The Heart of the Matter

If there were a problem with a life-saving medical device implanted in your heart, someone would tell you, right? Tom Hatch thought so. He was wrong.

After his blood clots had finally been safely dissolved, Hatch developed an irregular heartbeat, requiring his doctor to periodically shock his heart back into normal rhythm. After a few years, the electrical jolts lose their effectiveness. And so, in early 2004, his doctor recommended a surgical fix. On June 1, in preparation for the procedure, Hatch had another TE echo.

"They found these blood clots, they were balloons on a string," he recalls. "They couldn't bust those with clot-busters because they would bust the string and there you go."

This time, he says, his cardiologist arranged for his immediate transport via ambulance to the Mayo Clinic, where he had heard there was a surgeon with considerable experience removing Silzone valves. Hatch didn't know it, but in fact the surgeon was one of the lead investigators in the study that prompted the recall of the valve.

Raoul Benavides

In Rochester, doctors spent a nerve-wracking week tapering Hatch off of his regime of blood thinners. He couldn't have surgery while he was on the medication, but there was a heightened risk that during the weaning the clots would break free and cause a stroke.

For 10 days after the operation, he was too stoned on morphine to know how sick he was. "My wife says that I was not progressing as well as the other heart patients," he says. "She was under the impression that the nurses thought maybe I was not going to make it." He was sent home on June 17, but never really recovered.

A few weeks later, Hatch called his doctor and said that he was having trouble breathing. His abdomen hurt, and the inability to draw a full breath was keeping him awake. His pulse was sky-high. The doctor told him he was at risk of having a heart attack and needed to go to the hospital immediately. There an x-ray showed his lungs were half full of liquid. He was suffering congestive heart failure. He went home with medication to slow his heart down and diuretics to help flush the excess fluid.

He was back in the hospital a week later: "I was driving and I had to pull over because I got dizzy. My pulse was 30." His many medications were interacting badly, and he was taken off of some. The next Saturday, he woke up and his pulse was 25. That time he didn't bother to go to the hospital. He just cut out some medications and his heart rate came back up.

When Hatch had his first valve replacement, he had been assured that in all likelihood once the implant was in place, he could be as active as ever. Instead, after two open-heart surgeries and countless other potentially life-threatening procedures, he felt like an old, sick man.

"I have a friend that I have been walking with for years," he says. "We would go in the backyard and walk around the house and that went on for a while and that was as much exercise as I could do. That was it, that was like running 10 miles."

Hatch's health has been better since then, but he tires easily. "I spend 12 to 13 hours a day in bed. I used to walk six days a week for 45 minutes or an hour. Now I walk two or three days a week for a half-hour or 40 minutes. I've gained at least 10 pounds in the last year and I was overweight to start with. My metabolism is apparently very slow. I don't have much endurance or stamina."

The $1,650 St. Jude reimbursed him is a fraction of what's been spent on his care in recent years—$105,000 alone for his second valve replacement. "Every time I get a heart operation we have to get different insurance," he says. "My wife works at a private school and so it's a small group and the rest of them are pretty healthy. My out-of-pocket before they pay a nickel is $2,500, which we paid out in the first five months of the year." Even after his insurance kicks in, he owes 20 percent of each expense up to a ceiling he manages to meet every year. (By contrast, St. Jude was able to write off its $26 million in recalled inventory and expenses associated with the recall.)

After his second valve replacement, Hatch thought about trying again to get St. Jude to reimburse him. "But I couldn't decide how to tone the letter: angry, begging, a victim, humorous, sarcastic, bitter," he says. "So I never wrote it. And then last fall I saw this story in the business section, it says St. Jude is vigorously fighting the valve suits. So I thought, 'Well, no use writing them if they're fighting it vigorously."

He turned to the internet where one telling result of the FDA's laxity is immediately apparent to virtually anyone who types the name of any problem device into a search engine: The number of law firms pursuing Silzone lawsuits is mushrooming. Hatch queried several, ultimately putting his case in the hands of an attorney in Toronto, who filed suit in January in Ramsey County.

Ultimately, his case is likely to be merged with a number of others pressed by people who claim their Silzones caused dangerous clot formation. In addition, there are a number of Silzone class-action suits in state and federal courts in Minnesota, one filed in 2004 on behalf of some 14,000 people in 16 European countries, and another on behalf of 11,000 valve recipients is also underway. One final irony revealed by one of the cases: St. Jude argued that it should be immune because of a legal provision barring suits in state courts over products that received FDA approval. The judge decided in January 2004 that "the evidence against St. Jude showed there are questions that require a trial," according to the publication Medical Device Companies Analysis.

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