Thursday, May 31, 2012
Electronic Medical Records
Within the next few years, all health care providers will transition from paper charts to electronic medical records (“EMRs”) and operate exclusively within an EMR system.
ESI and EMR
Both the recently enacted “Patient Protection and Affordable Care Act” and “Health Information Technology for Economic and Clinical Health Act” and monetary incentives and compliance deadlines created by the Centers for Medicare and Medicaid Services are spurring health care providers to hurriedly transition to EMRs.
Beyond amassing and organizing existing Electronically Stored Information (“ESI”), EMRs will have an active role in patient treatment ranging from enabling providers to interface to offering clinical decision support.
Further, while sharing core functionalities, more sophisticated EMR systems may suggest courses of treatment upon an analysis of medical data, remind a provider of clinical practice guidelines or automatically warn of a patient's allergies or a dangerous combination of medications.
EMR and Personal Injury Litigation
EMRs widespread adoption may aid personal injury litigation by both placing unwieldy amounts of information in a user-friendly and searchable format and "definitively" provide the facts surrounding a patient's care.
EMRs may also alter fundamental elements of medical malpractice litigation including increasing the number of parties to sue, the costs of bringing a claim and the amount of time needed to resolve a dispute.
For example, because copying and pasting information from EMR to EMR is a basic system function, perpetuating an existing error or inaccuracy that will follow a patient from provider to provider will increase. Thus, errors like omitting a medication allergy during one provider's treatment may result in an adverse event through the course of treatment with other providers.
This error’s origin may only be discovered well into a claim’s litigation necessitating amending pleadings and creating liability disputes.
Extending liability to an EMR vendor is inevitable and will require significant technical discovery further complicating an already complex medical malpractice claim.
Further, beyond carefully choosing an EMR vendor and system, health care providers will need to avoid contractual agreements immunizing from technical errors (like software bugs and hardware malfunctions) causing adverse events.
EMR use may also change how medical malpractice standards of care are defined.
Providers implicated in an adverse event may be weighed and measured against a sophisticated EMR system providing differential diagnoses or recommending courses of treatment.
If a provider deviates from an EMR's recommended course of treatment, a jury may equate it to deviating from a legally defined standard of care requiring the defense to provide both a standard of care set forth by an expert and a justification for deviating from EMR-generated treatment recommendations.
Further, providers not using EMR systems may face exposure for failing to adhere to the diagnoses or courses of treatment that the EMR system would have provided.
Legislation has been proposed in Pennsylvania’s State House to provide medical malpractice claim immunity to suppliers of medical data to electronic databases and on the federal level, the proposed “Safeguarding Access for Every Medicare Patient Act” seeks to create legal protections for providers if an adverse event occurs as a result of EMR errors.
Wednesday, February 29, 2012
Van Rollovers
Because it’s 3 times more likely to rollover with 10 or more occupants, a 15-passenger van is the most dangerous vehicle on the road.
Half a million 15-passenger vans are currently operating often by schools, day care centers, hotels, churches, and scout troops.
Since 2000, more than 400 people have died and thousands have been seriously injured in 15-passenger van rollover accidents involving roof pillar failure or collapse (causing the roof to crush the passengers), tire failures, seatback failures, seatbelt injuries, lack of headrests, lack of glazing of windows, fuel-fed fires, gas tank fires, and fuel tank explosions.
The federal government has banned their purchase by schools, most insurers won’t cover them, and several universities no longer permit athletes to be transported in 15-passenger vans.
Engineers place the problem in the van’s design, weight and balance. First, the van’s manufacture with a car’s wheel base and an “extended back end” comprised of a 4 passenger seat behind the rear axle weigh down the rear end causing it to swing out following a “sudden swerve”, i.e., emergency action after steering in one direction and then being forced to rapidly correct in the opposite to avoid a hazard.
Second, 15-passenger vans are top heavy with a high center of gravity which increases with additional passengers.
According to National Highway Traffic Safety Association (“NHTSA”) research, 15-passenger van’s rollover risk increases dramatically with the number of occupants in that vans with 10 or more occupants have 3 times the rollover rate as those with fewer than 5 occupants.
Although research has consistently shown that improperly inflated tires drastically change the vehicle’s handling and significantly increase the prospect of a rollover, a recent NHTSA research reports that 74% of all 15-passenger vans had incorrectly inflated tires.
For the 3rd time in the past 5 years, NHTSA has issued a “15-passenger van consumer advisory” recommending that only trained and experienced drivers operate the vans, weekly check tire inflation levels against manufacturer's recommended pressure levels, and place no loads on the vehicle’s roof.
Half a million 15-passenger vans are currently operating often by schools, day care centers, hotels, churches, and scout troops.
Since 2000, more than 400 people have died and thousands have been seriously injured in 15-passenger van rollover accidents involving roof pillar failure or collapse (causing the roof to crush the passengers), tire failures, seatback failures, seatbelt injuries, lack of headrests, lack of glazing of windows, fuel-fed fires, gas tank fires, and fuel tank explosions.
The federal government has banned their purchase by schools, most insurers won’t cover them, and several universities no longer permit athletes to be transported in 15-passenger vans.
Engineers place the problem in the van’s design, weight and balance. First, the van’s manufacture with a car’s wheel base and an “extended back end” comprised of a 4 passenger seat behind the rear axle weigh down the rear end causing it to swing out following a “sudden swerve”, i.e., emergency action after steering in one direction and then being forced to rapidly correct in the opposite to avoid a hazard.
Second, 15-passenger vans are top heavy with a high center of gravity which increases with additional passengers.
According to National Highway Traffic Safety Association (“NHTSA”) research, 15-passenger van’s rollover risk increases dramatically with the number of occupants in that vans with 10 or more occupants have 3 times the rollover rate as those with fewer than 5 occupants.
Although research has consistently shown that improperly inflated tires drastically change the vehicle’s handling and significantly increase the prospect of a rollover, a recent NHTSA research reports that 74% of all 15-passenger vans had incorrectly inflated tires.
For the 3rd time in the past 5 years, NHTSA has issued a “15-passenger van consumer advisory” recommending that only trained and experienced drivers operate the vans, weekly check tire inflation levels against manufacturer's recommended pressure levels, and place no loads on the vehicle’s roof.
Tuesday, January 31, 2012
Bus Accidents
As public transportation’s use increases, so does the number of bus accident injuries and deaths.
According to the National Highway Transportation Safety Administration, in 2002 19,000 people were injured in bus accidents principally caused by driver negligence, defective equipment, dangerous roadways and improper maintenance.
In addition to city buses, each weekday 25 million children ride yellow school buses to school related activities as well as religious, athletic and youth events.
Approximately 450,000 school buses are in service travelling 2 million miles per day resulting in 16,000 annual collisions causing 12,000 injuries and 130 deaths per year.
Most full-size school buses lack seat belts exposing children to a greater risk of harm and budgetary pressures cause schools to stretch maintenance schedules, keep vehicles in service for prolonged periods and use lower paid, less experienced drivers.
Bus-related accidents cause brain and spinal cord injuries, sprains, fractures, abrasions, internal and soft tissue injuries, burns and death.
Bus companies’ legal responsibility to their passengers is that of a "common carrier", i.e., an individual, company or a public utility in business of transporting people and/or freight owing a greater duty of safety and protection than an ordinary car.
Despite this higher responsibility to drive with the utmost care and protect passengers and other vehicles sharing the road, buses are often owned or operated by city, county or regional transportation departments which vigorously defend bus accidents.
As a result, immediately investigating a bus accident while the physical evidence is still fresh and inspecting the driver's training history and driving record is crucial.
According to the National Highway Transportation Safety Administration, in 2002 19,000 people were injured in bus accidents principally caused by driver negligence, defective equipment, dangerous roadways and improper maintenance.
In addition to city buses, each weekday 25 million children ride yellow school buses to school related activities as well as religious, athletic and youth events.
Approximately 450,000 school buses are in service travelling 2 million miles per day resulting in 16,000 annual collisions causing 12,000 injuries and 130 deaths per year.
Most full-size school buses lack seat belts exposing children to a greater risk of harm and budgetary pressures cause schools to stretch maintenance schedules, keep vehicles in service for prolonged periods and use lower paid, less experienced drivers.
Bus-related accidents cause brain and spinal cord injuries, sprains, fractures, abrasions, internal and soft tissue injuries, burns and death.
Bus companies’ legal responsibility to their passengers is that of a "common carrier", i.e., an individual, company or a public utility in business of transporting people and/or freight owing a greater duty of safety and protection than an ordinary car.
Despite this higher responsibility to drive with the utmost care and protect passengers and other vehicles sharing the road, buses are often owned or operated by city, county or regional transportation departments which vigorously defend bus accidents.
As a result, immediately investigating a bus accident while the physical evidence is still fresh and inspecting the driver's training history and driving record is crucial.
Wednesday, December 21, 2011
2011 Amherst Bowl
Years ago I put together a father son Thanksgiving football game hoping to fill those empty morning hours and hang out with my son.
I succeeded beyond my wildest dreams.
Celebrating its 8th year, the tournament, christened "The Amherst Bowl", has swollen to 127 players spanning 6 football fields and 12 teams playing 5 continuous football games in authentic AFC or NFC team jerseys.
The trash talk begins on Labor Day and echoes through our Township’s lunchrooms and playing fields with kids wearing prior years’ jerseys like badges of glory.
During Thanksgiving’s wet early morning hours, we map out and line the fields and set up tables overflowing cakes, hot chocolate and coffee.
The horde shows up at around 8:00 a.m. eager to learn the team to which to they’ve been assigned, whom their teammates will be, and how gloriously muddy the fields are.
Shirts are distributed, rules are explained, and at 9:00 a.m. the carnage begins.
During the ensuing rigidly timed five games, fathers put their middle-aged bodies at risk, re-live their youth and play football with their sons.
Throughout the morning used soccer gear is collected by "Heads Up Soccer" which transports and distributes it to impoverished third world youth.
Additionally, monies raised are donated to "Katie at the Bat" http://www.katieatthebatteam.org/ (improving inner-city youths’ lives through athletics, literacy, nutrition and health, and the arts), "Adam Spandorfer Memorial Fund" http://www.adamsfield.org/ (raising monies for Variety Club Camp at which children with disabilities can play baseball), and Hope with Heart http://hopewithheart.com/ (providing a summer camp and building a community for children with moderate to severe heart problems).
Although, at the Tournament’s end, some need help getting off of the field, that evening’s Thanksgiving tables are abuzz with boasts of heroic plays, grudges revisited, and glorious victories.
Until next year, when we do it bigger and better.
Thursday, March 31, 2011
Unsafe Drug Alert: TOPAMAX
On March 4, 2011, the Food and Drug Administration (“FDA”) issued a warning that Topiramate, a seizure, epilepsy and migraine medication marketed as Topamax, increases the risk of oral birth defects including cleft lip and/or cleft palate.
The FDA approved Topiramate to prevent migraine headaches (but not to relieve migraine headache pain) and it has been used “off-label” to treat other conditions.
Topamax has been on the market since 1996 and was the 13th best selling prescription drug in 2008 with $2.4 billion pm annual U.S. sales.
Although previously classified as a “Pregnancy Category C” drug (meaning that animal studies data suggested potential fetal risks) because new human data shows an increased oral cleft risk, Topiramate was placed in “Pregnancy Category D” signifying human fetal risk.
Specifically, data indicates that if Topiramate is taken during pregnancy there is a higher risk that the baby will develop a cleft lip and/or cleft palate.
Cleft lip and cleft palate range from a small notch in the lip to a groove running into the roof of the mouth and nose, possibly leading to eating, talking and ear infection problems.
Oral clefts happen early in pregnancy, before many women even know they are pregnant, and surgery is used to close the lip and palate.
Topiramate’s benefits and risks should be carefully weighed when prescribing to women of childbearing age, particularly for conditions not usually associated with permanent injury or death.
Further, because suddenly stopping Topiramate can cause serious problems, Topiramate should not be stopped before talking to a healthcare professional, even in pregnant women.
The FDA approved Topiramate to prevent migraine headaches (but not to relieve migraine headache pain) and it has been used “off-label” to treat other conditions.
Topamax has been on the market since 1996 and was the 13th best selling prescription drug in 2008 with $2.4 billion pm annual U.S. sales.
Although previously classified as a “Pregnancy Category C” drug (meaning that animal studies data suggested potential fetal risks) because new human data shows an increased oral cleft risk, Topiramate was placed in “Pregnancy Category D” signifying human fetal risk.
Specifically, data indicates that if Topiramate is taken during pregnancy there is a higher risk that the baby will develop a cleft lip and/or cleft palate.
Cleft lip and cleft palate range from a small notch in the lip to a groove running into the roof of the mouth and nose, possibly leading to eating, talking and ear infection problems.
Oral clefts happen early in pregnancy, before many women even know they are pregnant, and surgery is used to close the lip and palate.
Topiramate’s benefits and risks should be carefully weighed when prescribing to women of childbearing age, particularly for conditions not usually associated with permanent injury or death.
Further, because suddenly stopping Topiramate can cause serious problems, Topiramate should not be stopped before talking to a healthcare professional, even in pregnant women.
Thursday, February 24, 2011
Consumer Product Safety Database
Starting in March 2011, consumers will be able to submit reports of harm caused by consumer products to a public database created by the Consumer Product Safety Commission ("CPSC").
The CPSC regulates consumer products sold in the United States including toys, furniture, clothing and accessories, electronics, sports and recreation items, containers, kitchen items, household chemicals and fuel.
The database, www.saferproducts.gov, will allow the public to post, search for, and review consumer product reports (previously available only through a Freedom of Information Act request) and manufacturers’ response to those reports.
The database was created to provide timely injury-causing-dangers information without waiting for a product recall by allowing consumers and others to submit consumer product safety reports directly to the CPSC.
Here is how it works.
Consumers log onto www.saferproducts.gov and submit a description of the product, the manufacturer’s identity, and a description of the harm caused by the product’s use.
If it meets the minimum criteria for publication, the CPSC will post the report on the database 15 business days after submission and forward a copy to the manufacturer for comment.
The manufacturer then has 10 business days to comment if it wishes to have its comments published simultaneously with the report’s posting.
Although the new CPSC database will both promote transparency and provide consumers with necessary product safety information, because anyone may submit a report, including competitors and lawyers representing claimants against the manufacturer, concerns exist that the database might unfairly damage reputations or lead to baseless litigation.
The CPSC regulates consumer products sold in the United States including toys, furniture, clothing and accessories, electronics, sports and recreation items, containers, kitchen items, household chemicals and fuel.
The database, www.saferproducts.gov, will allow the public to post, search for, and review consumer product reports (previously available only through a Freedom of Information Act request) and manufacturers’ response to those reports.
The database was created to provide timely injury-causing-dangers information without waiting for a product recall by allowing consumers and others to submit consumer product safety reports directly to the CPSC.
Here is how it works.
Consumers log onto www.saferproducts.gov and submit a description of the product, the manufacturer’s identity, and a description of the harm caused by the product’s use.
If it meets the minimum criteria for publication, the CPSC will post the report on the database 15 business days after submission and forward a copy to the manufacturer for comment.
The manufacturer then has 10 business days to comment if it wishes to have its comments published simultaneously with the report’s posting.
Although the new CPSC database will both promote transparency and provide consumers with necessary product safety information, because anyone may submit a report, including competitors and lawyers representing claimants against the manufacturer, concerns exist that the database might unfairly damage reputations or lead to baseless litigation.
Tuesday, October 26, 2010
Brain and Spinal Cord Injuries: Causes and Protections
Although design defects have not changed much over the last couple of decades, recent medical advances allow crash victims to survive formally fatal injuries.
Seriously brain damaged and paralyzed spinal cord victims’ survival and increased life expectancies require huge sums for lifetime medical expenses and costly functional and psychological problems.
How brain and spinal cord injuries occur - - and methods for eliminating or reducing their severity - - is discussed below.
Severe Brain Injury
Brain injuries are most commonly caused by head impact, inertial loading of the head, and loss of oxygen (hypoxia).
While brain injury from head impact requires direct impact, inertial loading of the brain results from direct or indirect loading like violent flexion/extension in a rear-end crash lacking properly designed head restraints.
This trauma causes diffuse and focal brain injury, the latter involving harm to defined brain regions in which victim experiences skull fractures and brain contusions or epidural or subdural hematomas located beneath - - or opposite to - - impact’s site.
Head contact may cause diffuse axonal injury, i.e., an initial concussion followed by cellular or bleeding damage to multiple brain regions.
Regardless of whether the injury is focal or diffuse, swelling or edema (tissue damage and increased fluid) more life threatening than the injury may occur and horribly injure the brain stem, i.e., the link between the brain and spinal cord.
Either direct head impact or indirect violent head movement induces two types of brain injury: translational and/or rotational movement.
Translational (or linear) motion is the movement in a direct path through head’s center of gravity (CG). Rotational motion occurs when the brain angulates around the head’s CG causing it to violently move in a non-uniform fashion and exposing areas of the brain to injury.
The brain is a viscoelastic organ susceptible to injury due to sensitivity to force, shape of impacting object, acceleration, and rate at which brain is accelerated.
While most closed head injuries occur within a fraction of a second of exposure to acceleration, the head injury’s nature and extent depends upon the acceleration’s rate of onset, directionality and peak.
Severe Cervical Spinal Cord Injury
The cervical spine is made up of vertebrae positioned to produce “lordotic curvature” causing the spine to arch when standing upright.
The lower cervical vertebrae are similar in shape, with size and mass increasing as there is movement toward the thoracic spine.
The commonly acknowledged mechanism causing cervical spine fracture or dislocation —resulting in catastrophic quadriplegia/paraplegia — is axial loading with failure of the spine in a flexion mode.
Considering the cervical spine with the neck in the neutral position, the spine’s normal alignment is with extension because of the lordotic curve. When the head moves forward and the neck flexes forward, the cervical spine is straightened.
With the force exerted from head impact or arrest of the head with the body in motion, along the axis of a straight spine, loading of the spine as a segmented column occurs. When energy input exceeds energy absorbing capacity, intervertebral disc injury, vertebral body fracture, ligamentous disruption or posterior element fracture results. When maximum vertical compressive deformation is reached, acute cervical spine flexion occurs, with fracture or dislocation. The spinal cord is traumatized by impingement of the spinal process.
Because current research places the critical limits on the compressive load’s magnitude at 700 to 1000 pounds, force exceeding this load causes spinal cord injury.
Automotive and Helmet Design and Injury
To properly design a motor vehicle to reduce brain or spinal cord injury, the restraint system and "head strike zone" (e.g., steering wheel, instrument panel, roof, windshield, etc.) must account for head contact, inertial loading of the head from torso restraint, and spinal cord loading.
Thus, manufacturers must set design/injury parameters under foreseeable accident circumstances then test and measure the safety componentry’s performance. Generally, the more shock attenuation provided by the component or system placed between the head/neck and loading force (e.g., helmet, instrument panel, "A" pillar padding, etc.), the less transmitted acceleration and less likely the victim will be injured.
Head and spinal cord injury is also a major cause of disability in sports activities associated with helmets often due to lax and outdated helmet test standards.
If designed correctly, all helmets protect through load distribution and energy absorption. Distribution depends on the stiffness of the shell while absorption is based upon the liner’s deformable properties, i.e., density and thickness.
Unfortunately, many helmet designers fail to provide head and neck protection in impacts with velocity changes exceeding 15 mile per hour often meeting only minimal governmental or industry standards.
Seriously brain damaged and paralyzed spinal cord victims’ survival and increased life expectancies require huge sums for lifetime medical expenses and costly functional and psychological problems.
How brain and spinal cord injuries occur - - and methods for eliminating or reducing their severity - - is discussed below.
Severe Brain Injury
Brain injuries are most commonly caused by head impact, inertial loading of the head, and loss of oxygen (hypoxia).
While brain injury from head impact requires direct impact, inertial loading of the brain results from direct or indirect loading like violent flexion/extension in a rear-end crash lacking properly designed head restraints.
This trauma causes diffuse and focal brain injury, the latter involving harm to defined brain regions in which victim experiences skull fractures and brain contusions or epidural or subdural hematomas located beneath - - or opposite to - - impact’s site.
Head contact may cause diffuse axonal injury, i.e., an initial concussion followed by cellular or bleeding damage to multiple brain regions.
Regardless of whether the injury is focal or diffuse, swelling or edema (tissue damage and increased fluid) more life threatening than the injury may occur and horribly injure the brain stem, i.e., the link between the brain and spinal cord.
Either direct head impact or indirect violent head movement induces two types of brain injury: translational and/or rotational movement.
Translational (or linear) motion is the movement in a direct path through head’s center of gravity (CG). Rotational motion occurs when the brain angulates around the head’s CG causing it to violently move in a non-uniform fashion and exposing areas of the brain to injury.
The brain is a viscoelastic organ susceptible to injury due to sensitivity to force, shape of impacting object, acceleration, and rate at which brain is accelerated.
While most closed head injuries occur within a fraction of a second of exposure to acceleration, the head injury’s nature and extent depends upon the acceleration’s rate of onset, directionality and peak.
Severe Cervical Spinal Cord Injury
The cervical spine is made up of vertebrae positioned to produce “lordotic curvature” causing the spine to arch when standing upright.
The lower cervical vertebrae are similar in shape, with size and mass increasing as there is movement toward the thoracic spine.
The commonly acknowledged mechanism causing cervical spine fracture or dislocation —resulting in catastrophic quadriplegia/paraplegia — is axial loading with failure of the spine in a flexion mode.
Considering the cervical spine with the neck in the neutral position, the spine’s normal alignment is with extension because of the lordotic curve. When the head moves forward and the neck flexes forward, the cervical spine is straightened.
With the force exerted from head impact or arrest of the head with the body in motion, along the axis of a straight spine, loading of the spine as a segmented column occurs. When energy input exceeds energy absorbing capacity, intervertebral disc injury, vertebral body fracture, ligamentous disruption or posterior element fracture results. When maximum vertical compressive deformation is reached, acute cervical spine flexion occurs, with fracture or dislocation. The spinal cord is traumatized by impingement of the spinal process.
Because current research places the critical limits on the compressive load’s magnitude at 700 to 1000 pounds, force exceeding this load causes spinal cord injury.
Automotive and Helmet Design and Injury
To properly design a motor vehicle to reduce brain or spinal cord injury, the restraint system and "head strike zone" (e.g., steering wheel, instrument panel, roof, windshield, etc.) must account for head contact, inertial loading of the head from torso restraint, and spinal cord loading.
Thus, manufacturers must set design/injury parameters under foreseeable accident circumstances then test and measure the safety componentry’s performance. Generally, the more shock attenuation provided by the component or system placed between the head/neck and loading force (e.g., helmet, instrument panel, "A" pillar padding, etc.), the less transmitted acceleration and less likely the victim will be injured.
Head and spinal cord injury is also a major cause of disability in sports activities associated with helmets often due to lax and outdated helmet test standards.
If designed correctly, all helmets protect through load distribution and energy absorption. Distribution depends on the stiffness of the shell while absorption is based upon the liner’s deformable properties, i.e., density and thickness.
Unfortunately, many helmet designers fail to provide head and neck protection in impacts with velocity changes exceeding 15 mile per hour often meeting only minimal governmental or industry standards.
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