/////Fw: [NVIC] Lawsuit Against Wyeth by Employee

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better read this story fast, as Big Pharmaceutical companies will be killing it quickly or what ever it takes to protect their profits ....

 

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Deborah A Delp

undisclosed-recipients

Cc: Deborah A Delp

Thursday, April 01, 2004 7:32 AM

Fw: [NVIC] Lawsuit Against Wyeth by Employee

 

 

 

 

 

 

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kathi

03/31/04 15:36:56

news

[NVIC] Lawsuit Against Wyeth by Employee

 

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

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

 

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

 

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

 

FROM THE WALL STREET JOURNAL

 

URL for this article:

http://online.wsj.com/article/0,,SB108068791016069510,00.html

 

March 31, 2004

 

Lawsuit Alleges Vaccine Problems

 

By SCOTT HENSLEY and BETSY MCKAY

Staff Reporters of THE WALL STREET JOURNAL

March 31, 2004; Page B1

 

Prevnar is the most lucrative vaccine ever made, shielding infants and

toddlers from an often-lethal type of brain infection. But manufacturing

problems have left Prevnar's producer, Wyeth, unable to meet surging demand

for the product. It's the latest in a series of supply glitches that have

haunted the vaccine since it was introduced four years ago.

 

The Centers for Disease Control and Prevention, of Atlanta, recommends that

all young children in the U.S. receive a full, four-dose inoculation with

Prevnar by the age of 15 months to protect them from pneumococcal

meningitis, the most common bacterial form of the infection in the U.S.

 

The vaccine, which takes a full year to produce, also provides some

protection from pneumococcal infections of the ear and sinus. But thousands

of infants and toddlers won't receive full inoculation at the recommended

age, when they are at greatest risk of infection, because of the most recent

shortage of Prevnar that began in February.

 

Last month, the CDC advised pediatricians to postpone the fourth shot of

Prevnar to conserve scarce vaccine stocks; this month, it advised that they

limit patients to two doses. Supplies are expected to remain tight through

the summer and perhaps beyond, the CDC says. "We're barely holding on to a

two-dose schedule," says Lance Rodewald, the CDC's director of immunization

services.

 

Wyeth says the current shortfall of Prevnar is the result of too little

capacity at its factory in Pearl River, N.Y., where sterile vials are filled

with vaccine and packaged. The company says it expects to resolve the

problems fully by the end of the first half of 2004. Meanwhile, a former

Wyeth executive has filed an unusual lawsuit alleging that in the haste to

create more vaccine, Wyeth cut corners at another plant involved in Prevnar

production, raising questions of quality control.

 

The lawsuit, naming Wyeth and two employees, was filed in October in U.S.

District Court in Greensboro, N.C., by a former Wyeth manufacturing manager,

Mark Livingston, who trained workers at a factory in Sanford, N.C.. Bulk

vaccine is processed there before being shipped to Pearl River for

packaging.

 

 

In the suit, Mr. Livingston says Wyeth was so far behind in efforts to meet

demand for Prevnar that it cut corners in training at the plant and failed

to comply with standards set by the Food and Drug Administration. The suit

alleges Wyeth at times kept lax records, raising quality-control questions

and contributing to the problem of shortages. Mr. Livingston says he was

dismissed in retaliation for complaining about these issues to higher-ups.

 

Mr. Livingston raised his allegations with the FDA at a meeting in July last

year and hasn't heard from the agency since. An FDA spokeswoman says the

agency can't comment on ongoing litigation but said it "monitors companies

closely for compliance with good manufacturing practices. When we become

aware of any problems, we will follow up and take action as necessary." Mr.

Livingston's suit doesn't allege any health risks with the vaccine.

 

What is novel about the suit is the plaintiff's claim that Wyeth's conduct

amounted to fraud against shareholders, violating the Sarbanes-Oxley Act,

enacted in 2002 to overhaul corporate-governance and financial disclosure

practices in the wake of scandals at Enron Corp. and other companies. The

suit says Wyeth violated the rules' disclosure requirements by concealing

material problems with Prevnar production from shareholders. It also is a

test of Sarbanes-Oxley's protection of individual plaintiffs against

retaliation and discharge by employers.

 

John Coffee, a Columbia University law professor, says a plaintiff must show

he reasonably believed company misconduct violated SEC rules and must have

made those concerns known to relevant federal officials or company

executives in a position to discover and terminate the misconduct. If those

conditions are met, the plaintiff could be covered by the law's protections

against retaliation and discharge, Prof. Coffee says.

 

Representing Mr. Livingston in his suit is the Government Accountability

Project, a Washington public-interest group also concerned with corporate

responsibility. "If compliance violations are significant enough to affect

the bottom line, an investor has the right to know about them" says Joanne

Royce, a lawyer for the group. Sarbanes-Oxley should have protected Mr.

Livingston from reprisals, she says. Mr. Livingston is seeking

reinstatement, back pay and unspecified monetary damages.

 

Wyeth denies Mr. Livingston's allegations. "Training of employees at our

Sanford site has never been a concern of the company or the FDA," a Wyeth

spokesman says. "All employees working at the site have the requisite

training, background and experience. In addition, there is no connection

between our training obligations and requirements and the supply constraints

currently affecting Prevnar."

 

Wyeth has faced questions about its manufacturing before. In October 2000,

the company paid a $30 million fine as part of a consent decree with the FDA

regarding manufacturing procedures at the Pearl River factory and at another

plant, in Marietta, Pa., which isn't involved in producing Prevnar. Wyeth

says it plans to close the Marietta plant.

 

The current shortage of Prevnar isn't the first one since the vaccine came

to market four years ago. A shortage early on resulted from inadequate

supply of bulk vaccine. At present, there are no vaccines that compete with

Prevnar on the market, although rival companies are working on products that

may be ready in a few years. Since its introduction, Prevnar's world-wide

sales have totaled $2.85 billion.

 

Mr. Livingston says during the plant's expansion he repeatedly complained to

management that standards weren't being met. He grew angry when he felt his

complaints were being ignored and spoke forcefully at meetings and

elsewhere. In May, Wyeth formally reprimanded Mr. Livingston for his

behavior, including the use of foul language.

 

In July 2002, Mr. Livingston stepped up his effort, complaining in writing

to Wyeth's corporate compliance and ethics offices. Still, in September, he

certified that Wyeth's training system was up to snuff. Soon after, Wyeth

placed Mr. Livingston on strict probation. In December 2002, Wyeth fired Mr.

Livingston following an angry confrontation with a human-resources executive

at an off-site Christmas party.

 

In the suit, Mr. Livingston says Wyeth engineered the confrontation as a

means of dismissing him. What is more, he says the company should be held

accountable for failing to level with shareholders about problems with

Prevnar.

 

Wyeth calls Mr. Livingston's dismissal "a run-of-the-mill employment matter"

and says it "has nothing to do with Sarbanes-Oxley." The Labor Department

last summer ruled on a complaint filed by Mr. Livingston by siding with

Wyeth. It found Wyeth was within its rights to discharge Mr. Livingston for

"unruly and unprofessional behavior towards a co-worker."

 

Wyeth disclosed Mr. Livingston's suit in a quarterly financial filing in

November and promised to defend itself vigorously. That same week Wyeth

disclosed it had temporarily halted shipments of Prevnar to assure that it

conformed to quality standards.

 

--Michael Schroeder contributed to this article.

 

 

 

 

 

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