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.

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 Heart of the Matter

by Beth Hawkins

Photos by Raoul Benavides

The normal adult human heart weighs about 11 ounces and resembles a fist in size. As every schoolchild learns at some point, blood enters the right side of the heart carrying carbon dioxide, travels to the lungs to be re-oxygenated, and exits out the left side. A body at rest propels some six quarts of blood per minute through the circulatory system in this fashion. Under exertion, the volume may reach 36 quarts. The electrical impulses that spur each heartbeat cause one muscle after another to contract, raising the pressure within successive compartments of the blood-filled heart. As the pressure in each chamber rises, the blood pushes open a valve that lets it rush into the next chamber. The leaves of tissue then shut, preventing the blood from flowing backward. These flaps are thin and delicate, but deceptively tough: They must open and close 60 to 90 times a minute, more than 100,000 times a day.

Tom Hatch's heart had logged nearly two billion beats before anyone suspected there might be something wrong. He was 54, a married father of six and a carpenter who took good care of himself. His blood carried enough oxygen to his muscles and organs to allow him to Rollerblade and to ski cross-country competitively. For most of his adult life he hadn't had health insurance; he'd never needed it.

But Hatch had come down with rheumatic fever as a child, and when he reached his 50s, his wife started pestering him to have his heart checked. A complication arising from untreated strep infections that was more common before penicillin, the illness causes calcium deposits on the heart valves of half of all sufferers.

Eventually Hatch gave in. The doctor he saw thought his heart sounded good, but sent him for an echocardiogram anyhow. He went home expecting to hear that his wife was a worrywart. But when the doctor called, it was to say that Hatch's heart wasn't beating correctly. She wanted him to report to the ICU for drugs and tests. Hatch tried to dismiss her, speculating that he was probably just upset. He'd relax with a couple of glasses of wine and everything would be fine. But somehow he knew better. Inside, he panicked.

The cardiologist insisted that the situation was critical. His mitral valve, the one that ushered blood into the left ventricle, was caked with calcium. The narrowed passageway prevented enough blood from getting through. Doctors tried several treatments, but over the next year Hatch's condition worsened rapidly.

On October 20, 1998, a surgeon at the University of Minnesota replaced Hatch's mitral valve. In his office before the surgery, he showed Hatch a model of the prosthetic replacement. A circle of pyrolytic carbon spanned by two flaps of the same tough material, it was surrounded on the outside by a polyester cuff called a sewing ring. The surgeon would sew through this ring to stitch the artificial valve to the heart muscle. The operation had been performed successfully for decades.

There was one small but ultimately devastating variation between the valve the surgeon showed him and the updated version he actually implanted in Hatch's heart. On the new one, the sewing cuff was covered with silver, a design change that the manufacturer hoped would help ward off infection. Hatch doesn't recall hearing this detail, but says it wouldn't have registered if he did. "It looked all right to me," recalls Hatch. "This is what they were recommending, and he was the expert."

Most people in Hatch's situation feel the same way, thankful they live in a time when their doctors have a vast array of options for repairing and replacing parts of the body. Some 25 million Americans have some form of prosthetic implant, and the devices are growing in sophistication. Some pacemakers can now phone doctors to report a heart's beats and receive adjustments, if needed. Much of the technology is nothing short of miraculous.

But, as Hatch was to learn, the U.S. system for identifying bad medical devices and protecting patients hasn't kept pace with the science. On the heels of a number of high-profile failures in the last couple of years, the industry and the Food and Drug Administration are in the throes of a crisis. Most notoriously, Guidant has come under investigation for reportedly first failing to report a potentially deadly flaw in 11 of its implantable defibrillators, and then continuing to sell existing stocks of the faulty model even after it had changed its manufacturing process to eliminate the defect. (While these troubles were unfolding, Guidant was also the object of a pending $25 billion takeover.)

The FDA, meanwhile, is increasingly under fire for making questionable concessions to the industry. Last year, for example, the agency approved an application for an implantable electrical nerve stimulator to treat depression despite staff reviewers' objections that there was no evidence the device worked. Understaffed and overwhelmed, the agency has been criticized repeatedly by congressional investigators and consumer advocates for allowing the industry to police itself.

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."

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.

"I think what I expected was that they would have a physician, or a cardiologist or surgeon, who I would see and who would monitor my condition, at their expense, for the rest of my life," he continues. "And that they would make determinations based on the tests that they would run as to what was to be done with my heart valve. That's kind of what I thought in the back of my mind, but of course that was kind of Pollyannaish because what would it cost for them to monitor 36,000 people? They don't want to do that because we're probably talking several thousand dollars a year per person."

In the months following the recall, St. Jude volunteered to pay Hatch only the cost of diagnosing or ruling out paravalvular leak, and then only expenses not covered by insurance. A year later, St. Jude sent him a check for $1,650 to pay for the first test to see whether his valve was leaking. St. Jude had marketed the Silzone as a "premium" product at a cost of about $5,000. No refund was forthcoming.

The size of the check angered Hatch, but not as much as St. Jude's assertion that his clots weren't a side effect of the Silzone. His desire to get St. Jude to acknowledge the risk was more than symbolic. He thought Silzone bearers ought to be told to ask for the kind of monitoring he was getting. What if his own doctor hadn't gone the extra step of ordering the second test that had found his clots? "Perhaps they would have grown or dislodged without treatment," he wrote in a letter to St. Jude. "I wonder if a loose clot would have lodged in my lungs or coronary arteries or in my brain. I wonder if I would be able to write this letter today.... What are my odds? What should I tell my wife and six children?"

After his own clots were discovered, Hatch did some research on the internet and learned that, months earlier, Great Britain had issued a warning about the Silzone based on a study by a Welsh surgeon who concluded there was an increased risk of clotting. Hatch mentioned this to the St. Jude employee coordinating his reimbursement request, but she dismissed it. Blood clots were a normal complication of heart valve replacement, she explained, and St. Jude's own research did not show a statistically significant increase in risk of clotting.

The Silzone went on the market in Europe in July 1997. Within weeks, a Welsh surgeon conducting a study of the rate of clot formation associated with several different artificial heart valves, the Cardiff Embolic Risk Factor Study, began including Silzone patients in his trial. Two years later, he reported a disturbing finding to the British agency that regulates medical devices: Seven of 51 Silzone patients in his study had clearly suffered strokes, and five more were suspected to have suffered them. Only one of the 115 patients bearing the conventional valve suffered clots.

"In my opinion," the surgeon, Eric Butchart, would later summarize his conclusions, "the large differences in thromboembolism [blood clots] are clinically significant and the incidence of thromboembolism after mitral valve replacement is so high that the Silzone valve would almost certainly not have received FDA approval if these figures had been submitted in pursuit of approval of a new prosthesis."

As a result, in November 1999, the British government issued a warning. Acting on the same report, New Zealand withdrew the valve altogether, requiring surgeons to contact each patient for monitoring. (This proved relatively easy: 28 of the 29 Silzones implanted in New Zealanders had been installed at a single facility.)

Unlike the leaking that prompted the recall, clots don't produce symptoms. Butchart asked more Silzone patients to undergo the more sophisticated test that would later find Hatch's thread-shaped formations. The TE echo found plenty of clots, he reported: "More intense surveillance using transoesophogeal echocardiography has revealed asymptomatic sewing ring thrombus in approximately 30 percent of mitral valve replacement patients and cinefluoroscopy has revealed abnormal leaflet motion of the Silzone prosthesis in approximately 27 percent of atrial valve replacement patients, raising concern about pannus [the growth of new tissue] and/or small thrombi interfering with leaflet movement."

Later, after patients claiming to be injured by the Silzone began to file suit, Butchart prepared a report at the request of several law firms pursuing the cases. His explanation for the unusually high number of thromboembolisms his study had found: He had been looking for them.

Thrombus would not have shown up in a clinical trial of the Silzone in human beings, because no such study had been carried out, just a small study of sheep and a 60-day European trial involving 38 patients. The FDA approved the device without further testing, but told St. Jude that if it wanted to claim that the silver coating combated infection, it would have to demonstrate that the improvement was effective.

To this end, St. Jude commissioned a study, dubbed AVERT, that was supposed to enroll 4,400 patients. According to St. Jude materials, AVERT participants were evaluated via regular office visits, phone calls, and mail survey. The researchers were looking for infection, not clotting.

Enrollment in the study was cut short. By the time 800 participants, half of them Silzone users, had signed up, researchers had identified a high rate of paravalvular leak. (As it happened, the Mayo Clinic surgeon who removed Hatch's valve was one of the survey's lead investigators.) They stopped enrolling new patients. St. Jude immediately recalled the valve. In its communications with doctors, the company explained that the panel monitoring AVERT met twice in 1999 to discuss Butchart's findings about clots in British patients. They concluded that the findings "were not statistically significant."

In a written comment submitted for this story, St. Jude points out that thromboembolic events (clotting, that is) are a known complication of all heart valve replacement surgery, regardless the type of prosthetic valve used. "Mr. Butchart's experience with thromboembolic events was reported to St. Jude Medical in late 1998," writes Angela Craig, vice president for corporate relations. "St. Jude Medical thoroughly investigated Mr. Butchart's concerns and the results of this investigation were presented to regulatory agencies worldwide, including regulatory agencies in the United Kingdom and the United States (FDA). The experience reported by Mr. Butchart differed markedly from other centers using the Silzone valve and from that in the AVERT clinical trial, which was a large, multi-centered randomized clinical study which included the Silzone valve.

"The investigators in the AVERT study continue to follow Silzone patients to this day," Craig adds. "The latest data show that there is no evidence of an increased risk of complications for those currently implanted with a Silzone valve versus those implanted with a non-Silzone valve."

Many of the documents filed in U.S. District Court in Minnesota, where jurisdiction over most Silzone-related suits has been transferred, have been sealed because St. Jude deems them "proprietary." Portions of depositions and transcripts that are public suggest that when the cases finally go to trial, there may be further argument about what St. Jude should have known, and how early. Documents on file in federal courts indicate, for instance, that one of five sheep in one of the preliminary trials was found dead with a large clot on its valve, and that this sheep was then eliminated from the study, meaning the FDA never learned of the incident.

Other documents suggest that St. Jude sponsored another investigation, the "top accounts" study, but never publicized the results. Portions of a plaintiffs' deposition on file with the court quote e-mails between a biostatistician who reviewed this study and other researchers noting that thrombosis rates in its data were in the range of Butchart's controversial U.K. findings.

In a report defending the differences between his findings and St. Jude's, Butchart says that after his examination of the AVERT data he can't be sure that reports of clots were even logged prior to the year 2000.

The way Tom Hatch sees it, the debate is no substitute for the thorough pre-market trial that the FDA did not require St. Jude to perform. "I feel like I was their guinea pig to some extent and that it was a failed experiment," he says. "But I paid for it."

According to congressional investigators, some 15,000 companies market nearly 100,000 different medical-device product lines each year. The vast majority of these do not, like Tom Hatch's shiny new valve, have life-or-death powers. As defined by the FDA, medical devices include everything from relatively uncomplicated products like tongue depressors and home pregnancy tests to implantable devices like artificial hips, and life-sustaining things like pacemakers and coronary artery stents.

There were far fewer devices in 1976 when the FDA began regulating the industry, and most were much simpler. The new regulations required manufacturers to provide research showing that new devices were safe and effective, but devices already on the market were grandfathered in. And in an effort to reduce the red tape keeping worthy innovations off the market, Congress agreed that new devices that were "substantially equivalent" to existing, grandfathered-in ones could enjoy a streamlined approval process. The products subject to this fast-track approval have come to be known as 510(k)s, after the statute that spells out this exception in the law.

"You can understand if you have a bandage that's flesh-colored and a bandage that has Mickey Mouse on it, those are substantially equivalent," explains Peter Lurie, deputy director of Public Citizen's Health Research Group and a physician. "No one would be particularly interested in seeing that go through a more elaborate approval process."

But Congress meant for the FDA to scrutinize the most critical category of devices, those that sustained life or could kill the bearer, he adds. "There just really isn't much scrutiny that applies at all to those 510(k)s," says Lurie. "The very basic problem is that they're dealing with a very large volume of material that comes through there. My general impression is that [the] process is being used far more often than Congress contemplated. There is discretion left to the agency about how to assign products, but the way it's been done, the 510(k) has become more the rule than the exception."

The Silzone's basic architecture was that of the most popular heart valve in existence, the St. Jude mechanical valve, which had proven safe and effective for decades, and which is still used quite successfully. Based on experiments run in labs, the company thought that coating the valve's polyester sewing cuff with elemental silver might reduce further the thorniest complication from valve replacement surgery, infection.

In March 1998, the FDA approved the valve—not via the 501(k) provision, but based on the filing of a supplement to the application for the original mechanical heart valve. The processes are legally distinct, but both result in the marketing of a device without full-scale trials. In fact, 98 percent of medical devices are approved without any clinical testing.

In theory, the agency has a process for identifying problem devices that do make it onto the market, a database of voluntary reports from manufacturers, health care providers, and patients. Unfortunately, research by congressional investigators and consumer advocates suggests that as many as 9 in 10 medical-device failures—including severe injuries and deaths—go unreported. One federal audit found that hospitals, doctors, and distributors failed to report some 5,000 device-related deaths to the FDA between fiscal years 1992 and 1995. Some of the failures that were reported weren't entered into the database for up to two years.

According to a City Pages analysis of the database, the FDA has received 411 reports of Silzone malfunctions. (Tom Hatch's valve was not found among the reports.) In 65 of the cases, the patient died. Thirty-eight of the database's reports mentioned thrombus, 27 included reports of TIA (small strokes that can be clot-related), and 18 involved strokes. By contrast, to date only seven deaths have been associated with the 300,000 recalled defibrillators that are the subject of Guidant's current scandal.

Even with the FDA's early-warning system broken, the number of recalls of the most critical devices has skyrocketed in recent years, nearly tripling between 1992 and 2002. Heart devices are recalled most frequently. Manufacturers say the recall rate has increased because the complexity of the devices has, too. The fastest-growing category is so-called combination devices, which marry an old technology—the pacemaker, say—to a new one, like the ability to call a patient's doctor with data about the heart's function.

Virtually all recalls are voluntary, allowing manufacturers much more control over the details of the process. Overworked and understaffed, the FDA prefers this.

"It's so unusual for the government to actually do the recalls that they'd have to create a mechanism to do it," explains Public Citizen's Lurie. "Part of what happens when you have a voluntary recall is you get to set the terms of the recall. So let's say the government feels that the following five models of the device should be recalled. But you, the company, think that the fifth one has a lower risk, perhaps, and might be a big seller. So you say we're going to voluntarily recall four of them. And that leaves the FDA sort of saying, 'Well, do we want to make a big fuss about the fifth? We're getting most of what we want.' It makes it likely that the government will compromise and put up with it."

The companies, Lurie adds, can say they are being good corporate citizens. "And it allows them to keep the government out of the whole process in the course of which the government might learn additional information which the company might [prefer] never see the light of day."

Despite repeated warnings from Congress, the FDA still does not require device makers to notify recipients of recalls. For years after medical devices were first regulated, the agency did not require their makers to track who received them. In November 1986, the Bjork-Shiley heart valve was recalled after 389 reports of fractures in the struts holding the device in place; 248 people died as a result. There were 23,000 of the valves in use, but the manufacturer, Shiley, Inc., could identify only 14,000 recipients.

In 1990, Congress gave the FDA two years to establish a system for tracking patients with implantable devices. In keeping with its history of arm's-length regulation, the agency passed the buck, requiring device manufacturers to maintain databases only of patients who have the most crucial life-sustaining implants. When a device is recalled, manufacturers notify only doctors—a dramatically lower standard than when a stroller or a car part fails.

It's Lurie's opinion that the FDA ought to require companies to notify individual patients and should demand a say in what they are told. "The history of the device companies is not an honest one when it comes to this," he says. "What you really want is very careful control over the information that's provided and you want some assurance that that information will make its way to the patient, otherwise some doctors will make a paternalistic decision that this doesn't affect their patients and just kind of bury it."

Doctors, he claims, typically don't go through their old charts and call patients. "The doctors probably aren't delighted to be dealing with people who come back and say, 'You implanted this device in me and it turns out to be faulty,'" says Lurie. "At that point, since the doctor is an active participant in the administration of the device in a way that's different from in drugs, I think the doctor develops an investment in the effectiveness and safety of the device that mirrors the manufacturer."

Hatch agrees. "The only reason I contacted [St. Jude] was because I read that the valve had been withdrawn," he says. "Now, they implanted 11,000 [Silzone valves] in this country and I'll bet that there are 11,000 people who didn't see the business section of the paper in January of 2000. And I think that people should know about it."

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.

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.

(Like most medical-device suits in this country, much of that evidence has been filed with the court under seal. Unlike courts in Canada, where Hatch's attorney's research is a matter of public record, courts here routinely bow to industry demands to close files, theoretically to protect trade secrets.)

It may be years before Hatch's case goes to trial, time he would rather not spend thinking about himself as an invalid. "After the first operation I was able to work three or four hours a day, although it would exhaust me," he says. "But certainly since the second operation it hasn't crossed my mind. My wife and I don't go out. We have virtually no social life. I have friends I see and talk to regularly. Some of them have stood by me very well.

"They want to put me on a program where I call in every day and I tell them my weight and I tell them my pulse rate and this and that and they've got all kinds of plans and programs for me to be on and I'm not going with them because I already have a tendency to look at myself as a victim, and if I started calling a medical facility every damn morning at 7:00 or 8:00 in the morning—I'm not ready for that. It's like the nursing home, which I will never go to. My nursing home is going to be a beach somewhere, with a hammock.

"There was a woman who climbed near to the top of Mt. Everest last year with the St. Jude valve who was part of an expedition and they paid for part of that," he says. "Her results with the valve are different than mine." 

City Pages news interns Em Murphy and Neil Munshi contributed research for this story.

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