Medical Safety Act of 2009 Article

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Medical Safety Act of 2009 Article

Post by Helen » June 18th, 2009, 9:05 am

"Drug Injury Watch" - 1 new article

June 18 Congressional Subcommittee Meeting About Medical Device Safety Act of 2009
This Bill, If Passed, Would Restore An Injured Patient's Right To Sue AÂ Medical Device Manufacturer By Reversing Riegel v. Medtronic Ruling

(Posted by Tom Lamb at

On June 18, 2009 the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009 (H.R. 1346).

This June 18 hearing has been titled "Medical Devices: Are Current Regulations Doing Enough for Patients?" It is my understanding that this hearing is intended to be a follow-up to the Health Subcommittee's May 12, 2009 hearing on H.R. 1346.Â

At this June 18 hearing I hope the idea of keeping medical device patients safe by maintaining "complementary" systems, i.e., the FDA and our civil court system, is stressed and understood. In order to insure that our medical devices are effective and safe we need both a rigorous FDA device-approval process and court access when a defective device harms a patient.

Unfortunately, as a result of the United State Supreme Court's decision in the Riegel v. Medtronic case -- which was handed down in the first part of 2008 -- injured patients are currently barred from going into the court system and holding medical device manufacturers legally accountable for an injury caused by a defective device, e.g., Sprint Fidelis lead wire malfunction victims.

From my perspective, this current situation is not fair to injured patients and that is why we need Congress to pass the Medical Device Safety Act of 2009 into law. Simply put, this bill would prevent medical device manufacturer from receiving total immunity as regards any patient injury claim simply by pointing to the FDA's prior approval of its device. Instead, if passed, the Medical Device Safety Act would allow an injured patient to recover legal compensation when her injury was caused by a defective medical device.

What do you think about this issue of whether the federal preemption doctrine should be applied so as to prevent injured patients from suing a medical device manufacturer?
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Re: Medical Safety Act of 2009 Article

Post by don » June 18th, 2009, 7:55 pm

Well, you asked what we thought, so here it is.\

First off, I don't believe in lawsuits except in extreme circumstances (death, permanent disability). My first ICD was defective and I had to have it replaced. I currently have the Fidelis leads. Yep, it could cause me a problem.

We have devices implanted in our chests. Let's get real here. Devices fail. Refrigerators fail, automobiles fail, dishwashers fail, etc. Electronic devices fail. Our computers go out, our TV's go out, everything is subject to failure.

I think this is just something we have to understand when we have these devices implanted. The manufacturers don't want them to fail. The FDA doesn't want them to fail. We don't want them to fail. Everyone tries to test the devices before they are implanted to keep failure at a minimum, but it still can and WILL happen.

Should a person be barred from suing? Absolutely not! Should the government be involved? Absolutely not! The government screws up everything it touches. I, for one, don't want them involved in my business. But!! Let's look at facts. The manufacturers subject their devices to rigorous testing to keep them working. The FDA monitors and regulates these tests because they don't want the devices to fail. Are they still going to fail? You bet they are!! It's the nature of the business. Despite the best efforts of the manufacturer and the government there are going to be devices that fail.

A few years ago I was strongly in favor of lawsuits against a particular manufacturer. My support of the suits wasn't because the devices had a problem, it was because the manufacturer tried to cover up the failures and continue to provide the defective devices to unsuspecting patients. That's a horse of a different color.
Every case is different and I don't want the government involved it it.


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Re: Medical Safety Act of 2009 Article

Post by maddytormoen » December 27th, 2014, 9:42 pm

I had the sprint fidelis lead and agreed that I would be dead without Medtronic so did not become part of the class action lawsuit. I regret it now. My lead broke one and a half years ago, and due to Medtronic tech's and doctor mistakes for a four-year period, my alarm did not go off and I got a bunch of unnecessary shocks. Through my own investigation I learned how Medtronic works hard to not deal with mistakes made. I see it all very differently, given how rude the doctor that made the original mistake was, and how professionals seemed to want to pretend no mistakes happened and I simply had to live with it all. I can't even write all the mistakes and unethical acts done, as it would take too long. There is too much money in all of this for it not to be monitored appropriately. Without monitoring of large money enterprises, unfortunately we have corruption. The FDA is not doing enough in my opinion. I had to call them back as they did not put my adverse event in their data base even though I reported it in full with all information they needed. I think they just want to keep their numbers low. A bad situation.

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Re: Medical Safety Act of 2009 Article

Post by TruckerRon » December 28th, 2014, 1:09 am

Instead of relying on yet more government intervention, I support the idea of device manufacturers, like doctors, being held liable and therefore purchasing liability coverage from private insurance companies. The insurer would then, like auto insurance companies dealing with bad drivers, adjust their rates according to the manufacturer's track record.

What do y'all think?
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Re: Medical Safety Act of 2009 Article

Post by maddytormoen » December 28th, 2014, 11:54 am

Makes sense to me. Something, as Medtronic has so many employees running around, and if they are not going to be responsible for their actions they should not be in surgery rooms and handling medical situations, making decisions, etc. My doctor stated to me the Medtronic rep is in surgery to "Make sure everything goes alright", then Medtronic says "they only do what the doctor tells them to do and carry no responsibility". I look at Medtronic very differently now. And the Director of the defibrillator division "doesn't talk to patients, because he does not get paid for that" according to one employee. I wrote him a letter and he refused to speak to me or respond himself. I could only speak to one person, the supervisor of patient representatives, and she was not too pleasant or interested in my well-being. Simply wanted me to blame the doctors and leave Medtronic out of the picture when it comes to responsibility (my opinion).

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Re: Medical Safety Act of 2009 Article

Post by David882 » December 31st, 2014, 8:06 pm

There is a book titled "Failure to Learn, the BP Texas City Refinery disaster" by Andrew Hopkins.

It is an interesting read because one gets tremendous insight into the inner working of BP and the safety program. As well it is not written in techno safety speak. Instead Dr. Hopkins wrote it for the non-technical reader in English or rather that Australian brand of English. (had to say that Ozchrissy lmao4dx )

The reason the details are in this book is because Eva Rowe would not settle out of court. Her husband died and she wanted the hard facts out in the open. She was a rather strong and courageous person. BP did not make it easy for her.

One of the interesting things about the BP safety culture was the ability to ignore prior mishaps like the Longford disaster. Recent events in the Gulf of Mexico would indicate the BP safety culture still struggles.

Because the makers of medical devices are effectively protected from legal actions there is limited if any chance that we will ever have insight into the configuration management or system safety tests/methods used. It is my view that visibility breeds compliance and honesty. I personally dislike the court system as a means to protect patients and assure that they are not treated as disposable test subjects. However, with such protections in place I am not sure such insight will ever be provided.
With Respect,

11 Sept 2012 / Idiopathic Ventricular Fibrillation
At about 2AM I started storming at home, and in the ambulance, and in the ER.
Sometimes I restated and sometimes I had to be defibrillated.
A number of times I went into arrest and stopped breathing.
External defibrillation count exceeded 18 and at some point the team induced a coma.
24 hours later I was revived and have never had another event.
13 Sept 2012 / Medtronic ICD was implanted.
My diagnosis is still idiopathic.

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