#Ivermectin: US District Judge, Jeffrey Vincent Brown, dismisses the suit brought against the FDA by Robert L Apter, Mary Talley Bowden and Paul E Marik

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Judge Rules on Lawsuit Against FDA Over Ivermectin

By Zachary Stieber

December 6, 2022Updated: December 6, 2022

A federal judge on Dec. 6 agreed to throw out a lawsuit that was filed against the U.S. government over its repeated exhortations not to take ivermectin against COVID-19.

Plaintiffs, three doctors, said the FDA violated the Federal Food, Drug, and Cosmetic Act by its warnings against using ivermectin to treat COVID-19.

But the law does not support their case, U.S. District Judge Jeffrey Brown, a Trump appointee, said in a 20-page ruling.

“First, while § 396 limits the FDA’s powers as applied to medical devices, it does not do so in the context of drugs. As there is no statute limiting the FDA’s actions here, it cannot have acted outside of any statutory limitations,” he said. “Further, it cannot be said that the FDA had no colorable basis of authority. The FDA is charged by Congress with protecting public health and ensuring that regulated medical products are safe and effective, among other things.

“The plaintiffs do not dispute that the FDA has the authority, generally, to make public statements in-line with these purposes. Although the FDA could have, and perhaps should have, been more prudent in their communications, they had at least a colorable basis in authority—and there is no statute saying otherwise,” he added.

The doctors had pointed to six FDA statements, including a post on social media that said, “You are not a horse” and told people to “stop” taking ivermectin for COVID-19.

They had said the statements amounted to a “final agency action,” which could trigger relief under the Administrative Procedure Act.

Brown disagreed, saying there was “no indication the FDA has adopted a legal position, no indication of any future liability on non-complying parties, and no establishment of safe harbors.

“While the plaintiffs allege that the FDA’s statements have incited third parties to investigate and fire the plaintiffs, the FDA’s statements do not state the FDA’s view of the law or create civil or criminal liability for noncompliance,” he added.

He ruled in favor of the government’s claim of sovereign immunity. The government can only be sued with its consent, and plaintiffs did not meet the exceptions they cited, according to the judge.

“We are conferring with our clients regarding an appeal to U.S. Court of Appeals for the Fifth Circuit. The improper actions of government agencies like the FDA leave many open legal questions that deserve a full public airing,” Boyden Gray, a lawyer for the plaintiffs, told The Epoch Times in an emailed statement.

The FDA declined to comment.

https://www.theepochtimes.com/lawsuit-against-fda-over-ivermectin-dismissed-by-judge_4906931.html

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Case 3:22-cv Document 29 Filed on 09/29/22 in TXSD Page 1 of 6 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS GALVESTON DIVISION ROBERT L. APTER, M.D., FACEP; MARY TALLEY BOWDEN, M.D.; and PAUL E. MARIK, MBBCh, M.MED, FCCM, FCCP, v. Plaintiffs, DEPARTMENT OF HEALTH AND HUMAN SERVICES; XAVIER BECERRA, in his official capacity as Secretary of Health and Human Services; FOOD AND DRUG ADMINISTRATION; and ROBERT M. CALIFF, M.D., MACC, in his official capacity as Commissioner of Food and Drugs, Defendants. Case No. 3:22-cv-184 (JVB UNOPPOSED MOTION FOR LEAVE TO FILE AMICUS CURIAE BRIEF OF THE ASSOCIATION OF AMERICAN PHYSICIANS AND SURGEONS SD Texas Bar ID NJ Old Chester Rd. Far Hills, NJ Tel: Fax: Counsel for Amicus Curiae Association of American Physicians and Surgeons

https://docplayer.net/230984771-In-the-united-states-district-court-for-the-southern-district-of-texas-galveston-division.html

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