BIAA NFL Concussion Lawsuits Amicus Documents

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  • 8/11/2019 BIAA NFL Concussion Lawsuits Amicus Documents

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    IN THE UNITED STATES DISTRICT COURT

    FOR THE EASTERN DISTRICT OF PENNSYLVANIA

    ____________________________________

    :

    IN RE NATIONAL FOOTBALL : No. 2:12-md-02323-ABLEAGUE PLAYERS CONCUSSION :

    INJURY LITIGATION : MDL No. 2323

    ____________________________________:

    :

    THIS DOCUMENT RELATES TO :

    :

    All Actions :

    :

    ____________________________________

    BRAIN INJURY ASSOCIATION OF AMERICAS MOTION

    FOR LEAVE TO FILE AMICUS CURIAE BRIEF

    The Brain Injury Association of America (BIAA) respectfully moves for leave to file

    an amicus curiaebrief to aid the Court in its assessment of the preliminarily-approved

    settlements ultimate fairness. BIAA is the nations oldest and largest nationwide brain injury

    advocacy organization. Its mission is to advance brain injury prevention, research, treatment,

    and education, and to improve the quality of life for all individuals affected by brain injury.

    Decades of work in the field make BIAA uniquely capable of contributing to the Courts

    understanding of the consequences of the unprecedented settlement in this case. Accordingly,

    BIAA asks the Court for leave file an amicus curiaebrief in advance of the Fairness Hearing

    scheduled for November 19, 2014 (Dkt. 6084 at 7) to assist the Court in assessing the fairness of

    the preliminarily-approved settlement.

    As grounds for this motion, BIAA states as follows:

    1. The Court earlier denied as moot BIAAs initial request to assist the Court as

    amicus-plus in assessing what became the first, and ultimately rejected, proposed settlement in

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    this case. (Dkt. 6103.) BIAA here moves simply for leave to file an amicus curiaebrief

    addressing the fairness of the new, preliminarily-approved settlement.

    2. BIAA has at least two special interests justifying its request to participate in this

    case. First, under the preliminarily-approved settlement, defendant National Football League

    will allocate $10 million of the settlement funds toward medical and safety education for football

    players, including children, and their families. As the nations leading advocate for all persons

    who have sustained brain injuries, BIAA has an interest in ensuring that these funds are directed

    toward projects with the greatest scientific backing and benefit for players and the public.

    BIAAs deep understanding of the disease-causative and disease-accelerative nature of brain

    injury, as well as the episodic and long-term treatment and support needs of patients and family

    caregivers, can help the Court evaluate questions of neuroscience and public health that the

    parties might not have sufficient incentive or expertise to bring to the Courts attention. Second,

    the largest piece of the settlement is to be allocated toward an injury compensation fund for

    eligible retired players who manifest severe cognitive impairment. BIAA and its team of experts

    (including National Medical Director Brent E. Masel, M.D., who authored the seminal paper,

    Conceptualizing Brain Injury as a Chronic Disease), are uniquely qualified to help the Court

    evaluate questions of fairness with respect to eligibility parameters and compensation levels in

    the proposed settlement by analyzing how these determinations relate to the progressive

    physical, psychiatric, and cognitive disease processes that are caused and/or accelerated by brain

    injury, but may not manifest in clinically significant symptoms upon initial examination. The

    Declaration of Drs. Brent E. Masel and Gregory J. OShanick, attached as Exhibit 2 to this

    Motion, provides further detail on the types of information BIAA is prepared to provide.

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    3. BIAAs special interests are not represented in the litigation. Whereas both

    plaintiffs and defendants represent their own limited constituencies, and the Special Master

    provided independent financial-related assistance, BIAA is an independent, national

    organization, whose interest is in the entire field of brain injury, and its work benefits all who

    suffer from brain injury. BIAAs interests correspond to the strong public interest in ensuring

    that the eligibility criteria adopted in this settlement do not exclude individuals who may already

    be at great risk of future neurological deficits, and who ultimately could make significant claims

    on public health resources. BIAA, as the voice of brain injury in the United States, can help the

    Court ensure that these larger public interests are not neglected in the settlement.

    4. BIAA proffers timely and useful information that will aid the Court in assessing

    the fairness of the proposed settlement. BIAAs expertise regarding brain injury, such as its

    expert knowledge of how brain injuries evolve over a lifespan, will aid the Court in assessing the

    fairness of how eligibility for the injury compensation fund is determined, and its work

    advocating for brain injury education, prevention, research, and treatment will enable BIAA to

    advise the Court on the fairness of any allocation of funds toward these activities. BIAAs

    submission of an amicus curiaebrief before the Fairness Hearing will be timely and will not

    delay the Courts assessment of the settlements fairness.

    5. BIAA is not partial to a particular outcome in this case. BIAA is not partial to

    whether the case settles; and if it does, BIAA does not care whether any defendant admits

    liability as part of the settlement, or whether any particular amount goes to any specific player or

    group of players. BIAAs mission is to help the victims (and their families) whose lives have

    been devastated by brain injury, to educate the public (including present and future participants

    in contact sports) about brain injury, and to work toward preventing brain injury.

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    For the foregoing reasons, and for those more fully discussed in BIAAs accompanying

    memorandum in support and in the attached Declaration of Drs. Masel and OShanick, this Court

    should grant BIAAs motion.

    Date: September 30, 2014 Respectfully submitted,

    Brain Injury Association of America, ProposedAmicus Curiae

    By: /s/ Christopher J. Wright

    Christopher J. Wright, DC Bar No. 367384Stephen W. Miller, DC Bar No. 1018103

    Harris, Wiltshire & Grannis LLP1919 M Street, NW, Eighth FloorWashington, DC 20036(202) 730-1300(202) 730-1301 (fax)[email protected]@hwglaw.com(Admittedpro hac vice)

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    IN THE UNITED STATES DISTRICT COURT

    FOR THE EASTERN DISTRICT OF PENNSYLVANIA

    ____________________________________

    :

    IN RE NATIONAL FOOTBALL : No. 2:12-md-02323-ABLEAGUE PLAYERS CONCUSSION :

    INJURY LITIGATION : MDL No. 2323

    ____________________________________:

    :

    THIS DOCUMENT RELATES TO :

    :

    All Actions :

    :

    ____________________________________

    MEMORANDUM OF LAW IN SUPPORT OF BRAIN INJURY ASSOCIATION OF

    AMERICAS MOTION FOR LEAVE TO FILE AMICUS CURIAE BRIEF

    Introduction

    In cases of great public concern, courts regularly receive input from experts in the

    relevant field as they work to reach a just decision. Here, the Court must decide whether to give

    final approval to a class settlement dealing with brain injury among retired National Football

    League (NFL) professional football players. The decision will have an immense effect not

    only on the parties involved here, but also on all current and future victims of brain injury. It is

    for this reason the nations oldest and largest nationwide brain injury advocacy organization, the

    Brain Injury Association of America (BIAA), now requests to submit an amicus curiaebrief to

    assist the Court with its assessment of the ultimate fairness and consequences of the settlement.

    BIAAs mission is to advance the causes of brain injury prevention, research, treatment,

    and education, and to improve the quality of life for all individuals affected by brain injury.

    Although BIAA has achieved noteworthy successes in its mission, much work remains on all

    fronts. After decades of work in the field, BIAA is uniquely capable of assisting the Courts

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    evaluation of the fairness and public-interest consequences of the preliminarily-approved

    settlement. Accordingly, BIAA respectfully asks the Court for leave to file an amicus curiae

    brief.

    Discussion

    A. Standard

    District courts have inherent authority and broad discretion to designate amici curiae.

    Liberty Res., Inc. v. Philadelphia Hous. Auth., 395 F. Supp. 2d 206, 209 (E.D. Pa. 2005); Sciotto

    v. Marple Newtown Sch. Dist., 70 F. Supp. 2d 553, 554 (E.D. Pa. 1999). Although no Federal

    Rule of Civil Procedure guides the analysis, district courts grant amicus curiae status where

    (1) the proposed amicushas a special interest in the particular case; (2) that interest is not

    represented competently or at all in the case; (3) the proffered information is timely and useful;

    and (4) the amicusis not partial to a particular outcome in the case. Liberty Res., 395 F. Supp.

    2d at 209. There is no rule . . . that amici must be totally disinterested, id.(quotingHoptowit

    v. Ray, 682 F.2d 1237, 1260 (9th Cir. 1982)), and there is no requirement that amicusmust not

    be motivated by pecuniary concerns, see Neonatology Assocs., P.A. v. C.I.R., 293 F.3d 128, 131

    (3d Cir. 2002). Participation by an amicusmay be particularly appropriate where the amicuswill

    ensure a complete and plenary presentation of difficult issues in a case involving important

    public interests,Liberty Res., 395 F. Supp. 2d at 209-10, or where the amicus can contribute to

    the court's understanding of the consequences of the settlement proposed by the parties,Harris

    v. Pernsley, 820 F.2d 592, 603 (3d Cir. 1987).

    B. BIAA Meets This Standard and Should be Given Leave to File an Amicus

    Curiae Brief Addressing the Fairness of the Settlement.

    BIAA should be designated amicus curiaebecause it has at least two special interests in

    this case. See Liberty Res., 395 F. Supp. 2dat 209. First, the NFL will allocate $10 million of

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    the settlement to fund education programs promoting safety and injury prevention in football

    players, including youth football players, and the education of retired NFL Football Players

    regarding the NFLs medical and disability benefits programs and initiatives. (Dkt. 6073-5 at

    16.) As the nations leading advocate for all persons who have sustained brain injuries, BIAA

    has an interest in ensuring that these funds are directed toward educational projects with the

    greatest scientific backing and benefit for players and the public. BIAAs deep understanding of

    the disease-causative and disease-accelerative nature of brain injury, as well as the episodic and

    long-term treatment and support needs of patients and family caregivers, can help the Court

    evaluate questions of neuroscience and public health that the parties might not have sufficient

    incentive or expertise to bring to the Courts attention.

    Second, the largest piece of the settlement is now an uncapped injury compensation fund

    for eligible retired players who manifest severe cognitive impairment. (See id. at 15-16.) BIAA

    and its team of experts (including National Medical Director Brent E. Masel, M.D., who

    authored the seminal paper, Conceptualizing Brain Injury as a Chronic Disease) are uniquely

    qualified to help the Court evaluate questions of fairness with respect to eligibility parameters

    and compensation levels in the proposed settlement by analyzing how these determinations relate

    to the progressive physical, psychiatric, and cognitive disease processes that are caused and/or

    accelerated by brain injury, but may not manifest in clinically significant symptoms upon initial

    examination. The Declaration of Drs. Masel and OShanick, also attached to the Motion, more

    fully describes BIAAs expertise and preliminary insights on the current settlement.

    In addition, BIAA satisfiesLiberty Resources second prong because its special interests

    are not represented in the litigation. 395 F. Supp. 2d at 209. Whereas both plaintiffs and

    defendants represent their own limited constituencies, BIAA is an established, recognized, and

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    independent national organization, whose interest is in the entire field of brain injury, and whose

    work benefits all who suffer because of brain injury. For example, there is no particular reason

    to expect either the plaintiffs or the defendants to care, to any meaningful degree, how the money

    for brain injury education is allocated, but the public has a strong interest in ensuring that these

    funds are not squandered as a public-relations afterthought to the overall settlement. Similarly,

    while class counsel are understandably and quite properly focused on the existing plaintiffs, there

    is a strong public interest in ensuring that the eligibility criteria adopted in this settlement do not

    exclude individuals who may already be at great risk of future neurological deficits, and who

    ultimately could make significant future claims on public health resources.

    Importantly, BIAAs interests were not represented by the Special Master, and its efforts

    will not duplicate the Special Masters. Whereas the Special Master was well equipped to assist

    the Court with the financial complexity of the settlement, BIAA will aid the Court in evaluating

    questions of neuroscience and public health as they relate to determinations of eligibility for the

    injury compensation fund and of which activities should receive proceeds from the education

    fund. BIAAs expertise, as demonstrated in the Declaration of Drs. Masel and OShanick, is

    rooted in its deep understanding of the disease-causative and disease-accelerative nature of brain

    injury, as well as the episodic and long-term treatment and support needs of brain injury patients

    and family caregivers.

    InLiberty Resources, this Court permitted a party to participate as amicus where it was a

    stakeholder in that cases core debate, but had no place at the table. Id.at 210. Similarly,

    BIAA, as the voice of brain injury in the United States, is a recognized and uniquely qualified

    stakeholder in the discussion of how best to prevent and treat brain injury at large, and how to

    improve the quality of life for all individuals affected by brain injury. Its submission of an

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    amicus curiaebrief at this stage in the case can help the Court ensure that these larger public

    interests are not neglected in the settlement.

    BIAA also satisfiesLiberty Resources third prong because it proffers timely and useful

    information that will aid the Court in assessing the fairness of the proposed settlement. Id.at

    209. BIAAs expertise regarding brain injury, compiled from its comprehensive, nationwide

    network of physicians, researchers, rehabilitation experts and facilities, caregivers, and brain

    injury sufferers and their families, makes it uniquely qualified to proffer useful information to

    the Court. In particular, BIAAs expert knowledge of how brain injuries evolve and progress

    across a lifespan will aid the Court in assessing the fairness of how eligibility determinations for

    the injury compensation fund are determined, and its work advocating for brain injury education,

    prevention, and treatment will enable BIAA to advise the Court on the fairness of any allocation

    of funds toward these activities. Further, BIAAs briefing will be timely and will not delay the

    Courts assessment of the settlements fairness.

    Moreover, BIAA is not partial to a particular outcome in this case, and thus satisfies the

    final prong of theLiberty Resources test. Id. BIAA is not partial to whether the case settles; and

    if it does, BIAA does not care whether any defendant admits liability as part of the settlement, or

    whether any particular amount goes to any specific player or group of players. BIAAs mission

    is to help the victims (and their families) whose lives have been devastated by brain injury, to

    educate the public (including present and future participants in contact sports) about brain injury,

    and to work toward preventing brain injury.

    Finally, this case is one of great public concern, not only because of professional

    footballs popularity, but also (and more importantly) because of the ripple effects any resolution

    here will have on the future of education, research, diagnosis, and treatment of brain injury.

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    Particularly with regard to the proposed settlements education and injury compensation funds,

    and owing to BIAAs unique expertise in the field, BIAAs participation in this case will serve

    the Court well as it seeks to reach a just decision on the ultimate fairness of the preliminarily-

    approved settlement.

    Conclusion

    For the foregoing reasons, BIAA respectfully requests that the Court grant BIAAs

    motion for leave to file an amicus curiaebrief to assist the Court in assessing the fairness of the

    preliminarily-approved settlement.

    Dated this 30th day of September, 2014.

    Respectfully submitted,

    Brain Injury Association of America, ProposedAmicus Curiae

    By: /s/ Christopher J. Wright

    Christopher J. Wright, DC Bar No. 367384Stephen W. Miller, DC Bar No. 1018103Harris, Wiltshire & Grannis LLP1919 M Street, NW, Eighth FloorWashington, DC 20036(202) 730-1300(202) 730-1301 (fax)[email protected]@hwglaw.com(Admittedpro hac vice)

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    IN THE UNITED STATES DISTRICT COURT

    FOR THE EASTERN DISTRICT OF PENNSYLVANIA

    ____________________________________

    :IN RE NATIONAL FOOTBALL : No. 2:12-md-02323-AB

    LEAGUE PLAYERS CONCUSSION :

    INJURY LITIGATION : MDL No. 2323

    ____________________________________:

    :

    THIS DOCUMENT RELATES TO :

    :

    All Actions :

    :

    ____________________________________

    DECLARATION OF DRS. BRENT E. MASEL AND GREGORY J. OSHANICK IN

    SUPPORT OF BIAAS MOTION FOR LEAVE TO FILEAMICUS CURIAE BRIEF

    I, Dr. Brent E. Masel, M.D., and I, Dr. Gregory J. OShanick, M.D., hereby declare as

    follows:

    1. We serve in the volunteer capacities of National Medical Director and National

    Medical Director Emeritus, respectively, for the Brain Injury Association of America (BIAA).

    2. BIAA is the nations oldest and largest brain injury patient advocacy organization.

    Its mission is to advance brain injury prevention, research, treatment, and education for the 2.4

    million children and adults who sustain traumatic brain injuries in the U.S. each year. BIAAs

    status as a publicly supported, tax-exempt organization under Section 501(c)(3) of the Internal

    Revenue Code compels the organization to bring certain facts pertaining to traumatic brain injury

    (TBI) to the attention of the Court in the interests of the public at large.

    3. I, Dr. Masel, graduated from Loyola Medical School in Maywood, Ill., in 1974. I

    completed my internship and Neurology residency at the University of Texas Medical Branch

    (UTMB) at Galveston in 1978. Following this training, I established a Neurology private

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    practice in Galveston and received certification in 1980 from the Board of Psychiatry and

    Neurology. Currently I am a Clinical Professor in the Department of Neurology, and Clinical

    Assistant Professor in Family Medicine, Internal Medicine, Physical Therapy and Occupational

    Therapy at UTMB. In 1992, I became the medical director of the Transitional Learning Center

    (TLC), and in January of 1994, I left private practice to become the president of this post-acute

    brain injury rehabilitation facility. I have provided numerous in-service training seminars and

    lectures at a variety of local, state and national conferences. I frequently speak on the topic of

    growth hormone deficiency and hypopituitarism and rehabilitation following a brain injury, as

    well as the long-term medical issues following a TBI. I currently serve on the governing board

    of The Moody Endowment, which supports organizations committed to the rehabilitation of

    individuals suffering from head injuries and related charitable, educational and scientific

    activities.

    4. I, Dr. OShanick, am a former chairman of the board of directors of BIAA. In

    May 2011, I became the medical director emeritus for BIAA, after serving for 14 years as its first

    national medical director. Over the past 30 years, I have treated more than 11,000 patients with

    brain injuries while serving on the faculties of three different medical schools and in private

    practice. Since 1991, I have served as the president and medical director of the Center for

    Neurorehabilitation Services in Richmond, Va. I hold board certification in four medical

    subspecialties (Behavioral Neurology and Neuropsychiatry, Neurorehabilitation, Psychosomatic

    Medicine and General Psychiatry) and have published three books, 12 academic textbook

    chapters and more than 70 peer-reviewed publications. I have presented at national and

    international medical conferences and have served as an advisor to numerous federal agencies

    including the Centers for Disease Control and Prevention, Department of Defense, National

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    Institutes of Health and National Institute on Disability and Rehabilitation Research. I was

    selected to serve on the Examination Oversight Committee by the American Board of Psychiatry

    and Neurology and the American Board of Physical Medicine and Rehabilitation to develop the

    subspecialty board certification in Brain Injury Medicine.

    5. BIAAs and our relevant expertise, acquired over decades of service in the fields

    of neuroscience and treatment of brain injury, makes us uniquely qualified to assist the Court

    with its assessment of the settlement in this case.

    6. We have identified several concerning aspects of the preliminarily-approved

    settlement, and respectfully ask the Court for the opportunity to present our findings more fully

    in an amicus curiaebrief. Below we outline our concerns.

    A. Numerous physical and behavioral consequences of TBI are excluded

    from the list of qualifying diagnoses for treatment and compensation

    under the settlement.

    7. A mild TBI, also known as a concussion, is a complex pathophysiological process

    induced by biomechanical forces to the head or to another part of the body that transmit to the

    head. The injury produces an alteration of brain function that results in a wide range of

    neurological, physical, cognitive, and neuropsychological impairments. These impairments can

    appear on an intermittent or persistent basis immediately or as many as ten or more years after

    injury.

    8. The neurologic consequences of mild TBI include motor, sensory, and autonomic

    dysfunction as well as vestibular (balance) disturbances, visual perceptual (depth perception,

    visual figure ground) and oculomotor deterioration (impaired eye tracking, eye-hand

    coordination), anosmia (loss of sense of smell), ageusia (loss of sense of taste), and posttraumatic

    headache. Mild TBI can bring about movement disorders, such as Parkinsonism and epilepsy.

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    The risk of developing epilepsy as long as ten years after TBI is 1.5 times that of non-injured

    persons. Sleep abnormalities (including central sleep apnea) are common in individuals with

    mild TBI and are associated with an increased risk of stroke. Mild TBI also increases the risk of

    pituitary hormonal dysfunction. Symptoms from these deficits include atherosclerosis

    (hardening of the arteries), fatigue, decreased muscle mass and weakness, mood abnormalities,

    and cognitive changes. A recent study of 68 retired NFL players who were screened for pituitary

    dysfunction found hormonal abnormalities in approximately 24% of those studied.

    9. The cognitive challenges associated with mild TBI vary and change over time.

    Early in recovery, arousal, attention, and concentration difficulties are prominent, as are

    memory-encoding problems. Later, difficulties with divided attention, memory retrieval and

    executive functioning, such as reasoning, planning, sequencing, decision-making and judgment,

    may emerge. Cognitive recovery evolves at a different pace for each person, with many

    interdependent factors affecting recovery. Some individuals with mild TBI recover well and

    return to previous levels of functioning; others do not. Even after returning to routine activities,

    individuals with mild TBI may experience reduced cognitive efficiency and inconsistency of

    performance. Such patients may have persistent difficulty recognizing, assessing and managing

    novel, complex or stressful situations, making it difficult to monitor changes in their health or to

    reliably comply with medication or medical treatment regimens.

    10. The neurobehavioral consequences of mild TBI are significant. Population-based

    studies demonstrate a several fold increase in depression, anxiety and impulse control disorders,

    such as disinhibition, aggression and substance abuse in patients with mild TBI. Even subtle

    damage to frontal lobe systems can prevent the person with mild TBI from effectively

    suppressing or consistently managing undesirable behavior, including suicide and suicidal

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    ideation. Thus, loss of frontal lobe inhibitory control in tandem with escalating depression and

    the tendency for males to seek self-medication solutions for physical or emotional pain form a

    potentially explosive combination for those with mild TBI.

    11. Many of the physical, neurological and neurobehavioral consequences of TBI are

    missing from the list of qualifying diagnoses in the preliminarily-approved settlement.

    B. The settlements approach to diagnosis of neurocognitive impairment

    is deeply flawed and will serve to exclude retired NFL players and

    limit their access to medical benefits and compensation.

    12. The determination of eligibility is heavily weighted towards those with severe

    memory dysfunction and/or evidence of neuromuscular abnormality, which is reflected in the

    reliance on neuropsychological evaluation in isolation from other indices of functional

    impairment in day-to-day settings (including information from reliable family members, etc.). In

    addition, the specification of a basic neurological evaluation excludes the abundance of literature

    on the multiplicity of other neurological abnormalities potentially present after mild TBI that

    would be undetected by a basic neurological examination. To be maximally effective at

    identifying those players with residual deficits, it is well accepted by the brain injury

    professional community that an approach that is more holistic, human-based, and less

    linguistically reliant is preferred. A more broadly based performance assessment that will not

    under-estimate pre-morbid intelligence for a personal baseline TBI comparison is needed. Such

    subtleties reinforce the need for clinical experience to make proper judgment in these

    assessments.

    13. The proposed settlement provides for a standard or basic neurological

    examination, which is not sufficient to diagnose and document all symptoms associated with

    post-concussion syndrome or mild TBI. An elemental or basic neurological examination

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    commonly assesses for those motor and sensory abnormalities that reflect either spinal cord

    dysfunction or motor or sensory cortex injury/disease and fails routinely to incorporate those

    regions of the brain involved in integrating multi-sensory or sensorimotor aspects of brain

    function. While it is reasonable that with an appropriately developed neuropsychological

    battery one can omit the mental status/cognitive portion of a neurological examination, it is a

    major deficit to omit detailed assessments of Cranial Nerves I-XII, motor integration, balance,

    fine motor control, pathological reflexes involving frontal suppressive systems, and

    extrapyramidal functions to name but a few. The standard neurological evaluation must be a

    detailed neurological evaluation.

    14.

    Eligibility for compensation is based on a discrepancy between current function

    and an estimate of pre-morbid function. The Test of Premorbid Function (TOPF) is used to

    assess pre-morbid function. The TOPF is a word reading test that requires the subject to read a

    list of words and pronounce them exactly. Thus individuals who speak with a dialect or accent

    are at a disadvantage, as are individuals with TBI-related speech impairments like dysarthria.

    (Estimates of the prevalence of dysarthria following traumatic brain injury vary from 10% to

    60%.) In addition, the TOPF is unreliable in cases where there is a history of reading disability

    or in cases where injury or illness affects reading ability.

    15. The way in which moderate cognitive decline is defined is also flawed. If a

    player has impairment in language or visual spatial function, but not in executive function,

    learning or memory, they would not qualify. This will exclude people with significant

    impairment in single domains, like aphasia, or severe memory dysfunction. While the

    prevalence of aphasia post-TBI is unknown, it presents in a variety of ways, sometimes

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    independent of other impairment. In addition, if a player is severely impaired in only a single

    domain, such as memory, he would be excluded from receiving benefits.

    C. The downward adjustment of monetary awards on the basis of the number

    of eligible seasons, the Class Members age at the time of QualifyingDiagnosis, and/or the presence of stroke or TBI demonstrates a serious lack

    of understanding of mild TBI.

    16. A single concussion, whether diagnosed or not, is capable of generating

    debilitating physical, cognitive and behavioral impairments that interfere with the activities of

    daily living and require treatment throughout the lifespan. Therefore, the nature and extent of

    the impairment not the number of seasons played should be the determining factor in any

    monetary award. Many retired NFL players who sustained concussions went undiagnosed or

    were not held-out from play or practice. Thus, the definition of eligible season unfairly excludes

    players who may have been concussed but did not spend at least two (2) regular or postseason

    games on the injured reserve list or inactive list due to a concussion or head injury. Similarly,

    while it is reasonable to assume that exposure to mild TBI increases as playing time increases, it

    is not reasonable to assume that multiple concussions sustained over a short period of time are

    less debilitating than multiple concussions sustained over a long period of time. In fact, the

    opposite is true. A patient who sustains repetitive concussions that go unresolved will exhibit

    symptoms akin to more severe TBI.

    17. Similarly, it is unfair to offset a monetary award by 75 percent based on the

    existence of a stroke or TBI occurring prior to a qualifying diagnosis. Persons who sustain one

    concussion are predisposed to re-injury, both on and off the field. Severity of injury increases

    with recurrent injury, as does the likelihood of disability. In a study of over 30,000 individuals

    in Taiwan, individuals with mild TBI had a 1.7 times increased risk of stroke over those who had

    not sustained a brain injury.

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    18. Finally, the Class Members age at the time of qualifying diagnosis should not be

    a factor in calculating a monetary award. The consequences of a brain injury are the same

    whether experienced in the past (as with the case of a hypothetical 60-year-old retired player

    who has exhibited symptoms for decades) or the future (as with the case of a hypothetical 30-

    year-old retired player who has not yet exhibited symptoms). The sole factor in determining

    monetary awards should be the nature and extent of the impairment.

    D. The proposed settlement over-relies on board certification as an indicator of

    expertise in diagnosing and treating patients with mild TBI.

    19. On its own, board certification is not a sufficient indicator of expertise in the

    subspecialty of TBI, as the American Boards of Psychiatry and Neurology and the American

    Board of Physical Medicine and Rehabilitation concluded with their establishment of a joint

    subspecialty Board certification in Brain Injury Medicine in September 2011. Years of

    experience, involvement in relevant scientific and professional societies, peer-reviewed journal

    publications, invited presentations, federal grant awards, or active practice in Joint Commission

    on Accreditation of Healthcare Organizations or Commission on Accreditation of Rehabilitation

    Facilities programs are more reliable indicators of expertise in diagnosing and treating the

    complex and heterogeneous consequences of mild TBI.

    E. The proposed settlement limits pharmacy vendors to mail order providers.

    20. While the establishment of a consistent means for providing routine and stable

    medications to injured players is appropriate, some medications particularly human growth

    hormone (costing $15-20,000 yearly for life) used to treat pituitary dysfunction in patients with

    mild TBI require distribution that controls for temperature, light, vibration and other conditions

    and cannot be reliably distributed by mail order. Further, during periods of medication

    adjustment and trials to determine efficacy and dosage amounts, the use of a mail order

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    pharmacy slows down the turnaround time in medication acquisition, preventing the physician

    from making quick and immediate medication changes, and, typically can only refill for a 90-day

    period which may be excessively wasteful should a therapeutic trial be unsuccessful after several

    days or even weeks.

    F. The BAP Supplemental Benefits program within the proposed settlement

    fails to recognize the full extent of the treatment team that may be required

    to support injured players in recovering or maintaining physical, cognitive

    and behavioral function after mild TBI.

    21. The standard of care for patients with TBI dictates that rehabilitation and other

    medical treatment plans be developed and carried out by a multi-disciplinary team of licensed,

    credentialed clinicians working in specialized settings and accredited programs. The specialties

    may include endocrinology, physical medicine, ophthalmology, neuro-optometry,

    otolaryngology, psychiatry, physical therapy, occupational therapy, speech language therapy, and

    neurobehavioral therapy. Settings may include inpatient rehabilitation hospitals or units,

    residential rehabilitation facilities, outpatient clinics or at home by licensed providers. As

    proposed, only board-certified neuropsychologists would be eligible to provide treatment.

    * * *

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    IN THE UNITED STATES DISTRICT COURT

    FOR THE EASTERN DISTRICT OF PENNSYLVANIA

    ____________________________________

    :

    IN RE NATIONAL FOOTBALL : No. 2:12-md-02323-ABLEAGUE PLAYERS CONCUSSION :

    INJURY LITIGATION : MDL No. 2323

    ____________________________________:

    :

    THIS DOCUMENT RELATES TO :

    :

    All Actions :

    :

    ____________________________________

    [Proposed] O R D E R

    AND NOW this ____ day of ___________, 2014, upon consideration of Brain Injury

    Association of Americas Motion for leave to file amicus curiaebrief, it is hereby ORDERED

    and DECREED that Movant Brain Injury Association of Americas Motion is GRANTED.

    Brain Injury Association of America may file its amicus curiaebrief no later than

    _________________________.

    BY THE COURT

    _____________________

    Anita B. Brody, J.

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    IN THE UNITED STATES DISTRICT COURT

    FOR THE EASTERN DISTRICT OF PENNSYLVANIA

    ____________________________________

    :

    IN RE NATIONAL FOOTBALL : No. 2:12-md-02323-AB

    LEAGUE PLAYERS CONCUSSION :

    INJURY LITIGATION : MDL No. 2323

    ____________________________________:

    :

    THIS DOCUMENT RELATES TO :

    :

    All Actions :

    :

    ____________________________________

    CERTIFICATE OF SERVICE

    I, Christopher J. Wright, hereby certify that on September 30, 2014, I caused the

    following documents: (1) Brain Injury Association of Americas Motion for Leave to File an

    Amicus Curiae Brief; (2) Memorandum of Law in Support of Brain Injury Association of

    Americas Motion for Leave to File anAmicus Curiae Brief; (3) Affidavit of Drs. Brent E.

    Masel and Gregory J. OShanick in Support of BIAAs Motion for Leave to FileAmicus

    Curiae Brief; and (4) [Proposed] Order, to be electronically filed with the Clerk of Court

    through ECF and be available for viewing and downloading from the ECF system, and that ECF

    will send an electronic notice of electronic filing to counsel of record in the above-captioned

    case.

    /s/ Christopher J. Wright

    Attorney for Proposed Amicus Brain Injury

    Association of AmericaAdmittedpro hac vice(DC Bar No. 367384)

    Harris, Wiltshire & Grannis LLP

    1919 M Street, NW, Eighth FloorWashington, DC 20036

    (202) 730-1300

    (202) 730-1301 (fax)[email protected]

    Case 2:12-md-02323-AB Document 6180-4 Filed 09/30/14 Page 1 of 1