Just Because a Drug or Medical Device Is “FDA-approved” Doesn’t Mean It’s Safe
When we get sick or hurt, when we want to know why we’re not feeling well and how to improve, trust plays a central role. We trust our doctors to know what they’re doing when diagnosing and treating our ills. When those doctors prescribe medication or recommend the use of a medical device, we also place our trust in the system created to ensure that those drugs and devices are thoroughly tested, reviewed, and determined to be safe before they enter the marketplace.
Tragically and all too frequently, however, the U.S. Food and Drug Administration (FDA) and the pharmaceutical and medical device companies it oversees breach that trust.
Drugs and devices that should never have been allowed on pharmacy shelves or in operating rooms have hurt millions of people and led to the deaths of tens of thousands more over the past decade alone.
While the FDA issues warnings and drug and device manufacturers recall products with alarming regularity, they usually do so only after those products have already caused substantial harm to patients or left families wondering how a drug or device that was “FDA-approved” could lead to the death of their loved one.
When the FDA Fails to Do Its Job, Clients Turn to Berman & Simmons
At Berman & Simmons, Maine’s premier dangerous drug and medical device law firm, we see clients every week who ask that same question. They can’t understand how a government agency whose mission is to protect the public from harmful medications and devices allows so many flawed products to reach patients. They express anger when they learn how often big pharmaceutical companies and device manufacturers who stand to make billions in profits rush products to market without adequate testing or while ignoring red flags about potential dangers.
And those clients turn to us to hold greedy pharmaceutical and medical device companies accountable, expose the flaws and failures of the FDA in giving their blessing to such harmful products, and get them the maximum amount of compensation for their suffering and losses.
What the FDA Does – And What It Doesn’t
The federal government established the FDA in the early part of the 20th Century to ensure both the safety and efficacy of drugs (and later, medical devices) prior to marketing. Before then, “snake oil” salesmen would peddle magic elixirs, miracle cures, and wonder drugs that offered relief from all kinds of ailments but were effective at nothing other than separating Americans from their hard-earned money.
Over the years, the FDA developed regulations and standards that companies needed to follow and satisfy before they could start selling drugs and devices to the public. These standards were designed to ensure that manufacturers conducted ample testing on products; that they had sufficient data and scientific evidence to support any claims about what the products would do for patients and reveal any potential harm or side effects those products could cause.
Unfortunately, as detailed in both sprawling investigative reports and television exposes released in 2017, flaws and loopholes in these processes have allowed dangerous and defective drugs, devices, and implants to reach the market prematurely without satisfying the requirements that should have stopped them in their tracks. Additionally, manufacturers blinded by dollar signs can cut corners or misrepresent the results of their testing to get approval as quickly as possible.
That is why you see so many news stories about drug and device warnings and recalls. That is also why you see such stories only after these products have already hurt or killed hundreds or thousands of patients.
FDA Warnings and Recalls
FDA warnings and manufacturer recalls often occur only after reports of adverse health effects, injuries, or deaths make their way to the FDA through patient, manufacturer, and physician reporting processes or subsequent studies. It is important to note that some voluntary recalls do not necessarily mean a device is dangerous or defective.
The FDA maintains its MAUDE database to collect reports of problems and adverse events associated with medical devices, and its MedWatch Safety Information and Adverse Event Reporting Program collects reports of adverse events and announces any warnings and recalls regarding drugs and medical devices.
Several widely used and implanted devices have been the subjects of warnings, recalls, and thousands of lawsuits by injured patients and their families over the past decade. These products have also led to thousands of lawsuits for compensation and billions of dollars in damages recovered.
