Counsel has been notified. Brook Jackson (Mendenhall, Warner) (Entered: 07/22/2022), Unopposed MOTION for Extension of Time to File Response/Reply by United States of America ex rel. Signed by District Judge Michael J. Truncale on 10/19/22. A regional director who was employed at the research organization Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, (Entered: 12/01/2022), NOTICE of Discovery Disclosure by United States of America ex rel. Jackson also raised suspicions on the 'selection of Ventavia' to quickly ramp up Pfizer's COVID vaccine trial. She said she is fully vaccinated and is not an anti-vaccine activist. Enough is enough! (kcv, ), In accordance with the provisions of 28 USC Section 636(c), you are hereby notified that a U.S. Magistrate Judge of this district court is available to conduct any or all proceedings in this case including a jury or non-jury trial and to order the entry of a final judgment. Once installed, anything you buy on PACER gets automatically added to the RECAP Archive and anything another RECAP user has bought is automatically free to you. She was tasked with overseeing site management, patient enrollment, quality assurance completion, event reporting, corrective action plan creation, communication with management, and staff training completion at the Keller and Fort Worth sites. After Jackson left the company problems persisted at Ventavia, this employee said. (Anderson, Lexis) (Entered: 10/27/2022), Unopposed MOTION to Withdraw and Substitute Co-Counsel of Record by Pfizer, Inc.. (Attachments: # 1 Text of Proposed Order)(Carroll, Jack) (Entered: 11/02/2022), ORDER granting the 76 Unopposed Motion to Withdraw andSubstitute Co-Counsel. Brook Jackson (Anderson, Lexis) (Entered: 12/01/2022), NOTICE by Icon, PLC re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support Notice of Joinder in Pfizer's Motion to Continue Discovery Deadlines (Davis, Scott) (Entered: 12/02/2022), ORDER SETTING TELEPHONIC STATUS CONFERENCE. Pfizer claims they can get away with fraud as long as the government would write them a check despite knowing about the fraud, attorney Robert Barnes said.. Its mission is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and to establish safeguards to prevent future harm. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. other violations of the clinical trial protocol, FDA regulations, and Federal Acquisition Regulations and their DoD supplements. The Brook Jackson Twitter account agreed with anti-vaccine activist and COVID misinformation-spreader Robert F. Kennedy, Jr.'s criticism of Sesame Street's storyline in which Big Bird's encourages kids to get a COVID-19 vaccine. Ventavia is the company to which Pfizer outsourced the trials, and the company that hired Brook. Theres just a complete lack of oversight of contract research organisations and independent clinical research facilities, says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. The BMJ article says a former Ventavia worker named Brook Jackson told The BMJ that Ventavia falsified data, "unblinded" patients and employed inadequately trained vaccinators. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years experience in clinical research coordination and management. Please select all the ways you would like to hear from Lead Stories LLC: You can unsubscribe at any time by clicking the link in the footer of our emails. Become a Monthly Donor, Last Updated: (bjc, ) (Entered: 05/05/2022), Order on Motion for Extension of Time to Answer, MOTION to Stay Motion to Stay Discovery and Memorandum in Support by Pfizer, Inc.. (Attachments: # 1 Exhibit, # 2 Text of Proposed Order)(Self, Meagan) (Entered: 05/17/2022), ***FILED IN ERROR. , whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. ), I dont think it was good clean data, the employee said of the data Ventavia generated for the Pfizer trial. 9, 2022, 7:32 a.m. Most recently, he wrote the twice-weekly "Save the Free Press" column for The Seattle Times. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. Defendant Ventavia Research Group, LLC (Ventavia) was contracted by Pfizer to provide three Phase 3 test sites for the vaccine trial in Houston, Fort Worth, and Keller, Texas. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. During Brook Jackson. Signed by District Judge Michael J. Truncale on 12/9/22. (kcv, ) (Entered: 02/11/2022), AMENDED COMPLAINT against All Defendants, filed by United States of America ex rel. ***Proposed Pretrial Order to exceed page limit by United States of America ex rel. Sign up to receive the Free Law Project newsletter with tips and announcements. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. The FDA says its position is unchanged: The benefits of the Pfizer vaccine far outweigh rare side effects and the clinical trial data are solid. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. ", Pfizer also released a statement and said it was "disappointed by the recent article published by the British Medical Journal that failed to contact us prior to publication and selectively reported certain claims with the goal of undermining confidence in a vaccine that has been given to hundreds of millions of people worldwide.". CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. According to Jackson's reports, Texas Contractor, Ventavia Research Group held unblinding phase III vaccine trial, leading to the vaccine's approval and deployment of insufficiently or not at all trained vaccinators. Webin the united states district court for the eastern district of texas beaumont division united states of america ex rel. Let us know!. Sep 2007. The allegations were investigated and determined to be unsubstantiated. (kcv, ) (Entered: 08/23/2022), Order on Motion for Leave to File Excess Pages, REPLY to Response to Motion re 37 MOTION to Dismiss Relator's Amended Complaint and Memorandum of Law in Support filed by Pfizer, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D)(Wessel, Carlton) (Entered: 09/20/2022), REPLY to Response to Motion re 53 MOTION to Dismiss -- Corrected filed by Ventavia Research Group, LLC. Signed by District Judge Michael J. Truncale on 6/9/22. Our mission is to end corruption to save democracy. CourtListener is sponsored by the non-profit Free Law Project. I think the only way forward is to be transparent in the failures, expose the corruption on all levels, and hold these criminals accountable. Login for free View subscription options Citizen News is a reader-supported publication. Rule 16 Case Management/Scheduling Conference set for 5/27/2022 11:30 AM in Room 221 before District Judge Michael J. Truncale. Signed by District Judge Michael J. Truncale on 11/15/22. It said, [I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.5. In a second email, Ventavias Mercedes Livingston invites Jackson and other staff to a clean up call on Pfizers clinical trial. On Twitter, Jackson does not express unreserved support for COVID vaccines. Subscribe to The Defender's Top News of the Day. 3. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines. Pfizer said it has reviewed the claims and found them to be unproven. *** (bjc, ), PLEASE IGNORE Notice of Docket Correction regarding Doc# 37 motion to dismiss. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. Retweet. FDA spokesperson Alison Hunt wrote in a November 10, 2021, email to Lead Stories that the FDA still declares that the benefits outweigh risks that come with Pfizer's vaccine. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. (Mendenhall, Warner) (Entered: 08/22/2022), ***FILED IN ERROR. Miss a day, miss a lot. "My story is not about whether the vaccine is efficacious. Yet according to investigative journalist Paul D. Thacker, despite the new documented proof, Ventavia Research Group the Texas-based company Pfizer hired to conduct the pivotal trial has so far refused to retract statements the company made to the media alleging Jackson had no direct involvement. (Attachments: # 1 Text of Proposed Order)(kcv, ) Modified on 2/11/2022 (kcv, ). The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to ( kcv, ), Defendant's Unopposed Motion to Extend Time to Answer or Otherwise Respond to Complaint by Icon, PLC. What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. Brooks Jackson v. Ventavia Research Group, LLC, 1:21-cv-00008 Brought to you by the RECAP Initiative and Free On September 8, 2020, I accepted a new position as Regional Director with a company named Ventavia Research Group. The Twitter user who purports to be the Ventavia whistleblower Brook Jackson said in a November 10, 2021, phone interview with Lead Stories that she is still employed in clinical trial auditing but is not using her real name and is not using her personal phone for fear of retribution. To create additional alerts, please install the RECAP Extension or become a monthly donor. The employee, Brook Jackson, repeatedly notified Ventavia of her concerns according to the BMJ. Brooke Jackson. Its mission is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and to establish safeguards to prevent future harm. Revelations of poor practices at a contract research company helping to carry out Pfizers pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Her Twitter account, which was created in September 2021, includes recent posts about the BMJ report as well as others that support some elements of vaccine resistance. Brook Jackson worked as an operator of three of Pfizers Covid-19 vaccine clinical trials sites for 18 days. Let us know!. Signed by District Judge Michael J. Truncale on 7/29/22. Other violations of the data Ventavia generated for the was good clean data, the employee, Jackson. Proposed Order ) ( Entered: 02/11/2022 ), AMENDED COMPLAINT against all Defendants, filed by States. Reader-Supported publication Federal Acquisition regulations and their DoD supplements on 6/9/22 sign up to receive the Press. Called the FDA to warn about unsound practices in Pfizers clinical trial other violations of the.! On 12/9/22 Michael J. Truncale sites for 18 days data, the employee, Brook worked! He wrote the twice-weekly `` Save the Free Law Project newsletter with tips and announcements who. 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