TOV Injury and Safety Blog

Doctors' groups block patient access to data on physician errors

A Tulsa daily newpaper reported today on its efforts to examine why a federal data base on physician errors is not available to patients.  The reporter, Gavin Off, noted that most State Medical Boards, like Oklahoma's, use the data base before granting physicians' licenses to practice, but the system continues to succumb to physician pressure to hide the doctors' identities from the public.  The data has been gathered on doctors' errors since 1989 and includes information on 23,768 preventable patient deaths, 8100 major permanent injuries and 3896 cases that resulted in quadriplegia, brain damage or lifelong care.  It includes, for example, in Oklahoma alone, nine cases of sexual misconduct and 28 lawsuits over procedures conducted on a mistaken body part (with $2.9 million dollars in settlements). 

The reporter spoke with one authority who pointed out that if the information was reliable enough to use in making licensing decisions, it was reasonable to provide it to patients.  As with credit files, doctors could be free to supplement the data, if they believed there was an error.  Nonetheless, the experts report that the data will remain unavailable to patients and consumers, even though it is available to hospitals granting staffing privileges, because the AMA has a lock on politicians who would have to vote to make it available to the public.

Employee with Parkinson's fails to stop working before termination; disability benefits denied

Roger Heikkinen became concerned in January, 2003, that his employer would terminate him.  He was reprimanded that month for missing a deadline and reluctantly informed his employers that he suffered from Parkinson's disease.  He immediately sought advice from a law  firm, and the attorneys suggested that he apply for disability immediately.  Heikkinen did not want to give up his full salary (or his job) any earlier than necessary, however, so he continued to work while the attorneys negotiated a termination agreement with his employer.

Sixth Circuit says health insurer need not pay its share of attorneys fees or costs

On November 16, 2009, the Sixth Circuit decided Longaberger Company v. Kolt,  a dispute over an ERISA health insurance plan's demand for an injury victim's negligence recovery from the at-fault driver's insurance.  Samuel Billiter was hurt in a car accident in Ohio, and his medical expenses were covered by Longaberger, a self-funded employee welfare benefit plan.  Billiter sued, through his attorney Jeffrey Kolt, and recovered $135,000.00 from the negligent driver's insurers.  Acting on the law as he understood it prior to the Supreme Court's recent decision in Sereboff v. Mid-Atlantic, Kolt distributed the insurance recovery without honoring the claimed Longaberger lien of $113,000.00. 

Longaberger sued Kolt and Billiter, claiming that they were held in an equitable constructive trust for "reimbursement" of the plan.  The Sixth Circuit upheld the District Court's summary judgment for Longaberger and refused to honor Kolt's state law "charging lien" for creating the recovery.  Billiter was required to pay Longaberger almost $76,000.00 of his $86,000.00 recovery and Kolt was required to turn over about $38,000.00 of his $45,000.00 fee.  Chances are that if it weren't "for the honor of the thing," both men would have forsaken the lawsuit entirely, had they known that their efforts would only inure to the ERISA plan's benefit.

The outcome of this case either violates or endorses our belief that "pigs get fat and hogs get slaughtered," but we don't know which of the parties initially exhibited the pig-headedness.   It would appear that a fair outcome would have involved some compromise by both parties.

Disability insurer cannot avoid obligation to drunk driver by characterizing his injuries as "intentional"

The Sixth Circuit recently handed down an important decision interpreting ERISA insurance policies.  Under these policies, insurers have traditionally excluded payment of benefits where an insured intentionally suffered injury.  The Reagan-Bush appointees to the Court has, over the past decade, begun recognizing a broader range of negligent conduct as "intentional" at the request of insurers seeking to avoid a duty to pay health or accident benefits.  The result has been the "activist" development of a line of cases suggesting that insurers could avoid paying benefits where an insured did something "stupid," in cases where no one would categorize the actual injuries as "intentionally" suffered.  In Kovach, et al. v. Zurich American Insurance Company, the Sixth Circuit finally handed down a ruling placing a limit on this development under ERISA.

Malpractice verdict against prostate cancer patient is affirmed

James Burek's family continued his malpractice case against Dr. Kimberly Hart, Dr. Arthur Frazier and Harper-Hutzel, Huron Valley Sinai and Karmanos Cancer Institute, after Burek died of severe radiation burns.  Burek was diagnosed with early-stage, localized prostate cancer in 2001, at age 49, and the Defendants recommended treatment with mixed-beam radiation therapy.  By "general agreement of the experts," Burek suffered "the most severe and extensive [radiation burns and injuries that the experts] had ever seen," including burns to organs outside the treatment area.  Burek died from complications of the radiation burns. 

Burek's family argued that the doctors were negligent in choosing an experimental form of treatment, that they failed to properly inform Burek of the investigational nature of the treatment chosen, and that he had been over-radiated by one or more of the two participating institutions.  The jury found in favor of the doctors and hospitals after a lengthy trial, and the family appealed.  Among other claims, the family argued that the trial court erred by refusing to admit into evidence testimony from a  Blue Cross doctor confirming the insurer's categorization of mixed-beam radiation therapy as experimental.  It also faulted the judge's refusal to admit a policy statement published by the American Society for Therapeutic Radiation and Oncology, documenting the lack of scientific acceptance of mixed-beam radiation therapy for early stage, localized prostate cancer.

Two former employees win battle with "defamed" home health care provider

Evergreen Home Health Care sued two former employees (a nurse and a nurse aid) in an effort to punish them for criticizing the care given by Evergreen.  It alleged breach of a non-compete agreement, defamation and interference in its legal contracts with residents and their families.  It rejected mediation-proposed settlements and nominal settlement offers before its claims were ultimately dismissed by the trial court. 

Evergreen never produced a non-compete involving one of the former employees and the court deemed the other agreement "unreasonable" and unenforcible.  It concluded the suit was filed in retaliation for the employees' complaints reaching the office of the Attorney General and were in the nature of a "spite" or vengeance action--particularly given the fact that the employees had no insurance coverage and the suit appeared intended primarily to "ruin them financially."  The Court found no "significant, material" evidentiary support for Evergreen's claim and awarded the employees  sanctions in the form of costs and fees. 

The Court of Appeals upheld the decision, and agreed with the lower court that the action was frivolous. The higher court also returned the case to the lower court to explain why it had not awarded the employees' attorney the full amount of fees that they documented.  Given the attorney's 30+ years of experience, the lower court's failure to sanction his $200.00 per hour fee appeared to the Court of Appeals to be arbitrary on its face.

Supreme Court holds that lack of informed consent is simple malpractice, not denial of an opportunity for better outcome.

The unanimous Michigan Supreme Court granted Deborah Compton's appeal and reversed a Court of Appeals' decision that would have virtually dismissed Compton's malpractice claim against Helen Pass, M.D., Jane Pettinga, M.D., and William Beaumont Hospital.  Compton argued that the doctors did not provide her with an informed basis to consent to a more invasive treatment for breast cancer (removal of additional lymph nodes, resulting in axillary cording and lymphedema), and therefore commited malpractice in subjecting her to these complications without proper consent, in violation of the standard of care. 

Still wondering if its safe to eat ground beef?

This was another bad week for the American meat industry, in terms of public relations.  First, a New Hampshire resident died after consuming meat infected with E.coli bacteria.  The source was apparently the same meat that sickened Rhode Island school children in October.  This contamination event resulted in the recall of a half-million pounds of ground beef from the New York Fairbanks Farms.  It is thought that the primary risk associated with this beef is meat stored in freezers by consumers unaware of the recall.

Then South Shore Meats Co. of Brockton, Massachusetts initiated a recall after making 20 additional Rhode Island children and adults ill at a camp in Plymouth. Purchases of the meat in each case were made at large chain grocers.

The news became slightly less worrisome, but infinitely more disgusting, when the beef industry announced it would fight attempts to ban meat producers from feeding cows chicken feces.  The Consumers Union, McDonald's Corp., and others have asked the FDA to ban the practice of feeding this chicken waste to cattle. (We wonder why McDonald's doesn't just refuse to contract with suppliers who refuse to avoid the practice:  is that asking too much?)  The FDA estimates that farmers feed between one and two million pounds of chicken litter/feces to cattle, annually.

The practice isn't just disgusting, however.  It is also unsafe:  chicken "litter" includes tissue from other ruminants which had been fed to chickens--thus following the precise practice which is responsible for bovine spongiform encephalopathy, or "mad cow disease." The National Cattlemen's Beef Association, which will cry for help when beef consumption falls with the next report of "mad cow" or the next resulting foreign ban on American beef, objected to such a ban because the risk is "too remote".  The Consumers Union scientists interviewed noted that the practice is also objectionable because the litter contains "disease-causing bacteria, antibiotics and foreign objects such as dead rodents, rocks, nails and glass."

A food safety expert from Cal Davis said that while the practice sounds gross, it is as old as agriculture, with "anything that falls to the ground being fair game."  On the other hand, the practice was probably safer before the onset of industrial, chemical-laced food production practices when animals were not slaughtered by a stranger on an assembly line.

Radiology magazine reports that doctors surveyed would not report errors

According to HealthImaging.com, radiologists would be reluctant, and a majority would not inform patients of errors in interpreting previous x-rays.  A physician from the departments of medicine and bioethics at the University of Washington conducted a study that surveyed 364 radiology specialists from seven different geographic regions.  He found that if presented with a historical error in mammogram interpretation, only 15 percent answered that they would inform the patient "that an error had occurred" and that calcifications had increased in number between mammograms.

American Cancer Society elucidates issues involved in breast and prostate cancer screening

The ACS has been attempting to respond to recent research documenting the fact that "American medicine has overpromised when it comes to screening" without discouraging patients from seeking appropriate medical evaluations.  Unlike colon and cervical cancer screening, which have lead to the identification of deadly cancers and a substantial improvement in the related death rate, prostate and breast cancer screening have not significantly improved the survival rates for these cancers.  Instead, it appears that prostate cancer screening in particular, and to a lesser extent breast cancer screening, have resulted in the early identification and treatment of non-fatal tumors, while failing to catch fatal tumors early enough to be effective.   The ACS noted that while there has been a 40 percent increasein the diagnosis of breast cancer, this has led to only a ten percent decline in the diagnosis of Stage II and IV breast cancer.

The ACS notes that timely mammography is still an important health choice, although its effectiveness has been exaggerated.  Researchers suggest that the problem lies with our inability to distinguish between relatively benign cancers and cancers that will be fatal if left untreated.  Until we make that scientific leap, many patients will undergo expensive, invasive and dangerous treatments that ultimately prove to be unnecessary.  Recent research has demonstrated that in many cases the complications arising from treatment may outweigh the benefits gained.  A long-term study from New England documented the fact that survival rates among "over-treated" patients were lower than survival rates among the "under-treated" population.  This is not simply a question of "more is better."  We must determine how to judiciously apply resources where they will best serve the patient.

Pfizer hit with 1.3 billion dollar penalty for illegal practices: no big deal if your annual revenue is 48 billion

The U.S. government began investigating Pfizer's illegal activities in promoting Bextra--a pain killer since removed from the market--in a criminal action arising out of the government's payment of medical expenses for its beneficiaries.  Ultimately, the U.S. Attorney concluded that Pfizer was illegally promoting Bextra and other drugs to doctors through kickbacks and other illegal practices that included marketing the drugs for uses not approved by the FDA.  The claim was recently resolved by agreement of Pfizer to pay $1.3 BILLION dollars in civil and criminal fines.  Given that Pfizer reported revenues of $48.3 billion dollars in 2008, this kind of punishment is unlikely to phase the company's executives or deter future illegal activity of this nature.   Bextra was removed from the market because it was implicated in an unreasonble number of heart attacks and strokes among pain-relief users.

Washington Supreme Court rules malpractice scheme similar to Michigan's is unconstitutional

This week, the Washington State Supreme Court unanimously agreed that a 2006 law governing medical malpractice suits was unconstitutional.  The judicial activists appointed by Governor Engler to the Michigan Supreme Court last decade had previously rejected similar challenges to several provisions of Michigan's tort "reform" statutes.  In short, the Washington court rejected the concept that an injury victim must prove his claim has merit prior to filing suit and enjoying the opportunity to investigate.  It noted that in many situations, reputable phyisicians will not sign a "certificate of merit" attesting to the victim's allegations, without hearing a complete explanation of what actually occurred. 

Ultimately, the Court concluded, it is a violation of constitutional separation of powers for the legislature to attempt to dictate court rules and procedures to the judiciary.  The so-called Engler Majority or "gang of four" overturned Michigan precedent and scoffed at this notion, even allowing the legislature to dictate which qualified experts would be allowed to testify.

Pfizer admits fraud in marketing drugs and is fined $2.3 billion dollars

If you are wondering why pharmaceuticals are adding so much to the cost of health care, take a look at Pfizer.  For the fourth time since 2002, the company or one of its subsidiaries has agreed to settle criminal or civil charges arising out of its improper marketing of a drug.  Previously it was Lipitor, Neurontin and Genotropin.  This time it is Bextra and three other medications which Pfizer was promoting to doctors for uses not authorized by the Food and Drug Administration.  Bextra has since been pulled off the market by Pfizer after serious safety concerns were raised.

Spleen injuries and "serious impairment"

When the Engler Majority of the Michigan Supreme Court jacked up the proof required to document a "serious impairment of bodily function" under the no fault act, one group of victims denied compensation was composed of people who suffered injuries to the spleen.  In a number of cases, Michigan courts applying the "life-altering injury" standard engrafted on the threshold by insurance activists had held that a victim's spleen injury was not "serious," even if it resulted in a major operation and removal of the spleen.  Recent medical research has documented the short-sighted unfairness of these decisions.

Simplicity bassinet recall is emphasized after two more deaths

The Consumer Product Safety Commission reemphasized its August 2008 recall of some 900,000 Simplicity bassinets after four more entrapment incidents resulted in two fatalities.  Sadly, research shows that recalls result in less than twenty percent of recalled products being removed from the stream of commerce, and only a small percentage of products being repaired or improved.

This recall involves Simplicity 3-in-1 and 4-in-1 convertible bassinets sold under the Simplicty name or by Graco between 2001 and 2008.  The deaths and injuries have typically resulted from entrapment between metal bars or in pockets of fabric where velcro-attached fabric is not attached to the bars or is attached improperly.

Gastric bypass surgery is now much safer

The Washington Post recently detailed new findings showing that the safety of gastric bypass surgery has been improved immensely.  A decade ago the morbidity and mortality figures associated with gastric bypass surgery made it questionable whether the surgery was worthwhile--despite the known dangers of morbid obesity.  New safety results at major hospitals show, however, that fewer than five percent of patients now suffer major complications.  The results are published in the New England Journal of Medicine.

Generally, the surgery is recommended for persons with a body mass index over 40, or over 35 if obesity is combined with another significant health problems such as diabetes or high blood pressure.  Last year the surgery was performed nearly a quarter million times in the U.S.  Death, serious complications or the need for additional surgery ocurred in one percent of patients whose stomachs were banded, almost five percent of patients having laparoscopic bypass and almost eight percent of those given a bypass by traditional surgical means.

Clearly, where possible, gastric bypass patients should select a surgeon who performs banding or laparscopic bypass at an institution that performs hundreds of the procedures each year.

Michigan's high court addresses class action status of claims versus Dow Chemical

In the next chapter of the on-going battle between residents of the Tittabawassee River basin and Dow Chemical, the Michigan Supreme Court concluded on the last day of July that the plaintiffs did not meet the qualifications for a class action.  Residents of the river basin have been seeking redress from Dow over dioxin poisoning for years.  In previous rulings, Michigan courts have concluded that they cannot recover for medical monitoring, despite the risks and dangers associated with dioxin pollution. 

Tanning beds cause cancer

The highly respected English medical journal Lancet Oncology published an analysis this week, documenting the cancer risk of tanning beds.  The authors evaluated 20 existing studies and concluded that the risk of skin cancer increases by 75 percent among young people who visit tanning beds before the age of 30.    The scientists concluded that all types of ultraviolet radiation contribute to cellular mutations and render radiation carcinogenic.  The Associated Press noted that as tanning bed use has increased in the U.K., melanoma, the deadliest form of skin cancer, is now the leading cancer diagnosed among women in their 20s.  Previous studies have suggested that younger people who regularly use tanning beds increase their risk of melanoma to eight times the average among the population in general.

Former chairman of NTSB calls for national medical safety board

Jim Hall, former chairman of the National Transportation Safety Board recently filed an op-ed calling for a similar organization to analyze medical errors and recommend solutions.  He noted that the NTSB costs taxpayers about 25 cents each, per year, and for that cost it has saved millions of lives as a result of its activities in commercial airline and highway safety alone.  He noted that 10 years ago, the Instititute of Medicine placed the cost of avoidable medical error at $17 to $29 billion per year--and likely much higher today.  With the current focus on the cost of health care (which now approaches approximately 1/3 of the average annual family income in the United States) an organization similar to the NTSB to study and eliminate routine and avoidable medical errors is long overdue.

Nurses indicted for reporting doctor's malpractice to licensing board

Two nurses who lodged a complaint with the Texas Medical Board were indicted for "misuse of information" this week, because they included in their (confidential) complaint the medical records of several patients whose names had been redacted from the records.  While the ten patients' records did include patient numbers, no patients were identified and the licensing board's activities are entirely confidential, meaning there was no risk that the patients' confidential records would be disclosed in any broader venue.  Over the objections of the licensing authority and the Texas Nursing Association, local authorities and the hospital have chosen to attempt a prosecution charging the nurses with a felony, simply for acting to advocate for patient safety. 

More evidence that links cancers to hormone therapy

A Danish study involving 900,000 women aged 50 to 79 found that hormone-replacement therapy during menopause results in an increased risk of deadly ovarian cancer.  Similar links had previously been identified between hormone therapy and both breast cancer and ovarian cancer, as well as strokes and other problems, resulting in a dramatic diminution in the prescription of estrogen to minimize  symptoms of menopause.  Prescriptions of Wyeth's Prempro have fallen by about 50 percent since the first study was published in 2001.    The cancer risk is thought to last for about two years after estrogen therapy ends.  Ovarian cancer kills about 15,000 American women each year.  Over the eight years of the Danish study, current hormone use conferred a 38 percent higher risk of contracting the disease.

Denver hospital closed to new patients after inadequate staffing and training cause death

The Colorado Orthopaedic and Surgical Hospital was closed to elective surgeries after a 25-year old died following surgery and a drug administration error.  The state inspectors found that the hospital--which relied upon a neighboring hospital to provide emergency services and which was forced to call EMTs to respond to Hilary Carpenter's complications--was unprepared for emergencies due to inadequate training and staffing.  The wrong drug had been given to the young woman, in the wrong dose and via the wrong means of administration, causing her to suffer cardiac and respiratory distress.  The responders were unfamiliar with the crash cart and its contents and could not revive her in what became a scene of "chaos."  Responders from the nearby hospital could not locate the proper room for twenty minutes and EMTs from an ambulance service had to be called!  Ultimately Carpenter's family was forced to remove her life support.

Progressive can't duck insurance obligation to rodeo

In Progressive Michigan Insurance Co. v. Super Kicker Rodeo Productions, et al., Progressive and ACE American Insurance Co. both tried to avoid paying for injuries suffered by Donielle Hart.  Both companies had underwritten liability coverage for the Rodeo's activities, but both argued that the coverage did not apply to Hart's very severe injuries.  Hart was a family member who helped out with the rodeo on an unpaid basis.  She helped to tear down the aluminum rodeo gates following a performance and suffered a skull fracture and other severe injuries when the loaded gates fell off a semi-trailer after a rope broke.  The trial court had dismissed the case against ACE and Progressive concluding that there were no questions of fact regarding the application of the insurance policies to the various individuals' employment status and the nature of Donielle's activities at the time of the injuries.

Federal government ban on routine use of antibiotics in livestock likely to falter

Many health authorities believe that overuse of antibiotics in healthy livestock, simply to stimulate growth, is contributing to the development of antibiotic-resistant bacteria.  On July 14, the Obama Administration indicated it intends to introduce legislation to ban this routine use of lifesaving medications.   The Obama plan was contained in written testimony provided to the House Rules Committee by Joshua Sharfstein, principal deputy commissioner of the FDA.  The move is supported by the AMA but opposed by the National Pork Producers Council:  most observers believe that farm-lobby opposition will prevent the ban from passing.  The Union of Concerned Scientists has estimated that 70 percent of antibiotics used in the U.S. are disseminated to healthy animals to stimulate growth and without supervision by a veterinarian. 

Football trainers recommend elimination of "two-a-day" practices

Almost every year, several high school football players die of heat-related illness during two-a-day practice sessions.  The NFL and the NCAA have eliminated the practice of commencing the season, during the hottest months of the year, with multiple daily practices.  Yesterday, the national association of football trainers recommended that high school follow the NCAA's lead and eliminate twice-daily practices during the first 14 days of conditioning.  It also recommended that if twice-daily practices are scheduled after the first week, they be followed by single practices on the next day.  On the same day this report was issued, a Western Carolina defensive back collapsed and died during a voluntary work-out.

Newly assertive FDA warns about use of Zicam and loss of smell

The Food and Drug Administration has been roundly criticized for its failure to act in numerous matters over the past 8 years and for the consequent deaths, illnesses and corporate fraud that have resulted.  The FDA has become more proactive under the Obama administration, despite its inadquate resources and funding, and on June 17 it issued a warning about the use of Zicam, a popular homeopathic cold remedy that can permanently damage or even eliminate a consumer's sense of smell.  The FDA has received 130 reports of olfactory injury resulting from the use of Zicam nasal products, dating back to 1999.  The manufacturer has received more than 800 reports of Zicam users losing their sense of smell, but failed to provide those complaints to the FDA.

Concern expressed over asthma drug Singulair

U.S. regulators concluded that Merck & Co.'s top-sulling asthma drug, Singulair, should come with a caution about psychiatric problems.  The caution would also apply to Accolate, manufactured by AstraZeneca, Zyflo and Zyflo CR, made by Cornerstone Therapeutics.  A "caution" is less serious than a warning, according to Reuters News Service, and applies to problems incluidng agitation, aggression, suicidal ideation, depression, insomnia and irritability, which may be associated with the medications in some patients.  Singulair is prescribed to tens of millions of patients since approval in 1998 and has annual sales of $4.5 billion dollars.

Deadly consequences of FDA's failure to shutdown tainted syringe manufacturer

The June 7, 2009 edition of the Chicago Tribune carried a long article discussing the consequences of the Food and Drug Administration's failure to shut down a contaminated plant operated by a syringe manufacturer now associated with four deaths and hundreds of illnesses.   The plant in North Carolina was inspected in July of 2007 by the FDA in response to reports of contamination with "red, brown and black particles."  She reported that the plant had a plan to respond to  the "rust contamination" and took no action beyond reporting that the plant had "switched to an unreliable sterilization method."

Lawsuits claim zinc in denture cream builds up in body causing health problems

A dozen claims are pending around the country, alleging that PoliGrip and Fixodent contain unsafe levels of zinc. The lawsuits allege that zinc competes with copper in the body to bind to certain receptors, and a build up over time negatively affects neurological function.  The manufacturers claim the amount of zinc ingested is safe and comparable to eating six ounces of beef.

Two of three bankruptcies stem from medical expenses

The American Journal of Medicine published a study last week derived from data collected before the economic crisis of 2008.  The study demonstrated that medical problems contributed to 62.1 percent of all bankruptcies filed between 2001 and 2007.  During that period, the proportion of bankruptcies attributable to medical problems rose by nearly 50 percent.  Experts believe that the proportion would be even higher today, since the current economy has left more families without coverage and persons suffering a significant illness are even more likely to be without a nest egg to cover exceptional expenses.  The study concluded that "The U.S. health care financing system is broken, and not only for the poor and uninsured...Middle-class families frequently collapse under the strain..."

Republicans reject food safety initiatives

In response to a broad range of food safety problems experienced by Americans over the past five years, the FDA and Congress have been attempting to adopt new food safety regulations.  Unfortunately, Republican leaders have already undercut the initiative by rejecting needed improvements.  The bill, originally devised with bipartisan support, called for all food manufacturers to pay an annual $1,000.00 fee to support quadrennial inspections and other monitoring.  The head of the FDA says that this fee is not adequate, but Republican leaders in Congress have already refused to support even this fee as "too high." 

Recent developments in cancer therapy, including hormone replacement and use of anti-depressants

It has long been understood that hormone therapy to mediate the symptoms of menopause probably has a deleterious impact on cancer treatment.  Nearly twenty years ago, we prevailed in a malpractice claim against a General Surgeon who continued estrogen therapy throughout a woman's treatment for breast cancer.  Our claim was supported by an oncologist from the National Cancer Institute, and even the Defendant's expert was forced to concede the connection.  Even at that time, the medical research showed a likely negative impact, and continuing estrogen therapy was not recommended.  A new study out of the UCLA Medical Center adds weight to the argument and also suggests a tie between hormone replacement therapy, smoking and an enhanced cancer risk.

Court stretches to enforce pre-injury release executed by volunteer

Teresa Theodore volunteered to work at a racetrack in Oakland County.  On her first day, she was required by the racetrack to execute a release which "waives, discharges and covenants not to sue" for any injuries suffered "arising out of or related to the event(s)" held at the racetrack. An undetermined time later, she was struck by Raymond Horenstein's trailer as he was leaving the paddock area.  She sued Horenstein for her injuries, but his insurer persuaded the trial court that her claim against Horenstein was waived by the release she signed when she agreed to volunteer.  The Court of Appeals agreed.

Death of Tyson's child draws attention to danger of treadmills

When Mike Tyson's four-year old daughter died in the boxer's home after becoming entangled in a treadmill, it helped to publicize the potential danger of home exercise equipment.  The New York Times indicated that about 25,000 children are brought to Emergency Rooms each year as a result of injuries suffered on recreational equipment, including burns from contact with the treadmill belt.  An Australian study suggests that friction burns to children account for one percent of all severe burns suffered by kids.  Medical authorities have documented a propensity for children to approach their parents on the treadmill and friction burn injuries so severe that skin grafting is required.  The Australian government, doctors and Consumer Reports recommend that treadmills be unplugged whenever they are not in use and that they be positioned so as to allow parents to detect the approach of children when they are in use.

JAMA article relates increased risk of pneumonia to acid-reflux drugs

The Journal of the American Medical Association today published an article disclosing research that ties the routine, prophylactic use of acid-reflux drugs to an increased risk of pneumonia in hospitalized patients.  The study followed more than 63,000 patients at Beth Israel Deaconess Hospital for three years.  The drugs involved, so-called proton pump inhibitors, including Nexium, Prilosec and Prevacid, are given to an estimated 40-70 percent of hospitalized patients, with about one-half receiving them for the first time.  They are intended to prevent the development of stress ulcers, but are not currently recommended for patients who are not at high risk.

Profile of an autism "expert"

Perhaps looking at the record of Dr. Mayer Eisenstein from Chicago will shed some light on why courts have recently refused to allow testimony from some of the doctors who are willing to testify that mercury  preservative formerly used in childhoon vaccines caused autism.  Large European and American studies involving literally hundreds of thousands of children have failed to show any causal link between mercury preservatives and autism, yet some physicians continue to suggest there is a link.  If Dr. Eisenstein is typical of these "scientists," we may have a little better understanding of why the courts have been reluctant to allow them to offer expert testimony.

Vermont requires publication of drug company payments to doctors; Medtronic rebuked

In the absence of meaningful regulation at the federal level, states have begun to act to achieve greater transparency in the relationship between medical manufacturers and doctors.   Vermont took the most meaningful step thus far, with the Vermont legislature adopting a statute that requires drug and medical device manufacturers to publicly disclose all payments to physicians or health care providers.  It also bans all free meals.  While a drug industry spokesman claimed the legislation would be "onerous" for doctors, it was supported by the Vermont Medical Association, which represents 65 percent of the state's doctors.  It is explected that the Governor will sign the act into law next month.

Lawsuit filed, claims baby shampoo and other products contaminated with formaldehyde

Bloomberg.com reported on Tuesday that Johnson & Johnson, Procter & Gamble and other personal-care product retailers were selling items contaminated with known carcinogens.  Bloomberg only identified the contaminated products as "shampoos and soaps," although a spokesperson for the firm involved suggested that Johnson's Baby Shampoo was one of the contaminated products.

Court analyzes mobile home mold claim

Steven and Amber Raab purchased a manufactured home and leased a lot from River Ridge-Saline, LLC in November 2000.  The lot didn't drain properly, resulting in mold problems focused primarily underneath the mobile home.  The Raabs consulted experts who documented the mold problems, however, their findings did not indicate catastrophic damages.  One expert did testify, however, that it would cost $48,000.00 to remediate the problems.  Despite this claim, the trial court removed the case to District Court on the basis that reasonable minds could not conclude that the family suffered more than $25,000.00--the jurisdictional limit of the Court.

Medtronic, Inc., implicated in doctor's fraudulent study supporting bone-growth product, Infuse.

Dr. Timothy Kuklo, a West Point graduate, attorney and surgeon specialist who recently retired from the Army, is alleged to have falsified information used in an article he wrote supporting the effectiveness of Medtronic's "Infuse" to assist bone-growth after trauma.  His article was originally published in a British medical journal, which retracted the article after one of the three physicians whom Kuklo listed as co-authors challenged his claims. 

Cancer patients sue to deny patent to company claiming ownership of gene

Myriad Genetics was allowed to patent two genes that are closely associated with a risk of breast or ovarian cancer, and on the testing that measures that risk.  This week, Genae Girard and other cancer patients sued to challenge Myriad's patenting of human genes.  Professional organizations of pathologists and individual physicians joined in the suit.

Lobbyists for health care promise to reduce costs to avoid regulation

According to the May 11, 2009, New York Times, executives representing the Advanced Medical Technology Association, the American Hospital Association, America's Health Insurance Plans, the Pharmaceutical Research and Manufacturers of America and the Service Employees International Union, in other words the major health care lobbying entities in the U.S. have promised to join with the federal government to hold down health care costs.  They claim they can achieve large savings by aggressive efforts to prevent obesity, coordination of care, better management of chronic illnesses, by curtailment of unnecessary tests and procedures, by standardizing insurance forms and by increased use of information technology.   Don't hold your breath.  And don't bet next year's health care insurance premium increase, either. 

The White House seems to think this venture, patterned on a proposal made by several health care insurers during the winter, can be an adequate substitute for universal health care, according to White House spokesperson Real Poli'ana.

FDA warns of contamination in Olay cosmetics plant

Reuters reported on May 5 that the FDA had warned Procter & Gamble that it had not adequately addressed contamination and other manufacturing problems at its Puerto Rico manufacturing plant.  The plant produces over-the-counter drugs such as Vicks Sinex nasal spray, and Olay cosmetics such as Revitalizing Daily Foam and Foaming Face Wash.  The FDA's previous inspection report pointed out that products were packaged or prepared in "unsanitary conditions" and that they may have been "contaminated by filth...or... rendered injurious to health." 

Boy, there's an endorsement for your next "Face Wash."  The warning letter is posted on the FDA's website.

FDA alerts doctors to heightened suicide warnings on anti-seizure drugs

On May 5, the FDA reminded doctors that new warnings are being placed on 20 medications used to control seizures, psychiatric disorders and nerve pain.   The warnings point out the "risk of suicidal thoughts or behavior" in patients taking the medications, including Lamictal, Topamax and Lyrica and applies to all medicines in the antiepileptic class.  These medications were the fourth-best-selling class of drugs in the U.S. last year, with total sales of more than 11 billion dollars, according to the Associated Press. 

ProDisc maker settles conflict of interest allegations

The Synthes company makes an artificial device, the ProDisc, which is surgically implanted between spinal vertebrae in a high-risk, expensive procedure that remains controversial.  The company did not disclose for several years that the very doctors who were recommending use of the device were being compensated with shares in the company.  In a negotiated settlement with the New Jersey Attorney General, the company agreed to pay $236,000.00 to the State for the cost of its investigation and to disclose all financial arrangements with medical "researchers."  It also agreed to stop paying with stock or stock options doctors who conduct clinical trials of its products.   

Doctor claims American cigarettes have become more dangerous

Dr. David M. Burns has been a long-time campaigner against smoking.  He published or edited some of the seminal work on tobacco health issues, according to the New York Times, including surgeon general reports, National Cancer Institute monographs and World Health Organization studies.  On May 6, as Congress is considering whether or not to regulate cigarettes, Dr. Burns drew attention to the abstract of a current study which has not yet been published.  Dr. Burns pointed out that it appears that U.S. cigarettes have become almost twice as likely to cause lung cancer as they were in 1964.

Dr. Burns compared the American cigarettes, which are now cured by an accelerated method involving nitrogen fertilizers and propane heaters, to Australian cigarettes which are still made as cigarettes were made in the U.S. back when the original health warnings were devised.  He noted that the American curing process leads to the formation of nitrosamines, which are among 47 known animal or human carcinogens in cigarette smoke.  Dr. Burns believes this curing process explains why the frequency of deadly adenocarcinoma--the most common lung cancer among smokers--has steadily increased in the U.S. over the past fifty years, but not in Australia.

Health Insurer trade group offers to eliminate gender rate disparity

As matters currently stand, U.S. women pay from 25 to 50 percent more than men for health insurance.  The reasons for this disparity have been discussed previously in this web log, and include higher utilization rates by women, childbearing issues and better medical compliance by female patients, in addition to old-fashioned gender bias.  Although the health insurance industry has always maintained that underwriting principles underly the disparity, Karen M. Ignagni, president of America's Health Insurance Plans, a trade group, was quoted by the New York Times as having told the Senate Finance Committee on May 5, 2009, that the practice would be discontinued.

This is one of a series of concessions the trade group has offered since the Obama Administration began discussing creation of a government-run insurance option to compete or replace private insurers in the market place.

Tylenol and Advil to carry bolder liver-damage and gastrointestinal bleeding warnings

The FDA announced on April 29 that over-the-counter pain relievers such as Tylenol and Advil (known as NSAIDs, and including aspirin, ibuprofen, naproxen and ketophrofennlude, for example) will need to carry bolder packaging warnings because of the continuing injury resulting from over-use of the products.

Doctor's opinion that chemical exposure caused loss of smell is admissible

When a Lowe's employee opened the packaging on some pool chemicals, one bottle was punctured, but still placed on a retail shelf.  David Best suffered a chemical burn on his face and hands when he pulled the bottle off the shelf to examine it.  Soon after, he lost his sense of smell completely.  His doctor confirmed that he suffered from "permanent anosmia" and by means of differential diagnosis the doctor excluded other possible causes of the loss.  Lowes persuaded the trial judge to dismiss Best's case, however, by persuading the judge that the doctor's expert opinion was unduly "speculative".

Depakote, taken for epilepsy and migraine headache, injures fetal IQ

The New England Journal of Medicine published a study this month documenting the fact that children born to women who took Depakote (valproate) scored lower on IQ tests administered at age three.  The children scored 9 points lower than children of women taking other antiseizure medications.  Only about one-half of the women taking Depakote suffer from epilepsy.  The five-year study followed 300 pregnant women and 258 children, including 53 who took Depakote.  IQ correlated closely with mothers' IQs, except among moms taking Depakote.  The mean IQ of children taking other anti-seizure meds was almost 101, but only 92 for children whose mothers took valproate.  Doctors confirmed that Depakote should never be the first drug of choice for a pregnant mother.