Houston Methodist Hospital Faces Fifth Circuit Appeal Over Investigational Drug Mandate

More than 100 healthcare professionals have taken their fight against Houston Methodist Hospital to the Fifth Circuit Court of Appeals, challenging the hospital’s 2021 COVID-19 shot mandate.

The lawsuit filed in Galveston federal court in 2023 alleges that Houston Methodist and CEO Marc Boom violated federal agreements by requiring employees to inject federally owned investigational drugs under threat of penalty.

The case has drawn the attention of medical ethics experts, including consultant Brian Ward. Ward spoke to The Gateway Pundit, saying that “the drugs under Houston Methodist’s mandate were wholly owned by the federal government and classified by the FDA as investigational new drugs.” For example, Ward noted that “Pfizer-BioNTech COVID-19 Vaccine is under Investigational New Drug (IND) application 19736 to this day and is only administered under laws regulating investigational drug treatments.”

Ward argued that Houston Methodist’s actions violated fundamental principles governing investigational medical treatments. He was adamant that “Houston Methodist could not even take possession of the drugs unless it explicitly promised the federal government that it only offers them under voluntary conditions.”

Ward argued that Houston Methodist’s actions violated fundamental principles governing investigational medical treatments. He was adamant that “Houston Methodist could not even take possession of the drugs unless it explicitly promised the federal government that it only offers them under voluntary conditions.”

The case’s origins trace back to deeper historical roots in medical research oversight. In 1973, following Senate hearings led by Edward Kennedy that exposed the federal government’s medical research abuses, Congress passed the 1974 National Research Act.

According to Ward, this legislation led to the creation of “the Common Rule,” a set of federal regulations designed to protect individuals, such as the Plaintiffs in the case before the Fifth Circuit, from coming under threat of penalty to participate in “federally funded or authorized investigational drugs involuntarily.” This protection is guaranteed by the U.S. Congress, which requires Houston Methodist to “obtain Plaintiffs legally effective informed consent.”

“Legally effective informed consent” requires far more than “mere consent,” said Ward, explaining that consent must be obtained in advance of the product’s administration and that an offer to participate must be presented under a legally approved environment where the potential recipient is not under outside pressure to participate in its administration.

“The duty of Houston Methodist,” Ward asserted, “is to accept an individual’s free consent on behalf of the United States Government,” which requirement is “predicated upon the hospital billing the government for services under the emergency CDC COVID-19 Vaccination Program,” a program established to administer the drugs to the public under a nationally declared emergency.

Ward noted that among the nation’s 160,000 personal injury lawyers, “maybe less than five know of these legal requirements, and it is for that single reason that Houston Methodist almost got away with the crime of the century.”

Federal District Court Judge George C. Hanks Jr. dismissed the case after a year’s deliberation and issued a ruling that, according to Ward, “unquestionably violates the Separation of Powers Doctrine.” For Ward, “Hanks’ ruling defies legal logic and is nonsensical.”

Ward said that Judge Hanks found that Houston Methodist did not violate any law because, citing the judge, the “Plaintiffs do not allege that any defendant directly administered the vaccine to them, so their claims against Defendants fall outside of the reach of the informed consent provisions [because the] ‘right to refuse’ the vaccine never came into being because none of the parties ever actually administered the COVID-19 vaccination to any of the plaintiffs.”

“Exactly when do Plaintiffs get the right to refuse? Is it after they inject the drugs, which refusal then is pointless,” Ward questioned. “The whole case is about the fact that Houston Methodist offered the healthcare workers an opportunity to participate, at which time the workers refused.”

However, Ward offered that the right to refuse “does not come ‘into being’ when someone physically administers the drug; it comes into being the moment the FDA classifies the drug as investigational, and the Department of Health & Human Services (HHS) Secretary authorizes them only for emergency use.”

Ward considers himself “passionate about the judge’s ruling,” stating that “it completely ignored Congress’s authority to prohibit persons acting on the government’s behalf from pressuring individuals to participate.”

He pointed out that “this legal requirement has regulated the $600 billion pharmaceutical industry for more than 40 years, and with the stroke of a pen, the judge amended a legal requirement which all U.S. states, territories, and counties have a current written agreement on file with HHS to comply with.”

Because of Judge Hanks’ ruling, Ward lamented, “Houston Methodist and others can pressure anyone to use unlicensed, unapproved, investigational drug treatments,” which, up to Hanks’ ruling, “was always a violation of federal law.”

When asked why it is important for a person to have the right to refuse an IND, Ward claimed, “One drug can potentially have more than one trillion adverse reactions to 19,000 FDA-licensed drugs, hundreds of diseases, and thousands of medical conditions, which the drugs have not been tested for.”

According to Ward, “The Fifth Circuit’s appeal brief reveals a legal framework that will shock the conscience of most readers once they realize the layers of legal protections designed to stop what potentially occurred under Houston Methodist’s COVID-19 mandates.”

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