TOP NEW YORK PRODUCTS LIABILITY LAWYER CAUTIONS CONSUMERS REGARDING DISCREPANCIES IN FDA RULES AND REGULATIONS
One of the lesser-known, but critically important responsibilities of the U.S. Food & Drug Administration (FDA), is to monitor reports of adverse events and other problems involving medical devices, and alert health professionals and the public when needed to ensure proper use of devices; and to protect the health and safety of patients. The public tends to think of the FDA as the watchdog of the pharmaceutical and food and beverage products industries only.
“The process is rigorous,” explains Jay W. Dankner, managing partner in the top New York products liability law firm of Dankner Milstein, P.C. “FDA protocol requires manufacturers to design and manufacture medical devices in accordance with the agency’s strict specifications.”
However, Dankner cautions, consumers should take heed of an important distinction between medical devices and prescription drugs. According to Dankner, laws that could impact the outcome of a civil lawsuit brought by an individual who has been injured, or sickened, by a medical device — like knee and hip-replacement joints – differ from those laws that apply to someone who has been injured, or sickened, by an ethical pharmaceutical product — such as Actos, Avandia, Heperin and Propecia, among many others.
“If someone is injured by an FDA approved medical device,” Dankner explained, “his, or her, claim of defect will be pre-empted, or better said, extinguished, if the manufacturer can show that it designed and built the product in compliance with FDA rules and regulations.
“That’s unfair,” Dankner added, “when you consider that the same rules that protect manufacturers of medical devices don’t always apply in cases when manufacturers of prescription drugs are at fault. Recoveries for plaintiffs in claims against a drug company – all of whose products must first receive FDA approval before they can be prescribed and sold in the U.S. — are more likely than they typically are when the defendant is a medical device manufacturer whose products have been FDA approved.”
Dankner explained that’s why you see plenty of attorney advertising asking if you have had a reported side effect from a controversial drug currently on the market. Conversely, he continued, you hardly ever see similar advertisements highlighting problems with medical devices, with some egregious exceptions, of course, like the transvaginal mesh implant and the DePuy hip replacement joint.
But, according to Dankner, these discrepancies in the law are not always so clear-cut.
“At our products liability law firm,” Dankner added, “we have successfully recovered compensation, considerable at times, for victims of medical device defects, even in instances when those devices had obtained prior FDA approval.
“In those cases,” he added, “when our products liability attorneys were able to prove that the manufacturer of a medical device did not comply with strict FDA procedures we have, in spite of the legal anomaly, been able to prevail in court on behalf of our clients.”
For more information about how the FDA classifies and regulates medical products, consumers can visit the following websites:
“FDA Classification of Medical Devices”. U.S. Food and Drug Administration.
“FDA Medical Device Registration and Listing”. U.S. Food and Drug Administration.
“FDA Overview of Medical Device Regulation”. U.S. Food and Drug Administration.