Saliva Test Predicts Prolonged Concussion Symptoms in Children

According to the American Academy of Pediatrics, although the majority of concussions that are diagnosed annually occur in children, clinical guidelines are usually based on adult concussion sufferers. The lack of guidelines may limit the ability of pediatricians to accurately predict the duration of a child’s symptoms, including headaches, fatigue, and concentration problems — which can interfere with school and other activities.

In many concussion cases, concussion symptoms last only a few days. However, up to 25 percent of children have prolonged concussion symptoms which can last for months.

Concussion Symptom Saliva Test Study Presented at Annual Meeting

New research presented at the 2017 Pediatric Academic Societies (PAS) Meeting suggests that a saliva test for children may offer answers as to how long concussion symptoms will last. Researchers presented an abstract of the study, “Peripheral microRNA patterns predict prolonged concussion symptoms in pediatric patients.” The PAS Meeting is produced through a partnership of four organizations: Academic Pediatric Association, American Academy of Pediatrics, American Pediatric Society, and Society for Pediatric Research.

Results of Concussion Symptom Saliva Test Study

Following a concussion, injured brain cells release fragments of genetic material (microRNAs) which show up in blood and saliva. Studies have found altered micro ribonucleic acids (miRNA) levels in the saliva of children with mild concussions. Similar miRNA changes have been found in cerebrospinal fluid of patients with severe brain injury.

Researchers at Penn State College of Medicine studied 50 children, ages 7 to 18 years old who experienced mild traumatic brain injury. Spit samples from each child were tested for miRNA levels. Concussion symptoms were evaluated through the parent and child Sports Concussion Assessment Tool (SCAT-3) surveys.

Researchers found that salivary miRNA levels were more effective than SCAT-3 surveys in predicting which children would continue to experience concussion symptoms that lasted longer than four weeks. The SCAT-3 surveys were less than 70 percent accurate in identifying children who would have prolonged concussion symptoms. The miRNA saliva test correctly predicted whether concussion symptoms would last for at least a month nearly 90 percent of the time.

The saliva-based RNA testing indicates the potential for an accurate and non-invasive method to evaluate pediatric concussions and provide a more accurate prognosis.

This post was written by Bruce H. Stern of STARK & STARK., COPYRIGHT © 2017
For more Health Care Law legal analysis go to The National Law Review

Mild Traumatic Brain Injury and the Pupillary Light Reflex

According to a recent review study of Pubmed Central/National Library of Medicine databases, the pupillary light reflex provides an optimal opportunity to investigate mild traumatic brain injury (mTBI).

Based on the findings of the review, the pupillary system may provide a noninvasive “window” to mTBI, in terms of documenting its existence and the often-accompanying symptom of photosensitivity. When an individual experiences mTBI, visual dysfunction may occur, and the pupillary light reflex may be affected. Pupils are routinely assessed for abnormal size and responsivity to determine the neural integrity of the visual system. Investigating pupillary light reflex in the mTBI population, researchers found that pupillary response was significantly delayed, slowed, and reduced, symmetrically, with a smaller baseline diameter. These findings may indicate dysfunction of the pupillary pathway.

Several objective biomarkers for the presence of mTBI and photosensitivity provide further insight into neurological dysfunction. In mTBI, photosensitivity may be due to dysfunction in the baseline neural sensor. Photosensitivity as a perceptual phenomenon can be confirmed through objective, noninvasive, rapid, vision-based, pupillary biomarkers.

Pupillary light reflex in mTBI may be investigated with pupillometers to assess subtle abnormalities in pupil size as well as pupillary responses. The resulting information can provide diagnostic or prognostic indicators relating to the extent of the injury, and neurophysiological linkages. Pupillometers offer precise and extensive pupillary testing for the mTBI population, especially those individuals who experience photosensitivity. The major drawback is cost. Development of a more inexpensive hand-held pupillometer would help with diagnosis of mTBI and improve patient care.

With such instrumentation, pupillary light reflex could be used to investigate the possibility of a very early, acute-stage mTBI/concussion in emergency rooms, in the workplace, and even on the sideline of sports games. Such information can be relevant to a worker’s compensation determinations, social security disability determinations, and return-to-play/work/learn standards for both adults and children.

This post was written by Bruce H. Stern of STARK & STARK., COPYRIGHT © 2017
For more Biotech legal analysis, go to The National Law Review 

Telemedicine – Are There Increased Risks With Virtual Doctor Visits?

“Telemedicine” or “Telehealth” are the terms most often used when referring to clinical diagnosis and monitoring that is delivered by technology. Telemedicine encompasses healthcare provided via real time two-way video conferencing; file sharing, including transmission of health history, x-rays, films, or photos; remote patient monitoring; and consumer mobile health apps on smart phones, tablets, and devices that collect data and transmit it to a healthcare provider. Telemedicine is increasingly being used for everything from diagnosing common viruses to monitoring patients with serious long-term health issues.

The American Telemedicine Association reports that majority of hospitals now use some form of telemedicine. Two years ago, there were approximately 20 million telemedicine video consultations; that number is expected to increase to about 160 million by 2020. An estimated one-third of employer group plans already cover some type of telehealth.

Telemedicine implicates legal and regulatory issues as licensing, prescribing, credentialing, and cybersecurity. Pennsylvania recently passed legislation joining the Interstate Medical Licensing Compact, an agreement whereby licensed physicians can qualify to practice medicine across state lines within the Compact if they meet the eligibility requirements. The Compact enables physicians to obtain licenses to practice in multiple states, while strengthening public protection through the sharing of investigative and disciplinary information.

Federal and state laws and regulations may differ in their definitions and regulation of telemedicine. New Jersey recently passed legislation authorizing health care providers to engage in telemedicine and telehealth. The law establishes telemedicine practice standards, requirements for health care providers, and telehealth coverage requirements for various types of health insurance plans. Earlier this year, Texas became the last state to abolish the requirement that patient-physician relationships must first be established during an in-person patient/doctor visit before a telemedicine visit.

As telemedicine use increases, there will likely be an increase in related professional liability claims. One legal issue that arises in the context of telemedicine involves the standard of care that applies. The New Jersey statute states that the doctor is held to the same standard of care as applies to in-person settings. If that is not possible, the health care provider is required direct the patient to seek in-person care. However, the standard of care for telemedicine is neither clear nor uniform across the states.

Another issue that arises in the context of telemedicine is informed consent, especially in terms of communication, and keeping in mind that the Pennsylvania Supreme Court recently held that only the doctor, and not staff members, can obtain informed consent from patients. Miscommunication between a healthcare provider and patient is often an underlying cause of medical malpractice allegations in terms of whether informed consent was obtained.

In addition, equipment deficiencies or malfunctions can mask symptoms that would be evident during an in-person examination or result in the failure to transmit data accurately or timely, affecting the diagnosis or treatment of the patient.

Some of these issues will likely ultimately be addressed by legislative or regulatory bodies but others may end up in the courts. According to one medical malpractice insurer, claims relating to telemedicine have resulted from situations involving the remote reading of x-rays and fetal monitor strips by physicians, attempts to diagnose a patient via telemedicine, delays in treatment, and failure to order medication.

recent Pennsylvania case illustrates how telemedicine may also impact the way medical malpractice claims are treated in the courts. In Pennsylvania, a medical malpractice lawsuit must be filed in the county where the alleged malpractice occurred. Transferring venue back to Philadelphia County, the Superior Court in Pennsylvania found that alleged medical malpractice occurred in Philadelphia — where the physician and staff failed to timely transmit the physician’s interpretation of an infant’s echocardiogram to the hospital in another county where the infant was being treated.

The use of telemedicine will likely have wide-reaching implications for health care and health care law, including medical malpractice.

This post was written by Michael C. Ksiazek of STARK & STARK, COPYRIGHT ©
2017
For more Health Care legal analysis, go to The National Law Review 

Airlines’ Shrinking Seat Space May Increase Likelihood of Head Injuries

While the Federal Aviation Administration (FAA) has addressed protection from head injuries for flight attendants, according to a recent article, it has not addressed the impact of shrinking seat designs on the safety of passengers. A second article states that no seat in coach meets the FAA’s standards for the space required for flight attendant seat safety.

Graphic Sheds Light on Impact of Smaller Seats and Rows on Safety

Embedded in the regulations governing commercial airline safety is a graphic that may offer evidence that smaller seats and rows on airplanes may affect passengers’ safety. The DOT graphic shows the “head strike zone” for a seated flight attendant and is intended to offer guidance on seat design to reduce the risk of injury to flight attendants during takeoff and landing but apparently a similar analysis has not been undertaken as to passengers.

The head strike zone is the space that must be kept clear so that the occupant’s head avoids contact with an adjacent seat in the event of an impact. The graphic suggests that shortening the distance between passenger seat rows may have increased the likelihood of a passenger suffering head trauma from the seat in front.

Lawsuit Seeks FAA Rules on Minimum Seat and Aisle Sizes

FlyersRights.Org filed a petition for rulemaking requesting that the FAA set rules on minimum seat and aisle sizes. In its petition, FlyersRights.org documented that economy class seat pitch, that is the distance between a point on one seat and the same point on the seat in front of it has shrunk from an average of 35 inches to 31 inches and in some airplanes, 28 inches. Among other things, FlyersRights.Org argues that passengers may not be able to evacuate quickly in a crash due to the cramped seating. Another concern is the risk of passengers developing potentially dangerous blood clots in their legs.

The FAA declined to draw up regulations on seat size, arguing that its rulemaking authority does not extend to comfort – and that safety tests indicate the smaller seats pose no danger. The FAA also maintains that flight attendants and passengers have the same injury protection regulations.

FlyersRights.Org filed a petition for review with the U.S. Court of Appeals for the District of Columbia, challenging the FAA’s refusal to engage in rulemaking and its unsupported conclusions about passenger seat safety. In recent opinion, the Court ordered the FAA to reexamine whether shrinking seats have safety consequences and to provide scientific evidence as to why narrower aisles and tighter seats are not safety issues.

This post was written by Bruce H. Stern of STARK & STARK, COPYRIGHT © 2017
For more legal analysis go to The National Law Review

Court Orders Monsanto Roundup Safety Documents to be Disclosed

Monsanto is catching a lot of heat now that a court has unsealed documents that cast the company in a negative light and suggest that it was responsible for providing false assertions to the government and public regarding the safety of Roundup. As the most popular herbicide in the world, Roundup and similar products produced by Monsanto are used across the globe for the elimination of pests from lawns, crops, gardens and nurseries. It has provided research that opposes the belief Roundup’s main active ingredient can cause cancer, but the documents unsealed by the court show that these accounts were misleading and, in some cases, false.

Ghostwritten Research

The research that was presented to defend the safety of its products was in fact, ghostwritten and attributed to academics. It also claimed that a senior EPA official attempted to dismiss a report from the United States Department of Health and Human Services that the product could in fact be linked to the deaths of numerous people who suffered from non-Hodgkin’s lymphoma. The evidence tells a story of arguments within the Environmental Protection Agency and conflicting beliefs over whether Roundup and similar products were safe to use.

Emails between Monsanto executives and Jess Rowland of the EPA discuss an effort to disrupt the efforts of the Department of Health and Human Services to make its own determination and review of the product. Rowland states in the emails that he should receive a medal if he is able to succeed in his interference.

World Health Organization Classifies Products as Carcinogenic

The growing litigation over Roundup was sparked off by the classification of Roundup as a carcinogen, due to the discovery of a link between glyphosate and cancer in animals and the destruction of DNA and chromosomes in human cells. Despite the research provided by the WHO, Monsanto went to great lengths to continue the defense of its product and to assert that it was as safe to consume as salt.

While Monsanto claims that glyphosate is safe, those who have come forward with claims against the company allege that Monsanto has repeatedly falsified research and information in order to fool the government and the public. In its defense, Monsanto has claimed that the unsealed documents are being presented out of context and that they provide isolated information. Numerous health agencies around the world have presented conflicting arguments over the safety of these products, so the science has not been settled just yet.

This post was written by Jonathan Rosenfeld of Rosenfeld Injury Lawyers, Copyright © 2017
For more legal analysis go to The National Law Review

Long-Term Effects of Nonfatal Drowning Cannot Be Accurately Predicted

According to the Centers for Disease Control and Prevention (CDC), from 2005-2014, an average of 3,536 fatal unintentional drownings occurred per year in the United States. Approximately one in five people who die from drowning are children 14 years old or younger; children one to four years old have the highest drowning rates.

For every death caused by drowning, five children receive emergency room care for nonfatal drowning injuries. Nonfatal drowning can cause hypoxic-ischemic brain injury that may result in long-term disabilities ranging from memory problems and learning disabilities to total loss of basic functioning (persistent vegetative state).

A recent review study found that neurocognitive outcome of children after drowning incidents cannot be accurately predicted from early examinations and treatment. In the study, researchers sought to:  a) report the main factors related to the outcome of drowned children, and b) present existing evidence of long-term neurologic outcome. While some injuries caused by near drownings become evident shortly after the incident, the evidence showed that the initial neurological examination may not reveal all of the long-term effects related to hypoxic brain injury in young children. Skills such as divided attention and executive functions may be negatively affected after a brain injury caused by a nonfatal drowning. Long-term follow-up of drowned resuscitated children should be undertaken.

The review study showed that the long-term outcome of survived drowning victims depends mainly on the severity of the initial ischemic brain insult, the effectiveness of immediate resuscitation with transfer to the ER, and on the post-resuscitation management in the hospital. The study noted that the most susceptible areas to ischemic injury are vascular end zones, hippocampus, insular cortex, and basal ganglia. With greater severity of hypoxic-ischemia, more extensive and global neocortical injury will occur.

Electroencephalograms (EEG) provide useful information to differentiate between patients with good and poor neurological outcome. However, the accuracy in predicting long-term neurological outcome is lacking. The increased use of neuroimaging techniques such as MRIs can add valuable information. The ability to see the degree of edema and brain swelling is better with an MRI than with a CT scan. But the fact remains that data on long-term follow-up and outcome are scarce.

This post was written by Bruce H. Stern of  Stark & Stark.

Distracted Driving vs. DUI: The Legal Consequences

Distracted DrivingWith the explosion of cell phones in the consumer marketplace, texting and driving has emerged as a national health crisis for individual motorists, the public, and the courts. In 2013, 10 percent of all fatal crashes involved distraction, resulting in the deaths of 3,154 people. Additionally, it is estimated that another 424,000 people were injured in accidents involving distracted drivers.1 In addition to texting while driving, other types of distracted driving include talking on cell phones, eating, using in-dash electronics, and any other activity that takes a driver’s attention away from the road.2

In response to the problems presented by texting and driving, 46 states and the District of Columbia have instituted laws forbidding the action, criminalizing texting and driving as at least an infraction.3 At the same time, other forms of distracted driving, including using social media applications such as Twitter, Facebook, LinkedIn, SnapChat and recently, Pokemon Go, have emerged as major problems in their own right.4 In a study recently completed by Liberty Mutual Insurance, a survey of 2,500 teenagers revealed that almost 70 percent admitted to using social media apps while they drive.5 In another survey completed by the National Safety Council of 2,409 drivers of all ages, 74 percent of those who were surveyed indicated that they would use Facebook while they drove.6

Distracted Driving vs. DUI: Levels of Impairment

A 2006 study looked at the impairment levels of people who were using cell phones versus people who were intoxicated while driving. The University of Utah researchers used a driving simulator and compared study participants who were talking on their cell phones versus those who were legally intoxicated. The researchers looked at results using the simulator involving 49 adult participants who ranged in age from 22 to 45. They first obtained baseline driving results, then looked at driving while using cell phones and finally, driving with blood alcohol concentrations of 0.08 percent over a 3-day period.7 By looking at data obtained from driving profiles the researchers created using 10-second epochs, the researchers found that cell phone users, regardless of whether or not they were using hands-free or handheld devices, showed greater levels of driver impairment than did the drivers who were intoxicated by alcohol.8

Injury and Fatality Statistics for Distracted Driving Vs. Drunk Driving

The Centers for Disease Control and Prevention reports that distracted driving injures 1,161 people and kills eight every day in the U.S.9 By comparison, the agency reports that 28 people are killed every day in accidents involving drunk drivers.10 While the percentages of people using cell phones while driving has increased, drinking and driving has decreased.11, 12

Overview of State Laws: Distracted Driving vs. DUI Penalties in California and Alaska

The penalties for texting and driving vary from state to state. While the act is banned in 46 states, some jurisdictions, such as California, make texting and driving only an infraction. In California, a first offense is punishable by a fine of $20, and subsequent convictions are punishable by fines of $50.13

By comparison, Alaska treats texting while driving quite harshly, along with using other electronic devices while operating a motor vehicle. If a person does not injure another while texting and driving, he or she may still be convicted of a class A misdemeanor carrying a fine of up to $10,000 and imprisonment in a county jail of up to one year.14 If a person is injured in an accident caused by someone who was texting while driving in Alaska, the driver may be convicted of a class C felony, and if a person is killed, the driver may be convicted of a class A felony, making the felony sentencing range anywhere from 5 years for a class C conviction up to 20 years for a class A conviction and a fine of up to $50,000 for a class C conviction and up to $250,000 for a class A conviction.

As compared to its treatment of texting while driving, California takes a much harsher approach to people who are convicted of driving under the influence. For a first offense, a person may receive up to 6 months in jail and a fine of up to $1,000.If the DUI offense resulted in an injury, then the person may either be charged with a misdemeanor or a felony as a wobbler offense. A felony conviction can result in up to 3 years in jail along with a fine of up to $5,000.16

Distracted Driving: Does the Punishment Fit the Crime?

In states like California, which make texting while driving only a traffic infraction carrying very minimal fines, it is interesting to note the disparity between it and a DUI conviction in the same state. While texting and driving may cause greater driver impairment and potentially serious injuries or deaths, it is treated as a much less serious offense. In Alaska, by contrast, texting while driving is treated very seriously, potentially carrying penalties that are as great or greater than those for various levels of drunk driving offenses. The remainder of the states represents a mishmash, ranging between the four with no penalties at all to Alaska with the potential for a serious felony conviction.

Conclusion

Distracted driving is potentially just as or more dangerous than driving while under the influence of alcohol. With millions of people routinely texting while driving or using social media applications while driving, the roads are becoming more dangerous. Still, the states have yet to catch up to the dangers posed by these forms of distracted driving with a majority treating them as minor infractions. States should review the research and consider bringing parity between their DUI statutes and penalties with their statutes criminalizing texting and driving. An added emphasis on educational campaigns about texting while driving along with campaigns about using social media apps while driving may also be added steps that states should consider. Failing to take further action to curb these forms of distracted driving could be potentially disastrous.

ARTICLE BY Steven M. Sweat
Copyright © 2016 · Steven Sweat

1. NATIONAL CENTER FOR STATISTICS AND ANALYSIS, NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, [hereinafter NHTSA 2013 report] available at http://www.distraction.gov/downloads/pdfs/Distracted_Driving_2013_Resear….

2. CENTERS FOR DISEASE CONTROL AND PREVENTION, INJURY PREVENTION and CONTROL, MOTOR VEHICLE SAFETY, DISTRACTED DRIVING, 1 (2016)[hereinafter CDC report] available at http://www.cdc.gov/motorvehiclesafety/distracted_driving/.

3. Governors Highway Safety Association, Distracted Driving Laws (2016), available athttp://www.ghsa.org/html/stateinfo/laws/cellphone_laws.html.

4. Liberty Mutual Insurance, Teen Driving Study Reveals “App and Drive” is New Danger Among Teens, New Worry for Parents (2016), available at https://libertymutualgroup.com/about-lm/news/news-release-archive/articl….

5. Id.

6. National Safety Council, Distracted Driving Public Opinion Poll (March 2016), available at http://www.nsc.org/NewsDocuments/2016/DD-Methodology-Summary-033116.pdf.

7. David L. Strayer et al., Fatal Distraction? A Comparison of the Cell-Phone Driver and the Drunk Driver (2006), available athttp://www.psych.utah.edu/AppliedCognitionLab/DrivingAssessment2003.pdf.

8. Id.

9. Supra note 2.

10. CENTERS FOR DISEASE CONTROL AND PREVENTION, INJURY PREVENTION AND CONTROL, MOTOR VEHICLE SAFETY, IMPAIRED DRIVING, 1 (2016), available at http://www.cdc.gov/motorvehiclesafety/impaired_driving/impaired-drv_fact….

11. Distraction.gov, What is Distracted Driving?, http://www.distraction.gov/stats-research-laws/facts-and-statistics.html (last visited Aug. 2, 2016).

12. Matthew Chambers et al., UNITED STATES DEPARTMENT OF TRANSPORTATION, BUREAU OF TRANSPORTATION STATISTICS, DRUNK DRIVING BY THENUMBERS (2016), available at http://www.rita.dot.gov/bts/sites/rita.dot.gov.bts/files/publications/by….

13. Cal. Veh. Code § 23123.5(d).

14. Alaska Stat. §§ 28.35.161, 12.55.035, 12.55.135, 12.55.125.

15. Cal. Veh. Code §§ 23152, 23153.

Copyright © 2016 · Steven Sweat