A new lawsuit filed August 20 in federal court in Portland sheds light on the enormous financial and human costs of the complex clinical testing that underlies modern pharmaceutical breakthroughs.
The lawsuit, filed by Connecticut-based biotechnology company Immunofree, accuses Oregon Health & Sciences University of enrolling a kidney transplant patient in a risky late-stage clinical trial even though the patient suffered from a number of pre-existing conditions, including diabetes and obesity, that should have made her ineligible for the experimental treatment.
“OHSU failed to follow its own protocols by enrolling the patient in the study,” the lawsuit states. OHSU declined to comment.
The patient, whose name is not disclosed in legal documents, participated in a 2021 trial called Freedom-1, which tested a novel stem cell therapy to reduce the likelihood of side effects after kidney transplants.
But shortly after the 120-participant study began, the patient developed “chronic graft-versus-host disease” and began a course of treatment that includes eight-hour round-trip trips to OHSU for life-saving infusions and has so far racked up a $1.4 million bill.
Normally, the company conducting the study would cover the costs. But Immunofree is citing a clause in its contract with OHSU that requires the hospital to pay in cases of “negligence or willful misconduct.” The company also accuses OHSU of not billing the patient’s insurance and of keeping her “trapped in its system by not allowing the patient to seek medical care off campus.”
Freedom-1 was paused in 2022 after a patient died. The trial was later restarted, but was paused the following year due to layoffs at Talaris Therapeutics, the biotech company that originally started the trial. A brand new company, Immunofree, bought the remnants of the Freedom-1 trial last summer with the promise of revamping it and trying again in the future.
The deal did not go smoothly. Talaris eventually paid Immunofree $4 million to settle allegations that the company “failed to disclose certain information and costs related to a patient in the FREEDOM-1 program,” according to a demand letter cited in a filing with the U.S. Securities and Exchange Commission (SEC). The company estimates that the cost of treating that patient will be $9 million over 30 years.
