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  • Taxotere Lawyers for Permanent Hair Loss: Taxotere Baldness Lawyers For  Permanent Hair Loss Lawsuits Have you received Taxotere for breast cancer? Taxotere can result in hair loss or baldness  that is permanent. Taxotere  is a chemotherapy drug used for the treatment of breas...

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  • Zimmer Hip Replacement Lawyers: Network Zimmer Hip Replacement  Lawyer Win $2 Million Against Zimmer Hip Replacement Do You Have A Faulty Zimmer M/L Taper Hip Prothesis With Connective Technology and Cobalt Chromium Head? Do You Have Have Metallosis or Chromium Cobalt T...

Tylenol Liver damage lawyer, Tylenol lawyer, New Liver Cancer treatments

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

Liver Cancer Treatment Turns Up the Heat on Chemotherapy
By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today
Published: November 21, 2011

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Doctors at Froedtert Hospital, in Wauwatosa, Wis., performing isolated hepatic perfusion surgery on Mark Vetter. Photo credit: John Fauber, Milwaukee Journal Sentinel.

As Mark Vetter lay on the operating table, doctors isolated his liver and began bathing it in a heated, highly toxic poison sent through the organ's blood vessels.

Over the course of an hour, cancer cells in the liver started to die and continued doing so for days.

The operating room at Froedtert Hospital in the Milwaukee was filled with onlookers who wanted to get a glimpse because the treatment was one that few doctors have witnessed.

"If everything is successful it will kill the remaining cancer cells and it is a healthy liver," a hopeful Vetter said a couple weeks after recovering from the surgery.

For someone like Vetter, who hopes to live for years, there is enough science to offer a glimmer of hope, but also the dark reality that the treatment may only offer another year or so.

The therapy he chose to undergo may have its physiological underpinnings in a theory that has come to be known as the "Lance Armstrong Effect."

The legendary cyclist bounced back from testicular cancer that had metastasized to his lungs and brain, and he went on to win several Tour de France races.

The Armstrong Effect

Why did Armstrong and nearly 70% of other testicular cancer patients survive, even when the disease had metastasized to other parts of the body?

The answer, according to proponents of this theory, lies in anatomy — the testicles normally are a few degrees cooler than the rest of the body, and when testicular cancer cells spread to other, warmer environments inside the body, they are confronted by a heat wave.

In that stressed state, the theory goes, the cancer cells become more susceptible to treatments such as chemotherapy and radiation.

The combination of heat and chemo may be a promising approach to treating intractable cancers, said Robert Getzenberg, MD, the Johns Hopkins University School of Medicine researcher who coined the term "Lance Armstrong Effect" five years ago in a commentary in the Journal of the American Medical Association.

"We have not had much success with cancer," Getzenberg said. "There are few things that really work. Every drug we come up with, cancer develops a resistance to," Getzenberg said.

Old Idea Finds New Believers

For decades, doctors have known that heat can kill cancer cells. Dating back to the 1960s, small trials of combining heat and chemotherapy were conducted, but the treatment never caught on mainly because of its complexity and a lack of data showing a clear survival benefit, said H. Richard Alexander, MD, associate chairman of clinical research at the University of Maryland Medical Center.

But in the 1990s, Alexander and other researchers began finding benefit in difficult-to-treat cancers that had spread to the liver.

"If (liver perfusion) were just a pill, the FDA would approve it immediately because it is as good as anything else we have tried," he said. "In some patients you see very dramatic results. In some cases, you can make tumors disappear from X-rays."
Mark Vetter and his wife, Nancy. Photo credit: Mike Sears, Milwaukee Journal Sentinel.

But tumors can come back. So far, the gold standard of research — a large, randomized clinical trial — has yet to be done. So data on the survival benefit remain lacking.

To date, most of the observational research suggests that average survival is extended about a year.

At the University of Pittsburgh Medical Center, about 25 liver perfusion cases are done a year, said cancer surgeon David Bartlett, MD.

Average survival is about two years, he said. About 5% of patients live five years. One man still is alive 12 years after undergoing the treatment, Bartlett said.

Not Too Hot, Not Too Cold

At Froedtert, the doctors use a basic, highly invasive approach:

    Wheel the patient to the operating room
    Make a long incision in the abdomen
    Isolate the liver with clips, catheters, and cannulas, and perfuse it with the drug melphalan
    The drug is heated to about 102 degrees and mixed at concentration 20 times stronger than a standard chemotherapy dose

Others are in the early stages of testing more sophisticated methods for using heat and chemo, including the use of iron oxide and gold nanoparticles that have been chemically bonded with antibodies designed that seek out specific cancer cells. With the tiny metallic particles inside, the tumors, but not healthy tissue, then are heated using friction caused by radiofrequency or alternating magnetic field devices.

"We can heat them so much that we can burn them up," Getzenberg said.

The ideal approach, though, which now is being tested with prostate cancer in lab and animal models, involves heating the tumors to 107 degrees, which makes them much more vulnerable to chemotherapy agents, he said. Such nanoparticle and heat cancer therapies remain unproven and likely are a few years down the road

The "If" Factor

From his perspective as a patient undergoing a newly discovered "old" therapeutic approach, the treatment is just one more "if" for Vetter.

If he had not gone in for a routine eye exam two years ago, doctors would not have found the tumor in his left eye and he might be dead — he's one of about five in one million people a year who develop ocular melanoma, a disease that often metastasizes to the liver.
Doctors at Froedtert Hospital, in Wauwatosa, Wis., performing isolated hepatic perfusion surgery on Mark Vetter. Photo credit: John Fauber, Milwaukee Journal Sentinel.

If he had preferred, he could have traveled hundreds of miles to one of a couple centers in the country that specialize in the unconventional treatment. Instead, he chose to be one of the first such patients to undergo that unconventional treatment at a center in his hometown.

Of course, there is the biggest if: if this treatment works, how long will he live?

At 66, Vetter, a Milwaukee area private labor attorney, is no Lance Armstrong.

He looks trim and fit, hardly like someone who had been battling an often fatal disease for more than two years.

The Process

The treatment Vetter underwent lasted about an hour, "the most tolerable duration," according to T. Clark Gamblin, MD, one of the Froedtert/Medical College of Wisconsin cancer surgeon who operated on Vetter.

The trick is to get the right mix of chemo, heat, and time so to be lethal to cancer cells without causing too much harm to healthy liver cells. While some normal liver cells may die, that's acceptable because the liver has the ability to regenerate tissue.

"You are putting the liver on bypass," said Kiran Turaga, MD, a Froedtert/Medical College cancer surgeon. "It's like the liver is out of the body."

Vetter's surgery was the second such case at the hospital and the latest in a long line of treatments he has tried.

As a veteran of the cancer war, he knows he will be undergoing continual monitoring in the months to come.

He also says he understands there is no way to know how much the treatment will help.

"I have not changed much of anything about the way I live my life," he said in a recent interview from his Milwaukee area home. "My goal is to be sitting in this room in 20 years."

First Transvaginal Mesh Trials to be Heard in New Jersey

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

New Jersey Judge Schedules First Transvaginal Mesh Trials

The first Ethicon Gynecare vaginal mesh lawsuits will be presented by transvaginal mesh lawyers and go before a jury at the end of next year in New Jersey state court. These will be heard November 2012.

Judge Carol E. Higbee is overseeing the consolidated Ethicon vaginal mesh lawsuits in New Jersey Superior Court and scheduled the first of a number of Ethicon Gynecare bellwether trials, to begin in November 2012.
Preliminary discovery for cases being prepared for early trial dates is to be completed by March 30, and expert witnesses are to be deposed by October 5, according to a scheduling order Judge Higbee issued on October 28.

About 350 transvaginal mesh lawsuits  have been centralized under Judge Higbee for pretrial proceedings. These cases involve women who were implanted with the Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare Prolene mesh, Gynecare TVT sling or another pelvic mesh product manufactured by Ethicon.

These vaginal mesh products were designed to secure weakened or damaged vaginal muscle, ligamants and tissue in the pelvic muscle floor that holds the bladder,  uterus, the top of the vagina or the bowel in a secure position. These have been falling apart with severe complications.

All of the complaints involve  lawsuits that state Johnson & Johnson and their Ethicon subsidiary knew the mesh products were unreasonably dangerous when used to repair pelvic organ prolapse or female stress urinary incontinence, but continued to manufacture and sell them.

Tylenol may Leave Children Gasping

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

Omaha doctors are split on whether Tylenol's correlation with asthma is enough to stop prescribing it.

Published Tuesday November 8, 2011

Tylenol may leave children gasping

By Bob Glissmann
WORLD-HERALD STAFF WRITER

 

Tylenol has been shown to cause liver damage with long term, overdose or excessive use. Do we have a new Tylenol warning ready to o emerge?

Links between acetaminophen and asthma are so prevalent that until future studies document the drug's safety, it's being suggested that parents avoid giving the common medication to their children.

A new report on the matter is not enough to persuade at least two Omaha physicians to stop recommending acetaminophen, commonly sold as Tylenol. But a third local doctor who reviewed the report says she no longer will recommend that her young patients take the pain reliever/fever reducer.

The report, written by Dr. John McBride, director of the Robert T. Stone Respiratory Center at Akron (Ohio) Children's Hospital, doesn't say the drug causes asthma. But it does note that "a growing number of studies have documented such a strong association between acetaminophen exposure and asthma that it is possible that much of the dramatic increase in childhood asthma over the past 30 years has been related to the use of acetaminophen." The report appeared in the December issues of the journal Pediatrics.

Dr. Russell Hopp, director of pediatric allergy and asthma at Creighton University School of Medicine and Children's Hospital & Medical Center, said he doesn't see a smoking gun.

The presence of acetaminophen would be a risk factor for asthma, he said. "So would smoking. So would allergies. So would the mother having asthma.

"This is an additional risk factor," Hopp said. "It's not the risk factor."

McBride cites the International Study of Allergy and Asthma in Childhood, which looked at data for 200,000 children 6 and 7 years old and 320,000 children ages 13 and 14. Nearly 30 percent of all 13- and 14-year-olds reported taking acetaminophen at least once a month, McBride wrote. For 6- to 7-year-olds, the risk of asthma increased more than 60 percent for those who took the drug more than once per year but less than once per month. If they took the drug at least once per month, he wrote, the risk of asthma more than tripled.

For the older group, he wrote, the risks increased 43 percent and 2.5 times, respectively.

McBride also noted that other studies had found associations between the weekly use of acetaminophen and an increased asthma risk among adults.

One also could ask whether the decreased use of aspirin among children — because of its link with Reye's syndrome — is behind the increase in asthma, said Dr. Jeff Stokes, an associate professor in the allergy department at Creighton's medical school and an allergy specialist. Aspirin, he said, is an anti-inflammatory drug, and asthma is an inflammatory disease.

"Is it the increased taking of something or the decreased taking of something else that's leading to this association? The answer is we don't know," Stokes said.

Dr. Laura Wilwerding, a clinical associate professor in pediatrics at the University of Nebraska Medical Center and a pediatrician with Children's Specialty Physicians, said that although the report doesn't say definitively that acetaminophen causes asthma, the report "potentially could be concerning."

"My thought is that until they get better studies out to really know if there's truly a causal relationship (between the drug and asthma), if there are other medications not associated with increased risks, I would probably go to them first — such as ibuprofen."

A spokeswoman for Tylenol, Jodie Wertheim, said in an emailed statement that "While we are aware of the article published in the December issue of Pediatrics, there are no prospective, randomized controlled studies that show a causal link between acetaminophen, the active ingredient in Tylenol, and asthma.

"Consumers who have medical concerns or questions about acetaminophen should contact their health care provider," she wrote.

The local physicians say that in any case, parents shouldn't fret. "There are lots and lots of children who have taken Tylenol and who don't have asthma," Wilwerding said. She noted, however, that parents must weigh the potential risks and benefits before giving their kids the drug.

Tylenol has been shown to cause liver damage with long term excessive use.  Do we now have another problem emerging.

If you or a loved one has liver damage due to Tylenol overdose call immediately to speak to our Medical social worker and a Tylenol lawyer. You may have a claim.

Current Class Actions Overview

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

The purpose of Drugs,Orthopedic Devices and Medical Device class action lawsuits is to give the people the ability to obtain justice from large corporations who can afford powerful legal defense and who have strong influential connections. Let's look at class action Lawyers for the dangerous drug Actos for instance. Actos has been shown to cause bladder cancer in long term use.Many Tpe 2 diabetics took this drug under the advise of their physicians however, warning cam too late and many individual became  victims of bladder cancer. Yaz is a birth control drug which has been shown to cause blood clots and potential stroke. Both Actos and Yaz can cause wrongful death. The Prolapse mesh,transvaginal mesh inplant is a surgical implant for uterine prolapse and unrinary incontinence.  This is perhaos the worse we have seen yet. These mesh implants were approved on the "fast track" without sufficient testing. The prolapse mesh is causing horrific complications in women. Women across the U.S, Canada, U.K and Europe are describing complications that are unbearable. The Depuy Hip Replacement ,Zimmer Duram Cup and Depuy ASR and Pinnacle hip replacement prothesis metal on metal has been causing severe complications. The metal itself has become toxic. These effect our huge senior populations which go in for second surgeries. Class Action Attorney Network, and and its team of lawyers is concerned for the senior victims of a failed Depuy, the women victims of the failed vaginal mesh and the Diabetics dealing with a life changing adult onset disease that now must fear for bladder cancer.  The Attorney for class action team is concerned for the women who simply wanted a birth control device and now must fear for clots and stroke. So many drugs and medical devices gone bad so much suffering and so many whose voices must be heard. Their families and caregivers,husbands and children are suffering along with them. To quote one caller "when mommy hurts the entire family suffers". These medical discoveries offered hope but have turned to pain and suffering. If you, a family member, a child or someone you care for is a victim of a dangerous drug or medical device call Today. Justice must be sought.

CURRENT CLASS ACTION LITIGATIONS INCLUDE:

  • Accutane
  • Actos lawyers for bladder cancer
  • Aranasp, Aredia                                                           
  • Ambien,
  • Amnesteem
  • Anticonvulsant, Anti-seizure & Antiepileptic Drugs: Cleft Lip or Cleft Palate Birth Defects
  • Asbestos , Mesothelioma lawyers
     
  • Advair
  • Avandia: Heart Attacks
  • Arava: Liver Injury?
  • Baycol, Bextra, Botox, Byetta,
  • Chantix
  • Carbamazepine, Cefepime, Celebrex, Cialis, Cipro, Crestor, Cytotec,
  • Claravis
  • Crestor: Several consumer groups are asking the FDA to recall Crestor due in part to the reported serious complications within five months of Crestor's approval. Kidney failure or muscle damage, and rhabdomyolysis were shown as a side effect leading to wrongful death
  • Darvocet: Heart Attacks & Arrhythmia
  • Darvon: Heart Attacks & Arrhythmia
  • Depakot:

           Depuy Hip replacement

  • Digitek, Duract, Duragesic,
  • Effexor Birth Defects
  • Ephedra, Epogen
  • Femara, Fen-Phen,Fentanyl, Fluorquinolone
  • Fixodent: Zinc Toxicity & Neuropathy
  • Fosamax: Osteonecrosis

While many Americans are filing Fosamax lawsuits because of the evidence indicating that the drug, manufactured by Merck, causes femur fractures and jawbone death in people who take it to combat osteoporosis, reports out of the United Kingdom indicate that the disease has reached catastrophic levels in the population in that area of the world.

  • Gardasil, Gadolinium, Gleevec
  • Generic Keppra (Levetiracetam): Seizures
  • Hismanal, Heparin, Hydroxycut,
  • Isotretinoin
  • Ketek,
  • Lamisil, Leukine, Levitra, Levaquin, Lotronex,
  • Meridia, Mifeprex, Mirapex, Mobic,
  • Mesothelioma: Mesothelioma and other asbestos diseases are very serious illnesses affecting the smooth lining of the chest, lungs, heart and abdomen. Between 2,000 and 3,000 new cases of malignant Mesothelioma are diagnosed in the United States each year.
  • Ocella Birth Control Pills & Oral Contraceptives
  • Ortho Evra,
  • Paxil Birth Defects,
  • Permax, Phenergan, Pondimin, Posicor, Prempro, Prilosec, Procrit, Propulsid, Provigil,
  • Poligrip: Zinc Toxicity & Neuropathy
  • Plavix
  • Propoxyphene: Heart Attacks & Arrhythmia
  • Provichol
  • Propecia: The FDA recently announced a label change for the drug Propecia – a drug designed to treat male-pattern hair loss and enlarged prostate glands – to include the warning risk of prostate cancer. Propecia, also known as the 5-alpha reductase inhibitor Finasteride, underwent multiple trials [including The Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE)] and was found to increase the risk of developing high-grade prostate cancer, the most serious form of prostate cancer.
  • Prozac Birth Defects
  • Reglan (Metoclopramide): Tardive Dyskinesia
  • Raplon, Raptiva, Raxar, Redux, Reglan, Rezulin, Risperdal, Ritalin, Rituxan,
  • Seldane, Seroquel,
  • Sotret
  • Tequin, Trasylol, Tylenol
  • Tylenol: The  painkiller Tylenol (generic name acetaminophen) has been linked to  toxicity and liver damage. Tylenol is one of the most popular painkillers in the world: About 8 billion pills are taken every year, making accidental Tylenol overdose not uncommon, mainly because consumers think the drug is safe and may ignore label warnings and take too large of a dosage or take dosages too often. People are taking many medications with acetaminophen as the active ingredient at the same time. This can cause acetaminophen toxicity, leading to side  liver damage
  • Topamax® & Topiramate: Cleft Lip or Cleft Palate
  • Upsher – Smith Recall
  • Viagra, Vioxx, Vytorin,
  • Xolair,
  • Lawyer for Yasmin
  • Lawyers for YAZ blood clots from a birth control drug
  • Zelnorm, Zencore Tabs, Zicam, , Zometa, Zyprexa
  • Zicam: Loss Of Smell or Taste
  • Zocor
  • Zoloft

                                                            ORTHOPEDIC AND MEDICAL DEVICES

  • Animas Insulin Pump
  • Depuy ASR Hip Implants
  • Depuy Updates:    Most people know by now that DePuy Orthopaedics successfully consolidated all DePuy lawsuits into multidistrict litigation (MDL) under federal District Court Judge David Katz of the Northern District of Ohio in Toledo (In re: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation (MDL Docket No. 1:10-md-02197)). Despite the initial status conference being delayed one month, MDL has been moving efficiently.
  • Depuy Pinnacle Hip Implants
  • Smith & Nephew Knee Implant
  • Stryker Hip Implants
  • Zimmer Durom Cup Hip Replacements
  • Zimmer NexGen Knee Implant

Medtronic

November 6, 2011. By Jane Mundy.
Medtronic Infuse Bone Graft Neck: Off-Label and Off-Limits New York, NY: Defective medical device attorneys are filing lawsuits against Medtronic for marketing its InFuse Bone Graft off-label, particularly for neck surgery. A number of personal injury lawsuits and a wrongful death suit (a California woman died after neck surgery) have also been filed against Medtronic.

                                                                   VAGINAL MESH MANUFACTURERS

 

Johnson & Johnson

  • Ethicon TVT
  • Gynecare TVT
  • Gynemesh PS
  • Prolene Polypropylene Mesh Patch class action
  • Secur

Bard

  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh

American Medical Systems or AMS

SPARC®

Boston Scientific

  • Advantage™ Sling System
  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System

Mesh Updates

Sept. 8 (Bloomberg) — Johnson & Johnson and rival makers of transvaginal meshes told Food and Drug Administration advisers they agreed on the need for more safety studies of the implants as well as labeling changes to warn of potential risks.

If you have been injured by a pharmaceutical drug, medical ,surgical device or implant or any of the above listed medical products call the class action lawyer team today for an experienced class action lawyer.

Update Oct 18 2011

 

Clomid (clomiphene citrate), one of the most popular fertility drugs on the market, has been found to increase the risk to severe birth defects, according to a recent report by the Centers for Disease Control.

Clomid, also marketed as Serophenea, induces ovulation in women who do not usually produce eggs. According to the recent research, which looked at women using Clomid anywhere from two months before conception to one month of pregnancy, serious birth defects – ranging from anencephaly (open cranium lacking a brain), esophageal atresia (closed esophagus), omphalocele (abdominal wall defect), craniosynostosis (premature fusion of skull bones), and gastrointestinal and genital defects – were observed.

Class Action Lawyers

A class action is  brought by a class action lawyer,lawyers,attorney or law firms  against a company whose actions have injured a group of people in a similar way. An individual  who has been injured may bring a class action on behalf of  all individuals who has been harmed.  After the class action has been started  the other injured people  join the class action lawsuit  they in effect become class members

CooperVision Continues the Voluntary Recall of Avaira™ Toric Contact Lenses

 

The Latest on Breast Implants

Implant brands include Dow Corning, Silastic II, Cronin, DCW, MSI, Mueller 5 and Varifil. For those women that do have qualifing implants, there is still compensation available under the Dow Settlement until June 1, 2019.
 

Consumer groups at this week's FDA advisory panel on general and plastic surgery devices ask the watchdog agency to take Johnson & Johnson breast implants off the market until more safety data can be gathered.
 

  • Dow Corning Breast Implant Settlement there is still time until June 1 2019
  • Breast implant claimants, registered with the Dow Corning Settlement Facility,having trouble with a deficiency should retain a breast implant lawyer
  • MDL 926 Revised Settlement Program (RSP)For Breast Implants may be able to help you
  • Many claiments received a status letter from the Claims Office indicating that their Disease Claim for the MDL 926 Revised Settlement Program contained a Deficiency.
  • Lupus a rare from of cancer has been shown to be a complication of both Saline and Silicone Breast Implants.

Congress Urge Hearing on DePuy Metal-on Metal Hip Implant

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

Congressmen Urge Hearing on DePuy Metal-On-Metal Hip Implant

 

Congressmen Urge Hearing on DePuy Metal-On-Metal Hip Implant

 
 
 

Bloomberg Businessweek reports that a group of concerned Congressmen have written to the chairpersons of several committees, requesting hearings on the safety of Johnson & Johnson’s DePuy metal-on-metal hip implants and Boston Scientific brain stents.

The DePuy ASR metal-on-metal hip implant, which was approved under the FDA’s 510(k) approval process, in which a device can be cleared for market if it is “substantially equivalent” to devices already on the market, is known to release small metal particles into patients’ bloodstreams, potentially damaging nearby bone and tissue and necessitating painful correctional surgery. The Congressmen note that the FDA has already received over 5,000 complaints since January 2011. However, the United States does not have a registry to track medical device failure and it is possible that the number of failed devices is higher than 5,000 and will continue to rise in the coming years. The high failure rate and lack of a reliable tracking registry led the FDA “to order 20 manufactureres of these devices to submit a plan to the FDA to study how frequently they were failing and to examine the health implications of device failures.” 

The Congressmen hope that hearings on the DePuy metal-on-metal hip implants will serve as a foundation to “provide important lessons about the device clearance and approval process as well as the adequacy of our postmarketing safety system.” In the past few years, Congressional “hearings on medical devices have examined claims about delays in FDA approval and overregulation,” but the letter writers believe Congress should be wary of underregulation and should examine “evidence as to whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices.”

Black Box Warning on Label for the Antibiotic Tigecycline

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

Oct. 26, 2011

Antibiotic’s Label Should Include a Stronger Warning About Higher Mortality Rate, Public Citizen Tells FDA

Public Citizen Calls on FDA to Require Black Box Warning on Label for the Antibiotic Tigecycline

WASHINGTON, D.C. – The Food and Drug Administration (FDA) should place a black box warning on an antibiotic used to treat a wide range of infections because of a higher mortality rate associated with taking the drug than other widely used antibiotics, Public Citizen said in a petition sent today to the agency.

The antibiotic, tigecycline, also known as Tygacil, was approved by the FDA in 2005 to treat complicated skin infections and intra-abdominal infections and in 2009 to treat community-acquired pneumonia.

But in 2010, the FDA issued a safety alert to health care professionals informing them of an increased mortality rate associated with the use of intravenous tigecycline compared to that of other antibiotics. The agency said that alternatives to tigecycline should be considered in patients with serious infections. At the same time, the FDA required that the drug label be modified to include data about the increased mortality risk, but these warnings were inadequate, Public Citizen said in the petition. Critical safety information does not appear in a black box warning at the top of the label and fails to describe appropriate restrictions on the use of the drug.

“Given the approximately 30 percent higher rate of mortality in subjects receiving tigecycline, as well the significantly higher rates of failures to cure serious infections, in comparison to subjects treated with comparator antibiotics, the content and placement of the warnings in the current drug label are woefully insufficient,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “Because of the increased death rate and the likely inappropriate use of tigecycline as a first-line, rather than last-resort, antibiotic for serious infections without simultaneous administration of other antibiotics, it is inexcusable that there is currently no black box warning for tigecycline. Such a warning, accompanied by stronger warnings describing appropriate restrictions on its use in other parts of the label, clearly is warranted to more effectively advise physicians about the dangers of using tigecycline to treat serious infections and to better protect public health.”

Public Citizen calls on the FDA to add a black box warning to the antibiotic’s label indicating the increased risk of death and advising that it should be used only as a last-resort antibiotic and then only in combination with one or more bactericidal antibiotics (antibiotics that directly kill bacteria, rather than interfere with bacteria growth). Public Citizen also is petitioning the agency to require an FDA-approved medication guide to be distributed to patients, as well as a “Dear Doctor” letter to physicians, warning them of the dangers of the drug and the need for restricted use

CooperVision Parent Hit With Class-Action Suit

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

CooperVision Parent Hit With Class-Action Suit


A California law firm has initiated a class action lawsuit against the Cooper Companies Inc., parent company of CooperVision Inc., alleging company management defrauded investors by making false and inflated projections about the company's performance.

Los Angeles firm Milberg Weiss Bershad & Schulman filed suit Wednesday in federal district court in the Central District of California on behalf of people who purchased Cooper Cos. stock between July 29, 2004, and Nov. 21, 2005, including those who received Cooper shares in exchange for shares of Ocular Sciences Inc. after the two companies merged last year.

The firm said the company, Chief Executive A. Thomas Bender, Chief Financial Officer Robert Weiss and Director John Fruth gave inflated earnings guidance and overstated the benefit to company revenue contributed by a new CooperVision contact lenses that was meant to compete with similar lenses developed by competitors such as Johnson & Johnson and Bausch & Lomb Inc.

CooperVision employs more than 1,000 at several facilities in the Rochester area.

A company representative could not immediately be reached for comment.

 

False Claims Act

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

False Claims Act, Fraud Protection Helpline

False Claims Act, Jewish LawyerThe False Claims Act is the single most important tool U.S. taxpayers have to recover the billions of dollars stolen through fraud by U.S. government contractors every year.

Under the False Claims Act, 31 U.S.C. §§ 3729-3733, those who knowingly submit, or cause another person or entity to submit, false claims for payment of government funds are liable for three times the government’s damages plus civil penalties of $5,500 to $11,000 per false claim.

The False Claims Act explicitly excludes tax fraud. Section 3729(e) states that the Act “does not apply to claims, records, or statements made under the Internal Revenue Code.” If you wish to report tax fraud, please call the IRS Fraud Hotline at 800-829-0433.
Qui Tam Whistleblower Provisions

The False Claims Act contains qui tam, or whistleblower, provisions. Qui tam is a unique mechanism in the law that allows citizens with evidence of fraud against government contracts and programs to sue, on behalf of the government, in order to recover the stolen funds. In compensation for the risk and effort of filing a qui tam case, the citizen whistleblower or “relator” may be awarded a portion of the funds recovered, typically between 15 and 25 percent. A qui tam suit initially remains under seal for at least 60 days during which the Department of Justice can investigate and decide whether to join the action

A Public-Private Partnership

Congress recognized that the Government alone, with its limited resources, was overmatched in the fight against rampant fraud. In response to widespread reports that the U.S. Treasury was being repeatedly bilked, in 1986 Congress rejuvenated a Civil War-era law—the False Claims Act. The 1986 amendments strengthened the False Claims Act’s qui tam provisions, creating incentives for private citizens with evidence of fraud to commit their time and resources to supplement the Government’s efforts. By doing so, Congress put into play a powerful public-private partnership for uncovering fraud against the federal fisc and obtaining the maximum recovery for American taxpayers.

Changing the Culture of Fraud

The False Claims Act is about more than money. It is also about discouraging fraud and changing the culture of corporate America. As Sen. Charles Grassley (R-IA) and Rep. Howard Berman (D-CA) have noted:

“Studies estimate the fraud deterred thus far by the qui tam provisions runs into the hundreds of billions of dollars. Instead of encouraging or rewarding a culture of deceit, corporations now spend substantial sums on sophisticated and meaningful compliance programs. That change in the corporate culture — and in the values-based decisions that ordinary Americans make daily in the workplace — may be the law’s most durable legacy.”

Who the Law Applies To

In general, the False Claims Act covers fraud involving any federally funded contract or program, with the exception of tax fraud.

While many qui tam actions in the late 1980s and early 1990s involved Department of Defense contracts, in recent years most qui tam actions have been used to fight Medicare fraud and fraud against other federally funded health care programs. A broad array of scenarios can constitute FCA violations. Some examples include the following:

    A contractor falsifies test results or other information regarding the quality or cost of products it sells to the Government;
    A health care provider bills Medicare for services that were not performed or were unnecessary, or;
    A grant recipient charges the Government for costs not related to the grant.

Types of Fraud Prosecuted Under the FCA

It is impossible to list all of the frauds that have been prosecuted under the False Claims Act, but the following list gives some idea of the scope of the false claims on the Government that have been uncovered to date:

    Billing for goods and services that were never delivered or rendered.
    Billing for marketing, lobbying or other non-contract related corporate activities.
    Submitting false service records or samples in order to show better-than-actual performance.
    Presenting broken or untested equipment as operational and tested.
    Performing inappropriate or unnecessary medical procedures in order to increase Medicare reimbursement.
    Billing for work or tests not performed.
    Billing for premium equipment but actually providing inferior equipment.
    Automatically running a lab test whenever the results of some other test fall within a certain range, even though the second test was not specifically requested.
    Defective testing – Certifying that something has passed a test, when in fact it has not.
    “Lick and stick” prescription rebate fraud and “marketing the spread” prescription fraud, both of which involve lying to the government about the true wholesale price of prescription drugs.
    Unbundling – Using multiple billing codes instead of one billing code for a drug panel test in order to increase remuneration.
    Bundling — Billing more for a panel of tests when a single test was asked for.
    Double billing – Charging more than once for the same goods or service.
    Upcoding – Inflating bills by using diagnosis billing codes that suggest a more expensive illness or treatment.
    Billing for brand — Billing for brand-named drugs when generic drugs are actually provided.
    Phantom employees and doctored time slips: Charging for employees that were not actually on the job, or billing for made-up hours in order to maximize reimbursements.
    Upcoding employee work: Billing at doctor rates for work that was actually conducted by a nurse or resident intern.
    Yield burning — skimming off the profits from the sale of municipal bonds.
    Falsifying natural resource production records — Pumping, mining or harvesting more natural resources from public lands that is actually reported to the government.
    Being over-paid by the government for sale of a good or service, and then not reporting that overpayment.
    Misrepresenting the value of imported goods or their country of origin for tariff purposes.
    False certification that a contract falls within certain guidelines (i.e. the contractor is a minority or veteran).
    Billing in order to increase revenue instead of billing to reflect actual work performed.
    Failing to report known product defects in order to be able to continue to sell or bill the government for the product.
    Billing for research that was never conducted; falsifying research data that was paid for by the U.S. government.
    Winning a contract through kickbacks or bribes.
    Prescribing a medicine or recommending a type of treatment or diagnosis regimen in order to win kickbacks from hospitals, labs or pharmaceutical companies.
    Billing for unlicensed or unapproved drugs.
    Forging physician signatures when such signatures are required for reimbursement from Medicare or Medicaid.

Limits on the False Claims Act

Though the False Claims Act is a powerful tool to combat fraud, it is a tool that is sharply constrained by both the law and economics of litigation.
Tax issues are not covered by the False Claims Act.

For a civil case to be filed, the fraud has to reach a certain size, otherwise it is generally not worth it for the relator to risk his or her career to file suit, nor is it worth it for a law firm to take on the case and risk the loss of the enormous time and expense that a False Claims Act represents.

A defendant in a False Claims Act has to have relatively deep pockets. Many of the smaller companies that may be defrauding the government are liable to declare bankruptcy if faced with the triple damages that can be levied under the False Claims Act.

A law firm that take on a False Claims Act case must believe it has a very strong case in order to proceed. Not only can a firm be out time and money, but if the government does not take the case and the whistleblower proceeds, he or she can be forced to pay the defendants attorney’s fees if the court finds that the claim was frivolous or brought primarily for purposes of harassment.
State False Claims Acts

In addition to the Federal False Claims Act, a number of states also have False Claims Acts that work to discourage frauds perpetrated against state governments. States with False Claims Acts include: California, Delaware, the District of Columbia, Florida, Hawaii, Illinois, Louisiana, Massachusetts, Nevada, New Mexico, Tennessee, Texas, and Virginia.

GlaxoSmithKline Plc agreed to pay $3 billion to resolve U.S.

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

By Phil Serafino and Makiko Kitamura, Published: November 3

Nov. 3 (Bloomberg) — GlaxoSmithKline Plc agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement.

Negotiations over the terms will be completed next year, the London-based company said in a statement today. The cost is covered by existing legal provisions and will be paid from the company’s cash resources, Glaxo said.

The potential settlement brings Glaxo closer to putting years of legal probes behind it. The company set aside 2.2 billion pounds ($3.5 billion) in the fourth quarter last year in anticipation of reaching an agreement on the cases. Glaxo said it will have about 1 billion pounds of its 2.9 billion pounds in total legal provisions remaining after today’s settlement is completed, and it hasn’t decided what to do with the money.

“This news essentially draws a line under a 10-year legal saga,” Gbola Amusa, an analyst at UBS AG in London who recommends buying Glaxo shares, said in an e-mail. “This removes significant uncertainty on ongoing legal issues.”

Glaxo rose 1.7 percent to close at 1,378 pence in London.

Pfizer Settlement

The Glaxo settlement would trump the $2.3 billion Pfizer Inc. paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly & Co. paid the same year over sales of its Zyprexa anti-psychotic medicine. The Bextra accord had been the largest pharmaceutical marketing settlement in U.S. history.

Abbott Laboratories agreed to pay at least $1.3 billion to settle claims by the U.S. government and 24 states alleging the company illegally marketed its Depakote epilepsy drug, people familiar with the accords said last month.

“Litigation is an ever-present business risk in the pharmaceuticals industry,” Mark Purcell, a Barclays Capital analyst, wrote in a note to investors today.

The proposed $3 billion settlement is “manageable,” Fitch Ratings said today in a statement. “It should help remove some uncertainty about the group’s finances without putting significant pressure on its ’A+’ credit rating.”

Federal prosecutors began an investigation in Colorado in 2004, later taken over by the U.S. attorney in Massachusetts, into whether Glaxo promoted drugs for unapproved uses, and into ways Glaxo potentially influenced doctors. The probe concerns nine of the company’s best-selling products from 1997 to 2004, including the Advair lung treatment, Glaxo said in its annual report.

Medicaid Rebates

Today’s settlement also covers a U.S. Justice Department probe of Glaxo and a Medicaid rebate program, and a Justice Department investigation into the development and marketing of the Avandia diabetes drug, the company said.

Drugmakers are required to give rebates to Medicaid, the government health insurance program for the poor. The investigation examined how Glaxo reported prices charged to other payers, which are used in calculating the Medicaid rebates.

Regulators said last year that Avandia would be withdrawn from the market in Europe and sales would be limited in the U.S. because of an increased risk of heart attacks.

“This is a significant step toward resolving difficult, longstanding matters which do not reflect the company that we are today,” Chief Executive Officer Andrew Witty said in the statement. “In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity.”

Compensation Changes

Earlier this year, Glaxo changed incentive compensation programs for U.S. sales representatives. The company has eliminated the link between sales goals and bonuses, which are now based on selling competency, customer evaluations and overall performance of the representative’s business unit.

Glaxo still faces probes involving the United Nations oil- for-food program, and HIV product sales and marketing in the U.S., JPMorgan Chase & Co. analysts wrote in a note to investors today.

The company agreed to pay more than $250 million to resolve about 5,500 claims related to Avandia to avoid the first trials over claims it can kill users, two people familiar with the accords said in February. Glaxo declined to comment on those figures today.

‘Speed Bumps’

“These settlements are just speed bumps to drug companies, a small blip in their global revenue,” said Kevin Outterson, a professor of health law at Boston University and editor-in-chief of the Journal of Law, Medicine & Ethics. “This may also be the last U.S. settlement on off-label promotion, as the companies are now using the First Amendment as a shield for off-label promotion.”

The legal provision, announced in January, led to a loss for Glaxo in the fourth quarter of 2010. Less than three weeks after the provision was disclosed, the company said it would begin a share repurchase for the first time since 2008 to enhance investor returns.

Causes of the Polybutylene Class Action Lawsuit – What You Should Know

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

By Jerry Work

 

Polybutylene Class Action Lawsuit cases are all over the country right now.These cases have been going on since the 1908s when people started to see serious failures with their poly piping systems throughout the home. The cause of the lawsuit is varied for everyone, but basically comes down to a situation where the pipes are not safe for use and have caused serious issues, including water damage, leaks, burst pipes, and other problems for consumers in up to 10 million homes around the United States. This product was first introduced in 1978, and was used all the way up until 1995 in homes all over the nation.

The Polybutylene Class Action Lawsuit was caused by:

 

  • Poly pipes that are affected by chemicals in the water supply.
  • Breakdowns in the pipes because of damage done over time
  • Faulty installation or improper connectors and piping used

 

These three elements are all reasons that this lawsuit has succeeded. Even though the manufacturers of these pipes will not admit that their product is defective and needs to be taken off the market, it is no longer used and they have given $950 million to fund the lawsuit settlements of consumers who have dealt with problems with their pipes. A company giving up money for a problem that they don't think exists is ridiculous. This company knows very well what they did and are now paying the fine for their ignorance.

Polybutylene pipes are used in the home, outside the home, in water distribution plants, and anywhere that small � to 1 inch pipes are needed. Therefore, there are many different people who have to look to see if they have these pipes and indeed need to become a part of the class action lawsuit to replace the pipes. Replacement can occur at anytime, and you should get enough from the settlement to at least cover that cost, plus any damages that occurred.

Because these pipes proved to be an utter failure in plumbing, anyone who has them in their home has the right to sue for money damages, even if no damages have occurred yet. The class action lawsuit was simply caused by a company that didn't take everything into consideration before putting a new product on the market and promoting it for a use where it actually isn't safe to be used because of environmental factors. Because of this, consumers are now battling lawsuit settlements all over the country to recoup their losses.

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