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.

431 total views, no views today

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

491 total views, no views today

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

840 total views, 4 views today