Over the past decade, recalls of defective and dangerous medical devices have nearly doubled in the United States. There has also been a substantial increase in defects that could cause very serious injury or death, rather than minor faults. Medical device recall lawyers at Pintas & Mullins Law Firm examine how and why the recall rates are increasing.
In 2003, just over 600 medical devices were nationally recalled; by 2012, that number jumped to 1,190. A few years ago, the Government Accountability Office wrote a report noting that device recalls often were not announced until it was far too late to prevent injuries in patients. One example of this type of negligence occurred in 2007, when Medtronic recalled its Sprint Fidelis defibrillator wires, which are implanted in patients with irregular heartbeats.
These defibrillator wires were recalled because they could fracture while inside patients, causing death or very serious injury. Some patients did die, because by the time Medtronic decided to recall the wires they had already been implanted in thousands of people, many of whom had no idea there was a recall at all.
A Class I recall is the most serious type of recall, reserved for devices that have reasonable potential to cause devastating injury and death. One of the most recent Class I recalls was initiated in August 2013 by Medline Industries. The company recalled its ACME Monaco Guidewires, similar to the Medtronic defibrillator wires, because the coating could flake off the wires.
Recalls with Real Consequences
An executive at AdvaMed, a medical industry trade group, stated that the spike in recalls can be attributed to device manufacturers being more conscientious and pro-active approach to FDA compliance. Other experts wonder if the recalls are reflective of a more serious problem – the lack of rigorous federal oversight during the premarket approval process.
Some officials note that, had the FDA required more testing on these medical devices before they were approved for sale, some recalls could be avoided completely. However, it is a significant step forward that the federal government is making attempt to analyze this information at all.
When a recall occurs, patients can request repair kits or go to the hospital to receive a replacement device, free of charge. If the recalled medical device is implanted inside the patient, however, the remedial options are often detrimental to the patients.
Take for example, the recent massive recalls of
metal-on-metal hip implants due to high rates of premature failure, dislocation and metal poisoning.
Patients who require hip implants are already vulnerable to injury, and
forcing them to undergo painful and often risky revision surgeries to
remove and replace the recalled hip is incredibly negligent and certainly
not in the best interest of the patient.
For this reason, companies that manufactured and sold metal-on-metal hip implants are now facing massive litigation. Any patient who was implanted with an all-metal hip can take part in the lawsuits, as it is now widely known that they are inherently defective and in some cases poisonous. Manufacturers have already set aside billions of dollars to settle these suits, which will compensate patients forced to undergo revision surgeries and uproot their lives because of the defective hips.
Unfortunately, it is likely that medical device recalls in the upcoming years will only continue to increase, at least until the FDA’ premarket approval program is updated or reformed. If you or someone you love was seriously injured by a recalled or defective medical device, contact our firm immediately to discuss your legal options. Patients injured through the negligence of medical manufacturers should not have to pay for their own suffering – the company should beat the responsibility and costs. Our dangerous medical device attorneys offer case reviews are free, confidential, and available to patients nationwide.