Showing posts with label Stryker Howmedica Cervicore. Show all posts
Showing posts with label Stryker Howmedica Cervicore. Show all posts

Wednesday, January 20, 2016

Cercivore Clincal Trial Crimes At Stryker Medical

 There is an attempt to keep this out of mainstream media.. Please get this article out everywhere you can post it.

When it comes to crime corporate crime outpaces street crime by a country mile and when it comes to corporate crime one generally thinks of the financial industry. While financial industry crime is rampant it pales in comparison to medical industry crime. If they were giving out Olympic medals for corporate crime the medical industry would win the gold, silver and bronze. Generally when one thinks about medical crime they think about, billing fraud and big pharma bribing the FDA. As serious as those crimes are we mustn't forget the medical device industry and perhaps the biggest gangster in the medical industry is Stryker Medical. Stryker has committed many criminal acts but one of their most egregious that cause the most grievous injuries was the illegal Cervicore clinical trial in which while colluding with the FDA Stryker knowingly implanted the the dangerous Cervicore into the cervical spines of 250 test subjects many of whom are dying slow and agonizing deaths from metal poisoning. Sadly for these victims, because  this is considered a experimental device no other surgeon has the courage to remove it for fear of reprisals from the goon squads or golden handcuffs at Stryker Medical.

I think what worries the gang at Stryker is not criminal fines or a lawsuit. Corporate gangsters buy their way out of prison all the time but in this case I suspect that the criminals at Stryker are worried about criminal prosecution because lawyers for the victims have strong evidence that Stryker and it clinical investigators were aware that the Cervicore disk implant had not received approval as an experimental device.

Stryker Medical's Long And Bloody History Of Criminal Misconduct




    Otismed Corporation And Former CEO Plead Guilty To ...

    www.justice.gov/.../otismed-corporati...

    United States Department of Justice
    Dec 8, 2014 - Corporation to Pay More than $80 Million to Resolve Criminal and Civil... criminal conduct, and was later acquired by Stryker Corp., a medical  ...

    Stryker Gets Non Prosecution Agreement in FDA Criminal ...

    www.corporatecrimereporter.com/.../stryker-gets-non-prosecution-agree...

    Dec 8, 2014 - Stryker Gets Non Prosecution Agreement in FDA Criminal Case ...Stryker, OtisMed's parent corporation, cooperated with the government with  ...

    Former head of Stryker Corp. subsidiary pleads guilty to fraud

    www.northjersey.com/.../former-head-of-stryker-corp-subsid...

    The Record
    Dec 8, 2014 - The former head of a Stryker Corp. subsidiary pleaded guilty Monday to ... was bought by Stryker, the medical device maker, in 2009, after the fraudulent ...Stryker's OtisMed unit agreed to pay $80 million in criminal and civil  ...

    Bigger Fatter Politics: Stryker Medical Crimes

    biggerfatterpolitics.blogspot.com/2015/08/stryker-medical-crimes.html

    Aug 20, 2015 - Stryker Spine Faces More Lawsuits. Stryker Corp. (NYSE:SYK) is fielding legal challenges on two fronts, one from a former distributor and ...

    June 26, 2015: Former OtisMed CEO Sentenced for Selling ...

    www.fda.gov/.../CriminalInvestigations/uc...

    Food and Drug Administration
    Jun 26, 2015 - The former president and CEO of OtisMed Corporation was ... Strykeracquired the company after the criminal conduct for which he was  ...

    Former CEO of Stryker subsidiary sentenced to two years in ...

    www.modernhealthcare.com › ... › Medical Devices

    Modern Healthcare
    Jun 26, 2015 - A former CEO of a Stryker Corp. subsidiary was sentenced to two years in ... and that OtisMed's criminal conduct happened before Stryker acquired it and without Stryker's knowledge. ... Tags: Medical Devices, Technology  ...

    Stryker faces major fines over a subsidiary's past ...

    www.modernhealthcare.com › ... › Medical Devices

    Modern Healthcare
    Dec 8, 2014 - Stryker Corp. is facing stiff penalties, including $80 million in fines and ...that OtisMed's criminal conduct 'occurred prior to Stryker's acquisition of ... led to believe by the FDA that the devices were Class 1 medical devices that  ...

    Stryker Biotech spars with prosecutors over criminal charges ...

    medcitynews.com/.../stryker-biotech-spars-with-prosecutors-over-crimin...

    Nov 12, 2010 - The indictment also charges that Stryker and Philip lied to the FDA about the ... the government agency that regulated Stryker Biotech's medical ...

    Pharmaceutical Criminal Liability: Continuing Risks for ...

    www.pharmacompliancemonitor.com/...criminal-liability...for.../2141/

    Apr 23, 2012 - Pharmaceutical Criminal Liability: Continuing Risks for Executives and ...in a case involving the off-label promotion of Stryker's Biotech medical  ...

    Stryker pleads guilty to selling unapproved devices, to pay ...

    www.reuters.com/.../us-health-stryker-idUSKBN0JM24K201412...

    Reuters
    Dec 8, 2014 - Medical device maker Stryker Corp will pay the U.S. government $80 million to settle criminal and civil charges that its OtisMed Corp subsidiary ...

This is why I need I need my readers to send this out to everyone you know including and especially members of Congress... Please. I will give you more details later.

This is the mirror article:
http://www.qmed.com/mpmn/medtechpulse/stryker-accused-hiding-metal-metal-spine-implant-problems

Tuesday, May 13, 2014

Stryker Howmedica Cervicore: Criminals of the Year

White Collar Crime Exceeds all Other Crime!

Of all the white collar crime health care fraud beats all other industries combined with it's annual theft exceeding $750 billion per year. That breaks down to 1 in every 3 dollar Americans pay. $750 BILLION exceed all US defense spending!



With medical greed being the biggest driver of death and theft in the US it's no secret that of all the industries in the US the most homicidal and larcenous is without a doubt the medical industry. Their thievery even exceeds that of the financial industry. The medical industry kills about 1 million people each year and that exceeds ALL other industries including the United States Military. (Yes the US Military is a for profit industry.)


Stryker Howmedica the Worst of the Worst?


It's a tough comparison but when it comes to sheer medical corporate sleaze but given it's decades long criminal past and regulatory misconduct (All went unpunished) Stryker Medical, HowMedica WhoreMedica and and its deadly sellout reseacher/physician/surgeons aka clinical investigators win the dubious achievement award for being the worst medical industry gangsters. 


Please read the following article:



In Search of a CerviCore “Smoking Gun”



Legal & Regulatory
Carol McGrew and eight other patients implanted with Stryker Corporation’s CerviCore cervical disc filed suit against Howmedica, owned by Stryker on April 11, 2014 in an Illinois federal court for alleged damages caused by the disc.


Source: Howmedica Complaint

The Plaintiffs claim the disc was “unreasonably dangerous due to design defects, manufacturing defects and insufficient warnings.” Their case rests on similar metal ion poisoning arguments used in the DePuy ASR metal-on-metal hip lawsuits, with an additional claim of improperly using OP-1 during some of the surgeries.

CerviCore Disc

The CerviCore disc was initially developed by SpineCore, Inc. In 2004, Stryker purchased SpineCore for $120 million in cash, plus up to $265 more when CerviCore and another SpineCore product, FlexiCore, gained FDA approval and were launched.

SpineCore was founded in 2001 by Thomas Errico, M.D. and J.P. Errico. In the 2004 Stryker press release announcing the acquisition, the company said after completion of enrollment in a clinical study, a two-year patient follow-up was planned prior to submission of a premarket approval (PMA) application to the FDA. The company said it expected to submit an IDE (investigational device exemption) application to the FDA for the CerviCore before year end and begin a clinical study in 2005 which would lead to submission of a PMA application in 2008.

The company recruited the Plaintiffs, along with 391 other people to take part in the study. The patients signed “Consent to Participate in a Research Study” forms.

Dangerous Metals Alleged

According to a description in Motion Preservation Surgery of the Spine, published by Elsevier, Inc. in 2008, the device is “composed of two opposing cobalt-chromium-molybdenum bearing surfaces backed with a titanium plasma spray coating to enhance osseous fixation. Two fins on each baseplate, each with three spikes, help achieve initial fixation. An anterior vertebral body stop decreases the chance of posterior placement or migration.”


Source: The Cervicore artificial cervical disc/ www.spine-health.com

The Plaintiffs allege the company portrayed the disc as a device made entirely of titanium.

However, according to their claims, the company used cobalt, chromium, molybdenum, titanium, and nickel to construct many of the discs implanted in the patients, who were not told of the “dangerous” metals contained in the disc.

One of the patients, Colleen Jaeger’s original consent form contains the following description of the CerviCore unit: “The CerviCore Disc is made of two saddleshaped plates and it is implanted in place of the degenerated disc after it is removed. It is made entirely of metal (a cobalt/chrome/molybdenum alloy with a titanium coating).”

Drs. Jonathan Stieber, Jeffrey Fischgrund and Jean-Jacques Abitbol co-authored a book chapter entitled “The CerviCore Cervical Intervertebral Disc Replacement,” in which they listed one of CerviCore’s contraindications as: “Allergy to components of the device, including cobalt, chromium, molybdenum, titanium, or nickel.” James Yue, et al., MOTION PRESERVATION SURGERY OF THE SPINE: ADVANCED TECHNIQUES AND CONTROVERSIES, p. 238, Saunders, 2008.

In 2011, according to the suit, Stryker took out a full page ad in the program for the April Las Vegas meeting of the SAS International Society for the Advancement of Spine Surgery that, “bragged…CerviCore was ‘[c]omprised of CoCrMo – biocompatible material with a history of safety and proven durability with low metal ion release and wear rates in orthopedic implants.’”

Jaeger claims she was informed that she was one of the few who would have her metal levels monitored. She says the company “flatly refused to conduct metal ion tests in many patients and flatly refused to provide most with the results of any tests it had conducted.”

The patients claim to suffer from symptoms consistent with metallosis.

The company’s manufacturing processes were “so faulty they increased the metal-on-metal CerviCore device’s likelihood of emitting metal ions into the subject’s body,” says the suit.

The company produced CerviCore at one of its traditional Stryker Spine plants in Cestas, France, that was used to heat-treating non-articulating products and, according to the suit, was unfamiliar with producing articulating cobalt chromium products.

Rate of Failure Disputed

The Plaintiffs also claim that Stryker misled the public about CerviCore’s rate of failure.

For instance, in 2010, they say through four “affiliated” doctors (Drs. Abitbol, Maroon, Edwards and Fischgrund), the company “bragged that at two years, there were fewer device-related surgical interventions in the CerviCore group (2%) than in the Control group (4%).” 2-Year Results from Four IDE Study Sites: CerviCore Intervertebral Disc vs. Fusion, The Spine Journal, Volume 10, issue 9 Supplement, Pages S139–S140, September, 2010.”

However, they argue that the article’s sample size was only 49 CerviCore patients and the authors admit they lost track of 18 of the patients, so even one surgical revision would be 3.2% of the population.

Dr. Fischgrund operated on Plaintiff Pepke to correct his CerviCore prior to this article’s publication. The suit also claims that long before the article was published, Plaintiff Zaretzka, “had repeatedly reported to her surgeon, Dr. Edwards, that she had unresolved neck pain, hears clicking and grinding noises, suffered from metallosis symptoms and wanted a surgical revision of her device.” She says he refused.

Plaintiff Good also claims that long before the article was published, she informed her surgeon, Dr. Fischgrund, the she had unresolved neck pain, suffered from metallosis symptoms and wanted a revision. The surgeon also allegedly refused. Another CerviCore patient, in a separate lawsuit, claims she told Dr. Maroon long before the article that she also had problems.

“Thus,” claims the suit, “prior to this article’s publication, these co-authors knew of at least five surgical interventions caused by the CerviCore device, which is 16% of the responding sample size, not 2%.”

Stryker Quality Control Problems

In November 2007, the FDA publicly warned Stryker about quality control problems at its Mahwah, New Jersey, plant. The lawsuit says that the FDA cited the company for taking complaints on failures of one of its hip products, “but not applying lessons learned from that failure to its other products (which would include CerviCore).”

The discs were allegedly manufactured at the French facility and then shipped to Mahwah, New Jersey, for final coating and packaging.

The company’s Mahwah facility, “had rampant quality control problems that caused unsafe, unreliable, and contaminant-ridden devices to be released into the market at the very time [Stryker] was manufacturing CerviCore in that facility,” states the suit.

OP-1 Use Claimed

Plaintiffs also argue that due to the fact that CerviCore did not have screws, it had to rely on “some” bone growth to hold it in place. To accomplish that bone growth, they say Stryker, “illegally used or promoted the use of its TCP putty (also called Calstrux, Osteogenic Protein-1, or OP-1) in CerviCore patients.

In April 2008, it was widely reported that the FDA warned Stryker Biotech that the company had violated the law by conducting human experiments without a proper IDE.

The FDA, states the lawsuit, discovered Stryker Biotech had illegally entered into contracts with clinical investigators to use OP-1 in combination with some investigational device study. The FDA did not specify which study OP-1 was used with because records remain sealed when a device has not been approved by the FDA. Plaintiffs say the warning, even if it didn’t specify CerviCore, “demonstrates Stryker’s propensity to conduct studies on human beings without an IDE and to use OP-1 in conjunction with some unapproved study.”

Plaintiff Jaeger claims she had to have a revision because, “among other things, she developed a large bone mass growing from the area of her CerviCore.” Good claims she was found to have a boney growth at the C5 vertebrae.

“Other Plaintiffs are suffering the ill effects of improper use of OP-1, but, since [Stryker] has consistently resisted providing more testing, providing proper and accurate information, providing proper medical care, and/or removing faulty units, it has concealed the true nature of whether it used OP-1 from Plaintiffs,” states the complaint.

Feeling Abandoned

The Plaintiffs say the company became aware of the device’s adverse events and its potential for causing metal poisoning during the study period and abandoned the product. They claim Stryker also abandoned them even though the company continued the human study, actively attended Plaintiff’s doctors’ appointments, and actively denied that the device was faulty.

They claim the company insisted each study participant sign study renewal agreements that contained further waivers in order to continue receiving medical care. Then, shortly after obtaining each renewal and waiver, the company, “abruptly ended its study early and informed Plaintiffs it would no longer provide any care for them.”

They say that the company has never provided them with accurate information about what was put in their bodies. Because of this “concealment”, they claim they could not have discovered any of this prior to the commencement of this action.

Summary of Allegations

In summary, the nine patients and their spouses allege that the company, knew of multiple dangers with CerviCore, including that it might not implant properly, that its design caused excessive wear, that it was prone to breaking down prematurely, that it was prone to delaminating, that they manufactured it using improper processes, that they manufactured it in a facility prone to contamination, that it was made from cobalt, chromium, molybdenum, titanium, and nickel, and that it was likely to cause metallosis.

They allege “Gross Negligence” because the company knew it operated a human trial outside the bounds of any regulatory approval it obtained; knew they did not have regulatory approval to use OP-1 in conjunction with CerviCore on Plaintiffs or other humans and proceeded nonetheless [and] knew CerviCore presented danger to patients, particularly those with allergies to certain metals but knew the study participants were not being tested for metal allergies.”

In a parting shot, the patients say Stryker’s conduct was “so despicable and so contemptible that it would be looked down upon and despised by ordinary decent people.”

Fishing for a “Smoking Gun”

Plaintiffs want a jury trial, compensatory damages, punitive damages, attorneys’ fees and any other relief the court deems proper.

The attorneys for the patients clearly want a chance to depose Stryker executives and go fishing—hoping to find a “smoking gun.” So far, plaintiffs have only circumstantial evidence. Stryker has not publicly responded to the allegations.