University of Cincinnati Study to Test Progesterone Effectiveness in Severely Brain Injured Individuals

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Posted on 12th January 2010 by Gordon Johnson in Uncategorized

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Editors Note: The greatest advancements in the treatment of brain injury have been in the area of increasing the number of people who survive the severest injuries. Helicopters, CT scans and ICP monitors account for the biggest chunk of that improvement. The press release below from the University of Cincinnati details a new study that is being proposed for 100 severely brain injured people to see what benefit administration of the hormone progesterone will have on outcomes.

Such research is extremely important and the double blind method is critical for research to have any scientific validity. My only concern with this study is that we don’t know how progesterone is supposed to help. If the projected improvement rate is 5%, that may be a lot of effort for what may not be a statistically significant result. But that is what scientific research is there to determine. And if you were one of the 5% who got better that would be significant to you and your family.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
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©Attorney Gordon S. Johnson, Jr. 2010


(Media-Newswire.com) – CINCINNATI–Neurotrauma experts at the University of Cincinnati Neuroscience Institute at University Hospital are seeking public input before launching federally funded research aimed at improving outcomes for patients who suffer traumatic brain injury ( TBI ).

The randomized clinical trial will assess whether administering the naturally occurring hormone progesterone in patients immediately after a moderate to severe traumatic brain injury will reduce brain damage and swelling and thereby improve the patients’ mental and physical outcomes.

The Cincinnati portion of the study will be led by Jay Johannigman, MD, associate professor and director of the division of trauma and critical care, and Lori Shutter, MD, associate professor of neurosurgery and neurology and director of the neurocritical care program.

“The nation is becoming increasingly aware of the devastation that traumatic brain injury can have on a person’s life,” Shutter says. “Unfortunately, although there have been many efforts, we still do not have an effective treatment for a traumatic injury to the brain. The early information on progesterone for treatment of TBI renews our hopes that we may have something that can improve long-term outcomes.”

The progesterone study, funded by the National Institute of Neurological Disorders and Stroke, is known as ProTECT III, which stands for Progesterone for Traumatic Brain Injury–Experimental Clinical Treatment. The $14.5 million trial will enroll 1,140 patients over a period of three years at 17 medical centers throughout the United States. David Wright, MD, assistant professor of emergency medicine at Emory University in Atlanta, is the multicenter study’s lead investigator.

Public comment is required before the ProTECT study begins because a patient who has suffered a brain injury is unconscious and would not be able to give consent before doctors administer the treatment. In addition, a relative or guardian may not be immediately available to grant consent on the patient’s behalf.

Traumatic brain injury involves sudden damage to the brain caused by an outside force to the head, such as a car crash, a fall or a forceful blow from a heavy object. Roughly 1.5 million to 2 million adults and children suffer a traumatic brain injury in the United States each year. About 50,000 die and another 80,000 are permanently disabled, according to the Centers for Disease Control and Prevention. Traumatic brain injury is the leading cause of death and disability among people aged 1 to 44.

ProTECT III is the third phase of groundbreaking research into the effectiveness of progesterone, which is most commonly recognized as a female hormone but also has “protective” properties. Progesterone receptors are abundant in the brain, and laboratory research suggests that progesterone plays a role in the development of brain cells and in the protection of injured brain tissue.

Emory researchers concluded in an earlier pilot study involving 100 patients that giving progesterone to trauma victims shortly after a brain injury appeared to be safe and effective. Emory researchers also reported a 5 percent reduction in mortality among patients treated with progesterone as well as improved outcomes among patients with moderate injury.

Progesterone is an attractive therapy for several reasons, Shutter says. “It is FDA-approved; it can be administered quickly; it enters the brain quickly; and it is inexpensive.”

The current study, ProTECT III, involves patients aged 18 and over who have suffered a moderate to severe traumatic brain injury and who can begin treatment within four hours of their injury. A qualifying patient will be randomly assigned to one of two groups. One group will receive an IV mixture that contains progesterone ( the study medicine ). The other group will receive an IV mixture that has no progesterone ( a placebo ). The UC team expects to enroll approximately 100 patients over the three-year period at University Hospital.

Federal law established the “waiver of consent” in 1996 so that physicians could begin emergency treatment after any injury before obtaining consent from the patient or from a legal guardian or family member. Under terms of the ProTECT study, if a hospital is unable to reach a family member after 60 minutes of diligent effort, the emergency medicine team is allowed to enroll patients who meet the study’s stringent criteria.

To qualify for the waiver, researchers must first explain the research to the community and gather feedback. UC researchers will discuss the ProTECT trial at community meetings during the next several months, with particular emphasis on demographic groups known to have a statistically elevated risk of severe traumatic brain injury. In addition, UC researchers must assess local residents’ willingness for themselves or a family member to participate in this study. A complete description of the study can be reviewed at www.protectiii.com.

Those who review the study description will be invited to complete a short accompanying survey.

ProTECT III is a project of the Neurological Emergencies Treatment Trials ( NETT ), which was established by NIH in early 2007. NETT is a permanent research network that currently involves 17 university medical centers throughout the United States. UC’s involvement in NETT is overseen by Arthur Pancioli, MD, associate professor of emergency medicine and a member of UCNI.



Individuals who are opposed to being enrolled in a NETT study in the event that they were to suffer a neurological emergency can request an “opt out” bracelet by calling ( 513 ) 558-NETT ( 0095 ).

For more information about ProTECT, please contact Sara Stark at ( 513 ) 558-0095 or sara.stark@uc.edu. For more information about NETT, please visit http://nett.umich.edu/nett/welcome.

Brain Damage Can Kill Too – Car Pedestrian Collision Kills 104 NY Legend

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Posted on 11th January 2010 by Gordon Johnson in Uncategorized

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I know it is a continuing oversight by me, but the reality is that brain damage does not only disable, it can kill. In fact statistically, about the same number of people die each year from brain damage as those who have severe brain injury. Now I could be wrong about that, because that is a statistic I have kept in my mind for over 15 years, and perhaps. we are doing a little better with keeping people alive.

Today, one of the world’s most interesting people died. He survived boxing, acting and old age, to be struck down in the prime of his life, at 104 years old, by a minivan. The New York Times told the story exquisitely well. Reading the story I felt like I reading the first chapter of a great novel. Carnivals, Coney Island and all of that lost colorful history of New York and America when we still believed what is says about welcoming immigrants on the Statue of Liberty.

Anyone who was a fledgling reporter on any newspaper, knows about writing obituaries. Yet when it came time to tell the story of Joe Rollino’s life, Manny Fernandez and Michael S. Schmidt of the NY Times did all Pulitzer Prize hopefuls, proud. The story is and the character they portray such a delight, I don’t even want to quote it hear. I am thankful that there are those like Joe Rollino who make it to 104. I am saddened that a life lived so well, could end so quickly because of brain damage. I am proud of the profession of which I was first trained that the NY Times reporter saw that this was not just a story about who survived Joe, but about the life he lived.

The story is so good I don’t want to even quote from it or sum it up. Read it. It is a great story. http://www.nytimes.com/2010/01/12/nyregion/12ironman.html?hp

Post Concussion Syndrome – Diagnosing and Treating for All Risk Factors

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Posted on 4th January 2010 by Gordon Johnson in Uncategorized

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I said this last week on my Justice and American Politics blog, http://subtlebraininjury.com/blog:
In the days after a concussion, the brain is trying mightily to rewire itself to deal with the new challenges. That rewiring is not always positive. Add panic or emotional distress and the plasticity that we all hope will avoid negative consequences, can rewire the brain in the wrong ways. I call this “negative plasticity” and I believe it is one of the strongest arguments for better and more thorough diagnosis and follow-up for concussion.
To answer that question one must first define the term “plasticity.” I found a great definition of it at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1526649/

Brain plasticity refers to the brain’s lifelong capacity for physical and functional change; it is this capacity that enables experience to induce learning throughout life. Research in this field has demonstrated that the adult brain continuously adapts to disproportionately represent relevant sensory stimuli and behavioral outputs with well coordinated populations of neurons. This adaptation is achieved by engaging competitive processes in brain networks that refine the selective representations of sensory inputs or motor actions, typically resulting in increased strengths of cortical resources devoted to, and enhanced representational fidelity of, the learned stimulus or behavior.


In severe brain injury lingo, plasticity is the capacity of one part of brain to take on the function of a part of the brain which is damaged. But as the brain has the capacity to rewire itself in positive ways, so can it in negative ways.

As long as I have been doing Post Concussion Syndrome cases, I have been asking myself this question: Why is there this significant subset of people who have such bad results from an injury that the majority of people have apparent full recoveries, within days if not hours? This small minority of people that fall into the symptomatic category have been referred to most often as either the “miserable minority” (Ron Ruff, neuropsychologist) or as suffering from the Persistent Post Concussive Syndrome. “PPCS” (Michael Alexander, M.D. , Neurology, 1995). That “miserable minority” of people consistently make up between 5 and 15% of those who suffer a concussion or mild traumatic brain injury. What explains this divergent outcome for this PPCS group?

I believe there are a number of issues. First, some of them have far more than a “simple concussion.” This portion have fairly serious brain injuries but because the symptoms of those concussions occurred when they were not being monitored by medical professionals, the severity of the brain injury is grossly underrated.

Second, some of them have other neurological injuries, which again, went misdiagnosed. The most common among this group are those with vestibular disorders. See http://vestibulardisorder.com Symptoms of dizziness, balance and vertigo can put significant demands upon the brains attentional resources and account for many of the cognitive and emotional complaints associated with the post concussion syndrome. In my career, I have found nearly a 50% incidence of vestibular disorder among my clients.

Third, there may be an artery dissection that happened contemporaneously with the head injury or as a result of treatment for the head injury, particularly from a chiropractor. Artery dissections can cause a stroke, with resultant moderate to severe brain damage.

Fourth, the brain injured person may be emotionally more vulnerable than the 85 to 90% of those who have good recoveries. This is likely the most significant factor and is the area where my term of “negative plasticity” comes into play. While the evidence of this particular component of concussion pathology is incomplete, I believe that as we learn more about the limbic system and the axonal connections between it and the lower frontal lobes, the emotional component of concussion recovery will become a huge field of discovery and potentially treatment.

What is the reason this is important in a week when a football coach gets fired for locking an athlete with a concussion up in a dark place? There is a major overlap between PTSD and the post concussion syndrome. After all, both are “all in the head”. “All in the head” means it is in the brain. There is not a bright line of demarcation between emotional injury and organic or “hard wire” injury in the brain. In all likelihood, there is no line at all. If you damage a person’s emotional center, regardless of whether you do so by direct trauma or via emotional rewiring, the hard wiring change is the same.

Concussion survivors need the best treatment, not just to protect them from repeat trauma’s, but also to protect the vulnerable brain from negative rewiring. A concussion in its infancy can become a life long disability if the vulnerable brain is neglected or abused. We worry about “shaken baby syndrome”. We should also worry about the neglected emotional state of all brains that are injured.

Mike Leach Firing Clearly Justified by Evidence of Abuse of Brain Injured Athlete

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Posted on 3rd January 2010 by Gordon Johnson in Uncategorized

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Texas Tech has won its bowl game without the Concussion abuser Mike Leach as its head coach. Leach was fired on Thursday, just before his hearing to force reinstatement. The court case was odd, especially since Leach chose to try his case in the media with out of context claims of support from the team doctor and trainer. As reported by the New York Times, neither the trainer nor the team doctor are supporting his treatment of Adam James. See http://www.nytimes.com/2010/01/03/sports/ncaafootball/03leach.html?hp

A Texas Tech athletic trainer said he was told by the fired coach Mike Leach to lock wide receiver Adam James in the dark after doctors determined that he had a concussion, according to an affidavit released Saturday by the university.

According to the NY Times story:

In a Dec. 21 interview with a university investigative attorney looking into James’s treatment, Steve Pincock, Texas Tech’s head football trainer, said he told James he was sorry about placing him inside an equipment shed on Dec. 17 near the practice field. According to the affidavit, Pincock also said he was not aware that any other player had ever been treated in such a manner.

“I do not agree with this form of treatment for anyone,” Pincock said in the affidavit.

In describing what Leach told him to do, Pincock quoted the coach as using graphic and profane language about locking James in a dark place, according to the affidavit. Pincock also told the investigator that Leach “wanted James to be uncomfortable,” the affidavit said. Pincock did not return a message left on his cellphone or reply to a text message Saturday.

Despite Leach’s media claims, the team doctor did not support the treatment of James, either. According to the NY Times:

In another affidavit released Saturday by the university, the team physician Michael Phy told the investigator on Dec. 22 that James “may not have been harmed,” but that Phy considered “this practice inappropriate.” In the statement announcing Leach’s firing, Texas Tech said Leach’s actions put James “at risk for additional injury.”
As I said on one of my other blogs last week, while isolation does not necessarily expose the injured brain to any new physical forces, it can expose the brain to additional stress, which can result in further Post Concussion Syndrome problems. See http://blog.subtlebraininjury.com/2009/12/texas-tech-isolation-for-concussed.html

Last year was a remarkable year for concussion awareness, but we are only scratching the surface of treating the secondary effects of concussion, especially those that involve emotional stressors. I hope the Leach chapter stays in the media focus long enough to get some of the leading thinkers on concussion to educate on this issue further.

Brain Injury Association of Wisconsin Looks for Volunteers for Sleep Study

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Posted on 29th December 2009 by Gordon Johnson in Uncategorized

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From the Brain Injury Association of Wisconsin:

The Sleep Wellness Institute Research Study
 
Many people with a traumatic brain injury may feel sleepy during the day, even if the injury happened years ago. Researchers are inviting those with a traumatic brain injury who feel sleepy during the day to take part in a clinical study. This study will assess how well a study medicine works for people who feel sleepy during the day as a result of traumatic brain injury.
 
To qualify you must:  
• Be age 18 to 65
• Have had 1 traumatic brain injury in the past 10 years
• Feel sleepy or tired during the day 5 or more days a week on average
• Be willing to take medical tests and a study medicine for 12 weeks
• Be available to sleep overnight in a sleep lab 5 times (some sleep labs are similar to hotel rooms)
 
This study will last 14 to 16 weeks (approximately 88 hours total) and include:  
•  7 visits
• 4 phone contacts
• 4 overnight sleep studies
• 4 daytime studies, three of which follow the overnight studies
 
If you qualify:  
• You may learn more about your sleep patterns
• You will receive study-related medical care and study medicine at no cost
• You may or may not benefit from study medicine
• Compensation for time and travel may also be provided 
 
If interested in participating in this research study, please contact Skyler Baake at 414-328-5637, skyler@sleepwell.org or Anne Papke at 414-477-4198, anne_papke@yahoo.com.
 
The Sleep Wellness Institute is located at 2356 S. 102nd Street, West Allis, WI  53227.  www.sleepwell.org
 
Sincerely,
Mark Warhus, Executive Director
Brain Injury Association of Wisconsin

Primary Care Reimbursement Under Health Care Reform

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Posted on 28th December 2009 by Gordon Johnson in Uncategorized

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We have heard much about the size of the new Health Care Reform Act, something nearly 2,000 pages. We have heard very little about what is inside of it except that it will cover more people, provide coverage for those with preexisting conditions and expand the coverage by as much as 30 million people. But how is it going to cut costs? And how will it assure that low income people truly have access to medical care?

One of the provisions included in the Senate plan is to increase the reimbursement rate of primary care doctors who are seeing Medicaid patients. See Health Care Business News at http://www.modernhealthcare.com/article/20091227/REG/312279992/0 In that article they explain:
A key objective of the bill is to bolster the ranks of the primary care workforce. The legislation includes a raft or new funding and measures aimed to encourage doctors to move into primary care . And in a measure to help increase transparency, the legislation requires HHS to develop a “Physician Compare” web site where Medicare beneficiaries can compare measures of physician quality and a patient’s perception of care.
This is an important part of the plan. Primary care doctors are in my opinion, the most important doctors in our system and sadly the lowest paid. See http://www.cejkasearch.com/compensation/amga_physician_compensation_survey.htm

Our current medical system is built around the concept of a gatekeeper, the primary care or family practice doctor. If you have a problem, it is only through treatment by the family care doctor or referral to a specialist from the primary care doctor that you get treated. Thus it is the gatekeeper who plays the most important role in diagnosis of disease. It is also the gatekeeper who must retain the most overall knowledge of medicine as he must be able to spot a problem across the entire spectrum of medical diagnosis. People think that because they are less specialized they have lower skills. For our system to work properly, that can’t be the case. As capitalist, if we want to attract our best doctors to this role, we have to pay them like our best doctors.

When I look at brain injury diagnosis, I see the enormous role that family doctors have to play. In my model, each concussed person would go back to the Emergency Room the day after his or her injury to be seen by the same doctors who saw them on the day of concussion, to determine if there was continuing or worsening symptoms. That is not what is happening in our current system. What happens in our current system is that the concussed patient is told to follow-up with their family doctor, if they get worse. If the family doctor does not know more about diagnosing a concussion than the average neurologist, then the diagnosis and the documentation of symptomotology that is so important will be missed. The reason that second day documentation is so significant is that without it, it becomes extremely difficult to sort out the issue of whether the symptoms that come later are related to brain injury.

My pet project – had I a lobbyist in my pocket for concussion care reform – would be to require the follow-up visit to the ER. Since I don’t have those kind of connections, this provision to increase access (and compensation to family doctors) is a step in the right direction. Now we must do what we can to educate the primary care doctor that testing for amnesia in the days after the accident will tell us more about the severity of injury and potential for disability than all of the scans that have been or will ever be invented.

Health Care Reform Now Awaits Reconciliation

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Posted on 27th December 2009 by Gordon Johnson in Uncategorized

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The New York Times is the world’s best newspaper. I learned that in Journalism school almost 40 years ago. It is still true today. Like all newspapers, it is at risk of failure because of the revolutionary shift in advertising revenues caused by the rise in the internet. I never subscribed to the New York Times, because I was a Midwesterner and it just didn’t seem practical. Well the NY Times is now part of my daily reading, because they have perhaps the best online newspaper: http://nytimes.com. I sure hopes the webpage helps the newspaper survive.

I was newly impressed with the NY Times this morning when I read their analysis of the two health care proposals in our Congress, the House version and the Senate version. I think it is a must read for anyone concerned about the health care debate, or about the health of brain injured people. That article is here: http://www.nytimes.com/2009/12/22/health/policy/22health.html?hp If you are required to register to get to this page, by all means, register. In fact, make the http://nytimes.com your home page, I did.

This article has the most comprehensive explanation of the two bills in Congress and a simple and reasoned explanation of which aspects of each bill should be retained. We hope that our Senators are capable of seeing the big picture and allowing small compromises to get this historic legislation passed. We hope our progressive colleagues in the House don’t blow up the coalition on Health Care Reform over a liberal agenda that can wait for another day.

Read the details. This comes under the category of things you need to know as a citizen.

Health Care Reform Gets Over its Biggest Hurdle

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Posted on 24th December 2009 by Gordon Johnson in Uncategorized

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Congratulations to Harry Reid for getting a health care reform bill thru the Senate. After 50 years of effort, the Democrats have almost done it. The next step is reconciliation with the House version and even though the outcome isn’t perfect, it is a huge step. While President Barack Obama has gotten criticism from every direction in the process, he must get high grades for this achievement. When he signs a Health Care Reform bill into law, it will be a moment in history as historic as his election.

I admit that there have been times in the last few weeks when I wondered if the special interest control of our legislatures might ultimately mean that the American system of making laws was broken. But Obama, Reid and Pelosi have found a way to get this done. The found a way to get it done despite the most intensive lobbying effort in history and a complete blockade of legislative cooperation by the Republicans.

Is this the bill that would have best for me? Of course not. I would have preferred the Medicare buy in at 55 because of course, I am 56. Is it the bill that would have been best for all Americans? Probably not. But is it a tremendous step towards coverage for all? Yes it is. After 50 years of nothing, after the collapse of the last major attempt led by two of the great politicians of the last 50 years, Bill and Hillary Clinton, to get this bill out of the Senate is remarkable.

There is some sausage making left over, but when it is done, millions will have health coverage that didn’t, and even though it isn’t everyone, it is still millions whose will have access to medical care.

NFL and Brain Injury

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Posted on 5th October 2009 by Gordon Johnson in Uncategorized

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From the NFL and its Players Association:

NFLPA ANNOUNCES FORMATION OF
CONCUSSION AND TRAUMATIC BRAIN INJURY COMMITTEE

For the past few months, the NFL Players Association, led by Executive Director DeMaurice Smith, President Kevin Mawae, Medical Director Dr. Thom Mayer and Arizona Cardinals wide receiver Sean Morey, has been working on compiling support for a special committee to address the issue of head trauma among professional football players. Today, the NFLPA announces the formation of the Concussion and Traumatic Brain Injury (TBI) Committee.

The NFLPA Concussion and TBI Committee will address two fundamental, timely and critical issues facing professional football players: first, the diagnosis, treatment and prevention of concussions and TBI in active players; and second, the long-term cumulative effects of isolated or repetitive TBI in NFL players as patients in order to discover how these effects can be reduced and eliminated.

DeMaurice Smith issued a statement saying, “The health, safety and welfare of our players is never just an issue of collective bargaining. While we have already raised this issue in the CBA negotiations and Dr. Mayer participated in the first meeting, this committee and the work we do around the health and safety of our players will extend much further. The creation of this committee was designed to bring both independence and expertise to the ongoing analysis of serious head injuries so we can better protect our players. I am confident that Sean Morey and Dr. Mayer will lead this team to gather more comprehensive data and provide real solutions for our players, both past and present.”

The Concussion and TBI Committee will be co-chaired by Sean Morey and Dr. Mayer. It will also be comprised of other active players, former players, researchers in the field of TBI and physicians with expertise in neurological injuries.

Joanna Comfort
Communications Coordinator, Communications

1133 20th Street, NW
Washington, DC 20036
(P) (202) 756-9170
(F) (202) 756-9310
NFLPLAYERS.COM


The words read good on paper. I will start to believe the NFL when I don’t see players going back into the same game that they suffer a concussion. We can’t know the severity of a concussion the same day as the injury because brain injury is a “process not an event”. See http://blog.tbilaw.com

Medical Malpractice – Consumers versus Corporate Interests

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Posted on 15th September 2009 by Gordon Johnson in Uncategorized

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In my previous blog I asked the question: Are Republican’s immune from Medical Malpractice? Of course they are not. Are consumers immune to big business and its institutional greed and corruption? Sadly not. Yet the Republican’s are all about the politics of converting the interests of Big Business into scare tactics aimed at average people.

Let us take an average person. Francisco Torres was a retired assembly line worked with a cancerous tumor on his left kidney. Sounds like the kind of person the anti-health care reform lobby has been courting. Fear of death panels. Cuts to medicare. A year ago, Mr. Torres would have probably thought that tort reform was good for the country and would lower his medical costs.

Not any longer. When Mr. Torres went in for surgery to remove the diseased kidney, the doctor cut out his healthy one. See the Press Enterprise News: http://www.pe.com/localnews/sbcounty/stories/PE_News_Local_S_kidney03.46a9e43.html According to the pe.com:
A retired assembly line worker is suing a Riverside hospital and doctor, claiming that they removed his healthy kidney instead of the diseased one. He has to endure dialysis every three days to stay alive.

On July 14, Dr. H. Erik Wahlstrom, who was performing surgery at Parkview Community Hospital Medical Center, was to remove Francisco Torres’ left kidney, Torres’ lawsuit states. Instead, Wahlstrom removed Torres’ healthy right kidney before realizing the mistake, said Shirley Watkins, Torres’ Los Angeles attorney.

Shortly after surgery, Wahlstrom told Torres’ daughter what he had done, Watkins said. Torres said through an interpreter that Wahlstrom apologized to him. But Torres, who does not speak or read English, said he was still groggy from the surgery and has little recollection of what was said.
Guess what? The hospital is now denying all claims in the civil suit. According to PE.com: “Hospital officials have denied responsibility. Neither Wahlstrom nor representatives from Parkview Community Hospital returned telephone calls made Tuesday and Wednesday.” If there is anything about medical malpractice claims that drives up the cost of medical bills, which almost all studies have disproved, it is the cost of frivilous and obstructionist defenses to those claims.

When you listen to the outraged rhetoric about how trial lawyers are ruining the country, you don’t hear the stories of people like Mr. Torres. Thus, in my upcoming blogs, I will tell some of those stories. You the reader get to choose. Protect Big Business from the predator trial lawyers, or protect you from the abuses of neglect and greed.