HB 1247 which recently became law applies to all legal actions to recover wages or compensation commenced on or after the date the bill was signed under the Wage Act statute. It makes a number of important changes to the wage claim statute including eliminating the provision for a mandatory award of fees to a defendant in any case in which the plaintiff fails to recover more than the amount the defendant had tendered. This eliminates some of the risk and allows for more cases to be filed under this statute.

It also increases the penalties to an employee who prevails under the Wage Act to 125% for the first $7,500 in unpaid wages or compensation, and 50% of unpaid wages or compensation above that amount.

Posted by Rosemary Orsini at 10:33 PM | Permalink | Comments (0) | TrackBacks (0)

Jesse Ramirez of Arizona, 36, suffered traumatic brain injury in a May 30 car accident that put him in a coma. He had been in this minimally-conscious state for a little more than a week when doctors informed his wife that he may never recover and she made the decision to have his feeding and water tubes removed. Ramirez's family made a legal appeal and won and his feeding tubes were reconnected. Ramirez has since regained consciousness and recovered to the extent that he can interact with visitors. The injuries Ramirez sustained in his accident were traumatic in nature, meaning that the shock of impact likely ripped apart some of the fragile connections in his brain, leading to his coma. These injuries, on occasion, can heal to a certain extent, allowing the patient to recover functionality. This is far different from the damage caused by anoxia, in which a lack of oxygen to the brain causes irreparable brain damage. The fact that the nature of Ramirez's injury meant that he still had a chance to recover raises a natural question: Was the decision to discontinue his life support premature? Dr. Ausim Azizi says the decision to cut off life support usually takes weeks, or even longer. In this case, however, Ramirez's wife asked doctors to remove her husband's feeding and water tubes nine days after the accident. Whether Ramirez's wife's decision was a good decision is open for debate. The case raises the question of whether people should trust spouses or parents to make these life or death decisions.

Posted by Kerry N. Jardine at 07:55 PM | Permalink | Comments (0) | TrackBacks (0)

The widow and son of 60-year-old Larry Stanford of Beaumont Texas have filed a lawsuit against GlaxoSmithKline, the maker of Avandia (rosiglitazone), claiming that the diabetes drug contributed to his fatal heart attack. Ironically, Mr. Stanford's heart attack occurred on the same day that a report warning of Avandia's dangers was published in the New England Journal of Medicine. The family's attorney emphasized, "But what truly matters is what happened long before that date. I believe the evidence will show the company knew there were problems with Avandia, but decided to keep on selling it to Larry and others."

Avandia was first approved by the FDA in 1999. By 2006, doctors were writing about 13 million prescriptions for the drug, resulting in about $2.2 billion in sales. Since the warnings of heart risks appeared in the New England Journal of Medicine, new prescriptions of Avandia have dropped.

Patients aren't the only ones who are unhappy about Avandia's recently-disclosed heart risks--investors have filed a class-action lawsuit against GlaxoSmithKline, claiming the company "failed to adequately disclose" information linking use of the drug to an elevated risk of heart problems.

Posted by Kerry N. Jardine at 11:59 AM | Permalink | Comments (0) | TrackBacks (0)

Workers had better complain quickly if they want to seek relief under federal discrimination laws. This was the impact of the U.S. Supreme Court's decision last week in Ledbetter v. Goodyear Tire & Rubber Co., Inc. (No.05-1074). Ms. Ledbetter, a former supervisor at Goodyear Tire & Rubber Co. claimed she had been paid thousand of dollars less than male co-supervisors. She reported the discrimination just before retiring after twenty years with the Company. The United States Supreme Court found that Ms. Ledbetter had no valid discrimination claim because the discriminatory pay decisions she had suffered earlier in her tenure with Goodyear happened outside of the statutory 180-day time period for filing discriminatory charge.

Even if lower courts choose to view the ruling narrowly, it will affect a large share of discrimination cases.

Under Title VII of the Civil Rights Act of 1964, a claim must be made within 180 days of the discriminatory act to be valid, the court said. In some states including Colorado, state law allows 300 days to file.

Posted by Rosemary Orsini at 11:53 AM | Permalink | Comments (0) | TrackBacks (0)

Dr. Frank Abuzzahab, a Minnesota psychiatrist, was sanctioned by the Minnesota Board of Medical Practice a decade ago, having been accused of a "reckless, if not willful, disregard" for the well-being of 46 patients, 5 of whom died. Dr. Abuzzahab's license was suspended for seven months, and it was restricted for two years after that.

Among the patients who died was Mr. Olson ("Patient No. 46"). Drug makers paid Dr. Abuzzahab thousands of dollars for every patient he recruited for a study. When Mr. Olson refused in July, 1997, to be a test subject, Dr. Abuzzahab discharged him from the hospital, even though he was suicidal. Mr. Olson committed suicide two weeks later. The medical board found that "Dr. Abuzzahab failed to appreciate the risks of taking Patient No. 46 off Clozaril, failed to respond appropriately to the patient's rapid deterioration and virtually ignored this patient's suicidality." Mr. Olson's sister said that Dr. Abuzzahab "had no time for my brother unless David agreed to get into a drug study. He said, 'You're wasting my time and the hospital's.' It was all about money."

Yet Dr. Abuzzahab is still being paid by drug companies to oversee the testing of drugs on patients. In fact, at least a dozen pharmaceutical companies have paid him for research or marketing since he was disciplined. In the period 1997 - 2005, Dr. Abuzzahab has received more than $55,000 from drug makers.

Medical ethicists argue that doctors who give experimental drugs should be chosen with the utmost of care. The drug industry agrees in principle, stating in clinical trial guidelines, "Investigators are selected based on qualifications, training, research or clinical expertise in relevant fields."

Dr. Abuzzahab is not an anomaly. An analysis of Minnesota state records by the New York Times found 103 doctors who had been disciplined or criticized by a medical board, two of whom had criminal fraud convictions. These 103 doctors received a total of $1.7 million from drug makers. The median payment was $1,250, and the largest was $479,000. This analysis focused on Minnesota because it's the only state to make its records publicly available, but experts say the problem exists nationwide.

Posted by Kerry N. Jardine at 08:11 PM | Permalink | Comments (0) | TrackBacks (0)

The current drug surveillance system needs to be fixed, argues an editorial in this week's British Medical Journal. The call follows a recent analysis of the diabetes drug rosiglitazone (Avandia) which raised serious questions about the drug's safety. Rosiglitazone was approved by the US Food and Drug Administration (FDA) in 1999 and by the European Medicines Agency (EMEA) in 2000. Its popularity has increased steadily, with more than one million prescriptions written in the one year period ending March 2006 in England alone. Emerging safety concerns highlight the need for a better system of drug evaluation both before and after approval, says Dr Dhruv Kazi from the London School of Economics. He argues that the current approach relies heavily on passive surveillance and is based on reports of unusual adverse events from consumers, practitioners, manufacturers, and national regulatory authorities. Alternatively, the regulatory authorities may require further (phase IV) trials after approval, but these are often not completed in a timely manner, he says. This results in a fractured regulatory process, where postmarketing surveillance falls short of the standards the agencies set for themselves. For the system to be fixed, it will require systematic rethinking of the existing regulatory and funding processes and expediting changes currently in the pipeline. In the meantime, doctors will need to revisit the indication for the drug on a case by case basis, bearing in mind that several alternatives are cheaper, supported by robust evidence and now perhaps safer.

Posted by Kerry N. Jardine at 07:45 AM | Permalink | Comments (0) | TrackBacks (0)

Responding to recent revelations of insufficient treatment of wounded soldiers at Walter Reed Army Medical Center, a group of senators moved on Wednesday to boost disability pay to those hurt in combat and improve care for brain injury. The 93-page measure, introduced by 30 senators from both parties, also would expand medical care and counseling to family members and require better cooperation to end red tape for disabled service members moving from Pentagon to Veterans Affairs care. The bill would affect some of the more than 25,000 U.S. service members wounded in hostile action since military operations began in Iraq and Afghanistan. Veterans groups have long said that more serious problems remain involving an unwieldy disability ratings system. A preliminary review by the federal Veterans' Disability Benefits Commission found the Army was much more likely than the other active forces to assign a disability rating of less than 30 percent, the typical cutoff to determine whether a person can get lifetime retirement payments and health care. The legislation would require Defense Secretary Robert Gates to establish a special board to independently review the military disability ratings decisions since 2001. The review would involve cases in which disability rates of 20 percent or less were awarded to determine if soldiers were shortchanged. The measure would boost military severance pay for those rated with less than 30 percent disability and eliminate the current requirement that severance pay be deducted from disability pay. It would set up Pentagon pilot programs that would give the VA a greater role in the evaluation system, a major shift in how benefits are administered. Both critics and supporters acknowledge it would likely add significantly to costs since the VA takes into account all the disabilities a soldier has, not just one.

The bill would also: Provide $50 million for improved diagnosis, treatment and rehabilitation of veterans with traumatic brain injury or post-traumatic stress disorder. Require the VA secretary and Defense secretary to develop a joint comprehensive plan for care by Jan. 1, 2008, so injured troops don't slip through the cracks. The two departments would also have to create an interagency office to develop a joint system for electronic health records. It would Allow military and VA health care providers to provide urgent medical care and counseling to family members of those injured in combat. As well as require the Defense secretary to establish standards for housing for military outpatients and for military hospitals and clinics. Meanwhile, the Pentagon said it created a new Web site to help veterans who face difficulty returning to their old jobs or finding new ones after deployments in Iraq and Afghanistan. Michael Dominguez, principal deputy under secretary of Defense, said the program, dubbed TurboTAP, seeks to improve on its current Transition Assistance Program by letting National Guard and Reserve service members get job information, build a resume online and do a job search all in one place. In addition, veterans would be able to create a customized transition plan from military to civilian life. They also would be able to access "helpful checklists" regarding key things they should be doing after leaving the military.

Posted by Kerry N. Jardine at 07:40 AM | Permalink | Comments (0) | TrackBacks (0)

The Jeffersontown company where a man lost both arms in a drywall shredder in January willfully violated a "serious" safety rule and will be fined a total of $88,500, a state agency has ruled. The findings of the Kentucky Labor Department should help William "Billy" Parker if he sues his former employer, Six Sigma Inc., a machine manufacturing company, according to attorneys who specialize in workers' compensation law. The lawyers said the finding is extremely rare. And they say it could prompt a reexamination of a state law that says employees can successfully sue employers for a workplace injury only if they can prove the company deliberately intended for them to be harmed. The company has 15 days to contest the citations, which were issued May 31 and June 6. The Courier-Journal reported May 19 that no employee in Kentucky has ever successfully sued an employer for injuries suffered on the job. The department found that Six Sigma committed a "willful serious" violation by failing to have procedures for locking out electricity to the shredder, as well as lathes and mills throughout the shop, while they were under repair. That put 30 employees at risk, including Parker, who was critically injured, the citation said. If the citation stands, the company would pay a $56,000 fine for that violation alone.

The maximum fine for any violation is $70,000, and 14 of 1,876 citations issued by the department last year were willful, said Leslie Renkey, its general counsel. A willful violation is defined as one committed with "intentional, knowing or voluntary disregard" for the law or with "plain indifference to employee safety," he said. The company committed another "serious" violation by failing to maintain guards on the shredder, according to a citation. In a follow-up inspection, the department cited the company for 15 other "serious" violations, including exposing workers to electric shock hazards; failing to have guards on air compressors; failing to inspect cranes and slings; and failing to train electricians in safety-related work practices. The department proposed fines of $28,500 for those and other violations found in the follow-up visit and gave Six Sigma until June 22 to take corrective action. Parker's lawyer, John Talbott, said the findings support his client's contention that the plant was unsafe and was responsible for his catastrophic injuries. He has said he and Parker are awaiting the department's complete findings before deciding whether to file a lawsuit. Talbott said that the finding that Six Sigma acted willfully wouldn't necessarily mean Parker would prevail in lawsuit, but that it is "terribly helpful.” "Just the semantics add strength to our argument," Talbott said. If Parker, 39, were unable to sue, he would have to settle for benefits available under workers' compensation, possibly as little as $546 a week.

Posted by Kerry N. Jardine at 07:35 AM | Permalink | Comments (0) | TrackBacks (0)

LegalView.com, which Burg Simpson is pleased to be associated with, is pleased to announce its continuing expansion of its comprehensive portal for information on traumatic brain injuries (TBI) with a regularly updated blog. The blog focuses on recent TBI cases as well as settlements and neuroscience news related to traumatic brain injuries. The TBI blog, located at http://blogs.legalview.com/tbi/, is frequently updated with the latest news and research on head injuries and brain injury law. The blog complements LegalView's existing collection of TBI resources, which include original articles, links to updated news and government health authorities' information, a comprehensive TBI glossary and the latest jury verdicts in TBI cases. The TBI blog is just one of dozens of blogs on cutting-edge legal topics maintained by LegalView. Americans who are concerned about unsafe drugs, recalls and environmental contamination may browse timely, frequently updated blogs on those topics, as well as related blogs on specific topics, such as Peter Pan Peanut Butter lawsuits, MoisturePlus litigation, Avandia lawyers and Asbestosis & Mesothelioma attorneys. The blogs complement LegalView's vast collection of informational portals on important legal issues including auto accident lawsuits, birth injuries and workers' compensation. And those who are considering legal action can take advantage of LegalView's totally free set of legal resources, including links to regional legal information, complete information on specific legal topics, an encyclopedia and a legal dictionary, and a free nationwide attorney referral service.

Posted by Kerry N. Jardine at 07:43 AM | Permalink | Comments (0) | TrackBacks (0)

Like many diabetics, pharmacist Ben Briggs was eager to see his blood sugar drop when he began taking his new medicine. However, within two weeks, his ankles started swelling, his weight surged eight pounds, and he felt short of breath. "I was feeling awful," said Briggs. The symptoms stopped after he went off the drug. Briggs wasn't taking Avandia, the GlaxoSmithKline drug caught in a media firestorm in recent weeks because of its alleged links to higher heart-attack risk. The 59-year-old diabetic was trying Januvia, a competing pill from Merck & Co. Inc. that has benefited mightily from Avandia's problems. Many doctors are switching patients to other drugs, including Januvia. Yet, as Briggs' experience shows, patients and investors may need to tread carefully. Even newer than Avandia, Januvia has been on the market for only eight months and prominent critics are already questioning why patients should take it when more proven choices, such as metformin and insulin, are available. Experts say the questions around diabetes drugs underscore a greater weakness in the drug-approval system. Many diabetes drugs are approved for improving a dimension of care, such as lowering blood sugar. But no one knows whether many of those new drugs can go further and help prevent the bad outcomes that really matter: heart attack, stroke, blindness, and amputation. Proving that can take years and add hundreds of millions of dollars to a drug's development.

For now, Januvia and Merck are riding high. Januvia could gain $300 million a year in sales from Avandia's problems, Deutsche Bank analyst Barbara Ryan said, citing an analysis of doctors' prescribing habits by Mount Laurel-based ImpactRx. Ryan's firm put out a buy recommendation June 5 on Merck stock, citing its cost-cutting and likely sales increases. Actos, a chemical cousin of Avandia, could benefit even more than Januvia, Ryan said, though it remains unclear whether the problems that appear to bedevil Avandia will apply to Actos, made by Takeda Pharmaceutical Co. Ltd.

Posted by Kerry N. Jardine at 07:25 AM | Permalink | Comments (0) | TrackBacks (0)

Dr. Beth Hudnall Stamm is the director of the Institute of Rural Health at Idaho State University. After suffering severe brain injuries that affect her sense of direction and balance, Stamm soon found a four-legged companion to help her move on with her life. Sophie is a three-year-old service dog who is the eyes, ears, and navigation system for Dr. Beth Hudnall Stamm of the Institute of Rural Health. Dr. Stamm goes on to say "Sophie reminds me at intervals to do my basic ADLs (activities of daily living) - to eat and actually, she reminds me to go to bed." Twenty years ago, Dr. Stamm fell down a flight of stairs, which caused traumatic brain injury. In life's irony, Stamm is a leading expert in traumatic brain injury and stress research. Stamm managed to work through her trials, until November of 2004, when she slipped on a patch of ice and caused even more damage to her brain. Today she suffers from a variety of orientation, hearing, vision, and balance problems. Stamm has since begun directing a multi-million dollar agency, the Institute of Rural Health, which receives funding through grants written by Dr. Beth Hudnall Stamm. It's a job she is able to do because of Sophie.

Sophie is a dedicated service dog allowed by federal law to go anywhere the owner can. But Stamm found some places that simply won't allow Sophie to be with her, despite a federal law that says it's illegal to refuse service. The Federal Americans with Disabilities Act says a service animal can't be denied access to any business, public facility, restaurant, hotel, store, medical facility or theater. While the business can ask what service the dog provides, a person with a disability can't be asked for special certification or I.D. A person with a disability can't be charged additional fees for having a service animal and they can't be isolated, segregated, or treated less favorably than other patrons.

Posted by Kerry N. Jardine at 07:23 AM | Permalink | Comments (0) | TrackBacks (0)

It's summer and time for opening the windows, lounging in the sun and embarking on countless outdoor activities. Among health professionals, summertime is also called "trauma season," since the rate of accidental injuries usually spikes. Children are especially at risk during the summer, with unintentional injuries such as drowning, falls and accidents with bikes and other wheeled sports the leading cause of death in children ages 14 and younger, according to the National Center for Health Statistics. The Centers for Disease Control and Prevention offers extensive advice for reducing the hazards of swimming, noting that survivors who came close to drowning nonetheless may have brain damage resulting in long-term cognitive disabilities such as learning problems, or worse. Most young children who drowned in pools, the CDC noted, were last seen inside a house and had been out of sight for less than five minutes. The CDC also offers safety tips, either online or by calling to request information, on preventing accidents while biking, skateboarding, horseback riding and numerous other outdoor activities. On average, 17 children in the United States died each day from these preventable injuries between May 1 and Aug. 31, 2004, according to a new report from Safe Kids USA citing the most recent year for which figures are available. In total, 2,143 children were killed in accidental injuries in 2004. Lucile Packard's Agarwal, who has worked at the Santa Clara Valley Medical Center as well, has a particular interest in preventing the tragedy of children falling from open windows. She explained that most falls from windows occur with younger children who climb on furniture near windows to get a look outside. Or they sit on window sills, leaning against a screen that gives way. Besides accidental injuries, there's the risk of sunburns to contend with during the summer months. Even a few serious sunburns can significantly increase chances of developing skin cancer later in life, warned the CDC. The chief advice for sun protection is familiar. Slather on at least 15 SPF sunscreen and do so every two hours, regardless of promises from sunscreen manufacturers of longer-lasting protection. Children and adults should also try to reduce sun exposure between 10 a.m. and 4 p.m., when skin-damaging UV rays are at their peak. A moderate amount of sun is healthful, as it generates vitamin D production in the skin, which not only is necessary for building strong bones and teeth, but is increasingly linked to the prevention of cancers and other diseases.

Posted by Kerry N. Jardine at 07:20 AM | Permalink | Comments (0) | TrackBacks (0)

BP's outgoing refining chief testified in a deposition last year that he first learned of serious safety concerns at the company's Texas City refinery in March 2005 when 15 people died in an explosion there, despite internal reports and warnings of potential danger. Plaintiffs' attorney Anthony Buzbee asked in the September 2006 deposition, "Before that, you had no idea that there was a risk of catastrophic injury?" Manzoni replied that had he been aware that catastrophic failure could occur BP would have taken action earlier. Manzoni's deposition was among hundreds of pages of blast-related documents and depositions made public June 11th under a Galveston judge's order. The release came less than two weeks after Manzoni resigned as refining chief. BP spokesman Neil Chapman declined to comment on whether the release of the documents played a role in Manzoni's departure.

Brent Coon, who represents hundreds of workers and Texas City residents who have sued or are suing BP, said the company knew Manzoni’s deposition would be among those unveiled Monday. In the deposition, Coon and Buzbee presented Manzoni with examples of how safety concerns had been expressed long before the blast. In 2004, then-plant manager Don Parus commissioned an internal survey of workers and gave the report to management in January 2005. Some workers surveyed said they felt pressured to bend safety rules; fixing things without shutting down operations earned rewards; and years of deferred maintenance had begun to take a toll. Manzoni, who works at BP headquarters in London, testified he received the report of the survey as part of BP's inquiry into the March 2005 blast. He also was shown a January 2005 business plan that stated among key risks, Texas City "kills someone in the next 12-18 months." Manzoni said part of business planning was to articulate risks. "It is not a prediction. It is a planning mechanism," he said. Manzoni also insisted safety didn't suffer from budget cuts which was contrary to the findings of the U.S. Chemical Safety and Hazard Investigation Board in its investigation of the blast. Manzoni conceded that BP demanded 25 percent cuts in spending in 1999, but insisted that spending had increased annually since 2002 and critical safety items were fixed first.

Posted by David P. Hersh at 05:14 PM | Permalink | Comments (0) | TrackBacks (0)

A class action lawsuit has been filed a in the United States District Court for the Southern District of New York against GlaxoSmithKline PLC (Nachrichten/Aktienkurs) (NYSE: GSK) and certain of its officers, on behalf of all persons or entities who purchased GSK securities between October 27, 2005 and May 21, 2007, inclusive. The Complaint alleges that during the Class Period defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 by publicly issuing a series of false and misleading statements regarding Avandia, In particular, the Complaint alleges that GSK failed to adequately disclose the fact that it had performed a pooled analysis of several clinical trials related to Avandia which showed an increased risk of heart attacks. Preliminary results of this analysis were presented to the FDA in September 2005 and updated results were disclosed to the FDA in August 2006. However, the results of GSK's analysis were never adequately disclosed to the investing public. As alleged in the Complaint, on May 21, 2007, before the close of trading, the results of a meta-analysis on Avandia conducted by a doctor with the Cleveland Clinic was reported and published in the New England Journal of Medicine. As a result of the reports regarding the meta-analysis, the price of GSK securities declined US$4.53 per share, or 7.8%, to close at US$53.18 per share, on unusually heavy trading volume.

Posted by Kerry N. Jardine at 05:10 PM | Permalink | Comments (0) | TrackBacks (0)

While revising their drug-review policy last year, Food and Drug Administration officials met 112 times with industry representatives but only five times with consumer and patient groups, according to data out Monday from the House Appropriations Committee. The meetings occurred between October 2005 and December 2006 and focused on the Prescription Drug User Fee Act, under which manufacturers help pay for the review of their new drugs. According to the Appropriations Committee, two officials of the Biotechnology Industry Organization and two officials of the Pharmaceutical Research and Manufacturers Association attended at least half of the 112 meetings. "The FDA has essentially become the government affairs office of the pharmaceutical industry," Rep. Maurice Hinchey, D-N.Y said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate." Hinchey is the author, and Bart Stupak, D-Mich., the chief co-sponsor of an FDA reform bill that would prohibit the agency from collecting fees from the companies it regulates. Instead, the money would be deposited into the general fund of the U.S. Treasury. In a statement, the FDA's Susan Cruzan said the agency faced a number of technical problems to be resolved before submitting the proposal. The FDA had "extensive discussions" with the industry about financing, marketing and infrastructure. She added that the agency also met with consumer groups and that each meeting followed the law's requirements.

Posted by Kerry N. Jardine at 04:49 PM | Permalink | Comments (0) | TrackBacks (0)

Intelect Medical, Inc., a Cleveland Clinic-founded company that develops implantable neuromodulation systems for brain injury recovery, plans to expand clinical feasibility trials for its investigational traumatic brain injury (TBI) recovery and stroke recovery therapies using deep brain stimulation (DBS) with funding from Boston Scientific and Greatbatch. "Stroke and traumatic brain injury affect millions of people," said Vincent Owens, President and Chief Executive Officer, Intelect Medical. "The funding will allow us to continue our applied research and clinical studies of DBS therapies and provide therapeutic options to help patients recover from stroke and TBI disabilities." Ali Rezai, M.D., Director of Cleveland Clinic's Center for Neurological Restoration further adds, "It is gratifying to see our technology and therapies move from the lab and closer to patient care. Our therapies present a significant opportunity to improve treatment options for stroke and TBI recovery." Both stroke and TBI are leading causes of serious, long-term disability worldwide. According to the National Institute for Neurological Disorders and Stroke, these two disabilities combined have an annual incidence of 2.2 million, while creating in excess of $115 billion in direct healthcare costs annually. Four million people in the United States are survivors of stroke and more than 5 million suffer from TBI disabilities.

Posted by Kerry N. Jardine at 04:40 PM | Permalink | Comments (0) | TrackBacks (0)

Rosemary Johann-Liang took her staff's advice and recommended in February 2006 that Avandia get a "black box" warning about congestive heart failure. FDA staffers told the Senate Finance Committee investigators that Johann-Liang was verbally reprimanded and told to talk to her director before making any major recommendations related to drug safety. Johann-Liang says, "I really advocate for drug safety, and a lot of times the agency doesn't want to hear that there are problems. I think, in general, there is a culture of 'The drug is always innocent.' " Part of the problem, she says, is that the Office of Surveillance and Epidemiology can only recommend how to manage risks linked to drugs. The Office of New Drugs, the same office that approves drugs, is the one that decides whether to take action. With Avandia, Johann-Liang says, "when we recommended this black box, they said they wanted to look at it further." But the Office of New Drugs never got around to it, she says, because they were pressed to meet deadlines for acting on new drug applications. In her two years in the Office of Surveillance and Epidemiology she worked hard to institute systematic safety meetings with the Office of New Drugs. She says Congress needs to increase staffing in the surveillance and epidemiology office and give it the authority "to take action in a timely manner."

Johann-Liang speaks of a convoluted system in which the FDA requires a higher level of proof of risk than of effectiveness. The FDA approves diabetes drugs such as Avandia if clinical trials show they meet the "surrogate endpoint," or goal, of lowering blood sugar, but then doesn't require makers to do follow-up studies of whether patients actually feel better and live longer. On the other hand, Johann-Liang says, "if there is a safety issue with the drug, it must be confirmed. I just don't think that that's appropriate." As a result, "we're not doing things in a timely way." Meanwhile, Johann-Liang says, "people are continuing to be hurt." Congestive heart failure "is a very, very clear adverse reaction syndrome" with Avandia, she says, adding that she's concerned some patients might blame congestive heart failure symptoms, such as shortness of breath, on their diabetes and take even more Avandia. The drug's label has mentioned heart failure for a few years, but "the stuff is all over the label," so doctors and patients can easily miss it, Johann-Liang says. Despite her frustrations, Johann-Liang says, she is leaving FDA mostly for personal reasons.

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

January 1997: The FDA approves Rezulin to treat type 2 diabetes, the first glitazone drug. A class of drugs that help the body use insulin more effectively.

May 1999: May 1999: The FDA OKs Avandia, the second glitazone.
July 1999: The FDA approves Actos, the third glitazone.
March 2000: The FDA asks Rezulin's maker to withdraw the drug because it is more toxic to the liver than Avandia or Actos.
April 2002: Avandia and Actos labels get new warnings about an increased risk of heart failure.
December 2005: Avandia maker GlaxoSmithKline and the FDA notify doctors of reports of new or worsening diabetic macular edema, fluid retention in the eye that can cause vision impairment, in patients taking the drug.
February 2007: Glaxo sends out a "Dear Health Care Professional" letter saying a clinical trial found a "significantly" higher risk of fracture in women who received Avandia compared with those who received metformin or glyburide, two older diabetes medications.
March 2007: Actos maker Takeda sends out a "Dear Health Care Professional" letter saying a review of its clinical trials database found an increased risk of fracture in women who received the drug.
May 2007: A New England Journal of Medicine study suggests Avandia raises risk of heart attacks. The FDA issues an Avandia "safety alert."

Posted by Kerry N. Jardine at 04:29 PM | Permalink | Comments (0) | TrackBacks (0)

The United Food Group LLC has expanded its voluntary ground beef recall to include about 5.7 million pounds of fresh and frozen meat that may be contaminated with E. coli. David Goldman, acting administrator of the USDA Food Safety and Inspection Service, announced on Saturday that the recall would be expanded to include products with sell-by dates from April 6-April 20. The beef was sold in 11 Western states. Goldman said that none of the latest batch of suspect beef is in stores now because the product would be well past its expiration date, but consumers may still have some of the meat at home. The meat has been blamed for an E. coli outbreak in the Western states that resulted in 14 illnesses, spanning April 25 through May 18. All the patients have recovered. "It is important for consumers to look in their freezers," Goldman said.

The recalled products were shipped to stores in Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington and Wyoming. They were sold under the brand names Moran's All Natural, Miller Meat Company, Stater Bros., Trader Joe's Butcher Shop, Inter-American Products Inc. and Basha's. The affected grocery stores included Albertson's, Basha's, Grocery Outlet, Fry's, "R" Ranch Markets, Save-A-Lot, Save-Mart, Scolari's Wholesale Markets, Smart and Final, Smith's, Stater Bros. and Superior Warehouse.

Posted by Kerry N. Jardine at 03:01 PM | Permalink | Comments (0) | TrackBacks (0)

Greta Carolus, a former nurse, resident and citizen of Loveland, Colorado, is suing General Electric Company, GE Healthcare, Inc. and GE Healthcare Bio-Sciences Corporation for a rare disease caused by the drug OmniscanTM, through the Law Firm of Burg Simpson Eldredge Hersh & Jardine, P.C. claiming that their drug caused her the debilitating skin and joint disease known as Nephrogenic Systemic Fibrosis (NSF). Burg Simpson is currently involved in the representation of more than 20 individuals with Nephrogenic Systemic Fibrosis (NSF). The suit seeks damages for fifteen separate causes of action. "Within days after being administered OmniscanTM, Ms. Carolus developed symptoms associated with NSF/NFD, which was formally diagnosed in November 2005, and which has progressed to widespread fibrosis and edema in areas including, but not limited to, her arms, legs, and associated joints," says Peter W. Burg, a partner in the Denver litigation law firm of Burg Simpson Eldredge Hersh & Jardine. "This disease has caused Ms. Carolus to suffer this condition and has caused permanent effects affecting her throughout her lifetime and could lead to death," said Burg. Ms. Carolus is now wheelchair bound with limited extension of her legs, several fingers and elbows. Ms. Carolus was forced to leave her employment as a nurse as a result of her debilitating injuries.

The suit claims that GE was aware or should have been aware of the risks of OmniscanTM and that during the years the defendants manufactured, marketed and sold OmniscanTM, there were numerous reports, studies, assessments, papers and other clinical data describing or demonstrating NSF/NFD in connection with the use of gadodiamide contrast agents, including OmniscanTM. "Despite this, defendants have repeatedly failed to take prompt, reasonable, and effective measures to alert the appropriate members of the health care community and its patients, including but not limited to, renal patients, nephrologists and other physicians, radiologists, administrations, technicians, and hospital/radiology supply personnel, to the serious adverse health risks presented by OmniscanTM administration."

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

Rudine Aycock had never been an artist, but after a bicycle accident caused her a traumatic brain injury nine years ago she is suddenly an artist. "God reached down and gave me the talent to paint," Ms. Aycock said. That is not her only miracle. Doctors tell her she is lucky to be alive. It all started the day she flew over the handle bars of her bicycle. A helicopter rushed her to the Duke Medical Center for emergency brain surgery. She was put on life support and doctors told her family they didn't think she would survive. If she did, they said, she would be a vegetable. Ms. Aycock pulled through at Duke, and the doctors transferred her to the rehabilitation unit at Wake Medical Center. "They said I would be there up to two years," Ms. Aycock said. "I was out in three weeks. I was blowing their minds. Their eyes would get big, and their mouths would fly open. I thought, 'Oh no. I must be doing terrible.' It was the reverse." However, her recovery was not without struggle. Her brain functions as well as it ever did, but she suffers headaches that send her to bed for half a day and her energy escapes her when she least expects it. Her new disability forced Ms. Aycock to retire from her work as a supervisor for the fraud unit at the Wayne County Department of Social Services and as a part-time special deputy for the sheriff's office. "I was extremely depressed over losing the job," she said.

Then, one day, she told her friend, Kenneth Sasser, she had an urge to try a new talent. "I think I can paint," she told him. She bought an easel and canvas and started work. Now, five years later, she has had work appear in local galleries including the White House. The picture of Jesus pulling a sheep out of thorns that hangs in President George W. Bush's office is her work. She said she knew she had achieved something when the White House first called to ask for the painting. In order to get to it though, she had to place a value on it. Since it was a gift, she asked the experts there to place a monetary value on it. "They valued it at $2,500 and gave it to the president," she said. Before the accident, she said she could not draw a thing. Her newly discovered talent is nothing short of a miracle.

What happened to Ms. Aycock is very believable, said Doug Harrison, director of Growth and Development at Re Nu Life assisted living center for traumatic brain injury victims. The brain is constantly trying to heal itself and may have connected something that was not connected before, he said. "The most heartwarming thought is that the brain rewired itself and gave her the ability. But you never can say definitively, because the brain is so complex," he said. "It is very possible the brain healed itself in a new way that the ability was uncovered." Ms. Aycock said she is just glad that her tragedy has turned into a viable new hobby.

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Alex and Jenny Latham of Lafeyette, CO were victims of an October 2005 car accident caused by a man fleeing from police. Since the accident the couple has lost their jobs and their Longmont home to foreclosure. They are badly injured and unable to work. They now live in a small townhouse in Lafayette with their four children, ages 4, 5, 13 and 14. “The doctor even told my parents that I wouldn’t make it alive,” said Alex. He was hospitalized for eight weeks and spent four months at home primarily bed ridden. Jenny was hospitalized for six weeks. They each went through surgeries and will face more. Scars memorialize the accident, and some shifts in personality hint at their mental changes. The family now lives primarily on Jenny Latham’s disability and it is a sparse existence. They also are learning to work around new challenges caused by traumatic brain injury.

Both attempted re-entering the work force but were stymied primarily by the brain injuries. “The year before the accident, I made $140,000, and I had a brand new house and a brand new car and four kids,” Alex Latham said. He owned a real estate business and had four other agents who worked for him before the accident. He attempted to work in real estate again after his recovery, but his brain injury made it impossible for him to handle the multiple tasks. He recently worked for two months as a cashier at a store in Lafayette but was fired because he couldn’t concentrate well enough to collect money from all of his customers. He said he is grateful for the small Lafayette townhouse that the couple owned before they moved to Longmont, Medicaid and food stamps. They’re also thankful for the people who helped arrange paperwork for Medicaid to pay medical bills and who have donated goods and services to help the family and their pets. Jenny Latham’s brain injury left her susceptible to fits of rage and panic attacks in public, and she is now unable to read, a particular tragedy because her love of the Beat poets and writers led her to Colorado in the first place.

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http://www.burgsimpson.com/defective_drugs.htmlLawmakers are questioning conflict-of-interest policies at the Food and Drug Administration, where an agency official with ties to the drug industry attacked industry watchdog Dr. Steven Nissen of the Cleveland Clinic. FDA communications consultant Douglas Arbesfeld recently sent journalists a flaming e-mail about Nissen, who was the co-author of a study in the New England Journal of Medicine that raises safety questions about the diabetes drug Avandia. The e-mail referred to Nissen as "St. Steven" and included an anonymous blog item that accused the doctor of criticizing manufacturers that don't support drug trials at the Clinic, according to ABC News online. "He's trying to let Congress deal with it now," Clinic spokeswoman Erinne Dyer said. "He's been advised not to stoke the fire."

Sr. Sherrod Brown and four other lawmakers said in a letter Thursday to FDA Commissioner Andrew von Eschenbach that Arbesfeld "may be using his position with the FDA to settle old scores with Dr. Nissen." It noted that Nissen and Arbesfeld had been adversaries in an earlier controversy over the safety of a Johnson & Johnson heart drug. Arbesfeld was a spokesman for Johnson & Johnson at the time. The lawmakers said Arbesfeld's e-mail may give the impression the government encourages smear campaigns against independent scientists. Their letter asks the commissioner to explain policies on hiring from drug companies and potential conflicts of interest. An FDA spokeswoman did not respond to requests for comment Friday.

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The FDA issued a press release on May 23, 2007 to ask manufacturers to include a new black box warning on the labeling of all gadolinium based contrast agents because of the risk of Nephrogenic Systemic Fibrosis. This NSF warning will likely bring into the spotlight the MRI for profit scheme revealed on January 17, 2007. Illinois Attorney General Lisa Madigan announced that her office had intervened in a whistleblower lawsuit filed by John Donaldson in 2006 against more than 10 Chicago-area MRI centers over their payment of kickbacks to doctors in exchange for referring patients to the centers. According to the complaint, "Each participating MRI Service Center involved performs the subject MRI services and then engages in the making of illegal and unlawful kickbacks to the physicians from payments made by both Illinois citizen patients and their insurers." The kickbacks, the complaint alleges, provide a financial incentive for a physician to order unnecessary scan services, or excessive scan services, and thus bill insurers for unnecessary scans. The schemes, the lawsuit alleges, make it impossible for legitimate providers to engage in legitimate practice of providing MRI services and remain in business if the scheme and unlawful practice of paying kickbacks for patients is not stopped.

According to Mr. Donaldson, he has experienced a substantial drop in physician referrals over the past 24 months as more doctors referred patients to centers involved in the kickback scheme. In the complaint, he says, physicians have advised him that they would prefer to utilize his services, but only if his "business would pay kickback payments to physicians for referring MRI patients." Physicians were told the referrals could earn an annual revenue of $84,900 to $132,900, assuming the doctor had a referral rate of 40 scans per month, according to the May 10, 2007, Chicago Tribune, and although there are only 11 companies named in the complaint, the attorney general's office thinks the scheme stretches across the country.

The FDA issued a press release on May 23, 2007, to announce that the agency was asking manufacturers to include a new black box warning on the labeling of all gadolinium based contrast agents used to enhance the quality of magnetic resonance imaging (MRI). The warning states that patients with severe kidney insufficiency who receive the agents are at risk for developing a debilitating and potentially fatal disease known as known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD). In addition, the FDA warns that patients receiving the agents just before or just after liver transplantation, or patients with chronic liver disease, are also at risk for NSF if they are experiencing kidney insufficiency of any severity. Experts say neonates and infants up to 1 year of age may also be at risk because their kidneys are not fully developed.

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Nevada's medical board ranks 47th in the nation for taking serious disciplinary actions against doctors in the last 3 years, according to a new report compiled by the Washington, D.C.-based advocacy group Public Citizen. Serious disciplinary actions are taken by medical boards against physicians involved in criminal offenses, malpractice and other negative outcomes that result from their care. The number of disciplinary actions issued by a board can be used as a barometer on how medical oversight boards adequately protect patients' safety by aggressively pursuing physicians who practice substandard care. The 2001 to 2003 report ranked Nevada 33rd

Although Public Citizen's report raises some valid issues, it doesn't show the complete picture, said Tony Clark, executive secretary of the Nevada State Board of Medical Examiners. Nevada has stricter licensing requirements, requiring doctors to have three years of postgraduate progressive education while most states require one or two years, Clark said. Because doctors that come here are more experienced, it helps reduce the number of problem doctors. The report also doesn't take into account minor disciplinary measures, and assistance and monitoring programs that help doctors with potential problems, Clark said. These include alcohol, drug and anger management programs to help doctors deal with such personal issues.

Dr. Sidney Wolfe, director of Public Citizen's health research group, remained skeptical. "I doubt whether Nevada is the only state that has those requirements," Wolfe said. "Nevada's getting worse. If that's a factor, are they really saying that it has had such an impact in the quality of doctors in just three years? I doubt that."

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Hospital lawyers urged the Florida Supreme Court to delay implementation of a state constitutional amendment that gives patients the "right to know" about past mistakes made by doctors and medical facilities. They also asked the justices to reverse two separate appellate court rulings that struck down a law the Legislature passed to implement the amendment and limit the records of "adverse medical incidents" that patients can obtain. The appellate courts disagreed on whether the amendment applies to past records or only those created since voters approved the measure in November 2004. The amendment itself does not specifically say if it's prospective or retroactive.

The Patients' Right to Know Amendment should cover only new records, said Arthur England, a former Supreme Court justice, who argued on behalf of Florida Hospital Waterman Inc. in Tavares. That means it would be many years before the measure gives patients any meaningful help in its intended purpose of letting them check on the past performance of doctors and hospitals. England also argued the amendment cannot be applied retroactively because that would violate confidentiality rights of doctors and hospitals during peer reviews designed to encourage frank discussion in the interests of improving medical procedures.

Christopher Carlyle, a lawyer representing Teresa Buster, who had sued Florida Hospital over her husband's death, disagreed. It defies common sense to argue voters intended the amendment wouldn't apply to existing records, he said. Carlyle responded that such confidentiality is not an absolute right and could be lifted at any time by the Legislature or, as in this case, by voters. The amendment is one of two voters passed in 2004 after they had been placed on the ballot through citizen initiatives organized by trial lawyers who represent patients in medical malpractice cases. The other amendment bars doctors with three malpractice judgments against them from practicing. The same year voters also passed an amendment promoted by the Florida Medical Association to limit how much lawyers can collect from medical malpractice judgments. The three amendments were part of a continuing feud between plaintiffs' lawyers and doctors over Florida's medical malpractice procedures. The Florida Hospital lawsuit was filed before the amendment passed but once it did, Buster's lawyers tried to use it to obtain access to confidential performance records. The 5th District Court of Appeal in Daytona Beach denied that request, ruling the amendment was not retroactive.

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A proposed prescription drug safety bill released June 7th by a House panel is a major victory for patient safety and builds on legislation passed in the Senate by including stronger limits on advertising of unsafe drugs, ensuring clinical drug trial results are made public and limiting conflicts-of-interest on drug advisory committees. The legislative draft from Rep. Pallone, chairman of the House Energy and Commerce Health subcommittee, is expected to be discussed at a hearing Tuesday, June 12. The House proposal includes many of the Senate features, including $225 million more in drug industry user fees to help pay for drug safety, and the active monitoring of huge medical databases to detect safety problems. The House proposal goes further than the Senate bill by requiring all new drugs display a symbol that they are new to the market; that all new drugs go through a risk evaluation process that can include limiting of direct-to-consumer ads for those drugs with severe and unusual safety issues; and granting only one conflict-of-interest waiver per drug advisory committee. The House measure also sets guidelines for how the drug industry must register and report their clinical drug trials to make them publicly accessible. The Senate bill calls for a 30-month study and rulemaking for those trial results guidelines, and it is unclear how comprehensive the final proposal will be.

"The House has the opportunity to pass real reforms that will give the FDA the power to act quickly and decisively when drug safety problems arise," Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. "This proposal should help put an end to incidents like Vioxx, where the public was kept in the dark about possible health risks. If such a monitoring system had been in place years ago, the whole Avandia controversy may well have been resolved years earlier," Vaughan continues. "The diabetic community would have had answers on the safety of this drug within a year or two, rather than drifting for eight years."

The House proposal also calls for including consumer and patient advocates to participate in negotiations between the drug industry and the FDA on the next user fee proposal, slated for 2012. Currently, the FDA and pharma negotiate behind closed doors on how much the industry will pay to expedite the drug approval process, and what the FDA will do in return. These user fees, known as the Prescription Drug User Fee Act, are up for reauthorization this year and are renegotiated every five years. The House bill also gives the FDA the authority to impose tough fines on drug companies that fail to comply with safety measures, such as performing post-market studies or posting clinical trial results. Rather than a set fine, the House measure calls for a drug maker to pay a percentage of the drug's profits for not complying with law.

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The Centers for Disease Control and Prevention on June 7th said it will revise educational materials for physicians treating concussions, based in part on advice from the University of Pittsburgh Medical Center. “Heads Up: Brain Injury in Your Practice” is a multimedia toolkit the CDC gives physicians to help provide earlier diagnosis, management and appropriate referral for patients with concussions. Doctors at the UPMC Sports Medicine Concussion Program, as well as experts from other organizations, contributed to the project.

A key component of the revised kit is an assessment guide called the Acute Concussion Evaluation (ACE) assessment tool created by UPMC neuropsychologist Michael "Micky" Collins and Gerard Gioia, a neuropsychologist at Children's National Medical Center in Washington, to help physicians recognize a concussion earlier. We believe that the ACE assessment tool will provide a needed diagnostic tool for physicians because it provides the most up-to-date information on how to recognize and treat concussion” said Dr. Jean Langlois, one of CDC’s leading TBI researchers and one of the authors of the tool kit.

The tool kit also contains practical, easy-to-use clinical information and tools:

* The “Facts for Physicians” booklet
* Fact Sheets in English and Spanish on preventing concussion
* A palm card for on-field management of sports-related concussion
* CD-ROM with downloadable kit materials and additional TBI resources

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