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

By Jane Akre

Retired Judge Michael Schattman

National Voices : One Story of Defective Medical Devices

LEARN MORE InjuryBoard News -Medtronic Reveals More Fatalities, April, 2009 Alliance for Justice - Web site  AFJ- Faces of Preemption  InjuryBoard News -Injured Support Overturn of Riegel, April 09 FDA - Recall of Medtronic Sprint Fidelis leads, October 2007 NEJM Editorial  - on The Medical Device Safety Act of 2009,  March 18, 2009 Medtronic letter to physicians March 13, 2009 Introduction of Medical Device Act  IB Help Center- Sprint Fidelis Leads  Medtronic Web site    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." #

Originally posted at Jane Akre

Full post as published by InjuryBoard on April 02, 2009 (boomark / email).