Dr. Barry Gustin - Medical-Legal Expert Services

An FDA panel has voted against the current version of the opioid risk evaluation and mitigation strategies (REMS) plan. Such a plan is critical to curb the misuse, abuse, and accidental overdoses related to these agents and to ensure opioids are used appropriately. However, experts feel the proposed approach does not go far enough to protect patients.  It is unclear if the FDA agrees with this.

Drug overdose death rates in the United States are at an all-time high. According to some reports, there are more deaths from oral opioid overdoses than from heroin and cocaine overdoses combined. In some states, these rates are higher than deaths from automobile accidents. In addition to the clear human costs, an estimated 60% of hospital costs related to opioid overdoses are paid for with public funds.

This is clearly a risk management problem that needs urgent attention.  Over the past year I have seen a dramatic increase in medical malpractice and toxicology litigation in this area.

To read the entire report, please CLICK HERE.

Recently the FDA finally agreed to step into the foray regarding infusion pumps because of increasing reports of preventable death, leading to more and more medical malpractice actions.  Infusion pumps have been increasingly involved in adverse patient outcomes that lead to medical malpractice suits and very large settlements or verdicts.  Infusion pumps pump medications and solutions, and when they don't function properly, patients can be overdosed, leading to death or disability.  In fact, in the past 5 years the FDA has received reports of 710 patient deaths associated with malfunctioning infusion pumps.

To read the entire NY Times article, CLICK HERE.

A special advisory panel recently concluded that the drug Avastin, the world's best selling cancer drug, is useless for breast cancer.  This panel has now recommended that the Food and Drug Administration revoke its approval for this indication.  This expensive drug has been a go-to drug for breast cancer patients for the past few years. 

Unfortunately, studies now show that there has been no benefit, only false hope. This announcement may inevitably lead to an increase in product liability or medical malpractice lawsuits.  Attorneys practicing in this area of law should educate themselves according.

To read the full NY Times article, CLICK HERE.

Lead poisoning among young children, which can cause learning and behavior problems, has decreased so sharply in recent decades that it is tempting to consider it a toxicology problem of the past. The Centers for Disease Control and Prevention was so confident about the decline in childhood lead poisoning that it set a goal of 2010 for eliminating it. Personal injury cases have decreased in recent years.

But federal health officials now say eradication may still be years away because hazards remain in often poor urban pockets — mostly from old, badly maintained housing with lead-based paint.

If the remaining cases are to be tackled effectively, local laws must be strengthened and enforcement increased, experts say.  To read the entire NY Times article:  Click Here.

A new analysis of reviews and articles about the controversial diabetes drug Avandia has found substantial unfounded and unsupported bias in the testifying medical experts who were hired by GlaxoSmithKline, the makers of Avandia, to analyze and discuss the drug's safety and efficacy.  Often, medical expert witnesses with favorable opinions about the drug were paid not only by GlaxoSmithKline, but also by its competitors.  Of those who offered favorable views, 87% had potential conflicts with Glaxo.  Among those who had unfavorable opinions about the drug, only 20% had received money from Glaxo.

Click here to read the entire NY Times article.

When medical devices or equipment fail, product liability lawsuits are often filed in order to recover from the victims or victims in class action.  Medical and technical expert witnesses have always disputed who is to blame:  negligent product formulation, negligent product manufacture, negligent labeling, negligent dispensing, or negligent usage.  But a cardiology product liability case has galvanized healthcare providers into raising the fundamental question about medical safety and the law: who should be held accountable when a company sells a flawed product that can injure or kill patients?  Is it the company or the people who run it?

The legal case that grew from the cardiologist's revelations involves heart defibrillators once made by the Guidant Corporation, which is now a division of Boston Scientific. Guidant continues to sell the devices even after it discovered that some might short-circuit and fail.  The defibrillators, which are known to life saving devices, have been associated with at least six deaths, including that of a 21 year old patient.

A federal judge will soon consider an agreement with Guidant in which the company would plead guilty to two criminal misdemeanors and pay a $296 million fine.  While the Justice Department is hailing this outcome, the cardiologists aren't, because nobody is being held accountable.  Read about the actions these cardiologists are taking to bring the people who run Guidant to justice.

Click here to see the entire NY Times article.

I have previously written about medical malpractice and hospital malpractice actions stemming from mistakes made while delivering radiation therapy.  Last week the FDA finally said that they will take steps to reduce radiation overdoses, underdoses, and other errors associated with radiation therapy.  The way they will do this is by strengthening the agency's approval process for new radiotherapy equipment.  Unfortunately, these new regulations do not yet address existing radiotherapy equipment.

To read the news article: click here

Traumatic brain injuries (TBIs) have increased 21% since 2004, whereas the population has grown only 6.3%, according to new data from the Centers for Disease Control and Prevention (CDC). In particular, TBIs are increasing among children as more become active in sports and among the elderly as that demographic grows.

The new report is an update of the CDC's landmark 2004 report on the impact of TBI in the United States. Researchers led by Mark Faul, PhD, a behavioral scientist in the CDC's Injury Center Division of Injury Response, analyzed data from 2002 to 2006 and found that 1.7 million deaths, hospitalizations, and emergency department visits related to traumatic brain injury (TBI) occur in the United States each year.

An interesting finding from this report is that TBI was a contributing factor in 30.5% of all injury-related deaths.

The study showed that there were 52,000 deaths and 275,000 hospitalizations annually during the study period. Almost 1.4 million, or 80%, of the people who sustained a TBI were treated and released from an emergency department.

Children, Adolescents, Elderly Most at Risk

According to the new report, called "Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations, and Death," the groups at highest risk for TBI are children from birth to 4 years of age, adolescents aged 15 to 19 years, and adults 65 years and older. Falls were the leading cause of TBI (35.2%), and rates were highest for children from birth to 4 years and for adults 75 years and older.

The data show a 62% increase in fall-related TBIs seen in emergency departments among children 14 years and younger from 2002 to 2006. However, there was no increase in deaths, and there was a decrease in hospitalizations.

Although it is difficult to determine the exact cause of the increase in TBIs among American children aged 14 and younger, the large increase in emergency department visits for children from birth to age 14 from 2002 through 2006 may explain the increase. In addition, public awareness that TBI is a treatable injury may be an important factor as well. We also think that since more children are participating in organized sports, more sports-related injuries occur in this age group than we have seen before.

The increasing numbers of persons 65 years and older is also driving a portion of the TBI increase. CDC has been monitoring the increase in falls among this population in recent years. The study found that increases in senior falls are probably due to people living longer, increase in sedentary lifestyle that contributes to a lack of agility, and an increase in the use of prescription medication.

Evidence-Based Recommendations

Dr. Faul referred clinicians to the CDC's evidence-based recommendations on the Injury Center Website (http://www.cdc.gov/HomeandRecreationalSafety/Falls/adultfalls.html) to help older adults and caregivers reduce the potential for falls through exercise, health checks, and home safety evaluation.

Traffic accidents were the second leading cause of TBI among all age groups (17.3%) and caused the largest percentage of TBI-related deaths (31.8%). In every age group, TBI rates are higher for males than for females.

This report not only presents TBI numbers, it helps to show the impact of this injury nationwide. These data can help to impact the lives of millions of Americans as they serve as building blocks that guide TBI prevention strategies. They also help to identify research and education priorities and support the need for services among individuals at risk or living with a TBI.

The current report shows an increase in TBI in the United States. Falls are the leading cause of TBI. Even though hospitalizations for TBI have increased, TBI-related death remains stable. This suggests improved treatment strategies for the treatment of TBI; but specific research is needed to verify this.

To download a free copy of the report, go to http://www.cdc.gov/traumaticbraininjury/tbi_ed.html.

Faul M, Xy L, Wald MM, Coronado VG. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations and Deaths 2002-2006. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control; 2010.

Some of the nation’s leading orthopedic surgeons in expert witness testimony have reduced or stopped use of a popular category of artificial hips amid concerns that the devices are causing severe tissue and bone damage in some patients, often requiring replacement surgery within a year or two.

In recent years, such devices, known as “metal on metal” implants, have been used in about one-third of the approximately 250,000 hip replacements performed annually in this country. They are used in conventional hip replacements and in a popular alternative procedure known as resurfacing.

To read the entire article: Click Here  

The report notes that over the last several decades, the role of the ED has expanded from primarily treating seriously ill and injured patients. The report recognizes that EDs now also provide urgent and unscheduled care to patients unable to access their providers in a timely fashion and provide primary care to Medicaid beneficiaries and uninsured patients. As a result, EDs are frequently overcrowded with the most common contributing factor being the inability to transfer ED patients to an inpatient bed once the decision is made to admit them. "As the ED begins to 'board' patients, the space, the staff, and the resources available to treat new patients are further reduced," the report states. It continues, "A consequence of overcrowded EDs is ambulance diversion, in which EDs close their doors to incoming ambulances. The resulting treatment delay can be catastrophic for the patient."

To read the complete article: Click Here