Glaxo Said to Have Paid $1 Billion So Far to Settle Various Paxil Lawsuits

NOTE FROM Ann Blake-Tracy:

Excellent article! Many would still be alive and many more
would have avoided being damaged had they been able to see this coming as
clearly as I did years ago when I began warning about these drugs. But it is not
over! There will tragically be many more losses due to the ability of drug
manufacturers to buy the silence this doctor from Tufts says below should
not happen. These settlements need to be made public!

The one glaring omission in this article is a case I am very
familiar with Tobin vs Glaxo. This Paxil-induced murder/suicide
case was allowed to go to court, rather than being settled by Glaxo.
And after hearing all the evidence the jury ruled
that it was clear that Paxil was the main cause of this tragic
murder/suicide that cost 4 lives in one WY family. They ordered Glaxo to pay
$6.3 Million – in my opinion a very small amount for four lives!

But it will not be the end of these types of cases being filed.
The authors did not figure the losses Glaxo will face from those cases
of murder/suicide so their losses could be far greater than detailed
below.

Ann Blake-Tracy, Executive Director
International Coalition for Drug Awareness
Author: Prozac: Panacea or Pandora? – Our Serotonin
Nightmare & Help! I Can’t Get Off My Antidepresant!

The company hasn’t specified in regulatory filings
the number of suicide, birth-defect and addiction cases settled.

“It’s important to disclose such settlements because
it raises the red flag for both doctors and patients that there might be a
problem,” said Dan Carlat, a psychiatrist at Tufts University School of Medicine
in Boston who writes and edits a
blog and a monthly

Psychiatry
Report
. “It would motivate
doctors to dig into the literature even more before prescribing these
drugs.”

  • About 450 suicide-related Paxil cases were settled. Only about a dozen
    haven’t been, the people said. The $1 billion total doesn’t include more than
    600 claims that Paxil caused birth defects.
  • A Philadelphia jury on Oct. 13 found the drugmaker should pay $2.5 million
    to the family of Lyam Kilker, a 3-year-old boy born with a heart defect after
    his mother took Paxil while pregnant. Based on that outcome, an analyst
    estimated the company may potentially face additional verdicts in birth-defect
    cases waiting to be tried in Pennsylvania.
  • 600 More Cases
  • “A liability totaling $1.5 billion is possible,” wrote Savvas Neophytou, a
    Panmure Gordon analyst in London, in a note to investors the day after the
    Kilker verdict.
  • In comparison, Pfizer Inc., parent of Wyeth, the maker of diet-drug
    combination fen-phen, has had to set aside about $21 billion to resolve about
    200,000 personal-injury claims over that medicine. Merck & Co. agreed to
    pay $4.85 billion to resolve more than 48,000 claims over the withdrawn
    painkiller.
  • Harris Pogust, an
    attorney for Paxil plaintiffs, couldn’t confirm the total. He said the amounts
    are confidential.
  • The suicide settlements included a suit over the death of a 14-year-old
    boy who had been taking Paxil for two months. The parents of Scott Cunningham,
    of Valparaiso, Indiana, sued after the boy hung himself in 2001. They alleged
    Glaxo suppressed evidence that Paxil use was linked to the risk of suicide
    attempts by adolescents. Glaxo denied the allegations, according to court
    papers.
  • The family settled its suit in May, according to court filings. Family
    attorney Bijan Esfandiari confirmed the settlement, saying the amount was
    confidential.
  • About 150 cases over suicides by Paxil users were settled for an average
    of about $2 million, and about 300 over suicide attempts settled for an
    average of $300,000, they said. Some of the claims were resolved before suits
    were filed, according to the people familiar with the matter.
  • Glaxo has settled about 10 birth-defect cases, Sean Tracey, a
    Houston-based lawyer who represented the family of a child victim, said in
    court Dec. 2. The settlements averaged about $4 million, the people familiar
    with the cases said.
  • Glaxo paid an average of about $50,000 per case to resolve about 3,200
    claims linking Paxil to addiction problems, the people familiar with the cases
    said.
  • In its 2008 annual report, company officials noted they had reached a
    “conditional settlement agreement” in January 2006 with Paxil users who
    alleged they suffered withdrawal symptoms after taking the drug. The case,
    filed in Los Angeles federal court, was marked closed in court records in
    February.
Glaxo Said to Have Paid $1 Billion to Settle Paxil

Lawsuits

By Jef Feeley and Margaret Cronin Fisk

Dec. 14 (Bloomberg) — GlaxoSmithKline Plc has
paid almost $1 billion to resolve lawsuits over Paxil since it introduced the
antidepressant in 1993, including about $390 million for suicides or attempted
suicides said to be linked to the drug, according to court records and people
familiar with the cases.

As part of the total, Glaxo, the U.K.’s largest drugmaker, so far has paid
$200 million to settle Paxil addiction and birth-defect cases and $400 million

to end antitrust, fraud and design claims, according to the people and court
records.

The $1 billion “would be worse than many people are expecting,” said Navid Malik, an analyst
at Matrix Corporate Capital in London. “I don’t think this is within the
boundaries of current assumptions for analysts.”

The London-based company hasn’t disclosed the settlement total in company
filings. It has made public some accords. Glaxo’s provision for legal and other
non-tax disputes as of the end of 2008 was 1.9 billion pounds ($3.09 billion),
according to its latest annual report. This included all legal matters, not just
Paxil. The company said 112 million pounds of this sum would be “reimbursed by
third-party issuers.”

The drugmaker has reduced its insurance coverage to contain costs, “accepting
a greater degree of uninsured exposure,” the annual report states. “Recent
insurance loss experience, including pharmaceutical product-liability exposures,
has increased the cost of, and narrowed the coverage afforded by, insurance for
pharmaceutical companies generally,” Glaxo said.

Glaxo Comment

Glaxo declined to confirm the $1 billion figure. “Paxil has been on the
market in the U.S. since 1993. Like many other pharmaceutical products, it has
been the subject of different kinds of litigation over the years,” said Sarah Alspach, a
spokeswoman for Glaxo, in an e-mailed statement. “It would be inappropriate and
potentially misleading to aggregate payments in these various types of
litigation.”

Chief Executive Officer Andrew Witty has moved
to replace revenue lost to generic versions of drugs such as Paxil. Worldwide,
Paxil generated about 514 million pounds in sales last year, or 2.1 percent of
the total. Glaxo closed up 5 pence to 1,303 pence in London trading Dec. 11,
down 8.8 percent from a year ago.

About 450 suicide-related Paxil cases were settled. Only about a dozen
haven’t been, the people said. The $1 billion total doesn’t include more than
600 claims that Paxil caused birth defects.

A Philadelphia jury on Oct. 13 found the drugmaker should pay $2.5 million to

the family of Lyam Kilker, a 3-year-old boy born with a heart defect after his
mother took Paxil while pregnant. Based on that outcome, an analyst estimated
the company may potentially face additional verdicts in birth-defect cases
waiting to be tried in Pennsylvania.

600 More Cases

“A liability totaling $1.5 billion is possible,” wrote Savvas Neophytou, a
Panmure Gordon analyst in London, in a note to investors the day after the
Kilker verdict. He still recommended buying Glaxo shares because a likely appeal
may reduce the amount paid by the company.

In comparison, Pfizer Inc., parent of Wyeth, the maker of diet-drug
combination fen-phen, has had to set aside about $21 billion to resolve about
200,000 personal-injury claims over that medicine. Merck & Co. agreed to pay
$4.85 billion to resolve more than 48,000 claims over the withdrawn painkiller.

Harris Pogust, an
attorney for Paxil plaintiffs, couldn’t confirm the total. He said the amounts
are confidential.

Paxil Is Different

Paxil’s been different from most drugs,” said Pogust, a lawyer from
Conshohocken, Pennsylvania, who is handling suicide and withdrawal cases.
“You’ve had three major personal injury litigations over one drug — the
suicide, the birth defect and the withdrawal cases. To have three significant
problems with one drug is really unusual.”

The company had $11.7 billion in U.S. Paxil sales for nine years starting in
1997, according to documents made public this year in a Pennsylvania trial. In
2002, the year before Paxil faced generic competition in the U.S., sales of the
drug there were $2.12 billion. Last year, U.S. sales had fallen to $129 million.
Through September of this year, sales were $52 million, down 52 percent from the
same period in 2008.

Since at least 2003, Glaxo has faced claims in U.S. courts that some Paxil
users were subjected to an undisclosed, higher risk for suicide and birth
defects.

A Suicide Settlement

The suicide settlements included a suit over the death of a 14-year-old boy
who had been taking Paxil for two months. The parents of Scott Cunningham, of
Valparaiso, Indiana, sued after the boy hung himself in 2001. They alleged Glaxo

suppressed evidence that Paxil use was linked to the risk of suicide attempts by
adolescents. Glaxo denied the allegations, according to court papers.

The family settled its suit in May, according to court filings. Family
attorney Bijan Esfandiari confirmed the settlement, saying the amount was
confidential.

About 150 cases over suicides by Paxil users were settled for an average of
about $2 million, and about 300 over suicide attempts settled for an average of
$300,000, they said. Some of the claims were resolved before suits were filed,
according to the people familiar with the matter.

Glaxo has settled about 10 birth-defect cases, Sean Tracey, a Houston-based
lawyer who represented the family of a child victim, said in court Dec. 2. The
settlements averaged about $4 million, the people familiar with the cases said.

Hasn’t Specified

The company hasn’t specified in regulatory filings the number of suicide,
birth-defect and addiction cases settled.

“It’s important to disclose such settlements because it raises the red flag
for both doctors and patients that there might be a problem,” said Dan Carlat, a
psychiatrist at Tufts University School of Medicine in Boston who writes and
edits a blog and a monthly Psychiatry Report. “It would motivate doctors to dig into the
literature even more before prescribing these drugs.”

Glaxo paid an average of about $50,000 per case to resolve about 3,200 claims
linking Paxil to addiction problems, the people familiar with the cases said.

In its 2008 annual report, company officials noted they had reached a
“conditional settlement agreement” in January 2006 with Paxil users who alleged
they suffered withdrawal symptoms after taking the drug. The case, filed in Los
Angeles federal court, was marked closed in court records in February.

Glaxo did not admit liability” in the addiction settlements, the company’s
officials said in a March 2009 filing with the U.S. Securities and Exchange
Commission.

The Other $400 Million

In one of eight accords unrelated to individual suicide, addiction or
birth-defect claims, Glaxo agreed in 2003 to pay $87.6 million to the U.S. and
49 states over claims it repackaged and privately labeled Paxil and another
drug, Flonase, to a health maintenance organization at discounted prices.

Glaxo, denying liability, agreed in 2004 to pay $165 million to settle two
antitrust suits over allegations it engaged in sham patent infringement
litigation to stall approval of generic versions of the drug, court records
show. Of that total, $100 million was for direct purchasers of Paxil, such as
drug wholesalers, and $65 million was for indirect buyers, the records show.

In the same year, Glaxo agreed to pay $2.5 million to New York to resolve
accusations the company withheld safety data about the antidepressant. The
company, calling the claims unfounded, agreed to release safety studies on the
medicine’s effect on children.

In 2005, the company added a black-box warning to its Paxil label that the
drug increased the risk of suicidal thoughts among adolescents, following a
request by the U.S. Food and Drug Administration to do so.

The Philadelphia case is Kilker v. SmithKline Beecham Corp. dba
GlaxoSmithKline, 07-001813, Court of Common Pleas, Philadelphia County,
Pennsylvania (Philadelphia).

To contact the reporters on this story: Jef Feeley in
Wilmington, Delaware, at jfeeley@bloomberg.net and; Margaret Cronin Fisk in
Southfield, Michigan, at mcfisk@bloomberg.net.

Last Updated:
December 14, 2009 00:01 EST

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ANTIDEPRESSANT: Overdose ruled as cause of Reading High student’s death

NOTE FROM Ann Blake-Tracy:

This case reminds me of a neighbor boy who attempted suicide after taking
Zoloft for about a month that he had gotten from his cousin without his parents
having any idea of what he was doing. When he ran out of the drug and found
himself in cold turkey withdrawal he made a suicide attempt. Because of his
suicide attempt they started him on Paxil with no idea how large a part
antidepressants had played in his suicide attempt. Of course with Paxil added to
the mix the reactions only began to worsen.
Anyway I mention his case to let you know that these drugs are so
widespread in use now that this young woman could have gotten these lethal drugs
anywhere and who knows how long she had been taking them?!
____________________________________________
Noelle-Cian Rodriguez, a senior, took a lethal dose of an antidepressant
medication and the death was ruled a suicide, Deputy Coroner Jonn M. Hollenbach
said.
Hollenbach ruled after receiving the final autopsy report Friday. He said
officials do not know how Rodriguez got the antidepressant pills.
Originally Published:
11/28/2009

Area digest: Overdose ruled
as cause of Reading High student’s death


Reading Eagle

An overdose of a
prescription drug caused the death last month of a 17-year-old Reading
High School student, the Berks County coroner’s office said
Friday.

Noelle-Cian Rodriguez, a senior, took a lethal dose of an
antidepressant medication and the death was ruled a suicide, Deputy
Coroner Jonn M. Hollenbach said.

Rodriguez was pronounced
dead Oct. 8 in Reading Hospital after she experienced seizurelike symptoms
in her home.

Hollenbach ruled after receiving the final autopsy
report Friday. He said officials do not know how Rodriguez got the
antidepressant
pills.

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Paxil Survivor – Prozac, Zoloft, Paxil

Paxil Survivor – Prozac, Zoloft, Paxil
Ellen Heath
An Open Letter to Anyone Seeking Information About the Harmful Effects of Psychiatric Drugs:

I am writing my story because I want to do something to help inform people about the harmful effects of antidepressant drugs. It took me several years, after using antidepressant medications for more than ten, to become clear headed enough to figure out what happened to me. I wound up having a minor stroke or a seizure according to the MRI. Now I’m trying to get my life back together.

Here’s what happened:

I went to a Psychiatrist in 1990 because I couldn’t control crying jags at work. I had been sad over a horrible accident that left my 19-year-old son permanently brain injured.

The lady psychiatrist saw me for less than five minutes, announced I was clinically depressed and prescribed Prozac. When I asked, she said it was not habit forming.

I remember feeling almost immediate relief after the first dose (surprising, since she said it would take 3 weeks to take effect). All of the sudden life became wonderful! I sang to myself all day long. I was the life of every party (or so I thought). I began drinking too much and running around like I was on speed. I just had so much fun at everything I did. The world was at my feet and I was setting it on fire! Wow…why didn’t I find these drugs sooner?

But really, as the years went by, I became unattached to the world emotionally. I became very self-centered. I lost a lot of friends. I missed major life occurrences, like the death of my father. I was not there for him during his illness nor was I emotionally present at his funeral. I was absolutely giddy all of the time. My most radical act was to sue my employer. I know now that it’s better not to sue your local government! As I look back at bad life decisions and embarrassing behavior, I can only be grateful that it was not worse. I read daily of cases describing people committing crimes and displaying truly bizarre behavior on these drugs, some turning into homicidal monsters when they try to withdraw. There are people spending the rest of their lives in prison because of these drugs. I realize I am one of the lucky ones to have come out of the fog and be able to tell my story. I have an insecure (shy), reserved personality by nature, and I come from a conservative family. I know now that the ‘drug fog’ kept me from seeing what was really happening in my life for many years. I know now that I would not have made all those bad decisions had I not been on those drugs. These pharmaceuticals that I so trusted to ‘cure’ my disease of depression have altered my entire life.

I realized I wanted off the drugs in the fall of 2001. It was nothing noble on my part that I finally decided to get off (an entirely different and very long story that I am not proud of…we’ll just say I wanted to be clear headed and leave it at that). It took from the fall of 2001 until the fall of 2003. And guess what? By December 2003 I was experiencing severe brain fogginess, mental confusion and panic attacks! I was deathly afraid of what was wrong with me and just as afraid to take any kind of medication to treat the crying jags. At this point, I did not know that I was experiencing was drug withdrawal.

I began to seek help. I had an MRI done because of the terrible brain fog.(1) They found ‘non-specific white focal matter’, which the doctor said could have been caused by a minor stroke or seizure. I searched for answers for an entire year from: three PHD therapists, one medical doctor of internal medicine, one general practitioner MD and one gastroenterologist MD. None of these professionals would discuss withdrawal effects of psych drugs! One guy curtly said in a very harsh tone, “if you want to talk about antidepressant drugs, you have to go to a psychiatrist!” Another, the PHD Psychologist lady, was giddy and scatter-brained. She left me sitting in her waiting room a half hour, then sashayed in laughing hilariously, saying she was so sorry she forgot about our appointment…then she proceeded to prop her feet up on her chair with her keyboard in her lap and and pounded in my name address and insurance information, saying “you know this drill, right?” I told her that I did not want to take antipressant drugs. She quickly explained to me that “our brains need help” and gave me some websites that supported her position. I finished the session with her and asked her not to file a claim on my insurance. I gave her a check. And guess what? The next day there was a claim on my insurance website! The woman obviously was in a world of her own. I suppose I should have written her a thank-you note for yet another example of the bizarre behavior caused by drugs that claim to “help” our brains!

Well, in fairness to these professionals, I was an emotional wreck, and probably presented a scary dilemma to them. While, all doctors may not know about the devastating physical effects these drugs have on our bodies and brains, most of them have heard about suicidal tendencies associated with them, and the well documented stories of people committing horrendous acts either on or while trying to quit these drugs. I’m sure when I mentioned I had recently quit them, I was quite the pariah.

I finally found a psychologist here in Austin, Texas, Dr. John Breeding, that lent me a copy of Ann Blake-Tracy’s tape, ‘Help, I Can’t Get Off My Anti-depressants’. And wow…what a relief! I wasn’t crazy after all. It really was the drugs, as I suspected. I began reading and researching, and discovered that everything that had been happening to me was directly related to the years of antidepressant drug use.

It took a personal crisis for me to wake up. And that’s exactly what happened. The details of the crisis are not important. What’s important is that things had to get pretty bad before I realized that the antidepressant drugs were wrecking my life and absolutely destroying my soul. Author and Psychiatrist Peter Breggin writes about a spellbinding effect these drugs have on people. Believe me, I was spellbound for a long time. I absolutely accepted as truth that these drugs were helping me. Even when I got off of them it took awhile for me to ‘come back’ and fully realize how duped I had been. This year will be the 6th year I am free from those mind captivating drugs, and never have I been tempted to get back on. Each week that goes by I still continue to gain memories and mental clarity.

It’s hard to get over the fact that more than 10 years of my life were lost in a fog because of drugs that doctors said would help me. It feels like my life has been turned totally upside down because of these drugs.

There must be a reason my mind was spared. I am now supporting an effort to enhance public awareness about the harmful effects of SSRI drugs in any way I can. That is the reason for this open letter. Please people …wake up! How many more lives must be ruined before you will see the truth?

I am asking that the medical community embrace the concept of ‘informed consent’. I went to three psychiatrists. None of them were willing to discuss the negative side effects of the SSRI drugs they prescribed for me. I went to professional counselors and psychologists who said ‘our brains need help’ and ‘the drugs help so many people’. Now after extensive reading and researching, I am absolutely disappointed in the prevailing viewpoint by the mental health community that mind-altering drugs are the answer. There is clear scientific evidence that they are not. When I see the giddy, drunken behavior of people on these drugs today, I am simply appalled that they continue to be touted as helpful by professionals who take an oath do ‘do no harm’!

I have started a support group for families, friends and bio-psychiatric drug survivors as a means of helping one another to heal. The lack of support from the medical community made me feel alone and isolated much of the time as I was coming off these drugs. By forming a community support group I hope to be able to help people avoid what I went through by sharing some of the information that is not readily available to the general public. I want to do something to spare people the anguish I went through. The information that I know now that I did not know when I went through all this should be readily available. My question to the medical community is why isn’t it?

It is my opinion that SSRI drug use today is epidemic, and that our society is being adversely affected because of it. It is my belief that those of us who have been on the drugs and successfully withdrawn have a responsibility to spread the truth that we have so painfully learned. We can change the world. We must share our stories and get the truth out there. If you are in a position to spread the word about how harmful psychiatric drugs are, do so…don’t hesitate. If you touch one life, you have made a difference.

Sincerely,
Ellen Heath
Transformers Support Group

P. S. Please feel free to contact me at 512-626-7986 or e-mail me at MHEATH3@AUSTIN.RR
(1) Brain fog means: I could not think straight. I felt confused about day to day activities at work (I am a financial analyst), my short term memory was so bad that I could barely put a sentence together, and I just found myself in a state of mental confusion, not knowing if this was my fault or the rest of the world that was askew. Mental confusion is hard to describe because you don’t really recognize it until you have begun to regain your clarity. You get lost on the way to a location that you’ve travelled many times before. You forget names of people that you’ve known for years… you turn the wrong way down a familiar hallway.

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SSRI Birth Defects: Glaxo must pay $2.5M in Paxil case

The verdict is the first in 600 cases alleging that
London-based Glaxo knew Paxil caused birth defects and hid those risks to boost
profits.

The drug, approved for U.S. use in 1992, generated about $942
million in sales last year, 2.1 percent of Glaxo‘s total revenue.

Michelle David had claimed that her 3-year-old son Lyam Kilker
suffered life-threatening heart defects because she took Paxil while she was
pregnant with him.

Posted on Tue, Oct.
13, 2009

Glaxo must pay $2.5M in Paxil case

By Miriam Hill

INQUIRER STAFF WRITER

GlaxoSmithKline P.L.C. must pay $2.5 million to settle a
claim that its Paxil antidepressant caused severe heart defects in a
3-year-old Bensalem boy, a Philadelphia common pleas jury ruled
today.

The verdict is the first in 600 cases alleging that
London-based Glaxo knew Paxil caused birth defects and hid those risks to
boost profits.

The drug, approved for U.S. use in 1992, generated about $942
million in sales last year, 2.1 percent of Glaxo‘s total
revenue.

London-based Glaxo has major operations in the Philadelphia
region.

Michelle David had claimed that her 3-year-old son Lyam
Kilker suffered life-threatening heart defects because she took Paxil while
she was pregnant with him.

Glaxo issued a statement saying it disagrees with the verdict
and will appeal.

“While we sympathize with Lyam Kilker and his family, the
scientific evidence does not establish that exposure to Paxil during pregnancy
caused his condition. Very unfortunately, birth defects occur in three to five
percent of all live births, whether or not the mother was taking medication
during pregnancy,” the company’s statement said.

David and Kilker’s lawyers, Sean Tracey of Houston and Jamie
Sheller of the Philadelphia firm Sheller P.C., argued that Glaxo withheld
information from consumers and regulators about the risk of birth defects and
failed to properly test Paxil.

“The first win is always huge, especially when you get a jury
saying the drug caused the injury,” Sean Tracey, Kilker’s lawyer, told
Bloomberg in an interview after the jury reached its decision.

Glaxo‘s lawyer, Chilton Varner of King & Spalding in
Atlanta, countered that the company reported any sign of problems to federal
authorities. She had accused Tracey of cherry-picking sentences from
documents.

During the trial, she also noted that Kilker, who underwent
several surgeries to fix his heart problems today “has no cardiac symptoms . .
.. is at preschool and runs and walks like an [almost] 4-year-old
should.”

In its statement today, Glaxo said it “acted properly and
responsibly in conducting its clinical trial program for Paxil, including
sharing documentation and submitting results from studies on Paxil to
regulators.”

Kilker will require more surgeries as he
grows.

David was a former cheerleader for the Philadelphia
76ers.

The case was heard by Judge Stephen Levin in Common Pleas
Court.

The FDA initially classified Paxil as a drug with no known
connections to birth defects. In 2005, the agency reclassified it as a drug
with some evidence of human fetal risk but allowed doctors to continue
prescribing it to women of childbearing age if the benefits outweigh the
risks.


Contact staff writer Miriam Hill at 215-854-5520 or hillmb@phillynews.com.

This story contains information from Bloomberg
News.

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ANTIDEPRESSANT: Mother of Columbine killer tells of horror 10 yrs after massacre

Michael Moore obtained a copy of Ann Blake-Tracy’s book at the premiere of his movie Bowling for Columbine. Now listen to his bold statement about what really did cause Columbine.


SEE FULL VIDEO Click here

INFO ON OTHER SCHOOL SHOOTINGS

Mark Taylors Site.
NOTE FROM Ann Blake-Tracy: Michael Moore, after reviewing all
the data on Columbine in making his movie, Bowling for Columbine, made his
message clear in the new movie The Drugging of Our Children about what he NOW
believes caused Columbine. Click on his picture to view his video
statement at www.drugawareness.org

In all of these articles out yesterday in the news covering the story by
Dylan’s mother there is STILL no mention of any medication use on Dylan’s part.
Yet we have a friend of Dylan’s who came forward claiming to have been helping
him withdraw from both Zoloft and Paxil.
But the coroner claims they found nothing in his system (I could go into
why that report is suspect but will save that for another time).
IF there really was nothing in his system, was Dylan in withdrawal from his
SSRIs at that point? We know that withdrawal can produce that same extreme out
of character violence since the REM Sleep Behavior Disorder (RBD) is more
prevalent in the withdrawal from these drugs than while on them. And yet of
those being diagnosed with RBD a staggering 86% were taking an antidepressant!
(To learn more about RBD read my FDA testimony on comedian Phil Hartman and is
wife’s Zoloft-induced murder/suicide – a classic case of RBD also found posted
at www.drugawareness.org.)
And if Dylan had been taking antidepressants were they prescribed to
Dylan? If not, where was he getting them? (Let us point out that anyone can
obtain these drugs easily. They have been sold in the streets since the early
90’s to be used recreationally and samples can be found ANYWHERE. Someone just
let me know that they found a bottle of Effexor in a shoe at a second
hand store!) Was a friend sharing their prescription? It happens regularly
from reports I get from kids. Were either of his parents taking one that he was
using for himself?
Years ago I was called in on a case of a 19 year old who was staying with a
married couple where the wife had been prescribed Zoloft and did not like how it
made her feel. She stopped taking it and placed in on top of the fridge. So when
the young man started feeling a little down he remembered the pills were for
depression and were suppose to help you feel better. So he took a couple, waited
a couple of hours and took more because he still was not feeling any better.
Then again took more a little later expecting to feel better right away. After

about five pills he recalls nothing about stabbing a man over 100 times with a
screwdriver.

Mother
of Columbine killer tells of horror 10 years after massacre

•Susan Klebold says she is haunted by school killings
•’I cannot look at a child without thinking about it’

Columbine High School student Dylan Klebold

Dylan
Klebold pictured in the 1999 Columbine High School yearbook. Photograph:
Reuters/© Ho New

The
mother of one of the two teenagers who murdered a dozen fellow students and a
teacher in the massacre at Columbine high school has broken a decade of

silence to say that she is unable to look at another child without thinking
about the horror and suffering her son caused.

Susan
Klebold, whose son Dylan and another youth, Eric Harris, hunted down pupils at
the Colorado school with shotguns, a semi-automatic pistol and a rifle before
killing themselves, has described her trauma over her son’s actions.

“For
the rest of my life, I will be haunted by the horror and anguish Dylan caused,”
she wrote in O, The Oprah Magazine. “I cannot look at a child in a grocery
store or on the street without thinking about how my son’s schoolmates spent the
last moments of their lives. Dylan changed everything I believed about myself,
about God, about family and about love.”

Neither
the Klebold nor Harris families has spoken about the massacre, in which 21
students were also wounded.

Klebold
recounts how the last word she heard from her son was a gruff goodbye as he
rushed out of the door early on the morning of the killings in April 1999.

“I
was getting dressed for work when I heard Dylan bound down the stairs and open
the front door … I poked my head out of the bedroom. ‘Dyl?’ All he said was
‘Bye.’ … His voice had sounded sharp. I figured he was mad because he’d had
to get up early to give someone a lift to class. I had no idea that I had just
heard his voice for the last time,” she said.

Dylan
Klebold was headed to make a final video with Harris to say goodbye and
apologise to their families before they drove to the school to plant bombs,
which failed to detonate, and to carry through their plan to kill their fellow
students.

After
the killings, the authorities said there were indications that the two youths
were disturbed and hints of the looming catastrophe. Harris’s blog included
instructions on how to make explosives and, later, angry denunciations of
society that attracted the attention of the police after Harris posted a death
threat against another student. Closer to the massacre, Harris listed his
stockpile of weapons and posted a hit list. Klebold was less overt but with
Harris made secret videos of their weapons and wrote in his diary of a desire to
plan an attack that would match the bombing in Oklahoma City by rightwing
militiamen that killed 168 people.

Klebold
writes that she had no idea that Dylan was contemplating killing himself or
anyone else. “From the writings Dylan left behind, criminal psychologists have
concluded that he was depressed and suicidal. I’d had no inkling of the battle
Dylan was waging in his mind,” she wrote.

“Dylan’s
participation in the massacre was impossible for me to accept until I began to
connect it to his own death. Once I saw his journals, it was clear to me that
Dylan entered the school with the intention of dying there. In order to
understand what he might have been thinking, I started to learn all I could
about suicide.”

Five
years after the killings, the FBI said they believe that Harris was a clinical
psychopath who masterminded the plan and Klebold depressive.

The
massacre continues to generate debate about the motives of the two youths and
whether anything could have been done to stop them. The magazine said that Susan
Klebold was not paid for the article and will not be making an appearance on
Oprah Winfrey’s television
show.


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PAXIL: BIRTH DEFECTS – TEST CASE FOR OVER 600 MORE CASES – USA

First two paragraphs read:  “GlaxoSmithKline P.L.C., the
world’s second-biggest drugmaker, begins a trial in Philadelphia next week in
what may be a test case for more than 600

lawsuits over claims that the company’s antidepressant drug Paxil causes birth defects.”

“Patients and their parents say internal company documents
show Glaxo failed to warn consumers about the risks of Paxil until forced
to do so in 2005 by the Food and Drug Administration.
In the trial set
to start Monday, Michelle David blames the drug for causing life-threatening
heart defects in her son, Lyam Kilker, now age 3.”

Glaxo trial opens here Monday in what could be Paxil test case

By Sophia Pearson and Margaret Cronin Fisk

Bloomberg
News
GlaxoSmithKline P.L.C., the world’s second-biggest drugmaker, begins a
trial in Philadelphia next week in what may be a test case for more than 600

lawsuits over claims that the company’s antidepressant drug Paxil causes birth
defects.

Patients and their parents say internal company documents show
Glaxo failed to warn consumers about the risks of Paxil until forced to do so in
2005 by the Food and Drug Administration. In the trial set to start Monday,
Michelle David blames the drug for causing life-threatening heart defects in her
son, Lyam Kilker, now age 3.

The company, based in London and with major
operations in Philadelphia and its suburbs, faces two more such trials each
month from October through January in state court in Philadelphia.

“The
early cases set the parameters for any global settlement negotiations,” said
David Logan, dean and professor of law at Roger Williams University in Bristol,
R.I.

Paxil, approved by the FDA in 1992, generated about $942 million in
sales last year, 2.1 percent of the total for the company.

Glaxo has
settled other Paxil-related cases, including a suit brought by the New York
Attorney General’s Office accusing the company of withholding safety data about
the antidepressant.

The drugmaker isn’t liable for Lyam Kilker’s heart

defects, and it acted responsibly in testing Paxil and updating safety
information, Kevin Colgan, a Glaxo spokesman, said in an e-mail.

“The
scientific evidence simply does not establish that exposure to Paxil during
pregnancy caused Lyam Kilker’s condition,” Colgan said. “Very unfortunately,
birth defects occur in 3 to 5 percent of all live births, whether or not the
mother was taking medication during pregnancy.”

The FDA said in an alert
to doctors on Dec. 8, 2005, that preliminary studies suggested Paxil might
contribute to heart defects in infants when taken in the first three months of
pregnancy. The government asked the company to update the label enclosed with
the medicine, changing its birth-defect warning.

The FDA’s action does
not prove any connection between Paxil use and birth defects, Glaxo said in
court filings in July.

“GlaxoSmithKline will show it acted properly and
responsibly in conducting its clinical trial program for Paxil, in marketing the
medicine, in monitoring its safety once it was approved for use and in updating
pregnancy information in the medicine’s label as new information became
available,” Glaxo’s Colgan said.

Lawyers for patients say Glaxo
documents show the company had known since 1980 that Paxil could raise the risk
of birth defects.

Buzz
up!
Buzz this story.

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Effexor/SSRI Withdrawal: Brain Zaps: Peoples Pharmacy

Paragraph two reads:  “After cutting my dose in half, I have had brain zaps (impossible to explain) and pressure in my ears.”

http://www2.timesdispatch.com/rtd/lifestyles/local_other/article/S-PHAR06_20090902-190006/290023/

Q:I have been taking Effexor XR for two years. At first I was pleased that it relieved the anxiety, depression and excessive worrying I had been suffering. Then I began experiencing insomnia and night sweats and decided to taper off this antidepressant.

After cutting my dose in half, I have had brain zaps (impossible to explain) and pressure in my ears.

Answer: Many people find that antidepressants such as Effexor (venlafaxine), Cymbalta (duloxetine), Lexapro (escitalopram), Paxil (paroxetine) and Zoloft (sertraline) are helpful for depression. But there can be a dark side.

Stopping this type of drug can lead to withdrawal symptoms such as dizziness, headaches, insomnia, anxiety, sweating, visual disturbances and difficulty concentrating. Many people complain of shocklike sensations in their head (brainzaps” or “shivers”).

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PAXIL: Postpartum Depression Medication Worsens Depression

Sentences three through seven read:  ” I went through
postpartum depression with my first baby eight years ago but at
that time I didn’t have anxiety and I didn’t take any medication.
And I started getting better after 3½ months itself. But now it’s
been three months that I am going through this. I have been
taking medications (Paxil 20 mg, Buspar 10 mg) and getting counseling but
it’s not helping much. I still don’t feel myself and am having unwanted
thoughts.”

http://www.cnn.com/2009/HEALTH/expert.q.a/09/08/postpartum.depression.raison/

Expert Q&A

updated 10:03 a.m. EDT, Tue September
8, 2009

How long will my postpartum depression last?

Asked
by Sheeza Ashraf, Fremont, California

I have a 4-month-old baby. I am
going through postpartum depression with a lot of anxiety and panic attacks. I
went through postpartum depression with my first baby eight years ago but at
that time I didn’t have anxiety and I didn’t take any medication. And I started
getting better after 3½ months itself. But now it’s been three months that I am
going through this. I have been taking medications (Paxil 20 mg, Buspar 10 mg)
and getting counseling but it’s not helping much. I still don’t feel myself and
am having unwanted thoughts. How long does postpartum depression last? Is this
temporary? Will this anxiety and depression ever go away? Should I stop the
medications and try it on my own? Does exercise help to get out of the

depression? Will I ever be normal like I was before?

Mental
Health Expert
Dr.
Charles Raison
Psychiatrist,
Emory University Medical School

Expert answer

Dear Sheeza,

I am sorry to hear
of your difficulties — you are far from alone in your struggles with postpartum
depression. Indeed, up to 20 percent of women become depressed in the six months
following delivery, but company doesn’t help much when it comes to depression
or at least the company we typically provide in the U.S. Traditional cultures
understood the vulnerability of new mothers and would often surround them with
family and friends to help with the significant emotional and practical burdens
of coping with the newborn.

I am going to make some general
recommendations about what you might want to consider doing, based only on the
information you have provided above. As always, this should not be taken as
specific advice for your actual situation. That kind of advice can come only
from a clinician who knows you and is involved in your care.

First and
most important, it is very important to continue medication when one is still
depressed, so given what you describe, I would counsel against stopping the
antidepressant. It is not clear how long you have been on the Paxil (generic:
paroxetine), but let’s assume you’ve been on it for at least six weeks. You are
on a low dose. A reasonable first step would be to talk with your doctor about
raising the dose to 40 mg a day and trying this dose for at least several weeks.

If you see no benefit, there are in general two paths your doctor might
recommend (and I say doctor in the generic sense, given that many folks nowadays
see physician assistants or nurse practitioners who often — in my experience —
do a better job diagnosing and treating depression than do MDs). First, your
doctor might add a second antidepressant or an atypical antipsychotic to your
Paxil. Although they are called “antipsychotics,” these agents (for example
Seroquel, Abilify, Zyprexa) are also widely used to help with severe depression
and anxiety and are often quite effective. Second, your doctor might switch you
from the Paxil to another antidepressant. Unfortunately, we have no scientific
way of knowing which agent you should switch to — our best data suggest that
they are all about equal. But one thing is clear: Many people who don’t do well
with one antidepressant will have a great response to a different
one.

Anxiety and panic are quite common when one has a bad depression,
and they can be more miserable to endure than the feeling of depression itself.
It is unlikely that the low dose of Buspar (generic: buspirone) you are taking
is of much benefit. You might want to discuss with your doctor raising the dose
to at least 10 mg three times a day or discontinuing it. The best immediate way
to relieve disabling anxiety is through the use of benzodiazepines (for example
lorazepam or clonazepam). These medications can be lifesavers, but if you take
them for more than three or four weeks your body will become dependent upon
them, and should you want to stop, you will have to reduce them slowly under the
supervision of a doctor.

Let me say a word about exercise. Yes, exercise
has been shown in many studies not only to raise a person’s mood immediately,
but also to work over time as an antidepressant. Therefore, I strongly recommend
adding regular exercise to your treatment regimen. Try to exercise in the
morning, especially when it is sunny. To get the best effect you will need to
work up a sweat. I find that it is even better if you can exercise in a place
with some natural beauty — as being in nature is itself quite comforting for
most of us.

I don’t have an answer to your question about how long the

depression will last and whether it will ever go away. Everyone is different. We
do know, however, that the longer one stays depressed and/or the more episodes
one has had, the harder it is to treat the condition. This is just the
frightening truth of the disease, and it really highlights how important it is
for you to really get aggressive about your treatment. My sincere hope is that
whatever specific treatment route you follow, you will start feeling like
yourself again as quickly as possible.

Finally, whenever I talk about
specific pharmacologic treatments I need to disclose that in addition to my
academic work I have given lectures for two pharmaceutical companies in the last
year: Lilly and Wyeth. I have also served on an advisory board for Lilly in the
last 12 months.
[]

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SSRI: 100-500% Increased Risk of Heart Birth Defects If Taken In Early Pregnancy

NOTE FROM Ann Blake-Tracy (www.drugawareness.org): This new study SHOULD stop the Mother’s Act dead in its tracks! The Mother’s Act is designed to medicate pregnant and nursing mothers for depression and we know what they medicate them with – these drugs that they have just shown amazingly damaging effects upon the heart of the fetus!

ANY YOUNG WOMAN WHO INTENDS TO HAVE A FAMILY SHOULD BE WARNED OF THIS POSSIBILITY OF SERIOUS LIFE THREATING BIRTH DEFECTS IN HER OFFSPRING BEFORE EVER BEING STARTED ON AN SSRI ANTIDEPRESSANT!! Marketing these drugs to this age group should be considered criminal when you look at what this study shows to be the risks to the children born to these mothers.

And if you think this does not affect you, think again. You need to see what these children go through (if they survived their mother’s use of these drugs) throughout their lives due to their mother’s use of these drugs! Who do you think ends up paying the bills for the numerous reconstructive surgeries, the lifetime of medications and medical treatment? We do. All of us in higher insurance rates, disability payments, etc., etc., etc.

PLEASE CAREFULLY EXAMINE THE FOLLOWING RESULTS OF THIS STUDY AND SHARE IT WITH EVERYONE YOU KNOW!!! Doing so may spare at least one baby from this horror.

Here is just one small example: http://bigpharmavictim.blogspot.com Manie’s mother was given Paxil and assured it would be okay as so many mothers are told. Her infant son, Manie, was born with Transposition of the Great Arteries and had to have open heart surgery when he was only 8 days old. The surgery lasted 12 hours.
___________________________

Paragraph one reads: “If you take antidepressants such as fluoxetine (marketed as Prozac) early in your pregnancy, you may be doubling the risk that your newborn will be born with a heart defect, according to a new study.”

Paragraph four reads: “Along with fluoxetine, sertraline (marketed as Zoloft) and citalopram (marketed as Celexa) seemed to increase the risk more than others, as did using more than one antidepressant at a time, according to the report in the September 25th Online First issue of BMJ.”

Paragraph six reads: “Sertraline [Zoloft] more than tripled the risk, while citalopram [Celexa] more than doubled it. Using more than one SSRI nearly quintupled the risk of the heart defect.”

http://www.reuters.com/article/healthNews/idUSTRE58O39F20090925

Antidepressants in pregnancy up heart defect risk
Fri Sep 25, 2009 9:58am EDT Email | Print | Share| Reprints | Single Page[-] Text [+]

By Anthony J. Brown, MD

NEW YORK (Reuters Health) – If you take antidepressants such as fluoxetine (marketed as Prozac) early in your pregnancy, you may be doubling the risk that your newborn will be born with a heart defect, according to a new study.

However, the vast majority of children born to women who take such antidepressants – known as selective serotonin reuptake inhibitors (SSRIs) – do not have such defects, the researchers are quick to note.

Earlier studies have tied SSRIs during pregnancy to heart defects, but also to even more serious birth defects. According to the new study of nearly half a million children born in Denmark between 1996 and 2003, however, only heart defects are likely to be associated with the antidepressants, note co-author Dr. Lars Henning Pedersen, from Aarhus University, Denmark, and colleagues.

Along with fluoxetine, sertraline (marketed as Zoloft) and citalopram (marketed as Celexa) seemed to increase the risk more than others, as did using more than one antidepressant at a time, according to the report in the September 25th Online First issue of BMJ.

Overall, SSRI use in early pregnancy, defined as 28 days before to 112 days after conception, doubled the risk of a particular kind of heart defect involving a piece of tissue that separates parts of the heart.

Sertraline more than tripled the risk, while citalopram more than doubled it. Using more than one SSRI nearly quintupled the risk of the heart defect.

However, the number of children born with such defects was still quite small: For about every 250 pregnant women who did not take SSRIs, one infant was born with the defect, while about two were born with the defect for every 250 women who took one SSRI, and four for every 200 mothers who took more than one.

Pedersen told Reuters Health that the results surprised the team.

Still, in an accompanying editorial, Dr. Christina Chambers, from the University of California, San Diego, comments that doctors and patients “need to balance the small risks associated with SSRIs against those associated with undertreatment or no treatment.”

SOURCE: BMJ, online September 25, 2009.

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PAXIL TRIAL: Glaxo Executive’s Memo Suggested Burying Drug Studies (Update4)

An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.
“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits.

NOTE BY Ann Blake-Tracy (www.drugawareness.org): In my small church congregation in Utah (maybe 100 families) there were two cases of SSRIs birth defects that I was aware of. In one case the mother was on Paxil and the other was a mother on Prozac. Both babies had to have heart surgery at birth or not long after. Because of that the number of 600 cases that have been filed is no surprise to me at all other than the number seems small in comparrison.

http://www.bloomberg.com/apps/news?pid=20670001&sid=ae8Ie3hNoafw

Glaxo Executive’s Memo Suggested Burying Drug Studies (Update4)
Share | Email | Print | A A A

By Jef Feeley and Margaret Cronin Fisk

Sept. 15 (Bloomberg) — An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.

Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.

“They said if there’s any doubt, take it out,” Tracey told jurors. “They do not want to scare anybody. It’s a very competitive marketplace. It’s a multibillion-dollar industry.”

‘Rare Thing’

Glaxo executives contend that the boy’s heart defect wasn’t caused by Paxil, Chilton Varner, one of the company’s lawyers, told jurors today in her opening statement. In court filings, Glaxo has said it appropriately tested and marketed the antidepressant drug.

“When Lyam Kilker was born in 2005, GSK had not received notice” of his specific type of heart defect in connection with Paxil use, Varner said. “The numbers will tell you the defect is a rare thing.”

The Paxil label at that time reported about animal studies, “including the rate of deaths,” she said.

Glaxo didn’t target pregnant women and its sales force didn’t use strong-arm tactics to push prescriptions, Varner said. “Whatever the marketing was, it played no role in Ms. David’s doctors’ decision to prescribe Paxil or Ms. David’s decision” to take the drug, she said.

Rat Studies

Glaxo officials purchased the compound sold as Paxil from a Danish company that had done animal studies showing young rats died after taking low doses of the drug, Tracey said in his opening statement.

One of the company’s scientists noted in internal documents in 1980 that information in the rat studies suggested Paxil “could be” a cause of birth defects, Tracey said. Still, the drugmaker refused for almost 20 years to do studies on why the young rats died, he added.

Tracey told jurors they would see documents in the trial that the company hadn’t turned over to regulators or congressional investigators. “You are going to see docs that have never seen light of day before,” he said.

For example, Tracey pointed to a 1998 internal review by Glaxo of all reports of side effects tied to Paxil and officials found “an alarmingly high number” of birth-defect reports. Even with those concerns, the report was never turned over to the U.S. Food and Drug Administration and “the alarming language” was deleted from it, the lawyer said.

In 2001, the company received a letter from a woman who used Paxil during her pregnancy and decided to abort her fetus after tests showed it had birth defects, Tracey said.

Internal Report

In analyzing the woman’s case, Glaxo officials concluded in an internal report that it was “almost certain” the fetus’s birth defects were caused by his mother’s Paxil use, the family’s lawyer added. Still, the company didn’t turn over its analysis to the FDA or beef up the drug’s warning label, Tracey said.

It wasn’t until after the FDA ordered Glaxo and other makers of antidepressants in 2003 to do more safety studies on their products that Glaxo officials publicly acknowledged that Paxil increased the risk of birth defects, Tracey said.

The lawyer for David, a college nursing student who was a former cheerleader for the National Basketball Association’s Philadelphia 76ers, told jurors that Glaxo hid Paxil’s problems to protect its profits.

Paxil is “the No. 1 asset to this day this company has ever owned,” the attorney said.

‘Quite Different’

Varner said she will present “quite different” evidence on animal tests tied to Paxil.

“The animal testing did not suggest Paxil caused birth defects,” Varner said. The FDA considered the tests when it approved the drug for use by U.S. consumers in 1992, she said.

When Glaxo officials considered offering Paxil for sale in Japan, internal records show executives worried in 1994 they might have to do more safety testing on the antidepressant, said Dr. David Healy, an Irish psychiatrist testifying as an expert for Kilker’s family in the case.

It may be the “type of study we wish to avoid,” Jenny Greenhorn, an official in Glaxo’s international regulatory affairs unit, said in a memo.

Glaxo also is fighting suits in the U.S., Canada and the U.K. over claims that Paxil, also known by the generic name paroxetine, causes homicidal and suicidal behavior. The company has settled some suicide claims, though terms of the settlements haven’t been released.

New York Settlement

In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement also required Glaxo to publicly disclose the studies.

The company’s provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn’t mention the Paxil litigation.

“We do not disclose our legal reserves for any specific litigation matter,” Glaxo spokesman Kevin Colgan said earlier this month.

Glaxo American depositary receipts, each representing two ordinary shares, fell 68 cents, or 1.7 percent, to $38.76 in New York Stock Exchange composite trading today. Glaxo fell 14 pence, or 1.2 percent, to 1,175.5 pence in London.

The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania.

To contact the reporters on this story: Jef Feeley in Philadelphia jfeeley@bloomberg.net; Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.

Last Updated: September 15, 2009 17:03 EDT

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