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FDA Warning: No dietary supplements approved to treat concussions or other brain injury.
The Food and Drug Administration (FDA) has issued a warning that there are no approved dietary supplements to treat a concussions or other types of brain injury.
Can a Dietary Supplement Treat a Concussion? No!
The concussion supplement warning published by the FDA is published in full below:
Exploiting the public's rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).
The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.
One common but misleading claim: Using a particular dietary supplement promotes faster healing after a concussion or other TBI.
Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA's National Health Fraud Coordinator.
"We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," says Coody. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."
A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional. The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.
A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion. Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.
“There is simply no scientific evidence to support the use of any dietary supplement for the prevention of concussions or the reduction of post-concussion symptoms that would allow athletes to return to play sooner,” said Charlotte Christin, acting director of FDA’s Division of Dietary Supplement Programs.
Click here for more information.
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Legal discussion analyzing class action soccer lawsuit againt FILA
I will be participating tomorrow morning—Saturday, August 30th at 10:40 AM in a discussion on the class action lawsuit commenced against FIFA and US Soccer leagues for concussion injuries in youth soccer on "The Classroom" from the Marist College Center for Sports Communication.
I will be analyzing the claims made in this soccer case, the relief that the plainitff's are seeking and the legal arguments that I anticipate each side will be making.
1220 ESPN Radio and the Marist College Center for Sports Communication have launched a weekly sports radio program produced live from the Marist College campus, representing the nation’s first partnerships between an ESPN radio affiliate and an academic center on a college campus.
The program, named “The Classroom,” is heard on Saturday mornings on Fox1220, 95.7 and 94.1 ESPN Radio and live on the web at 10 a.m. to noon. My segment is scheduled for 10:40 AM.
To listen to the broadcase live, click here
Brain Injury and Sports, Brain Injury Lawyers and Law, Brain Injury Prevention
Class Action Lawsuit Commenced by Parents for Soccer Concussions
A class action lawsuit was filed yesterday in US Federal District Court against the Federal of International Football Association (FIFA) and US Soccer leagues by parents seeking changes to the associations concussion management rules to prevent brain injuries from occurring.
The plaintiffs are not seeking financial compensation but changes to how the game is played. They are seeing an injunction compelling the leagues to changes their rules regarding heading a soccer ball, when to remove a player from the game after a suspected concussion takes place, how long to keep the player out and educational requirements. The lawsuit wants the league to any player under 14 from heading the ball.
I was interviewed for a story published in the New York Times, Concussion Lawsuit Bids to Force Rule Changes in Soccer regarding this lawsuit. While I agree with the purported motivation for commencing this action, I have serious doubts whether the court can grant the plaintiffs the relief they demand.
The complaint is an excellent primer on the history of sports concussions, what was known and when it was known, the need for sports concussion management and the dangers faced by children who sustain a concussion while engaged in a sporting activity. I am attaching the full complaint: Download Soccer complaint
A concussion is a brain injury. The best cure for a brain injury is prevention. When in doubt, keep them out!
Brain Injury Lawyers and Law
Congratulations to Shana De Caro -- New Chair Traumatic Brain Injury Litigation Group, American Association for Justice
Congratulations to my partner, Shana De Caro on her election as chair of the American Association For Justice, Traumatic Brain Injury Litigation Group at the association's annual conference held earlier this week in Baltimore, Maryland.
The traumatic brain injury litigation group provides the latest information to attorneys representing victims of traumatic brain injury on effective strategies to establish and prove the lifelong consequences of brain damage sustained; new advances in brain injury medicine including diagnosis, treatment and using imaging studies. Each year the group sponsors seminars to educate attorneys on cutting-edge developments in traumatic brain injury litigation. The group reviews the latest medical literature on traumatic brain injury, new diagnostic test methods, and recent court decisions pertaining to the traumatic brain injury litigation and the latest trial techniques to convey the full extent of the consequences of traumatic brain injury in court.
The group comprises attorneys from throughout the nation who represent clients with traumatic brain injury caused by automobile collisions, truck and bus accidents, head injuries sustained on construction sites, falls and medical malpractice.
Shana De Caro has been an active participant in the group since its inception in 1991 and has served on its executive board for the past ten years. In addition to her service on the traumatic brain injury litigation group, Shana also serves on the board of directors of the New York State Academy of Trial Lawyers, is a trustee and officer of the Civil Justice Foundation and an elected fellow of the Melvin Belli Society. Shana is also a member of the Advisory Board, Acquired Brain Injury Program, The George Washington University, Washington, D.C., Graduate School of Education, and Human Development and has been selected as a New York Super Lawyer.
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Lead Off Speaker at American Association for Justice-Traumatic Brain Injury Litigation Group
On Sunday, July 27th, I will be the lead off speakier at the annual conference of the American Association for Justice, Traumatic Brain Injury Litigation Group’s annual program to be held this year in Baltimore, Maryland.
My topic this year is entitled, From Concussion to the Classroom and Playing Field. I will explore the many legal issues in recently enacted concussion management legislation, public health issues and additional steps that must be taken to protect our nation’s youth from the epidemic of traumatic brain injury in all sports.
Recent evidence points to over 250 million of our nation’s youth sustain some type of a traumatic brain injury each year while participating in athletic competition all athletic training. Brain injury in sports is a public health crisis that must be approached from many different areas including education, prevention, return to play guidelines and legal liability when a preventable brain injury takes place.
The legal conference is a part of the four day conference sponsored each year by the nation’s largest trial lawyer association, the American Association for Justice. The conference each year is attended by over 2,000 attorneys from across the nation. The conference provides educational skills to attorneys on how to more effectively represent their clients following a personal injury.
The traumatic brain injury litigation group is comprised of attorneys who have a special interest in the area of traumatic brain injury litigation. I have been honored to have been a chair of this group and continue to serve on the group’s executive board.
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Save VA Benefits for Brain Injured Veterans
The Brain Injury Association of America has just issued the following Action Alert:
Protect Access to Care for Veterans
Call Congress Today!
As a member of the large and growing community that understands the importance of thoughtful, comprehensive care for individuals living with brain injury, we wanted to inform you of an important program for America's veterans that is in danger of shutting down if Congress does not act soon.
Established by Congress in 2008, the Assisted Living TBI Pilot Program has made it possible for hundreds of wounded warriors to receive specialized, post-acute brain injury rehabilitation in the community.The program provides critical, real-life skills to help veterans return to their homes and communities. It has been a lifeline for dozens and dozens of veterans.
Unfortunately, the Department of Veterans Affairs has announced that it will end the pilot program on September 30, 2014 unless Congress takes action to extend it. This means that the VA will soon begin to discharge veterans from the program.The Wall Street Journal recently highlighted the importance of the program and the challenges faced by many if Congress doesn't act soon.
We need your help to make sure the Assisted Living Pilot Program for Veterans with TBI continues to make a meaningful difference for America's heroes.
Please call your Member of Congress and make sure they know how important the program is to veterans and urge them to support extending the pilot program. You can reach your Representatives and Senators by calling the U.S. Capitol Switchboard at (202) 224-3121 where you will be transferred directly to their offices. Thank you for your crucial contribution to this effort.
Brain Injury and Sports, Brain Injury Lawyers and Law
Congressional Brain Injury Task Force Urges FIFA To Take a Hard Look at its Concussion Management Protocol
In a letter to FIFA, the co-chairs of the Congressional Brain Injury Task Force, urged that the world soccer organization take immediate steps to address their “inadequate approach toward traumatic brain injury.”
Here are some excerpts from the congressional correspondence raising questions about FIFA’s concussion management protocol:
“This threat was on full display during the World Cup, where several players were left in obvious pain after receiving blows to the head. Of note, Álvaro Pereira, Javier Mascherano, and Christoph Kramer all endured brutal head injuries during play. Unfortunately, their pain wasn’t the only thing that these players had in common: each of them returned to the field almost immediately after a brief, sideline evaluation by a team doctor. In the case of Mr. Pereira, the team doctor even signaled to the manager that a substitution was necessary; however, the player insisted that he continue and he was reintroduced to the game. While Messrs. Periera and Mascherano continued to play for the remainder of their matches, Mr. Kramer collapsed on the field after fifteen minutes and was finally substituted out. He stated the next morning that he had little memory of the game.”
" Unlike in many other professional sports, following a player injury, the decisions of team doctors, who are rarely neurologists, can be overruled by coaches or the players themselves. This flies in the face of everything we know about TBIs, inadequate diagnosis and treatment, and the severity of this condition. Even after his team’s doctor advised him to leave the field, Mr. Pereira refused. This strategy is not sufficient in adequately diagnosing and treating players who have sustained head injuries. In the National Football League, for example, an independent doctor, unaffiliated with the team, must be present to evaluate all potential head injuries and make final decisions about whether it is safe for a player to return to the field."
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Even Phineas Gage would be denied benefits under the NFL class action settlement if received his injury while playing football!
Illustrative of the inadequacy of the NFL class action settlement are the injuries sustained by Phineas Gage and how he would fair under this agreement.
Perhaps the most famous traumatic brain injury patient in the history of medicine was Phineas Gage. In 1848, Gage was a 25-year-old railway construction foreman, working with explosive powder and a packing rod. A spark caused an explosion that propelled the three-foot long pointed rod through his head. It penetrated his skull at the top, passed through his brain, and exited through his temple. Before the accident Gage was a quiet, mild-mannered man; after his injuries he became an obscene, obstinate, self-absorbed man. His personality and behavioral problems persisted until his death in 1861.
Had Phineas Gage sustained these injuries while playing professional football, he would not be entitled to any benefit under the proposed settlement agreement.
Brain Injury & Concussions, Brain Injury and Sports, Brain Injury Association Information, Brain Injury Lawyers and Law
NFL settlement fails to provide redress for majority of players
It is unfortunate that the U.S. District Court Brody granted preliminary approval to the proposed settlement of the NFL class action lawsuit without first holding a hearing to examine significant issues affecting the ability of players to obtain the compensation they deserve.
I am hopeful that hearing scheduled for November 19th, will explore the obstacles, roadblocks, and hurdles that players in all classes of injury must overcome before receiving compensation under this settlement proposal. The majority of players suffering with brain injuries are not embraced within the settlement and will receive no compensation.
The revised settlement is flawed in many respects. The proposal neither recognizes nor compensates the majority of players who suffer the long-term consequences of brain trauma, but merely carves out certain, small and discrete groups. The majority of players who have physical, cognitive, emotional, and behavioral impairments will remain uncompensated under this settlement.
Though this settlement proposal purports to generously provide financial stability for the futures of thousands of players who suffer from traumatic brain injury and its consequences, closer scrutiny reveals something entirely different. An examination of the terms and conditions of the settlement reveals a design to systematically exclude players from participation and reduce payments to the small group who meet the arbitrary criteria. It imposes unfair and illogical restrictions on the categories of compensable injuries and requires players to have participated in NFL play for excessively long periods, implicitly denying that a player can sustain a life-altering concussion after only a short NFL career. The plan is replete with complex, arbitrary, and overlapping omissions in its unwieldy and overly intricate criteria, which are then further reduced by offset for liens.
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Hearing needed before NFL revised settlement agreement is considered by Federal Court
The revised NFL brain injuy settlement agreement is fatally flawed. Judge Brody should hold a hearing before she even considers granting preliminary approval to the settlement.
Here are some preliminary observations that were published yesterday by my partner, Shana De Caro and myself on the Huffington Post:
The revised proposed settlement of the class action lawsuit against the NFL remains fundamentally flawed. The settlement neither recognizes nor compensates the majority of players who suffer the long-term consequences of repeated concussive injury.
The foundation of the lawsuit was the deliberate and longstanding misrepresentations by the NFL and its committee on traumatic brain injury, concerning the known health risks that players confronted from repetitive brain trauma so ingrained in the game. For years, the NFL has staunchly refused to acknowledge the accumulating body of objective medical evidence revealing the risk of permanent brain damage from repeated head trauma. The NFL remained shrouded by inaccurate statements propagated by its own Committee on Mild Head Injury, including false declarations that "mild TBIs in football are not serious injuries" and that "many NFL players can be safely allowed to return to play on the day of the injury after sustaining a mild TBI." This deception imperiled professional football players and was calculated to mislead players and the public.
Today's proposed revised settlement persists in disregarding the issues that are essential to the vast majority of players that are affected. A concussion is a brain injury. A mild brain injury is only mild if it is someone else's brain. The silent majority of players who have cognitive, emotional, and behavioral impairments because of their reliance on the fraudulent conduct by the NFL will remain uncompensated under this settlement.
The court has an obligation to protect all players who are part of this class action lawsuit. Any settlement that fails to address the claims and interests of the majority of players should be rejected as imprudent and contrary to the best interests of the majority of class members.
The claims of the preponderance of players must be allowed to continue in order to expose the reprehensible pattern of deception and intentional misconduct committed by the league, whose control of the negotiations of this settlement, elevates profits over player safety.