SEROXAT AND OTHER SSRIs

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Posts Tagged ‘Litigation’

GSK gives in – Last-minute deal in Avandia suit

Posted by shutah on January 31, 2011

A federal court in Philadelphia was all set to hear a liability lawsuit against GlaxoSmithKline today, but an 11th-hour settlement took that case right off the docket. GSK made a deal with the family of Avandia patient James Burford to resolve claims that the diabetes drug caused his fatal heart attack. GSK recently took a $3.5 billion charge for legal expenses, including new Avandia litigation filed in the U.S.

The settlement lets GSK avoid the risk of a jury trial, Matrix Corporate Capital analyst Navid Malik told Bloomberg. Investors had worried that a trial “could lead to substantial punitive damages,” Malik said. “GSK needs to successfully settle as many of these cases as possible.”

Two other suits brought by the same plaintiff attorneys were also settled. “GSK has resolved the Burford case scheduled for trial today in the U.S. District Court in Philadelphia, and all cases represented by attorneys Joseph Zonies and Thomas Cartmell,” GSK said in a statement, which also emphasizes that, “GSK continues to stand behind the safety and efficacy of Avandia when used appropriately and according to its label.”

Avandia’s safety, particularly its potential link to heart attack risks, has been under debate for several years, and GSK has already resolved some 10,000 liability suits with a $460 million settlement. In September, European regulators banned Avandia, saying its risks outweighed its benefits. The FDA stopped short of withdrawing the drug, but sharply restricted its use, and GSK agreed to stop promoting it. About 2,000 more lawsuits remain outstanding.

This SUCKS!!!  Not for the Claimants, I’m thrilled for them.  But GSK have ‘settled’ the case, thereby allowing them to walk away from their responsibilities by not having to testify in Court.

Their statement … “GSK continues to stand behind the safety and efficacy of Avandia ….” shows them to be lily-livered, cold-hearted bureaucrats with a seemingly bottomless well of money to throw about.  I’ll bet GSK doesn’t have the balls to ‘fess up to their errors when it comes to the SSRI drugs they ‘peddle’ around the World!!!  Boo, Hiss GSK!!!!

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Legal Action Delayed

Posted by shutah on January 30, 2011

End to epilepsy drug action delayed

By Cathy Gordon, PA 28 January 2011

 

A move to discontinue legal action brought by families who blame an epilepsy drug for causing defects in their children suffered a delay today.

Claims by more than 150 families were expected to be formally discontinued at a hearing before a judge at the High Court in London.

But Mr Justice Eady was told that a “difficulty” had arisen which meant that the proceedings would have to be adjourned.

Lawyers representing the families had earlier announced they had been forced to abandon the trial of the action following the withdrawal of legal aid.

The Legal Services Commission (LSC) said in November it was no longer funding an action against the makers of sodium valproate, a drug used to prevent epileptic seizures.

Claimants allege that the drug, also known as Epilim, caused a range of birth defects, including spina bifida, damage to the heart, learning difficulties, cleft palate and deformities of the hands and feet.

They have been pursuing a legal action for damages against manufacturer sanofi-aventis, claiming there were inadequate warnings about possible harm in the 1990s.

The firm has denied the claims, saying it has always provided appropriate precautions and warnings on the risks associated with possible side-effects of the medicine.

The plan for today was for lawyers for the families to advise the judge that the case against the manufacturers must be discontinued because continuing without legal aid funding would place their clients at “too great a financial risk”.

But the proceedings were adjourned for clarification to be sought relating to the terms of a proposed final order in the case.

Mr Justice Eady heard that the defendant would be taking instructions from representatives in France relating to one part of the order – that concerning the circumstances in which it would seek to enforce costs at any time in the future.

The court heard that there may have to be further consultation with all of the claimants by their lawyers to explain the situation to them with regard to the costs implications – a process which could take three months.

A further hearing is now expected to take place at the High Court in May.

Announcing the move to discontinue recently, solicitors Irwin Mitchell said their clients were “devastated” that their case would never be heard in court after six years of preparation for trial.

Despite the fact that the legal action has had to be dropped, families have vowed to continue their campaign.

A Legal Services Commission spokesman said: “Following advice from counsel, the Legal Services Commission has withdrawn legal aid funding for the multi-party action claim against the makers of the drug Epilim.

“Before making the decision, LSC had to await the exchange of evidence and the provision of comprehensive opinions from counsel – this process was only completed by the solicitors in late October.

“The claimants then exercised their right to appeal to a panel of lawyers who are independent of the LSC. This panel upheld the decision to withdraw funding.

“We have great sympathy with those who claim to have had adverse effects in connection with this medication, but our funding decisions must always be based on solid legal grounds.”

 

Posted in Blogroll, Health | Tagged: , | 2 Comments »

When secret settlements are taken to their illogical extreme

Posted by shutah on January 26, 2011

from The Moral Compass of the American Lawyer
by Richard Zitrin & Carol M. Langford

This story is not about Prozac, which from the weight of evidence appears to be a relatively safe drug. Rather, this is a tale of what happens when secret settlements are taken to their illogical extreme — in this case, a “sham” trial in which the plaintiffs and their lawyers were paid to pull their punches so the defendant could get a favorable verdict.

It started in September 1989, when Joseph Wesbecker armed himself with an AK-47, walked into the Louisville printing plant where he had worked, and started shooting. He killed eight people, wounded twelve more, and finished matters by blowing his own brains out. One month before, Wesbecker had begun taking Prozac. The lawyers for the shooting victims soon focused on the drug as the cause for Wesbecker’s extraordinary violence, and they targeted Eli Lilly, Prozac’s manufacturer, as the “deep pocket.”

The Fentress case, named for one of Wesbecker’s victims, was the first of 160 cases pending against Prozac to go to trial in the autumn of 1994. By then, Prozac had become the aspirin of anti-depressants — the wonder drug everyone was talking about and millions were using. Prozac represented almost one-third of all Lilly sales in 1994 — $1.7 billion. A great deal was at stake: If Lilly lost, other plaintiffs waiting in the wings would gain strength and resolve. But a verdict for the drug company might make those other plaintiffs reconsider.

Throughout the case, plaintiffs’ attorneys pushed Judge John Potter to allow evidence about another Lilly product, the anti-inflammatory drug Oraflex, which had been taken off the market in 1982 as too dangerous. In 1985, Lilly had pled guilty to 25 criminal counts of failing to report adverse reactions to Oraflex, including four deaths, to the Food & Drug Administration. Central to the plaintiffs’s claims was that Lilly had done the same thing with Prozac. Potter refused to allow the evidence, saying it was marginally relevant at best, and would prejudice the jury more than it would prove anything.

But when Lilly executives testified that the company had an excellent reputation for reporting problem incidents — what they euphemistically called “adverse events” — plaintiffs’ counsel immediately renewed their request to bring in the Oraflex evidence. Potter agreed, noting that “Lilly has injected the issue into the trial.” Potter’s ruling set off a flurry of activity around his courtroom. The lawyers jointly asked for a recess, and then asked to adjourn for a day.

By mid-afternoon, a strong scent of settlement was in the air. But when Judge Potter reconvened the case the following afternoon, he was surprised by what he heard. Chief plaintiffs’ counsel Paul Smith announced that the plaintiffs would rest without presenting the Oraflex evidence unless the trial went to its second phase, which would address the amount of the financial award. That stage would occur only if the jury decided in the first phase that Lilly was liable. If the jury found Lilly not liable, the case would be over, and the Oraflex evidence would never be heard.

The plaintiffs’ high-risk strategy puzzled Judge Potter; they could lose their whole case without presenting their best evidence. Potter asked the lawyers whether they had reached a settlement. He was told unequivocally that they had not. While the jury was deliberating, a juror came forward and told Judge Potter that she had overheard settlement negotiations going on in the hallway. She repeated this in chambers with the lawyers present and was then excused. Potter turned to the lawyers and said, “Does anybody have anything they want to say?” A moment later, he asked again, “Does anybody have the slightest clue?” “No,” said Smith. “I can’t imagine,” said one of the defense lawyers.

In other chambers meetings, lawyers from both sides emphasized their plans for Phase Two of the trial — the money, or “damages” phase — and the possibility of settlement discussions if the plaintiffs won Phase One. All this would be unnecessary, of course, if the case actually had been settled already. On December 12, only three court days after Potter’s ruling allowing the Oraflex evidence, the jury returned a verdict for Lilly.

In January 1995, Judge Potter formally entered his order in Fentress v. Eli Lilly, dismissing the case after verdict by jury. As soon as the verdict was in, Lilly and its lawyers trumpeted their victory across the country. “We were able, finally,” said one of Lilly’s lead attorneys, “to get people head to head in a courtroom and say ‘Put up or shut up.’ … [T]his is a complete vindication of the medicine.”

Had John Potter not been the judge, the Fentress case might have ended there. He asked himself why any lawyer would fight so hard over the key Oraflex evidence and then not present it in the most important part of the case.

Despite what the lawyers had told him, Potter suspected that some kind of deal had been made. But he decided to be patient. He waited to see whether the plaintiffs filed a notice of their intent to appeal, a routine matter after losing a case. When they didn’t, Potter called in the lawyers from both sides. They continued to deny that a settlement had been reached. Although Potter was more suspicious than ever, he had no power to do anything, except as to his own order of dismissal. So in April 1995, stating “it is more likely than not that the case was settled,” Potter filed an unusual document: his own motion to change his post-trial order from a dismissal after verdict to “dismissed as settled.” He set a hearing for May.

Quickly, the lawyers on both sides joined forces to file an objection with Kentucky’s appeals court to prevent Judge Potter’s hearing anything about what they considered a closed case. Paul Smith stated flatly that “there was no secret settlement…. This was a hard fought case.” Potter, meanwhile, now needed a lawyer himself. After Potter’s changed order had become public, Richard Hay, then President of the Kentucky Academy of Trial Attorneys, told reporters that if money had been traded for evidence, the trial was “a sham,” like “taking a dive in a boxing match.”

Potter read Hay’s comments, called him, and asked how outraged Hay was about the case. “Enough to represent you,” Hay replied. Together, Hay and Potter filed a brief that emphasized a “public silence [that] has been bought and paid for,” robbing millions who “want the truth.”

In June 1995, the appeals court ruled against Potter, saying he no longer had jurisdiction over the case. Potter appealed to the Kentucky Supreme Court. Before the fall Supreme Court hearing, lawyers for both sides finally acknowledged that they had indeed settled all money issues and had agreed to go through only the first phase of the trial no matter what the result. Still, they refused to disclose specifics.

Meanwhile, in Indianapolis, Lilly’s hometown, Paul Smith suddenly withdrew as lead counsel in a series of consolidated Prozac cases in federal court. He wouldn’t say whether he had settled his Indianapolis cases as part of the Fentress settlement, and the judge refused to ask. In their appeal to the Supreme Court, Potter and Hay de-emphasized the importance of public disclosure, and focused instead on the lawyers’ failure to be candid with the judge.

On May 23, 1996, the Kentucky Supreme Court decided the case of Hon. John W. Potter v. Eli Lilly unanimously in Judge Potter’s favor, citing the lawyers’ “serious lack of candor” and evidence of bad faith, abuse of process, even fraud. Although the court said that “the only result” of exposing the secret Fentress agreement “is that the truth will be revealed,” the decision was less a victory for open settlements, and more a demand that the judge be included in the secret.

Judge Potter, though, still saw the larger issue. Armed with Supreme Court authority to conduct an investigation and hold a hearing, Potter asked Deputy State Attorney General Ann Sheadel to investigate, giving her the power to subpoena documents and question witnesses under oath. Sheadel’s March 1997 report uncovered new twists to the story. A complex agreement did exist between Lilly and the plaintiffs, one so secret that it was never fully reduced to writing. All Sheadel could find was a written summary of the verbal agreement. No lawyer would admit preparing it, and no plaintiff was allowed to have it.

In exchange for the plaintiffs agreeing not to present the evidence of Lilly’s criminal conduct with Oraflex, Lilly had agreed to pay all plaintiffs, win or lose. Part of the agreement was that all of chief plaintiffs’ counsel Smith’s Prozac cases, including those in Indianapolis, were settled, and half his overall expenses paid by Lilly.

Judge Potter set a hearing to take sworn testimony on March 27, 1997. The hearing never happened.

On March 24, in a surprise move, attorneys for Lilly and the plaintiffs presented Judge Potter with a new stipulation and order in Fentress showing that the case was dismissed “as settled,” exactly what Potter had insisted on two years before. The judge signed the order. Three days later, Lilly’s attorney went before the appeals court to argue that any further proceedings were now moot. He also claimed that Potter had violated judicial ethics and was on a “vendetta” against Lilly. Potter recused himself, saying “the spotlight should be on what … is under the log, not the person trying to roll it over.”

The judge had succeeded in uncovering the collusive settlement. But of the approximately 160 active Prozac cases in December 1994, less than half remained.

Inexplicably, Fentress had received almost no attention in the national media, and the Kentucky court of appeal closed any further hearings to the public. Plaintiffs’ attorney Paul Smith was still practicing law in Dallas.

And the only thing that anyone ever learned about the amount of the settlement was the comment of a Louisville lawyer who represented one of the Fentress plaintiffs in a divorce. The amount, he said, was “tremendous.”

Adopted from pages 193-201 of The Moral Compass of the American Lawyer: Truth, Justice, Power, and Greed, © 1999, Richard Zitrin rzitrin@usfca.edu & Carol M. Langford langford@usfca.edu. All rights reserved.
This critically acclaimed book, about how the legal system allows lawyers to define “ethics” as what they can get away with rather than how they should behave, is written by two noted legal ethics professors who write frequently about ethics and morality in the legal profession.

 

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Glaxo Avandia Settlement [latest news]

Posted by shutah on January 25, 2011

Oh Dear!!  GSK in the spotlight a lot this week.

Reports said Monday thatGlaxoSmithKline is bound to face a multi-district litigation amounting to an estimated $3.4 billion against its anti-diabetes drug, Avandia.

According to the reports, a number of pending litigations against Avandia, an oral anti-diabetic agent which acts primarily by increasing insulin sensitivity, are filed in different states of America. Federal courts’ records show that more than 50,000 complaints were reported against the adverse effect of Avandia.

In 2010, Glaxo already settled an approximated 10,000 Avandia cases with an average settlement of $460 million. On Monday, another lawsuit was heard in the US District Court for the Eastern District of Pennslyvania. The lawsuit involves a claim filed by the relatives of James Buford, a diabetic patient who had been taking Avandia for 15 months, after the latter died of heart attack.

The incident proves a meta-analysis of 42 clinical studies, saying that daily intake of the anti-diabetes drug can relatively increase the risk of myocardial ischemic attack such as angina pectoris and myocardial infarction. Buford’slawyer argued that approximately three weeks after Buford started takingAvandia, the patient suffered symptoms that suggested a mild heart attack. Earlier this month, Glaxo announced that it was reserving $ 3.4 billion to cover the contingency loss brought by the Avandia lawsuits.

Meanwhile, a second trial against Avandia is scheduled to begin on March 28 this year, which involves a patient who allegedly used the drug and suffered congestive heart failure from Avandia. Experts said that Avandia has caused 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the United States from 1999 to 2006. Glaxo is currently under investigation by the US Department of Justice and several other state lawyers for potential fraud.

Wouldn’t it be great if the UK ‘Justice Department’ investigated Glaxo on behalf of all those, past and present, who suffer at the hands of their drug Seroxat/Paxil?

Posted in SSRIs | Tagged: , , , , , , , , | 2 Comments »

Possible legal action – Quote from 10 years ago

Posted by shutah on January 22, 2011

More than 60 people in Britain who say they have become hooked on the anti-depressant Seroxat – a drug in the Prozac class – are exploring the possibility of legal action against the pharmaceutical company which they claim failed to warn doctors that that it could create dependency.

Two firms of solicitors say they already have between 30 and 40 cases each. The people have come forward following news of a legal case in the US in which 35 people allege they suffered severe side-effects when they tried to stop taking the drug.

The Los Angeles law firm Baum, Hedlund, Aristei, Guilford and Schiavo – which filed its action against the British manufacturers GlaxoSmithKline in September – has since had more than 2,000 calls from people to tell of their addiction to the drug, which is known in the US as Paxil. The side-effects they suffer when they try to stop taking the tablets, include jolting pains in the head, vertigo, loss of coordination, abdominal discomfort, agitation and confusion.

The US lawyers have asked GSK to set up treatment centres to help people attempting to withdraw from Paxil/Seroxat. GSK say there is no reliable scientific evidence that the drug causes addiction or dependency.

The British solicitors, Ross & Co, based in the Wirral, and Hugh James Ford Simey of Cardiff, have been receiving calls from people who did not realise that others had suffered the same symptoms when they tried to cut down and come off the drug.

“We have been contacted by 30 to 40 people, most of whom have startlingly similar tales to tell of being put on the drug and being taken off it, and then going back on,” said Mark Harvey of Hugh James Ford Simey.

Mr Harvey said most people are told by the doctor that their problems are the symptoms of their depression re-appearing and do not suspect that the drug might be to blame. “This does have the smell of something that is a problem,” he said. “The patient information sheet says it is not addictive twice.”

Graham Ross, of Ross & Co, thinks that there is a good potential case against the manufacturers. “So far as evidence of dependency is concerned, that is pretty strong,” he said.

“I feel we can prove that. Failure to ensure that GPs are aware of that risk and therefore warn patients accordingly – there is plenty of evidence that they are not doing that.”

But group actions face particular problems in Britain. Attempts to litigate against the makers of benzodiazapines – including Valium, Librium and Ativan, which were also said not to be addictive when they were launched – collapsed because the legal aid granted to the claimants was used up in the lengthy investigations of the cases demanded by the companies before the action reached court.

Posted in GlaxoSmithKline, GSK, Paroxetine, Paxil, Seroxat, Seroxat Legal, SSRIs, Withdrawal | Tagged: , , , , , , , , | 1 Comment »