The recall of an ASR artificial hip joint manufactured by Johnson & Johnson has been an ongoing problem for over six years. On October 14, this problem will be put on the table during the parliamentary inspection by the Health and Welfare Committee, and all eyes are on whether the lawmakers will be able to put an end to this age-old problem.
In 2010, Johnson & Johnson voluntarily conducted a recall of the ASR artificial hip joint made by its subsidiary, Depuy, because the reoperation rate from side effects caused by this product was higher (12-13%) than the company’s expectations (8-9%).
Artificial hip joints are implanted during arthroplasty procedures and are a substitute that is implanted when the hip joint malfunctions. In South Korea, the import license of the ASR product in question was withdrawn in 2013, but there were a series of side effects due to the debris caused by friction reported overseas, and the company decided on a worldwide recall of the product in 2010.
The Ministry of Food and Drug Safety also distributed a letter on safety in May 2010 and warned of side effects such as the ASR debris reacting with and necrotizing the soft tissue. The ministry recommended doctors to conduct a regular medical examination for five years after the surgery and to carry out tests for patients complaining of pain.
The problem is that in Korea, the patients who had the ASR product implanted were not properly informed about the recall until recently and the company has been passive in recovering their products and providing compensation to patients here, where the penalty is relatively weaker than in the U.S.
According to an investigation carried out by the office of lawmaker Oh Jae-sae (the Minjoo Party of Korea), a member of the parliamentary Health and Welfare Committee, among the 320 patients who have had the ASR product implanted in 28 medical institutions in Korea, (as of August 2016) only 162 people signed up for the compensation program (scheduled to end in August 24, 2017) provided by the company.
South Korea, an Easy Target? Voices Cry for Stronger Punishment
This case has brought more and more people to call for the government to introduce punitive damages, which forces companies to cough up compensations much larger than the actual damage.
Johnson & Johnson was fined 2 million won and the person in charge was fined 700,000 won after the ministry reported the company to the Prosecutors’ Office for submitting false information during an investigation. But in 2014, the court suspended the sentence after taking into consideration the fact that the company had voluntarily carried out a recall, provided a compensation package and voluntarily withdrawn its import license.
In contrast, in the U.S., the company agreed to provide $250,000 per person for over 8,000 patients after a trial.
Patient groups are demanding stronger penalties and are also urging the company to provide patients with information on the recall and on the application process for the compensation package along with an extension of the deadline for the compensations.
Ahn Gi-jong, head of the Korea Alliance of Patients Organization said, “Despite the fact that this concerns a device that is inserted into the human body, the punishment in Korea is too weak. Since we don’t have a punitive damage system, problems about responses to the damage caused by multinational companies like the Oxy incident keep repeating. If things are left as they are, similar incidents will continue to occur.”
“If we had penalties as strong as in the U.S., the company would not have been so late in reporting to the government or so passive in recovering the faulty apparatus. Along with punitive damages, we need to give the Ministry of Food and Drug Safety more authority to impose stronger penalties,” he continued.
Since the debris from the ASR, which is mainly made of cobalt and chromium, has the possibility of causing a number of diseases, it is important to satisfy the patient’s right to know. In fact, some foreign experts warned that such debris could float around in the blood causing heart failure or dementia.
Ahn said, “Since the ASR can cause a number of problems, the company should inform patients of the exact details instead of just replacing the product. And since the company only provides the costs for those who registered for the compensation program, they should quickly inform the patients that they had surgery with a product that is being recalled. ”
The Ministry of Food and Drug Safety announced that they obtained the addresses of the patients not registered in the compensation program with the cooperation of the Ministry of Government Administration and Home Affairs and that they notified the hospitals that used the ASR in question.
A ministry official said, “On October 6, we received the addresses of the patients from the Ministry of Government Administration and Home Affairs and sent them to the hospitals. We asked the hospitals to notify the patients of the recall and to report back the results by October 20.”
He also mentioned that this was a measure taken by retroactively applying the partial amendment of the Medical Devices Act (motioned by lawmaker Choi Dong-ik), which the National Assembly passed last year.
According to the relevant amendment, when the Ministry of Food and Drug Safety notifies hospitals of medical devices that pose the risk of causing serious side effects, the hospitals are obligated to notify the relevant patient and submit the results to the ministry.
A ministry official said, “We applied this law since September 7 and asked the hospitals to report their recovery of the product, but there were some people who couldn’t be contacted. So we made a second request with new addresses. We had been late in responding to this problem, but this time, we are working hard to close the case. ”
Compensation Provided when Side Effects Occur: Examination Fees Only Covered Until August 2017
Johnson & Johnson’s compensation program supports costs for examinations and treatment, but does not include consolation compensation. Also patients need a doctor’s opinion stating that the side effects were caused by the ASR product in order to receive support.
A representative of Johnson & Johnson explained, “If the patient is suffering side effects from ASR, the patient will be compensated for all the costs due to the (second) surgery including transportation, etc. The compensation period is a decade from the date of the surgery, so if the patient received surgery in 2010, she can receive compensation until 2020.”
He continued, “The patient will not receive support if the side effects were not caused by ASR. It is difficult to say that consolation compensation will be provided (by the program). In the case of such compensation, there will be an individual review of each patient, and when necessary, the company will make the judgment together with the insurance company.”
The company also stated that the support of costs, which will end in August 2017, are limited to examination costs, such as an MRI or ultrasound. The company will continue to support costs for treatment other than examination fees, even after the compensation program ends.
As for allegations that the company has been passive in providing compensations in Korea compared to other countries with stricter regulations, the company argued that it was only due to a difference in abiding by South Korean law and that it was not intentional. In addition, the company also dismissed allegations that they rushed to voluntarily withdraw the import license for ASR in order to avoid administrative action.
A representative of Johnson & Johnson said, “Since we are abiding by domestic law, some things are inevitable. We are not discriminating against Korea. We canceled the import license because retaining it seemed inappropriate since we were no longer supplying the product.”
The company also argued that they were not passive in recovering the problematic product. The company explained that, according to the existing Personal Information Protection Act and the Medical Service Act, a company cannot receive the personal information of patients, who did not give prior consent, from the hospitals, so the company only asked the medical staff at verified hospitals to pass on information concerning the recall.
Meanwhile, the National Assembly urged the ministry to inform patients to register for the compensation program and called for the need to strengthen penalties.
An official from lawmaker Oh Jae-sae’s office said, “Johnson & Johnson made a false report and received a fine of 2 million won for the company and 700,000 won for the individual. The penalties are too weak. We are researching legislation in other countries to see how they punish similar cases in order to strengthen the penalties.”
He added, “In addition to administrative improvements, we also need to introduce punitive damages in civil cases. In a situation where companies only get a slap on the wrist for having neglected to take active measures, Johnson & Johnson has no reason to take action.”
He also mentioned that they requested the drug safety ministry to seek ways to take administrative action even when an import license has been canceled.
“The government could not take further administrative action in connection to that product because the company voluntarily recalled the product and stopped production. We will discuss stronger penalties and the obligation to inform patients during the parliamentary inspection (this coming October 14),” he conveyed.
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