TORTS TODAY - course materials
& news for Torts, Business Torts, Product Liability, and Remedies students of George Conk at Fordham Law School
gconk@law.fordham.edu
Alabama schools - long segregated by law - created inferior schools - especially majority Black schools which got particularly low funding. When a court was about to impose equitable funding, Jeff Sessions - then the state's Attorney General - fought back.
A recently developed category of NSAIDs, the world’s highly-demanded class of drugs, was associated with some concerns about their cardiovascular side effects that led to discontinuation of one of the two drugs of this new category. New research findings compare the side effects of Celecoxib, the only remaining drug of this category, with two other commonly prescribed NSAIDs, Ibuprofen and Naproxen.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are a class of drugs that were introduced in the 1960s and are widely used to reduce pain, inflammation, and fever associated with a vast variety of conditions from rheumatoid arthritis and viral or bacterial infections, to common muscular or joint pains and even simple headaches.
The main flaw of NSAIDs is the alteration of protective mechanisms of the stomach mucosal membrane, due to their non-specific action, that leads to gastrointestinal complications. A new strand of this class of drugs including Rofecoxib and Celecoxib, with a specific action – to target pain and inflammation while avoiding the stomach mucosal receptors – was produced a number of years ago. But later, in 2004, Rofecoxib was withdrawn from the market after evidence of its cardiovascular side effects. Celecoxib, however, could remain in the market with permission of Food and Drug Administration (FDA) with the condition of conducting a cardiovascular safety study, after the results of another study showed that its cardiovascular side effects were associated with doses higher than recommended. The results of the Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen (PRECISION) study have been published recently in the New England Journal of Medicine to fulfill the requirement of that condition.
This randomized clinical trial has been conducted at 926 centers in 13 countries on more than 24,000 patients with rheumatoid arthritis or osteoarthritis who were at an increased cardiovascular risk. Although the study has been sponsored by Pfizer, the main producer of Celecoxib, measures were applied to ensure precision of the process and results of the study. For example, an executive committee, the sponsor and the FDA collaborated in designing the study; the statistical analysis was done by an independent centre that was not aware of which drug was given to each group; and the academic writers who wrote the report were not dependent on the company and were free to decide on the content of the article. The participants of the study were randomly assigned to three groups of about 8,000 patients each, who were prescribed an average recommended daily dose of Celecoxib, Naproxen or Ibuprofen. The dose of each drug could be modified based on the symptoms of each patient. The patients took their medications for an average length of about 20 months and were followed-up for an average of about 34 months.
Comparing events of death or hospitalization due to cardiovascular conditions showed that the patients who received Celecoxib were not at any more cardiovascular risk than patients in the Ibuprofen or Naproxen groups. Other cardiovascular symptoms like coronary revascularization, non-fatal stroke or hospitalization for transient ischemic attack (TIA) were also not reported more often in Celecoxib group than in the Naproxen or Ibuprofen groups. The researchers were not surprised by the results showing less frequent gastrointestinal complications in Celecoxib group than in the other two groups, because this drug had been originally designed to have less gastrointestinal side effects. Renal complications of Celecoxib were less common than that of Ibuprofen and Naproxen, as well.
In conclusion, physicians can prescribe Celecoxib to patients with inflammatory diseases, who have sensitive stomachs, with peace of mind.
Theorists like to do a lot with a little. And not just because simple theories seem more elegant: we deepen our understanding when we learn that disparate phenomena are linked together. In physics, for example, the theory of thermodynamics showed us the relationship between mechanics and heat. In economics, the theory of the firm showed us that, across industries that look nothing alike, a simple principle helps explain the organization of economic activity. Of course, there is no guarantee that the disparate phenomena we suspect are linked actually are. Particle physicists continue to search for a Grand Unified Theory, which would integrate gravity with the other fundamental forces. It may be that there is no such theory, or that we are not in a position to discover it, even if there is one. But absent such a theory, our understanding of the way the world works seems incomplete. And our track record of linking disparate physical phenomena (mechanics and heat, electricity and magnetism, space and time) gives us good reason to suppose that there are deeper explanations in the offing.
By Arthur Ripstein. Cambridge, Mass.: Harvard University Press. 2016. Pp. ix, 313. $49.95.
Legal theorists like to do a lot with a little too, but their track record is decidedly less impressive. John Austin, for example, thought that he could capture the nature of law in a simple slogan: law is the command of the sovereign. H.L.A. Hart showed that Austin’s theory was too simple. Among other problems, some laws are not commands, and some legal systems do not have sovereigns, at least in Austin’s sense. But Hart had a simple theory of his own: a legal system is a union of primary and secondary rules. Alas, Hart’s theory was too simple too. It didn’t distinguish law from other systems with primary and secondary rules (chess, for example, or a university’s regulations). And there are reasons to doubt that rules are the fundamental building blocks of law, or that law even has fundamental building blocks at all. Indeed, it is possible that the connections between the things we regard as legal systems are simply historical, such that there is nothing — or at least nothing significant — that all of them share in common. To make this point, Ronald Dworkin invoked Wittgenstein’s image “of a rope composed of many strands no one of which runs for its entire length or across its entire width.” If law is like that, then the search for a common thread that runs through it, wherever and whenever it is found, is doomed to fail.
But doom does not entail gloom: you can learn a lot from reading Austin and Hart, even though you cannot learn what law is. And you can learn a lot from reading Professor Arthur Ripstein’s provocative new book, Private Wrongs, even though his project is just as doomed as theirs. Ripstein’s target is tort law, and he aims at nothing less than a Grand Unified Theory. He wants to explain both the rights that tort law recognizes and the remedies that it offers. But he is not satisfied with piecemeal explanations of this or that right or remedy. Rather, he says that recognizing “the unity of right and remedy is the key to understanding tort law” (p. ix). And one simple idea, he says, accounts for all of tort’s rights and remedies: no one is in charge of anyone else.
I am skeptical about legalization by referendum. I am opposed to criminalization. But is pot safe? It affects heart rate - are there dangers there? It is rule of thumb in toxicology that the dose makes the poison. We don't know- really - what a safe dose it. We know the smoke is harsh. If it were up to me the FDA would regulate it and the CDC would conduct rigorous studies.- gwc
On Nov 8, while Americans elected Donald Trump as their next president, those in California, Maine, Nevada, and Massachusetts quietly voted for a different kind of change: legalisation of the use, sale, and consumption of recreational marijuana for adults over 21 years of age. Meanwhile, voters in North Dakota, Montana, Arkansas, and Florida legalised or reduced restrictions on medical (or prescription) marijuana. An ongoing controversy, marijuana legislation in 30 US states now conflicts with US federal law, in which marijuana is a Schedule I controlled substance with “no currently accepted medical use” and “high potential for abuse”, but brings these states in line with a global trend. For individuals with chronic pain and treatment-induced side-effects—both common in patients with cancer and cancer survivors—legalisation of marijuana use could change the treatment landscape, but evidence-based, rational policies must be a top priority.
Cannabis is legal for medicinal use or is decriminalised in more than 11 European countries, including the Netherlands, Belgium, and Spain. Australia legalised medicinal cannabis on Nov 1, 2016, and Germany and the Canadian federal government will follow in 2017. The US National Institutes of Health lists cannabis and cannabinoids (of which tetrahydrocannabinol [THC] is the most notable) as having potential for treating cancer-related symptoms caused by the disease itself or its treatment, although the evidence for its benefits and harms is conflicting. Randomised controlled trials testing cannabis and cannabinoids for the treatment of chemotherapy-induced nausea and vomiting and cancer-related pain have reported mixed results. Cannabis itself has not been approved for use by the US Food and Drug Administration (FDA). Dronabinol and nabilone, synthetic versions of THC, have been approved by the FDA to treat cancer-related and chemotherapy-induced nausea, but these are not derived from the native plant. This is in part because research on marijuana in the USA is highly restricted: it requires approval from three separate federal agencies and the drug must only be supplied by the National Institute on Drug Abuse. However, for a product rapidly becoming mainstream, clinical trials and basic research are crucial: the requirement for evidence of the benefits and risks of marijuana use will grow as access increases and regulations, including clear guidelines for safe and effective use, must be developed.
As well as improving quality and safety, legalisation could lift barriers to marijuana access and lessen social stigmas around its use. This could certainly benefit patients with cancer using marijuana products as part of their palliative and supportive care. However, there remain several potential pitfalls. The first is due to the peculiarity of the adoption of legalisation on a state-by-state basis rather than as federal law. Patients in legal states will have unrestricted access, while those living across state lines will be disadvantaged. This leaves opportunities for criminals to traffic marijuana to capitalise on unequal access. Consequently, law enforcement in states bordering those with legalised use will be difficult. And, is it possible, or ethical, to distinguish recreational users from patients with cancer who might have legitimate palliative care needs to ensure their access?
Taxes from the regulated sale of marijuana could be enormous; a 2015 report on the economic impact of legalisation in Colorado, USA, since Jan 2014 stated that “legal marijuana activities” generated “$121 million in combined sales and excise tax revenues”. The use of monies from taxes and other regulatory steps must be balanced with the needs of the public for affordable effective therapies. Using economic gains to improve health-care overall would be a worthy goal. Conversely, medicalisation of marijuana might lead to profit-based pricing that takes no account of, or artificially controls, supply and demand. In turn, this could promote black market trade and predatory practices on vulnerable people, two of the main evils legalisation is intended to combat.
One role of the government is to provide the best health care to its citizens. Government should, through judicious regulation, ensure that legal medicinal products are safe, efficacious, and cost-effective; that they are widely accessible; and that any potential profits are used to develop and improve the health system. Crucially, at a time when countries and governments are just starting to control the cancer epidemic caused by tobacco smoking, we must ensure that we do not legalise another inhalable product that could lead to another major public health crisis in 20 years' time. Questions arising over access, regulation, and cost must be handled appropriately to promote improved health and ensure equitable and appropriate access for all.
A Dallas federal judge has slashed a $1.04 billion verdict against Johnson & Johnson nearly in half, a month after a jury punished the company over a hip implant device made by its DePuy Orthopaedics division.
It took the jury less than a day on Dec. 1 to issue the billion dollar award to six plaintiffs after concluding that Johnson & Johnson misled them and their doctors about the safety of the Pinnacle hip implant.
U.S. District Judge Ed Kinkeade on late Tuesday issued final judgments in those six cases that reduced the total award to $540 million — a cut that sliced the plaintiffs' punitive damages awards in half but left compensatory damages untouched.
To justify the reduction, Kinkeade cited the U.S. Supreme Court's 2003 decision in State Farm v. Campbell, which holds that the due process clause usually limits punitive damages to less than ten times the size of compensatory damages.
Mark Lanier of Houston's The Lanier Law Firm said he respects Kinkeade's decision but filed an immediate notice of appeal challenging the decision to the U.S. Court of Appeals for the Fifth Circuit.
"He's a conservative judge but he's a fair judge," Lanier said. "I'm appealing this because $500 million just disappeared in a puff of smoke. I think the judge is being conservative but I don't think that the law is that conservative. We'll just see what happens.''
