In a free-market in which pharmaceuticals and medical devices are manufactured and sold by private companies, who is should be held accountable for product safety? In the U.S., the FDA has the responsibility of approving and regulating drugs and medical devices. But the large number of product recalls, adverse event reports, and major drug shortcomings and failures lead critics to wonder of the FDA is really doing its job appropriately. There are huge loopholes in the system that allow drug companies and medical device manufacturers to produce and market devices that really are not safe for general use. One glaring example is exemplified by da Vinci robot surgery lawsuits, which have been brought against Intuitive Surgical for making false advertising claims about the efficacy of the surgical robot. These same marketing brochures have been reproduced by hospitals throughout the nation to attract patients to robot surgery. Patients looking to hospitals for medical advice and information are, in many cases, actually reading information that was crafted and produced by the manufacturer and has not been approved by any medical board.
Studies prompted by da Vinci robot surgery lawsuit cases and the larger scandal around the device show the most Americans look to hospital websites to learn the opinion of the facility’s doctors. The truth of the matter is that these materials are written or compiled by marketing teams, not doctors. The FDA does not regulate what information is offered to patients through these sources. Intuitive Surgical’s claims about the benefits of robot surgery are generalizations that are not backed by sound evidence. The advertising materials don’t say what the procedure is better than – and upon conducting a small amount of research, patients would quickly learn that many surgeons say laparoscopy has similar results and fewer risks. The risks associated with this new technology include unintentional cuts, lacerations, and perforations that damage internal organs and tissues. Cases have been reported of people who only learned of internal injuries after being sent home from their surgery because they started to develop serious health problems. There have been instances of patients requiring numerous surgeries to repair the problems caused by robot surgery, and others who have died as a result of their injuries.
Given the major health risks this device poses to patients, there begs the question: Do hospitals have a responsibility to warn patients of the risks associated with the procedures offered at their institution? Or perhaps the responsibility lies with patients to conduct in-depth research to learn about the problems with the surgery? Others argue, including da Vinci robot surgery lawyers, that the manufacturer, Intuitive Surgical, should be held responsible for claims made in their written materials. The risk factors associated with robot surgery have not routinely been disclosed by the company in their marketing campaigns. At the very least, proponents of increased regulation of these advertising materials say the company should be obligated to cite studies that back up their claims, and also to disclose the risk factors associated with the procedure.