Patients injected with gene therapy treatment initiate class action lawsuit against Kolon Life Science

Posted on : 2019-05-09 16:54 KST Modified on : 2019-05-09 16:54 KST
Kidney cells present in Invossa-K found to potentially cause tumors
Sales of Kolon TissueGene’s Invossa-K treatment have been suspended after it was discovered to contain potentially harmful cell alterations.
Sales of Kolon TissueGene’s Invossa-K treatment have been suspended after it was discovered to contain potentially harmful cell alterations.

Patients who received injections of Invossa-K Inj. for degenerative arthritis initiated legal procedures to claim collective damages amid fears that the alteration of a major component of the injection – approved as South Korea’s first form of gene therapy – could pose risks.

Among those taking part in the class action are patients suffering from stomach, breast, and other forms of cancer in addition to arthritis, who reportedly joined the lawsuit after being troubled by reports that the kidney cells (GP2-293) found to have been present – instead of the cartilage cells (chondrocytes) that are a major component of Invossa – may cause tumors.

Several sources at Oh Kims law firm told the Hankyoreh on May 8 that more than 120 individuals previously injected with Invossa-K have expressed their intention to participate in the class action damages lawsuit against Kolon Life Science, the manufacturer of the gene therapy. About half of the patients have already submitted the documents necessary for the lawsuit, including letters of attorney and certificates of diagnosis.

Considering that Invossa-K has been administered to 3,707 individuals altogether from its approval by South Korea’s Ministry of Food and Drug Safety in July 2017 until domestic sales were suspended at the end of March, the number of people participating in the class action is expected to increase.

“Since it came out that Kolon TissueGene, a subsidiary of Kolon Life Science, found out two years ago that the cells that are the primary ingredient of Invossa-K were not the ones it had originally reported, there has been a major increase in the number of patients inquiring about participating in the lawsuit,” said Eom Tae-seop, an attorney at Oh Kims who is handling the class action.

“We’ll continue recruiting patients to participate in the class action until the end of the month, when we’re planning to file the lawsuit. Even after we file, people who received the gene therapy can join the lawsuit,” Eom said.

The pending request for compensation states that receiving a gene therapy whose main ingredients were misrepresented subjected the plaintiffs to as much as 7 million won (US$5,952) worth of property damage and that the plaintiffs had suffered physical and mental harm because the gene therapy robbed them of the chance to receive another treatment for their arthritis.

Some of the people who have already submitted their medical certificates with the intention of taking part in the class action are reportedly suffering from stomach cancer or breast cancer in addition to arthritis. “The primary ingredient of Invossa-K isn’t cartilage cells but kidney cells. People who have stomach cancer or breast cancer along with arthritis were furious to learn that those cells can cause tumors,” Eom said. In short, the alteration of the primary ingredient put these individuals at risk of contracting a tumor, while simultaneously preventing them from enjoying the benefits of arthritis treatment. According to Eom, a majority of the patients who intend to participate in the lawsuit reported suffering side effects after receiving an Invossa-K injection, such as pain and swelling in their knee joints.

Injections of Invossa-K had been administered as treatment for degenerative arthritis since the substance was approved as South Korea’s first gene therapy in July 2017, but domestic sales were discontinued at the end of March after a clinical test in the US found that the primary ingredient of the substance was actually kidney cells. On May 3, Kolon Life Science announced that Lonza, the company contracted to manufacture Invossa-K, had determined that the primary ingredient of the substance was kidney cells and had notified Kolon TissueGene of this in March 2017.

The Ministry of Food and Drug Safety, the agency that had originally approved Invossa-K, is planning to take administrative action following a test in the US that’s likely to wrap up around May 20. The Ministry will consider a number of factors in its decision, including the fact that Kolon TissueGene became aware that the wrong cells were involved in March 2017.

By Kim Yang-joong, medical correspondent

Please direct comments or questions to [english@hani.co.kr]

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