Creative Use of Scientific Tools in Litigation
Lawrence Molton is an SLS alum who has developed an interdisciplinary approach and ended up on an unusual career track. This guide to the creative use of scientific tools in litigation reflects the training provided to him by his early career and interest in health policy.
Twenty years ago, I was working for a prominent San Francisco trial attorney, representing a global company that was one of the few manufacturers of anesthesia machines.
Our client was the lead defendant in a products liability/medical malpractice action for the devastating injuries suffered by two small children during surgery. The injuries were caused by a lack of oxygen to the brain.
Anesthesia is a classic “black box” problem. Its precise mechanism is not understood. All physicians can do is administer a gas (e.g. sevoflurane) that maintains unconsciousness and observe vital signs and measurements at regular intervals, which are carefully charted.
There was nothing in the contemporaneous charting of the patient’s condition that indicated when or why the disastrous consequences occurred.
I discovered that a Harvard Medical School Professor had just developed a computerized teaching tool that simulated anesthesia, and purchased a copy.
I then recruited an unusual expert witness, a trauma surgeon who was also a Ph.D. in a quantitative discipline, and enlisted him to run simulations using the new software. By using the recorded concentrations of the various agents administered, and the time record of the clinical parameters, we were able to argue that the hypoxia was not due to machine malfunction.
This was never used at trial, but was used in mediation to help persuade the opposing side and the judge of the strength of our case, and helped us reach an acceptable settlement.
A Primer of Malpractice Law for the Neuroanesthesiologist
After the work for this client was concluded, I was asked by a Stanford Medical School Professor to contribute a chapter to his book on neuroanesthesia. It was called A Primer of Malpractice Law for the Neuroanesthesiologist, and was published in 1996. It focused on the possible effects of improved data gathering and recording on potential lawsuits.
This is not a topic I’ve gone very far with, but am still intrigued by.
In 1996, a friend asked me to join a small team of medical people in developing a startup that would use the then-new Internet to revolutionize telemedicine. After several months, the company never succeeded, but the leaders did go on to work in the field.
This sparked my interest in using the combination of medical informatics and new forms of communication to enable individual patients to gain access to far superior health care. There are of course significant legal issues that can make this difficult, including privacy and scope of liability.
Molecular Biology of Cancer
I was the “science attorney” on a team representing a global insurer in a series of insurance coverage suits. At issue was who would bear the financial responsibility for the payments made to tens of thousands of plaintiffs with asbestos-related cancers. Hundreds of millions of dollars were at stake, and the outcome depended on a determination of when the “disease” had occurred, which would control the application of the insurance policies. That is a trivial question when dealing with a patient who was in an accident, or who noticed symptoms of an acute illness and is quickly diagnosed. But for insurance law and cancer, it was a morass.
At that time, over 20 years ago, molecular biology had just come of age. The first multistage models of carcinogenesis had appeared, and it was understood that a cancer cell was the product of a series of heritable mutations, numbering from a few to perhaps a dozen. Each mutation is an independent event that can be caused by exposure to a carcinogen. The combination of genetic factors and environmental ones, and how they contribute to the carcinogenic process, is extremely complex.
Cancer cells appear in all persons with frequency. In certain cases, that first cell eventually leads to a mass of cells of clinical significance. But in the overwhelming majority of instances, a series of natural defense mechanisms eliminates most cancer cells long before that happens. If it did not, human lifespan would be very short. Again, the factors affecting this process are most complex.
The process from initial “insult”, where a cell is first permanently damaged by a carcinogen, to the ultimate diagnosis of cancer may take 50 years. The shortest known interval is perhaps 10 years, which has been observed in cases of radiation exposure.
In order for the veteran attorneys to argue to a court that “disease” in the legal sense occurred at a particular time, it would be necessary for the court to understand what actually happened in the body before cancer was diagnosed – something completely unnecessary when arguing about an auto accident.
I recruited a team of experts at a leading think tank and at a medical school, and over nearly two years, developed a method for explaining molecular biology and carcinogenesis to a jury. The most challenging part was that conventional wisdom states a jury should be seen as an eighth grade class – if the material is more advanced than that, some jurors will not follow the testimony.
The tools we developed included color charts done with then-current technology that used creative analogies to explain tumor suppressor genes, oncogenes, point mutations, and other basic concepts of molecular biology. We went on to use them in two major trials, one in San Francisco and one in White Plains NY.
I also had the mission of cross-examining one of the nation’s leading cancer researchers before a federal court jury.
After spending two years working on this analysis of the causation of cancer, one of the experts I worked with, a medical school Professor, was kind enough to ask me to present a paper at the annual meeting of the American Chemical Society in 1993. That was unusual for non-scientists. This was my topic.
One of the central issues in tort litigation involving cancer is the distinction between population-based and individual-based causation. Attorneys often speak of general v. specific causation when discussing this.
Epidemiology is a population-based discipline, going back to 19th Century studies in England. Proving a hypothesis in epidemiology does not require showing how or why an agent is causing disease; in fact, many crucial relationships between agent and disease were discovered long before the relevant biological mechanism was understood.
In the most famous example, epidemiology conclusively established in the early 1950s that cigarette smoking is the principal cause of lung cancer. This was done before the biochemists discovered the discovery of the double helix structure of DNA, let alone identified the mutations caused by various carcinogens in the smoke.
Public health measures, and government regulation of carcinogens, are always based on population data. But the tort system requires individual level analysis, sufficient to prove that an injured person’s cancer was caused (as law defines that) by exposure to an agent for which defendant was responsible.
Clinical medicine is of no help, because the behavior of a tumor will be precisely the same no matter what agents originally caused the tumor to develop.
There are only a handful of rare cancers, such as mesothelioma, and angiosarcoma of the liver, whose appearance is overwhelmingly associated with exposure to a single agent. That is what makes the mesothelioma litigation unique. It has been going on for nearly 40 years and shows no signs of abating. Most plaintiffs with mesothelioma have no trouble proving that their specific cancer was caused by asbestos, because the other known cause, large dose radiation, is very rare.
When I gave this paper about 20 years ago, I believed that the rapid pace of knowledge in our understanding of cancer would lead to the discovery of precise molecular “footprints” in tumors. More precisely, given that we already had the ability to sequence the DNA of any given cell, we would one day be able to detect patterns of mutations in the DNA of Mr. X’s lung cancer that were specific to individual carcinogens. For example, if Mr. X’s lung cell had deletions of a known tumor suppressor gene, and it was now clear that chromium VI caused that deletion, while benz(a)pyrene did not, it would be possible to prove that it was the chromium in the water and not the teenage smoking that caused the cancer. This would revolutionize injury litigation.
But we are not there yet. Most common cancers, in contrast to mesothelioma, have multiple environmental causes (or none that have yet been found), and it is not possible for science, and thus a court, to determine that plaintiff X’s cancer had a specific cause.
LAWRENCE ("Larry") MOLTON – An Interdisciplinary Biography
While in the JD program at Stanford, I took two outside courses in lieu of the usual electives during my last two years of law school. In the last term of third year, I took Health Policy at Stanford Business School.
(Insider note: at that time, the Law School considered itself much more elite than the rest of the school. My class had 145 members, while the Business School classes were 300-350, I think. For those not in a joint JD-MBA program, but who wanted to take only a single course, the Law School did not allow students from B-school to take law classes for credit, unless they had been admitted to the law school. But law students could earn credit for courses at any other graduate school.)
Health Policy was taught by Alain Enthoven, one of the giants of the health policy field. He is still an emeritus today. This was shortly after the explosion of HMOs and the first steps to move away from the straight fee for service model in health care. Our class project required a small team of students to design an employee health benefits program for a major company.
Because of that course, I was asked to participate in a series of interdisciplinary seminars run by the health policy scholars at Stanford. Perhaps 50 people showed up every month to hear presentations from the most renowned experts from many disciplines, including Daniel Kahnemann and Amos Tversky, Victor Fuchs, and many others.
I was also appointed to serve for a year on the Santa Clara County Health Systems Agency taskforce, which was good experience in understanding the larger health planning world.
My participation in the health seminars led to my first job in 1978. I became a Research Associate at the Stanford Medical School, in the Division of Health Policy, which had just received a large federal grant to study the effects of medical innovations in the broadest sense.
The co-investigators were a senior Professor who was an anesthesiologist and a junior Professor who was a sociologist. They assembled an interdisciplinary study group that included a professor of medicine, a professor of history, and a mix of students at various levels. I was the in-house attorney (I actually passed the CA bar a couple of months after starting the work).
This project lasted for two years, and I now realize it functioned like a graduate school fellowship in medicine and society. The case studies we examined were recombinant DNA, the drug DES, the artificial heart, and the swine flu vaccine program of 1976. There were presentations from many perspectives on the political, social, and scientific dilemmas created by new breakthroughs. We tried to incorporate everything from the philosophy of John Rawls to bioethics to the economics of drugs and cancer in the research, which eventually led to a book.
The training in reading everything from books to medical journals, in writing for an academic audience, in doing exhaustive legal research in products liability law, and most interestingly, in responding to challenges from other disciplines with different worldviews, was instrumental in giving me the ability to think about complex problems.