The Reluctant Hero

Jürgen Thoma has waited eight years for this moment. The mustachioed 61-year-old in jeans, a gray jacket and a white shirt, walks briskly as he takes his final steps toward the court building in the historic center of Freiburg, a German university town. He doesn't want to be late. He opens the heavy wooden door.

It's a sunny day in October 2018, and the ruling is soon set to be announced in Room 2 of the district court – a judgment that not only has the potential to help Thoma bring closure to his suffering, but also that of around 100 other patients. Many of them experience the same sharp pain he used to feel in his legs, some can hardly walk more than a few hundred meters before the pain becomes unbearable. All of them trace their problems back to the Durom-Metasul-LDH hip prosthesis, made by manufacturer Zimmer Biomet. They are hoping the court will provide an answer to the question as to who bears the responsibility for the harmful chromium and cobalt fragments that apparently abraded off their artificial hips and began grinding away at their bones.
A man wearing round glasses leans on his crutches in the corridor of the Freiburg court and gray-haired women sit on the wooden bench. Thoma nods toward them and shakes their hands. They've known each other for quite a while.

"I'm still having a hard time with my hip," one elderly gentleman says to Thoma. "And, you?" "I'm OK," Thoma replies.

They're all waiting for the ruling in the civil suit Jürgen Thoma vs. Zimmer Biomet. The case seeks to find answers to some critical questions: Is it possible the manufacturer knew of potential metal abrasion before Thoma's operation? And did the company's artificial hip go through sufficient testing?

Thoma is too level-headed to wear the activist's cap, but also too ambitious to allow himself to fall into the role of victim.

Thoma, if you will, is the lucky one. He's at least able to walk again. He underwent an operation to remove the metal and install a new ceramic head on his prosthetic hip. It's a makeshift solution that is working for now, but no one can say for how long it will hold.

When Thoma sued Zimmer Biomet in Freiburg in July 2010, he still had images in his head of his mangled bones. Doctors had performed a second operation on him because Thoma was again experiencing pain in his right hip and they suspected the prosthesis had loosened. The surgeons cut open his thigh and took photographs of the reddened flesh, flecks of black metal and abrasion of his bones. They also registered elevated levels of chromium and cobalt.

The photos revealed bone damage where that part of the prosthesis is anchored on which the ball socket is attached via an adapter. Thoma was convinced that the bits of metal had been released through abrasion. But he couldn't prove it.

Before his surgery, Thoma didn't even know how artificial hips worked, but today he's fighting against one of the most influential manufacturers of the medical devices. One man against a massive corporation: Zimmer Biomet is one of the largest companies in the orthopedic implant industry, with annual revenues of around $7 billion and 8,300 employees. Thoma is the technical director of a winery. A normal guy.

And Thoma doesn't have the backing of the authorities, either. When it emerged nine years ago that traces of heavy metals had been detected in the blood of dozens of patients in Freiburg, no government agency stepped in to stop the sale of the potentially dangerous hip joints. It's easy enough for manufacturers to introduce new products to the market, but the victims of troublesome prostheses are often forced to spend years laboriously trying to prove in court that the medical industry may have made a mistake.

Thoma sits down on a chair in the court room and crosses his legs under the table, his fingers interlaced. The judge asks a woman on crutches to sit down and says there's an empty seat up front, adding that he wants to explain his ruling at length. "I can't," the woman says quietly. The judge doesn't hear her. " Have a seat," he repeats. "I can't," the woman says, a little louder now. "It's too painful when I sit."

Thoma's hip problems began when he was 23, when he rammed into a post during a football game. When he started limping in his late 30s, the doctors diagnosed osteoarthritis in his right hip. Thoma waited another 10 years before getting an operation. He didn't want to go under the knife, but the pain kept getting worse. And he was dragging his leg around like an old man.

Freiburg's Loretto Hospital has a good reputation, and Thoma made the decision to have his operation there. He recalls how one of the hospital's chief physicians, Marcel Rütschi, had pitched the artificial hip model from Zimmer Biomet as the "Maybach of hips," a reference to the ultra-luxury German sedan that auto enthusiasts praise as the best of the best – safe, noble and durable. He had been promised that the Durom-Metasul prosthesis, with its large-diameter head, the so-called "Durom cup," offered the maximum freedom of movement. It would allow mountain climbers to enjoy the sport once again, dancers to return to the dancefloor and tennis players to get back on the court. In interviews with journalists from the Süddeutsche Zeitung and from German public broadcasters NDR and WDR during their reporting on the "Implant Files," many patients recalled hearing that same message.

Thoma, who was 48 at the time, chose to go with the highly praised Durom model. "The doctors told me it was the best one on the market," says Thoma. "Why should I have doubted them?"

What he didn't know at the time was that the artificial hip had never gone through clinical trials. Nobody had tested how well it performed in people, let alone what might happen in a fall or when subjected to severe strain.

The Süddeutsche Zeitung is in possession of the internal company document that was the basis for the market release of the prosthesis in 2003. The "Declaration of Conformity," in which the manufacturer attests to the safety of its product, states that in principle, the prosthesis doesn't contain any major innovations. The manufacturer didn't subject the new hip to any clinical trials involving people and merely referred to laboratory tests on individual components. This loophole, which exists in Germany as well, is called "substantial equivalence." In the United States, it is referred to by the Food and Drug Administration (FDA) by the name 510(k).The idea is that new variants of products with similar functions already on the market don't need to be re-tested. 

In the four years after the implant, Thoma could initially walk again without experiencing any pain. He could climb stairs and even clamber up to the roof of the winery where he worked to inspect the solar panels. Gradually, though, the pain returned. And he wasn't the only one suffering. That was in 2009.

A number of patients began contacting Freiburg chief physician Rütschi, reporting problems that doctors couldn't explain. He then performed an operation on a woman and found a significant amount of metal in her body. "It was just black, and you could see with the naked eye that metal had abraded," Rütschi would say years later, at a July 2016 public hearing at the Freiburg district court on this case.

In August 2009, Rütschi even went to the media because he suspected that the Durom artificial hips were causing problems for patients. "Orthopedic Surgeons at Freiburg Hospital Implanted Defective Hips," wrote Badische Zeitung, the local newspaper. "As the surgeon, you don't notice anything," he told the paper at the time. By that point already, he said he believed that more than 800 patients in Freiburg might have been affected. A few months later, Rütschi would say it was suspected that one in three patients with a Durom-Metasul hip was experiencing problems. And as it happens, every third wearer of the prosthesis has since undergone follow-up surgery in Freiburg. 

Internal documents obtained by the Süddeutsche Zeitung show that the numbers reported by Rütschi set off alarm bells at the German Health Ministry. In early March 2010, a ministry employee sent an urgent email to the Federal Institute for Drugs and Medicinal Devices (BfArM) in Bonn. The email requested immediate information about what the authorities knew about the "serious problems" with hip replacements. BfArM responded promptly that it had received 114 problem reports and that almost all the prostheses in question had been implanted at the same hospital.

A Series of Failures

But the conclusion reached by the health supervisory authority is surprising. BfArM wrote that it saw no need for action. Only months later did the agency issue a recommendation that the prosthesis no longer be implanted. But the state office in Freiburg, which had the authority to stop sales of the prosthesis, did not implement the recommendation. Even today, officials in the office still believe the criteria for ordering the suspension of sales had not been met at the time.

Internal documents illustrate a series of failures. In August 2008, officials at the FDA in the U.S. had written to BfArM in Germany that they had been experiencing problems with the loosening of Durom acetabular components (the Durom cup) that were almost identical in design. The American agency wrote that it had advised doctors in the U.S. to stop implanting the hip joint components. In response, BfArM contacted the manufacturer and inquired whether the problem was also an issue in Germany. Zimmer Biomet asserted that the problems in the U.S. were the result of the doctors' lack of training with the prosthesis and that the Germans had been better prepared.

In spring 2009, however, a growing number of reports about problems with hip prostheses began arriving at the federal authority – so many that BfArM ruled in early September that year that the product wasn't safe. Officials at BfArM wrote to manufacturer Zimmer Biomet that action would be taken if the company didn't move to halt the use of the product. Five days later, Zimmer Biomet announced a cessation of deliveries. But that didn't happen. Instead, Zimmer Biomet replied again a few days later, this time blaming the problem on the surgeons, claiming they had likely failed to follow the prescribed surgical technique instructions for the implants. The company said it had not identified any product defect.

The "Maybach of artificial hips" remained on the market, and in 2011, two years after metal had been found in dozens of patients, Zimmer Biomet was still selling hip prostheses in Germany, although not many.

Biomechanist Daniel Klüss has spent years working as a court-appointed expert on problems with Durom-Metasul hips from Zimmer Biomet and also provided expertise in Jürgen Thoma's lawsuit against the company. He reviewed boxes full of files, including patient data and documents from the manufacturer. He was surprised to find that one set of surgical technique instructions was from 2009, well after the problems with metal abrasion had emerged. He continued to investigate and found there were several, contradictory sets of operating instructions. Initially, for example, doctors were instructed to place the prosthesis with a gentle blow, but a later set of instructions noted that at least three strong blows should be used.

One time. Three times. Gentle. Strong? How could surgeons have correctly followed those instructions?

Today, nine years later, the lawyer keeps jumping out of his chair at his Freiburg law firm, pulling yet another document out of one of the seven binders he has spread across the carpet and shaking his head. "There are thousands of pages of briefs," he says. Initially, the company denied there had been any metal abrasion at all with their artificial hips, he adds. "Just imagine," says Berst-Frediani. "We presented them with photos with several centimeters of black fluid on the flesh." But that wasn't all. "The crowning moment was when they accused a patient who was well over 70 of intentionally having another operation so she could sue for damages." That, the lawyer says, "was the lowest of low."

The FDA regulatory authority in the U.S. has been highly critical of Zimmmer's factories.

In response to a request for comment from the Süddeutsche Zeitung, Zimmer Biomet stated it does its utmost to "conduct its business operations responsibly and with the highest ethical standards" and that it believes the hip joints are "not defective."

It's a sunny October day in Room 2 of the Freiburg district court, and the judge is set to announce his ruling in the case. He apologizes for the protracted proceedings and says that he knows how important it is for those affected to finally get some answers. He adds that it had been difficult to find experts. And then, finally, he utters the sentence that they had all been waiting for: "The prostheses are defective."

The district court rules that Jürgen Thoma should be paid 25,000 euros in damages for pain and suffering. "There should have been clinical tests," the judge says. The metal abrasion in Thoma's hip goes beyond what could be considered harmless to health. "It is clear," he continues in explaining his judgment, "that the strength of the cone connection is the decisive point for abrasion."

Thoma leans back and smiles. Had he been right, all these years? Is it over? A few weeks later, the news would reach him that Zimmer Biomet will appeal the ruling. After eight years, his ordeal still hasn't come to an end.

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