Is it legally possible to bring an untested vaccine to market (in USA)? Here Neil DeGrasse Tyson says there was testing and a system in place assuring the safe production of the new vaccines. He addresses people who have claimed there was no testing. That got me curious about the process so I did some research. Looking to fill in some gaps. Could the new mRNA vaccines have come to market without any testing? I keep hearing claims that the new Covid vaccines weren't tested before being brought to market, and that there's a law eliminating all liability, both criminal and civil, in the emergency situation. Lacking legal incentives to test, Pfizer, Moderna, and the rest did not, so it is claimed. My own research suggests otherwise, perhaps on a technicality, but I'm no lawyer. Best I can tell, limited liability for vaccine manufacturers comes from the 2005 law PREPA. It still allows for prosecuting &quot;willful misconduct&quot;. Am I right to take that to mean criminal liability is still on the table? From what I can tell, an effort is made to rein in what qualifies as &quot;willful misconduct&quot; which could potentially reduce even criminal liability to nothing. It's also been said that those potentially hurt by an emergency vaccine have no recourse when injured. From what I can tell, they may have no legal recourse but VICP and CICP of The Healthcare Systems Bureau will compensate people. This happens rarely and with a pittance, so arguably doesn't exist. If there are no legal consequences, what reason would pharmaceutical companies have to conduct clinical trials before going to market? A gesture of good faith? I can't tell if companies are legally required to test before going to market. Is there a specific law about that?
Could the new mRNA vaccines have come to market without any testing? No. The FDA still has to approve emergency limited approvals of new vaccines. At least as a practical matter, the FDA requires some testing to grant this approval, although not the full testing regime of a non-emergency application for a new vaccine or drug approval. FDA approval is the limiting principle that prevents emergency drug approval from being used recklessly despite a lack of civil liability. I know this from news reports about the COVID vaccine approval process and can't cite chapter and verse of the relevant statutes. If there are no legal consequences, what reason would pharmaceutical companies have to conduct clinical trials before going to market? Drug companies have to get FDA approval for every single product they make. If they act in bad faith to get emergency approval, the FDA will not treat them well in the future and could even revoke their authority to manufacture any drugs going forward. Also, keep in mind that vaccines are not particularly high profit margin products for drug companies.
In general, anyone can buy potentially dangerous chemicals. My local service station sells petrol, my local liquor store sells alcohol, my local supermarket sells ammonia, my local pool shop sells chlorine, my local hardware store sells poisons and my local chemist sells drugs. The world is full of dangerous stuff and all of it is for sale. Certain governments may regulate the sale of certain products. Such regulations may cover packaging, storage, quantities, reporting and limits on who can be a buyer or seller. For example, who can be a buyer of Uranium is pretty strictly limited. The decision about what and how to regulate is a political one, not a legal one. In general, governments apply a cost/benefit approach (including political costs/benefits). The fact that one (or a small number) of people use something inappropriately must be balanced with the cost that regulation imposed on government and legitimate users. Also, in most parts of the developed world people are allowed to take risks with their own bodies - climbing mountains, surfing, parachuting and, yes, injecting themselves with foreign substances. It’s unwise but it’s not illegal. I am unable to assist you with who would be responsible for regulating such matters in France but I can suggest that neither the FDA nor the EPA would be relevant in the USA because its neither a food nor a drug (FDA) nor is it being sole in quantities that are likely to adversely affect the environment (EPA).
As an academic matter, the US system has struggled with this, and law professors spend their lives debating it. As a realistic matter, I'd bet that company in your example gets nailed. On the theory, the issue here is but-for cause. Civil liability requires that the jury find it more likely than not, or over 50% likely, that but-for D's actions, P's injuries would not have occurred. Your hypo puts it at exactly 50, and tie goes to the defendant, so in this case even the theory is clear. But, say you change it a little bit to make it more like 65 or 70%. Now, you're getting into the territory of the classic blue bus case. A man is hit by a blue bus. Two companies in town own blue busses, and one company owns 90% of them. Can he recover against that company with no other evidence? The black letter answer is no, that naked statistical evidence doesn't cut it. The rationale is that if it were the other way, anytime someone got hit by a blue bus, that company would automatically have to pay out unless they had some evidence to disprove their liability. The burden of proof has been shifted, violating a fundamental tenet of our legal system. But, this doctrine obviously poses an issue for plaintiffs like yours. It's one thing to say that someone hit by a bus needs to have more evidence. Theoretically, they could go out and get it: they could find the bus routes and schedules, examine where they were, and show that X company had a bus going by there at that time. They can also canvas for witnesses. It's much harder when, as your excellent hypo touches on, the science is so complicated. One controversial solution that has been debated a lot recently is market-share liability, but that doesn't seem pertinent here because you have mentioned another company. On the legal realist side. As far as I can tell the system usually finds a way to hold the company responsible. One example is the tobacco litigation. My understanding is the science couldn't definitively prove that smoking caused cancer, but it could prove that it raised the risk significantly. Here's some information on that https://www.tortmuseum.org/the-tobacco-cases/ from the American Museum of Tort Law, which, yes, is a real thing.
Every State in the union has some form of involuntary mental health hold. Regardless of whether or not the patient claims it was an accident, it is incumbent upon the hospital or facility where the individual is held (which is typically at least 72 hours) to do an in-depth analysis of whether the person is a danger to themselves or others. While in this scenario it may've been an inadvertent overdose, the empirical evidence suggests it could have been intentional as the practitioner cannot see into the thoughts and motivations behind the patient's actions. Even taking the patient at face-value, addiction to the extent of overdose is also a mental health issue, which may cause a person to be a danger to themselves. From a clinical perspective, it is much more likely than not that one of the two scenarios occurred, versus a truly mistaken overdose. One would need to mistake their actions numerous times in a day to take so much as to overdose. If you look at it from the inverse perspective, if the facility failed to keep a person who'd just overdosed, or the first responder failed to initiate a hold and the person later died, minimally they would be liable if sued by the family in an action for wrongful death. The unfortunate facts are that if a person was set on committing suicide, it unlikely they would be forthcoming with that fact, for this very reason (the mandatory hold), so a person's word cannot be the determining factor. Even if someone was not intentionally trying to take their life, having taken enough Xanax to cause medical overdose would suggest the potential that even if not suicidal, the individual was at a minimum abusing the medication by taking much more than prescribed (or in a way that is contraindicated - such as with alcohol or other depressants) and potentially suffering from benzodiazepine addiction. Either way, if the hold was not initiated or cut short - and then someone ended up dying from an overdoes - the responsibility and potential liability is the same. A person who is suicidal can reassess what may be a snap decision, or have a chemical imbalance stabilized, or a severe addiction identified in that amount of time. For the person who ctually takes so much medication as to mistakenly cause overdose, this is certainly inconvenient; however, 72 hours is a short time in the grand scheme of things to potentially save a life. The law will nearly always err on the side of safety and prevention.
IANAL, and I don't live in America, but some of this depends on their intent. If they gave the drugs away by mistake, they probably have not broken any laws. If they were given away deliberately (and you would need to prove this &ndash; which might be hard) then yes, he has broken laws. Either way, I expect you have a right to compensation (i.e. $900) from the physician to "make you whole again." If required necessary you could file for that in your local small claims court: The physician will either come to the party pretty quickly and sort it out, or the court will award you the money you need to buy the replacement meds. (But you will need to evidence the replacement cost, for a start....)
The only applicable federal law is the Animal Welfare Act. Since you are presumably not operating under a federal research grant, and are not engaged in interstate trading of research animals, you are not subject to that law. That leaves you with state laws. An example is Washington's law on prevention of cruelty to animals. In general, you can't be cruel to an animal, but animal experiments are not per se animal cruelty. If you were a "research institution", you would be subject to RCW 16.52.220 which imposes certification and registration requirements on you and the animal suppliers. If an animal suffers pain from your experiments, you could be prosecuted for cruelty to animals, but that requires causing suffering "knowingly, recklessly, or with criminal negligence".
The health insurance contract should set forth what is and is not covered in detail (in addition, there would be a short summary version). They probably don't have to provide procedure codes that are covered or not covered because no such one to one correspondence exists because the language of the insurance contract is controlling and does not exactly correspond to procedure codes. For example, one of the basic eligibility questions is whether a procedure is medically necessary. A procedure may be medically necessary for one person, but not for another, and usually a denial based upon medical necessity is subject to appeal to other medical professionals engaged by the insurance company. Unless the insurance contract provides that an EOB must contain procedure codes, it probably doesn't have an affirmative obligation to do so, because there is no general principle of law that would require them to disclose their internal classification of services provided outside of a litigation context. And, in a litigation context, you probably could obtain procedure codes in discovery from the insurance company, as the code assigned to a procedure on an EOB would almost surely not be privileged or a legally protected secret. It may very well be that the company has an in house set of procedures for certain common diagnosis codes that are routinely allowed or are flagged for review by an insurance company bureaucrat. But, that would ordinarily be considered something of a trade secret of the company and is not a statement of what is or is not allowed under the actual health insurance contract. However, the privilege against disclosing the information in that context would flow from trade secret law and not from the fact that they are PHI. I don't agree that PHI is the correct reason for failing to disclose that information (unless some case law of which I am not aware has interpreted it differently). The federal law definition of PHI is at 45 CFR 160.103: Protected health information means individually identifiable health information: (1) Except as provided in paragraph (2) of this definition, that is: (i) Transmitted by electronic media; (ii) Maintained in electronic media; or (iii) Transmitted or maintained in any other form or medium. (2) Protected health information excludes individually identifiable health information: (i) In education records covered by the Family Educational Rights and Privacy Act, as amended, 20 U.S.C. 1232g; (ii) In records described at 20 U.S.C. 1232g(a)(4)(B)(iv); (iii) In employment records held by a covered entity in its role as employer; and (iv) Regarding a person who has been deceased for more than 50 years. The cross reference to 20 U.S.c. 1232g(a)(4)(B)(iv) reads as follows: (iv) records on a student who is eighteen years of age or older, or is attending an institution of postsecondary education, which are made or maintained by a physician, psychiatrist, psychologist, or other recognized professional or paraprofessional acting in his professional or paraprofessional capacity, or assisting in that capacity, and which are made, maintained, or used only in connection with the provision of treatment to the student, and are not available to anyone other than persons providing such treatment, except that such records can be personally reviewed by a physician or other appropriate professional of the student’s choice. In short, it is B.S. that you are being given an illegitimate reason for not complying with your request, but it is probably still within the company's rights for other legitimate reasons to deny your request.
There is commonly a law like RCW 69.50.309 which says that A person to whom or for whose use any controlled substance has been prescribed, sold, or dispensed by a practitioner, and the owner of any animal for which such controlled substance has been prescribed, sold, or dispensed may lawfully possess it only in the container in which it was delivered to him or her by the person selling or dispensing the same. A controlled substance is "a drug, substance, or immediate precursor included in Schedules I through V as set forth in federal or state laws, or federal or commission rules". Schedule V includes some opiates with low potential for abuse and dependency. It does not include prescription antibiotics, and does not include Ibuprofen and other OTC NSAIDs. The cop may be right about keeping your narcotics in the original container, but wrong about anything less. I can't presently locate the Oklahoma analog of this law. After diligent searching, I even suspect that Oklahoma does not have such an "original container" law. It would count as a "counterfeit substance" if it is a controlled substance and is in a container with labeling that is not that of the original distributor, but if the contain is completely blank, it is not legally a "counterfeit substance". And again, that only applies to controlled substances.