During a recent recall compliance audit, the FDA discovered that King International has closed its doors and abandoned any attempt to recall its ShoulderFlex Massager. King International, in cooperation with the FDA, initiated the recall of its ShoulderFlex Massager on August 31, 2011. At the time, the FDA was aware of reports of one strangulation death and one near strangulation death. Because of these adverse events, the FDA classified the recall as a Class I.
A Class I recall is the most serious type of recall. The FDA uses this high-risk distinction only when there is a reasonable probability that the product will cause serious adverse health consequences or death. A recall's classification determines not only the steps the company has to take, but also the FDA's level of oversight. For any class of recall, the FDA's main goal is to ensure that the actions taken by the company are adequate to protect the public health. In a Class I recall, the FDA conducts a number of audits to make sure the company's recall efforts are appropriate and effective.
What the FDA discovered during its most recent audit of King International's recall efforts is startling. King International has gone out of business; the 1-800 number established by the firm for the recall is no longer in service; and many of the retailers who sold the massager are either unaware of the recall or did not properly notify consumers who purchased the product. In short, King International has failed to follow through and comply with appropriate FDA recall procedures.
The FDA views a recall as a voluntary action that occurs when manufacturers and distributors carry out their responsibility to protect the public health and well being from products that present a risk of injury to consumers. The responsibility for an adequate recall belongs to the manufacturer or distributor. The level of involvement and timing of the FDA's intervention does not change the company's obligation to take appropriate action.
In this case, by closing its doors without effectuating an adequate recall, King International has failed to carry out its responsibility to protect the public from its defective massagers. Its inaction violates FDA regulations, is contrary to good industry practice, and places all consumers at serious risk. Companies like King International must be held responsible for their own actions and liable for the damages their defective products inflict on innocent consumers.
The attorneys of Jones Ward PLC represent hundreds of persons all across the country who have been injured by defective products, prescription drugs and medical devices. If you or someone you know has been injured by a ShoulderFlex Massager or any other type of product, contact attorney Terrance Massey. You can reach him by phone at (502) 882-6000 or by email at tj@jonesward.com.
