Boy! Medtronic BACK in the News-Court Injunction Against their Spine ScrewsSomervell County Salon-Glen Rose, Rainbow, Nemo, Glass....Texas


 

Boy! Medtronic BACK in the News-Court Injunction Against their Spine Screws
 


21 December 2007 at 1:40:58 PM
salon

It's ALMOST to laugh about except it's pretty creepy. First, I read about this bone-snatching scheme that Medtronic was part of. Then I read about how their defibrillators don't work right. NOW... They infringed on someone else's patent.

DePuy Spine, Inc. announced that the U.S. District Court in Boston has granted a permanent injunction against Medtronic that prohibits Medtronic from making, using and selling VERTEX and VERTEX MAX polyaxial screws in the United States effective today. 

(Multi-axial screws not impacted, so I guess you don't have to get them pried out your spine.)

The Court further ordered that all VERTEX and VERTEX MAX polyaxial screws in the possession of Medtronic's affiliates, subsidiaries and distributors be returned to Medtronic immediately. All consignment and loaner inventory in the possession of any of Medtronic's customers must also be immediately returned to Medtronic under the Court's order.

This ruling comes after a federal jury in Boston found that Medtronic infringed a patent directed to polyaxial screw technology owned by Biedermann Motech GmbH and licensed to DePuy Spine. The jury awarded Biedermann Motech and DePuy Spine $226.1 million in damages following a September 2007 trial.

And the problems just don't stop for this company. (Have to do a shoutout right here- BEWARE!!!!!) There's a securities fraud lawsuit against them in Minnesota. France's competition regulator hasfined 5 defibrillator companies, including Medtronic, for "refusing to participate in the country's first attempt at a public bidding process to supply medical products to hospitals."


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1 - whitkat   21 Dec 2007 @ 7:08:04 PM 

I don't know anything about the Medtronic screws for spinal fusion, but a family member had a Medtronic defibrillator implanted recently.  The cardiologist has not removed my family member's defibrillator and is not removing most of the ones he has implanted.  He contends that the risk of removal is greater than the risk of leaving the defibrillator implanted.  Another family member who works in cardiology has told me that most cardiologist are NOT removing the defibrillators unless a problem develops. 

All medical procedures have a margin of error; the risk reward ratio must always be assessed whether it is a RX or a surgical procedure.  There have been approximately 250,000 Medtronic defibrillators implanted with only 5 deaths due to the faulty lead reported.  I wonder how many lives have been saved by these devices. 

However, after looking up Medtronics on the internet, it was interesting to note that the first two pages were nothing but lawyers' sites looking for patients wanting to sue Medtronics.

The French lawsuit against the defibrillator companies is interesting.  When did it become mandatory to bid on a contract?  Is it not the company's decision as to whether it is profitable to do so?

WK 


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2 - salon   23 Dec 2007 @ 12:16:21 PM 

Well, I certainly agree with you that there are a certain number of frivolous lawsuits created by unscrupulous attorneys. (One of my favorite jokes is what do you call a lawyer at the bottom of the ocean? Answer: a good start). However, there would be no need for lawsuits if manufacturers went to extra lengths to make sure their products are reliable.. and people who are harmed by faulty merchandise also need to be able to seek justice in court. Heck, even Tom Delay, who was a lead torch-bearer in the Schiavo case, used attorneys to sue about his own father's death (showing of course his hypocrisy)

On Medtronics. I hope you would agree with me that if a manufacturer finds out (however that happens) that they would warn people about using the product and pull it from sales. That's what Medtronics did about their defibrillator.

Defibrillator manufacturer Medtronic Inc. is warning patients and health care providers that an electrical wire (called a "lead") that links the defibrillator to the heart could fracture. Medtronic is voluntarily suspending all distribution of the "Sprint Fidelis" leads. Medtronic defibrillators have included the Fidelis lead since 2004. According to a Press Release from Medtronic, Inc., the estimated 268,000 patients who have been implanted with Sprint Fidelis leads might experience lead fractures as "audible alerts, inappropriate shocks and/or loss of output," and the company has identified five deaths "in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor." At this time, Medtronic is not recommending replacement of the leads, because risks posed by implanting of a different lead are greater than risks presented by fracture of the Sprint Fidelis lead.

Plus, their warranty doesn't cover it-it must be elective surgery, and insurance doesn't typically pay it unless recommended by a doctor. Story in the Minneapolis Tribune.

She, and many others, have embarked on a series of phone calls to doctors and insurers that may prove confusing and frustrating.

All face similar options: Remove the leads -- an often difficult surgery -- and replace it with a new one. Leave the old lead in the body and snake a new one in the chest using a different vein. Or reprogram the defibrillator to new settings that may detect fractures.

That option would leave the leads in place, and they would have to be frequently tracked using sophisticated monitoring equipment.

Medtronic and the U.S. Food and Drug Administration (FDA) have advised patients to leave the leads intact. But for many patients, the choice isn't so clear-cut. The potential rate of fracture is small, at 2.3 percent, but a risk nonetheless.

I don't know about the France lawsuit but I suspect there are interesting details about why the lawsuit occurred that went beyond the short blurb.

Incidentally, I noticed another article about Medtronic in a bribery lawsuit, where they were bribing doctors to sell their products.

Last week, the New York Times reported on documents filed in a lawsuit against Medtronic, one of America's largest medical device makers, with $10 billion in annual sales.

A prominent surgeon in Wisconsin was paid $400,000 a year by Medtronic for a consulting contract requiring him to work just eight days. Another doctor in Virginia received nearly $700,000 in consulting fees from Medtronic for the first nine months of 2005.

These doctors work in a growing field, complex back surgery, and this makes them particularly valuable to the spinal-implant division of Medtronic. In recent years, the company has spent tens of millions of dollars on consulting contracts and other types of payments to them and numerous other prominent surgeons, according to papers filed as part of a whistle-blower lawsuit. The suit contends that some of these payments were made to attract or retain the doctors' business.


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3 - whitkat   23 Dec 2007 @ 4:27:46 PM 

In a perfect world, FDA trials of  drugs and medical devices would catch and cause any potential hazards before the general public is involved.  Of course, the FDA gets criticized because its protocol for approving new meds and other devices is longer than European counter parts.

Medtronics is offering some compensation for the patients who need their defibrillators issue corrected.  It may not be enough and I think the courts will decide that in the future.  But the overall benefit of the implantable defibrillator has been significant.  If it wasn't, cardiologists would be jerking them out by the hundreds.  High risk docs like cardiologists have high enough med malpractice without leaving themselves  open to more suits due to a device that is more apt to kill a patient than not. 

The five deaths attributable to the leads is a tragedy, but that is a small number compared to other issues that can lead to death in high risk patients.  Many more patients have died as a result of non-cardiac related problems after the implant such as sepsis or pneumonia.

To implant or not is the question and here are the statistics:  in three year studies patients who are only treated pharmolcolgically reduce their risk of a heart-related death by 5% while the ICD patient's chance of a heart related death is reduced by 30%. 

The most important thing is to have a cardiologist who evaluates each patients needs and does what is right for that person and an informed patient who has an open dialogue with the doctor.

WK


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4 - salon   23 Dec 2007 @ 5:30:09 PM 

With you that every person has to decide, in consultation with his or her physican, what medical procedures to follow. It's good when all facts regarding potential faulty merchandise is out there where people can make informed decisions and weigh risks for themselves, and I applaud Medtronic for putting out the release about that particular problem with defibrillators. That said, I'm not impressed with them as a company.

My beef with the FDA is when I read about delays that come about because of either underfunding or ethical issues.  For example this type of thing regarding Dendreon/Provenge.

three members of Congress are asking the House Energy and Commerce Committee to hold a hearing about the Dendreon/Provenge saga. Dendreon (NasdaqGM:DNDN - News) shares spiked on very heavy volume.

The trio want an investigation into alleged conflicts of interest by two of the outspoken doctors who sat on the FDA panel that reviewed the prostate cancer drug and who voted against recommending approval of it. The targets are Drs. Howard Scher and Maha Hussein. The letter doesn’t detail any specific allegations against Dr. Hussein, but it does point out that Dr. Scher was the lead clinical trial investigator for a prostate cancer drug from the biotech Novacea (NasdaqGM:NOVC - News) and that he has a relationship with an investment fund that owns or owned NOVC shares. That stock tanked last month on negative news about that drug. 

You can read the Congressmen's letter to the Committee Chair, Rep. John Dingell (D-MI), here.

Incidentally, Whitkat, wishing you and your family a wonderful holiday season!


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