On April 11, 2014, the Law Firm of Zoll Kranz & Borgess, with David Zoll,Esq. and James OBrien Esq., as Counsel and attorneys of record, filed a Product Liability Complaint (Stryker Spine CerviCore Disc) against Howmedica Osteonics, a wholly owned subsidiary of Stryker Corporation in the: In The United States District Court For a The Southern District Of Illinois East St. Louis Division Styled as : Carol McGrew, Phyllis Ann Good, et al, Plaintiffs, vs Howmedica Osteonic Corp.,. Plaintiffs will be represented by: Zoll, Kranz & Borgess, LLC , and James OBrien and David Zoll as attorney of record. 6620 W. Central Ave., Suite 200, Toledo, OH 43617 (419)841-9623. Case # 3:14 -cv-00430-DRH-PMF On April 14, 2014, I followed up with a letter/email to the Honorable Senator Carl Levin requesting US Congress to hold hearings to review the evidence of unauthorized human experimentation using the never approved Stryker Spine CerviCore trial device [Stryker Spine - CT-002-04] and the violation of Interstate Commerce Act for shipping the unapproved CerviCore device between 2005 to 2012. clinicaltrials.gov/archive/NCT00588601/2008_01_07 The intent of this letter is to request that your office use its authority to contact the corresponding congressional committee with oversight and jurisdiction to investigate an ongoing coverup inside the FDA for failing to enforce federal laws governing investigation into Clinical Trial Fraud, Unauthorized Human Experiments, and shipping unapproved Class III Serious Risks devices in violation of Interstate Commerce Act, by a Stryker subsidiary known as Howmedica Osteonics, a wholly owned subsidiary within the Stryker Corporation and dba Stryker Spine. This is just the tip of the iceberg. biotech.law.lsu.edu/cases/immunity/ftca_handbook.pdf Dear Honorable Senator Levin, First, I would like to wish you a Happy Pesach and to thank you for the timely email indicating that I could continue to contact you personally regarding a very serious concern I have regarding unauthorized human experiments conducted by Stryker Corporation and their wholly owned subsidiary, Howmedica Osteonics between 2005 to 2012. The intent of this letter is to request that your office use its authority to contact the corresponding congressional committee with oversight and jurisdiction to investigate an ongoing coverup inside the FDA for failing to enforce federal laws governing investigation into Clinical Trial Fraud, Unauthorized Human Experiments, and shipping unapproved Class III Serious Risks devices in violation of Interstate Commerce Act, by a Stryker subsidiary known as Howmedica Osteonics, a wholly owned subsidiary within the Stryker Corporation and dba Stryker Spine. This is just the tip of the iceberg. The victims of the unauthorized implantation of a defective metal on metal device, trademarked as CerviCore Intervertebral Disc, have filed repeated complaints to officials inside the FDA with request for an investigation into the injuries that this device caused from 2006 to present to no avail. Even more earthshaking is the fact that the FDA has chosen to turn a blind eye to Stryker Corporations outrageous subversion of all Rule of Law regulating corporations who commercialize their medical devices in the United States and under the jurisdiction of the Department of Health & Human a Services & FDA [21 USC 360j(g); 21 CFR 812.20; 21 CFR 812.30(3)] Most egregious is that the FDA has chosen to ignore Strykers multiple subversions of federal laws with regard to the Protection of Human Research Subjects and violations of Interstate Commerce Act by giving our written complaints the classic lip service brush off. It seems as though the FDA is in place to be an agent for Stryker Corporation pushing sub standard devices unto the market instead of an agency that is the arm of US Congress acting in a regulatory capacity in order to protect the public from exploitation as experienced by the CerviCore victims. Stryker Corporation and its subsidiary, Howmedica Osteonics dba Stryker Spine ruthlessly used, abused and then abandoned the CerviCore subjects in an unauthorized surgical implantation of a device trademarked as : CerviCore Intervertebral Disc, a metal on metal prosthetic. Our rights to Equal Protection Under the Law juxtapositional to the Stryker Corporation abuses and the FDA apathy appear to be non-existent. How is it that Stryker has been allowed to subvert federal laws enacted by US Congress with impunity and turn around and deny the severely injured victims of their clinical trial abuses of due process and equal protection under the law? This is happening because the FDA has absolutely no control over the Stryker entity. The FDA has been compromised by the misconduct of a past insider ( Daniel Schultz, MD) and now the FDA is unable to effectively enforce the laws that were enacted by Congress to protect the human rights of clinical trial subjects. The CerviCore subjects were duped into believing that the CerviCore trial device had a valid and legitimate IDE, and were protected by the FDA and Office of Protection for Human Research Subjects. The evidence in the FDA archived lock box for Stryker Spine CT 002-04 protocol for the CerviCore disc reveals a totally different outcome for the application for an IDE for the CerviCore CT 002-04 trial device submitted by Howmedical Osteonics dba as Stryker Spine. With the registration of Stryker Spines CT -002-04 trial device (aka CerviCore) in the database for trial of device NOT PREVIOUSLY APPROVED or cleared by the US FDA for any use, the evidence demonstrates that the CerviCore recruits were induced into volunteering to participate in a clinical trial that was not approved with a valid IDE from the FDA. We all now suffer permanent & severe spinal injuries and a condition called Metallosis, or metal toxicity. clinicaltrials.gov/ct2/show/NCT00588601 and clinicaltrials.gov/archive/NCT00588601 The FDA has continued to turn a blind eye to Strykers continuing criminal pattern of subverting federals laws authorizing and regulating clinical trial research. The FDA turned a blind eye to the illegal coercion and manipulation of the subjects by the use of unapproved and inadequate consent forms that never disclosed all the metals in the component, or the risks of cancer and metallosis. This means that when a Class III, serious risk, metal on metal medical device is implanted into the spine of a human research subject without a valid investigational device exemption requiring FDA approval that there was NOT a valid monitoring board or institutional review board (IRB) in position to protect the rights of the research subjects or to report life threatening injuries or deaths to the FDA. The deliberate failure by the Stryker cabal of surgeon to NOT REPORT the numerous adverse events caused by the CerviCore metal on metal device is a direct violation of the FDA Mandatory Reporting Rule, that comes with both civil and criminal penalties. fda.gov/downloads/MedicalDevices/.../UCM095266.pdf And finally, that the FDA turned a blind eye to CerviCore participants having an unapproved dangerous device surgically implanted into their spines that resulted in extremely painful outcomes, with the risk of introducing a carcinogenic metal toxicity into the subjects spine explicitly implies that the FDA condoned the infliction of corporate-biomedical assault, battery and torture. And sadly for the American Public, this corporate-government agency alliance demonstrates that both the FDA and Stryker Corporation have been allowed to act as though they are Above The Law. As for instance, with the FDA turning a blind eye to Stryker shipping devices without the proper authorization and adequate exemption in violation of the Interstate Commerce Act. See Prohibited 21 USC 331. Acts: law.cornell.edu/uscode/text/21/331 What this tells me is that there is an unspoken alliance between the FDA and Stryker that has given both entities the impression that they are untouchable. With Stryker acting as though they have nothing but contempt for the Rule of Law, the human research victims that were severely injured , the American public and the Laws of the United Stares Congress. I found irrefutable evidence that the Stryker Spine CerviCore CT -002-04 trial device had been registered in the government database & archived lock box for applicable clinical trials that were never approved by the FDA with a valid investigational device exemption for any use at the government website for clinicaltrials.gov on December 21, 2007. clinicaltrials.gov/ct2/show/NCT00588601 and clinicaltrials.gov/archive/NCT00588601 This evidence clarifies that a division inside Stryker Howmedica Osteonics dba Stryker Spine, had to register their corporate protocol CT 002-04 on 12/21/2007 for a device that is trademarked as: CerviCore Intervertebral Disc., as a trial device NOT PREVIOUSLY approved or cleared by the US FDA for any use - under the code for Delayed Posting of the Record. Here are the two links that will substantiate my allegations: clinicaltrials.gov/ct2/show/NCT00588601 and clinicaltrials.gov/archive/NCT00588601 There are approximately 288 CerviCore victims who were involved in the unauthorized human experiments. This device had to be registered in the MAUDE adverse device event database for malfunctioning on July 6, 2006. See MAUDE ADVERSE EVENT REPORT DATABASE: accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=739251 Also, Pursuant to the FDA regulations for WHEN AND WHAT TO REPORT [§803.3(q)], Harold Young, MD, reported that the CerviCore Intervertebral Disc - MALFUNCTIONED on June 13, 2006. At the time of this report to the MAUDE DATABASE that the CerviCore Disc malfunctioned, Dr. Harold Young was one of the Principal Investigators for Stryker Spine at the VCU Medical Center, Richmond, Va.. What is odd about this report to MAUDE, an adverse device event report database, is that this database is not the database for reporting trial devices that MALFUNCTION in clinical trials with valid and approved investigational device exemption aka an IDE. The regulatory pathway for reporting adverse device events during a trial with a valid IDE is found in the regulatory scheme for Investigational Device Exemptions pursuant to 21 CFR 812. And one of the specific regulations within section 812 is 21 CFR 812.46 (1) (b) (2) (3). Why Dr. Young did not or could not follow the chain of command for reporting trial devices that malfunction to the proper monitoring committee (e.g. The FDA required Institutional Review Board) suggests that it was because there was NOT a monitoring board ( IRB) in place at the VCU Medical Center for this surgeon to report that the CerviCore device malfunctioned after it had been implanted into the cervical spine of his patient, Angela Moneymaker. The regulations for a trial device that malfunctions requires that the Sponsor of the study (if it had a valid IDE) was required by federal law to report that the CerviCore malfunctioned pursuant to: 21 CFR 812.46 and, if necessary, in conjunction with the regulations for WHEN AND WHAT TO REPORT [§803.3(q)] to report malfunctioning devices: Wherefore, both regulations require that the Sponsor evaluate what caused the malfunction, report its findings to the FDA , and terminate the trial device study with in 5 to 15 days of discovery if there were: (b)Unanticipated adverse device effects. (1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect. (2) A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects shall terminate all investigations or parts of investigations presenting that risk as soon as possible. Termination shall occur not later than 5 working days after the sponsor makes this determination and not later than 15 working days after the sponsor first received notice of the effect. The CerviCore device broke apart and fell behind the spine of the subject requiring immediate surgery to remove the device and revert to a fusion. FDA regulations for serious injuries caused by device malfunctions are defined as: Pursuant to: Serious injury/(Serious illness) [§803.3(aa) the FDA defined a serious injury caused by a device that malfunctioned to be: (1)] is an injury or illness that is life threatening, even if temporary in nature; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Also, the regulations for malfunctioning devices states that: Reporters do not need to assess the likelihood that a malfunction will recur. The regulation presumes that the malfunction will recur. Furthermore, FDA believes that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.This presumption will continue until the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show, through valid data, that the likelihood of another death or serious injury as a result of the malfunction is remote. It was due to the fact that the Stryker Spine CerviCore trial device aka CT -002-04 did NOT have a valid IDE that allowed Stryker to subvert the federal laws and regulations that govern legitimate clinical trial research.Any violation of one of these federal laws are to be enforced in order to protect the human rights, health and welfare of the subjects who volunteer their bodies to further science for the public good. The trial device that malfunctioned in Angela Moneymakers spine had broken apart and fell behind her throat and spine. She is now one of the plaintiffs in a lawsuit recently filed In The United States District Court For a The Southern District Of Illinois East St. Louis Division on April 11, 2014 and Styled as : Carol McGrew, Phyllis Ann Good, et al, Plaintiffs, vs Howmeidica Osteonic Corp.,. Plaintiffs will be represented by: Zoll, Kranz & Borgess, LLC , and James OBrien and David Zoll as attorney of record. 6620 W. Central Ave., Suite 200, Toledo, OHS 43617 (419)!841-9623. This is a civil lawsuit only. But in order to protect the public from further criminal subversion of federal laws regulating clinical trials and the protection of the research subjects who were deceived from day one by the Stryker cabal-- hearings in Congress are necessary to establish if there is sufficient cause for an in depth investigation into the criminal allegation of Stryker covertly performing unauthorized human experiments & shipping of unauthorized device in violation of Interstate Commerce Act ; and whether the FDA turned a blind eye to our continuous complaints that were filed in order to determine (1) how we were to enforce the terms of the bogus consent forms in order to have the toxic device removed; and (2) and to question whether or if our human rights are being violated by both the FDA and Stryker respectively. The silence from the FDA regarding the complaints we filed was deafening. And parallel to the complaints being filed with the FDA, Stryker refused to approve revision surgery and pay for removal of the device - as this would have raised red flags regarding the illegal status of the trial device. Removal of the device would have required the surgeon and the facility to comply the the Mandatory Reporting Rule for Devices that clinically fail or malfunction as was happening with the rogue Metal on Metal CerviCore disc manufactured by Stryker Spine in Cestas, France and reprocessed with Titanium Plasma Spray at the Mahwah Facilities for Howmedica Osteonics, dba Stryker Spine. Instead, Stryker and the FDA continued their chilling silence leaving the severely injured CerviCore victims with no way out, in spite of myelograms CTScans showing evidence of soft tissue pseudo tumors rapidly developing and masses of cloud bubble signs surrounding the device indicative of Metallosis from metal wear debris. An investigation must be conducted by the Department of Justice, by and thru a recommendation from the US Congress and or the finance committee who has oversight and jurisdiction over the FDA if there is to be equal justice for all. We CerviCore subjects are the victim of a classic bureaucratic syndrome that we see in government regulatory agencies that are comprised of layers of bureaucratic locks, like the FDA. These bureaucratic locks prevent a serious matter like this one (unauthorized human experimentation) from being dealt with in a timely, effective and resolute manner. I refer to this as the very inefficient yet very effective Orwellian hand off of official accountability that is referred to as Bureaucratic Mystification. This is the ability to smokescreen or conceal criminal acts within a federal agency like the FDA by the use of an official term used to cover up - the fraud, the deception and the subversive usurpation of federal laws in place to protect human research subjects by sweeping the crimes under a seal and cover of trade secret confidentiality. Bureaucratic Mystification means that a bloated bureaucracy like the FDA can very effectively cover up the crimes of its clients e.g. Stryker Corporation, by its layered compartmentalizations of the evidence and stonewalling the complaints by lock boxing the evidence e.g. Archived Lock Box and Trade Secret Confidentility. This is what causes fatal deadlocks and classic stonewalling until so much time passes that the issue is left for the next administration to bury even deeper into a layered bureaucratic deception. In the meantime, the crippled and maimed subjects continue to live a life of silent pain and suffering, with no voice or means to invoke their rights to equal protection under the law. And the only response the severely injured victims gets from the FDA is lip service in the guise of sanitized letters making humoring statement like we are taking your complaint very serious but ...... Meanwhile, absolutely nothing is being done to help the severely injured victims of unauthorized human experimentation and clinical trial fraud. And, Stryker continues to get away with serial biomedical assaults and slow motion murder under the FDA color of law and trade secret confidentiality. The laundry list of egregious official acts of misconduct committed by the FDA officials, who were rubber stamping approval of Stryker devices without requiring sound scientific merit to warrant their allowance on the market ; -- to the FDA implicitly covering up that Stryker implanted hundreds of unapproved CerviCore devices into the spines of hundreds of victims without following any protocol for pre-surgical qualification; --- and then to cover up this crime under the convenience of Trade Secret Confidentiality demonstrates a shocking and inhumane disregard for the humanity of the CerviCore victims, all American citizens, like you and me. We are being treated like second class citizens by both the FDA and Stryker. This is very similar to how the victims of Nazi Biomedical crimes were brutalized in inhumane human experimentations by the collaboration of the Nazi State with Nazi corporations like IG Farben and Bayer, for wealth and profit. This is no different. And if it isnt stopped now, it will escalate to the level that any physician affiliated with a corporation like Stryker, will use what ever device or biologic implant they want off label with impunity. And this is because they will know it is because they can get away with it -- because those in power (FDA) refuse to enforce the laws that protect human research subjects from these very real abuses. This is just the tip of a very serious problem within this rogue clinical trial using the rogue CerviCore device. Because the device was not approved for any use, everyone affiliated with the covert implantation, like the hospitals and the surgeons are now part of maintaining the cover up - by and thru a conspiracy of silence. We victims have been blacklisted by the surgeons and hospitals; and we are being denied competent treatment for our injuries. The FDA has been stonewalling us and spying on us, instead of investigating Strykers criminal abuse of power and subversion of federal laws for protecting subjects in clinical trials and unapproved investigational devices. The FDA has removed evidence that I found on the Internet reporting that the government knew as far back as 1999 that nickel alloy in medical devices causes cancer. This was part of the RoC report to Congress on Nickel that has vanished as soon as I reported that this report existed on my forum, Spine Talk. ntp.niehs.nih.gov/ntp/newhomeroc/roc10/ni.pdf Department of Human and Health Services commissioned report of nickel and its genotoxic/carcinogenic pathologies (implants with nickel alloy) This letter would be 20 pages long if I were to go into every detail. Therefore, I am writing a brief account first in the hope that I will get your kind and competent attention on the matter. I am requesting that you act as our advocates in Congress where this can be addressed in a proper open democratic forum with open hearing to establish precisely what crimes were committed and by whom within the FDA and Stryker Corporation. The smoking gun is that there are 288 Stryker CerviCore devices that were shipped nationwide without the required investigational device exemption pursuant to the prohibited acts defined in the Interstate Commerce Act. I thank you for your kind attention to this matter. I am very sick at this time of writing. I have tumors from C2 to C7 and severe Metallosis. And I suffer from significant bouts of cervical angina - which is similar to feeling like I am having a heart attack. The hospital in Royal Oak, Michigan where I was recruited on February 12, 2008 has had me blacklisted and I cannot receive the proper medical attention I require to save my life. At this time, I do not know if the tumors are benign or malignant. And I am living on borrowed time. Please, help us - I am asking from the bottom of my heart before it is too late for me to continue to advocate for myself and the many others who were similarly injured. In Kind Regard, Phyllis Ann Good SENATOR LEVIN: REQUEST TO INVESTIGATE UNAUTHORIZED HUMAN EXPERIMENTS FDA/STRYKER CERVICORE « Reply #1 on: April 15, 2014, 01:51:02 PM » Quote Modify Remove Split Topic This was the first letter we sent to the Honorable Carl Levin on October 20, 2011 regarding the questionable IDE status for the Stryker Spine CerviCore CT-002-04. As it turns out, Stryker Spine did NOT apply for an IDE for the CerviCore model / prototype that was implanted into our spines.
Posted on: Sun, 16 Nov 2014 07:02:10 +0000