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.

The company that made Tom Hatch's replacement valve, St. Jude, declined to answer specific questions for this story, explaining that it does not comment on pending litigation. But if Hatch's account is ultimately borne out, his case could serve as a tutorial in the problems dogging the companies and their regulators. The valve implanted in his chest was not put through a wide-scale clinical trial before it was put on the market. And when the company was informed that a British study had uncovered a life-threatening complication he would soon develop, it dismissed the research. Other governments quickly issued warnings or took the device off the market; the FDA did nothing. In fact, when the valve was eventually recalled for a different problem, potentially just as serious, the agency didn't even require St. Jude to notify Hatch and other recipients.

Nor did St. Jude pay for the costs associated with diagnosing and treating Hatch's complication, or for replacing the valve in a second open-heart surgery six years later.

As Tom Hatch contemplated the lifesaving slender black ring in his doctor's office eight years ago, he knew none of this. His overwhelming feeling was relief there was a fix. "When they diagnosed me, to me that was a death sentence," he says. "I felt like my life was over. I felt like I was going down the chute, and that was it."

Raoul Benavides

Not so, his doctors said: He could expect to make a full recovery.

It was dumb luck that Tom Hatch found out about his damaged heart in the first place. It was even more amazing that he found out about the problem with his prosthetic valve. On the morning of January 25, 2000, 15 months after his surgery, Hatch opened the newspaper to find a short article noting that an artificial heart valve manufactured by a local company had been recalled.

Hatch (who happens to be the brother of Minnesota Attorney General Mike Hatch) dug up the little card that his surgeon had given him bearing the serial number of his new valve and compared it with information on the maker's website. Sure enough, St. Jude Medical's Silzone was the device snapping open and shut in his chest.

That Hatch saw the story at all was serendipitous. It ran in the business section, which most readers do not track as a source of consumer medical information. Based in St. Paul, St. Jude is one of the crown jewels in a 350-mile-long corridor known to industry insiders as Medical Alley. Stretching from Rochester through the Twin Cities, the zone is home to St. Jude, Medtronic, Boston Scientific, and Guidant, as well as countless smaller medical device and biotech concerns, making it a beat for both daily papers.

The undisputed industry leader in the manufacture of artificial heart valves, St. Jude has sold more than 1.5 million of the mechanical devices since its founding in 1976. When it recalled the Silzone, the company went out of its way to note that the valve was being recalled voluntarily because a study had found a heightened risk of leakage. The silver coating on the valve's sewing ring could damage adjacent heart tissue, critics believed, creating a poor seal.

St. Jude had introduced the coating in the hope that coating the polyester cuff with elemental silver, a toxin, would retard bacteria and ward off endocarditis, a deadly infection that is one of the major complications of valve replacement. The recall affected only unused valves, the company emphasized; Silzone wearers like Hatch should ask their doctors whether they needed to be concerned.

Here he got lucky again. The first test his doctor performed, essentially an ultrasound of Hatch's heart, looked clear. But the image didn't quite show the whole heart, so the doctor took an unusual step: He ordered a second, more exacting test called a transesophogeal echocardiogram, or TE echo, in which a probe is put down the patient's throat. The second test also revealed no leakage, but this time the physician could clearly see three long, string-like growths on the outside of the artificial valve.

More tests brought more bad news: They were blood clots, potential strokes in the making, essentially poised on the edge of a metal gate that snapped open and shut dozens of times a minute.

Hatch started taking more blood thinners, and when that didn't do the trick, still more. Each time, the clots at first shrunk, but then grew again. Over the next few months, he had 10 or 15 more TE echos to check whether the problem was resolved. Finally, in late 2000, the doctor admitted Hatch to the cardiac intensive care unit at Methodist Hospital and ordered an intravenous course of a more potent blood thinner that was very effective, but potentially deadly. One round of treatment shrunk the clots, and a second finished the job. Hatch went home with more blood thinners and instructions to come back regularly to be checked for new clots.

Right after Hatch had seen the article about the recall in the paper, he called St. Jude Medical. "I just wanted to know what was going on," he says. "I wanted to know if they were going to take care of me. If they were responsible. I didn't know what to expect. It was a whole new ballgame.

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