GlobalTort : Commentary from lawyers and experts on mass torts, law, insurance and science

Here's some information that has implications for the roles of futures representatives for class action. The subject in general is multigeneration effects of carcinogens. The context in this instance is tobacco. This summary from ScienceDaily brings word that another study confirms that second hand tobacco smoke exposure for a pregant woman causes genetic mutations in the fetus.  So, more phyical harm caused by tobacco, and it effects more than one generation.

The key paragragh states:

"In the current study, Dr. Grant confirmed smoke-induced mutation in another gene called glycophorin A, or GPA, that is representative of oncogenes -- genes that transform normal cells into cancer cells and cause solid tumors. The GPA mutation was the same level and type in newborns of mothers who were active smokers and of non-smoking mothers exposed to tobacco smoke. Likewise, the mutations were discernable in newborns of women who had stopped smoking during their pregnancies, but who did not actively avoid secondhand smoke."

• Email This
• Print
• Comments
• Trackbacks
• Share Link

 4% of Americans are cancer survivors. That’s well over 10 million people. The numbers are the net result of an annual US toll of 1.5 million new cancer diagnoses, and 550,000 deaths.

America’s over 10 million cancer survivors move forward with their lives with increasingly specialized legal needs. I'm proud to say that my law firm's experience in enforcing legal rights insurers is now being applied as part of a group of volunteer lawyers willing to assist survivors pro bono in asserting their legal rights to care. To that end, my firm, Childress Duffy Goldblatt. also  is the presenting sponsor for a Friday June 18, 2010 Cancer Rights Conference at Loyola Law School in Chicago.

The conference agenda and registration packet is here. A similar seminar will be held on Friday October 8, 2010 at the Ronal;d Reagan UCLA Medical Center in Los Angeles; the conference registration form is online here.

The 2010 Cancer Rights Conferences are results of the great work of the Cancer Legal Resource Center (CLRC), a joint program of the Disability Rights Legal Center and Loyola Law School Los Angeles. The CLRC  is a national, nonprofit organization that provides information and resources on cancer-related legal issues to people coping with cancer. The CLRC is the only national effort aimed at specifically asserting the legal rights for persons with all types of cancer. There also are growing efforts by groups associated with particular forms of cancer. A growing American Bar Association group is focused on asserting the rights of breast cancer patients. 

Sadly, the needs for legal advocacy are increasing for cancer patients. More advocacy is needed in part because of the improper claims handling practices habits of some national insurers. Advocacy needs also are increasing because rates of cancer are still climbing for some types of cancers, including continuing increases in some cancer rates for children. Data from the National Cancer Institute shows: “Cancer is the leading cause of death by disease among U.S. children between infancy and age 15. Approximately 10,730 new cases of pediatric cancer are expected to be diagnosed in children 0–14 years of age in 2009.”

According to detailed 2010 data from the American Cancer Society, the overall odds of facing a cancer diagnosis during are a lifetime are about 1 in 2 for men, and 1 in 3 for women.  This YouTube presentation from the ACS provides all the depressing data, including that 25% of annual US deaths are from cancer.

The CLRC’s Director is a tireless and wonderful person, Joanna Fawzy Morales. Mrs. Morales is also an Adjunct Professor of Law at Loyola Law School, teaching a seminar in Cancer Rights Law.

The CLRC’s mission and accomplishments are as follows, as taken from its website:

The CLRC has a national, toll-free Telephone Assistance Line (866-THE-CLRC) where callers can receive free and confidential information about relevant laws and resources for their particular situation. Members of the CLRC's Professional Panel of attorneys, insurance agents, and accountants can provide more in-depth information and counsel to CLRC callers.

In July of 2009, the CLRC received its 30,000th call to its Telephone Assistance Line (866-THE-CLRC). Since its founding in 1997, the CLRC remains unique, providing invaluable cancer-related legal information and resources to people nationwide. The success of the Center's work is reflected in the enormous need for the information they provide. Throughout its 12-year history, the CLRC has served over 155,000 people through the Telephone Assistance Line, conferences, seminars, workshops, outreach programs, and other community activities.

CLRC staff members also speak at seminars and outreach events in the cancer community, across the nation, including trainings for health care professionals. If you would like CLRC staff to attend your next event, please complete our Event Request & Material Order Form or call us at (213) 252-8449 or (866) 843-2572.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

From the January 26, 2010  NCI Cancer Bulletin is a story that provides the latest example of the dawning age of new science brought about by committed doctors, brilliant scientists, your donations, high speed computers and software, and the  desire  to save lives.

Recall that the Humane Genome project was announced in 1990 and completed in 2003. Now, less than seven years lateer, genomes are sequences in days.

Note that the results all will be made public at no expense.

This project illustrates why patents should not be allowed for gene sequences, a battle the ACLU and others are fighting right now.

_____________________________________________________________________________


St. Jude, Washington University Launch Genome Project for Childhood Cancers


Researchers at St. Jude Children's Research Hospital and the Washington University School of Medicine in St. Louis have launched the Pediatric Cancer Genome Project 1 to sequence the genomes of at least 600 children with cancer over the next 3 years. The collaboration marks the first time that whole-genome sequencing will be used on a large scale to discover genetic changes driving pediatric cancers.

"This is the largest and most powerful single initiative in the 50-year history of St. Jude," the research hospital's director, Dr. William E. Evans, said at a press briefing announcing the project yesterday. "DNA is being sequenced as we speak," he added.

St. Jude has a repository of biological samples and clinical information from children who have been treated there since the 1970s. The collection represents a treasure trove of information about cancer, and it can now be scrutinized using the latest genomic technologies at a cost that continues to decline substantially over time.

"This is a new era for pediatric cancers," NIH Director Dr. Francis Collins said at the briefing. "The study represents an opportunity to discover all the ways that a good cell in an innocent child goes wrong."


The project--estimated to cost $65 million and funded by St. Jude--aims to discover the genetic origins of pediatric cancers while creating knowledge that can be used to improve the care of young people with these rare diseases. Early results could reveal new uses for available drugs, and, over the long term, lead to targeted agents for these cancers, the researchers said.

New genetic signatures for classifying and treating patients are also anticipated. Knowing that a child has a subtype with a poor prognosis would allow physicians to select aggressive treatments early in the course of the disease. Similarly, doctors could safely withhold treatments from a patient who has a better prognosis, based on a genetic profile.

"These two great NCI-designated comprehensive cancer centers are demonstrating yet again their commitment to making a difference for kids with cancer," said NCI Director Dr. John Niederhuber.

Dr. Larry J. Shapiro, dean of the Washington University School of Medicine and a pediatric geneticist, said at the briefing: "This project will provide a detailed and complete picture of the mutations in the cancer cells."

In 2008, researchers at Washington University and their colleagues published 2 the first genome sequence of a person with cancer--a woman with leukemia. They have since published 3 the genome of a second person with leukemia, and they have also sequenced dozens of additional cancer genomes using the same whole-genome approach.

The new effort will focus on leukemias, brain tumors, and sarcomas (tumors of bone, muscle, and other connective tissues). To identify genetic changes associated with cancer, the researchers will sequence DNA from both the tumor cells and normal cells of each patient.

The project complements in every way the efforts of The Cancer Genome Atlas 4 (TCGA) Research Network, which focuses on adult cancers, noted Dr. Collins. Just last week, TCGA investigators identified new subtypes 5 of brain cancer using genomic and clinical data--an example of the kind of knowledge Dr. Collins expects to come from the pediatric project.

Another genome effort in pediatric cancer is the NCI-supported childhood cancer TARGET 6 initiative, which includes St. Jude investigators as well as other childhood cancer researchers. The initial discoveries from this project are being translated to the clinic through an early stage clinical trial that is in development for a newly described 7 type of acute lymphoblastic leukemia.

What distinguishes the new project from past efforts, said Dr. Richard Wilson, director of the Genome Center at Washington University, is that this one will be "all whole-genomes all the time." Most genome studies have been limited to sets of genes or genetic markers because of the costs of sequencing DNA. Those costs have now fallen to below $100,000 for a tumor-normal combination, and the sequencing can be done in about a week, Dr. Wilson said. (See "A Conversation with Dr. Elaine Mardis 8" in this issue.)

"There is a sense of urgency to make progress here, and it has now become affordable," said Dr. Evans. "We see this effort as a marathon, and the first 3 years are really just the beginning. I am certain there will be lots of unanswered questions at the end of this period, and there will be much more work to be done."

He acknowledged the enormous challenge of managing and making sense of as much as 100 trillion pieces of data (600 cases, 2 genomes per case, and each genome will be sequenced 30 times to ensure that nothing is missed). To meet this challenge, Washington University is adding new instruments and computational power, and the researchers are confident that they are ready.

"The data storage, management, and analysis problems are substantial," Dr. Wilson said in an interview. "But this project is coming along at just the right time in terms of our technical capabilities. We've really come a long way in just the last 6 months in terms of our data production technology."

St. Jude has, in effect, been preparing for this project for 45 years by creating the tissue repository and developing a capacity for preclinical research studies. The infrastructure and resources required for follow-up studies of the genomic data, such as mouse models, already exist at St. Jude, noted Dr. Elaine Mardis, co-director of the Genome Center at Washington University. "The genome project will fill these pipelines with new information to be analyzed."

In the future, the project will include other types of alterations in cancer, such as those involving RNA and epigenetic changes, which alter the activity of genes without causing a change in DNA sequence, the researchers said.

They stressed that the results will be made publicly available through a Web site once the information has been validated. The hope is that other investigators will bring their own expertise and perspectives to the data and help move the science forward.

"We view this as creating a resource not just for our efforts but for the world," said Dr. Evans. He quoted the founder of St. Jude, the entertainer Danny Thomas, who liked to say, "To cure one child in Memphis is to cure a thousand worldwide."

"It is always a good thing if our discoveries can be amplified and leveraged elsewhere," Dr. Evans added, "and that's what has to happen." (emphasis added)


--Edward R. Winstead

• Email This
• Print
• Comments
• Trackbacks
• Share Link

90,000 people per year travel to Houston's MD Anderson Cancer Center for treatment. Many are children. Most will not find a cure. Some will obtain more time. Almost all will suffer to achieve those additional years or months. Some will be in agonizing treatments for many months or even years. Forty years after President Nixon acknowledged the need for the so-called war on cancer, the therapies are still barbaric. Indeed, too many treatments are still so barbaric that more people than you would know will some day die from the treatments instead of the original cancer.

The staggering 90,000 number and other harsh realities are part of Gina Kolata's latest NYT article on why changes are needed in the race to prevent, manage and cure cancers. Her latest story focuses on MD Anderson to starkly highlight part of why our nation needs health care reform in general, and why our nation needs to exponentially accelerate and improve the manner in which individuals are treated for the myriad forms of cancers. Here is the image of yesterday's powerful front page picture and story. Here is the story itself.




Much more can and should be done, now. Happily, there is some expanded support triggered by the Obama Administration's support for science as detailed here. For example, the NIH and NCI are accelerating great new programs, including the Cancer Genome Atlas with wide-spread "cloud" access to the incredible amounts of new genomic information. But, much more can and should be done. Myriad cancers are starting to surrender their secrets to the brilliant doctors, new machines, and staggeringly fast computers and software that are sequencing genes and visualizing molecules at an unprecedented pace and in ways never before accomplished. Please, stay focused on the debates over health care and demand that our nation act to devote far more resources to saving more of our nation's 500,000 annual US victims and to prevent future cancers.

Can more be done in an effective way. Absolutely !

Who says so? For one, Dr. James Watson (of the Nobel prize team regarding DNA) in this powerful 2009 NYT editorial article. In just a few paragraphs, he outlines where we've been, where we are now, and why now is the time to accelerate and move forward in new ways.

For another, this 2008 book by Dr. Guy Faguet, an experienced doctor/scientist, has much to say on the subject of what's ahead and what needs to change on cancer research and treatment. http://www.amazon.com/War-Cancer-anatomy-failure-blueprint/dp/1402036183.

Dr. Faguet makes three main points. First, the "cell kill" approach to cancer is in large measure a failure. He also explains how and why the cell kill clinical trial is so slow and so tied to outmoded reimbursement systems and short-term profit models. Second, cancer prevention deserves far more effort and attention. For example, many oncogenic chromosome changes are caused by retroviruses, and so preventive vaccines are key to prevention and warrant far more effort and money. Some remarkable reductions in cancer appear to been achieved in some nations through vaccinations to eliminate one hepatitis virus. Third, the fast arriving future is finding cancer early and applying human and workable genomic therapy instead of trying to kill cancer cells after they are widespread.

Can this be done, politically speaking ? Yes. For that subject, see Dr. Harold Varmus' book - The Art and Politics of Science.

Dr. Varmus credentials ? Nobel Prize winner as part of a team of cancer researchers, head of the NIH for the Clinton Administration, and now the leader of Memorial Sloan Kettering. http://www.amazon.com/Art-Politics-Science-Harold-Varmus/dp/0393061280/ref=sr_1_1?ie=UTF8&s=books&qid=1256563341&sr=1-1

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Ms. Gina Kolata is back with another important but depressing New York Times article on the failure of our national policy for addressing cancer. Her series started with a late April article. I mentioned it here in a post that provided links to sources showing that more people die in the US every two days due to cancer than died on 9/11/01, and that a careful, extended study showed that the direct costs of cancer treatment are exceed by indirect costs of cancer at a ration of about 2.3 to 1 by the indirect costs.

The gist of her new article is to demonstrate that our nation fails to fund research on new ideas and instead strongly tends to fund new research in old areas. Doing so of course has its advantages in that little risk is taken, but the article also explains that taking risks and following new ideas is often how we make real progress. Indeed, just think of where we might be if Dr. Salk had been stuck thinking in conventional ways. Ironically, the later online version of the Sunday NYT includes a new article reporting on success in battling cancer in animals through some unusual techniques developed in Australia that take advantage of leaks in tumor blood vessels to deliver minicells that mark the area for treatment.

For a dramatic, detailed and easy to read example of why new thinking is a MUST for cancer, read Dr. Folkman's War. http://www.amazon.com/Dr-Folkmans-War-Angiogenesis-Struggle/dp/0375502440
The book tells the story of how a stint doing pathology and seeing tiny tumors throughout bodies ultimately caused Dr. Judah Folkman to reach the profound insight that all solid tumors need blood vessels to grow, and that something in the body must turn on and off the ability to generate blood vessels. As the book details, Dr. Folkman and his ideas were rejected and indeed even ridiculed. But after many years , his unorthodox theories ere proven correct. Research continues today into how to delay or stop tumor growth using some of the principles he developed, and some promising results have been obtained.

In short, there is much to be done to create a strong national or global strategy for solving or managing the myriad types of cancer. Indeed, I've come to the view that all the walkathons and charities are in a way counterproductive. Why? Because they implicitly send the message that cancer has to be solved through relatively modest hard-earned donations instead of through a massive national and international funding of efforts to find cures for cancers.

Finding ways to cure or manage cancer should be a priority of our government for both objective and subjective reasons. On the objective side, the direct and indirect costs of cancer are huge as detailed by the study mentioned above, and our economy needs the short term and long term jobs that new science may create (which would blue collar jobs as well because fermenting yeast to grow medicines is much like brewing beer, except even cleaner). For subjective reasons to find answers for cancer, consider that every two days, over 4,000 people will die from cancer. Our government, however, has not spent hundreds of billions of dollars a year to avenge the thousands of the thousands of "homeland" cancer deaths that occur every day.


For data for cancer for 2009, see:
http://www.cancer.org/docroot/STT/STT_0.asp

• Email This
• Print
• Comments
• Trackbacks
• Share Link

In a win for defendants in general and some asbestos defendants in particular, the U.S. Supreme Court issued a June 1, 2009 per curiam opinion holding that when FELA claimants pursue "fear of cancer" claims, the defendant is entitled to an instruction that the jury must find evidence that the fear is "genuine and serious." The opinion is titled CSX Transp., Inc. v. Hensley, 556 U.S. _______ (2009). The slip opinion is here. The issue arose because a plaintiff said to have suffered other severe diseases also claimed damages for alleged fear of cancer due to having been diagnosed as having asbestosis.


The win is significant for railroads and others because FELA applies nationally since it is a federal statute. Click here for a Wikipedia article on the history of FELA.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Science moves much faster than does "the law," and the changes in science over time will have a profound impact on the framing and resolution of legal issues.

For a new example, consider that respected medical journals Nature and Nature Genetics this month published articles from three research teams asserting identification of one or more genes they say are materially related to an increased risk of contracting non- small cell lung cancer, which comprises about 80% of lung cancers. Having one copy of the gene is said to be a characteristic of about 50% for persons of European descent, and far lower among persons from Asia and Africa. According to the authors, inheriting one copy of the gene raises the risk by about 28%, and inheriting two copies of the gene raises the risk by 70-80%. Some of the authors suggest the gene may be tied to the tendency to smoke. The press articles indicate that the research teams made the usual prediction that tests for the two genes will be available in the future.

The implications for law in general are profound when one considers all of the societal and legal issues related to health itself, and the obligations of insurers, governments or individuals for the expenses of treating (or, some day, preventing) a non small cell tumor in the lung. Those many issues are far beyond the scope of this blog. Here, the focus will remain on the potential tort litigation issues that may flow from these studies, and the other studies that surely will follow.

For example, many asbestos claimants with "lung cancer" attibute the disease in whole or in part to inhalation of asbestos fibers and/or cigarette smoking. In such cases, what difference should it or does it make if the claimant has one or more copies of the identified genes, and has the non small cell tumor? Defendants may ask for genetic testing and if they find the presence of one or two copies of the gene said to be relevant, they may argue that their presence breaks the legal causation chain and so precludes liability. Defense counsel also may invoke Daubert principles and seek to bar expert testimony from plaintiff's experts if the testimony is not focused in persons with two copies of the gene - will that tactic be allowed to work ? How soon?

Plaintiffs' counsel, on the other hand, may be expected to argue that the "two copies" claimant is just like the "eggshell skull" plaintiff we all heard about in law school. We were taught that the general rule is that a liable defendant cannot avoid financial responsibility simply because a particular person had an especially thin skull. Will that rule continue in force in the age of genomic testing? Should it stay in force as is, or does it need modification?

Plaintiffs also may use the presence of two copies of the gene to try to meet legal standards they cannot meet today for some claimants advancing fear of cancer claims or other claims. For example, some state law opinions (e.g Havner in Texas) will for the most part refuse to permit a claim unless the plaintiff proves that there is a relative risk of a specific disease created by "exposure" to a substance that is at or exceeds 2.0. Will science over time allow plaintiffs' lawyers to meet the 2.0 standard for claimants with the "two copies" even if the 2.0 standard could not be met for a person without the two copies of the "lung cancer" gene?

These and many other issues are arriving fast. For press articles with more details on the lung cancer studies, see:

http://news.bbc.co.uk/2/hi/health/7325971.stm; http://www.latimes.com/features/health/medicine/la-sci-lung3apr03,1,483181.story

• Email This
• Print
• Comments
• Trackbacks
• Share Link