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September 30, 2007

Limitations on Motions to Dismiss

Recently, FINRA,(Financial Industry Regulatory Authority, the successor to the merger between the NASD and the NYSE) announced that it was proposing an new rule designed to limit the pervasive and what many believe to be the abusive use of dispositive motions in securities arbitration. Quoting from the Notice to Members:

“Under FINRA's proposal, if a party (typically a respondent firm) files a dispositive motion before a claimant finishes presenting its case, the arbitration panel would be limited to three grounds on which to grant the motion: (1) if the parties previously had settled their dispute in writing; (2) "factual impossibility," meaning the party could not have been associated with the conduct at issue; or (3) the existing six-year time limit on the submission of arbitration claims. The rule proposal also would require that arbitrators hold a hearing on such motions and that any decision to grant a motion to dismiss be unanimous, and be accompanied by a written explanation.

The proposed amendments also would require the panel to assess against the filing party all forum fees associated with hearings on dispositive motions if the panel denies the motion, and would require the panel to award costs and attorneys' fees to the party that opposed a dispositive motion deemed frivolous by the panel. Under the rule proposal, when a respondent files a dispositive motion after the conclusion of the claimant's case, the provisions above would not apply. However, the rule would not preclude the arbitrators from issuing an explanation or awarding costs or fees.”

This proposal is a big step in the right direction. Claimants and their attorneys have long had to respond to many baseless and time consuming dispositive motions, in an attempt by Respondents to deny them their day in court. Hopefully, this rule proposal signifies a more pro-investor stance on the part of the organization charged with investor protection.

 


 

UCLA Neurosurgery expert notes war has revealed much more about TBI

"For all of the right reasons, there has been an increase in awareness about traumatic brain injury in soldiers returning from Iraq and Afghanistan," says David Hovda, professor and vice chief of research affairs for UCLA's Division of Neurosurgery and director of the UCLA Brain Injury Research Center. Hovda has several years experience in treating patients who have suffered traumatic brain injury (TBI) in sports injuries, car accidents and many other situations. Hovda and his neurosurgery team have made a number of breakthroughs in the field of brain injury. Working in cooperation with Walter Reed Naval Medical Center over the last several years, Hovda says treating the soldiers who return from the Iraq war has yielded some interesting revelations. These revelations have redefined TBI beyond sports medicine and car accidents and revealed new ways to treat head injuries from combat. The new research into brain injuries is slowly yielding new treatments. One such revelation is UCLA neurosurgeons are now researching the use of lactate, once thought to be a "waste" chemical of the body, as a possible replacement "fuel" for the brain in the immediate hours after a traumatic brain injury. This lactate infusion replaces glucose, which is the current standard. If they are right, this could change how emergency room physicians and intensive care physicians treat patients with brain injuries in the first critical hours after injury.

 


 

One Doctor's Lone Quest to Heal Brain Injury

As a young researcher in the 1960s, Donald G. Stein tested rats with brain injuries to see the effect on their behavior. Outside the scope of the research he noted that some female rats promptly recovered from their injuries, while males remained impaired. Donald G. Stein, a medical researcher at Emory University, may be on the path to treating traumatic brain injuries. The solution may be as simple as providing head injury patients with high dosages of progesterone. Decades of research conducted in his spare time and with little funding, led him to a surprising hypothesis: that progesterone, a natural female hormone that protects fetuses in the womb, may actually protect and heal injured brains. He found that female rats with much higher, pregnancy-level amounts of progesterone did far better than other rats in following mazes. Even male rats also recovered far better from injury when given the hormone, performing just as well as the highest-performing females. The stuff worked when given up to 24 hours after injury. Over the next 40 years his work slowly helped overturn medical orthodoxy stating that brain tissue, once injured, stays that way. Now he and colleagues plan a large-scale human trial over the next several years. While the outcome is far from assured, the effort could produce a new treatment for the estimated 10 million people world-wide who suffer traumatic brain injuries each year.

Dr. Stein's journey shows how difficult it is to challenge the medical establishment, which often begrudges ideas outside the mainstream. It also underscores how difficult it is for a lone researcher to persevere without drug-company or other major financial support. Drug companies tend to focus more on blockbuster drugs they design than on naturally occurring ones with minimal profit potential. A naturally occurring hormone like progesterone is of little interest to drug makers. Finally after 40 years, NIH began to back his progesterone research, and the Centers for Disease Control and Prevention began giving him grants. His studies continued to show positive findings with progesterone, and scientists elsewhere began to confirm them. However, as a practical matter, this was still just nifty rat science. Dr. Stein's hypotheses wouldn't be relevant until they were proven in humans.

After hearing Dr. Stein lecture a decade ago, Arthur Kellermann, then Emory's chief of emergency medicine, resolved to get human studies going. He introduced Dr. Stein to David Wright, a young Emory emergency doctor with research ambitions. Drs. Wright and Kellermann wrote an NIH grant application in 1999 for the first phase of human study. Two years later, the federal agency approved a grant of $2.2 million for the first stage of human research. Over the next three years, the study focused on 100 head-injured patients who had been brought into the emergency room. Some patients received standard treatment to control bleeding and fevers along with state-of-the-art head-injury treatment. Others were given intravenous progesterone; at triple the highest natural levels at the end of pregnancy. In 2005 Dr. Kellermann called him and said he had just learned the study's findings. Patients on progesterone had a death rate of just 13% from their head injuries, less than half the 30% death rate of those on standard treatment. Further, progesterone showed no negative side effects. The 100-subject study was too small to prove that progesterone caused the lowered death rate, but the findings were consistent with animal research.

 


 

September 29, 2007

Rochester Investigating Blood Test for Concussions

The University Of Rochester Medical Center received $1.5 million to develop a blood test for concussions by isolating proteins that can predict memory loss, chronic headaches or other neurological problems. At least one million Americans seek treatment for head injuries each year. However, many people initially assume their injury is mild and do not visit a doctor until after they experience cognitive difficulties. A rapid test that could be administered in brain injury incidents would give medical personnel a head start and offer clues about the extent of the brain injury. The blood test would help doctors diagnose axonal injury, a type of brain injury that often occurs after a concussion but does not show up on a CT scan of the brain. Diagnosis of axonal injury is difficult because CT scans are designed to detect bleeding in the brain and not more subtle injury to neurons, the cells responsible for cognitive functioning. Axons make up the bulk of the neuron’s structure and travel in clusters, providing a connection to different areas of the brain through delicate, spaghetti-like strands. When axon fibers are stretched or strained, they stop working and the entire cell dies. Blows to the head, falls, or sudden deceleration from motor vehicle accidents can cause axonal injuries.

In a pilot study it was investigated whether a new type of brain scan called Diffusion Tensor Imaging (DTI), a dynamic form of the well-known MRI, could detect axonal damage from a minor injury. The DTI scans of six people with mild concussions were compared to six scans of non-injured brains. The DTI showed subtle axon swelling, which is known to occur when the axons are over-stretched. The axonal swelling correlated with the patients who were having trouble processing information or remembering things as well as before the injury.

With the latest funding from the National Institutes of Health, Researchers will use DTI technology to aid in a search for biomarkers that indicate axonal damage. They will conduct a clinical study by enrolling 37 adults, ages 18 to 65, who seek emergency treatment for head injuries. A control group will consist of 37 patients who seek treatment for orthopedic injuries such as sprained ankles or broken wrists. All patients will undergo a DTI brain scan and provide blood samples. Researchers expect to screen about 15,000 proteins from the blood samples, and search for the small number of proteins that are different among the head injury group. Further analysis will include a study of the serum markers one week and one month after the head injury, to determine how cells change as the brain heals.

 


 

U.S. Company expands ground beef recall

The Topps Meat Co. on Saturday 29Sep expanded its recall of frozen hamburger patties to include 21.7 million pounds of ground beef that may be contaminated with E. coli bacteria that sickened more than a dozen people in eight states. The recall of products distributed to retail grocery stores and food service institutions in the United States was a drastic increase from the 332,000 pounds recalled the week prior. The recall represents all Topps products with either a "sell by date" or a "best if used by date" between Sept. 25 this year and Sept. 25, 2008. The company said this information is found on a package's back panel. All recalled products also have a USDA establishment number of EST 9748, which is located on the back panel of the package and-or in the USDA legend.

The U.S. Department of Agriculture said Friday 28Sep it had suspended the grinding of raw products at the Topps plant after inspectors found inadequate safety measures on the premises. The USDA declined to offer further details. The USDA said three people are confirmed as getting E. Coli from Topps products, with 22 other cases under investigation. Cases were found in Connecticut, Florida, Indiana, Maine, New Jersey, New York, Ohio and Pennsylvania. E. coli causes intestinal illness that generally clears up within a week for adults but can be deadly for the very young, the elderly and people with compromised immune systems. Symptoms can include severe stomach cramps, bloody diarrhea and, in extreme cases, kidney failure.

 


 

Taco John’s suing food supplier for contaminated lettuce

Less than a year after contaminated lettuce was blamed for making dozens of customers sick, Taco John's corporations in South Dakota and surrounding states are suing food suppliers for negligence. The class-action lawsuit, filed in federal court in Sioux Falls, seeks a jury trial and $5 million. The plaintiffs named are Taco John's corporations in Iowa, Minnesota, and North and South Dakota. Defendants are Bix Produce Company and Roma Food Enterprises. The cover sheet on the filing describes the cause of the action as "negligence in the handling of food." The U.S. District Judge agreed to seal the complaint, so little else about the initial filing is publicly available. It is unclear if the lawsuit is connected to last year's E. coli contamination, but The Associated Press reported in December that Taco John's International dropped Bix Produce as a supplier in the wake of that outbreak.

 


 

September 28, 2007

Doctor for Med Mal Reform Escapes Accountability

Retired orthopedic surgeon Forney Fleming attracted the attention of Texans for Lawsuit Reform because he was eager to bash plaintiffs' lawyers, particularly those who targeted doctors. So TLR, a business group that has spent hundreds of thousands of dollars abusing plaintiffs' lawyers and winning restrictions on judgments against physicians and other defendants, signed him up as a volunteer speaker. TLR featured Fleming's "supporter profile" on its Web site, where he was quoted, “I was practicing in a 'judicial hellhole' and saw the effect of lawsuit abuse, which was decreasing the accessibility of medical care in Jefferson County.” Fleming, however, left out details of his professional life, including his reprimand and $7,500 fine by the Texas Medical Board in 2004 for misdiagnosing what turned out to be bone cancer in a 16-year-old girl's leg. Her leg was later amputated. The board also accused Fleming of providing substandard care to six other patients, including an 81-year-old woman with a fractured hip. That formal complaint was still pending when he let his medical license lapse and retired last December. According to state records, Fleming was sued or threatened with suits for malpractice three times. All were settled out of court or resolved through mediation for undisclosed terms. None of his professional problems was mentioned on the TLR Web site, but his profile was removed within an hour of a TLR spokeswoman being informed about them.

In 2003, TLR's political action committee spent at least $300,000 promoting voter approval of Proposition 12, a constitutional amendment ratifying new limits on noneconomic damages in medical malpractice cases. In a formal complaint filed that same year, the Texas Medical Board's staff alleged that Fleming, in treating the 16-year-old girl for a knot in her right leg, had failed to review reports by an emergency room radiologist and her primary care physician, who believed X-rays indicated the possibility of bone cancer. Fleming had seen the patient four times over a two-month period in 2001 before her family took her to another physician, who ordered an MRI. After several chemotherapy treatments, the leg was amputated at the knee. Fleming agreed to a negotiated disciplinary order, entered in April 2004, joining only a small fraction of Texas doctors who have ever been disciplined by the state. The regulatory board's staff filed another complaint against Fleming in August 2006, alleging substandard care for six additional patients, including the 81-year-old woman and patients treated for fractured ankles, a fractured wrist and a crushed leg. No action was taken on those cases before Fleming retired, but board spokeswoman Jill Wiggins said the complaint wasn't dismissed, only placed in limbo.

Naturally, Fleming has become a new symbol for TLR's opponents. "TLR's support has always come from industries and individuals that don't want to be held accountable for bringing physical and fiscal harm to Texas families," said Alex Winslow, executive director of Texas Watch, a consumer advocacy group.

 


 

TBI from war worse than thought

Scientists trying to understand traumatic brain injury from bomb blasts are finding the wound more insidious than once thought. They find that even with no outward signs of injury, cells deep within the brain can be altered, their metabolism changed, causing them to die, said Geoff Ling, an advance-research scientist with the Pentagon. The new findings are the result of blast experiments in recent years on animals, followed by microscopic examination of brain tissue. The findings could mean that the number of brain-injured soldiers and Marines, many of whom appear unhurt after exposure to a blast, may be far greater than reported, said Ibolja Cernak, a scientist with the Johns Hopkins University Applied Physics Laboratory. In the animal studies, scientists said they have found a fundamentally different wound than the “brain concussion” historically associated with undetected brain injuries. The newly discovered brain damage at the cellular level can be permanent and lead to lasting neurological deterioration, Ling and Cernak said. The microscopic damage changes brain cell metabolism, Cernak said, creating a cascading effect that leads to the premature aging and death of neurons that cannot be replaced.

 


 

September 27, 2007

Husband sues for negligence rather than Medical Malpractice

The husband of a woman who fatally shot herself while undergoing mental health treatment at Waukesha Memorial Hospital in 2005 filed a lawsuit alleging negligence in his wife's death. Christopher Snyder's suit against the hospital does not seek monetary damages but asks a judge to decide whether legal action concerning his wife's death can be pursued as a matter of alleged negligence rather than medical malpractice. In so doing, Waukesha County Circuit Judge Kathryn Foster will determine whether mediation efforts must precede a lawsuit seeking monetary damages and whether malpractice damage caps are applicable.

The suit contends that Wendy L. Snyder's suicide resulted from "negligent custodial care" and is therefore a matter that should be litigated as a "wrongful death" instead of medical malpractice. Snyder, a 43-year-old mother of four, died Feb. 23, 2005, while undergoing treatment in the locked behavioral health unit at the hospital. The day before, according to the lawsuit, Snyder was released on a five-hour pass. Upon her return, according to the lawsuit, staff failed to perform a proper search of Snyder and her possessions. "As a result of failing to follow procedure upon Wendy Snyder's re-entry to the unit, staff failed to search a pair of jeans and confiscate from Wendy Snyder certain restricted and potentially dangerous items, which included a bag, jacket, handgun and ammunition," the lawsuit says. "On Feb. 22 and Feb. 23, Waukesha Memorial Hospital staff in conducting the required routine room searches failed to remove dangerous items, including a jacket, handgun with ammunition and bed sheet with a noose tied on each end." Snyder subsequently shot herself in the head. Snyder's death was the second suicide involving the unit in 2 1/2 years. A patient jumped to his death from the top floor of the hospital parking ramp in 2002.

 


 

Medical Center facing malpractice lawsuit for woman’s death

Janice Kooser, a 63-year-old woman recovering from an operation on her thigh, died Sept. 5, 2003, at Fort Walton Beach Medical Center. Her son, Chip Kooser, was stunned to learn through a medical examiner’s report issued several days later that the cause of his mother’s death was listed as “blunt force trauma” to her head. No one at the hospital told him that his mother, whose condition made her a high-risk candidate for falling, fell on Sept. 2. Kooser is suing the hospital, alleging medical malpractice. She went into a coma two days after the stumble and died the next day. Kooser fell when she tried to get out of bed to use the bathroom, according to testimony. The hospital’s attorneys maintain the nurse on duty the night of the fall actually prevented the woman’s head from striking anything other than the mattress of her bed. The undisputed facts of the case are that Kooser had been hospitalized since mid-August 2003 and that she was physically unsteady and at times delusional or mostly incoherent. She was listed on charts that rate a patient’s risk of falling as a 31, one point higher than the chart’s maximum. Medical testimony also established that Janice Kooser had what is known as a subdural hematoma, a condition that would have made her more vulnerable to head injury than she already was.

One issue has been whether the hospital staff did enough to prevent Kooser from falling. A plaintiff’s expert, Dr. Michael Langan from Boston General Hospital, said no. Langan said the staff ignored protocol requiring high-risk fall patients to be fitted with armbands. The hospital also failed to provide a “card-ex,” a card providing “all the information needed to know a patient’s condition right away,” Langan testified. The hospital also failed to put post a sign at the entrance to Kooser’s room notifying all staffers of her risk of falling and didn’t do enough to make sure she stayed in her bed, Langan testified. Langan also testified that the hospital staff failed to properly advise Kooser’s doctor of the severity of her fall or to note later that she was not eating, not using the morphine pump to ease her pain and was not responsive. Asked if he was seeking punitive damages against the hospital, Vernon Kooser said no. “The most frustrating part for our family is that no one told us our mother had taken a fall,” he said. “I just want the hospital put on notice.”

 


 

Nevada doctor receives ‘slap on the wrist’ for malpractice

A Carson City, NV doctor has admitted to malpractice for failing to diagnose colon cancer in an elderly patient who later died of the disease, state officials said. Dr. Frank Shallenberger entered a guilty plea before the Nevada Board of Medical Examiners concerning the care of his longtime patient, David Horton. Ed Cousineau, deputy general counsel for the medical board, said Shallenberger agreed to plead guilty in Horton's case to one count of malpractice. As a result, Shallenberger was fined $5,000, ordered to take 16 hours of classes on cancer screening, issued a public reprimand and ordered to pay investigation costs of about $6,500. Shallenberger, licensed as a physician, is also licensed in Nevada as a homeopath, or alternative medical doctor. In February 2000, Horton complained to Shallenberger of rectal bleeding and abdominal pain, symptoms of colon cancer. But the medical board complaint said Shallenberger told Horton that he suffered from hemorrhoids and advised him to use suppositories and take baths in witch hazel. Horton was later diagnosed by emergency room doctors with stage-four colon cancer and told he had six months to live. He returned to Shallenberger for homeopathic cancer treatments, records show. Horton, 76, died in October 2003. It's the second time in 12 years Shallenberger has been disciplined by the medical board. In March 1995, Shallenberger surrendered his California medical license after four patients claimed he was incompetent and grossly negligent in their care. Months later, Nevada's medical board gave him a public reprimand for surrendering his California license, stating, "Your conduct casts great discredit upon you personally and professionally, and upon the medical profession in general."

 


 

State Supreme Court upholds 2006 malpractice ruling

West Virginia’s state Supreme Court upheld a multi-million dollar medical malpractice verdict against a Camden-Clark hospital. Testimony in the case showed the hospital had turned off operating room safety monitors on a patient who ultimately died. Hilda Boggs received too much anesthesia while having surgery in 2001 for a broken ankle, causing an overdose that could have been prevented if safety monitors had remained hooked up in the operating room. Instead, testimony in the trial showed Boggs had already turned blue prior to those in the operating room noticing. She died six days later. Boggs was a 51-year-old elementary school teacher in 2001 when she broke her ankle. By the time a jury gave her family a favorable ruling in March 2006, they had already settled with the anesthesiologist in the case. Jurors awarded them $4.8 million, which combined with the earlier settlement made it $6.5 million total.

Supreme Court justices heard arguments from attorneys for Camden-Clark Hospital, even allowing the hospital to file legal briefs three times the normal size (150 pages) for the case. Justices voted 3-2 to refuse to hear the case. Apparently, the hospital attempted to mislead the court and cover up facts. Testimony showed that the hospital basically told nurses to destroy notes. That’s why, after jurors delivered their verdict, the judge went further and ordered a $1.3 million sanction against the hospital and its lawyers for misconduct. The judge wrote in his order, “By breaching court orders, filing false discovery responses and by giving and permitting to be given inaccurate testimony under oath, and through multiple false statements to the court, the plaintiff and the jury, Camden-Clark engaged in litigation misconduct.”

 


 

September 26, 2007

Homecoming float accident sends 6 to the hospital

Idaho State Police are investigating an accident that sent six kids to the hospital after a homecoming float came unhitched from a truck. One freshman student was seriously hurt and flown by Life Flight to a medical center in Boise. Witnesses say the freshman float fell off the pickup that was towing it. Another girl suffered a broken arm and was among five students taken to another medical center. Tim Rosandick, Superintendent of Schools, said some kids are understandably worried about their classmates and this accident put a "touch of somberness" on the homecoming game.

 


 

Trial for 2 Men Involved In Boating Accident Could Be Delayed

The men accused of drinking, then driving the boat that crashed into an 11-year old boy and permanently injuring him, may not face trial for several months. Court documents reveal affidavits that led to the arrests of Roger Guzman and Tom Kirby. They include witness accounts from several people, and expert analysis, but defense attorneys say they only recently got all the information and the prosecutor's push for a speedy trial is unfair. Court documents show Guzman admitted to boating a few hours after drinking six beers the day of the accident, despite a 2004 DUI conviction. Roger Guzman and Tom Kirby are facing felony charges in connection with the high-speed collision, but it took investigators nearly a year to get enough evidence to file charges. Now, the suspects' lawyers want a similar time frame to conduct their own investigation. The accident left McEntire blind in one eye and forced him to learn to walk again, however, the prosecutor will have a tough time proving Guzman and Kirby knew they hit him.

 


 

Neuren Completes Trial for Brain Injury Compound

Neuren, a New Zealand drugmaker, has concluded studies with two groups in its Phase 1b trial to test the safety, tolerability and pharmacokinetic action of NNZ-2566 as a compound to treat traumatic brain injury. The completed groups have provided Neuren with sufficient safety data to proceed with a Phase II trial. Neuren said it expects to file an ethics application to conduct the trial in the last quarter of the year. Each group in the Phase 1b trial had seven patients, five who received the drug and two who received placebo. The first group was given 20 mg per kg of NNZ-2566 through a 10-minute infusion, followed by 1 mg per kg each hour of the drug for 12 hours. The second group was given a 10-minute infusion of the drug, followed by 3 mg per kg each hour for 24 hours. The company submitted a safety report to the Local Ethics Committee in Australia that resulted in a recommendation that the company proceed with the dosing of groups three and four. The two groups will receive higher doses and longer infusions. According to the company, the completion of the third and fourth groups will allow it to proceed with a Phase IIa traumatic brain injury study to begin in mid-2008 in the U.S.

 


 

Book written about life after brain injury

Marjorie Windheim and her son Daniel are authors of a new book, “It’s Not All Black & White: A Survivor’s View of Life” about life from the perspective of a survivor and parent of traumatic brain injury. The book is a hybrid of autobiography, journal, advice, and poetry, discussing life after a traumatic brain injury (TBI) that occurred in 1979. In July of 1979 Daniel Windheim's life at the age of 16 was changed when he was a passenger in a car involved in an accident. He sustained a brain stem injury and spent weeks in a coma before he regained consciousness. later he spent years in recovery. Now he works at a library in the processing department and runs a website, www.tbilife.com that discusses his TBI experience and helps others learn more about brain injuries.

 


 

September 25, 2007

Shaken baby had previous head injury

The doctor who performed an autopsy on 6-month-old Serenitee Halbert, who investigators say was shaken to death in August 2006 by a 23-year-old man, testified in court that the infant showed evidence of having sustained a severe head injury at least two weeks before her death. Medical Examiner, Doug Kelley,testified that Serenitee showed signs of bleeding between her brain and the wall of her skull, indicating she had suffered a "traumatic brain injury" two to four weeks before Aug. 18, 2006, when Craig C. Tolonen is accused of shaking her to death. Tolonen is charged with first-degree reckless homicide, for which he could be sentenced to 60 years in prison if convicted. Jurors saw a video of Tolonen using a doll to show the sheriff's detectives how he was awakened by Serenitee's crying about 6 a.m. Aug. 18, 2006. He showed how he picked up the child, eventually shaking her for more than 30 seconds and twice asking her, "What's wrong with you?" before throwing her against a couch.
After that, he told detectives, she began to cry "a little harder." Serenitee was pronounced dead two days later. Kelley testified that Serenitee's recent injuries had included bruising about her head, chest and thigh, a quarter-inch
skull fracture, and bleeding and swelling in her brain. Those injuries led him to conclude that the cause of her death was severe trauma to the brain caused by injuries suffered Aug. 18, 2006, he said.

 


 

Texas widower struggles to find lawyer

May 24, 2006, Richard Miller and his 73-year-old wife went to a San Antonio clinic for what should have been a quick and easy day surgery. Instead, when Richard Miller entered her recovery room, he found her screaming in pain. His wife Arlene, was unable to stand, was given several doses of morphine and told the procedure “had irritated a nerve.” Richard Miller said the doctor and nurse ignored the complaints and failed to check out the source of his wife’s pain. Instead, Miller was told to take his wife home, give her medication and food, and she would be OK. Miller obtained a report of her treatment dated a week later that noted, “The patient was comfortable, warm, and had no complaints in the PACU (post-anesthesia care unit).” She wasn’t OK. Spinal fluid had leaked into her brain. Doctors, who examined her a few days later, ordered she be airlifted to a specialist at a hospital in San Antonio. During the next three months, she underwent numerous tests and treatments and was tran sported to several different hospitals for physical therapy. She eventually ended up in hospice care.

Since her death, Miller has amassed pages of his wife’s medical records and found medical journals that contradict procedures taken during and immediately following his wife’s surgery. He also compiled a list of doctors and nurses who treated her and pointed to the surgery as a likely cause of her death. Contrary to the gathered evidence, Miller, 73, can’t find a lawyer to file suit against the San Antonio doctor who operated on her. Even worse, he now has only six months before the statute of limitations to file runs out. Richard Miller’s case is not unique.

In 2003, legislators reformed state laws and capped non-economic damages for malpractice suits at $250,000. Since then, possibly thousands of patients and families affected by medical negligence have been turned down by lawyers for the same reason Miller has, because it isn’t “economically possible to pursue” the claim. Taking on a medical malpractice case not only requires time spent, but also expenses for research, contracting medical experts for specialized testimony, paying for access to medical records and hiring court reporters. Depending on the situation, it could cost a lawyer more than $60,000 to present the case during a trial lasting two weeks or longer. “It’s the only area of law that we have an arbitrary cap for fair compensation. It shows a lack of trust in the jury system. We will trust a jury to decide if someone will die from lethal injection, but not grant fair compensation,” said Harvey of Winckler & Harvey. “That’s the human cost of tort reform. That’s not
good
for our society and that’s not good for our judicial system.” Not only does the new law distort “personal accountability,” but it also makes patients less safe, said N. Alex Winslow, executive director of Texas Watch, another organization that spoke against the award cap. He recommended patients should ask lots of questions, demand answers and keep their own records. Meanwhile, Miller, who knows a lawsuit won’t bring back his wife, said he doesn’t want money as compensation for her death. He simply wants to prevent this doctor’s purported
medical negligence to slip by unrecognized.

 


 

Malpractice Involving Anesthesia Often Hard to Prove

Medical malpractice involving anesthesia accounts for a large number of medical malpractice in the United States. In any surgery with anesthesia, the risks involved greatly increase. It is the anesthesia that is more dangerous to the patient at times than the surgeon's blade. There is little room for error when using anesthesia in any procedure. For these reasons, allegations of medical malpractice are common in anesthesiology because problems are so common and the resulting outcome for the patient is generally poor. Medical insurance premiums for anesthesiologists are generally very high and substantially higher than most other medical specialties. While anesthesia injuries are most often thought of as occurring in the operating room, they can occur in a wide variety of settings including the pre-operative and recovery rooms, a procedure room, during labor and child delivery, during sedation for certain dental procedures, and during a wide variety of out-patient medical procedures in doctors' offices and surgery clinics. Contrary to popular belief, anesthesia medical malpractice cases are not limited to anesthesiologists. Many medical practitioners administer sedatives and anesthetics themselves. Extremely severe complications and even death have occurred in surgery clinics and dentist offices during procedures that required general anesthesia. Trained anesthesia staff were typically absent in the majority of these cases. Potential defendants in anesthesia-related medical malpractice cases can include anesthesiologists, nurse anesthetists, nurses, surgeons, doctors, dentists and residents. Demonstrating the negligence of the anesthesiologist or anesthesia staff is also among the most difficult since the plaintiff is often unconscious or sedated at the time of the malpractice. Unreliable and scant records are often the only source of information as to what actually happened.

 


 

Ortho Evra Lawsuits Increasing

Facing a rising number of lawsuits filed over its Ortho Evra birth-control patch, Johnson & Johnson still and has always maintained that the patch is a “safe and needed” form of contraception. The hundreds of plaintiffs suing the pharmaceutical company feel otherwise, with most of them claiming that Johnson & Johnson had prior knowledge that the Ortho Evra patch had a higher risk of causing blood clots, stokes and heart attacks than oral contraceptives. Unfortunately for Johnson & Johnson, at least two former employees of the company have backed up those allegations. In 2005, the Food & Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. Following key events in 2005 and 2006 prompted the FDA to request a change on the Ortho Evra label to i nclude
a stronger safety warning. Since then, the Ortho Evra patch has been the subject of more than 2500 lawsuits. The plaintiffs have ammunition to back up their claims. Two former employees at Johnson & Johnson had long ago expressed concerns that the company purposely chose to downplay the risks associated with the Ortho Evra patch. The revelations from the former employees are not good news for Johnson & Johnson. There is evidence that the company knew women using Ortho Evra were exposed to dangerously high levels of estrogen.

Johnson & Johnson has already settled hundreds of Ortho Evra cases, but many more are scheduled to come to trial. One of the first trials is expected to begin in November in Manhattan. That lawsuit, brought by the family of a 19-year-old woman, alleges that her death was a result of the Ortho Evra patch. The case of Zakiya Kennedy, who collapsed and died from a pulmonary embolism while she waited for a New York City Subway, made headlines and was one of the first deaths to be blamed on the defective Ortho Evra birth-control patch.

 


 

September 24, 2007

Ortho Evra Company Downplayed Risk

Johnson & Johnson improperly claimed its Ortho Evra birth-control patch posed a low safety risk to women, a product-safety executive told Chief Executive Officer William Weldon in a 2005 letter, court records show. J&J faces lawsuits by more than 2,400 of the 5 million women who used the patch. Most claim they suffered strokes or clots in their legs or lungs. The company hasn't publicly identified reserves for the Ortho Evra litigation. The author of the letter investigated an “unusually high number” of blood clots caused by the patch and cited more than 20 reported deaths, according to the letter, made public on Aug. 25 by a New Jersey judge who oversaw some of the lawsuits. The executive, whose name was removed from the letter, said J&J conducted two studies and emphasized “partial and incomplete” results of the one that found the patch no riskier than birth control pills. The writer resigned because the company's conduct undermined his ability to evaluate product safety, t he let
ter said. The writer was a vice president who spent seven years at Johnson & Johnson, overseeing benefit and safety risk analysis in reproductive medicine and oncology, according to the letter.

New Jersey Superior Court Judge Bryan Garruto, who oversaw 309 Ortho Evra lawsuits, made the two-page letter public after ordering lawyers to black out portions of the text and the author's name. At the request of plaintiffs' lawyers, Garruto removed the letter and other documents from a protective order covering evidence gathered for Ortho Evra cases around the U.S. The released records show the company confidentially settled dozens of Ortho Evra cases. No Ortho Evra case has gone to trial yet. The first is slated to begin in state court in Manhattan on Nov. 19. Survivors of Zakiya Kennedy, who was 19, blame her death on April 2, 2004, on her use of the patch. The documents case is Brown v. Johnson & Johnson, MID-L- 5446-05, Superior Court of New Jersey, Middlesex County (New Brunswick).

 


 

Johnson and Johnson faces thousands of Ortho Evra lawsuits

The numbers keep adding up for the Ortho Evra birth-control patch, but not in sales. They are down sharply, but the docket of product liability cases filed against Johnson & Johnson, the maker of Ortho Evra, is up. In its latest update, J&J said more than 2,400 Ortho Evra lawsuits have been filed in state and federal courts. Most of the lawsuits have a common theme: J&J allegedly knew the skin patch had greater safety risks than birth-control pills, particularly in the incidence of harmful blood clots that could develop in women's legs and lungs. Nevertheless, it chose to aggressively market the contraceptive in ads and played down the dangers of the patch.

J&J denies the claims, and says Ortho Evra is a "safe and needed" contraceptive if used according to its label. The company's defense has a complication. Two former executives have said they raised red flags about the patch's safety but were ignored. One is Joel Lippman, a medical officer whose claims about problems with Ortho Evra and other products were first made public in a state whistleblower suit last year. The other is a J&J vice president who decided to resign from a job overseeing the "benefit risk and safety evaluation" of reproductive products, including the patch, after being unable to properly "exercise this responsibility." The officer said he or she had left the company the previous month in part because Ortho Evra's risks had been downplayed despite "compelling evidence" to the contrary. Currently his identity is still withheld.

In 2005, the FDA and J&J agreed to make a change in Ortho Evra's label that said users of the patch could be exposed to 60 percent more estrogen than women who used the pill. An FDA medical reviewer cited the potential for clot-related problems with Ortho Evra in 2001, and said post-market studies would be necessary. Regardless, the patch was ultimately approved by the agency, and the revised label says "it is not known" if the patch's different profile of estrogen exposure leads to more serious health problems than the pill.

 


 

The Fiji Government will not import Ortho Evra Birth Control Patches

The Fiji Government Pharmacy says it does not import the birth control patch Ortho Evra because it is causing health complications for women in the United States. The pharmacy report comes in response to the filing of another lawsuit against the maker of the birth control patch in Washington. The lawsuit claims 43 women developed blood clots and other health problems since taking the prescription contraceptive. The Fiji Government pharmacist Waisea Kelo said the health ministry has never purchased the product nor issued them at its health centers and hospitals. A number of major drug wholesalers and chemists around Fiji confirm they have not imported nor sold the birth control patch. The international medical journal quoted lawyers in the US as saying the Ortho McNeil Pharmaceutical Company should pay substantial financial damages to their clients for the health problems suffered. According to the journal, similar lawsuits have been filed on behalf of 400 women nationwide but the company is not commenting.

 


 

Fundraiser for Minnesota TBI Walk for Thought was Oct. 6

The Saint Teresa Leadership and Service Institute for Women of Saint Mary's University and the Brain Injury Association of Minnesota will sponsor a Walk for Thought fundraiser Oct. 6 at Lake Winona. The sixth annual Walk for Thought raises public awareness about brain injury and funding to support those affected by brain injury. Each year more than 20,000 Minnesotans sustain a traumatic brain injury from events such as motor vehicle crashes, falls and firearms. Six times more than the combined annual number of people who will experience HIV/AIDS, breast cancer and multiple sclerosis. Last year more than 1,000 participants and sponsors raised nearly $80,000 for the cause and this year the goal is to raise a record-breaking $100,000 for the Brain Injury Association of
Minnesota.

 


 

September 21, 2007

DOD and VA medical programs too complex for those with brain-injuries

The bureaucracies that are supposed to help brain-injured war veterans are too complex for them to navigate, a panel of military and medical experts concluded at a meeting Tuesday Sept 18th. Specifically, the departments of Veterans Affairs and Defense need better coordination of their programs, according to the panel, which was part of a daylong Washington Defense Forum sponsored by the U.S. Naval Institute and the Military Officers Association of America. The panel included two military officers, a doctor, a lobbyist and the chief executive officer of the Brain Injury Association of America.

"The systems in the VA and DOD seem to be against what brain injury can handle," said Susan Connor, chief executive officer the Brain Injury Association. "Because the frontal lobe controls memory, thinking, judgment and processing ... if you shove paperwork in front of someone with sustained brain injury or put them in a large group with scripted instructions, they can't follow it." Meredith Beck, national policy director of the Wounded Warrior Project, agreed saying veterans become confused about which of many existing programs might suit their individual needs. Retired U.S. Air Force Col. Peter Bunce is experiencing the two systems firsthand with his son, Justin Bunce, a former Marine corporal who has a severe brain injury after being hit by shrapnel in Iraq. Bunce called the VA bureaucracy "extremely daunting. They have been doing things the same way since Vietnam and can't adapt to traumatic brain injury," Bunce said. Beck said the solution is to overlap the benefits the two departments provide. Both military officers, Bunce and Cmdr. Rich Jadick, a Navy mass communications specialist, agreed that the most pressing problem is the transition injured service members must make from the active duty to the VA. "An assisted program is needed to point them in the right direction," Jadick said. "Right now the transition is not seamless."

 


 

Texas Law Firm Investigating Possible Gadolinium Litigation

Another law firm in Dallas, Texas is investigating possible Gadolinium litigation in light of recent public health advisories by the Food and Drug Administration. The FDA published an alert showing a possible link between Gadolinium, a heavy metal used in MRI and MRA, with the disease Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD). According to the FDA, the problem has so far been found only in instances of "off-label" use of the Gadolinium agents for MRA, or Magnetic Resonance Angiography. "Off-label" means the drug has not been approved by the FDA for a particular use, which might be dangerous given that often 3 times the FDA approved dose is used during an MRA. "Gadolinium is supposed to secrete out of the body quickly", says t he lawyer, "but, according to preliminary FDA reports, it looks like people with impaired kidney function might not be able to secrete the toxic substance out of the body quickly enough to avoid suffering lifelong impairment from Gadolinium". The products possibly responsible are Omniscan, OptiMARK, Magnevist, ProHance and MultiHance

 


 

TBI survivor cannot be placed for lack of services

“‘I can’t hear. I can’t walk. I can’t speak.’” Lindsay Young’s arm shakes slightly as her fingers come to rest on her lips while her father interprets her gestures.”That’s usually what she says when she meets someone for the first
time," Richard Young, 58, said on Wednesday. The 29-year-old woman lies on her father’s bed at his Nova Scotia home, her head lolling slightly to one side. She gives Richard a thumbs-up sign when he sits down but then points to her ears with her left hand. "She’ll do that 30 or 40 times a day," her father said, adding that Lindsay has no short-term memory. When Lindsay sees the date on a newspaper, she makes an angry motion with her hand; she thinks it’s still 2004. On Feb. 22, 2004, the car Lindsay was traveling in crossed into oncoming traffic on a Sydney highway. A pickup truck smashed into the passenger side of the car where Lindsay wa s sitt ing. She suffered a traumatic brain injury and was in a coma for months. The accident left her deaf and unable to speak, feed or care
for herself. The right side of her body is immobile. Richard says Lindsay continues to become more alert but that without proper therapy, she will stop improving. In almost four years his daughter has received no extensive
rehabilitation. She has visited the Nova Scotia Rehabilitation Centre in Halifax, where she received some speech therapy, but has now spent more than two years at the hospital. She lives on a transitional ward where seniors wait to get into nursing homes. Her father thinks that Lindsay may be shipped off to a home herself.

“‘I can’t hear. I can’t walk. I can’t speak.’” Lindsay Young’s arm shakes slightly as her fingers come to rest on her lips while her father interprets her gestures.”That’s usually what she says when she meets someone for the first
time," Richard Young, 58, said on Wednesday. The 29-year-old woman lies on her father’s bed at his Nova Scotia home, her head lolling slightly to one side. She gives Richard a thumbs-up sign when he sits down but then points to her ears with her left hand. "She’ll do that 30 or 40 times a day," her father said, adding that Lindsay has no short-term memory. When Lindsay sees the date on a newspaper, she makes an angry motion with her hand; she thinks it’s still 2004. On Feb. 22, 2004, the car Lindsay was traveling in crossed into oncoming traffic on a Sydney highway. A pickup truck smashed into the passenger side of the car where Lindsay wa s sitt ing. She suffered a traumatic brain injury and was in a coma for months. The accident left her deaf and unable to speak, feed or care
for herself. The right side of her body is immobile. Richard says Lindsay continues to become more alert but that without proper therapy, she will stop improving. In almost four years his daughter has received no extensive
rehabilitation. She has visited the Nova Scotia Rehabilitation Centre in Halifax, where she received some speech therapy, but has now spent more than two years at the hospital. She lives on a transitional ward where seniors wait to get into nursing homes. Her father thinks that Lindsay may be shipped off to a home herself.

 


 

Brain injury is not the end

Milly Parker thought her life was over when she was diagnosed with an acquired or traumatic brain injury after a car crash 13 years ago. Launching Brain Injury Awareness Week in Geelong, Australia, Ms Parker explained how she woke up in the intensive care unit after an accident and discovered her life had changed. She was a 21-year-old accounting student with a hectic social life and a career carefully mapped out. Suddenly, she couldn't study. Her injury affected her memory, her ability to work with numbers and complex plans. Socializing was traumatic and working a nine-to-five job was impossible. For seven years, Ms Parker struggled with depression, unable to come to terms with her injury. She spent a year in rehabilitation and five years in the system. Eventually she learned to work with her strengths and focus on what she could do, rather than what she couldn't. “I stopped being embarr assed of my brain injury,” Ms Parker said. “And I stopped thinking I was broken and useless.” She realized while her gift for numbers was gone, her creativity had grown. “Having a short attention span is great for coming up with new ideas,” she said. She created a home business called Happy Yappers, selling gourmet dog biscuits. The business flourished and she now exports the dog biscuits nationally and around the world, including Harrod's in London.

 


 

September 20, 2007

Cooling Therapy May Have Aided Injured Football Player

As Buffalo Bills football player Kevin Everett was being rushed by ambulance to a hospital the night of his life-threatening spinal cord injury, he was already getting experimental treatment that may have saved him from paralysis. In the ambulance prior to surgery, a doctor injected Everett with steroids, standard treatment to reduce swelling and potentially damaging inflammation. At the same time, paramedics started pumping an ice-cold saline solution into Everett's veins, to lower his body temperature. The experimental approach has shown promise in stroke and cardiac arrest patients, and even in infants deprived of oxygen. The theory behind the therapy: By lowering the core body temperature between six and eight degrees, doctors can tamp down swelling and inflammation, and limit the release of harmful chemicals that can cause even more damage than the initial injury. For hypothermia to be effective, it needs to be started as soon after the injury as possible. Using cooling for a spinal injury is a new application of the technique. It has been used in traumatic brain injury for years as a neuro-protective agent. Soldiers who suffer severe traumatic brain injury in Iraq are being treated this way.

Everett's spinal cord was damaged in his neck as he tried to tackle a Denver Bronco during the football game. Everett was diagnosed with a potentially fatal fracture/dislocation between the third and fourth cervical vertebrae in the neck. He underwent emergency decompressive surgery to prevent pinching and pressure of the spinal cord and to repair the break in the vertebrae. A bone graft was made and a plate inserted, held in place by four screws. Two small rods were implanted and kept in place with additional screws. The next day, Everett's doctors said there was not much hope that he'd make a full recovery. However, the following day, they announced that he could move his arms and legs, and his spinal cord was intact. "Walking out of this hospital is not a realistic goal, but walking may be," Dr. Andrew Cappuccino, the Bill's orthopedic surgeon, said at a news conference.

 


 

E. Coli fear spark bagged salad recall

A package of Dole salad mix that tested positive for E. coli has triggered a recall in at least nine states, prompting new produce fears almost exactly a year after a nationwide spinach scare. The tainted bag of Dole's Hearts Delight salad mix was sold at a store in Canada, officials said. Neither Canadian health officials nor Dole Food Co. have received reports of anyone getting sick from the product. The voluntary recall, issued Monday Sep 17th, affects all packages of Hearts Delight sold in the United States and Canada with a "best if used by" date of September 19, 2007, and a production code of "A24924A" or "A24924B." The salad mix subject to the recall may have been available in the U.S. in states other than the nine already identified by Dole because in some areas a wholesaler distributed the product with clients in overlapping markets. The latest recall affects packages sold in Ontario, Quebec and the Maritime Provinces in Canad a and in Illinois, Indiana, Maine, Michigan, Mississippi, New York, Ohio, Pennsylvania and Tennessee starting around Sept. 8. Eighty-eight cases or 528 bags were distributed in Canada, and 755 cases containing 4,530 bags were distributed in the U.S.

Food contaminated with this strain of E. coli may not look or smell spoiled but health officials say the bacteria can cause life-threatening illnesses. Symptoms include severe abdominal pain and bloody diarrhea; some people can have seizures or strokes and some may need blood transfusions and kidney dialysis, while others may live with permanent kidney damage.