Korean patients, who received Invossa-K injection for degenerative arthritis treatment, are increasingly becoming jittery over the mislabeled cell ingredients of the drug, recently revealed as cancerous GP2-293 cells.
Kolon Life Science on Tuesday confirmed that the cancerous cell lines used for clinical trials of Invossa in the U.S. were found to be identical to those made and distributed in the local market. Some of the patients treated with Invossa are seeking response measures such as discussing with a law firm filing a class-action lawsuit or sharing side effect cases.
A total of 3,548 patients have received Invossa injections for 11 years from clinical trials to prescriptions. Most of them are seniors, unaware of the mislabeling.
However, some are enraged that the cells injected into their body were different from those described for approval and that the cells were abnormal and cancerous.
Some others are seeking to file a class-action lawsuit via an online platform, “Angry People,” supported by law firm Oh Kims.
Eom Tae-seob, a lawyer at Oh Kims who is pursuing the lawsuit, said it was illegal to distribute a drug containing unauthorized cells and inject it to patients. “The company must compensate for patients’ mental damages and drug expenses,” he argued.
Eom noted that whether the Ministry of Food and Drug Administration would impose an administrative punishment on Kolon or whether the company could prove Invossa’s safety was irrelevant to the nature of the incident.
“The point is that the cells found to be mislabeled were not those written in the report submitted for drug approval,” he emphasized.
Eom met several patients to discuss filing a civil lawsuit or pressing criminal charges against Kolon for the violation of the Pharmaceutical Affairs Act.
Another online community, “A group for Invossa victims,” is collecting Invossa injection cases to identify the scope of damage. Over 30 members of the community are sharing their examples of side effects.
Ahn Jae-han, a lawyer at Hanyang who opened the community, said the victims were searching for the right way to respond to the issue because all of the data related to Invossa was biased towards Kolon.
He was cautious about filing a lawsuit.
“Korea has not adopted the U.S. class action lawsuit system, so we need to be careful. It is not too late to gather evidence after fully observing the ministry’s decision on punishment and further development of the issue,” Ahn said. “I made the online community for the victims to help them get the full compensation.”
Observers said not only the result of the ministry’s investigation and punishment decision but how Kolon will respond to the patients will affect the patient’s response measures.