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CABIRI Research: Big Pharma Research & Investigations IG Farben – Berlex – Schering Plough

Schering – Plough – Berlex – Bayer AG
Mirena IUD – Bayer AG & Subsidiaries
Corporate History – Lawsuits – Plaintiff Emails

Date: 02/23/2014

To: Bayer AG – Executive Members & Subsidiaries
RE: Mirena – Bayer AG, Bayer Healthcare, Schering AG, Berlex Corporation, I.G. Farben
Schering Plough – Founded in 1851, by Ernest Christian Friedrich Schering
Company Formed: Schering AG – Germany


History: Following the entry of the United States into World War II in 1941. U.S. President
Franklin D. Roosevelt ordered Schering AG’s, U.S. Assets to be seized. The company was placed under Government administratorship until, 1952, by which all prior assets were sold to corporates his business and generated $254.5 million in sales by 1954. That figure doubled by 1962.


In 1971 Plough merged Plough Chemical Company Incorporated with Schering Corporation. The Schering corporation was a manufacturer of prescription pharmaceuticals, the merger name of the two corporations was named, Schering-Plough. Schering was able to gain entry back into the United State’s by merging with Plough in the pharmaceutical industry.


Release date from U.S. – 1941 to Re-entry date back into U.S. – 1971
Mr. Abe Plough, exhausted his full business ownership in his company and became chairman of the new merging corporation. Five years after the merger in 1976, Plough retired from his company he’d started in 1908.
Schering – Plough remained in America, growing there corporation no back in the United States. By 2005 Schering-Plough had 1.4% market share in the United States., becoming 17th in the top 20 pharmaceutical corporations by sales compiled y IMS Health of America.

Schering-Plough was a full member of the “European Federation of Pharmaceutical Industry and Associations” (EFPIA).
In November 2009, Schering-Plough merged with Merck & Company, or Merck KGAA in a reverse merger. Merck became a subsidiary of Schering-Plough. The two companies manufactured several pharmaceutical drugs, Claritin, and Clarinex, an anti-cholesterol drug Vytorin and a brain tumor drug Temodar.

Clarinex, Claritin, Vytorin, Temodar, Pipeline pharmaceutical Products

Lawsuits

Class-Action Lawsuit Filed Against Claritin’s Maker – 2003

Consumer groups have filed a class-action lawsuit against pharmaceutical giant Schering-Plough – http://product-liability.laws.com/claritin-lawsuit – The [agency] has reviewed these ads and concluded that they are misleading and violate the Federal Food, Drug and Cosmetic Act and applicable regulations and should be discontinued immediately,” says the letter from Joan Hankin, JD, a consumer promotion analyst at the FDA.

The complaint, brought to a New Jersey state court, accuses the drug company of “deceptive advertising and overpricing” for Claritin, America’s most widely prescribed allergy drug.


Schering-Plough Settles Clarinex Class Action for $165 Million –

http://www.bigclassaction.com/settlement/schering-plough-settles-clarinex-
class-action.php– 2010 Specifically, the suit alleged that between May 2000 and February 2001 Schering-Plough made false statements that did not adequately disclose “serious and widespread deficiencies” in its quality and manufacturing operations. This, in turn, risked delay of FDA approval of Clarinex, a successor drug to Claritin.

Vytorin Class Action Lawsuits Mount as Justice Department Investigates – See more at: http://www.aboutlawsuits.com/vytorin-class-action-lawsuits-mount-1636/#sthash.nl7O9PnQ.dpuf – 2008 Vytorin lawsuits have been filed against Merck and Schering-Plough involving consumer fraud actions for selling a medication which provides no benefits, cases alleging personal injuries caused by the drug and claims to establish medical monitoring for users who were given

the drug.
Temodar Bone Marrow Injury & Birth Defects –
http://www.rotlaw.com/temodar/
Two Temodar lawsuits were filed against the drug’s parent companies, regarding illicit marketing and sales practices. In 2006, Schering-Plough, the former Temodar manufacturer, faced a Department of Justice investigation which uncovered mis-marketing and illegal sales practices.

The Temodar lawsuit found that the company marketed Temodar for unapproved forms of brain cancer, bribed doctors and promoted the sale of its Temodar products. For these charges, the company was ultimately forced to pay $435 million fines. – See more at: http://product-liability.laws.com/temodar


Following the resolution of this Temodar lawsuit, the drug was purchased by Merck. In 2011, the Department of Justice issued a subpoena seeking materials concerning marketing of Temodar dosage products.

This Temodar lawsuit was issued as part of an investigation which could lead to a Temodar concerning marketing abuses committed by Schering-Plough. In the past, similar Temodar lawsuits have included a fund for victims of adverse effects as a condition of settlement. http://product-liability.laws.com/temodar-lawsuit


Summary: Schering-Plough 1971 – Merck & Company or Merck KGAA merger – 2009
Merck & Company – Schering Plough Schering Products: sugammadex, Cerazette, Desloratadines, Neoclarit, Esmeron, Famvir, Famcilovir, Intron A & PEG-Intron, Levitra, Livial, Marvelon, NuvaRing, Quazepam, Remeron, Buprenorphine, Zetia; OTC: Afrin, Coricidin, Coppertone, Dr. Scholl’s, Zinka, Bain de Soleil, PD-1 antibody.

Schering-Plough – Merck & Company
Organon Research Analysis

2004 – Schering – Plough was accused of marketing gimmicks and payoffs to doctors for prescribing the company’s pharmaceutical products. At that time Schering entered into a consent decree with the FDA in 3/2002, from their manufacturing problems with Albuterol inhaler. Schering-Plough was ordered to pay $500 Million US dollars to the US Treasury.
Bridon (sugammadex’s) – Rejected 3x by U.S. FDA – 2008 due to hypersensitivity reaction concerns to the drug. Clinical trial
inconsistencies


Approved by the European Union – 2008
Sugammadex’s – PD-1 antibody, repoductive medicine, contraception, psychiatry, HRT, anesthesia, Diosynth, birth control pills,
Marvelon, asenapine: some products acquired by purchase of Organon of Scotland

Organon Company Analysis:
Orgination: Akzo Nobel: 1646 – Sweden-Denmark-1777-
Organon: Human health business unit of Akzo Nobel – 80yrs.(Pharmaceutical industry)
Founded: Dr. Saal van Zwanenberg in Oss, Netherlands – 1923
Zwanenberg-Organon – New House Research – Scotland, United Kingdom, Courtaulds
Products – estrogens, insulin, cortisone, fibre
Koninklijke Zawnenberg Organon (KZO) – Fiber company AKZO
Base: New Jersery – Arnhem, Amsterdam
Manufacturing: Netherlands, Germany, United Kingdom, Ireland, China, Japan, Americas. High-Tech coatings, artificial fibers, paint,
chemicals, vetinary,
2007 Schering-Plough New Jersey, acquired Organon, 2009 Schering-Plough mergered with Merck and Company aka Merck Sharp &
Dohme or MSD
Schering-Plough, N.J. The American Drug Maker agrees to purchase Akzko Nobel’s Organon Biosciences Unit – valued @ 14.4Billion –
13.7x’s EBIT
The merger astounded many investors, who were waiting for the announcement of a planned IPO offering of Organon, the maker of birth control pills, for about $10 billion.
Azko Nobel world’s largest paint maker and coatings, chemicals – Amsterdam
Akzo – Last European company with chemical and pharmaceutical
1895 – Akzo Nobel’s: Eka Chemicals Pulp and paper chemicals
1923 – Produced Insulin from pancreases of animals
1968- Courtaulds acquires international paints
1969 – Merger AKU – KZO = AKZO
1994 – Akzo Nobel industries merge Akzo Nobel
1998 Akzo acquires – Courtaulads
2007 – Akzo Nobel sells Organon Biosciences NV – New Jersey Schering – Plough

Research Analysis
Organon – Akzo Nobel Analysis

CFO: Organon Biosciences N.V. – Arhem, Netherlands – Dr. Jorg Spiekerkotter – 2006
Prior: Schering AG executive board member responsible for Leader of Finance Administration and Human Resources – Also prior, Head of Legal Hoescht Schering Agrevo. Organon hire’s Dr. Spiekerkotter as CFO, U.S. Schering-Plough New Jersey purchases
Organon a year later – 2007
Dr. Spiekerkotter CFO and board member of management leaves Organon Biosciences N.V., 2007. After the Schering-Plough purchase of Organon, Akzo Nobel, reduced pension liabilities, debt and paid for a share buy back of 1.3Million
Organon Pharmaceutical Inconsistencies:


Akzo Nobel Feels the pinned as Organon contraceptive sales drop in 2002
The Organon units of Akzo Nobel NV faired poorer than competitor Schering AG reporting a two perecent a year – on – year decline in the use of the contraceptive pill in the Netherlands in the first half of 2002. Sales of third-generation pills recorded the worst fall, declining 13% over a review period. Sales of Organon’s third-generation pills Marvelon & Mercilon fell 19% and 21%, while Schering’s Femodeen fell 18%.

(AFX Report)
Media – 2001 Alerts:
Users of third-generation pills had 70% greater chance of developing thrombosis than users of second-generation pills.
Dutch Foundation Pharmaceutical Statistics: Market leader Microgynon, Schering’s second generation pills, appears to have benefited from a drop in sales of third-generation pills – research published by the Dutch Foundation (SFK) indicates 13%
increase in the first half of sales. In addition, third-generation pills are were losing ground to Schering’s “Yasmin,” a pill launched in the Netherlands 4/2001. Organon was battling negative news regarding Implanon – a contraceptive inserted under the skin.
Women filed lawsuits, some claims stating they had fell pregnant while using the product, headaches, vein inflammation, bleeding and more lawsuit claims.
http://www.nytimes.com/1999/08/27/us/maker-of-norplant-offers-a-settlement-in-suit-over-effects.html Maker of Norplant Offers a Settlement In Suit Over Effects
(Plaintiff: Also participated in Norplant lawsuit and settlement)
Norplant II developed by Population Council Schering (OY) & Norplant 1 by Wyeth
Schering AG, Akzo Nobel’s Unit to end collaboration on Male Contraceptives – 2006
Schering AG and Akzo Nobel’s Organon unit will terminate a research collaboration into male fertility control at the end of Phase II clinical trial, which was designed to test a combination of two hormones known to suppress sperm production.

Bayer – Berlex
Research Analysis

Schering AG – Dates back to Chemische Fabrik auf Actien – Chemicals operations
1930’s – Company diversified for Schering AG
1876 – Schering Glatz – Medicine distribution company launched – 1929 dissolved
1929 – Established Schering Corporation hormone research and synthesize steroid drugs based in New York
Formed Berlex Corporation in 1979 after acquiring assets of the Internal Medicine division of Cooper Laboratories, New Jersey

Area’s – Cardiovascular disease, birth control, diagnostic imaging, endocrinology
1980’s: Iodinated contrast agents used in imaging launched in U.S.
1982: Oral contraceptives, Leveln and Tri-Leveln, Magnevist launched
Schering- Plough sued Schering AG, claiming Berlex infringed upon it’s trademark
Results: Schering AG agreed to use the Schering name in the U.S., and Canada in connection with its pharmaceutical products, relying on the Berlex trademark.
Triton and Codon U.S. Corporation consolidation and purchase to form Berlex Biosciences of California – prior Ortho Research Center – built by Ortho Division of Chevron Chemical Company – Purchased @ $53million
Schering acquired Shell Oil biotech portion 1990 – Fludura, Betaseron
Schering acquires in 1993 – Chevron Chemical Company
Co-Partnership: Abbott Laboratories to sell Magnevist and Ultravist
Berlex Products: Fludara, Betaseron, Climara, Feridex I.V.,
Berlex acquired by Bayer AG
Berlex Lawsuits – Magnevist, Fludara, Betaseron
http://www.drug-injury.com/drug_injury/magnevist/
FDA Panel Suggests Bayer, GE MRI Drugs Be Restricted

Critical Drug Recall and Drug Shortages http://www.gilmanlawllp.com/defective-drug-side-effect-lawsuits/ben-venue-and-novartis-drug-recalls-and-shortages/

In the case of Ben Venue Laboratories, the shut-down of its Ohio manufacturing plant has resulted in the recall of the Fludara leukemia drug, as well as shortages of vital medications, including the life-saving cancer drugs, methotrexate and Doxil.
Betaseron – BigClassAction.com: Class Action News … http://www.bigclassaction.com/lawsuit/betaseron.php –
Berlex, Inc., the manufacturer of the medication, recently contacted healthcare professionals to remind them about certain aspects of the prescribing information for Betaseron as it relates to liver toxicity.

Bayer AG – Berlex – Schering
Research & Analysis

Berlex
1999 launched – Acutect and Neotect lmaging products
2000 – Berlex Products launched – Levulan Kerstick used to treat keratoses
Betapace AF – replacement for Betapace and generic sotalol
Campath, Refludan, Finevin, Mirena – Iud, Yasmin, Leukine, Finacea
Berlex marketed some 20 products such as oral contraceptives called Yasmin, and Mirena, a implanted contraceptive and medicines to treat multiple sclerosis, dermatology disorders and cancers
Berlex contributed $1.2 billion in annual sales, which was one-quarter of it’s parent corporation Schering AG total revenue’s.

Bayer
Bayer AG- Founded Friedrich Bayer & Johann Freidrich Weskott – 1863
1
st Product – acetylsalicylic acid (Aspirin) discovered by French Chemist Charles Frederic Gernhardt in 1853
1899 Bayer trademark of Aspirin was registered After World War I U.S. confiscation of assets – Lost Trademark status in U.S., UK, France – Trademark name currently registered in 80 countries under Bayer AG
1904 – Established Bayer Cross logo only for doctors and pharmacists Bayer’s U.S., confiscated assets acquired by U.S. Sterling Drug aka Sterling Winthrop Bayer became a subsidiary of IG Farben, German Chemical company conglomerate
World War II
IG Farben known for using slave labor in factories attached to concentration camps
Mauthausen-Gusen, concentration camps with 42.5% ownership
IG Farben produced Zyklon B – Chemical used in gas chamber of Auschwitz
After World War II IG Farben – Bayer separated into individual corporations
IG Farben ordered closed by Soviet Union for war reparations although, known for currently trading on Germany stock exchange

Bayer AG – Berlex – Schering
Research and Analysis

Bayer AG Executive Fritz ter Meer, was sentenced to 7yrs. In prison by the Nuremberg War Crimes Tribunal, when released he was appointed on the supervisory board of Bayer AG in 1956 – On the facts proven on record, the defendants who were members of the [managing board of I.G.] were accessories to and took a consenting part in the commission of war crimes and crimes against humanity as alleged in count three of indictments.


1978 – Bayer purchases – Miles laboratories and subsidiaries, Miles Canada, Cutter Laboratories – Products: Alka Seltzer, Flinstone Vitamins, One-A-Day vitimans, and Cutter insect, repellant


1994 – Bayer purchase Sterling Winthrop’s – OTC portion from SmithKline Beachman aka – Galxo Smith Kline – Enabling Bayer to acquire U.S., Canadian trademark rights to Bayer and Bayer Cross, as well as Aspirin trademark in Canada, that was previously
confiscated.

Bayer AG reorganized into a Holding Company in 2003 – Core businesses were transformed into limited companies, controlled by
Bayer AG
Bayer CropScience AG, Bayer Healthcare, Bayer Material Science, Bayer Chemicals AG, Bayer Business Services GmbH, and Bayer
Industry Services GmbH & Co. OHG,
Bayer shares: Frankfurt Stock Exchange, London Stock Exchange, N.Y. Stock Exchange
Bayers 2004 Chemical reorganization – Formed Lanxess excluding H.S. Starack and Wolff Walsrode – polymers – Lanxess listed on
Frankfort Stock Exchange – 2005
2004 – Bayer Healthcare AG – Acquired OTC Pharmaceutica divison of Roche Pharmaceutical
2006 – Merck Kga $14.6 billion dollar take over Schering AG surpassed Bayer $19.5 bid
2007 – Bayer Healthcare Diagnostic Division acquires Siemens Medical Solutions
2008 – Bayer Healthcare acquires OTC U.S. Company Sagmel, Inc – which distributed
to most of common wealth countries, Russia, Ukraine, Kazakhstan, Belarus etc.,
Currently holding subsidiaries all over the world – Bayer’s holding company located in Germany
Bayer specialty area’s: Bayer Healthcare – Pharmaceutical and medical product sub-group – Bayer Healthcare 4 divisions – Bayer
Consumer Care, Bayer Animal Health, Bayer Medical Care, Bayer Schering Pharma
2007 Bayer Pharma took over Schering AG – Berlex and formed “Bayer Schering Pharma,” the largest take over in Bayer’s history. Named changed to Bayer Pharma in 2011.

Bayer AG – Berlex – Schering
Research and Analysis

Bayer Healthcare Pharmaceuticals is divided into two business units = General Medicine and Specialty Medicine. Women’s healthcare is example of General Medicine business unit.


Bayer’s Pharma unit produces birth control pills Yaz and Yasmin. Both pills use a newer type of progesterone a hormone called
drospirenone in combination of estrogen. (How many times had these products been passed through multiple mergers?)
Yaz was advertised as a treatment for premenstrual dysphroic disorder (PMDD), and moderate acne. Bayer also picked up Nexavar and Betaferon/Betaseron, and blood clotting drug, Kogenate,
(Many of these drugs were passed down by several prior German corporations)
2009 – U.S. Adrea, entered a global agreement with Bayer Healthcare AG, a subsidiary of Bayer AG. Where Bayer was in control of the completion of the ongoing phase I and phase II studies of RDEA119, which Bayer would be responsible for the further development and commercialization of RDEA119 and any of Adrea’s other MEK inhibitors.


*United States Adrea Biosciences, was acquired by AstraZeneca in 2012 a biotechnology company
AstraZeneca – Formed in 1913 in Sodertalje, Sweden by 400 doctors and apothercaries formed Astra AB. In 1993 British chemicals ICI consolidated it’s pharmaceutical business and its agrochemicals, specialty businesses, to form, The Zeneca Group plc.


1999 – Astra and Zeneca Group merged pharmaceutical companies to form AstraZeneca plc – U.S Headquarters in Wilmington,
Delaware
Astra AB – British multinational pharmaceutical company based in U.K.
Products by Bayer AG and multiple subsidiaries: Women reproductive,
Aspirin, analgesic, antipyretic, anticoagulant medicine, Prontosil, Levitra,
Herion (diacetylmorphine) formerly sold as cough treatment, Sulonamide,
Ciprofloxacin, Polyurethane, Polycarbonate, CD’s, Makrolon, Suramin-Parathion, Insecticide Propoxur, Primodos – hormone pregnancy test

BAYER’S SPECIALTY AREA’S

Bayer Specialty Medicine business unit – Diagnostic Imaging
Contrast agents from his unit helps play crucial role in precise early diagnosis – Computed tomography (CT), magnetic resonance
imaging (MRI) and ultrasound
The Pet tracer Florbetaben, in Bayer’s pipeline is to recognize beta Amyloid, on of the pathological hallmarks of Alzheimer’s disease.
Bayer Consumer Care – Manages Bayer’s OTC medicine portfolio – Key products include, Aspirin, Aleve, food supplements, Redoxon, and Berocca, and skin products Bepanthen and Bepanthol.
Bayer Diabetes Care – Manages Bayer’s medical device portfolio, Key products; Mirena Iud, Blood glucose monitors, Contour Next EZ (XT), Contour USB, Breeze 2
Bayer Material Science: High-Tech Polymers, and develops solutions for a broad range of application relevant to everyday life
Bayer Business Services: Technology infrastructure and technical support, portion of Bayer USA and Bayer Canada – Bayer AG USA


Headquarters of North America Service Desk, and the Central IT Help Desk – Located in Robinson Township, Pennsylvania

Bayer Technology Services: Plant engineering, construction, optimization. Currenta; offers services for the chemical industry,
including utility supply, waste management, infrastructure, safety, security, analytic and vocational training
1904: Founded sports club, “Turn-und-Spielverein der Farbenfabriken vorm. Friedr. Bayer & Co., later SV Bayer 04, TSV Bayer 04
Levekusen, 1984 Bayer 04 Leverkusen
2014: Bayer, Novartis, Reckitt eye $10B-$12B bids for Merck consumer unit

Bayer AG -Berlex aka Schering
Lawsuit Research & Analysis

A cite from http://www.haemophilia-litigation.com/, access date 31 May 2006:
“After 1978, there were four major companies in the United States engaged in the manufacture, production and sale of Factor VIII and IX: Armour Pharmaceutical Company, Bayer Corporation and its Cutter Biological division, Baxter Healthcare and its Hyland
Pharmaceutical division and Alpha Therapeutic Corporation, which have been or are defendants in certain lawsuits.


The plaintiffs allege that the companies manufactured and sold blood factor products as beneficial “medicines” that were, in fact of
likely to be contaminated with HIV and/or HCV. This resulted in the mass infection and/or deaths of thousands of haemophiliac
worldwide
Baycor – After 52 deaths were blamed on an alleged side effect of Bayer’s anticholesterol drug Baycol, its manufacture and sale were discontinued in 2001. The side effect was rhabdomyolysis, causingrenal failure, which occurred with a tenfold greater frequency in patients treated with Baycol in comparison to those prescribed alternate medications of the statin class
Medicaid reimbursement


In January 2001, Bayer agreed to pay $14 million to the United States and 45 states to settle allegations under the federal False Claims Act that the company caused physicians and other health care providers to submit fraudulently inflated reimbursement claims to Medicaid Methyl parathion poisoning case – In October 2001, Bayer was taken to court after 24 children in the remote Andean village of Tauccamarca, Peru were killed and 18 severely poisoned when they drank a powdered milk substitute contaminated with the insecticide methyl parathion.

A Peruvian Congressional Subcommittee found significant evidence of criminal responsibility by Bayer and the Peruvian Ministry of Agriculture Liberty Link rice – In August 2006, it became apparent that the United States rice crop had been contaminated with unapproved genetically engineered Bayer CropScience rice. The genetically engineered rice has an herbicide-resistance trait. These forms of rice are commonly referred to among US rice growers as “Liberty Link rice 601” or “LL 601”. Approximately 100 varieties of rice are produced primarily in Arkansas,
Texas,Louisiana, Mississippi, Missouri, and California.

Bayer AG -Berlex aka Schering
Lawsuit Research

2006 Trasylol safety advisory – In September 2006, Bayer was faulted by the FDA for not revealing during testimony the existence of a commissioned retrospective study of 67,000 patients, 30,000 of whom received Trasylol and the rest other antifibrinolytics. The study concluded Trasylol carried greater risks.


The FDA was alerted to the study by one of the researchers involved. Although the FDA issued a statement of concern, they did not change their recommendation that the drug may benefit certain patients. In a Public Health Advisory Update dated 3 October
2006, the FDA recommended “physicians consider limiting Trasylol use to those situations in which the clinical benefit of reduced
blood loss is necessary to medical management and outweighs the potential risks” and carefully monitor patients.The FDA took
Trasylol off the market on 5 November 2007.

Prostate cancer claims – In October 2009, the Center for Science in the Public Interest sued Bayer for “falsely claiming that the selenium in Men’s One-A-Day multivitamins might reduce the risk of prostate cancer

Yasmin / Yaz birth control pills – The FDA has repeatedly warned and punished Bayer for misstating the benefits of Yasmin (also known as Yaz) while understating its risks. In 2011, the FDA’s panel of experts voted 21-5 that the labeling on Yaz was inadequate and needed more information about the potential risk of blood clots in the legs and lungs. The former president of the Australian Medical Associationwas nearly killed by a blood clot that resulted from taking the pill.


The pill has been linked to 23 deaths in Canada. In April 2012, the FDA ordered Bayer to change its U.S. labeling to reference the increased risk for blood clots Neonicotinoid pesticides Clothianidin


In December 2010, a leaked memo from the EPA’s Environmental Fate and Effects Division asserted “Clothianidin’s (Bayer’s neonicotinoid pesticide) major risk concern is to non-target insects (that is, honey bees). Exposure through contaminated pollen and nectar and potential toxic effects therefore remain an uncertainty for pollinators.

“In January 2011,Avaaz.org launched an online petition to ban neonicotinoid pesticides Imidacloprid French and Nova Scotian beekeepers claim Bayer’s seed treatment midacloprid kills honeybees. France has since issued a provisional ban on the use of
imidacloprid for corn seed treatment pending further action. A consortium of U.S. beekeepers filed a civil suit against Bayer CropScience for alleged losses.

Bayer AG -Berlex aka Schering
Lawsuit Research and Analysis

Europe restrictions & challenge The European Commission has restricted the use of both of Bayer’s neonicotinoids. Bayer is challenging the restrictions.


Nexavar claims In an interview given to the Businessweek following controversies surrounding the Indian government’s decision to award a compulsory license to Indian company Natco Pharma Ltd. for Naxavar (Sorafenib), Bayer CEO Marijn Dekkers equated the compulsory license with theft. Regarding targeted markets, he said, “Is this going to have a big effect on our business model? No, because we did not develop this product for the Indian market, let’s be honest. We developed this product for Western patients who can afford this product, quite honestly. It is an expensive product, being an oncology product.”

Chemical Spills:
In 28 August 2008, an explosion occurred at the Bayer CropScience facility at Institute,West Virginia. A runaway reaction ruptured a tank and the resulting explosion killed two employees. The ruptured tank was close to a methyl isocyanate tank which was undamaged by the explosion


Bayer Sued Over Unsupported Prostate Cancer Claims on One A Day 10/2009 http://www.cspinet.org/new/200910011.html
BAYER TO PAY $14 MILLION TO SETTLE CLAIMS FOR CAUSING PROVIDERS TO SUBMIT FRAUDULENT CLAIMS
TO 45 STATE MEDICAID PROGRAMS – January 2001 – http://www.justice.gov/opa/pr/2001/January/039civ.htm
Bayer Sold HIV-Risky Meds – 5/2003 http://www.cbsnews.com/news/bayer-sold-hiv-risky-meds/
BAYER FOUND RESPONSIBLE FOR POISONING OF CHILDREN IN PERU – http://www.twnside.org.sg/title/2410.htm

Bayer AG -Berlex aka Schering
Lawsuit Research & Analysis

FDA to Review Safety Issues Surrounding Leading Birth Control Pill Yaz – 12/2011
http://abcnews.go.com/Health/fda-discuss-safety-issues-surrounding-leading-birth-control/story?id=15099220

Yaz, Yasmin birth control pills linked to 23 deaths in Canada – 7/2013 http://www.nydailynews.com/life-style/health/yaz-yasmin-birth-
control-pills-linked-23-deaths-canada-article-1.1370853#ixzz2uD2nxBf7

Yaz and Yasmin birth control pills linked to 23 deaths: Health Canada documents

http://www.ctvnews.ca/health/health-headlines/yaz-and-yasmin-birth-control-pills-linked-to-23-deaths-health-canada-documents-
1.1321110#ixzz2uD3dzpwU – 06/2013

Neonicotinoids: Syngenta and Bayer go to court against the European Commission

http://www.slowfood.com/sloweurope/eng/news/191739/-neonicotinoids-syngenta-and-bayer-go-to-court-against-the-european-
commission 3/2013

Leaked document shows EPA allowed bee-toxic pesticide despite own scientists’ red flags- http://grist.org/article/food-2010-12-10-leaked-documents-show-epa-allowed-bee-toxic-pesticide/ 12/2010
Bayer in settlement over Cipro pricing – http://www.cbgnetwork.org/5208.html 9/2013
The spying Scotsman who hunted the Nazis of New York: The amazing story of Britain’s clandestine war on Hitler’s agents… and his big- money backers in the US –

http://www.dailymail.co.uk/news/article-2530447/ The-spying-Scotsman-hunted-Nazis-New-York-The-amazing-story-Britains-clandestine-war-Hitlers-agents-big-money-backers 12/2013

Primodos victims from UK demand apology – Cologne, Germany – 26th April 2013 Bayer Shareholder Meeting – Speech Valerie Williams Lipobay/Baycol Victim Goes To Court – Argentina: BAYER Sentenced To Pay Compensation – http://www.cbgnetwork.org/4649.html

10/2013

Bayer AG -Berlex aka Schering
Lawsuit Research Analysis

State ignored plan for tougher chemical oversight – West Virginia ignores a plan for tougher chemical oversight which
was worked out after an explosion in BAYER ́s Institute plant (more info). 300,000 residents are still without usable water
after a chemical spill – 1/2014 http://www.cbgnetwork.org/5405.html


Leaked Documents Reveal the Secret Finances of a Pro-Industry Science Group –
http://www.cbgnetwork.org/5301.html 10/2013


Whistleblower Lawsuit Filed Over Baycol Fraud – http://www.cbgnetwork.org/2703.html 4/2008


Bayer Held Back on Drug Dangers – http://www.cbgnetwork.org/288.html

11/2004
Has died / Hemophiliacs infected by Bayer products – 8/2012 http://www.cbgnetwork.org/4607.html
Bayer, Baxter pay multimillion indemnity to haemophiliacs –
http://www.cbgnetwork.org/3678.html – Settlement in the US with victims from 22 countries / HIV
infections were preventable / “why is BAYER concealing the payments? 1/2010

NY Times: Bayer sold AIDS infected blood product – 5/2003
http://www.cbgnetwork.org/378.html

US elections: BAYER donates to Republicans and Tea Party-????? http://www.cbgnetwork.org/4595.html – 8/2012

Trial-related deaths in India – Open letter to BAYER – Bayer AG

CEO Marijn Dekkers -http://www.cbgnetwork.org/4109.html 10/2011

BAYER: Marketing Expenses Concealed – http://www.cbgnetwork.org/4317.html – 3/2012

Papantonio: Bayer’s Deceptive Marketing Is Killing Women – https://www.youtube.com/watch?v=19zwklFd9z0 3/2013

Bayer AG -Berlex aka Schering
Lawsuit Research & Analysis

$300 Million Compensation in the US
Settlements in Yaz litigation continue, mediator is “cautiously optimistic” that end is in sight – http://www.cbgnetwork.org/4512.html

6/2012
Yaz: Food and Drug Administration to Discuss Dangerous Contraceptive Pills – http://www.cbgnetwork.org/4173.html 11/2011
Bayer contraceptive advert breaches Code of Practice – http://www.cbgnetwork.org/3922.html 5/2011
Newer Birth Control Pills Carry a Higher Risk of Blood Clots – http://www.cbgnetwork.org/3803.html

4/2011 – Complete Study “Risk of venous thromboembolism in users of oral contraceptives containing drospirenone”
(DownloadBMJ_Study_Drospirenone.pdf) and the study on US data
Yaz victims to appear in Bayer shareholder meeting
Ban demanded / Coalition introduces countermotions / more than 50 deaths in the US – http://www.cbgnetwork.org/3327.html

4/2010
RISK OF THROMBOEMBOLISM ASSOCIATED WITH DROSPIRENONE-CONTAINING CONTRACEPTIVES (YASMIN, YAZ, MIRENA – IUD
ETC.) http://www.arznei-telegramm.de/journal/j_0710_a.php3?&knr=073085/318353&name1=ENCEPUR&organ=Sinnesorgane

10/07
Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives. –
http://www.ncbi.nlm.nih.gov/pubmed?
Db=pubmed&Cmd=ShowDetailView&TermToSearch=17766604&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPa

09/2007
Safety of a new oral contraceptive containing drospirenone. – http://www.ncbi.nlm.nih.gov/pubmed?
Db=pubmed&Cmd=ShowDetailView&TermToSearch=15471507&ordinalpos=8&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPa

Bayer AG -Berlex aka Schering
Lawsuit Research and Analysis

Risk of hyperkalemia in women taking ethinylestradiol/drospirenone and other oral contraceptives. –
http://www.ncbi.nlm.nih.gov/pubmed/18929734 8/2008

Schering AG Storms Birth Control Market http://www.forbes.com/2003/07/11/cx_ad_0710shr.html 7/2003

Coalition introduces Countermotion on blood thinner Xarelto – http://www.cbgnetwork.org/4337.html – 4/2012

Bayer Sells AIDS-Infected Drug Banned in U.S. in Europe, Asia –
http://articles.mercola.com/sites/articles/archive/2006/08/05/bayer-sells-aids-infected-drug-banned-in-us-in-europe-asia.aspx
– 8/2006

IG Farben – Bayer AG
IG Farben to be dissolved -The company’s shares continue to trade on the German stock exchange even thought it went into
liquidation in 1952. IG Farben has been heavily criticized for not paying any compensation to former Nazi slave laborers after hundreds of Germany’s leading industrial companies contributed to a 10bn Deutschmark fund this year. Germany’s IG Farben, the company that made the Zyklon-B gas used in the Nazi death camps, has announced it will be dissolved by 2003?
http://news.bbc.co.uk/2/hi/business/1549092.stm

In year 1928, the American holdings of IG Farben, namely, the American branches of Bayer Company, General Aniline Works, Agfa Ansco, and Winthrop Chemical Company, were organized into a Swiss holding company, which was christened Internationale Gesellschaft für Chemische Unternehmungen AG or IG Chemie, in short. The controlling interest of this entity rested with IG Farben in Germany. In the following year, 1929, just a decade before the outbreak of the Second World War, these American firms merged to become American IG Chemical Corporation, or American IG, later renamed General Aniline & Film. –
http://en.wikipedia.org/wiki/American_IG

In 1952, IG Farben was split into BASF, Bayer, an Hoechst again.
German chemical companies —Badische Anilin- und Sodafabrik Ludwigshafen (BASF), Bayer, Agfa, Hoechst,Weiler-ter-Meer, and Griesheim-Elektron. These six companies were merged intoInteressen-Gemeinschaft Farbenindustrie AG or, IG Farben, for short.

Bayer AG -Berlex aka Schering
Lawsuit Research and Analysis

RAG To Take Over Degussa – http://cen.acs.org/articles/84/i1/RAG-Take-Over-Degussa.html 1/2006
Bayer Combination Aspirin Class Action Lawsuit Settlement –
http://www.topclassactions.com/lawsuit-settlements/lawsuit-news/14735-checks-go-bayer-combination-aspirin-class-action-settlement/ -Checks Go Out in

Bayer Combination Aspirin Class Action Settlement
Bayer HealthCare Pharmaceuticals Gender Discrimination Class Action Lawsuit Complaint
Female Bayer HealthCare Pharmaceuticals Employees File Gender Discrimination Class Action Lawsuit Complaint Against Bayer

HealthCare Pharmaceuticals. http://classactionlawsuitsinthenews.com/class-action-lawsuits/bayer-healthcare-pharmaceuticals-gender-discrimination-class-action-lawsuit-complaint/ 3/2011

Bayer’s Yasmin Lawsuit Settlements Rise to $402.6 Million – http://www.businessweek.com/news/2012-07-31/bayer-s-yasmin-lawsuit-settlements-rise-to-402-dot-6-million 7/2013

Bayer Combination Aspirin Multidistrict Litigation – http://www.douglasandlondon.com/legal-news/bayer-combination-aspirin-multidistrict-litigation/Yasmin/Yaz Litigation Heats Up, Bayer Accuses Litigation Lawyers of “Negative Advertising” –
http://www.lawyersandsettlements.com/articles/yasmin-side-effects-yaz-blood/yasmin-birth-control-pill-yaz-side-effects-35-
14476.html#.UwsEMPldVQ4 5/2010


MIRENA IUD and Risk of Uterine Perforation – http://www.lawyersandsettlements.com/lawsuit/mirena-IUD.html#.UwsElvldVQ4 1/2014

Bayer IUD Litigation Consolidated in New York – http://www.nationallawjournal.com/id=1202597081274?
slreturn=20140124033833 4/2013
Bayer Cipro Drug Litigation Settlement – ttp://classactionsnews.com/settlements/bayer-cipro-drug-litigation-settlement 3/2014

Mirena IUD Migration Problems Result in Lawsuit Against Bayer – http://www.aboutlawsuits.com/mirena-iud-migration-problems-lawsuit-31490/#sthash.6SHEPghs.dpuf 8/2012 – Mirena IUD Reported Problems and Complications Topped 70,000 –

http://www.aboutlawsuits.com/mirena-iud-problems-complications-report-49000/#sthash.ps6wrOVy.dpuf

CABIRI Business Services

CABIRI Research: Mirena IUD Maude Adverse Event Reports

MAUDE Adverse Event Report: BERLEX INC.MIRENA IUD

Sarah, see below information you requested concerning FDA Safety and adverse effects. In our conversation 2/28/2014, you stated that the FDA did not mention Mirena was a unsafe product for women – See Below Mirena Iud – FDA articles, I’ve outlined a few for your review:

Lot Number 31218D
Event Date 04/11/2005
Event Type Other
Event Description
Staff assisting physician handed the mirena box to the provider. The mirena iud was placed into the patient. After placement it was noted that the iud had an expiration date of 03/05. This was reported to the medical director. The mirena distributor was contacted & stated that if the device was placed a week after the expiration date it should not be a problem. Per the distributor, no ill effects have been noted if inserted 10 days after expiration date. The patient will be monitored for any adverse effects.
Brand NameMIRENA IUD
Type of DeviceIUD
Manufacturer(Section F) BERLEX INC. 340 Changebridge Rd. P.O. Box 1000 Montville NJ 07045 1000
Manufacturer (Section D) BERLEX INC. 340 Changebridge Rd. P.O. Box 1000 Montville NJ 07045 1000
Device Event Key585173
MDR Report Key595346
Event Key565764
Report Number595346
Device Sequence Number1
Product CodeHDT
Report SourceUser Facility
Reporter OccupationRISK MANAGER
Type of ReportInitial
Report Date04/20/2005
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/20/2005
Is This An Adverse Event Report?No
Device OperatorPhysician
Device LOT Number31218D
Was Device Available For Evaluation?No
Is The Reporter A Health Professional?No Answer Provided
Was the Report Sent to FDA?Yes
Date Report Sent to FDA04/20/2005
Event LocationOther
Is the Device an Implant?Yes
Is this an Explanted Device?No Answer Provided
Patient TREATMENT DATA
Date Received: 04/20/2005 Patient Sequence Number:1

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=595346

MAUDE Adverse Event Report: MIRENAIUD HORMONE FILLED

MIRENA IUD HORMONE FILLED

Event Date 01/08/2004Event Type Injury Patient Outcome Life Threatening,Other Event Description – Pt had the mirena iud inserted in 04 – the pain upon insertion nearly made pt pass out – double painkillers didn’t help.

Pt whole body broke out in a severe sweat. Since having the iud inserted pt had severe cramps. Lower abdominal pain, pt had gained 30 pounds -size 4 to 14-, bloating, severe fatigue, mood swings – irritability, severe leg cramps, tingling in their fingers, joint pain and chest pain. Pt went back to the dr who steered the conversation away from the mirena and put them on estrogen for menopause. They took an ultrasound and said the iud appeared to be fine. Pt bled after the ultrasound for three days. They say “no one has any complaints about the mirena” yet this site http://www. Dysmenorrhea. Org/forum/documents all and more of the same symptoms pt is having and pt going to have their IUD removed. Pt hopes that their experience is not like others where the mirena has traveled on its own into their uterus, their stomach and even up to their head. Pt feels FDA needs to do something about the mirena. Consumers should be alerted to the side effects a huge amount of women are having from this product. Also, pain upon insertion is said to be negligible – but it is not negligible. It is severe in many cases.

Brand NameMIRENA
Type of DeviceIUD HORMONE FILLED
Device Event Key550739
MDR Report Key561031
Event Key532986
Report NumberMW1033889
Device Sequence Number1
Product CodeHDT
Report SourceVoluntary
Reporter OccupationPatient
Type of ReportInitial
Report Date10/27/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2004
Is This An Adverse Event Report?Yes
Is This A Product Problem Report?Yes
Device OperatorInvalid Data
Was Device Available For Evaluation?No Answer Provided
Is The Reporter A Health Professional?No
Event LocationUnknown
Was The Report Sent To Manufacturer?No
Is this a Reprocessed and Reused Single-Use Device?No
Is the Device an Implant?Yes
Is this an Explanted Device?No Answer Provided


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=561031

Bribed Doctor Fraudulent Mirena Actions –

The FDA also reported in April 2013 – Counterfeit Device circulating

Shrum, Kelly Dean., D.O.



Department of Health and Human Services logo Department of Health and Human ServicesPublic Health Service
Food and Drug Administration

Rockville, MD 20857

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

05-09-2012

Kelly Dean Shrum, D.O.
(b)(6)

PROPOSAL TO DEBAR
NOTICE OF OPPORTUNITY FOR HEARING
DOCKET No. FDA-2012-N-0246

Dear Dr. Shrum:

This letter is to inform you that the Food and Drug Administration (FDA) is proposing to issue an order permanently debarring you from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this proposal on a finding that you were convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the Federal Food, Drug, and Cosmetic Act (the Act). This letter also offers you an opportunity to request a hearing on this proposal.

Conduct Related to Conviction

On November 17, 2010, you were convicted by a jury of one count of Misbranding, a class A misdemeanor in violation of 21 U.S.C.§§ 331(a), 333(a)(1), 352(c) and 352(f)(1), and one count of

Health Care Fraud, a class C felony in violation of 18 U.S.C.§§ 1347 and 2. On September 30, 2011 the United States District Court for the Eastern District of Arkansas entered judgment against you. The underlying facts supporting this conviction are as follows.

You were a licensed physician practicing in the state of Arkansas. You offered gynecological and obstetric services to women, including providing forms of birth control. Your favored form of contraception was a levonorgestrel-releasing intrauterine device (IUD) known as Mirena. Mirena was made for BHCP, Inc. by Bayer Schering Pharma OY (Bayer). The only version of Mirena approved by FDA for marketing in the United States was approved on December 6, 2000 in New Drug Application (NDA) 21-225.

From in or about June of 2009, in the Eastern District of Arkansas and elsewhere, you purchased a foreign version of Mirena for use in your patients that was not FDA-approved. The labeling of the unapproved IUD was not in English, and did not include adequate directions for use. Arkansas Center for Women, Ltd. was registered with the Arkansas Medicaid Program. You were listed as the only physician affiliated with that clinic, and you signed the Medicaid provider contract on behalf of the Arkansas Center for Women. You submitted claims to the Arkansas Medicaid Program under the clinic’s provider number for procedure code J7302, Levonorgestrel Releasing Intrauterine Contraceptive (Mirena). This procedure code is specific to Bayer’s FDA-approved Mirena product and any item billed under this procedure code must be the FDA-approved version of Bayer’s Mirena.

From on or about January 15, 2008 through on or about June 12, 2009, you caused to be submitted claims for reimbursement to the Arkansas Medicaid Program, which included false representations. Specifically, you billed the Arkansas Medicaid Program as if you were administering the FDA approved version of Mirena, when you were actually administering a non-FDA-approved IUD.

FDA’s Finding

Section 306(a)(2)(B) of the Act (21 U.S.C. § 335a(a)(2)(B)) requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the Act. As described above, you knowingly and willfully caused to be executed and attempted to cause to be executed a scheme and artifice to defraud the Arkansas Medicaid Program, and to obtain by fraudulent pretense and representations money under the custody and control of the Arkansas Medicaid Program, in connection with the delivery of or payment for health care benefits, items, or services, all in violation of Title 18 U.S.C. §§ 1347 and FDA finds that the conduct underlying this felony conviction relates to the regulation of a drug product under the Act because the use of an unapproved and misbranded drug undermines the drug approval process and FDA’s regulatory oversight over drug products marketed in the United States.

Section 306(c)(2)(A)(ii) of the Act (21 U.S.C. § 335a(c)(2)(A)(ii)) requires that your debarment be permanent. Proposed Action and Notice of Opportunity for Hearing – Based on the findings discussed above, FDA proposes to issue an order under section 306(a)(2)(B) of the Act (21 U.S.C. § 335a(a)(2)(B)) permanently debarring you from providing services in any capacity to a person having an approved or pending drug product application.

In accordance with section 306 of the Act and 21 CFR Part 12, you are hereby given an opportunity to request a hearing to show why you should not be debarred as proposed in this letter.

If you decide to seek a hearing, you must file the following: (1) on or before 30 days from the date of receipt of this letter, a written notice of appearance and request for hearing; and (2) on or before 60 days from the date of receipt of this letter, the information on which you rely to justify a hearing. The procedures and requirements governing this notice of opportunity for hearing, a notice of appearance and request for a hearing, information and analysis to justify a hearing, and a grant or denial of a hearing are contained in 21 CFR part 12 and section 306(i) of the Act (21 U.S.C. 335a(i)).

Your failure to file a timely written notice of appearance and request for hearing constitutes an election by you not to use the opportunity for a hearing concerning your debarment and a waiver of any contentions concerning this action. If you do not request a hearing in the manner prescribed by the regulations, FDA will not hold a hearing and will issue a final debarment order as proposed in this letter.

A request for a hearing may not rest upon mere allegations or denials but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. A hearing will be denied if the data and information you submit, even if accurate, are insufficient to justify the factual determination urged. If it conclusively appears from the face of the information and factual analyses in your request for a hearing that there is no genuine and substantial issue of fact that precludes the order of debarment, the Commissioner of Food and Drugs will deny your request for a hearing and enter a final order of debarment.

You should understand that the facts underlying your conviction are not at issue in this proceeding. The only material issue is whether you were convicted as alleged in this notice and, if so, whether, as a matter of law, this conviction permits your debarment under section 306(a)(2)(B) of the Act (21 U.S.C. § 335a(a)(2)(B)) as proposed in this letter.

Your request for a hearing, including any information or factual analyses relied on to justify a hearing, must be identified with Docket No. FDA-2012-N-0246 and sent to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. You must file four copies of all submissions pursuant to this notice of opportunity for hearing. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

This notice is issued under section 306 of the Act (21 U.S.C. § 335a) and under authority delegated to the Director, Office of Enforcement within the Food and Drug Administration.
Sincerely,

/S/
rmando Zamora
Acting Director
Office of Enforcement
Office of Regulatory Affairs

As noted above, you were also convicted of causing the introduction and delivery for introduction into interstate commerce of a misbranded drug in violation of 21 U.S.C. §§ 331 (a), 333(a)(1), 352(c), and 352(f)(1), a misdemeanor. This conviction independently could form the basis for permissive debarment under section 306(b)(2)(B) of the Act; however, FDA declines to make a determination regarding permissive debarment at this time in light of your felony conviction.
Page Last Updated: 07/16/201

http://www.fda.gov/regulatoryinformation/foi/electronicreadingroom/ucm312157.htm

Website: FDA Safety & Adverse Effects – Related Articles: http://google2.fda.gov/search?q=mirena+iud&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*

ARTICLES: Search Results

Showing 1 – 10 of about 36 for mirena iud in All of FDA.MAUDE Adverse Event Report: BERLEX INC.MIRENA IUD

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=595346- 39k- 2014-02-21-
…MAUDE Adverse Event Report: BERLEX INC.MIRENA IUD.…BERLEX INC.
MIRENA IUD, Back to Search Results. Lot Number 31218D….

MAUDE Adverse Event Report: MIRENAIUD HORMONE …

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=561031 39k- 2014-02-21-
…MIRENA IUD HORMONE FILLED, Back to Search Results. Event Date
01/08/2004….Brand Name,MIRENA. Type of Device,IUDHORMONE FILLED…. more info arrow More results from www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm

Shrum, Kelly Dean., DO REGULATORY INFORMATION]

http://www.fda.gov/regulatoryinformation/foi/electronicreadingroom/ucm312157.htm- 41k- 2012-07-16-
…Your favored form of contraception was a levonorgestrel-releasing intrauterine
device (IUD) known as Mirena. Mirena was made for BHCP, Inc….

[PDF] HIGHLIGHTS OF PRESCRIBING INFORMATION These…

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021225s027lbl.pdf- 153k- 2009-10-14 Text Version
…For the contraception indication, Mirena was compared to a copper UD
(n=1,855), to another formulation of levonorgestrel intrauterine system (n…

[PDF] Mirena® (levonorgestrel-releasing intrauterine system)…

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf- 148k- 2009-03-31-Text Version
…The following are serious but uncommon side effects of Mirena: • Pelvic
inflammatory disease (PID). Some IUD users get a serious pelvic infection…

[PDF]Department of Health and Human Services Public Health…[ADVISORY COMMITTEES]

http://www.fda.gov/…/advisorycommittees/committeesmeetingmaterials/pediatricadvisorycommittee/ucm288710.pdf- 72k-Text Version…and older, approximately 59% of drug use mentions for Mirena® were
associated with the health care encounter code of “Insertion of IUD” (V251….

Adverse Effects Continued

[PDF]American College of Obstetrics and Gynecologists[DRUGS]

http://www.fda.gov/…/enforcementactivitiesbyfda/selectedenforcementactionsonunapproveddrugs/ucm219965.pdf- 10-Text Version
…use, and distribution of unapproved intrauterine devices (IUD) and intrauterine …
of FDA-approved products such as Mirena, Implanon, Copper-T, and…

September 30, 2011: Pine Bluff Doctor Sentenced in Health…[INSPECTIONS AND COMPLIANCE]

http://www.fda.gov/iceci/criminalinvestigations/ucm274435.htm- 46k- 2011-10-04
…the Arkansas Medicaid Program as if he was providing Medicaid beneficiaries with the FDA-approved, Bayer manufactured IUD Mirena®, when in…

FDA Cautions Against Using Unapproved IUDs[FOR CONSUMERS]

http://www.fda.gov/forconsumers/consumerupdates/ucm219837.htm- 43k- 2010-07-22
…“Federal law requires that IUD/IUSs (intrauterine systems) be FDA-approved prior to marketing….What advantages are there for keeping my IUD in?..

[PDF]Prescriber Contraception Counseling Guide [FOR INDUSTRY]

http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm361078.pdf- 201k Text Version
… IUD insertion for emergency contraception is not recommended for female…7. Mirena® Prescribing Information, Berlex Corporation, April 2006….

[PDF]203159Orig1s000

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203159Orig1s000ClinPharmR.pdf- 297k- 2013-10-04-Text Version
…Mirena®, the only LNG-IUD currently on the market, was approved
in the US on December 6, 2000 under NDA 021225.…

[PDF]An Oncologist’s Perspective on the Clinical Use of Teratogenic…[ADVISORY COMMITTEES]

http://www.fda.gov/…/drugs/drugsafetyandriskmanagementadvisorycommittee/ucm333370.pdf- 79k-Text Version
…IUD– Copper only, progesterone-containing LNG-IUD (Mirena) • Permanent contraception…28 Page 29. What About LNG-IUD (Mirena)?…

[PDF] N203-159 Clinical PREA[DRUGS]

http://www.fda.gov/downloads/drugs/developmentapprovalprocess/developmentresources/ucm350706.pdf- 302k-Text Version …low (0.2%) and is similar to the risk of ectopic with Mirena (0.1…Pelvic inflammatory disease and endometritis are historically associated with IUD…

Adverse Effects Continued:

[PDF] N22252 Natazia Clinical PREA [DRUGS]

www.fda.gov/downloads/drugs/developmentapprovalprocess/developmentresources/ucm283121.pd f- 1255kText Version …of efficacy ISS Integrated summary of safety IUD Intrauterine device IUS…such as fibroids or uterine cancer) •Mirena® (levonorgestrel-releasing… More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

October 8, 2009: Pine Bluff Doctor Indicted on Misbranding…[INSPECTIONS AND COMPLIANCE]

http://www.fda.gov/iceci/criminalinvestigations/ucm271159.htm- 49k- 2011-09-08
…Center for Women, LTD in Pine Bluff, Arkansas, federal agents located several non-approved versions of the Bayer manufactured IUD,Mirena®.…

[PDF]iPledge (isotretinoin) REMS [DRUGS]

http://www.fda.gov/…/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm234639.pdf- 1888k-Text Version
…20 Page 31. Unacceptable Forms Of Contraception Include: • Progesterone- only “mini-pills,” eg: – Ortho Micronor® Tablets* •IUDProgesterone T...

FDA News Releases–Women’s Health [FOR CONSUMERS]

http://www.fda.gov/forconsumers/byaudience/forwomen/ucm118628.htm- 45k- 2009-04-16-cached
…October 16); FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users (October 1); FDA…

[TEXT] primaryid$caseid$drug_seq$role_cod$drugname$val_vbm…[DRUGS]

http://www.fda.gov/…/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm350261.txt- 2560k-
…MG X 1$$$$$69941665$6994166$1$PS$MIRENA$1$IU…$2$SS$COPPER-
CONTAINING INTRAUTERINE DEVICE (IUD)$1$$$$$Does…

[PDF] Human Drugs Program [ABOUT FDA]

http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/reports/budgetreports/ucm298355.pdf- 253k-Text Version
… in patients, Mirena IUDs (Intrauterine Devices) from foreign sources that were not approved for use in the United States. The IUD’s were labeled in…

Adverse Effects Continued

MAUDE Adverse Event Report: BERLEX…

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=428416- 37k- 2014-02-21
…BERLEX LABORATORIES MIRENA IUD, Back to Search Results. Event Date
04/01/2002….Brand Name,MIRENA. Type of Device,IUD….Event Date 04/01/2002

MAUDE Adverse Event Report: HERNIAMESH SRL …

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2076427 – 42k- 2014-02-21
…She had a mirena iud in place for contraception and the bleeding was
attributed to the iud which was eventually removed.…

MAUDE Adverse Event Report: CONCEPTUS OR…

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3580915- 41k- 2014-02-21-
…liters of blood, coded twice. I had the mirena iud at the time which the
surgeons left in place. Two days later, i requested…

MAUDE Adverse Event Report: CONCEPTUSESSURE

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3339279- 41k- 2014-02-21-
…can have essure. Pt’s body rejects foreign objects as two mirena iud’s fell out, one resulting in pregnancy. The pain was…

MAUDE Adverse Event Report: HERNIAMESH, SR1T…

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1393932- 41k- 2014-02-21-cached
…vaginal bleeding. She had a mirena iud placed by her primary md which
was removed approx after 1 year. Granulation tissue…

Additional Research Links

October 8, 2009: Pine Bluff Doctor Indicted on Misbranding…[INSPECTIONS AND COMPLIANCE]

http://www.fda.gov/iceci/criminalinvestigations/ucm271159.htm- 49k- 2011-09-08
…Center for Women, LTD in Pine Bluff, Arkansas, federal agents located several non-approved versions of the Bayer manufactured IUD, Mirena®….

MAUDE Adverse Event Report…

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3101345- 40k- 2014-02-21
…I desired no more children. My gyno suggested the iud mirena. It was
unsuccessful, so they suggested essure. I had the coils inserted in 2010….
Model Number ESS305-R1
Event Date 02/25/2013
Event TypePatient Outcome – Event Description I am a mother of 3. My last two pregnancies were 2007 and 2008. I desired no more children. My gyno suggested the iud mirena. It was unsuccessful, so they suggested essure. I had the coils inserted in 2010. First 6 months was fine. Normal period. Even light at times. But i started to feel like i had the flu everyday and i was bleeding through my clothes. Constant headaches. Depression increased. Was told i had a hormone imbalance. Had an ablation the summer of 2011. One day surgery at (b)(6) hospital. Periods were somewhat normal for about 8 months. Then the side effects mentioned previously progressed. My periods were unstable and heavy and put me in the bed. How can you be a mother, wife, employee when you feel like you are dying?
InvegaLawsuit | Gynecomastia, Hyperprolactinemia –http://www.classaction.org/invega-Lawsuits have been filed against Janssen Pharmaceuticals alleging that Invega can increase a user’s risk of developing gynecomastia and/or hyperprolactinemia. Invega Breast Lawsuit – Victim of Male Breast Enlargement? – MaleBreastLawsuit.com/InvegaLawsuit Lexapro Lawsuits | Lawyers for Heart, Birth Defects … http://www.classaction.org/lexapro If you took the antidepressant Lexapro and delivered a child with a birth defect, contact ClassAction.org. You may be entitled to damages. Free consultations. Develop Pancreatic Cancer – After Taking Diabetes Drugs? diabeticdruglawyers.com –JanuviaLawsuit | Januvia Side Effects Lawsuits –www.januvialawsuit.net – Januvia lawsuits for Januvia patients who experienced side effects such as pancreatic cancer, thyroid cancer, and pancreatitis,
Additional Research Links
Prempro settlements cost Pfizer $896M; 4,000 lawsuits remain http://www.yourlawyer.com Articles Pharmaceutical giant Pfizer Inc. has disclosed that it has paid at least $896 million to settle 6,000 Prempro injury lawsuits filed by or on behalf of women who … Pfizer Settles Class Action Lawsuit by Former Wyeth … http://www.stollberne.com/…/pfizer…lawsuit-by-former-wyeth-shareholders Pfizer Inc. (“Pfizer”), the world’s largest pharmaceutical company, has agreed to pay $67.5 million to settle a class action lawsuit by shareholders of the … Remicade Lawsuit and Side Effect Information – i-Lawsuit http://www.i-lawsuit.com/remicade-lawsuit-and-side-effect-information Remicade is sold by Jansessen Biotech, Inc., … Vaginal Mesh Lawsuits– What You Need to KnowJanuary 28, 2013; Adderall Linked to Heart Failure and Sudden Death … Janssen Keeping Risperdal Side Effects a Secret Amidst … http://www.topclassactions.com/lawsuit-settlements/lawsuit-news/12396… A recent motion filed by Janssen Pharmaceuticals requests that plaintiffs may not use certain documents in court trials regarding Risperdal side effects. Gardasil Lawsuits | Gardasil Paralysis, Seizureswww.classaction.org/gardasil – Gardasil Lawsuits: Gardasil side effects may include death, paralysis, seizures and Guillain-Barre Syndrome. Lawsuit filed over side effects of HPV vaccine | Vaccine … vaccinenewsdaily.com/vaccine_development/212947-lawsuit-filed-over.-Lawsuit filed over side effects of HPV vaccine. … Merck & Co., the maker of Gardasil, allegedly caused the unnamed 16-year-old girl “physical and behavioral problems.” Takeda Pharmaceuticals – Manufacturer of Diabetes Drug, Actos www.drugwatch.com/manufacturer/takeda – Takeda Pharmaceuticals is a U.S. subsidiary of Takeda Pharmaceutical Company and manufactures Actos, a type 2 diabetes drug. Actos Litigation – Class Action Lawsuit, MDL Against Takeda injurylawyer-news.com/actos/class-action-lawsuit Actos litigation is pending in several U.S. courts as MDL, mass torts and individual claims, with patients alleging injuries like bladder cancer Crestor Diabetes Lawsuit | ClassAction.org – orLawsuit – A Drug Recall – w.adrugrecall.com/crestor/lawsuit.html –Sn patients taking Crestor developed life-threa tening rhabdomyolysis only a few months after the FDA approved the drug. Nine patients suffered from severe kidney … www.classaction.org/crestor – AstraZenecae Crestor lawsuits are mass tort cases, ng Diabetes Drugs? diabeticdruglawyers.com – You May Have A Case. Call Us Today. Januvia Lawsuit | Januvia Side Effects Lawsuits www.januvialawsuit.net – Januvia lawsuits for Januvia patients who experienced side effects such as pancreatic cancer, thyroid cancer, and pancreatitis, Click here to learn more. Federal Lipitor Diabetes Lawsuits Consolidated as MDL 2502 – Androderm® Lawsuit Filed in California Court After Testosterone Therapy Linked to Cardiac Events – Injury Lawyer News – IT Business Net


Additional Research Links Yaz, Yasmin Lawsuit Settlements Continuehttp://www.classaction.org/blog/yaz-yasmin-lawsuit-settlements-continue
Yaz, Yasmin Lawsuit Settlements Continue Jul 13, 2012 … After allegations of serious blood clotting complications and deaths as a result of Yaz and Yasmin use, Bayer is progressing smoothly in the…
Gadolinium Lawsuits | Gadolinium NSFhttp://www.classaction.org/gadolinium-injection-risk
Gadolinium Lawsuits | Gadolinium NSF Company(ies): Bayer Schering Pharma, GE Healthcare, Mallinckrodt, Inc. and Bracco Diagnostics, Inc. Additional Details: Gadolinium contrast dyes are injected
Levaquin and Cipro Tendon Injuries | Levaquin Cipro Lawsuitshttp://www.classaction.org/levaquin-and-cipro

Levaquin and Cipro Tendon Injuries | Levaquin Cipro Lawsuits Company(ies): Ortho-McNeil Pharmaceuticals, Bayer Pharmaceuticals; Additional Details: Part of the fluoroquinolone group of antibiotics, Levaquin and Cipro… http://www.classaction.org/levaquin-and-cipro
clipped from Google – 3/2014-Mirena Petition Signed by 1500 Womenhttp://www.classaction.org/blog/mirena-petition-signed-by-1500-women
Mirena Petition Signed by 1500 Women Lawsuit List … The FDA sent a letter to Bayer in 2010 which said their direct advertising program “overstates the efficacy of Mirena, presents unsubstantiated Trasylol Black Box Warning | Trasylol Side Effects – http://www.classaction.org/trasylol
Another Blood Thinner Prompts Concerns Over Serious Injurieshttp://www.classaction.org/…/another-blood-thinner-prompts-concerns-over- serious-injuries
Another Blood Thinner Prompts Concerns Over Serious Injuries As Pradaxa lawsuits continue to mount, the newest blood thinner approved by … Johnson) and Bayer, reports that it believes the number of adverse reports is
Monsanto Genetically Modified Wheat –http://www.classaction.org/monsanto-genetically-modified-wheat Bayer eventually agreed to a settlement. … Lawsuits are already being filed seeking compensation from Monsanto for negligence, loss of income, product News about Daiichi Sankyo Inc. Lawsuits Firms Kick Off Benicar Diarrhea Suits Against Daiichi – Two plaintiffs firms are planning to launch lawsuits against Daiichi Sankyo Inc. later this week in New Jersey that claim the company’s blood pressure drug Benicar… Daiichi Sankyo Accused Of Gender Discrimination – http://www.manufacturing.net/news/2013/02/daiichi-sankyo-accused-of… TRENTON, N.J. (AP) — Six current and former female sales representatives are accusing drugmaker Daiichi Sankyo of gender discrimination in a

Additional Research Links

Byetta Thyroid Cancer Lawsuit Filed Against Amylin, Eli …

Greg Abbott (R) pushes to block disabled Texans’ lawsuits …

http://www.dallasnews.com› News› Politics› Politics Headlines

Abbott Laboratories and Hospira retirement

Abbott Labs Sued by Five Men Claiming Androgel Injuries …

Pfizer’s Wyeth Pharmaceuticals Exposed By Whistleblower

Additional Research Links

Bayer Hiv Scandal – World Newshttp://www.definitionofnegligence.com/bayer-scandal-hiv-contaminated-drug-1000s-contracted-hiv/

wn.com/Bayer_HIV_scandal

FDA MAJOR COVER UP FOR BAYER~ Spreading HIV/ Aids Virus.wmv.mp4,BAYER scandal – HIV Contaminated Drug – 1000’s contracted HIV,Bayer…

http://www.ristoranti-napoli.it/v/cphkD-9NUe8/bayer_scandal_hiv…

Drugs company Bayer realised their product had been contaminated with AIDS, so what did they do, they still sold it because they didn’t want to lose money, and when …

http://www.cbsnews.com/news/bayer-admits-it-paid-millions-in-hiv…

Jan 28, 2011· … of dollars to end a scandal in which the company sold HIV.. in which the company sold HIV–contaminated…contracted HIV from the blood. You …

BAYER scandal – HIV Contaminated Drug – 1000′s contracted HIV – See more at: http://www.definitionofnegligence.com/bayer-scandal-hiv-contaminated-drug-1000s-contracted-hiv/#sthash.UimVMQVp.dpuf

Pfizer Unit Sued by Regulator for ‘Deterring Competition’ -http://wallstcheatsheet.com/business/pfizer-unit-sued-by-regulator-for-deterring-competition.html/?a=viewall – As full disclosure nears, doctors’ pay for drug talks plummetsSan Jose Mercury News

New England Compounding Center: Avoid Drugs From Company Tied To Meningitis, FDA Says http://www.huffingtonpost.com/2012/10/04/new-england-compounding-center-fda-drugs-meningitis_n_1940564.html

Multistate Outbreak of Fungal Meningitis and Other www2c.cdc.gov/podcasts/download.asp?f=8625771 – Oct 23, 2013· FDA reports conditions observed at NewEnglandCompoundingCenter facility (FDA Press Release: Oct. 26, …

Lawsuit on Behalf of Affymax, Inc. (AFFY) Investors Over …

EUGENICS CRIMES AGAINGST WOMEN

There is a influx of international corruption throughout America – Against women and this is now being brought to the forefront.

NO WOMAN DESERVES TO BE USED FOR MEDICAL EXPERIMENTS OR BECOME STERALIZED DUE TO PAST DICTACTOR’S EUGENICS THEORIES OF USING WOMEN’S BODIES AND THEIR CHILDREN BORN OR UNBORN TO CONTROL THE WORLD POPULATION!

PLEASE FEEL FREE TO RESEARCH AND INVESTIGATE ALL STATED FACTS IN THIS RESEARCH ANALYSIS! FOR YOUR FURTHER KNOWLEDGE! CABIRI, HAS MORE HIDDEN FACT’S TO REPORT!