Law suits by clinical trial participants are coming … that’s right and if you are a clinical investigator, the legal profession has found a new angle compensation for participants of clinical trials. Sue everyone involved and if they forgot to disclose some relationship they had with industry, even better.
This case was discussed in After Hip Replacements, a lawsuit the second story of a two part series in the Philadelphia Inquirer on the relationships between orthopedic surgeons and the device industry.
The manufacturer, Smith and Nephew, an orthopedic surgeon, Jonathan Garino, MD and his institution (University of Pennsylvania Health Systems) are being sued for a hip replacement surgery testing a new device that didn’t quite work in this patient’s case.
In the case they are bringing up that the physicians’ lack of disclosure to his patient for royalties and consulting payments he received, served as a conflict of interest to enroll the patient.
At the time of the surgery, Dr. Garino estimated he was earning $20,000 – $50,000 for consulting fees and royalties. He was paid $200 – $400/hour to instruct other surgeons on how to us devices, surgical techniques, royalties for product development and ideas on how to improve current and future products.
The lawsuit is scheduled for August.
It is important to remember that in clinical trials many new compounds and devices hurt vs. help the patient. The purpose of clinical trials is to determine whether the treatment works or not. If successful, this case will open up a whole new area of law suits and will serve as a huge disincentive for clinical trialists.