Safety and effectiveness have not been established for _ If an FDA approval says the following for treatment with a medical device, does this mean a doctor absolutely cannot treat a patient (with any of the conditions) with the device? Or does it just mean be cautious? &quot;Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 18; or for patients with progressive, systemic neurological diseases.&quot;
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.
There are circumstances in which medical ethics historically authorized treating physicians to defer sharing information with patients or even to mislead them in their best interests medically, although the scope of what is considered ethical in that regard is narrowing. But in the fact pattern described in the quoted material there is no plausible way that this withholding of information could be justified. If it was intentional (or for that matter, even if it was negligent) there could be grounds for tort liability for harm caused as a result (although causation and damages are hard to prove). On the other hand, just because it could give rise to tort liability, doesn't imply that the action is necessarily a crime, at least without some kind of motive other than random spite to intentionally provide a false result. However, it is quite difficult to come up with a believable reason that this would happen to someone at random. If the person taking the test bribed someone to provide a false result, which is plausible, that is one thing, but just doing it randomly really doesn't make any sense. The fact pattern provided sounds like it doesn't include the &quot;full story.&quot; Why keep records of the actual test results (or for that matter why do the actual tests at all) if you are merely going to intentionally provide a false negative?
There are, as far as I know, no &quot;FDA-approved&quot; vaccines against covid in the US. The FDA has given Emergency Use Authorization to some vaccines. This does not currently include the Johnson &amp; Johnson vaccine. It is impossible for a person to get the J&amp;J vaccine in the US, because it is not authorized, and J&amp;J does not distribute it. One could imagine an unauthorized foreign vaccine being smuggled into the US, but it would be illegal to distribute it. I assume that you specifically mean, can a person refuse to get a vaccination on the grounds that it only has an emergency authorization and is not actually approved: and can one sue an employer for firing you because you refused to get vaccinated? In general, the employer can fire for anything they want, unless you have an employment contract that limits the grounds for termination. There are discrimination-based grounds that they cannot use, such as race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, disability, age (age 40 or older), or genetic information at the federal level. Mississippi has no specific employment discrimination laws. Other that that, an employer can fire an employee for any reason, or no reason (Mississippi is what's known as an &quot;employment at will&quot; state). There are some state restrictions where it is prohibited for an employer to fire an employee for engaging in a specific required activity such as being called for jury duty or being called to military duty. An employer could not require an employee to break the law, but that is not applicable here.
The "Privacy Rule" (45 CFR Part 160 and Part 164, Subparts A, E) don't forbid this. Sect. 164.502 states the general rule: (a) Standard. A covered entity or business associate may not use or disclose protected health information, except as permitted or required by this subpart or by subpart C of part 160 of this subchapter. "Health information" is defnes in part 160 as any information, including genetic information, whether oral or recorded in any form or medium, that: (1) Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual. Your picture would not constitute health information (and anyhow, they are allowed to gather health information, just not freely disseminate it – the pictures on the wall were presumably with permission). There is no general law (which would be state law) against taking a person's picture (though commercially exploiting someone's picture would require permission, via the concept of personality rights), and it is directly required in a number of instances (for identification purposes – school ID, driver's license, passport, voting in some states). It is an unusual requirement and since they scanned your driver's license it is especially inexplicable. Assuming that this is just a story they tell all patients because they want before and after pictures (which you would have to consent to, if you didn't already in one of those "sign here" flurries), saying that this is for "security purposes" would be untrue, but I don't think it's actually illegal. Taking but not using a photo would not cause you harm, so if you had let them take the picture, there would not be a basis for suing. If they use it for advertising without permission, that would be a problem.
Providing the antenna was installed in accordance with the law it's hard to see what basis they could either void their lease or seek damages. The antenna poses no risk to health (non-ionising RF radiation is harmless) and you have no rights in any view it may be blocking there is no damage. The only thing that I can see is if there was misrepresentation at the time the lease was formed. That is, the developer knew that there was going to be an antenna and specifically said there wouldn't be. This falls flat if a) they never mentioned antennas or b) the decision to install it was made after the lease was formed.
Yes - patents are not for results but for devices and processes that can achieve the result. An airplane and a helicopter can have similar results; more than one medication helps to reduce blood sugar levels.
There is no parallelism between the Texas decision and the proposed lawsuit. In the anti-mifepristone lawsuit, there exists a statute granting the FDA authority to regulate and review new drugs, and a petition procedure whereby citizens can state ground for the Commissioner of Food and Drugs to consider a regulatory action. There is no statutory basis on which a ban of meat-eating could be created by executive action. Congress cannot be sued for not passing a law (failure or refusal of Congress to pass a particular law is not justiciable). If, for example someone were to submit a petition to the FDA urging such a regulation, the petition would have to be denied because the FDA does not have statutory authority to issue such a regulation. As argued here, the anti-mifepristone plaintiffs lack standing in that case, so one can expect that to be a substantial issue in the subsequent appeal.
There is no prospect for equitable relief in such an outcome. The Texas state government enjoys sovereign immunity, except as specified under the Tort Claims Act. Under that law, immunity is waived only in the case of damage caused by negligence of a state employee, and is limited primarily to vehicle accidents and physical injuries. So the state cannot be sued for passing a law found to be unconstitutional. An individual would not enjoy such immunity, but given the law, there is no identifiable defendant to seek relief from (everybody is a potential defendant). An former abortion provider who now declines to perform an abortion can't be sued, because doctors in general have no obligation to perform particular medical procedures (most doctors in Texas won't perform an abortion, even before SB8), and the course will not render a judgment against a doctor on the grounds that they obeyed an existing law but should have known that it would be found unconstitutional.