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Class action planned against Kolon

Apr 18,2019
OhKims Law & Company is seeking people injected with arthritis-treatment Invossa to pursue a class-action lawsuit against Kolon Life Science for mislabeling a key ingredient of the drug.

The law firm announced Monday that it is gathering patients who were treated with Invossa for the class-action lawsuit via an online platform known as “Angry People.”

According to OhKims Law & Company, Kolon violated the Pharmaceutical Affairs Act as the company manufactured and sold drugs that contained different ingredients to the version of the drug that was licensed. The lawsuit will look for monetary compensation for the cost of the gene therapy drug, as well as the psychological damage the alleged mistreatment caused.

“We need to express our anger towards Kolon TissueGene for distributing a product not proven to be safe,” said Eom Taeseob, a partner at OhKims Law & Company who is in charge of pursuing the lawsuit.

Kolon TissueGene is the affiliate of Kolon Life Science that developed Invossa, the first drug in Korea to use gene therapy to treat osteoarthritis.

Kolon Life Science suspended the distribution and sale of Invossa after discovering the inclusion of cell lines not mentioned in the data it submitted to the Ministry of Food and Drug Safety for approval while preparing to conduct Phase 3 clinical trials in the United States.

Two weeks after the suspension, the company confirmed through its own inspection that all Invossa products contained the same kidney-originated cells, which the ministry confirmed in a statement Monday.

Kolon admitted to mislabeling a key ingredient in the drug.

“Patients paid nearly 7 million won ($6,200) to get an injection treatment that contained a completely unexpected ingredient,” Eom said. “The patients who were injected with Invossa are exposed to the risk of developing an unknown malignancy.”

Despite banning doctors from prescribing Invossa to patients, the ministry concluded two weeks ago that public safety was not an issue as no threatening side effects were reported during the 11 years since Kolon Life Science began clinical trials. The injectable drug has been administered to 3,403 patients in Korea since it was officially released in July 2017.

However, some experts have contended that the kidney cell lines unexpectedly included in Invossa could cause tumors to develop. Kolon Life Science responded last week that this should not be an issue as it uses radiation to suppress tumor development.

Dozens of patients have already contacted the firm to join the lawsuit. The law firm expects to file the claim within this month.

Kolon Life Science did not respond to calls for comment Wednesday.


BY KO JUN-TAE [ko.juntae@joongang.co.kr]


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