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Consumers seeking important safety information about their medical devices are often confused about the different terms that are used by specific manufacturers, the industry as a whole and the Food and Drug Administration (FDA). Attorney Neil Overholtz, a Florida attorney whose firm assists consumers with medical device cases, explained what recalls, product advisories and field actions really mean.

Recalls

The FDA may force a manufacturer to recall a dangerous or defective product or a manufacturer can do it voluntarily. All FDA recalls are classified as Class I, Class II or Class III. Here’s what each of these mean:

• Class I: The most severe classification where there is a potential for serious injury or death.
• Class II: A less severe classification where there is a lesser potential for major injuries or death, but where there is still the possibility of serious enough adverse events to have irreversible consequences.
• Class III: The least severe classification where there is an unlikely potential for adverse health consequences, but there is still a chance and therefore the product is being recalled.

Product Advisories & Field Actions

Medical device manufacturers don’t particularly like to label a ‘recall’ as a ‘recall’. Overholtz explained:

When the Guidant / Boston Scientific ICD (implantable cardioverter defibrillator) litigation first started, we learned early on in depositions that manufacturers do not like to use the term ‘recall’. They like to call them ‘product advisories’ or ‘field advisories’. In fact, Medtronic would never refer to anything as a recall. They always referred to it as a ‘Medtronic Field Action.’ That’s how these manufacturers classify them – but that’s all from the company’s perspective. Regulations require manufacturers to notify the FDA of these actions. When the FDA is made aware of a product or field advisory, it will immediately classify it as a Class I, Class II or Class III recall.

The FDA has to classify what Guidant, Boston Scientific, Medtronic or any other medical device manufacturer does. Sometimes the FDA doesn’t classify it as a recall at all and then it's just left as an advisory on the manufacturers’ web page. However, I can tell you from experience that I think there were over 75 different Guidant product advisories since 2005 and every single one of those advisories has now been classified as either a Class 1 or a Class 2 recall by the FDA.

Why manufacturers avoid the ‘R’ word

Medical device manufacturers clearly want to avoid using the dreaded ‘R’ word – RECALL. We asked Overholtz to explain these tactics. He told us, “When the FDA classifies something as a recall, it sends out a pretty scathing letter. An official Class I recall comes with a letter that becomes a very important exhibit in fighting the liability of the case and any pre-emption issues. It describes the product as ‘violative’, forces the manufacturer to comply with the terms of the recall and reserves the right to raid the manufacturer’s premises and forcefully seize the product.”

If you or a loved one has been injured by a defective medical device, contact an attorney whose practice focuses in this area of the law. To contact a qualified attorney for a free, no-obligation consultation, please click here.