Search Site
Menu

Whistleblower Claims Officials at Merck COVID Vaccine Plant Minimized Safety Risks

A new complaint filed by the Office of Special counsel indicates inspection officials at the Food and Drug Administration downplayed major concerns regarding safety and hygiene at a Merck factory being used to produce the Johnson & Johnson COVID vaccine.

According to a former safety officer with the FDA, inspectors downgraded the facility from a category that would require immediate corrective action to a category with less urgency after a 2017 inspection, but did so without following the proper procedures and despite some significant public health concerns.

Case background

In 2018, the whistleblower discovered Merck was improperly disposing of biohazard bins that had been used to collect employees’ waste, and that rather than taking bathroom breaks that would have required them to leave the manufacturing area, employees were soiling their uniforms. He accused Merck of purposefully destroying evidence of these health and safety violations.

In early March, Merck agreed to help Johnson & Johnson bottle millions of its vaccine doses, and would begin producing the vaccine itself by the later half of this year.

The FDA reclassified the status of the plant to ensure it would not undergo further scrutiny, according to the whistleblower. If it had instead stayed classified in the more severe category. Merck would have needed to prove it addressed the past FDA concerns, or else face restrictions.

The whistleblower also claimed the FDA’s inspection unit was horribly understaffed in such a way that could compromise compliance efforts.

For more information about the steps you should take if you uncover serious safety risks being covered up by your employer, contact an experienced whistleblower lawyer at Kardell Law Group.

Honors
Our Office
  • Dallas Office
    4514 Cole Ave
    #600
    Dallas, Texas 75205
    Phone: 214-306-8045
    Fax: 469-729-9926
Testimonials
  • "Steve Kardell was terrific in representing me in some very adversarial discussions with Citigroup and also later represented me in my testimony before the Financial Crisis Inquiry Commission."  -Richard Bowen, Citigroup Whistleblower

  • "Incredible knowledge of employee related concerns and equally brilliant knowledge of health care regulations, standards of practice. I would recommend this firm to anyone."  -V.B.

  • "Reaching out to Steve Kardell was the best decision I made. His ability to provide immediate insight and direction was very powerful, and a huge relief during a very stressful time period. For anyone struggling with a whistleblower situation, I would highly recommend at least speaking with Steve. After a 10 minute call with him, I had a better understanding of what I was dealing with. Even better, he gave me some immediate hope. In the end Steve did a better job than I thought was possible. Steve was able to get in contact with people in my organization, that I didn’t have access to. Because of his years of experience, he already has contacts in many organizations in Dallas. The entire situation was handled peacefully. I was impressed by his ability to “keep the peace”–rather than creating a battle with the organization. The reason I didn’t reach out to a lawyer initially, was because I thought it would mean an immediate end to any hope of a positive relationship with the company. Steve was able to address my concerns, and in the end I was able to continue to work for them."  -KS

  • "Never thought my career would end like it did after 30 years of service. I was part of the first round of the so called reduction of force. I asked myself how can I be part of this with 30 years of seniority. How did they pick these 90 plus employees? Now, the culture of this organization made you question every decision they made. It wasn’t what you knew it’s was a culture of who you know. Nonetheless, I did not accept their severance package. I immediately starting looking for an attorney who would take on my case. After the initial call to Steve I had hope again. He was open and honest about everything and reassured me he would do his best for me, and he did. I had an awesome outcome. Thanks Steve you’re the best."  -S.S.

FOLLOW US
Facebook Twitter Linkedin RSS Feed JD Supra