Houston Methodist

.The only COVID-19 drugs available to Houston Methodist employees are FDA-classified as investigational new drugs (IND) under expanded access protocols via emergency use authorization (EUA) 21 USC 360bbb-3. Federal law defines an IND as a drug used in clinical research (i.e., medical experimentation). The legal definition of what constitutes a medical experiment is any use of an unlicensed drug in the course of medical practice. Federal law defines EUA drugs or biologics as experimental for their intended use under the declared emergency according to the product’s labeling.

Legal Fact: When Houston Methodist executive staff chose to place their employees under threat of penalty should they refuse voluntary participation in clinical research drug activity, they violated the following:

(1) the prohibition of entities subjecting individuals to medical or scientific experimentation outside of their free will and voluntary consent

(2) the legal power held by individuals to make an autonomous decision to participate in an EUA product only if they believe the product can benefit their personal health goals

(3) the Scope of Authorization as issued by the FDA Commissioner for each EUA, of which they had no power to amend

(4) the PREP Act’s requirement that all participants involved in the countermeasure program are under voluntary conditions

(5) their Institutional Review Board’s legal obligations under 45 CFR 46

(6) their CDC COVID-19 Preferred Provider Agreement directly or indirectly through the state of Texas

(7) corporate governance laws for institutions receiving more than $750,000 in annual federal funding

(8) their Federal Wide Assurance agreement with HHS

(9) potentially violated misbranding laws since they “promoted” an unlicensed product “as if” it was a product licensed and approved for general commercial marketing by the FDA

(10) Interfered with federal requirements of Texas to ensure individuals are not under outside pressures to participate in an emergency countermeasure program

(11) Interfered with employees’ right to enjoy a federally funded program (punishable up to ten years in prison)

(12) Interfered with the U.S. government’s responsibility to comply with Article VII of the ICCPR 1992 ratified Treaty

(13) federal and state laws prohibiting employers from engaging in harassment, isolation, gaslighting, and intimidation tactics all in an effort to criminally coerce employees into participating in a legally binding agreement outside of their free will and voluntary consent (when an individual agrees to participate in an EUA product, they agree to forfeit litigation rights and to allow the data about their involvement with the product to be utilized for research purposes).

(14) the Belmont Report’s requirement to ensure they are not placing individuals under “sanctions,” “coercion,” or “unjustifiable pressures” to participate in the product before the offer to participate is presented to the employee.

Therefore, were/are you an employee of Houston Methodist Hospital in Texas and were/are under threat of penalty for refusing to volunteer for participation in an investigational new drug (e.g., Pfizer BioNTech COVID-19 Vaccine)? Do you believe it is time to seek redress for the injustices perpetrated against you by executive staff? If so, funding is being assembled to finance that litigation on your behalf at no upfront cost to you. The following request aims to ascertain the number of persons interested in seeking redress. Please complete the form below if you meet the above description and want additional information about this effort. You are not being offered legal representation, only funding to acquire quality legal representation. Houston Methodist might reside in an at-will employment state. However, they do not have the legal right to use their position of power to coerce employee participation in clinical research activity (e.g., EUA drug administration).