The U.S. Food & Drug Administration deals with the malfunctioning of a medical device which is in violation of an FDA rule. Reasons for violations could include a risk to health or a defective device. If the device requires alteration, adjustment or repair, an inspection is made by the FDA. Use of the device must be stopped and the patient may require monitoring by a physician. When a company’s product breaches FDA regulations, a voluntary recall is likely to be issued by the manufacturer. The FDA, however, does not have the legal authority to require a recall if the company refuses to issue one voluntarily.
Once the recall is declared by the company, they must notify customers directly via a letter and public disclosure. Information must include how to identify the product recalled and how to avoid any potential health risks. The company also devises actions in order to prevent the problem from occurring again. Three “classess” of recalls categorize their severity:
- Class I – most serious type of recall, great effort is taken to notify customer and public.
- Class II – temporary or reversible problems cause a recall. Customer are notified, not the public.
- Class III – violation of FDA happens involving little danger. Only customers are notified.
As a hip replacement recall attorney, I think something needs to change so defective products like the DePuy ASR hip implants wont remain on the market without a recall due to the FDA’s lack of legal authority. They will continue to face DePuy hip recall lawsuits due to the long-term pain and suffering of many artificial hip patients.