13 May Medical Device Recalls Double in Last 10 Yrs, Shows FDA Report
The number of medical device recalls issued by the FDA has nearly doubled since 2003, as federal regulators have significantly increased recalls on devices used in various aspects of medical care. Some of the medical devices that have been the focal point of these recalls (as well as public scrutiny and, in some cases, federal product liability litigation) have included (but are not limited to) metal-on-metal hip implants, blood glucose monitors and defibrillators.
News regarding the significant spike in FDA medical device recalls was recently brought to light by a report compiled by the FDA’s Center for Devices and Radiological Health Office of Compliance. The details of this report have started to engender a number of new questions, as many are wondering why the increase in medical device recalls has been so substantial.
Specifically, there are growing concerns regarding whether the increase in recalls points to increasing negligence on behalf of the device manufacturers or potentially even the regulators themselves.
Could Loopholes in FDA Approval Process Be a Factor?
Although traditional means for obtaining FDA approval of medical devices requires extensive safety evaluations of these devices, there is a loophole in this process that can be to blame for some dangerous and defective medical devices making it to market.
Namely, the FDA’s 510(k) application allows manufacturers to:
- Get around having to conduct clinical trials on their devices
- Obtain FDA approval by contending that their new device is substantially the same as another device already approved by the FDA and already available to the public.
While this controversial process has been the subject of some scrutiny, it may also be responsible (at least in part) for the surge in FDA medical device recalls over the last decade.
Phoenix Product Liability Lawyers at the Law Office of Richard Langerman
You have a choice in the lawyer you hire to handle your claim, and the choice you make can affect the compensation you receive. Make sure that your lawyer has the ability and experience to handle your case. If dangerous or defective medical devices have been the cause of your serious injuries, the Phoenix product liability lawyers at the Law Office of Richard Langerman will fight to help you obtain the highest possible settlement to cover your injuries and losses.
For more than 25 years, our attorneys have been representing clients and aggressively defending their rights both inside and outside of the courtroom against defense attorneys, corporate lawyers and insurance company agents alike. In addition to having extensive experience handling dangerous medical device lawsuits, our attorneys are also skilled at overseeing various product liability cases, motor vehicle accident cases, insurance bad faith cases and various other types of personal injury cases.
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