[NVIC] Prevnar Whistleblower Trial

[Guest guest]

Share this with all in UK too since this just added to the schedule there

Sheri

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia http://www.nvic.org

* * * * * * * * * * * * * * * * * * * * * * *

UNITED WAY/COMBINED FEDERAL CAMPAIGN

#8122

* * * * * * * * * * * * * * * * * * * * * * *

" Protecting the health and informed consent rights of children since 1982. "

============================================================================

==============

BL Fisher Note:

When one solitary individual stands up for the truth no matter what the

risks, he or she is protecting all those who have neither the knowledge, the

strength or the ability to stand up and face the consequences. Mark

Livingston is a hero. Hopefully the federal judge who now has an opportunity

to acknowledge what Mark Libingston has done on behalf of innocent children,

will have the strength and the integrity to stand up to a giant

pharmaceutical company with nothing to lose but its profits.

http://www.washingtonpost.com/wp-dyn/content/article/2006/02/08/AR2006020801

760.html?referrer=emailarticle

The Washington Post

Lawsuit Tests Whistleblowers' Protection

By ADAM GELLER

The Associated Press

Wednesday, February 8, 2006; 5:17 PM

-- Was Mark Livingston trying to blow the whistle on suspect corporate

behavior, and protect his company's shareholders? Or was he making trouble?

Next week, a judge in Greensboro, N.C. will parse through the story of

Livingston and the company that fired him, pharmaceutical maker Wyeth, and

weigh those questions. The answer could have implications for companies,

workers and investors well beyond their bitter dispute.

Livingston, a former training director at a Wyeth vaccine plant, seeks to

cast himself in the mold of whistleblowers like Sherron Watkins, who became

a folk hero for trying to call attention to massive accounting fraud at

Enron Corp.

But unlike Enron, the Wyeth case is noteworthy for what it is not. It has

nothing to do with accounting or with allegations of financial fraud, at

least not the way most people think about it.

After Enron and WorldCom Inc. imploded, lawmakers sought to prevent future

scandals, adopting reforms including job protection for insiders who blow

the whistle on suspected fraud. But it's not clear if the law _ known as

Sarbanes-Oxley _ protects workers like Livingston who raise concerns beyond

financial matters.

Lawmakers' effort to protect whistleblowers " intended a pretty broad sweep, "

said Vaughn, a professor of law at American University who has

examined Sarbanes-Oxley whistleblower cases. " The basic principle is this:

Is the information something that investors and shareholders should know

about? "

Yes, says Livingston, arguing his complaints of gaps in training and

oversight pointed to potential problems with a production of a vaccine that

is a major contributor to Wyeth's profits.

Wyeth disagrees. The company, based in Madison, N.J., has asked a federal

judge to dismiss a 2003 lawsuit by Livingston demanding his job back.

Livingston's complaints about the plant's operations are well beyond matters

covered by the law, the company says. He was fired, not in retaliation, but

because of what the company calls " repeated misconduct, " culminating in a

confrontation with a company executive at a holiday party.

If Livingston wins protection as a whistleblower " certainly we would say it

would be an unwarranted expansion of what the law explicitly covers and what

it was designed to cover, " said Delikat, a New York attorney

representing Wyeth. " But that's going to be for the court to decide. "

The dispute that raises these issues played out at a plant in Sanford, N.C.

where Wyeth makes Prevnar, a vaccine to protect infants and young children

against pneumococcal disease, which can cause meningitis, pneumonia and

other illnesses.

When Livingston was hired in 2000 to develop and track employee training at

the plant, Wyeth was still ramping up production of the vaccine. Even then,

Prevnar's profit potential was obvious.

The Centers for Disease Control recommends the vaccine be administered to

every infant and young child. The resulting demand outpaced the company's

production, creating shortages not resolved until 2004.

In the five years since it was introduced, Prevnar has become one of Wyeth's

biggest selling products, with sales last year up 43 percent to $1.5

billion.

Wyeth hired a familiar face in Livingston, who had worked for the company as

a manufacturing consultant. Tired of frequent business travel, Livingston,

married and the father of two, saw the job as a chance to stay at home in

Sanford, an outlying bedroom community for North Carolina's research

triangle.

" Wow, " he recalls thinking, " this is a place that I could grow for a good

long while. "

After six weeks, though, Livingston says he saw problems. Workers were

signing off on federally required records and adopting procedures without

proper training, his lawsuit says. Some records did not match production

activity. Wyeth has denied the allegations.

Livingston says he raised concerns with the director of manufacturing in

September 2000 and was warned to " back off. "

But the following month, the Food and Drug Administration announced a

consent decree with Wyeth after inspectors determined the company was not

meeting manufacturing standards at plants in Pennsylvania and New York.

Wyeth agreed to pay $30 million, engage experts to do a comprehensive

inspection at the plants and review and certify overall quality efforts.

That reassured him, Livingston said. His confidence was bolstered further

when plant managers allowed him to organize worker focus groups to talk

about whether the plant was meeting manufacturing requirements.

The good feelings didn't last.

Livingston alleges that in 2001 and 2002 he repeatedly pointed out problems

to an outside auditor, the plant managing director and a quality council of

managers. The company acknowledges some of these meetings, but denies his

account of what took place.

In July 2002, Livingston wrote a memo to the plant's executives saying

problems were so serious he could not sign off on the company's efforts to

overhaul its compliance training.

" To indicate otherwise provides false and misleading information to outside

auditors, including the FDA, " Livingston wrote in his memo.

Soon after, Livingston was called into a meeting with the plant's top

executive. Livingston says the man was livid, waving the memo, and shouting

at him. A few days later, Livingston filed a complaint with the company's

ethics office, alleging harassment as well as problems in its training

systems.

In October, the managing director and the plant's personnel director told

Livingston his performance had to improve or he would be fired.

The end came in December 2002, when Livingston hosted a holiday lunch at a

local restaurant for his staff. As they gathered, the personnel executive

arrived uninvited and Livingston confronted him. The following Monday,

Livingston was notified he'd been fired.

By then, Wyeth says it had looked into all the issues he raised.

" Wyeth had conducted an extensive investigation of Mr. Livingston's internal

complaint and we determined it was without merit, " Wyeth spokesman Doug

Petkus said.

Livingston filed a complaint with the Department of Labor _ where an initial

investigation found the company had not violated the law _ then shifted his

case to federal court.

When the two sides go to court Monday, they will be arguing whether

Livingston's lawsuit should be dismissed or go to trial. The law says

workers are protected if they report company actions they believe might

constitute mail, wire or bank fraud, violate securities rules or fraud

against shareholders. A decision is not expected for a few weeks.

" It is equally important to an investor to know that there's possibly huge

deficiencies in the manufacturing regulations, " said Joanne Royce, general

counsel for the Government Accountability Project, a whistleblower advocacy

group representing Livingston, " just as important as deficiencies in

accounting. "

Livingston says his motivation is broader, driven partly by his own

misgivings.

He recounts one focus group held for plant workers during which a technician

posed an open-ended question.

" What is it we're all about here? Are we about saving lives or making

money? " Livingston recalled the woman asked.

" I sort of gave what I thought was the right answer, which is we're here to

save lives, " Livingston said. " But then I thought, what would the

corporation want me to answer, and I said, 'Well, we're here to do both.' "

Livingston says he regretted that equivocation ever since.

=============================================

News@... is a free service of the National Vaccine Information

Center and is supported through membership donations. Learn more about

vaccines, diseases and how to protect your informed consent rights

http://www.nvic.org

Become a member and support NVIC's work

https://www.nvic.org/making%20cash%20donations.htm

To sign up for a free e-mail subscription http://www.nvic.org/emaillist.htm

[Guest guest]

This trial is happening here in my town. I'll try to keep us posted.

Sheri B.

Sheri Nakken <snakken@...> wrote:

Share this with all in UK too since this just added to the schedule there

Sheri

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia http://www.nvic.org

* * * * * * * * * * * * * * * * * * * * * * *

UNITED WAY/COMBINED FEDERAL CAMPAIGN

#8122

* * * * * * * * * * * * * * * * * * * * * * *

" Protecting the health and informed consent rights of children since 1982. "

============================================================================

==============

BL Fisher Note:

When one solitary individual stands up for the truth no matter what the

risks, he or she is protecting all those who have neither the knowledge, the

strength or the ability to stand up and face the consequences. Mark

Livingston is a hero. Hopefully the federal judge who now has an opportunity

to acknowledge what Mark Libingston has done on behalf of innocent children,

will have the strength and the integrity to stand up to a giant

pharmaceutical company with nothing to lose but its profits.

http://www.washingtonpost.com/wp-dyn/content/article/2006/02/08/AR2006020801

760.html?referrer=emailarticle

The Washington Post

Lawsuit Tests Whistleblowers' Protection

By ADAM GELLER

The Associated Press

Wednesday, February 8, 2006; 5:17 PM

-- Was Mark Livingston trying to blow the whistle on suspect corporate

behavior, and protect his company's shareholders? Or was he making trouble?

Next week, a judge in Greensboro, N.C. will parse through the story of

Livingston and the company that fired him, pharmaceutical maker Wyeth, and

weigh those questions. The answer could have implications for companies,

workers and investors well beyond their bitter dispute.

Livingston, a former training director at a Wyeth vaccine plant, seeks to

cast himself in the mold of whistleblowers like Sherron Watkins, who became

a folk hero for trying to call attention to massive accounting fraud at

Enron Corp.

But unlike Enron, the Wyeth case is noteworthy for what it is not. It has

nothing to do with accounting or with allegations of financial fraud, at

least not the way most people think about it.

After Enron and WorldCom Inc. imploded, lawmakers sought to prevent future

scandals, adopting reforms including job protection for insiders who blow

the whistle on suspected fraud. But it's not clear if the law _ known as

Sarbanes-Oxley _ protects workers like Livingston who raise concerns beyond

financial matters.

Lawmakers' effort to protect whistleblowers " intended a pretty broad sweep, "

said Vaughn, a professor of law at American University who has

examined Sarbanes-Oxley whistleblower cases. " The basic principle is this:

Is the information something that investors and shareholders should know

about? "

Yes, says Livingston, arguing his complaints of gaps in training and

oversight pointed to potential problems with a production of a vaccine that

is a major contributor to Wyeth's profits.

Wyeth disagrees. The company, based in Madison, N.J., has asked a federal

judge to dismiss a 2003 lawsuit by Livingston demanding his job back.

Livingston's complaints about the plant's operations are well beyond matters

covered by the law, the company says. He was fired, not in retaliation, but

because of what the company calls " repeated misconduct, " culminating in a

confrontation with a company executive at a holiday party.

If Livingston wins protection as a whistleblower " certainly we would say it

would be an unwarranted expansion of what the law explicitly covers and what

it was designed to cover, " said Delikat, a New York attorney

representing Wyeth. " But that's going to be for the court to decide. "

The dispute that raises these issues played out at a plant in Sanford, N.C.

where Wyeth makes Prevnar, a vaccine to protect infants and young children

against pneumococcal disease, which can cause meningitis, pneumonia and

other illnesses.

When Livingston was hired in 2000 to develop and track employee training at

the plant, Wyeth was still ramping up production of the vaccine. Even then,

Prevnar's profit potential was obvious.

The Centers for Disease Control recommends the vaccine be administered to

every infant and young child. The resulting demand outpaced the company's

production, creating shortages not resolved until 2004.

In the five years since it was introduced, Prevnar has become one of Wyeth's

biggest selling products, with sales last year up 43 percent to $1.5

billion.

Wyeth hired a familiar face in Livingston, who had worked for the company as

a manufacturing consultant. Tired of frequent business travel, Livingston,

married and the father of two, saw the job as a chance to stay at home in

Sanford, an outlying bedroom community for North Carolina's research

triangle.

" Wow, " he recalls thinking, " this is a place that I could grow for a good

long while. "

After six weeks, though, Livingston says he saw problems. Workers were

signing off on federally required records and adopting procedures without

proper training, his lawsuit says. Some records did not match production

activity. Wyeth has denied the allegations.

Livingston says he raised concerns with the director of manufacturing in

September 2000 and was warned to " back off. "

But the following month, the Food and Drug Administration announced a

consent decree with Wyeth after inspectors determined the company was not

meeting manufacturing standards at plants in Pennsylvania and New York.

Wyeth agreed to pay $30 million, engage experts to do a comprehensive

inspection at the plants and review and certify overall quality efforts.

That reassured him, Livingston said. His confidence was bolstered further

when plant managers allowed him to organize worker focus groups to talk

about whether the plant was meeting manufacturing requirements.

The good feelings didn't last.

Livingston alleges that in 2001 and 2002 he repeatedly pointed out problems

to an outside auditor, the plant managing director and a quality council of

managers. The company acknowledges some of these meetings, but denies his

account of what took place.

In July 2002, Livingston wrote a memo to the plant's executives saying

problems were so serious he could not sign off on the company's efforts to

overhaul its compliance training.

" To indicate otherwise provides false and misleading information to outside

auditors, including the FDA, " Livingston wrote in his memo.

Soon after, Livingston was called into a meeting with the plant's top

executive. Livingston says the man was livid, waving the memo, and shouting

at him. A few days later, Livingston filed a complaint with the company's

ethics office, alleging harassment as well as problems in its training

systems.

In October, the managing director and the plant's personnel director told

Livingston his performance had to improve or he would be fired.

The end came in December 2002, when Livingston hosted a holiday lunch at a

local restaurant for his staff. As they gathered, the personnel executive

arrived uninvited and Livingston confronted him. The following Monday,

Livingston was notified he'd been fired.

By then, Wyeth says it had looked into all the issues he raised.

" Wyeth had conducted an extensive investigation of Mr. Livingston's internal

complaint and we determined it was without merit, " Wyeth spokesman Doug

Petkus said.

Livingston filed a complaint with the Department of Labor _ where an initial

investigation found the company had not violated the law _ then shifted his

case to federal court.

When the two sides go to court Monday, they will be arguing whether

Livingston's lawsuit should be dismissed or go to trial. The law says

workers are protected if they report company actions they believe might

constitute mail, wire or bank fraud, violate securities rules or fraud

against shareholders. A decision is not expected for a few weeks.

" It is equally important to an investor to know that there's possibly huge

deficiencies in the manufacturing regulations, " said Joanne Royce, general

counsel for the Government Accountability Project, a whistleblower advocacy

group representing Livingston, " just as important as deficiencies in

accounting. "

Livingston says his motivation is broader, driven partly by his own

misgivings.

He recounts one focus group held for plant workers during which a technician

posed an open-ended question.

" What is it we're all about here? Are we about saving lives or making

money? " Livingston recalled the woman asked.

" I sort of gave what I thought was the right answer, which is we're here to

save lives, " Livingston said. " But then I thought, what would the

corporation want me to answer, and I said, 'Well, we're here to do both.' "

Livingston says he regretted that equivocation ever since.

=============================================

News@... is a free service of the National Vaccine Information

Center and is supported through membership donations. Learn more about

vaccines, diseases and how to protect your informed consent rights

http://www.nvic.org

Become a member and support NVIC's work

https://www.nvic.org/making%20cash%20donations.htm

To sign up for a free e-mail subscription http://www.nvic.org/emaillist.htm