Fort Worth, Texas resident Debbie Wooten filed a personal injury lawsuit against Advanced Medical Optics, Inc. (AMO) for her suffering after the use of their Complete MoisturePlus Multi Purpose contact lens solution. The 44 year old says she suffered permanent vision loss due to Acanthamoeba keratitis, an extremely painful infection of the cornea, from use of the solution. Wooten was a regular purchaser of AMO contact lens solution, using the product as instructed. In late 2004, she began to suffer symptoms of light sensitivity, tearing, and redness. Wooten sought medical attention but her doctors were unable to accurately diagnose her condition. At the end of 2004, Wooten lost the vision in her left eye. In January 2005, Wooten was diagnosed with Acanthamoeba keratitis. She had to wait nine months for a corneal replacement surgery to make sure that after treatment of the infestation, the microorganism was dormant.

The Complaint charges that AMO's contact lens solution was not effective in disinfecting contacts lenses, and vastly inferior to other multipurpose solutions available on the market. The Complaint alleges that AMO's own data demonstrated the product's lack of effectiveness in preventing the growth of protozoa microorganisms, including acanthameoba. The protozoa acanthameoba are directly associated with a disproportionate risk and increased incidence of Acanthamoeba keratitis in users of contact lens solution products. Wooten's lawsuit brings claims of negligence, strict liability, breach of warranty, fraud, unjust enrichment, and violations of California statutory law. Wooten seeks compensatory and punitive damages against AMO for the injuries she has suffered.

On May 25, 2007, the FDA alerted health care professionals and their patients who wear soft contact lenses about a voluntary recall of AMO's Complete MoisturePlus Multi Purpose. The recall was undertaken because of reports of a link between the rare, but serious eye infection, Acanthamoeba keratitis, caused by a parasite and use of AMO's contact lens solution.

Posted by Seth A. Katz at 07:01 PM | Permalink | Comments (0) | TrackBacks (0)

A group of doctors in Tennessee has decided to stop prescribing the Ortho Evra patch to patients over concerns that it could increase risk of blood clots or other problems. In a letter to their patients, the doctors cited a study which showed that women who use the Ortho Evra patch are at an increased risk of deep vein thrombosis. Concerns about the potential side effects of Ortho Evra have risen steadily in the five years since the patch came on the market. As result, the Food and Drug Administration forced Ortho-McNeil, the manufacturer of the birth control patch, to strengthen consumer warnings about the risk of Ortho Evra side effects. A "black-box" warning was added to the labeling in order to alert consumers and their doctors about the risks posed by the Ortho Evra birth control patch. Despite these warnings, at least 23 women died as a result of side effects they suffered while using the Patch, and at least 17 of these deaths were the result of blood clots. Hundreds more women have suffered blood clots, heart attacks, pulmonary embolisms or strokes after using the patch.

Studies indicate that health officials received at least 9,000 reports of side effects among Ortho Evra users during the first year and a half that the patch was on the market. Over a six year period, officials received only about 1,300 adverse reports from users of birth control pills. Based on these statistics, the rate of Ortho Evra side effects was more than 27 times greater than that experienced by users of the pill. Despite evidence linking the Ortho Evra patch to cases of blood clots, heart attack, pulmonary embolism, stroke and even death, neither the FDA nor its manufacturer, Ortho-McNeil, have called for an Ortho Evra recall.

Posted by Seth A. Katz at 02:39 PM | Permalink | Comments (0) | TrackBacks (0)

Fourteen-year-old Scotty Raymond of New Jersey was released from the hospital August 25th after being seriously injured August 2nd when he was struck by a car. He was walking his bike with a friend at around 10:30 pm at the time of the accident. Scotty, who was not wearing a helmet, suffered a traumatic brain injury when his head hit the concrete. He also had a large open wound on his leg that would require plastic surgery and another on his arm. His head and ear had large lacerations, and his whole body was bruised. Scotty was released from Children's Specialized Hospital at Mountainside after a miraculous recovery helped by family support and a message board created by his aunt of which more than 500 comments of support were posted. He was transferred to Children's on August 17th from Hackensack Unive rsity Medical Center, where he had been in the intensive-care and acute-care units. At Children’s, he underwent six hours of speech, occupational and physical therapy daily. Nevertheless, he was still suffering from "confusion, short-term memory deficit, mood swings and poor attention span," according to Dr. Krishan Yalamanchi, a neurodevelopmental pediatrician who treated him at Children's. On August 18th, everything changed. He started looking at some pictures of his German shepherd on his father's computer and remembered. "I started remembering things after I saw the picture, and then everything just snapped into place," the teen said. His father couldn't believe his son's instant recovery. His pediatrician says his recovery has been remarkable.

Posted by Kerry N. Jardine at 02:15 PM | Permalink | Comments (0) | TrackBacks (0)

An article in Popular Science mentions Doctor Bennet Omalu who is finding that football players are at increased risk of dementia brought on by head injuries on the field. A condition he calls football-induced chronic traumatic encephalopathy, or CTE. Other researchers are getting involved but the NFL still isn't convinced, but New Hampshire-based Simbex is offering something that can help lessen the problem. Their Head Impact Telemetry System, or HIT System, is a football helmet packed with sensors that can detect sudden impacts and wirelessly relay information to a remote station. So if a player takes a particularly hard hit, the coach can see it right away and take steps, even if the player looks fine. The side benefit is that the HIT System might help determine whether CTE is a genuine condition or not. Since its introduction, it's been used to collect data on over 250,000 impacts, the kind of real-world data set that researchers look for.

Posted by Kerry N. Jardine at 10:38 AM | Permalink | Comments (0) | TrackBacks (0)

Dear Mayor Newberry and the Lexington Community:

One year has passed since so many lives were forever changed by the accident involving Comair Flight 5191. The many family members and friends of the passengers who lost their lives that day have been left to carry on without them. The entire city of Lexington continues to bear the burden of such a tragedy occurring in your tight-knit community. And finally, Comair employees also mourn the lost members of our family.

This accident will forever be part of all of us, and as we approach the anniversary, our hearts remain heavy. I am a man of faith and believe that those left behind will meet again with those we have lost. Until then, we remember them through our many memories and honor them in our daily actions.

The upcoming memorial events are a milestone in the ongoing journey to heal. The enormous effort put forth for these events is a testament to the caring people of Lexington. Throughout the past year, you have helped lift the families' burdens by making their sorrow your own and reassuring them that they are not alone in their time of grief. I cannot think of a better example of what it means to be a truly supportive community.

On behalf of everyone at Comair, please accept our sincere appreciation for the year-long support we have received. We are grateful for all your efforts to honor the Flight 5191 passengers and your kindness to the Comair team. I personally am honored to call Kentucky my home.

Now, even one year later, it's difficult for me to find the words to express my sorrow. We continue to keep the passengers, crew and their loved ones in our thoughts and wish them peace and loving remembrance always.

Respectfully,
Don Bornhorst
Comair President
(Representing Comair's 6,600 employees and their families)

Posted by Kerry N. Jardine at 06:57 PM | Permalink | Comments (0) | TrackBacks (0)

Since 1997, the medical community has been trying to determine the cause of Nephrogenic Systemic Fibrosis (NSF). NSF is also known as Nephrogenic Fibrosing Dermopathy. It is a rare and little understood disease that affects people with kidney problems. Since the first cases were documented, research into NSF has provided few clues into its cause, and even fewer as to its treatment. Most patients eventually diagnosed with NSF are first found to have high blood pressure, which is followed by burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and can eventually lead to death. The progression of the disease can be slow and can take several years for all of the symptoms to appear. However, some patients have a form that progresses so quickly that they often die of complications brought on by the disease.

There are no consistently successful treatments for NSF, but symptoms can be improved with several methods. Physical therapy, oral steroids and some other drug therapies have shown promise in treating NSF. Unfortunately, NSF is such a recent phenomenon that few studies on treatments have been completed. According to the International Center for Nephrogenic Fibrosing Dermopathy Research, NSF patients show the most improvement when improved kidney function can ease symptoms, and in some patients this seems to reverse the disease overtime. Some NSF patients who have received kidney transplants have improved dramatically, but there is no guarantee that all patients will see such results.

It is important that people with kidney problems be aware that the disease is associated with Gadolinium based contrast agents used in MRIs. These agents are injected into patients prior to an MRI in order to enhance images. Anyone with a kidney problem who is to undergo an MRI should make sure that agents with Gadolinium will not be used. Also, patients scheduled for an MRI using such contrast agents should always be screened for kidney efficacy.

Posted by Kerry N. Jardine at 02:39 PM | Permalink | Comments (0) | TrackBacks (0)

Soldiers deploying next month with the 1st Armored Division headquarters staff are taking part in the U.S. Army’s first large-scale test for traumatic brain injury. A traumatic brain injury, or TBI, disrupts normal brain function. The test on 1st AD soldiers in Wiesbaden, Germany could be especially useful in assessing mild brain injuries. “It’s the mild TBI guys” who are the focus, said Lt. Col. Jerome L. Buller, the division surgeon-general. “They are the diagnostic dilemma.” That’s because any damage done is generally hard to diagnose, since the injury is internal and thus more difficult to detect.

The computer based test, which takes 15 to 20 minutes, is part of the pre-deployment regimen that about 1,200 soldiers are going through at Wiesbaden Army Airfield. Buller indicated that the test likely would become part of the Army’s pre-deployment and post-deployment process. More than 400 soldiers at Fort Campbell, Ky., participated in a pilot program in June and July. It’s designed to capture baseline data on a soldier’s reaction time, processing speed, spatial memory, short-term memory and working memory, which is the skill to temporarily retain facts or thoughts while handling a task or solving a problem. All of the data won’t come into play unless a soldier is injured or experiences TBI symptoms following a blast. The expectation is that the baseline data on each soldier will help in the identification and treatment of mild brain injuries.

Posted by Kerry N. Jardine at 10:34 AM | Permalink | Comments (0) | TrackBacks (0)

Most everyone assumes if a doctor prescribes a drug or it's available through a pharmacy, then it's been approved by the Food and Drug Administration. That statement however, is not true. Hormone replacement therapy is a common treatment for women going through menopause. In the past couple of years studies have found the drugs can have dangerous side effects. One study released found women taking the drugs had twice the risk of breast cancer. Even though it's been prescribed to thousands of women, the drug Estratest has never been approved by the FDA. Estratest is a widely prescribed combination of synthetic estrogen and testosterone to treat the symptoms of menopause. One woman experienced an increase in facial acne and hair growth. It was the testosterone that seemingly caused it. Estratest has never been approved by the FDA and by law all drugs are required to get FDA approval before they are sold. Since Estratest has been on the market since 1964, most people assume it's been approved. The maker of Estratest applied for approval in 1979, but the FDA turned them down. The company tried again in 1981. Twenty-six years later and there is still no approval. The company doesn't hide the fact. Its literature clearly states, "This product has not obtained FDA pre-market approval." A federal appeals court in Atlanta said it was baffled and wrote, "It is incomprehensible that Estratest has been allowed on the market without approval for 35 years." They added, "There can be no good excuse for allowing a company to violate the law for 35 years."

Estratest isn't the only unapproved drug on the market. The FDA admits there are several hundreds. In June 2006, the FDA announced it was cracking down, but unapproved drugs like Estratest are still being sold. There are some safety concerns due to new studies on drugs used to treat the symptoms of menopause. The largest study had to be stopped because of safety concerns and the New England Journal of Medicine released another study that showed an increased risk of breast cancer among women who took the hormone replacement drugs. These studies are not going unnoticed. Consumer group Public Citizen put Estratest on its list of worst pills because of its link to breast cancer. In August of last year, the National Women's Health Network filed a petition asking the FDA to force the manufacturer to stop selling it. Two public interests groups have filed a class action lawsuit in California against the maker of Estratest.

Posted by Kerry N. Jardine at 06:32 AM | Permalink | Comments (0) | TrackBacks (0)

A new study, led by Timothy Hla at the University of Connecticut, may explain how COX-2 drugs such as Vioxx, Bextra, and Celebrex trigger life-threatening cardiovascular side effects such as heart attacks and strokes. The study was published online yesterday in The Journal of Experimental Medicine.

Drugs such as Vioxx target the COX-2 enzyme, which is produced in response to infection or injury and releases pain- and fever-inducing byproducts. Thus, blocking COX-2 reduces pain. But when scientists in the study blocked COX-2 in mice, it also stimulated the production of a protein called tissue factor, or TF, which initiates clotting. As heart attacks and strokes are often triggered by blood clots, it's possible that the production of TF is partly responsible for the drug's adverse effects on people. Scientists were able to counter the levels of TF in the blood by administering TF-lowering drugs.

Posted by Kerry N. Jardine at 06:40 PM | Permalink | Comments (0) | TrackBacks (0)

It seems our diabetic population has had to face a double wammy in recent months. First it was the effects of gadodiamide contrasting agent used in MRIs and MRAs causing a rare and possibly fatal skin disease called Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Systemic Dermopathy (NSD). Then it was an article written for the New England Journal of Medicine concerning the diabetic drug Avandia that helps the body use insulin more efficiently, causing a higher risk of cardiovascular death (64% increase) and heart attacks (43% increase). As well as possibly causing macular edema, it is fluid retention in the eye that can cause vision impairment. Now the FDA is under attack by the government for not taking more extensive steps in preventing these types of drugs reaching the market without proper drug trials. It is in these times that we need to keep asking questions of our doctors. If you or loved one is experiencing kidney disease or any degree of renal failure, you may want to talk to your doctor about getting an MRI or an MRA and discuss the current gadodiamide issues. You may also want to discuss the possible risks in taking Avandia and Actos (another diabetic drug). In today’s times of insufficient and expensive health care we need to take control of our own medical issues and know the current events concerning drugs and treatments. Stay aware and stay involved.

Posted by Kerry N. Jardine at 02:53 PM | Permalink | Comments (0) | TrackBacks (0)

Saving human memory is one of the highest level of care sought by modern medicine. The concept is integral in the treatment and care of individuals suffering from a traumatic brain injury or Alzheimer’s. New research suggests the discovery of a protein that controls the odds of memory formation may lead to an entirely new approach for preserving memory. The finding, by scientists from UCLA/University of Toronto is important because until now, scientists knew little about how the brain assigns cells to participate in encoding and storing memories. As reported in the April 20 edition of Science, a new approach for preserving memory in people suffering from Alzheimer’s or other brain injury may be forthcoming. Alcino Silva, principal investigator and a professor of neurobiology and psychiatry at the David Geffen School of Medicine at UCLA explains, “Learning triggers a cascade of chemicals in the brain that influence which memories are kept and which are lost. Earlier studies have linked the CREB protein to keeping memories stable. We suspected it also played a key role in channeling memories to brain cells that are ready to store them.”

http://www.burgsimpson.com/brain.htmlSilva and his colleagues used a mouse model to evaluate their hypothesis. They implanted CREB into a virus, which they introduced into some of the cells in the animal’s amygdala, a brain region critical to emotional memory. Next they tested the mouse’s ability to recall a specific cage it had visited before. To visualize which brain cells stored the mouse’s memories about the cage, the scientists tracked a genetic marker that reveals recent neuron activity. When the team examined the animals’ amygdalas after the experiment, they found substantial amounts of CREB and the marker in neurons. “We discovered that the amount of CREB influences whether or not the brain stores a memory,” said Silva. “If a cell is low in CREB, it is less likely to keep a memory. If the cell is high in CREB, it is more likely to store the memory.” Human implications of the new research could be profound. “By artificially manipulating CREB levels among groups of cells, we can determine where the brain stores its memories,” he explained. “This approach could potentially be used to preserve memory in people suffering from Alzheimer’s or other brain injury. We may be able to guide memories into healthy cells and away from sick cells in dying regions of the brain.”

Posted by Kerry N. Jardine at 10:02 AM | Permalink | Comments (0) | TrackBacks (0)

A 22-month study of Fort Carson soldiers returning from the Middle East found that nearly 18 percent suffered from at least a mild form of traumatic brain injury. Of 13,440 soldiers examined since June 2005, 2,392 exhibited some of the symptoms associated with mild TBI which include headaches, memory loss, irritability, difficulty sleeping and balance problems. Like post-traumatic stress disorder, there is no "identifying marker" that would make brain injuries easy to diagnose. Bullets and shrapnel that penetrate the skull are the obvious causes of TBI, but explosions that have rattled the head of Fort Carson soldiers are overwhelmingly to blame. Blast waves and the resulting sudden change in air pressure from explosions are the leading cause of the closed-head injuries.

In many instances in soldiers examined, symptoms did not occur until months after a soldier's return, and in others, symptoms resolved themselves even before a soldier got home. The post relies on a second screening 90-120 days after homecoming and on input from family members and the chain of command. "Symptoms can present themselves at different points in time. And you might ask why. I can only surmise that when a soldier returns to the United States and is subjected to the activities of daily living -- traffic, making formation ... perhaps the stressors then bring some of these symptoms to light," Col. John Cho, who commands the Evans Army Community Hospital at Fort Carson, said. "The good news in all of this is we have the mechanism to catch this."

Capt. Matthew Staton, 30, noticed he was having symptoms after returning home from a 2003-04 deployment after surviving several improvised explosive device and bomb explosions. "It's like getting your bell rung," he said of the blasts. He relies on a digital voice recorder and palm computer to remember things. He also is quick to anger. "It's depressing, frustrating. I'm a 30-year-old man," he said.

Posted by Kerry N. Jardine at 06:18 AM | Permalink | Comments (0) | TrackBacks (0)

A rare and painful disease, known as Nephrogenic Systemic Fibrosis, has caused Jeanie Deason legs and right arm to become frozen in a bent position. She fears that the condition will soon leave her an invalid. A Vanderbilt University Medical Center doctor says there is a therapy that may improve Deason's condition. However, TennCare, the state's insurance plan for the poor and disabled, will not pay for it because it's considered to be experimental.

Getting treatment for rare diseases is a widespread problem, said Mary Dunkle, spokeswoman for the National Organization for Rare Disorders. The organization estimates that there are 6,000 to 7,000 rare diseases affecting more than 25 million Americans. Marilyn Wilson, TennCare's spokeswoman, said TennCare had never covered experimental treatments. Patients with rare diseases often are left in a predicament: Insurance companies typically won't cover a treatment unless the FDA has approved it for that disease, but for the majority of rare diseases there are no FDA approved treatments. The National Organization for Rare Disorders says it’s a matter of economics and researchers have difficulty securing funding because the diseases affect such a small number of people. Additionally, drug companies will not put money toward research for rare diseases because it is not lucrative proposition for them.

For Jeanie Deason, she is appealing Tenn-Care's decision. An administrative law judge ruled in her favor in April, but that decision was overturned by a state finance representative. Her case will be reviewed for the last time by a judge in Davidson County Chancery Court. Kevin Fowler, Deason’s attorney is arguing that her illness is so rare that all treatments for it are by definition experimental. "This treatment has been shown to work," Fowler said, "When only 250 people in the world have a disease, how could you statistically prove what treatment is most effective?"

Posted by Kerry N. Jardine at 06:10 PM | Permalink | Comments (0) | TrackBacks (0)

A retired 71-year-old suburban Cleveland restaurant supplier, filed a lawsuit in U.S. District Court on March 14 against Tyco International and two healthcare subsidiaries, Tyco Healthcare Group and Mallinckrodt, Inc., claiming that their drug Optimark caused him a debilitating skin and joint disease known as Nephrogenic Systemic Fibrosis (NSF). It may be the first against Tyco stemming from the effects of Optimark, a contrast agent containing the metal gadolinium. Optimark is injected into patients prior to magnetic resonance imaging (MRI) to help diagnosticians distinguish blood vessels from nearby tissues. The suit notes that in 2006 the FDA issued Public Health Advisory alerts about the development of serious, sometimes fatal, NSF/NFD following patient exposure to gadolinium-based contrast agents, including Optimark. The suit claims that Tyco was aware, or should have been aware of the risks of Optimark. There have been numerous case reports, studies, assessments, papers, and other clinical data that have described and/or demonstrated NSF/NFD in connection with the use of certain gadolinium-based contrast agents, including Optimark according to the suit. Further, the suit alledges that the Defendants have not revised their package inserts, material safety data sheets, and other product-related literature, nor conducted appropriate post-marketing communications in order to convey adequate warnings.

Within days of his Optimark injection last year, this retiree experienced excruciating pain and suffered serious, progressive, and incurable injuries," says Peter J. Brodhead, a partner in the Cleveland litigation law firm of Spangenberg, Shibley & Liber, who filed the suit. Spangenberg, Shibley & Liber in association with Burg Simpson Eldredge Hersh & Jardine are seeking to represent NSF victims nationwide. "This man-made disease caused his skin to harden and his joints to lock up and to swell," says Brodhead "He was sent to a nursing home and confined to bed and a wheel chair. Today he is at home, but he continues to require regular physical therapy in order to walk." The lawsuit asserts that the plaintiff was admitted to University Hospitals in Cleveland in January 2006 for dialysis and other treatment. Before his MRI, he was injected with Optimark. Shortly afterward, he developed NSF with its incapacitating consequences, according to the complaint. "Neither he, nor his prescribing physician, nor the performing radiologists or technicians were warned or cautioned by the defendants about the serious health risks presented by the administration of Optimark," states the suit.

Much has been made public recently about the relationship between gadolinium-based contrast agents and NSF. In its Public Health Advisory last December, the FDA said it was notifying health care providers that patients with moderate to end-stage kidney disease that receive an MRI with a gadolinium-based contrast agent may get NSF. The FDA called NSF "debilitating" and added "it may cause death." The Clinical Journal of the American Society of Nephrology reported on NSF in its February issue. "NSF is a fibrosing disorder that involves predominantly the skin but also affects systemic organs, such as the liver, heart, lungs, diaphragm, and skeletal muscles," said the publication. The U.S. Centers for Disease Control (CDC) also has been investigating illnesses related to metallic dyes containing gadolinium used in MRI scans. "When possible, use of gadolinium-containing contrast agents should be avoided in patients with advanced renal failure, particularly in patients who are undergoing peritoneal dialysis," the CDC concluded in its late February Morbidity and Mortality Weekly Report. The American College of Radiology, in a Guidance Document for Safe Practices, recently recommended that gadolinium-based contrast agents not be administered to patients with advanced kidney disease unless the benefits clearly outweigh the risks. Even more strongly, the European Agency for the Evaluation of Medicinal Products issued a recent advisory against the use of Optimark and one other gadolinium-based contrast agent for patients with severe renal disease.

Posted by Kerry N. Jardine at 04:56 PM | Permalink | Comments (0) | TrackBacks (0)

Evaluating a patient's kidney function can help determine their ability to safely receive IV contrast including gadolinium prior to CT and MR imaging procedures. This is an important precaution especially for patients with risk factors such as diabetes, known kidney impairment, and advanced age especially in the wake of nephrogenic systemic fibrosis. Currently, such blood tests must be sent to a lab before the patient can undergo a CT or MRI procedure, a time-consuming step that can cause delays in busy radiology departments. E-Z-EM, Inc. a leading manufacturer of contrast agents for gastrointestinal radiology announced the release of the company's new EZ CHEMTM blood analyzer. The blood analyzer is a convenient device used in detecting blood creatinine levels in patients prior to CT and MRI. The FDA cleared the technology in May 2007. EZ CHEMTM performs a simple test for assessing kidney function in the imaging room and produces results in as little as 30 seconds. The device analyzes a finger prick sample of blood for levels of creatinine which is an important indicator of a patient's renal function. Such blood values are often required to determine a patient's kidney function before IV contrast agents are administered. This new technology may not help current victims of nephrogenic systemic fibrosis, but for radiologists the release is welcome news

Commenting on the announcement, Brad S. Schreck, the Company's Senior Vice President-Global Sales, Marketing and Engineering, said, "EZ CHEM provides the ability to quickly and accurately assess kidney function where it is needed most, at the point-of-care. Screening for patients with renal insufficiency has been in focus recently, as certain contrast agents, particularly those used in MRI, have been associated with Nephrogenic Systemic Fibrosis (NSF)-a debilitating and potentially severe condition that currently has no clear and widely successful treatment. We believe EZ CHEM will help reduce the risks associated with the use of IV contrasts for certain patients while improving productivity in the imaging suites, all through a simple, reimbursable test. We have been pleased to work with Nova Biomedical during the development phase and are excited to begin offering EZ CHEM to the radiology and gastroenterology marketplace."

Posted by Kerry N. Jardine at 02:23 PM | Permalink | Comments (0) | TrackBacks (0)

A study published by the Journal of the American Society of Nephrology written by researches at Copenhagen University Hospital in Denmark reports on its findings back in 2006. They found that Nephrogenic Systemic Fibrosis was a new, rare disease that affects patients with renal failure. Single cases led to the suspicion of the role of gadodiamide being used for magnetic resonance imaging. A study reviewed all of the confirmed cases of Nephrogenic Systemic Fibrosis with respect to clinical characteristics, gadodiamide exposure, and subsequent clinical course. It was found that all had been exposed to gadodiamide before the development of nephrogenic systemic fibrosis. The ratio for acquiring the disease when exposed to gadodiamide was seven (54%) patients became severely disabled, and one died 21 months after exposure. No other exposure or event related to gadodiamide was common in the patients that could be identified. These findings indicate that gadodiamide played a role in Nephrogenic Systemic Fibrosis.

Posted by Kerry N. Jardine at 06:13 AM | Permalink | Comments (0) | TrackBacks (0)

The FDA has announced that labeling for MRI and MRA imaging contrast agents that contain gadolinium will have stronger new warnings. The contrast agents are often used to improve the visibility of internal structures when patients undergo MRI/MRA procedures. Five of the contrasting agents have been approved in the US: Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. The new boxed warning describes risks and necessary screening procedures for a serious condition related to gadolinium exposure called nephrogenic systemic fibrosis (NSF). NSF is characterized by fibrosis of the skin, muscle and internal organs. It is debilitating and potentially fatal. The warning will state that certain patients have a higher risk of developing NSF if they are given any of these gadolinium-based agents. Specifically those affected with severe acute or chronic renal failure and those with acute renal failure of any severity who have hepato-renal syndrome or are currently preparing for or are healing from a liver transplant. Hepato-renal syndrome is a term used for a group of diseases involving both the liver and kidney. Clinicians should avoid using these products with high-risk patients unless the diagnostic information is essential and cannot be obtained any other way.

The new labeling will contain several other recommendations. Before using these agents, all patients should be evaluated for renal failure either by obtaining a medical history or conducting laboratory tests. When administering these products, do not exceed the dose recommended in the product labeling. And do not re-administer these agents until enough time has elapsed to ensure that the prior dose has been eliminated from the body. After administering a gadolinium-based contrast agent, consider prompt dialysis for patients already receiving hemodialysis. It is unknown whether dialysis prevents NSF, but data indicate that it does speed up the elimination of the agent from the body.

Posted by Kerry N. Jardine at 02:29 PM | Permalink | Comments (0) | TrackBacks (0)

http://www.burgsimpson.com/defective_drugs.htmlThe FDA announced that the Nonprescription Drugs Advisory Committee will meet in October to discuss the safety and effectiveness of cough and cold drug product use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age. In preparation for the meeting, FDA is reviewing safety and efficacy data for the ingredients of these products.

Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the “Drug Facts” box on the package label.

What should parents know about using cough and cold products in children?

* Do not use cough and cold products in children under 2 years of age UNLESS given specific directions to do so by a healthcare provider.

* Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children (sometimes called “pediatric” use).

* Cough and cold medicines come in many different strengths. If you are unsure about the right product for your child, ask a healthcare provider.

*If other medicines (over-the-counter or prescription) are being given to a child, the child’s healthcare provider should review and approve their combined use.

* Read all of the information in the “Drug Facts” box on the package label so that you know the active ingredients and the warnings.

* Follow the directions in the “Drug Facts” box. Do not give a child medicine more often or in greater amounts than is stated on the package.

* Too much medicine may lead to serious and life-threatening side effects, particularly in children aged 2 years and younger.

* For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with each different medicine formulation and that is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children.

* If a measuring device is not included with the product, parents should purchase one at the pharmacy. Make sure that the dropper, dosing cup or dosing spoon has markings on it that match the dosing that is in the directions in the “Drug Facts” box on the package label, or is recommended by the child’s health care provider.

* If you DO NOT UNDERSTAND the instructions on the product, or how to use the dosing device (dropper, dosing cup or dosing spoon), DO NOT USE the medicine. Consult your healthcare provider if you have questions or are confused.

* Cough and cold medicines only treat the symptoms of the common cold such as runny nose, congestion, fever, aches, and irritability. They do not cure the common cold. Children get better with time.

* If a child’s condition worsens or does not improve, stop using the product and immediately take the child to a health care provider for evaluation.

Posted by Kerry N. Jardine at 10:53 AM | Permalink | Comments (0) | TrackBacks (0)

At present, there is no known effective treatment for NSF. Physical therapy or treatment with topical and systemic steroids has had a variable benefit. Immunosuppressive therapy is ineffective. Plasmapheresis, a process in which blood taken from a patients is treated to extract the cells and corpuscles which are then added to another fluid and returned to the body, has led to an improvement in some. The drug Thalidomide led to an improvement in a few patients as well. Others have improved after restoration of normal renal function either spontaneously or as a result of a renal transplant. There is a proposal that a dose reduction in erythropoietin, a hormone produced in the kidneys that increases development of red blood cells in bone marrow, might improve NSF. Two patients were given Pentoxifylline, a substance with activity against tumor necrosis factor. Skin changes in the first patient who had late-stage disease seemed to slow or arrest it and the second patient stabilized and had a slight reversal of disease.

Posted by Kerry N. Jardine at 10:16 AM | Permalink | Comments (0) | TrackBacks (0)

Gadolinium contrast agents have long been used in Magnetic Resonance Imagining (MRI) to enhance the quality of images, but in some patients, it can have a toxic affect, causing a condition known of Nephrogenic Systemic Fibrosis (NSF). It is injected into the bloodstream right before an individual undergoes an MRI. The agent helps the MRI computer differentiate between normal and abnormal tissue. In 2006, researchers discovered that the use of Gadolinium based contrast agents had a direct correlation to the development of NSF in patients with pre-existing kidney problems. The FDA then warned that the agents were tied to a number of NSF cases. At that time the FDA warned physicians to screen patients for kidney problems prior to using a Gadolinium based contrast agent during MRIs. In May 2007, the FDA requested that the manufactures of the five Gadolinium contrast agents (including Ominiscan, Magnevist and OptiMark) used in MRIs include a boxed warning on their labels highlighting the risk they pose to patients with kidney problems.

NSF is a disorder that can cause high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. Further it can progress to the point of causing severe stiffness in joints, and could possibly be terminal. Currently, there is no proven treatment or cure for NSF. However, improved kidney function does seem to slow the development of the disease. Unfortunately, for many patients with NSF, the only way to improve their kidney function is with a transplant.

Gadolinium based contrast agents could potentially injure millions of people. According to the National Kidney Foundation, some 20 million people have chronic kidney disease. The foundation also estimates that 20 million more are at increased risk for developing chronic kidney problems. It is vital that patients who are about to undergo an MRI speak with their healthcare providers about the risks associated with Gadolinium based contrast agents.

Posted by Kerry N. Jardine at 06:24 AM | Permalink | Comments (0) | TrackBacks (0)

A man employed by a subcontractor as part of a two-man rubber removal team on a runway at Denver International Airport was killed earlier this month when he was struck by a giant runway sweeper operated by a DIA employee.

A Denver Police Department spokesman said the dead man was about 46 years of age, had apparently bent over to retrieve an item, and could not be seen by the operator of the sweeper. He was struck and killed by the machine, which is a very large vehicle used to pick up debris on the runway. The sweeper has a broom about 22-to-24 feet long.

OSHA has been notified and will conduct an investigation into the events that led to the death. It's still unknown what occurred in the moments before the accident.

The runway was closed for a brief period of time, but reopened by 8:45 a.m. Since the airport's other runways were able to handle all incoming and outgoing flights, the accident did not cause a disruption to airport operations.

Posted by Kerry N. Jardine at 02:55 PM | Permalink | Comments (0) | TrackBacks (0)

Up to 23,750 people die in Canada each year as a result of medical mistakes. For the first time, organizations that represent medical institutions are developing policies to bring an end to medical secrecy in Canada, eventually making disclosing medical errors a routine part of medical care. Ontario leads the way, with changes to legislation moving through the Legislature that will make the records of all health professionals available to the public. Patients will be able find out if a physician is under investigation, has been accused of medical malpractice or professional negligence, and whether disciplinary action has been taken against a care provider or limits placed on a physician's license. Health professionals found guilty of an offense will be obliged to report findings against them, their respective health regulatory colleges will then make any subsequent findings of misconduct public on their websites. A single committee will be formed to address patient concerns rather than the current system in which complaints are channeled to a variety of committees. Starting July 1 2008, hospitals will be required to report medical errors to patients.

Posted by Scott J. Eldredge at 10:48 AM | Permalink | Comments (0) | TrackBacks (0)

Adeline Papke of Aberdeen South Dakota legs were amputated because of complications following knee-replacement surgery. The South Dakota Supreme court ruled she must get a new trial in her malpractice lawsuit against two doctors. The high court said Adeline Papke is entitled to a new trial because the jury in her first trial was given an improper instruction that probably influenced its decision to rule against her. Papke, who was 70 at the time, fell when her left knee gave out while she was watering flowers in her yard in September 2002. After she was taken to a hospital emergency room, she was evaluated by one of the defendants. Both defendants performed surgery to replace both of Papke's knees in October 2002, but her knees dislocated while she was recovering. The doctors put casts on both of her legs and she developed sores on her feet. Another doctor diagnosed Papke with circulation problems. Her condition worsened and both legs were eventually amputated above the knee. She then sued alleging that her medical treatment fell below the appropriate standard of care.

The original instructions to the jury said a doctor is not necessarily negligent because the doctor errs in judgment nor because the doctor's efforts prove unsuccessful. That instruction also said a doctor is negligent if the error in judgment or lack of successful treatment is due to a failure to perform duties defined in other instructions. The Supreme Court said language on "error in judgment" should not be used in jury instructions for ordinary medical malpractice cases in South Dakota because it does not explain the applicable standard of care at issue in those lawsuits. Papke's right to a fair trial also was violated when she was not given sufficient notice about testimony given by an expert witness for the doctors, the high court said. The ruling gives Papke another trial.

Posted by Scott J. Eldredge at 10:46 AM | Permalink | Comments (0) | TrackBacks (0)

http://www.burgsimpson.com/defective_drugs.htmlThe FDA and Confidence, Inc., has recalled one lot of Metabolism Apple Cider Vinegar Brand Dietary Supplement Capsules (Lot: 3001006, Exp. 10/2009) because it contains an undeclared drug ingredient, sibutramine. Although sibutramine is an FDA-approved drug used for appetite suppression, Metabolism Apple Cider Vinegar Brand Dietary Supplement has not been approved as a drug, so the safety and effectiveness of the product is unknown.

The use of sibutramine may pose a threat to consumers because it is known to substantially increase blood pressure and/or pulse rate in some people, and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Consumers should return any unused product to the manufacturer.

Posted by Kerry N. Jardine at 10:31 AM | Permalink | Comments (0) | TrackBacks (0)

Doctors are human and make mistakes. Most experience significant distress when they do, according to a new study of more than 3,100 doctors in the United States and Canada. Doctors say they need additional training on how to disclose errors and counseling to deal with the aftermath of serious errors, but many fear that such counseling might not be kept confidential or that their malpractice insurance costs would rise. Here are some stats on what doctors in the survey reported:

* Involved with a near-miss or a minor or serious error: 92%
* Increased anxiety about future errors: 61%
* A loss of confidence following errors: 44%
* Difficulty sleeping following errors: 42%
* Reduced job satisfaction following errors: 42%
* Harm to their reputation after making an error: 13%
* Received education or training in disclosure of errors: 18%
* Interested in receiving education or training in disclosure of errors: 86%
* Feel their healthcare organizations adequately supported them in coping with error-related stress: 10%

Posted by Scott J. Eldredge at 06:44 AM | Permalink | Comments (0) | TrackBacks (0)

A New Jersey state appeals court has refused to reduce a $70.8 million medical malpractice award to the family of a brain-damaged infant, ruling it was not excessive in light of the injuries. The three-judge panel chose to confine its ruling to the facts, finding that courts should not interfere with a jury award unless it was shocking. "A civil plaintiff has a constitutional right to have a jury decide the merits and worth of her case," the Court said. "Determining just compensation for an accident victim, particularly when the damages are not susceptible to scientific precision, as in the case of pain and suffering damages, necessarily requires a high degree of discretion. That is so because there is no neat formula for translating pain and suffering into monetary compensation. "

The plaintiff, Casey Pellicer, underwent successful spina bifida surgery at St. Barnabas Hospital in Livingston, N.J., in 1998 when he was 4 months old. During recovery, an endotracial tube aiding his breathing moved, depriving his brain of oxygen for five to 15 minutes. Casey was rendered a quadriplegic, is blind and cognitively delayed, and will require around-the-clock care for the rest of his life. His attorney says Casey will live for six or seven decades.

Posted by Scott J. Eldredge at 06:43 PM | Permalink | Comments (0) | TrackBacks (0)

The manual is the first of its kind. It guides medical staff through how to inform patients and their families of medical mistakes and apologize for them. The manual, called "When Things Go Wrong: Responding to Adverse Events," was compiled by 16 facilities affiliated with Harvard Medical School and published in March last year. The writers of the guide urge doctors and hospitals to be honest about mistakes. The manual states: Even if it is not clear whether medical malpractice has occurred, explain everything that is known and take responsibility. Express regret over the incident. If malpractice is discovered, apologize. Identify measures to avoid a recurrence of the error.

By adopting the manual, the University of Michigan Health System has succeeded in cutting claims and lawsuits filed against it by 56 percent over four years. Court expenses, which had cost upward of 3 million dollars annually, have been slashed by two-thirds. When a lawsuit is filed, the law in some states does not consider an apology a liability for the doctor being sued.

Posted by Scott J. Eldredge at 02:40 PM | Permalink | Comments (0) | TrackBacks (0)

Every year in the United States, 7 million people go to hospital emergency rooms complaining of chest pain or other symptoms suggesting they might be having a heart attack. A missed heart attack diagnosis has the highest malpractice payout among all medical malpractice cases. When patients enter a hospital or an emergency room, doctors have a professional obligation to perform all the routine tests that will either diagnose heart disease or rule it out. When profit is put ahead of patient care, doctors may not take the required time to do their jobs thoroughly and effectively. Patients are often discharged from the hospital when they should be admitted for further testing and treatment. Patients not admitted to the hospital are twice as likely to die as patients properly diagnosed, admitted and treated.

If physicians and ER staff used certain technology within the first hour of a suspected heart attack, patients would have a much greater chance for survival. ACI (acute cardiac ischemia) predictive software can reduce the number of heart attacks missed by physicians. When thrombolytic therapy (blood clot dissolving therapy), is done in the first hour after a heart attack, it increases the chance of survival. A cardiac sestamibi scan allows doctors to evaluate the heart's pumping ability and monitor the amount of blood flow to the heart muscle.

Heart disease is the number one killer in the nation, and failure to diagnose a heart attack is the number one medical malpractice mistake in our country. Being aware of the warning signs and what diagnostic options should be made available to you in the hospital may just help save your life.

Posted by Scott J. Eldredge at 10:38 AM | Permalink | Comments (0) | TrackBacks (0)

Utah soldier Doyle Peterson joined fellow service members and volunteered to help the people of Afghanistan develop new agriculture skills. A roadside bomb destroyed Peterson's vehicle in rural Afghanistan two years ago. Physically he is recovering, but like many roadside bomb survivors Peterson sustained permanent damage to his brain. Utah has more National Guard soldiers and reservists than any state in the nation, and an increasing number of returning soldiers with brain injuries. Those not killed usually suffer traumatic brain injuries from the shock wave of the blast. The new type of bombs used by insurgents focus the blast into the vehicle that sends a tremendous shock wave with it. The resulting concussion causes an injury similar to shaken baby syndrome. The damage to Doyle Peterson’s brain forever changed his life and personality, but he says he does not regret his decision to volunteer. Military doctors say many of the returning soldiers don't immediately know they have a brain injury and neither do medical care providers. Doyle Peterson and his wife spoke with community health workers at Camp Williams, Utah to help them better identify and treat soldiers with brain injuries.

Posted by Kerry N. Jardine at 06:35 AM | Permalink | Comments (0) | TrackBacks (0)

Cruising down the street in a padded bicycle helmet might not be the look you want, but helmet hair is the least of your problems as compared to what would happen if you were in an accident without head protection. Each year, more than 500,000 people are treated in emergency departments across the United States for bike-related injuries. The most serious and fatal injuries often involve the head, commonly experienced as a traumatic brain injury which has life long implications. Helmets are too often ignored. During the summer months, with the start of school and fall semester at universities and colleges, there are more bikes in use than any other time of the year. Often, bike riders share local roads with vehicles, which can present safety issues. Bikers should always remember to use caution and follow traffic signs and signals. Parents should also remain vigilant in ensuring that their children understand and adhere to basic bike safety rules.

These rules include:
- Wearing a properly fitting helmet that meets standards set by the Consumer Product Safety Commission; these helmets come with a CPSC sticker on them;
- Never riding against the flow of traffic;
- Using proper hand signals;
- Avoiding road obstacles that can be associated with falls, such as wet leaves, large puddles, rough surfaces, curbs, gravel or rocks and, most important, other bikers or pedestrians.

Posted by Kerry N. Jardine at 06:20 PM | Permalink | Comments (0) | TrackBacks (0)