By Na Jeong-ju
Staff Reporter
More than 10 people will launch a legal battle with local and multinational drug manufacturers to demand compensation for their loss of health after taking medicines containing a stroke-causing substance.
The DeRyook International Law Firm said Monday that it will soon file damage suits with a local court against domestic firms and with the U.S. federal court against the multinational makers.
A lawyer with the legal service said his legal team plans to seek compensation for product liability and punitive damages arising from cold and diet drugs having phenylpropanolamine (PPA), which had allegedly caused hemorrhagic strokes in his clients.
He said Korean and foreign pharmaceutical firms have continued to produce PPA-containing drugs over the last four years, despite that the U.S. Food and Drug Administration (FDA) removed almost all such products in the American market since November 2000.
The lawyer claimed that the Korean Food and Drug Administration (KFDA) have failed to take proper measures against drugs with PPA although the regulator imposed a voluntary ban on local firms.
He also said the his team is studying ways of filing a damage suit against the KFDA for their neglecting its duty of ensuring drug safety.
He cited a U.S. case against Chattem, Inc., which was accused of causing damages by supplying PPA-containing diet product Dexatrim. The firm has recently agreed on the out-of-court settlement to pay $60 million in compensation to those suffering from damages from its product.
Meanwhile, the Ministry of Health and Welfare on Monday concluded the KFDA have taken belated measures against the PPA products as it took four years for the regulator to ban them.
``The negligence of duty and lukewarm attitude of the KFDA officials in handling the case put the public health in serious danger,’’ the ministry said in a report. ``The KFDA failed to report the case to the ministry and consult with related agencies, without recognizing the importance of the case.’’
The report, an outcome of the ministry’s week-long investigation into the KFDA’s handling of cold medications containing PPA, a property that can cause hemorrhagic strokes, signified the KFDA had made serious mistakes and failed to fulfill its duty to protect public health.
On August 1, the KFDA banned production and sale of 167 prescription and over-the-counter cold remedies having PPA which were manufactured by 75 pharmaceutical firms, about fours years after it first recognized the potential side-effect of the products in 2000.
Monday, KFDA head Shim Chang-koo stepped down, taking responsibility for the scandal surrounding a delayed ban on the PPA-containing medications.
``I decided to tender my resignation to take responsibility for the scandal,’’ Shim told a news conference in his office in Seoul.
Shim’s resignation is seen as the beginning of a shake-up of the KFDA and its monitoring system for drug safety. The ministry said it will install an independent committee comprising medical experts and consumer groups to strengthen monitoring of drugs and for research of the possible side effects of drugs on sale.
Despite the ministry’s action, many questions still remain. Suspicions have been emerging that the KFDA attempted to protect pharmaceutical firms and downplay the risk of the PPA-containing drugs, but the ministry failed to report the suspicions.
The KFDA was also criticized for delaying the announcement of a years-long study by a medical research group that concluded the PPA-containing drugs may cause strokes.
Yuhan Corp, Choongwae Pharma, Hanmi Pharm, Yungjin Pharm, Wyeth Korea and BMS Korea are some of the 75 manufacturers.
The KFDA has been under fire for downplaying the risk of the PPA-containing drugs. The drug agency did not mention the level of risk in its press release on July 31, although it was aware of the fact that use of the PPA increases the likelihood of hemorrhagic strokes among people over the age of 30, especially women.
The research, which was taken by from March 2002 to June 25 by nine medical professors, was financed by the pharmaceutical firms producing the PPA products.
Regulators last week found one of the 167 banned medicines received a sales permit on July 20, days after the KFDA received the research results on June 15. Another 13 cold medicines containing PPA obtained sales permits after July 2001, after the government requested pharmaceutical firms to refrain from manufacturing PPA-containing drugs.
The Board of Audit and Inspection last week said it will investigate the handling of the PPA drugs by the health ministry and the KFDA and the relationship between the KFDA and pharmacy firms involved.
jj@koreatimes.co.kr
