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Sci Tech    H3'ed 9/14/09

Guidant/Boston Scientific Survives Lawsuit for death of 14 month old Infant

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"I didn't think there was any question on how it was going to go," she said. "I thought we proved that they didn't do what they needed to do."

Her father, Jim McGookin, said he also was shocked.

"I can't understand how they came to the decision they came to," he said. "I think our lawyers (May Oberfell Lorber) did an excellent job. They presented our case past our expectations."

Staff writer Jeff Parrott:
jparrott@sbtinfo.com
(574) 235-6320


On the article "Jury rules for device maker in the Wednesday, September 9, 2009 edition we would like to add a little more insight on that lawsuit. It was a wrongful death along with other claims against Guidant Corporation, which was acquired by Boston Scientific in 2006. We will start at the beginning. On April 27, 2004, Samantha McGookin was born in Indianapolis at the IU Medical Hospital. On April 30, 2004, she had an operation to implant a pacemaker. Samantha was the very first infant in the world to receive this new pacemaker. The pacemaker (Insignia Ultra 1290) was introduced in the U.S. market on April 5, 2004, just 25 days before Samantha received her pacemaker. This Guidant Insignia Ultra 1290 was considered one of the best on the market, because of its small size and a new feature called Automatic Capture. This new feature was designed so the battery would last longer and the patient would have to go through fewer surgeries over their lifetime. These pacemakers like all other pacemakers are mostly tested in the adult populations above the age of 60. When a person gets a pacemaker, they also get a product called a lead. The lead is basically a wire that connects the pacemaker to the heart. There are many different types of leads. The two main differences in leads are the way they connect to the heart. The endocardal lead connects inside the heart and the epicardial lead connects on the outside of the heart.
Samantha had a unipolar epicardial lead, which was manufactured by Medtronic Corporation. When Guidant got FDA approval for the Insignia Ultra 1290 it was stated that the device was safe to use with any lead. Guidant did not test the unipolar epicardial leads. Unipolar epicardial leads are mostly used in children and not in adults. Medtronic at the time also had a pacemaker with a feature similar to the Automatic Capture. Medtronic tested their unipolar epicardial lead with their pacemaker and discovered that the auto capture feature was not reliable. Medtronic added a warning on their unipolar epicardial leads, that if these leads are used with a pacemaker using the auto capture feature to turn it off. Within a couple of weeks, Samantha's cardiologist had concerns about the pacemaker. He questioned Guidant about his concerns, and nobody knew the answer to his question; "what does V-ER? mean and "why is the device in Retry mode? It started with the sales representative, he didn't know. The Rep. asked Technical Services, they didn't know. Tech. Services asked the engineers, they didn't know. Engineers asked the person that designed the Insignia Ultra 1290 and he didn't know the answer. They came up with a theory and a possible solution, "tell the doctor to turn the Automatic Capture feature OFF . The only problem was that nobody got back to the doctor to tell him to turn it OFF. So, in the mean time Samantha's pacemaker goes into Retry and stays in Retry for 4 months. Now Retry by Guidant's definition means safe mode. What that means is that if the pacemaker doesn't see a response from the heart, it goes into Retry and sends a larger voltage signal to the heart. When in Retry, more of the battery source is used. The Insignia Ultra 1290 was not designed to stay in the Retry mode, only for safety reasons should it go into Retry. Let me give you an example of what I mean. Most people have a computer, so I hope this makes sense. You are using your computer and all of a sudden it freezes up and crashes. You try to restart it and it will only start in "safe mode and when you are in safe mode all the features are not usable, but it still works. Now, did you buy that computer to only work in safe mode? No, of course not, there is a problem and it needs to be fixed or it will keep going into safe mode. That is the same thing with a pacemaker going into Retry mode. Something is causing it to go into the Retry mode and it needs to be fixed. Nobody cared because it was doing what it was designed to do, go into Retry. The reason it went into Retry didn't matter. On July 9, 2005 the pacemaker went into Retry again and this time Samantha died.
I know this is just the Reader Digest edition of what this lawsuit was about, but I think it covers most of the main points.
Let see if we can simplify it a little more.
Guidant had a new product with new features. The smaller size and the Automatic Capture feature would be great for infants and small children. The only problem was that infants and small children use epicardial leads and Guidant never tested those leads.

The very first infant in the world implanted with their product, being at a children's hospital, where a good outcome, for pediatrics, would boost sales (there is a memo from a Guidant employee stating that very fact).
FDA was never informed that infants and small children where going to be a target population when the Insignia Ultra 1290 was processed for approval and that it did not test it with epicardial leads used for children. Even after FDA approval Guidant did not inform the FDA about using their device on children with untested leads.
Samantha has her pacemaker in for a couple of weeks and her doctor has some concerns. You would think that the very first infant implant, with their new product, Guidant would want to watch very carefully. Instead, nobody has any answers and when they come up with an idea, nobody gets back to the doctor to tell him their idea.
After the doctor raised his concerns and it was discovered that the Insignia Ultra 1290 was never tested with the Medtronic leads that Samantha was using, a employee request a clinical study be done with the Insignia Ultra 1290 and the unipolar epicardial leads in children. This was in 2004 when Samantha was still alive. That clinical study never happened. Guidant had multiple chances to save Samantha's life, but instead ignored all the signs that something was wrong.
One month after Samantha died, another request for a clinical study was requested, and still to this day, none have been done.
We have had four years to look at all the evidence and the jury only had two weeks. All kinds of regulations, statutes and laws were thrown at them, which may have caused confusion or clouded the simple facts.
There are two types of lawsuits, criminal and civil lawsuits. In a criminal lawsuit the defendants have to be found guilty of breaking the law. In a civil lawsuit a crime or breaking the law does not have to be present. There are many different areas for a civil lawsuits, ours was for wrongful death caused by negligence along with some other claims. Here is what our case was about:

Guidant did not test the Insignia Ultra 1290 with unipolar epicardial leads before it was implanted in Samantha.

Guidant never tested the Automatic Capture feature with pediatric patients.

Medtronic had a warning not to use the Automatic Capture feature ON with epicardial leads.

Medtronic's test data and Guidant's V-ER? Code demonstrate similar symptoms and issues. Which could cause a potential of lack of capture resulting in injury or death.

Guidant did not warn doctors that the Insignia Ultra 1290 was not tested with epicardial leads.

Guidant did not even tell their sales representatives that the Insignia Ultra 1290 was not tested with epicardial leads. Sales representatives are the "person to person main source of information for the doctors.

Guidant wanted to enlarge their sales by going into a children's hospital. With the knowledge that pediatrics mostly use epicardial leads and they never tested those leads.

Samantha was the first pediatric patient implanted with the Insignia Ultra 1290.

Guidant did not respond to Samantha's doctor's concerns.

Guidant never told Samantha's doctor to turn the Automatic Capture feature OFF.

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My granddaughter, Samantha, had a Guidant pacemaker implanted in her when she was three days old. She was just 14 months and 12 days old when her pacemaker failed and killed her. Guidant and companies that manufacture life saving devices need to (more...)
 
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