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Medical Devices: Judge Sits On Other Side Of Bench In Product Liability Case

Posted by Jane Akre
Thursday, April 02, 2009 10:49 PM EST
Category: Major Medical, Protecting Your Family
Tags: Medtronic, Defibrilator, Recalls, Federal Preemption, Riegel, FDA, Medical Device, Heart Attack, Alliance for Justice, Medical Device Safety Act

National Voices: Medical Device Injury, medtronic
Retired Judge Michael Schattman

National Voices : One Story of Defective Medical Devices

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IMAGE SOURCE:  Michael Schattman, Courtesy, Michael Schattman

 

For years, Texas District Judge Michael Schattman sat on the bench in Fort Worth listening to product liability and personal injury cases. 

There was the time a dentist went out for a sandwich during surgery, leaving the drugged, unconscious patient in the chair. When he returned an hour later, the patient was dead.  

Then there was the case when a child died during surgery. During the second week of trial, the charging nurse on the stand surprised everyone when she pulled from her purse the original records on the child, proving without a doubt, that the doctor had changed the chart to cover his behind.  

Now Schattman is considering becoming one of those plaintiffs following four surgeries to install then replace defective Medtronic heart equipment in his chest. 

Just like other plaintiffs, he is prevented from doing so because of a Supreme Court decision in February 2008, Riegel v. Medtronic,  that affirms medical device makers have a shield from litigation. 

The Defective Medical Device

The first time he knew he had a problem was when he hit the floor at night.  The doctor said falling on the floor likely saved him from dying from a heart attack from irregular heartbeats.  

The solution would be a defibrillator, the doctor said, and in August 2006, Michael Schattman got a Medtronic model implanted in his check.  Then it happened again.

He tells IB News, “What was that” he said when it went off the first time.

“After several seconds it popped me again. I thought it’s saving my life, this is a good deal.  I moved on the floor toward the phone. It popped me again. It kept popping, 38 shocks in 50 minutes. 

“After about a dozen, I figured this is not what’s supposed to be happening.  I got to the phone and called 9-1-1. “

He began to anticipate the shocks, he says, and that was the worst part.  A flash, a shock, then a little click. Click, Bang, Shock.  While the EMTs can use a magnet to stop the shocking defibrillator, they don’t know if it’s saving a person’s life, so instead they administer medicine by injection to bring the heart rhythm down.

“In my lifetime, with police related things, they demonstrated tasers. It’s not dissimilar to that. The anticipation is the worst part. You know and you can’t avoid it.”

Before the cardiologist got to the hospital, a representative from Medtronic was there.

“I’m told this is not unusual. The rep may actually know more about the device and its function than the regular cardiologist, though the electro physiologist should be able to do the same thing.”

“The rep told me the machine had not malfunctioned.  ‘I don’t think I had been born with wires and a machine in me to do this,’ I said.  His explanation was the lead had probably slipped off the screw that ties it to the heart. That would indicate the doctor didn’t do the procedure properly. Medtronic was already doing a CYA.”

The next day surgery was performed to correct the lead. By the time he woke up, the Medtronic rep had taken the lead from the surgical theater and sent it to Medtronic.  

“A day or so later I had a lawyer write Medtronic saying you can test it but don’t destroy it. They never sent it back.”  He never found out what it showed.

It was replaced with another Medtronic Lead, this improved version was called the Sprint Fidelis. 

Schattman was later told after he moved Philadelphia that the heart rhythm wasn’t right.  His heart was going lub-lub-dub instead of dub, lub, dub.  No synchronicity he was told.

Schattman was advised to get a pacemaker. His doctor decided to replace the defibrillator that was in him, the one that had gone off 38 times and may have a low battery, with a new model. A Medtronic defibrillator, but the Spring Fidelis lead would be left in.

It was his third surgery.

Medtronic Recall

In October, 2007 his wife told him she had bad news. “You’ve been recalled.” 

On October 15, 2007, Medtronic recalled the Sprint Fidelis leads and the FDA issued a Class I recall –  the most serious type of medical device recall that has a probability of causing serious injury or death.  At that time 257,000 Sprint Fidelis leads remained implanted in patients.  Since his model and serial number were involved in the recall, Schattman had had enough. 

“I want it out” he told the cardiologist, who suggested leaving the Sprint Fidelis lead in.   

When you have a former college friend who heads the Jefferson Medical System’s Jefferson Heart Institute, and insurance to cover surgeries, one can search for the best medical care available, and that’s what he did.

“Fate has no respect for a person,” he says.

Michael Schattman was awake as he watched the doctor remove the Sprint Fidelis Lead.  Schattman had a choice of replacements. One would be another Sprint Fidelis because it’s thin, the other a St. Jude Medical.  “I said let’s try the St. Jude because he’s the patron saint of hopeless cases” says Schattman.   

Today at 62, Schattman is told he’s 90 percent pacemaker dependant. He attributes that to the 38 shocks. He never had that before.  

Expense For All To Pay

Four surgeries in 15 months at a cost of about $40,000 each is just the financial toll so far. but it might be a good place to start  in the effort to reform the rising cost of health care, he believes.   

“I don’t pay all of it but somebody pays it. I pay my part, insurance pays their part. Hospitals eat part of the bill. Doctors get paid. When Medicare pays money, you and I are paying for it.  All sorts of people are paying out huge amounts of money for something that looks like it was completely avoidable, and certainly Medtronic knew there would be problems.”

Does that rise to the level of criminal conduct?   Schattman thinks it might, and the federal preemption argument as decided by Riegel decision that is preventing medical device lawsuits around the country, such as his, would provide no shield against criminal charges. 

“That’s something Medtronic needs to keep in mind,” he says.  

Medical Device Safety Act

In the meanwhile, he’s actively supporting the Medical Device Safety Act of 2009, until it is nullified, aware that patients like him are prevented from bringing an action in court.   

“If there is something wrong in the manufacturing process, if information is withheld from licensing agencies,  people who are injured by those medical products, drugs or devices should have recourse in the court system.  The court system is there so you can resolve disputes without people picking up a brick and beating on each other.  When you deprive people of that, in this country, you have destroyed the expectations people have and confidence and trust in government.” #


5 Comments

Anonymous User
Posted by JOAN PETTY
Friday, April 03, 2009 12:29 AM EST

Well it is about time someone in the court system realized how bad things are when it comes to medical devises and prescription drug ACT. The part of the FDCA Act that was omitted. Preempted by congress in 1962. Congress needs to correct the FDCA Act and include product liability for a medical devise and prescription drugs that damage or kill innocent Americans. There is no remedy for any product liability for medical devise or prescription drugs. Is anyone listening????

Anonymous User
Posted by Suzanne McClain
Friday, April 03, 2009 12:43 AM EST

I am wondering if it was even legal for the Medtronic rep to take the lead from the surgical theater and send it to Medtronic? Who had the authority to authorize that, and was Judge Schattman given the option to approve or disapprove that decision in advance?

Our medical system is in a sorry state of affairs, and needs a total overhaul. Frankly, I don't believe that medical reps should be allowed in a surgical theater without prior patient approval. They are neither doctors, nurses, anesthesiologist, etc. . . nor do they have any business being present in this genre. Ludicrous!

Posted by Jane Akre
Monday, April 06, 2009 11:25 AM EST

A very interesting report was released on this topic recently. From the Center for Justice and Democracy - It reports on thousands of injuries and deaths from medical devices and urges support for the Medical Device Safety Act of 2009 to restore patient rights.

See the report: "Heart Sick"

LINK

Anonymous User
Posted by JILL PAUL RN
Monday, April 06, 2009 2:45 PM EST

Judge Schattman, I am very sorry that this had to happen to you and I am very grateful that you have come forward and have revealed your harrowing experience from a faulty medical device. Unless you have experienced it yourself, or watched a loved one go through it, it is very difficult to accurately relay to others, how debilitating those shocks from a faulty device can be. I watched my husband suffer 37 horrific shocks from his fractured Sprint Fidelis lead 5 months ago all the while "screaming" "just kill me"!!! As a seasoned RN, I never felt so totally helpless to do something for him to releave his pain & suffering. I was shocked when I touched his hand. 2 surgeries later at a cost of $150,000, he now has a new & improved Pacemaker/ICD which, from what I am reading, has never been tested by the FDA. There is an ongoing petition to support The Medical Device Safety Act - 2009 - S540/HR1346 which can be found at:
LINK
I urge everyone who has been injured, or, has had a loved one injured by a faulty medical device, to sign it and post comments. `The petition was started by Josephine McKee who received 56 horrific, inappropriate shocks from her faulty debibrillator. I also urge anyone reading this to contact their respective Congressmen/Women & Senators to support and co-sponsor "The Medical Device Safety Act" so that you, your Children & Grandchildren will not have to endure the pain and suffering that we have had to endure. Thank you.

Anonymous User
Posted by NLS
Friday, April 10, 2009 8:53 PM EST

This is the result of the tort reform movement led by the Chamber of Commerce and corporate America. If citizens were fortunate enough to pass the Medical Device Safety Act corporations still have a way to protect themselves form legal action in our court system. They can simply add a well written predispute binding mandatory arbitration clause naming the arbitration service that must be used. Everyone should also support the Arbitration Fairness Act of 2009 if they want to regain their 7th amendment rights.

Comments for this article are closed.

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