Medical device companies want their products to hit the market as soon as possible. After all, they incur almost all of their costs upfront during research and development, and they can’t begin to offset these significant costs until the device has received FDA approval. This desire often stands contrary to the interests of public health, which relies on through testing and strict controls concerning medical device regulation.
Legislation allows the FDA to bypass some parts of the regulation process in certain circumstances to “fast track” devices for approval. While they claim that this allows for a more streamlined approval process, the consequences of a medical device – such as a power morcellators or IVC filters – that do not receive adequate clinical trials can be disastrous for patients. If you or a loved one have been affected by this negligence in medical device regulation, you need an experienced products liability attorney to help you seek the compensation you deserve for the pain and suffering you have experienced.
How the 21st Century Cures Act Could Affect Medical Device Regulation
One of the components of the 21st Century Cures Act, which was passed by the House of Representatives last summer and scheduled for debate in the Senate in September, would allow companies that market medical devices to provide evidence of safety based on sources other than clinical trials. In other words, they would not be required to conduct a clinical trial. For certain devices and drugs such as new antibiotics, the organization tasked with ensuring the safety of all medical products for the American public will use results of case studies in place of normal processes in multiphase clinical trials. Proponents of the act claim that it is necessary in order to modernize the FDA approval process. Meanwhile, opponents counter with the argument that this statute may result in the approval of products that haven’t met the necessary safety standards typically required.
The normal FDA approval process is a long and detailed process, but its existence is integral to protecting patients from unsafe drugs or medical devices that can cause serious medical complications or even death.
Processes Failed with Power Morcellators and IVC Filters
One of the most notable instances of device failure following FDA approval is the increased cancer rates due to the use of power morcellators. Power morcellators were used by surgeons in hysterectomies, but later evidence showed a link between the devices and rates of uterine cancer in women following their use. Manufacturers were allowed to go through the FDA’s clearance process and then monitor potential side effects themselves. They later failed to inform the FDA upon learning of the link between their devices and uterine cancer.
In another case, there is evidence that during clinical trials of retractable IVC filters, there were known problems with the device. This evidence was suppressed and the manufacturer C.R. Bard may have known that their IVC filters could put patients at risk. C.R. Bard kept the product on the market even after they had a study commissioned that showed a greater risk for complications than competitor’s filters. Doctors and patients were left unaware of the potential risks of using a retractable IVC filter.
The Medical Device Guardian’s Act and the Future of Regulation
Legislation was recently proposed that would shift the responsibility of reporting side effects to the FDA from the manufacturers to the doctors. The Medical Device Guardian’s Act is based on the view that doctors are usually the first people to notice the effects of a device and are seen as having less of a vested interest when it comes to reporting to the FDA.
The FDA can fast track “breakthrough” medical devices that are needed or in demand, but there are many instances where they are not thoroughly tested before hitting the market. A products liability attorney will fight for you or your loved ones that experience adverse side effects because of a device was not tested thoroughly, potential side effects and complications were not made clear to you, and when there wasn’t a device recall when problems first arise.
Have you or a loved one have experienced side effects due to the use of a medical device? Submit your case to a product liability attorney for a free legal review today. We can review your case and help you determine the legal steps to take next, as you could be entitled to significant legal compensation for your injuries.