May 15th, 2019|
The New York Times recently published a comprehensive look at how patients suffer when companies and regulators fail to effectively screen or monitor defective medical devices on the market.
In the past decade, nearly two million injuries and more than 80,000 deaths have been linked to faulty medical devices, many approved with little to no clinical testing, according to a global investigation.
When a defective medical device is implanted or used in a patient, the results can be catastrophic. Negligence in the product design or manufacturing process can result in serious injuries and death. In these cases, a device intended to help heal someone ends up causing more harm than good.
Even worse, some defects are known and subsequently covered up by a company so that it can sell as many units as possible before an inevitable recall, investigation, and public outrage.
At Cory Watson Attorneys, we investigate all injuries caused by dangerous and defective medical devices, regardless of whether or not a device has been recalled. If you or a loved one was seriously injured by a medical device, contact our personal injury lawyers to get the help that you deserve. Call (877) 562-0000 now or fill out our free online consultation form.
The FDA announced last month that it couldn’t guarantee the long-term safety of vaginal mesh products when used to correct pelvic organ prolapse. These mesh products that have been on the market for decades, unfortunately resulting in harm to tens of thousands of women.
Pelvic mesh has long been tied to life-altering injuries, including nearly 80 deaths as of 2018. Litigation over vaginal mesh is now one of the largest mass tort cases in U.S. history. As these lawsuits have made clear, most of these medical devices were approved for market with nearly no clinical data.
It seems incredible that products meant to reside inside the human body would be used on patients without any proof of safety or effectiveness. But thanks to regulatory loopholes, many medical devices are poorly vetted before their release into the marketplace and poorly monitored after the fact.
Problems can take years to emerge and can be impossible to correct, in part because permanent implants are not easily extracted from the body. When trouble does arise, device makers often redirect blame and patients seeking compensation are forced into lengthy court battles in pursuit of justice.
In the end, faulty products can remain on the market for years without warning.
ESSURE BIRTH CONTROL
Essure, a permanent birth control device consisting of two metal coils injected into the fallopian tubes, has been linked to serious injuries such as device migration, organ perforation, autoimmune disorders, accidental pregnancies, and hysterectomies. The product was pulled from the market last year by its manufacturer, Bayer Pharmaceuticals.
Not only women are affected: There have been hip implants that require painful revision surgery, defibrillators that short-circuit, and artificial heart valves with questionable shelf lives. In operating rooms, there are staplers that misfire; temperature control machines that spray bacteria into open chest cavities; and surgical robots that burn and injure patients.
In these cases, a combination of unreliable regulatory approvals, skimpy post-market surveillance, and faltering responses from companies caused irrevocable harm that might have been avoided.
HOW DOES THIS HAPPEN?
A regulatory loophole enables medical device companies to bring new or “updated” medical devices to market without first testing them in human trials. Companies need only to convince regulators that their products are similar to ones that are already approved, even if the other products are decades old or were subsequently pulled from the market. This loophole is known as the 510(k) pathway.
Industry proponents claim that medical devices can be brought to market quickly and safely by having companies conduct rigorous testing after products go to market instead of beforehand. However, companies often fail to complete such studies, even when they’re ordered by regulators.
What’s more, device makers often ignore rules requiring them to report publicly all incidents of malfunction, injury or illness. And after years of dispute, the medical device industry has still not fully put a system in place to better notify patients of product recalls and other safety issues.
Patients should not have to wonder whether devices will save their lives or destroy them.
At Cory Watson Attorneys, we believe companies must ensure that no medical device intended for permanent residence inside a human body is used on patients without first being rigorously tested.
After investigations by journalists and patient advocates, and even a Netflix documentary, the F.D.A. promised to make “transformative” changes to medical device regulation. The F.D.A. has vowed to fix some of these medical device lapses, promising to abolish reporting exemptions that keep safety issues hidden from the public. Stronger device regulation would help the agency to fulfill its ultimate mission: to protect patients.
It’s true that some of these devices have restored health and provided benefits to millions of people. However, the drive to innovate does not justify the growing list of medical device disasters.
Get Help with Your Defective Medical Device Case
At Cory Watson Attorneys, our defective medical device lawyers believe the makers of these dangerous medical devices should be held accountable for the products they push onto the market.
Don’t pay out of pocket for a medical device manufacturer’s negligence before talking to us. Our experienced legal team can review your case and get you the compensation that you deserve. If you or someone you love has been injured by a defective medical device, we are ready to fight for you.
Call (877) 562-0000 today or fill out our free initial consultation form to get started with your defective medical device claim.
Don’t wait to reach out —time is limited, and your health may be on the line.