Fwd: Details of Class Action PAXIL Parents Suit Against GSK

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Gerdts v Kline Beecham Corporation

Kline Beecham Misled US Doctors Regarding Paxil Use for Children

A class action has been filed against pharmaceutical company

Kline Beecham Corporation on behalf of all persons who purchased

the antidepressant Paxil or Paxil CR (paroxatine) for children under

the age of 18 between November 19, 1998, and the present. The suit

alleges that the company committed fraud by suppressing clinical

study data that indicated Paxil was ineffective for children. The

action seeks reimbursement of all money spent purchasing Paxil for

this use, and disgorgement of all profits wrongly made.

The action alleges that Kline has misrepresented the information

concerning the safety and efficacy of Paxil for treating pediatric

depression. While dispensing positive information about this

particular use of the antidepressant, the company has allegedly

withheld negative information regarding its safety and effectiveness

for children.

The FDA approves drugs for use based upon whether or not they are

safe and effective, as determined through scientifically conducted

clinical studies.

Drugs are approved for specific conditions and for specific

populations. The FDA has approved Paxil as safe and effective in

treating various conditions and adults, but not for any illness or

condition in children. Physicians may prescribe a drug for conditions

for which FDA approval has not been obtained when, in the physician's

professional judgment, it is an appropriate treatment for the

individual patient as long as the drug has already been approved by

the FDA for some other use. This type of use is referred to as

" off-label " use. A physician's judgment is based on the balance

between the benefit the patient is likely to derive from the

treatment and the risk that the proposed treatment will cause the

patient harm. In deciding whether to prescribe a drug for an off-

label use, physicians typically rely upon information received from

other sources-- if information is false or misleading, a physician

cannot accurately assess the crucial risk-benefit balance for use of

the treatment.

The action alleges that Kline conducted three scientific studies

to assess the safety and efficacy of Paxil in treating children and

adolescents diagnosed with Major Depressive Disorder. It received the

final reports for two of the studies in November 1998 and the third

on July 31, 2001. The clinical trials met with mixed success at best--

the report on Study 329 (issue date November 24, 1998) concluded

that, of two primary and five secondary measures of efficacy, Paxil

was superior to a placebo only in three of the five secondary

measures. Study 377 (issue date November 19, 1998) concluded, " the

results failed to show any superiority for paroxetine over placebo in

the treatment of adolescent depression. " In Study 701 (issue

date July 30, 2001), the placebo actually outperformed paroxetine in

treatment of adolescent depression. The studies also showed a

numerically increased rate of adverse events, including increased

suicidal ideation and increased hostility as compared to placebo,

when prescribed for adolescents and children.

Internal Kline documents allegedly point to a cover-up " to

effectively manage the dissemination of these data in order to

minimize any potential negative commercial impact. " Thereafter, in

accordance with the recommended plan, only the positive data from

study 329 was presented-- neither study 377 nor study 701 was ever

published, and remained unavailable to the general public until being

posted on the GlaxoKline website early in the summer of 2004.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the

UK commented in a warning issued on June 10, 2003, on the

questionable safety of paroxetine: it " should not be used in children

and adolescents under the age of 18 years to treat depressive

illness. " That agency has also added pediatric status as a

contraindication on paroxetine labeling in the UK.

In response to the MHRA's warning, GlaxoKline admitted in a

letter to physicians in the UK that the " clinical trials in children

and adolescents under 18 years of age failed to demonstrate efficacy

in Major Depressive Disorder, and that there was a doubling of the

rate of reporting of adverse events in the paroxetine group compared

with placebo, including emotional liability. " On June 19, 2003, the

US FDA issued a Talk Paper stating that it was reviewing data from

studies of paroxetine use in children and adolescents with depression

to assess a possible increased risk of suicidal thinking and

attempts. The FDA now recommends " that Paxil not be used in children

and adolescents for the treatment of MDD. "

Despite its 2003 admissions to regulatory agencies and to the public

in other countries, GlaxoKline has allegedly continued to

misrepresent and foster a false impression in the US about the

efficacy of Paxil in treating pediatric depression. Furthermore, the

company has allegedly controlled US physicians' access to the

negative information by controlling the information provided to its

own sales personnel, who provide the company's major promotional

avenue to doctors. Unlike its June 10, 2003, press release in the UK

which admitted a lack of efficacy for children and significant

adverse side effects, the company's June 19, 2003, American press

release noted only that, " there is no evidence that Paxil is

associated with an increase of suicidal thinking or acts and adults, "

and that, " not a single person [who participated in the pediatric

paroxetine trials] committed suicide. " It was only in May 2004 that

the company finally issued a " Dear Healthcare Professional " letter to

US physicians stating that medical trials for Paxil failed to

demonstrate efficacy in pediatric depression. That letter still

omitted the critical fact that paroxetine is now contraindicated for

pediatric depression, a fact admitted by the company in Europe and

Canada.

More than two million prescriptions for Paxil were written for

children and adolescents in the United States in 2002. Nearly 900,000

of those prescriptions were for children whose primary diagnosis was

a mood disorder, the most common of which is depression.

Prescriptions for Paxil to treat mood disorders in children and

adolescents translated into US sales for GlaxoKline to

approximately $55 million in 2002 alone.

Amount At Issue: $100,000,000

Category: Drugs / Medical

Added to Site: 8/17/2004

Stage: Filing

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How Class Actions Work:

It's simple. A class action is a lawsuit filed by one or more

plaintiffs (who are known as the " named plaintiffs " ) on behalf of

others who have a similar legal claim. Because they allow people to

join together as a group in one lawsuit against common defendants,

class actions are important for consumers.

The Stages of a Class Action

1. Filing

Case Initiated - A complaint is filed by the attorney(s) on behalf of

the plaintiff(s).

2. Response

The defendant(s) respond(s) with an answer, motion to dismiss or

other legal pleading.

3. Discovery

Both sides disclose evidence to each other that supports their

respective cases.

4. Certification Request

Plaintiff(s) file(s) a motion to certify the case as a class action.

5. Certification Opposed

Defendant(s) file(s) opposing briefs to the plaintiff(s) motion for

class certification.

6. Class Action Certification

Judge certifies or denies the class action (if the judge denies, the

case can continue as individual lawsuit(s) filed by the plaintiff(s).

7. Notification

If certified, notification of class action to prospective claimants,

who must choose whether to stay in the case or file their own

individual case.

8. Trial

Case is either set for trial, in trial, or has been tried before a

judge or jury.

9. Appeal

A judgment of the trial court has been appealed to a higher level

court.

10. Settlement Phase

Deadline is set for class action members to submit claims with

supporting documentation.

11. Pay Out

Proceeds are distributed to class members.

12. Closed

The distribution of the proceeds to class members has been completed,

and the time for filing a claim under the settlement has expired.

* Dismissed

A case can be dismissed at any point during the ten-stage process.

This is not actually a stage, but the end of the process. This means

that the case has terminated, at least for now, without the

plaintiffs receiving any relief. The plaintiffs may have voluntarily

dismissed the case, or the court may have ordered the case to be

dismissed. Depending on the circumstances, the plaintiff may be able

to file the action again later.

NOTE: The stages outlined above are only meant as a general guide,

and may not be applicable to all class action cases. Some class

actions will proceed to a trial when settlement between the parties

cannot be reached.

Why are class actions important?

The ability to join together in one lawsuit is particularly important

for our judicial system to function efficiently. Without class

actions, thousands, possibly millions of claims might theoretically

flood the court system. Instead, the class action procedure

encourages the filing of one single case on behalf of all people

harmed, minimizing the need for thousands of individual cases. More

importantly, class actions encourage more responsible behavior on the

part of corporate defendants.

Why are class actions under attack?

Over the past several years, certain corporations, PAC's, and other

interests have attacked class actions and the attorneys who bring

them. Much of this criticism has been unfounded. Find out why

citizen's groups, consumer groups and other public watchdogs are

trying to safeguard your rights. To learn more:

https://www.classactionamerica.com/cases/expFacts.asp

The old adage " power in numbers " holds true in class action cases. By

spreading the costs of litigation, which can be substantial, among

many people, each individual claim can achieve justice. Class

actions, comprised of groups of consumers working together to stand

up for their rights, demand the attention of corporations and other

wrongdoers.

In order for a court to certify a case as a class action, the

plaintiffs must prove four legal requirements under the law.

1. Numerosity: There must be many people who can be part of the class

action. If only you and two other people suffered a loss as a result

of a defendant's conduct, the numerosity requirement would not be

satisfied.

2. Commonality: There must be a question of law or fact that is

common to all the class action members. If a company defrauded one

thousand people in the same investment scheme, this requirement might

be satisfied. However, if the same company defrauded one thousand

people in different investment schemes, this requirement might not be

satisfied.

3. Typicality: The claims of the named plaintiffs who filed the class

action must be typical of the class action members on whose behalf

the case is filed. If the named plaintiffs suffered different damages

or have different interests than the members of the class action,

this requirement would not be satisfied.

4. Adequacy: The named plaintiffs must fairly and adequately

represent the interests of the class members. The court must find

that the named plaintiffs will act in the best interests of the whole

class.

Once a court is satisfied that the plaintiffs meet the four legal

requirements for a class action, it will certify the case as a class

action.

The Facts Behind Class Actions

Congress is currently considering legislation that would dramatically

limit Americans' rights to bring class action lawsuits. The national

class action debate has provided consumer groups a forum in which to

respond to many of the unfounded criticisms thrust upon class

actions. Below are some insights into the debate:

" State court class actions continue to provide significant

relief to consumers who would otherwise have gone without

compensation. For instance, state-court class actions involving

polybutylene pipe illustrate the importance of consumers banding

together to fight corporate irresponsibility. Shell, Dupont and other

corporate giants sold leaky plastic pipes, which caused severe damage

to the homes of tens of thousands of unsuspecting consumers. This

state-court litigation resulted in hundreds of millions of dollars in

recoveries and replacement of the faulty piping, which would never

have occurred if the homeowners were required to face off against the

companies on their own. "

The testimony of Wolfman, Esq. staff attorney, Public Citizen

Litigation Group before the House Committee on the Judiciary

Subcommittee on Courts and Intellectual Property regarding H.R. 3789,

June 18, 1998.

" Class actions economize on judicial resources. Class actions are an

efficient and practical method of bringing action since they combine

similar claims; they also reduce the number of inconsistent judgments

and lower court costs. "

Sally J. Greenberg, Senior Product Safety Counsel, Consumers Union,

Publisher of Consumer Reports, June 26, 2000.

" Class actions are an important tool that can be used to protect the

public's health and critical natural resources by offering a legal

means to aggregate claims to address them more efficiently and

effectively than can be done through individual litigation. Citizens

may use the state class action mechanism to gain access to the courts

in situations where defendants, through a single act or series of

acts, have inflicted similar injuries on a large number of people in

a community exposed to toxins from a chemical accident, or whose

wells have been contaminated, or who have suffered other

environmental harm. "

Letter to the Judiciary Committee Members, United States Senate, by

Schwartz, National Campaigns Director, Clean Water Action, Joan

Mulhern, Legislative Counsel, Earthjustice Legal Defense Fund, and

Aurilio, Legislative Director, U.S. Public Interest Research

Group.

" Historically, state court class action litigation has been one of

the most effective and efficient tools for injured citizens to gain

access to the courts, particularly in cases where a defendant has

injured a large number of people. Class action cases give plaintiffs

the opportunity to consolidate their claims, making it financially

possible for them to bring the case.

Prior to recent class action victories, tobacco companies had been

largely successful in avoiding litigation by making it too expensive

for plaintiffs to sue them. H.R. 1875 would make this a likely

scenario once again, ending the gains consumers have made in holding

tobacco companies accountable for the harm they have done. "

Action on Smoking and Health

Alabama Citizens Action Program

Alliance for Lung Cancer Advocacy, Support, and Education ALCASE), WA

American Association of Public Health Physicians (AAPHP) Tobacco

Policy Task Force American Academy of Pediatrics, Nebraska Chapter

American Association for Health Education American Cancer Society

American Council on Science and Health American Heart Association

American Heart Association of Hawaii American Lung Association

American Medical Student Association American Medical Women's

Association American Society of Addiction Medicine Americans for

Nonsmokers' Rights Arizona Consumers Council Arkansas Section of the

American Academy of Pediatrics Arlington Citizens for Clean Air, TX

Association for Nonsmokers - Minnesota Charlevoix-Emmet-Antrim

Tobacco Reduction Coalition, (NW MI Comm Health) MI Children

Afflicted by Toxic Substances Chippewa Valley Tobacco-Free Youth

Coalition, WI Citizens for A Toabcco-free Society (CATS) Inc., OH

Citizens for Consumer Justice, PA City of Fort Worth Public Health

Department, TX Coalition for a Smoke-Free Valley, PA Coalition for

Consumer Rights Community Health Education Institute Clean Air

Council, PA CYR and Associates, Consultants to Public and Private Non-

Profit Agencies (Member of the Nevada Tobacco Prevention Coalition)

Environmental Improvement Associates, Salem, NJ Empire State Consumer

Association, NY Families Advocating Injury Reduction (FAIR)

Family Counseling Center, Colorado Florida PIRG Foundation for a

Smokefree America- Reynolds, President GASP of Florida

Georgians Against Smoking Pollution (GASP) Health Advocacy Group of

Southside VA INFACT- Campaign for Corporate Accountability

Kauai Tobacco-Free Community Coalition, HI

La Crosse Area Health Initiative/S.A.F.E. Coalition/La Crosse Public

Schools, WI

Marshfield Citizens for Crud Free Alveoli, MA

land Group Against Smokers Pollution (GASP)

Massachusetts Association of Health Boards

Minorities For Tobacco, Alcohol & Drug-Free Communities

Montana PIRG

National Association of Local Boards of Health (NALBH)

Oral Health America

Oregon Consumer League

Oregon State PIRG

Pennsylvania Citizens Consumer Council

Pennsylvania Institute for Community Services

PRIDE-Omaha, Inc.(Parent Resources and Information on DrugEducation),

NE Progressive Democtratic Network, WI REPACE ASSOCIATES, Inc.

Secondhand Smoke Consultants Roswell Park Cancer Institute, NY San

Francisco Trial Lawyers Association Society Created to Reduce Urban

Blight, PA SmokeFree Air For Everyone (S.A.F.E.), CA SmokeFree

Educational Services, Inc. SmokeFree Florida SmokeFree land

SmokeFree Montgomery County Coalition, Rockville, MD SmokeFree

Pennsylvania Smoke-Free USA.Com, Inc. St. ph Medical Center, MD

St. Louis County Public Health The BADvertising Institute, NY The

Crime Prevention Group, MI The Great Cincinnati Coalition on Smoking

and Health Inc., OH The Greater New York Chapter of SOPHE (Society

for Public Health Education) Tobacco Control Law & Policy Consulting,

MI Tobacco Free Future Project, MN Tobacco Free Las Cruces Coalition,

NM Tobacco Free Youth Coalition-Penn State ative Extension,PA

United States Public Interest Research Group (USPIRG) Virginia GASP

Wisconsin Initiative on Smoking and Health Zumbro Valley Medical

Society, MN

" Class actions are filed when many individuals are similarly injured

and are essential to protect the rights of people whose individual

claims do not warrant separate litigation. They deter and encourage

reform of deceptive and fraudulent business practices that cost

Americans billions of dollars a year. In addition, class actions do

all this while conserving limited judicial resources that would be

wasted in duplicative proceedings. "

Citizens for Corporate Accountability and Individual Rights Coalition

to Stop Gun Violence Consumer Federation of America Handgun Control,

Inc. National Association of Consumer Advocates National Consumers

League National Employment Lawyers Association Public Citizen U.S.

PIRG Violence Policy Center

" The class action mechanism is an important tool for patients who

have received similar injuries from prescription drugs, allowing them

to aggregate their cases for cost-effective litigation; without it,

patients in many cases would be unable to pursue their legitimate

claims individually.

That may explain why such billion-dollar pharmaceutical firms as

Procter & Gamble, Bristol-Myers Squibb, and Pfizer actively lobbied

Congress last year to pass H.R. 3789, the Class Action " Fairness " Act

of 1998 [similar in scope to this year's H.R. 1875]. "

AIDS Action Council

Center on Disability and Health

Citizens for Reliable and Safe Highways

Communications Workers of America

Consumers for Auto Reliability and Safety

Families USA

National Association of Protection & Advocacy Systems

National Black Women's Health Project

National Citizen's Coalition for Nursing Home Reform

National Health Law Program

National Senior Citizen's Law Center

National Women's Health Network

NETWORK: A National Catholic Social Justice Lobby

Service Employees International Union (SEIU)

The Arc of the United States

" It is important at the outset to note the role that class actions

play in making the courts available to all Americans. In some

situations, a large number of individuals are significantly harmed as

a group but they have no realistic avenue to obtain justice

individually because their respective harms are too small to make

individual suits practical. In these cases, a class action in a local

forum is virtually the only way these individuals can seek redress

through the legal system. Just a few years ago, 500 individuals, most

of whom were Washington State residents, sued Foodmaker, a Delaware

corporation, in state court for negligence in serving undercooked

hamburgers infected with the E. coli bacteria and its " Jack in the

Box " restaurants. They received a $14 million settlement. Similarly,

some 750 people, most of whom were Colorado residents, were able to

bring a Colorado-based class action against a health care center for

maintaining unhygienic conditions that caused outbreaks of illness.

In Pennsylvania, a class of largely Pennsylvanian car owners burned

when their airbags deployed were able to recover from Chrysler the

cost of re-fitting their cars with safer airbags. Class actions are

also a very efficient means of resolving large numbers of claims that

share common issues of fact and law, particularly when state citizens

can seek redress in their state courts for violations of their rights

under state law. Moreover, without fair access to class action

procedures, many individuals' claims could simply not go forward and

those that could, as individual suits, would require greater

investments of judicial time than class actions, which could delay --

and sometimes even deny -- justice to those plaintiffs as well; class

actions can keep the courtroom doors open. Class actions can also

reduce or eliminate inconsistent verdicts, which benefits plaintiffs,

defendants, and the entire system of justice. Because of the

importance of class actions, we should be cautious in curtailing

access to them. "

Eleanor D. Acheson, Assistant Attorney General, United States

Department of Justice, Interstate Class Action Jurisdiction Act of

1999 (H.R. 1875), Workplace Goods Job Growth and Competitiveness Act

of 1999 (H.R. 2005), House Judiciary Committee, July 21, 1999 10:00

am.

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

[ASPIRE-US] Class Action Filed Against GSK:

At Issue $100,000,000.00

Kline Beecham Corporation

AMOUNT AT ISSUE: $100,000,000.00

Kline Beecham Misled US Doctors Regarding Paxil Use for Children

A class action has been filed against pharmaceutical company

Kline Beecham Corporation on behalf of all persons who purchased

the antidepressant Paxil or Paxil CR (paroxatine) for children under

the age of 18 between November 19, 1998, and the present. The suit

alleges that the company committed fraud by suppressing clinical

study data that indicated Paxil was ineffective for children.

See http://www.classactionamerica.com

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