Among the many problems listed in FDA reports, inspectors described dirty work areas, sloppy operating procedures, contamination, improper environmental monitoring and insects in a hallway outside the room where vials were filled with the vaccine.
Wyeth's own internal investigations were also found to be inadequate. "Manufacturing investigation reports are not always completed in a timely manner," the FDA inspectors wrote in reviewing Wyeth's compliance in correcting previously cited problems. "Further," they said, "there is a lack of evidence that product impact is addressed in a timely manner and that all batches/processes are fully investigated."
In one FDA report alone, inspectors identified 59 problems.
In 2001 and 2002, Livingston says he repeatedly reported the violations to the managing director at the plant, an outside auditor, and a quality council of managers and nothing was done to correct the problems.
Livington says he was also concerned about the dangerous working conditions for employees. "I had many manufacturing technicians from 2000-2002 tell me," he said, "they did not want to work in the Prevnar manufacturing area for fear of the chemicals used in the production process, including cyanide."
"Sodium cyanide is a dangerous chemical," he says, "mix it with water and you get hydrogen cyanide, the gas of choice used in the Holocaust."
Sodium cyanide is used in the Prevnar manufacturing process, but trace amounts remain in the vaccine itself, according to Livingston.
There are in fact, he says, many toxic substances in vaccines. "Mercury, lead, aluminum, cyanide, it's not a pretty picture," Livingston warns, "for a child's immune system, for unsuspecting parents and caregivers, who are never told about the presence of these chemicals, and for employees who have to keep their mouths shut or face losing employment," he adds.
Attorney, Thad Guyer, now of T.M. Guyer, Ayers & Friends, PC, says the Livingston case is still undecided, but that a favorable ruling on the same issue was handed down on March 29, 2006, in the whistleblower case of Walton vs Nova Information System and US Bancorp.
Guyer's private law firm handled the Bancorp action and Guyer describes the ruling as a "major victory," because the "court held for the first time that a SOX claim does not require the allegation of fraud, but merely of any violation of any SEC law," he explained.
In Bancorp, the company had also denied that any security lapses had occurred, but said that even if some did, Walton's voicing concerns about them did not constitute activity protected by the Act.
Like in Livingston, Guyer disagreed and argued that SOX protects the providing of information on a violation of any provision of Federal law relating to fraud against shareholders, or the violation of a rule or regulation of the SEC.
The Administrative Law Judge agreed and stated: "the argument that SOX does not protect providing information of a violation of a rule or regulation of the SEC unless the Complainant also shows that the rule or regulation is related to fraud against shareholder is rejected."
The ALJ pointed out that the Act contains the specific phrase, "any rule or regulation of the Security and Exchange Commission," and said if the activity was not protected, "there would be no reason to specify as protected activity a violation of SEC rule or regulation as such a violation is of course also a violation of Federal law."
"It is an elementary rule of statutory construction that every statute shall be construed, if possible," the court added, "to give effect to all its provision."
More information for whistleblowers can be found at Lawyers and Lettlements.com
Wyeth's own internal investigations were also found to be inadequate. "Manufacturing investigation reports are not always completed in a timely manner," the FDA inspectors wrote in reviewing Wyeth's compliance in correcting previously cited problems. "Further," they said, "there is a lack of evidence that product impact is addressed in a timely manner and that all batches/processes are fully investigated."
In one FDA report alone, inspectors identified 59 problems.
In 2001 and 2002, Livingston says he repeatedly reported the violations to the managing director at the plant, an outside auditor, and a quality council of managers and nothing was done to correct the problems.
"Sodium cyanide is a dangerous chemical," he says, "mix it with water and you get hydrogen cyanide, the gas of choice used in the Holocaust."
Sodium cyanide is used in the Prevnar manufacturing process, but trace amounts remain in the vaccine itself, according to Livingston.
There are in fact, he says, many toxic substances in vaccines. "Mercury, lead, aluminum, cyanide, it's not a pretty picture," Livingston warns, "for a child's immune system, for unsuspecting parents and caregivers, who are never told about the presence of these chemicals, and for employees who have to keep their mouths shut or face losing employment," he adds.
Attorney, Thad Guyer, now of T.M. Guyer, Ayers & Friends, PC, says the Livingston case is still undecided, but that a favorable ruling on the same issue was handed down on March 29, 2006, in the whistleblower case of Walton vs Nova Information System and US Bancorp.
Guyer's private law firm handled the Bancorp action and Guyer describes the ruling as a "major victory," because the "court held for the first time that a SOX claim does not require the allegation of fraud, but merely of any violation of any SEC law," he explained.
In Bancorp, the company had also denied that any security lapses had occurred, but said that even if some did, Walton's voicing concerns about them did not constitute activity protected by the Act.
Like in Livingston, Guyer disagreed and argued that SOX protects the providing of information on a violation of any provision of Federal law relating to fraud against shareholders, or the violation of a rule or regulation of the SEC.
The Administrative Law Judge agreed and stated: "the argument that SOX does not protect providing information of a violation of a rule or regulation of the SEC unless the Complainant also shows that the rule or regulation is related to fraud against shareholder is rejected."
The ALJ pointed out that the Act contains the specific phrase, "any rule or regulation of the Security and Exchange Commission," and said if the activity was not protected, "there would be no reason to specify as protected activity a violation of SEC rule or regulation as such a violation is of course also a violation of Federal law."
"It is an elementary rule of statutory construction that every statute shall be construed, if possible," the court added, "to give effect to all its provision."
More information for whistleblowers can be found at Lawyers and Lettlements.com
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