FDA Failures, Warnings, and Recalls
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.
Commonly Used Drugs and Devices That Are the Subjects of Warnings, Recalls, and Lawsuits
IVC (inferior vena cava) filters manufactured by C.R. Bard and Cook Medical are particularly vulnerable to breaking down and fracturing inside the body. When an IVC filter fractures, parts of the device – including sharp metal shards – can migrate to other parts of the body where they can cause a range of adverse effects, including:
- Chronic chest pain
- Pulmonary embolisms
- Respiratory problems
- Organ and tissue damage
Sorin Stockert heater-coolers
The Sorin Stockert 3T Heater-Cooler System, which helps keep the body’s organs at a safe temperature and helps keep blood circulating during surgery, was recalled in July 2015 because it was found to transmit bacteria into patients during surgery. Given that most surgical patients have weakened immune systems, these infections can and do lead to severe illness and even death.
Metal-on-metal hip replacements
After tens of thousands of metal-on-metal hip replacements were implanted in patients around the world, researchers discovered that hip replacement devices designed with metal-on-metal or metal-on-polyethylene components fail at higher rates than plastic or ceramic options. Specifically, there is a significant risk that metal debris will release high levels of cobalt and chromium into the bloodstream and surrounding tissue where it can cause cardiovascular, neurological, renal, and thyroid problems, and destroy soft tissue, muscle, and bone.
Even though they remain on the market and millions of Americans take them every day, Invokana and other SGLT2 inhibitors used to control type 2 diabetes have been linked to severe and sometimes fatal health complications, including conditions such as ketoacidosis, heart attacks, kidney damage, severe genital infection, and other problems.
In July 2018, the FDA, along with several health and safety agencies in other countries, issued recalls for numerous medications containing Valsartan, one of the world’s most widely prescribed drugs for the treatment of high blood pressure, after discovering the presence of N-nitrosodimethylamine (NDMA), a known carcinogen.
Physiomesh was one of the most widely used hernia mesh implants before the manufacturer withdrew it from the market in May 2016 after FDA warnings and reports of serious complications. Made of the flexible composite mesh called polypropylene, Physiomesh can degrade and enter the bowels causing the need for further surgical procedures to remove the mesh and damaged tissue. Additional complications experienced by patients who received a Physiomesh hernia implant include:
- Bowel perforation or obstruction
- Removal surgery
- Mesh migration, rejection or shrinkage
- Hernia recurrence
- Abdominal infection
- Organ removal
- Nerve injury
- Blood vessel damage
- Intestinal blockage
Berman & Simmons: New England’s Premier Dangerous Drug and Defective Medical Device Law Firm
When pharmaceutical companies and medical device manufacturers put profits before patient safety, the attorneys at Berman & Simmons are prepared to hold them accountable. With a long record of success in such cases and more resources than any other firm in New England, our team of experienced lawyers will make sure you receive full compensation for your injuries.
We’re proud to be the trusted firm in Maine for people who have been seriously injured and families that have suffered losses through no fault of their own. We are recognized as the best personal injury and medical malpractice law firm in Maine and among the best in the U.S. We have obtained several of the largest personal injury jury verdicts and settlements in Maine history, recovering over $1 billion for our injured clients and their families.
The first step in determining whether or not you have a valid claim is a free consultation with one of our attorneys. We will conduct a thorough review of your medical records and answer any questions you might have. There are strict statutes of limitations in dangerous drug and medical device cases, so it’s crucial to get in touch with us as soon as possible if you believe you have a claim.
Please contact the Maine dangerous drug and defective medical device attorneys at Berman & Simmons today at (207)784-3576 to arrange for your free consultation. You pay nothing unless we obtain compensation for you by settlement or jury verdict.