From the United States to Peru: The destination for defective medical devices
Johnson & Johnson and Medtronic imported the majority of the defective medical devices into Peru between 2012 and 2017. The industry’s lack of transparency and the absence of controls allow these supplies to reach hospitals and clinics and be implanted in patients. The victims of this failed system have no access to mechanisms to defend their most basic rights.
In April 2013 when the multinational Johnson & Johnson presented one of the most modern and complete knee prosthesis to the international orthopedic surgeon community gathered in Chicago, the news hit the media and gave new hope to improve the quality of life of arthritis patients, injured athletes, and disabled people. The innovative implant was designed to avoid pain, improve range of motion, and reduce the sensation of instability that some patients with old knee prostheses experienced during daily activities such as squatting or going downstairs. “The Attune Knee model is the result of our largest research and development project,” said Hannah McEwen, the then world director of knee product development at DePuy Synthes, a subsidiary of Johnson & Johnson, which manufactures joint replacement devices.
Just two years later, however, several prosthetic models of the Johnson & Johnson Attune Knee system, including its most modern knee implant, presented serious manufacturing defects that generated recall warnings from the Food and Drug Administration (FDA) for the United States and all countries where the devices were sold. Although the Attune Knee prosthesis scandal was global, the Peruvian Directorate General of Medicines, Supplies, and Drugs (DIGEMID), responsible for the medical technology surveillance system, took no action to determine if these implants had been acquired and used in patients inside the country. The majority of claims against the Attune Knee prosthesis pointed to design defects, including that the surgical glue did not properly fix the device to the tibia. In several cases, this caused early failure, severe pain, and loss of mobility.
The Implant Files, a global investigation conducted in alliance with reporters from 58 media organizations in 36 countries and convened by the International Consortium of Investigative Journalists (ICIJ), found that the DIGEMID allowed Johnson & Johnson’s distributors in Peru to import 64 units of the defective knee prosthesis model over the period 2015 to 2017 at the same time hundreds of American patients were filing lawsuits against the company.
Ojo-publico.com cross-checked the database of alerts issued by the FDA with the reports of medical devices imported into the country in the period from January 2012 to June 2018 and discovered that the American company imported a total of 40 batches of two types of defective medical devices (knee prostheses and automated equipment to process clinical tests) a few days before the manufacturing failure recall alerts were issued.
The Food and Drug Administration of the United States has issued 1,676 recall notices for malfunctioning medical devices from Johnson & Johnson and Medtronic companies between 2012 and this year. Photo:
Johnson & Johnson heads the list of medical technology corporations that have withdrawn defective products from the world market. No other company has imported more failed medical devices into Peru. However, it is not alone. Our review of the records showed that Medtronic, Baxter International and Hoffmann-La Roche also introduced medical devices with serious manufacturing defects. These companies took advantage of the lack of clear rules and minimum quality controls for devices purchased and implanted in patients in hospitals and clinics throughout the country.
These four transnational corporations account for 12% of recalls issued by the FDA between 2012 and 2018. Johnson & Johnson accrued 1,030 alerts and Baxter International, 130. Medtronic recalled 646 devices and Hoffmann-La Roche, 168. These are the same corporations that dominate the powerful medical device industry, with profits of more than 400 billion dollars a year. This sum exceeds that of the medicine business or the sale of arms, according to the report of the international consultancy PwC, which evaluated the medical technology market in 2017.
The central problem is that the medical device industry is one of the least regulated in the world and has practices that lack transparency and allow fraud, bribery, and conflict of interest. “Maintaining this system is unacceptable,” says Carl Heneghan, a clinical epidemiologist at the Oxford University, who has written extensively on the regulation of medical devices and met with ICIJ members in April this year in Washington.
Johnson & Johnson tops the list of corporations with the most withdrawals of defective medical products in the world. It is also the one that most failed appliances imported to Peru.
The FDA itself has eased the existing rules to accelerate the release to the market of innovative devices even when their safety and efficacy are not guaranteed. The evidence is the indiscriminate use of the procedure known as 510 (k). This allows the FDA to approve a medical device if the manufacturer can demonstrate equivalence with at least one product with the same use and technical characteristics that is already circulating in the U.S. market. Unlike the regular review process, this procedure does not require evidence of effectiveness in humans. Although the 510 (k) procedure was introduced as an exceptional approval method, some 98% of medical devices have been approved through the process over recent years. That is, the exception has become the rule.
In the European Union, the implant approval system is even more flexible for business. The manufacturers of medical devices pay private consulting companies to undertake the certification process to ensure medium and high risk devices comply with European safety standards.
Damage caused by Medtronic
In early 2017, 20 brain pacemakers manufactured by Medtronic in the United States and exported to different European distributors arrived in Peru on a commercial flight from Amsterdam. At the same time, complaints were being received from Parkinson’s disease patients who had suffered injuries related to this equipment. This was despite the fact that the FDA had been warning about these devices since 2015 due to failures in their battery cycle. The devices passed the customs controls and were received by the logistics operators of Covidien, Medtronic's main subsidiary in the country and supplier to the most important hospitals and clinics in Lima.
The famous ‘brain pacemaker’, launched onto the market by Metronic in 2011, represented a therapeutic alternative to reduce several symptoms of Parkinson's disease. The device, similar to a pacemaker, was surgically implanted under the skin of the chest to provide electrical stimulation to some areas of the brain and block the signals that prevent a person's movement. However, Medtronic manufactured several batches of these products containing serious deficiencies and was forced to cease their use in 2015.
Medtronic has twenty distributors and fifteen subsidiaries in Peru. The most important are Covidien and Tyco Healthcare, which imported batches of nine classes of medical devices with warnings between 2012 and 2018.
Defective Medtronic products that entered the country included scalpels, ventilation equipment, 170 pulse oximeters or blood oxygen meters, 40 boxes of surgical staples with packaging problems, 19 boxes of wires that connect to brain pacemakers and exhibited energy problems, and 10 Palindrome catheter kits used in Hemodialysis therapies which arrived without proper packaging to ensure sterile conditions.
This is in addition to the long list of scandals for defective devices that have struck Meditronic worldwide. In May 2018, a U.S. citizen sued the company for problems with the MiniMed Surte - T Infusion insulin pump, which caused serious harm to his wife and ultimately led to her death. According to the plaintiff, on January 6, 2017, his wife changed her insulin equipment. She was subsequently admitted to a Mississippi hospital, where doctors discovered that she had suffered a stroke due to hypoglycemia. Only later did it come to light that in November 2017 the FDA had ordered the recall of this device because it was manufactured with defective ventilation membranes that could block the pump's filling tube and cause an excessive supply of insulin.
Medtronic has 20 distributors in Peru. The most important, Covidien and Tyco Healthcare, imported batches of nine classes of medical devices alerted between 2009 and 2018.
Another serious problem occurred in March 2014 when more than a thousand patients sued Medtronic in the United States for damages related to its Infuse product, a bone growth graft. This device was implanted in more than one million people without the approved therapeutic properties. According to research in The Spine Journal, although the FDA had only authorized its use for certain spinal fusion surgeries (surgery for teenagers suffering from spinal problems such as scoliosis), doctors had begun recommending it for cervical spine operations.
It would later be revealed that Medtronic, in collusion with a group of doctors, had lied in scientific studies about the safety of the product’s use on the cervical spine. This caused chronic pain and nerve damage to thousands of patients who had undergone surgery to implant the Infuse device. The company had to pay around 22 million dollars in compensation. Its lawyers are currently responding to more than 6,000 complaints from patients who claim to have been harmed by the product.
Medtronic, which earns annual revenues in excess of 30 billion dollars through sales of its health technology, is a repeat offender. In October 2007, a group of 32 patients in Puerto Rico sued the company for problems with wires from the defibrillators (devices that are part of the pacemaker and used to regulate heart rhythm in patients suffering from arrhythmia). The resulting failures caused vascular injuries and led to the deaths of five people from heart complications. The defibrillators with alerts were Maximo™ VR/DR ICD, Marquis ™ VR/DR InSync ICD, I/II/III Marquis ™ CRT-D, and InSync III Protect™ CRT-D. Almost 268 thousand of these devices were implanted around the world. According to Medtronic estimates, 75% of these devices were implanted in the United States.
Even after all these scandals and the poor reputation it has developed in the medical technology industry, Medtronic has not apologized to the thousands of people affected by its products. On the contrary, a message on its website states: “We take our role in changing health care very seriously. We fully assume the responsibility of ensuring patient safety and ethical behavior in all of our work.”
The route of the defective medical devices
In order for an implant or medical device to reach a hospital or a clinic and be implanted in a patient's body, it has to undergo an evaluation process that begins at the FDA’s offices in the U.S. city of Maryland. The agency reviews and approves a wide range of products that include drugs, food, cosmetics, medical devices, and many other health-related items. An FDA approval means that “the benefits of the approved item outweigh the potential risks for the item's planned use.” From that moment, the manufacturer can launch the product on the market.
A ‘medical device’ means any instrument, apparatus, implement, machine, appliance, implant, a reagent for in vitro use, software, and any material for medical purposes, according to the World Health Organization (WHO). People can be subject to these devices even before birth: Some are used to reveal the sex and the likely date of birth of a baby, while others can rule out and combat a disease. They can range from a tongue depressor to artificial intelligence programs that detect cancer early. There are also masks; gloves; syringes; pacemakers; drug-eluting catheters, ultrasound, and tomography equipment; breast, knee and hip implants; 3D printers to create prosthetics; and watches and cell phones capable of monitoring blood sugar.
In Peru, as in most countries in Latin America, Afric, and Asia, governments do not regulate medical devices, but rely instead on the FDA or the authorities of the European Medicines Agency (EMA), which are generally considered the best supervisors of the health industry. For this reason, importers or distributors of medical devices in our country have only to show FDA or EMA approval documents and the manufacturer’s certification of good practices in order to process a health registration with DIGEMID and then sell the product in the country.
In Peru, as in most countries in Latin America, Africa and Asia, governments do not regulate medical devices, but rely on the FDA or the EMA.
DIGEMID’s evaluation technicians perform a check based on the scientific and administrative information provided by the interested company. They lack the technology necessary to carry out their own quality assessments. The DIGEMID medical devices surveillance team is located in a 60 square meter office cubicle where just five people undertake the review of administrative and scientific documents. It is one of the smallest offices contained in the modern building with tinted windows occupied by the health surveillance agency in Lima.
DIGEMID, which falls under the Ministry of Health, has up to 120 days to respond to requests for health registration, although, in practice, this period is usually shorter. Once an approval has been issued, when a batch of medical devices arrives in the country by plane or by ship, a customs agent and a DIGEMID officer check it in the offices located at the ports of entry. They only focus on verifying that the product has an approved and complete invoice, health registration, purchase order, and sterility certificate. The protocols do not include a cross check with the database of defective medical products maintained by DIGEMID on its own website. Indeed, DIGEMID officials do not even review the alerts about medical product recalls in the United States and Europe when they assess the initial health registration request.
According to José Carlos Saravia Paz Soldán, head of the DIGEMID Medical Devices Functional Unit, some 270 requests for health registration reach his office every month. This same team of five people is responsible for handling the drug and medical device alert system activated in 2009 on the entity’s website. The problem is that doctors and administrative employees of the national health service have no legal obligation to check the system and patients are unaware of its existence.
The supervision black hole
Once the medical devices are sold to hospitals and clinics around the country DIGEMID loses track of them. In Peru there is no official record of people living with an implant in their body. The type, model, brand and, where appropriate, expiry date of the device that doctors implant in patients in hospitals and private clinics in the country are not known. “This data is not recorded in all cases in the medical records of patients who receive an implant,” says Víctor Dongo, former director of the Health Technology and Research Evaluation Institute of EsSalud.
The internal protocols of each social security hospital generally direct a patient who has a problem related to their medical device to report it to their doctor. A user must file a direct complaint with a health professional, rather than through DIGEMID.
A conflict arises because several doctors have undeclared relationships with the companies supplying the equipment, who provide them with training courses, and hire them for conferences and even for product promotion. In the United States, where drug and device manufacturers must disclose payments to doctors, the top ten healthcare technology companies paid nearly $600 million to doctors or their hospitals last year, according to an ICIJ analysis of data from the Medicare and Medicaid Service Centers. In Peru, companies are not obliged to report their payments to health personnel.
José Saravia Paz Soldán preferred to respond to our questions by mail rather than in a face-to-face interview. On complaint channels for defective medical devices, he stated the following: “Our complaint system is not very well known. Doctors know about it, but we get more problems related to drugs than medical devices.”
Patients who wish to report a failure in their medical devices to DIGEMID have to provide difficult-to-obtain information such as invoices, sale dockets, the full name of the product and the company that manufactured the product, and photographs of the implant that can be considered evidence of the purchase.
Spokesmen for ESSALUD Institute of Health Technology Assessment and Research pointed out that while they frequently report cases of defective medical devices to DIGEMID, the answers or actions may take up to a year. “Some hospitals cannot wait because they need to urgently use medical devices on their patients. Then, their own staff choose to process the change of device with the distributor and manufacturer,” said one of our sources.
DIGEMID will only request an evaluation from the National Quality Assurance Center or any of the authorized laboratories of the National Network of Official Quality Assurance Laboratories (public or private laboratories that are certified to perform evaluations) in cases where irregularities or inconsistencies are found in the administrative reports delivered by the medical technology corporations that process their health registrations in Peru. These are extraordinary situations and have not occurred in recent years.
The pharmaceutical chemist Nora Graña, an Argentine expert in medical device surveillance, raised the urgency of regulating and making the medical device industry more transparent. “Our regulations have placed importance only on medicines and not medical technology,” she said last August before an audience of 40 health sector officials at a conference held at the Pharmaceutical Chemical College of Lima.
The risk of not knowing what to do
Where a patient has had an implant inserted that has since exhibited defects or any other unusual condition, his or her first reaction should be to report it immediately to the treating doctor. The next key step, which not everyone follows, is to seek legal advice. A lawyer can help identify if similar cases caused by the same medical device are under investigation in one’s own country or in other parts of the world.
People with a malfunctioning implant can die with it or live with greater damage to their health for the rest of their lives.
In the United States several law firms specialize in these types of cases, including Lerner & Rowe, Hardison & Cochran, Riddle & Brantley, and Hill Peterson Carper Bee & Deitzler PLLC. Their web pages contain full guides to the lawsuits they have made and the claims against large medical technology corporations for injuries caused to thousands of users. In Peru, the public health system ombudsmen lack specialized lawyers, and the high cost of private counseling prevents an affected person without resources from engaging in a long and expensive trial.
“The manufacturers of medical devices must be responsible for the damage caused by their defective products,” says Mario Ríos, a lawyer specializing in defending cases of medical malpractice. There is no record of criminal and administrative sanctions against companies for marketing defective medical devices in Peru, and compensation for the victims of malpractice in the medical technology industry is unreported.
“If patients are informed that they are taking bad quality pills, they can throw the jar away. But people with a malfunctioning implant can die with it, or live with greater damage to their health for the rest of their lives,” says Adriane Fugh-Berman, a professor at Georgetown University who studies marketing practices for health care, and who gave an interview for this investigation.
Patients are defenseless against this type of abuse. Without money and information, they are pitted against a billion-dollar industry that has no difficulty paying fines and engaging in litigation. According to an ICIJ review of data from the U.S. Department of Justice and the Securities and Exchange Commission, medical technology manufacturers have paid at least $1.6 billion since 2008 to settle charges of corruption, fraud and other violations with regulators in the United States and other countries.
The Implant Files investigation reveals a business in which large corporations continually take on authorities and use different means to maintain a system of approval and sales that ensures profits but does not take into account the impact on the lives of millions of people. “It's a battle between David and Goliath,” says Julio César Cruz, president of the Peruvian Network of Patients and Users in Lima.