BOSTON, MA— TransMedics, the creator of a medical device designed to revolutionize organ transportation across the country, is now facing a class-action lawsuit accusing it of concealing safety concerns and engaging in fraudulent billing practices.
The Organ Care System (OCS) is TransMedics’ signature technology. It enables transplant teams to keep hearts, lungs, and livers alive and functional while in transit between donors and recipients.
The cutting-edge technology was developed to save more lives by expanding the donor pool and allowing organs to travel further than traditional ice storage had previously permitted. But the device, once hailed as a medical breakthrough, is now under legal and public scrutiny.
The lawsuit, which is unrelated, follows a KARE 11 investigation that revealed a Mayo Clinic surgeon’s suspicion that the OCS “Heart in a Box” contributed to a failed heart transplant.
Lawsuit Allegations
The Rosen Law Firm filed the lawsuit in Massachusetts Federal Court, alleging that TransMedics’ senior executives violated federal securities laws and misled shareholders through what it calls “coercive tactics to market its OCS devices,” such as fraudulent overbilling and the use of illegal kickbacks. Furthermore, it claimed the company actively sought to conceal safety concerns about its devices.
The lawsuit also cited a February 2024 letter to TransMedics written by Arizona Congressman Paul Gosar, a member of the House Committee on Oversight and Accountability. According to the lawsuit, the Congressman accused TransMedics of misconduct and holding the life-saving devices as “hostage by a public company that has lost its true north.”
According to Gosar, the lawsuit states, “Once FDA approval was achieved, TransMedics began to change the entirety of its business model.” And the story continues: “Almost immediately, the cost of the one-time disposable cassette utilized to encompass the organ during transportation and perfusion increased from the initial $7,000 to greater than $60,000 per disposable cassette.”
The lawsuit goes on to restate Gosar’s claim that, “TransMedics is more driven by revenue generation and continuous forced bundling of services than it is by the opportunity to reduce the patient transplant waiting list.”
TransMedics has yet to respond to the lawsuit, and founder and CEO Waleed Hassanein declined an interview with KARE 11, stating in an email, “We do not comment on the details of pending legal matters and will defend the meritless allegations in the appropriate legal forum.” In a separate statement, the company refuted Congressman Gosar’s claims, calling them “inaccurate allegations.”
According to sources in Minnesota’s transplant community, TransMedics has received concerns about communication, cost issues, and evolving logistics.
A Mayo Surgeon’s Concern
This is not the first time that concerns about the OCS device have been raised. A recent KARE 11 investigation uncovered a sworn court deposition in a different lawsuit in which a Mayo Clinic surgeon, under oath, expressed his concerns that the OCS device contributed to a failed heart transplant in Rochester.
“I suspect that there might have been micro, micro holes, you know, that caused this,” Dr. Mauricio Villavicencio, Surgical Director of Heart & Lung Transplantation in Rochester, stated.
In his medical notes from the day of the surgery, Villavicencio wrote, “we thought the bleeding came from microscopic tears from the aortic root perfusion in the OCS.”
Villavicencio later admitted in his deposition that the event made him concerned about the OCS’s future use in transplants.
“Of course, this concerns me. “You know, we remember our bad experiences,” he explained.
Dr. Villavicencio also stated that he had not reported the incident to TransMedics. To date, no investigation has been conducted into his claims that the OCS device may have caused a failed heart transplant.
When KARE 11 contacted TransMedics’ CEO, he stated, “The Mayo comments were about an internal matter for them. We are not in a position to discuss this.
Local Insight
TransMedics lists Abbott Northwestern and M Health Fairview as National OCS Partners, or “NOP’s.” KARE 11 reached out to inquire about their experiences with the devices. M Health Fairview issued the following statement in response:
“Our clinical experience with the OCS device has been positive.” To ensure the best possible care for our patients, we adhere to national transplant standards, employ rigorous informed consent protocols, and carefully evaluate all tools and vendors involved in the transplant process.
At M Health Fairview, patient safety and quality of care are central to everything we do. For nearly 60 years, our transplant program has been a trailblazer in medical advancement, performing over 13,000 organ transplants of all types and pioneering numerous first-in-the-world and first-in-the-nation discoveries.
By utilizing advanced technologies such as organ perfusion, we increase access to life-saving donor organs, significantly improving survival rates and post-transplant quality of life. Our results consistently meet or exceed national averages, and many of the practices developed here have become global standards in transplant care.”