American Cancer Society Issues Controversial Guideline To Try To Reduce Lung Cancer Deaths

Despite the long-standing debate and controversy on the topic, the American Cancer Society just issued a new guideline which supports use of annual low-dose CT scans to screen for lung cancer in older smokers.  The guideline utilizes specific criteria for the cancer screening by CT scan, including screening patients who are between 55 and 74 years old, who have at least a 30 pack year smoking history.

The guideline relies heavily upon the evidence generated by the National Lung Screening Trial.  The study found an impressive reduction in lung cancer death of 20% in high risk patients who underwent low-dose CT scan on an annual basis rather than plain chest x-ray screening.

Many studies have been done on the utility of CT scanning for lung cancer, and a lot of controversy still exists among the experts.  However, with the National Lung Cancer Screening Trial and other important medical research, cancer experts now seem to concur that there is sufficient information available to support screening for lung cancer by CT scanning.  Given the clout of the American Cancer Society’s endorsement, more CT scanning may be undertaken in the future to address this serious health issue.

Lung cancer is the most common cause of death in this country and in the world, among men and women.  In this country, lung cancer is responsible for more deaths than breast cancer, colon cancer and prostate cancer combined.

Virginia Buchanan is a shareholder at Levin, Papantonio.  She has served on the Board of Directions of the Florida Bar Foundation and has been Treasurer of ABOTA, Chairperson of the Civil Process Server Grievance Committee and has been a member of the Chief Judge’s Council on Children. She currently is a member of the Women’s Caucus of the Florida Justice Association.

Growing Controversy Over Safety of New Oral Anticoagulant Pradaxa

Pradaxa is a novel oral anticoagulant designed to reduce the risk of stroke in patients with atrial fibrillation. From the day it was approved for sale in the United States an unprecedented number of serious adverse events and deaths attributed to the drug that were reported to the FDA. In response, the FDA launched an investigation into the safety of Pradaxa announcing that “the FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected…” Less than a year later, in November 2012, the FDA concluded that “bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.” The FDA based their conclusion on an analysis of data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The approach utilized by the FDA was immediately criticized by health care professionals as “problematic” and described the conclusions reached by the FDA as “tantamount to a guess.” It appears the FDA did nothing more than ineffectively attempt to provide itself political cover for approving such an unsafe drug.

The problem with Pradaxa, and its hasty approval, lies in the fact that, unlike warfarin – the drug it is compared to in both its clinical trials and television advertisements – is that it cannot be reversed. Or to put another way, it has no antidote. When a warfarin patient experiences a bleeding event or is in need of emergency surgery, health care providers have a host of options available to them to reverse the blood thinning effects of warfarin and stop or slow the bleeding event or allow for safe surgical invention. Pradaxa has no such reversal agent or antidote. What does this mean in the real world use of Pradaxa? Are more Pradaxa patients bleeding to death than warfarin patients as a result of this lack of antidote? If you look to the pivotal clinical trial, the Randomized Evaluation of Long-Term Anticoagulation Therapy (“RE-LY”) you won’t find the answer. It’s a pretty simple question. Did more patients bleed to death on Pradaxa than they did on warfarin?

More than five years since the RE-LY trial was completed and more than two years since Pradaxa was approved, we are only just now beginning to answer this question. Rather than provide an answer to this important question in the original analysis and publication of RE-LY, the makers of Pradaxa waited until December 2012, after hundreds of lawsuits had been filed on behalf of Pradaxa patients who suffered a major or fatal bleed, and released data at a medical conference in a poster abstract. Amazingly, their “new” analysis of five-year-old data showed that Pradaxa patients were 44% less likely to die as a result of a major bleed than warfarin patients. Amazing in that if this were true, why not include it in the original analysis and publication? Perhaps the answer lies in the fact that poster abstracts are not peer-reviewed or subjected to scientific or regulatory scrutiny.

Less than a month after these “amazing” results were released by the makers of Pradaxa, on January 9, 2013, the Institute for Safe Medication Practice (“ISMP”), an independent research organization, published their own analysis of this very same question: are more patients bleedings to death on Pradaxa than warfarin? Amazingly, the ISMP reached a radically different answer than the makers of Pradaxa. ISMP determined that “reported [Pradaxa] bleeds were about 5 times more likely than warfarin to result in death…” 500% more likely to die as a result of a major bleed if you are on Pradaxa instead of warfarin. This really shouldn’t come as a surprise based on what we know about the availability of a reversal agent for these two drugs. What is surprising is the total disconnect between these two studies that reportedly addressed the same question.

Simply put: One of these two new studies got it wrong. Way wrong. Is this a matter of sloppy science or perhaps is this a deliberate effort by someone, for whatever rea$on, to mislead prescribers and users of Pradaxa? Only time will tell. Stay tuned.

Florida Court Refuses To Dismiss Claim For Pregnant Woman’s Death

An appellate court in Florida refused  today to dismiss a claim for the wrongful death of a young pregnant woman while she was in the care of a mental health facility known as Park Place.  The Defendant, Osceola Mental Health, Inc., sought to have the case thrown out because the woman’s family did not sue under the Florida Medical Malpractice laws.

The patient, 25 year old Farrah Krystle Jean, went to the hospital with complaints of pain.  While there, she was transferred involuntarily to Park Place.  The involuntary commitment was done under Florida’s Baker Act, a law that allows patients to be held against their will when a court, police officer or healthcare provider believes the patient poses a serious risk of imminent harm to herself or others.

Jean complained of severe abdominal pain and other problems over the two days following her confinement. Tragically, she died at the beginning of the third day.  The family filed suit against the facility, alleging that the acts and omissions of the staff caused the death.  The court rejected the facility’s arguments that the Medical Malpractice laws had to be complied with and ruled that the case could go forward.  The court stated that mental patients have rights under the Baker Act, and the facility was not a healthcare provider as defined under the Medical Malpractice statutes.

Virginia Buchanan is a shareholder at Levin, Papantonio.  She has served on the Board of Directions of the Florida Bar Foundation and has been Treasurer of ABOTA, Chairperson of the Civil Process Server Grievance Committee and has been a member of the Chief Judge’s Council on Children. She currently is a member of the Women’s Caucus of the Florida Justice Association.

Wind Tax Credit Avoids Fall Over Fiscal Cliff

The U.S. government has managed to postpone financial calamity for a few months with the passage of a so-called “fiscal cliff” deal.  But hidden within the bill was tax credit that was considered dead on arrival – The wind energy production tax credit.

The credit has been in jeopardy since it was first introduced, with Republicans in Washington threatening to kill the tax credit, citing its estimated cost of $12.1 billion over the next decade as too costly.  However, the credit breaks down to a mere 2.2 cents per kilowatt hour of wind energy produced in America, making it one of the cheapest subsidies approved for energy projects.

The extension of the credit comes at the perfect time, as the United Nations recently released a report detailing the ways in which climate change could cause financial disasters across the globe.

Among the more dire warnings in the U.N. report is the threat of water scarcity, which could devastate commodity markets, as agriculture would take a massive hit and crops would be decimated.  So while the United States might have postponed the drop over the fiscal cliff, the threat of the environmental cliff is very real, and very much in need of addressing.

The wind production credit extension will keep the tax credit alive for the year 2013, and its fate after that remains unclear.

Farron Cousins is the executive editor of The Trial Lawyer Magazine, a contributing writer at DeSmogBlog, and the producer of Ring of Fire.  Follow him on Twitter @farronbalanced.

Medical Malpractice: “Never Events” Occur At Least 4000 Times Per Year

“Never Event” is a universally recognized term in the medical profession referring to something that should never happen during surgery, such as a retained-foreign-body (an instrument or sponge left in the body) or a wrong-site, wrong patient, or wrong procedure surgery.

According to a recently released Johns Hopkins’ medical malpractice study, “never events” occur approximately 4000 times per year in the United States:

-  retained-foreign-body occurs 39/week;

-  wrong procedure occurs 20/week; and

-  wrong-site/patient occurs 20/week.

This astonishing number only further substantiates a fact that we all should already know:  physicians, just like the rest of us, are capable of negligence.  And, just like the rest of us, when their negligence causes injuries and damages to others, physicians should be held financially accountable.

From 1990 to 2010, the study, based upon information from the National Practitioner Data Bank (NPDB), identified 9,744 paid malpractice judgments and claims resulting from “never events” with death reported in 6.6 percent of the patients and permanent injury reported in 32.9 percent of the patients.  The total compensatory payout amount of the 9,744 claims was approximately $1.3 billion.

To think, this data only accounts for “never events”.  It does not even begin to consider and account for medical malpractice claims resulting from the less egregious forms of medical negligence that occur each and every year.  Make no mistake, medical malpractice is a prevalent and unavoidable consequence of medical treatment in our society, and injured patients and their families deserve just compensation.

Cameron Stephenson is a lawyer with the Levin, Papantonio law firm in Pensacola, Florida, and handles medical malpractice and other wrongful death cases.  He has devoted his legal practice to fighting for the rights of Florida’s injured patients.

More information on medical malpractice lawsuits.

Surgical Malpractice Associated With Surgeon’s Inexperience

Although it comes as no surprise that an inexperienced surgeon may be more likely to commit medical negligence in the performance of a surgical procedure, the surprising thing is that it happens at all, given the stringent training, licensing and credentialing requirements for surgeons.  Nonetheless, surgical inexperience continues to be associated with poor patient outcomes.

Researchers have identified a number of factors associated with bad surgical outcomes. In addition to inexperience, they cite low hospital volume for some surgeries, excessive workload, fatigue, lack of optimal technology, poor supervision of staff and trainees, poor communication, emergency circumstances and even the time of day.  Fortunately, these issues can be addressed, as they are “system” problems rather than unavoidable and inherent ones.  Unfortunately, though, we have not yet found a way to require these system issues to be adequately addressed.

Just last week, a claim against a Veteran’s Hospital in Ohio was settled after a 59 year old veteran died following a simple hernia surgery.  The patient’s family discovered that the surgeon had never performed this type of surgery on his own and had only been licensed a few months when the patient had his surgery.  The claim was settled for $500,000.

Virginia Buchanan is a shareholder at Levin, Papantonio.  She has served on the Board of Directions of the Florida Bar Foundation and has been Treasurer of ABOTA, Chairperson of the Civil Process Server Grievance Committee and has been a member of the Chief Judge’s Council on Children. She currently is a member of the Women’s Caucus of the Florida Justice Association.

Obama Foregoing Chance To Change Federal Court By Inaction

The President has an opportunity to affect the makeup of the federal judicial branch through his power of appointment, yet he may not be using that power to the fullest.  There are 874 federal judicial slots which are filled upon appointment by the President and confirmation by the Senate.  That number includes all the judges who serve at the district trial court level, the circuit courts of appeal, the Court of International Trade and the nine members of the United States Supreme Court.  According to the Administrative Office of the U.S. Courts, there are currently 75 judicial vacancies, which is about 10% of the total federal district and appellate court positions.  The President has nominated people for 32 of those available slots, and they are awaiting Senate confirmation.  However, 43 of the slots are open.  27 of the existing judicial vacancies have presented what has been described as “judicial emergencies.”

Chief Justice John Roberts has expressed concern about the consequences of long term reductions in funding for the judiciary.  In the Chief Justice’s annual report to the President and Congress, he cautioned that the courts need vital resources, including an adequate number of judges, to keep up with pending cases.  He warned that a delay or denial of justice could occur if the court does not have sufficient judges and staff to do its work.

Virginia Buchanan is a shareholder at Levin, Papantonio.  She has served on the Board of Directions of the Florida Bar Foundation and has been Treasurer of ABOTA, Chairperson of the Civil Process Server Grievance Committee and has been a member of the Chief Judge’s Council on Children. She currently is a member of the Women’s Caucus of the Florida Justice Association.