Lawyer calls for improving injury relief system

A man, known by just the initial of A, recently took an OTC medication containing acetaminophen, and went to the emergency room of a neighborhood hospital because of a rash with itching. Medical staffs, not knowing A had taken acetaminophen, treated rash and cold, prescribing a drug with the same compound. That exacerbated A’s rash, forcing him to visit another hospital, which diagnosed him with Stevens-Johnson syndrome and Toxic epidermal necrolysis caused by acetaminophen. Later he went blind.

A filed a suit for damage against the pharmaceutical company, the pharmacist, and the doctors who treated him. The Seoul High Court rejected the charges on the pharmaceutical company and pharmacist, but ordered the physicians to compensate 400 million won ($357,000) in fines to A, recognizing their mistakes of prescribing the same drug without asking A about his condition.

A could get compensation thanks to the Projects for Relief of Harm from Side Effects of Drugs (PRHSED). The projects, introduced by the Ministry of Food and Drug Safety in December 2014, call for paying medical fees and compensation to patients who died, became disabled, and suffered damage from side effects of medicines, or their family members.

Lawyer Hyun Doo-youn points out the problems of the Projects for Relief of Harm from Side Effects of Drugs (PRHSED), in a recent interview with Korea Biomedical Review.

Some experts, however, point out that the projects are creating situations, in which all parties involved pass the responsibility to cover damages to only doctors.

“Although the government has been implementing PRHSED, victims often cannot receive the relief because of restrictive regulations, while doctors end up holding all the bags (liability for damages),” said Hyun Doo-youn현두륜, a lawyer at Kim&Hyun Lawfirm법무법인 세승, in a recent interview with Korea Biomedical Review.

According to the Pharmaceutical Affairs Act, people can’t get the compensation according to PRHSED if they are killed or disabled because of medical malpractices. In other words, if adverse drug reactions and medical malpractices overlap with each other, people can’t apply for remedy of damages from adverse drug reactions.

In the case of pharmaceutical companies, most of them evade responsibility as courts do not recognize manufacturing faults. Pharmacists also shirk the responsibility under the pretext of providing medication counseling. Eventually, only doctors remain as litigation parties, compensating entire damages.

An even bigger problem is the subject of the application. The regulations on relief of injury from adverse drug reaction limit the subjects of application to patients who suffered damages and their family members. It means even if doctors compensate for damages from adverse drug reactions, the physicians cannot make up for their financial losses.

“Doctors should be included in the subjects for the compensation if medicinal side effects are the leading causes of medical incidents,” Hyun said. “The Ministry of Food and Drug Safety식품의약품안전처(MFDS) also has to expand the scope of relief payments, currently limited to medical costs, compensation for death disability and funeral fees, so that patients can receive reasonable compensation to a certain extent.”

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