[Edaily Reporter SONG YOUNG-DOO ] In a damages lawsuit filed by patients who received the osteoarthritis gene therapy “Inbosa” against KOLON CORPORATION and its affiliates, the court recognized product liability and ruled in favor of the plaintiffs in part.

According to legal circles on the 29th, the 29th Civil Division of the Seoul Central District Court (Presiding Judge Ko Seung-il) ruled in favor of the plaintiffs in part in a damages lawsuit filed by 18 individuals—including patients who received Invos and their bereaved families—against Lee Woong-yeol, Honorary Chairman of KOLON CORPORATION, KOLON LIFE SCIENCE Inc.(102940), Kolon TissueGene, Inc.(950160), and Lee Woo-seok, former CEO of KOLON LIFE SCIENCE Inc.

The court ordered the defendants to jointly pay the plaintiffs a total of approximately 664 million won.

The plaintiffs consist of 15 patients who received Inbosa between April 2018 and March 2019, as well as the bereaved families of three patients who died after receiving the treatment. They sought damages, claiming that manufacturing defects in Inbosa caused them to suffer from persistent pain and require long-term follow-up, and that some suffered physical and mental harm, including the development of cancer.

Inbosa is a gene therapy for osteoarthritis developed by Kolon TissueGene, Inc., which received approval from the Ministry of Food and Drug Safety (MFDS) in 2017 as South Korea’s first gene therapy. However, in 2019, it was confirmed that, contrary to the data submitted at the time of approval, the second component contained kidney-derived cells rather than cartilage cells; consequently, the MFDS revoked the product license that same year.

The court ruled that Inbosa had a manufacturing defect and lacked the safety typically expected of such a product. In particular, it noted that cells different from those intended in the design were used, and that it was difficult to believe the manufacturer failed to detect this even given the state of the art at the time.

The court stated, “It is evident based on the rules of experience that the plaintiffs and the deceased suffered significant mental anguish due to the manufacturing defect,” adding, “A causal relationship between the defect and the mental distress is also recognized.”

Furthermore, the court recognized the manufacturer’s liability for mislabeling the product as “cartilage-derived cells” when it was not, and for manufacturing and selling a drug that differed from the approved formulation.

The court ruled, “The defendant companies, former CEO Lee Woo-seok, and Honorary Chairman Lee Woong-yeol manufactured and sold Inbosa despite being aware of its defects,” adding, “They are liable to compensate the patients and the deceased for the damages they suffered.”

The court awarded 30 million won in compensation to each surviving patient and 50 million won to the families of deceased patients. It also found the medical staff who treated the deceased patients and the medical foundation partially liable for damages, ordering them to pay 14 million won. Surgical costs incurred for the administration of Inbosa were also included in the scope of compensation.