Paxil Birth-Defect trial, closing arguments. - decision time soon

[jeremy9282]

Glaxo Ignored Paxil's Birth-Defect Risks, Lawyer Says (Update2)


By Jef Feeley and Sophia Pearson
http://www.bloomberg.com/apps/news?p...d=al5HBXqhZVho

Oct. 8 (Bloomberg) -- GlaxoSmithKline Plc officials intentionally ignored the possibility that the Paxil antidepressant caused birth defects, a lawyer said in closing arguments of a trial over the drug.

Glaxo researchers never followed up on studies showing Paxil posed a birth-defect risk for fear of harming sales, Sean Tracey, lawyer for a family suing over the drug, told jurors yesterday in state court in Philadelphia.

The London-based drugmaker "made a concerted effort" not to study Paxil's links to birth defects, Tracey said. Glaxo executives sought to "avoid doing studies that would have revealed the truth about their drugs," he said.

The trial is the first of more than 600 cases alleging that Glaxo, the U.K.'s largest drugmaker, knew Paxil caused birth defects and hid those risks to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, or 2.1 percent of Glaxo's total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about Paxil's risks and failed to properly test the drug. Lyam's mother, Michelle David, blames Paxil for causing her son's life-threatening heart defects.

`Set Sympathy Aside'

Glaxo's lawyers contend the company isn't liable for Lyam's heart defects and acted responsibly in testing Paxil and updating safety information.

Jurors must "set sympathy aside and decide this case fairly," Chilton Varner, one of Glaxo's lawyers, told the panel in her closing statement today.

Arguments that Glaxo "has acted improperly or unethically" in its testing and marketing of Paxil "don't ring true," Varner added.

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

Glaxo's American depositary receipts, each representing two ordinary shares, rose 37 cents to $39.68 in New York Stock Exchange composite trading at 12:30 p.m. Glaxo rose 4 pence to 1,235 pence in London trading.

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

To contact the reporters on this story: Jef Feeley in Philadelphia at jfeeley@...; Sophia Pearson in Philadelphia at Spearson3@...

[jeremy9282]

Paxil Birth Defects Trial Now in Jury’s Hands

The first of more than 600 lawsuits claiming the makers of the antidepressant Paxil hid evidence that its drug caused birth defects in order to boost profits is now in the hands of a Philadelphia jury.


Testimony in the state-court trial, which began in September, wrapped up yesterday. Jury deliberations have begun and a verdict is expected sometime in the coming days or week, court watchers said.

The lawsuit involves allegations from Michelle David, who claims drug maker GlaxoSmithKline concealed negative study results linking Paxil to a life-threatening heart malformation in newborns of women who took the drug during pregnancy. The company marketed Paxil for treating pregnant women with anxiety, despite knowing about the apparent connection to birth defects, David contends.

David took Paxil while pregnant with her son, Lyam Kilker, who was born with life-threatening heart defects. The boy is now four and has fully recovered after being hospitalized as a newborn and undergoing multiple surgeries to repair his heart.

Glaxo’s lawyers argued during the trial that there is not sufficient evidence to prove that use of Paxil caused Lyam’s birth defects.


‘Test Case’ for Future Paxil Litigation
As the first of hundreds lawsuits alleging Paxil birth defect injuries, David’s case is being closely watched. The outcome could help shape the future of litigation against Glaxo for injuries allegedly caused by Paxil. A win for David could pave the way for other Paxil victims to receive the financial compensation they deserve for medical bills, pain and suffering, and other injuries.

Paxil was approved in 1992 and generated about $942 million in sales for Glaxo in 2008. The drug belongs to a class of antidepressants called selective serotonin reuptake inhibitor (SSRI), the most prescribed type of antidepressants in the world that also includes big-name drugs like Prozac, Celexa, Lexapro, and Zoloft.


Paxil Warnings Were Ignored for Years
Glaxo knew about the possibility that Paxil could cause birth defects as long ago as the late 1980s, David’s attorneys argued during the trial. Laboratory testing of the drug on rats showed animals injected with Paxil had pups that did not live past four days. However, Glaxo failed to further investigate the problem with Paxil for 20 years, according to the attorneys.

Concerns about heart-related birth defects in babies born to Paxil users prompted the FDA in 2005 to require GlaxoSmithKline to revise the drug’s labeling to warn of the risks. The FDA also warned women about the dangers of taking Paxil during pregnancy and the increased risks of birth defects.

Within five years of Paxil being released, in 1997, Glaxo had received reports of 50 miscarriages or intrauterine deaths in women taking the drug during pregnancy, David’s attorneys argued. Company scientists called the number of birth defects “alarming” but that opinion was not included in a report to the FDA, her attorneys said during the trial.





http://www.attorneyatlaw.com/2009/10...n-jurys-hands/

[jeremy9282]

First Paxil trial goes to the jury


http://thestar.blogs.com/ethics/2009...-the-jury.html

The first of some 600 civil trials to be held alleging that GlaxoSmithKline's anti-depressant causes birth defects was put in the hands of a Philadelphia jury this morning.

Testimony in the state-court trial, which began in September, wrapped up yesterday. Jury deliberations have begun and a verdict is expected sometime in the coming days or week, court watchers said.

The lawsuit involves allegations from Michelle David, who claims drug maker GlaxoSmithKline concealed negative study results linking Paxil to a life-threatening heart malformation in newborns of women who took the drug during pregnancy. The company marketed Paxil for treating pregnant women with anxiety, despite knowing about the apparent connection to birth defects, David contends.

David took Paxil while pregnant with her son, Lyam Kilker, who was born with life-threatening heart defects. The boy is now four and has fully recovered after being hospitalized as a newborn and undergoing multiple surgeries to repair his heart.

The trial is considered a test case for 600 such lawsuits expected to be heard the coming months in Philadelphia, where Glaxo's US headquarters are located. Lawyers for several of those upcoming cases have been in Philadelphia monitoring the David/Kilker case as they prepare their own arguments.

In his closing statement, David's lawyer Sean Tracey said Glaxo intentionally ignored the possibility that Paxil caused birth defects.

Glaxo researchers never followed up on studies showing Paxil posed a birth-defect risk for fear of harming sales, Sean Tracey, lawyer for a family suing over the drug, told jurors yesterday in state court in Philadelphia.

The London-based drugmaker made a concerted effort not to study Paxils links to birth defects, Tracey said. Glaxo executives sought to avoid doing studies that would have revealed the truth about their drugs, he said.

The drug, approved for use in the U.S. in 1992, generated about $942 million (US) in sales last year.

In her closing statement, Glaxo lawyer Chilton Varner urged jurors to set sympathy aside and decide this case fairly, adding that arguments that Glaxo has acted improperly or unethically in its testing and marketing of Paxil dont ring true.

She said the company isn't liable for Kilker's heart defects.

The company has set aside $2.8 billion to deal with legal and other non-tax disputes.

A second Paxil case, expected to begin next Tuesday, was settled out of court last weekend. The next is not scheduled to begin in mid-November.

[jeremy9282]

Originally Posted by jeremy9282

First Paxil trial goes to the jury


http://thestar.blogs.com/ethics/2009...-the-jury.html

The first of some 600 civil trials to be held alleging that GlaxoSmithKline's anti-depressant causes birth defects was put in the hands of a Philadelphia jury this morning.

continues ----



The company has set aside $2.8 billion to deal with legal and other non-tax disputes.

A second Paxil case, expected to begin next Tuesday, was settled out of court last weekend. The next is not scheduled to begin in mid-November.

A second Paxil case, expected to begin next Tuesday, was settled out of court last weekend. The next is not scheduled to begin in mid-November.

source -

http://thestar.blogs.com/ethics/2009...-the-jury.html

date - October 09, 2009





..

[jeremy9282]

Glaxo loses Paxil lawsuit


Drugs giant GlaxoSmithKline was ordered this morning to pay $2.5 million (US) to the family of a young boy born with heart defects after his mother took the anti-depressant Paxil during pregnancy.

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

It’s the first time a jury has considered claims that Glaxo, the U.K.’s largest drugmaker, knew Paxil caused birth defects and hid those risks to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, or 2.1 percent of Glaxo’s total revenue.

“We’re disappointed with the verdict and I think we’ll be filing an appeal,” Joseph O’Neil, one of Glaxo’s lawyers, said in an interview.

Lyam Kilker, who turns four next week, was born with a rare heart deformity. During the trial, the first of some 600 filed against Glaxo, Tracey argued the company failed to warn doctors and patients about possible side effects to the drug.

Company lawyers presented studies and experts arguing that the drug is safe, despite warnings added to its label in 2005 (after Lyam was born) about the possibility of birth defects. Tracey countered by arguing before the jury that such researchers had close ties to the pharmaceutical industry.

The jury deliberated for seven hours. The Kilker case, brought by his mother Michelle David, was considered a test case for future lawsuits. The next will be heard in about a month -- also in Philadelphia, home to Glaxo's US headquarters.

Lawyers for many of those cases have been in Philadelphia monitoring the progress of the Kilker suit as part of their preparation for going to court.

[scotty]

Originally Posted by jeremy9282

It’s the first time a jury has considered claims that Glaxo, the U.K.’s largest drugmaker, knew Paxil caused birth defects and hid those risks to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, or 2.1 percent of Glaxo’s total revenue.

AWESOME!!!!!!!!!!!!!!!!

[carolyn]

Woohoo!!!

[jeremy9282]

GSK Statement on Jury Verdict in Paxil Product Liability Trial in Philadelphia Court of Common Pleas

On October 13, 2009, a jury in the Philadelphia Court of Common Pleas returned a verdict against GlaxoSmithKline in a case alleging that Lyam Kilker was born with a rare heart defect as a result of his mothers use of Paxil during pregnancy.

GlaxoSmithKline 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.

GlaxoSmithKline acted properly and responsibly in conducting its clinical trial program for Paxil, including sharing documentation and submitting results from studies on Paxil to regulators. Once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicines labeling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community and the public.

US Media enquiries:
Nancy Pekarek
(919) 483 2839
Mary Anne Rhyne
(919) 483 2839
Kevin Colgan
(919) 483 2839
Sarah Alspach
(919) 483 2839

[scotty]

Originally Posted by jeremy9282

GlaxoSmithKline acted properly and responsibly in conducting its clinical trial program for Paxil, including sharing documentation and submitting results from studies on Paxil to regulators. Once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicines labeling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community and the public.

The standard line that GSK uses when they get caught.

[scared36wife]

I am not nor ever have been pregnant but I do remember distinctly when I was on a/d for a short time the doctor tellling me the following, which in my head I was thinking if its dangerous for a baby, why the he*& would be save for me?

1) are you currently on birth control?
2) are you trying to get pregant
3) if you become pregnant you must tell me immediately!! You cant take these drugs. I didnt respond b/c I was in such shock and disgust. If I knew what I did now, I would of recorded him and sued..

Or my husband was told by a different doctor:

" Let your brain heal."(cymbalta) and she told me, " Ohh.. you can't stay on that too long. (Lyrica)

Hello, a bell went off and I too went off the poisons...case closed..that explains it all!