Last week, the Senate proposed a bill purporting to accelerate the FDA’s review times for medical devices. The proposed legislation would relax current conflict of interest rules that apply to FDA advisers, reversing an existing law. Currently, federal law prohibits an expert with a financial stake in medical device companies or competitors from serving on an FDA advisory panel.
Congress implemented these conflict of interest rules to remove corporate self-interest from FDA advisory panels. But since the implementation of these rules, critics have alleged that the current law prevents the release of new medical devices to consumers. The new legislation could benefit consumers by shortening the waiting period for cutting-edge medical devices.
This proposed legislation could also have unintended effects. Most notably, the legislation could also increase the number of dangerous medical devices on the market, endangering the health and safety of patients as biased FDA advisors could lead to the release of medical devices without adequate testing or warning to consumers.
Medical device manufacturers have a duty to adequately test medical devices, to safely build their products, and to inform consumers about any dangers or risks associated with the product. If a medical device manufacturer breaches this duty, it can be held liable for resulting injuries to consumers.
If you or a loved were injured by a medical device, you should speak with an experienced attorney who can assist you in analyzing your legal claims. For questions, contact Broussard, David & Moroux at 1-888-337-2323 (toll free) or 337-233-2323 (local).