A patient has a right to know if there is an element of risk inherent to a medical procedure or treatment. Without that knowledge, a patient can hardly be deemed to have made an informed consent. Yet a recent article questions whether medical device innovations truly put a patient’s best interests in the forefront.
The author goes so far as to characterize medical device product development as a separate process from risk management, aka protection from lawsuits alleging injuries or wrongful deaths from the device. Although a medical device manufacturer generally must submit a medical device to the U.S. Food and Drug Administration for premarket approval, much of the FDA’s analysis relies on the manufacturer’s own testing data. If that data was incomplete, a patient’s safety may be at risk.
True, a doctor that recommends a medical device may not be privy to the product’s entire testing data. However, a doctor has a duty not to overstate the safety of a new device. A doctor must communicate any known risks to his or her patient, as well as whether a device’s long-term impact is unknown.
Our law firm has helped surviving loved ones bring wrongful death lawsuits arising from a variety of contexts, including medical negligence. We utilize civil discovery techniques, even a subpoena, to obtain the information we need to conduct a thorough investigation.
We also have established relationships with medical experts. Working together, we analyze the information we have obtained. If a patient suffered a fatal reaction to a device, we may question whether the device should not have been recommended in the first place. Our approach is similar in other types of medical mistakes, as well, such as medication errors, misdiagnosed conditions, or surgical errors.
Source: MedCity News, “3 tips for applying risk management across medical device product development,” Jon Speer, May 26, 2016