TOV Injury and Safety Blog

Abbott Laboratories agrees to pay $1.6 billion dollar fine for illegal marketing of Depakote

The pharmaceutical maker announced this week that it would pay this combined criminal and civil fines by agreement with the federal government, after admitting that it violated federal law in marketing the anti-seizure medication.   As seems to be the case in most pharmaceutical manufacturers' punishments, the fines probably don't even approach the profits the company earned by its illegal conduct.

Although Depakote was approved for sale by the FDA, the FDA did not approve its use for schizophrenia or dementia.  Abbott illegally set up a "specialized sales force" that attempted to persuade nursing homes and others to purchase the drug to control patients' and residents' agitation.    This effort to "sedate" elderly patients, without securing FDA screening of the use for this purpose, was considered particularly egregious, given the patients' inability to protect themselves or to give their informed consent.

Abbott also wrongly marketed the drug for schizophrenia, even though its own clinical trials had not proven the drug to be more effective than existing antipsychotic medications.  Doctors may experiment with "off-label" or unapproved, untested uses of FDA-approved drugs, however, the manufacturer cannot market a drug for such an un-tested use.  In Michigan, drug manufacturers enjoy immunity for FDA-approved drugs--even though the approval was not secured for the marketed use of the drug.  Michigan is the only state that affords pharmaceutical manufacturers this form of immunity.

With profits down, Pfizer announces it will re-focus on research.

For years, apologists for the pharmaceutical industry have attempted to justify outrageous industry profits by arguing that they were necessary to support industry research that ultimately benefits consumers with new medications.  Last week's announcement by Pfizer that it now would re-focus on research in response to dwindling profits demonstrates how ill-founded the prior claim was.

Since Pfizer lost its monopoly on Lipitor last fall [parenthetically the best-selling drug in history], its profits have already dropped by 19% and company executives are announcing a radical shift.  Instead of buying up small competitors, Pfizer now plans to divest its animal health and infant nutrition subsidiaries, and instead focus its research efforts on only "the most promising" areas of pharmaceutical research.  One executive was quoted to the effect that "...we were spending huge amounts of money...we weren't producing the drugs we needed..." 

The Company also announced that it would spend less on research and development at the same time that it improved its focus on developing market-worthy new medicines.  Critics called this a risky and counter-intuitive strategy. In any event, it is yet another acknowledgement that enormous profits were not being directed to effective research in human medicine.

Academic research by University of Texas, University of Illinois and Nowrthwestern University demonstrates malpractice "reforms" did not increase doctor supply

A recent study by three highly-respected Universities demonstrated that the wholesale "reforms" [anti-victim limitations on medical negligence recoveries] adopted in the State of Texas had NO impact on the supply of doctors in the state.  The study concluded that the supply of physicians operating in the state was relatively "inelastic" and not influenced by steps taken to protect doctors from negligence claims.

The authors concluded that their research was consistent with prior multi-state studies showing that there is no relationship between "tort reform" and physician supply.  Even though special interest-Republican "reforms...dramatically changed the malpractice environment..." in Texas, they did not have any impact on the number of doctors in practice--even in poorer rural areas or high-risk specialties.  

The authors also found that the "reforms" did not influence health care costs in the state.  On the contrary, studies in Texas have shown that the major influence on health care costs in Texas is "fee for service" medicine and physician-ownership of ancillary services they can charge to provide.  Lastly, the authors noted that  insurance companies have fought "tooth and nail" to eliminate public access to reliable claims data which the National Association of Insurance Commissioners has attempted to create:  without this data, the authors indicated it would have been  impossible to ascertain the true impact of "reforms" such as those undertaken in Texas.

The authors explicitly pointed out that there was no factual support for "reformers' " claims that the lack of a cap on malpractice awards deterred doctors from practicing in Texas or that adopting a cap had increased the number of practicing doctors.  Supply was not stunted before reform and did not measurably improve after--even in so-called "high risk" specialties.  Neither did it influence health care costs by eliminating or limiting the practice of "defensive medicine."  The article is entitled "Does Tort Reform Affect Physician Supply?  Evidence From Texas."  It can be downloaded at http://ssrn.com/abstract=2047433.

Supreme Court's conservative majority dismisses dental malpractice claim

Rodney Hanna sued his dentist, whom he claimed improperly capped two teeth.  Hanna claimed that among other problems, the dentist, Dario Merlos, DDS, had failed to perform root canals under the crowns he placed.  Hanna sent a detailed letter to Merlos, informing him of the claims of malpractice and then retained an attorney to sue.  The attorney filed a Complaint in Circuit Court which alluded to the attached Affidavit of Merit, but no one could locate the attachment.

The dentist's insurer sought summary disposition, arguing that Hanna's letter wasn't an adequate Notice of Intent to Sue and that the case must be dismissed because the Affidavit of Merit was not properly filed with Hanna's Complaint.  The trial court dismissed the claim, however, the Court of Appeals reversed.  It held that Hanna's letter of specific complaints was adequate to meet the Notice of Intent requirements.  It also held that since Hanna's attorney promptly filed a copy of his Affidavit of Merit when its absence in the court file was brought to his attention, "the interests of justice" did not justify permanent dismissal of his claim. 

This week the four insurance-oriented Justices on the Michigan Supreme Court summarily overturned the Court of Appeals' decision. It held that since there was no proof that the original Affidavit of Merit had been filed with the Complaint, the action must be dismissed (and cannot be filed again later).  It did not address "the interests of justice" as those interests don't particularly interest or influence the current Supreme Court majority.

Malpractice insurer discusses expenses associated with defending malpractice claims

In a letter to the New England Journal of Medicine, several doctors reviewing data from a national malpractice insurer attempted to quantify the cost of defending malpractice claims.  Of course, data from 50 states is inherently misleading in any one state, since there are 50 entirely different systems for proving fault and collecting damages, and 50 different responses to insurers' calls for "tort reform."  In many states, "reforms" have granted doctors and their insurers enormous special advantages, and, for example, damages are "capped" at levels ranging from $250,000.00 per injury to $1,000,000.00 per injury.  In other states, where consumer advocates have balanced the impact of big-money contributors, "reforms" have been more balanced and precise.

Federal Court allows injured workers to sue employer, insurer and "independent" [IME] doctors for fraud

A group of Cassens Transport Company employees who had been injured on the job sued Dr. Saul Margules, Cassens, and Cassens' self-insured claims manager, Crawford & Company, alleging that the three conspired to deny benefits to injured workers.  The suit alleged that Crawford consistently retained unqualified and biased physicians to render fraudulent reports disputing the workers' injuries or medical condition.

Court denies medical provider's attempt to intervene in No Fault PIP action

Carolyn Nicholson is the mother and guardian of her daughter, Jeanne, who suffered a severe and incapacitating head injury in a motor vehicle collision.  She was forced to sue Citizens Insurance Company to secure PIP Medical benefits for her daughter.  After the case had been pending for some time, the parties agreed on a settlement that included the payment of fees and costs to Nicholson's attorneys.  At that stage, Willowbrook Rehabilitation Services sought to join the case to secure full payment for its services and to deny Nicholson's attorneys fees based on Willowbrook services.

Attention brought to immunity issue involving generic drugs

In most states, a drug manufacturer may be sued if a drug it patents is sold with inadequate warnings and instructions to consumers.  The FDA approves drug warnings and labeling, but the manufacturer remains liable if the language proves inadequate in practice.  Well, actually the manufacturer remains liable in all states except Michigan where "tort reformers" gave manufacturers immunity for all drug claims involving FDA-approved drugs (even if the approval was later withdrawn or originally achieved by fraud or falsified data).

Last year, the U.S. Supreme Court majority granted immunity to generic drug manufacturers for "failing to warn," with the conservative majority holding that since generic manufacturers were merely copying the drug and labeling from patented drugs, they owed no duty to consumers to provide further information.  This immunity grant created an unlikely situation. Consider this example:  Diana Levine, a professional musician who lost a hand when an injection of anti-nausea drug in the ER caused gangrene, collected $5.8 million dollars in damages against Wyeth, the drug manufacturer.  Debbie Schork suffered the identical injury in similar circumstances, however, her claim was dismissed without compensation, because the ER nurse injected her with a generic version of the drug.

Since 80 percent of prescriptions filled in the U.S. are now filled with generics; since many health insurers now require the use of generics and the law allows pharmacies to substitute generics for prescribed medications, there is little or no justification for granting generic manufacturers immunity for inadequate warnings and instructions.  The ultimate goal of a legal system should be to render justice that is uniform, predictable, and consistent.  The situation existing with regard to pharmaceutical manufacturers enjoys none of these characteristics.

Painter loses common work area injury claim

James Shawl suffered injury to his back when a large electrical box  with protruding screws fell and struck him while he was working as a subcontractor painting the entrance to the Saginaw County Event Center.  The General Contractor on the project was Spence Brothers construction company.  Shawl sued Spence Brothers, arguing that it negligently fulfilled its duty to protect employees working in the common area from construction hazards.

The Court of Appeals upheld the dismissal of Shawl's claim.  It ruled that the electrical box did not pose a substantial risk of severe harm and that a significant number of workers were not endangered by the box.  Therefore, the risk it posed did not create a "common work area" duty on the part of Spence Brothers to protect the employees of subcontractors.

Driver who claimed medical emergency cannot reverse strategy and claim physician-patient privilege to avoid turning over medical records.

Medical records are privileged:  normally a person can decline to produce medical records even in response to a subpoena.  In order to sue on an injury, however, the victim must make his or her records availabe to the at-fault individual and his or her insurance attorneys.  The victim has voluntarily placed his physical condition "in issue" by filing suit.   If the victim does not allow access to these records, his or her injury claim must be dismissed.  Similarly, if the allegedly at-fault person wants to avoid turning over his or her privileged medical records, the defendant cannot rely on a medical emergency to explain the occurrence. He or she has placed the his medical condition "at issue."

USA Today points out that pharmaceuticals have paid at least 8 billion dollars in fraud penalties

In today's USA TODAY, it was pointed out that Pfizer has paid 3 billion dollars in fines and Merck an additional $1.6 billion, with other major pharmaceutical manufacturers paying more than $3.4 billion.  Despite this record of overwhelming fraud on Medicare and Medicaid, the companies continue to make record profits from sales to Medicare and Medicaid recipients, because under their patent protection, the consumers have no where else to purchase needed medications.  An Assistant inspector general for Health and Human Services pointed out that the government is "seeing some of the big companies a second and third time...the corporate integrity agreement [which convicted companies sign as part of the resolution of claims] is not sufficient to deter further misconduct."  In response, Republican Chuck Grassley of Iowa joined with Democrats to attempt to pass a federal bill that would include individual liability for corporate executives, however, heavy spending (over 200 million dollars including 12 million by Pfizer) and lobbying by the pharmaceutical companies has thus far prevented passage.

University of Michigan investigation demonstrates filthy surgical instruments are common hazard

It does little good for your surgeon to "scrub up" carefully, if the tools of his profession harbor bacteria.  In part because of a design flaw in many surgical instruments, it turns out that bacteria and debris are frequently carried from patient to patient in inflow/outflow cannulas, arthroscopic shavers, endoscopes and other instruments. Recent investigations have documented literally hundreds of infections, some fatal, transported within these instruments because the medical professionals using them had not followed manufacturers' instructions on cleaning.  In other cases, however, investigators have determined that the manufacturers' instructions are simply not adequate to remove surgical debris (and germs). 

Higher court reverses dismissal of 34-year old woman's negligence case arising out of double-mastectomy where pathology report found no cancer

Stacey Van Buren identified a suspicious lump on her breast and visited the doctor for evaluation.  Her surgeon, Carlotta Maresca, M.D.,  performed a needle aspiration, sent the specimen for analysis in the Covenant Health System, and recommended an immediate double mastectomy.   Although the pathology report indicated no cancer was present, that message never made its way to Maresca, and she removed both of the 34-year old woman's breasts nine days later.  When Van Buren learned that the double-mastectomy had occurred in the absence of any cancer, she sued Maresca and everyone else in the chain of custody of the path report for negligence.  She argued that it was not medical malpractice, but rather a lack of "ordinary care" to allow such invasive surgery to occur in the presence of a benign pathology report.

Nurse who supervised and taught Hospital nurses was "actively engaged" in nursing and qualified to testify for malpractice victim

The family of Patricia Gay sued the Battle Creek Health System after Patricia died in the hospital.  They argued that Ms. Gay died as a result of negligent nursing care.  She fell from the commode when she reached to answer a ringing telephone and died two days later.  She was subject to a medical order that required that she receive constant nursing supervision whenever she was not in bed, and the family argued that it was negligence for the nurse who accompanied her to the commode to leave her there unattended.

Revision to DSM 5 will likely include depression resulting from grief

The New York Times reported last week that the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) published by the American Psychiatric Association will likely include a sub-classification of depression resulting from the loss of a loved one.  The DSM 5, the first revision since 1994, will be controversial in this regard as practicing Psychiatrists disagree about whether normal grieving ("bereavement") should be classified as depression.

The current DSM did not include bereavement as a form of depression.  Under the current criteria, a patient must display five of the nine symptoms of depression for more than two weeks in order to be diagnosed with that condition.  The symptoms include, for example, sleeping problems, feelings of worthlessness, inability to concentrate.  Research suggests that 8 to 10 million people lose a loved one each year and that between one-third and one-half would qualify as "depressed" under these criteria for more than one month.

Other controversies arising out of the new DSM include a re-classification of autism that would significantly reduce the number of persons diagnosed, and the promulgation of a new classification "attenuated psychosis syndrome" which some treaters believe is a thinly-veiled attempt by Big Pharma to sell more drugs.

Newspaper derides claim that "tort reform" resulted in savings to consumers

The editors of the Henderson Daily News in Texas published an article this month repudiating claims that adopting aggressive "tort reforms" had resulted in benefits to consumers.  The Editors pointed out that limiting victims of medical malpractice to $250,000.00, as Texas did in 2003, was touted as a means of lowering the cost of medical care and health insurance.  It was also suggested that it would make Texas a more hospitable location for doctors.  The outcome after almost nine years? Well, not so good.  Texas did not obtain a competitive advantage over other states by reason of tort reform. 

Insurers battle over PIP benefits for woman "employee" providing attendant care

Nancy Clement was hurt when the car she was driving was struck by another motorist.   Clement was driving Nancy Denman to an appointment in Denman's automobile.  Clement was a caregiver for Denman, hired by Denman's daughter.  Clement sought PIP benefits, but had to sue the Auto Club and Cincinnati Insurance Company after the two companies fought over which owed first priority to pay Clement's PIP benefits (medical and up to three years of wages and services). 

The two companies fought over the definition of "employment" as used in the no fault act and under Michigan law.  If Clement was "employed" by Denman, under the no fault act Denman's insurer, the Auto Club, would assume from Cincinnati (Clement's personal no fault insurer) the duty to pay PIP.   Section 500.3114 does not define "employment" for no fault purposes, so the court looked to the "economic reality test" which controls in other situations. 

The Court held that Denman's daughter controlled Clement's daily routine, not Denman; it suggested that Denman's daughter--not Denman-- had hired Clement and was the only person who could fire or discipline her.  While Clement was paid ten dollars per hour,  Denman's family made no "employee" deduction of taxes or benefits.  Finally, while Clement's activities were "integral to Denman's well-being," Denman was not "in the business of being well," and therefore, Clement did not meet Michigan's definition of "employment."

While some of this decision makes sense, the opinion is faulty in part because it is based on the flawed suggestion that Denman's daughter was not acting as Denman's agent in supervising Clement's hiring, discipline, firing and "employment."  Simply because the family did not properly pay employment taxes on Clement's wages should not have controlled the outcome where the family did, in fact, hire Clement, control her daily activity, and retain the right to discipline or fire her.

Risperdal maker faces additional exposure (in hundreds of millions of dollars) for illegal marketing

In 2010, a Court in Louisiana awarded the State 257.7 million dollars against Johnson & Johnson, for its illegal marketing of the drug. In 2011, a South Carolina judge ordered the company to pay $327 million dollars because of its illegal marketing efforts in that state.  Two weeks ago, the company agreed to a one billion dollar civil settlement with the federal government over the latter's claim that Risperdal was marketed illegally.  This week a trial started in Texas over that state's claim that Johnson & Johnson owed more than one billion dollars in false marketing damages.    Risperdal is an antipsychotic drug that was never approved by the FDA for treatment of children or the elderly.  Despite that limited approval, courts and experts have determined that the manufacturer lied about the drug's efficacy and encouraged physicians to prescribe it for unsafe and unproven purposes.  Cases are also pending in seven additional states.  Cases in two states are on appeal, including a 330 million dollar judgment in Louisiana. There are also approximately 500 individual injury claims pending against the company.

Risperdal was once the company's best selling dru, generating sales in excess of 24 billion dollars from 2003 to 2007 when it lost patent protection. Profit margins were apparently pretty good, as the South Carolina judge concluded that Johnson & Johnson's profit on the drug was 97 percent of total sales.  Other competing manufacturers have paida total of2.66 billion dollars to resolve similar government marketing claims.

The Texas allegations against the manufacturer include claims that it paid $340,000.00 to Texas state mental health employees to promote the drug.  They also include claims that sales representatives were making marketing calls on doctors who only treat children--despite the company's claim that it did not market the drug for use with children or the elderly.  The Complaint filed in Texas includes specific facts that seem unlikely to be false, for example the allegation that the company's sales representatives called on one child psychiatrist a total of 96 times.

Michigan citizens won't be recovering any of their hundreds of thousands of mis-used tax dollars from the companies who defrauded our taxpayers:  Michigan Republicans passed the only law in the nation that grants immunity to drug manufacturers if their product was approved by the FDA.  They can safely lie, cheat, steal or bribe in our jurisdiction, apparently.

Scientists explore weighty data linking asthma and acetaminophen

In 1998 Dr. Arthur Varner, a fellow at the University of Wisconsin Medical School, published his suggestion that perhaps the dramatic rise in asthma occurring during the past thirty years was associated with the radical change from aspirin to acetaminophen as the treatment of choice for childhood fevers.  Since then, 20 different studies have been published suggesting a link between acetaminophen and asthma.  Unfortunately, most have been confounded by the fact that the subject children are likely to be receiving acetaminophen to address viral illnesses that have also been linked to asthma:  it has not been clear whether scientists are simply tracing the association between a treatment for infectious fever and an infectious cause of asthma.

One study intended to address this potential confounding of causation randomly assigned young patients to receive either ibuprofen or acetaminophen for fevers.  The acetaminophen patients did report significantly more asthma symptoms in the following year. A larger study is now being undertaken in an attempt to further quantify this relationship and scientists note that both acetaminophen and non-steroidal anti-inflammatories each have risks and advantages.  Nevertheless, one physician was quoted in the New York Times to the effect that he would prescribe his child ibuprofen for fever, given the present state of knowledge.

Insurers sue Michigan Blue Cross alleging illegal conduct

Aetna, Inc. filed suit against Blue Cross Blue Shield of Michigan this week, alleging it uses an anti-competitive scheme that forces other insurers to pay higher prices for hospital care.  Blue Cross reportedly insures almost sixty percent of Michigan residents.  According to the lawsuit, Blue Cross enters into agreements with providers that exclude other insurers and require the providers to charge as much as forty percent more for services.  These allegations would constitute a violation of federal anti-trust law. 

The State and the federal government already have a suit pending against Blue Cross, alleging the same illegal conduct:  Blue Cross sought dismissal of that suit earlier in the year and was denied.  According to the Aetna lawsuit, Blue Cross raised rates to insurers and passed the money generated through higher rates through to providers to induce them to raise rates on insurance competitors.  According to Aetna, 70 Michigan hospitals have signed this type of contract with Blue Cross; one anonymous hospital executive was quoted to the effect that "Blue Cross represents thirty percent of our patients, we can't put that in jeopardy."

New statute allows use of Medicare data base to evaluate doctors

One little noticed aspect of President Obama's health care legislation was a statute expressly allowing use of Medicare data to evaluate the performance of physicians paid by the government for services.  Previously, a federal court case had held that the use of such information would violate the doctors' "right to privacy."  Legislators from both parties voted to adopt the statute expressly over-turning this holding. On Monday, the government announced that the Medicare data base will be opened to employers, insurance companies and consumer groups, solely for the purpose of identifying the experience and complication rate of physicians.  Individual patient records will not be identifiable or accessible.

Merck pleads guilty to illegal marketing of Vioxx; pays additional 950 million dollars

This week Merck & Co., the second-largest U.S. drug manufacturer, agreed to plead guilty to making false statements in marketing the pain-killer Vioxx.  It acknowledged multiple incidents of sales persons informing doctors that Vioxx had been approved and was safe and effective in treating rheumatoid arthritis, when in fact it had not been approved.  Merck, Sharp and Dohme will actually enter the guilty plea.   Merck pulled Vioxx off the market in 2004 after research showed it increased the risk of heart attack and stroke.  It has since paid $4.85 billion dollars to settle thousands of civil lawsuits by injured patients.  Some 43 states have also sued Merck to recover Medicaid expenses incurred in reliance on false representations.  Michigan residents were not eligible to participate in these settlements because Michigan is the only state that provided Merck complete immunity from liability due to its FDA approval.  Vioxx had been generating $2.5 billion dollars in annual sales before it was pulled from the market.  Many of the civil suits allege that Merck failed to disclose research which demonstrated, early on, that Vioxx increased the risk of heart attack and stroke by as much as five times, when compared with a competing pain killer.

Supreme Court overturns decision allowing PIP attorney to charge fees against medical providers

The Conservator of Ryan Scott Miller employed counsel to sue Citizens Insurance Company to recover overdue Personal Injury Protection medical benefits.  He was successful and attempted to charge a contingent fee against the total settlement.  The Circuit Court and Court of Appeals approved his fee claim, finding that he had a lien on the "common fund" that he had created.  The Supreme Court overturned, however, and held that he could not claim a part of the medical expenses recovered without the acquiescence of the medical providers.

Feds continue to document payments by device makers to surgeons

Still wondering why that recent hospital procedure was so expensive?  Maybe it was the several thousand dollar cost of the medical device used by the surgeon.  Wondering why that cost so much?  Maybe because some surgeons earn nearly a quarter million dollars annually with payments from medical device makers.  A study published in the Archives of Internal Medicine examining the disclosures of five major medical device manufacturers showed that they paid surgeons more than $198 million dollars in 2007, alone.  The data comes from a U.S. Senate investigation sparked by disclosures that Medtronic had paid surgeons to promote the use of it's since-discredited bone-growth implant Infuse and perhaps fudged their data on infections and complications.

Basic techniques like hand-washing save "100s of [childrens'] lives" in recent study

Medpage Today published the results of a recent study by the National Association of Children's Hospitals and Related Institutions.  It looked at data from the first 29 hospital ICUs to adopt guidelines developed by Johns Hopkins and the University of Michigan for management of central lines and catheters.  The basic "maintenance bundle" of guidelines emphasizes hand-washing, timely replacement of dressings and devices and use of pre-packaged supplies.  Pediatric-ICU central line-associated blood streat infections were reduced by 56%, from a rate of 5.2 per 1,000 patient-days to a rate of 2.3.  Savings kids' lives by attention to sterility:  maybe our practices have been more barbaric than we suspected.

New infection guidelines show significant impact on hospital infections.

Bloomberg News reported today that the Department of Healthand Human Services has concluded that the rate of four common hospital ("nosocomial") infections dropped significantly in 2010.  The number of patients who acquired methicillin-resistant Staph (MRSA) declined by 18 percent.  There was also a 33 percent reduction in bloodstream infections (sepsis) caused by insertion of central lines.  Surgical-site infections were reduced by ten percent and urinary tract infections were down by seven percent. 

These developments are not coincidental. They arise out of work by Johns Hopkins and the University of Michigan in popularizing the institutionalization of basic infection-preventing measures and the federal government's decision to reduce reimbursement of expenses resulting from preventable infections.

Pediatricians warn against using bumper pads in cribs

The nation's American Academy of Pediatricians issued a recommendation on Tuesday, suggesting that parents not use bumper pads in cribs.  The doctors pointed out that the bumper pads are a suffocation hazard and apparently can contibute to the risk of Sudden Infant Death Syndrome (SIDS).  They are not effective in preventing injuries caused by limbs being trapped in slats.  The City of Chicago has already issued a ban on bumper pads and the State of Maryland is considering a ban.

Court upholds single woman's right to purchase in vitro fertilization services from Grand Rapids Clinic

Allison Moon, a single woman, attempted to secure in vitro fertilization services from Michigan Reproductive & IVF Center and from the Grand Rapids Fertility and IVF Professional Corporation. Both entities informed Moon that they would not provide these services to an unmarried woman.  She filed suit, alleging illegal discrimination based upon marital status.  The Kent County Circuit Court judge dismissed her claim, holding that a doctor is free to refuse to treat any patient for any reason.  The Court of Appeals overturned the lower court, holding that a service may not be denied to a category of patients where the Legislature has prohibited discrimination on that basis.

Texas report repudiates claims that "reforms" delivered benefits

The Fort Worth Star Telegram of October 12 published an article describing the findings of a Public Citizen report that refuted the claim that malpractice reforms had benefitted medical care in Texas.  The "reforms" enacted in 2003 did not reduce health care costs or insurance premiums, which have risen faster than the national average since 2003.  During this period, the number of Texans without health insurance, and their percentage of the total population, have also risen faster than the national average.  The legislation also did not improve the per capita number of doctors in the state (i.e., doctors did not stop leaving the state or flock in, as suggested by some).  One of the authors of the Report suggested that the only "winners" from Texas "reforms" were doctors and insurers. Malpractice payouts have dropped by 65% and malpractice premiums have dropped by approximately 50%.

Federally-sponsored task force recommends against prostate screening for men

The United States Preventative Services Task Force issued a recommendation this week that men not undergo routine prostate cancer screening.  So-called PSA or prostate-specific-antigen testing has become routine with many physicians and is now a very lucrative business for the manufacturers of the test, the labs who process tests, and the doctors who treat prostate cancer.  Nevertheless, the Task Force called for elimination of routine screening and cited five well-controlled clinical trials to support its conclusion that PSA screening does not save lives and does cause untold misery to many men.

Consumer Product Safety Commision votes 5-0 to seek guarding on table saws

The U.S. CPSCvoted 5-0 on October 5, 2011, to initiate an investigation into regulating tables saw safety.  It noted that they cause more than 4,000 serious finger, hand and arm injuries each year.  The agency plans to examine technologies such as that offered by SawStop LLC which will purportedly stop a blade instantly when human flesh is encountered. The Power Tool Institute (meaning Stanley Black and Decker, Ryobi and other manufacturers) objects to adopting SawStop's technology for fear that it "could create a monopoly" for the company.

Diagnose your own heart attack because Medicaid won't pay for the E.R. doc to do it.

The future of health care in America was on display in a Washington State Court house this week, as a group of patients and Emergency Room doctors sued the state over new Medicaid rules.    The group objected to a proposed rule that characterized 700 diagnoses, including "chest pain," miscarriage, abdominal pain, and breathing problems, as "non-emergent" and may require the patient to pay for the E.R. visit if the patient is a return visitor to the E.R.  The physicians argued that the new rule puts patient safety at risk and unfairly denies payment for reasonable medical care. 

With one-third of the population of the State of Texas lacking any health insurance, and one in four kids in Michigan below the poverty line, rules like the one adopted in Washington threaten basic care needs for a significant and growing share of the U.S. population.

Listeria outbreak appears to be third-most fatal food-borne illness outbreak since Feds began record-keeping

The New York Times reported today that the listeria outbreak associated with cantaloupe sold by Jensen Farms' Rocky Ford Company in Colorado is now the third-most deadly food-borne illness recorded in the U.S. since the early 1970s.  13 deaths have been recorded, with most of the victims being elderly.

Study by cardiologists demonstrates better care, higher survival rates for privately insured patients

In reporting a study that was described as "shocking and equally disturbing" by one of its cardiologist authors, the September 27 issue of the Journal of the American College of Cardiology documents that the outcomes for cardiology patients vary by the type of medical coverage they enjoy.  HealthDay reported on September 21 that the study evaluated the medical charts of 99,508 patients from 244 different hospitals that had agreed to participate in the AHA national quality improvement program.  Even in these hospitals that had opted to participate in a quality improvement program, it was determined that Medicare and Medicaid patients and uninsured patients were less likely to receive certain essential treatments and more likely to die in the hospital, than  were patients who are covered by private insurance plans.

The study noted that "disparities do exist" and they are "associated with worse outcomes."  One of the authors explained that "care continues to be tailored to the individuals bsed on their pocketbook, and not on their condition." Patients with no coverage, Medicare or Medicaid were less likely to be given any of several blood pressure medications and less likely to receive an implantable cardioverter defibrillator, all "proven therapies" that result in documented improvement in recovery and decreased mortality.  In part because of the failure to provide evidence-based therapies, the hospital stays for uninsured or publicly-insured patients are also longer.  The authors questioned whether the results are also influenced by the obvious socio-economic disparity between privately-insured patients and the the other groups with whom they were compared.

Johns Hopkins study confirms temporary ER staff pose higher medication risk for patients

On August 30, 2011, it was reported that Johns Hopkins' researchers had analyzed 24,000 mediation errors that occurred in 592 U.S. hospitals between 2000 and 2005.  The medical researchers concluded that care involving temporary emergency room staff doubled the risk of medication errors, when compared with mishaps involving permanent ER staff.  Researchers noted that while temporary staff may be relatively unfamiliar with a hospital's procedures, contributing to error, it was also likely that hospitals employing temporary staff may have more quality of care issues, in general.  It is also very possible that professionals available to provide temporary staffing are not as competent as professionals who have been employed on a permanent basis.  Certainly they would be less "vested" in the professional performance of their temporary employer.  It seems logical, also, that temporary professionals are more likely to be serving in smaller hospitals where a particular medication or condition would be encountered less frequently.  It is a well known phenomenon that medical professionals improve with practice: don't employ a surgeon to cut on you if he or she doesn't have a crew that performs the subject surgery, or a closely-related procedure, 200 times per year. 

Regardless of the genesis of the errors, it is worth noting that Hopkins' researchers found more than 4,000 medication errors, on average, for each of the 592 hospitals over 6 years, or an average of about two per day, per hospital.  In spite of this error rate, some Michigan legislators would like to confer immunity on any health care professional taking care of an E.R. patient:  these patients would have no recourse for errors.  This is, obviously, an over-reach by insurance companies and health care corporations, given the frequency of the mistakes, the well-compensated and well-educated nature of these professions, and the potential gravity of the errors.  Health care providers enjoy enough protections through the malpractice "reforms" adopted in Michigan in the 1980s, 1990s and early in this century.  The claims history doesn't justify granting these careproviders complete immunity for their own mistakes. The article is published in the Journal for Healthcare Quality, July/August 2011 issue.

Our experience mimics the Johns Hopkins findings, with temporary ER staff commonly involved in Emeregency Room mishaps.  In our most recent case, a temporary ER physician staffing a rural hospital failed to take action in response to an overdose ofa new diabetic medication ordered by the family doctor.  The 61 year-old marginal diabetic was sent home after less than four hours; at home, she suffered a seizure, brain damage and death. Standard ER and Internal Medicine textbooks recommend hospitalization of these patients for at least 24 hours.

"Surrogate mother's" expenses are not covered by her health insurer; statutory definition of "surrogate mom" not controlling

Stephanie Lehr and Spectrum Health Hospital sued NGS American, Inc., the Administrator of Lehr's health plan, arguing that the plan should have covered the health costs of the triplets Lehr delivered after being implanted with embryos from another couple.  Under existing rules, since the ERISA Plan Administrator was granted discretion in the ERISA Plan, the Court is constrained to uphold the administrator's decision unless it is arbitrary and capricious. [This standard is weaker if the Plan administrator would pay out of its own pocket.] Lehr and the Hospital argued that the administrator was required to consider the statutory definition of a "surrogate mother" in the Surrogate Parenting Act, and that to do so would require benefit payment.

NSAIDs increase risk of miscarriage

A study from Quebec, comparing the records of 5,000 women who miscarried with the medical records of 50,000 women who experienced a pregnancy but did not miscarry, demonstrated that women taking  NSAIDs during the first 20 weeks of pregnancy increase the risk of miscarriage by 2.64 times.  It is believed that NSAIDs may interfere with levels of prostaglandin hormones that are involved in inducing labor.  Therisk was greatest for diclofenac, and higher for naproxen (Aleve) than for ibuprofen.  The author recommended acetaminophen as a safe alternativefor use early in pregnancy.

Chiropractor wins appeal in suit with AAA over breadth of chiropractic care

Zigmond Chiropractic sued the Auto Club for payment of benefits rendered to three of Zigmond's chiropractic patients.  Zigmond argued it was owed benefits for hot pack therapy, physical therapy, massage, mechanical traction, and therapeutic exercise treatments.  AAA persuaded the lower court to dismiss the claims on the argument that Zigmond was "unlawfully" practicing medicine.  The Court of Appeals reversed, noting prior cases establishing that a chiropractor can lawfully practice within the bounds of chiropractic in areas that are also approved for other medical specialties.  The appellate judges sent the case back to the lower court to determine whether the services were properly within the practice of chiropractic and "reasonable and necessary" services under the no fault act.

FDA determines drug research firm faked results

Reuters reported on July 27 that contractor Cetero Research has faked documents and manipulated samples in research it performed on pharmaceuticals.  An series of studies and audits reportedly uncovered "significant instances of misconduct and violations."  The North Carolina firm was guilty of a pattern of misuse in research for several drugmakers during the period 2005-2010.  The lack of integrity in Cetero's research places in question the quality of research supporting drug applications by the involved drug makers, who were not identified.   Despite the lack of integrity and control in the drug approval process, the State of Michigan provides complete immunity for drug-makers whose pharmaceuticals are approved by the FDA.  Michigan is the only state that grants this immunity.

Judge improperly dismisses injury case for lack of scientific evidence

Robert Avery worked as a laborer and welder for Grand Trunk Western Railroad for 28 years before he died as a result of a brain tumor.  Under the Federal Employer's Liability Act (FELA) governing railroad employees, Avery could hold the employer responsible for injuries suffered at work, even if proof of the  "proximate cause" of the injury and damage did not rise to the normal legal threshold.  Avery's widow argued that he suffered the brain tumor and died as a result of various chemical exposures he suffered at work.  The Railroad denied any basis for proving causation, refused to provide discovery to the widow and ultimately persuaded the trial judge to dismiss the widow's claim.

Spine specialists repudiate Medtronic spinal fusion product; doctors who cashed in.

Medtronic earns something over 900 million dollars per year selling Infuse, a bone growth product used by surgeons performing spinal fusions.  The product is used in about one-quarter of the 432,000 spinal fusions performed in the U.S. annually (a number that has increased substantially as surgeons have created regional corporate entities to buy and sell to hospitals the products they use during fusion surgeries). It is used as a replacement for bone grafting material.

The Spine Journal devoted an entire edition to repudiating the research cited by Medtronic and the ethics of the company and its supporting surgeons.  The editors of The New England Journal of Medicine and the Journal of the American Medical Association told the New York Times that this situation was unprecedented.  Dr. Christopher Bono, editor of The Spinal Journal told the paper that the "spinal care field is currently at a precarious intersection of professionalism, morality and public safety."

According to the special edition of the journal, Infuse presents a much higher risk of complications (male sterility, infection, bone loss and unwanted bone growth), including dangerous complications, than was published by Medtronic.  Use of Infuse in the cervical spine was never approved, due to dangerous complications that were identified originally and not understated.  

In addition, the research conducted supporting the use of Infuse was the product of surgical consultants who earned--on median---between 12 and 16 million dollars from Medtronic.  One surgeon, Thomas a. Zdeblick of the University of Wisconsin, was reported to have claimed that he had no direct financial interest in the product, even though he has received more than 20 million dollars in royalty payments from Medtronic.  Zdeblick's colleagues were quoted in the paper describing his position as "hardly credible" and a "fascinating denial...[of an] enormous conflict of interest."

Nevada punitive damage claim against hormone replacement drug manufacturer upheld

This week the U.S. Supreme Court upheld a $58 million dollar damage award against Wyeth Pharmaceuticals, Inc., arising out of the company's failure to warn three women taking Premarin and Prempro of the risk associated with breast cancer.    The verdict, including 35 million dollars in punitive damages, was handed down in 2007.  The jurors had found that Wyeth acted recklessly in failing to warn women that taking estrogen replacement drugs significantly increased the risk of developing breast cancer. 

Court of Appeals holds that Circuit Court has jurisdiction to decide "exclusive remedy"

William H. Schmitt was badly hurt when a driver for Jaguar/Land Rover of Lakeside caused a collision  with another vehicle:  Schmitt was a passenger in the dealership's vehicle.  Schmitt delivered cars for Jaguar/Land Rover as an "independent contractor"/porter, however, after he was hurt, Jaguar/Land Rover argued Schmitt could not sue it or the driver because Schmitt was an "employee" and subject to the exclusive remedy of workers compensation. 

The Court of Appeals noted that while Republican judicial activists on the Supreme Court had recently criticized a 1984 ruling that acknowledged the Circuit Court's jurisdiction to decide "employee" status, the Justices had not actually over-turned the thiry-year-old decision in a majority opinion.  Therefore, the opinion remained good law and the Circuit Court has the authority to hear the facts and decide whether the dealership should enjoy the protections of an "employer" when it attempted to structure the relationship as one of principal-agent/independent contractor.

Ski instructor assumes no duty to children taking class

Frederick Sieradzki suffered a fractured leg when he was struck by an out-of-control skier while taking a beginning snowboarding lesson.  His mother sued the instructor and Mt. Holly Resort, alleging that the instructor was negligent in exposing Frederick to injury.  The Court of Appeals upheld the lower court's dismissal of Frederick's claim, deciding that the instructor owed no duty to Frederick.  That would be news to most parents who sign their kid up for skiing or snowboarding lessons.

FDA issues warning regarding Spiriva inhaler

This week the Food and Drug Administration issued a warning to victims of Chronic Obstructive Pulmonary Disease (COPD), also described as chronic bronchitis or emphysema, about increased mortality associated with the use of the Spiriva Mist Inhaler.  Experts speculate that the mist inhaler increases the plasma (blood) concentration of Spiriva as a result of the improved drug delivery system.  In any event, a series of five recent studies demonstrated a 52% higher mortality rate among Spiriva mist inhaler users, when compared to patients given only a placebo.  Apparently in this form, Spiriva results in a higher risk of heart attack and stroke--conditions that former smokers, in particular, are likely to run.  Doctors were encouraged to avoid recommending the mist inhaler form of the medication to patients with heart disease.

Bipartisan group of senators calls for investigation of surgeons profiting by steering medical devices through hospital

Most surgeons dictate to the hospital what type of medical device they will implant in a patient.  Some have abused this authority by opening Physican-owned distributorships (PODs) that act as middle-men, taking a cut of profit between the manufacturer-supplier of the devices and the hospital where the surgeon operates.  The Wall Street Journal reported recently that in Oregon, a Portland neurosurgeon and other physician investors earned $500,000.00 a year from the manufacturer of a spinal implant, on top of their surgical fees, by funneling the implants through their own POD called Omega Solutions.

Doctor is critical of FDA delay in recognizing danger of 80 mg doses of Simvastatin

Last week when the FDA warned against the use of 80 mg doses of simvastatin because nearly one percent of patients suffer severe muscle damage, Dr. Steven Nissen of the Cleveland Clinic publicly criticized the Agency for its dilatory action.  Nissen, who was widely applauded for his independent investigation and criticism of the pharmaceutical industry, pointed out that the drug has been recognized as unreasonably dangerous--with safer, effective options--for 11 years.  He noted that he stopped prescribing the 80 mg dose seven years earlier.

The drug poses an unacceptable risk of rhabdomyolysis, which can cause kidney failure and death.  Nevertheless, simvastatin is the second most widely prescribed drug in the U.S., with 2.1 million Americans currently taking it to lower cholesterol.  Thus the financial stakes are high and another cheap alternative won't be available until fall of 2011 when Lipitor becomes available in a generic.  Currently, non-generic statin drugs run about $1.20 per day for a patient, which simvastatin costs only four cents per day.

Recent data on malpractice "reform" and cost containment

Two recent articles, one by a pediatrician at Indiana University's School of Medicine and another by an independent insurance broker, Lockton, confirm the hypocrisy involved in blaming malpractice claims for the current cost of health care.  In its report on cost-savings, Lockton pointed out that two recent comprehensive studies demonstrate that error disclosure to patients actually reduces the over-all cost of medical negligence claims, while "reforms" that limit patient rights do not. 

    Lockton noted that the 2010 "Annals of Internal Medicine" study reported by the  University of Michigan confirmed that a medical error disclosure policy resulted in:   1.  20 fewer lawsuits per year;

2.  shorter resolution time  by one-third of one year; and,

3.  average cost per lawsuit of $228,000.00, down from $405,000.00. 

Lockton noted that a similar Veteran's Affairs study from Kentucky demonstrated a reduction in the average payout from $100,000.00 per claim to $15,000.00 per claim over seven years.

Meanwhile, Dr. Aaron Carroll, a pediatrician and healt care researcher from IU, noted that the following statistics are well-established, broadly accepted, and leave little room to argue for liability as a driving measure in health costs:

1.  Health Affairs recently published a widely-accepted, comprehensive study that estimated medical liability costs, nation-wide, at 55.6 billion dollars in 2008.

2.  This  represents about 2.4 % of all health care costs.

3. $47 billion dollars or 90-some percent of this expense was so-called defensive medicine--not legal costs.

4.  When "reformers" cap damages at $250,000.00, as they did in Texas in 2003, the cost of care went up in each of the next 5 years---not down, as the "reformers" had predicted.  (Drawing on the Dartmouth Atlas of Health Care.

5. In comparing areas with high- and low- malpractice premiums, a ten percent reduction in malpractice premiums resulted in a reduction of health care expenditures of only one-tenth of one percent. Thus if the entire nation adopted comprehensive "tort reform" limits on patients' rights, the total savings--if there was any--would be 55 million dollars of the total 55 billion dollar cost.  That is an awfully high price for a few individuals with catastrophic injuries to pay for a very small relative savings.

Multiple lawsuits against USAA for using outside auditor who uniformly rejects medical claims.

The Texas insurer, USAA, was sued again this week by customers denied reimbursement for auto-related medical expenses.  This claim was filed in Oregon, and is the third similar class-action filing against USAA in the past several  years.  A class-action filed in Arizona was settled last summer. An Illinois class action was reportedly settled for 35 million dollars in 2005. The allegedly-sham reviewer utilized by USAA is Alabama-based Auto Injury Solutions.

Controversy over annual mammograms for women under 50

Radiologists who make their living interpreting mammograms have authored three small recent studies contradicting U.S. Guidelines that suggest women under fifty with on risk factors do not benefit from annual mammograms.  Breast cancer remains the second-leading killer of American women (after lung cancer) and it is estimated that breast cancer caused 40,000 deaths last year.  The U.S. Preventive Services Task Force recommended in  2009 that women under fifty not undergo annual mammograms because the risks and complications of "false positives" out-weighed the advantage of a rare early detection.  The studies published by radiologists this year tend to confirm the fact that mammograms do identify cancers at an earlier, smaller stage and enhance survival.  Donna Plecha of University Hospitals Medical Center in Cleveland summarized the conclusion she drew from the studies:  women int their 40s who are diagnosed with breast cancer as a result of annual mammograms have a better prognosis and endure less toxic treatment plans.

Modern  researchers are attempting to elucidate the risks and advantages of early detection in breast and prostate cancer, in particular, as they have found that many patients must endure aggressive treatment of relatively benign cancers in order to catch and successfully treat a single aggressive cancer.