Laurie Brown
From Cyberlaw
March 13, my dad's birthday. Today, while reading about adverse device reporting to the FDA in preparation for class, I was reminded of a case my dad recently defended. His client, a doctor, had used a certain type of suture during a surgery on a 50-something year old woman's aorta. After the surgery, the suture broke, and the woman hemorrhaged and died. The doctor was sued, as well as the suture company, but the suture company got out because the hospital had not kept the remains of the suture (which it claimed split). The defense was that the doctor properly used a defective suture. The jury found that there was no cause for a medical malpractice suit. My father visited the suture company's facilities, investigated and found that the company had previously settled several cases (where hospitals had kept sutures, I assume). I asked him if he'd considered taking on a class-action against the company (certainly not his usual line of work). He laughed, and said no, the current suture was the best technology today has to offer patients, that we'd rather have it than no suture at all.
Should companies that know their devices have potential defects (or the FDA) be required to instruct doctors to advise their patients of those risks when the doctor is outlining the patient's options before surgery, etc? Or are some risks so improbable that it's better, therapeutically, for the patient not to know?
Also, how should FDA reporting and legal settlements be utilized in medical malpractice suits against doctors? Should the bulk of the investigatory work be left to defense attorneys, or is there a better way to proliferate information that might exonerate doctors?
March 6, 2006: Negotiating Points
Representatives of Harvard II and Biotech II met to negotiate a licensing agreement on Thursday evening. While we could not agree on a full contract, we resolved some points between us, which are posted on Lauren Robinson’s journal page.
Some questions I have coming out of the negotiation about biotech and negotiating (never having taken the Negotiation Workshop at HLS):
1. How much does one have to disclose? We learned about disclosure of material facts in Contracts. Beyond that, however, what is a lawyer ethically obligated to tell or not to tell the other party? Should her loyalties to her client prevent her from telling some things? For example, if we, Biotech II, propose a term to Harvard II, do we have to spell out the future implications that term might have for the University?
2. We, Biotech II, wanted a clause that if we breached, Harvard II would look to the pharma partner we had chosen to make good on our contract. Our Biotech II materials also suggested that Pharma would primarily be used to fund and commercialize the product. These two elements led us to the following structural questions: In the course of ordinary business (before breach), would Pharma be doing any research, or just Biotech? What type of research capacity would the Pharma have? Is there a research component in “commercializing”? Perhaps commercializing includes making our super protein accessible to consumers (for example, creating a product deliverable to the body in a small but potent size). Would Pharma’s research capacity be expanded if we breached, or would Pharma find a new biotech company?
3. How hard does one bargain with future partners?
4. We were unable to come to an agreement about the supervision of continued research by Dr. Onc. In class, we had already discussed the biased outcomes that corporate supervision of academic research might create. Representing Biotech, it was interesting to try to see the other side. Why would we want to approve studies? Our materials said that we didn’t want any materials wasted or studies that would derail the project. To the extent that we funded the research, the concern about wasted materials is logical enough, but Harvard II then argued that Univeristy-funded research should go unsupervised by Biotech II. That left us wondering whether it is legitimate that a company investing so much of its limited funds into a research project have some means of risk-control. Would it be in our interests to see negative results, and up to what point in the project? What if they were kept confidential? Is there a way we could limit risk without violating academic and scientific integrity? Is there some legal structure for borrowing funds or limiting damages that could be used instead?
From Last Week, Feb 27, Scientific v. Judicial Searches for Truth (originally under class notes and discussion for week 3)
In class, Professor Krimsky warned that with tort reform, “you’re going to lose a lot of knowledge that we get through litigation,” such as the information brought to light by the tobacco litigation. In his article The Funding Effect in Science, he elaborates, explaining that “through the tobacco litigation and the discovery process, internal documents of cigarette manufacturers became public and revealed a systematic campaign to construct a science around tobacco safety, while attempting to dismiss as 'junk science' findings that connect tobacco use to excess morbidity and mortality”(55). He states further that the research funded by the tobacco industry “was designed as advocacy science” (56). It is striking that the very problem Krimsky frames – that science is losing its objective methodology for truth-seeking and replacing it with the biased, advocacy method of the judicial system – is exposed by the advocacy method of the courts.
What is it about scientific peer testing (“objective skepticism”) that differentiates it from a defense counsel’s testing of the prosecution or plaintiff’s version of the truth?
One might argue that judicial and scientific methods are not so different. As the literary and social theorists Krimsky mentions observed, scientists, even working out of their own pockets, are always biased in favor of finding positive results for their hypotheses by the possibility of reputational and financial success, as well as by normative assumptions that blind them to possible weakness in their hypotheses. These biases will lead them to become “advocates” for their projects, both in the research and presentation stages.
One might instead argue that traditional scientific and advocacy methods are in fact different because they serve different goals. Objective accuracy is favored by science because our physical world would fall apart if scientists and technicians ignored fundamental principles, like the laws of gravity. On the other hand, as Professor Nesson proposed to his Evidence class last term, the judicial system favors community acceptance and the finality of its verdicts. These goals are best served if a coherent narrative can be told about the disputed factual event, even in cases where numeric probabilities do not favor the likelihood of the ‘truth’ of that story. While the finality and acceptability of verdicts is important for social peace and the predictability of law, objective science states its results more tentatively in a way that they may be “debated in the open literature” (53).
What is it about science that feeds our impulse to test it again and again? What is it about social conflicts that leads us to bury them in the finality of verdicts? Is it only the utilitarian goals just mentioned? Are scientific truths harder and social interests more malleable? How, then, did the social system bring to light the failings of the scientific community in the case of tobacco? Krimsky writes that the financial interest of a scientist does not become part of the public debate, which may answer the tobacco question in part. His article further suggests that unequal funding of various viewpoints in our increasingly advocacy-science oriented system produces biased results. The same can be said of the court system, where money can buy a better lawyer and therefore a better case. If it appears that the trend in science is toward advocacy science, should the government fund otherwise under-researched areas and alternative hypotheses the way it funds our advocacy-legal system by supplying defense attorneys to poor people? Or is it possible to regulate science funding to keep results more objective? -Laurie Brown
