It appears that LA County California has had it's share of Fentanyl related overdoses.
November 25, 2005 latimes.com THE NATION
FDA Slow to Sound Alarm on Pain Drug
Fentanyl's overdose rate and side effects show holes in monitoring medicine on the market.
By Ricardo Alonso-Zaldivar, Times Staff Writer
WASHINGTON — Dory Bauler prides herself on staying active despite painful back problems. But at one point this year, she was getting so short of breath that she could barely walk. Doctors could find nothing wrong.
It never occurred to them that the medicinal skin patch she was using to deliver pain relief might also be poisoning her.
"I was just shutting down," said Bauler, 76, a retired paralegal from Laguna Woods in Orange County, who suffers from a severe curvature of the spine. "There were literally times I felt I wasn't getting any oxygen at all."
Bauler's patch was delivering fentanyl, a narcotic many times more powerful than morphine. Like morphine and other opioid drugs, fentanyl controls pain but also reduces respiratory function — and too much fentanyl can shut down one's breathing entirely. Luckily, Bauler figured out what was happening in time to stop using the drug.
The leading brand of the fentanyl patch is Johnson & Johnson's Duragesic; last year, pharmacists filled more than 4 million prescriptions for it.
The drug was developed to help people with extreme, unremitting pain, such as cancer patients. But it is increasingly being used for other medical conditions and, in some cases, by drug abusers.
Misuse can be lethal.
In the last six years, the Los Angeles County coroner's office has investigated more than 230 deaths involving fentanyl. Of the deaths, records show 127 were classified as "accidental"— suggesting that the victims inadvertently had taken too much. And evidence from other states and the Food and Drug Administration suggests there may be many more such cases nationwide.
The fentanyl patch illustrates a broad and still-unresolved problem with the nation's system for protecting patients against drug risks: Neither the FDA nor the pharmaceutical industry has a comprehensive system for monitoring what happens after a new drug is approved for market.
Sometimes, as with the highly publicized discovery of heart and stroke risks associated with the painkiller Vioxx, the problem is that dangers show up only after millions of people begin using a drug. In other cases, as with fentanyl, the problem is that a drug approved for one purpose and in one context can be prescribed and used for other purposes. Known as off-label use, the risks of such use are not always understood.
"You've got a spectrum of the [drug safety] problem here," said Dr. Alastair J.J. Wood, associate dean at Vanderbilt University Medical School and an advisor to the FDA. "There isn't one easy solution. You need to have doctors think through whether this is the appropriate medicine for the patient."
Cancer patients, for whom the fentanyl patch was developed, are usually monitored closely by a physician. Increasingly, however, the patches are being prescribed for other patients and conditions, sometimes without close monitoring.
The FDA says it is investigating about 130 fatalities that occurred over a 15-year period. Evidence from autopsies in Los Angeles and Florida suggests the number of fentanyl-related deaths may be much higher. The federal reporting system picks up a fraction of bad drug reactions.
"There are hundreds more cases not evaluated by the FDA," said Bruce A. Goldberger, director of toxicology at the University of Florida Medical School.
In Los Angeles County, criminalist Daniel T. Anderson of the coroner's office said the "vast majority" of fentanyl-related deaths involved the patch. The deaths occurred over a 5 1/2 -year period ending this summer.
For the 127 classified as accidental, it is believed that patients often misunderstood how to avoid the drug's risks.
"Typically, the people we see here are people who have a legitimate use for the patch," Anderson said. He had called attention to overdose deaths involving the Duragesic patch in a professional journal article published in 2000.
In Florida, state authorities reported 115 deaths from fentanyl poisoning in 2004, records show. Goldberger, whose office handles about one-fourth of the autopsies in the state, said the majority involved the patch.
Drug abuse involving fentanyl also is on the rise. Emergency-room cases involving the drug rose from 28 in 1994 to 1,506 last year, according to the federal Substance Abuse and Mental Health Services Administration.
"It is definitely a neglected drug safety problem," Goldberger said.
FDA Slow to Sound Alarm on Pain Drug
As Congress weighs changes to strengthen the drug safety system, the history of the fentanyl patch shows that the FDA and many in the medical community knew of risks but failed to closely monitor the growing use of a potent narcotic.
Duragesic sales more than doubled from 2000 to 2004, as manufacturer Johnson & Johnson promoted it as safe in advertising to doctors that the FDA called "misleading." With $1.2 billion in sales in 2004, Duragesic surpassed Vioxx, according to Drugtopics.com, a pharmaceutical website. Yet as early as 2001, a drug safety group had warned that patients on the patch were dying of overdoses. Some doctors were prescribing the patch for patients who did not tolerate opioid drugs well, cautioned the Institute for Safe Medication Practices in Pennsylvania.
It took another four years for the FDA to issue its own nationwide alert, on July 15.
The FDA warnings, though welcome, are not enough, in the view of Michael Cohen, president of the safety group that initially sounded the alarm. Cohen, a pharmacist, said he was frustrated that the agency took so long to recognize the problem.
"We are the main safety organization for medication error reporting, and the FDA receives our information," Cohen said. "Sometimes, information that is provided by us does seem to get lost within the FDA."
Dr. Robert J. Meyer, head of the FDA office that oversees painkillers, said that safety officers this year noticed a trend of adverse reactions involving the drug.
"The system in place, though never ideal, does work well," Meyer said. "The FDA did the right thing in [issuing] its communication. One of the things we need to think about in the future is continuing communications in terms of drugs like this that have some safety concerns."
Cohen's organization is calling for more aggressive FDA action, including a program to educate patients about the risks of the patch, new instructions for disposing of used and unwanted patches, and wider use of childproof packaging.
Vanderbilt's Wood does not believe that warnings will suffice. "It's like the warnings on an SUV: Beware of rollover," he said. "The lawyers are happy with that, but does it prevent rollovers? Warnings probably don't work."
Bauler, the Laguna Woods paralegal, said reading a newspaper report about the FDA warning may have saved her life. She took herself off the patch, and her breathing problems cleared up in a few days.
"It was like having to be my own detective," Bauler said. "Then I got angry. I have been through this hell that could have been prevented."
Others were not so fortunate. Among the victims was a preschooler from East Toledo, Ohio. Four-year-old Timothy Rhodes was found dead in January after he got hold of a Duragesic patch prescribed for his mother, Stephanie, her family said.
A spokesman for Johnson & Johnson, which makes Duragesic, said the drug met an important need for cancer patients and others with chronic pain. The company is working with the FDA, doctors and patients to make sure it is used safely — and has introduced child-resistant packaging, Doug Arbesfeld said.
"We take the health and safety of the patients who use this product very seriously," Arbesfeld said. "We work very closely with the FDA to look into all reports of serious adverse consequences, and we believe that the product is safe and effective when used as directed."
The manufacturer had promoted Duragesic to doctors as superior medication for back pain and other problems.
"Game, uninterrupted," reads the caption on a Duragesic brochure that showed a middle-aged man shooting pool.
Another photo showed a pair of hands kneading dough. "1,360 loaves … and counting," read the caption. "Work, uninterrupted."
Last year, the FDA sent the company a sharply worded letter about its advertising to doctors. The agency said many of the claims about Duragesic were not substantiated.
And, "by suggesting that Duragesic has a lower potential for abuse compared to other opioid products, the [promotional material] could encourage the unsafe use of the drug, potentially resulting in serious or life-threatening hypoventilation" — a reduced capacity to breathe, the FDA said.
FDA Slow to Sound Alarm on Pain Drug
Arbesfeld said the company had stopped using the literature.
The FDA approved Duragesic in 1990 to treat chronic pain. The patch consists of a drug reservoir encased in a soft plastic film. When applied to the body, it releases fentanyl through a membrane. The drug is absorbed into the upper layers of the skin and circulates through the bloodstream. From the beginning, Duragesic carried strong warnings. Doctors were cautioned about fentanyl's potency. Patients were warned not to use more than one patch and to avoid seemingly innocuous actions that could cause the drug to be released more rapidly, such as wearing a heating pad or sunbathing.
Physicians and pharmacists say the patch is a good treatment for patients with severe pain. Each patch can be worn for 72 hours, maintaining a stable level of painkiller in the body.
"If you have a patient who can't swallow pills, it is really important to have patches available," said Dr. Judith Ford, a professor of radiation oncology at UCLA's Jonsson Comprehensive Cancer Center. Ford says she starts her patients with a small dose and asks them to keep diaries to track the results.
"Fentanyl is a useful drug, but the market is not very big," said Larry Sasich, a pharmacist who teaches drug policy at the Lake Erie College of Osteopathic Medicine in Erie, Pa. "This is a serious drug for serious pain, and that is a pretty limited market."
But the fact that Duragesic comes in a patch may have made it seem more benign to patients than other strong painkillers.
Ford said she recalled a conversation with a patient who did not want to take another narcotic because he feared becoming addicted. But the same patient had no problems with using the patch, although fentanyl also can create dependency.
Roslyn Joress of Boynton Beach, Fla., said her doctor put her on the Duragesic patch for pain for a connective tissue disorder called fibromyalgia.
"I didn't even realize that I was on a narcotic for the longest time," said Joress, 67. "I thought it was like another medication they come out with in patch form and that it was going to relax the muscles. If the doctor had said to me, 'This is like morphine,' never in my wildest dreams would I have taken it."
Joress said she found out Duragesic was a narcotic from another woman she saw wearing a patch at poolside.
When Joress tried to strike up a conversation about the patch, the woman responded, "Oh yeah, I'm a junkie."
Joress got scared and decided to quit the drug, but went through intense withdrawal symptoms.
"I went from an addiction I didn't even know was an addiction, to needing sleeping aids," she said.
As for her pain, "it's nothing a couple of Tylenol won't take care of."
*
Pain patch profits
From 2000 to 2004, sales of Duragesic, the leading brand-name painkiller patch, more than tripled, and the number of prescriptions more than doubled.
Revenue
(In millions) 2000: $352.9
2001: $530.0
2002: $752.7
2003: $1,049.8
2004: $1,208.4
--
Prescriptions
(In thousands)
2000: 1,766
2001: 2,426
2002: 3,009
2003: 3,659
2004: 4,114
Source: Drugtopics.com
Wednesday, November 30, 2005
Wednesday, November 23, 2005
Beware of Duragesic Pain Patch Use
Duragesic Pain Patch Issues
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 who require continuous opioid administration should use the patch.
Approved by the U.S. Food and Drug Administration (FDA) in 1990, Duragesic releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is made by Janssen Pharmaceutica and available by prescription only.
A boxed warning indicates that Duragesic is not to be used in the following circumstances: to manage acute or postoperative pain, including pain after outpatient surgery for mild or intermittent chronic pain that can be managed with less powerful drugs at a dose higher than 25 micrograms per hour by children under age 12 by patients under age 18 who weigh less than 110 lbs. Side effects include, but may not be limited to, nausea, vomiting, constipation, drowsiness, weakness, dry mouth, hypotension and loss of appetite. Users are warned to avoid exposure to external heat sources such as heating pads and electric blankets, hot tubs, heated water beds, heat lamps, etc., because of a potential for temperature-dependent increases in fentanyl release that may lead to an overdose.
In February 2004, Janssen and the FDA notified healthcare professionals of a Class I recall of DURAGESIC 75 mcg/h. Only Control Number 0327192 (expiration October 2005) is subject to this recall. A potential seal breach on one edge may allow the drug to leak from the patch and could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications. Conversely, if the hydrogel contents leak out of the patch, there may not be adequate medication to treat the patients' pain. In an opioid tolerant patient, this may lead to withdrawal symptoms, which include sweating, sleeplessness and abdominal discomfort. Over 400,000 patches are included in the recall.
In April 2004, Janssen expanded the Duragesic patch recall to include a total of 2.2 million patches. Health officials believe that over 20 percent of the recalled patches are still in use.In July 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued identifying several important safety precautions for the use of fentanyl transdermal patches. These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal.
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.The Agency is working closely with the manufacturers of fentanyl patches to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose.
See your doctor if you suffered an adverse side effect while using the Duragesic patch. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.
Duragesic Lawsuit
On Apr-05-04, Janssen Pharmaceutical Products LP issued an urgent recall for defective patches. The recall applies only to specific manufacturing lots of the 75mcg strength patches, which have a faulty seal that permits full strength fentanyl to leak from the patch. This could result in patients being given an overdose of fentanyl, which can cause fatal respiratory and/or cardiac arrest.
Only the following lot numbers are affected:NDC no. 50458-035-05Lot Control nos. 0327192, 0327193, 0327294, 0327295, and 0330362
Symptoms of Overdose Symptoms of a fentanyl overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness or coma, confusion, tiredness, cold and clammy skin, and small pupils. Continued exposure to uncontrolled amounts of fentanyl can lead to addiction and dependency.
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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 who require continuous opioid administration should use the patch.
Approved by the U.S. Food and Drug Administration (FDA) in 1990, Duragesic releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is made by Janssen Pharmaceutica and available by prescription only.
A boxed warning indicates that Duragesic is not to be used in the following circumstances: to manage acute or postoperative pain, including pain after outpatient surgery for mild or intermittent chronic pain that can be managed with less powerful drugs at a dose higher than 25 micrograms per hour by children under age 12 by patients under age 18 who weigh less than 110 lbs. Side effects include, but may not be limited to, nausea, vomiting, constipation, drowsiness, weakness, dry mouth, hypotension and loss of appetite. Users are warned to avoid exposure to external heat sources such as heating pads and electric blankets, hot tubs, heated water beds, heat lamps, etc., because of a potential for temperature-dependent increases in fentanyl release that may lead to an overdose.
In February 2004, Janssen and the FDA notified healthcare professionals of a Class I recall of DURAGESIC 75 mcg/h. Only Control Number 0327192 (expiration October 2005) is subject to this recall. A potential seal breach on one edge may allow the drug to leak from the patch and could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications. Conversely, if the hydrogel contents leak out of the patch, there may not be adequate medication to treat the patients' pain. In an opioid tolerant patient, this may lead to withdrawal symptoms, which include sweating, sleeplessness and abdominal discomfort. Over 400,000 patches are included in the recall.
In April 2004, Janssen expanded the Duragesic patch recall to include a total of 2.2 million patches. Health officials believe that over 20 percent of the recalled patches are still in use.In July 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued identifying several important safety precautions for the use of fentanyl transdermal patches. These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal.
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.The Agency is working closely with the manufacturers of fentanyl patches to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose.
See your doctor if you suffered an adverse side effect while using the Duragesic patch. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.
Duragesic Lawsuit
On Apr-05-04, Janssen Pharmaceutical Products LP issued an urgent recall for defective patches. The recall applies only to specific manufacturing lots of the 75mcg strength patches, which have a faulty seal that permits full strength fentanyl to leak from the patch. This could result in patients being given an overdose of fentanyl, which can cause fatal respiratory and/or cardiac arrest.
Only the following lot numbers are affected:NDC no. 50458-035-05Lot Control nos. 0327192, 0327193, 0327294, 0327295, and 0330362
Symptoms of Overdose Symptoms of a fentanyl overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness or coma, confusion, tiredness, cold and clammy skin, and small pupils. Continued exposure to uncontrolled amounts of fentanyl can lead to addiction and dependency.
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About the Charite Medical School.
Charité - Universitätsmedizin Berlin
The Charite Medical school and university hospital of the Berlin Humboldt University with three campuses: “Campus Mitte”, “Campus Virchow-Klinikum”, and “Campus Berlin Buch”. This facility is not to be confused with the Charite Artificial Replacement Disc, the subject of controversey and litigation and currently being investigated by Bagolie Friedman Injury Lawyers.
The largest university hospital in Europe, with 2,307 beds in 49 clinics, treating roughly 100,000 inpatients and 250,000 outpatients per year with support from 26 theoretical institutes. An employer of 9,384 people, including 2,120 scientists. Educational facility for 4,905 students in human medicine and dentistry, nursing education and nursing science and medical physics. A large business enterprise using state-of-the-art data processing and management technology in medicine and administration. It has a total budget of 1.3 billion marks, 0.88 billion of which goes directly to patient care. A medical complex with three campuses: “Campus Virchow- Klinikum”, completed in 1998 and one of the most modern university hospitals in Europe; “Campus Mitte”, Germany’s oldest medical treatment facility still located on its original site; and “Campus Buch”, which provides the link to a large national research facility. The only medical school in Europe whose name is both a virtue and a mission: charity. Charite
charite
The Charite Medical school and university hospital of the Berlin Humboldt University with three campuses: “Campus Mitte”, “Campus Virchow-Klinikum”, and “Campus Berlin Buch”. This facility is not to be confused with the Charite Artificial Replacement Disc, the subject of controversey and litigation and currently being investigated by Bagolie Friedman Injury Lawyers.
The largest university hospital in Europe, with 2,307 beds in 49 clinics, treating roughly 100,000 inpatients and 250,000 outpatients per year with support from 26 theoretical institutes. An employer of 9,384 people, including 2,120 scientists. Educational facility for 4,905 students in human medicine and dentistry, nursing education and nursing science and medical physics. A large business enterprise using state-of-the-art data processing and management technology in medicine and administration. It has a total budget of 1.3 billion marks, 0.88 billion of which goes directly to patient care. A medical complex with three campuses: “Campus Virchow- Klinikum”, completed in 1998 and one of the most modern university hospitals in Europe; “Campus Mitte”, Germany’s oldest medical treatment facility still located on its original site; and “Campus Buch”, which provides the link to a large national research facility. The only medical school in Europe whose name is both a virtue and a mission: charity. Charite
charite
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Ghoul case transplant recipients may face risk of HIV, syphilis, other ailments
Ghoul case transplant recipients may face risk of HIV, syphilis, other ailments
BY WILLIAM SHERMANDAILY NEWS STAFF WRITER
Daily News dug up scandal Oct. 8. Biomedical president Michael Mastromarino. A body-snatching ring that illicitly harvested bone and tissue from corpses has placed thousands of transplant patients at risk for contracting infectious diseases.In a product recall notice, Tutogen Medical Inc. warned that human cadaveric tissue obtained from Biomedical Tissue Services Ltd. could be tainted.
The diseases could include HIV, syphilis, hepatitis and viral infections, according to regulatory authorities.
"There is a lack of assurance that appropriate [corpse] donor identification, donor screening and medical history data collection was performed and therefore, a risk of infectious disease exists," states the warning issued to doctors and hospitals throughout North America.
Tutogen, among others, distributed bone and tissue products it bought from Biomedical until earlier this month when the Daily News disclosed that the operation was under investigation by the Brooklyn district attorney's office.
The recall notice cited The News' disclosures on the ring, which is headed by Biomedical president Michael Mastromarino, a former dentist based in Fort Lee, N.J.
Along with others, Mastromarino personally carved up corpses and sold body parts to tissue processing companies that then distributed the products to doctors, dentists and medical centers for final transplant into human beings.
The Food and Drug Administration last week said that corpses harvested by the body-snatching ring "may not have been properly screened for certain infectious diseases."
"Some recipients of the tissues may be at increased risk of infections that could potentially be transmitted," the FDA said.
The agency also said that the risks of infection are low and that no adverse reactions have been reported so far, adding, "however, the actual infectious risk is unknown."
HIV, hepatitis, syphilis and viral infections are among the possible diseases cited by U.S. and Canadian health authorities.
Transplants possibly affected include bone for dental implants and a variety of orthopedic reconstructive procedures, skin for burn victims, fatty thigh tissue for cosmetic procedures and tendons and ligaments for those who have torn them.
FDA officials and the Centers for Disease Control and Prevention recommended blood tests for patients who got the questionable products.
The latest developments sent shock waves through the tissue transplant industry and doctors who use the products.
Dr. David Behrman, chief of the division of oral surgery at New York Weill Cornell Medical Center, said, "Many surgeons have been notified by their suppliers of bone-graft material that likely came from some of these questionable donors."
"We are awaiting guidance from the FDA as to what should be done and whether we should begin testing our patients for infectious disease among other recommendations," he said.
In Canada, Calgary public health officials immediately moved to quarantine product derived from Biomedical and said they will test one at-risk patient for HIV, hepatitis B and C, human T-cell lymphotrophic virus and syphilis.
"We confiscated the product, and traced it back, found one patient, contacted the patient, and we will begin the blood tests," said Leanne Niblock, spokeswoman for the Calgary Health Region.
Although the incidence of transplant recipients contracting disease from corpse body parts has been rare, several scandals have shaken the industry.
Three years ago, a 23-year-old Minnesota man died of an infection that came with transplanted ligaments inserted during knee surgery. The tissue was supplied by CryoLife, an Atlanta tissue bank, and the infection was identified as the rare bacterium Clostridium soredelli.
More recently, dozens of patients in Oregon were infected with hepatitis C contracted from tissue supplied from a single corpse.
Mastromarino's body parts were carved from hundreds of corpses obtained at funeral homes throughout the city and other states beginning in 2002 in an enterprise that continued until this month.
Mastromarino is under investigation by Brooklyn prosecutors for allegedly creating forged relatives' consent forms and phony medical records for the deceased in the harvesting scam.
The alleged medical record forgeries were designed to conceal conditions that would normally render the products unacceptable for sale. Those conditions include cancer, habitual intravenous drug use and many contagious diseases.
Joseph Nicelli of Staten Island an embalmer who was once Mastromarino's partner in the tissue recovery business, is also under investigation along with numerous funeral home directors who provided bodies.
After harvesting, the bone, tissue and other body parts were frozen by BTS and then shipped out overnight to Tutogen and other companies for processing before final transplant.
The other four processing companies are Lifecell Corp. of Branchburg, N.J., Lost Mountain Tissue Bank of Kennesaw, Ga., Blood and Tissue Center of Central Texas in Austin and Regeneration Technologies Inc. of Alachua, Fla.
All but Lost Mountain Tissue Bank told The News they were unaware of Mastromarino's allegedly illegal activities and that they follow extensive tissue testing and sterilization procedures of their own before they ship any product out.
James Wade, director of Lost Mountain, said, "I have no comment at all; we're following the FDA guidelines. I can't say more than that."
Originally published on October 30, 2005
BY WILLIAM SHERMANDAILY NEWS STAFF WRITER
Daily News dug up scandal Oct. 8. Biomedical president Michael Mastromarino. A body-snatching ring that illicitly harvested bone and tissue from corpses has placed thousands of transplant patients at risk for contracting infectious diseases.In a product recall notice, Tutogen Medical Inc. warned that human cadaveric tissue obtained from Biomedical Tissue Services Ltd. could be tainted.
The diseases could include HIV, syphilis, hepatitis and viral infections, according to regulatory authorities.
"There is a lack of assurance that appropriate [corpse] donor identification, donor screening and medical history data collection was performed and therefore, a risk of infectious disease exists," states the warning issued to doctors and hospitals throughout North America.
Tutogen, among others, distributed bone and tissue products it bought from Biomedical until earlier this month when the Daily News disclosed that the operation was under investigation by the Brooklyn district attorney's office.
The recall notice cited The News' disclosures on the ring, which is headed by Biomedical president Michael Mastromarino, a former dentist based in Fort Lee, N.J.
Along with others, Mastromarino personally carved up corpses and sold body parts to tissue processing companies that then distributed the products to doctors, dentists and medical centers for final transplant into human beings.
The Food and Drug Administration last week said that corpses harvested by the body-snatching ring "may not have been properly screened for certain infectious diseases."
"Some recipients of the tissues may be at increased risk of infections that could potentially be transmitted," the FDA said.
The agency also said that the risks of infection are low and that no adverse reactions have been reported so far, adding, "however, the actual infectious risk is unknown."
HIV, hepatitis, syphilis and viral infections are among the possible diseases cited by U.S. and Canadian health authorities.
Transplants possibly affected include bone for dental implants and a variety of orthopedic reconstructive procedures, skin for burn victims, fatty thigh tissue for cosmetic procedures and tendons and ligaments for those who have torn them.
FDA officials and the Centers for Disease Control and Prevention recommended blood tests for patients who got the questionable products.
The latest developments sent shock waves through the tissue transplant industry and doctors who use the products.
Dr. David Behrman, chief of the division of oral surgery at New York Weill Cornell Medical Center, said, "Many surgeons have been notified by their suppliers of bone-graft material that likely came from some of these questionable donors."
"We are awaiting guidance from the FDA as to what should be done and whether we should begin testing our patients for infectious disease among other recommendations," he said.
In Canada, Calgary public health officials immediately moved to quarantine product derived from Biomedical and said they will test one at-risk patient for HIV, hepatitis B and C, human T-cell lymphotrophic virus and syphilis.
"We confiscated the product, and traced it back, found one patient, contacted the patient, and we will begin the blood tests," said Leanne Niblock, spokeswoman for the Calgary Health Region.
Although the incidence of transplant recipients contracting disease from corpse body parts has been rare, several scandals have shaken the industry.
Three years ago, a 23-year-old Minnesota man died of an infection that came with transplanted ligaments inserted during knee surgery. The tissue was supplied by CryoLife, an Atlanta tissue bank, and the infection was identified as the rare bacterium Clostridium soredelli.
More recently, dozens of patients in Oregon were infected with hepatitis C contracted from tissue supplied from a single corpse.
Mastromarino's body parts were carved from hundreds of corpses obtained at funeral homes throughout the city and other states beginning in 2002 in an enterprise that continued until this month.
Mastromarino is under investigation by Brooklyn prosecutors for allegedly creating forged relatives' consent forms and phony medical records for the deceased in the harvesting scam.
The alleged medical record forgeries were designed to conceal conditions that would normally render the products unacceptable for sale. Those conditions include cancer, habitual intravenous drug use and many contagious diseases.
Joseph Nicelli of Staten Island an embalmer who was once Mastromarino's partner in the tissue recovery business, is also under investigation along with numerous funeral home directors who provided bodies.
After harvesting, the bone, tissue and other body parts were frozen by BTS and then shipped out overnight to Tutogen and other companies for processing before final transplant.
The other four processing companies are Lifecell Corp. of Branchburg, N.J., Lost Mountain Tissue Bank of Kennesaw, Ga., Blood and Tissue Center of Central Texas in Austin and Regeneration Technologies Inc. of Alachua, Fla.
All but Lost Mountain Tissue Bank told The News they were unaware of Mastromarino's allegedly illegal activities and that they follow extensive tissue testing and sterilization procedures of their own before they ship any product out.
James Wade, director of Lost Mountain, said, "I have no comment at all; we're following the FDA guidelines. I can't say more than that."
Originally published on October 30, 2005
Tuesday, November 15, 2005
FDA Provides Information on Investigation into Human Tissue for Transplantation
The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. At this time, the implicated tissues from BTS include human bone, skin, and tendons. These products represent only a small percentage of the overall U.S. tissue supply.
While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown. FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.
The following tissue processors received tissue from BTS:LifeCell Corporation of Branchburg, NJ Lost Mountain Tissue Bank of Kennesaw, GA Blood and Tissue Center of Central Texas in Austin, TX Tutogen Medical, Inc., of Alachua, FL Regeneration Technologies, Inc., of Alachua, FL These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility. FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed.
While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed. Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at http://www.fda.gov/medwatch. Additional information is available on FDA’s web site at http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.####
While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown. FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.
The following tissue processors received tissue from BTS:LifeCell Corporation of Branchburg, NJ Lost Mountain Tissue Bank of Kennesaw, GA Blood and Tissue Center of Central Texas in Austin, TX Tutogen Medical, Inc., of Alachua, FL Regeneration Technologies, Inc., of Alachua, FL These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility. FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed.
While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed. Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at http://www.fda.gov/medwatch. Additional information is available on FDA’s web site at http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.####
Monday, November 07, 2005
NAPO FILES $77.5 MILLION+ LAWSUIT OVER BULLETPROOF VESTS
NAPO FILES $77.5 MILLION+ LAWSUIT OVER BULLETPROOF VESTS
Ft. Meyers, Florida, April 7, 2004--The National Association of Police Organizations (NAPO) and Lieutenant Scott Ashby of the Sanibel Police Department filed a national class action suit against Armor Holdings (NYSE:AH), Toyobo, America, Inc. and Toyobo Co., Ltd. (Toyobo Japan) for sale of defective body armor to more than 100,000 persons, agencies and entities all across the United States at an average price of $775. NAPO filed suit in Michigan State court against another manufacturer, Second Chance that utilizes Zylon® in their vests. It should be noted that Second Chance discontinued the sale of two of its vests, ULTIMA® and ULTIMAX® and has issued free "Performance Pacs" to its customers because as Second Chance's President stated "Unfortunately, for all involved these results indicated unexpected decrease in the Zylon® fiber strength."
The petition claims that the vests represented and warranted to have certain qualities and performance characteristics, which, in fact they do not have. "It's a travesty to have men and women who risk their lives everyday in an effort to make our lives safer, to have been misled and given a false sense of security by depending on a vest that is ineffective," said attorney Michael G. Crow. The petition currently seeks compensatory damages in the amount of $77.5 million with Crow stating that "if counsels' suspicions are confirmed the complaint will be amended to seek punitive damages in the amount of treble compensatory damages."
About NAPO: NAPO is a coalition of police unions and associations from across the United States that serves to advance the interests of America's law enforcement officers through legislative and legal advocacy, political action and education. Founded in 1978, NAPO is now the strongest unified voice supporting law enforcement officers in the United States. NAPO represents police unions and associations whose law enforcement officers are located across the country including: New York, Chicago, Los Angeles, Phoenix and Dallas to name a few. NAPO also represents almost half of the sworn law enforcement officers in the country plus 11,000 retired officers and more than 100,000 citizens who share a common dedication to fair and effective crime control and law enforcement.
Additional information: The Special Report "Status Report to the Attorney General on Body Armor Safety Initiative Testing and Activities" dated March 11, 2004 can be downloaded here.
Ft. Meyers, Florida, April 7, 2004--The National Association of Police Organizations (NAPO) and Lieutenant Scott Ashby of the Sanibel Police Department filed a national class action suit against Armor Holdings (NYSE:AH), Toyobo, America, Inc. and Toyobo Co., Ltd. (Toyobo Japan) for sale of defective body armor to more than 100,000 persons, agencies and entities all across the United States at an average price of $775. NAPO filed suit in Michigan State court against another manufacturer, Second Chance that utilizes Zylon® in their vests. It should be noted that Second Chance discontinued the sale of two of its vests, ULTIMA® and ULTIMAX® and has issued free "Performance Pacs" to its customers because as Second Chance's President stated "Unfortunately, for all involved these results indicated unexpected decrease in the Zylon® fiber strength."
The petition claims that the vests represented and warranted to have certain qualities and performance characteristics, which, in fact they do not have. "It's a travesty to have men and women who risk their lives everyday in an effort to make our lives safer, to have been misled and given a false sense of security by depending on a vest that is ineffective," said attorney Michael G. Crow. The petition currently seeks compensatory damages in the amount of $77.5 million with Crow stating that "if counsels' suspicions are confirmed the complaint will be amended to seek punitive damages in the amount of treble compensatory damages."
About NAPO: NAPO is a coalition of police unions and associations from across the United States that serves to advance the interests of America's law enforcement officers through legislative and legal advocacy, political action and education. Founded in 1978, NAPO is now the strongest unified voice supporting law enforcement officers in the United States. NAPO represents police unions and associations whose law enforcement officers are located across the country including: New York, Chicago, Los Angeles, Phoenix and Dallas to name a few. NAPO also represents almost half of the sworn law enforcement officers in the country plus 11,000 retired officers and more than 100,000 citizens who share a common dedication to fair and effective crime control and law enforcement.
Additional information: The Special Report "Status Report to the Attorney General on Body Armor Safety Initiative Testing and Activities" dated March 11, 2004 can be downloaded here.
A Comment On New Jersey Workers' Compensation Claims
Regarding workers compensation aka workmans comp aka workmens comp in New Jersey: Since workers compensation cases, among the various types of disability claims, provide some of the most antagonistic and inhospitable situations for injured and sick workers in new jersey to endure, it is very important have suitable representation. Because, unfortunately, and all too often, the individual who became ill as a result of their work environment or was injured on the job, does not find relief from the workman's comp system. Quite the opposite, sick and/or injured workers find themselves in a undesirable position where it is them versus both their employer and the workers compensation carrier. Amazingly, many sick and injured workers pursue workmens comp claims without the benefit of attorney representation. Such a position is hardly unwise and for several reasons: a worker may end up losing their battle for workman's comp benefits or take a settlement that is clearly not in their best interest. For this reason, a new jersey worker who has become ill or injured because of an accident at work should seek qualified legal counsel before going ahead with a workmans comp claim.
Sunday, November 06, 2005
Mesothelioma and Asbestosis Still A Threat To Workers
Mesothelioma is a very serious but rare form of cancer that is almost always caused by exposure to asbestos. The most common forms of Mesothelioma affect the lining of the lung (the pleura) or the lining of the abdominal cavity (the peritoneum). Approximately 3,000 people are diagnosed with Mesothelioma in the United States each year.Even a brief or minimal exposure to asbestos can cause Mesothelioma. For example, in several cases we have represented the wives and children of workers who unknowingly brought asbestos dust into their homes on their work clothes. Mesothelioma is also a "dose response" disease. This means that the more a person is exposed to asbestos, the greater the risk he has for developing the disease.Mesothelioma has a long latency period. This means that victims of Mesothelioma were exposed to asbestos many years before the cancer developed. The average latency period for Mesothelioma is approximately 30 years, but can be shorter than 15 years or longer than 40 years. Victims of Mesothelioma may also have another asbestos-related disease such as asbestosis or pleural disease. These non-cancerous conditions, although caused by asbestos, are medically separate and distinct diseases from Mesothelioma. Therefore, a disease such as asbestosis does not "develop" into Mesothelioma. Because asbestosis has a shorter latency period than Mesothelioma, some Mesothelioma victims also develop asbestosis many years before developing the cancer. Many medical experts believe that less than 15% of asbestosis victims will ever develop Mesothelioma. Also, a person can develop Mesothelioma but never have asbestosis or any other asbestos-related disease. If you have mesothelioma, you were likely exposed to asbestos. Many asbestos manufacturers and distributors have known for years that asbestos was hazardous. These companies were well aware of the health implication of their products yet they made the business decision not to warn the public and their customers of those hazards. You may have a right of recovery against those manufacturers because these companies are now being held responsible for compensating mesothelioma sufferers and their families. This could help defray the costs of treatment and provide compensation for you and your loved ones for your pain and suffering.We are currently focusing our efforts on aiding persons who have been diagnosed with mesothelioma. We will review mesothelioma claims anywhere in the country.
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