SPECIAL REPORT:
MEDICAL DEVICE RECALLS REMAIN SERIOUS BUSINESS
While the FDA rarely “officially” mandates a recall, savvy medical device manufactuters understand that the agency can apply pressure in subtle and not so subtle ways to “encourage” a firm to issue a mandatory recall.
“The FDA usually asks companies to do it,” says Pam Forrest, partner with King & Spalding and a leading attorney and writer covering medical devices. “But the FDA’s implicit message is that it takes enforcement seriously.”
A quick review of recent FDA warning letters for what it deems potential serious threats to the public health – Class I recalls – shows that the agency has remained relatively consistent in its enforcement pattern going back several years. For example, the FDA posts the most serious medical device recalls that it deems pose a “reasonable chance” that they could cause serious health problems or death. Looking at that data, we find ten such medical device recalls posted in 2008 (through Nov. 6, 2008), 24 in 2007, 13 in 2006, 27 in 2005, and 26 in 2004.
Forrest for one isn’t certain if there are more device recall problems today because of company practices, or because more is simply being reported today. “I think the FDA has become stricter in its interpretation [in this area] in the past several years,” Forrest says.
Forrest says the clearer trend is that the FDA now fully expects companies to publicly report their recall actions almost regardless of how serious the recall is. “I see more FDA enforcement in the required reporting of what would normally be classified a Class I or Class II recall” she says (see box).
Former FDA Chief Counsel Sheldon Bradshaw, who left the FDA in late 2007, and is now with the Food & Drug Practice at Hunton & Williams LLP, says most device recalls are about mislabeling, GMP violations or the making of claims for the device that cannot be adequately backed-up.
He also says he saw a trend when he was an inspector: Larger companies buying smaller medical device companies often did not do adequate due diligence. The result? They would end up buying a company with a looming device recall on the horizon.”The key is to be diligent during your acquisitions,” he stresses.
Bradshaw also advocates thorough due diligence during mergers and acquisitions, and also regular FDA mock audits to make certain a medical device manufactures’ system is up to FDA standards. During those audits it is important to make certain your CAPA system is strong and that your GMP is sound.
Finally, a word of warning. When it comes to medical device liability, a recall situation can become a strict liability criminal offense. In other words, defendants to not have to prove that you knowingly made a faulty product that could cause harm. The only burden on them is to demonstrate that the product is harmful.
And that makes understanding, handling and, if possible, all together avoiding medical device recall situations all the more important.
BACKGROUND:
When a company recalls a medical device, it
- contacts directly the customers who received the product from them, and takes steps to reach others who need to be notified (for example, by issuing press releases or providing detailed instructions);
- supplies information to help users identify the product and take steps to minimize health consequences; and
- takes action to prevent the problem from happening again.
FDA oversees each recall to make sure that the actions the company takes are adequate to protect the public health. During a medical device recall, FDA
- works with the recalling firm to obtain information about the product, the problem, the recall strategy, and the steps to prevent the problem from happening again;
- conducts audits to make sure the recall efforts are appropriate and effective;
- makes sure the company takes necessary actions to prevent the problem from happening again.
FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, Class II, and Class III. This classification process usually takes place after the company has issued its recall.
Class I
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High risk
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Class II
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Less serious risk
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Class III
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Low risk
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