing this complaint as a:

1/ gynecological surgical ethics specialist

2/ creator of a new surgical branch of gynecology called Female Reconstructive Surgery prior to 1985

3/ student of Kurt Semm (Germany) and Viktor Bonney (UK)

4/ First Physician to write law to protect patients in USA CA TX NY INFORMED CONSENT FOR HYSTERECOMY.

5/ International known women’s health care expert and whistle-blower on abuses.

I will assist law firms to bring law suits against all makers of morcellation devices and against physicians and medical organizations who have hurt women with their actions.
I will work towards actual jail time for these crimes not a slap on the wrist and payment of money. Our society must change and be leaders of ethics protecting the people.
I will assist all government agents to take action to stop these abuses.
I will provide interviews to all press and media.

FACTS OF EVENTS THAT HAVE TAKEN PLACE

A/Investors who bought stock from laparoscope device manufactures were lied to. Investors were told that morcellation was the new next breakthrough in women’s surgical technology. They were lied to about its safety and its use application. They were told that women would only elect for morcellation because it was done as an outpatient with no major incision on the body (no laparotomy). That morcellation was an evolutionary advancement that would bring money to the company and the stock they bought would soar. Investing in morcellation would make investors rich. The fact is that these corporations knew that the device used as it was and remains marketed would spread disease and would spread cancer and kill women. These corporations did not advise investors of the complications that would occur with the device.

No one can defend the performance of an elective procedure that has a significant risk factor that it will kill a percentage of patients and harm others by spreading disease. This was not told to investors but known to the surgeons and corporate heads because of the knowledge we have about sarcoma.

Moreover, gynecology has evolved over time to establish protocol and procedures for surgical oncology. The public in general knows little about this science, so that the corporations can create confusion. But science has rules and regulations based on repeated studies which have been totally ignored. I will be filing attempted murder charges and conspiracy to murder at the end of January 2016 on this issue. I will do this as it should have been done long ago. I will do what no one has done in the past to end this insanity. I have nothing to lose everything has been taking from me for speaking the truth. I will explain a single case to the world that will reflect the harm done to many thousands of women. I will not stop this effort and know far better having been through this on other issues before on how to take action. I have tried to instruct those who are victims. However, the psychological damage when this sarcoma occurs is so great that depression and grief keep victims and their families from action.

I will explain this in my next position paper naming those that murder and am seeking a full criminal trial. This is not about error or misjudgment in medicine. This is about knowing that women will die from the procedure and proceeding to do it despite full and complete knowledge.

In surgical oncology the rules are clear, NOT ambiguous:

A complete and through work up to identify any cancer or disease process is to take place prior to any major operation. In this process many studies take place including various scans, blood tests, imaging and biopsy of tissues is routine. It is the biopsy of tissues in 1990 I began to ask the laparoscopy corporations for assistance with. I am now taking this work to a major university to create an educational development program based in bioethics. The plan is to develop needed devices to improve health care for women and men through ethical processes.

During any operation all tissues must be treated as if they are cancer.

There needs to be isolation of the surgical site and prevention of spillage of material and a full and extensive cleanup process to remove any spillage. In the morcellation process all of the science used to develop oncological protocol to give the best outcome for the patient was and is totally ignored. It is truly madness. A chopper is racing about chopping up tissue emulsifying it into small particles and with it speeds spreading tissue about the body.

This is the terrible reality of what has taken place around the world since the morcellation device was created. Marketing has pushed the use of this device to investors to put more money in the hands of corporations to promote insane actions of mayhem. Women have been kept ignorant of the risks. The psychology that any physician in a white coat will seek to do no harm is a ruse for this scam. People need to awaken that physicians buy stock and do many things for greed just like bankers. Marketing companies know what they have done to cover up these abuses and requires putting their heads on stakes as well. This is an issue in which enforcement needs to become what it was put in place to do. You are to carry a big stick and knock down evil of any form.

There unfortunately is a history of these horror stories. The deaths of the 100’s of thousand infants killed by non-life supporting formula bought by women in Africa by Nestle’s who marketed the infant formula as being better than mothers milk was covered up by the marketing company Abelson Taylor. Abelson Taylor has never paid for its collusion in so many crimes. This needs to end. Those that cover up crimes are in collusion with the corporations that hire them and are guilty of covering up and hiding crimes.

SO WHAT THERE IS SARCOMA … ITS RARE

is the attitude of the corporations and those that support morcellation. These individuals need to be boycotted in mass. A list will be provided in March 2016 to boycott and expose these corporations, organizations and individuals. Each on the list will be exposed in full to enforcement and to the media/press.

The data we have on uterine sarcoma underestimates the number of annual cases. Many women die from other causes than sarcoma who have sarcoma within their uterus. With no autopsy we fail to learn the number of contained capsuled sarcoma that exists in the population. A morcellator would release the cancer cells by disrupting the capsule and releasing the cancer into the pelvic cavity. We need a comprehensive study to determine the number of women per year who have uterine sarcoma. The old number estimate was without proper data was .1 to .2 percent. Today with the reporting of cases is maybe 1 percent. No one in their right mind would take that risk for an elective operation.

CONCEPT TO TAKE HOME:

If a hundred women have morcellation for fibroid tumors 1 woman will die. 1 women and their families will suffer a long arduous and painful fight for life. The life of wives and mothers are lost and cut short because they were never told they had this risk. This is a fraud for all women undergoing morcellation that the risks are not provided to them.

All the time the morcellation device makers and surgeons knew that an open operation to protect the patient could be performed to reduce this risk. I can say this because I removed sarcomas via FRS and sent patients for extensive oncological removal. All patients had a risk for sarcoma because physicians know that every tumor mass is at risk for being a cancer and there is no such thing as “unexpected cancer“.

The phrase “unexpected cancer” is an intentional lie, misrepresentation, and fraud created by corporations and the physicians bought by them because with any uterine or ovarian mass cancer is never unexpected.

In each case of the FRS cases, the oncological surgeons found NO TRACE OF SARCOMA. In removing an encapsulated tumor in total (not cutting it open or leaking the contents) one can avoid spread of cancer cells.

Also the public needs to force the government to re activate the US ARMY PATHOLOGY DIVISION for the public. We had the US ARMY Pathology division as a major source for data and research. During our economic crisis caused by the moral corruption of our banks we lost this major source of data and assistance in medical science research. The US ARMY sector on Pathology was forced to stop all assistance to non-enlisted patients. The media and press NEVER brought this issue to the public. The public and world lost access to this incredible science division without even knowing what it did for medicine in America.

The device corporations and surgeons told women there was no risks or complications with morcellation, basically not giving women any informed consent. The marketing was simple; make women fear major laparotomy operations and create high levels of fear in them. Women when they are taught all the negative aspects of a laparotomy will ALWAYS elect to have a laparoscopy. This way morcellation can be sold to women. The sales pitch caused women to fear a laparotomy more and sell the morcellation to them. 
Thus, investors invested not knowing the complications that existed and provided money to increase sales. Investors where increasing the risks to women and did not know this.

I told Johnson and Johnson Ethicon division and Karl Storz that the morcellation device was going to spread disease (infection, endometriosis, adenomyosis, and fibroids) as a common complication prior to 1993 and

I told them also that they would KILL women with sarcoma. I had informed them that the instrument was not properly designed and that tissue cannot be chopped up and then spread all throughout the pelvic cavity.

Tissue needs to be isolated and identified prior to removal and no tissues released.

I was very clear on this issue to Johnson and Johnson, Karl Storz, and to the FDA in my 1995 meeting with the FDA Device Committee meeting which I called for and attended with two witnesses.

The witnesses were Susan Wine and Mark Popp. I spoke on sterilization issues, breast cancer, problems with breast implants, hormones, and morcellation. I wrote and called Karl Storz and Johnson and Johnson and sent them letters explaining the design flaw. No chopping inside the pelvic cavity can take place. All tissues need to be evaluated for cancer and other conditions before operating on any woman. The other issues I brought to the FDA will be reported to enforcement including The Hague in February 2016.

HISTORY OF EVENTS

This is about my personal involvement that gives me exact knowledge and information. I was a previous member of the AAGL. I presented papers at their meetings. I was the President of the Los Angeles JR ACOG, member of the AMA, ACOG etc and many more organizations.

I had created FRS — Female Reconstructive Surgery based on the work of Viktor Bonney and needed new instruments for diagnosis and the operations I was creating. I could get no help at all. I had the highest usage of anti-adhesives in Los Angeles purchased for gynecological operations from J&J. I was labeled a nobody because I was female and not appointed to division. A female surgeon is not the model used to sell devices to other surgeons the head of US Storz told me. He had long hair, wore glasses and a mustache. I was told I needed to work with a male surgeon in order to develop the devices I needed. The GYN who I was referred to work with said it was insane to save the uterus of any woman over 30. Priscilla Coolidge (sister of Rita) and I were attacked by the words this surgeon. He was attacking the saving of female organs. She had just saved her own reproductive organs with FRS. This was the surgeon Karl Storz wanted me to partner and work with.

Karl Storz

Both Karl Storz and J&J knew of the papers I presented at the AAGL. Also I was the first surgeon in California to remove a fibroid with a laparoscope from my studies with Kurt Semm. What resulted from that was saving the fertility of Nazhat Hester so she could have a child and having the Medical Establishment attack me and condemn me as a fraud. No one removed fibroids with a laparoscope so I had to be burned at the stake. I was female, promoting and saving women's reproductive organs and I could not do (or be allowed to do) such operations. Even with the pathology report proving I removed the fibroid and the medical records confirm this, I was attacked. I was never paid for the operation because it was falsely determined by others it could never be done.

I was told by the heads of development of devices that their companies where only focused on the development of the morcellator. They told me nothing else was needed for laparoscopy. That my work was useless because no laparotomy operations would be needed in the future. That the morcellator would remove everything from the pelvis.

I needed instruments for tissue to diagnosis without spread of disease for sarcoma, fibroids, endometriosis and adenomyosis. I had to modify instruments that existed in areas outside gynecology. I was able to diagnosis disease before a major operation.

I saw the insanity of the selling of morcellation.

I referred an over 50 year old female with an ovarian cyst to a gynecological oncologist. He told her she was at risk for ovarian cancer because of her age. He told her the sales pitch of the device company:

1/No scar on your belly
2/ No complications
3/ in and out operation — you go home the same day. 
4/Little post-operative pain
5/Rapid healing and back to normal function in a matter of days

He told her morcellation was a revolutionary advancement and she would be one of the first to be operated on with the MIRACLE MORCELLATOR. This was during the studies time and the device was not released for sales as yet. I had given the woman a reading assignment on ovarian masses. After her morcellation operation she became very ill and came back to see me. The gynecology oncologist told her all of her problems after the operation were in her head.

She cried and told me she never read the material because the oncologist was well respected and it was Cedars Sinai Medical Center which the public considers one of the best hospitals in the country. She was never told any negatives of the operation at all. She had my 30 page consent but never read it. The oncologist told her I was overly protective of my patients. He told her the entire operation would last about 10 minutes, it was simple, and all the stuff I was concerned about would never be an issue. He said I was an extremist and not to worry he had operated on thousands of women.

I heard how the operation was sold to her. She was told that the ovary had to be removed. And she could get cancer in the other ovary so it needed to be removed as well to save her life. He never gave her the operative or pathology report. Now she was in pain all of the time and had all of the complications of castration. She never needed her ovaries removed this was simply an opportunity for the surgeon to get to use the new toy the morcellator. I suspect many surgeons were overly excited to use this new surgical toy. As a result of this they over sold morcellation to learn how to use it.

Ann had endometriosis on one ovary. The cyst could have been removed. However removing with the morcellator spread the endometriosis, created severe adhesions in the pelvic area so her organs were all twisted and bound down. So she needed an operation to repair these findings. She needed hormones for her life time that she would not get because of the current ignorance in the field of medicine. Sale is the first and only concept that reigns in women’s health care.

Doctors sell operations and the device manufactures sell the devices and the stock.

Anyone with a basic knowledge of gynecology KNOWS there is NO “UNEXPECTED TUMOR” and NO “UNEXPECTED CANCER”.

Today in an attempt to cover up the malice, intentional fraud, and mayhem by these surgeons and corporations who have acted with full knowledge of the frauds, abuses and murderous acts they have perpetrated on women of the world they have fabricated the concept of “Unexpected Tumor” and “Unexpected Cancer” as a marketing and false medical finding/diagnostic term to try and take away the full knowledge that all have had.

No one has absolution for their actions in these crimes. They have all studied oncology and all know that any mass maybe cancer. Again, any mass represents a potential cancer. No mass is ever considered clear of cancer until the pathologist has fully reviewed the tissue which takes about 3 days currently. What I am saying here is the STANDARD OF CARE around the globe. There was no mistake and all involved know the rules of oncology. They all broke these rules for profit and have placed the lives of women in danger. EVERY MASS IN THE HUMAN BODY is a potential cancer or a disease that can be spread. This is all basic and everyone involved in creating and using the morcellator is guilty of gross malpractice and gross negligence. I suspect many can be found guilty of manslaughter and murder. Yet, all of these years the cover up for these crimes has continued. Things have not been corrected. Thus, I am taking this action to have government to enforce because the device is very flawed, dangerous, and kills women. Investors have been lied to and a full and complete investigation needs to take place and action against these corporations for cheating investors and cheating women of their right to truthful and full informed consent. Why has no one filed complaints on this extreme abuses since 1993? 18 years of medical abuses without proper oversight needs to be part of the investigation I am asking for.

I am also asking the government for a National department on Ethics and Oversight. We need the Dept. of Education to insure we have Ethics taught in USA schools at all levels.

At this time those who relied on the stories and lies of the corporations need to bring legal action against these companies. Those who supported these stocks I ask to realize they unknowingly contributed to the mayhem and death that the corporations and surgeons created. Think of all the husbands who lost their wives and the children who lost their mothers because of the blindness of greed and the intentional lack of truth. During my career I created new operations to prevent hysterectomy. I was the first surgeon in California to remove a fibroid with a laparoscope. As an international center I saw I more fibroid sarcomas than were seen in the life time of a normal gynecological surgeon. The chopping up of a sarcoma will kill the patient. Chopping of a fibroid will seed more fibroids. And on and on for infections, endometriosis and adenomyosis spreading.

Any reasonable surgeon of gynecology should know this BASIC information and know that the morcellation device is flawed and would spread disease and kill women.

However, Storz and J&J pushed only for sales of the device and the scheduling of operations using the device. They have used fear and ignorance of women to prey upon them. There was NO concern whatsoever as to the outcome for the women patients by Storz, J&J, and surgeons using the device. Their main focus was and still is profit and income for themselves and stock holders. The fact that I have to write this document and bring this to enforcement reflects the failure of our current systems that are in place.

Enforcement with the FDA, SEC, and FTC should have prevented these events from taking place and continuing. It is clear we need the creation of ethics oversight in government and reestablishment of ethical conduct in humans. We reap what we sow. If we do not teach and enforce ethics we will not have ethics in our society.

Be of valor and bring this issue to justice.

Dr. V.G. Hufnagel

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Please assist the work of the Hufnagel Bioethics Institute. We are providing work to support the health and welfare of all females on earth no matter their age, race, or status in society. We are supported by donations. We provide receipts for tax submittal and thank you on our web site. If you would like to work on our projects contact us at doctorvikki@gmail.com. We have many projects and your personal help and corporation help is necessary for success. Please partner with us. The Hufnagel Bioethics Institute provides educational programs for all medical and medical legal institutions. We teach FRS to surgical centers and work with corporations on ethical review and development of protocols and risk assessment programs. Dr. Hufnagel lectures to universities and private groups.