Medtronic Pain Pump Lawsuit Brought By Paralyzed Man Dismissed

A federal court has upheld the dismissal of a product liability lawsuit brought by an Arizona man who was allegedly paralyzed due to problems with a Medtronic pain pump.

The U.S. Court of Appeals for the 9th Circuit ruled that Richard Stengel is unable to sue Medtronic over its SynchroMed EL pain pump, because a 2008 Supreme Court decision shields medical device manufacturers from lawsuits as long as their device went through the FDA’s pre-market approval process.

Although the Court of Appeals described the ruling as “harsh,” the judges indicated that they had to follow the precedent set by the U.S. Supreme Court.

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According to allegations raised in the Medtronic pain pump lawsuit, Stengel was using the SynchroMed in 2005 to deliver medication to his spine through an intrathecal catheter when he developed inflammation around the catheter tip and his spine due to design defects with the device. Damage from the inflammation has rendered him permanently paraplegic.

TheĀ 2008 Supreme Court decision in Riegel v. Medtronic found that product liability lawsuits against medical device manufacturers are pre-empted by federal law if the device was approved through the FDA’s pre-market approval process, the most stringent process a medical device can undergo before being sold in the U.S.

The decision has been widely criticized since the FDA is not equipped to be the last line of defense for product safety, and critics argue that ultimate responsibility for the safety of medical devices should fall to the manufacturer.

As a result of the ruling, manufacturers have been able to escape responsibility for injuries caused by dangerous defects associated with products they sell, even if there is evidence that the company knew or should have known about the problems.

Although legislation has been introduced in recent years to restore medical device product liability lawsuits, such efforts have not made it through both the U.S. House of Representatives and U.S. Senate.

6 Comments

  • ThomasDecember 1, 2014 at 4:08 pm

    Thomas, The guy from April 3rd 2014, I have had problems with my first pump which shifted and moved and the cathador came apart from the pump and I was always sick and so on. Lost over 70lbs.. Plus the pump was broke. Now I have a stimulator and where he screwed into my upper spine to mount the leads I have had nothing but problems and a major set back in my life style. We should maybe contact eac[Show More]Thomas, The guy from April 3rd 2014, I have had problems with my first pump which shifted and moved and the cathador came apart from the pump and I was always sick and so on. Lost over 70lbs.. Plus the pump was broke. Now I have a stimulator and where he screwed into my upper spine to mount the leads I have had nothing but problems and a major set back in my life style. We should maybe contact each other if your comfortable because I wo like to get to the bottom of all this and file suit against the people responsible. All this is BS, I've lost my family and most of all a lot of thing I use to enjoy doing in life. Let me know if you or anyone else is interested in communicating.

  • StaceyOctober 4, 2014 at 4:16 am

    Does anyone know if their model number was 8637-20 on any of the pumps they had problems with?

  • ThomasApril 3, 2014 at 3:01 pm

    My pump locked up ,and doctor had three meds mixed together in pump ,I have looked the meds up on the FDA site for the pumps ,my pump locked up all most full of these meds and got back with the doctor the stupid alarm went off every hour and there was no way for the pump to be completely turned off and was a few months before getting the piece of junk out of me can ya beleve this and was replaced [Show More]My pump locked up ,and doctor had three meds mixed together in pump ,I have looked the meds up on the FDA site for the pumps ,my pump locked up all most full of these meds and got back with the doctor the stupid alarm went off every hour and there was no way for the pump to be completely turned off and was a few months before getting the piece of junk out of me can ya beleve this and was replaced also the doctor only gave me one of the meds to take when the junk did this and now have been playing the game of waiting to get my stimulator fixed over a year now and still waiting. HUM

  • MarleneJanuary 5, 2014 at 12:55 am

    My boyfriend has had 2 pain pumps fail in 4 years. The last one was on a recall list but a he was never advised to have it replaced before it failed and through him into drug withdrawal. That was a terrible experience for both of us. I am going to launch a letter writing campaign to my congressmen to reinstate product liability lawsuits on medical devices. Why should they be exempt? I urge every[Show More]My boyfriend has had 2 pain pumps fail in 4 years. The last one was on a recall list but a he was never advised to have it replaced before it failed and through him into drug withdrawal. That was a terrible experience for both of us. I am going to launch a letter writing campaign to my congressmen to reinstate product liability lawsuits on medical devices. Why should they be exempt? I urge everyone who has been affected by medtronic to write letters and demand a change in favor of the victims of pain pumps.

  • BeckieJanuary 2, 2014 at 12:18 pm

    I am trying to find how I can go after Medtronic for the 5, yes 5 pain pumps put in me, and taking them out. I even had a malfunctioning pump. I awoke in so much pain and a bubble the size of my fist on my back, More bubbles started popping up. When I reached the hospital I was told that my pump failed and the lead was what caused the massive bubbles on my back. i am just so tired of the b.s. wh[Show More]I am trying to find how I can go after Medtronic for the 5, yes 5 pain pumps put in me, and taking them out. I even had a malfunctioning pump. I awoke in so much pain and a bubble the size of my fist on my back, More bubbles started popping up. When I reached the hospital I was told that my pump failed and the lead was what caused the massive bubbles on my back. i am just so tired of the b.s. when it comes to pain pumps

  • EricDecember 1, 2012 at 5:43 am

    In 2009 I had my Medtronic pain pump fail it shut down with no warning until pain escalated then it alarmed speratically/ The same model was reimplanted in emergancy surgery, Medtronic failed to give my physician an explaination for the failure even after he returned the unit to them and requested explaination. I now received another letter that the pump can fail but Medtronics is not recommendi[Show More]In 2009 I had my Medtronic pain pump fail it shut down with no warning until pain escalated then it alarmed speratically/ The same model was reimplanted in emergancy surgery, Medtronic failed to give my physician an explaination for the failure even after he returned the unit to them and requested explaination. I now received another letter that the pump can fail but Medtronics is not recommending replacing it. I have had one failure I don't think I want to antisipate the next one. I also just read that there is no security on these devises and that the proverbal "hacker" can alfter the unit via his computer putting all patients of this devise at risk, not only from failure but security risks. Not sleeping well with this information from Medtronics until I get into my doctor for an exam of the devise and its componants.

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