Did Dr. Norwood Go Too Far? (Part Two)

"He was trying to figure out some scheme, some set of hookups," says Norwood's longtime confidant. It occupied him 24/7. He would sit at the breakfast table, sketching pictures of the heart. On weekends, when he watched football games on TV, he kept a pad nearby in case inspiration struck.

Finally, it did. Norwood would try to turn part of the baby's pulmonary artery -- the one that normally goes from the heart to the lungs -- into a "new" aorta. The right ventricle would pump blood to the body through the "new" aorta. If he then created a passageway between the "new" aorta and the original pulmonary artery, some blood would get to the lungs, too.

It was just a temporary solution, meant to buy the baby some time. The baby's single ventricle was now doing double the work. It would stress out. So after this Stage One rerouting -- what came to be called the Norwood procedure -- doctors would perform another surgery, to give the heart a breather. They would take the vena cavas, which normally return oxygen-poor blood to the heart, and detour them straight to the lungs. In those days, surgeons built the detour in one step; they've since split it into two, both open-heart. In the Stage Two surgery, at about six months of age, they reroute the blood from the top half of the body. In Stage Three, by the age of two, they reroute blood from the bottom half.

Norwood thought his procedure would work, but he didn't know for sure. He had to dive in. There wasn't much to lose, since 100 percent of hlhs babies were dying anyway.

The first operations, begun in 1979, were tough. It took Norwood a while to get his procedure working, and in the interim, kids died. Peter Lang took care of the first 150 infant patients, overseeing them in the icu. "We felt terrible," he says. But they knew it was leading somewhere good.

The families knew it, too, even though their babies didn't survive. "They never got upset with him," says Norwood's confidant. "I think there was actually a feeling they knew they had contributed something important, even though it hadn't worked out well for their child." In 1982, after years of fine-tuning, the first patient made it through the surgeries and lived. Norwood and his colleagues published a landmark paper announcing their discovery.

Then a strange thing happened. Instead of being greeted with hosannahs, Norwood was attacked. Doctors said he was prolonging the babies' agony, and that "compassionate care" -- letting them die in comfort -- was preferable. Norwood stood by his good results.

But even his own colleagues in Boston turned against him. Their resentment had to do, in a strange way, with Norwood's devotion to his work. "I remember [Norwood] in the beginning, sitting in the icu for days, never leaving the side of those patients," says Paula Bokesch, an anesthesiologist at Emory University who worked at Boston then. Norwood wasn't staying with them out of sentiment -- he was afraid other doctors, clueless about the intricacies of the hypoplast kids' alien circulations, would screw things up. If a doctor who wasn't part of Norwood's team tried to tweak a dial, Norwood would tell him to get lost.

"And their response," says Norwood's confidant, "was not ‘Okay' … they held it against him personally."

That was the price of progress, but Norwood stood his ground. He used to compare his situation to a line from Don McLean's "American Pie":

 

The players tried to take the field;

The marching band refused to yield.

There was Norwood and his players, and there was everybody else.

Norwood's troubles at nemours started with a phone call. Last fall, according to a complaint filed with the fda, Judith Guinan got a call from a Nemours doctor, asking her to"sign and backdate" a consent form. The Inquirer reported that the hospital claimed the original consent form "could not be located." The form said that Judith's daughter, Molly, had been implanted with a non-fda-approved stent during a heart operation in 2002. "Neither my husband or I recalled ever seeing it before," Guinan declared in her fda complaint, so she refused to sign.

Concerned, the Guinans filed their complaint with the fda, which launched an investigation. The state of Delaware investigated as well. According to the state's report, Nemours doctors failed to obtain required "informed consent" paperwork in four cases, failed to follow fda regulations covering experimental devices, and also failed in 14 cases to get approval from the hospital's Internal Review Board, which monitors experimental devices. Both doctors were fired, along with the Cardiac Center's administrator, John Walsh. (The attorney for Norwood, Walsh and John Murphy, Norwood's longtime chief of cardiology, claims to have the original consent form, which he says is signed by Kevin Guinan. He also says that Murphy had asked the irb's vice chairman if he needed approval, and the vice chairman told him no.) Since then, at least seven sets of parents have hired lawyers to investigate their cases.

This wasn't the first time questions of informed consent had arisen around Norwood. In 1992, when he was chief of cardiothoracic surgery at the Children's Hospital of Philadelphia, Stephen and Karen Gault took their son Stephen Jr. to him for surgery, not open-heart, to widen his aorta. They signed consent forms to that effect. According to court records, Norwood told them -- 15 minutes before Stephen Jr.'s operation -- that he'd be doing a full-fledged open-heart surgery that the Gaults had been told by another doctor wasn't necessary. Karen Gault later testified that when she asked why, Norwood told her, "I'm the one with the medical background."

During surgery, Norwood stopped Stephen Jr.'s heart using a rapid hypothermic cooling technique he had been investigating in his chop research lab. The morning after surgery, Stephen Jr. had a devastating seizure. He's now a quadriplegic and partially blind. The Gaults sued, and in 2000 the jury announced a verdict of $55 million -- at the time, the biggest malpractice award in state history. (As it turned out, the parties had reached a settlement of $7.5 million just before the verdict was read, so the verdict didn't stand.) During Norwood's decade-long tenure at chop, he was sued at least 25 times, according to court records.

The lawsuits -- most settled, some

dismissed, and some won by Norwood -- didn't seem to sully his professional reputation. The field of pediatric heart surgery is small, and there are maybe 15 big-name surgeons worldwide. Norwood was -- is -- one of them. Cardiac centers bring in big bucks for children's hospitals, so hospitals try to attract name players like Norwood. "He was a huge moneymaker," says Norwood's friend, former hospital administrator John Walsh.

Nemours was lucky to get a marquee player like Bill Norwood. Parents could sense how highly he was valued -- so much that some say he created what one mom describes as a "secret society" that prevented their kids from getting the care they needed when things went awry. And they felt this way even before they discovered that the stents used on their kids were experimental. Kevin Guinan's daughter Molly had a stent implanted for a condition similar to hlhs. According to the complaint filed with the fda, he had trouble getting Molly consultations he thought she needed with specialists outside the Cardiac Center, even though these specialists were at the same location. The center doctors "told us they could handle it," says Guinan. Chris Conway says he tried in vain for four weeks to get his son, Teagh, a GI consult after Teagh received a stent. Conway finally transferred Teagh to chop. Both the Guinans and the Conways are now clients of Philadelphia's Beasley Firm.

"All I can say," says Bill Norwood, "is that the people associated with the Nemours Cardiac Center are so advanced, and so specialized, that they were the best medical care possibilities available." He seems surprised by the families' complaints. "Excuse me? Why in the world would we not use all available resources? We did. Always."

But when Julie Kerr brought her daughter to Nemours for the Stage Two in July, she could see that the atmosphere had changed since her first surgery in March 2003. "The nurses, they were all depressed," says Julie. "They were like, ‘They're dropping like flies. We haven't seen anything like this since we've been here.'" Julie's daughter died on August 21st. In fact, parents who were at Nemours that summer say between eight and 10 children died there from July to September 2003.

They wonder why alarms didn't go off.

To understand, you've got to grasp how the Cardiac Center is unique, and why Norwood set it up that way. Most hospitals are chopped into departments, each with its own chief. Nurses report to the nursing chief, cardiologists to the cardiology chief, and so on. At Nemours, it was different. At Nemours, everyone reported to one man: Norwood. He believes this structure -- which he calls the Programmatic Approach -- lets doctors and nurses be more focused and work more efficiently. As Norwood described it in the 2002 Cardiac Center annual report, "The esprit de corps is remarkable."

He'd been trying to implement this for decades. He tried for 10 years at chop, where he became chief cardiothoracic surgeon in 1984, but he clashed with the hospital brass and couldn't get his hierarchy in place. "There's a tremendous amount of inertia in staid, administrative structure," says Norwood. Finally, in 1994, he left chop to start his own cardiac clinic in Genolier, Switzerland, along with his mentor, Aldo Castaneda. But after two years, Castaneda developed prostate cancer and became too ill to operate. Meanwhile, the clinic's patient base never materialized, and it couldn't stay afloat.

Norwood started getting offers to come back to the U.S. A few "name" places, like the Cleveland Clinic and Case Western, wanted him. But in 1997 he settled on Nemours in Wilmington, according to his friend John Walsh, because Nemours was willing to let him build his dream center.

"What we had here was what we wanted," says Walsh. And what they had was an amazing level of autonomy. They basically wrote their own budgets, and determined their own salaries, which Walsh says were generous but not excessive. Norwood even had a profit-sharing agreement: He was given a pot of money to hand out as bonuses. In 2003, the pot amounted to $2 million, which was distributed among the Cardiac Center's 150 staffers.

For the first time in his career, Norwood had successfully built a "programmatic" center. He had his handpicked team of players. He had control.

But in the end, that control might not have been in his best interest. "Everybody's greatest strength is their greatest weakness," says H. Scott Baldwin, an oncologist who worked with Norwood at chop. "There was no arguing with him, you know. You either saw it his way or you were wrong."

The way Norwood saw it, stents were the wave of the future. Indeed, he and John Murphy -- the cardiologist who implanted the stents, using a catheter that saved the kids from that third open-heart surgery -- weren't hiding what they were doing. Norwood wrote about the stents in his 2002 and 2003 annual reports to the Nemours Foundation board; Murphy presented his findings at professional meetings. There was even a picture of the stent on the Nemours website. Norwood and Murphy thought they had a good idea, and forged full speed ahead. As Norwood said in his 2002 annual report, "The efforts of this Center are always directed at setting the mark."

The stent procedure could end up saving lives -- most of the kids who've gotten it are doing fine. It could also turn out to be a dead end. But there's no way of knowing until years from now. This is where the ethical equations get sticky with guys like Norwood. How much of a learning curve should a doctor -- or parent -- tolerate, considering the potential payoffs down the road? Is it okay for Norwood to keep innovating, just as long as it's not on your kid?

There are no concrete answers, because surgery isn't regulated, even today. Hospital review boards and the fda have yet to challenge the surgeon's essential freedom -- the ability to modify operations at will. Take three reputable pediatric heart surgeons, ask them how they do a Stage Three, and you'll get three different answers.

"I modify all my surgeries all the time," says Norwood. Regulation, he says, would be "a disaster," and "would immediately stop progress." And progress is what he wants -- what he's revered for.

All Norwood needs is permission from the parents of his patients. Case law has established some regulation -- a patient's right to "informed consent." But that's not necessarily satisfied by getting a signature on a form. According to Delaware state law, for a doctor to obtain consent, he has to explain "the risks and alternatives to treatment" that a "reasonable patient" would want to know.

Parents, though, aren't always reasonable. Sometimes, they're simply not smart enough to understand, or too emotionally overwhelmed to pay attention. No matter what a doctor tells some parents, they just won't get it -- especially with something as complex as congenital heart surgery. Norwood says he gave the parents enough information that they understood what was going on, what the realistic possibilities were. "I'm not trying to deceive anybody," he says. Anyway, he insists, informed consent "cannot involve full disclosure of all possibilities. 'Cause all possibilities are contained in 15 volumes of medical text that we can't teach the parents about in a 15-minute conversation. Excuse me?"

Some doctors go to greater lengths to protect themselves. One renowned pediatric cardiac surgeon at a leading institution says that whenever he makes a "significant" surgical modification, he has parents sign a separate consent form. Another heart surgeon, Emile Bacha at the University of Chicago Children's Hospital, says that he's experimenting with a modified hlhs surgery that also uses stents -- but Bacha says he makes sure he gives parents any data he has comparing the traditional surgery to the new one. "We didn't want somebody to come back and say, ‘My child died, and you were doing something experimental, and why did you do it?'" says Bacha. "We wanted it to be explained. We tell the parents, always."

Even if a doctor goes to great lengths to make sure a family understands, it's impossible to know if they really do, says one heart doctor familiar with consent lawsuits: "That's always going to be the subject of controversy and debate."

"It's almost ridiculous how … things can occur in the world of human nature," he continues. "People will say, in retrospect, ‘Well, we didn't understand that.' That's an unfortunate aspect of the system. There's absolutely no way to guarantee anything. You do the best you can."

Still, it's one thing to neglect to tell parents about a surgical complication or a specific risk. It's another altogether to plan to alter an operation and not tell the parents about all the potential risks. That's what some parents suspect Norwood did. That's why Julie Kerr, Michelle Madden and three others have hired lawyer Theresa Blanco.

At least one parent, Suzanne Dant, says she wasn't told anything about changes to the standard procedures. She brought her day-old son Connor to Nemours in June 2001. She says the doctors gave her a brochure describing the traditional hlhs surgeries -- the open-heart kind. After Stage Two surgery, which Norwood performed, Connor developed pleural effusions, the fluid around the lungs. About two weeks later, Suzanne says, she gleaned a disturbing bit of information from a nurse: Connor had been given a "modified" version of the Stage Two. It said so on the hospital's operative report, she says: "I was like, ‘What?'"

Other moms, like Julie Kerr and Michelle Madden, say they were told the new procedures would be different, but didn't understand how, exactly, and weren't given a choice. "They were told: This is the way it's going to be," Theresa Blanco says of her clients.

If given a choice, they might have opted for the standard procedures, because those have very low risks, while there's little or no data on the new ones. The mothers say that Norwood never explicitly compared the risks of the standard surgeries with the new ones. "If you tried to do brand-new procedures in patients who are excellent candidates for standard procedures, that's very hard to do," says world-renowned James Lock, chairman of the department of cardiology at Children's Hospital Boston.

The standard Stage Three operation -- the one Nemours replaced with the stents -- is low-risk. At chop, only two kids died after the Stage Three between 1994 and 1999. The standard Stage Two is also low-risk. At good hospitals, at least 96 percent of kids survive it. This April, the Children's Hospital of Wisconsin reported results of 85 consecutive Stage Two surgeries -- with not one hospital death. Last summer at Nemours, at least four children died who had been given Stage Twos, including one who'd had the surgery two years before. It might just have been a bad group, says a leading pediatric heart surgeon. Still, he says, four Stage Two deaths "seems like more than you would expect."

"It's complicated territory," says Norwood. All his surgical modifications, he says, are "designed with a positive purpose." About modifications to the Stage Two, he says, "They don't increase the risks. It's exactly the same."

Without full medical records for the babies in question -- which the parents have requested from Nemours -- it's impossible to tell whether their deaths were unusual, or to pinpoint what Norwood might have done differently in some Stage Twos. According to partial operative reports for two of the kids and a journal kept by one set of parents, it appears he tried at least two different versions. Even more confusing, Julie Kerr says she was told her daughter's Stage Two would be modified, but the operative report doesn't say it was. Blanco -- who says that four children whose parents she represents developed pleural effusions after their Stage Twos -- is investigating whether a modified Stage Two might have resulted in the kids' deaths.

Norwood says he didn't do anything to cause the babies' pleural effusions -- that his modifications were "not simple, but medically sound." The families and their lawyers, he says, are "so wrong, it's unbelievable."

"Lawyers want money."

Another late-evening phone call to Bill Norwood. It's April 28th, a Wednesday. He is … expansive. "I don't think lawyers, in general, have a large-picture societal view of things," he says. "They are in the bidness of their bidness."

He is very perceptive. Over the phone, he hears that the computer keys of his interlocutor stop clicking whenever he's not talking. He doesn't like it.

"You type down what I think," says Norwood, "and you type down what you think, and we continue this. … Fair is fair."

"You're right."

"Goddamn I'm right," says Norwood.

"It'll take me longer, but I can do it this way."

"That's okay," says Norwood. "Getting the right out takes time. Getting the truth out takes time."

And here's the truth about informed consent, according to Bill Norwood:

"The idea of informed consent from a medical standpoint is wrong. It's a legal term."

But lawyers aren't the only ones pushing for informed consent. Times have changed, and not only in the obvious ways. It's not just that lawyers are in "bidness," and the fda is on a rampage, and the hospital is using the stent controversy as a smokescreen for a bureaucratic shake-up -- which is what Norwood's supporters believe.

The field has changed, too. Back in Norwood's Boston days, there were still big problems left to solve. It's different now. Today, most heart-defect operations have very good results. "Now, it's a matter of refining the technique … rather than enormous leaps forward," says James Tweddell, chief of pediatric cardiothoracic surgery at Children's Hospital of Wisconsin. The mavericks like Norwood have gone by the wayside. The field is full of fastidious surgeons who have had to become expert at managing risk.

And the families, too, have changed. These aren't the Boston moms of 1979. This is a new breed. The new mom has fewer kids, and may have had to try harder to have the ones she does. And she can eat doctors like Norwood alive.

She may not have time to wade through 15 volumes of medical texts, but she's got dsl Internet and online support groups and all the resources in the world to learn the right questions to ask. She wants to know her kid's pulse ox levels. She wants to be told the published risk figures for certain types of operations. She wants, goddammit, to know if her doctor is doing something new -- something he's never tried before. "I think he should be honest with families," says Peter Lang. Especially since the new surgeries, the ones that got Norwood into trouble, were "the kind of things families would embrace," says Lang. "If things don't go well and they feel they've been had, then it becomes bad on many fronts."

Norwood's old colleagues can't believe how bad it's gotten for him. They agree with former Norwood colleague Marco Cavaglia, chief of cardiac anesthesia at a hospital near Milan, who says, "This is just really sad." The controversy, they say, could eclipse the whole of Norwood's career, and they feel he deserves so much more -- a worldwide conference in his honor, a medical school dedicated to his legacy. Even the families are sensitive to the pathos of Norwood's situation. When Nemours moms saw his sentimental quote about being fired in Wilmington's News-Journal -- "I spent half my days crying, and half my days hoping and wishing" -- they sympathized.

"That touched me," says Suzanne Dant, Connor's mom -- Connor, who she says was given a modified Stage Two without her knowledge. "I can't imagine what [the doctors are] going through now. But my other thought was, what do you think the parents are doing? I have spent a lot of time crying. And my child's alive."

Michelle Madden's is not. Nine months after Mykenzie died in the CICU, Michelle is haunted by a problem she can't solve. She thinks she did everything she could for her daughter, but how can she be sure, considering all the gaps in what she knows? According to one operative report, it appears Mykenzie's Stage Two wasn't modified after all. But she knows others were. Michelle doesn't trust the hospital anymore. She doesn't know what might have happened if she'd only done some more Web research, or asked more questions, or transferred Mykenzie to chop.

No. Stop.

But she can't stop.

"I keep wondering," she says, "what if things were different? Would my daughter still be here? What if has me bothered." For Michelle Madden, the world has gotten tough as well. b

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