The Law Office of Robert L. Teel

“The Janssen Vaccine is known to cause thrombosis with thrombocytopenia syndrome (“TTS”) which it did after it was injected into Plaintiff by the defendants. TTS can be life-threatening. See “WARNING: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME” on the Janssen Vaccine fact sheet attached as Exhibit B to Affidavit of Robert Teel In Support of Plaintiff’s Opposition to Motion for Protective Order and to Quash Subpoena Issued to Janssen Biotech, Inc. and Request to Enforce (“Teel Decl.”). 

“[An estimated] approximately 29,000 doses of lot 1805031 of the Janssen Vaccine were administered and used to vaccinate the public in the United States with 1437 associated severe adverse reactions and 67 associated deaths. Exhibit C.”  “This is a incidence rate ratio of over one (1) severe adverse reaction associated with every 20 injections and one (1) death associated with every 433 injections of lot 1805031 of the Janssen Vaccine.”

“What this action does not concern is the nationwide debate over vaccinations [or] fantastical conspiracy theories about vaccines . . .”  See conformed copy of Complaint for Damages and Petition for Writ of Mandate Upon Affidavit, Zimmerman v. King County, et al., King County Superior Court Case No. 24-2-04429-9 KNT, ¶ 2.   To the contrary, this lawsuit is about the harm caused by negligent acts and omissions in administering and injecting the public with the J&J Vaccine that were inconsistent with the Secretary’s emergency declarations and mandated public health guidelines, including the failure to comply with:

(a) the requirements of the Secretary’s of Health and Human Services emergency declarations and the FDA and CDC as well as other mandatory public health guidelines and directives when local authorities administered, dispensed, and used the Johnson &Johnson Vaccine;

(b) public health guidance from all applicable authorities having jurisdiction over the administration and use of the J&J Vaccine;

(c) applicable federal contracts and agreements related to the administration, dispensing, and use of the J&J Vaccine; and

(d) all requirements of federal and other authorities having jurisdiction applicable to the administration, dispensing, and use of the J&J Vaccine.

As a result, this complaint and petition seeks to compel compliance with applicable laws in connection with the administration of vaccines as well as damages and the other relief.

On April 23, 2020, Emergent Biosolutions and Johnson & Johnson announced an agreement for Emergent to provide J&J with contract development and manufacturing (“CDMO”) services for J&J’s then lead vaccine candidate for COVID-19. Under the agreement, valued at approximately $135 million, Emergent provided drug substance manufacturing services to J&J with its “molecule-to-market” CDMO offering (supported by large investments from J&J beginning in 2020) and reserved large-scale manufacturing capacity at its Bayview Plant to pave the way for commercial manufacturing of J&J’s adenovirus-based COVID-19 vaccine beginning in 2021.

While ramping up production of those vaccines, Emergent cross-contaminated nearly 400 million doses of the J&J Vaccine according to a May 10, 2022 report (the “House Report”) jointly issued by the House Committee on Oversight and Reform and the Select Subcommittee on the Coronavirus Crisis (the “House Committee”). J&J and Emergent told Congress, the FDA, and the public that no contaminated doses were ever released to the public. However, to date, despite repeated inquiries, neither the local department of public health, nor J&J, nor the federal government have been willing to provide any information sufficient to determine what batch substance was in fact used in the manufacture of lot number 1805031 of the J&J Vaccine, where that batch substance was manufactured or where it came from, or where lot number 1805031 was in fact manufactured.

Johnson & Johnson issued a statement on its website on March 31, 2021 stating that “This batch was never advanced to the filling and finishing states of our manufacturing process.”  March 31, 2021 Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing.  It was reported in various news outlets, including the New York Times, CNN, and ABC between April 1, 2021 and April 10, 2021 that all doses delivered, used, and available in the United States were produced in the Netherlands because the FDA had not approved the Bayview Plant to make parts of the J&J Vaccine.  The F.D.A. tells Johnson & Johnson that about 60 million doses made at a troubled plant cannot be used. The doses, produced at a Baltimore factory under federal review, could have been contaminated.  June 11, 2021 updated July 29, 2021 by Sharon LaFraniere, Noah Weiland and Sheryl Gay Stolberg.

But according to Congresswoman Maxine Waters speaking at the May 19, 2021 First Session of the Hearing Before the Select Subcommittee on the Coronavirus Crisis of the Committee on Oversight and Reform of the House of Representatives, One Hundred Seventeenth Congress, Examining Emergent Biosolutions’ Failure to Protect Public Health and Public Funds (the “Hearing”),

“[Emergent] can’t be trusted. They have had serious manufacturing problems, multiple inspections and audits that were conducted in 2020, that warned of serious quality control. Evidence recently obtained by the committee shows that Emergent was aware of serious control issues at its Bayview facility, but failed to act. In June 2020, an advisor to Operation Warp Speed identified risks in relying on Emergent to handle the production of two coronavirus vaccines. During a separate audit, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, found that the Bayview facility had a deficient contamination control strategy.”  Hearing Transcript at pg. 30.

Emergent Biosolutions’ Chief Executive Office, Robert Kramer, admitted its Bayview Plant did not comply with Current Good Manufacturing Practices controls and testified at the Hearing that as of March 31, 2021 Emergent had to throw out, discard, and destroy a batch of J&J Vaccine bulk drug substance equivalent to 15 million doses which had been cross-contaminated with the AstraZeneca viral vector.  Hearing Transcript at pg. 10. Mr. Kramer told the House Select Subcommittee examining Emergent Biosolutions’ failure to protect public health:

“I apologize for the failure of our controls and I give you my personal assurance that I will take every step that is needed to resume production safely.” Hearing Transcript at pg. 8.

Before the J&J Vaccine’s Emergency Use Authorization was revoked on June 1, 2023, millions of doses were administered to millions of consumers and patients, despite that fact that the FDA found as early as April 20, 2020 that Johnson & Johnson and Emergent had failed to follow “established specifications, test procedures, and laboratory control mechanisms” at the Baltimore, Maryland Emergent plant which manufactured the J&J Vaccine.