Local patients who got Invossa-K injection for arthritis treatment will pursue a class-action lawsuit against Kolon Life Science for mislabeling the drug ingredient cells, which were revealed as cancerous GP2-293 cells instead of cartilage-derived cells, according to law firm Oh Kims.
Under the Pharmaceutical Affairs Act, no pharmaceutical manufacturer or seller is allowed to sell drugs or manufacturing them for sales, which have different ingredients or quantities as licensed or reported.
The law firm claimed that using 293 cells in Invossa instead of cartilage cells as reported for approval conditions violated the Pharmaceutical Affairs Act.
“Manufacturing and selling the drug that had ingredients different from authorized ones was in breach of the law. Due to the illegal act of the manufacturer,” Oh Kims, pursuing the lawsuit, said. “Patients paid nearly 7 million won ($6,158) to get an injection treatment that contained a completely unexpected ingredient. After the injection, they became exposed to the risk of developing an unknown malignancy.”
To prevent a similar case, all of the patients treated with Invossa must participate in the class-action lawsuit, said Eom Tae-seob, a lawyer at Oh Kims. “We should be aware that this could be another ‘humidifier disinfectant scandal.’”
Eom was referring to the deadly humidifier sterilizer incident that caused the deaths of more than 70 people between 2006 and 2011.
Kolon said 293 cells were “mistakenly mixed” in Invossa during the process of extracting viruses from 293 cells. The company emphasized that the drug’s efficacy and safety have been already verified through clinical trials and approval procedures.
Besides, thorough radiation blocked potential tumorigenicity in 293 cells, Kolon argued. The company hopes that the regulator could order a change in approval condition, instead of revoking the license for Invossa.
Oh Kims, however, noted that the American Type Culture Collection (ATCC) banned the use of 293 cells in the human body due to their tumorigenicity.
“Kolon says patients should not worry, citing only fewer than 200 cases and a clinical result with a short follow-up,” the law firm said. “If Kolon’s allegation is true, the company never developed a drug as it initially planned. So, it should not make non-sense requests such as asking a change in approval condition.”
Oh Kims is gathering patients treated with Invossa for the class-action suit via an online platform, “Angry People.” Those who had Invossa since 2017 can join.
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