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NoMoDo

04/07/21 10:54 PM

#105786 RE: Zues #105784

But I would be surprised if the 11th Circuit were to lift the injunction prior to retrial considering USRM's stem cell operations were in defiance of FDA law.

FDA doesn't make laws. Congress does.

Agencies are tasked with creating rules and regulations within the scope of the laws enacted. Sure, the regulations carry almost as much weight as congress enacted laws because we have allowed them, but there is a distinction. Courts are starting to look at bit closer at the weight of those regulations as well as how they comport with the laws passed by Congress.

Laws cannot be arbitrary. If a law is found to be arbitrary, it is invalid. The FDA has admitted that similar procedures are allowed because they have been grandfathered in. This is the single greatest argument for demonstrating arbitrarness of the stem cell guidance. The procedure is either dangerous or it is not. Grandfathered in works for rate hikes, not health and safety.

Finally, if the lower court ruled on a perminant injunction based on an incorrect ruling of summary judgment, then the appellate court MUST reverse the perminant injunction. Otherwise it would be an improper taking.