Spanish Orthopedics scandal results in 6,000 patients under observation with faulty implants

 

 

 

 

An unreported case in May 2014

Traiber’s expired orthopedic products began hurting patients six months before the AEMPS learned of it and issued a recall. The judge in charge of the case knows of at least one case on May 5, 2014 when doctors at Santa Tecla Hospital in Tarragona had to operate on a patient just six weeks after receiving a Traiber knee implant. During this second surgery, medics found that the recent implant was severely deteriorated and berated a Traiber representative for it, yet failed to report the case.

Former Traiber workers said that there was a moment of great tension inside the operating room, where a company representative was present to witness the surgery.

“When they cut the knee open, the orthopedic surgeons found that the white polyethylene piece implanted just weeks earlier was highly deteriorated and yellowish,” they said.

The doctors turned angrily to the Traiber representative. “You guys can say goodbye to this hospital right now. We’re never going to buy another piece from you again. This is bad enough to file a complaint,” they said, according to Traiber workers.

But the doctors did not report the case to the AEMPS. Investigators say this is a highly relevant decision, as the recall was delayed six months. “Six months during which expired and falsified products continued to be implanted into many more patients,” said sources familiar with the case.

The case first came to the attention of the authorities in October, when Traiber employees decided to file a complaint against their own bosses

Political corruption and corporate fraud have come together in the Catalan city of Reus (Tarragona) to create an unprecedented medical crisis in Spain.

For several months, a public hospital was using defective or expired surgical orthopedic implants after hospital chiefs were pressured by city officials to buy their supplies from a local provider called Traiber.

Now, after reviewing 1,700 cases at Sant Joan de Reus Hospital, doctors have called in 250 patients and ordered new surgeries for at least 20 of them in order to extract the faulty items.

Meanwhile, nearly 6,000 patients across Spain who are walking around with Traiber knee, hip and backbone implants have been put under observation, according to the head of the Spanish Medicine and Health Product Agency (AEMPS), Belén Crespo.

Nearly half of these are in Catalonia, while many others live in the Valencia, Madrid and Galicia regions, according to Traiber. Because the company worked with several distributors, however, their products may have reached all of Spain.

But Crespo has been trying to convey a message of calm. “The problems involve the company’s last few months of activity, in 2014, until our November 7 alert. Until recently, Traiber had all necessary permits and licenses, so the vast majority of patients can rest assured that they have quality implants.”

The case first came to the attention of the authorities in October of last year, when Traiber employees decided to file a complaint against their own bosses after hearing about people experiencing intense pain following surgeries.

The AEMPS informed the Catalan health department, which issued a warning and alerted prosecutors. This led to a court investigation and the arrest of the deputy mayor of Reus, Teresa Gomis, of the ruling nationalist party Convergència i Unió (CiU).

The Reus court is also investigating why doctors did not immediately inform health authorities after operating on a patient in May 2014 and finding a badly damaged Traiber knee implant just six weeks after it had been implanted. This failure to report the case means that between May and November, when Traiber products were recalled, many other patients may have received defective implants.

The April 28 arrest of the deputy mayor and of Traiber owner Lluís Márquez was the climax of an investigation that began six months earlier, when the AEMPS ordered a recall of all Traiber products after they were found to be “made without a license” and lacking the CE conformity marking, which symbolizes that a product meets European requirements. This, said the agency, posed “a serious risk to patients’ health.”

EL PAÍS learned that it was Traiber’s own employees who reported the situation to the Spanish health agency.

“The company heads had crossed all ethical and legal limits,” said several former workers on condition of anonymity.

A fast fall from grace

Despite a successful past, Traiber was a company in trouble. After years of solid business, it had been unable to handle growing competition, and in 2007 its turnover began dropping at an annual rate of over 10 percent. By 2013, the company was teetering on the brink of disaster, and it stopped paying its employees.

Its troubles had been compounded in 2011 with the arrival of a new head of orthopedic surgery at San Joan Hospital. Alfredo Rodríguez decided to stop working with Traiber because he felt that their products were obsolete and did not seem trustworthy, according to the inquiry. This decision deprived the company of a quarter of its sales, which in 2011 stood at €1.47 million.

Traiber was a company with a long tradition in Reus, and its owner Lluis Márquez carried considerable weight with the local business community. He sat on the boards of the Chamber of Commerce and the Catalan Small and Medium Business Association (PIMEC). Several sources said that Márquez “always took good care of his political contacts.” The CFO at Traiber, Eduard Correcher, also happens to be the health councilor for CiU in the nearby town of Les Borges del Camp.

According to the former employees, whose statements are included in the ongoing inquiry, the company got caught up in dangerous dynamics.

“After once making products with state-of-the-art components, bosses began resorting to increasingly cheap suppliers. After that, they stopped making their own products altogether and began reusing equipment samples that were not meant for use in patients. The last step was when they started selling items that had expired years ago after tampering with the seals.”

Their deposition underscores the moral dilemma faced by Traiber employees.

“Reporting it was not easy. The company was in a bad shape, and this was going to deliver the final blow. It was also our own ticket to the unemployment offices. But the last straw was when we heard that patients were suffering from serious complications.”

The court investigation has since found connections between Traiber and another company in dire financial straits: Innova, the municipal group of Reus corporations. Innova’s health branch, Sagessa, runs Sant Joan Hospital and 20 other health centers in Tarragona province, for which it receives over €150 million a year from the Catalan government alone.

“After once making products with state-of-the-art components, bosses resorted to cheap suppliers”After once making products with state-of-the-art components, bosses resorted to cheap suppliers”

For the last three years, this company has been at the heart of one of the largest corruption cases to come to light in Catalonia, involving businesspeople, healthcare managers and over 50 councilors – including Teresa Gomis, the deputy mayor of Reus who was arrested over the Traiber scandal.

Investigators soon found points in common between Traiber and Innova. For nearly a decade, Traiber had secured its contracts with Sant Joan Hospital without any public bidding. But this was a common occurrence at a health center where 85 percent of acquisitions did not meet legal public procurement requirements.

The investigating judge has also noticed a “hole” of €2.4 million in 2007, when the hospital declared having bought €2.9 million worth of equipment from Traiber, while the latter only declared earnings of €518,000 in its tax filings.

But the most relevant information to arise from the inquiry is the way that Lluís Márquez and high-ranking municipal officials maneuvered to ensure that Sant Joan would buy products from Traiber again after the two-year hiatus. The examining magistrate considers that these individuals exerted “pressure” on hospital chiefs, and considers this “especially serious” because officials at Sant Joan, unlike other hospitals, were aware of the problems with this company’s products.

Court papers show Sagessa director general Joan Benet admitting that after the new hospital orthopedics chief expressed disapproval of the Traiber products, he “consulted with doctors regarding the quality of the implants, and [they] questioned their quality.” Even so, Benet and Teresa Gomis agreed to meet with Traiber owner Márquez in the first half of 2013. At this meeting, Márquez demanded “a solution to his situation, because he needed to get back in the hospital.”

Months later, there was another meeting between the owner of Traiber, the local councilor of economic development, the medical director of the hospital and the head of orthopedic surgery. The councilor, Marc Arza, has denied putting any pressure on the hospital representatives, but investigators believe that orthopedics chief Alfredo Rodríguez finally buckled. According to the investigation, the owner of Traiber kept pressuring him throughout 2012 and 2013, and even offered to reach “some kind of economic deal.”

Despite the doctor’s constant refusals, “he finally adopted a different attitude after seeing councilors and hospital officials insist on the need to use Traiber prostheses,” said sources familiar with the case.

Sant Joan began buying from Traiber again in early 2014. The health alert was issued in November. The investigation is likely to be lengthy, as the AEMPS does not even know how many illegal products may have been sold “due to the irregularities in the company’s quality controls.”

Meanwhile, Gomis’ arrest has been received angrily by CiU, which views it as a deliberate blow to the ruling party in Catalonia just days ahead of municipal elections on May 24.

Catalan premier Artur Mas and his spokesman Francesc Homs have both openly criticized the judge in charge of the case, Diego Álvarez de Juan, for holding Gomis in custody for three days.

“She was treated like a terrorist,” said Mas, who failed to express any concern for the affected patients. Neither did the mayor of Reus, Carles Pellicer, whose chief complaint was that the police operation “has damaged the image of Reus.”

Reus official favored Traiber boss

Court papers released by the Reus judge investigating the defective orthopedic equipment used at a local hospital indicate that Lluis Márquez, owner of Traiber, enjoyed favors from deputy mayor Teresa Gomis, of the Catalan nationalist coalition CiU.

The revelations put a damper on regional premier Artur Mas’ attempts to link the health irregularities to earlier Socialist-run governments. Márquez, according to the investigation, even met with Mas himself at one point.

The owner of Traiber has been released on charges of corporate and public health crimes as well as document forgery and money laundering. Gomis faces similar charges and has been barred from leaving Spain.

The inquiry holds that “all the people with whom [Márquez] met at the city council, including Ms Gomis,” told him to go back to see the head of orthopedic surgery at the hospital. “The meetings and the pressure were successful, because [Márquez] himself stated that as a result of this, he managed to secure a meeting with the hospital’s head of orthopedic surgery.”

“The city facilitated the meeting, meaning that the doctor was aware that [Márquez] had already spoken with city officials,” read the court papers. Prosecutors have stated that the accused “went to see city chiefs to get them to pressure hospital doctors into buying his prostheses.”

The inquiry also reflects the lack of legal and financial control at health centers run by Sagessa, the health branch of the Innova Group. Sagessa, which runs around 20 centers, handles over €300 million a year, most of which comes from the Catalan government.

Gomis played an “essential role” in this lack of oversight because she was the COO at Sagessa and a member of the board before that.

 

 

 

 

 

 

Political corruption and corporate fraud have come together in the Catalan city of Reus (Tarragona) to create an unprecedented medical crisis in Spain.

For several months, a public hospital was using defective or expired surgical orthopedic implants after hospital chiefs were pressured by city officials to buy their supplies from a local provider called Traiber.

Now, after reviewing 1,700 cases at Sant Joan de Reus Hospital, doctors have called in 250 patients and ordered new surgeries for at least 20 of them in order to extract the faulty items.

The case first came to the attention of the authorities in October, when Traiber employees decided to file a complaint against their own bosses

Meanwhile, nearly 6,000 patients across Spain who are walking around with Traiber knee, hip and backbone implants have been put under observation, according to the head of the Spanish Medicine and Health Product Agency (AEMPS), Belén Crespo.

Nearly half of these are in Catalonia, while many others live in the Valencia, Madrid and Galicia regions, according to Traiber. Because the company worked with several distributors, however, their products may have reached all of Spain.

But Crespo has been trying to convey a message of calm. “The problems involve the company’s last few months of activity, in 2014, until our November 7 alert. Until recently, Traiber had all necessary permits and licenses, so the vast majority of patients can rest assured that they have quality implants.”

The case first came to the attention of the authorities in October of last year, when Traiber employees decided to file a complaint against their own bosses after hearing about people experiencing intense pain following surgeries.

The AEMPS informed the Catalan health department, which issued a warning and alerted prosecutors. This led to a court investigation and the arrest of the deputy mayor of Reus, Teresa Gomis, of the ruling nationalist party Convergència i Unió (CiU).

The Reus court is also investigating why doctors did not immediately inform health authorities after operating on a patient in May 2014 and finding a badly damaged Traiber knee implant just six weeks after it had been implanted. This failure to report the case means that between May and November, when Traiber products were recalled, many other patients may have received defective implants.

The April 28 arrest of the deputy mayor and of Traiber owner Lluís Márquez was the climax of an investigation that began six months earlier, when the AEMPS ordered a recall of all Traiber products after they were found to be “made without a license” and lacking the CE conformity marking, which symbolizes that a product meets European requirements. This, said the agency, posed “a serious risk to patients’ health.”

EL PAÍS learned that it was Traiber’s own employees who reported the situation to the Spanish health agency.

“The company heads had crossed all ethical and legal limits,” said several former workers on condition of anonymity.

A fast fall from grace

Despite a successful past, Traiber was a company in trouble. After years of solid business, it had been unable to handle growing competition, and in 2007 its turnover began dropping at an annual rate of over 10 percent. By 2013, the company was teetering on the brink of disaster, and it stopped paying its employees.

Its troubles had been compounded in 2011 with the arrival of a new head of orthopedic surgery at San Joan Hospital. Alfredo Rodríguez decided to stop working with Traiber because he felt that their products were obsolete and did not seem trustworthy, according to the inquiry. This decision deprived the company of a quarter of its sales, which in 2011 stood at €1.47 million.

Traiber was a company with a long tradition in Reus, and its owner Lluis Márquez carried considerable weight with the local business community. He sat on the boards of the Chamber of Commerce and the Catalan Small and Medium Business Association (PIMEC). Several sources said that Márquez “always took good care of his political contacts.” The CFO at Traiber, Eduard Correcher, also happens to be the health councilor for CiU in the nearby town of Les Borges del Camp.

According to the former employees, whose statements are included in the ongoing inquiry, the company got caught up in dangerous dynamics.

“After once making products with state-of-the-art components, bosses began resorting to increasingly cheap suppliers. After that, they stopped making their own products altogether and began reusing equipment samples that were not meant for use in patients. The last step was when they started selling items that had expired years ago after tampering with the seals.”

Their deposition underscores the moral dilemma faced by Traiber employees.

“Reporting it was not easy. The company was in a bad shape, and this was going to deliver the final blow. It was also our own ticket to the unemployment offices. But the last straw was when we heard that patients were suffering from serious complications.”

The court investigation has since found connections between Traiber and another company in dire financial straits: Innova, the municipal group of Reus corporations. Innova’s health branch, Sagessa, runs Sant Joan Hospital and 20 other health centers in Tarragona province, for which it receives over €150 million a year from the Catalan government alone.

For the last three years, this company has been at the heart of one of the largest corruption cases to come to light in Catalonia, involving businesspeople, healthcare managers and over 50 councilors – including Teresa Gomis, the deputy mayor of Reus who was arrested over the Traiber scandal.

Investigators soon found points in common between Traiber and Innova. For nearly a decade, Traiber had secured its contracts with Sant Joan Hospital without any public bidding. But this was a common occurrence at a health center where 85 percent of acquisitions did not meet legal public procurement requirements.

The investigating judge has also noticed a “hole” of €2.4 million in 2007, when the hospital declared having bought €2.9 million worth of equipment from Traiber, while the latter only declared earnings of €518,000 in its tax filings.

But the most relevant information to arise from the inquiry is the way that Lluís Márquez and high-ranking municipal officials maneuvered to ensure that Sant Joan would buy products from Traiber again after the two-year hiatus. The examining magistrate considers that these individuals exerted “pressure” on hospital chiefs, and considers this “especially serious” because officials at Sant Joan, unlike other hospitals, were aware of the problems with this company’s products.

Court papers show Sagessa director general Joan Benet admitting that after the new hospital orthopedics chief expressed disapproval of the Traiber products, he “consulted with doctors regarding the quality of the implants, and [they] questioned their quality.” Even so, Benet and Teresa Gomis agreed to meet with Traiber owner Márquez in the first half of 2013. At this meeting, Márquez demanded “a solution to his situation, because he needed to get back in the hospital.”

Months later, there was another meeting between the owner of Traiber, the local councilor of economic development, the medical director of the hospital and the head of orthopedic surgery. The councilor, Marc Arza, has denied putting any pressure on the hospital representatives, but investigators believe that orthopedics chief Alfredo Rodríguez finally buckled. According to the investigation, the owner of Traiber kept pressuring him throughout 2012 and 2013, and even offered to reach “some kind of economic deal.”

Despite the doctor’s constant refusals, “he finally adopted a different attitude after seeing councilors and hospital officials insist on the need to use Traiber prostheses,” said sources familiar with the case.

Sant Joan began buying from Traiber again in early 2014. The health alert was issued in November. The investigation is likely to be lengthy, as the AEMPS does not even know how many illegal products may have been sold “due to the irregularities in the company’s quality controls.”

Meanwhile, Gomis’ arrest has been received angrily by CiU, which views it as a deliberate blow to the ruling party in Catalonia just days ahead of municipal elections on May 24.

Catalan premier Artur Mas and his spokesman Francesc Homs have both openly criticized the judge in charge of the case, Diego Álvarez de Juan, for holding Gomis in custody for three days.

“She was treated like a terrorist,” said Mas, who failed to express any concern for the affected patients. Neither did the mayor of Reus, Carles Pellicer, whose chief complaint was that the police operation “has damaged the image of Reus.”