Posts Tagged ‘lawsuits’

Killing You with Drugs: Legally—Pharma’s attempts to bury increasing # of studies linking psychiatric drugs to suicide

Thursday, April 15th, 2010

The Market Oracle
By Michael Stathis
April 15, 2010

Is there any reason why Pfizer shares are down today?

Just yesterday, shares were trading at ~ $17.30. Today, with the DJIA up by 0.7%, Pfizer is down by nearly 1%.

A clue to this sell-off MIGHT be due to the anticipation by investors of increasing pressure to change the way drugs are prescribed. This could also trigger several lawsuits down the road.

Recently, another study was published in the Journal of the American Medical Association discussing elevated suicide risks associated with the use of anticonvulsant drugs. Anticonvulsants have been approved by the FDA for people diagnosed with epilepsy.

Of course, this is not the first study showing anticonvulsants raised the risk of suicide.

In 2008, the FDA required all anticonvulsant drugs to have a warning label that disclosed a two-fold increased risk of suicide. However, warning labels are rarely effective. They simply enable drug companies to continue to sell what many experts feel to be dangerous drugs, while having the safeguard of a disclaimer.

When patients receive a prescription for a drug to address a medical condition, they assume it’s a safe drug; otherwise, it wouldn’t be approved for use. And their doctor certainly wouldn’t prescribe it if it weren’t safe, would he?

According to DEA and FDA regulations, physicians are free to prescribe any drug for any condition they see fit, known as off-label use. As a result of off-label usage, anticonvulsants are prescribed for many different medical conditions like bipolar disorder, pain and migraine headaches. As you might imagine, in some cases, off-label use has accounted for a big chunk of drug sales.

The class of drugs prescribed most by physicians for off-label uses are the antipsychotics (Prozac, Xanax, Zyprexa, etc). The FDA has approved these drugs to treat a variety of neurologic conditions such as depression and bipolar disease. However, drug companies have used many methods to get physicians to prescribe them for a wide range of off-label uses.

Read entire article:  http://www.marketoracle.co.uk/Article18652.html

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Antipsychotic Drug Ad: If Calling Mom Makes You Hear Voices, Then AstraZeneca Has a Pill for You

Monday, March 22nd, 2010

BNet
By Jim Edwards
March 22, 2010

Can calling your mom worsen your symptoms if you’re a schizophrenic? Or does taking antipsychotic medicine help you to remember to call your mom more often?

One of those possibilities seems to be the claim in this ad for AstraZeneca (AZN)’s Seroquel, an antipsychotic that has been the subject of 10,399 lawsuits.

The ad shows a chart with two variables, “Calling mom?” and “Dosing.” The line between them indicates that more you call her, the more Seroquel you’ll need to deal with the mental fallout. Alternatively — and I’m guessing this was AZ’s intent — the chart shows that the more Seroquel you take, the more you’ll be psychologically stable enough to call her.

Underneath that, a headline says, “Up to 800mg … and who knows how many calls to mom.”

Read entire article:  http://industry.bnet.com/pharma/10007312/if-calling-mom-makes-you-schizophrenic-then-astrazeneca-has-a-pill-for-that/

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Paxil Birth Defect Litigation – 600 Cases Pending

Wednesday, February 17th, 2010

Scoop Independent News
By Evelyn Pringle
February 18, 2010

GlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in 1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.

Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.

First Trial A Bust for Glaxo

The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The jury awarded the family $2.5 million in compensatory damages.

After the trial, juror Joe Mellon told Bloomberg that Glaxo did not conduct adequate studies on Paxil. “There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further,” he said.

On October 14, 2009, the American Lawyer reported that the plaintiff’s lead attorney, Sean Tracey, had quizzed the jurors about what swayed their decision. “They said the fact that GSK never adequately studied their own drug was a big deal,” Tracey said. “The animal testing they did showed that they had a potential problem, and they didn’t follow up with adequate studies on animals or humans.”

Read entire article:  http://www.scoop.co.nz/stories/HL1002/S00128.htm

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Drug maker AstraZeneca facing 26,000 lawsuits over its antipsychotic drug Seroquel causing diabetes

Wednesday, February 3rd, 2010

Bloomberg.com
By Jef Feeley and Margaret Cronin Fisk
February 3, 2010

AstraZeneca Plc is facing as many as 26,000 lawsuits over its antipsychotic drug Seroquel as the drugmaker prepares for its first jury trial over claims the medicine causes diabetes, according to court filings.

Attorneys for AstraZeneca, the U.K.’s second-largest drugmaker, met with plaintiffs’ lawyers in court-ordered mediation sessions last month to discuss a possible settlement of the Seroquel cases, according to court filings. Consumers’ lawyers said they had about 26,000 cases in their inventories, Stephen Saltzburg, a George Washington University Law School professor who served as mediator, said in the filing.

“I wish there were a magic wand that could be waived to settle all Seroquel cases instantly,” Saltzburg said in the filing. “Such wand does not exist.”

AstraZeneca’s stock fell last week after the drugmaker’s sales forecast and stock-buyback plan disappointed some analysts and fourth-quarter profit missed estimates. The company plans to buy back as much as $1 billion of shares this year, officials said Jan. 28.

The company said in a U.S. Securities and Exchange Commission filing last week it faces more than 25,000 claims that Seroquel caused diabetes.

Read entire article:  http://www.bloomberg.com/apps/news?pid=20601087&sid=a6MfYbj9JtRc&pos=7

That’s a 65 percent increase in cases over the number the company reported in a January 2009 regulatory filing. Many of the suits also claim AstraZeneca promoted Seroquel, approved for schizophrenic and bipolar patients, for unapproved uses.

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That British Drug Maker Glaxo’s $1 Billion Paxil Settlements Were Disclosed by Press – Not Drug Maker – Is Cause for Concern

Tuesday, December 15th, 2009

Jim Edwards
BNET
December 15, 2009

British drug company GlaxoSmithKline (GSK) has paid $1 billion to settle lawsuits related to Paxil. The fact that it was disclosed by Bloomberg and not the company itself illustrates how lousy financial disclosure rules are in Europe and why drug companies based there cannot be trusted to tell the truth about what is going on with their litigation liabilities and, by extension, the safety of their drugs.

Bloomberg got the $1 billion number by piecing together litigation records, analysts’ reports and GSK’s own partial statements on the issue. But compare the Paxil situation with those faced by Eli Lilly (LLY) and AstraZeneca (AZN). Both companies have been engaged in litigation that has cost them billions (over the antipsychotics Zyprexa and Seroquel, respectively). And both companies have disclosed the full legal bill attached to those suits. (It’s more than $3.3 billion for Lilly and $1.1 billion for AZ.

Those numbers were disclosed in both companies’ earnings reports. Interestingly, Lilly disclosed them because it was required to report anything “material” by the SEC — it’s an American company and that’s the law. Fines and prosecutions await American firms that fail to report bad news.

Read entire article: http://industry.bnet.com/pharma/10005807/gsks-1b-paxil-problem-highlights-murky-disclosures-from-euro-drug-companies/

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