Due Diligence: Habit forming medications What responsibility do patients have to make informed decisions? Opioids are known to be habit forming throughout history. Given the context of Purdue's Oxycontin. Let us assume this statement is true: Purdue Pharma still led healthcare providers to believe that the Opioid was a non-habit-forming solution to help patients manage their pain safely. Let us also assume that Oxycontin bottles are labeled: “WARNING: May be Habit Forming” “OxyContin is a mu-agonist with an abuse liability similar to morphine, and is a Schedule II controlled substance.” “Oxycodone products are common targets for both drug abusers and addicts.” “Patients should be advised that OxyContin is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.” “Physicians should be aware that psychological dependence may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true psychological dependence and is characterized by misuse for non-medical purposes.” Did patients have any responsibility to research / read labels and understand the risk associated with opiates?
The question of a patient's legal responsibility would arise under a negligence lawsuit, where the patient &quot;should have known&quot;. The standard for determining what things a person &quot;should have known&quot; is fluid, but obviously you can start with &quot;could have known&quot;. If a patient's can't know a fact, they cannot be said to have negligently contributed to the damage. Doctors are given these warnings, but patients are not, uniformly. It is therefore possible that a patient was never warned of the effects of an opioid prescription (I can personally attest to that lacuna in the system). Your assumption about the bottle being so labeled is only valid for the original supply bottles from which the pharmacist dispenses. However, there is also a rather compelling argument to the effect that no person in the US can in fact be unaware of the addiction risk of opioids. It is a defeasible argument, possibly applicable to a hypothetical person who has lived in complete isolation for decades. A patient is not required to undertake independent research in order to validate the science that underlies statutorily-mandated FDA approval or drugs, instead, the burden is assigned to the manufacturers and distributors (primarily doctors and pharmacists) to convey the relevant information. Thus HR 1026 would, if enacted, mandate a different warning. But the bill does not assert a lack of liability on either side, therefore the question reduces to the &quot;simple&quot; matter of determining if a person knew or should have known.
The most important consideration is whether you're giving advice "as" something special. An example would be claiming to be a medical doctor and advising people to do something clearly harmful such as "take 10 Tylenol and call me next week". In such an extreme case, there could be criminal charges. Less severe would be an accountant giving grossly wrong and incompetent tax advice to a client, in which case the accountant could be civilly liable. (For instance, telling a client "you don't have to declare royalties for textbook sales"). In such cases, a client depends on the professional to give competent advice, and you rely on him to work according to a certain professional standard of care. There is a difference between the standard of care that an ordinary "reasonable person" owes to any other person, and the standard of care owed by a professional in an area. What would be excusable bad advice that I might give on how to build a wall would be inexcusable if given by an engineer. The basic idea is that if you interact with a person (even indirectly, manufacturing something that a 3rd party buys), you have a certain duty to be cautious. If this is just an ordinary-person on ordinary-person interaction, then the parties (both parties) are expected to exhibit the degree of caution that a "reasonable person" would exhibit (attempts to pin down what a "reasonable person" would do have proven impossible, though juries always know subjectively what a reasonable person would do). However, your duty to not give bad advice is offset by the advice-taker's duty to not take bad advice – that is, if a reasonable person would know that taking 10 Tylenol is a bad idea (thus I, as a non-physician might have some duty to not give such stupid advice), then the person who stupidly took 10 Tylenol was contributorily negligent in taking the 10 Tylenol. As far as I can tell, if you do not represent yourself as a member of a technical guild (lawyer, doctor, accountant, many others) giving technical advice in that capacity, and you are not directly contracting with a person (i.e. they hire you to give them advice on how to keep your yard from falling over the cliff), then you can say stuff like "If X, then you should Y", and not have to pay if someone does that Y and they suffer a loss.
In the US, it depends on why you are doing this, and how you go about performing the operation. There are approved devices and procedures, and there is the other stuff. In an emergency that is life-threatening or threatens severe debilitation, it is permitted for a physician to try an extreme measure – if the state has a "Right to Try" law. Otherwise, a review and official approval by the relevant IRB is required. The devices are regulated by the FDA, but the FDA does not regulate the practice of medicine, so the feds don't have a say in whether a procedure is allowed. Nevertheless, use of unapproved devices can be taken to be evidence of failing to meet the required standard of care, in the case of a malpractice suit or punitive action by the state regulatory board. There is no specific law prohibiting removing lots of organs and replacing them with prostheses, though arguable what happened was that the brain was removed (it's not that a replacement shell was built around the person). Ordinarily, intentionally "killing" a person is illegal (except in case of sanctioned execution or self-defense). There is zero case law that would tell us whether removing a brain from a body "kills" the person. Most likely, there would be a prosecution for unlawfully causing a death, and either the legislature would tune up the law w.r.t. the definition of "causing death", or the courts would do so.
It means what it literally says, that safety and effectiveness have not been established in certain contexts. The rationale behind saying this is §201.57 of 21 CFR 201, a regulation that mandates giving warnings. It is permitted to use a device or prescribe a substance where it is not yet proven that it is effective or safe for that usage, but you must not imply that it is perfectly safe and effective in all contexts. This part of the federal regulations dictates language aimed at particular scientific uncertainties. Insofar as a patient is expected to give informed consent for a treatment, informing the patient that a treatment is to some extent unproven is an essential part of the information that must be given for informed consent. So you can interpret it as a flag to the patient (or the prescribing doctor) that there is greater risk.
If that person becomes incapacitated or is deemed unfit to make their own decisions, will I be required to be physically present (for example, to sign something) to make those decisions if called upon? While it is customary for someone making decisions as weighty as removal of life support, to come to the hospital or care facility in person and discuss the issues with treating physicians, it isn't required. When you are physically there it is easier for you to personally assess the patient's condition rather than just taking someone else's word for it, and you have more informal access to everything that is going on in terms of people coming in and out of the patient's room, providers you wouldn't have known to speak to initiating conversations with you (e.g. there is typically an ER nurse for each shift, several residents doing rounds checking on a patient, and often also an outside specialist doctor involved in the treatment team). It is also usually easy when you are physically in a hospital to locate someone knowledgable and familiar with the kinds of issues you are facing at the moment to provide spiritual and religious guidance if you feel this would help you make your decision, while your neighborhood clergy person may not have a good understanding of these issues since they don't come up as often for someone is doesn't frequently spend time around people being treated in hospitals or hospices. And, this kind of pastoral counseling requires not just religious knowledge but an understanding of the options that are being presented through the lens of what is religiously and morally important about the differences between the different options. When I was an attorney for a hospital handling these issues for the hospital, we would have been willing to work with an out of state medical power of attorney agent without their physical presence. But, the fact that this was deep in the Rocky Mountains far from other urban areas (i.e. Grand Junction, Colorado) may have influenced a willingness to be flexible since it would often take a lot of time and money for someone to arrive in person. Also, while the medical power of attorney gives a specific person authority to act, an advanced medical directive is simply a document that goes into a patient's medical record that advises treating providers of the patient's intent and doesn't actually need next of kin approval or a medical power of attorney agent's say so to implement, although better practice is to seek that consent first in case there are any reasons why that advanced medical directive might have been procured improperly from someone lacking capacity or subsequently revoked. There usually will be forms for a medical power of attorney agent to sign, not authorizing a particular medical procedure, but authorizing treatment in general and providing personal and financial information about the patient in connection with admitting that person. But, these days, hospitals are relatively comfortable with handling that paperwork via fax or scanned copies sent via email, and some of the more flexible hospitals will even accept photos of signed documents sent via text message.
In the United States, many jurisdictions have criminal offenses outlawing behavior that may include what you're describing here. In Ohio, for instance, disorderly conduct (R.C. 2917.11) includes "insulting, taunting, or challenging another, under circumstances in which that conduct is likely to provoke a violent response." In Indiana, there's the offense of provocation (IC 35-42-2-3), which is even broader and includes "recklessly, knowingly, or intentionally [engaging] in conduct that is likely to provoke a reasonable person to commit battery." It looks like this has been interpreted to include even actions that don't directly involve the provoked person, such as kissing another man's wife. Beyond the criminal offense, there are also jurisdictions that will permit a civil suit for damages resulting from the criminal act. There are also states where this could constitute intentional interference with business relations or intentional interference with an employment contract. In any of those cases, your co-workers could be looking at damages for lost wages, loss of reputation, etc.
It is difficult to keep track of the rapidly changing legal variables, but it would be illegal and unconstitutional for state police to set up an unauthorized stop-and-search checkpoint on the road ("due process" means "following the law"). As a prelude, there would have to be some higher authority that empowers them to do this. You would have to scrutinize the emergency powers legislation of every state to be certain, but no governor has the power to mandate blanket body searches in case of a medical emergency. (Martial law shifts enforcement of the law to the military, but doesn't generally create arbitrary decree-writing powers). The legal foundation of such searching would have to be a new law: then the question is what the law requires that could make on-the-road body searches constitutional. Since the right to be free of unreasonable searches is a fundamental constitutional right, this law would be reviewed under strict scrutiny. Searches "just for fun" will not pass such scrutiny, nor will "because it's an emergency" or "keep the public safe". Having the disease is not and cannot be a crime, so this law would have to be founded on a strict no-travel requirement. That brings the matter within the sphere of the "officer safety" exception in the case of an arrest. I'm not suggesting that an absolute travel ban would be upheld as constitutional in the US, but that is the kind of legal foundation that would be required for state police to force people to be Covid-searched.
Regular maintenance does not include repairs for being broken – I have a contract with a company that (for a monthly payment) provides regular maintenance on the furnace, which does not cover the situation where the motor wears out, or whatever. In the worst case scenario of an oil line breech, the tenant would not be liable for the tens of thousands of dollars of cleanup that would be required. Under Pennsylvania law, there is an implied warranty of habilitability, for example the landlord warrants that it doesn't rain inside the house, there is hot and cold running water, and so on. Safe heat is an example of something that is included in a place being habitable. This warranty is not waivable by lease provision (Fair v. Negley, 390 A.2d 240). However, the subjective recommendation of a repair guy has little legal cash value: what is needed is an arms-length evaluation of the safety and functionality of the system. If the recommendation is based on inefficient fuel use and long-term likelihood of eventual system failure, that is probably not sufficient to compel a repair. Excess CO on the other hand is a clear danger. The repairman should be able to at least explain the specifics of the improper setup and the consequences of doing nothing. Documentation of actions taken is a good idea.