This is the last post on Blogger. New posts will be hosted at Lexblog and reachable by our main domain address www.globaltort.com. We've even moved the archive over to the new locale!
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Thursday, February 25, 2010
CDG Wins For the Third Straight Time Against One Recalcitrant Insurer
A brief self-promotional note for Childress Duffy Goldblatt. Yesterday my partner Mike Duffy and his trial team won a first party insurance property damage verdict for $ 2.85 million after allowing for the deductible. This is the third recent seven-figure trial verdict against the same recalcitrant insurer that refuses to pay fair values to its insureds. You may recall this prior post regarding that situation; the following is the key excerpt from an interview of my partner Mike Childress.
"We tried a seven-figure case last year after the insurance lawyer said that, if he could not win that particular trial, he should just return the rest of the files involving claims against that insurer. We have twelve cases against that same insurer, all of which involve the same type of loss. Our client won full damages at trial, but the insurer is still refusing to settle the remaining cases. In fact, it is the second case we have tried against this insurer and won. So, we will try the rest of the cases."
"We tried a seven-figure case last year after the insurance lawyer said that, if he could not win that particular trial, he should just return the rest of the files involving claims against that insurer. We have twelve cases against that same insurer, all of which involve the same type of loss. Our client won full damages at trial, but the insurer is still refusing to settle the remaining cases. In fact, it is the second case we have tried against this insurer and won. So, we will try the rest of the cases."
GlobalTort is Moving to a New Platform
As of later today or tomorrow, GlobalTort is moving to a new Internet home with LexBlog. A new home is needed because this platform lacks a reliable spell checker and various other "back end" utilities that make writing easier. I'm also told some browsers could not reliably hit the site.
Your browser should make the change without you having to do anything, but if you have a problem, please let me know at khartley@cdglawyers.com. The subscription options also will be broader.
Your browser should make the change without you having to do anything, but if you have a problem, please let me know at khartley@cdglawyers.com. The subscription options also will be broader.
Tuesday, February 23, 2010
Actual Great Results from New Cancer Therapies Tailored to Particular Genomes !!!!!
God love smart scientists and doctors ! Back in February, this post covered some of the ground on medical treatments aimed at individual genomes. In August, this post reported on Abbbott and Pfizer working in creating a gene chip to screen patients with a specific type of cancer for specific genomic changes so that a clinical trial can be run using people with that specific genomic defect. In this week of focus on health care, it is just plain wonderful to read that similar approaches are starting to produce the "miracles" needed for some of the almost 1.5 million Americans who will be diagnosed with cancer this year.
The specifics ? Now coming on line are humane therapies - pills !- tailored to particular changes in individual genomes. These therapies are actually shrinking tumors, and are doing so without the incredible brutality of chemotherapy and bone marrow transplants. There are still issues and uncertainties ahead, but these types of results prove the merit to treating specific genomes.
Here are the absolute key quotes from an article this morning in the NYT:
"The trial of PLX4032 offers a glimpse at how doctors, patients and drug developers navigate a medical frontier as more drugs tailored to the genetic profile of a cancer are being widely tested on humans for the first time.
Throughout the fall, the only two patients on the trial whose tumors continued to grow were the ones who did not have the particular gene mutation for which the drug had been designed. They were removed from the trial. By late December, tumors in the 11 patients who did have the mutation had shrunk. Those involved in the trial held their collective breath waiting to see how long the remissions would last. "
The entire article is here; addtional key excerpts on the science are pasted below. The entire article is well worth reading for the human side of the story.
_____________________________________________________________________________
February 23, 2010
Target CancerAfter Long Fight, Drug Gives Sudden Reprieve
By AMY HARMON
For the melanoma patients who signed on to try a drug known as PLX4032, the clinical trial was a last resort. Their bodies were riddled with tumors, leaving them almost certainly just months to live.
But a few weeks after taking their first dose, nearly all of them began to recover.
Lee Reyes, 30, of Fresno, Calif., who had begun using a feeding tube because of a growth pressing against his throat, bit into a cinnamon roll.
Rita Quigley, who had been grateful just to find herself breathing each morning since learning she had the virulent skin cancer, went shopping for new clothes with her daughters at a mall in Huntsville, Ala.
Randy Williams, 46, who drove 600 miles from his home in Jonesboro, Ark., to the M.D. Anderson Cancer Center in Houston to get the experimental drug, rolled out of bed. “Something’s working,” he thought, “because nothing’s hurting.”
It was a sweet moment, in autumn 2008, for Dr. Keith Flaherty, the University of Pennsylvania oncologist leading the drug’s first clinical trial. A new kind of cancer therapy, it was tailored to a particular genetic mutation that was driving the disease, and after six years of disappointments his faith in the promise of such a “targeted” approach finally seemed borne out. His collaborators at five other major cancer centers, melanoma clinicians who had tested dozens of potential therapies for their patients with no success, were equally elated.
In a kind of “pinch me” exercise, the six doctors sent one another “before and after” CT scans of their patients.
One was of Mark Bunting, 52, an airline pilot in Sandy, Utah. His initial scan in early October showed the cancer in his bones, an incursion considered virtually impossible to reverse. After two months on the drug, it had all but disappeared.
“Holy Cow!” Dr. Flaherty typed in reply to the slide from Dr. Antoni Ribas at the University of California, Los Angeles, that Dec. 17.
The trial of PLX4032 offers a glimpse at how doctors, patients and drug developers navigate a medical frontier as more drugs tailored to the genetic profile of a cancer are being widely tested on humans for the first time.
Throughout the fall, the only two patients on the trial whose tumors continued to grow were the ones who did not have the particular gene mutation for which the drug had been designed. They were removed from the trial. By late December, tumors in the 11 patients who did have the mutation had shrunk. Those involved in the trial held their collective breath waiting to see how long the remissions would last.
It was a far cry from where they had been a year earlier, when a previous incarnation of the drug had no effect. Urged on by Dr. Flaherty and Dr. Chapman, the companies that owned it had spent months devising a new formulation that could be absorbed at higher doses.
But the new drug, still in the earliest phase of testing, had to pass several more hurdles before federal regulators would determine whether it was safe and effective enough for widespread use.
In December, as the doctors added more patients to the Phase 1 trial, looking for the highest dose they could give without intolerable side effects, they scrambled to prepare slides with graphs and statistics to convince the Food and Drug Administration that the drug should be tested in a larger Phase 2 trial. The agency required a summary of any and all side effects — there had been only a few — and any deaths of patients on the study; thankfully, there had been none since the drug was reformulated. In a matter of days they needed to submit their findings for a prestigious meeting of clinical oncologists in June.
The trial in Bethesda, run by the National Cancer Institute, involved coaxing immune cells to grow in a test tube in a procedure that worked for only a small fraction of patients, Dr. Flaherty knew.
But there would be no point in Mr. Nelson taking PLX4032 if his tumor did not carry the right mutation. For now, the doctor had a slot for only one more patient on the trial, and he and his collaborators had agreed it was almost unethical to give the drug to people without that mutation.
He wished, not for the first time, that he could snap his fingers and know the genetic profile of his patient’s cancer cells. But getting a hospital that had operated on a patient months earlier to retrieve a tumor sample from storage could take days or weeks; the test for the gene mutation could take even longer. To speed the process, Mr. Nelson drove his tumor sample himself from Robert Wood Johnson University Hospital in New Brunswick, N.J., where it had been removed from his lymph nodes, to the laboratory at the University of Pennsylvania.
Once unleashed, however, any cancer seemed to rely on the protein made by a particular mutated gene to fuel its wild growth. In all of the PLX patients, that gene was B-RAF. And whatever the cause, they came to consider themselves, so far as it was possible with what has always been a virtually untreatable cancer, charmed.
Dialing Back
The side effects struck at the 1,120-milligram dose.
Many patients had been taking the reformulated drug for five months with no signs of relapsing. The doctors had hoped that by pushing up the dose they could shut down the cancer more effectively. Some patients were taking as many as 28 pills a day.
Ms. Adams, in Oklahoma City, woke up one morning covered in a rash. Frightened that she would be dropped from the trial, she tried to ignore it. But at work, her boss was horrified and insisted that she call the doctor. Another woman’s hand swelled up, and she could not make a fist. A Philadelphia patient had horrible nausea and diarrhea, and Mr. Bunting’s joints grew so stiff that he had to hand jars to his wife to remove the lids, even when they had already been opened.
Maybe the drug, designed to turn off only the defective B-RAF protein, was, at high doses, also affecting its role in healthy cells. Or perhaps it was interfering with other proteins the body needed to function properly. On their next conference call, the doctors agreed that they had to dial back the dose.
As the side effects began to subside, many of the patients began to believe they had beaten their cancer. One evening, Mr. Bunting performed what had become his pill-taking ritual as his wife puttered around the kitchen.
One Step Forward ...
When Mr. Nelson strolled into the University of Pennsylvania for a scheduled day of blood work and monitoring in mid-March, Ms. Redlinger greeted him as if he had risen from the dead.
Gazing out the window of the clinic room, he spied a hot dog stand.
He had never seen a melanoma patient who had been that sick improve that much. He was not sure he had ever seen a melanoma patient that sick who improved at all.
The first patient to respond in the trial, Elmer Bucksbaum, had been admitted to the hospital. The cancer had spread to his brain.
Dr. Flaherty stopped walking.
The drug, Dr. Flaherty knew, was powerless in the brain. But had the drug held off the cancer elsewhere in Mr. Bucksbaum’s body? Or would other patients, too, begin to relapse?
Mr. Bucksbaum died a few days later.
Wednesday: The Next Hurdle.
The specifics ? Now coming on line are humane therapies - pills !- tailored to particular changes in individual genomes. These therapies are actually shrinking tumors, and are doing so without the incredible brutality of chemotherapy and bone marrow transplants. There are still issues and uncertainties ahead, but these types of results prove the merit to treating specific genomes.
Here are the absolute key quotes from an article this morning in the NYT:
"The trial of PLX4032 offers a glimpse at how doctors, patients and drug developers navigate a medical frontier as more drugs tailored to the genetic profile of a cancer are being widely tested on humans for the first time.
Throughout the fall, the only two patients on the trial whose tumors continued to grow were the ones who did not have the particular gene mutation for which the drug had been designed. They were removed from the trial. By late December, tumors in the 11 patients who did have the mutation had shrunk. Those involved in the trial held their collective breath waiting to see how long the remissions would last. "
The entire article is here; addtional key excerpts on the science are pasted below. The entire article is well worth reading for the human side of the story.
_____________________________________________________________________________
February 23, 2010
Target CancerAfter Long Fight, Drug Gives Sudden Reprieve
By AMY HARMON
For the melanoma patients who signed on to try a drug known as PLX4032, the clinical trial was a last resort. Their bodies were riddled with tumors, leaving them almost certainly just months to live.
But a few weeks after taking their first dose, nearly all of them began to recover.
Lee Reyes, 30, of Fresno, Calif., who had begun using a feeding tube because of a growth pressing against his throat, bit into a cinnamon roll.
Rita Quigley, who had been grateful just to find herself breathing each morning since learning she had the virulent skin cancer, went shopping for new clothes with her daughters at a mall in Huntsville, Ala.
Randy Williams, 46, who drove 600 miles from his home in Jonesboro, Ark., to the M.D. Anderson Cancer Center in Houston to get the experimental drug, rolled out of bed. “Something’s working,” he thought, “because nothing’s hurting.”
It was a sweet moment, in autumn 2008, for Dr. Keith Flaherty, the University of Pennsylvania oncologist leading the drug’s first clinical trial. A new kind of cancer therapy, it was tailored to a particular genetic mutation that was driving the disease, and after six years of disappointments his faith in the promise of such a “targeted” approach finally seemed borne out. His collaborators at five other major cancer centers, melanoma clinicians who had tested dozens of potential therapies for their patients with no success, were equally elated.
In a kind of “pinch me” exercise, the six doctors sent one another “before and after” CT scans of their patients.
One was of Mark Bunting, 52, an airline pilot in Sandy, Utah. His initial scan in early October showed the cancer in his bones, an incursion considered virtually impossible to reverse. After two months on the drug, it had all but disappeared.
“Holy Cow!” Dr. Flaherty typed in reply to the slide from Dr. Antoni Ribas at the University of California, Los Angeles, that Dec. 17.
The trial of PLX4032 offers a glimpse at how doctors, patients and drug developers navigate a medical frontier as more drugs tailored to the genetic profile of a cancer are being widely tested on humans for the first time.
Throughout the fall, the only two patients on the trial whose tumors continued to grow were the ones who did not have the particular gene mutation for which the drug had been designed. They were removed from the trial. By late December, tumors in the 11 patients who did have the mutation had shrunk. Those involved in the trial held their collective breath waiting to see how long the remissions would last.
It was a far cry from where they had been a year earlier, when a previous incarnation of the drug had no effect. Urged on by Dr. Flaherty and Dr. Chapman, the companies that owned it had spent months devising a new formulation that could be absorbed at higher doses.
But the new drug, still in the earliest phase of testing, had to pass several more hurdles before federal regulators would determine whether it was safe and effective enough for widespread use.
In December, as the doctors added more patients to the Phase 1 trial, looking for the highest dose they could give without intolerable side effects, they scrambled to prepare slides with graphs and statistics to convince the Food and Drug Administration that the drug should be tested in a larger Phase 2 trial. The agency required a summary of any and all side effects — there had been only a few — and any deaths of patients on the study; thankfully, there had been none since the drug was reformulated. In a matter of days they needed to submit their findings for a prestigious meeting of clinical oncologists in June.
The trial in Bethesda, run by the National Cancer Institute, involved coaxing immune cells to grow in a test tube in a procedure that worked for only a small fraction of patients, Dr. Flaherty knew.
But there would be no point in Mr. Nelson taking PLX4032 if his tumor did not carry the right mutation. For now, the doctor had a slot for only one more patient on the trial, and he and his collaborators had agreed it was almost unethical to give the drug to people without that mutation.
He wished, not for the first time, that he could snap his fingers and know the genetic profile of his patient’s cancer cells. But getting a hospital that had operated on a patient months earlier to retrieve a tumor sample from storage could take days or weeks; the test for the gene mutation could take even longer. To speed the process, Mr. Nelson drove his tumor sample himself from Robert Wood Johnson University Hospital in New Brunswick, N.J., where it had been removed from his lymph nodes, to the laboratory at the University of Pennsylvania.
Once unleashed, however, any cancer seemed to rely on the protein made by a particular mutated gene to fuel its wild growth. In all of the PLX patients, that gene was B-RAF. And whatever the cause, they came to consider themselves, so far as it was possible with what has always been a virtually untreatable cancer, charmed.
Dialing Back
The side effects struck at the 1,120-milligram dose.
Many patients had been taking the reformulated drug for five months with no signs of relapsing. The doctors had hoped that by pushing up the dose they could shut down the cancer more effectively. Some patients were taking as many as 28 pills a day.
Ms. Adams, in Oklahoma City, woke up one morning covered in a rash. Frightened that she would be dropped from the trial, she tried to ignore it. But at work, her boss was horrified and insisted that she call the doctor. Another woman’s hand swelled up, and she could not make a fist. A Philadelphia patient had horrible nausea and diarrhea, and Mr. Bunting’s joints grew so stiff that he had to hand jars to his wife to remove the lids, even when they had already been opened.
Maybe the drug, designed to turn off only the defective B-RAF protein, was, at high doses, also affecting its role in healthy cells. Or perhaps it was interfering with other proteins the body needed to function properly. On their next conference call, the doctors agreed that they had to dial back the dose.
As the side effects began to subside, many of the patients began to believe they had beaten their cancer. One evening, Mr. Bunting performed what had become his pill-taking ritual as his wife puttered around the kitchen.
One Step Forward ...
When Mr. Nelson strolled into the University of Pennsylvania for a scheduled day of blood work and monitoring in mid-March, Ms. Redlinger greeted him as if he had risen from the dead.
Gazing out the window of the clinic room, he spied a hot dog stand.
He had never seen a melanoma patient who had been that sick improve that much. He was not sure he had ever seen a melanoma patient that sick who improved at all.
The first patient to respond in the trial, Elmer Bucksbaum, had been admitted to the hospital. The cancer had spread to his brain.
Dr. Flaherty stopped walking.
The drug, Dr. Flaherty knew, was powerless in the brain. But had the drug held off the cancer elsewhere in Mr. Bucksbaum’s body? Or would other patients, too, begin to relapse?
Mr. Bucksbaum died a few days later.
Wednesday: The Next Hurdle.
Sunday, February 21, 2010
Sovereigns and Their Roles Related to Commercial Activities Involving Substances that Present Health Risks
Here's an invitation for readers to guest blog or comment on a question related to mass tort litigation, governments and substances that are extracted and exported despite known health risks and the absence of complete certainty regarding health effects. Feel free to reframe the question, but I see it as:
when, if ever, should government agencies and/or officials be held liable for statements or other actions taken in support of commercial mining, extracting, distributing or manufacturing of substances known to have some health risks. For example, mining , exporting and manufacturing involving chrysotile asbestos fibers.
Obviously various sovereign immnunity doctrines already exist and tend to draw lines between tradtional government activties, discretionary functions, and commercial activities. Those lines and these issues seem to me likely to face renewed scrutiny over the next few years due to increased globalization and explicit government outreach to and involvement in commercial activities with international impacts. For some context for the question, consider this prior post regarding "aiding and abetting" claims asserted against two goverments for assisting the Stanford ponzi scheme. Consider also a recent article regarding Canadian physicians accusing Canadian officials of issuing misleading statements about the absence or presence of health hazards from chrsyotile asbestos fibers. The text pasted below is from this February 12, 2010 article by Michelle Lalonde from the Canadian Gazette.
__________________________________________________________________________________
On hot seat over asbestos
Physicians attack Premier; Damning report rebuts his contention mineral can have benign uses
By MICHELLE LALONDE, The GazetteFebruary 12, 2010
Just as a group of prominent Canadian physicians accuse Premier Jean Charest of lying to the public about asbestos, another damning report on the mineral will be published today in the American Journal of Industrial Medicine.
Charest recently returned from a trade mission in India, where anti-asbestos protesters accused his government of hypocrisy for exporting the cancer-causing mineral to developing countries while removing it from Quebec schools and public buildings because of health concerns.
On the trade mission, the premier was quoted in La Presse as saying "Chrysotile (asbestos) can be used in a safe manner; this is what WHO reports say. It is not a banned substance. It is up to the government of India to put the necessary laws in place."
In fact, the World Health Organization has said that all types of asbestos, including the type mined in Quebec (chrysotile) cause asbestosis, mesothelioma and cancer of the lung, and recommends against continued use of any form of asbestos. The International Labour Organization adopted a resolution in 2006 urging the elimination of use of all forms of asbestos and of materials containing asbestos.
A group of 14 Canadian physicians, including McGill University's Abby Lippman and Dick Menzies of the Montreal Chest Institute, sent a letter to Charest yesterday expressing their "shock" at his statements and accusing him of misrepresenting the position of the World Health Organization.
"Premier Charest, you have the right to oppose the WHO position. However, and especially because of the public trust in your position, you do not have the right to misrepresent the WHO position as being what you perhaps wish it were, instead of what it is," the letter says.
Menzies, a respiratory physician at the Montreal Chest Institute and one of the signatories of the letter, said selling asbestos to countries that clearly lack the resources to enforce workplace safety standards is like selling guns to children. You can say that you warned them about the danger, but it is still morally unacceptable.
"They simply do not have the same workplace safety standards we do here. To argue that it is not a carcinogen is ludicrous. To argue that it's dangerous, but it is their responsibility to handle it safely is a moral question."
The physicians have asked for a meeting with the premier on the issue, and also urged him to clarify his statement. Calls by The Gazette to the premier's office were not returned.
Meanwhile, a report to be published today in the March issue of the American Journal of Industrial Medicine shows the devastating impact Quebec's asbestos is having on the health of workers in Mexico who come into contact with the mineral.
The researchers looked at 472 Mexican workers, 119 of whom had been found to have pleural mesothelioma, a fatal lung disease. More than 80 per cent of those with the disease had been exposed to asbestos on the job.
"Our results show a clear relationship between industrial use of all types of asbestos and malignant pleural mesothelioma, and in Mexico the major type of asbestos is chrysotile imported from Canada, confirming that asbestos is a carcinogenic agent that has been recognized as such by the IARC (International Agency for Research on Cancer) since 1977," the report says.
The cost of medical attention for each mesothelioma case during the first year of treatment was estimated at $8,238 U.S.
"The social and economic impact of these diseases and asbestos-related deaths should be absorbed by the industries that have generated the damage and not by the health institutions, as it occurs at present," the authors conclude.
mlalonde@thegazette.canwest.com
© Copyright (c) The Montreal Gazette
Read more: http://www.montrealgazette.com/health/seat+over+asbestos/2553167/story.html#ixzz0gBdvY3kv
when, if ever, should government agencies and/or officials be held liable for statements or other actions taken in support of commercial mining, extracting, distributing or manufacturing of substances known to have some health risks. For example, mining , exporting and manufacturing involving chrysotile asbestos fibers.
Obviously various sovereign immnunity doctrines already exist and tend to draw lines between tradtional government activties, discretionary functions, and commercial activities. Those lines and these issues seem to me likely to face renewed scrutiny over the next few years due to increased globalization and explicit government outreach to and involvement in commercial activities with international impacts. For some context for the question, consider this prior post regarding "aiding and abetting" claims asserted against two goverments for assisting the Stanford ponzi scheme. Consider also a recent article regarding Canadian physicians accusing Canadian officials of issuing misleading statements about the absence or presence of health hazards from chrsyotile asbestos fibers. The text pasted below is from this February 12, 2010 article by Michelle Lalonde from the Canadian Gazette.
__________________________________________________________________________________
On hot seat over asbestos
Physicians attack Premier; Damning report rebuts his contention mineral can have benign uses
By MICHELLE LALONDE, The GazetteFebruary 12, 2010
Just as a group of prominent Canadian physicians accuse Premier Jean Charest of lying to the public about asbestos, another damning report on the mineral will be published today in the American Journal of Industrial Medicine.
Charest recently returned from a trade mission in India, where anti-asbestos protesters accused his government of hypocrisy for exporting the cancer-causing mineral to developing countries while removing it from Quebec schools and public buildings because of health concerns.
On the trade mission, the premier was quoted in La Presse as saying "Chrysotile (asbestos) can be used in a safe manner; this is what WHO reports say. It is not a banned substance. It is up to the government of India to put the necessary laws in place."
In fact, the World Health Organization has said that all types of asbestos, including the type mined in Quebec (chrysotile) cause asbestosis, mesothelioma and cancer of the lung, and recommends against continued use of any form of asbestos. The International Labour Organization adopted a resolution in 2006 urging the elimination of use of all forms of asbestos and of materials containing asbestos.
A group of 14 Canadian physicians, including McGill University's Abby Lippman and Dick Menzies of the Montreal Chest Institute, sent a letter to Charest yesterday expressing their "shock" at his statements and accusing him of misrepresenting the position of the World Health Organization.
"Premier Charest, you have the right to oppose the WHO position. However, and especially because of the public trust in your position, you do not have the right to misrepresent the WHO position as being what you perhaps wish it were, instead of what it is," the letter says.
Menzies, a respiratory physician at the Montreal Chest Institute and one of the signatories of the letter, said selling asbestos to countries that clearly lack the resources to enforce workplace safety standards is like selling guns to children. You can say that you warned them about the danger, but it is still morally unacceptable.
"They simply do not have the same workplace safety standards we do here. To argue that it is not a carcinogen is ludicrous. To argue that it's dangerous, but it is their responsibility to handle it safely is a moral question."
The physicians have asked for a meeting with the premier on the issue, and also urged him to clarify his statement. Calls by The Gazette to the premier's office were not returned.
Meanwhile, a report to be published today in the March issue of the American Journal of Industrial Medicine shows the devastating impact Quebec's asbestos is having on the health of workers in Mexico who come into contact with the mineral.
The researchers looked at 472 Mexican workers, 119 of whom had been found to have pleural mesothelioma, a fatal lung disease. More than 80 per cent of those with the disease had been exposed to asbestos on the job.
"Our results show a clear relationship between industrial use of all types of asbestos and malignant pleural mesothelioma, and in Mexico the major type of asbestos is chrysotile imported from Canada, confirming that asbestos is a carcinogenic agent that has been recognized as such by the IARC (International Agency for Research on Cancer) since 1977," the report says.
The cost of medical attention for each mesothelioma case during the first year of treatment was estimated at $8,238 U.S.
"The social and economic impact of these diseases and asbestos-related deaths should be absorbed by the industries that have generated the damage and not by the health institutions, as it occurs at present," the authors conclude.
mlalonde@thegazette.canwest.com
© Copyright (c) The Montreal Gazette
Read more: http://www.montrealgazette.com/health/seat+over+asbestos/2553167/story.html#ixzz0gBdvY3kv
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