When I pick up a professional journal, I am already convinced that what I read is based on impartial research and evidence. But should I be?
My assumption that articles are being provided by professionals with the public interest as a priority is the wrong assumption. I was unaware until just recently that pharmaceutical companies and medical device companies can be very generous in order to receive positive press about their latest drug or gadget. While, as a health care professional, I would like to believe that other health care professionals can provide unbiased research despite the gifts, I am not that trusting of human nature.
To be fair, journals are taking steps to prevent this practice of padding their publications with articles favouring the “latest and greatest.” Until it becomes routine, and every journal checks the background of their authors, I would suggest a double-check on that research your case may depend on.
Showing posts with label product liability. Show all posts
Showing posts with label product liability. Show all posts
Thursday, October 1, 2009
Saturday, September 5, 2009
Toddlers at risk from codeine
The maternity world was turned upside down in the past few years with the realization that a common painkiller administered to mothers following childbirth was having disasterous results for newborns. Now it has been established by Canadian researchers that toddlers with the same genetic variation as those newborns have died from the same drug given directly to them following surgery.
According to research done at the University of Western Ontario in London and the Hospital for Sick Children in Toronto, the very common drug is acetaminophen and codeine (one familiar brand name of this combination is Tylenol 3). Unfortunately, there are very young children with a genetic variation who convert the codeine into morphine very rapidly. The morphine then slows breathing and a high enough dose will stop breathing resulting in death.
These findings are significant for cases where an otherwise “healthy” young child has undergone an uneventful procedure yet had complications such as respiratory arrest or death. If the child received codeine, that could be the root of the problem.
According to research done at the University of Western Ontario in London and the Hospital for Sick Children in Toronto, the very common drug is acetaminophen and codeine (one familiar brand name of this combination is Tylenol 3). Unfortunately, there are very young children with a genetic variation who convert the codeine into morphine very rapidly. The morphine then slows breathing and a high enough dose will stop breathing resulting in death.
These findings are significant for cases where an otherwise “healthy” young child has undergone an uneventful procedure yet had complications such as respiratory arrest or death. If the child received codeine, that could be the root of the problem.
Sunday, August 23, 2009
Avandia Increases Risk to Type 2 Diabetics
In a recent study by Toronto’s Clinical Evaluative Sciences, the drug Avandia (rosiglitazone) demonstrated an increased risk of heart failure and death when compared to the other drug for the treatment of Type 2 diabetes, Actos (pioglitazone).
As published in the British Medical Journal, the study examined the records of 40 000 patients treated with these drugs; 23% were less likely to be hospitalized for heart failure and 14% less likely to die when given Actos (pioglitazone) instead of Avandia (rosiglitazone). This has major implications for the millions of patients treated for Type 2 diabetes in the last several years. Based on the study, for every 120 people taking Avandia, one more was hospitalized and for every 269 people, one would die.
The makers of Avandia, GlaxoSmithKiline, have initiated their own study in response. The results will not be known for several years probably after the two drugs become available as generic formulas.
Dr. Juurlink, principal investigator, has dismissed criticisms from GlaxoSmithKline that the study may have only dealt with patients who were sicker. He points out that you would expect to see more heart attacks if the patients taking Avandia were sicker yet the study revealed that there was no difference in heart attack rates between the two groups.
As Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, has said, “I guess the final word would be: Who would want to take the chance? Why would you? So from my perspective while you can argue that it may not end the story, in the meantime, what should physicians do? And I think the answer is they should use the safer of the two drugs.”
As published in the British Medical Journal, the study examined the records of 40 000 patients treated with these drugs; 23% were less likely to be hospitalized for heart failure and 14% less likely to die when given Actos (pioglitazone) instead of Avandia (rosiglitazone). This has major implications for the millions of patients treated for Type 2 diabetes in the last several years. Based on the study, for every 120 people taking Avandia, one more was hospitalized and for every 269 people, one would die.
The makers of Avandia, GlaxoSmithKiline, have initiated their own study in response. The results will not be known for several years probably after the two drugs become available as generic formulas.
Dr. Juurlink, principal investigator, has dismissed criticisms from GlaxoSmithKline that the study may have only dealt with patients who were sicker. He points out that you would expect to see more heart attacks if the patients taking Avandia were sicker yet the study revealed that there was no difference in heart attack rates between the two groups.
As Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, has said, “I guess the final word would be: Who would want to take the chance? Why would you? So from my perspective while you can argue that it may not end the story, in the meantime, what should physicians do? And I think the answer is they should use the safer of the two drugs.”
Wednesday, July 22, 2009
Personal Injury Lawyers Need to Consider This
A personal injury claim can be a complicated process. A client can present with injuries that seem to have been minor but turned much worse. Under the current conditions of an overloaded, budget-cutting health care system like the one we currently have in Canada, as an attorney, you need to consider the timeline of medical care provided to your client.
It is not unusual for me as a practising RN to hear of patients being delayed care that would have made receovery that much easier and faster. Only ten days ago, I heard from a friend who went to see a physician for a suspected broken ankle. The wait to see a doctor was five hours with no pain relief or comfort measures. He was given a requisition for an x-ray. A full week later, he receives a call to return for a cast... he really does have a broken ankle. The long term consequences of having a fracture in joint that will now not heal properly are immense. Surgeries, physiotherapy, degenerating joint health all that could have been prevented by an immediate diagnosis and treatment with a cast.
Is your client a pharmaceutical firm facing claims about side-effects and adverse reactions involving long-term injuries? Evaluate how quickly the client was seen by a doctor, how soon were they given treatment for the symptoms? Did they spend days in a hallway in a crowded emergency room?
Unfortunately, this is not an unknown story in hospitals and doctors' offices. Perhaps you have more than an injury claim... perhaps you also have a negligence claim against a hospital.
It is not unusual for me as a practising RN to hear of patients being delayed care that would have made receovery that much easier and faster. Only ten days ago, I heard from a friend who went to see a physician for a suspected broken ankle. The wait to see a doctor was five hours with no pain relief or comfort measures. He was given a requisition for an x-ray. A full week later, he receives a call to return for a cast... he really does have a broken ankle. The long term consequences of having a fracture in joint that will now not heal properly are immense. Surgeries, physiotherapy, degenerating joint health all that could have been prevented by an immediate diagnosis and treatment with a cast.
Is your client a pharmaceutical firm facing claims about side-effects and adverse reactions involving long-term injuries? Evaluate how quickly the client was seen by a doctor, how soon were they given treatment for the symptoms? Did they spend days in a hallway in a crowded emergency room?
Unfortunately, this is not an unknown story in hospitals and doctors' offices. Perhaps you have more than an injury claim... perhaps you also have a negligence claim against a hospital.
Monday, June 15, 2009
Defective Implanted Defibrillator Leads
A common procedure for people with irregular or unusual heart rhythms often receive defibrillators implanted into their chest to provide a necessary shock to maintain a healthy heart rhythm whenever necessary. It was a big, and unwelcome, surprise when the manufacturer, Medtronic, announced last year that their Sprint Fidelis leads were malfunctioning at rates that were higher than other leads. These defective leads were pulled from the implant market but cannot be changed or removed without a real risk of harm to the patient. Numbers vary depending on the source, but in the range of 87.9% to 94.3% of the leads are still in place in patients.
In May of 2009, the Heart Rhythm Society, an American cardiac physicians’ group representing MDs who implant and extract defibrillators and their associated leads, issued policy statements calling for hospitals to better police the experience and training of the surgeons who extract defibrillator leads. This is especially important given the risk to the patient to remove or change these defective leads. HRS also issued a statement calling for companies that produce the leads to do be more accountable in the tracking the performance of their devices once they’re on the market.
A legal nurse consultant can provide information for a case where there may be a suspicion of a malfunctioning cardiac defibrillator, its leads or an injury that occurred while the leads were being removed. One of the questions that must be answered is the experience of the doctor who connected or extracted the leads. While the new guidelines have yet to be determined in Canada, the training and experience of the physician may be relevant to the injury. Legal nurse consultants for the defence may be able to raise the level of experience as an avenue of defence of the doctor. Legal nurse consultants for the plaintiff will question the lack of experience of the physician as evidence of negligence.
The incidence of medical device failure is a serious one. And is definitely the type of case requiring the expertise of a legal nurse consultant.
In May of 2009, the Heart Rhythm Society, an American cardiac physicians’ group representing MDs who implant and extract defibrillators and their associated leads, issued policy statements calling for hospitals to better police the experience and training of the surgeons who extract defibrillator leads. This is especially important given the risk to the patient to remove or change these defective leads. HRS also issued a statement calling for companies that produce the leads to do be more accountable in the tracking the performance of their devices once they’re on the market.
A legal nurse consultant can provide information for a case where there may be a suspicion of a malfunctioning cardiac defibrillator, its leads or an injury that occurred while the leads were being removed. One of the questions that must be answered is the experience of the doctor who connected or extracted the leads. While the new guidelines have yet to be determined in Canada, the training and experience of the physician may be relevant to the injury. Legal nurse consultants for the defence may be able to raise the level of experience as an avenue of defence of the doctor. Legal nurse consultants for the plaintiff will question the lack of experience of the physician as evidence of negligence.
The incidence of medical device failure is a serious one. And is definitely the type of case requiring the expertise of a legal nurse consultant.
Thursday, May 7, 2009
Another Diet Pill Recall Alert
According to a May 1, 2009 news release by attorneys at Morgan & Morgan, the Food & Drug Administration (FDA) issued a warning to consumers to immediately stop using Hydroxycut products. Hydroxycut products, dietary supplements manufactured by Iovate Health Sciences, Inc., have been linked to serious liver injuries and at least one death. The products were sold in Canada as well.
This recent example in the product liability field is within the expertise of the legal nurse consultant as part of the legal team. Legal nurse consultants are not hired to know the law but rather to understand the injury, what caused it, its extent and how it could have been prevented. Once the free legal consultation has been completed, the legal nurse consultant can piece together vital pieces of information to assist the attorneys in evaluating the merit of each case.
Nurses have specialized knowledge and resources to assess the risks and benefits of a product, whether it was regulated and for what particular use, identify common off label uses of a product, explore the history of the product and the side effects that have been reported as well as personal patient histories which might have affected the outcome with this product. Then they can assist in the preparation of cases for legal teams faced with a large scale recall within the healthcare-related industry.
This recent example in the product liability field is within the expertise of the legal nurse consultant as part of the legal team. Legal nurse consultants are not hired to know the law but rather to understand the injury, what caused it, its extent and how it could have been prevented. Once the free legal consultation has been completed, the legal nurse consultant can piece together vital pieces of information to assist the attorneys in evaluating the merit of each case.
Nurses have specialized knowledge and resources to assess the risks and benefits of a product, whether it was regulated and for what particular use, identify common off label uses of a product, explore the history of the product and the side effects that have been reported as well as personal patient histories which might have affected the outcome with this product. Then they can assist in the preparation of cases for legal teams faced with a large scale recall within the healthcare-related industry.
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