Mirena Lawsuit News

Mirena Lawsuit News Updates

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BAYER PHARMACEUTICALS WARNING LETTER

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration Silver Spring, MD 20993

“FDA Warning Letter To Bayer”

Fadwa Almanakly, Pharm.D.

Associate Director, Advertising and Promotions

Bayer HealthCare Pharmaceuticals Inc.

6 West Belt Wayne, NJ 07470-6806

RE: NDA 21-225 Mirena® (levonorgestrel-releasing intrauterine system) MACMIS # 18166

Dear Dr. Almanakly:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a script for a live consumer-directed program (program) entitled “Mirena Simple Style Statements Program” (150-74-0002-09) for Mirena® (levonorgestrel-releasing intrauterine system) (Mirena), submitted by Bayer HealthCare Pharmaceuticals Inc. (Bayer) under cover of Form FDA-2253.

The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i).

Background According to the DESCRIPTION section of its FDA-approved product labeling (PI),1 “Mirena® (levonorgestrel-releasing intrauterine system) consists of a T-shaped polyethylene frame (Tbody) with a steroid reservoir (hormone elastomer core) around the vertical stem.” The steroid reservoir contains the progestogen levonorgestrel, which is secreted slowly into the uterus over time upon the insertion of Mirena by a trained healthcare provider. According to the INDICATIONS AND USAGE section of its PI, Mirena is approved for the following indication: Mirena is indicated for intrauterine contraception for up to 5 years.

Thereafter, if continued contraception is desired, the system should be replaced. Mirena is recommended for women who have had at least one child. The PI for Mirena also includes numerous contraindications, including “[u]ntreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled,” and “[c]onditions associated with increased susceptibility to pelvic infections.”

1 The most current version of the FDA-approved PI as of the dissemination date indicated on Form FDA-2253 was the July 21, 2008, version, and that is the version referred to in this letter. We note that the PI for Mirena was updated on October 1, 2009. Fadwa Almanakly, Pharm.D.

Page 2

Bayer HealthCare Pharmaceuticals Inc. NDA 21-225 / MACMIS 18166 The use of Mirena is associated with a number of risks, including warnings regarding the increased risk of pelvic inflammatory disease (PID), ovarian cysts, and irregular bleeding and amenorrhea.

Additional warnings include the risk of Mirena embedding in, perforating, or being expelled from the uterus, as well as the increased risk of ectopic pregnancy, and the risks to an intrauterine pregnancy that occurs with Mirena in place. Should a woman become pregnant while using Mirena, serious risks include pregnancy loss and a permanent loss of fertility. In addition to the warnings noted above, the PI details the common adverse reactions that were observed during the clinical trials for Mirena.

According to the PI, “Very common adverse reactions” (>10% of clinical trial patients) included “uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea), and ovarian cysts.” Adverse reactions that were reported by 5% or more of clinical trial patients include, among others, abdominal/pelvic pain, nausea, headache, nervousness, back pain, weight increase, breast pain/tenderness, acne, decreased libido, and depressed mood. The PI also includes precautions that patients should be counseled that Mirena does not protect against HIV infection (AIDS) or other sexually transmitted diseases, and that patients should be instructed to check that the threads attached to Mirena are still in place after each menstrual period, as there is no contraceptive protection if Mirena is displaced or expelled.

Additionally, in regards to patient follow-up following the insertion of Mirena, the DOSAGE AND ADMINISTRATION, Patient Follow-up section of the PI states (in pertinent part): • Patients should be reexamined and evaluated 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. Overstatement of Efficacy/Unsubstantiated Claims Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience.

The Mirena program is a live presentation designed for a consumer audience of “busy moms.” The program is presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central (a social networking internet site) and a nurse practitioner (Ms. Barb Dehn).2 The script of this program submitted to FDA includes an introduction from the Mom Central representative, a presentation given by Ms. Dehn regarding the use of Mirena, and a “post-party” questionnaire for the audience. The script includes the following statements to be delivered by the Mom Central representative (emphasis added):

• “This party was brought to you by Mom Central in partnership with Bayer HealthCare Pharmaceuticals’ Mirena which may help couples keep life simple!” 2 The Mirena program submitted to FDA also references a presentation given by a fashion stylist (Ms. Angela Hastings) that immediately follows Ms. Dehn’s presentation regarding the use of Mirena. The script of Ms. Hastings’ presentation regarding fashion tips was not submitted to FDA.

Fadwa Almanakly, Pharm.D.

Page 3

Bayer HealthCare Pharmaceuticals Inc. NDA 21-225 / MACMIS 18166 • “Barb Dehn is a practicing Women’s Health Nurse Practitioner, award-winning author and nationally recognized health expert from San Francisco. Barb is going to kick things off with a discussion about romamance and how to find simple ways to reconnect with our partners.” The script also includes the following statements to be delivered by Ms. Dehn (emphasis added): •

“. . . And, let’s face it, when we feel good about the way we’re put together, we feel better about approaching the romance in our lives.” • “What we’re here to talk about today – is how to find those simple ways to reconnect with ourselves and our partners.” Following the introduction of the program, the script states that “Barb [Dehn] will begin presentation with an icebreaker – an interactive Q&A – which will touch upon issues such as busy schedules, barriers to intimacy and contraception” (emphasis added). The “icebreaker” questions include the following (in pertinent part; emphasis added): • “How many of you feel so busy that you often can’t find time to take care of yourself? And do you think this impacts your level of intimacy?”

• “Do you ever feel so overwhelmed by your schedule that intimacy is much more of a “to do” on a list than a desire?” • “If you didn’t have to worry about contraception, do you think you would be more likely to be intimate with your partner?”

• “Do you think if you didn’t have to worry about taking your birth control everyday, it would help you be more intimate?” Immediately following the “icebreaker” questions, the script for Ms. Dehn states (emphasis added):

• “So you mentioned that convenience and reliability are among the most important benefits of your birth control method. One strategy that I recommend for busy couples is choosing a birth control method that allows for spontaneous intimacy and which you don’t have to think about every day, such as the intrauterine contraceptive Mirena®.”

The above statements clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena. Mirena has been proven to be an effective intrauterine contraceptive device. While we note that Mirena does not involve a daily routine and is not a barrier method of contraception, FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners. Claims that state or suggest such quality of life outcomes, such as those described above, must be Fadwa Almanakly, Pharm.D.

Page 4

Bayer HealthCare Pharmaceuticals Inc. NDA 21-225 / MACMIS 18166 supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated patient assessment instruments to measure the outcomes of interest. If you do, in fact, have data to support these claims, you should submit them to FDA for review. We note that, according to the Mirena PI, at least 5% of clinical trial patients reported decreased libido as a side effect of Mirena use. Patients also experienced abdominal/pelvic pain, nausea, headache, nervousness, and depressed mood, which could adversely affect a woman’s feelings relating to romance or intimacy. The script also includes the following statements, to be presented by Ms. Dehn (emphasis added):

• “But what this party is really about is looking at the whole picture and figuring out steps to take to simplify your lifestyle while still looking and feeling great. One of those ways is finding a birth control that is compatible with your busy lifestyle.” The above statement goes beyond the suggestion of increased intimacy to suggest that Mirena can help patients “look and feel great.

” Again, FDA is not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great. Patients using Mirena may experience various side effects, such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness, and acne, in addition to the side effects indicated above. The experience of these side effects can prevent patients from “looking and feeling great.” Such claims of improved patient-reported outcomes must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated instruments to measure these outcomes of interest.

If you do, in fact, have data to support these claims, you should submit them to FDA for review. Omission and Minimization of Risk Information Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The script includes the following risk presentation, to be presented by Ms. Dehn (emphasis in original):

• Only you and your healthcare professional can decide if Mirena is right for you. Mirena does not protect against HIV or STDs. Candidates for Mirena have had a child, and do not have certain cancers or acute pelvic inflammatory disease. In rare cases, perforation or embedment may occur. Mirena may become completely or partially dislodged. In the uncommon event you think you’re pregnant, contact your healthcare professional without delay.

Ovarian cysts may occur and typically disappear. Changes in bleeding are common in the first few months followed by shorter, lighter periods. Periods, however, may remain irregular. The risk presentation omits the contraindications regarding untreated lower genital tract infections and conditions associated with increased susceptibility to pelvic infections, and does not adequately convey that should a woman become pregnant while using Mirena, she may lose her baby or her fertility. Fadwa Almanakly, Pharm.D.

Page 5

Bayer HealthCare Pharmaceuticals Inc. NDA 21-225 / MACMIS 18166

We refer you to the December 17, 2008, advisory letter from DDMAC to Bayer, regarding the promotion of Mirena. This advisory letter includes a change of opinion regarding the risk presentation for Mirena. The letter states (in pertinent part, emphasis added): Because this constitutes a change in our position, you will be provided a reasonable period of time to revise any Mirena promotional materials currently in use that omit this important risk information.

Accordingly, the revisions should be completed within 90 days of receipt of this letter or at the next production of new promotional materials, whichever comes first. The promotional program at issue here was newly developed, and as stated on the Form FDA-2253 accompanying the materials, it was disseminated on February 28, 2009, after the change of opinion letter was issued.

We also refer you to your January 5, 2009, response to the change of opinion letter, stating that you intend to comply with our request. Additionally, the script minimizes the risks associated with Mirena. Specifically, the “looking and feeling great” statement referenced above, in the context of the program as a whole, minimizes the risks associated with the use of Mirena.

As stated in the Background section above, the PI for Mirena includes “very common” (experienced by >10% of clinical trial patients) adverse reactions, in addition to other serious warnings, precautions, and safety issues associated with the use of Mirena. The suggestion that Mirena will help patients “feel great” minimizes the side effects that patients may experience as a result of using the drug. False/Misleading Statements The script includes the following statements to be presented by Ms. Dehn (emphasis added):

• “. . . Mirena has no daily, weekly, or monthly routines to comply with as compared to the negatives associated with other birth control methods.” The above claim that Mirena has “no . . . monthly routines” directly contradicts information contained in Mirena’s PI.

According to PRECAUTIONS, Continuation and Removal section (repeated in the DOSAGE AND ADMINISTRATION, Patient Follow-up section) of the PI for Mirena, “[Patients should be] reexamine[d] and evaluate[d] . . . 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.”

The PRECAUTIONS, Patient Counseling Information section of the PI also states that patients should check that the threads attached to Mirena are in place after each menstrual cycle (thus on a monthly basis), to ensure that Mirena has not become displaced or expelled, which would result in a loss of contraceptive efficacy. Therefore, the claim that there is no “monthly routine to comply with” is a false statement.

We note that the script includes instructions to check the Mirena threads monthly in a separate part of the presentation; however, this does not correct the false statement highlighted above. Fadwa Almanakly, Pharm.D.

Page 6 Bayer HealthCare Pharmaceuticals Inc. NDA 21-225 / MACMIS 18166 Conclusion and Requested Action For the reasons discussed above, the program is misleading in violation of the Act, 21 U.S.C. 352(n), and FDA implementing regulations.

See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i). DDMAC requests that Bayer immediately cease the dissemination of violative promotional materials for Mirena such as those described above.

Please submit a written response to this letter on or before January 14, 2010, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Mirena that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.

Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266; facsimile at 301-847-8444. In all future correspondence regarding this matter, please refer to MACMIS # 18166 in addition to the NDA number for Mirena. We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Mirena comply with each applicable requirement of the Act and FDA implementing regulations. Sincerely, {See appended electronic signature page} Carrie Newcomer for Cynthia Collins, Ph.D. Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications

Sincerely,

Carrie Newcomer for Cynthia Collins,

Ph.D. Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications

“CandyK’s Communication Outreach”

Dec 9, 2018

DRUGINFO@fda.hhs.gov

Thank you for contacting the Division of Drug Information (DDI). This message is an automatic acknowledgment of your inquiry.

Dec 9, 2018

Automatische Antwort: Mirena Claim

Thank you very much for your email. I’m not in the office until Monday, December 10th. During this time, I have no access to my emails. In case of emergency, you will reach my colleague Ms. Heber,mailto:kerstin.heber@bayer.com

Date: Thu, Mar 6, 2014

Subject: Incident #01980MMJ-42104CCO

To: <complaint@jointcommission.org HYPERLINK “”>

Oct. 21st, 2014

Your Comment Submitted on Regulations.gov (ID: CMS-2014-0115-0002)

Jan. 23, 2015

@aclufl.org

Legal Director – American Civil Liberties Union of Florida

Hello Candace-

I got your voicemail yesterday, but had a filing due in court. I just sent you an email copying Jeff Weinberger so I hope the two of you will follow up. I’m supposed to be in Palm Beach on Wed., Feb. 4, for a meeting at noon. However, if you have time that morning, I could probably get there by 10 a.m. and meet you someplace convenient. Please let me know if that works for you

Jan, 28th, 2015

Hello Candace-

Are you available to meet next Wed. at 10 a.m.? My meeting is at 11:30 a.m. and then I have to head back to Miami, but we can talk about this and the homeless rights work you’ve been doing then. If that time works, just let me know where you’d like to meet

Apr 10, 2014

Ellen Malcolm, National Partnership

Dear Candance,I’m the chairwoman for the National Partnership’s board of directors, and tomorrow I plan to mention you at our semi-annual meeting. Yes, you.

Apr 15, 2014

Balboa Press – jstogsdill@balboapress.com

I want to help you tell your story

To get started publishing right away or to discuss your options. I look forward to speaking with you again soon.

Mar 6, 2014

PATIENTSAFETY-L@LISTSERV.NPSF.ORG

LISTSERV@listserv.npsf.org

May 7, 2015

Cecile Richards, Planned Parenthood – NO Response

pponline@ppfa.org

Jul 23, 2014 – Planned Parenthood – No Response

Lisa.Murano@ppsoflo.org

Tue, Jul 31, 2018

CDER DRUG INFO <DRUGINFO@fda.hhs.gov>

druginfo@fda.hhs.gov

Incident #01980MMJ-42104CCO – Reporting to MedWatch

Division of Drug Information – Center for Drug Evaluation and Research

Thank you for writing to DICE@fda.hhs.gov. Your inquiry was forwarded to the Division of Drug Information in the FDA’s Center for Drug Evaluation and Research for a response.

Stay Tuned: Episode 7 – More Adverse Complications Continued

CABIRI Business Services

American Medical Rehabilitation Fund – For Unexpected Medical Trauma’s (AMRF)

American Medical Rehabilitation Fund

 For Unanticipated Medical Trauma’s

 

 American citizens are suddenly becoming ill and losing there entire life’s history due to major unforeseen medical trauma’s caused by faulty drugs, medical device and/or tainted products.

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CABIRI, is seeking investors to help establish an American Medical Rehabilitation Fund for victims of unexpected life-threatening medical trauma’s that has altered, their households and families lives.

 The fund will be established for individuals who have pending lawsuits and are having difficulties maintaining their households while undergoing rehabilitation and additional surgery’s while awaiting their pending lawsuits to be resolved.

 Many employers will only disburse sick pay for previous time worked, leaving many individuals and their families struggling to cover living expenses such as; food, utilities, mortgage, child care, car payments, medications or any other pertinent family household living expenses that has to be paid while they are in recovery.  

 AMRF, is imperative for many individuals who are suffering from unforeseen major medical side-effects and surgery’s due too life-threatening faulty drugs or medical devices. Many individuals are losing their entire lives while their cases are tied up in Multi-Jurisdiction or Supreme Court proceedings. What would you do if your life was on track and all of sudden you became severely medically ill, from deadly side-effects that had left you incapacitated and unable to maintain your job, household or lifestyle for over 9 months?   

 “Hypothetically speaking,” let’s say you’ve recently been told you have a severe deadly disease,  and/or you need several surgeries’ to correct a current medical trauma, your presently experiencing from a faulty drug or medical device, and you may have to be out of work for a period of 9 months or more recuperating, and under continuous doctor’s care?  

 How would you cover your living expenses for 9 months?

 Would your employer hold your position open while you go back and forth to the Doctor 2 and 3 times a week?

 Would you’re your employer hold your job for you if your hospitalized on 4 separate occasions resulting in 1 to 2 week stays?

 Can your family members cover your living expenses while you’re incapacitated for 9 months?

 Do you have enough sick time saved up to be compensated while you are out of work for a period of 9 month extended sick leave?

 Can your spouse or family members cover your mortgage or rent for 9 months?  

 

Do you have family members you can move in with or take care of you while recuperating from several major surgeries?

 

Do you have anyone who can care for your children and daycare expenses?

 

Do you have income to purchase food for your family?

 

Do you have income to purchase additional medical costs not covered by your insurance?

 

How would you provide transportation for your family if you can’t keep up with your car insurance and car payments over a 9 month period of time?

 Will you borrow money or receive a loan that you do not know when you can pay back do to your health status and rebuilding your life?

 These are very important questions every family should ask themselves the above scenario’s could be you or any of your family members; mother, daughter, father, or your elderly parents on a fixed income. Ask yourselves, what if I was in a predicament as such, what would I do? How would I survive?  Could your immediate family and friends help care for you and your children for a 9 month period of time or more?

 Will your attorney help you from going into debt and stop bill collectors from calling, while your lawsuit is being resolved and you are still in recuperation mode.

 Will you be able too rebuild your entire life again, from an unforeseen severe medical illness that has left you lifeless, homeless and unable to provide for yourself or your family?    

 What if you called around for assistance to be told by many agencies, churches and other establishments there are no funds available at this time, or the limited help provided isn’t enough to cover basic household expenses?

 If you had trouble answering any of the above questions, please join CABIRI, in our new quest and help Invest and contribute to the “American Medical Rehabilitation Fund,” that will be there to help cover expenses for individuals who are faced with severe unforeseen life-threatening major medical problems, that are beyond their control and require extensive lengthy medical rehabilitation and constant doctor care.  

 The American Medical Rehabilitation Fund (AMRF), will help many suffering families who are facing severe medical financial dilemma’s such as these in America, and have no where to turn for temporary financial assistance, while they are in recuperating stages and under doctors care. In addition, AMRF will help fund individuals trying to rebuild their lives once again from being medically incapacitated for a period of 4 months or more. The fund will also reach out and assist Veterans and their families who are in need of additional assistance due to unexpected injuries caused by war, impacting their families and children’s lives. AMRF will continually assist American citizens who have recent unexpected life-threatening major illnesses and their cases are currently in litigation. The other portion of the funding will assist individuals with major medical rehabilitation for a period of 6 months, helping them maintain their medically interrupted households so they can heal accurately without the stress of worrying about their households and how bills will be maintained while they are in rehabilitation and recovery stages.     

 The new AMRF fund, was established for a young lady who recently lost her and her children’s entire life in a recent storage unit sale, she was forced to rent after undergoing 9 months of extensive life-threatening medical traumas from a medical device that was not foreseen for a period of 6yrs. The young lady has lost her home, vehicle, and her children’s personal belongings, family memorabilia, along with displacement of her children, and her two pets.

 The sudden unforeseen life-threatening medical debacle impacted her entire family and has left her in a very distraught trying situation, now having to somehow pull herself out of this medical nightmare after receiving a hysterectomy towards the end of 2013. The medical trauma has turned the young lady and her two children’s, and family’s worlds upside down in a split second from 2012-2013 and currently 2014.    

 How is this young lady able to rebuild her life from scratch from losing her life for 9 months, and awaiting a pending lawsuit that can take several years to resolve? In the meantime, her employer has let her go, her unemployment benefits have run out, and she’s having trouble finding employment due to the length of time she’s been out of work, potential employers question her about why she’s been out of work for such a long period of time, she told them due to medical reasons, this throws up a red flag to the employer who does not want to hire someone who’s recently had severe medical problems, that has left them out of work for  a period of 9 months. What is this young lady to do? She has to start rebuilding her and her children’s lives somehow. She’s borrowed from all her friends and family members while ill and now the well has run dry, and she has no other means to provide for her or her children to start rebuilding their lives.

 This is a very sad trying situation for this particular young lady, especially when she’s used to being the bread winner, providing for her family and helping others. She’s currently facing displacement and frustration do to no help from local tapped out organizations with no funding.

This young lady needs urgent help getting her life back on track from falling suddenly ill from a faulty medical product she had no clue would alter her life in such a drastic way. Prior to her medical trauma the young lady was a very active, healthy, hardworking upper-level business professional.      

 CABIRI, is asking help from all American citizens to contribute to the newly established American Medical Rehabilitation Fund (AMRF), for victims such as the young lady mentioned above and any other American families who may be in need of additional assistance, whom are facing life-threatening medical trauma’s and rehabilitation from horrific unforeseen medical illnesses from faulty drugs or medical devices. The fund can help many families who need urgent assistance preventing families from spiraling out of control, and help individuals get their lives back on track from being continuously deathly ill for a period of 3 months or more.  

 A sudden unforeseen life-threatening medical dilemma is not the fault of the individual, and isn’t fair to them. Why should someone have to endure losing their life history, and become displaced all due to a major medical nightmare, then turn around and endure trying too rebuild a entire new life with no resources? This is not moral, fair or humane in this day and age and American citizens should have a funding source who can assist with helping individuals and their families stay, or get back up on their feet after sudden severe medical dilemma’s that have occurred that were out of their control.

 The doctors, pharmaceutical corporations and lawyers continue on with their  daily lives with their families, while the infected patient and their family’s lives have been destroyed by their faulty drugs, medical devices, and products. Is this fair in America? All of the top three business professionals have profited from the patient and moved on to their next culprits. Is this fair to the patient? Please climb aboard and help these families and contribute to AMRF, American Medical Rehabilitation Fund! AMRF would be no different than Hospice who keeps individuals comfortable for a certain length of time.  

 CABIRI

Consumer Advocacy Business Industry Research and Investigations

If anyone would like to donate to the young lady who remained Anonymous due to her current medical litigation case.

Please go to:  consumer2savlies.com FOR AMRF Donations’

Thank you for helping rebuild lives from unexpected life altering medical issue’s! 

CABIRI Business Services

AMERICA’S INEQUALITY JUSTICE REBOUND

AMERICA’S INEQUALITY JUSTICE REBOUND

The New Year has rang in, everyone has made there resolutions for 2014! Its now time to get down to business in hand and help start re-building America, the fact still remains United States has a serious Economical Warfare quietly being pursued against the United States as every citizen goes along with their daily lives.

Disparity, homelessness, unemployment, vital daily economical resources, American inequality vs. International equality, and high health care cost (which are driven by top pharmaceutical/biotech international corporations who sponsor Interpol),who are impacting many American lives. This is a major problem for all United States citizens and their families whom depend on these type’s of agencies for their health, safety and well-being.

So along with the international run U.S. businesses that are severely impacting American lives, several sources have reported China will eventually, take over the United States.

Answer the below questions:

What does this mean for every American Born Citizen? What does this mean for the next American generation many of your children?

What does this mean for each city in the United States?

Will America’s History change to benefit the liking’s of another international country, instead of the original American forefathers?

How would a new international country treat American Citizens and their children, if they took control of America?

What would American families tell their children, why America is not America anymore and now is a communist country under dictatorship?

The above questions should make every American citizen re-think many things concerning the protection of America and the next American generations, which are your children, nieces, nephews? The next generation is supposed to carry on the American Dream for many more decades to come, how Is this possible if America is being controlled by another country? America’s rules will change, the American Constitution and the Bill of rights may become Obsolete, and every America citizens will have to abide by new implemented rules, of dictatorship type of leadership, now controlling America and its citizens.

It’s very important for every American citizen to join together and start re-building America for the protection off the next American generations. I’m sure many of Americans wouldn’t take too kindly, if they or their children were controlled by another international country telling them what to do. Let’s not forget to mention Americans seem to forget about all the hard work past Forefathers and War Veterans put into building America, did they do this in vein Only for the country to eventually be controlled by another international country, decades later?

Many American’s would not be in the positions their in today if they didn’t have the prior American Forefathers or War Veterans who protected America Soil! Not against the American people, foreign predators!

Many past Presidents such as Franklin D. Roosevelt and Dwight D. Eisenhower, warned America a time would come where United States would become a policed Run country under dictatorship. Decades have now past since their presidency and their exact same frightening words are currently occurring discreetly in America. American’s have to open their eyes to the facts, about what America is currently being faced with and everyone must stand up, team up, and pair up to keep America an American Country!

Every American citizen can do their part in protecting American soil; your children’s future depends on you. Start standing up for America and one day very soon the culprit’s will have to justify why they’ve waged an economical war on the American population, and other global countries affecting many human lives for the past decade. Just as Snowden, it will be a process bringing the culprits to justice since they’ve brilliantly infiltrated American society, judicial, and governmental offices using Money, conspiracy, fraud and espionage.

America, please understand many laws are changing to benefit another country Not America! Currently there is an increased governmental expansion, which relates to U.S. Corporations which many are international run! The current economical warfare debacle resembles putting a huge puzzle together piece by piece, and once it’s done it reveals a picture, in America’s case the puzzle has revealed a Frightening, deadly, disastrous nightmare for United States and its citizens!

Please stand up and make a difference for your country in 2014, show the next generation you care about them staying a true American, helping keep America, a country for The American people for many more decades to come! America please view all news reports, and CABIRI news reports, there are many organizations, and individuals, and Book authors who have caught on to what’s occurring and now trying to alert American Citizens, there is a huge problem in American and it must get fixed! The new Mayor of New York DiBlasio, is on the right track in standing up for his city and country, although be aware the culprits are right next door living silently in New Jersey where many of them originally set up shop decades ago to start their chain of events to take over America!

Let’s Get Going – Protect America!

Kaila’s Truth’s
CABIRI – Consumer Business Industry Research and Investigations
Website: consumer2savlives.com

Related Video’s 

Stand Up America – http://www.youtube.com/watch?v=maSpz9nrA5M – Great Video!

The Dollar Collapse And WW3 HAS BEGUN, MUST –  http://www.youtube.com/watch?v=5IX2DCsuDa4

The End of America 2014-2016: “ITS WORSE THAN YOU KNOW – http://www.youtube.com/watch?v=Rc3QezVTQ20

DISCOVER YOUR 3 DAY WARNING BEFORE THE DECLARATION OF MARTIAL LAW – http://www.youtube.com/watch?v=_9U1DES2_SI

END TIME – OBAMA IS BRINGING MARTIAL LAW TO AMERICA IN 2014! – http://www.youtube.com/watch?v=VKiWFo_cya0

CABIRI Business Services

Consumer Advocacy Business Industry Research & Investigations – CABIRI

Check out Pharma news! This blog is very popular!

Consumer Advocacy Business Industry Research & Investigations (CABIRI)

 PHARMACEUTICAL VS. AGRICULTURE

Industry: Pharmaceutical & Agriculture News
Business: Bayer AG – Monsanto

Business information this week will be advertised freely, all information after December 20th, 2013 will be based upon consumer request. The format will be a power point news presentation for easy viewing and convenience to review important business investigations & research news pertaining to the specific corporation or industry request. Information is for consumer corporation business knowledge operating in the United States and Abroad!

                                   

Current Highlight – Germany Agricultural and Pharmaceutical Business Industry Connection

 Many government agencies has somehow missed the boat, by not overseeing mergers and business purchases made by corporations and private businesses. With no governmental monitoring there are several international business industry owners who seem to be “Keeping it in the family!”

  Many consumers may not know that U.S. German Bayer AG (Holding Company) entered a series of cross-licensing…

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CABIRI Business Services

HlN1 PANDEMIC CONSPIRACY

This article is for those who are down on your luck with the Flu virus or if you no someone who has it, please pass this along! Very Beneficial

Consumer Advocacy Business Industry Research & Investigations (CABIRI)

                                                                  HlN1 – FLU PANDEMIC CULPRITS 

CABIRI, Consumer Advocacy Business Industry Research and Investigations decided to release some very important unknown business information and facts for all American citizens pertaining to the current H1N1 Pandemic that has spread all across the United States and affected thousands of families. Please do not get a Flu Shot America, it’s very deadly and toxic! Do what you can to fight the illness, try home remedies anything you can to fight it off naturally!  

  The upsetting factor about the H1N1 aka Swine Flu, is the severity of illnesses it has caused too the American population. Many American citizens may not know were the pandemic derived from or it’s original owners. H1N1…

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America’s country Re-adjustment in 2014

Happy New Year to all from CABIRI! May the upcoming year see many changes around the world!

Consumer Advocacy Business Industry Research & Investigations (CABIRI)

America’s Country Re – Adjustment in 2014

2013 has been a very trying year for many American and global families. There has been one crisis after the other impacting human lives. Nothing has changed for the betterment of the world in general, our country is still being presented with corruption, economic war, conspiracies, political agenda’s, fraudulent activities, homelessness, a increase in poverty, unemployment ratings considerably high, America’s still debt , national security breaches and many more disparities to list that are not good for America.

 Homeland Appreciation

2014, is the year change has to take place for all generations moving forward into the New Year. All Americans and global citizens must sit back and think about country value re-adjustments! The world is diverse for many reasons each city, state, and country has its own unique differences, including the citizens, who’ve lived in their communities for most of their…

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Women Being Denied restraining orders

Palm Beach county 15th Judicial Court, is denying women restraining orders for domestic violence, dating and stalking!

Women depend on these courts for protection against violent spouses, boyfriends and individuals, for them and their children’s

lives. How are these poor women supposed to get protection against these predators, does something drastic have to happen

in order for women to get a restraining order or do they have to die first, before getting help?

This should be addressed immediately for the protection of women’s lives. Being denied protection is no joke to women, where

are they to go for protection if they can’t depend on their local law enforcement and judicial courts to protect them and and their

children lives. Women are suffering in every aspect in today’s world this is just one of many things they have to endure and it has too

stop!

Many Men fail to realize, they were brought into this world by a woman, if she didn’t not give him the right to life, many men would

not be in this world now! Start respecting and caring for women lives that gave you life!

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Client Service Negligence against American Citizens

Stop Client Negligence and Bad Customer Service, citizens are not a paycheck or addition to your bottom line profits!

 Client Services have faltered throughout the past several years, local service providers, businesses and local government agencies, Lack of client and customer respect has to end!

 A business civil duty is to provide services, they’ve promised to society. Every business has a mission statements which outlines what type of services they’ll be providing to the American public, which is their sole duty to uphold, honor and follow through with their promises reflecting their business model mission statement, explaining the services they will be providing.

 Many service providers local, non local or governmental agencies are failing to provide what their mission statement claims, which is a major issue in today’s society. Their professional services listed should be adhered too the utmost quality as they’ve portrayed in their business plans, mission statements or have communicated to their clients.

 Service providers, agencies and private business owners are running scams against society, by boosting up their advertising and marketing practices to lure the American public to their faulty non respectable services or establishments. Unprofessional bad business practices fall back on the American public, who depend on these services providers in some form or fashion for their health, safety and well being. Why as American citizens do we continually support negligent businesses practices?  

 In many instances, the public has been coerced by false marketing practices, referrals via another business, friends, or family members who may have their own private hidden agendas to profit from by sending citizens to a specific service provider or agency.

 Citizens are finding out they will not be receiving the quality of service or product initially promised, communicated or anticipated! Which has now cost them and their families, Time, Effort and Money? This should be considered a crime against humanity, these service providers are playing with peoples lives by not providing the services they have promised. All of these factors have a huge impact on American households and local communities. Client Service providers and government agencies must be held accountable for falsifying, neglecting and affecting human lives on the service level.

 With all the turmoil in the country American citizens can start doing their part by communicating to the public who these service providers and agencies are, who are not holding true on their business service model outlined in their mission statements, or who are not providing professional quality services to the public they’ve promised to uphold.

 CABIRI, Consumer Advocacy Business Industry Research and Investigations, is starting a new campaign for the American public to start reporting service providers, businesses, and agencies to the public, holding these services providers accountable for their false advertising, fraudulent business practices, Bad Customer Service, False statements, delayed response times, Faulty contract services and Consumer fraud against humanity!   

 Please realize no matter what type of service they are providing it’s their sole duty to provide citizens with professional courteous customer service, products and services. America citizens who do not report negligent service providers, bad business practices or negligent business owners and government entities, are the same citizens impacting and bringing down the American society by not allowing substantial professional service providers to excel in society who really want to help there fellow citizens of America!

 America must remember not all business is good business!

Join in and support CABIRI, with the efforts in stopping Client and Customer Negligence Against humanity, it is the right thing to do for your fellow American!  

 CABIRI – Consumer Advocacy Business Industry Research and Investigations

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