The Philadelphia Inquirer reported this week that Katrina McKenzie has filed a lawsuit against Jonathan Garino, M.D. and the University of Pennsylvania Health System following a hip replacement she received as a participant in a clinical trial. The suit alleges that the implants failed and that Garino was influenced by the consulting payments he received from Smith & Nephew, who manufactured the ceramic-on-ceramic hips implanted in McKenzie. He did not disclose the payments to her, which Penn says is a violation of their policy. The suit also alleges that Garino concealed McKenzie's outcomes to avoid jeopardizing the product's bid for FDA approval.
Garino said he was making $20,000 to $50,000 annually from Smith & Nephew at the time of McKenzie's surgery and concedes that he did not tell patients of these payments. The suit will go to trial in August.
McKenzie's allegations reflect a climate of increased scrutiny of surgeons' industry relationships, both from regulatory bodies and patients. Some have suggested that the scrutiny may deter physicians from providing input during product development processes. At the same time, institutional ethics codes aside, the details of some consulting agreements are widely available online, and these public disclosures could increase if the Physician Payment Sunshine Act is passed. Surgeons must become acclimated to heightened transparency.
