A new lawsuit filed against Oregon Health & Science University sheds light on the risks of drug trials, with an OHSU employee alleging the university enrolled her in one that caused permanent nerve damage.
Susan Woods worked for OHSU while also a patient there when an OHSU administrator asked her to participate in a trial of an investigational new drug known as JK07 that may have potential to treat heart failure. She was not warned that the drug could cause potential neurological or neuromuscular disorders, the suit claims.
Soon after an infusion of the drug in October 2022 at the OHSU hospital, she began to experience “multi-focal neuropathy,” according to the suit, with symptoms that included pain, loss of sensation and diminished or loss of use of her hands, fingers, arms and legs.
OHSU did not immediately respond to a request for comment.
Woods, who had worked as a computer analyst, no longer works for OHSU.
“Had Susan Woods been informed of the drug's risks of neurological, muscular, and/or neuromuscular disorders, she would not have participated in the investigational drug study,” according to the suit, calling the injuries “serious and permanent.”
The suit is the second one in five weeks to accuse OHSU of improper conduct of drug trials. In August a biotech firm sued the university saying it had improperly enrolled a patient with preexisting conditions in one of its drug trials, leading to a disease that has required $1.4 million in medical bills for treatment.
The new complaint filed on behalf of Susan Woods also names Salubris Biotherapeutics, Inc, a Maryland-based subsidiary of a Chinese corporation, contending it failed to inform OHSU of the risks. According to the company’s website, JK07 has completed Phase 1 of its trials, intended to gauge safety, and it is in Phase 2 of trials to ascertain whether the drug is effective. Salubris did not immediately respond to a request for comment.
The suit, filed by The Corson & Johnson Law Firm and Scannellaw, seeks up to $5.75 million in damages.
