GLAXO ORDERED TO PAY OUT ANOTHER MULTIMILLION DOLLAR VERDICT IN ATTORNEY’S SUICIDE

  • Definitely great news to be getting on the 18th anniversary of Columbine!!!

I cannot believe how incredibly stupid this drug company is!!!! If they were not made foolish enough in the Tobin vs Glaxo case by their own expert testifying under oath that according to his decades of research on serotonin that the two pills of their deadly antidepressant Paxil taken by a mild mannered elderly grandfather Donald Schell should have been expected to cause him to shoot his wife, visiting daughter and infant granddaughter and himself….Yet they were stupid enough to take the case of a suicide by a prominent attorney to court instead of settling the case with a gag order in place to keep this from the public as they have done for decades?!!

They must all be on these antidepressant drugs shown in 1993 research to turn brain cells into corkscrew shapes!!!!! There clearly are not a lot of smarts in that company!

Or maybe they think they have produced enough corkscrew shaped brain cells in the general public with these drugs that no one will notice this verdict….

Generic Paxil Garners Guilty Verdict For GSK

Whatever this is great news for victims because apparently this attorney took the generic version of Paxil, Paroxetine, which has been able to avoid wrongful death suits because it is a generic form of a drug that has been ruled “safe and effective” by the FDA. It did not work this time! Glaxo who put out the original Paxil and Brisdelle (Paxil with a name change given for Menopause) has now been found liable for this suicide!! I love it! Karma has found them and they have reaped what they sowed for putting these deadly drugs on the market.

Our Facebook Groups for Paxil & Brisdelle

If you have been harmed by either Paxil or the new Brisdelle please join our Facebook groups:

Paxil Should Be Illegal: https://www.facebook.com/groups/370289153168180/

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GSK Hit With $3M Verdict For Reed Smith Atty’s Suicide
By Jessica Corso

Law360, Chicago (April 20, 2017, 4:20 PM EDT) — An Illinois federal jury on Thursday found GlaxoSmithKline liable for the death of Reed Smith LLP partner Stewart Dolin and ordered the pharmaceutical giant to pay $3 million to the attorney’s widow, reaching the conclusion that a generic version of GSK’s Paxil caused Dolin to take his own life.

A nine-person jury agreed with Wendy Dolin that her husband had committed suicide in 2010 under the influence of generic paroxetine, an antidepressant sold as brand-named Paxil. (AP) Following five weeks of trial testimony, the nine-person jury agreed…

ORIGINAL ARTICLE: https://www.law360.com/productliability/articles/912864/breaking-gsk-hit-with-3m-verdict-for-reed-smith-atty-s-suicide?nl_pk=c1c2604e-b651-48ad-8061-e111b387ca43&utm_source=newsletter&utm_medium=email&utm_campaign=productliability

Attorney Stu Dolan’s suicide was horrific. It was yet another suicide by train which in my research I have RARELY found any of these extremely violent suicides which did not include the use of an antidepressant. Read here about this extremely high profile and very successful attorney to know that a $3Million verdict did not even begin to compensate for this man’s life!!!

http://abovethelaw.com/2010/07/reed-smith-partner-commits-suicide-in-chicago/?show=comments#comments

Original Articles on Stu Dolan suicide:

http://articles.chicagotribune.com/2010-07-18/features/ct-met-dolin-obit-0718-20100718_1_mr-dolin-cta-train-corporate-lawyer

http://abovethelaw.com/2010/07/reed-smith-partner-commits-suicide-in-chicago/

http://articles.chicagotribune.com/2010-07-18/features/ct-met-dolin-obit-0718-20100718_1_mr-dolin-cta-train-corporate-lawyer

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Glaxo Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide Risks

The only word for this news is “Criminal!” I hope they are watching these children 24-7 to keep them from committingsuicide or homicide while in the study. I recall the seven year old boy on Paxil I worked with who wanted to cut the baby out of his mother’s belly and the 17 year old who impulsively jumped off an overpass in front of a semi-truck to end his life. Then there was the 10 year old brother and 15 year old sister, both on Paxil, who stabbed their 7 year old brother and buried him in the back yard. Sounds like a great drug for kids, doesn’t it?
I just finished a court report (I have been testifying as an expert in these cases for almost two decades) on a Paxil case and noted that 18 of the listed side effects were indicators of mania. If Glaxo had labeled those effects for what really are instead of the labels they gave those reactions then no one would be surprised to know that in children the rate of Bipolar Disorder increased 4000% from 1996-2004.
As for Paxil being beneficial apparently someone missed the news that came out just over two years ago where the original studies done on SSRI antidepressants finally surfaced – many the FDA had never seen – indicating that the drugs offer no more benefit than a placebo. So if even the worst drugs perform better than placebo, where does that leave the SSRI antidepressants?
Ann Blake-Tracy, Executive Director
International Coalition for Drug Awareness
www.drugawareness.orgwww.ssristories.drugawareness.org

Glaxo Is Testing Paxil on 7-Year-Olds Despite WellKnown Suicide Risks

By Jim Edwards | May 21, 2010

It was established years ago that Paxil carries a risk of suicide in children and teens, but GlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan. It’s not clear why the company would want to draw more attention to its already controversial pill, but it appears as if GSK might be hoping to see a reduced suicide risk in a small population of users — a result the company could use to cast doubt on the Paxil-equals-teen-suicide meme that dominates discussion of the drug.

GSK didn’t immediately respond to a request for comment. A staffer on GSK’s trials hotline confirmed the study was ongoing, however. The drug carries a “black box” warning on its patient information sheet, warning doctors and consumers that the antidepressant is twice as likely to generate lethal thoughts than a placebo.

The trial criteria listed on ClinicalTrials.gov, however, provide an interesting lesson in how managers can carefully design drug trials designed to flatter their products — something good companies don’t do.

The primary aim of the study is not to find out why Paxil makes some children kill themselves. Rather, it’s yet another efficacy study, which the drug doesn’t need because it was approved years ago — we already know the drug works.

Paxil is being tested against a placebo, so the results won’t be very surprising — even terrible drugs work better than sugar pills.

To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they’re bad, expect the company to dismiss them in favor of the primary endpoint results.

About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won’t be too statistically robust — there only need to be two or three outlier results to skew the numbers by several percentage points.

The trial will wrap up in September.

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PAXIL: Catholic Priest Commits Suicide: IN Lawsuit

Paragraph three reads:  “Father Rick Tucker, who took Paxil because he was upset about the way his parish ignored a child abuse scandal, may have committed suicide because of side effects from the drug and not the stress from the cover-up, a federal judge ruled. Judge David H. Hamilton of Indiana’s federal court found that Tucker’s sister Debra could sue GSK over the death of her brother, who shot himself to death in September 2002.”

http://industry.bnet.com/pharma/10007579/glaxo-paxil-and-the-catholic-church-sex-abuse-cover-up-drug-implicated-in-suicide-of-priest/

Glaxo, Paxil and the Catholic Church Sex Abuse Cover-up: Drug Implicated in Suicide of Priest

By Jim Edwards | Apr 7, 2010

GlaxoSmithKline (GSK), which was already the focus of controversy over whether it ignored thesuicide risk of its antidepressant Paxil, has found itself linked to the Catholic Church’s cover-up of child abuse in the death of a priest who took the drug.

The case seems bound to become a further PR headache for GSK, which in 2008 was accused of obscuring the suicide risk of Paxil in studies for 15 years.

Father Rick Tucker, who took Paxil because he was upset about the way his parish ignored a child abuse scandal, may have committed suicide because of side effects from the drug and not the stress from the cover-up, a federal judge ruled. Judge David H. Hamilton of Indiana’s federal court found that Tucker’s sister Debra could sue GSK over the death of her brother, who shot himself to death inSeptember 2002.

The Tucker case stems from 1966, when Debra Tucker was 10 years old and attended the St. Lawrence Parish church in the Diocese of Lafayette-in-Indiana. At the same time, Rick attended St. Mary’s Seminary in the same parish. Between 1966 and 1968, Debra was raped two to four times a month by St. Lawrence’s children’s choir instruction, a lay employee of the church, she alleges. In1968, Tucker had an abortion at the abuser’s behest, and then her family  including Rick, who had no idea what was going on  moved house and the abuse stopped. Debra remained in the area and over the years the abuser painted her house and attended the funerals of both her parents, she alleges.

In July 2000, after Debra discovered that the abuser had also allegedly assaulted his own children, she attended a meeting with Father Tucker, St. Lawrence’s Monsignor Robert Sell and other church officials. She claims that Sell and the church agreed to ensure that the abuser had no further contact with children in the parish and in return she would not sue the church.

After learning that Sell and the church allegedly did nothing about the man, Debra Tucker sued for breach of contract in a separate case not involving GSK.

The parish dragged its feet over the lawsuit, and as Father Tucker waited for word over whether his employers would settle his sister’s case, he became increasingly anxious. He was also worried about an upcoming audit by the diocese because, the judge wrote, he had “advanced himself some monies” and the Church would discover these “irregularities.”

However, his anxieties were misplaced: the audit did not uncover any irregularities in Father Tucker’s bookkeeping, the ruling says. The Tucker family’s lawyer said that the amounts involved were in the $50 range  and thus proof that Father Tucker’s anxiety was a product of the drug and not the situation he was in.

After taking Paxil, Tucker went into a sudden depressive tailspin. His diary for Aug. 30, 2002, just two days after he was prescribed the pill, says:

“Things have gotten behind and I do not know how to catch up. I want to live, but I want out of the pain. I feel like I am in an ocean and I can’t swim to the top for air. . . . I can see no way out of it. I know that if I follow through with the thoughts that come to my mind, there will be people hurt. … Debra I am sorry.”

Father Tucker killed himself on Sept. 18.

Debra Tucker alleges in her complaint against GSK that the company knew as early as 1990 thatPaxil potentially had an increased risk of suicide, and that the company failed to warn patients of the risk of akathisia, psychosis or violent self harm. Akathisia is a profound state of anxiety in which patients, unable to rest, believe they are doomed.

GSK had asked the judge to summarily dismiss the case based because the expert witnesses who testified that Father Tucker’s death was triggered by the Paxil and not the other stresses in his life were inadequate. The judge ruled there was a case to answer.

GSK and Msgr. Sell did not immediately respond to emails and a voicemail requesting comment. I’ve decided not to name the alleged abuser  although his name is published in Debra Tucker’s complaint against the church because I could not reach him for comment.

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PAXIL: Birth Defect Case: Test Case for Over 600 Lawsuit: USA- Pennsylvania

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.”

http://www.philly.com/inquirer/business/20090912_Glaxo_trial_opens_here_Monday_in_what_could_be_Paxil_test_case.html

Posted on Sat, Sep. 12, 2009

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 birthdefect 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.

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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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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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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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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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9/11-Paxil Birth Defect Case-One Year Anniversary of the Death of Baby Indiana

Why would it even be going to court? Glaxo is so stupid! They let the Donald Schell murder/suicide case go to court and look what it got them. Now they are going to do this????

Who is handling this one? Hope the attorneys are using Dr. Pal Paucher whose work has demonstrated this for a very long time.

-Ann

[NOTE: This is being sent to you directly as well as being posted on our “BREAKING NEWS” section of our new website. We are posting new cases there as they come in as well..]

We just had the anniversary of 9/11. And today is the anniversary of the death of baby Indiana. And this week we will have the first Paxil Birth Defect case hit the courts.

So what do all of these have in common? PLENTY!!

Baby Indiana lost her life a year ago today due to the fact that her mother took Effexor during her pregnancy and her parents were not warned of the potentially fatal dangers involved. (Please go to one of the sites below to lend support to her family in their battle to raise awareness and also to see what happened to baby Indy.)

All antidepressants increase serotonin levels. The main function of serotonin is constriction of smooth muscle tissue – the lungs and broncial tubes, the intestines, uterus, and the major organs of the body.

Serotonin was originally given to put pregnant women into labor so is it any wonder that Indy and so many other babies born to mothers on antidepressants are either miscarried or born early?

When serotonin levels go too high it results in Serotonin Syndrome which can be fatal producing death via multiple organ failure as the organs constrict and shut down as happened with baby Indy’s lungs.

Now the 9/11 connection: EVERY WEEK IN THIS COUNTRY WE LOSE AS MANY LIVES AS WE LOST IN THE 9/11 TRAGEDY TO ADVERSE REACTIONS FROM PRESCRIPTION DRUGS PRESCRIBED VIA FDA GUIDELINES – NOT ABUSED, BUT GIVEN AND TAKEN ACCORDING TO FDA GUIDELINES.

Why, are we at war in the Middle East over so few deaths (not that they did not matter or were any less important) as opposed to the thousands upon thousands of needless and senseless deaths that continue to happen every week in America due to these deadly prescription drugs that the world tends to ignore?!!! This is an ongoing, never ending 9/11 tragedy striking every week for years before 9/11 and for many years now since 9/11.

Who are the real terrorists? And why have we not declared war on them?

Now this week another family will go into court to fight the battle their little one cannot fight on his/her own. The birth defects have been known of for some time in medical science, but not shared with the parents of those who should be watching for them.

And just how many are there? We have NO idea. Most families are dealing with them with no idea even yet what the cause is. Last year I was speaking with a father about a business matter who explained he could not speak long because his 15 year old daughter was born with a hole in her heart and he had to run her to a doctor’s appointment.

I immediately asked which antidepressant his wife was taking during pregnancy with his daughter. Without hesitation he turned to his wife and asked, “Honey, which antidepressant were you on when you carried ________? Paxil. It was Paxil remember? That was when you had me start taking it.”

Of course I told him he needed to look up the FDA warnings on the drug and heart defects at birth due to the drug. I then gave him the numbers of several attorneys and explained that his daughter has every right to file for this terrible problem that has so affected her life for the past 15 years and will for the rest of her life that will be cut short as a result of the damage done by the drug.

So how many other 15 year olds are there out there dealing with these birth defects even though they have no knowledge of this being a side effect of their mother’s medication? And how many others like Indy did not survive their damages? We need to know. Hopefully this case finally making its way into court will stir up enough publicity to wake up enough people to give these children and their families answers.

Dr. Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & www.ssristories.drugawareness.org
Author of Prozac: Panacea or Pandora? – Our
Serotonin Nightmare (Order #)

http://wp.me/phViU-qd

Today, September 13, 2009 is the one year anniversary of Indiana Delahunty’s death. We encourage you to please go to her parent’s, Christian & Matt Delahunty’s, blog to offer some moral support to the family at this time.

http://indibaby.wordpress.com/

http://www.fiercepharma.com/story/test-paxil-case-hits-court-next-week/2009-09-11
Test Paxil case hits court next week
September 11, 2009 — 10:43am ET | By Tracy Staton
Related Stories

* AP: Glaxo reps aided Paxil ghostwriting
* Supremes ask for Obama view in vaccine case
* Glaxo under scrutiny in EU
* U.S. Paxil probe broadens
* Grassley asks FDA for Paxil review

GlaxoSmithKline and a bunch of plaintiffs’ lawyers will have their eyes on a Philadelphia court next week. That court is hosting a bellwether liability case over claims that the antidepressant Paxil causes birth defects. Glaxo faces some 600 lawsuits with similar claims. “These cases are sort of like the canary in the coal mine,” law professor David Logan told Bloomberg. “The early cases set the parameters for any global settlement negotiations.”

In this first case, plaintiff Michelle David claims that Paxil caused heart defects in her son Lyam Kilker and that Glaxo failed to warn about the drug’s potential to cause birth defects. As you know, FDA asked Glaxo in 2005 to update Paxil’s label with information on heart defects in infants. Glaxo says the FDA’s action doesn’t prove that Paxil causes birth defects; its own studies after the warning “have been inconclusive with mixed results,” the company says.

But David’s attorney says that Glaxo failed to follow up on early animal studies that suggested Paxil might cause birth defects, and that the company designed Paxil studies to use low doses of the drug to avoid triggering adverse events. “In 1998, GSK internally concluded that it had received an ‘alarming’ number of abnormal pregnancy adverse events for Paxil and failed to disclose this information to the FDA, physicians or the public,” the lawyers said in a court filing. We’ll be hearing much more from both sides next week.

– read the Bloomberg piece

Read more: http://www.fiercepharma.com/story/test-paxil-case-hits-court-next-week/2009-09-11#ixzz0Qq0vDCIS

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Antidepressant use doubles in U.S., study finds

“Not only are more U.S. residents being treated with antidepressants, but also those who are being treated are receiving more antidepressant prescriptions,” they added.
[Note by Ann Blake-Tracy: Far too many doctors are prescribing two and even three antidepressants at a time which should never be done due to the high potential of resulting Serotonin Syndrome from the combination.]
“During this period, individuals treated with antidepressants became more likely to also receive treatment with antipsychotic medications . . . “
[Note by Ann Blake-Tracy: Additional supporting data to add to the story we just sent out on 81% of those diagnosed with Bipolar Disorder having been previously treated with antidepressants or Ritalin type drugs – making these popular drugs the main triggers for Bipolar Disorder and manic psychosis.]

Antidepressant use doubles in U.S., study finds

1 in 10 are taking medication to improve mood, fewer going to talk therapy

By Maggie Fox

updated 2:44 p.m. CT, Mon., Aug 3, 2009

WASHINGTON – Use of antidepressant drugs in the United States doubled between 1996 and 2005, probably because of a mix of factors, researchers reported on Monday.

About 6 percent of people were prescribed an antidepressant in 1996 — 13 million people. This rose to more than 10 percent or 27 million people by 2005, the researchers found.

“Significant increases in antidepressant use were evident across all sociodemographic groups examined, except African Americans,” Dr. Mark Olfson of Columbia University in New York and Steven Marcus of the University of Pennsylvania in Philadelphia wrote in the Archives of General Psychiatry.

“Not only are more U.S. residents being treated with antidepressants, but also those who are being treated are receiving more antidepressant prescriptions,” they added.

More than 164 million prescriptions were written in 2008 for antidepressants, totaling $9.6 billion in U.S. sales, according to IMS Health.

Drugs that affect the brain chemical serotonin like GlaxoSmithKline’s Paxil, known generically as paroxetine, and Eli Lilly and Co’s Prozac, known generically as fluoxetine, are the most commonly prescribed class of antidepressant. But the study found the effect in all classes of the drugs.

Olfson and Marcus looked at the Medical Expenditure Panel Surveys done by the U.S. Agency for Healthcare Research and Quality, involving more than 50,000 people in 1996 and 2005.

“During this period, individuals treated with antidepressants became more likely to also receive treatment with antipsychotic medications and less likely to undergo psychotherapy,” they wrote.

Newer drugs, more social acceptance
The survey did not look at why, but the researchers made some educated guesses. It may be more socially acceptable to be diagnosed with and treated for depression, they said. The availability of new drugs may also have been a factor.

“Although there was little change in total promotional spending for antidepressants between 1999 ($0.98 billion) and 2005 ($1.02 billion), there was a marked increase in the percentage of this spending that was devoted to direct-to consumer advertising, from 3.3 percent ($32 million) to 12 percent ($122.00 million),” they added.

Dr. Eric Caine of the University of Rochester in New York said he was concerned by the findings. “Antidepressants are only moderately effective on population level,” he said in a telephone interview.

Cost may be deterrent to talk therapy
Caine, who was not involved in the research, noted that several studies show therapy is as effective as, if not more effective than, drug use alone.

“There are no data to say that the population is healthier. Indeed, the suicide rate in the middle years of life has been climbing,” he said.

Olfson and Marcus said out-of-pocket costs for psychotherapy and lower insurance coverage for such visits may have driven patients away from seeing therapists in favor of an easy-to-prescribe pill.

The rise in antidepressant prescriptions also is seen despite a series of public health warnings on use of antidepressant drugs beginning in 2003 after clinical trials showed they increased the risk of suicidal thoughts and behaviors in children and teens.

In February 2005, the U.S. Food and Drug Administration added its strongest warning, a so-called black box, on the use of all antidepressants in children and teens.

Copyright 2009 Reuters. Click for restrictions.

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