California Personal Injury Law Case Notes : California Personal Injury Lawyer & Attorney : Kristine Meredith : The Danko Law Firm : Car Accidents & Product Liability

The wrinkle reducer, Botox is approved by the FDA for very narrow uses only. But Allergan, its manufacturer, has promoted it to doctors all over the country for other uses, including muscle spasms. A doctor’s use of a drug for a purpose not approved by the FDA is often referred to as an “off-label” use. When a doctor used Botox “off-label” to treat Virginian Douglas Ray for hand tremors, it quickly led to brain damage. According to his wife, he now requires round-the-clock care and speaks very few words.

Botox is a purified form of the poison botulinum and is given as an injection. The drug is approved to treat “muscle stiffness” in the fingers and arms, “upper limb” spasticity, and chronic migraine headaches. Botox can migrate outside the injected muscles and cause side effects including botulism and severe autoimmune reactions with resulting brain damage.

Ray claimed Allergan did not properly warn his doctor about the risks of using the drug. A jury agreed, ordering Allergan Inc. to pay to Ray $12 million in compensatory damages and $200 million in punitive damages. This award by the U.S. District Court jury in Richmond, Va., was the largest penalty ever in a Botox injury case.

Botox is Allergan’s top-selling drug, with $1.42 billion in sales last year, or 29 percent of the drug maker’s revenue, according to data collected by Bloomberg.

This is not the first time the Botox manufacturer has had to pay penalties. In September of 2010, the federal government ordered Allergan to pay $600 million to settle civil and criminal allegations against the drug manufacturer for illegally marketing Botox for other uses. Allergan has also been accused of paying kickbacks to doctors and enticing them with all expense paid weekends to learn about off-label usage. 

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Decompressive craniectomies are an aggressive surgical strategy increasingly used at trauma centers for victims of diffuse traumatic brain injury. Although surgical methods vary, the decompressive craniectomy involves temporarily removing a portion of the skull to relieve the pressure from the swelling of the injured brain.

As recently reported in the New England Journal of Medicine, results of a randomized trial show that although decompressive craniectomy reduced intracranial pressure and the length of stay in the intensive care unit, it was also associated with a greater risk for unfavorable outcome at 6 months for patients with diffuse traumatic brain injury (TBI) compared with standard care. The standard care involves lowering the patient's body temperature and administering barbiturates.Rates of death didn't differ between groups, but scores on the Extended Glasgow Outcomes Scale were lower in the group undergoing bifrontotemporoparietal craniectomy, and there was a significant increase in risk, more than double, for an unfavorable outcome on that same scale, the researchers report. The unfavorable outcomes included vegetative state and conscious but disabled.

Our findings differ from those of most nonrandomized studies and are contrary to our hypothesis," the researchers, with lead study author D. James Cooper, MD, from the Department of Intensive Care at Alfred Hospital, Monash University, in Melbourne, Australia, acknowledge. " Our unexpected findings underscore the critical importance of performing such trials to test common therapies, particularly in patients with complex critical illnesses."

Experts stress that that the procedure should not be abandoned on the basis of these results. Surgeons must think more carefully about the risks and benefits of the decompressive craniectomy before performing the procedure and must work to further define appropriate clinical settings for this procedure.
 

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Following a recent threat by Air Canada to pull its sponsorship dollars, the NHL announced a revision of the NHL Protocol for Concussion Evaluation and Management. The Protocol now requires:

1.  Mandatory removal from play if a player reports any listed symptoms or shows any listed signs of a concussion;
2. Examination by the team physician in a quiet place free from distraction and use of "an acute evaluation tool" by team physicians rather than a quick rinkside assessment.
3. The NHL board will be asked to elevate the standard for holding a team and its coach accountable if there are a number of "repeat offenders" with regard to supplementary discipline.
4. A safety engineering firm will evaluate all 30 arenas and determine what changes, if any, can and should be made to enhance player safety.
5.  A 'blue-ribbon' committee of former players including Brendan Shanahan, Rob Blake, Steve Yzerman and Joe Nieuwendyk will look at safety issues.

The Ontario Hockey League has been a proponent of concussion education. Its president David Branch gives a nod to the NHL revisions but emphasizes that it does not go as far as the OHL which penalizes all hits to the head.  Also, the OHL has circulated a DVD to its players. OHL said:

The message to players is: You have to recognize these symptoms and you have an obligation to tell your team . . . We’ve got a problem with head injuries in our game and you are part – part – of the solution. It wasn’t intended to scare them. It wasn’t a threat – that we plan to suspend you. It was intended to educate, to get buy-in from the players, and to support the players.”

Thumbs up to Air Canada and the professional hockey leagues.  As they encourage education about brain injuries education, their fans will also better understand the seriousness of concussions.

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Array tomography is a state-of-the-art imaging system invented by Stanford University researchers. It allows researchers to count the myriad connections between nerve cells, as well as to catalog those connections’ surprising variety.

A typical healthy human brain contains about 200 billion nerve cells, or neurons, linked to one another via hundreds of trillions of tiny contacts called synapses. It is at these synapses that an electrical impulse traveling along one neuron is relayed to another, either enhancing or inhibiting the likelihood that the second nerve will fire an impulse of its own. One neuron may make tens of thousands of synaptic contacts with other neurons, said Stephen Smith, PhD, senior author of a paper published Nov. 18 in Neuron.

The new imaging system allows researchers to “travel” through the 3-D mosaic of neurons and observe different colors corresponding to different synaptic types just as a voyager might transit outer space and note the different hues of the stars dotting the infinite blackness. And to make a movie of the whole trip.  

This level of detailed visualization has never been achieved before. “The entire anatomical context of the synapses is preserved. You know right where each one is, and what kind it is. Observed in this manner, the brain’s overall complexity is almost beyond belief", said Smith. “One synapse, by itself, is more like a microprocessor —with both memory-storage and information-processing elements — than a mere on/off switch. In fact, one synapse may contain on the order of 1,000 molecular-scale switches. A single human brain has more switches than all the computers and routers and Internet connections on Earth,” he said.

Researchers plan to use array tomography to tease out more such distinctions within classes of synapses. That should accelerate neuroscientists’ progress in, for example, identifying the synapses that are lost after traumatic brain injury, or in neurodegenerative disorders such as Alzheimer’s.

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“Second Impact Syndrome” refers to mild brain injuries suffered repeatedly within a short period (hours, days, or weeks). Although all brain injuries are serious, second impacts can be catastrophic or even fatal. The American Academy of Neurology has developed guidelines  for deciding when it is safe to return to play after a first injury. The Academy recommends that, to reduce the risk of the second impact syndrome, an athlete who suffers a head injury resulting in temporary confusion, amnesia, or other alteration of mental status should not return to play until examined by a health-care provider familiar with these guidelines. Sport oversight committees such as California Interscholastic Federation, have begun to adopt these recommendations.

The guidelines rely in part on self-reporting by student athletes or close observation by coaches and other players. Unfortunately, athletes are often reluctant to admit their injury. To prevent their child athlete from suffering a second impact catastrophe, parents should do the following:

• Know and recognize the symptoms of a brain injury. As described here.
• Learn what the coaches know about brain injuries.
• Find out whether the school has policy for handling brain injuries.
• Educate your child about the catastrophic risks of a second impact and
• Emphasize to your child the danger of hiding even the seemingly minor symptoms of brain injury.
  

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Friday night lights. Marching bands. And the smacking of football pads. Yes, it’s football season!

As parents prepare to watch their kids on the football field, discussion returns to topics of injuries and helmet safety. The risk of football-related brain injurieses is undeniable. Each year designers and manufacturers unveil the latest and greatest helmet.  The new helmets can cost between $300 and $400. Does a more expensive high tech helmet make a difference?

Opinions vary.

Some medical experts say there are no conclusive studies that show one brand or style of helmet to be more effective at preventing concussions than another. "We just know that helmets in general don't protect against concussions," said Dr. Robert Cantu, who has been studying football-related head injuries since 1987. "We do know a newer helmet is better than an older one," he added.
While manufacturers such as Riddell claims that its Revolution helmet reduces the risk of concussion by 31 percent, and Xenith does not call its product a helmet, rather it boasts of an “adaptive head protection system of integrated technologies designed to reduce the sudden movement of the head by adapting to different energy levels."

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A study published in the September 2010 issue of Pediatrics reports the number of sports-related concussions is highest in high school-aged athletes, but the number in younger athletes is significant and rising. Visits to emergency departments for minor traumatic brain injuries occurring during organized team sports have increased dramatically over a 10-year period, and appear to be highest in ice hockey and football.

What should schools being doing to protect their students? For one thing, every coach can take the free online concussion training course offered by the Center for Disease Control. The course, which is designed for parents as well as coaches, includes video segments, quizzes and a resource center. It takes approximately 40 minutes to complete, but the time will vary because it’s interactive. The training dispels many of the “myths” about brain injuries that we’ve blogged about previously here and here.

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1. "You couldn't have suffered a brain injury if you didn't lose consciousness." 

Not so.  A brain injury results from any traumatically induced disruption in brain function.  The victim needn't have "blacked out" to have suffered a brain injury.  A disruption of brain function may be evidenced by the victim's inability to recall events immediately before or after the accident, or any feelings of being dazed or confused after an accident.

2. "You couldn't have suffered a brain injury if you didn't hit your head."  

The brain can be injured anytime the head comes to a sudden stop.  The damage occurs when the brain moves inside the skull.  No impact to the head is needed.  If the head and neck makes a sufficient whipping motion, or if the head is shaken sufficiently hard, a brain injury can result..

3.  "Children recover from brain injuries better than adults do."

In fact, children often seem to do worse than adults. The reason is that, for a child, the injury is a "double hazard."  First, the child struggles in the first year or two to recover physically from the injury, if he can.  But even if his physical condition improves, he will find himself behind his peers in school.  Unable to catch up, he may simply fall further behind. 
If you don't have any complaints, you're fine.

4. "It's just a concussion."  

Concussions, though considered "mild" brain injuries, are serious.  For most victims, their symptoms of a concussion will resolve within a year.  However, for a minority of victims -- perhaps as many as 15% -- their symptoms can persist for many years of for the rest of their lives, and can be devastating. 

5. "If you feel OK, then you're fine."

Sometimes, the symptoms of a brain injury occur right away.  Sometimes, however, they can begin weeks later.  Frequently, a victim of a brain injury will suffer a serious loss -- such as the loss of his sense of smell -- and not even be aware of it until he is tested.

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Many people with TBI have problems with basic cognitive skills: learning, remembering, thinking. It’s more than a mere loss of "intelligence." TBI victims may find it hard to pay attention or concentrate, and they might have trouble learning new material. A TBI can also cause the victim to think more slowly, or to get easily confused. Sometimes these skills are described as “executive functions” because they require a higher level of thinking, such as planning, understanding abstract ideas and conceptualization. People with TBI may become impulsive, or develop unusual habits. Things that were once easy — like talking and listening — may become difficult or impossible.
 

Because the brain regulates our emotional and psychological lives, a TBI can alter a victim’s sense of mental wellness. The TBI might cause a personality change, or introduce mental problems. A person with TBI may have mood swings, depression, irritability, aggression, or disinhibition. 

To assess the extent of the victim’s deficit, a neuropsychological evaluation may be recommended. The person conducting the evaluation interviews the victims and then administers a series of tests. The majority of the tests are pencil and paper standardized tests, meaning that they are given in the same manner to all patients and scored in a similar manner time after time. The tests must be administered by a neuropsychologist or a trained, skilled test administrator. 

The test giver will rarely, however, give a test that was specifically designed for someone who suffered a TBI.  For that reason, the cognitive test scores – alone-- seldom paint the full picture of the TBI victim's deficits. 

When dealing with a TBI victim, the test administrator should personally observe and evaluate the victim’s behavior during the test.  The test administrator's observations may corroborate the reports of close friends and family members that the victim's behavior has changed as a result of the injury.  In fact, interviews of friends and family are critical sources information concerning the loss the TBI victim has suffered.  

Regardless, cognitive testing is not designed to evaluate all behavioral changes that may result from a TBI.   Cognitive test results cannot be relied on as a sole measure of the TBI victim's loss.
 

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A child's head injury can have devastating effects.  To reduce the risk of the injured child suffering a second and perhaps worse injury, medical professionals should use the term “mild traumatic brain injury” to describe the child's head injury rather than “concussion.”

In a study to be published in the February issue of the journal Pediatrics, Carol DeMatteo, an associate clinical professor at McMaster University in the School of Rehabilitation Science, found that children whose injuries are labeled as "concussion" are allowed fewer days in the hospital and are sent back to school sooner than their counterparts with head injuries not diagnosed as "concussion."

Our study suggests that if a child is given a diagnosis of a concussion, the family is less likely to consider it an actual injury to the brain. These children may be sent back to school or allowed to return to activity sooner, and maybe before they should. This puts them at greater risk for a second injury, poor school performance and wondering what is wrong with them.

Professor DeMatteo said using the term "mild traumatic brain injury" instead of "concussion" will help people to better understand what they are dealing with so that they can make decisions accordingly.  

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The Consumer Attorneys of California (formerly called The Trial Lawyers of California), named my partner Trial Attorney of the Year Finalist for 2009 in honor of our work for a brain injured client in the case of Burdett v. Teledyne Continental Motors.  The Trial Lawyers Association presented a video about the case at its annual convention awards dinner in San Francisco.

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One would assume that if a TBI victim cannot remember the injury producing event, he cannot suffer flashbacks or nightmares re-experiencing the event. Right? Wrong.

Indeed, a diagnosis of a TBI generally requires a loss of consciousness. But the victim's loss of consciousnesss does not shield him from post traumatic stress disorder, or PTSD.  Apparently PTSD can occur after a TBI, but the TBI may alter the symptoms' development.  A TBI victim's symptoms may relate to events that just preceded his loss of consciousness, or to events that occurred immediately after.  The symptoms may even relate to details about the trauma-producing event itself that the victim learned about later in his recovery.

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Some insurance company doctors say that young brains are more resilient. These doctors testify at trial that, when it is a young child who has suffered a traumatic brain injury, the prospects for a good recovery are brighter than they would be if the child were older.

New research shows that the opposite may be true.  A traumatic brain injury may throw off a child's normal developmental timetable. Though the child may experience encouraging improvement in the first two years after an injury, after that, it may be that the child never really catch up to his peers. Rather, he may simply fall further behind over time. Because younger children have more development ahead of them, brain injuries at younger age is a "double hazard," the researchers noted.  That means that the same injury can cause much more trouble for a 4 year old than a 12 year old.

The study was published earlier this year in Neuropsychology, 2009; 23 (3) (subscription required).
 

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When a head is twisted violently, such as in a car crash, microscopic brain structures, called axons, can tear.  The damage to the brain is a called a "diffuse axonal injury," or DAI.  When the axons tear, chemicals that were contained in those structures can leak into the brain tissue.  The torn axons and chemicals in the brain tissue disrupt the brain’s regular processes.  

The injury has been named "diffuse" because it was believed the damage occurred throughout the brain, and not in any one particular location.  We now know that that isn't quite right.  For example, in severe cases, the axonal injury appears on an MRI.  When it does, it usually appears as one small foggy area.  (Seen in the center of the graphic as an opaque area.)   In fact, as it turns out, the damage caused by a "diffuse axonal injury" is usually centered in a specific part of the brain called the corpus callosum -- the bundle of fibers that connect the two-halves of the brain. 

Victims suffering from DAI often have cognitive problems such as:

• lack of concentration
• poor long-term memory
• difficulty dealing with more than one thing at a time,
• lack of attentiveness
• trouble keeping track of appointments, and
• disorganization.

A victim can suffer a diffuse axonal injury even if there wasn't any impact to the head. Because there is no tell-tale external bruising or bleeding, and because the DAI doesn't always appear on an MRI, health care providers sometimes fail to diagnose the injury initially.  To represent an accident victim effectively, the personal injury attorney must be alert to symptoms which may suggest that the client should seek further medical evaluation.

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Most TBI victims suffer from seizures and so need anti-seizure drugs. The drugs don't eliminate the seizures, they attempt only to control them. Even if the TBI victim takes the drugs exactly as prescribed, the victim may still experience "breakthrough seizures." The seizures can lead to embarassment, social stigma and most troubling, a blackout while driving. The victim who experiences breakthrough seizures may lose his driving privileges until he is seizure free for three months or maybe permanently. A TBI victim is entitled to compensation for all seizure-related damages. So, for example, if the victim loses his driving privileges, one form of damages might be the costs of hiring a driver. And don’t forget damages in the form of pain and suffering associated with the loss of driving privileges (ie. embarassment, loss of independence, etc.).
 

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Neuropsychologist researcher and professor Erin Bigler, PhD. recently spoke about the advances in images of post-concussion brains.  As discussed here, concussions or mild traumatic brain injuries may not show up on standard MRI or CT images.  Dr. Bigler described a new technique for analyzing MRI scans called "diffusion tensor imaging" or DTI.  This technique illustrates the direction of water flow through the fiber tracts of the brain. A comparison of images between an injured group and a control group revealed differences in the fiber tracts of injured patients.  It is believed that the head injuries caused swelling or edema in the fiber tracts, disrupting their normal ability to transmit messages in the brain.  This imaging allows researchers to determine the extent of injury between the fiber tracts.  Such research will have many applications, including diagnosing and assessing the scope of damage to a mild traumatic brain injury victim.

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Most victims of a Mild Traumatic Brain Injury recover fully within one year of their injury. But, sometimes, victims can be left with long-term cognitive problems that affect both their jobs and their family lives for years to come.  Despite the potentially devastating effects of a mild brain trauma -- also known as a " concussion " -- the injury seldom appears on X-Rays, CT scans, or other common imaging techniques.  Without such objective proof, the wrongdoer who caused the injury invariably argues that its victim suffered no brain injury at all, and that the victim is simply making up his symptoms.

One sure way to prove that a victim suffered a brain injury is to prove that the accident caused the victim to lose consciousness, or "black out."  Though an accident victim can suffer a brain injury even without losing consciousness, doctors agree that if an accident causes a victim to lose consciousness, however briefly, brain injury has always resulted. Unfortunately, many victims who black out never realize it, and so insist to paramedics or doctors at the hospital that they did not. Therefore, the first challenge for a lawyer representing the victim of a Mild Traumatic Brain Injury is proving that the brain injury even exits.

Brain specialists can help. A neurologist can conduct sophisticated tests, such as PET scans and SPECT studies.   These studies may show an impairment in brain functioning that doesn't appear on an MRI.  A neuropsychologist can administer objective tests of memory, attention, problem-solving, sensory perception, planning, organization, and other cognitive functioning. The results of such testing can sometimes prove that the accident victim, does, in fact, suffer from a brain injury.

When confronted with proof -- from either cognitive test results or PET/SPECT studies -- that there is a brain injury, wrongdoers argue that the victim's symptoms are attributable to a previous accident and not the one that they caused.  And, in fact, many of those who suffer long term effects from a Mild Traumatic Brain Injury have a prior concussion in their medical history.  However, research shows that one concussion -- even if it caused the victim no lasting symptoms -- leaves the victim at risk of permanent symptoms should he receive another concussion.   That is why professional football players retire after receiving multiple concussions despite "feeling fine", and why boxers who don't retire eventually become "punch drunk."

To prove that the victim had fully recovered from the prior injury, and that it was the most recent concussion that caused the symptoms, it can be helpful for family, friends, and employers to testify.  These witnesses can frequently establish that the victim exhibited no changes in his behavior, mood, or cognitive abilities until after the most recent injury.
 

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Some traumatic brain injuries can be seen on an MRI scan. Many, however, cannot. The structural damage caused by the trauma is just too subtle. Of course, even subtle changes in brain structure can cause profound changes in brain functioning. Simply because  the brain injury cannot be seen on an MRI, it doesn’t mean that it doesn't exist.

While an MRI (upper photo) shows abnormalities in the brain’s structure, a PET scan (lower photo) shows abnormalities in the brain’s functioning. PET scans do this by measuring the distribution of metabolic activity in the brain.  The parts that are not experiencing the expected biochemical activity have a functional abnormality. The PET scan, then, can serve as objective evidence of a brain injury that can’t be seen on an MRI.

PET scans can help prove that a victim has suffered a traumatic brain injury.  But before a judge will allow the jury to see the PET scan, he has to be convinced that the PET scan reliably depicts what the testifying expert says it depicts,.  The judge will also need to be convinced that PET scanning is widely accepted in the medical community.

Doctors frequently use PET scans to find changes in brain functioning in an Alzheimer’s patient or an epileptic.  They less commonly use them to diagnose victims of traumatic brain injuries. This is one reason why some judges are reluctant to allow PET scans to be used in a trial of a traumatic brain injury case. These judges, however, are often more willing to allow the PET scans to be shown to the jury when the scan was ordered by the victim's treating doctor for the purpose of diagnosis or treatment – before any lawsuit was filed.
 

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Doctors once believed that, whenever a blow to the head resulted in a brain injury, the victim would lose consciousness. Without a loss of consciousness, they would say, there could be no brain injury. That's no longer the case. Now, medical professionals agree that a brain injury can result without the victim ever blacking out. Further, we now know that traumatic brain injury can result even without a blow to the head, such as in cases of "shaken baby syndrome" or, in adults, as a result of a whiplash-induced contrecoup injury.

An injury victim is considered to have suffered a Mild Traumatic Brain Injury (frequently referred to as a "concussion") if a trauma has caused a disruption of brain function as evidenced by any of the following:

• A loss of consciousness, however brief; OR
• Inability to recall events immediately before or after the accident; OR
• Any alteration of mental state (for example, feelings of being dazed or confused) right after the accident.

A concussion can result in a long list of symptoms. The symptoms are sometimes called "post concussive syndrome" and can include:

• pain,
• fatigue,
• sleep problems,
• mood changes,
• headaches,
• inability to concentrate,
• word finding difficulties and other cognitive problems,
• memory problems,
• frustration,
• loss of sense of smell,
• nausea,
• dizziness,
• visual problems,
• ringing in the ears,
• frequently becoming lost or confused,
• feelings of depression.

The symptoms may not appear until days or weeks after an injury. Fortunately, most victims of mild traumatic brain injury completely recover from their symptoms within a year. However, a minority of victims -- perhaps up to 15% -- do not.  For some of those people, "mild " traumatic brain injury can lead to a lifetime of problems. The problems can be devastating.  For example, the victim's inability to concentrate can result in his losing his job and mood changes can place great stress on family relationships.

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An impact on one side of the head can cause the pudding-like substance of the brain to hit the inside of the skull and then bounce back and hit the inside of the skull on the opposite side of the head.  When the brain suffers two injuries from one impact, it is called a “coup contrecoup,” or “coup contra coup” injury. Sometimes, the secondary (contrecoup) injury is more damaging than the primary (coup) injury. To complicate things, internal bleeding and swelling from the primary injury can mask the brain damage caused by the secondary injury.  One of my clients went weeks before sophisticated imaging of his brain and neuroevaluations showed that his cognitive problems were almost all due to a “contrecoup injury,” rather than the more obvious “coup” injury.

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