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20/20 Transcripts

============================================= == ABC NEWS 20/20 Transcript #1353 December 17, 1993 HUGH DOWNS, ABC News: Good evening. I'm Hugh Downs. BARBARA WALTERS, ABC News: And I'm Barbara Walters and this is 20/20 ANNOUNCER: From ABC News, around the world and into you home, the stories that touch your lives, with Hugh Downs and Barbara Walters -- this is 20/20. Tonight, the medical device they say ruined their lives-- JOE WILLIAMSON: Steffe Back Screw Victim: I put my wife and child through hell every day, every day, because of this. ANNOUNCER: --back screws inserted in their spines. The FDA insists they were experimental, but these patients never knew it. CARROLL CARDER: Steffe Back Screw Victim: He said "These things are a sure shot. Without it you don't have a chance." ANNOUNCER: Now they live with terrible pain that may never go away, How can this happen with the top doctors, the best hospital: and the government watching?. Dr. DAVID KESSLER, FDA Commissioner: There is a full scale investigation underway. ANNOUNCER: Dr. Timothy JOHNSON with a shocking exposé and a warning that could save you from 'The Secret of the Back Screws." [Commercial break] HUGH DOWNS: It's a fact that 80 percent of us will have hack pain sometime during our lives. Now, for some of those with serious pain, there is a surgical treatment using back screws and every year tens of thousands of people have these screws surgically implanted into their spines. But a 20/20 investigation has uncovered some shocking facts about this technique that have never been reported before. BARBARA WALTERS: Well, first, the FDA says that these back screws are experimental. Patients don't know that and the results can be disastrous. And how can this happen when they are being used by doctors in hospitals across the country? And isn't the govern-government supposed to protect us from this kind of risk? [voice-over] Tonight Dr. Timothy JOHNSON investigates these important- questions. Dr. TIMOTHY JOHNSON, ABC News Medical Editor: [voice-over] Lake Charles is a town of 76,000 people in southwest Louisiana. The area is rich in oil end is just upriver from the Gulf of Mexico, which makes it ideal for oil refineries and chemical plants. But Lake Charles is also the scene of a burning controversy about a medical device for back surgery, a controversy that raises ques-tions about how thousands of patients across the country became virtual guinea pigs. At the heart of this potential scandal are a group of patients in Lake Charles who were told they needed special back surgery, and then ended up with canes and braces and ruined lives after screws and plates were implanted in their backs. Some had previous back surgery that had failed. Others had simple ruptured disks. Un-fortunately, the screws that were supposed to help them broke. CARROLL CARDFER, Steffe Back Screw Victim: It got to where when the plates was in here, it felt like somebody had a knife in my back. MARIE RAYBURN, Steffe Back Screw Victim: My back felt like it was being pulled apart, like something was behind me and something was in front of me, just pulling. JOE WILLIAMSON, Steffe Back Screw Victim: I put my wife and child through hell every day, every day, because of this. JOHNSON: [voice-over] Screws and plates are used in back surgery when there is a concern about the stability of the spine after surgery. In a typical operation, bone from the vertebra is removed. Then, to stabilize the spine, screws are inserted through plates into the part of the vertebra called the pedicle. The risks of the operation are frightening. The pedicle is right next to the spinal column and emerging spinal nerves. If the screws break or are inserted incorrectly, the results can be catastrophic, including permanent nerve damage. And the screws, as first developed in the early '80s, did often break, nearly one in three, according to one early study. They broke so often they had to be repeatedly redesigned. The screws in Willie Gilbert tore his vertebra, causing loss of feeling in his legs and bladder problems. Joe Williamson suffered damage to the nerves leading to his bladder when four screws broke. Carroll Carter had two broken screws that had to be removed. MR. CARDER: And ever since then I've had pain in both of my legs. I can hardly walk. Sometimes a Leg will go out end I fall and it just-- it's ridiculous. JOHNSON: [voice-over] We asked the Lake Charles patients how many have suffered nerve damage hike loss of bladder control or weakness in a leg since the surgery. We then asked the patients how many have been unable to work since the devices were im-planted. Dr. ARTHUR STEFFE, Former Chairman, AcroMed Corp.: We can put those in and they are stronger than a brace. JOHNSON: [voice-over] The men many of these patients blame is Dr. Arthur Steffe, the Cleveland back surgeon who developed and sold the so-called "Steffe screws end plates" to many surgeons. The Lake Charles patients say their surgeons then sold them on the devices. MR. CARDER: And he said, "The only way that it's going to work," he said, if I use these Steffe plates." He said, "These things are a sure shot. Without it you don t have a chance." Mr. WlLLIAMSON: State of art -- this was his presentation to me of my introduction to Steffes. JOHNSON: [voice-over] But after the surgery, the Lake Charles patients discovered to their horror that they were much worse. Their lives had changed dramatically. CAROLYN DOUCETTE, Steffe Back Screw Victim: Well, I was a road runner before the surgery. I was on the go all the time. But since the surgery, I can't. I can't do any of my housework. WILLIE GILBERT, 8teffe Back Screw Victim: I can't tie my shoes. It took me six months to learn how to go to the bathroom, just to learn how because I couldn't wipe myself. MR WILLIAMSON: I've lost my activities with my wife. I have not slept in the same bed with my wife since my surgery of 1986. JOHNSON: [voice-over] For some, the anger has turned to tears. CORNELIUS BULLER: Steffe Back Screw Victim: I'm just--l'm a nothing now. I can't do anything. I can't travel. I can't stand to go across town too much. It's just-- l hurt too much. KENNETH WADE, Staffs Back Screw Victim: They don't know how it feels when your six-year-old son has to come up and ask you, "Daddy, is your Legs hurting?.' And ! tell him, "Yes. Why?" "Cause I wanted to sit on your lap." And you can't let him sit on your lap because your Legs are hurting too bad. JOHNSON: [voice-over] But were the problems with the Steffe devices limited to Lake Charles? Dr. Steffe was asked about the ex-tent of the breakage problem during a malpractice deposition. DR. STEFFE: --The breakage because it's not been a problem. It's only been a problem in your cases. JOHNSON: [voice-over] Not so, according to our investigation. For example, in Philadelphia, we found many patients like this who suffered complications when screws broke following surgery. In fact, when WPVI-TV, who had been working with 20/20 on this story, aired their report last month, the station was flooded with nearly 200 calls, most of them from Philadelphia patients complaining of painful complications. Typical of these Philadelphia patients is RON ROSCI, a truck drive, who has been in almost constant pain since the Steffe screws in this back broke in 1986. He hurts when he walks. He hurts when he's sitting down. He even hurts when he's in the whirlpool for therapy. Ron's pain was very visible during our interview with him and his wife, Kim. RON ROSCI, Steffe Back Screw Victim: When I lay down, my spine lays down. I actually feel it drop. If I was to get in bed and lay down and roll over on my back, I could feel-- I could actually feel my spine move. JOHNSON: [voice-over] Back in 1987, Ron actually tried to kill himself by swallowing a half-bottle of Valium. Mr. ROSCI: I felt like I was useless, worthless and didn't have no life and why should I be here if I'm going to be like that? JOHNSON: Were you surprised by this or shocked by this? KIM ROSCI, Wife: I don't know what he's going to do to himself, so I just-- I just watch him. JOHNSON: [voice-over] But who was responsible for protecting patients like Ron Rosci and those in Louisiana? There is a lot of finger-pointing. Mr. WILLIAMSON: They should stop these quack doctors from doing what they're doing to people. I think it's out of control. They do what they want to. MARIE RAYBURN: How about, the hospitals too? Aren't the hospitals supposed to get an approval on things before they're used in their facilities? Mr. GILBERT: Who is the FDA? Nobody knows nothing. Where were they at when all this was going on? This has been going on for years. Where are they at? JOHNSON: So how did spine plates and screws get unleashed on the public? Before a new device or an old device being proposed for a new use can be marketed, it must be approved by the Food and Drug Administration. Now, plates and screws like this have been approved for a long time for use in long bones -- arms and legs --but back in the mid-1980's, Dr. Steffe and his new company, called AcroMed, went to the FDA and asked for the device to be approved for a new use, in the spine. Twice, they said no. They said, '"That's a new, potentially dangerous use. It must be studied first for safety and effectiveness." However, just a few months later, the FDA did approve the device after AcroMed simply changed the name from "spine plates and screws" to "bone plates and screws," and Dr. Steffe now claims that meant he could use it in any bone, including the spine. [voice-over] But did the FDA ever give such approval? We showed current FDA commissioner, Dr. David Kessler, Dr. Steffe's video testimony when he was asked if the FDA said he could market his device for use in the spine. DR. STEFFE: There was no – ATTORNEY: Did they say that, sir? DR. STEFFE: Yes, they did. Dr. DAVID KESSLER, FDA Commissioner: That is an— JOHNSON: Okay, stop the-- Dr. KESSLER: That is an incorrect statement. JOHNSON: He said, "Yes, they did." They never said that? Dr. KESSLER: FDA never said that. In fact, we repeatedly said they could not market the device for use in the spine. We had al-ready told them twice. JOHNSON: And they weren't changing their tune at this meeting. Dr. KESSLER: Absolutely not. JOHNSON: [voice-over/But for years. Dr. Steffe bas stuck by his claim that the FDA did give him approval after he simply changed the name to bone screw, DR. STEFFE: But they said I could use it and could teach it and we could sell it as a bone plate and bone screw and it could be used by the physician at his discretion. JOHNSON: [voice-over] But now, for the first time, Dr. Kessler not only disputes Dr. Steffe's claim that he could use the device in the back, but Dr. Kessler makes a serious charge about what AcroMed did. Dr. KESSLER: It's fair to say that they circumvented the law. JOHNSON: You're being kindly and lawyerly and I know you're also a lawyer, but I mean they just literally— DR. KESSLER: Tim-- JOHNSON: It sounds to me like they lied, fiat and simple. They said they were going to use it in long bones for fractures. They didn't do it. Instead, they turn around and use it in the spine. Dr. KESSLER: Tim, it's an enormous concern to me what hap-pened back in 1985, 1986. There is e fun-scale investigation un-derway. JOHNSON: 20/20 has learned that AcroMed is in fact the subject of a grand jury investigation for possible criminal violations, but the serious questions about AcroMed have remained a virtual secret until now, a secret that has allowed widespread abuse and the treatment of patients with an experimental device without their knowledge. [voice-over] At St. Vincent's Hospital in Cleveland, Dr. Steffe taught the procedure to hundreds of surgeons. He not only trained the doctors in Lake Charles and Philadelphia, but they have testified Dr. Steffe told them the device was approved for use in the spine. After he trained in Cleveland, Lake Charles orthopedic surgeon Dr. William Akens testified that he performed about a hundred procedures in the next year. Dr. Clark Gunderson, who still practices in this building in Lake Charles, testified he did over 50 in the next year. In contrast, many experts we talked to do less than 10 screw-and-plate operations a year. Darryl Tschrin, attorney for the Lake Charles patients, said he could not believe how often the surgeons were implanting the devices. DARRYL TSCHIRN, Victims' Attorney: I asked the doctor, I said, "Well, do you mean that every Monday, Wednesday and Fri-day you all were implanting one of these--- doing one of these pro-cedures?" And, "Well, he said, I guess that's about right." JOHNSON: [voice-over] While none of the device manufacturers limited their sales to doctors who were doing approved research studies, other companies sold to anyone who would buy. One for-mer salesperson not with AcroMed told 20/20 his company encouraged him to sell unapproved devices. FORMER MEDICAL SALESMAN: I was also told, "Don't worry about it. Go ahead and sell it.' JOHNSON: [voice-over] This kind of aggressive marketing helped to spread the operation. Today an estimated 50,000 to 70,000 of these procedures are done every year. The FDA estimates up to 300,000 patients have these devices in their backs. Dr. KESSLER: Here's a device that's being used that was never approved by the agency, and the best I can discern, the patients didn't know that. JOHNSON: [voice-over] Patients also didn't know that name doc-tors had financial ties to AcroMed. Ron Rosci's attorney says that Ron's orthopedic surgeon, Dr. Sanford Davne, who testified he per-formed over 700 procedures, had potential conflicts of interest. JOSEPH MESSA, Jr., Attorney for Ran Rosci: Dr. Davne himself was a member of AcroMed's medical advisory board. He held stock options in AcroMed Corporation and he himself had a finan-cial interest in implanting and selling these screws end plates. JOHNSON: Once the operation had spread, the FDA conducted a largely ineffective campaign to stop unapproved use. Critics say the FDA often sent confusing or mixed signals, on the one hand sending stern warning letters to AcroMed while at the same time tolerating repeated and obviously illegal marketing efforts. It wasn't until 1990, when Dr. Kessler took command, that the FDA got tougher, but as he himself says. by that time the genie was out of the bottle. [voice-over] Meet Dr. Arthur White, one of the leading spine surgeons in the country. Dr. White actually did one of the early studies of pedicle screws, using AcroMed's devices. We showed him excerpts from Dr. Kessler's interview, in which Dr. Kessler sug-gests AcroMed circumvented the law by getting approval for a bone screw which they then used in the spine. Dr. ARTHUR WHITE, Spine Surgeon: I guarantee you 90 per-cent of the people using pedicle screws did not know what the status was and that there was all of this problem going on, includ-ing myself. JOHNSON: So the company was lying to you guys, too, in essence. DR. WHITE: I think that's true, but we were thanking them for doing so because they were making these things available to us to use on our patients. JOHNSON: [voice-over] Even Dr. White admits these devices are being abused and should be limited to skilled spine surgeons. But even if a surgeon is skilled, shouldn't a patient be told that the device is not approved for use in the spine? Neither Lake Charles Memorial Hospital in Louisiana nor Thomas Jefferson University Medical Center, where Ron had his surgery, realized that the devices had never been approved for use in the spine. In fact, 20/20 surveyed 18 of the most prestigious medical centers in, the United States who appeared on an AcroMed customer list. Thirteen of them either didn't know or refused to tell us whether they thought the devices were experimental. While the hospitals were under no legal obligation to know that, attorney Tschrin thinks they had a moral obligation. Mr. TSCHIRN: Oh, no question about it. The hospitals, I think, have a responsibility to ascertain that before a product comes into their hospital that it's been properly approved by the FDA for the intended usage for which that hospital is getting the product. JOHNSON: [voice-over] And so hospitals and doctors are still put-ting these devices in backs, often without telling their patients that they are experimental, Companies openly promote and sell these devices. An industry seemingly built around lies continues to flourish to the tune of ever $150 million a year. And patients who were injured grow more and more angry over what they feel is at the heart of what went wrong. CAROLYN DOUCETTE: It all boils down to one thing -- greed. money. They saw easy money and they took it. WALTERS: Well, Tim, then should these screws and plates never be used? JOHNSON: No. In the right hands, the hands of a skilled surgeon who has experience in this kind of surgery, for the right reasons, such as certain surgery for tumors of the back of for certain kinds of frac-tures, those plates and screws can be very helpful. The problem is that when we're doing 50,000 to 70,000 s year, it's far too many. We talked to many experts off the record about how many should be done a year. And nobody can say for sure, obviously. but one person said only 10 percent of tho~9 being done today are tru-ly necessary. The highest estimate we could get was 50 percent, which would mean, in the best case, even 50 percent are unnecessary. So obviously too many are being done. WALTERS: But if you can't believe in the hospital that you're going to, then how do you know whether it should be used for you? JOHNSON: Well, if there was ever a mandatory case for a second opinion, this is it. If a doctor says. "You need these plates and screws," you must seek another opinion and not from the doctor's partner or the same hospital, from a disinterested party because this is a case where it's a huge decision, as we've obviously illustrated. You've got to get a second opinion. WALTERS: Thank you, T