Recent developments surrounding the U.S. Food and Drug Administration’s (FDA) medical device regulations raises serious questions about the agency’s liability in personal injury lawsuits. Developments surrounding four medical devices—inferior vena cava filters, the Essure permanent sterilization implant, transvaginal mesh products, and superbug-infected duodenoscopes—have raised red flags over the efficiency of the FDA’s regulations.
Flaws in FDA approval process
In recent lawsuits, testimonies have begun to focus on the convoluted and often slow-to-react FDA approval processes currently in place. A Northwestern University research study revealed that certain medical devices were approved by the FDA based on flawed research data. In addition to the study’s findings, emerging issues with the approval process include:
- The majority of Class III (highest-risk) devices approved between 2000 and 2015 have demonstrated severe problems.
- Four devices failed to demonstrate efficacy in clinical trials.
- Six devices weren’t required to submit to post-market studies to evaluate ongoing safety.
- Three devices were eventually withdrawn from the market post-approved.
- Two of these devices were not reviewed by FDA physician experts and the remaining device was reviewed but not recommended for approval.
- Some of the approval trials for the Essure birth control device were based on the patients’ pregnancy rates one year after placements—meaning that a permanent device’s efficacy was only measured up to one year.
- The FDA doesn’t specify clinical trial requirements for all premarket approvals.
- The 21st Century Cures Act currently pending Senate approval broadens the interpretation of “valid scientific evidence” used to evaluate a device’s safety. This looser interpretation could cause devices to become approved with a lower standard of scientific evidence.
Bills for change?
Congress is starting to get involved and we have recently seen a number of new bills seeking Congressional approval:
- Ariel Grace’s Law — Removes Essure’s federal preemption shield and opens Bayer to liability for personal injury and wrongful death lawsuits.
- Medical Device Guardians Act — Enforces the American Medical Association’s Code of Medical Ethics’s mandate that places adverse event reporting—when problems with medical devices and medications are formally reported—responsibility onto physicians. It also protects physicians’ FDA reports from civil lawsuit liability.
- An earlier bill dubbed the E-Free Act sought to remove Essure from the market but has since stalled in Congressional approval.
The Medical Device Guardians Act is the more important of the two new bills in legislative efforts toward FDA policy reform. In its current state, the FDA’s policies for adverse event reporting make the process voluntary for medical professionals and consumers with no incentive for filing reports. The Act aims to offer an incentive of legal protection to medical professionals in the event that a device or drug manufacturer is sued over a product the medical professional provided.
Several legislators contend that the FDA’s regulatory policies have needed reform for years, but little has been done to protect civilians over manufacturer interests. This is not just a manufacturer problem. The questions that are now being raised include:
- Who at the FDA is approving these devices despite the inefficient research?
- Who/what is obstructing policy reform?
- Can these people and/or the FDA be held legally accountable alongside the manufacturers?
Can the FDA be sued?
While in most situations citizens cannot sue government agencies, the Federal Tort Claims Act (FTCA) governs the special circumstances in which citizens can. Damages caused by a federal employee from negligence, wrongful action, or failure to act may make the government liable for lawsuits.
There are strict limitations to filing lawsuits under the FTCA, including statutes of limitations and who can be sued. Before you can sue, you must file a claim to the government agency under which the offending employee works within two years from the point of the incident. It is important to note that lawsuits against the government cannot demand punitive damages—only the actual damages made in the claim.
While this is new territory for most cases, experienced personal injury lawyers are looking to hold the federal government accountable for their role in the injuries suffered by consumers. This is an emerging area of the defective medical device law. If you were injured by a medical device, contact an attorney to learn about your legal options.