The Usage Of Vicodin And Percocet et. al. Is Questioned

Acetaminophen Leading Culprit in Drug-Induced Liver Injury

Acetaminophen leads the list of drugs implicated in liver damage requiring transplantation, although antiepileptics are more lethal, according to a new study.
Action Points

Analysis of records from a transplant database found that patients with acetaminophen-induced injury were also more likely to be on life support than patients with liver failure caused by the next most common culprits, antituberculosis drugs, antiepileptics, and antibiotics (82%, versus 44% to 70%, P <0.0001), according to Ayse L. Mindikoglu, MD, of the University of Maryland in Baltimore and colleagues.

Patients whose liver failure was caused by acetaminophen also had a higher mean serum creatinine (3.21 mg/dL versus 1.31 to 1.86 mg/dL, P<0.0001), and a greater requirement for dialysis prior to transplantation (27% versus 3% to 10%, P<0.0001), the investigators reported in the July issue of Liver Transplantation.

Their report was issued just days after an FDA advisory panel recommended a “black box” warning for prescription combination drugs that contain acetaminophen. The panel also recommended that the maximum single adult dose be reduced from 1,000 mg to 650 mg, and that the maximum daily dose be reduced from its current level of 4,000 mg. (See FDA Panel Backs ‘Black Box’ Warning for Acetaminophen Prescription Combos)

As potentially hazardous to the liver as acetaminophen may be, the risk of death following liver transplantation was highest among patients whose liver injury was caused by antiepileptics, Dr. Mindikoglu found. In fact, the risk attributable to antiepileptics increased by a factor of 4.13 for patients under 18 and 1.03 for older patients.

The findings emerged from a retrospective cohort study of the United Network for Organ Sharing database, which includes almost all liver transplants in the U.S.

The records show that between October 1987 and December 2006, there were 661 liver transplantations for drug-induced injury.

A total of 567 were adults. The median age was 36, and the majority were female and white.

The implicated agents were:

* Acetaminophen in 265 (40%)
* Antituberculosis drugs in 50 (8%)
* Antiepileptics in 46 (7%)
* Antibiotics in 39 (6%)

Median survival for the whole cohort was 14.4 years, and one-year estimated survival probabilities were:

* Acetaminophen 76%
* Antituberculosis drugs 82%
* Antiepileptics 52%
* Antibiotics 82%
* Other drugs 79%

Comparison of outcomes according to age showed no overall significant differences in survival rates between pediatric and adult patients (P=0.56).

Two-year survival probabilities were 0.06 for children and .074 for adults.

But a marked difference was seen in survival following acute liver failure resulting from the use of antiepileptics, with a one-year survival of only 27% for children, compared with 75% for adults.

The high rate of death among pediatric patients with antiepileptic-induced liver failure may relate to valproic acid-induced hyperammonemic encephalopathy and carnitine depletion, the investigators suggested.

Patients whose liver failure related to antiepileptic use also had a greater frequency of retransplantation than the other groups (24% versus 4% to 9%).

Males were 1.4 times more likely to die than females, while a doubling of the serum creatinine increased mortality risk by 1.19. Patients on life support were 2.08 times more likely to die, the researchers reported.

Cox stepwise regression analysis found that independent pretransplant predictors of death were a requirement for life support, liver failure from antiepileptic drugs before age 18, and elevated serum creatinine.

The researchers proposed that those independent predictors could be used in a prognostic model for predicting post-transplant outcomes.

In an accompanying editorial, Paul H. Hayashi and Paul Watkins of the University of North Carolina wrote that this is the first study to propose a mathematical model to predict survival after transplantation for acute liver failure.

“Their attempt at modeling falls short of immediate usefulness, but the identification of poorer outcomes for children with antiepileptic [drug-induced acute liver failure] is intriguing and points out the need for more focused research,” the editorialists wrote.

They also observed that drug-induced liver failure, while a rare event, “has wide implications for all of us who take and prescribe medications,” and that in coming years significant advances can be expected in understanding of factors such as genetic predisposition.

The investigators noted that their study had limitations, “as expected from any retrospective database analysis,” such as the fact that they were unable to estimate numbers of patients who died before transplantation or spontaneously recovered.

Because they Can…

Insurers Wrongfully Charged Consumers Billions

Health insurers have forced consumers to pay billions of dollars in medical bills that the insurers themselves should have paid, according to a report released today by the staff of the Senate Commerce Committee.

The report is part of multi-pronged assault today on the trustworthiness of private insurers by Commerce Committee Chairman John D. Rockefeller IV (D-W.Va.). It comes at a time when the insurance industry is battling efforts to offer consumers a public alternative to private health plans.

Music is Treatment for Almost Anything…

Music Keeps Rhythm for Heart and Lungs

Cardiovascular and breathing rates consistently fall into step with musical crescendos and rhythms, according to a controlled clinical trial that may give impetus to new musical therapies.

Contrary to the conventional view of music as an intensely personal medium, researchers found that the same piece of music had similar cardiovascular effects on all subjects.

Taking advantage of these interactions may open the way to standardized treatments for blood pressure control and rehabilitation, Luciano Bernardi, MD, of Pavia University in Pavia, Italy, and colleagues wrote in the June 30 issue of Circulation.

Young v. Old Views of Medicine…

AMA: Delegates Still Mulling Position on Obama Healthcare Reform Plan

A day after President Barack Obama made his case for support of healthcare reform that would include a public plan option to the American Medical Association, it’s still not clear if the AMA is buying his message.

At issue is a resolution from the Kansas State Medical Society that asked the AMA to “express its opposition to ‘public option’ proposals which could result in the elimination of the private health insurance system.”

Obama would like the government to run a Medicare-like insurance option alongside private plans, all of which would be purchased through an insurance clearinghouse called the “exchange.”

But Republicans in Congress are sharply opposed to the idea, calling it a “government takeover,” that would drive private insurance companies out of business.

Last week, the AMA began to signal its opposition to a public plan and immediately found itself enmeshed in controversy as other organized medicine groups criticized the position.

A day after voicing its objections to a public option, the AMA was forced to issue a second statement — this time rebuking The New York Times for its reporting of the AMA stance.

AMA outgoing president Nancy Nielsen, M.D., Ph.D., said the AMA wouldn’t support a public plan option that requires physician involvement and pays Medicare rates.

As the public plan option was debated in a reference committee on Sunday, AMA members streamed to the “pro,” and “con” microphones in equal numbers.

There was a notable age gap, with the youngest members speaking against the resolution that would place the AMA squarely against Obama’s public plan option, while the AMA’s old guard took the contrarian’s role.

Those who opposed the Kansas resolution said it would send a message of resistance at a time when the AMA should be working with the president.

“It does give the appearance of drawing a line in the sand,” said Jacob Ryan, a member the medical student section.

“We can’t let anyone claim we weren’t part of the solution,” he said.

But another AMA member took a different stance.

“This sends the message that we’re opposed to it, and gives [us] a stronger stand to negotiate,” said Peter Lund, M.D., a urologist from Erie, Pa., who is a member of that state’s delegation.

On both sides, the AMA members said they support a system in which there are multiple insurance options — so much so that the reference committee report characterized the debate this way: “Both sides are vehemently agreeing.”

The delegates will vote on the reference committee report later today or tomorrow.

Although it is always difficult to predict which way the AMA’s diverse house will vote, in general the delegates take their lead from the reference committee, which has recommended a substitute resolution stating that the AMA supports ” ‘public option’ alternatives that are consistent with AMA principles of pluralism, freedom of choice, freedom of practice, and universal access for patients.”

But, in matters of healthcare reform the delegates have often balked at following reference committee resolutions, and another likely scenario would be a return to the original Kansas resolution.

Swine Flu is Still Out There…

WHO Declares First Flu Pandemic in 41 Years

The novel H1N1 influenza is now a full-blown pandemic, the World Health Organization said today, the first in 41 years.

“The scientific criteria for an influenza pandemic have been met,” WHO Director-General Margaret Chan, M.D., said in a Geneva press conference.

Those criteria include sustained community transmission in at least two regions of the world, but say nothing about the severity of the outbreak, Dr. Chan said.

Indeed, on the basis of available evidence, she said, the pandemic will be “of moderate severity.”

“The overwhelming majority of patients experience mild symptoms and make a rapid and full recovery, often in the absence of any form of medical care,” Dr. Chan said.

Although there have been 144 deaths, she said, “we do not expect to see a sudden and dramatic jump in the number of fatal infections.”

That said, Dr. Chan noted, influenza is highly variable and can “change the rules without rhyme or reason,” so a sudden increase in severity can’t be ruled out.

Agency officials added that the severity of a pandemic also depends on the population it attacks. In this case, poorer countries and those with a younger population might be harder hit, according to Keiji Fukuda, M.D., an assistant director-general of the agency.

The jump to phase six is no surprise, according to new CDC Director Thomas Frieden, M.D. “It was expected on the basis of the data,” he told a press conference today.

The main implication of the WHO declaration is that the virus is continuing to spread and is “likely here to stay,” he said.

But for the U.S., he said, there are few practical implications. “We have been acting as if it’s a pandemic for some time,” Dr. Frieden said, and no new initiatives are planned.

World-wide, WHO has had official reports of nearly 30,000 cases, Dr. Chan said, but that number is almost certainly an underestimate, since about half of those cases have been reported in countries — like the U.S. and Canada — with highly developed public health and surveillance systems.

The change to phase six of the agency’s pandemic preparedness scale was widely expected, as the disease continued to spread from its origins in North America.

UN officials were at pains earlier in the week, however, to emphasize that most cases of the disease are mild and that increasing the pandemic level would not mean the outbreak is causing more severe disease.

A change to phase six “does not mean that the severity of the situation has increased and that people are getting seriously sick at higher numbers or higher rates than they are right now,” Dr. Fukuda said.

Dr. Chan said it’s very likely that a second wave of the virus will hit northern hemisphere countries in the fall, and urged them to remain vigilant, even if the current outbreak appears to be waning, as it is in Mexico.

In the U.S., the CDC said, most areas of the country are seeing only a few cases of the flu, with the exceptions of New England and the New York/New Jersey region, where flu-like illness remains above baseline values.

For the U.S., Mexico, and Canada — the countries hardest hit so far — the change to phase six means relatively little, a cross-section of experts agreed.

The declaration “merely confirms the obvious — that there is community transmission worldwide,” said Pascal James Imperato, M.D., of the SUNY Downstate Medical Center in New York.

“The raising of the pandemic level is a response to statistics,” said Richard Bradley, M.D., of the University of Texas Medical School in Houston. “For us in the U.S. there is no major significance or effect of the level being raised.”

In essence, he said, “it’s been pandemic all along, nothing is different. Don’t panic. The virus is still mild.”

“Not much, if anything, will change in the U.S.,” agreed William Schaffner, M.D., of Vanderbilt University School of Medicine in Atlanta.

“The U.S. public health structure already is performing enhanced surveillance for influenza throughout the summer,” he said, and hospitals, health departments, and other agencies are revising their pandemic plans.

But, he said, other national governments, especially in the developing world, may respond by enhancing their own planning.

“This is not a surprise,” said Christian Sandrock, M.D., of the University of California Davis School of Medicine, but he said the announcement may lead to better planning for the fall flu season “when we will see these cases in higher numbers.”

Dr. Sandrock said “money and planning from a government level will be improved with this declaration,” although he cautioned it could also cause “misunderstanding and panic.”

Julie Gerberding, M.D., the former director of the CDC, said the main actions suggested by the WHO under phases five and six are identical. But she noted that some countries may have tied their national responses to the different levels, so that going to phase six might lead to “significant local, regional, or national impact.”

But she agreed with other experts that “technically, we have been in phase six for some time.”

Stephen Morse, Ph.D., of Columbia University Medical Center, said the declaration is “essentially just acknowledging the facts that already exist on the ground.”

Like other experts, he cautioned that the term “pandemic” says nothing about the severity of the disease. “As far as I can tell, nothing has really changed dramatically since yesterday,” Dr. Morse said, adding that WHO held off so long to avoid what he called “perceptual” impacts.

That was probably the right decision, according to Philip Alcabes, Ph.D., of CUNY Hunter College in New York City. Dr. Alcabes is the author of Dread: How Fear and Fantasy Have Fueled Epidemics from the Black Death to Avian Flu.

“WHO was right to be cautious about raising the threat barometer to six,” Dr. Alcabes said.

But he said officials were being disingenuous when they said the delay was to avoid panicking the public.

“In general, people don’t panic about disease outbreaks,” Dr. Alcabes said. “The problem, of which WHO is abundantly aware, is that governments do panic.”

In other words, he said, governments often use the threat of disease as a rationale for political acts, such as the “unnecessary” Chinese quarantines or the slaughter of pigs in Egypt.

“In the context of other disease outbreaks, we’ve seen border closings, travel warnings, and nutty investigations of airline passengers,” he said. “All of that is politics, masquerading as public health.”

In the long run, he said, WHO should abandon the pandemic-threat scale altogether.

“That day is probably a ways off, though,” Dr. Alcabes said. “It will take political will on the part of a lot of countries’ governments — including ones that still imagine they can ward off disease by shutting borders (or killing pigs).”

On the other hand, the move to phase six puts “everyone on the same page,” according to Gregory Poland, M.D., of the Mayo Clinic in Rochester, Minn., with the goals of:

* Communicating to individuals, health systems, and governments that there is a pandemic and altering them to be ready for potentially rapid changes and to put plans into action
* Enabling global communication and coordination
* Allowing vaccines, antiviral drugs, masks, medical assistance, and other resources to be moved to poorer countries

Among other things, the move puts pressure on governments and health officials to get ready, Dr. Poland said.

Just Like Wine…

Older Population Might Have Immunity to H1N1 Swine Flu

Older adults might have some pre-existing immunity to the 2009 H1N1 (swine) flu virus, according to the CDC.

Serological tests showed that some adults, particularly those over 60, had antibodies effective against the new strain, Jacqueline Katz, Ph.D., of the influenza division of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues wrote in the May 22 issue of Morbidity and Mortality Weekly Report.

But Anne Schuchat, M.D., interim deputy director for the CDC’s science and public health programs, cautioned against reading too much into the finding.

“We don’t know yet what that will mean in terms of actual immunity or clinical protection,” she said on a conference call with reporters.

As the worldwide H1N1 flu outbreak progresses, epidemiological evidence continues to point to a disproportionate number of infections in school-age children and younger adults.

Of the cases reported to the CDC, 64% are in 5- to 24-year-olds and just 1% are in individuals older than 65, an unusual pattern compared with seasonal influenza.

This has led to speculation that older individuals have at least some degree of pre-existing immunity, possibly from years of immunization with seasonal flu vaccines. They contained different H1N1 viruses than the current outbreak strain, or previous infection.

“The study we’re reporting today provides a little clue that’s consistent with that clinical observation,” Dr. Schuchat said.

She noted, however, that genetic testing has found that the new H1N1 virus is not a close relative to any of the other H1N1 viruses that have circulated among people.

The tests also confirmed that seasonal flu vaccine is likely to have “little or no immune benefit” in protecting against the new virus, as many researchers had suspected.

Seasonal vaccines from the past four flu seasons induced some cross-reactive antibody response to the new virus, but probably not enough to stave off infection.

“CDC does not believe that seasonal influenza vaccine would provide any meaningful protection against this novel H1N1 strain,” Dr. Schuchat said.

Agency researchers analyzed 359 stored serum samples from individuals ranging from 6 months to 64 years, before and after vaccination during flu seasons since 2005-2006. The samples were obtained during U.S. and European vaccine studies.

Both before and after vaccination, children up to 9 years had no level of cross-reactive antibody to the new virus.

Before vaccination, in up to 9% of adults ages 18 to 64, and in 33% of those older than 60, cross-reactive antibody to the new H1N1 virus was present at levels that have been associated with a 50% reduction in the risk of influenza infection or disease.

This pre-existing immunity possibly results from previous exposure to H1N1 viruses more similar to the new virus than to current seasonal H1N1 viruses — either through vaccination or infection.

After receiving a seasonal flu shot, up to 25% of 18- to 64-year-olds and 43% of individuals over 60 had cross-reactive antibody to the new virus.

Dr. Schuchat discounted the apparent booster effect following vaccination, noting that the results were based on a relatively small number of specimens and an unconventional test of antibody response to influenza.

Free Drugs for A Year to Unemployed

Pfizer Offers Year of Free Meds to Unemployed

Drug giant Pfizer said unemployed people who have been taking its branded products could receive them free for up to a year in a new program — with some exceptions.

The program, called MAINTAIN, will provide access to more than 70 Pfizer drugs including atorvastatin (Lipitor), celecoxib (Celebrex), pregabalin (Lyrica), and sildenafil (Viagra).

But the program excludes biologics, most cancer drugs, and other of Pfizer’s most expensive products.

Individuals who became unemployed after Jan. 1 of this year are eligible for the program and may sign up through Dec. 31.

Other eligibility requirements include having taken the branded Pfizer drug for at least three months prior to losing a job, having no other prescription drug coverage, and being able to attest to financial hardship.

Income prior to becoming unemployed is not a factor, Pfizer said. But participants who regain employment or prescription drug coverage will have to start paying again.

A stock analyst quoted by the Associated Press pointed out that the program is likely to prevent some current Pfizer drug customers from switching to generic equivalents.

The company said it was taking signups today, although the program would not be fully operational until July 1.

Pfizer said signups and additional information on the MAINTAIN program would be available at Pfizer Helpful Answers or by calling 866-706-2400 toll-free.

Containing the Swine Flu

Europe Tries to Contain H1N1 Flu With Drugs

In an effort to contain the H1N1 (swine) flu outbreak, European countries are using antiviral drugs “very aggressively” to prevent transmission, a World Health Organization official said.

But WHO is cautioning that most cases of the disease appear to be mild ones that won’t need hospital care or antivirals, according to Nikki Shindo, M.D., who leads the agency’s clinical team that’s responding to the outbreak.

Dr. Shindo added that there’s no evidence yet of how well the medications — oseltamivir (Tamiflu) and zanamivir (Relenza) — work against the novel H1N1 strain.

In contrast, in the U.S. and Mexico — where the H1N1 outbreak can no longer be contained — officials are using antivirals mainly for treatment of people in high-risk groups or who have severe disease.

“The circumstance in the U.S. are very different from the circumstances in a number of European countries,” according to Anne Schuchat, M.D., of the CDC’s Science and Public Health Program.

“We don’t have a situation where we can contain the virus’s geographic distribution, and our focus is on reducing illness and death and mitigating the impact this virus has,” Dr. Schuchat said.

The priority for antiviral drugs is “where we think the treatment will make a difference,” she added.

Pandemic Vaccines May Not Arrive in Time!

Pandemic Vaccines May be Too Little, Too Late

If the swine flu outbreak develops into a pandemic — and that’s a big if — the earliest the public would see a vaccine against the disease would be September, a researcher said here at the conference on Influenza Vaccines for the World.

And that’s if the government asks industry to start production today, said Klaus Stohr, D.V.M., vice president and global head of Novartis Vaccines and Diagnostics and former head of the World Health Organization’s global influenza program.

“What we have seen the last two or three days is that the current pandemic vaccine system is not ideal not only in terms of timing . . . but also in terms of vaccine production,” he said.

A Lot to Consider in Healthcare Reform

Few Hospitals Meet Mortality-Reducing Quality Goals

Most hospitals in the 2008 Leapfrog Group quality survey did not meet standards shown to reduce mortality, researchers said.

Of the 1,282 hospitals taking part in the voluntary survey, which represents 48% of urban medical centers, many are falling short of mortality-reduction measures and are not delivering care efficiently, the nonprofit’s annual report said.

“As the Obama administration and Congress consider healthcare reform options, it is clear we have a long way to go to achieve hospital quality and cost-effectiveness worthy of the nation’s $2.3 trillion annual investment,” said Leapfrog CEO Leah Binder.

The new survey comes just weeks after the Journal of the American Medical Association published a study showing that adherence to National Quality Forum safety standards — including hand washing and having a competent nursing staff — do not result in lower mortality rates. (See: Hospital Mortality Not Linked to Safe Practices Score )

But the new survey focuses on factors that are known to reduce mortality, such as physician staffing levels in intensive care units and meeting prescription order-entry standards, said Binder.

Hospitals are not doing a good job of following recognized protocols for high-risk procedures, procedures that can reduce the risk of death significantly, said Barbara Rudolph, Ph.D., of the Leapfrog Group.

The State of Economy Doesn’t Help Either!

More Americans Report Frequent Mental Distress

State of mind may have a lot to do with state of residence — people who live in Hawaii have the lowest “frequency of mental distress” (6.6%), while Kentucky residents have the highest (14.4%), according to the CDC.
Action Points

* Explain to interested patients that this report is an analysis of self-reported survey data, which need to be cautiously interpreted because the findings are subject to a number of limitations.

But overall, more Americans have been experiencing more bad days in recent years — 10.2% of adults reported frequent mental distress in the period from 2003-2006, up from 9% in 1993-2001, wrote Matthew M. Zack, M.D., M.P.H., of the division of adult and community health at the National Center for Chronic Disease Prevention and Health Promotion at the CDC in Atlanta, and colleagues.

Those findings, published online today by the American Journal of Preventive Medicine,emerged from an analysis of responses from 2.4 million adults collected by the ongoing, random-digit-dialed telephone surveys conducted by the Behavioral Risk Factor Surveillance System. The analysis was performed in 2007 and 2008.

Dr. Zack and colleagues used 14 mentally unhealthy days as the threshold to define frequent mental distress.

The final analysis included results from 3,112 counties representing all 50 states and Washington, D.C.

“For the 1993-2001 period, the smoothed [frequent mental distress] prevalence was less than 8% in 989 (31.8%) of the 3,112 counties analyzed and was ≥12.0% in 148 (4.8%) of counties,” they wrote.

By comparison, in 2003-2006, “the smoothed [frequent mental distress] prevalence was <8% in 494 counties (15.9%) and ≥12.0% in 502 (16.1%) of the counties.”

The researchers excluded counties in which there were fewer than 30 responses to this question: “Now thinking about your mental health, which includes stress, depression, and problems with emotions, for how many days during the previous 30 days was your mental health not good?”

Among the findings:

* During 1993-2001, 15 states had at least one county where the prevalence of frequent mental distress was ≥12.0% and by 2003-206 that number had doubled to 30 states.
* The prevalence of frequent mental distress tended to decrease in contiguous parts of the upper Midwest (Minnesota, Wisconsin, and Michigan), and to increase in the Four Corners area (Utah, Arizona, Colorado, and New Mexico), the Mississippi Valley (Missouri, Arkansas, Tennessee, Mississippi, and Alabama), and the central Appalachian region (Pennsylvania, Maryland, West Virginia, Ohio, Kentucky, and Virginia).
* Alabama and Kentucky were the only states that remained in the top five for frequent mental distress prevalence in both time periods — 9.8% and 12.7% for Alabama in 1993-2001 and 2003-2006 and 14.4% in both time periods for Kentucky.
* In addition to Hawaii, other states with low rates of mental distress were South Dakota, Iowa, Nebraska, and North Dakota.

The authors pointed out that the survey has a number of limitations, including the fact that “risk factors do not respect state boundaries.” Moreover, states that have large urban populations “tend to reflect the [frequent mental distress] prevalence in those areas due to their sheer numbers, potentially obscuring the detection of high or low [frequent mental distress] prevalence in less-populated areas of the state.”

Additionally, they said, because the Behavioral Risk Factor Surveillance System excludes homeless persons, people who reside in institutions, households without landlines, and those who are unable to complete the survey because of language problems, the survey might underrepresent people with frequent mental distress.

Moreover, the prevalence rates might reflect factors such as age, gender, race/ethnicity, employment status, occupation, educational background, natural disasters and a number of other factors that were not controlled for in the study.

Nonetheless, the authors concluded that because the data do indicate “potentially unmet health and social service needs, programs for public health, community mental health, and social services whose jurisdictions include areas with high [frequent mental distress] levels should collaborate to identify and eliminate the specific preventable sources of this distress.”

No financial disclosures were reported by the authors.

Primary source: American Journal of Preventive Medicine
Source reference:
Moriarty DG, et al “Geographic patterns of frequent mental distress U.S. adults, 1993-2001 and 2003-2006″ Am J Prev Med 2009;

We Have Come a Long Way…

Tort Reform Sounds Good, Smells Bad

When I came to the bar in 1959, there were a whole series of immunities, bars, evidentiary rules and canons of ethics that prevented injured people from having their day in court. These roadblocks originated around 1840 with the rise of the Industrial Revolution. At that time, the courts recognized the natural tension between the litigious nature of Americans and our burgeoning system of free enterprise. So, they set out to help big business by preventing injured people from suing.

For instance, you couldn’t sue the government because of “sovereign immunity.” Certain charitable institutions were granted immunity from lawsuits.

The law of “privity,” which meant you had to have direct contact with the party you were suing, effectively granted immunity to manufacturers of defective products. If you bought a car, and it blew up and killed your family, you couldn’t sue anyone, unless you could prove it was the dealer’s fault.

Until the 1960s, there was no uninsured motorist coverage to protect you in case you were hit by someone with no auto insurance. Then, in the 1970s, we added underinsured motorist coverage in case someone with too little insurance hit and injured you. Even with all of that insurance, if you and your wife were in a car accident and you were at fault, she couldn’t recover any compensation from your insurance company because of “spousal immunity.” You would have to bear the financial burden of your wife’s recovery.

A lawsuit on behalf of an infant had to be brought within two years after birth, regardless of the circumstances; wrongful death suits had to be rifled within 12 months, before enough investigation could be done; and recoveries that included loss of future income had to be reduced to present worth. The deck was stacked against the average person.

But with the rise of the consumer movement in the 1960s, the courts recognized the injustice of making victims bear the cost of their injuries. The great changes in liability law that ensued came about because capable and dedicated trial lawyers recognized that the law is never settled until it is right and it is never right until it is just.

Today’s “tort reformers” want to return us to the late 19th and early 20th century.

Watch that Bulge!

Bulging Waistline Boosts Heart Failure Risk

Every 10-cm increase in waist circumference raised the risk by 15% to 20%, Emily Levitan, Sc.D., of Beth Israel Deaconess Medical Center in Boston, and colleagues reported in Circulation: Heart Failure.

In women, rising BMI, independent of waist circumference, did not predict the risk of heart failure hospitalization or mortality.

Among men, however, both a greater waist circumference and greater BMI posed an increasing heart failure hazard.

“We found that waist circumference was predictive of heart failure events regardless of BMI, but there was a suggestion of an association with BMI only at high waist circumference among women,” the authors said. “In contrast both abdominal and overall adiposity appeared to be associated with heart failure events among men.

“For all participants, the strength of the association between adiposity and heart failure events appeared to weaken with age.”

The worldwide incidence of obesity and heart failure has increased in parallel, and several epidemiologic studies have associated obesity and overweight with heart failure.

Product Defect

Removing Medtronic Heart Cable

Pulling a medical device off the market is one thing. Removing it from the bodies of thousands of patients is a lot more complicated and dangerous.

Consider the Sprint Fidelis, a heart defibrillator cable. In 2007 its maker, Medtronic, stopped selling it after five patients who had the cables died.

But only now is the full scope of the public health problem becoming clear for the Sprint Fidelis, which is still used by 150,000 people in this country.

In the next few years, thousands of those patients may face risky surgical procedures to remove and replace the electrical cable, which connects a defibrillator to a chamber of the heart.

Medtronic estimates that the cable has failed in a little more than 5 percent of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed.

Already, four patients have died during extractions. Experts fear that the toll could quickly rise if such procedures are not performed by skilled doctors at medical centers that have performed many of the operations.

“I think we are just seeing the tip of the iceberg,” said Dr. Charles J. Love, a cardiologist at Ohio State University Medical Center in Columbus, who specializes in cable extractions.

For many of the patients around the country who may need the procedure, finding the right medical center will not be easy.

FDA Approval Does Not Provide Immunity

In one of the most important business cases in years, the Supreme Court on Wednesday ruled that a drug company is not protected from injury claims in state court merely because the federal government had approved the product and its labeling.

The 6-to-3 ruling went in favor of a Vermont musician, Diana Levine, who was awarded more than $6 million after losing much of her arm following a botched injection of an anti-nausea drug. It was a defeat for the Wyeth pharmaceutical company, which had asked the justices to throw out the award, and by extension other companies that might have pursued Wyeth’s line of argument in similar cases.

Drug Approval Is Not a Shield From Lawsuits, Justices Rule

One-Size-Fits-All Does Not Work in Malpractice Cases

Supporters of medical malpractice award caps continue to spread untruths regarding the state of Illinois’ health care prior to the unfair Medical Malpractice Reform Act of 2005. They claim that prior to the law’s enactment, our state was in chaos. However, the American Medical Association’s very own data included in the recent “Physicians Characteristics and Distribution” in the United States mocks this claim. Doctors, it seems, never did begin an exodus from our state, as some people boldly claim. Moreover, there has not been an explosion of medical malpractice cases. Sadly, this was all propaganda put forth by an advertising campaign paid for by the state’s largest medical malpractice insurer.

The law enacted in 2005 is nothing new in Illinois. In fact, twice before, this type of law was enacted and subsequently struck down as a violation of the Illinois Constitution. Our state’s highest court twice has decided in favor of patients and against insurance companies seeking to protect their own profits.

The case now before the Illinois Supreme Court is about a little girl named Abigaile LeBron. Abigaile is a 3-year-old girl whose life has been changed by the severe brain damage she suffered as a result of medical negligence. It is likely that Abigaile will have to be fed through a tube for the rest of her life. She never will develop cognitively or physically as her peers do. And she probably never will live independently.

The arbitrary cap that is part of the 2005 law has been castigated as a one-size-fits-all approach that does not protect those who have been most harmed by medical or hospital negligence. The caps ordain that a little girl, like Abigaile, should be entitled to the same monetary damages as someone who suffered a much lesser injury, despite the fact that she and her family will be burdened for a lifetime.

Long-supressed insurance reforms that are contained in the same legislation have resulted in the reduction of malpractice premiums. Most important, this law has forced malpractice insurance providers to provide greater transparency on rate-setting and payouts, which, in turn, has spurred competition, motivated more companies to enter the marketplace and lowered premiums for doctors.

The Illinois Constitution was put in place to ensure individual rights and freedoms to all Illinoisans, rich and poor, black and white, young and old. While corporations and profit-hungry executives often stack the deck against individuals in the marketplace and the halls of government, the courtrooms of our state still can provide all parties with a level playing field. The Illinois Supreme Court now will decided whether that constitutional standard remains in place for patients like Abigaile LeBron. We hope that the state’s highest court again will decided in favor of patients and against the big insurance companies’ profits.

Philip Harnett Corboy Jr.
ChicagoPresident, Illinois Trial LawyersAssociation

One-size-fits-all does not work in malpractice cases

Tulsa World: Beware of ‘reform’

I get nervous whenever I see the word “reform” attached to legislation. “Tax reform” meant big tax cuts for the rich, and nothing for the rest of us. “Court reform” meant we lost the right to vote for (or against) half of our judges. The latest insult, “tort reform,” is another con job. By limiting the contingent-fee percentage a lawyer can charge, this new law would make it impossible for lawyers to handle many cases, leaving injured people unable to get competent representation.You don’t see a proposal to limit fees charged by defense lawyers, do you? Of course not. The rich and powerful insurance industry hires gunslingers by the hour, and they get a big, fat check every month, while the injured plaintiff’s lawyer gets nothing (except the right to pay his overhead), month after month unless and until he secures a recovery for his client.Don’t be misled the target of this legislation is not us trial lawyers. It’s you. It’s the person injured, or the survivors of someone killed by a defective product or a negligent (but heavily insured) doctor or the negligence of some corporate employee. They don’t want to pay you, and they don’t want you represented by a lawyer who can make them pay you. They’re rich, and powerful, and can wine and dine legislators and take them on free vacations in their corporate jets. Injured people have no organizations; they have no lobbyists; they have only their trial lawyers.Tell your legislator to oppose tort “reform.”

Tulsa World: Beware of ‘reform’

Law professor disputes “hellhole” ranking

A Southern Methodist University law professor says it’s doubtful that West Virginia’s judicial climate is as bad as some groups claim.Elizabeth Thornburg said reports from groups such as the American Tort Reform Association and the U.S. Chamber of Commerce’s Institute for Legal Reform that routinely rank West Virginia as a “judicial hellhole” has more to do with pushing the groups’ agendas than the actual state of West Virginia’s legal system.Thornburg also pointed to the Chamber’s starting publications — such as The West Virginia Record — which she said are meant to push that agenda, which many have characterized as working to slant state courts to favor business in personal injury lawsuits.

West Virginia Record | Law professor disputes “hellhole” ranking

Recall of Peanut Butter Frozen Cookie Dough

MINNETONKA, Minnesota — January 30, 2009 – Best Brands Corp. today announced that it is expanding its voluntarily recall of peanut butter frozen cookie dough as a precaution because the dough contains peanut products manufactured by Peanut Corporation of America (PCA). PCA is the focus of an investigation by the U.S. Food and Drug Administration (FDA) concerning a recent Salmonella outbreak. In response to PCA’s recently expanded recall, Best Brands Corp. is expanding its peanut butter frozen cookie dough recall to include all product manufactured since January 1, 2007.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare cases, infection with salmonella can result in the organism getting into the bloodstream and producing more severe illnesses, such as arterial infections (i.e. infected aneurysms), endocarditis and arthritis. For more information on Salmonella, please visit the Centers for Disease Control and Prevention’s website at http://www.cdc.gov.

Best Brands Corp. Expands Voluntary Recall of Peanut Butter Frozen Cookie Dough

Looks Like There Will Be Litigation

Initially, we had a discussion in my office and some attorneys believed there would be no litigation since this was simple as act of God and not negligence. Believing that airplanes just simply do not fall from the sky absent negligence I disagreed.

Well, it looks like I may have been right! We will see how this story develops.

Passengers report scare on earlier US Airways Flight 1549

Two days before US Airways Flight 1549 crashed into the Hudson River, passengers on the same route and same aircraft say they heard a series of loud bangs and the flight crew told them they could have to make an emergency landing, CNN has learned.

Just For Fun!

Barack Obama and a plunger: He might not want to remember this photo

Before he was even a senator, let alone president-elect, then-unknown Barack Obama was, at a 2003 St. Patrick’s Day parade, a plunger wrangler. (Photo courtesy Mats Selen)

Shifting The Blame Onto the Victim is Not the Answer

The Medical Malpractice Myth, by Tom Baker (Everyday Citizen)

Medical malpractice law traces its roots back to 19th Century English common law. The law that developed concerning medical malpractice is part of the more general body of law dealing with injuries to people or property, known as “tort law.” Medical malpractice cases are an example of one particular type of tort, the tort known as “negligence.”

The concept of negligence is that people should be reasonably careful in what they do, and, if they are not, they should be held responsible for the injuries that can be reasonably foreseen as resulting from their negligent conduct.

Even though a series of major reports from the Institute of Medicine and others have pointed out serious deficiencies in the quality of medical care delivered in this country, with high rates of medical error causing harm or death, the talk in Congress and in the White House is not about quality of care or protection of patients.

Instead, the talk in Washington DC seems obsessed with tort reform. Medical malpractice law and insurance have become popular topics for debate in Washington, DC and around the country. Why?

Any Which Way One Looks at it: Tort Reform is a Hoax!

‘Tort reform’ not the answer for state’s fiscal crisis – The Delaware County Daily Times

“Tort reform” doesn’t work. Texas is the national model for so called “tort reform,” but medical-malpractice insurance premiums there only went down by 1.2 percent. In our state, because of a more competitive market, doctors saw their insurance bills go down by an average of 10.2 percent.

The doctors are not leaving our state. The number of doctors here has steadily grown since 1992 by 5,322. Lawsuits are down dramatically, as are verdicts.

“Tort reform” leads to unsafe health care. What is even more ironic is the quality of health care in Texas has declined precipitously in the past year. According to a just-released study by the United Health Foundation, it fell behind six other states compared to the past year’s ranking.

More on Tort Reform

Limits are unfair to malpractice victims

The fact is that the positive climate for doctors has resulted from strong, long suppressed insurance reforms, which were included in the legislation. That law has forced malpractice insurance companies to provide greater transparency on rate-setting and payouts that has, in turn, spurred competition, motivated more companies to enter the marketplace, and lowered premiums for doctors. Important to the discussion is the additional fact that Illinois’ largest malpractice insurer has reported that payouts have remained flat for the past 13 years. That same insurance carrier admitted in legislative hearings in 2005 that capping awards would not guarantee lower premiums for doctors.

Search for Food Recalls

Which foods are dangerous?

This database contains all allergy-related food recalls by the U.S. Food and Drug Administration and the U.S. Department of Agriculture from Oct. 1, 1998 through Oct. 1, 2008 — about 2,800 total. Also included are New York state alerts publicized by the FDA.

A Step in the Right Direction

No More Goodies for Doctors

Last year, besides giving away nearly $16 billion in free drug samples to doctors, pharmaceutical companies spent more than $6 billion on “detailing” – an industry term for the sales activities of drug representatives including office visits to doctors, meal-time presentations and branded pens and other handouts, according to IMS Health, a health care information company.

The industry code also permits drug makers to pay doctors as consultants “based on fair market value” – which critics say means that companies can continue to pay individual doctors tens of thousands of dollars or more a year.

“We have arrived at a point in the history of medicine in America where doctors have deep, deep financial ties with the drug makers and marketers,” said Allan Coukell, the director of policy for the Prescription Project, a nonprofit group in Boston working to promote evidence-based medicine. “Financial entanglements at all the levels have the potential to influence prescribing in a way that is not good.”

About 40 drug makers, including Eli Lilly & Company, Johnson & Johnson and Pfizer, have signed on to the code. Representatives of several pharmaceutical makers said their companies intended to comply with the guidelines, but they declined to discuss past marketing programs involving branded gifts.

Nothing Special About Your Head…!

Six Homespun Medical Myths Debunked

Drs. Vreeman and Carroll generated a list of six popular beliefs associated with either winter or the holiday season and searched the medical literature for evidence one way or another.

It turns out that:

* Holiday sweets don’t make the kids more hyperactive.
* Suicides don’t go up over the holidays.
* Poinsettias aren’t poisonous.
* Avoiding eating at night won’t keep the pounds off.
* The only way to cure a hangover is not to get one in the first place.

Oh, and the hat thing. The roots of the myth probably lie in military tests, in which volunteers were dressed in arctic survival suits but no hats. When researchers measured heat loss, most of it — for obvious reasons — was from the unprotected head.

But if the myth was true, the researchers said, “humans would be just as cold if they went without trousers as if they went without a hat.”

Increasing the Numbers of the Uninsured

When a Job Disappears, So Does the Health Care

About 10.3 million Americans were unemployed in November, according to the Bureau of Labor Statistics. The number of unemployed has increased by 2.8 million, or 36 percent, since January of this year, and by 4.3 million, or 71 percent, since January 2001.

Most people are covered through the workplace, so when they lose their jobs, they lose their health benefits. On average, for each jobless worker who has lost insurance, at least one child or spouse covered under the same policy has also lost protection, public health experts said.

Expanding access to health insurance, with federal subsidies, was a priority for President-elect Barack Obama and the new Democratic Congress. The increase in the ranks of the uninsured, including middle-class families with strong ties to the work force, adds urgency to their efforts.

“This shows why — no matter how bad the condition of the economy — we can’t delay pursuing comprehensive health care,” said Senator Sherrod Brown, Democrat of Ohio. “There are too many victims who are innocent of anything but working at the wrong place at the wrong time.”

FDA Contradicts Itself

With the FDA having become a politicized entity, I am not sure I can trust any of its findings and especially when they contradict itself. So which is it: melamine and cyanuric acid in baby formula is OK or not OK?

FDA Discounts Danger From Melamine in U.S.-Made Infant Formula

Levels of melamine found in a sample of U.S.-made infant formula do not pose a safety risk, the FDA said.

The agency detected trace amounts of the toxic chemical in a single sample of Nestle Nutrition’s Good Start Supreme Infant Formula with Iron.

Melamine was found in concentrations of 137 and 140 parts per billion. In an updated risk assessment, the FDA said that concentrations less than 1,000 parts per billion do not raise safety concerns. Earlier the FDA had said no level of melamine was safe. (See: FDA Says No Safe Level of Melamine in Baby Formula)

Agency testing also found cyanuric acid — a chemical relative of melamine — at concentrations of 247, 245, and 249 parts per billion in a single sample of Mead Johnson’s Enfamil Lipil with Iron. Levels below 1,000 parts per billion are considered tolerable, according to the updated risk assessment.

The FDA is still awaiting results from 13 of the 87 samples tested.

Report Ties Children’s Use of Media to Their Health

Full Story Here

Dr. Emanuel, Mr. Steyer and others plan to brief Washington policy makers on the study on Tuesday. Joined by researchers at Yale University and California Pacific Medical Center, Dr. Emanuel’s team analyzed almost 1,800 studies conducted since 1980 and identified 173 that met the criteria the researchers set.

In a clear majority of those studies more time with television, films, video games, magazines, music and the Internet was linked to rises in childhood obesity, tobacco use and sexual behavior. A majority also showed strong correlations — what the researchers deemed “statistically significant associations” — with drug and alcohol use and low academic achievement.

The evidence was somewhat less indicative of a relationship between media exposure and attention-deficit hyperactivity disorder, the seventh health outcome that was studied.

Dr. Emanuel, whose brother, Rahm, is the president-elect’s chief of staff, said he was surprised by how lopsided the findings were. “We found very few studies that had any positive association” for children’s health, he said.

Abusive Character and Medical Malpractice

Arrogant, Abusive and Disruptive — and a Doctor

It was the middle of the night, and Laura Silverthorn, a nurse at a hospital in Washington, knew her patient was in danger.

The boy had a shunt in his brain to drain fluid, but he was vomiting and had an extreme headache, two signs that the shunt was blocked and fluid was building up. When she paged the on-call resident, who was asleep in the hospital, he told her not to worry.

After a second page, Ms. Silverthorn said, “he became arrogant and said, ‘You don’t know what to look for — you’re not a doctor.’ ”

He ignored her third page, and after another harrowing hour she called the attending physician at home. The child was rushed into surgery.

“He could have died or had serious brain injury,” Ms. Silverthorn said, “but I was treated like a pest for calling in the middle of the night.”

Her experience is borne out by surveys of hospital staff members, who blame badly behaved doctors for low morale, stress and high turnover. (Ms. Silverthorn said she had been brought to tears so many times that she was trying to start her own business and leave nursing.)

A Bit of Humor

Do your exercises.

Begin by standing on a comfortable surface,
where you have plenty of room at each side.

With a 5-lb potato sack in each hand, extend your arms straight out from your sides and hold them there as long as you can.

Try to reach a full minute, and then relax.

Each day you’ll find that you can hold this position for just a bit longer

After a couple of weeks, move up to 10-lb potato sacks.

Then try 50-lb potato sacks.

Then eventually try to get to where; you can lift a 100-lb potato sack in each hand and hold your arms straight for more than a full minute.

(I’m currently at this level.)

After you feel confident at that level,
put a potato in each sack.

President Barack Obama

November 4, 2008

Broken System… Yes, But Which One?

In the same line, I am sure everyone has heard that a large portion of the $700B bail out package passed by the Congress to give more liquidity to the financial institutions are ear marked to go for executive bonuses and paying out dividend to shareholders… And they blame trial lawyers for all the ill we are facing.

The Institute for Legal Reform is Full of it.

In the case of so-called lawsuit abuse, what the ILR does not mention is that America’s economic crisis is happening right now as a result of the deregulation of the financial industry, or in other words, the accountability-free zone the Bush administration has given to America’s largest businesses to screw around in. The corruption and greed that now runs rampant in these businesses, and which both parties recognize as the ultimate root of the financial crisis, has grown to its cancerous proportions not because of lawsuit abuse, but because of tort reform, which has already given our biggest businesses carte blanche to risk—and lose—the jobs, retirement plans, and life savings of everyday Americans without the threat of legal consequences.

Let’s all recognize the ILR’s “Broken System” (BS) for what it is.