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 Name | MIRENA IUD |
|---|---|
| Type of Device | IUD |
| 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 Key | 585173 |
| MDR Report Key | 595346 |
| Event Key | 565764 |
| Report Number | 595346 |
| Device Sequence Number | 1 |
| Product Code | HDT |
| Report Source | User Facility |
| Reporter Occupation | RISK MANAGER |
| Type of Report | Initial |
| Report Date | 04/20/2005 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 04/20/2005 |
| Is This An Adverse Event Report? | No |
| Device Operator | Physician |
| Device LOT Number | 31218D |
| 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 FDA | 04/20/2005 |
| Event Location | Other |
| 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 Name | MIRENA |
|---|---|
| Type of Device | IUD HORMONE FILLED |
| Device Event Key | 550739 |
| MDR Report Key | 561031 |
| Event Key | 532986 |
| Report Number | MW1033889 |
| Device Sequence Number | 1 |
| Product Code | HDT |
| Report Source | Voluntary |
| Reporter Occupation | Patient |
| Type of Report | Initial |
| Report Date | 10/27/2004 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 10/27/2004 |
| Is This An Adverse Event Report? | Yes |
| Is This A Product Problem Report? | Yes |
| Device Operator | Invalid Data |
| Was Device Available For Evaluation? | No Answer Provided |
| Is The Reporter A Health Professional? | No |
| Event Location | Unknown |
| 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 | Public 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 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… |
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®…. |
| 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, |
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| 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 |
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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!
Consumer Advocacy Business Industry Research & Investigations (CABIRI) 