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October 2007

October 30, 2007

CPSC: "Don't give us resources"

      President Bush's appointment to head the Consumer Product Safety Commission has spearheaded an effort in Congress to defeat legislation that would increase the agency's budget and staffing.  Its budget has been dramatically decreased during the Bush years, at the same time that significant questions have been raised about the safety of consumer products including Chinese imports like children's toys and jewelry, toothpaste, baby cribs and SUV tires--all of which have been the subject of major recalls. 

        The proposed legislation would increase the CPSC's budget and enhance its regulatory duties and powers to include the ability to block unsafe products and to police the marketplace.  It would increase CPSC staffing by about twenty percent.  Consumer advocates were "stunned" by the agency's written rejection of enhanced resources that it had applauded previously.

Continue reading "CPSC: "Don't give us resources"" »

October 29, 2007

Helmet safety and concussions

        Injuries to NFL football players have kept the issue of concussion and closed head injury in the public eye.  Because of the recent retirement of the Kansas City Chiefs' quarterback (and past retirements of well-known players such as Steve Young), the public has become better educated about the potential long-term effect of multiple concussions.  It is estimated that more than ten percent of all high school football players suffer a concussion each season.  As the size and speed of the game increase, the rate of head injury also increases.

          Studies have shown that while many high schools attempt to refurbish helmets regularly, this process is haphazard and often does not include the padding in helmets.  In a recently documented case, a high school athlete suffered permanent deficits after sustaining a hard blow in a helmet that turned out to be more than twenty years old with the original padding.  Surveys have shown that this is not uncommon, and while football helmets are designed for multiple impacts (unlike bike helmets, for example) they do not have an unlimited life.

        A former Harvard quarterback has developed a new helmet that may revolutionize football helmet safety.  The so-called Xenith helmet has passed several testing requirements alrady and may be marketable at a reasonable price (initially $350.00).   One safety expert, Dr. Robert Cantu calls the helmet "the greatest advance in helmet design in at least 30 years."   Probably not all players would be assigned this helmet initially, however, it would be available for young men who have already suffered one concussion.  A company called SportSoft now maerkets tracking stickers to help equipment managers to better monitor each helmet's age and history.  Other companies (Simbex and Schutt) are also marketing specialized helmets that may improve safety, and for $1,000.00 Riddel sells a helmet that would help safety personnel to identify players who should not return to a game after a severe impact.

Air travel safety and NASA

          Over a four-year period, NASA conducted 24,000 interviews with airline and general aviation pilots to assess risky incidents such as near-collisions or last-second changes in landing instructions.  The data was so ugly that NASA has refused to make it public, as it "could materially affect the public confidence in, and the commercial welfare of" the flying industry and public.  Did they think that refusing to release this information to us would have a laudatory effect?  More importantly, though, doesn't the public have "the right to know"?  How is it that a Republican administration has adopted such a "big brother"-ly attitude toward the information that it has collected with its citizens' money?

          This data may not be reliable.  We should be able to examine that question.  We should be able to make our own, informed decision about when and how we will fly.  If this information is reliable, it should be available for outside-government experts to evaluate:  Wisdom is not limited to government sources, and it is entirely possible that outside experts would derive information from this data which would make air traffic control safer for everyone.  It is a sign that the government is too cozy with big business when it refuses to make this information available to everyone.

October 24, 2007

Pain and sleep

        The New York Times reported on October 23, 2007, that a sleep researcher from the Johns Hopkins School of Medicine had conducted a new study that shed light on the relationship between pain and sleep.  Michael Smith explained that three groups of healthy young students were subjected to variable amounts of sleep disturbance or deprivation.    He found that "fragmented sleep" led to severe impairments the following day in pain pathways.  The subjects "felt pain more easily, were less able to inhibit pain, and even developed spontanteous pain" such as mild backaches and headaches. 

        Timothy Roehrs, director of sleep disorders research at the Henry Ford Hospital corroborated these findings in a separate study of fragmented sleep, and also demonstrated that "getting more sleep...had the opposite effect."  Study participants in the sub-group who stayed in bed a minimum of ten hours per day demonstrated reduced sensitivity to pain "to the same degree as [if they had taken] a tablet of codeine".

Worker safety at BP

  The New York Times today reported that British Petroleum is expected to settle accusations of criminal responsibility for the explosion and fire of 1990 that killed 15 workers and injured 80 more.  Government officials report that they will continue to investigate the responsibility of BP executives.  BP reported 4.4 billion dolars in profit for the most recent quarter, beating analyst expectations and proving that crime can pay if lives are cheap and we don't include environmental degradation in the equation.  Perhaps that equation will be re-balanced eventually, as BP faces more than 1,000 civil lawsuits for injuries and property damage, and the company has already set aside nearly 2 billion dollars to satisfy the claims. 

        Earlier in the year, a federal safety panel attributed the explosion to safety deficiencies "at all levels" of the plant  and found that the BP executives had ignored warning signs of impending disaster.  BP has pledged to spend a billion dollars to remedy safety problems at the Texas City plant.  To date, no one has reported that the Bush Administration intends to introduce legislation to protect American refineries from frivolous lawsuits, but that step wouldn't surprise us.  That seems to be the next step whenever a negligent contributor to the incumbents finds itself facing legal exposure of a level that makes it uncomfortable. 

        Next thing you know, we'll find out that BP actually earned higher profits after the output of this refinery was cut in half by the explosion:  because the huge reduction in supply increased prices in the industry and paying workers comp to the maimed and widowed was cheaper than paying to actually produce oil.

       

Hamburger recall

    One of the larger meat producers supplying Wal-Mart with frozen hamburger patties cranked up its  production during the summer of 2007 after it was purchased by a private equity firm which installed new managers.  The Topps Meat company (now out of business) began to cut safety corners as it was squeezed between the high summer demand and Wal-Mart price concessions, and ultimately it distributed three large batches of meat contaminated by E-coli.  More than forty people were made ill and 21.7 million pounds of beef were recalled.

         The Company had been family-owned for 67 years before it was sold to the private equity firm in 2003.  It didn't take long for the new ownership to exact a price in quality and safety, in the name of enhanced profits.  Escherichia coli is normally not dangerous, however if the bacteria is the strain 0157:H7, it can cause severe diarrhea, kidney failure and death.  The New York Times reported that the government estimates that up to 73,000 Americans per year are made ill by this strain of E. Coli--which is the underlying basis for recent recommendations on more complete cooking of beef.

        In recent years, American beef, in particular, is showing up with higher levels of E. Coli and American distributors are also purchasing more beef from abroad.  The Agriculture Department has refused to institute regulations on the meat packing industry, instead relying upon the industry to police itself.  Topps' recall is the 16th of 2007 in the United States.  After-the-fact, the Ag Department concluded that Topps did not conduct the testing necessary to protect its consumers and became lax in safety and pathogen-eliminating procedures as it attempted to ramp up production.  Practices including failing to test incoming beef and mixing untested beef with other production runs have been identified.  The Industry's 2002 "Guidelines" were not being followed.  None of these problems was identified in daily on-site visits by the Ag Department inspectors.

        The anti-regulation Bush Administration has agreed to "conduct a nationwide survey of what meat plants are doing to fight E.coli", according to "undersecretary for food Safety", Dr. Richard Raymond, responding to claims that the Ag Department was a "toothless tiger".  In the case of Topps, the first E.coli problem surfaced in the summer of 2005, when the Company promised to make safety-related changes, including more thorough meat-testing.  During the next two years it received citations for "persistent cleanliness problems" but the Ag Department claimed these citations are "routine";  think about that the next time the wait-staff asks you how you want your burger cooked.  The Ag Department did not become seriously concerned until 2007, according to Dr. Raymond [I'm betting its a Ph.D.], when " a lot of the policies they had had in place were not being followed."  Its records were so poor that no one could determine whether any of the meat it had produced in the past year was safe. 

        With government supervision such as this episode demonstrates, the Republican "Starve-the-beasters" are confirming their claim that government is of little practical value--at least when it is run by people who consider that the only value of government is as an opportunity to do private favors for friends.

October 19, 2007

Childrens' cold and cough medicines

On October 18, the FDA heard testimony from pediatric experts recommending that it ban some of the 800 pedicatric cough and cold products, containing combinations of 39 different drugs.  The pediatric experts agree that the medicines are largely ineffective in young children and can be dangerous for several reasons.  The drug industry would only acknowledge that deaths can result from accidental overdose and resisted the call to ban the products, preferring to limit the FDA to a call for voluntary educational services.  Pediatric medical witnesses pointed to the aggressive marketing of the medicines, often with infants depicted on the packaging, and the circumstances of delivery of the medicine (often in the middle of the night, in the dark, with one or more ill family members) and re-stated their opinion that educational programs would not be effective or adequate.

        As expected, on October 19, the FDA panel considering this issue called for a ban on childrens' cold medicines for use in children under six.  They acted on reports of rare but serious harm suffered by children, and the fact that there is no evidence that the medicines reduce cold symptoms in young children.    The vote to ban the medicines in children two and under was 21 to 1.  The vote to ban these medicines in children aged two through five was only 13-9, with most medical experts supporting the ban.   A consumer representative voted against the ban among older children because some of her friends use the medication to help their children sleep when ill.  Numerous medical speciailists and their academic societies also supported the ban.

October 16, 2007

Cancer death rates

  The American Cancer Society recently announced data that showed a continuing decrease in cancer deaths in the United States.    Death rates have been dropping, on average, by more than one percent per year since 1993, and by two percent the past few years, according to researchers.  In the U.S., one percent means 5,000 lives saved.  Researchers attributed the improvement in survival to mundane improvements in prevention, early detection and treatment and pointed in particular to decreased smoking and increased use of screening tests such as mammograms and colonscopies.  Unfortunately, the data also shows that poverty, lower education levels, lack of insurance or access to medical care have resulted in higher cancer rates for some insular groups, including Native Americans.

        Cancer remains the second-leading cause of death in the U.S., after heart disease.   A 2002 study that linked breast cancer to the use of hormone therapy after menopause and resulted in a significant reduction in hormone therapy is considered to have resulted in a signficant reduction in the incidence of breast cancer.  Lung, liver and esophageal cancers are still occurring at a higher rate than previously, among select populations.

        The spokespersons commenting on the data emphasized the impact of available health insurance in the fight against cancer.  The one most common denominator separating good outcomes from bad outcomes appears to be the availability and affordability of standard screening methods.

Problems with food safety in the U.S.

  The McClatchy-Tribune Company reported on October 14 that  while our nation's top food safety officials were in Miama setting the "course for the next 100 years of food safety", the handful of boots left on the ground at the USDA were initiating a recall of 21.7 million pounds of hamburger.  While our national government is spending billions on the "war on terror" and in particular making enemies by attempting to police a civil war in Iraq, it is continuously stripping every other element of the Federal government of the workers needed to protect our citizens.

        The "starve the beasters" have used a combination of tax cuts and budget cuts to strip the number of inspectors in the USDA (and many other branches of government, including the Consumer Product Safety Commission and the Occupational Safety and Health Administration), resulting in glaring problems  with safety in our food supply.  This recent embarrassment started in September when consumers in New York and Florida fell ill from E.Coli exposure.  By the time 32 people had been poisoned, inspectors had finally traced the problem to New Jersey-based Topps Meat Company.  A full 18 additional days passed, however, before Topps was forced to recall a FULL YEAR'S PRODUCTION:  apparently the problem that lead to the E.Coli poisoning had existed for that many months without being identified.   Inspectors who insisted on anonymity to avoid retaliation told the paper that managers are doubling and tripling their workload as a result of downsizing that has left the agency under-staffed [and over-managed in Miami, apparently].

Recall of defibrillator leads

  Once again, the activism of Dr. Robert G. Hauser, a cardiologist at the Minneapolis Heart Institute, has improved safety for cardiac patients worldwide.  Dr. Hauser published an analysis earlier this year that suggested problems with the leads in Medtronic defibrillators, and unnecessary, painful firings of the defibrillator.  Dr. Hauser's research had previously resulted in the recall of malfunctioning defibrillators manufactured by Guidant Corp.  Dr. Hauser brought his findings to Medtronic's attention earlier this year, but was told that there was insufficient data to support a recall or reach any conclusion.  Data from other clinical trials has since corroborated Hauser's concerns and resulted in the decision to halt sales.

        It turns out that the small wire leads on Medtronic defibrillators were showing a pattern of stress failures that had already resulted in five documented deaths by the time Dr. Hauser's research was published.  Medtronic has now begun urging doctors to use a different, larger implanted lead and indicated a willingness to pay a limited amount ($800.00) to re-implant fractured leads in uninsured patients.  Medtronic is unwilling to voluntarily replace defective leads which have not yet fractured, however.

        Approximately a quarter million patients have the small diameter "Fidelis" lead implanted, and Medtronic estimates that 4 to 5 thousand of these patients will experience a lead fracture in the next 30 months.   It is far more dangerous to replace these leads than it is to replace a defibrillator.  The leads Medtronic was using prior to 2004 are larger in diameter and have not demonstrated a history of failure.  The two other manufacturers of defibrillators claim that they have not experienced similar difficulties, due to the use of different materials or larger diameter leads.

        According to FDA records, one patient death was linked to a lead failure in August of 2006.  Two additional deaths were identified in FDA records in January and March of 2007.  A Medtronic spokesman confirmed that it had identified two additional deaths since March.

        While Medtronic acted more quickly than Guidant responded to similar problems several years ago, it still responded more slowly than it should have.  The defibrillator market is a six billion dollar business and each implant costs $30,000.00 or more.  Medtronic, with 12 billion dollars in sales in 2006, has 55 percent of the defibrillator market and according to the New York Times, the device is its "biggest" product.  Needless to say, it would delay an announcement that would disrupt its sales and upend its stock price for as long as possible.

        The New York Times quoted Dr. William Maisel, a heart device expert at Beth Israel Deaconess Medical Center in Boston, who pointed out that the general reluctance to stop sale of a lucrative device is compounded in the medical device field because manufacturers have not created monitoring methods of anticipating or recognizing potential failures and device manufacturers are consistently scrambling to "catch up" with safety developments.

        Thirty-five year old Stephanie Martinson, a speech pathologist in Palo Alto, California, puts a human face on this problem:  her Fidelis lead gave her 26 painful shocks in a single hour before the lead was removed in March of this year.  It was replaced, with another Fidelis lead, unfortunately, in May of 2007.  This was almost a year after the first FDA-recognized death, two months after Medtronic sent a warning notice to doctors, but four months before the product was recalled.  Sleep well with your new lead in place, Stephanie.

Canceling homeowners' coverages

        If you watch any television, you have probably seen some of Liberty Mutual Insurance Company's high-priced advertising campaign focused on people "doing the right thing" for other people. The ads trace good deeds from one person to another--in a shadow of that movie theme from a few years back--and then attempt to claim this spirit of social responsibility for Liberty Mutual.  Well, just as with Allstate's long-standing "good hands" campaign, if an insurer spends a lot of money to applaud its own fiduciary nature, consumers should be suspicious.  As Shakespeare would have described it:  "Methinks [it] dost protest too much." 

        If you look at prior blogs in our system, you can read all about Allstate's ruthless "good hands or boxing gloves" campaign, by which it has successfully achieved dramatically higher profits by  sacrificing its fiduciary duty to consumers.  Because it spends enormous sums of money on fancy advertising, it has been able to remain in business, despite a business plan that sacrifices its own insureds to higher profits.  Taking a page from Allstate's profit-book, Liberty Mutual--an insurer that we believe repeatedly puts its own interests before the interests of consumers and policy holders--spends mightily on advertising, while making avaricious business choices that do not serve its customers.

        Recently Liberty Mutual sent notices of cancellation to hundreds of homeowners in Northeast states in order to eliminate hurricane coverage risks.  Elsewhere in our blog, you can read about insurance industry studies that documented the enormous profits made by the American insurance industry post-Katrina.  Liberty Mutual's response was unique, however, in that it tied cancellation (or "nonrenewal") to the fact that homeowners were cancelled because they did not have auto insurance with the company:  that practice of bundling services in a non-competitive manner is illegal and Liberty Mutual was rebuked by state insurance authorities.

        In the long run, a valid public policy is served by making insurance costs reflect the actual risks of loss.  If people make a conscious decision to buy or build in coastal regions where flood damage is a genuine risk, they should know "up front" the actual financial risks they are assuming and share those risks with other risk-taking consumers.  On the other hand, consumers should be wary of insurers such as Liberty Mutual, Allstate and State Farm, who advertise heavily while making business choices that are inconsistent with public policy.

Health Insurance Reform and malpractice reform

     Former Republican Secretary of the Treasury and commentator Paul O'Neill raised issues related to national health coverage in his column of October 16, 2007.  Acknowledging the need for uniform health coverage and the inevitability of moving away from employer-based coverage, O'Neill still endorsed the intermediary role of insurers.  O'Neill did offer a new idea or two, however, when he acknowledged that too many medical errors are "buried" with the patients, resulting in a failure to recognize and address common sources of malpractice.  Of course, O'Neill blames "fear of malpractice suits" for this secrecy and suggests a remedy that involves the creation of a special administrative process that would reimburse victims or their families for economic damages, only.

        There are several assumptions in O'Neill's essay which deserve consideration, and several which disclose either a lack of sophistication or an inherent bias.  The first assumption is that no good can result from compensating victims or their families if the patient suffered no economic loss.  In our experience, the brittle elderly are less resilient and more likely to suffer death or catastrophic outcome as a result of a medical error.  If medical care providers are to learn from these errors, some value should be assigned to these patients' lives--even if the victim no longer earned an outside income.  This same philosophy applies with respect to housewives who don't have an income outside the home and to children.  And of course, there is the added question of justice--something that a Republican Treasury Secretary would likely be trying to quantify in dollar terms:  aren't these non-earning lives worth something and isn't their health and happiness of some value when it is taken by negligence?

        O'Neill's comments must also be considered in the context of the well-entrenched insurance lobby.  It is likely that no major party politician will bite that wealthy hand:  certainly not the element of the Republican party that is captured by "big business".  Insurers and arguments over insurance coverage result in a substantial administrative overlay of expense on top of medical care.  By some estimates, fully ten percent of all jobs in medical care are insurance-payment related.  Insurers can also be an influence to drive down prices--but perhaps in a manner that does not serve patients or medical providers.  No solution to America's health care expense crisis should assume that insurers have the primary role or that their influence is benign.

        Finally, should the victim's and the health care provider's right to a "jury of one's peers" be sacrificed to achieve universal coverage?  It is heresy for a trial lawyer to say this, but perhaps that suggestion deserves consideration.  Studies have documented that jurys are less willing to recognize malpractice than are medical experts:  it appears that victims and their families would be better served by a tribunal that is sophisticated in medical issues----provided it is a neutral and objective fact-finder.  Unfortunately, when these systems have been tried in the past, they have resulted in one of two outcomes:  in Ohio, where a fair system of binding arbitration was devised, medical providers quickly realized that it was more likely to hold a negligent provider accountable for mistakes and immediately sought legislative intervention to discard the system.  In Michigan, the system of binding arbitration that was devised in the 80s was so skewed in favor of health care providers that it hardly paid lip-service to due process for victims.

        It would be easier to consider insurers' and health care providers' pleas for "reform" if the first stage of "reform" did not always turn out to be a grab for greater insulation from even legitimate malpractice claims.  With respect to the issue of "burying mistakes", most states have bought into a system of "peer review" that encourages a bunker mentality among health care providers.  In Michigan, for example, when a mistake is identified or suspected, a conference or an investigation can be conducted, and the results of the investigation or conference will not be disclosed to the victim or his or her family.

        We sincerely question whether this process is fair to anyone and we doubt that it serves a legitimate public policy.  Overall, it is our assumption that truth and disclosure are always the best policy, and if some form of legitimate malpractice "reform" is necessary to achieve a more open policy, it is probably a worthy goal and the means may justify the end.

October 12, 2007

Drunk driving "accidents" under ERISA

  In applying ERISA law governing insurance policies, the Sixth Circuit held that Nancy Lennon's son was not involved in an "accident" when he caused a motor vehicle collision while driving drunk.  26 year-old David Lennon was a GMAC accountant, and at the time of his death, his blood alcohol was three times the legal limit.  The Trial Judge had held that while he was "grossly negligent", his death was still an "accident" under the Met Life policy.

        The Sixth Circuit judges reversed, holding that it was not "arbitrary and capricious" to treat Lennon's "gross negligence" as tantamount to intentional conduct, because his behavior rendered the risk of serious injury or death "foreseeable."  The court relied heavily upon the common sense recognition that the risk associated with driving under the influence increases as the level of intoxication increases, and stressed that it was not upholding the suggestion that death caused by any ingestion of alcohol could be excluded from ERISA coverage.

        Of the three judges on the panel, one would apply a generous interpretation to the concept of "reasonable forseeability", one would hold the plan administrator to a high standard of proof (i.e., proving "gross intoxication" to establish "intent") , and the third dissented:  the latter judge would interpret the language of the policy as written and require proof of an intentionally-caused injury. 

         It seems that the policy language is only interpreted "as written" when it disadvantages a consumer:  when the language, as here, is inconvenient to the insurer, the Court applies its own interpretation of common sense to avoid the impact of black and white rules.  This young man did not "intend" to injure himself or anyone.  He was, however, stupidly negligent.  The ERISA policy, however, did not exclude injuries caused by "gross stupidity":  it excluded injuries caused intentionally.  No ordinary person we know would suggest that in normal parlance, as a culture we equate drunk driving with intentional suicide.

The activist Supreme Court

    As if further proof were needed of the Michigan Supreme Court's contempt for injury victims, on October 11 the majority provided additional evidence with its holding in Ells v. Eaton County Road Commission.   Steven Ells sued on behalf of the Estate of Maynard Ells, claiming that his decedent was killed by a road defect.  Under the law as it was interpreted for more than two decades, the Road Commission had to be advised of the alleged defect in the road within months of the injury, but if notice was late, the case would not be dismissed unless the Road Commission could demonstrate that it suffered actual prejudice through the late notice.

      In Ells, the Road Commission was aware of the alleged defect and could not prove that it had been prejudiced by the late notice.  The Plaintiff Estate apparently relied upon this fact in filing suit despite the lack of a timely notice.  A few months later, the Supreme Court's activist majority overturned the decades-old rule requiring a showing of actual prejudice, and held that cases would be dismissed if the notice was late--regardless of any prejudice to the Road Commission.  Normally when there is a substantive change in the law overturning pre-existing precedent, the new rule is applied only prospectively to "new" cases filed after the Court declares the change.  In Ells, however, the conservative majority followed its own pattern of ignoring precedent, and it applied the "no prejudice required" rule retroactively, dismissing Ells' claim.

Cold remedies for infants and toddlers

   NPR reported yesterday that in response to pressure brought by a group of Pediatricians, several makers of infant and toddler cold medications were pulling the medications from the shelves.  The withdrawal was voluntary and included only medicines designed for children under the age of two.  The Pediatrician and consumer groups whose activism led to the withdrawal claimed that it did not go far enough and should have included all meds marketed to children under the age of six.  The physicians and consumers maintain that these drugs are not effective in children under the age of six and that they result in nearly 100,000 overdose hotline calls per year.  Manufacturers conceded that the drugs have not been tested in younger children and that accidental overdoses administered by parents (in the middle of a sleepless night) must be addressed.  The manufacturers deny that the drugs are dangerous on any other basis and continue to sell medications designed and marketed for "infants".  Between 1969 and 2006 there were more than one hundred confirmed deaths of children related to the administration of antihistamines or decongestants.

Another decision on serious impairment

        Relying upon the Supreme Court's ruling in the Kreiner case, the Court of Appeals recently held that a woman who suffered (among other injuries) a rotator cuff tear in her right shoulder, did not suffer a "serious" injury.  The victim endured surgery in June of 2005 after she failed to respond to a February injury.  She wore a shoulder brace for the next four weeks, and missed six weeks of work.  She attended physical therapy three times per week for six weeks and intermittently through March of 2006, 13 months after the wreck.

        In May of 2006, she testified that her shoulder had not recovered fully.  She had continued difficulty with various household and grooming tasks and had to train herself to do some things with her non-dominant left hand.  She could no longer bowl, but otherwise conceded that there was nothing else that she "absolutely could not do".  The trial court denied the Defendant's motion to dismiss her claim on the threshold basis, but the Court of Appeals reversed and threw her claim out.  The three judges held that under Kreiner, "the plaintiff failed to show that the course or trajectory of her normal life was affected".  We'd be willing to bet that the "ordinary person" would consider her injury to be "serious"--the actual legislative standard before it was manipulated by an aggressively conservative majority on the Supreme Court.

October 11, 2007

Compensating the innocent

  This week the Supreme Court of the United States once again documented the compassionate and law-abiding nature of our people and government.  When an innocent German citizen was kidnapped, tortured and detained for more than six months, it was a failure of our anti-terrorism intelligence.  When the admittedly innocent man was denied any form of compensation by our government and our judiciary, it was a failure of our conscience.

        Khaled el-Masri was picked up while vacationing in Macedonia and transported by the CIA [through "extraordinary renditition"] to a squalid prison in Afghanistan before being dumped in remote Albania without ever being charged with a crime.  His account of what he endured, and his apparent innocence, have been documented by several western investigations, and German Chancellor Angela Merkel claims that Condoleeza Rice acknowledged off-the-record that el-Masri's kidnapping was a mistake. 

        In fighting a war with terrorists, it is probably unavoidable that mistakes will be made and that some of those mistakes will be well nigh unforgivable.  Still, if we expect to maintain some degree of respect and moral authority with the other nations of the world, we should at least try to pay for our mistakes.  Compensation is paid to innocent victims in Iraq on a daily basis.  It is incredible to remember the out-pouring of affection that Americans enjoyed immediately after the 9/11 attacks and the influence we could exert internationally.  It is more incredible to think that we have completely wasted and squandered that moral authority and goodwill in the few years since by heavy-handed tactics and arrogance.

        Even more distressing to U.S. citizens is the recognition that the "State secrets privilege" that was relied upon to dismiss el-Masri's claim for compensation was based on the coldwar-era U. S. v. Reynolds case decided in the 1950s.  In Reynolds, the government denied discovery of plane crash investigation results to the widows of three civilians killed in a U.S. bomber crash, where the government claimed revealing the investigation results would damage national security.  The results of the Reynolds crash investigation were released, just in the past few years, and demonstrated that the only injury the government would actually have suffered had it been released back in the 50s was embarrassment.

        As a nation, we are wealthy enough to pay for our mistakes.  Whether the issue is global warming or state-sponsored terrorism, we should be at the forefront of solving problems and making the world safer.  Our economy should be benefitting from the economic  and technological impulse of addressing global warming and pollution concerns.  Our government is robust enough to withstand disclosure of its mistakes, and in fact it would probably be stronger if its mistakes were catalogued rather than being buried or arrogantly ignored.  Certainly our credibility would be enhanced.   As citizens, we should demand more:  we should insist that our leaders give more time to investigating and addressing the real issues that affect all of us, and less time to investigating whose feet are under what stall of a mens' room. 

        As someone else has already pointed out, when the American colonies had only four million souls, they could produce Washington and Jefferson, Franklin and Adams.  Now we have more than 250 million people, and our current leaders are the best that we can do?  I think those founders would shudder at what happened to el-Masri if it had happened on their watch; I believe they thought they had created a nation of limited government where it could not happen that an innocent person could be kidnapped, held for months under despicable conditions, tortured, dropped by the roadside and then denied compensation--all in the name of freedom and democracy.  There is a hint here of the famous post-Nazi era quote that went something like this:  "they came for the Jews and no one cared; they came for the Communists and no one cared; they came for the Gypsies and no one responded; they came for me and there was no one left to object". 

Third-world dental care in the U.S.

        When a child dies due to infection caused by decaying teeth, we tend to think we are talking about a third-world issue.  Not so, apparently.  THIS YEAR, children's deaths in Mississippi and Maryland were documented to have occurred as a result of tooth decay.  Thousands of children suffer illness and pain due to dental problems that are only miserable but not fatal. 

        While most middle and upper class children enjoy "straight white teeth as a virtual birthright", the New York Times reported the above deaths and the fact that untreated tooth decay has reached higher rates among children (27 percent) and adults (29 percent) than the U.S. has seen in decades.  100 million people in the U.S. (one-third of the population) lack dental coverage, most dentists won't take Medicaid patients, and the waiting list for care in state-supported institutions often reaches six months or more.

        The number of dentists in the U.S. has remained relative flat--150,000 to 160,000 (including part-timers who are more common today) since 1990, while the population has risen by 22 percent.  In 2004, the average income for dentists was $185,000.00, while oral surgeons and orthodontists reported average incomes of more than $300,000.00 annually.  Several dental schools have closed their doors, leading to fewer graduates in 2003 (4440) than there were in 1982 (5750), and an average age among practitioners of 49.  This is apparently because training dentists is expensive and there is no hospital training ground or "hands-on" resident finishing school for dentists.

        In most other first-world nations (50 to be precise), "dental therapists" have been trained to perform simple cavity treatment, however, in the U.S., the ADA has fought the licensing of this type of therapist, even in areas of Alaska that have never seen a real-live dentist.  The result is a decaying dental health system that is deadly for poor children but very lucrative for dentists.

October 09, 2007

"Caps" or limitations on recovery

        Since some politicians have made tort "reform" a vote-chasing mantra, caps and other limitations on recovery have been a popular legislative "fix" for "frivolous" lawsuits.  Off the top, everyone should recognize that limitations on recovery are not really a solution to frivolous cases for several reasons.  First and foremost, caps limit the top-end recovery on meritorious cases, not on cases having no value.  Second, by definition, "frivolous" cases have NO merit and are subject to dismissal and numerous other sanctions--usually judicially imposed.  Caps reduce what people with substantial injuries can recover.

        Caps are not really a new thing.  Almost every auto or homeowner liability claim has built-in caps determined by the limits of coverage purchased by the person who was at fault.  If the at-fault purchased only $100,000.00 of liability coverage it is likely that a victim will recover no more than that:  usually the at-fault's assets are thoroughly protected by the appointment of counsel with a fiduciary duty, the cost of litigation when compared with likely supra-insurance recovery, and other limitations based on creditor and bankruptcy protections.

        The most common limitation on auto policies from good companies is in the range of $100,000.00 to $300,000.00.  Homeowner coverages in Michigan tend to fall in the $300,000.00 to $500,000.00 range.  Professional liability coverage is very unpredictable, but $200,000.00 to $400,000.00 is very common.  Some individuals and many corporations purchase some form of umbrella coverage which usually adds one million dollars of liability coverage to an underlying policy.

        Despite three decades of tort "reform", the Michigan legislature has refused to increase the mandatory minimum limits of liability coverage on automobiles.  Just as in the early 70s, a driver or owner can put a car on the road in Michigan, legally, with only $20,000.00 in liability coverage.  If that driver is also a youngster or an alcoholic unable to hold a job, it is likely that the $20,000.00 of coverage he or she bought is all the compensation that a victim will ever see (and perhaps not all of that if there are fees and costs).  $20,000.00 doesn't do much to compensate a victim for a lifetime of paralysis, for example.  For that reason, wise consumers of auto insurance also purchase Uninsured and Underinsured Motorist Coverage, to protect their own family members from an at-fault with limited or no coverage.  For a very cheap premium, protection for family members can be augmented or increased to the level of liability coverage purchased.  A few of the lower tier insurers (i.e., Allstate, State Farm, AAA) either won't sell Underinsured Coverage, or will sell only coverage with very small limits).

        Part of tort "reform" in Michigan was to institute similar caps, through legislation, on all product liability and medical malpractice judgments for non-economic damages.  While the victim is allowed to recover (to the extent of the insurance coverage available) all of his or her economic damages (that is, lost wages or medical expenses, sometimes domestic service expenses), they can recover only the capped amount to compensate for pain and suffering or for the loss of society and companionship of a decedent.  Malpractice judgments are rendered in two tiers, indexed to the cost of living, so that people with catastrophic injuries can recover more money than people with undesignated serious injuries.  The limits started at $280,000.00 and $500,000.00, depending on the nature of the injury.  These caps can be very unfair to retired persons and others who do not have a concrete wage.

        Just as victims cannot tell the jury that there is insurance coverage or what the at-fault's coverage limits are, the litigants aren't allowed to tell the jury of these statutory "caps".  The jury is allowed to render a verdict in whatever amount it deems appropriate, but the judge subsequently reduces the verdict to the capped amount.  These rules on disclosure were instituted at the behest of insurers who believe that juries will artificially depress verdict amounts to protect an individual and his family from a large award, if they are unaware of the fact or amount of insurance.

        Of course, the legislature did not consider some of the other ramifications of instituting a cap.  For example, if a company knows that an award cannot exceed $300,000.00, it need not fear a "runaway" jury, or even a significant award, and the impetus for the insurer to compromise is removed or significantly reduced.  Further, since the cap represents the MOST the insurer can award, many insurance adjusters will not offer to settle by paying the "cap"--even if payment would be warranted:  in effect, the practical cap on recovery becomes an amount much smaller than the actual cap.  The "true cap" becomes the statutory cap, reduced by the cost of drawn-out legislation, taking into account the risk of losing or winning a smaller verdict.

        One of the most difficult aspects of recovery limits is the public policy impact of the choice to institute caps or to minimize coverage limits.  In the case of catastrophic injuries, if the applicable liability coverage is minimal, it is likely that taxpayers and the victim's family end up bearing the cost of the injury or death.  If the injury resulted from risky behavior by the at-fault, the cost of that behavior is not increased in advance to reflect its actual human toll by realistic underwriting.

        In Michigan, the caps and limitations on death cases operate to limit the total recovery for the death--not the recovery for each family member.  Thus, if an at-fault purchased liability limits of $20,000.00/$40,000.00, only $20,000.00 will be paid, in total, to all of the survivors of the victim, and only $40,000.00 will be paid, in total, to all of the victims of a single occurrence, regardless of how many victims were killed or injured.  Under Michigan "stacking" rules, if the at-fault owned two different vehicles, the policies are normally written so that only one policy limit applies and the coverages cannot be "stacked", and these coverage rules are enforced by the Courts.  Coverages on two separate people (say the owner and the driver) through two separate companies can be "stacked".

October 08, 2007

Cold medicine for children under the age of six

Last week, safety experts urged the FDA to consider an outright ban on over-the-counter cough and cold medicines for children under the age of six.  Marketed under product names such as Toddler Dimetapp, Triaminic Infant and Little Colds, these medicines are reportedly of little effect in that age group, yet as many as 54 children have died in the past eight years after taking decongestants, and during the same period 69 children died after taking antihistamines.  The 300+ page report to the FDA points out that since these deaths are reported only on a voluntary basis, the actual death toll is probably significantly higher than the voluntary reports would suggest.

        An industry trade group that objects to the report from the FDA's scientists would limit the FDA to adding warning labels to pediatric cold medicines  advising against administering them to children under age two, in place of the current advisory to "consult a physician" before giving such medicines to infants:  despite this 150 page industry report--released on Friday, October 5, some companies such as Johnson & Johnson, continue to sell products labeled "infant" with labels depicting children under twenty-four months.

        The Centers for Disease Control and Prevention found that more than 1500 children under 24 months have suffered serious health problems associated with cold medicines in just the past three years.  In an article published on October 1, the New York Times reported that the Journal of the American Medical Association--one of medicine's most prestigious journals--demonstrated that more than one-third of all 3 year olds had received over-the-counter cough and cold medicines during a single 30 day period.    In 1990, American consumers spent almost $2 billion dollars on 30 separate brands marketed for kids--who suffer 6-10 colds per year, on average. 

        On Friday, the FDA also warned makers of 200 unapproved prescription medicines containing hydrocodone to discontinue sale of these medicines for use with children under age six.  There are reportedly a total of 800 pediatric cough and cold medicines on the market, despite consistent research findings suggesting that these products are not effective in children.  While it was once widely assumed that separate testing on childrens' bodies was unnecessary (and therefore has never been conducted), most scientists reject that assumption today.

Improvement in aircraft safety

        With so much talk about unsafe products and the failure of government regulators, we need to remind ourselves about some of the product safety accomplishments we have achieved.  In 1996, after two air crashes that killed 375 people, a White House Commission recommended that the airline industry and regulators make changes that would reduce the number of fatalities by eighty percent over the next ten years.  According to the New York Times, the industry and government regulators had nearly achieved that goal by October of 2007, through a sustained safety effort and a touch of luck.

        While there have been seven crashes elsewhere in the world this year, there had been no fatal airliner crash involving a scheduled U.S. flight during 2007.  The drop in the number of fatalities was about 65 percent since the Commission made its report public.  Unquestionably, this represents some degree of luck, but it also represents an earnest effort to improve aircraft, equipment and other subtle problems identified by investigators.  Much of the improvement is attributable to the pooling and closer analysis of data collected from various sources and collated.  Some of this data was collected from uneventful flights--which represented a new area of investigation for the FAA. 

         The only blemish on this record of increased safety is the increase, over the past decade, of "proximity" events, as crowded flight paths cause havoc for over-worked air controllers in particular geographic locations.

The Panamanian who brought China to its knees

        It would probably be difficult to identify a single reasonably-informed consumer anywhere in the world who is not aware of the difficulties that Chinese manufacturers have experienced lately with respect to the safety of their products.  Whether one is talking Thomas the Train, SUV tires, childrens' jewelry, Hot Wheels cars, toothpaste, or dozens of other products, the Chinese have taken a beating over quality control.  The government even executed its own top regulator after convicting him of taking bribes.

        It may have been inevitable given the pervasiveness of the problem, but  it turns out that the catalyst to the recognition of safety problems in China was not a European safety investigator, a U.S. Consumer Product Safety Commissioner, a trial lawyer pursuing a civil action or any other "typical" Erin Brockovitch character.  The hero was a mid-level bureaucrat in Panama; a 51-year old Kuna Indian who grew oup on a Caribbean reservation.  The New York Times edition for October 1, 2007, identified Eduardo Arias as the man who humbled the most powerful consumer product producer of our age.

        Mr. Arias was shopping for blank CDs on a Saturday morning when he noticed the terms "diethylene glycol" on a 59 cent tube of toothpaste.  The latter is a sweet-tasting and cheap, but poisonous antifreeze additive that had killed a number of Panamanian kids when it was substituted for glycerin in cough syrup.  A mid-level government employee who writes environmental reports, Mr. Arias was struck that the toxic additive was present in consumer products that were being promiently displayed for sale.

      Arias bought one tube of the toothpaste (which was being purchased all across the globe, to be handed out to prison inmates, hotel patrons and various other hospitals and institutions).    Assuming that complaining to the store would have no impact, he used his own vacation day to walk the tube to the crowded Health Ministry office in Panama City.  Workers there refused to accept the toothpaste and directed him to a second, equally crowded office.  When workers there attempted to send him to a third--very remote--office, Arias objected and insisted on filing a report with the Ministry.  He filled out a form and left the toothpaste with the Ministry, half-convinced that nothing would come of his wasted vacation day. 

        Three days later, Panama's top health officalmade a public announcement of the problem and within a few weeks, 24 contaminated brands had been identified in Canada and 16 in New Zealand.  Japan identified 20 million tubes of toxic toothpaste, and it was identified in the United States being sold under counterfeited brand names Colgate and Sensodyne.  Chinese authorities, meanwhile, claimed that the product was a legitimate thickener and did not present a health concern.  Health officials outside China were quoted describing this claim as "ridiculous".  Canadian authorities found a concentration of the toxin as great as fourteen percent in some tubes, and of course the same additive had previously killed a number of children in Panama and Nigeria.  In July of 2007, the Chinese government finally ordered Chinese manufacturers to stop using the additive in toothpaste.  It is interesting to speculate just how much longer this problem would have continued, and how many other people would have been poisoned, if Eduardo Arias had not used his vacation day to bring the toxic toothpaste to the authorities' attention.

When government does not regulate

       An RPI Coating company spokesman told the Associated Press that it was "devastated" over the loss of five of its employees who were killed in a deadly fire in a hydroelectric plant in Georgetown, Colorado.  "They were very experienced guys.  They were some of our best."  The fire has been traced to a heated device in which the workers were mixing an epoxy-based sealant.  It turns out that RPI has been issued numerous safety violations by the California Occupational Safety and Health Administration and the Denver-area Federal OSHA office.  Since 1986, the Denver office had issued 35 safety violations against the company ("more than most companies"), and an OSHA spokesman was quoted in the New York Times to the effect that "They have a significant history with OSHA, and these are serious violations".  One employee of the company was killed while working on the Oakland Bay Bridge in 2002.  The dead employees were 18 year-old Anthony Aguirre; Donald Dejaynes, 43; Gary Foster, 48; Dupree Hold, 37; and James St. Peters, 52.  It has been our experience that when a tragedy like this occurs, it can frequently be traced to a culture of corner-cutting and a lack of safety-consciousness that is ingrained in some companies.  Individual workers who might object to safety compromises end up biting their tongue and attempting to ignore potential risks, in order to preserve their jobs and their sanity.

Paintball product crusader

        Mark Contois has been a crusader for safety in the paintball industry, since his wife was killed while watching their ten-year old son's birthday paintball party at a supervised course.  One of the contestants accidentally discharged the pressurized prepellant cylinder which struck Ms. Contois in the head:  she never regained consciousness and died at the scene.  The owner of the facility closed it down soon afterwards, even though he had done nothing wrong or dangerous.  It turned out that a 15-year old had died from a similar injury a few months earlier.

        Any game that involves a gas under pressure or high velocity projectiles has the potential for danger.  Paintball presents an additional, avoidable danger, though, in that the valve and cylinder involved in the Contois fatality was defective in that it could detach from the gun on the pressurized side, and then be unwittingly discharged--like a rocket--by the user.  Modifications that young paintballers read about on the internet could also increase the propensity for failure with these guns.

          While improvements in valve design have since minimized the danger on new manufactures, the New York Times reported that ASTM International--a group that sets voluntary standards for various products--believes there are thousands of old and dangerous guns in the hands of consumers.  The CPSC has documented at least 73 accidental gas-cartridge ejections and seven resulting injuries.  The industry has discussed creating a system of disseminating paintball safety information since the 1990 severe facial injuries suffered by a California resident, however, to date no action has actually been taken.  Ms. Contois' husband has been crusading to change that fact and recently filed suit to force the successor corporation to National Paintball Supply to fulfill the promises it made when it settled the civil action against it, arising out of Contois' death.

The limitations of our consumer safety system

    An article published in the October 8, 2007, New York Times helps to illustrate the short-comings of our consumer product safety system in this country.  Unlike Europe, for example, we do not have any process for pre-approval of childrens' toys and other specific product areas.  We rely solely upon product recalls, and it is clear that our product recall system is overly reliant upon manufacturer and retailer initiative.  The recent investigation of Stand 'n Seal, sold by Home Depot, helps to explain the limitations and problems. 

        Stand 'n Seal was marketed in 2003 as a time-saving method of waterproofing tile grout on tile floors.  The in-store displays demonstrated a consumer applying the sealer with an aerosol can, without any form of breathing protection in front of a closed window.  No problems were encountered until the manufactuerer, Roanoke Company [now BRTT] switched the active ingredient from a DuPont chemical to a chemical known as Flexipel S-22WS, mad by a company in Georgia.  The safety data sheet published by the maker of Flexipel explicitly stated that it should not be used in aerosol form because it could cause respiratory injury, however, it was marketed in this form by BRTT, and when customers began calling with complaints, phone responders were told to deny previous complaints and to suggest that victims were not securing adequate ventilation because the newly-formulated product was less "pungent".

        Although Federal rules require a manufacturer to report a potential health threat to the CPSC within 24 hours, BRTT did not contact the CPSC for several months, and when it finally did, it was apparently in response to a threat by the Rocky Mountain Poison and Drug Center to call the commission directly.  Still, no action was taken to remove the product, and almost three months passed before a recall was initiated.  In the interim, dozens more people suffered respiratory injury and two men died from exposure to the aerosol.

        Because the CPSC doesn't have the facilities or the resources to test the product on its own, it then relied upon the manufacturer's representation that the product had been fixed.  Instead, the company merely added additional odor components but left the dangerous chemical [which the supplier said should not be used in this manner] in the aerosol and re-supplied Home Depot with 50,000 new cans to re-stock shelves.   

        Meanwhile dozens of additional injuries have occurred, including a contractor from Zeeland, Michigan, who purchased a replacement can, and an office manager from California who in 2006 purchased a can from the original batch of recalled Stand 'n Seal that had remained on the Home Depot shelves.  The Michigan purchaser is likely to find that Home Depot felt no pressure to market only safe products, since product "reform" in Michigan often holds the retailer harmless if the retailer did not modify the product it sells:  it recognizes little duty or no duty for retailers to use "due care" in identifying and avoiding unsafe products. 

        The NYT article identifies a number of consumers who were injured by the "reformulated" product before Home Depot and the manufacturer finally pulled it from product shelves in March of 2007.  Sadly, the CPSC has never acknowledged that the problem was not "fixed" in 2005, and consumer recommendations from the commission claim that Stand 'n Seal manufactured after June of 2005 are "safe"--even after the manufacturer and seller have admitted otherwise.

        With that kind of protection for consumers, perhaps we should simply close the doors on the CPSC entirely, and give its budget to European governmental agencies that actually do investigate the safety of products:  we would have to out-source a few more jobs, but no one seems particularly concerned about that issue, either.