Off-Label Use of Biliary Stents

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In May of 2007 my mother was admitted into Holy Cross Hospital for a dislocated hip. Before it was all over she was left permanently paralyzed because a stent that was designed to be used in the bile duct of terminally ill cancer patients was used, "off-label" in her renal artery. Although there were other approved alternatives her doctors chose the off-label route without ever discussing the alternatives or the dangerous and controversial nature of the procedure with the patient or the family. To make matters worse symptoms of the stroke were ignored and not acted upon for 24 hours robbing her of any chance of having the stroke reversed. Then out of fear of liability the family was talked into moving her out of the Hospital which was a Stroke Center into a nursing home ("for her own good") just three days after the stroke and subsequent paralysis. What they did was a crime.

Presently the U.S. Department of Justice is investigating the top stent Manufacturers for illegally promoting off-label use to physicians despite warnings from the FDA, the Justice Department and Medical Journals. Despite the bad publicity Cook Medical, the manufacturer of the stent that paralyzed my mother is still advertising their Biliary Stent as a Renal Stent! (See the Cook Medical website screen capture below.)

IMPORTANT  NOTE: To give you an idea of the way device manufacturers operate: 1) Find an article that shines a positive light on Renal Stenting. 2) Go to Google.com and type in the doctors name who wrote the article. 3) Next to the doctor's name type in:  "consultant for" OR "paid consultant" OR "receives royalties" OR "research grant".  This will find their disclosure statements. You will be amazed at how many doctors are in the pocket of stent manufacturers. Paid to put their name on propaganda intended for other doctors that may ultimately cripple or kill you or a loved one.

Even seemingly good doctors are being duped into engaging in this dangerous practice as if it's the greatest thing since sliced bread. Then when an injury occurs the Manufacturer blames it on the doctor and hospital because they say the doctor, "knew the device was not intended for off-label use." Then the doctors, based on what they're "taught" by the manufacturer's paid consultants, defend what they did by saying it's a safe and accepted practice and they did nothing wrong. Meanwhile, innocent people are being crippled and killed while the Manufactures enjoy a billion dollar a year business. William Cook the CEO of Cook Medical is worth 3.5 BILLION according to Forbes.

Below is a 3/7/09 screen capture of the Cook Medical website illustrating illegal marketing of their Formula 418 Biliary Stent to Doctors. (The Formula 418 was used on my mother)

Check it out for yourself. Go to www.cookmedical.com/mri.do. There you will see their Biliary stent being called a "Formula Renal Stent." Then go to www.cookmedical.com/di/dataSheet.do?id=4704 on that page you will see the appropriate warning label stating the safety and effectiveness in the vascular system has not been established.

Further down on this page is a screen capture from the International Symposium On Endovascular Therapy. This is where Interventional Radiologists and Vascular Surgeons must get their, "education," being that off label techniques cannot be taught at legitimate medical institutions. These "educational seminars" are supported by the stent manufactures and the speakers are mostly paid consultants of the stent manufacturers.


 

 Below is a 3/8/09 screen capture from the 2008 International Symposium On Endovascular Therapy at http://www.iset.org/2008. This is where Interventional Radiologists and Vascular Surgeons get their "education." If you are a Physician and are willing to sign a confidentiality agreement you will be privy to their closed-door complications session. The faculty will talk about, "downright disastrous cases and poor outcomes."  These "educational seminars" are supported by the stent manufactures and the speaker are mostly paid consultants of the stent manufacturers. Cook Medical and Cordis get special *recognition being that they are 20 year supporters.
 

 

Device Makers Profit by Promoting Biliary Stents for Dangerous Unapproved Uses
May 16, 2007. By Evelyn Pringle

Washington DC: There is a major controversy brewing over the off-label sale of biliary stents for unapproved uses. On March 12, 2007, the FDA held a meeting in Washington with the makers of the bile stents to remind them about the restrictions on their promotion of these devices for unapproved uses.

And to be sure, the hospital and surgeons are not going to own up to the mistake after the fact, unless they find themselves blocked into a corner where they absolutely have no choice. They are also not going to warn other medical providers not to us the bile stents because it would require them to disclose their own culpability for what happened to the patient.

This in turn is a win-win situation for device makers because it allows them to avoid any liability for the injuries directly caused by the illegal marketing of the biliary stents for dangerous unapproved uses while the off-label profits continue to roll in.

With all the secrecy agreements in place as far as what goes on in the operating room, calculating an accurate estimate of exactly how many patients may have been injured or killed due to the off-label use of these devices is not possible.

Click here to read full article...

 

"Although the results of some published studies suggest that RAS may ameliorate hypertension and retard the decline in renal function in some patients, no renal stents have been approved as a primary treatment option for atherosclerotic lesions."

Potential procedural adverse events that can result from such use are vascular trauma, such as dissections and perforations, and embolization of air bubbles from the delivery system or particulates from the lesion.

It is important to keep in mind that every patient treated in an off-label manner is one less patient available for enrollment in a renal stenting study.


Click here to read full article...

Watch FDA Video Warning on Using
Biliary Stent in the Vascular System
(Video, print, and e-mail functions)
FDA Warning on Using Cordis Biliary Stent in the Vascular System - May 4th 2004

Cordis Corporation is cautioning health care professionals about the use of the company's biliary stent, the PRECISEŽ RX Nitinol Stent Transhepatic Biliary System. The PRECISE RX stents are intended to treat obstructions in the bile duct due to malignancies. FDA has not cleared these stents for use outside the biliary tract. In fact, the stent's current labeling contains a warning that the device's safety and effectiveness in the vascular system have not been established. Nonetheless, some physicians have used these devices in the vascular system. When used this way, air can be introduced into the patient by the stent system, and this can cause serious problems, including coma, seizure and stroke. In fact, we've had several reports of malfunction, and also of patient injuries due to air embolism, when this system is used outside the biliary tract. On May 4, Cordis sent a notification to their customers describing these severe adverse events and advising them to limit the use of this device to the FDA-cleared uses only.

Click here to read full article...