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Why the FDA can't protect patients from hazardous medical devices

Most Americans consider the F.D.A a line of defense against dangerous food, pharmaceuticals, or medical devices, but by the agency’s own admission it is understaffed and underfunded. What’s more, just because a product has the F.D.A stamp of approval does not mean it is safe.

The F.D.A is crippled with a lack of funding and an inspection agency that is spread too thin. Every year, the F.D.A approves mounting numbers of new drugs, but does not have enough staff to adequately inspect those products. With such a high demand for product inspection mixed with a lack of personnel, it is easy to understand how products can be rushed through F.D.A inspections.
  • Consumers pay the price for FDA’s lack of staff and funding
The person who pays that high price is you, the consumer, with life-altering or even fatal consequences due to dangerous drugs or devices that were improperly tested before marketing to the public.
  • Recent examples of medical device product recalls
The most recent example is the recall of defibrillators, specifically St. Jude Medical, Riata and Riata ST Silicone Defibrillation Leads. The leads are implanted in 79,000 patients in the United States.
The products have a unique failure mechanism where the conductor cables wear through the insulation and end up outside the body of the lead (“externalized conductors”). If this occurs, this product may cause serious adverse health consequences, including death. The externalized conductors may not be detected until they are seen on radiography or fluoroscopy or until the patient has an adverse event.
  • Who can be held liable for defective products?
Recent product recalls like the DePuy hip implant recall have made it clear that the Food and Drug Administration cannot protect consumers from dangerous and faulty medical devices.
At a time when pharmaceutical drugs and medical devices are becoming increasingly complex, the agency credited with keeping us safe simply cannot keep up with the flood of medical products and drugs being approved. The only way to draw attention to this issue is to hold the companies responsible liable for defective products or dangerous drugs.
  • What to do if you are injured by a recalled product
If you are injured by a defective product or a recalled product the best recourse is to make sure those companies hear you by filing a personal injury lawsuit. This is the only way to make big corporations listen and take notice. This is one method of keeping these companies in check, since consumers cannot rely on the F.D.A to catch every dangerous product before it goes on the market.

If you or a loved one were harmed because of a recalled or defective product, contact our personal injury lawyers to review your case for free. Our office operates on a contingency fee basis, which means if we do not make a recovery for you, you owe us nothing. We currently represent clients in defective product lawsuits, including DePuy hip implant recall cases.

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