Ladies and gentlemen, thank you for being here tonight. I
believe we are here to recognize not only Dr. Graham and myself, but all
individuals who summon the faith and courage to challenge unethical
and unlawful practices. I want to share with you the story regarding my
attempt to change the dysfunctional regulatory compliance culture of a
pharmaceutical manufacturing plant in the years 2000-2002.
- I was hired in 2000 by Wyeth Pharmaceuticals to help in the introduction of
Prevnar, a new vaccine designed to fight pneumoccocal pneumonia and
meningitis in babies. The North Carolina facility where I worked is the sole
production site for this pediatric vaccine which is taken in a four-dose
regimen by every infant in the United States at 2, 4, 6, and 12 months. One
of my key responsibilities was to assure compliant manufacturing through
quality training and continuous improvement systems.
- Within weeks of hire, I was approached by numerous employees with
regulatory compliance and safety concerns. My own investigation revealed
chronic under-staffing at this 24x7 operation as well as shortcuts within
basic quality control and training processes.
- As Wyeth attempted to meet the rapidly growing demand for Prevnar and to
meet mandates of a FDA consent decree for quality control violations, large
numbers of new employees with limited backgrounds in vaccine production were
being hired. Because of the complex nature of biological vaccine
manufacturing, basic training for front-line employees took 12 months.
- At the same time, repeated quality audits in 2000, 2001, and 2002 revealed
noncompliance with corporate and FDA regulatory standards.
- In mid-2002, I wrote a letter to Wyeth management refusing to misrepresent
the compliance status of the site in an upcoming consent-decree audit whose
results were to be forward to the FDA.
- After being directed by management to not discuss or provide information
regarding noncompliance, I filed complaints with ethics and compliance
officers of the company, alleging gross noncompliance and release of product
in violation of FDA regulations.
- Two months after my internal whistleblowing, I faced disciplinary action
with a threat of termination for 10 alleged performance deficiencies, one of
which included a "gag order" to not discuss compliance deficiencies with
internal or external contacts (which I interpreted to mean the FDA).
- Two months after this retaliation, I was terminated for alleged
"professional misconduct" by the same two company officials who delivered the
gag order.
In reality, I was terminated for my efforts to address and rectify quality
compliance failures leading to the adulterated release of vaccine in
violation of both FDA consent decree mandates and SEC regulations regarding
disclosure. With help from the Government Accountability Project, I brought
suit against Wyeth in federal district court for retaliatory discharge in
violation of whistleblower protection provisions of the 2002 Sarbanes-Oxley
Act.
Throughout my 21-year career as an organization development, human resource,
training, and quality improvement professional, I have helped talented and
progressive leaders learn how to change their organizational cultures to
continuously improve workplace performance. I have spent a considerable
amount of time and effort teaching and coaching people to use diagnostic
tools to discover the root causes of problems and take action to prevent
recurrence of systemic failures and breakdowns. As a result, I've developed
expertise in redesigning and implementing operating and quality systems that
engage workforces to deliver intended compliance and financial outcomes.
Organization or workplace culture is defined as the shared attitudes and
perceptions within an organization. It is made up of the values and behaviors
that formally and informally influence how employees think about themselves,
their colleagues, their leadership, and their work. The "way we do things
around here" gives people a common identity, builds commitment to achieve
important objectives, and shapes human performance. Considerable research in
the last ten years has verified the relationship between an organization's
culture and its operating results and financial performance.
The valuable lessons I've learned from successful as well as failed efforts
to change culture and improve performance include these:
1. Successful leaders proactively become aware of what's really taking place
on the front-line of their organization.
2. Successful leaders quickly move through the typical responses of denial
and resistance.
3. Successful leaders move past personal fear and confront unacceptable
situations, including intimidating forces of resistance assembled against
them.
In fighting the battle between greed, financial security, and personal
integrity, successful and ethical leaders absolutely know the "right choice"
to make and the "right thing" to do.
I've also learned that the most successful of leaders and work cultures are
not afraid of bad news, they do not shoot messengers of bad news, nor do they
seek to blame or ostracize people with dissenting points of view. They don't
spend precious time and resources in complaining, whining, and looking for
legalistic justifications to rationalize misconduct.
Within FDA regulated facilities, a work culture – whether high performing or
dysfunctional - has a significant impact on the attitudes and performance of
front-line employees. This is especially true when it comes to compliance
with safety regulations that have an impact on product quality.
cGMPs – or current Good Manufacturing Practices - are the bedrock of
regulatory requirements designed to assure the safety, integrity, sterility,
quality, and purity of pharmaceutical or biological vaccine products. When
you read about GMP issues at the Chiron flu vaccine facility or hear about
FDA consent decrees at Wyeth and Schering-Plough for GMP manufacturing
violations – think safety, integrity, sterility, quality, and purity – or
simply, SISQP.
In the complex world of biological vaccine manufacturing, anything that has a
direct impact on SISQP must come under documented and/or validated quality
control protocols and procedures. These quality requirements are audited by
the company and at times by third-party consultants, as well as by CBER, the
FDA's Center for Biological Evaluation and Research. These inspection audits
take place every two years to ensure compliance with GMP requirements. Do not
believe Wyeth or any pharmaceutical or biotechnology company if they tell you
the Code of Federal Regulations and quality system procedures are mere
guidelines or expectations with no legal or financial consequences. Or that
effective dates which drive quality system operations are simply internal
moving targets. Recent fines levied by the FDA for violation of GMPs destroy
this wishful thinking.
Reference the $30 million fine paid by Wyeth, the $100 million fine of Eli
Lilly, the $229 million in fines of Abbott Labs, and the $500 million fine
paid by Schering-Plough in four easy installments.
In fact, the FDA is atypically and unusually clear in this area.
Quote: "There is a public health significance to cGMP noncompliance. A
manufacturer who fails to comply with cGMP requirements is less likely to
produce a product that performs as intended."
I'm sure you can appreciate the alignment created by the FDA and the SEC
between noncompliance and the disclosure of production, sales, and financial
information which securities analysts and hareholders use to make investment
decisions.
Nor should you believe the pharmaceutical company or trade association
spokesperson who claims there is no connection between operating, product
safety, and compliance results in a regulated industry and the financial
information disclosed to shareholders. In fact, they are "heads" and "tails"
of the same coin.
Finally, do not believe the Wyeth representative who claims there is no
significant impact on the safety and health of newborn infants for violating
regulatory requirements that drive product safety and manufacturing
integrity.
As over 1 million doses of the pediatric vaccine Prevnar are distributed and
administered each month in the United States alone, even odds of 1 million to
1 that anything significant could happen
with a batch of vaccine means that 1 child each month could be harmed by this
brew of chemicals – which is manufactured, by the way, with one of the most
toxic substances known to human beings.
Changing the organizational culture at this North Carolina manufacturing
facility was extremely difficult and painful, despite the presence of a
consent decree and permanent injunction that prohibited Wyeth from releasing
adulterated product into interstate commerce. Pharmaceutical drug or
biological vaccine products are considered adulterated if they are
manufactured in violation of current Good Manufacturing Practices.
Product adulteration – if willful and intentional – constitutes fraud. As the
Associate Director of Training and Continuous Improvement at the site, I
personally led two courses which covered basic ethical and compliance
requirements. In addition, a comprehensive GMP curriculum was in place that
specifically addressed adulteration and both the legal obligation and
liability each manager and supervisor had for ensuring compliance.
So what happened? Why did it take over two years of internal struggle and
conflict to achieve integration of core quality systems and put basic GMP
compliance requirements into place? Why did the internal investigation, when
finally conducted in August 2002, fail to meet standards established by both
Wyeth and the FDA for just these noncompliant situations?
How did a $14 Billion multinational corporation – with plenty of smart people
tripping over each other – manage to screw it up? And why was no one in the
financial community or at the FDA told about or aware of these GMP
compliancefailures in 2002? We heard Wyeth executives provide contradictory
and confusing disclosures about GMP manufacturing and Prevnar quality
problems in November 2003.
Why the silence in 2000, 2001, and 2002?
Was it the fear of monetary fines to the tune of $15,000 perday for missing
FDA consent decree commitment dates? After all, Wyeth had already paid out
$1.2 million in fines for missing deadlines in 2002.
Was it the fear of not being able to ship 200 batches of backlogged Prevnar,
worth $200+ million in sales? After all, shipments of Prevnar were down 40%
in mid-2002 and the 4th dose of this pediatric vaccine was yet again on
curtailment.
Was it the fear of continuing a backlog of Prevnar orders and not being able
to book and report revenue that commands a 95% gross profit margin?
Was it the fear of disclosing negative information about GMP non-compliance
to the FDA or Centers for Disease Control? After all, the Vaccines for
Children Program which purchased approximately $851 million dollars of
Prevnar through taxpayer and Medicaid dollars in the years 2000-2002 required
Wyeth to manufacture Prevnar in accordance with GMPs.
Was it the fear of having to disclose negative information to shareholders
and consumers coming on the heels of publicity in July 2002 that Wyeth's
hormone replacement therapies weren't all they were
marketed to be? After all, the stock price only crashed $20 dollars per share
wiping out $24 billion in market value in a matter of weeks.
Or was it the fear that after manipulating a gullible and inattentive FDA
about safety and compliance, investors, consumers, and government oversight
committees would see that Wyeth had rushed Prevnar – or had been allowed to
rush Prevnar - to market without adequate manufacturing capability and
regulatory controls?
I'm afraid we may never know the answer to why Prevnar was introduced in
February 2000 in a facility – supposedly inspected and approved by the FDA -
that was not GMP compliant. Or why it took another 2 ½ years for basic
quality systems and quality control processes to be enforced despite the FDA
consent decree. Or why senior officials at CBER during a July 2003 meeting at
FDA headquarters never responded to my concerns, allegations, or
documentation.
In thinking about my experience at Wyeth and the legal battle to hold key
decision makers accountable for their lack of courage in disclosing unlawful
and improper compliance and business practices, I often ask myself: How could
well-intentioned, intelligent people make such poor decisions related to a
chemical-based product that is injected into innocent babies.
Is it greed? Is it fear? Is there an ethics gene that undergoes mutation in
the heat of running large and complex organizations? What would possess a
person or a group of decision makers with great
influence to flunk such a basic test of ethics, business law, and social
responsibility?
I wonder if the answer might lie in a simple, elegant question posed by a
concerned manufacturing technician in October 2000 at this North Carolina
facility.
In front of a group of some 40-50 employees, this technician asked me a
question that I still remember to this day: "Mr. Livingston, are we here to
make money or to save lives?" Without hesitation, I told her that we were
here to save lives! I felt proud of my A+ response.
Then I blew it! The rational, left-side of my brain kicked into overdrive and
I started to worry how the corporation or my boss would react to my answer.
After all, we're a profit-making, free-enterprise, capitalistically-driven
company that seeks to serve shareholders and recapture our R&D investment –
right?
So I added, "But we also need to make money in order to continue making the
product that saves lives." I did not feel proud of my new grade, a revised
C-. Thank God the person was "North Carolina polite" and asked no more
questions. Upon reflection, I realized this technician was testing me and
that I had failed to answer two important questions:
1. What is the real purpose and mission for our work?
2. How do I make a decision when it comes to safety vs. profit?
I would suggest that many of the recent problems in the pharmaceutical
industry or at the FDA – indeed within our corporate and government
institutions in general – have germinated and grown as a result of confusion
and conflict over the answers to these two questions. Perhaps this is where
we need to start in order to re-establish trust and credibility – that is, to
revisit "mission" and "purpose."
Is it new drug approval or product safety? Is it treating the industry as a
partner and client or is it enforcing regulations that protect consumers and
patients? Is it having the courage to disclose bad news to shareholders or is
it a desire to mislead investors and consumers with deceptive business and
compliance practices?
In the stress of an ethical dilemma worth hundreds of millions of dollars, we
must be absolutely clear on what is the correct answer. No hesitation, no
waffling, no multiple-choice answers.
Courage has been defined as the state or quality of mind or spirit that
enables one to face danger, fear, or the vicissitudes of life with
self-possession, confidence, bravery, and resolve. Courage implies firmness
of mind and will in the face of danger or extreme difficulty.
To this day, I continue to thank that manufacturing technician for teaching
me – and us - a valuable lesson by asking the courageous question: are we
here to make money or save lives? I would like to thank the Shafeek Nader
Trust for the Community Interest for this prestigious award. I sincerely
appreciate the recognition – Ms. Nader – that you and directors of the Trust
have provided.
Thank you…and thank you ladies and gentlemen.
For additional information, contact:
Mark Livingston
3905 Ketch Point Drive
Rocky Mount, NC 27803
252-451-0367; careerps@e...
Joanne Royce
Government Accountability Project
1612 K Street NW, Suite 1100
Washington, D.C. 20006
http://www.opednews.com/articles/genera_evelyn_p_060510_whistleblower_mark_l
htm
OpEdNews
May 10, 2006
Whistleblower Mark Livingston Battles Wyeth Pharmaceuticals
by Evelyn Pringle
http://www.opednews.com
Washington DC Attorney, Jason Zuckerman, says a positive result of the recent
corporate scandals is the recognition of the value of whistleblowers in exposing
fraud, corruption, and other wrongdoing within a company. As a result of a shift
in the public's perception, he says, some whistleblowers are viewed as heroes
for taking on powerful corporations like Enron and serving the public interest.
“The recent trial of Kenneth Lay was a reminder that a whistleblower, in that
case Sherron Watkins, had warned senior management that the company would
implode in a wave of accounting scandals. Had management taken her concerns
seriously and implemented appropriate corrective action," he notes, "Enron might
not have collapsed.”
"This enhanced public perception," Zuckerman says, "coupled with the substantial
remedies available to whistleblowers, provides an incentive for employees who
have suffered retaliation for exposing fraud to bring claims under the
Sarbanes-Oxley Act, which contains a whistleblower protection provision.”
Zuckerman admits that battles against drug companies are extremely difficult. "I
can tell you that whistleblowers in the pharmaceutical industry really face an
uphill battle, a David versus Goliath struggle," he says. "Some pharmaceuticals
are obsessed only with the bottom line," he notes, "and they are determined not
to let a whistleblower get in the way." "My clients who have tried to raise
concerns to management about Medicate fraud, off-label marketing, and other
improprieties" he says, "often come under attack and are either terminated or
forced out." "Sadly," Zuckerman says, "management often adopts a
shoot-the-messenger mentality towards whistleblowers, and that is why we need to
vigorous enforcement of whistleblower protection laws."
A SOX action against a drug giant, is currently underway in a North Carolina
involving Mark Livingston, a former associate director of training at a Wyeth
vaccine manufacturing plant in North Carolina, who says he was fired for raising
concerns that vaccine production employees were not properly trained, in
violation of FDA regulations, and a consent decree previously imposed on Wyeth
by the FDA.
Whatever the outcome of the case, attorneys say it will be an important decision
due to the fact that it will be one of the first cases decided by a federal
court under the Sarbanes-Oxley Act. Sarbanes was signed into law on July 30,
2002, and provides a tool for the vigorous enforcement that Zuckerman says is
needed. Coming on the heels of the WorldCom, Enron and Author Andersen scandals,
the Act was intended to restore investor confidence in publicly traded companies
by improving corporate accountability through changes in corporate governance
and accounting practices and by providing whistleblower protection to employees
who report fraud.
The Act's official title is the "Public Company Accounting Reform and Investor
Protection Act of 2002," but is commonly called SOX. The law is named after its
sponsors Senator Paul Sarbanes (D-MD) and Representative Michael G Oxley (R-OH).
The Act "mandated a number of reforms to enhance corporate responsibility,
enhance financial disclosures and combat corporate and accounting fraud, and
created the "Public Company Accounting Oversight Board," also known as the
PCAOB, to oversee the activities of the auditing profession," according to the
Security and Exchange Commission.
SOX applies to all companies that have obtained a listing in the US or have
registered securities with the Security and Exchange Commission and as of this
year, all publicly-traded companies are required to submit an annual report on
the effectiveness of their internal accounting controls to the SEC.
To add teeth to the Act, the SEC adopted new rules that apply to top management
officials including: (1) requiring Chief Executive Officers and Chief Financial
Officers to certify information in company quarterly and annual reports; (2)
requires management to return bonuses or profits from stock sales received
within 12 months of a restatement resulting from material non-compliance with
financial reporting requirements as a result of misconduct; (3) prohibiting
company officers from trading during pension fund blackout periods; (4)
prohibits companies from making loans to insiders; (5) accelerated deadlines and
mandated electronic filing of disclosures of insider transactions in company
stock; (6) disclose whether they have a code of ethics for CEO, CFO and senior
accounting personnel.
SOX is one of 14 whistleblower laws passed since 1974, however, most of the
previous laws applied to specific areas such as nuclear materials; water and air
pollution, airline, trucking and shipping safety; and abuse of migrant workers.
Another feature of SOX whistleblower protection is that it contains both civil
and criminal provisions and creates a civil cause of action for whistleblowers
who have been subject to retaliation.
It protects two types of conduct: (1) employees who provide information, cause
information to be provided, or otherwise assist in an investigation regarding
any conduct which the employee reasonably believes constitutes” securities
fraud, bank fraud, wire fraud, or violation of “any rule or
regulation of the Securities and Exchange Commission, or any provision of
Federal law relating to fraud against shareholders;” and (2) employees who
“file, cause to be filed, testify, participate in, or otherwise assist in a
proceeding filed or about to be filed (with any knowledge of the employer)
relating to an alleged violation” of the laws.
Under SOX, the assistance must involve: (A) a Federal regulatory or law
enforcement agency; (B) a Member of Congress or committee of Congress; or (C) a
person with supervisory authority over the employee (or other person working for
the employer who has the authority to investigate, discover, or
terminate misconduct).
Enforcement of the civil provision falls to the Secretary of Labor. However, if
within 180 days of the filing of a complaint, the Secretary has not issued a
final decision, and the delay was due to the bad faith of the claimant, the
employee may bring a de novo action in federal district court. The US Courts of
Appeals have the authority to review the Secretary of Labor ’s final decisions.
Employees who believe that they have been subject to adverse action in
retaliation for a protected activity may file a complaint with the Secretary of
Labor within 90 days of the retaliatory act. The Secretary of Labor has assigned
responsibility for administering the Act to the Assistant Secretary
for Occupational Safety and Health Administration. Under SOX, companies may not
“discharge, demote, suspend, threaten, harass or in any other manner
discriminate against an employee in the terms and conditions of employment”
because of any protected activity. A broad range of whistleblower activities are
protected, including providing information to Congress, federal agencies, or
internally within a company, and also filing, causing to be filed, testifying,
participating in, or assisting in proceedings.
Protected activity includes providing information that the employee “reasonably
believes” constitutes a violation of federal mail, wire, bank or securities
fraud, or a violation of any SEC rule or federal law relating to fraud against
shareholders.
SOX’s criminal provision, makes it a felony for anyone to retaliate against or
take any action “harmful” to any person, including interfering with his
employment, for providing truthful information to a law enforcement officer
relating to the possible commission of a federal offense, and is enforced by the
US Department of Justice. Criminal penalties can include fines and or
imprisonment of up to 10 years. In addition to the whistleblower provisions, SOX
contains two other mechanisms to encourage the disclosure of corporate fraud.
First, it requires companies to establish procedures for the receipt, handling,
and retention of anonymous complaints from employees relating to accounting or
auditing matters.
And second, to ensure the reliability of corporate disclosures, the SEC issued a
rule requiring attorneys “appearing and practicing before the Commission” to
report “evidence of a material violation” to their client’s chief legal officer
or chief executive officer and, absent an “appropriate
response,” to the company’s audit committee or board of directors.
SOX whistleblower provisions also apply to “any officer, employee, contractor,
subcontractor or agent” of a covered company and therefore, private companies,
as well as other entities or individuals, that serve as “agents” or
“contractors” of the publicly traded employer, are subject to the whistleblower
provisions.
For instance, the 2003 OSHA, Whistleblower Investigations Manual, specifies that
a small accounting firm acting as a contractor could be liable for retaliation
against an employee who provides information regarding a violation of SEC rules
to the SEC.
And there have been cases, where the Act’s retaliation provisions have been
applied to private subsidiaries of publicly traded companies. For example, in
Platone v Atlantic Coast Airlines Holdings Inc., 2003-SOX-27 (April 30, 2004),
an Administrative Law Judge held that an employee of a subsidiary was a covered
“employee” where the subsidiary's parent company was publicly traded and the
company was the alter ego of the subsidiary and had the ability to affect the
employee’s employment.
The ALJ in Gonzalez v Colonial Bank, 2004-SOX-39 (ALJ August 20, 2004),concluded
that Congress intended to provide whistleblower protection to employees of
subsidiaries and held that an employee of a subsidiary set forth a cause of
action sufficient to withstand a motion for summary decision where the evidence
reflected that the action affected the plaintiff ’s employment and the company
shared management and function with the subsidiary.
In the first reported federal district court decision, Collins v Beazer Homes
USA, Inc, 334 F Supp 2d 1365 (ND Ga 2004), held that where the officers of a
publicly traded parent company had the authority to affect the employment of the
employees of the subsidiary, an employee was a “covered
employee” within the meaning of the SOX.
The remedies available to whistleblowers generally provide that an employee
subject to retaliation is “entitled to all relief necessary to make the employee
whole,” and employees who proceed before the Department of Labor are entitled to
“interim reinstatement.”
Tom Devine is the Legal Director of the Government Accountability Project, the
nation's leading whistleblower protection group, and describes the procedure for
filing and processing claims under SOX as follows:
(1) Claims must be filed with the Department of Labor (DOL) within 90 day of
the alleged retaliatory event.
(2) The DOL conducts an investigation, attempts to mediate a settlement, and, if
necessary, order temporary relief and issue an initial decision.
(3) Either party may appeal the final results of a DOL
investigation to an Administrative Law Judge. Relief from the initial ruling
remains in effect.
(4) Either side may appeal to the Department of Labor's Administrative Review
Board for a final agency decision.
(5) Either party may appeal to a US circuit court of appeals for review of the
final Department of Labor ruling.
Although by statute the Department of Labor normally must complete this process
in 120 days, Devine says, the actual range has extended to 14 years, with delays
of two to three years common.
However, if an investigation is not completed in 180 days, the employee has the
right to seek injunctive relief and have a jury trial in a District Court. "This
opportunity long has been the promised land for whistleblowers to have a fair
system protecting their legal rights," Devine notes. Since the SOX legislation
was enacted in 2002, about 750 cases have been filed with the DOL, by persons
saying they were retaliated against for revealing wrongdoings within a company.
"The number of cases has risen, with about 150 in the law's first year and
nearly twice that in its third," according to the article, "Whistle-Stop
Campaigns," by Kathleen Day, in the April 23, 2006 Washington Post. Day reports
that the majority of cases have been dismissed and that fewer than 100 cases
have been settled.
"And only five whistle-blowers have won," she wrote, "though that number
dwindled to four last summer when the agency's administrative review board
overturned a case on appeal."
In addition, three of those four cases have been appealed to the board, "whose
handful of judges so far have not decided an appeal in favor of a
whistle-blower," according to Day. The Washington Law Office of Jason M
Zuckerman, PLLC, primarily represents clients in whistleblower cases, including
retaliation claims under the Sarbanes-Oxley Act and qui tam actions under the
False Claims Act. The
firm's principal, Jason Zuckerman, has lectured and written extensively about
whistleblower protection laws.
Whistleblower claims generally fall into two categories. One is retaliation
claims, which Zuckerman explains, are essentially discrimination claims alleging
that an adverse employment action was taken in retaliation for the employee's
protected conduct (exposing wrongdoing), and the other are qui
tam actions under the False Claims Act, civil fraud claims brought on behalf of
the government against companies that have defrauded the government.
In a qui tam action, "A qui tam relator brings forward to a federal prosecutor
information demonstrating that a government contractor is engaged in fraud,
typically charging the government for a service that was not performed or a
product that was not provided," Zuckerman explains. Nowadays, he says, the
consequences of retaliating against a whistleblower can result in more
than a civil lawsuit. "In the post-Sarbanes Oxley regulatory climate," Zuckerman
warns, "a whistleblower retaliation lawsuit can also result in an investigation
by a regulatory agency such as the SEC, and in bad publicity."
Under the whistleblower protection provisions of SOX, the burden of proof is
more favorable to employees than it is under employment discrimination laws such
as Title VII of the Civil Rights Act of 1964. “A plaintiff in a SOX claim merely
needs to demonstrate that his protected conduct was a contributing factor, not a
motivating factor, in the employer’s decision to take an adverse employment
action,” Zuckerman explains, “and once the employee has met his burden, the
employer must demonstrate by clear and convincing evidence that it would have
taken the same adverse employment action absent the employee's whistleblowing."
If an employer is forced to defend against a retaliation claim, "it will need
strong evidence to demonstrate that it would have taken the same unfavorable
action against an employee in the absence of the employee's whistleblowing,"
Zuckerman points out. Employees who go up against big Pharma can find themselves
subjected to a wide variety of retaliatory acts. "Their managers put them on
pretextual performance improvement plans and do everything to make the work
environment unbearable," Zuckerman reports.
"Whistleblowers also find themselves alienated," he explains, "their coworkers
try not to associate with them for fear that management will view them as
disloyal." "My clients," he says, "whose only infraction was committing the
truth have found themselves unemployed and suffer permanent damage to career and
reputation." Fortunately, he says, the False Claims Act provides a good remedy.
"Damages under the anti-retaliation provision of the FCA include reinstatement,
three times lost wages, compensatory damages, and attorney’s fees," Zuckerman
notes. “In addition, a successful qui tam relator is entitled to between 15 to
25 percent of the amount that the government recovers.” Zuckerman, however,
notes that when he obtains favorable settlements for his clients, he feels that
the client is not truly getting “make whole relief” when the client has suffered
permanent damage to career and reputation.
For instance, after a client recently accepted a substantial settlement in a
whistleblower retaliation case, he asked the client why he was still so upset
and the client told Zuckerman that he felt it was unfair that his whistleblowing
had derailed his career and that what he really wanted back was the chance to
continue his successful career at this company.
Mark Livingston is entangled in the same type of battle with pharmaceutical
giant Wyeth.
Wyeth denies his allegations that employees were not properly trained, but says
even if they are true, Livington's reporting of concerns that vaccine production
employees were not properly trained, in violation of FDA regulations, is not a
protected activity unless the rules relate to a direct fraud against
shareholders. The Government Accountability Project is handling the case, with
General Counsel, Joanne Royce, Deputy General Counsel, Karen Gray, and former
GAP chief trial lawyer, Thad Guyer, as lead counsel, and disagrees.
The GAP and Livingston argue that SEC rules require the disclosure of any
violation of federal law, and all risks that could potently diminish stock
value, and that a failure to adequately train employees could lead the FDA to
halt the manufacturing process or result in infants being injected with
defective vaccines, and that either event would damage profits. Therefore,
Livingston maintains, the compliance failures are a direct threat to
stockholders. Wyeth hired Livingston in 2000 to help in the introduction of
Prevnar, a new vaccine designed to fight pneumoccocal pneumonia and meningitis
in infants. The facility where he worked was the vaccine's only production site.
One of Livingston's responsibilities was to assure manufacturing compliance
through quality training and he discovered serious deficiencies in training as
soon as he arrived.
"When I got to the Wyeth vaccine plant in August 2000," he said, "they had a
part-time nurse delivering safety training to new hires." An occupational health
and safety specialist was not hired until February 2001, a full year after
Prevnar was approved by the FDA, he says. "And this occurred only after the
October 2000 consent decree for ongoing manufacturing violations," he adds.
A consent decree results when a company repeatedly fails to comply with FDA
standards. The FDA announced a consent decree after inspectors determined that
Wyeth plants were not meeting manufacturing standards in New York and
Pennsylvania. As part of a settlement, Wyeth agreed to pay $30 million, and to
hire experts to conduct an all-inclusive inspection of the plants and to certify
overall quality efforts.
"This occurred," Livingston said, "after realization by Wyeth executives that
they had a blockbuster pediatric vaccine on their hands and no one had bothered
to do any planning for staff additions in the next several years." Prevnar is
definitely a blockbuster and its largest customer is the government. According
to a 2003 Institute of Medicine report, “Financing Vaccines in the 21st
Century,” the US government spends more than $1 billion annually to purchase
childhood vaccines to give to poor and uninsured children under the federal
Vaccines for Children (VFC) program. This represents about 55% of the total
market for childhood vaccines. After the CDC added the chicken pox and Prevnar
vaccines to the program, the VFC budget rose from $500 million in 2000, to over
$1 billion in 2002.
In 2004, it became the first vaccine to top $1 billion in yearly sales, mainly
because it costs more than $220 per 4-shot regimen and the "federal government
recommends Prevnar and pays a good price for it -- as do private purchasers,"
according to the November 9, 2005 Wall Street Journal. And sales have continued
to increase each year. According to Wyeth's first quarter earnings report for
2005, Prevnar achieved net revenues of $391 million, or more than double the
first quarter earnings reported in 2004. And the company's first quarter earning
report for 2006, show that Prevnar sales rose another 10% to $432 million so far
this year.
According to Livingston, once Prevnar was added to the childhood vaccine
schedule, Wyeth was caught totally unprepared, and as it attempted to meet the
skyrocketing demand for Prevnar, "large numbers of new employees with limited
backgrounds in vaccine production were being hired."
"Despite the presence of PhD's and MBA's out the wazoo," he said, "no one in the
marketing or research departments at Wyeth ever bothered to call the supply
chain folks up and ask if they could produce the vaccine in the amounts they
wanted." Which Livingston says amounted to 20 million plus does per year on a
consistent basis. In just 3 years, the plant's employment numbers went from 300
employees to over 1200, he says, and providing proper training to that number of
new employees would be impossible. "Because of the complex nature of biological
vaccine manufacturing," he explained, "basic training for front-line employees
took 12 months."
According to Livingston, "repeated quality audits in 2000, 2001, and 2002
revealed noncompliance with corporate and FDA regulatory standards." As it turns
out, his prediction that vaccines production could be halted came true and was
revealed in February 2004, when Wyeth came up short of Prevnar. In less than 4
months, the CDC, had to issue two advisories relating to the rationing of
Prevnar.
Publicly, Wyeth claimed that the supply was hampered by unspecified production
problems. However, many doctors were upset when they learned about the extent of
the manufacturing problems that led the shortage and that Wyeth had been cited
by the FDA for manufacturing violations again and again in the years before the
shortage occurred.
For instance, Wyeth failed to reveal that in 2003, FDA inspectors found so many
quality-control failings at the Prevnar packaging plant in Pearl River, NY, that
production was shutdown at the site.
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
http://www.lawyersandsettlements.com/articles/wyeth.html
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