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http://www.aboutlawsuits.com/lawsuit-fosamax-jaw-problems-new-jersey-15685/

Published: January 20th, 2011

Lawsuit Over Fosamax Jaw Problems Goes to Trial in New Jersey State Court

The fourth Fosamax trial in the United States is set to begin this week in New Jersey state court, involving a lawsuit filed by a Florida woman who alleges that she developed jaw necrosis from the popular osteoporosis drug.

Jury selection began on Wednesday in the Superior Court for Atlantic County, New Jersey, in a Fosamax lawsuit filed by 75 year-old Carolyn Hester, who was diagnosed with a painful and debilitating jawbone disease, known as osteonecrosis of the jaw (ONJ), after being prescribed Fosamax in 1999.

The trial will be the fourth lawsuit over Fosamax jaw problems to reach a jury in the United States, with the other three occurring in federal court.

Fosamax (alendronate sodium) is a member of a class of drugs known as bisphosphonates, which have been associated with decay of the jawbone when taken long-term or at high doses. With a very long half-life of 10 years,lawsuits over Fosamax allege that dose accumulation over time increases the risk of jaw necrosis, which causes portions of the jaw bone to die and may result in the need for surgery to remove portions of the jaw.

Approved by the FDA in October 1995, Fosamax has been used by more than 20 million people and generated annual sales of more than $3 billion a year for Merck before the medication became available as a generic.

There are more than 1,000 Fosamax lawsuits pending in state and federal courts across the country against Merck, including about 400 that have been centralized for “mass tort” treatment in New Jersey state court before Judge Carol E. Higbee in Atlantic County.

The New Jersey Fosamax trial will be the first case heard by a jury at the state court level. The previous three trials took place in federal court, where hundreds of lawsuits have been consolidated as part of a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of New York before Judge John F. Keenan.

These early trials, known as Fosamax bellwether lawsuits, are used as test cases to help the parties measure how juries are likely to respond to evidence, witness testimony and arguments that will be presented throughout other cases in the Fosamax litigation. The cases are selected so that the results may help the parties reach a potential Fosamax settlement agreement without having individual trials in hundreds of different courts.

The first bellwether trial, involving a lawsuit brought by Shirley Boles, ended in a mistrial in September 2009, after jurors failed to come to an agreement about whether Fosamax caused ONJ suffered by the plaintiff. Boles’ case was later retried and resulted in an $8 million verdict that Keenan ruled was excessive. Boles has elected to have another trial rather than accepting Keenan’s reduced award of $1.5 million.

Two other bellwether lawsuits, involving claims brought by Judith Graves and Louise Maley, have resulted in defense verdicts.

In a press release issued by Merck officials this week, the drug maker indicated that they intend to argue that Hester’s jaw problems were not from Fosamax, but were a result of other causes, including a history of dental treatments and steroid medications.

In addition to jaw necrosis lawsuits, Merck also faces a growing number of Fosamax femur fracture lawsuits that have been filed by individuals who have suffered a fractured femur after a low-impact or no-impact fall. In October, the FDA issued an alert to warn doctors and consumers about a potential link between Fosamax and femur fractures, requiring new information to be added to the warning label for Fosamax and other similar medications.

 

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Multaq Liver Problems Reported by FDA

According to an FDA Safety Announcement issued this afternoon, the potential side effects of Multaq, a prescription drug used to treat abnormal heart rhythm, may be linked to an increased risk of acute liver failure or other liver problems.

>>FDA WARNING: Severe Liver Injury with Multaq

Multaq (dronedaron) is a new medication that was just approved in July 2009. It is used to treat patients who have had an abnormal heart rhythm during the past six months, such as atrial fibrillation or atrial flutter. Although it has only been on the market for a short period of time, nearly 150,000 people in the United States filled a prescription for the heart drug as of October 2010.

The FDA has received a number of reports of heptocellular liver injury and hepatic failure among users of Multaq, including at least two cases of acute liver failure from Multaq that resulted in the need for a liver transplant.

The two cases of Multaq liver failure occurred within the first six months of use (4.5 months and 6 months). The patients were both females approximately 70 years old with previously normal hepatic serum enzymes.

New warnings and information will be added to the label about the potential risk of a Multaq liver injury, and the FDA is continuing to review reports of other Multaq problems submitted through their Adverse Event Reporting System.

Patients taking Multaq have been advised to speak with their doctor about any concerns about Multaq side effects, but the medication should not be stopped unless under a doctor’s direction.

Potential signs of liver problems from Multaq could include:

  • Anorexia
  • Nausea
  • Vomiting
  • Fever
  • Malaise
  • Fatigue
  • Right upper quadrant pain
  • Jaundice
  • Dark urine
  • Itching

MULTAQ LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are reviewing this new information and evaluating the possibility that individuals diagnosed with liver failure or another liver injury may be entitled to compensation through a Multaq lawsuit. To submit information about liver problems on Multaq experienced by yourself, a friend or family member, request a free consultation and claim evaluation.


  1. FDA warns of liver damage reports with Sanofi drug - USATODAY.com

    Jan 14, 2011 ... The Food and Drug Administration said Friday it has received several reports of liver damage with Multaq tablets, including two cases in ...
    www.usatoday.com/yourlife/health/.../2011-01-14-Multaq_N.htm - Cached
  2. Multaq Recall Lawsuit and Attorneys for class action Multaq settlments

    Jan 20, 2011 ... Again; if you've had any liver problems from Multaq, please contact ourMultaq Lawyers today, a possible lawsuit may take place, ...
    www.resource4thepeople.com/defectivedrugs/multaq.html - Cached
  3. [PDF] 

    Dear Healthcare Provider Letter - MULTAQ® (dronedarone)

    File Format: PDF/Adobe Acrobat
    Jan 14, 2011 ... Sanofi-aventis would like to inform you of several cases of hepatocellular liverinjury and hepatic failure in patients receiving Multaq ...
    www.multaq.com/docs/pdf/MultaqDHCPLetterJan2011.pdf
  4. Multaq Liver Problems Reported by FDA | Legal News & Updates Blog ...

    Jan 14, 2011 ... According to an FDA Safety Announcement issued this afternoon, the potential side effects of Multaq, a prescription drug used to treat ...
    www.youhavealawyer.com/blog/2011/01/.../multaq-liver-problems/ - Cached -Block all youhavealawyer.com results
  5. Two Patients On Sanofi's Multaq Have Liver Failure - FoxBusiness.com

    Jan 14, 2011 ... PARIS -(Dow Jones)- French pharmaceutical giant Sanofi-Aventis SA (SAN.FR) Friday said two patients treated with its Multaq atrial ...
    www.foxbusiness.com/.../01/.../patients-sanofis-multaq-liver-failure/ - Cached
  6. FDA Drug Safety Communication: Severe liver injury associated - FDA

    Jan 20, 2011 ... FDA Drug Safety Podcast for Healthcare Professionals: Severe liver injury associated with the use of dronedarone (marketed as Multaq...
    www.fda.gov › Drugs › Drug Safety and Availability - Cached
  7. Multaq Liver Problems | Dronedarone Liver Damage

    If you experience these Multaq liver problems, contact a Multaq liver injury attorney today for a free case evaluation.
    www.multaqliver.com/problems/ - Cached
  8. Multaq Liver Failure Reports Lead to Review in Europe ...

    Jan 24, 2011 ... European drug regulators have started a review of the liver side effects ofMultaq, a heart drug manufactured by Sanofi-Aventis, ...
    www.aboutlawsuits.com/multaq-liver-failure-reports-warning-15744/ - Cached
  9. Multaq Side Effects Lawsuits | Side Effects: Liver Damage, Liver ...

    Multaq Side Effects Lawsuits | Multaq (dronedarone) had been associated with liver injuries, including two cases of severe liver failure that required liver ...
    www.yourlawyer.com › Topics › Defective Drugs - Cached
  10. UPDATE 2-Sanofi confirms liver damage in 2 Multaq patients | Reuters

    Jan 14, 2011 ... Two patients needed liver transplants after taking drug * Sanofi says no causal link established in the two cases * Multaq 2014 consensus ...
    www.reuters.com/.../01/.../sanofi-multaq-idUSLDE70D17V20110114 -

 

 

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The FDA (Food and Drug Administration) issued a statement recently, advising health care professionals that it has updated product labels on Anti-psychotic drugs, warning of pregnancy dangers to newborns including EPS and withdrawal symptoms.

Anti-psychotic drugs included in the new labeling process and contra-indicated for use in pregnancy include: Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine and Symbyax.

These medications are prescribed to patients with schizophrenia, Bi-Polar Disorder and other psychiatric disorders.

The new FDA labels warn obstetric doctors and gynecologists that infants born to mothers taking any of these anti-psychotic drugs in the last trimester of pregnancy are at risk for withdrawal symptoms in response to the drug. Infants exposed in utero to anti-psychotic drugs show increased levels of EPS, or extrapyramidal signs.

How can you tell if an infant is experiencing anti-psychotic drug withdrawal symptoms or EPS? Both conditions are similar. In fact, EPS is not a condition of its own as much as a collection of symptoms in response to another condition. Extrapyramidal Symptoms include tremors, agitation, involuntary muscle movements, rigidity and restlessness. EPS are often Alzeheimer's Disease symptoms. Anti-psychotic drug withdrawal symptoms may also include severe breathing difficulties, sleepiness and difficulty eating. EPS and withdrawal symptoms may last from as brief as a few hours after birth to several days.

The FDA Med Watch reports that newborns do not require specific treatment, but may extend hospital staysafter birth. What this likely means is that there is no specific treatment protocol for babies experiencing anti-psychotic drug withdrawal. The infant's system must purge itself of the drug. What should you do if you or your baby is affected by this alert? Here is a voluntary reporting form if you took doctor prescribed anti-psychotic drugs while pregnant and your baby shows EPS or withdrawal symptoms.

It is advisable for physicians and OB-GYN doctors to consider other alternatives for their patients who are taking an anti-psychotic drug during pregnancy. Early post birth trauma has been linked to other physical and emotional conditions later in life. Eric Dolgan, DO, FCA discusses different birth traumas like drug withdrawal in his report on pregnancy and health. Whether anti-psychotic drug damage is permanent or the effects, temporary, it behooves mothers and babies to experience the most healthy, positive birthing experience possible.

Marilisa Kinney Sachteleben writes from 22+ years parenting and homeschooling four children and 25+ years teaching K-8, adult education and special needs students including EI, CI, LD and ASD populations. Marilisa is trained in psychology and mental health and writes about parenting concerns for the Yahoo! Contributor Network.

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.Demythologizing the High Costs of Developing New Drugs

February 21, 2011
By GoozNews

Press Release: Pharmaceutical companies continue to claim that high research and development (R&D) costs make it necessary for them to charge high prices and retain long ownership of patents to recoup costs. But a new study (subscription required) co-authored by health economists Rebecca Warburton and Donald W. Light demonstrates that high R&D estimates have been constructed by industry-supported economists to support the companies’ claims.

The widely accepted figure promoted by industry-supported economists is $1.3 billion to discover and develop a new drug.  This estimate, however, was done on a costly subsample and then generalized to all drugs, inflating the estimate for the average new drug by about 7 fold.

TAXPAYERS CONTRIBUTIONS

The $1.3 billion estimate also does not include the substantial contributions by taxpayers through R&D-related tax write-offs. Taxpayers indirectly pay for about 39 percent of company R&D, a substantial reductions in a company’s net costs.

The industry-based figure also includes a large sum inserted for the cost of discovery, even though no one has solid figures on what those costs are. The cost of discovery can range from serendipity to 30 years of frustrating research to find a key compound. Light and Warburton conclude that cost estimates can only be done for development and not basic research.

Light and Warburton also found that independent evidence showed the $1.3 billion estimate was based on trials much larger than reported by the Food and Drug Administration and the National Institutes of Health. The estimate was also based on trials lasting longer than the lengths that companies reported under audit. Finally, the percent of trials that failed was higher than independent sources showed, which multiplies the costs of trials that succeed.

FOREGONE PROFITS AS “COSTS”

Half the $1.3 billion estimate is not real costs but a high estimate of profits that companies would have made if they had not developed drugs but just put their money in bonds or equities. Industry-supported economists used an estimate of those profits more than twice the return on capital conventionally used and counted this high estimate as a “cost of R&D.” “Estimated profits get converted to ‘costs’, and then companies press to get that money back as well as a good return on it,” explained Light. “This amounts to charging high prices to get profits on profits.”

Light and Warburton used the median cost because a few very expensive drugs skew the average and result in a misleading figure. They corrected for inflated numbers and multipliers. The median net corporate R&D cost per new drug was only $59.4 million, plus the unknown cost of discovery, which varies 30 fold.  This estimate is in line with audited figures submitted by companies. “We found that the net median corporate costs varied greatly, from $13 million to $204 million, depending on the kind of drug,” Light said.

GOVERNMENT PROTECTED PRICES NOT WARRANTED

“The European Parliament is increasing market protections that will delay generic competition and extend monopoly prices,” Warburton said. “Lobbyists have persuaded European leaders that companies need more time to recover billions in research costs, when R&D costs are really a fraction of the $1.3 billion average claimed.”

PRACTICAL IMPLICATIONS

This study strengthens the view that drugs companies do not need prices as high as they are to recover R&D costs, and their corporate risks are much lower than claimed. Most of their R&D products are scores of drugs with few proven advantages over existing drugs that can command higher, government-protected prices. Gross profits are spent more for marketing than research in order to maximize the number of patients taking these drugs. A large number of clinical trials are conducted for marketing and signing up lead clinicians. These form elements of The Risk Proliferation Syndrome described in a new book, The Risks of Prescription Drugs.  The result is millions of patients exposed to adverse side effects with few offsetting benefits.  Prescription drugs are now the 4th leading cause of death and result in about 2 million hospitalizations a year. They have also become a major cause of auto and trucking accidents.

http://gooznews.com/?p=2520

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 When you compare retail prices for drugs against the wholesale cost at

 
 
and then read the following site, you will realize the extremely high cost of drugs is placed on them by the retailers.
 

 

FDA Approves dangerous drugs!

FDA Approved Drugs With Serious Side Effects

More Than 200,000 People Die Each Year From Prescription Drugs.
by Attorney Jonathan Emord

More than 200,000 people die each year from prescription drugs. They are often oblivious to the fact that the drugs their doctors have prescribed may include side effects that are life-threatening. The FDA is a great facilitator, aiding the pharmaceutical industry as its real primary mission and relegating patient interests to a secondary consideration. In testimony before the Senate Finance Committee, Dr. David Graham said that the American people are virtually defenseless against the onslaught of FDA approved drugs that are unsafe. It is therefore imperative for you to develop an understanding of the risks that drugs carry because your doctor may not inform you of them. Indeed, although it is a canon of medical ethics to warn patients of such risks, few physicians tell patients of drug risks before they make a prescription.

FDA APPROVED DRUGS WITH SERIOUS SIDE EFFECTS

 

By Attorney Jonathan Emord
Author of "The Rise of Tyranny" and,
"Global Censorship of Health Information
December 27, 2010
NewsWithViews.com

In my book The Rise of Tyranny I explain that FDA has become a captive of the drug industry and that repeatedly its Commissioner approves drugs over the safety objections of FDA medical reviewers. Dr. David Graham, FDA’s Associate Director of the Office of Drug Safety, has severely criticized his own agency for repeatedly approving unsafe drugs. “FDA is inherently biased in favor of the pharmaceutical industry,” said Dr. Graham. “It views industry as its client whose interests it must represent and advance. It views its primary mission as approving as many drugs as it can, regardless of whether the drugs are safe or needed.” Indeed, FDA performs no drug safety testing but relies entirely on the drug sponsor’s own testing. If the drug sponsor, who has an obvious economic interest in either not revealing or downplaying risks, fails to bring all identified risks to the agency’s attention, the agency presumes those risks de minimis or non-existent. Perhaps as many as 15% to 20% of all drugs on the market today are ones that carry serious side effects, including heart attack, stroke, neurological disorders, kidney failure, liver failure, and death.

Frequently I am asked to provide a listing of drugs linked to serious side effects. Below I provide a partial listing. Before taking any of the drugs listed below, you should discuss the side effects in detail with your physician and determine if there are substitutes or natural alternatives that could be taken in place of the drugs. Although FDA approved drugs frequently carry side effects, and in particular cases the potential benefits for the patient can reasonably be found to exceed the risks, when those side effects involve death or serious permanent disability, it is startling for most patients to learn that they may have been prescribed these drugs without being told by their doctors of the serious side effects and that they could instead be taking others that carry few, or no, serious side effects.

The following drugs have been linked to the side effects listed. This list is a subset of all drugs for which serious side effects have been reported. Consult with your physician concerning the side effects of every drug you are prescribed and, in particular, of the following:

Avandia (Type II Diabetes drug) – heart toxicity (including heart attacks, strokes, heart failure)
Byetta (Type II Diabetes drug) – acute pancreatitis; renal insufficiency; kidney failure; pancreatic cancer

Avastin (cancer drug) – gastrointestinal abnormalities (including perforation); kidney dysfunction; reduced white blood cell count; severe bleeding; heart attacks; strokes; and blood clots

Ketek (antibiotic) – liver toxicity
Omniflox (antibiotic) – hemolytic anemia
Trovan (antibiotic) – liver toxicity

Quinolones (antibiotics including Cipro, Levaquin, Floxin, and Tequin) – central nervous system and tendon toxicity; heart toxicity (including arrhtyhmias and QTc interval prolongation); convulsions; torsade de pointes; hypoglycemia; heightened risk of colonization with MRSA
Doribax (antibiotic) – seizures, liver toxicity, thrombosis, serious skin reactions

Meridia (weight loss drug) – heart arrhythmias; heart attacks; strokes
Orlistat (weight loss drug, including Xenical and Alli) – liver toxicity and rectal bleeding

Bisphosphonates (Boniva, Fosamax, Actonel) (drugs for osteopenia and osteoporosis) – esophageal cancer, jaw necrosis, brittle bones

Serevent (asthma drug) – increased risk of death from asthma
Singulair (asthma drug) – increased risk of behavioral changes and suicide
Accolate (asthma drug) – increased risk of behavioral changes and suicide
Zyflo (asthma drug) – increased risk of behavioral changes and suicide

Trasylol (drug to lessen bleeding after surgery) – heart attacks, strokes, and kidney failure

Lotronex (irritable bowel syndrome drug) – ischemic colitis
Zelnorm (irritable bowel syndrome drug) – heart attacks and strokes

Baycol (cholesterol lowering drug) – muscle injury (myopathy), including heart failure, and kidney toxicity
Crestor (cholesterol lowering drug) – muscle injury (myopathy), including heart failure and the rapid breakdown of skeletal muscle (rhabdomyalysis)
Zocor (cholesterol lowering drug) – kidney failure; liver toxicity; interstitial lung disease; tendon ruptures; muscle injury (myopathy), including heart failure and the rapid breakdown of skeletal muscle (rhabdomyalysis)
Zetia (cholesterol lowering drug) – liver toxicity (including liver damage, liver disease, liver failure); kidney failure; hepatitis; acute pancreatitis; and very low platelet levels in the blood (thrombocytopenia)
Vytorin (cholesterol lowering drug) – liver toxicity (including liver damage, liver disease, liver failure); liver failure; hepatitis; hepatic necrosis; and rapid breakdown of skeletal muscle (rhabdomyalysis)

Bextra (non-steroidal anti-inflammatory drug) – heart toxicity (including heart attacks and strokes)

Accutane (rheumatoid arthritis relief) – liver toxicity
Arava (rheumatoid arthritis relief) – liver toxicity
Humira/Prolia (rheumatoid arthritis relief) – serious infections, neurologic reactions, malignancies

Chantix (smoking cessation drug) – increased risk of suicide

Seldane (antihistamine) – heart arrhythmias

Propulsid (heart burn relief) – heart arrhythmias

Yasmin (oral contraceptive) – pancreatitis
Ocella (oral contraceptive) – blood clots, deep vein thrombosis, pulmonary embolism, strokes, heart attacks, gall bladder disease, kidney failure, pancreatitis, and death
Gianvi (oral contraceptive) – blood clots, deep vein thrombosis, pulmonary embolism, strokes, heart attacks, gall bladder disease, kidney failure, pancreatitis, and death

Avodart (drug for enlarged prostate) – increased risk of breast cancer
Propecia (drug for enlarged prostate) – increased risk of breast cancer
Proscar (drug for enlarged prostate) – increased risk of breast cancer

Reclast (drug for menopause) – renal impairment
Prempro/Premarin/Provera (drugs for menopause) – increased risk of breast cancer; strokes; heart attacks; cardiovascular disease; blood clots; urinary incontinence; cataracts; gout; joint degeneration; asthma; lupus; scleroderma; dementia; Alzheimer’s disease; lung, ovarian, endometrial, and gall bladder cancer; and melonoma

Paxil (antidepressant) – increased risk of suicide
Zoloft (antidepressant) – increased risk of suicide
Effexor (antidepressant) – increased risk of suicide
Clozapine (antipsychotic drug) – heart toxicity (including heart attack and stroke)
Exjade (iron chelator) – linked to sudden death

By Attorney Jonathan Emord

web site for more information:

http://www.newswithviews.com/Emord/jonathan169.htm

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Chantex

 

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Great site for Recall Drugs

Welcome To A Drug Recall

At ADrugRecall.com, we’re committed to providing our readers with the latest news and information about defective and harmful drugs. We cover breaking news stories, offer tips for consumer safety, provide information on alternative therapies, and more. Our goal is to empower you—our reader—by giving you the knowledge you need when you need it most. If you have a legal issue involving a defective drug, we can direct you to a respected and experienced attorney near you who can inform you of your legal rights and options. We hope you find our site helpful and easy-to-use. Please visit again soon! Read more about AdrugRecall.com.

http://www.adrugrecall.com/

    * Accutane® * Advair® * Asacol®   * Avandia® * Avelox® * Bextra® * Botox®   * Byetta®
  

  * CellCept®   * Chantix® * Cipro®   * Crestor® * Digitek®   * Duragesic® Patch
    
  
  * Fleet Phospho Soda®    * Floxin®    * Fluoroquinolone    * Fosamax®    * Gardasil®
    
      * Heparin®    * Hydroquinone    * Hydroxycut®     * Levaquin®    * Lupron®    * MRI Dye   

    * Multaq    * Neurontin®    * Noroxin®    * Nuvaring®    * Ortho Evra®    * Paxil®

    * Permax®    * PTU    * Raptiva®    * Reglan®    * Risperdal®    * Serevent®    * Seroquel®

    * Trasylol®    * Viagra®    * Vioxx®     * Wellbutrin®    * Xolair®    * Yasmin®    * Zelnorm®

    * Zicam®    * Zimmer NexGen®    * Zocor®    * Zyprexa®

______________________________________________________________________________

 

Rosiglitazone is Avandia has caused heart attacks, liver toxicity, stroke and death

Rosiglitazone is an anti-diabetic drug (thiazolidinedione-type, also called "glitazones") used with a proper diet and exercise program to control high bloodsugar in patients with type 2 diabetes (non-insulin-dependent diabetes). You should only begin taking rosiglitazone when other drugs have not worked well or cannot be taken. If you are currently taking rosiglitazone and have good control of your blood sugars and no new side effects/symptoms, continue to take this drug as directed. Ask your doctor about the risks and benefits of this drug, since a small number of people have had serious side effects.
___________________________________

http://www.avandiasideeffectslawsuit.com/

Avandia Side Effects Lawsuit



Vanderhyde and Associates Law Firm is helping people who have suffered heart related injuries associated with the use of Avandia.  We are

currently accepting Avandia cases nationwide.  If you or someone you know has been injured by Avandia, or if you have lost a loved one due to Avandia, please contact our firm for a free, no obligation consultation.  Call us Toll Free at 1-866-777-2557 or fill out our online contact form and an Avandia Side Effects Attorney will contact you as soon as possible.

Avandia (rosiglitazone maleate) is a popular prescription medicine used to treated Type 2 diabetes.  It was approved for use in 1999 as an adjunct to diet and exercise in order to  control blood sugar levels.  To date, Avandia has been used by over six million people.

Avandia Lawsuit

On May 21, 2007, the FDA warned that use of Avandia could potentially create an increased risk of injury to patients’ hearts.  The FDA issued a safety alert stating, “Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart related deaths in patients taking Avandia.”  Three weeks later, a study published by the New England Journal of Medicine stoked controversy when it suggested that there was a 43 percent higher risk of heart attack in Avandia users.

Avandia News – Black Box Warning

On November 14, 2007 the FDA issued a new updated Black Box Warning about the potential increase in heart problems.  A Black Box warning is the strongest warning that the FDA requires, and is used when medical studies suggest a significant risk of serious or life threatening side effects.

Avandia Lawsuits

MDL No. 1871 has been formed by the Judicial Panel on Multi District Litigation in the Eastern District of Pennsylvania.  People that have suffered heart attacks or other injuries have filed lawsuits claiming that Avandia and two of its sister drugs containing Avandia (Avandamet and Avandaryl) caused an increased risk of heart attack and other physical injury and that the defendants, SmithKlineBeecham Corporation (doing business as GlaxoSmithKline) failed to provide adequate warnings regarding the risk.  The defendants are denying these allegations.

We believe that the defendants should be held accountable for any harm that they have caused, and that the people who have suffered injuries from taking Avandia should be treated fairly and compensated for their losses.  If you or a loved one has suffered an Avandia related heart injury,Avandia Heart AttackAvandia Stroke, congestive heart failure, cardiovascular heart disease, or other heart injuries, you may have a legal claim.  Call us today for a free, no obligation consultation.  Call Toll Free 1-866-777-2557 to speak with an Avandia Lawyer, or use our online contact form and one of our Avandia Lawsuit Attorneys will get back to you as soon as possible.  We represent clients on a contingency fee basis, which means there are no legal fees unless we make a recovery for you.

If you believe you have a case, do not delay.  If your claim is not filed before the statutory deadline, you may be barred forever from making a claim and receiving any compensation.

Other Areas:

DePuy Hip Recall

Mesothelioma Lawyer

 

Necrosis of the bone in Arimidex and liver damage


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Chantix Lawsuits

 

Court to Hear Lawsuit Against Smoking-Cessation Drug Chantix

Published January 05, 2011

| Reuters

 

A federal court in Alabama will centralize at least 1,200 civil lawsuits against Pfizer Inc over its smoking-cessation drug Chantix, which plaintiffs say can lead to suicide.

U.S. Judge Inge Johnson of the Northern District of Alabama is handling pretrial proceedings and will preside over the civil trials unless the parties settle out of court, the court said.

"The centralization will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation," according to court documents.

About 60 percent of the cases allege suicide, attempted suicide or other overt acts of injury, Ernest Cory, lead counsel for the plaintiffs, said on Tuesday.

"Chantix was put on the market without adequate warnings and it is a dangerous drug ... Many people prior to July 2009 were not aware that this drug was not tested in any patient with any mental condition," he said.

 

 

EVIDENCE

Pfizer defends the drug, which has been approved in at least 86 countries as a smoking cessation aid.

"Pfizer acted responsibly and appropriately at all times in connection with the development, approval, and marketing of Chantix," said spokeswoman Victoria Davis.

"There is no reliable scientific evidence that Chantix causes the neuropsychiatric events alleged in these lawsuits. Chantix is an effective treatment option for many smokers who want to quit and we intend to defend this important medication," she said in a statement.

Johnson was first appointed by the U.S. Judicial Panel on Multi-district Litigation in late 2009 to handle the cases because she was already overseeing some cases and because a clear majority of plaintiffs favored her district.

The first lawsuit filed against Pfizer regarding Chantix was in Indiana in 2008 by the Birmingham-based law firm of Cory, Watson, Crowder & DeGaris.

Lawsuits filed in New York State Supreme Court in Manhattan claim that at the time the plaintiffs took Chantix, and that Pfizer did not tell doctors and patients about dangers it allegedly knew were related to the drug, including depression and thoughts of suicide.

Although Pfizer subsequently added warnings to its package insert, the law firm that filed all three lawsuits alleged the drug's label is still inadequate.

Pfizer introduced Chantix in the United States in 2006, hoping it would become a multibillion-dollar product and revive flagging profits. The drug's sales have fallen off as concerns about side effects increased.



Read more: 

http://www.foxnews.com/health/2011/01/05/court-hear-lawsuit-smoking-cessation-drug-chantix/#ixzz1AEYGOS6E

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Lawsuits Plague Industry

http://www.usatoday.com/money/industries/health/drugs/2006-08-23-drug-lawsuits-usat_x.htm

 

Hormone-replacement drug Prempro faces more than 5,000 lawsuits.
By JB Reed, Bloomberg News
Hormone-replacement drug Prempro faces more than 5,000 lawsuits.
 LAWSUITS PLAGUE INDUSTRY
Drug makers faced the most product liability lawsuits last year of any industry.
IndustryCases
Pharmaceutical 17,027
Manufacturing 3,236
Chemicals 2,875
Construction 2,717
Financial services 2,636
Insurance 1,926
Source: Thomson West
A new batch of drugs faces a barrage of lawsuits claiming that the drugs injured users and that manufacturers are to blame.

More than 6,000 lawsuits have been filed in recent years against four drugs taken by millions of patients: hormone-replacement drug Prempro, birth-control patch Ortho Evra, anti-psychotic Seroquel and anti-seizure drug Neurontin.

The plaintiffs claim drugmakers failed to disclose the drugs' risks or failed to properly test them, or both. The claims are similar to those against Merck's painkiller Vioxx, which faces 14,000 lawsuits. Unlike Vioxx, these drugs are still being sold, and the Food and Drug Administration considers their benefits worth their risks.

The first trials have begun or are near for Prempro and Neurontin. Johnson & Johnson has started settling some Ortho Evra cases, plaintiffs' lawyers say.

The lawsuits raise questions about whether drugmakers and the FDA pay ample attention to patient safety. Since 2000, more than 65,000 product liability lawsuits have been filed against prescription drugmakers, the most of any industry, says researcher Thomson West.

The pace isn't likely to slow, given the number of drugs on the market, the millions of consumers taking them and the skill of plaintiffs' lawyers in finding consumers who suffered adverse reactions, says professor Lars Noah of the University of Florida College of Law.

"The lawyers have created almost an assembly-line approach to use ... against an industry that's in tobacco-land in terms of how much people hate it," Noah says.

Drugmaker Wyeth faces more than 5,000 cases for Prempro and Premarin, hormone-replacement drugs for menopausal symptoms. The first trial started Monday in Little Rock. Plaintiff Linda Reeves alleges she developed breast cancer as a result of taking the drugs from 1983 through 2000. Breast cancer accounts for the majority of claims.

Wyeth and plaintiffs' lawyers refused comment, citing a judge's gag order. Wyeth has said it did nothing wrong and that the drugs' warnings reflected available scientific data and FDA requirements.

A study halted in 2002, the Women's Health Initiative, found that Prempro patients had a higher risk of breast cancer, stroke and heart disease. Later that year, Wyeth added a boldface warning on Prempro, which combines estrogen and progestin, and on Premarin, an estrogen, regarding the study.

In 2003, the warnings were put in a box, making them more prominent. The drugs' combined sales fell to $909 million last year from $2 billion in 2001.

In March, Wyeth won the first state case when a New York judge issued a summary judgment, saying the drugs' warnings were adequate. The case is being appealed, the plaintiff's lawyer says.

Wyeth's exposure is not likely to be nearly as large as the $21 billion it's paying to settle tens of thousands of claims over former diet drug fen-phen, linked to heart and lung problems. Not only are there fewer cases, but also it's difficult to prove that a drug caused someone's cancer — a key hurdle in most drug lawsuits, Noah says.

Plaintiffs in the Neurontin lawsuits face a similar challenge, says lawyer Mike Papantonio of Levin Papantonio Thomas Mitchell Echsner & Proctor, which does not represent any Neurontin plaintiffs.

Neurontin plaintiffs' lawyer Andrew Finkelstein has advocated that the FDA require a black-box suicide warning on Neurontin, which has been taken by more than 10 million people and is widely prescribed for pain and bipolar sufferers. Drugmaker Pfizer says there's no scientific evidence linking Neurontin and suicide.

"It's a difficult thing to get your arms around," Papantonio says. "Like the hormone-replacement therapy cases, there are so many complicating factors."

In December, Pfizer changed Neurontin's label to list "suicide" and "suicide attempt" as infrequent adverse events as opposed to "suicide gesture" as a rarer event. Pfizer says it made the change because of adverse event reports filed to the FDA. The reports do not prove a drug was to blame.

Warning raised

In the Ortho Evra birth-control patch cases, plaintiffs allege that the company failed to adequately test the patch's safety. Many of the women claim they suffered blood clots as a result of using it.

"The plaintiffs tend to be younger women, and you don't normally see strokes or blood clots in that population," Noah says.

The FDA last year required a warning on the patch, saying users will be exposed to 60% more estrogen than with typical birth-control pills. The warning came after the FDA and the drugmaker compared estrogen levels for the patch vs. pills. The FDA also said increased estrogen may raise the risk of clots.

When the FDA approved the patch in 2001, however, an FDA approval document said the risks were "similar to the risks of using birth-control pills."

The patch delivers more estrogen into the bloodstream. With pills, some estrogen is lost in the digestive tract.

Ortho-McNeil Pharmaceutical, and parent Johnson & Johnson, refused to comment specifically on the lawsuit allegations. In a general statement, it said that more than 5 million women have used the patch and that, when used as labeled, it is safe.

Settlements' cost

Last year, drugmaker Eli Lilly took a $1 billion charge to settle about 10,500 lawsuits claiming anti-psychotic Zyprexa caused diabetes or high blood glucose.

Similar claims have been made against AstraZeneca Pharmaceuticals' Seroquel, the No. 1 anti-psychotic, with more than 16 million users since its 1997 launch. Plaintiffs' lawyers claim AstraZeneca downplayed the diabetes risks and hid important safety information from the FDA.

AstraZeneca is confident in the drug and plans to defend itself, says spokesman Jim Minnick. He says the same lawyers who filed suit against Zyprexa are coming after Seroquel hoping for a similar result — a charge plaintiffs' lawyers deny.

Lawsuits' effects

Professor Noah says the threat of litigation will do little to stop companies from pursuing future drugs with such big markets.

Seroquel had 2005 sales of $2.8 billion. Neurontin, pre-generic competition, also posted annual sales in excess of $2 billion, as did the hormone-replacement drugs.

But Lisa Rickard, president of the U.S. Chamber Institute for Legal Reform, says litigation costs not only eat into research funds but change consumer behaviors. She cites a 2003 Harris Poll, commissioned by her group, that found that almost four out of 10 doctors had patients stop taking necessary medications after they heard a drug was involved in a liability lawsuit.

She says plaintiffs' lawyers jam courts with so many lawsuits, many frivolous, that firms settle to avoid the expense and uncertainty of fighting them. "The situation has gotten out of hand," says Rickard, whose group is affiliated with the U.S. Chamber of Commerce.

Lawyer Papantonio says law firms stand to lose $3 million to $5 million by bringing drugmakers to trial and don't pursue frivolous cases. "If a product hurts enough people, it gets the attention of the lawyers."

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