Defective Medical Devices: Lawyers, Lawsuits, and RecallsBrian Julkunen / 0 Comments /
Defective medical devices are surprisingly common. FDA records show that more than 60 defective medical devices were recalled in 2013. Seven more were recalled in January of 2014 alone. Medical device lawsuits address problems with medical devices that have been shown to cause illness, injury or death, in the worst cases. So just what is a medical device, and what makes one defective?
Medical Device or Drug?
According to the Federal Food Drug & Cosmetic Act, a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, … which does not achieve its primary intended purposes through chemical action within or on the body … and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
So, the main differentiator between a medical device and a drug is that the former doesn’t achieve its effect through a chemical action such as metabolization inside the body, but physically, thermally, or mechanically instead.
Defective Medical Devices
According to its own website, The FDA can order repair, replacement or refund (3-R) if, after opportunity for an informal hearing, it determines that:
- The device represents an unreasonable risk of substantial harm to the public health;
- The device was not designed and manufactured in accordance with the then prevailing state of the art;
- The risk is not due to negligent installation, maintenance, repair, or use of the device by persons other than a manufacturer, importer, distributor, or retailer;
- Notification alone is insufficient, and repair, replacement, or refund is necessary.
Steps Involved in a Medical Device Recall
When a defective medical device threatens public health or safety, the FDA has the power to order a recall of the device if it presents a danger to the public. There are several steps involved in a medical device recall.
The FDA is alerted to a defective medical device in a number of ways. The medical device manufacturer may contact the FDA after discovering a problem with one of its medical devices. Patients and others can file a report of problems with a medical device using one of the FDA’s various reporting systems. Other times, the FDA will discover a problem during an inspection or receive an alert from the Centers for Disease Control and Prevention (CDC).
After determining that a defective medical device is a threat to health or life and must be recalled, the FDA will often issue information about the recall to the media. Other times, the FDA will not seek media attention about a recall, but only if it isn’t a threat to health and safety.
After a recall, the FDA will determine the effectiveness of the recall and whether the necessary steps have been taken to correct a defective product or remove it from the market.
There are three recall classes based on how dangerous the item or drug is:
- Dangerous or defective medical devices that pose serious health problems and may cause death are issued a Class I recall.
- A drug or device that might cause short-term health problems or poses a less-serious threat, such as a drug or device that is not used to treat life-threatening conditions.
- Something that is unlikely to pose a threat to health or life but violates one or more of the FDA’s labeling or manufacturing laws is covered under a Class III recall.
FDA-Regulated Products Subject to Recall
The FDA has jurisdiction over the following types of food, drugs, and devices:
- Drugs for humans and animals
- Medical devices and radiation-emitting products
- Blood, blood products, & transplantable human tissue
- Roughly 80 percent of the foods eaten in the United States
- Animal feed
If you have questions or need advice regarding a medical device lawsuit, contact The Advocates today.