Details on the New Class Action Against GlaxoKline (SKB) & Paxil

August 28, 2004

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Mail:

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https://www.classactionamerica.com/cases/goldInfo.asp?lngCaseId=3618

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.

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[ASPIRE-US] Class Action Filed Against GSK:

At Issue $100,000,000.00

Kline Beecham Corporation

AMOUNT AT ISSUE: $100,000,000.00