Nam Hyun-woo has worked as a staff writer at The Korea Times since 2013, mostly covering business and politics. He currently belongs to the Business Desk where he covers topics such as emerging tech, AI, ICT and Korea's chaebol community. Prior to joining the team, he was the paper's correspondent for the presidential office of Korea during the Yoon Suk Yeol and Moon Jae-in administrations.
Kolon to face class action suit over Invossa
Invossa-K
By Nam Hyun-woo
By Nam Hyun-woo
Kolon Life Science CEO Lee Woo-sok
Kolon Life Science, which stirred up controversy over its “mislabeled” osteoarthritis gene medicine Invossa, will face a class action suit from domestic patients who received the injection, according to a law firm Thursday.
Oh Kims Law & Company said it is gathering patients who have received Invossa-K injections in their knees through a public website and will launch a class-action damage suit against Kolon Life Science.
“The point in this case is that the firm has distributed a drug which contains unauthorized materials and the drug was injected into people's knees,” lawyer Eom Tae-seob at the firm said.
Invossa-K is the injectable form of Invossa, which has been available for clinical use in Korea since July 2017. The drug was under phase three clinical trial for sales in the U.S., but its sales and tests were all suspended after the firm's U.S. body found the drug contained cell ingredients that were different from those used at the time of approval in 2017.
At the time of approval, Kolon Life Science reported the drug contained ingredients derived from cartilage, but they turned out to be GP2-293 cells, which were derived from kidneys.
Kolon Life Science CEO Lee Woo-sok apologized to the public earlier this month and later announced that the cell lines used for the U.S. clinical trials were identical to those made and distributed in the Korean market, but the firm continues to claim that the drug is still safe and no side effects were reported.
A total of 3,403 Invossa-K injections were reported in Korea as of February. Adding those who received the injection in domestic clinical trials in the past, the number rises to 3,549.
“It is questionable that patients can accept the firm's claim that the drug is safe because no cases of side effects were reported. They are spending their days in fear that potential side effects may occur in the future,” Eom said.
Eom stressed that regardless of the drug's safety, the firm violated the Pharmaceutical Affairs Act, which states “no one shall sell drugs which are licensed but whose ingredients are different from contents as licensed or reported.”
Oh Kims Law expects each participant will claim for damages equal to the cost of the drug, more than 5 million won ($4,400) per injection, plus additional compensation for mental and other harm.
“The most important thing in making a drug is safety,” he said. “The fact that the company has distributed a drug which contained unconfirmed ingredients itself is a very serious problem.”
Currently, Korea's Ministry of Food and Drug Safety is investigating the drug based on the findings by Kolon Life Science and will decide whether to cancel the drug's license or keep it available for sale after changing the label and documents.
In addition to Oh Kims Law, multiple civic groups are raising their voices against Kolon Life Science.
The Free Health Care Campaign Center, which is a federation of multiple medical related civic groups in Korea, denounced Kolon Life Science claiming the company has “deceived the public for the past 17 years and now is attempting to get away from it, downplaying the critical mistake as a labeling error.”
The center also claimed the firm should come up with measures to compensate patients who fear they will suffer from potential side effects in the future and urged the drug ministry to revamp its drug licensing process.