Search Site
Menu

Court Rules Whistleblower Claim Against Medtronic May Continue

The U.S. 9th Circuit Court of Appeals recently cleared the way for a whistleblower lawsuit against Medtronic to continue.

The lawsuit alleges the medical devices company fraudulently obtained clearance from the Food and Drug Administration (FDA) for several of its spinal fusion devices. A lawsuit had initially been dismissed in a California district court in 2019, and now the appeal will continue through court.

The appeals court did affirm the lower court’s decision to dismiss other allegations, including those that Medtronic illegally marketed the spin devices for off-label use, and that the company illegally compensated physicians and hospitals for use of the devices.

Case background

The spinal fusion devices had been cleared for vertebral body replacement use through the 510(k) process. The lawsuit alleges Medtronic fraudulently convinced the FDA to give Class II clearance to these devices by failing to disclose the products are meant to be used in the cervical spine.

Plaintiffs in the case include a former sales representative for the company, who first raised the alert in the case and accused Medtronic of knowing cervical use had different safety questions for approval than those that would be raised in other types of device approvals. The lawsuit alleges if Medtronic had properly disclosed this usage, the FDA would have put the products through Class III approval processes instead, which are more stringent.

Medtronic attempted to claim the False Claims Act was an improper method for bringing fraud claims, but the court rejected this argument.

Medtronic saw some sizable losses in third-quarter revenue, partially as a result of the COVID-19 pandemic. In February it announced 3.2 percent declines in revenue to the tune of $1.08 billion.

To learn more about how to file a False Claims Act case, 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