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STAMFORD, Conn. (AP) -- A former employee of OxyContin maker Purdue Pharma who told federal drug regulators that the powerful painkiller has dangerous flaws is suing the company, claiming he was fired because of his complaints.
Marek Zakrzewski also says in the lawsuit that the company pressured him to keep quiet, causing him to suffer physical and mental health stress, The Advocate of Stamford reported. He said he was told to keep quiet, later demoted and eventually fired.
Zakrzewski, who was hired by Stamford-based Purdue Pharma in July 2000, was an assistant director who researched OxyContin, also known as Oxycodone HCL.
Purdue Pharma spokesman Timothy Bannon said the company believes it will be cleared of wrongdoing.
"We consider that our actions with respect to this individual were perfectly appropriate and strongly deny his allegations that we acted in any way to discourage cooperation with the authorities," Bannon said.
"We value our relationship with the authorities and always work not only to meet, but to exceed, their requirements," he said.
Purdue Pharma has been criticized for the misuse of OxyContin, which had annual sales of more than $1 billion in 2000 and is the company's best-selling product.
Hailed as a breakthrough in the treatment of severe chronic pain when it was released in 1996, the drug became a problem after users discovered that crushing the time-release tablets and snorting or injecting the contents can yield an immediate, intense high, similar to heroin.
The drug, intended for use by terminal cancer patients and chronic pain sufferers, has been widely abused in some parts of the country. If taken properly, Oxycontin's active ingredient is released slowly into the body.
About 285 lawsuits are pending against Purdue Pharma in connection with OxyContin, Bannon said in an interview with The Associated Press earlier this month. He said the company detects a pattern of dismissals and is confident it will prevail in the pending cases as well.
An attorney in Ohio disagrees. Stanley Chesley, who is representing plaintiffs in a class action suit against Purdue Pharma, said the plaintiffs have developed a strong case.
Zakrzewski's lawsuit, filed last month in Danbury Superior Court, challenges the company's defense that the time-release technology behind the medication makes it safe for pain sufferers.
The lawsuit says that during Zakrzewski's time researching and testing the drug, he discovered that the dissolution speed varies in Oxycodone, and that the faster dissolving form of the drug was being used in uncontrolled amounts to produce OxyContin.
The faster form, he said, potentially could dissolve more quickly into the human body and cause overdosing and addiction.
Zakrzewski said he told management about the "serious negative implications" that his findings could have for consumers.
He said he was banned from doing additional research on the dissolution of the drug after telling management about his concerns, and later ordered not to tell the company's regulatory department.
Zakrzewski said he then found that the method of measuring the particle size of Oxycodone HCL, which influences dissolution speeds of the chemical, was not accurate.
He said he was demoted and stripped of supervisory responsibilities and title when he continued to press his concerns.
Zakrzewski reported his concerns to the Food and Drug Administration in April and was soon fired.
An FDA spokeswoman did not immediately return a telephone message Sunday evening.
On the agency's Web site, a section on OxyContin had not been updated since February. The site said there had been numerous reports of OxyContin diversion and abuse in several states, with some of the cases resulting in serious consequences including death.
The FDA said Purdue Pharma was to send doctors letters warning them about the risks.
Ron Baker, senior editor of Pharmaceutical Litigation Reporter, which covers the drug industry, said Zakrzewski's lawsuit could affect other litigation against Purdue Pharma.
"If all this stuff he is alleging comes out in court and is proven to be true, other people filing suits can use it in their suits," Baker said. "And then there's always the chance that Justice Department or FDA could latch on to this guy's case, support him and file on his behalf."
Bannon said Purdue Pharma officials expect the company to be vindicated in court.
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