Injured Infuse users struggle to get their day in court against Medtronic

  • Article by: Jim Spencer , Star Tribune
  • Updated: July 8, 2013 - 2:20 PM

Constitutional concept, device law and Supreme Court rulings stymie suits.

  • 6
  • Comments

  • Results per page:
  • 1 - 6 of 6
hjlazniJul. 7, 13 8:53 AM

Please provide pictures and/or drawings of spine area with cages and infuse.

1
0
publicvoiceJul. 7, 13 9:24 AM

This excellent article reveals yet another example of privatized gains and socialized losses in the health care industry. Device firms, physicians and hospitals make money from these products, but the human and financial cost of harm from product failure is socialized. Individuals, families, and society pay for repeat surgeries to repair the damage from faulty devices in the form of higher insurance premiums or Medicaid/Medicare costs; lost worker productivity if the person harmed is still able to work; disability payments if they are unable to work, and myriad other costs. A market economy works -- and the public benefits from safer products -- when the cost of harm is privatized. When firms bear the cost of harm from their products, they are more likely to ensure their products are safe and worthy of being implanted in humans. The worst outcome is the status quo: harm with no accountability. Rosemary Gibson Senior Advisor, The Hastings Center Author, Wall of Silence, The Treatment Trap, Battle Over Health Care, Medicare Meltdown

5
3
danwalterJul. 7, 1310:41 AM

Thank you for this story. Regulation of the medical device industry is a prime example of how this country is run by and for business interests at the expense of the public.

4
2
chalankanoaJul. 7, 13 5:45 PM

There are two sides to every story. Not all Medtronic Infuse outcomes are bad. I spinal fusion surgery on L5/S1 using Medtronic Sofamor Danek Technology (using Infuse, Capstone PEEK spacer, bone allograft) for a Grade 2 spondylolisthesis (slip disc), and it is a life changer. My spine has been stabilized, and I no longer have 24/7 pain. It has been seven years since I had this surgery, and I would do it again under the right circumstances. My surgeon considered surgery as the last resort, and we've have exhausted all non-surgical interventions first. The key is clear and accurate diagnosis. Two people can have similar conditions with two totally different outcomes. You are really at the mercy of the skill of a surgeon. What you don't want is a hardware salesman which my second opinion doctor was. The first opinion doctor told me I didn't need to know the details. I pretty much had to be my own best advocate by doing a lot of reading and researching before I found my third doctor who did the surgery on me. What will be interesting is if the feds can get a comprehensive statistical analysis of how many people actually had successful procedures using these technologies versus those whose outcomes where otherwise. Are we talking about 1/4% or 10%? It does bother me that there are no stringent regulations where this product is being used beyond the scope of FDA approval. Spinal surgery is big business.

0
1
explanthisJul. 7, 13 7:24 PM

Thank you, Jim Spencer, for this informative article! When all the research and post-market results are kept as proprietary by the product manufacturer patients cannot give informed consent to medical device implant surgery. The legislation that created FDA regulation of medical devices is antiquated (circa 1976). The industry is wagging this dog and our government must take the reins. Patient harm is mounting and trust in our medical providers is permanently eroding because of a few 'bad actors'. Medtronic cannot use public relations to distance itself from preventable lifelong injury that the public is left to remediate with increased support of the injured and their family . . .

1
0
dhenkelsJul. 9, 1310:05 AM

If anything they should be going after the FDA. An agency that is completely political and not looking out for the best interests of the citizens it was created to protect. I personally would feel better about companies self policing than the crap the FDA allows and doesn't allow based on what political candidate the business might have supported. Medtronic is out to make money, until they are told to cease and desist on what they are doing by the agency that is supposed to be overseeing them to you really expect them to stop? Not the way things are these days.

0
0
  • 1 - 6 of 6

Comment on this story   |  

ADVERTISEMENT

Connect with twitterConnect with facebookConnect with Google+Connect with PinterestConnect with PinterestConnect with RssfeedConnect with email newsletters

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT