In light of recent reports concerning medication errors being made in pharmacies such as Walgreens and CVS it has become clear that the companies need to insist their pharmacists follow established guidelines and take the time to counsel patients. In many professions mistakes happen which makes it imperative for pharmacists to follow through with double checking medication dispensed and counseling patients in the purpose, dosage direction and potential side effects of the drugs they are about to take. “If the pharmacist counseled the patient, eight of 10 errors that get through now would be caught,” says Carmen Catizone, executive director of the National Association of Boards of Pharmacy. Most states require an offer of counseling, but that is not enough according to Catizone. Patients typically decline an offer of counseling, but Catizone says pharmacists need to seize the initiative and counsel regardless. Universal counseling is possible only if the companies give pharmacists the staffing and the time to handle discussions with patients in an era of increasing prescription volume, says Daniel Hussar, a pharmacy professor at the University of the Sciences in Philadelphia. If patients “started to demand counseling from Walgreens and CVS, I can guarantee you CVS would be the best patient counselor in the United States, and so would Walgreens,” Hussar says. For patients to remain safe from possible medication errors disclosure is imperative when mistakes are made, but in an environment where victims are held hostage to silence by big pharmacies, justice and safety remain elusive. Hussar goes on to express frustration and impatience when the defense stonewalls and will not provide important data on individual errors due to the confidentiality agreements in place between parties. The Institute for Safe Medication Practices is preparing a federally financed study that could eventually recommend incentives to ensure that pharmacists counsel patients with prescriptions for 12 drugs associated with the most dangerous errors, but it remains to be seen if that will be enough.

Posted by David P. Hersh at 06:51 PM | Permalink | Comments (0) | TrackBacks (0)

Confidentiality agreements between plaintiffs and defendants on the surface may seem a fair practice so that the parties can be assured of a fair trial. However, when it comes to patient safety where is the line drawn. Chanda Givens was prescribed a prenatal vitamin for her unborn child, but instead Walgreens filled the prescription with Matulane, a chemotherapy drug that interferes with cell growth. After suffering weeks of nausea, vomiting, neurological symptoms such as dizziness, lightheadedness, chills and shortness of breath a medical exam showed her baby was not developing normally. She later miscarried the child. She sought actual and punitive damages in excess of $75,000. The lawsuit was settled out of court a few weeks after the lawsuit was filed. It was never determined whether Walgreens was at fault or not because the settlement included a confidentiality agreement so now the Givens family and their attorney can’t elaborate on the case. In fact, USA Today while reporting on the Givens learned that a number of lawsuits with alleged pharmacy misconduct have been settled and most with a confidentiality agreement attached. "Settlements buy silence," attorney J. Douglas Peters says. "Attorneys have an ethical Catch-22: They have a duty to their client and a duty to the public good. But their first duty is to their client. And if the client is going to get paid, the big-box pharmacies insist on silence." Even Peters is unable to elaborate specifically on similar cases he has handled because of the confidentiality agreements he is bound by. He says he is seeing a pattern in which cases are being settled after they have been asked to disclose data revealing what happens in the pharmacy, such as how much and how many prescriptions pharmacists are expected to fill. When all is said and done it sounds like extortion; money for silence.

Posted by David P. Hersh at 09:50 AM | Permalink | Comments (0) | TrackBacks (0)

A tool has become available for consumers to monitor their doctor’s for disciplinary actions, malpractice judgments, patient ratings and more. It is a new “watchdog” website with an email alert service at www.healthgrades.com. “Recent high-profile news stories underscore the need for patients to know more about their doctors,” said Sarah Loughran, HealthGrades' executive vice president. “If your doctor is sanctioned by his or her state medical board, has a substantial malpractice judgment or has received new training or expertise, you can know about it immediately through HealthGrades' Watchdog e-mail alert service. It's designed to give patients peace of mind.” Healthgrades maintains profiles on almost every practicing physician in the nation. The profiles contain information on each doctor’s medical training, board certification, patient-experience ratings, state and federal sanctions, malpractice judgments, procedure costs, hospital affiliations, the list goes on. The site has been well visited. More than four million people visited the site in January 2008 alone.

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

Medicare announced recently that starting in October they will not pay hospitals if a certain errors are committed. This is their way to push for patient safety. Other insurers such as Aetna are considering the same. In response, hospitals are exploring innovative programs to prevent injury and infection. Those include hand-washing spies and surgical sponges that sound an alarm if left in the body. “Money talks,” says Dr. Steven Gordon, infectious disease chief at the Cleveland Clinic Foundation. “Every hospital CFO, this gets their attention.” One change seen may be the decreased use of urinary catheters, which have triggered more than half a million urinary tract infections a year, the most common hospital-caused infection. The University of Michigan reported on a national study in which it found fewer than one in 10 hospitals check daily to see if a catheter is still needed. The urinary tract infection is one of Medicare’s top do-not-pay examples from the list. Starting October 1st, Medicare will no longer pay for eight preventable hospital errors, including catheter caused urinary tract infections, injuries from falls and leaving objects in the body after surgery. Nor can hospitals bill the injured patient for the extra costs in treating those mistakes. Next year, Medicare will add to the no-pay list; ventilator-caused pneumonia and drug-resistant staph infections. Medicare, which insures about 44 million elderly and disabled people, estimates the move will save the government about $190 million over five years.

Posted by David P. Hersh at 04:46 PM | Permalink | Comments (0) | TrackBacks (0)

Colorado Senate Bill 164 has cleared its first hurdle. The Senate State, Veterans and Military Affairs Committee has approved the bill which will now head to the Senate floor for debate. SB164 calls for an increase from $300,000 in non-economic damages to $450,000 to account for inflation in victims of medical malpractice. Additionally, impairment and disfigurement would not be subject to the cap as it had been previously. Senate President Peter Groff, D-Denver, sponsored the bill, which he called moderate and reasonable. The changes are in line with the 1988 Health Care Availability Act, which limited the amount doctors pay if found guilty of malpractice. Under that law, impairment and disfigurement weren’t considered non-economic damages, but a law passed in 2003 changed that. Doctors and lawyers who testified predictably disagreed on the outcome. Groff said he expects doctors and their lobbyists will continue to fight the bill once the full Senate takes up the debate. They are already using “fear, threats and distortion” to fight something that would affect “about a handful of . . . cases every year that dramatically alters (someone’s) quality of life,” he said. In 2006, 13 malpractice cases went to trial in Colorado. Of the six cases won by the plaintiffs, five exceeded the $1 million cap.

Posted by Scott J. Eldredge at 12:41 PM | Permalink | Comments (0) | TrackBacks (0)

It’s impossible to determine the number of dental malpractice cases because insurance companies that collect the malpractice claims do not release details. Dental malpractice may be more common than patients realize. Crystal Baxter who practiced dentistry in Chicago for 25 years prior to relocating to Arizona confirmed that many cases of dental malpractice go unreported. A dentist herself, Baxter has reviewed and provided expert opinions for more than 400 malpractice cases. After analyzing 242 of these cases, she determined that dental malpractice was "vastly, vastly underreported." She gave a number of reasons such as: patients are unaware of their options, existing legal roadblocks and a culture of silence around mistakes. When a patient initiates a complaint against a dentist, state regulators investigate and if they find evidence of malpractice, the dentist may receive a reprimand, fine or probation. In the extreme his or her license may be suspended or revoked. Patients who decide to sue face a difficult system. According to an American Dental Association study in excess of half of dental settlements involve less that $10,000. This amount does little to cover attorney’s fees let alone patients costs which leaves the incentive to pursue a claim lacking.

Posted by Scott J. Eldredge at 02:39 PM | Permalink | Comments (0) | TrackBacks (0)

In 2004 Nate Jorgenson of Fort Collins, Colorado was hit by a drunk driver in a bike lane he was walking in. The car was going 40 miles per hour when the driver lost control and hit Nate from behind. The collision caused his body to “skip” down the road and land in a ditch. The driver was too drunk to stop and check on the then 26-year-old. When his friends found him they took him to the hospital. There doctors discovered Nate had a broken neck and a traumatic brain injury. In an instant Nate Jorgenson’s life changed forever. Since the accident in October 2004, Jorgenson has been in extensive rehabilitation. In the first year after the accident he had to relearn how to eat, talk and walk. He still has issues with speech impairment and balance and uses a cane to help him. He was blessed by the help and support he received from family, friends and even the driver who struck him.

Now, Nate, 29, and his mother want to make sure all who have sustained traumatic brain injuries have support. Jorgenson is currently working to become a certified trainer to help others with traumatic brain injuries rehabilitate. His mother, Debbie shares the same vision. Both of them have started a non-profit foundation: The Shared Journeys Brain Injury Foundation. The goal of the non-profit is to help others who have sustained a TBI to continue rehabilitating after they have been released from acute rehab. “The biggest problem with recovery is the huge gap there often is after a patient gets discharged from the hospital,” Debbie said. Nate underwent therapy at the Center for Neurorehabilitation Services in Fort Collins, but hit the gap after completing a year and eight months of rehab. She said that there are very few programs to support brain injury patients in transitioning from intensive hospital care to independent living. Lacking services to reintegrate victims of TBI back into society by teaching them meal preparation, personal care and money management causes many of them to regress to pre-injury levels. Nate and Debbie ultimately want to see the organization succeed in offering specialized residential and rehabilitation programs so that those with TBIs can live independently and find fulfilling and productive lives.

Posted by Kerry N. Jardine at 09:30 AM | Permalink | Comments (0) | TrackBacks (0)

A small Minnesota town of little more than 1,000 residents was the scene of a horrific school bus crash that killed 4 children between the ages of 9 and 13 and injured 14 additional victims. Thirteen of them were students who were treated for a number of injuries including back and neck injuries and two child victims were in critical condition. The bus was on its regular route carrying 28 students when it was hit by a van driven by a 23 year-old that ran a stop sign. The bus then collided with a pickup and rolled onto the top of it.

Posted by Kerry N. Jardine at 07:21 PM | Permalink | Comments (0) | TrackBacks (0)

Bioness Inc., developers of the NESS L300™ Foot Drop System, produced results from a research study that showed improvements in overall walking ability among stroke and traumatic brain injury survivors. Foot drop is a partial leg paralysis that prevents the foot from lifting while walking causing instability. Prior to the release of NESS L300™ patients used rigid plastic braces that restricted ankle movement. Research data from the NESS L300™ neuro-prosthesis revealed that daily use over a 12-month period enabled TBI and stroke patients to significantly improve their walking skills. The positive results from the L300 provide a breakthrough in the treatment of foot drop because all of the subjects in the study were in a state of recovery where significant improvement is traditionally limited. The findings of the long term study are encouraging for patients who have experienced foot drop as a result of stroke, traumatic brain injury and other neurological disorders. The L300 uses the most recent electronic capabilities integrated into a compact and wireless design. Sensors detect whether a patient’s foot is in the air or on the ground and communicates wirelessly to a microprocessor placed just below the knee. As the patient walks, low-level stimulation is sent to the underlying nerves and muscles that control the lifting of the foot. The NESS L300 Foot Drop System has been approved by the Food and Drug Administration.

Posted by Kerry N. Jardine at 04:32 PM | Permalink | Comments (0) | TrackBacks (0)

The Colorado Senate is slated to vote on a proposal to raise caps in medical malpractice lawsuits. Currently non-economic damages are capped at $300,000. Sen. Peter Groff, D-Denver and Rep. Terrance Carroll, D-Denver are proposing the increase to be inflation-adjusted this year. Senate bill 164 also proposes that whatever the new cap becomes, that it be subject to potential doubling as in general liability cases now for extreme circumstances if a judge determines it is justified. Under the new bill, damages for physical impairment or disfigurement, previously considered non-economic, will now be considered as economic damages with a cap of $1 million. Current law allows judges to override the caps for economic losses if they feel the plaintiffs losses exceed $1 million. The new bill does not change that provision. Groff has said he supports the legislation because he believes the current medical malpractice system is unfair. “The caps haven't been adjusted for almost a decade and this isn't about trial lawyers or insurance companies -- it's about justice for the victims,” Groff said regarding an earlier draft of the bill late January. Supporters say the proposal would give victims better compensation when medical procedures are responsible for impairment of disfigurement.

Posted by Scott J. Eldredge at 12:36 PM | Permalink | Comments (0) | TrackBacks (0)

Adam Porter went in to have a kidney stone removed and left with brain damage. A jury as awarded him almost $24 million in a medical malpractice lawsuit. Now 34, Porter in 2001 suffered cardiac arrest which interrupted the flow of oxygen to his brain during the common surgery. The brain damage has put him in a wheelchair, caused spastic movements affecting his fine motor skills, left him with severe double vision and slurred speech. The $23.7 million judgment will help with the life-time of medical care he will experience for the rest of his life.

Posted by Kerry N. Jardine at 08:26 AM | Permalink | Comments (0) | TrackBacks (0)

In November 2007 the FDA requested the drug Trasylol manufactured by Bayer AG be withdrawn because of concerns raised by an observational study linking the medicine to kidney failure requiring dialysis and increased instances of death. Trasylol is used in open heart surgery to stem bleeding. The results were reported on CBS Television’s 60 Minutes program. Dr. Dennis Mangano, the study’s researcher, said that upwards of 22,000 lives could have been saved if it had been taken off the market when he first published his study in January 2006. He feels that Bayer failed to disclose to the FDA in September 2006 that it had confirmed the same dangers as Dr. Mangano’s study. Bayer spokeswoman Meredith Fischer says they are facing a number of product-liability lawsuits concerning Trasylol filed by patients or their families, but did not disclose how many.

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

Joining the Duragesic transdermal Fentanyl patch recall is the company Actavis Inc. They announced that 14 lots of their generic version Fentanyl CII sold in the United States by subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies. The recalled patches were manufactured by the contract manufacturer Corium International Inc. The 14 lots of the Fentanyl patch system may have a fold-over defect that can cause the patch to leak and expose patients and caregivers to the internal gel that could lead to serious side-effects such as respiratory depression and fatal overdose. Fentanyl is a potent Schedule II opiod medication. Anyone who comes in contact with the defective patches should rinse the exposed area thoroughly without the use of soap.

Posted by Kerry N. Jardine at 12:20 PM | Permalink | Comments (0) | TrackBacks (0)

Denver Channel 7 News reported recently on the little known disease Nephrogenic Systemic Fibrosis. In an interview attorney Peter Burg informed the news station that the medical profession believes the disease is caused by a contrasting dye used in Magnetic Resonance Imaging (MRI) procedures on people with kidney disease. "It is the most awful disease that I have ever seen in my life," said Burg, who is representing close to 100 clients who are suing the manufacturers of gadolinium. "And what makes it doubly awful is that it was manmade." Greta Carolus of Loveland, Colorado is one of his clients. In August 2006 while preparing for a kidney transplant, Carolus underwent an MRI using the contrasting dye, gadolinium. Gadolinium is used to improve the quality of the picture in an MRI. Four days later she was hospitalized and learned she had contracted NSF. The lesions and hardening of her skin was caused by gadolinium exposure and put Carolus in a wheelchair. "I am a registered nurse, but I have not worked since the day this happened," said Carolus. "I wouldn’t wish this on anybody; my worst enemy I wouldn’t wish it on. This is just a terrible disease." In people with healthy kidneys, gadolinium has been proven safe. It is believed that the chemicals surrounding the gadolinium make it safe for use in the human body, but sometimes breakdown. In patients with ill-functioning kidneys, the gadolinium cannot be expelled properly thus exposing the patients to the dye for an extended period of time. “When I found out it was the dye it was devastating because it was something that didn't need to happen,” said Carolus. According to Carolus’ attorney, Peter Burg, the 5 companies that manufacture gadolinium contrast knew they were toxic to patients with kidney insufficiency. “They knew how toxic it was, they may not have known the specific harm that was going to be caused but they knew the results were likely to be catastrophic,” said Burg.

General Electric Healthcare is the manufacturer of the contrasting dye labeled Omniscan and their spokesman Ryan Fitzgerald said, “there is no definitive causal relationship between gadolinium-based contrast…. given to patients with moderate to severe renal impairment…..and NSF.” Yet, studies have proven the correlation and the mechanism by which the dye triggers certain responses in the body of a patient with kidney insufficiency. In fact, the last year the FDA issued a “black box” warning, the highest level of communication, on all gadolinium dyes that stated patients with kidney insufficiency can develop the fatal disease. Since the FDA warning was issued, hospitals across the country, including Colorado have taken measures to protect patients. Carolus knows the changes in gadolinium awareness and use will not help her situation, but as a nurse, she is obviously pleased that the hospitals nationwide are taking additional precautions and urges anyone who is preparing for an MRI insist on being tested prior to receiving gadolinium containing contrast agents.

Posted by Peter W. Burg at 11:14 AM | Permalink | Comments (0) | TrackBacks (0)

The Department of Defense has granted an additional $971,000 to Banyan Biomarkers Inc. to support the development of non-invasive diagnostic tools used for Traumatic Brain Injuries. Gary Ascani, President and Chief Executive Officer, Banyan Biomarkers, Inc., commented that with this funding solutions in diagnosing Traumatic Brain Injuries will benefit military medics as well as physicians to detect the brain injury through a simple blood test. Valuable time and significant healthcare savings will be achieved. Brain injury is known as the “silent epidemic” because the injury is difficult to diagnose. In addition to military incidences, traumatic brain injury ranks as the leading cause of death and disability in children and young adults.

Posted by Kerry N. Jardine at 08:16 AM | Permalink | Comments (0) | TrackBacks (0)

In Stamford Connecticut a jury found obstetrician Corinne De Cholnoky responsible for a child’s cerebral palsy condition and has been told to pay $38.5 million to the family. The jury agreed that the doctor should have performed an emergency C-Section in 2003 when it was clear the umbilical cord was wrapped around Spencer Oram’s neck and was cutting off blood flow to the baby’s brain. She tried to deliver Spencer naturally for 12 minutes before deciding on a C-section in which he was born 15 minutes later with cerebral palsy. His twin sister had been born 27 minutes earlier and is healthy. The jury did not find the Hospital at fault in a separate claim. There have been a handful of medical malpractice verdicts in Connecticut totaling more than $20 million. The jury awarded $30 million to the Oram family to cover the past and future costs of caring for Spencer. It awarded $7.5 million to compensate Spencer for his suffering and $1 million to his parents.

Posted by Scott J. Eldredge at 10:24 AM | Permalink | Comments (0) | TrackBacks (0)

The FDA has announced a recall of a transdermal patch system, which contains the prescription painkiller Fentanyl. The patches are sold in the U.S. under the names, Duragesic by PriCara and a generic version by Sandoz Inc. In Canada, the recalled patches are sold under the Duragesic brand by Janssen-Ortho Inc. and generically by Ranbaxy Laboratories Ltd. The recall includes all 25-microgram-per-hour patches with expiration dates on or before December 2009. It has been discovered that some of the patches may have a cut in the lining of the internal reservoir where the drug is held in gel form. Fentanyl is a powerful “opiod” drug and if it leaks into the drug’s packaging, releasing into the skin it could cause difficulty breathing and a potentially fatal overdose. If skin has been exposed to an increased amount of the gel due to a cut in the reservoir the area should be thoroughly rinsed, but do not wash with soap.

Last December, the FDA announced a second warning in two years about the dangers of misusing the powerful drug. Fentanyl is intended for patients suffering from chronic pain who have been exposed to narcotics before, such as cancer patients. However, the FDA has found cases where doctors have prescribed it for headaches or post-surgical pain. PriCara estimates that two patches out of every million included in the recall have the defect that causes the leak. All of the patches were manufactured by PriCara affiliate ALZA Corp. PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Posted by Kerry N. Jardine at 04:22 PM | Permalink | Comments (0) | TrackBacks (0)

It has recently been discovered that the recalled pre-filled Heparin syringes made by Baxter International blamed for causing allergic reactions and four deaths, was manufactured in a Chinese facility that was never inspected by the Food and Drug Administration. Both Baxter and the FDA claim it is not clear whether the product from the Chinese supplier is tied to the allergic reactions and deaths to the blood thinning drug. Baxter said February 11th that it was temporarily suspending production of Heparin because of approximately 350 negative reactions that may be a result of the drug. The allergic reactions have been mostly among patients undergoing kidney dialysis and heart surgery.

Posted by Kerry N. Jardine at 10:20 AM | Permalink | Comments (0) | TrackBacks (0)

Talking Lights is a startup company developing a high-resolution tracking system that uses PDAs and audio directions to guide patients around hospitals as well as helping those with traumatic brain injuries rehabilitate. The navigation system uses optical signals from the ballast in hospital lights to send information to a PDA via an optical receiver worn by the patient. The PDA is also has mapping software, information about the building, and user-specific data such as appointment schedules. The Talking Lights guidance system is "a tremendous asset for someone with traumatic brain injury," says Heechin Chae, medical director of the brain injury center at Spaulding Rehabilitation Hospital, in Boston. The system has been tested at the hospital over the past two years and is currently used by about 20 patients. It not only helps patients navigate the rehab center, but it also appears to help them relearn how to process visual cues and navigate unfamiliar environments, Chae says. A future plan for Talking Lights involves developing software to run on smart phones and hardware for a Bluetooth headset with an optical receiver. The headset would pick up the optical signals, send them to the phone and then play back directions to the wearer.

Posted by Kerry N. Jardine at 10:18 AM | Permalink | Comments (0) | TrackBacks (0)

Justin Matylewicz was in a car accident at the age of 14 and sustained a traumatic brain injury that left him in a coma for 3 ½ months. At the time doctors suggested that his parents should consider taking him off life support. Years of physical, occupational and speech therapy gave him back his ability to walk and talk. He relearned everyday tasks such as holding a fork or glass and writing left-handed. He still struggles with short-term memory and balance. He is now 25 and has taken a new step in his long recovery. Until recently, he was unable to use his right hand and arm because of tremors that caused his arm to flail uncontrollably. Over the years Matylewicz tried medications, biofeedback, cranial therapy and other means to suspend the tremors, with little or no success.

In January that all changed. A therapy that has been in use for a decade for suffers of Parkinson’s disease, is now implanted in Justin’s brain. A long, razor-thin electrical stimulator was implanted a month prior and was activated by Dr. Alice Flaherty, director of the movement disorders program at Massachusetts General Hospital in Boston. A neurologist, Flaherty, was typing codes into a computer directed at a battery in Justin’s chest that sends electrical pulses to the four electrodes of the brain stimulator. Once activated and adjusted by Flaherty, three volts of electricity began continuously flowing from a pacemaker-like generator powered by a plutonium battery implanted in his chest to the stimulator, feeding a stream of tiny pulses to the part of Matylewicz's brain that controls the movement of his right arm, called the ventral medial nucleus of the thalamus. With a little therapy from his neurologist, he no longer has to hold his arm down to control the tremors.

Posted by Kerry N. Jardine at 10:17 AM | Permalink | Comments (0) | TrackBacks (0)

A new therapy has become popular among a number of doctors and physical therapists, it’s dubbed, “Wiihabilitation” and it’s fast becoming a therapy for patients recovering from strokes, spinal cord injuries, broken bones, and surgery and combat injuries. The typical stretching and lifting exercises are being supplemented with the popular Nintendo Wii video game system. Using the Wii’s unique, motion-sensitive controller, the games require body movements similar to traditional therapy exercises. A positive aspect of game use is that patients become so engrossed mentally they're oblivious to the rigor, according to James Osborn who oversees rehabilitation services at Herrin Hospital in southern Illinois. "In the Wii system, because it's kind of a game format, it does create this kind of inner competitiveness. Even though you may be boxing or playing tennis against some figure on the screen, it's amazing how many of our patients want to beat their opponent," said Osborn. "When people can refocus their attention from the tediousness of the physical task, oftentimes they do much better," Osborn said. The Hines Veterans Affairs Hospital west of Chicago recently bought a Wii system for its spinal cord injury unit. Pfc. Matthew Turpen, 22, paralyzed from the chest down while stationed in Germany, plays Wii golf and bowling from his wheelchair at Hines. He says the games help beat the monotony of rehab and seem to be doing his body good, too. "A lot of guys don't have full finger function so it definitely helps being able to work on using your fingers more and figuring out different ways to use your hands" and arms, Turpen said. It's proved useful in occupational therapy, which helps patients relearn daily living skills including brushing teeth, combing hair and buttoning clothes. Nintendo Co. does not market Wii as a rehabilitative tool, but is pleased that the game assists injured users to rehabilitate from their injuries.

Posted by Kerry N. Jardine at 04:13 PM | Permalink | Comments (0) | TrackBacks (0)

The Food and Drug Administration is notifying consumers about Icy Hot Heat Therapy products that have been voluntary recalled nationwide by makers Chattem Inc. This recall includes Icy Hot Heat Therapy Air Activitated Heat and the single use samples included in a limited promotion of its 3oz. Aspercreme® Pain Relieving Crème. Chattem is recalling these products because consumers have reported first, second and third degree burns as well as skin irritation resulting from consumer use.

All lots and all sizes of the following Icy Hot Heat Therapy products are affected by this recall:

1. Icy Hot Heat Therapy Air Activated Heat- Back

2. Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg

3. Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg single consumer use "samples" included on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Crème.

If the recalled products have been removed from their cartons they are packaged in a red colored plastic pouch which states Icy Hot Heat Therapy and either Back or Arm/Neck and Leg. Chattem is notifying its customers, including distributors and retailers, about this recall, and is arranging for immediate return of all recalled products to Chattem. If any adverse reactions have been experienced the FDA is encouraging consumers to report it to the FDA Adverse Event Reporting Program.

Posted by Kerry N. Jardine at 10:08 AM | Permalink | Comments (0) | TrackBacks (0)

George Lipscomb of West Virginia and his wife Ruth Ann have filed a medical malpractice lawsuit against Bayer Corporation and Bayer Healthcare Pharmaceuticals after he contracted Nephrogenic Systemic Fibrosis following MRIs that used a gadolinium containing contrast agent. According to the suit, George Lipscomb received five MRIs from May 2, 2005 to May 29, 2007. NSF causes muscle weakness and inhibits flexing and extending of joints resulting in contractures. It can also progress enough to cause total loss of use in arms, legs, hands and feet. Lipscomb claims he was suffering from chronic renal insufficiency at the time of the first MRI. He was later diagnosed with NSF on Sept. 25, 2007. The lawsuit claims that Lipscomb did not know or have reason to know that his insufficient renal condition would cause him to be harmed by the contrasting agent and as a result, he developed excruciating pain in his leg, hip and foot. He is also experiencing tightening, swelling and stiffening of his skin, muscles and joints, has had difficulty walking and is in jeopardy of having his heart and lungs impaired. The Lipscombs feel Bayer was irresponsible toward the safety and health of those receiving the contrast solution. They seek compensatory and punitive damages. Attorney Barry Hill is representing the Lipscombs.

Posted by Peter W. Burg at 04:56 PM | Permalink | Comments (0) | TrackBacks (0)

The latest research of Nephrogenic Systemic Fibrosis has come from the Center for Disease Control (CDC) and once again has tied NSF to exposure to Gadolinium contrast agents used in MRIs (Magnetic Resonance Images). Nephrogenic Systemic Fibrosis is a debilitating condition that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by 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. NSF can cause severe stiffness in joints, and can lead to death.

The CDC examined a cluster of patients presenting with NSF at an unidentified St. Louis Missouri Hospital and found that the exposure to Gadolinium contrast dyes during MRI was the singular association with the development of NSF. The CDC study reinforces the link between NSF and Gadolinium exposure. In May 2006, nephrologists at the St. Louis hospital reported a cluster of patients with NSF treated in the dialysis units. The CDC’s investigation revealed of the 19 patients in the study, five had no known gadolinium exposure within a year of an NSF diagnosis. Yet, of these five, four had gadolinium exposure from 16 to 68 months preceding NSF diagnosis. Ultimately, thirteen patients who presented with NSF had multiple gadolinium contrast agent exposures during the preceding year. The FDA has warned that patients with kidney problems not be given Gadolinium based MRI contrast dyes unless it is absolutely necessary because of their association with NSF. The CDC as well cautioned clinicians in its use that they should be aware of the potential in developing NSF. Unfortunately, there are not yet any alternatives to gadolinium based MRI contrast agents and no known cures.

Posted by Peter W. Burg at 10:53 AM | Permalink | Comments (0) | TrackBacks (0)

At five-years old Trey Jones was prescribed Inderal, a blood pressure drug, for hand tremors and hyperactivity. What the Walgreens pharmacist filled was Methitest, a synthetic form of testosterone. The prescription was refilled four more times by the pharmacy. The mistake caused Trey to go into premature puberty and uncontrolled rages. The devastating and fearful side effects also caused the 5-year old to eat three times as much food. Not surprisingly, Trey’s hands continued to shake, but rather than determine what the trouble was, his doctor doubled the dosage instead. Walgreens again misfilled the prescription and with the higher dosage. When the little boy began to experience genital pain his parents had enough and halted dispensing it. When the Walgreens pharmacist caught the error, Mrs. Jones was only told to contact Trey’s doctor. Trey's parents sued Walgreens, fearing the steroid could stunt the boy's growth or cause liver damage.

Pretrial discovery in the Jones case showed the Walgreens pharmacy where the errors occurred, two pharmacists filled 477 prescriptions the day Mrs. Jones was filling Trey’s. This is not the first time Walgreens has come under fire. They have lost trials involving deaths caused by drug mistakes made at their pharmacies since 2006. The cases include the 2002 death of a 31-year-old Arizona high school wrestling coach. He died from an interaction between Tramadol and methadone. A jury awarded his family $6 million when evidence showed that the pharmacist neither warned him about the potential drug interaction nor double-checked the second prescription with his doctor. In August, a Florida jury awarded $25.8 million to the family of a 42-year-old mother of three who died in 2002 after Walgreens mistakenly gave her a blood thinner 10 times stronger than prescribed. The list goes on. In a day of quantity verses quality and speed versus accuracy people are facing flagrant and devastating consequences of the system’s irresponsibility towards patients.

Posted by David P. Hersh at 03:35 PM | Permalink | Comments (0) | TrackBacks (0)

The popular actor and comedian John Ritter died in September 2003 of a purported heart attack. It turned out that Ritter had an aortic dissection, a preexisting condition. In 2001 Ritter had a full body scan administered by Dr. Matthew Lotysch and the doctor failed to recognize or warn Ritter about his potentially fatal condition. At the time of the aortic dissection Dr. Joseph Lee in the ER did not order a chest X-ray that may have revealed the tear in Ritter’s aorta and could have treated it. If the aortic dissection were treated properly, Ritter could have had surgery to repair it and recovered six to eight weeks later, says Ritter’s family’s attorney Moses Lebovits. The family has sued for medical malpractice and is seeking $67 million in damages because had the star lived that is how much he could have made from his new hit show 8 Simple Rules.

Posted by Scott J. Eldredge at 10:29 AM | Permalink | Comments (0) | TrackBacks (0)

The Food and Drug Administration has linked botulism in some users to the anti-wrinkle drugs Botox Cosmetic and competitor Myobloc. Some cases have been so severe that a few children given the drugs for muscle spasms have died. In rare cases, the toxin can spread to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect. Botox is best known for minimizing wrinkles by paralyzing facial muscles, but botulinum toxin is also widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms. The FDA said the deaths it is investigating so far all involve children, mostly cerebral palsy patients being treated for spasticity in their legs. The FDA has never formally approved that use for the drugs, but some other countries have. However, the FDA warned that it also is looking into reports of illnesses in people of all ages who used the drugs, including at least one hospitalization of a woman given Botox for forehead wrinkles. The FDA wouldn't say exactly how many reports it is researching.

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Big tobacco may come under additional pressure by State health commissioners. Fifty state health commissioners have been notified via letter by public interest law professor John Banzhaf that medical malpractice lawsuits could be brought against physicians by smokers if they fail to follow federal and other guidelines in treating and warning smokers of the hazards of smoking. John Banzhaf, is known as the “driving force behind the lawsuits that have cost tobacco companies billions of dollars,” and the “law professor who masterminded litigation against the tobacco industry,” The warning is based upon a recent article in a medical journal and recent study about saving smoker lives. The health commissioners were told that physicians are killing more that 40,000 American smokers each year by failing to follow federal guidelines that requires they warn patients about the dangers of smoking and to provide effective medical treatment for those who want to quit. “The families of any one of those 40,000 victims - or the hundreds of thousands more who suffer heart attacks, strokes, amputations, blindness, or other problems because of their smoking - could sue physicians for malpractice for failing to follow the standard of medical care mandated by these guidelines,” says Banzhaf. The New York City Department of Health has already warned that “because physician intervention can be so effective, failure to provide optimal counseling and treatment is failure to meet the standard of care - and could be considered malpractice.” In a report sponsored by the Centers for Disease Control and Prevention, the Robert Wood Johnson Foundation and the WellPoint Foundation, fewer than 30% of smoking patients receive even the minimal treatment required by the guidelines. Banzhaf's letter warned that: “Since many in the antismoking community (including hundreds of organizations, many with their own attorneys), as well as lawyers associated with antismoking groups and others in private practice, are now considering how to proceed with the article's litigation suggestion, the need to remind doctors of their responsibilities and of their potential legal liability is paramount - especially since their continued refusal to even warn many patients about smoking, much less to follow the guidelines' requirements of effective intervention, kills over 40,000 patients each year.”

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New York State Health Commissioner Richard Daines has asked the Food and Drug Administration to end the manufacture and distribution of medications delivered via multi-dose vials. This was in response to a second Long Island doctor who, similar to Harvey Finkelstein, reused syringes on multiple patients. The second offender is Dr. E. Jacob Simhaee, an obstetrician-gynecologist who admitted to reusing syringes on 36 additional patients. Earlier in the month, New York announced that Dr. E. Jacob Simhaee reused syringes in multi-dose vials while inoculating for the flu. Daines said despite “numerous guidelines and recommendations,” some doctors continue to misuse needles and syringes, leading to contamination of multi-dose vials. New York is the only state that requires infection prevention training every four years as well as strict infection control requirements in hospitals and office-based surgeries. Despite this, Daines listed five hepatitis C and B outbreaks caused by poor infection control in NY since 2001.

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The Food and Drug Administration has recalled the SynchroMed E1 pump for potential failure in a Medtronic drug pump. The recalled Medtronic drug pumps were deemed a “class 1”, the most serious type, by the Food and Drug Administration last August. The drug pump used to treat pain, spasticity and cancer was recalled after motors failed because of gear-shaft wear. They were manufactured in Fridley and Puerto Rico before September 1999. Fortunately, no deaths or serious injuries have been reported. There are currently estimated to be 52,000 patients using the pump with about 8,000 of them that have the type that could fail. Medtronic in August informed doctors of the possible pump failure and encouraged them to monitor patients using the device.

Posted by David P. Hersh at 10:33 AM | Permalink | Comments (0) | TrackBacks (0)

Victoria Krzywonos returned to school recently after recuperating from a hit-and-run accident in October that left her with a traumatic brain injury. She looks the same, but she isn’t. She can’t remember things and has trouble organizing and concentrating. Her classmates were confused. They couldn’t understand why she didn’t remember them. Principal Dawn Kelly said the confused students appeared in her office wondering why Victoria didn't remember who they were, how she knew them or why she takes longer to do things. They didn't seem to understand the severity of Victoria's brain injury. So the principal invited the trauma team overseeing her rehabilitation to explain it to the students in an assembly.

Victoria was one of two ninth-graders seriously injured Oct. 14 after they were struck by a car in the neighborhood where they live. The teens had been talking before the accident happened. Victoria was sitting on the curb when the car struck her. The force pushed her onto the hood, where her head cracked the windshield. She landed 70 feet from where she was hit. Her right leg was broken in two places and her pelvis was fractured in three spots. The head injury was the worst. Her skull fractured and her brain was bleeding. Her fontal lobe was damaged, which is associated with reasoning, planning, parts of speech, movement, emotions and problem solving. Her temporal lobe, associated with perception and recognition of auditory stimuli, memory, and speech, also were damaged. She has what’s called a diffuse axonal injury, meaning that her brain had rotated inside her skull. The twisting motion stretched and sheared large nerve fiber pathways that let nerve cells communicate with each other. That created microscopic damage throughout many areas of the brain. Patients with that type of injury usually face a poor prognosis and typically experience memory impairment and reduced cognitive function.

Patients with this type of brain injury usually face a poor prognosis and typically experience memory impairment and reduced cognitive function. Before the accident, Victoria was an honor student, and excelled at math, scoring at the advanced level on the state assessment tests. Now her cognitive abilities test at the lower end of average. Since her rehabilitation her memory has improved miraculously and she is happy to be back at school part-time.

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Toni Pratt was awarded $548,000 in a medical malpractice lawsuit against a former surgeon who botched abdominal surgery in 2002 which caused her chronic, pain and the loss of her right kidney. Dr. Michael Fenner was using a laparoscopic technique to remove a mass below her right kidney and unknowingly removed a 6 cm long section of Pratt’s ureter, (the tube has urine flow from the kidney to the bladder). Post surgery she complained of pain in the days after the surgery, but he dismissed her. Pratt later learned that her abdomen was infected and repairing the ureter could be dangerous so she chose to have her right kidney removed instead. The jury decided in her favor after a five-day trial, ruling that Fenner was negligent in performing abdominal surgery to remove a mass below her right kidney. The jury awarded Pratt $59,200 for medical bills, $154,000 for past and future lost earnings, and $335,000 for non-economic damages, including $150,000 for pain and suffering. Pratt was very pleased with the verdict because she had lost her home to foreclosure while sick. Fenner no longer practices in Springfield, Illinois and has moved to Alaska to practice.

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John A. King the embattled osteopathic physician who faces over one hundred medical malpractice lawsuits in West Virginia now faces the loss of his medical license in Alabama. The Alabama board of Medicine has cited two medical malpractice cases involving King which happened in October and November 2006. King was working at American Family Care when he apparently overdosed a woman with the antihistamine, Phenrgan that put her in a coma for 26 hours. The following day he overdosed a second patient with Phenergan and Valium. Larry D. Dixon, executive director of the Alabama medical board, signed a resolution adopted by the board on Jan. 2 stating King was “practicing medicine or osteopathy in such a manner as to endanger the health of the patients” and exhibited “a demonstrated lack of basic medical knowledge or clinical competency.” Since 2004, King has surrendered or had his license suspended in nine states: West Virginia, Florida, Georgia, Michigan, New Jersey, Ohio, Pennsylvania, Texas and Virginia. He still holds licenses in Indiana, Kentucky, Louisiana, New York and Oklahoma. He is facing 121 medical malpractice suits in West Virginia. In response, King filed for personal bankruptcy in Alabama in November. After leaving West Virginia, he briefly legally changed his name to Christopher Wallace Martin and then changed it back.

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Gregory Martinez, 16, suffered severe brain and spinal injuries in a bike accident six months ago. At the time of the accident he suffered massive head trauma, a broken neck, a collapsed lung, and spinal and internal injuries. He recently was able to visit his high school in a wheelchair. Greg still resides at Spaulding Rehabilitation Hospital, but comes home for daytime visits on the weekend. Among Greg's friends at his high school who surrounded him in support was Richard Hunt, who was riding on the pegs of the bicycle when it collided with a landscaping trailer towed by a city truck. Richard recovered from a broken arm and other injuries. Neither boy was wearing a helmet at the time of the collision. Greg’s mother is amazed at her son’s progress. He has regained his speech and can move his head, arms and legs. Greg is awaiting placement in a residential facility where he will continue his rehabilitation and his schooling, said his mother. From there, they look forward to eventually bringing him home. Like many brain and spinal injury survivors, the cost of his care will be on the shoulders of his parents. Donations received will help with modifying the home to better accommodate Greg and his injuries.

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Late January Baxter Healthcare Corp. voluntarily recalled thousands of pre-filled heparin injections because of questionable sterility and reports of adverse allergic events in dialysis patients. More that 50 dialysis patients in 12 states have had an allergic reaction in relation to the recalled batches of the blood thinner according federal health officials. The cases are being called the largest national outbreak of treatment-related allergic reactions ever seen in dialysis patients. The cases were reported at 19 dialysis facilities in California, Florida, Minnesota, Missouri, New Jersey, New York, North Carolina, North Dakota, Ohio, Pennsylvania, West Virginia and Wisconsin. Another 36 reports of allergic reactions are under investigation by the U.S Centers for Disease Control and Prevention. CDC officials are also looking into allergic-type reactions in seven cardiac patients in North Carolina who got Baxter-made heparin as well as looking into four cardiac cases in Florida, including one patient who died. Kidney patients receive heparin to prevent clotting of blood during the dialysis process. Allergic-type reactions occurred within minutes of starting dialysis, CDC officials said. The symptoms included facial swelling, nausea, rapid heart beat and decreased blood pressure. Baxter officials announced that some of these reactions may be severe or life threatening.

Posted by Kerry N. Jardine at 10:18 AM | Permalink | Comments (0) | TrackBacks (0)

An old and controversial technology called qEEG (quantitative electroencephalogram) developed in the 1930s is being used in the development of a new tool that may help doctors determine whether a brain injury has occurred. The handheld device is being developed by a startup company called BrainScope. The device is purported to determine the severity of concussions by reading the brain’s electrical signals. The National Collegiate Athletic Association is planning a clinical trial for later in the year. Claims have been made that qEEG can be used to diagnose and treat learning disabilities and depression, but the claims have never been fully substantiated. BrainScope’s CEO Elvir Causevic is well aware of the controversy surrounding qEEG. In response, he has solicited the advice of 30 leading brain experts before developing its first product in 2003. The result was a tool that's cheap and simple enough to be used on the sidelines. The BrainScope device displays a meter, which shows whether brain activity after an injury falls in or out of the danger zone. Built-in signal-processing technology picks up abnormal brain signals, while simultaneously canceling out electrical noise from blinking, breathing, and the like. The device calculates the severity of each injury by comparing brain wave readings to a database of 15,000 scans compiled at New York University's Brain Research Lab.

Before the use of BrainScope is released, they'll measure the brain activity of 750 high school and college players that will provide additional comparison to validate BrainScope's accuracy after an on-field collision. BrainScope will also be tested at four university hospitals that emergency room doctors can use to determine whether a patient complaining of a headache is in real danger or not. The company expects FDA approval this summer. It is also in talks with the U.S. Army, which it says plans to look into the technology later this year. A portable tool to gauge the severity of the soldiers’ injuries in real time could help protect wounded soldiers from returning to duty too quickly.

Posted by Kerry N. Jardine at 03:14 PM | Permalink | Comments (0) | TrackBacks (0)

Five months ago, Buffalo Bill’s tight end Kevin Everett suffered a catastrophic spinal injury that doctors thought he would never recover from. Now, he is walking and slowly regaining full use of his hands. “I'm happy people can know me like this,” Everett said in an interview with The Associated Press. “They can look at me and see what I've overcome and I'm still trying to overcome, and just see that life isn't that bad after all. It could be a whole lot worse.” At the time of the injury the orthopedic surgeon said the day following the accident that Everett’s chances of a full neurologic recovery were “bleak, dismal” and that it was unlikely he would ever walk again.

Everett has written a book with author Sam Carchidi about his accident and recovery entitled “Standing Tall: The Kevin Everett Story” The main goal of the book is telling his story and to inspire others with spinal-cord injuries. He knows his playing career is over, but he has future plans. He is working with The Miami Project to Cure Paralysis, and hopes to do more motivational speaking. Before the accident, he and a friend in Houston already had started a business selling special plastic sheets that prevent soap scum in showers, and he hopes to one day open a restaurant.

Posted by Kerry N. Jardine at 10:12 AM | Permalink | Comments (0) | TrackBacks (0)

A nine-year-old boy of Montreal was seriously injured in 2003 during ski school instruction. During the instruction the boy skied across the hill, through a T-bar track and crashed head-first into rock and trees, shattering his helmet. He was in a coma for 13 days and when he awoke it became apparent he had suffered serious neurological damage. The Mont Olympia Ski School used a 17-year-old instructor in a class of nine beginner skiers. The Quebec Superior Court Justice ruled the ski accident was a result of lack of supervision of an instructor so young and awarded the family $3.7 million in damages. The family’s lawyer said the award reflects the extent of the boy’s injuries.

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

The PG&E plant in San Francisco is the location of a construction accident during a demolition. Two five-story boiler towers collapsed, causing two workers to suffer life threatening injuries and took the life of another worker. San Francisco emergency crews had to cut through metal and debris to reach one of the injured workers. Another worker’s legs were crushed, but he was able to escape before rescue crews arrived. The third victim’s body could not be reached until later that night and had to be cut free from the unstable steel debris. The construction company responsible for the demolition apparently has a dark history. It has had a number of accidents. The demolition is three months ahead of schedule and crews have been pushed to rush the job. The accident involved death and life-threatening injuries and the power plant has been in the center of controversy for decades, yet very little news coverage was made of the disaster.

Posted by Kerry N. Jardine at 10:01 AM | Permalink | Comments (0) | TrackBacks (0)

A book by Dr. Robert Heilbronner entitled, “Neuropsychology in the Courtroom: Expert Analysis of Reports and Testimony” is being credited as being an informative legal guide for the evaluation of neuropsychological impairments in civil and criminal litigation. “Attorneys will learn how to properly evaluate clients who are claiming to suffer from such conditions as traumatic brain injury or chemical sensitivity,” reports Dr. Heilbronner. “Best practices in clinical decision making are identified to help experts and litigators avoid the common courtroom pitfalls in forensic analysis.” Experts from various fields provide in-depth chapters addressing such topics as brain injury, concussions, electrical injury, neurotoxic exposure and pediatric cases. It is believed this book will be an important resource for attorneys and experts to learn how to avoid common courtroom forensic errors. Dr. Heilbronner serves as a court-approved forensic expert who consults with plaintiff and defense attorneys in regard to the impact of brain injuries and various neurological disorders in civil, criminal and capital cases. His areas of specialty include the neuropsychological manifestations of mild traumatic brain injury and concussion; neurotoxic exposure; malingering; dementia; and other disabling medical and psychiatric conditions.

Posted by Kerry N. Jardine at 04:09 PM | Permalink | Comments (0) | TrackBacks (0)

Two new practice areas have been launched on the legal website LegalView.com. The areas address the lack of benefits when using the cholesterol drugs Vytorin and Zetia. The two drugs are used to control cholesterol levels in patients. According to a new study, Vytorin and Zetia have little success in decreasing arterial plaque and lowering a patient’s risk of heart disease compared to the generic versions. Further, Vytorin and Zetia can be up to three times more expensive. LegalView released these information portals to remind readers of the different varieties of medications available and that it is imperative that users understand the potential risks and issues associated with these drugs.

Posted by Kerry N. Jardine at 10:07 AM | Permalink | Comments (0) | TrackBacks (0)

The latest studies of the ineffectiveness of Vytorin and Zetia for reducing arterial plaque and decreasing the risk of heart disease has triggered a host of potential class-action lawsuits in several states. The suits allege that the companies Merck and Schering-Plough misled consumers into thinking the drugs were more effective than generics. Results from their ENHANCE study which ran from October 2002 to April 2006 showed Vytorin didn’t reduce plaque buildup any more than Zocor, which is available as a generic under the name simvastatin for about a third of the cost. Vytorin combines Schering-Plough’s Zetia with Merck’s Zocor. The 720-patient study was meant to show how well Vytorin limited plaque buildup in neck arteries in people whose genes gave them unusually high cholesterol levels. What the study really showed was that Vytorin was no more effective, and perhaps a bit worse, than Zocor alone.

The results of the study were to be released in November 2006, but continuous difficulties in analyzing the data led to repeated delays. A congressional committee began probing the delay of the results five weeks ago. They were finally released on January 14th. Critics are accusing the companies of trying to change how the results were analyzed, which the companies conceded to in a news release as well as admitting to foot-dragging. The Food and Drug Administration officials said the study's finding was unexpected. “At this time, we cannot explain why the lower levels of LDL cholesterol in the patients who took Vytorin did not lead to lesser amounts of plaque compared to those patients treated with simvastatin alone,” said Dr. John Jenkins, head of the FDA's Office of New Drugs. Concerned patients should talk to their doctors, the FDA said.

Posted by Kerry N. Jardine at 10:03 AM | Permalink | Comments (0) | TrackBacks (0)

Catherine O’Donnell, 86, underwent hip replacement surgery on Oct 6. and never regained consciousness. After surgery, while still under anesthesia she fell through a gap in an orthopedic surgical table after a nurse removed a safety strap around her torso in preparation of transferring her to a hospital bed. Her head slammed into the floor, fracturing her skull and causing internal bleeding. Hours after O'Donnell fell, she underwent surgery again to relieve the pressure of the bleeding on her brain. Catherine O’Donnell died a week later on Oct. 13. The Boston Medical Center, said the hospital has since changed it’s procedures to prevent further accidents in the future. Paul Dreyer, director of the Health Department's Bureau of Heath Care Safety and Quality, reviews an average of 800 serious injuries and medical errors involving patients at 90 Massachusetts hospitals a year. About 400 to 500 involve patients hurt in falls. A wrongful-death suit has been filed and names four defendants who were allegedly in the operating room at the time: an anesthesiology resident; an orthopedic resident; and two nurses.

Posted by Scott J. Eldredge at 07:56 PM | Permalink | Comments (0) | TrackBacks (0)

Medtronic Inc. won approval to end the consolidation of more than 2,600 lawsuits over defective defibrillators after reaching a $114 million settlement. U.S. District Judge James Rosenbaum in Minneapolis said he would disband the consolidation of lawsuits over Medtronic's Marquis line of defibrillators now that almost all the patients who asserted the devices malfunctioned have resolved their claims. The decision ends the majority of litigation over the defibrillators, which patients contend failed to help during heart attacks because of battery defects. The settlement resolves 2,682 claims filed since 2005 over the implantable defibrillators. There are still 19 defibrillator patients who have refused to settle their cases and will have a chance to press their claims at trial. Medtronic still has pending litigation in its defective Spring Fidelis leads in another version of their defibrillators.

Posted by David P. Hersh at 04:00 PM | Permalink | Comments (0) | TrackBacks (0)

After binding arbitration health care company Kaiser Permanente in Orange County California will pay $3.2 million to the family of a 14-year-old girl who suffered brain damage during her birth. When Ariana Ehtemam was delivered by Caesarean section she wasn’t breathing and had to be resuscitated. Afterwards, she was hospitalized for several weeks. She now suffers from physical and behavioral issues, hearing loss, poor impulse control and attention deficits. According to the court settlement papers, the C-section wasn’t performed in a timely manner. The money from Kaiser has purchased an annuity worth $20 million over her lifetime. She will receive the first payment at 18. The money will pay for future medical expenses, ongoing rehabilitation services and any residential supervision she may need. In California, malpractice judgments are capped at $250,000 for pain and suffering. Additional monetary damages result from loss of wages and need for ongoing care.

Posted by Scott J. Eldredge at 07:53 PM | Permalink | Comments (0) | TrackBacks (0)

A nationwide recall has been announced for NuCel Labs Eye Drops and Eye/Ear Wash. The recall is in response to a Food and Drug Administration inspection which found during product testing bacteria and particulate matter in the product. These products have been ruled non-sterile and pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness. The products are packaged in quarter ounce plastic bottles, have no lot numbers or expiration dates and approximately 500 units have been distributed nationwide through retail outlets and the internet. NuCel has ceased production and distribution and consumers are advised not to use them.

Posted by Seth A. Katz at 10:21 AM | Permalink | Comments (0) | TrackBacks (0)