Pharmaceutical Drug Litigation Updates

Antidepressants linked to risk of brain bleeds

Quoted from http://www.reuters.com/article/2012/10/17/us-antidepressants-idUSBRE89G1PB20121017

Antidepressants linked to risk of brain bleeds

By Amy Norton

NEW YORK | Wed Oct 17, 2012 4:24pm EDT

NEW YORK (Reuters Health) - People using a common class of antidepressants may have slightly increased odds of suffering bleeding in the brain - though the risk is still very small, researchers reported Wednesday.

The antidepressants are known as selective serotonin reuptake inhibitors (SSRIs), and include widely used drugs like fluoxetine (Prozac), sertraline (Zoloft), citalopram (Celexa) and paroxetine (Paxil).

SSRIs have been linked to a risk of stomach bleeding. But studies have come to conflicting findings on whether SSRI users have any higher risk of hemorrhagic strokes, which happen when there is bleeding in or around the brain.

So for the new study, researchers pooled the findings from 16 past studies involving more than 500,000 people who were on SSRIs or not.

Overall, antidepressant users were about 40 to 50 percent more likely to suffer bleeding in or around the brain, the researchers report in the journal Neurology.

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More suicidal thoughts with antidepressant: report

Quoted from http://www.reuters.com/article/2011/03/31/us-suicidal-thoughts-antidepressants-idUSTRE72U4EW20110331

More suicidal thoughts with antidepressant: report

By Frederik Joelving

NEW YORK | Thu Mar 31, 2011 11:19am EDT

NEW YORK (Reuters Health) - A new report from the drug company GlaxoSmithKline concludes that its antidepressant Paxil might make adults with major depression more likely to become suicidal.

But the rate of suicide attempts was low, at 0.34 percent for people on Paxil and 0.05 percent for people who got sham treatment with a placebo pill in clinical trials.

And it couldn't be entirely ruled out that the difference was due to chance, according to the report, published in the Journal of Clinical Psychiatry.

"The scientific evidence does not establish that paroxetine" - the ingredient in Paxil -- "causes suicide, suicide attempts, self-harm or suicidal thinking," said Sarah Alspach, a spokeswoman for the drug company.

"Nonetheless, all patients who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.

In general, antidepressants can be extremely helpful for people with depression. The American Academy of Family Physicians says on its web site, "Most people who have depression get better with treatment that includes these medicines."

But the link between suicide risk and antidepressants has long been a thorny issue for regulators and drugmakers alike. The current data were initially published in 2006 on GlaxoSmithKline's website in response to widespread concern.

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Glaxo Takes $3.4 Billion Charge on Legal Problems

Quoted from http://www.nytimes.com/2011/01/18/business/18drug.html

Glaxo Takes $3.4 Billion Charge on Legal Problems

By DUFF WILSON

Published: January 17, 2011

The British drug maker, GlaxoSmithKline, announced Monday that it was setting aside $3.4 billion to pay for United States government investigations and for product liability cases over its marketing of the diabetes drug Avandia in the face of heart attack risks.

The one-time charge is expected to wipe out its fourth-quarter profits, by consensus analyst estimates. GlaxoSmithKline’s European shares fell about 2 percent on the news.

Avandia, once the world’s top-selling diabetes medicine, was severely restricted in September by the Food and Drug Administration and banned by the European Medicines Agency after safety reviews.

GlaxoSmithKline took a $2.36 billion charge last summer to settle what it called “the substantial majority” of Avandia product liability lawsuits, as well as Paxil product liability cases and a Puerto Rico manufacturing case.

But it has received “substantial” new claims since then, the company said in a statement Monday to the London Stock Exchange. The $3.4 billion charge will be used for those product liability claims as well as costs related to an ongoing investigation by a federal prosecutor, the company said in the statement.

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Glaxo Failed to Warn About Paxil Risks, Lawyer Says at Philadelphia Trial

Quoted from http://www.bloomberg.com/news/2010-11-09/glaxo-failed-to-warn-about-paxil-risks-lawyer-says-at-philadelphia-trial.html

Glaxo Failed to Warn About Paxil Risks, Lawyer Says at Philadelphia Trial

By Jef Feeley - Nov 9, 2010 5:59 PM ET

GlaxoSmithKline Plc, the U.K.’s largest drugmaker, failed to properly warn consumers that its antidepressant drug Paxil could cause birth defects, a lawyer for the family of an injured teenager told jurors.

Glaxo had research from the 1980s showing Paxil caused deaths among the offspring of animal test subjects and didn’t provide clear warnings about the deaths, Kimberly Baden, a lawyer for Anna Blyth and her family, told a Philadelphia jury today. Baden said the drug caused a narrowing of the aorta leading from the heart of Anna, now 14 years old.

“We believe the evidence will show Paxil caused Anna’s birth defects,” Baden said in opening statements. “We believe the warnings and instructions put out in 1995 weren’t appropriate and reasonable.”

The Blyth family’s case is the first over Paxil’s birth- defect risks to go to trial since the company agreed in July to pay more than $1 billion to settle 800 cases alleging the company failed to adequately warn consumers and their doctors about the drug’s hazards. The Blyth case wasn’t part of the settlement.

In the first Philadelphia trial, a jury ordered Glaxo in October 2009 to pay $2.5 million to the family of a 3-year-old boy born with heart defects that his mother blamed on the drug.

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Glaxo Said to Have Paid $1 Billion Over Paxil Suits

Quoted from http://www.bloomberg.com/news/2010-07-20/glaxo-said-to-have-paid-1-billion-to-resolve-paxil-birth-defect-lawsuits.html

Glaxo Said to Have Paid $1 Billion Over Paxil Suits

By Jef Feeley and Trista Kelley - Jul 20, 2010

GlaxoSmithKline Plc has agreed to pay more than $1 billion to resolve more than 800 cases alleging its Paxil antidepressant caused birth defects in some users’ children, according to people familiar with the settlements.

The accords, which provide an average payout of more than $1.2 million to families of affected children, leave more than 100 birth-defect cases still pending, the people said. Officials of Glaxo, the U.K.’s biggest drugmaker, said July 15 they set aside $2.4 billion to resolve litigation over Paxil and its Avandia diabetes drug.

“It looks as if this should be covered in the liabilities to be charged in the second-quarter numbers,” Nick Turner, an analyst at Mirabaud Securities in London, said in an interview today. “If there are further liabilities to be disclosed in the third-quarter numbers, that would be very disappointing.”

The birth-defect settlements bring to more than $2 billion the amount Glaxo has agreed to pay to resolve a variety of Paxil-related suits, including claims it caused suicides or attempted suicides and addiction problems, the people said.

Glaxo officials confirmed yesterday they agreed to settle some Paxil birth-defect cases filed against the drugmaker. They refused to comment the terms of the settlements.

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Paxil Litigation Over Birth Defects Shifts to Settlement

Quoted from http://www.law.com/jsp/article.jsp?id=1202462916664

Paxil Litigation Over Birth Defects Shifts to Settlement

Amaris Elliott-Engel

The Legal Intelligencer

June 23, 2010

Drugmaker GlaxoSmithKline has agreed to settle almost 200 cases in which plaintiffs allege the use of the antidepressant Paxil caused birth defects.

Only one case in Philadelphia's mass tort Paxil program has gone to trial.

GSK has settled every other case scheduled for trial in the eight months since a Philadelphia jury awarded a $2.5 million plaintiffs verdict in the first Philadelphia Paxil test case to go to trial.

GSK started to appeal that plaintiffs verdict from October. The jury awarded only compensatory damages and no punitive damages. But GSK then decided to settle Kilker v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline along with another 190 cases, according to an order signed by Philadelphia Common Pleas Judge Sandra Mazer Moss last week.

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Glaxo Said to Have Paid $1 Billion to Settle Paxil Lawsuits

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aEr_s70bGdYo

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.

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First Paxil lawsuit in plaintiff's favor

Quoted from http://www.philly.com/philly/business/64682567.html

First Paxil lawsuit in plaintiff's favor

It's unclear what the jury's finding of negligence means to future cases. No punitive damages were awarded.

By Miriam Hill

Inquirer Staff Writer

Posted on Sun, Oct. 18, 2009

Negligent, but not outrageous.

Those words cost GlaxoSmithKline P.L.C. a $2.5 million judgment - but ruled out additional, punitive damages, in a Philadelphia courtroom last week. The case was the first of about 600 lawsuits to go to trial on claims that the company's Paxil antidepressant caused birth defects in children whose mothers took the drug during pregnancy.

Legal experts saw the 10-2 jury decision as a big win for plaintiffs in the remaining cases, even though the jurors awarded only compensatory damages to Michelle David of Bensalem. The jury found that Paxil had caused heart problems in David's 3-year-old son, Lyam Kilker, who required several surgeries after his birth to fix his heart.

Jurors linked Lyam's problems to Paxil and said Glaxo had been negligent in not properly warning David's doctor of the drug's risk, but they did not find the London company's behavior outrageous, which would have been necessary to award punitive damages.

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Glaxo Ordered to Pay $2.5 Million for Paxil Defects

Quoted from http://www.bloomberg.com/apps/news?pid=20601087&sid=aVU8D0AZ.zS8

Glaxo Ordered to Pay $2.5 Million for Paxil Defects

By Jef Feeley and Sophia Pearson

Oct. 13 (Bloomberg) -- GlaxoSmithKline Plc must pay $2.5 million over claims that its Paxil antidepressant caused birth defects, a Pennsylvania jury concluded in the first of 600 such cases to come to trial.

Jurors in state court in Philadelphia deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker. The 3-year-old was born with heart defects his mother blamed on the drug.

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

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 the risk 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 company disagrees with the verdict and will appeal, Kevin Colgan, a spokesman, said in an e-mailed statement.

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Glaxo Ignored Paxil’s Birth-Defect Risks, Lawyer Says

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=al5HBXqhZVho

Glaxo Ignored Paxil’s Birth-Defect Risks, Lawyer Says

By Jef Feeley and Sophia Pearson

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.

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