Federal Prosecutors Will Appeal Pending Asbestos Case Rulings
A case against W.R. Grace and Co. over an asbestos conspiracy will be appealed by federal prosecutors who disagree with recent court rulings. The prosecutors accuse the company of violating the Clean Air Act and knowingly poisoning former workers and residents. Three rulings however, have undermined their case by dismissing one count of conspiracy and barring the use of "critical evidence" of asbestos samples and scientific research. The Washington Post, Boston Globe 08/25/2006
asbestos lawyer
Wednesday, August 30, 2006
Beware of Asbestos in Automotive Brake & Clutch Repair Work
Asbestos-Automotive Brake and Clutch Repair Work
SHIB 07-26-2006
"OSHA is issuing this Safety and Health Information Bulletin to inform employees and employers in the automotive brake repair industry of the precautions that must be taken when working with automotive brakes and clutches containing asbestos. In the case of do-it-yourselfers *, OSHA does not have jurisdiction, and OSHA does not require theses practices to be followed. To reduce the potential exposure to asbestos, EPA strongly recommends that all automotive brake and clutch repair work be done by professional auto mechanics. "
If you or a loved one suffers from an asbestos related injury, contact Bagolie Friedman Injury Lawyers for a confidential and free consultation.
asbestos lawyer
SHIB 07-26-2006
"OSHA is issuing this Safety and Health Information Bulletin to inform employees and employers in the automotive brake repair industry of the precautions that must be taken when working with automotive brakes and clutches containing asbestos. In the case of do-it-yourselfers *, OSHA does not have jurisdiction, and OSHA does not require theses practices to be followed. To reduce the potential exposure to asbestos, EPA strongly recommends that all automotive brake and clutch repair work be done by professional auto mechanics. "
If you or a loved one suffers from an asbestos related injury, contact Bagolie Friedman Injury Lawyers for a confidential and free consultation.
asbestos lawyer
Tuesday, August 29, 2006
Saturday, August 26, 2006
Ortho Evra Lawsuit Filed
A law suit has been filed against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc. (NYSE:JNJ), on behalf of a 34 year-old woman. The woman was diagnosed with a severe pulmonary embolism after using the Ortho Evra birth control patch less than two years. The suit was filed in the United States District Court for the District of New Jersey earlier this month.
Friday, August 18, 2006
Saturday, August 12, 2006
Charite Artificial Disc Recipients Take Legal Steps
Artificial Disc Recipients Take Legal Steps
There are success stories, but more than two dozen patients claim the device is too risky
Aug 4, 2006 | Rong-Gong Lin II | Los Angeles Times
Since the moment a decade ago when Dane Titsworth picked up a box and a disc in his spine burst, he has been in ever-worsening pain.
So it was with great hope that the Bakersfield building maintenance manager agreed last year to a new procedure. It meant replacing the deteriorating disc in his lower back with a Charite-brand artificial one the first artificial replacement disc approved in the U.S.
"The artificial disc was going to restore my full motion and relieve all my pain," he recalled being told by his doctor. "I would be like a new person."
But after the surgery, he said, the pain became excruciating, virtually immobilizing him. He could no longer work, garden, play catch or ride his motorcycle. After about 10 months on sick leave, he lost his job.
"It failed," said Titsworth, 45, a married father of a 13-year-old son and 2-year-old daughter. "It's pretty much stopped my life." And now he is suing the disc's maker, DePuy Spine Inc., a Raynham, Mass.-based subsidiary of Johnson & Johnson.
Used in Europe since the 1980s and approved by the Food and Drug Administration in 2004, the Charite disc is marketed as an alternative to spinal fusion and is part of the growing and sometimes controversial use of spinal surgery.
The disc's maker says the product is safe and has helped thousands of patients. But DePuy had no comment on Titsworth's case or 27 similar lawsuits filed since January. Five involve California plaintiffs.
The suits allege that the disc is "unreasonably dangerous."
"They've designed a defective product that does not work as intended or as advertised, and in fact causes some horrific side effects," said Titsworth's lawyer.
DePuy spokeswoman Debbie Williams says the product garnered high satisfaction rates among patients and surgeons in a two-year, industry-funded study that was filed with the FDA before its approval.
"As with all surgical procedures, there is a potential for adverse events or complications," Williams said in an e-mail. Still, "the clinical evidence shows the Charite artificial disc is an effective treatment and an option for appropriate patients."
She said that the product "preserves some motion" and "has demonstrated a shorter recovery time compared to fusion." Spinal fusion, the leading surgical treatment for damaged discs, involves placing bone grafts around two or more of the vertebrae during surgery. The body then heals the grafts over several months, which "welds" the vertebrae into a rigid section.
Dr. John Regan, a Beverly Hills surgeon who performs surgery using the artificial disc, said fusion might add stress on adjacent, healthier discs, increasing the risk of future damage.
In contrast, an artificial replacement disc is designed to keep the damaged area flexible, said Regan, who receives some royalties from DePuy unrelated to surgeries he has performed.
Some patients say the Charite disc has given them a new chance for an active lifestyle they thought had been lost forever.
Ron Osborn, 57, of Saugus, said he was surprised at how well his Charite disc has performed. The natural disc it replaced had deteriorated so much that the bones on his spine were crushing a major nerve, leaving him unable to walk for weeks at a time.
"Now I'm back," said Osborn, a sales manager for a golf company. "I've got 100% restoration. I have a back of a 20-year-old."
Similarly, Rick Zayed, 38, an aerospace mechanical engineer from Hermosa Beach, went from struggling to lift a laundry basket to swimming, running and mountain biking.
"So far, everything they said it would do, it's been doing," Zayed said.
But Dr. Allyson Fried-Cain, a former foot-and-ankle surgeon who has sued the manufacturer, said that she suffered such an increase in pain after a Charite disc implantation that she lost her practice and had to sell her Marina del Rey home.
"I couldn't do surgery anymore. I couldn't bend over," said Fried-Cain, 52, a former marathon runner whose back injury resulted from a car accident.
"This implant has destroyed my life," she said.
The Charite disc is advertised on its website with the trademarked slogan "natural motion is back," along with a photo of a family walking through a field.
The suits come as spinal surgery is becoming a very lucrative business, with at least $3.2 billion spent last year in the U.S. on spinal fusion.
Millions of Americans who suffer from persistent lower back pain are looking for relief, and employers lose billions of dollars every year from lost work time due to back pain.
Other medical device companies, including West Chester, Pa.-based Synthes Inc. and Minneapolis-based Medtronic Inc., are developing disc replacements.
"It's an enormous commercial opportunity," said Phil Nabone, a medical technology analyst at RBC Capital Markets.
But since its launch, the Charite disc has been controversial.
Although two national insurance carriers and 60 regional providers cover the device, a medical advisory panel for the Blue Cross Blue Shield Assn. said in an evidence-based review last year that there was "no immediately evident advantage" to using the artificial disc.
And this year, the U.S. Centers for Medicare and Medicaid Services questioned the disc's overall effectiveness.
The original two-year trial sent to the FDA showed only that the disc was no worse than a specific type of spinal fusion surgery, the agency said in a 45-page report released in May.
The study is sometimes criticized because it compared the disc with a spinal fusion technique that has fallen out of favor among surgeons.
The trial submitted to the FDA found that 57% of Charite patients achieved "overall clinical success," compared with 47% in the spinal fusion procedure. More than 3 in 5 Charite disc patients who were considered successes continued taking narcotic pain killers two years after the surgery; while 4 in 5 did so in the control group.
But a higher percentage of Charite disc patients suffered severe or life-threatening events than the spinal fusion group: 15% compared with 9%, according to an FDA clinical review.
As a result, the agency ruled that Medicare would bar coverage of the device for anyone older than 60. Local Medicare contractors were allowed to make the decision for anyone younger.
"This composite outcome is unconvincing as a demonstration of health benefit," the Medicare report said.
Some doctors are equally skeptical.
Dr. Sohail Mirza, a University of Washington medical professor, took issue with Charite disc's marketing slogan of "natural motion is back." It "implies that the artificial disc creates a normal spine; it does not," he wrote in the journal Spine last year.
"Contrary to optimistic marketing, the data … argue for caution by patients and surgeons. Hope for a cure of back pain and a marketing bonanza must be held in check," he wrote.
Dr. Charles Rosen, associate clinical professor of spine surgery at UC Irvine, said he has seen 10 patients since late last year, including Titsworth, complaining of worsening pain after they received the Charite disc.
Rosen said he believes the disc is unsafe and should never have been approved by the FDA. After the surgery, some patients suffered fracturing and an abnormal pulling apart of the joints of the spine, he said. Rosen said the two-year study was too short for a disc that will remain in the spine for many years; the average age of a disc recipient is 40.
"There is no solid evidence that this will last for more than five or 10 years and they will not need to have another operation," Rosen said.
Regan, who helped conduct the clinical trial for the Charite disc, said he is convinced the disc is good technology.
"When you focus on the failures, everyone's thinking, 'What's wrong with this?' " Regan said. "Then it spoils it for the many, many patients who are doing great."
If you or a loved one suffer from problems due to a Charite Artificial Disc, contact Bagolie Friedman Injury Lawyers for a confidential and free consultation.
There are success stories, but more than two dozen patients claim the device is too risky
Aug 4, 2006 | Rong-Gong Lin II | Los Angeles Times
Since the moment a decade ago when Dane Titsworth picked up a box and a disc in his spine burst, he has been in ever-worsening pain.
So it was with great hope that the Bakersfield building maintenance manager agreed last year to a new procedure. It meant replacing the deteriorating disc in his lower back with a Charite-brand artificial one the first artificial replacement disc approved in the U.S.
"The artificial disc was going to restore my full motion and relieve all my pain," he recalled being told by his doctor. "I would be like a new person."
But after the surgery, he said, the pain became excruciating, virtually immobilizing him. He could no longer work, garden, play catch or ride his motorcycle. After about 10 months on sick leave, he lost his job.
"It failed," said Titsworth, 45, a married father of a 13-year-old son and 2-year-old daughter. "It's pretty much stopped my life." And now he is suing the disc's maker, DePuy Spine Inc., a Raynham, Mass.-based subsidiary of Johnson & Johnson.
Used in Europe since the 1980s and approved by the Food and Drug Administration in 2004, the Charite disc is marketed as an alternative to spinal fusion and is part of the growing and sometimes controversial use of spinal surgery.
The disc's maker says the product is safe and has helped thousands of patients. But DePuy had no comment on Titsworth's case or 27 similar lawsuits filed since January. Five involve California plaintiffs.
The suits allege that the disc is "unreasonably dangerous."
"They've designed a defective product that does not work as intended or as advertised, and in fact causes some horrific side effects," said Titsworth's lawyer.
DePuy spokeswoman Debbie Williams says the product garnered high satisfaction rates among patients and surgeons in a two-year, industry-funded study that was filed with the FDA before its approval.
"As with all surgical procedures, there is a potential for adverse events or complications," Williams said in an e-mail. Still, "the clinical evidence shows the Charite artificial disc is an effective treatment and an option for appropriate patients."
She said that the product "preserves some motion" and "has demonstrated a shorter recovery time compared to fusion." Spinal fusion, the leading surgical treatment for damaged discs, involves placing bone grafts around two or more of the vertebrae during surgery. The body then heals the grafts over several months, which "welds" the vertebrae into a rigid section.
Dr. John Regan, a Beverly Hills surgeon who performs surgery using the artificial disc, said fusion might add stress on adjacent, healthier discs, increasing the risk of future damage.
In contrast, an artificial replacement disc is designed to keep the damaged area flexible, said Regan, who receives some royalties from DePuy unrelated to surgeries he has performed.
Some patients say the Charite disc has given them a new chance for an active lifestyle they thought had been lost forever.
Ron Osborn, 57, of Saugus, said he was surprised at how well his Charite disc has performed. The natural disc it replaced had deteriorated so much that the bones on his spine were crushing a major nerve, leaving him unable to walk for weeks at a time.
"Now I'm back," said Osborn, a sales manager for a golf company. "I've got 100% restoration. I have a back of a 20-year-old."
Similarly, Rick Zayed, 38, an aerospace mechanical engineer from Hermosa Beach, went from struggling to lift a laundry basket to swimming, running and mountain biking.
"So far, everything they said it would do, it's been doing," Zayed said.
But Dr. Allyson Fried-Cain, a former foot-and-ankle surgeon who has sued the manufacturer, said that she suffered such an increase in pain after a Charite disc implantation that she lost her practice and had to sell her Marina del Rey home.
"I couldn't do surgery anymore. I couldn't bend over," said Fried-Cain, 52, a former marathon runner whose back injury resulted from a car accident.
"This implant has destroyed my life," she said.
The Charite disc is advertised on its website with the trademarked slogan "natural motion is back," along with a photo of a family walking through a field.
The suits come as spinal surgery is becoming a very lucrative business, with at least $3.2 billion spent last year in the U.S. on spinal fusion.
Millions of Americans who suffer from persistent lower back pain are looking for relief, and employers lose billions of dollars every year from lost work time due to back pain.
Other medical device companies, including West Chester, Pa.-based Synthes Inc. and Minneapolis-based Medtronic Inc., are developing disc replacements.
"It's an enormous commercial opportunity," said Phil Nabone, a medical technology analyst at RBC Capital Markets.
But since its launch, the Charite disc has been controversial.
Although two national insurance carriers and 60 regional providers cover the device, a medical advisory panel for the Blue Cross Blue Shield Assn. said in an evidence-based review last year that there was "no immediately evident advantage" to using the artificial disc.
And this year, the U.S. Centers for Medicare and Medicaid Services questioned the disc's overall effectiveness.
The original two-year trial sent to the FDA showed only that the disc was no worse than a specific type of spinal fusion surgery, the agency said in a 45-page report released in May.
The study is sometimes criticized because it compared the disc with a spinal fusion technique that has fallen out of favor among surgeons.
The trial submitted to the FDA found that 57% of Charite patients achieved "overall clinical success," compared with 47% in the spinal fusion procedure. More than 3 in 5 Charite disc patients who were considered successes continued taking narcotic pain killers two years after the surgery; while 4 in 5 did so in the control group.
But a higher percentage of Charite disc patients suffered severe or life-threatening events than the spinal fusion group: 15% compared with 9%, according to an FDA clinical review.
As a result, the agency ruled that Medicare would bar coverage of the device for anyone older than 60. Local Medicare contractors were allowed to make the decision for anyone younger.
"This composite outcome is unconvincing as a demonstration of health benefit," the Medicare report said.
Some doctors are equally skeptical.
Dr. Sohail Mirza, a University of Washington medical professor, took issue with Charite disc's marketing slogan of "natural motion is back." It "implies that the artificial disc creates a normal spine; it does not," he wrote in the journal Spine last year.
"Contrary to optimistic marketing, the data … argue for caution by patients and surgeons. Hope for a cure of back pain and a marketing bonanza must be held in check," he wrote.
Dr. Charles Rosen, associate clinical professor of spine surgery at UC Irvine, said he has seen 10 patients since late last year, including Titsworth, complaining of worsening pain after they received the Charite disc.
Rosen said he believes the disc is unsafe and should never have been approved by the FDA. After the surgery, some patients suffered fracturing and an abnormal pulling apart of the joints of the spine, he said. Rosen said the two-year study was too short for a disc that will remain in the spine for many years; the average age of a disc recipient is 40.
"There is no solid evidence that this will last for more than five or 10 years and they will not need to have another operation," Rosen said.
Regan, who helped conduct the clinical trial for the Charite disc, said he is convinced the disc is good technology.
"When you focus on the failures, everyone's thinking, 'What's wrong with this?' " Regan said. "Then it spoils it for the many, many patients who are doing great."
If you or a loved one suffer from problems due to a Charite Artificial Disc, contact Bagolie Friedman Injury Lawyers for a confidential and free consultation.
Injured by the Duragesic Fentanyl Patch?
Injured by the Duragesic Patch?
On July 15, 2005 the FDA issued a Public Health Advisory concerning the use of Duragesic Patches (Fentanyl transdermal) in response to reports of deaths in patients using the patch. The FDA is conducting an investigation into the deaths associated with these patches.
The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.
There has been an expanded recall of Duragesic Patches due to possible leaks. Janssen Pharmaceutica, the manufacturer of the Duragesic Patch notified healthcare professionals of an expanded recall of the Duragesic 75 mcg/h, in February 2004. Four additional lots have been subject to the present expanded recall. Some patches from the recalled lots may leak medication due to improper sealing of one of their edges.
If the medication leaks out of the patch, exposure to the medication can result in inadvertent ingestion or increased transdermal absorption of the active opiate component fentanyl, leading to potentially life-threatening complications. In addition, leakage of the medication could lead to inadequate dosing, resulting in treatment failure and/or opiate withdrawal.
The Duragesic Patch is indicated for the management of severe, chronic pain (such as cancer pain) that cannot be managed with less powerful drugs such as acetaminophen-opioid combinations and nonsteroidal analgesics.
Moreover, only patients who are already on and tolerant to opioid therapy, and require continuous opioid administration should use the patch. Approved by the U.S. Food and Drug Administration (FDA) in 1990, the Duragesic patch releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is available only by prescription.
If you or a loved one used a Duragesic Patch and suffered side effects, please fill out the form at the right for a free lawsuit case evaluation by Bagolie Friedman Injury Lawyers.
On July 15, 2005 the FDA issued a Public Health Advisory concerning the use of Duragesic Patches (Fentanyl transdermal) in response to reports of deaths in patients using the patch. The FDA is conducting an investigation into the deaths associated with these patches.
The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.
There has been an expanded recall of Duragesic Patches due to possible leaks. Janssen Pharmaceutica, the manufacturer of the Duragesic Patch notified healthcare professionals of an expanded recall of the Duragesic 75 mcg/h, in February 2004. Four additional lots have been subject to the present expanded recall. Some patches from the recalled lots may leak medication due to improper sealing of one of their edges.
If the medication leaks out of the patch, exposure to the medication can result in inadvertent ingestion or increased transdermal absorption of the active opiate component fentanyl, leading to potentially life-threatening complications. In addition, leakage of the medication could lead to inadequate dosing, resulting in treatment failure and/or opiate withdrawal.
The Duragesic Patch is indicated for the management of severe, chronic pain (such as cancer pain) that cannot be managed with less powerful drugs such as acetaminophen-opioid combinations and nonsteroidal analgesics.
Moreover, only patients who are already on and tolerant to opioid therapy, and require continuous opioid administration should use the patch. Approved by the U.S. Food and Drug Administration (FDA) in 1990, the Duragesic patch releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is available only by prescription.
If you or a loved one used a Duragesic Patch and suffered side effects, please fill out the form at the right for a free lawsuit case evaluation by Bagolie Friedman Injury Lawyers.
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