New Science - Creating a Test to Find People with Specific Genetic Defects to Create a Unique Cohort for a Clinical Trial
This August 27 press release from Abbott and Pfizer exemplifies another way science is changing and will over time create new legal issues as to remedies for tort claims. The pertinent part of the press release is quoted below; the gist is that the two are undertaking a joint effort to create a diagnostic test to find persons with a specific genetic defect so that a clinical trial can be then undertaken only with patients with that particular genetic defect. Soon enough, plaintiffs will be able to have good science behind requests asking courts to order a risk -creator to pay for much more than just a traditional annual check-up.
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Des Plaines, Illinois and New York -- Abbott (NYSE: ABT) announced today that it has entered into an agreement with Pfizer Inc to develop a molecular diagnostic test intended to screen non-small cell lung cancer (NSCLC) tumors for the presence of gene rearrangements. Pfizer has developed a novel investigational agent that selectively targets cancer-causing genes implicated in the progress of many cancers. To be eligible to receive Pfizer's oral therapy, a particular genetic translocation (rearrangement) known to be found in NSCLC tumors and a wide variety of other cancers, but not in normal cells, must be present.
Under terms of the agreement, Abbott will develop a companion diagnostic test that will determine a patient's genetic status and will be used in patient selection for future clinical trials of PF-02341066.
"We are very pleased to partner with Abbott to develop a companion diagnostic test for non-small cell lung cancer and ensure its global availability for patients and physicians who need this information to make the best treatment decisions," said Garry Nicholson, General Manager, Pfizer Oncology Business Unit. "This test will allow us to focus on the patient population most likely to benefit from our NSCLC candidate. Working in close partnership with the experienced Abbott team, we are confident that we will deliver yet another application of personalized medicine to address a currently unmet medical need in NSCLC."
"Pfizer's novel compound for treating non-small cell lung cancer appears to be ideally suited to individualized therapy," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "Abbott is a leader in the development and commercialization of companion diagnostics and we're delighted to collaborate with Pfizer, a leader in cancer therapeutics, on the development of a test to identify patients who might benefit from this important compound."
New Science - Observable Brain Changes in Rats Subjected to Stress
More on brain rewiring and damages potentially recoverable in current or future tort litigation. This prior post provided some fact patterns and legal issues on future damages issues as drawn from research breakthroughs described in a wonderful book on brain plasticity - The Brain That Changes Itself -- Stories of Personal Triumph from the Frontiers of Brain Science, by Dr. Norman Doidge.
Now, here's more to think about as both individuals and as tort lawyers who end up in arguments about what is "harm," how it is proved and measured, and how it is compensated. Specifically, yet more news on brain rewiring is out and indicates that stress does produce physical changes in the brain, thus providing possible evidentiary support for claims that stress is indeed a physical injury.
This August 17, 2009 NYT article by Natalie Angier summarizes new research on brain plasticity as it relates to stress. The gist is that scientists in Portugual this summer published an article in a prestigious medical journal regarding their findings on brain changes when rats were subjected to stress. The not so good news is that stress does indeed destroy brain wiring. The better news is that the brain can rewire and return to "normal" when the stress is reduced back to normal levels. Here are key quotes:
"Reporting earlier this summer in the journal Science, Nuno Sousa of the Life and Health Sciences Research Institute at the University of Minho in Portugal and his colleagues described experiments in which chronically stressed rats lost their elastic rat cunning and instead fell back on familiar routines and rote responses, like compulsively pressing a bar for food pellets they had no intention of eating.
Moreover, the rats' behavioral perturbations were reflected by a pair of complementary changes in their underlying neural circuitry. On the one hand, regions of the brain associated with executive decision-making and goal-directed behaviors had shriveled, while, conversely, brain sectors linked to habit formation had bloomed. (emphasis added).
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But with only four weeks' vacation in a supportive setting free of bullies and Tasers, the formerly stressed rats looked just like the controls, able to innovate, discriminate and lay off the bar. Atrophied synaptic connections in the decisive regions of the prefrontal cortex resprouted, while the overgrown dendritic vines of the habit-prone sensorimotor striatum retreated."
If I were a plaintiff's lawyer, the NYT and Science article would be dropped into my bag of citations and evidence to argue for a broader range of treatment after, for example, suffering a trauma from a one time physical event or after cancer has been countered via surgery, chemotherapy or other means. As a defense lawyer, I'm probably going to argue this is not (yet) accepted science and try to keep it out of evidence under the Daubert rules. But, one might also ask what makes sense for the long term - perhaps injured people should receive some paid for r & r to get them into good patterns and a better recovery that may save money in the long run. Then we lawyers can argue about who should pay for it - the health insurer, the Comphrehensive General Liability insurer, the tort defendant or some government agency.
Science, Intensive Therapies and Damages - New Issues Ahead ?
More on science and tort law. Suppose medical malpractice destroys a woman's inner ear balance function to the point she can stand up only when supported by a wall or other structure. Suppose you are the insurer for the doctor - how much do you offer to compensate for her inability to work or to live any kind of a normal life? Is the offer a structured settlement worth perhaps $ 10 million over 30 years? If you are the woman, do you accept that offer? Or, do you commit yourself to an experimental but potentially highly successful new approach to restore your balance by going around the destroyed system ?
The experimental approach may well be the better alternative for both the victim and the insurer. What is it? Helping the woman's brain to rewire itself through an intensive therapy process that calls for rebuilding and rewiring the brain and balance system by routing signals up to the brain through a Rube Goldberg hat with wires connected to the tongue. In fact, as is detailed below, this technique worked and restored - fully - "the wobbler's" balance. And, the therapy subsequently has worked repeatedly for other persons with similar problems.
Or, suppose you are the disability insurer for a physician who suffers a stroke in the prime of life and loses significant bodily function. Do you pay out millions in disability over the years or pay hundreds of thousands of dollars for an intensive therapy that may restore function by once again rewiring the brain ? The latter may well be the right choice.
Suppose you are a disability insurer facing the prospect of thousands more Alzheimer's claims than the underwriters had expected. What to do - pay, take the insurance company into "run-off" or pay for "learning software" for which there is objective clinical data indicating that use of the software therapy helps to block or delay the onset of Alzheimer's by helping the brain form new links ?
For all of the above fact patterns, consider some additional questions. Suppose the issues do not arise from insurance policies and instead arise from a lawsuit seeking remedies/damages for an injury caused by negligence ? Suppose the claim is based on strict liability - does that matter? Suppose the victim smoked or took some other action plainly viewed - today - as contributory fault - does that limit the remedy or damages?
Does the insurer get to choose the option or does the insured/victim make the choice? Suppose the insured/victim chooses not to try the intense therapy despite a proven track record of success in "like" patients - should that limit the amount of damages payable ? How "like" does "like" have to be ?
Suppose the therapy is available only at one or two facilities in the US - is there an obligation to pay for the travel and hotel expenses? How nice a hotel? What about paying for food and shelter for a supporting family member? What about paying for a family member or a professional nanny to stay with children while the wife goes through therapy and is supported by her husband? What about paying a supporting family member who goes with the patient to support the patient through the intensive, months-long therapy? What happens when the victim is from country x, speaks language y, and the therapy is - for now- available only in country q where they speak language b?
Excluding the insurance company parts, the examples above are all drawn from real world situations covered in a fantastic book on brain science. The thrust of the book is that brain rewiring principles today are well-accepted and indeed proven by "brain mapping," but 30 or so years ago were considered heresy. The most basic scientific principle? Contrary to conventional medical wisdom, the brain in fact can and will rewire itself IF worked intensely by therapists who know what they are doing. Are the results purely subjective? No - they've been objectively proven by laborious "brain mapping" and by observable results.
The book? The Brain That Changes Itself -- Stories of Personal Triumph from the Frontiers of Brain Science by Dr. Norman Doidge. Who is he? A physician turned researcher who took the time to write a brilliantly readable book explaining for everyone why and how science can cause seemingly miraculous recoveries for victims of strokes, disease, traumatic accidents and even psychological traumas. The book is in part an explanation of the insights of dedicated scientists who rejected conventional thinking about the brain and proved that in fact the brain is a remarkably "plastic" organ that can change and overcome profound injuries to the brain itself. The book also explains how the brain rewires to compensate for and overcome injuries to other parts of the body. The book begins, for example, with the story alluded to above regarding the brilliant new technique for rewiring the brain of the "wobbler" injured by a physician's error. Other chapters describe how intense, out-of-the -ordinary therapies produced virtually complete recoveries for victims of strokes, some birth defects and even some mental health issues.
The book also is a must read for everyone worried about dementia in old age. Pages 70-91 describe demonstrably successful software and exercise programs being developed by a company known as Scientific Learning that has developed a program known as Fast For Word, and other software developed by Posit Science. Also significant is the description of the Aerosmith School at pages 36-44.
Conclusion? New issues lie ahead. Centers of excellence with intensive therapies can and do offer some people wonderful, life-saving opportunities not available anywhere else. Which lawyer among us is good enough to - successfully - argue to a jury why the injured person is not entitled to access the center of excellence when the requested remedy is based on sound logic and science ? And, aren't all sides better off if the intensive therapy succeeds and produces fewer overall costs ?
Tort Claim Damages - The Impact of Immigration Possibilities and Claims for Lost Wages
With respect to tort claiming around the world, one frequent comment is that claiming will not increase very much because persons from developing nations may well have very limited claims for lost wages. That may be true in some cases, but the plaintiff's bar of course seeks ways to move by that barrier. One way to do that is to focus on the prospect that the claimant might have been able to or perhaps planned to immigrate to a more developed country and would have been gainfully employed in the new country. Reposted below is a Mondaq article on that topic from the Kennedys law firm. The article provides a useful example of the arguments being advanced to support and oppose claims of that sort.
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United Kingdom: Kennedys' Settlement Of Claim Involving A Polish Citizen Highlights Tactics For Defending Claims By Migrant Workers For Loss Of The Chance Of A UK Earnings Model
28 July 2009Article by Mark Burton, Partner
Kennedys has recently settled a claim by a Polish citizen for a fraction of the amount claimed by raising arguments in relation to the assessment of loss of a chance and making use of our network of international offices to gather relevant evidence.
In 2004, the Claimant in this case was studying for a business degree in Poland. She was the victim of a very unpleasant assault by an employee of a bus company whilst on holiday in London. Kennedys was instructed by the bus company.
Liability was not in dispute but significant issues arose in relation to quantum. In particular, the Claimant alleged that from the summer of 2005 she would have come to England and found employment at the average UK graduate starting salary and remained in employment here, receiving regular salary increases
Loss Of A Chance
Kennedys argued that the career model put forward heaped speculation upon speculation to the point where the Claimant failed to satisfy the threshold test of a "real or substantial chance" as required by law on loss of a chance. The numerous imponderables thrown up by the facts of the case included:
The fact that she might have decided to stay in Poland with her family.
She might have come over to the UK, not liked it or failed to find suitable work and returned home.
She might have worked in the UK for a while, then lost her job due to the recession or started a family and opted not to go back to work.
Following the approach adopted by the Court of Appeal in Langford v Hebran [2001] Kennedys advanced a model comprising 5 career options in descending order of likelihood. We proposed that the most likely option was that the Claimant would have worked as an estate agent in Poland, in line with her pre-accident work experience. We then assigned percentages to the chances of her obtaining additional income from better paid careers in both countries. Only a 10% chance was applied to the likelihood of her spending the whole of her working career in the UK.
Importantly, we argued that the Poles who did prosper by coming to the UK were those with a trade to fill a vacuum in the British market during the boom years, especially in the construction sector between 2004 and 2007. We did not accept there was a co-existing vacuum in the graduate sector or that Polish qualifications would necessarily be sufficiently competitive in the UK graduate market.
Kennedys' London office worked on this case with our associated Warsaw office, which assisted with assessing the likely levels of income the Claimant might have attained in Poland and the significantly lower Polish rates for residual care and therapy.
Comment
The latest Government statistics show that over half a million people arrived to live in the UK in 2007. The highest inflow of any individual citizenship was from Poland, with an estimated 96,000 Polish citizens migrating into the UK that year. In this context it is not surprising that defendants and their insurers are seeing increasing numbers of claims involving migrant workers.
Invariably many of these claimants will seek to maximise their claims by alleging that their careers would have progressed in the UK. As the above case shows, it is important that defendants adopt a strong and careful approach to these claims. They should break down the possible career options and consider the realistic prospects of the claimant achieving these. If the claimant has returned home, evidence may be needed as to local rates for any residual claims. The financial difference between the two countries can often be quite striking. By these means, settlements at much more reasonable levels will be achieved
