TOV Injury and Safety Blog

Delivering newspapers voids your auto coverage in Michigan

        Acting pursuant to an earlier decision by the Michigan Supreme Court, the Court of Appeals yesterday held that a woman who used her car to deliver newspapers could not avail herself of the auto liability insurance she had purchased.  In addition, the woman she had seriously injured in a car accident could not avail herself of the coverage.  In Bristol West v. Butzbach, the three Court of Appeals' judges felt constrained by a prior Supreme Court decision to invalidate Butzbach's coverage, because her auto policy contained a standard exclusion for "business pursuits." 

          In Michigan, no fault insurance is mandatory, and the coverage the carrier must provide is mandatory:  on that basis, prior court decisions had held that insurers are in a better position to evaluate and underwrite risks that include incidental money-making or "business" pursuits, and have required coverage of these activities that fall short of an actual commercial venture.  For example, a number of years ago, we prevailed against the insurer in Rossman v. State Farm, when it attempted to invalidate a volunteer fireman's coverage because he received a small per diem for fire runs. 

          This issue arises regularly because many unsophisticated insureds use their vehicle for incidental money-making activities (for example, teens delivering pizza, newspapers or other materials for an employer) that aren't normally considered to be a "business".  Even if an insured were to read his or her entire policy when it comes in the mail a month after buying it, most people wouldn't recognize this exclusion from coverage as applying to them.  And, under other activist rulings of our Supreme Court, the insured's agent owes no duty to explain the exclusion to the insured.

        Before the activist Engler Justices assumed control of the Supreme Court, these incidental income-generating activities were included in mandatory coverage, and an insured's agent owed a general duty to inform the insured:  under this Court, though, many naive or uneducated Michigan consumers who are unaware of this constraint will be purchasing illusory coverage for these poorly-compensated activities.  None of them will likely come from the neighborhood of these Republican activist jurists, however, so their concerns are ignored.

Dole South American laborers win verdict

        Six employees of The Dole Food Company recently recovered verdicts against Dole and Dow Chemical for illegal exposure to a toxic chemical.  The Dole Food Company continued to use in South America a chemical, DBCP, that it discontinued using in this country in 1977.  The chemical kills pests that attack the roots of fruit-bearing trees and increases banana production by twenty percent, however, it also rendered test animals--even the ubiquitously-procreating rabbit--sterile.  Production of DBCP was suspended in 1977 after workers producing it in California were found to have low or zero sperm counts. 

       When Dow attempted to stop shipping DBCP, Dole allegedly threatened to sue and forced Dow to honor its previous commitments.  According to the documents produced by Plaintiffs, as much as 1.4 million pounds of the chemical were used where the six laborers worked, and a Dole internal memorandum suggesting a policy that laborers be warned of the danger of the chemical in their own language was rejected in 1978 as "not operationally feasible...need not be implemented".  Dole's numerous arguments against liability included the specious claim that the employees had not proved that they were fertile before they were exposed to the chemical.  That kind of argument, alone, probably warrants a large verdict against the party who proffers it.

        Dole had originally objected to appearing to defend the suit in Central American Courts.  We understand that today it objects to defending the cases in Los Angeles.

Ice can't cause much harm

        It will stun some injury victims for a second time to learn that one cannot suffer a severe injury as a result of a fall on ice.  The activist majority of "Engler Justices" on Michigan's Supreme Court had previously expanded the concept of "open and obvious" danger to exclude premises liability for hazards which are "readily apparent to a casual observer".  Previously this concept had eliminated a landowner's responsibility to warn invitees of an "apparent" hazard, but the duty to eliminate unreasonable hazards still remained.  The activist group of Republican extremist jurists expanded "open and obvious", though, to eliminate any duty to alleviate the hazard --- unless the Judges concluded that the hazard posed "an unreasonable risk of severe injury".

        The latter questions of "unreasonable risk" and "risk of severe injury" had historically been questions of fact for jurors, and many courts have continued to examine the circumstances of injury to distinguish particular situations from the  Court's new blanket exclusion from duty or liability.  In a recent case, though, the five Republicans on the Supreme Court reversed the trial court and the Court of Appeals and appear to have drawn a black and white rule relating to ice.

        In its holding in Kaseta v. Binkowski, the Republican majority of the Supreme Court adopted the reasoning of the dissenting judge in the Court of Appeals, concluding that there is nothing in the character, location or surrounding conditions pertinent to ice which gives rise to an unreasonable risk of harm.  If the victim knew there was snow within the general area, he or she should have expected to encounter ice and to suffer an injury--[though apparently not a "severe" injury].  Although Ms. Kaseta (the injured woman) never saw ice in the driveway until after she fell [in the dark], she "could have avoided the driveway all together and chosen an alternate path".  In addition, there "was no risk of serious harm because she could not fall an 'extended distance' ".

          To suggest that one cannot suffer serious injury without falling an "extended distance" betrays either incredible ignorance or intentional bias and obtuseness.  OSHA studies, for example, have documented that any fall over 14 feet carries a high risk of fatality.  The jurisprudence is replete with examples of individuals suffering death or serious injury as a result of a fall of only a few feet or from a standing position.  We've encountered several dozen cases of this nature, including fatalities, paralysis and permanently incapacitating head injuries.  We represented the dependants of a local woman who ultimately died as a result of a fall on ice at the TCAPS bus garage, just to list one example.   

        Electing to re-define the law to exclude all liability for falls on ice is the kind of result-oriented activism that is typical of this "Engler majority".  It demonstrates poor public policy--since a landowner is no longer encouraged to eliminate hazardous conditions--and the exercise of raw, unrestrained legislative power by the Justices in an effort to accomplish an illegitimate end.

A reformed MD drug rep examines anti-depressants

        Dr. Daniel Carlat has written about his year as a drug rep on behalf of Wyeth.  He is a psychiatrist who was courted to persuade other physicians to prescribe Effexor XR as a treatment for depression.  Carlat explained that between fancy conferences in New York City (with theater tickets, haute cuisine, etc., and a $750 honorarium) and weekly medical lunches with potential prescribers ($500.00 or $750.00, depending on whether he had to drive an hour), he had supplemented his $140,000.00 private practice income with an additional $30,000.00 from Wyeth.   Not an insubstantial annual salary enhancement.

          Carlat explained that at first, he relied on metastudies which suggested that Effexor was ten percent more effective than serotonin reuptake inhibitors--the more common antidepressant--in achieving remission, and was completely comfortable serving as a salesman for Wyeth.  Over the course of the year, however, he studied the issue more carefully and learned that Effexor had originally been compared only with Prozac, and was only five percent more effective than other SSRIs when compared with SSRIs other than Prozac.  He was equally troubled by data showing that it was often very difficult to withdraw from Effexor--a serious issue when caregivers take into account the high likelihood that a particular drug regimen will need to be tweaked to achieve a response.  In addition, Effexor caused problems with high blood pressure fifty percent more often than SSRIs did.  Carlat began to wonder whether it made sense to prescribe a marginally more effective anti-depressant that would be more likely to cause problems with high blood pressure and be difficult to switch or withdraw.

          Ultimately Carlat gave up his $500 dollar lunches when he began to feel intellectually dishonest and recognized that the Wyeth salespeople who accompanied him to the doctors' offices would not retain him if he gave up his role as a cheerleader for Effexor.  When he honestly displayed equivocation on legitimate issues, his Wyeth companions made their displeasure clear immediately.  And Carlat used his free time to began producing a pharmacological newsletter that reflected his own opinions without editing--or support--from drug manufacturers.  He is on the faculty at Tufts and his newsletter is called the Carlat Psychiatry Report.  We hope the satisfaction he feels as a result of practicing intellectual honesty makes up for the income he sacrificed.

Private citizens keeping our kids safe

        When the Consumer Product Safety Commission recalled an additional half-million pieces of lead jewelry, the effort was not the result of leadership by the anemic regulators appointed by President Bush.  Rather, Ward Stone and his 10-year old daughter were responsible.  They "out-investigated" the Feds:  a seemingly difficult task, but in fact, relatively easy when industry-insiders are appointed to maintain only a semblance of regulation.  The Stones used a process developed to test for lead levels in deer carcasses (deposited by lead bullets), and found that 56 of 75 pieces of jewelry they tested exceeded Federal limits on lead (.06 percent).  Stone found that some jewelry was one-half lead by weight.

        When Stone tested the jewelry his daughter had received at birthday parties and found that it contained excessive levels of lead, he took his findings to the office of the New York State Attorney General.  The New York AG then pressed the CPSC for action and the recall was instituted.  (Sadly, it has been well documented that only a small portion of recalled merchandise is actually returned and taken out of commerce.)

          Andrew Cuomo, the New York AG, signed an agreement with 12 retailers to stop marketing products with unsafe levels of lead, but the CPSC was typically passive. Cuomo's hope is to force retailers to conduct independent testing, or to at least force them to require independent, reliabile testing.  As with other, similarly unsafe products, retailers have claimed that the problems lie solely with their suppliers. 

           As Charles Margulis, communications director for the Center for Environmental Health explained, the CPSC is often uncooperative and unresponsive to consumers who report safety issues.  People like Judy  Braiman, a grandmother of six in upstate New York, have been testing on their own and identifying items such as the "Sassy & Chic" bracelet sold at Dollar Tree stores.  The first bracelet she tested was composed of 23 percent cadmium, a metal classified as a carcinogen.  When Ms. Braiman repeated the test on another brand of bracelet sold at Dollar Tree, she found it was made up of 34 percent  cadmium.  In response to her press release, Dollar Tree has pulled the first brand of bracelet from its shelves--but not the second.  The CPSC has yet to act.  A spokesman for the Center for Environmental Health noted that the CPSC under the Bush Administration frequently omits from its recall notices the fact that the hazardous product was identified by private citizens, thereby allowing the rest of us to believe that the CPSC has actually accomplished something on its own.

          Yet another private citizen who has shown more motivation than the "loyal Bushies" is Marilyn Furer, an Illinois retiree who used a home testing kit to check her grand-child's bibs for lead.  She was appalled to find unsafe levels of lead on 8 of 20 bibs.  She took her findings to the Center for Environmental Health (a non-profit group) and ultimately secured the agreement of several companies, including Toys 'R' Us, to stop carrying the bibs.  The New York Times quoted Ms Furer as explaining that she kept thinking "someone should do something...[and] then you look around and realize that you've got to be the one to do it".  Its a sad comment on the well-paid "starve-the-beasters" in whose hands the Republicans have placed consumer safety, when well-intentioned retirees are more effective in protecting our children than are the "professionals". 

Problems with food safety

        After recalls of millions of pounds of hamburger, tainted seafood and all sorts of problems with e-coli in spinach and other fresh greens, American consumers are recognizing that their food supply is no longer the envy of the world.  That recognition is evidenced by the Food Marketing Institute survey showing a decline in confidence over food safety among American consumers from 82 percent to 66 percent.  One reason for this decline is corporate-friendly rules which, for example, do not require testing labs or importers to report a failed safety test.  The results are reported only to the importer who paid for it--which is then free to send the tainted foodstuff to a different, less reliable lab, for approval.  The FDA never learns of the failed test or concern over the imported product .

         Concern over issues such as this have lead the Food Marketing Institute's 1500 members to petition the Bush Administration to adopt new, more reliable rules and to stop coddling importers who put profit ahead of health and safety.  Perhaps with the FMI's influence, the Republicans will re-join the effort to maintain the safety of the American food supply.

Disclosure of clinical trials for popular medicines

        U.S. Cardiologists were complaining this week about the refusal of drug manufacturers to disclose the results of clinical trials on cholesterol-lowering drugs Zetia and Vytorin.  Despite the fact that they are prescribed to almost 800,000 Americans every week, at a total cost of $4 billion dollars, the manufacturers have consistently refused to provide prescribing physicians, consumers, or insurance payors with the results of clinical trials investigating [or documenting] their effectiveness.  We wonder why the physicians continue to prescribe these drugs if the manufacturers are unwilling to document that they are actually effective and continue to refuse and delay release of their test data?  The reason for this delay and obfuscation seems patently obvious.

        Despite heavy pressure from cardiologists, manufacturers Merck and Schering-Plough have refused to provide any results thus far, and have only promised to provide partial results in March of 2008.  Further, they announced that they were changing the "endpoint" of the study, thus re-designing the goal of the study mid-stream:  that is considered to be inappropriate in clinical research.

        These medications reduce cholesterol in a manner that is different than "statin" drugs such as Lipitor.  Unlike statins, these particular medications have never been shown to be effective in protecting patients from coronary artery disease.  The manufacturer originally claimed that this study would document that effectiveness, however, it is now suggesting that such documentation will have to be delayed until 2010 or later (while billions of dollars of revenue are generated annually).  The manufacturers' decision not to release their data must also be considered in the context of their 2005 agreement to "promptly" furnish drug effectiveness data.  The results of this particular study have been promised to cardiologists several times in the past and were originally to be produced by March of 2007.

        All-in-all, it is patently clear that the public has a significant interest in the data collected on patients included in these studies and that the FDA should be empowered to exercise greater control over this industry.  With medical expenses, and pharmacological expenses in particular, draining an ever-greater share of the gross domestic product and influencing the lives of more and more Americans, it is inappropriate and absurd to leave the regulation of safety in this area to manufacturers who have billions of dollars in annual sales at risk.  If, for example, these medications are not protecting patients against a future heart attack as well as a statin would, they and there doctors should be provided with the raw data that would allow them to make an informed decision about which medication to prescribe and purchase.

Serious impairment: a new low

      The rights of accident victims struck a new low in Michigan with the Court of Appeals' unpublished November 15, 2007, decision in Jones v. Jones, et al.  The Court upheld the Trial Court's dismissal of an auto negligence claim relying on the Kreiner Supreme Court decision requiring a "serious injury" to have "life-altering" consequences.  Under the no fault act, an injured person can only sue the at-fault driver if the injured person has a threshold injury (i.e., death, permanent serious disfigurement or a "serious impairment of a bodily function).  In 2005, the Engler majority on the Michigan Supreme Court reinterpreted "serious impairment" to require a "life-altering" impact.

          Controlled by this interpretation, the Court of Appeals in Jones held that the injured victim didn't have a "serious" injury, DESPITE THE FACT THAT SHE SUFFERED A FRACTURED BONE IN HER LEG THAT REQUIRED SURGERY AND INSERTION OF A ROD AND SCREWS TO MEND.  The woman required in-home health care for "several months" after discharge from the hospital, had to use a wheelchair or walker when she left home during that period, and required assistance with her activities of daily living.   She claimed she was left with a permanent limp and the need to use a cane for support.  She was unable to stand for extended periods or to walk any significant distance. 

        The Court relied heavily on the fact that Ms. Jones had not worked for three years prior to this injury and that "minor problems with walking or standing" are not "serious".  It noted that her physician had neither diagnosed the limp nor prescribed the cane and that she could perform most household tasks.  Her life was "not so different" from before the injury and therefore did not meet the Kreiner standard of a "serious" injury.  We wonder if the Justices who redefined "serious" to exclude an injury of this nature would still argue it was not "serious" if it was inflicted on one of them or their family.  We seriously doubt it.

"Operation of a motor vehicle"

      When America adopted the English common law, it also adopted the concept of "sovereign immunity".  This concept can be functionally described, historically, as the King's willingness to provide a court in which disputes could be heard, but his unwillingness to provide a venue for anyone to air a dispute against him.  How odd, that revolutionaries founding a democracy should adopt this view of the courts; but they did.  Sovereign immunity [now called governmental immunity] has remained a concept attracting strange bedfellows.  The people most likely to champion it today tend to be politically allied with "starve-the-beasters" hoping to minimize government and government services, and arch conservatives who resent special privileges being accorded to government and government agents.

        With that two cents of historical perspective, Michigan has adopted a handful of statutory exceptions to governmental immunity.  They involve governmental vehicles on the highway, public buildings, government employees guilty of "gross negligence" and a handful of other specific factual situations.  The arch-Conservative and insurance-industry-captive majority of the Michigan Supreme Court has done its best to whittle away at these exceptions, and another example of its impact was published in November of 2007.

        The victim in Martin v. Rapid Inter-Urban Transit fell down the bus exit stairs as she was leaving a City bus, suffering serious injury.  The driver acknowledged in his Incident Report that the steps were slippery, but claimed that the fall was not preventable because his bus was not equipped with either heated steps or an ice scraper.  The victim sued, claiming that she was injured as a result of the negligent "operation" of a motor vehicle.  The Court of Appeals dismissed her case because the Supreme Court has held, in Chandler v. Muskegon County, that statutory "operation of a motor vehicle" encompasses only activities that are directly associated with the driving of the vehicle....not its intended function. Thus, Ms. Martin can sue if the driver runs her over, but not if he pushes her under an approaching vehicle (or allows her to slide off the bus steps and under the wheels). 

        This absurdly result-oriented interpretation of statutory language is a common feature of the opinions written by Governor Engler's appointees to the Michigan Supreme Court:  they have held that governmental entities are not responsible for design flaws in public buildings; only maintenance problems.  There are dozens of other holdings that make little sense, either logically or from a public policy standpoint:  for example, Michigan cases now hold that an innocent victim injured by an out of control police vehicle can recover if the vehicle strikes him, but not if it forces another vehicle to strike him.  A fireman racing to a fire in a Township truck is responsible for negligence (say for running a red light at high speed); but if he is responding in his own truck, he is not.  A public buiding must be maintained in a safe condition, but the covered entrance need not.  There are literally dozens of other examples.

        In Martin, the Trial Court noted that there was no reason "on God's green earth" for the existence of this vehicle, other than to transport passengers, and denied the City's request to dismiss the case.   Logically, he felt that to "operate" a bus means to allow passengers to board safely.  The Court of Appeals judges acknowledged that keeping ice off the steps was "integral" to this purpose. Nevertheless, they reversed the trial court, holding that the "operation" of a bus does not include the essential functions of passenger boarding or transportation:  under Michigan law it includes only the functions associated with driving.  If Ms. Martin had alleged that the driver swerved slightly as he approached the curb, she would have a cause of action:  if he and the City completely fail to keep the walkway and steps clear, injured victims have no recourse.  What a sad state of affairs.  To paraphrase the famed jurist:  "The life of the law is not logic; it is influence."

Insurance agents and their authority

        In a recent Wayne County case, the Michigan Court of Appeals addressed the limits of authority of an insurance agent.  In  Briko's Market v. Emerson-Prew, Inc., a market suffered a loss of refrigeration and a significant loss of inventory.  They thought they were insured for such an eventuality, however, it turned out that their agent had never obtained a written binder for coverage on their market.

        When the owners went to the Oakland Insurance Agency to purchase insurance, Oakland's employee told them they had bound coverage, but did not comply with the insurer's requirements (i.e.,   submission of a twenty percent deposit, photos of the property and certain financial information).  The court concluded that even if Oakland was an agent of the insurance company, it had exceeded its authority by binding coverage without meeting these requirements.  Therefore the insurer owed nothing on the inventory loss.

          The insurer had also argued that Oakland Agency was not its agent and that Oakland was solely the agent of the insured.  In prior cases, the Michigan Supreme Court has held that an insurance agent is not normally the agent of the insured, and the agent's sole agency obligation is to sell as much insurance as it can for the insurer:  apparently a Michigan insured is damned either way, which seems to be a succinct statement of the state of the law in Michigan.

CPSC reforms

        Democrats in Congress continue to push reforms in the Consumer Product Safety Commission, over objections from Republicans and particularly the Bush Administration.  Belatedly concerned over the tsunami of unsafe products washing ashore and recalls, in particular, of dangerous toys, Congress is attempting to restore the CPSC's budget to its pre-war level and enhance its enforcement powers.  Despite its incompetence, indeed irrelevance (the CPSC has ONE toy inspector, currently), over the past few years, the Administration is fighting the reform of the CPSC and its acting director has maintained that no the reforms are unnecessary.

        The pending legislation in the House would enhance the CPSC budget, adopt standards on lead, renovate test labs, require third-party testing and generally focus on children's safety.  The Senate's proposed reforms would add safety inspectors and assign additional safety agents at ports of entry to the U.S.   Both versions would increase penalities for violators and give the agency more authority to recall products.  In response, Republicans have  suggested an "action plan" that relies upon volunatary reforms within the industry:  even industry executives deride that suggestion.  We think it was proposed by people who have been eating too many lead-based paint chips on one side of the Capital aisle.

       

Home foreclosures

      In a small victory for consumers, a federal judge in Ohio has ruled that lenders attempting to reclaim homes through foreclosure cannot side-step their obligation to document their standing.  They must prove that they own the mortgage security so that borrowers aren't faced with multiple deficiency claims--particularly since it has been documented that mortgages may be identified with more than one security trust. 

          Many media outlets have reported that consumers attempting to work out their differences with mortgagors have experienced difficulty identifying who they owe money to, and who speaks for the creditors.  This problem arises because the lender creates the note and mortgage and then sells it to companies who create mortgage "pools" to own the promissory notes as securities titled to hundreds of investors under the control of a bank trustee.

        Many of these notes carry burdensome interest rates--in some cases well above the current market rates.  A high percentage were adjustable rate mortgages that had "teaser" low rates initially, but then graduated to relatively punitive interest rates after a number of months or years.  They also have terms that prevent the borrower from paying the note early (by refinancing with another lender at market rates, for example), and borrowers and their counsel often cannot identify anyone with the authority to investigate a compromise of these terms.  The Judge chastised the banks in the instant case, writing in his opinion that the banks' argument "reveals a condescending mindset and quai-monopolistic system where financial institutions have traditionally controlled ... the foreclosure process."  He refused to allow the banks to dictate the law to him, but the banks are free to re-file in State Court where they may find greater success in imposing their ideas about ownership and accountability.

More on nursing homes as an "investment"

        In an earlier blog entry, we documented the difficulties that governmental entities and elderly injury victims have encountered when nursing homes are purchased by private investment groups dedicated to extract the maximum profit from the investment.  Staffing is reduced, less care is provided, safety issues become secondary to profit, and care decisions are made by financial executives sheltered behind several layers of corporate cover to shield them from liability.

        The New York Times reported in its November 16 issue that Congress has held hearings in an attempt to force nursing homes to make public greater information regarding ownership and to enhance accountability.  One of the proposed solutions is to make public the "special focus facility list" which identifies homes that are considered the worst by government regulators.  Can anyone imagine why taxpayers, who pay to investigate homes and to compile the list, should not have access to it when deciding where a loved one should reside? 

          Pete Stark from California pointed out that this industry derives almost its entire income from government and that there should be both transparency and accountability in the industry.  Wealthy owners should not be able to avoid paying court verdicts and fines assessed after poor care by hiding behind shell corporations:  the NYT article in  September identified several "successful" examples of this  practice.

          A study of thousands of nursing homes purchaed by private equity firms reported in September of 2007 showed that after purchace, expenses and staffing were routinely cut, in many cases below safe and legal levels.  Despite this practice, on many occasions the decision makers cannot be held responsible, either civilly or criminally, because of a complicated corporate ownership shell-game utilized by the investors to evade identification and liability. 

          One of the nursing home executives who appeared before Congress to object to any new accountability rules was forced to acknowledge that his employer had five sites on the "special focus" list.  Perahps he and his employers ought to change their "focus" and direct their attention away from Congress and toward providing better care; it won't happen without the government twisting their arm, however.  There have now been about half a dozen studies published on this issue, and they have consistently shown that after a home is purchased by private investment groups, average staffing goes down and quality of care declines:  but profits improve.

Helmet safety: chin strap recall by Nike

  Today, NIke recalled almost a quarter million football helmet chin straps because they broke under stress.  The Company had received reports of 18 injuries caused after chin strips failed during play allowing the player's helmet to come off.  The injuries varied from severe concussions to facial lacerations and apparently occurred over a period of years prior to the recall.  Prior studies have shown that recalls of this sort actually recapture less than ten percent of the recalled products from the market, as consumers are either unaware of the recall or fail to respond.

      Not surprisingly, the chin straps were manufactured in China.

More information on the safety of drug-coated stents

        The November 12 issue of the New York Times reported that the medical and pharmaceutical industries are re-examining the issue of drug-coated stents.  These stents had been in widespread use over the past decade as a means of reducing the likelihood of re-clotting at the location of a stent used to preserve the integrity of coronary arteries.  Over the past 18 months, research had suggested, however, that drug-coated stents presented a new hazard of later-developing clots.  As a result, there was a dramatic reduction in the use of drug-coated stents, with the NYT suggesting that the sale of these stents dropped from 6 billion to 5 billion dollars over the last year.   Very sick patients opted for open-heart surgery as an alternative, while other coronary artery disease patients chose bare metal stents or chemotherapy alone.   Patients treated with drug-coated stents were placed on a longer regimen of anti-clotting medications as a precaution.

        Newer studies have demonstrated that the issue is not as simple as originally thought, however.  Some studies have suggested that perhaps the original studies identifying the risk of clotting may be skewed because drug-coated stents were used in sicker patients.  Another study of 17,000 patients suggests that the survival of drug-coated stent patients is better, long-term, than the survival of bare-metal stent patients.  Other physicians point to the  risks and complications of open-heart surgery that must be weighed against the risk of late-developing clots.  It will probably require several years of experience and more subtle investigation to tease out the "truth" about drug-coated stents.  In the meantime, this is an issue that should be examined carefully by every patient and his or her physicians.

Merck settlement for Vioxx

        On November 10, 2007, the New York Times reported that the investment community considered the $5 billion settlement of Vioxx lawsuits to be a victory for the company.  The painkiller Vioxx was pulled from the market after it was shown to contribute to the likelihood of myocardial infarcts and strokes.  The settlement will occur only if 85 percent of the 27,000 pending lawsuit victims accept it, which the Federal Court apparently considers likely.  News of the settlement pushed Merck's stock value up.

        Merck had won about 2/3 of the cases that had been tried, including 8 of the last 10.  Where it had lost, however, it had also been compelled to pay significant punitive damages. To receive a settlement, victims will have to prove that they actually suffered a stroke or heart attack within 14 days of taking Vioxx for at least 30 days.  It will be difficult for Michigan resident victims to share in the recovery because the Michigan courts have granted immunity to any drug manufacturer whose product is approved by the FDA.

Immunity for the Catholic church

     Sunday's Traverse City Record Eagle quoted a Catholic Bishop--I think he was from the Catholic Diocese of Chicago--calling for immunity for the Catholic Church in the child-abuse scandals.  The Priest suggested that the verdicts and settlements resulting from the priest abuse of children were destroying the Church and punishing innocent parishioners.  He never mentioned the word "responsibility":  a concept that is only mentioned by tort reformers when they are chastising victims with potential contributory fault. 

          We can certainly understand the anger and frustration of ordinary people whose church contributions are being used to pay these settlements and verdicts, and we all could probably identify some settlements that seem too large or too stale.  If we were to ignore the Church's responsibility for enabling some of these serial abusers, immunity for the Church might make sense.

        Nevertheless, eliminating civil liability for these claims would be dreadful public policy.  Any organization that allows access to children in a fiduciary context and then fails to protect them from abuse must be held accountable.  In the instant situation, it is only civil liability that has brought  to the surface the incredible role that the Church hierarchy has frequently played in protecting perpetrators and enabling them to repeatedly abuse children--even through multiple generations.  Immunity is not the answer, and it is a harsh commentary on the state of our public discourse that an ethical figure can ignore the responsibility of his own institution and demand this type of "tort reform" without being shouted down by the public.

Toy beads coated with the "date-rape" drug cause seizures

        It will come as a surprise to almost no one that National Public Radio reported on November 8 that yet another Chinese-made toy had been yanked from the market.  In this case, the toy was "AquaDots", one of Wal Mart's designated "toys of the year".   The toy was designed in Australia and manufactured in China.  A child uses the beads supplied to create a mosaic; the beads are then melded in place by applying water.  The Australian doctors at Westmead Children's Hospital responded to a child's severe illness by ordering a urine sample and found GHB, the dangerous and banned chemical described colloquially as the "date rape drug" in the child's urine.  The drug is known to cause seizures and respiratory failure and has caused fatalities.

        Follow-up investigation confirmed that the two-year old had eaten some of the beads and vomited up some just before becoming comatose.  Within 48 hours, the GHB  disappeared from his system, confirming the recent ingestion of the chemical.  The child's beads were then tested with a mass spectrometer, and the presence of GHB was confirmed on these beads, apparently used to prevent the water-soluble glues coating the beads from adhering prematurely.  Although it wasn't listed on the manufacturer's list of ingredients, GHB apparently turned up on additional beads, and another Australian child was hospitalized with seizure and coma.

        The North American distibutor of the beads immediately notified retailers to withdraw them from their shelves,  and shortly thereafter the CPSC ordered the product recalled in the U.S.  The manufacturer is now proposing to add a foul-tasting coating to the beads to discourage chidren from swallowing them.  That doesn't seem to us to be an adequate solution--particularly at a time when candy makers mimic a popular movie by selling jelly beans that taste like vomit.  It will probably be enough to satisfy the current administration's head of the Consumer Product Safety Commission, however:  she has been willing to consume foul-tasting material on behalf of unregulated industry for some time now.

        Right now, our citizens are saving significant sums by out-sourcing to cheap, unregulated labor and manufacturing in the third-world, production of everything we buy.  We must have a principled discussion about whether we are willing to spend a few of those "saved" dollars to protect the safety of our children and ourselves.  It is clear that China and other third-world governments will not, or cannot, protect our consumers.  This is a new problem created by the "flat world", and our government has not only refused to address it:  under President Bush we have even stripped the CPSC budget by half.  We should be giving the matter some principled analysis and we are not.

        Legislators in Michigan should reconsider, for example, their tort-reform grant of immunity to retailers who sell defective products.  This immunity significantly reduces their financial incentive to market only safe products and eliminates their incentive to require that producers insure the products sold.  As a result, suppliers from China, for example, where the government won't allow service of process, are out of the reach of injured consumers.  And for a few cents saved on each product, our health care and welfare systems must provide for injured kids rather than the at-fault industry.

        The Bush Administration has finally proposed an "Action Plan" to address consumer safety, however, it is too little, too late, given the prior dismantling of the Consumer Product Safety Commission.  The FDA would get the right to recall foods (how absurd that it doesn't have that right, today, but keep in mind that recalls have been shown to be only marginally effective in removing many products from retail shelves or reclaiming them from purchasers).  The FDA could require foreign manufacturers to certify that products comply with its standards, however, the current debacle in product safety suggests that would be a hollow gesture.  It could levy larger fines (up to $10 million dollars), but marginal products produced by one of the thousands of marginal producers in China would be equally undeterred by potential fines of any size.  Finally, the "action plan" continues to rely on self-policing by the various industries and does not provide for the funding necessary to take an active role in actually protecting consumers.  That won't happen for as long as the "starve the beast of government" mentality remains prevalent.

Safety concerns with regulating the chemical industry

        The Department of Homeland Security has just released its rules on reporting stockpiling of toxic chemicals, and true to form, the Bush administration has imitated the fox in the henhouse.  The new rules allow, for example, unregulated storage of up to 2500 pounds of chlorine:  one of the most deadly chemicals in regular use.  A company does not even have to report the theft of 450 pounds of chlorine, even though it could be more deadly than  ten times that quantity of high explosive.    Chlorine has been used against civilians by insurgents in Iraq.  [Think of the disaster in Bhopal, for example, and then imagine if it was designed to achieve maximum mortality by the architects of 9/11.]  The Department had proposed more stringent rules in April, however, they have been watered-down since by the Administration's corporate allies who provide what cerebral power is exercised by this Administration.  A Greenpeace spokesman attributed the tepid and unsafe rules to the usual pattern of former industry executives now serving in the federal government as regulators----who refuse to regulate.

Infrastructure, regulation and government

       News from Russia during November of 2007 helps to clarify what happens in a first-world culture when the government does not dedicate adequate resources to regulating for the public good.  It is common knowledge that under Vladimir Putin, the Russian State has used oil wealth and unregulated capitalism to grow the country's economy and create instant billionaires by selling state resources to the private market.  The underside of this rampant grasp of unregulated capitalism has been less well documented.  The Russian death rate from fire is a telling statistic that sheds some light on the dangers associated with ignoring the public infrastructure.

        In 2006, more than 17,000 people died in fires in Russia.  That is  a rate of 40 people per day and more than 12 people for every 100,000 people in the population, and it is TEN TIMES THE RATE OF FATALITY EXPERIENCED IN EUROPE AND THE U.S.  Why the difference?  Probably some of it is attributable to higher rates of alcoholism and smoking, but that doesn't explain a multiplying factor of ten.  Much of the difference comes from a failure to invest in public safety.  The fire equipment is aged, poorly equipped and frequently poorly maintained.  Public and private buildings rarely comply with meaningful building codes and frequently lack normal safety amenities.  Inferior materials are used throughout construction. 

        When hundreds of school children died after terrorists seized a school in Beslan, many of the deaths were attributable to an uncontrolled fire that raged through the school and not directly to violent actions of the terrorists:  120 bodies were found under the collapsed roof of the gymnasium.  When fire engines arrived, they did not have adequate supplies of water.   Firefighters earn only about $400.00 per month, so firefighting agencies are unable to attract excellent candidates.   Even the road infrastructure plays a role; urban roads are clogged and response time for emergency vehicles is ridiculously high, given the distances involved.

        At a time in our country when all public discourse seems to be directed to reducing taxes, "starving the government beast" and deregulating the economy, it pays to look around the world and to examine what our tax dollars buy.  Being wealthy in a culture without infrastructure may not be what we really want.  While many "premium" buyers of home insurance managed to save their mega-homes in the American west during the forest fires of 2007 after their insurers supplied private fire protection, that two-tiered safety system isn't always reliable [regardless of the ethical questions].  Ten years ago, Premier Putin's own dacha burned to the ground.  He blamed the loss on inadequate firefighting resources.

After FDA refuses to act, data forces Bayer to remove drug from market

     The German manufacturer,  Bayer AG, recently removed Trasylol from the market after a Canadian study questioned its safety.  Trasylol had been approved by the FDA to enhance clotting and was used in a variety of situations, but particularly during open heart surgery.  Several recent studies had suggested that it carries a higher mortality rate than the cocktail of drugs used for this purpose previously, however, because the investigations were not done in classic "double-blind" methodology, the research is not clear-cut.   The most recent investigators felt, however, that it would be unethical to continue the study, given the developing findings suggesting that Trasylol patients were being exposed to an inappropriate and unjustifiable risk.   The FDA said it "could not identify a specific patient population where the benefits of using Trasylol could outweigh the risks", which included heart attack, kidney failure and stroke.

        Despite removing the drug from the market, Bayer continues to claim that it is effective.  While the concerns about the drug were raised several months ago, the drug was never officially removed from approval by the FDA, despite two hearings on the subject.  The pro-manufacturer bias of the FDA process makes it very hard to remove any drug that has been granted approval in the past--no matter how little research preceded approval or what the subsequent research has shown.  At a hearing in September of 2007, medical witnesses and scientists called by Bayer to support Trasylol did not disclose that Bayer had conducted a test of its own which strongly suggested worrisome findings about its safety.  When the study was brought to light after Trasylol remained on the market, Bayer concluded that the findings had been withheld from the FDA as a result of "regrettable human error".  Of course, there were no negative consequences for Bayer as a result of this "error" and the drug remained on the market for two more months until a more definitive study increased the pressure on the manufacturer.

Health, health care, trauma and health insurance in America

        According to the Army's Chief Surgeon, trauma is the third-leading cause of death in the U.S., taking 160,000 lives in 2004.  This is more than any cause other than heart disease or cancer.  Further, traumatic deaths are disproportionately inflicted on the young.  The Surgeon--Dr. John Holcomb--is determined that some good come out of the Iraq debacle by developing useful trauma data that can be applied to provide better care for military casualties and civilian trauma victims.  He has guided investigation in the area of blood clotting, burns, amputation and transporting patients directly to locations other than "the nearest level one facility".

        With respect to the other two leading causes of death, cancer and heart disease, recent research has confirmed that the primary method of effectively addressing these causes to reduce the resulting death rate, is to assure the availability of primary health care to all citizens.  In insured groups, the successful early diagnosis and treatment of these problems results in an improved survival rate.  The Chief Executive of the American Cancer Society reduced it to this simplicity: "A woman without health insurance who gets a breast cancer diagnosis is at  least 40 percent more likely to die."

          As for heart health, the primary culprits remain smoking and obesity, and obesity may also be implicated in cancer etiology.  The New York Times reports that two recently published books point out how complicated it can be to address modern health issues.  Just a few examples include the decision in the 1950s to attach a more effective filter to Kent cigarettes:  great idea, except that they used pure asbestos as the filtering mechanism.  Another example was the use of Estrogen supplements to combat menopausal symptoms; it turned out to enhance the growth of cancers in some patients.  Everyone knows about the prescribing of morning-sickness medication that lead to birth defects in children, and we all know that radiation can diagnose a tumor, treat it, or cause it--all depending on the circumstances and requiring a careful balancing of factors. 

        Along the same vein, NPR's recent Science Friday examined the question of a "healthy diet" and pointed out that in less than twenty years, medical science has made several 180 degree turns in its diet recommendations.  The "four food groups" and the food pyramid no longer stand scrutiny, and more recently Dean Ornish's focus on eliminating animal fats has come into question.   Current research suggests that the healthiest diet must limit the intake of carbohydrates and particularly complex carbohydrates, in order to limit the production of LDL or "bad" cholesterol.

The Bush CPSC: traveling on the toymakers' dime

    Perhaps there is a reason why President' Bush's appointed head of the CPSC has been reluctant to strengthen the Consumer Product Safety Commission.  She testified last week before Congress that her agency did not want Congress to put back in place the resources that had been stripped from the Agency over the past decade.  It was always known that Nancy Nord shared her boss's disdain for regulation, but what wasn't known at the time of her testimony is that she had been accepting favors from the toy making industry.  The Washington Post reported that she and her predecessor, Hal Stratton, had accepted "gift travel" from these businesses with products under examination by the CPSC, that included trips to China, Spain and a golf resort on Hilton Head.  Apparently she wasn't carrying her "lead paint detector" when she went to China.  Mattell would have been wiser to send a handful of product testers to China in her place--but then if it had, while it would have avoided a huge recall, it might have been saddled with a CPSC Director who took her job seriously.

Pediatric cold medicines

The FDA continues to wrestle with the question of the safety and viability of pediatric cold medicines.  These medicines were marketed for years before the FDA became involved in approving over-the-counter medications, and as a result they were "grandfathered" approval without normal testing requirements.  In addition, at the time the FDA did not impose any testing requirements or a sundown date on the approval, so they have never been tested for safety or efficacy.  The handful of clinical trials that have been undertaken suggested that they are no more effective than a placebo.

        As one pediatrician on the panel explained, children are not, metabolically, just little adults.  They respond to medication differently than do adults.  No medications should be approved for kids without appropriate testing on kids.  There are more than one hundred documented cases of deaths of children related to these medications, and the Advisory Panel has recommended taking them off the market.   Some experts would recommend that they be removed from the market for all kids up to age 12.   The panel noted that there were more than 1500 reported cases of serious childhood health problems associated with common cold medicines administered to children under two years of age, during 2004 and 2005 alone.   

        As this is a 2 billion dollar market, manufacturers have vigorously opposed removing these medicines from the market.  They have agreed to removal of some medicines being marketed to the parents of very young children and they have suggested that clearer product warnings would be an adequate safety measure.  Further information on these issues can be downloaded from websites for NPR and the New York Times Archives.

Chinese chemicals in the world market

        A column in the New York Times' October 31, 2007, edition pointed out that unregulated Chinese chemicals are flooding world markets.    Present at the annual international show in October were one manufacturer who was recently implicated in the American illegal steroid trade, and another whose representative at the 2006 trade show was arrested for patent violations.  Also in attendance were representatives of two state-run companies who had killed nearly 200 people in Haiti and Panama by selling mislabeled poison.  The CEO of another chemical company that reserved a booth at the trade show in Milan  could not attend because he was in jail in Houston for selling counterfeit medicine in the U.S.

        The NYT identified more than 80 Chinese companies who were selling pharmaceutical ingredients but who were not certified by the Chinese version of the FDA.  Because they are selling drug "ingredients" rather than drugs, Chinese drug regulators lack jurisdiction to regulate them.  As a result, their unregulated ingredients find their way in to the third-world consistently, and into highly regulated European and North American markets on occasion, as well.  Times reporters identifed dozens of examples of known-law breakers continuing to do business, unrelenting illegal and false advertising claims, and consistent unwillingness of the Chinese government to attempt to rein in these abuses.

        In truth, it isn't simply a failure of will by the Chinese government (although several of the known law-breakers have been companies owned by the Chinese government).  On October 30 of this year, the Chinese claimed to have arrested 774 people in a crackdown on the sale and production of tainted food and drugs.  It acknowledges that more than 80 percent of the food tested in medium and large Chinese cities does not meet safety standards and that one-third of all restaurants do not pass food safety inspections.  Since  July, the Chinese claim to have destroyed or recalled "over 1000 tons" of products. 

        Nevertheless, to some extent unbridled expansion of the Chinese economy has created nightmare that is incapable of regulation.  It is widely estimated that there are more than 80,000 chemical manufacturers in China, many of which are housed in family homes.  More than 1300 companies advertise on a major business-to-business website and Chinese products are sold in more than 150 countries.    More than 700 Chinese companies are known to manufacture drug products for U.S. consumption, but the American FDA has resources to conduct only about 20 inspections in China per year, according to Representative John Dingell of Michigan.

         The Chinese don't have the resources to clean their own house, and the American government doesn't have the political will to dedicate the resources to policing even our modest share of the Chinese manufacturing trade.  Our consumers will continue to live at risk of unsafe and unscrupulous practices.

More on "open and obvious"

        Victoria Engler took her daughter to the MacDonalds in Cadillac for lunch.  On the way in, she fell when she tripped over a gap between the floor tile and a grate in the entryway.  Ms. Engler said she observed the tile/grate area, but did not recognize that the gap was deep enough to constitute a trip hazard.  Her attorneys provided an affidavit from an engineering safety expert to support Engler's claim that the area was unsafe and "not readily visible upon casual inspection," which is the standard for application of the "open and obvious" doctrine.  Under the latter doctrine, the owner of property owes no duty to eliminate an obvious danger or to warn of it.  There are a few limited exceptions to this lack of duty.

        The Court of Appeals rejected Engler's testimony and that of her engineering expert.  It held that photographs of the area "demonstrate that the gap...is clearly visible".  On that basis, the Court held that a reasonable person would have identified the problem "on casual inspection" and foreseen the danger.   While the question of what dangers a reasonable person would recognize "on casual inspection" would appear to be a question of fact for the jury, the Supreme Court has held that "open and obvious" is a question of duty--and therefore a question of law--for the court to decide.  This leaves the Court of Appeals free to decide that a case should be dismissed based on the Judges' determination of what reasonable people would see or avoid. 

        We believe that in a less political atmosphere, this refusal to recognize the factual foundation for the open and obvious defense will (or would) be discarded.  In the meantime, ordinary people's day-to-day interactions with their environment will be gauged by (and second-guessed by) people who have the ability to make careful, studied analyses of the situations that injury victims were duty-bound to make only "casually". 

        There is a perverse and hypocritical aspect to this analysis that is fully divorced from real-world thinking.  Real people do not make in-depth investigations of every step that they take in public surroundings: they window-shop and they examine merchandise on display; they read advertising designed to attract their attention and conduct social and business intercourse while moving.  They react to the unexpected actions of others and at times their actions are influenced by lighting, black ice, unconscious assumptions about universal stair heights, and they make any number of additional reasonable decisions--decisions which architects and engineers have recognized for decades.   

          A simple public policy rejection of spurious premises liability claims would be far more intellectually honest than is a presumption that ordinary "reasonable" people will and do identify through casual inspection every possible hazard they may encounter.

CPSC recalls lead-painted teeth on Halloween day

  On Halloween Day, the day after Nancy Nord, the Bush-appointee in charge of the CPSC, told Congress her agency did not need the restored resources voted by Congress, the CPSC made a desparate attempt to recall "Scary Teeth" manufactured in China.  On Halloween Day, the CPSC acknowledged that the "costume" fangs designed as an oral accessory  for children's costumes, contained an unsafe level of lead paint. 

          In earlier blogs we have pointed out the lack of power and resources in the CPSC and the overall ineffectiveness of relying on recalls to remove products from the marketplace:  it has been well documented that recalls frequently remove only a small fraction  of the recalled product from the stream of commerce.  In this case, it is highly unlikely that the product alert issued  on Halloween afternoon accomplished anything to keep our children safe.  The head of the CPSC should be fired over this incident, alone:  she was appointed to the Agency after lawyering for Eastman Kodak and holding office at the United States Chamber of Commerce.  She is another example of the right-wing extremist effort to appoint foxes--no make that weasels--to guard the chicken coop.  In any event, it is certainly clear that "Scary Teeth" from China don't scare Nord; she probably has no children who are of a "trick-or-treating" age.