Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Mass. group sues Paxil drugmaker

By Ellen Barry
Globe Staff

A group of Massachusetts plaintiffs filed a class-action suit earlier this month against the maker of the blockbuster antidepressant Paxil, alleging that withdrawal from the drug brought on such ill effects as nausea, sweating, agitation, tremors, insomnia, dizziness, and the sensation of electric ”zaps” in the brain.

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

10/26/2002

Mass. group sues Paxil drugmaker

http://www.boston.com/dailyglobe2/299/nation/Mass_group_sues_Paxil_drugmaker+.shtml

By Ellen Barry
Globe Staff

To learn more, go to http://www.baumhedlundlaw.com.

A group of Massachusetts plaintiffs filed a class-action suit earlier this month against the maker of the blockbuster antidepressant Paxil, alleging that withdrawal from the drug brought on such ill effects as nausea, sweating, agitation, tremors, insomnia, dizziness, and the sensation of electric ”zaps” in the brain.

The lawsuit, filed Oct. 9 in Suffolk Superior Court, is part of a multipronged legal challenge to Paxil, taken by millions of people in the United States alone. It joins a nationwide class-action suit and nine other statewide lawsuits in asserting that GlaxoSmithKline, which manufactures Paxil, intentionally misled physicians and consumers about the drug’s ”addictive” qualities – an allegation that was denied yesterday by the company and the physicians who recommend it.

Paxil is one of a multibillion-dollar class of drugs – including Prozac and Zoloft – that relieve depression by building up levels of the neurotransmitter serotonin around nerve endings in the brain. Called selective serotonin reuptake inhibitors, or SSRIs, the drugs have succeeded in large part because they lack the serious side effects of earlier treatments for depression and anxiety, including habituation. And although previous lawsuits have alleged that SSRIs can spur violence, they have had little effect on the drugs’ enormous popularity.

Sales of Paxil, which received FDA approval in 1992, lagged for years behind competitors Prozac and Zoloft, but have benefited from the expiration of Prozac’s patent and by its increasing use for anxiety disorders. Last year it was GlaxoSmithKline’s top-selling drug, netting the company $2.7 billion, a spokesman said.

The company acknowledges that there are side effects to the ”discontinuation” of Paxil, including dizziness and occasionally abnormal dreaming and the sensation of electric shocks, but most last no longer than two weeks, said spokeswoman Mary Anne Rhyne. Rhyne added that ”any claims that Paxil is addictive are without foundation.”

But Janelle Leonard, a Bradford schoolteacher, said neither she nor her doctor were prepared for what happened when she decided to stop taking Paxil. Only when she accessed Internet chatrooms – where dozens of people compared their experiences upon going off Paxil – did she realize where her disabling symptoms were coming from.

”Nobody had told me it was habit-forming,” said Leonard, who is 30. ”I ended up really ill … I was bedridden, sick. I had insomnia. I was paranoid, and I was still sick to my stomach. I had diarrhea. I couldn’t leave the house.”
So far, 6,000 would-be plaintiffs have contacted the Los Angeles law firm that filed the nationwide lawsuit, and 1,000 have been confirmed as plaintiffs, said Karen Barth, lead counsel for Baum, Hedlund, Aristei, Guilford & Schiavo. The nationwide lawsuit will reach the certification phase on Nov. 18, and attorneys plan to file lawsuits in all 50 states in case the nationwide suit does not go forward, she said.

The suit had resulted in an injuction against GlaxoSmithKline not to advertise Paxil as ”nonhabit-forming.” The judge rescinded her order Oct. 11, after the Food and Drug Adminsitration determined that the ads were not misleading.
Barth’s law firm has brought previous class-action suits on behalf of the families of patients who committed suicide while taking Paxil, Prozac, or Zoloft – but the suicides have been so rare that they have had little ripple effect on the public, she said.

A lawsuit based on the effects of withdrawal may have more traction, because the experience is far more widespread, said Dr. Joseph Glenmullen, a Harvard University psychiatrist and author of ”Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and other Antidepressants with Safe, Effective Alternatives. ”

”You have countless individuals who have terrible experiences. Too many doctors have seen this, it’s too undeniable. Too many patients are very, very upset by it,” Glenmullen said.

But several psychopharmacologists interviewed said they rejected offhand the idea that SSRIs are addictive. Although the brain does adapt to SSRIs, the term ”addiction” suggests craving, intoxication, or an increased tolerance that requires ever-higher doses, none of which have been documented with Paxil, said Dr. Alexander Bodkin, a research psychiatrist at McLean Hospital.

”Insulin is habit-forming. Digitalis is habit-forming,” said Dr. William Appleton of Harvard University. ”Exercise is habit-forming, but no one ever brings a class-action suit against that.”

But perhaps, Appleton said, the lawsuit is just part of a predictable backlash against SSRIs, which were greeted as wonder drugs a decade ago.
”One of the interesting things about drugs is they’re a little bit like shopping centers,” said Appleton, author of ”Prozac and the New Antidepressants. ” ”They come in clean and brand-new and full of hope,” he said. ”They go out old and tired and dirty.”

This story ran on page A3 of the Boston Globe on 10/26/2002.
© Copyright 2002 Globe Newspaper Company.

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Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Judge: Paxil ads can’t say it isn’t habit-forming

LOS ANGELES (AP)

A federal judge ordered the maker of the popular anti-depressant Paxil to stop all television commercials nationwide that say the drug is not habit-forming.

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

8/20/2002

Judge: Paxil ads can’t say it isn’t habit-forming

http://www.usatoday.com/news/health/2002-08-20-paxil-ads_x.htm

LOS ANGELES (AP)

To learn more, go to http://www.baumhedlundlaw.com.

A federal judge ordered the maker of the popular anti-depressant Paxil to stop all television commercials nationwide that say the drug is not habit-forming.

The ruling against GlaxoSmithKline comes about a year after a class-action lawsuit was filed on behalf of 35 patients who said they suffered withdrawal symptoms such as nausea, fever, and “electric zaps” to their bodies.

U.S. District Judge Mariana Pfaelzer found that in other countries, labels on the drug warn of adverse reactions when use of the drug is discontinued.

The commercials were “misleading and created inaccurate expectations about the ease of withdrawal from the drug,” Pfaelzer ruled Monday.

Company attorneys are appealing.

“The U.S. Food and Drug Administration — and not the courts — has the expertise and responsibility for reviewing and regulating pharmaceutical ads,” David Stout, president of U.S. Pharmaceuticals at Paxil’s producers, GlaxoSmithKline, said in a statement.

“The Paxil television ad was submitted for FDA review prior to use, and the agency raised no objections to the language at issue,” Stout said.

The plaintiffs’ lead attorney, Karen Barth, said GlaxoSmithKline changed its labeling on Dec. 14 but continued to run commercials and distribute brochures saying Paxil “may cause mild, usually temporary side effects in some individuals.”
Plaintiffs’ attorneys said a hearing was set for Oct. 7 to decide whether the lawsuit should be converted to a nationwide class-action.

The ads also said “Paxil has been studied both in short-term and long-term use and is not associated with dependence and addiction.”

Surging U.S. sales of Paxil and the asthma drug Advair led a 15 % increase in second-quarter profit for London-based GlaxoSmithKline. Global sales of Paxil grew 29%.

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Donald Schell vs. SmithKline Beecham

Donald Schell vs. SmithKline Beecham

Glaxo Raises White Flag, Settles Paxil Trial Appeal, and Pays Up

Rick Giombetti

In a bombshell comparable to the recent belated revelation of the disaster that hormone replacement therapy has been, I have learned that Paxil manufacturer Glaxo-Smith-Kline (GSK) has secretly settled its appeal of the ruling in the Paxil trial last year.
Donald Schell vs. SmithKline Beecham

7/23/2002

Glaxo Raises White Flag, Settles Paxil Trial Appeal, and Pays Up

http://www.counterpunch.org/giombetti0723.html

Rick Giombetti

In a bombshell comparable to the recent belated revelation of the disaster that hormone replacement therapy has been, I have learned that Paxil manufacturer Glaxo-Smith-Kline (GSK) has secretly settled its appeal of the ruling in the Paxil trial last year.

GSK was sued in federal district court in Cheyenne by family members of Donald Schell, the Gillette, Wyoming man who killed his wife, daughter, granddaughter and then himself on February 13, 1998 after two days on the pharmaceutical giant’s anti-anxiety/depression drug Paxil. The plaintiff’s position was that Paxil was the primary cause of Donald Schell’s actions in the murder-suicide. The jury agreed and the judge in the trial rejected GSK’s challenge of the validity of the scientific data presented to the jury by the plaintiff’s. As a public service I will be publishing the crucial expert testimony and cross examination of British psychiatrist and psychiatric historian David Healy soon.

GSK appealed the verdict in the case in Denver, but recently gave up, I have been told by Healy. The deal in the appeal settlement GSK made with the plaintiff’s calls for the company getting all of its documents back, and a set of confidentiality statements from the plaintiffs side to not release anymore details of the case not already in the public domain. This is an important development in the history of psychiatric medicine. The jury verdict forced GSK to cave in to the demands of the Medicines Control Agency, the British government agency that regulates prescription drugs, that it place a suicide warning on Paxil. GSK has had to place a suicide warning on Paxil in Britain for about a year now. Now the question remains will this same warning ever make it over to this side of the Atlantic, with as much publicity as the hormone replacement story has gotten? Not likely, I believe, but I hope I am wrong.

Even though there isn’t a widely publicized suicide warning being given for Paxil, or any other drug in its class, known as “Selective Serotonin Reuptake Inhibitors,” or “SSRI’s,” it’s not like there is a complete information black out about these newer generation psychiatric drugs in consumer prescription drug guides.

For example, in the recently published 10th edition of The Pill Book, it warns patients taking SSRI’s (i.e. Celexa, Luvox, Paxil, Prozac and Zoloft) that “The possibility of suicide exists in severely depressed patients and may be present until the condition is significantly improved. Severely depressed people should be allowed to carry only small quantities of SSRI’s to limit the risk of overdose.” The term “overdose” can just as easily be read as “killing themselves.” Also, “As many as 1/3 of people taking an SSRI experience anxiety, sleeplessness and nervousness.” In other words all the symptoms that can push a depressed person over the edge and into a suicide attempt. Finally, the recently published 5th edition of The Physicians’ Desk Reference Pocket Guide to Prescription Drugs warns patients considering taking the SSRI known as Zoloft “May also cause mental or emotional symptoms such as: Abnormal dreams or thoughts, aggressiveness, exaggerated feeling well-being, depersonalization (“unreal” feeling), hallucinations, impaired concentration, memory loss, paranoia, rapid mood shifts, SUICIDAL THOUGHTS, tooth-grinding, WORSENED DEPRESSION (emphasis is the authors).”

Now why on Earth are pharmaceutical companies allowed to get away with marketing these drugs as “anti-depressants,” or “anti-anxiety” agents when they can produce in patients exactly what they are supposed to treat at such high rates? This is the deeper question about the mass marketing of these drugs the mass media is simply avoiding by a combination of cowardice, laziness and just outright ignorance in reporting on these issues.

Rick Giombetti is a freelance writer who. lives in Seattle. Visit his website at: http://rjgiombetti.blogspot.com/. He can be reached at: rickjgio@speakeasy.net

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Amby Cole vs. Eli Lilly

Eli LillyAmby Cole vs. Eli Lilly

Lilly faces another Prozac lawsuit
Tennessee widow says husband hanged himself 13 days after drug was prescribed.

By Jeff Swiatek
jeff.swiatek@indystar.com
The Indianapolis Star

The lawsuit, filed last week in U.S. District Court for the Western District of Tennessee, is the latest in more than 200 lawsuits against Prozac maker Eli Lilly and Co.  since the early 1990s.

Amby Cole vs. Eli Lilly

6/25/2002

Lilly faces another Prozac lawsuit
Tennessee widow says husband hanged himself 13 days after drug was prescribed.

http://www.starnews.com/article.php?prozac25.html,business

By Jeff Swiatek
jeff.swiatek@indystar.com
The Indianapolis Star

To read the lawsuit go to: http://www.justiceseekers.com/files/NLPP00000/060.PDF

A Tennessee woman charges that Prozac caused her husband to hang himself 13 days after being prescribed the drug by his cardiologist for chest pain and loss of weight.

The lawsuit, filed last week in U.S. District Court for the Western District of Tennessee, is the latest in more than 200 lawsuits against Prozac maker Eli Lilly and Co. since the early 1990s.

Plaintiff Amby Cole, joined by her two children, says in the lawsuit that Milton Cole’s death in June 2001 “fits the signature pattern” of suicide caused by the Prozac family of antidepressants.

Cole wasn’t seriously depressed or suicidal and “became nervous, jittery and aggravated” after taking Prozac, the lawsuit says.

The wrongful-death and product-liability lawsuit charges that Prozac causes violent side effects that are dose-related, but Lilly “chose not to pursue” a lower-dose Prozac and put a once-weekly version on the market only last year.

“Lilly did not start marketing a once-a-week Prozac until its patent rights had been adjudicated as over and it was threatened in the marketplace with a generic formulation,” the lawsuit says.

Lilly has always maintained that Prozac’s side effects don’t include suicidal or violent thoughts. In the only two Prozac civil suits to come to trial, juries have sided with Lilly.

Attorneys for plaintiffs in the latest suit are J. Houston Gordon of Covington, Tenn., and Andy Vickery of Houston. Call Jeff Swiatek at 1-317-444-6483.

Copyright 2002 The Indianapolis Star

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Healy vs. University of Toronto

Healy vs. University of Toronto

Scientist stands by views of drugs after settling lawsuit with U of T

A prominent British psychiatrist who found his offer of a post at a University of Toronto teaching hospital rescinded after he criticized a popular form of antidepressants says he stands by his controversial view of the drugs
Healy vs. University of Toronto

5/24/2002

Scientist stands by views of drugs after settling lawsuit with U of T

http://www.canoe.ca/NationalTicker/CANOE-wire.HEALTH-Healy.html

A prominent British psychiatrist who found his offer of a post at a University of Toronto teaching hospital rescinded after he criticized a popular form of antidepressants says he stands by his controversial view of the drugs. Dr. David Healy said he continues to believe that Prozac and other drugs of its class — known as selective serotonin reuptake inhibitors — can be addictive and cause suicidal tendencies in some people.

“My views haven’t changed at all,” said Healy, who recently reached an out-of-court settlement with the university and the hospital, the Centre for Mental Health and Addiction.

“I think the SSRIs can make people suicidal. I think you can get physically dependent on them and can have a withdrawal problem. You may not be able to stop. Full stop.”

Healy, who teaches at the University of Wales, made the comments at a news conference Thursday, his first since he settled his $9.4-million lawsuit against the university and hospital.

The settlement, many of the terms of which remain undisclosed, has resulted in the university offering Healy a visiting professorship which will see him spend a week a year at the University of Toronto for several years, beginning next spring.

Healy launched the lawsuit after the university withdrew in November 2000 a five-year job offer to run the centre’s mood and anxiety program.

“I bore no ill will towards them,” he insisted Thursday. “And clearly the process going on too violently or too long wouldn’t do them any good, wouldn’t do me any good.”

That’s because Healy has other issues he wants to bring to the public’s attention, such as the way drug companies selectively release safety and efficacy data on drugs and use ghost writers to author articles on their drugs for submission to scientific journals.

“And there’s a real hazard that I go on about these things and the legal action was still there, people would say: “Well, we don’t need to pay any heed to that. He’s just saying this because he’s trying to sue the University of Toronto.”

“If I want people to listen to some of the other things, it seemed to be a good idea, (especially) when people on the other side (the university) were being reasonable and weren’t awful people.

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Hassett vs. Leeds General Infirmary (LGI)

Hassett vs. Leeds General Infirmary (LGI)

Man Claims he Became Psychotic on Accutane

Luke Hassett, 22, who was diagnosed as being a paranoid schizophrenic after taking Roaccutane, is to sue Leeds General Infirmary and the clinician who prescribed him the drug.

Hassett vs. Leeds General Infirmary (LGI)

4/29/2002

Man Claims he Became Psychotic on Accutane

http://news.independent.co.uk/uk/health/story.jsp?story=289945

A patient is suing a hospital for giving him a controversial acne drug similar to the one prescribed to an American teenager who flew an aeroplane into the 28th floor of a skyscraper in a copycat 11 September attack.

Luke Hassett, 22, who was diagnosed as being a paranoid schizophrenic after taking Roaccutane, is to sue Leeds General Infirmary and the clinician who prescribed him the drug. Mr Hassett, one of hundreds of UK patients who claim to have suffered long-term adverse side-effects from taking the drug, decided to act after it was confirmed that Charles Bishop, the 15-year-old who flew into the Bank of America Plaza in Tampa, Florida, in January, had been taking Accutane, the American brand.

Last week lawyers for the Bishop family launched a $70m (£48m) law suit against Roche, makers of the drug, alleging that the medication was responsible for causing their son to commit suicide.

Labelling on Roaccutane in the UK and Accutane in the US warns that the drug can cause “depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide”. Other side-effects include painful joints, headaches and hair loss. The drug is extremely effective in many cases, but it has been linked to at least 138 suicides and many more suicide attempts.

Mr Hassett, who now lives in a psychiatric unit in Trafford General Hospital, Manchester, had no history of mental problems before he was prescribed Roaccutane for what he claims was mild acne in 1999. Subsequently, he became psychotic and had to be sectioned under the Mental Health Act. He is now on anti-psychotic medication and is allowed home for just four hours each day.

According to a US Food and Drugs Administration memo on Accutane issued in 1990: “The magnitude of injury and death has been great and permanent, with 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane-related birth defects.” In the UK, where tens of thousands of young people have been treated, there have been around 1,200 “adverse drug reactions” reported to the Medicines Control Agency, including 15 suicides.

Mr Hassett is being backed by Roaccutane action groups in the UK and Ireland, which have around 2,000 members reporting long-term adverse side-effects from taking the drug. They believe a court action will help them gain access to early research into Roaccutane.

The dermatological unit at Leeds has been at the forefront of research into Roaccutane. Trials there, which Roche helped to fund, were instrumental in the drug being given a licence in 1983. However, that licence states that it may be prescribed only for severe forms of acne.

But, in the UK, inquiries by The Independent have established that Roaccutane is routinely prescribed for use beyond the purpose for which it was licensed in 1983. Then, it was approved for “cystic and conglobate acne and severe acne which has failed to respond to an adequate course of antibiotics”.

Between 1983 and 1986 at Leeds General Infirmary (LGI) dermatological unit, where Mr Hassett was treated, 79 per cent of prescriptions for Roaccutane went to people suffering from severe acne. By 1995, however, according to a paper published by the Leeds team, 74 per cent of Roaccutane prescriptions were being given to the LGI patients with only mild or moderate forms of the condition and only 16 per cent of the total prescribed were severe sufferers.

Campaigners say that prescribing of the drug should return to the limitations laid down in its licence until more research is carried out.
The hospital in Leeds said it could not comment while under threat of legal action. A spokeswoman for Roche said there was no evidence of any side-effects attributable to the drug.

“We have had external scientists and internal scientists look into the side-effects and we have found no causal relationship between Roaccutane and any psychiatric events, from depression to suicide.”

Roche said many of the people likely to take Roaccutane–emotional adolescents with low self-esteem caused by acne–were more likely to become depressed than the average youngster.

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Culberson vs. Pfizer

Culberson vs. Pfizer

Jury: Pfizer Drug Did Not Cause Woman’s Death

Reuters

A jury on Monday found that the prescription drug Rezulin did not contribute to the death of a diabetic woman who died in January 2000, Pfizer Inc., whose subsidiary Warner-Lambert made the drug, said.
Culberson vs. Pfizer

12/17/2001

Jury: Pfizer Drug Did Not Cause Woman’s Death

http://www.reuters.com/news_article.jhtml?type=sciencenews&StoryID=461150

Reuters

The last thing that diabetics need is a drug that causes liver failure, yet that is precisely the kind of drug the FDA approved for diabetes patients.

“According to the FDA, an estimated 1.9 million patients with diabetes were prescribed Rezulin, with fewer than 100 reported acute liver failures leading to death or transplant as of the drug’s withdrawal in March 2000 following the introduction of two newer medicines of the same class.”

This case against this drug demonstrates that the public is unprotected from deadly, FDA-approved drugs. The FDA is no longer rigorous in its new speedy drug evaluation an approval process. As was revealed in the Pulitzer Prize winning series by David Willman in The Los Angeles Times, [1998-2001], the FDA has been approving harmful, even deadly drugs in rapid succession.

The case demonstrates how difficult it is for individuals to successfully sue the Goliath pharmaceutical industry. Is this the best service our government can provide to the citizens of this country?

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Contact: Vera Hassner Sharav Tel: 212-595-8974 veracare@rcn.com

A jury on Monday found that the prescription drug Rezulin did not contribute to the death of a diabetic woman who died in January 2000, Pfizer Inc., whose subsidiary Warner-Lambert made the drug, said.

The verdict, in District Court in Harris County, was the first jury decision in litigation involving thousands of claims against the diabetes drug Rezulin, including current trials in Liberty, Missouri, and Corpus Christi, Texas.

The drug, now withdrawn, has been blamed in 63 liver failure deaths worldwide for the period from 1997 to 2000 during which it was sold.

Norma Culberson, 58, had diabetes and took Rezulin, approved by the Food and Drug Administration in 1997 for the treatment of Type II diabetes, which affects about 15 million Americans, starting in late 1997 for a period of about two years, according to trial testimony.

Lawyers for Culberson’s daughters, who were seeking $25 million in damages, argued that the drug damaged her liver, leading to a coma and her eventual death in January 2000.

But Pfizer, the world’s largest drugmaker, argued that the risks from a drug like Rezulin had to be weighed against the threat posed by a disease like diabetes.

“Insulin has 395 deaths in every 100,000 patients,” attorney Jack Urquhart he told jurors. “Why do we tolerate 395 deaths in every 100,000 with insulin? There is no replacement right now,” he said.

Culberson’s death certificate listed kidney or renal failure due to diabetes as cause of death, with liver damage as a secondary factor.

Paul Miller, executive vice president and general counsel for Pfizer said in a statement “We are pleased … that the jury in Houston differentiated between the kidney failure which was the immediate cause of Norma Culberson’s death and the positive role Rezulin played in treating her diabetes.”

Pfizer, which affirmed on Monday it expects earnings to grow at least 20 percent next year, closed up $0.89 or 2.26 percent to $40.33.

“From June 2000, when Pfizer acquired Warner-Lambert,” Miller added, “we have clearly stated that Pfizer is committed to the fair and reasonable resolution, without litigation, of claims arising from those very rare injuries experienced by Rezulin patients.

“We have also said that, in cases where the alleged harm has not been demonstrably caused by Rezulin or where the plaintiff makes excessive demands, Pfizer will go to trial.” Other cases have been settled out of court with undisclosed terms.

The trial began on Nov. 27.

According to the FDA, an estimated 1.9 million patients with diabetes were prescribed Rezulin, with fewer than 100 reported acute liver failures leading to death or transplant as of the drug’s withdrawal in March 2000 following the introduction of two newer medicines of the same class.

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Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Anti-depressant ‘addicts’ threaten legal case

Sarah Boseley, Health Editor
The Guardian (UK)

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.
Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

12/10/2001

Anti-depressant ‘addicts’ threaten legal case

http://www.guardian.co.uk/Print/0,3858,4316527,00.html

Sarah Boseley, Health Editor
The Guardian (UK)

The Guardian (U.K.) reports that British lawyers are considering legal action similar to the actions taken in the U.S. against GlaxoSmithKline, the British manufacturers of the antidepressant drug, Paxil.

The issues involve patients who claim they have not been warned about severe withdrawal symptoms from antidepressant drugs, such as Prozac and 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.”

Since filing two class action lawsuits (August 24, 2001 and Sept 14, 2001), the Los Angeles law firm, Baum, Hedlund, Aristei, Guilford and Schiavo, has received more than 2,000 calls from people to tell of their addiction to Paxil.

If antidepressant drugs such as Prozac and Paxil are addictive, why has the FDA not required a warning on the label of these drugs? If they are addictive for adults, what are they doing to America’s children–even infants–who are prescribed psychotropic drugs?

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Contact: Vera Hassner Sharav Tel: 212-595-8974 FAX: 212-595-9086 veracare@rcn.com

To learn more, go to http://www.baumhedlundlaw.com.

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.

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Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Suit: Antidepressant is Addictive

A lawsuit contends the manufacturer of the popular anti-depressant Paxil concealed evidence that the drug can be addictive

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

8/25/2001

Suit: Antidepressant is Addictive

http://dailynews.yahoo.com/htx/ap/20010825/us/paxil_suit_1.html

To learn more, go to http://www.baumhedlundlaw.com

A lawsuit contends the manufacturer of the popular anti-depressant Paxil concealed evidence that the drug can be addictive.

The lawsuit was filed Friday on behalf of 35 people from around the country who say they suffered symptoms ranging from electric-like shocks to suicidal thoughts after discontinuing use of the drug.

The lawsuit, which seeks class-action status and unspecified damages, says GlaxoSmithkline PLC concealed the possibility of physical and psychological withdrawal symptoms from the drug. It alleges fraud, deceit, negligence, liability, and breach of warranty.

There was no immediate comment from the British-based company. Calls to its U.S. offices after business hours Friday were not returned.

Introduced on the U.S. market in 1992, Paxil is the country’s second-largest selling anti-depressant.

Paul Domb, 42, of Miami, said that after he stopped taking Paxil last year, he suffered from convulsions, night sweats, and suicidal thoughts for about six weeks.

He said he thought the problems had to do with recent heart surgery, but after researching his symptoms he concluded they were caused by his withdrawal from Paxil.

“I stopped taking this drug … and it destroyed me. It almost killed me,” he said.

In June, a Wyoming jury awarded $8 million in damages to the family of a man after determining that Paxil caused him to kill his wife, daughter and granddaughter before committing suicide.

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Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Victims File Lawsuit over Severe Withdrawal Reactions from the Antidepressant–PaxilFirst Class Action of its Kind Against an Antidepressant Maker

FOR IMMEDIATE RELEASE
Baum, Hedlund, Aristei, Guilford & Schiavo 12100 Wilshire Blvd., Ste. 950 Los Angeles, CA 90025

Contact: Robin McCall, Media Relations Day: (800) 827-0087 or (310) 207-3233 Night: (818) 558-5964 Email: RMcCall@BaumHedlundLaw.com

35 people who have suffered from severe withdrawal reactions as a result of taking the antidepressant Paxil, filed a class action complaint today in California Superior Court, LA County, against Glaxo Smithkline Corporation (GSK), formerly known as SmithKline Beecham.

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

8/24/2001

Victims File Lawsuit over Severe Withdrawal Reactions from the Antidepressant–PaxilFirst Class Action of its Kind Against an Antidepressant Maker

http://www.baumhedlundlaw.com

FOR IMMEDIATE RELEASE
Baum, Hedlund, Aristei, Guilford & Schiavo 12100 Wilshire Blvd., Ste. 950 Los Angeles, CA 90025

Contact: Robin McCall, Media Relations Day: (800) 827-0087 or (310) 207-3233 Night: (818) 558-5964 Email: RMcCall@BaumHedlundLaw.com

The lawsuit against the makers of Paxil for the potentially disabling and deadly withdrawal effects associated with Paxil has now been officially filed. This is clearly a suit that should be filed against the makers of all of these serotonergic antidepressants and DEFINITELY one that should have been filed against the makers of the serotonergic diet pills, Fen-Phen and Redux. What a crime it was to drop all of those Fen-Phen and Redux users off “cold turkey” when they were withdrawn forcing so many onto the serotonergic antidepressants creating additional damage and leading them into an additional serotonin nightmare. Why were patients not allowed to withdraw gradually?

All of these companies who put these extremely addictive drugs on the market with no warning of the addictive properties should be held accountable for the results of that lack of warning. The withdrawal from these serotonergic antidepressants, according to the World Health Organization, appears to be even worse than the benzodiazaphines – which already have one of the worst reputations for serious withdrawal. [Use the search engine to find our report on the World Health Organization’s statement that came out this spring.]

When we know that Ecstasy withdrawal can plunge users into the depths of depression we should not be the least bit surprised to learn that any of its chemical cohorts can do the same in withdrawal. All are serotonergic agents -Ecstasy, Prozac, LSD, Zoloft, PCP, Paxil, etc. – with similar effects due to the increase of serotonin and decrease of serotonin metabolism that they produce.

When one understands the steroid effect brought on by an increase in serotonin [one 30mg dose of Prozac DOUBLES cortisol levels!], it is not difficult to see that the initiation of use of these drugs should be very gradual as should the discontinuation be a very gradual process.

Contact information for the attorneys and links to additional information on the lawsuit is all listed in the press release that follows.

Ann Blake-TracyExecutive Director, International Coalition For Drug AwarenessAuthor of Prozac: Panacea or Pandora? – Our Serotonin Nightmare ()

To learn more, go to http://www.baumhedlundlaw.com.

35 people who have suffered from severe withdrawal reactions as a result of taking the antidepressant Paxil, filed a class action complaint today in California Superior Court, LA County, against Glaxo Smithkline Corporation (GSK), formerly known as SmithKline Beecham. This group represents thousands of Paxil users who have allegedly suffered from withdrawal reactions and dependency/withdrawal syndrome. They come from all walks of life (e.g., Lt. Col in the U.S. Air Force; former star athlete; web-designer; children; bank fraud investigator and many more) and reside throughout the United States. Each has experienced similar withdrawal reactions and problems such as: jolting electric “zaps,” dizziness, light-headedness, vertigo, in-coordination, gait disturbances, sweating, extreme nausea, vomiting, high fever, abdominal discomfort, flu symptoms, anorexia, diarrhea, agitation, tremulousness, irritability, aggression, sleep disturbance, nightmares, tremor, confusion, memory and concentration difficulties, lethargy, malaise, weakness, fatigue, paraesthesias, ataxia, and/or myalgia.

Paxil was introduced into the U.S. market on December 29, 1992, and is a well known antidepressant medication in the same class as Zoloft and Prozac (selective serotonin reuptake inhibitors or “SSRI’s”). Paxil is approved for marketing in the United States for conditions such as depression, obsessive compulsive disorder, panic disorder, and “social anxiety disorder.”

Complaint Allegations: 1) The complaint alleges Paxil can cause some people who take it to experience serious and unexpected withdrawal reactions. Neither the patients nor the physicians expect these withdrawal reactions because, according to the complaint, the manufacturer has deliberately failed to warn of their potential occurrence. Both physician and patient unwittingly commit to Paxil without knowing the drug’s addictive traits. None of the named plaintiffs were ever informed before starting Paxil that it was addictive, induced dependency, or created withdrawal reactions when dosage was reduced or terminated.

2) Paxil creates both physical and psychological dependency because GSK has suppressed the information about the severe withdrawal reactions of its drug, many patients and their physicians are fooled into thinking that the withdrawal reactions are caused by another condition (such as relapse), thus prompting further incorrect and unnecessary medical treatment, including increased dosages of Paxil. 3) GSK has known for years the distinct characteristics of Paxil which make it prone to cause withdrawal reactions when discontinued. While the medical community has acknowledged the potential for all SSRI’s to cause dependency/withdrawal syndrome, Paxil is, by far, the worst. According to World Health Organization (“WHO”) data obtained by the plaintiff class members, Paxil has the highest incidence rate of withdrawal adverse experiences of any antidepressant drug in the world. “Even despite our clients’ extreme difficulties caused by this drug, some remain on Paxil today because they are “hooked” and fear they cannot get off the drug,” says attorney Mary Schiavo.

The complaint charges include fraud and deceit, negligence, strict liability, breach of warranty and implied warranty which can be seen on the complaint.

The lawsuit was filed by Karen Barth (in association with Mary Schiavo) of Baum, Hedlund, Aristei, Guilford & Schiavo in Los Angeles and Donald Farber of San Rafael, California.

The attorneys have stated, “The scariest part about this is that there are people out there trying to get off this drug who are experiencing these horrible withdrawal reactions. They think its because of something wrong with them, when it’s really the Paxil – – and then they take even more and further exacerbate the problem!”

Fact Sheet is available on the web along with the complaint at www.baumhedlundlaw.com

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