Drugs and Medical Device Recalls

Like any other product, consumers should be able to trust that their medical devices are safe. Manufacturers have a duty of care to ensure their products are safe before they release them to the market. Unfortunately, new dangers can appear after manufacturers introduce them to the market.

One way for medical device manufacturers to keep future patients safe is to issue recalls when they discover a product may be unsafe. This section will address medical device recalls. It will explain when and why these recalls take place. It will also explain what to do if a defective medical device injures you.

The Food and Drug Administration and Medical Devices

The U.S. Food and Drug Administration (FDA) reviews and recalls medical devices. It does the same thing with food, drugs, and cosmetics. When the FDA discovers or learns that a medical device is unsafe, it will issue the recall or command the manufacturer to do the same.

The primary concern of the FDA is patient safety. If it believes a product is too dangerous to remain on the market, it can demand that the manufacturer take it off the shelves. These rules apply to American manufacturers and foreign companies exporting medical devices to the U.S.

What Is a Medical Device?

A "medical device" is any tool a doctor or healthcare professional uses to treat a patient. Since there is such a wide variety of medical devices, the FDA divides them into classes: Class I, II, and III. The FDA offers a detailed description of the classes at FDA.gov.

Note: The categorization of medical devices is not the same as the recall classification.

The FDA bases the different classes of medical devices on the potential for harm. Class I devices are less likely to injure patients than Class II devices. A detailed breakdown of the three classes appears below. (These classes only apply to the types of devices. For recall categories, the labels are backward. For example, Class I medical devices pose the least risk. But, a Class I recall is the most serious.)

Medical device manufacturers are strictly liable for any injuries their products cause. If the injured party can prove the device caused their harm, they may recover damages.

If a defective medical device injures you, there's a chance you'll need to file a product liability lawsuit. Your personal injury attorney will determine which class your device falls into. This classification will help guide their approach toward proving liability in your case.

Class I Medical Devices

Class I devices are those pivotal to patient care, such as surgical gloves and scalpels. These devices are not likely to cause serious injury. They pose the lowest health consequences and only need general controls.

Class II Medical Devices

Class II devices are those that, when used as directed, may still pose moderate to high risk of health hazards. Class II devices include powered wheelchairs and surgical pumps. This class of medical devices needs general and special controls.

Class III Medical Devices

Class III are devices that support or sustain human life. Manufacturers must use special controls to ensure patient safety. Examples of Class III devices include pacemakers and bone implants.

Medical Device Recalls

The FDA issues a recall when it learns that a medical device threatens patient health. Sometimes, the FDA knows about these defects through its investigation. Other times, the medical device manufacturer will contact the FDA on its own. There are also cases where an injured party may communicate a safety defect to the FDA or other government agency.

Once the FDA recalls a device, it will work with the manufacturer to remove it from the market. If the defect is relatively minor and has mild consequences, the FDA may choose to remove the devices from the market at the wholesale level only. Many consumers never learn of these recalls. But, all medical device recalls are available on the FDA's website.

If the defect is more severe, the FDA may recall the device from retail stores or patients' homes. This is particularly problematic for patients with recalled devices implanted in their bodies. Many patients with artificial hips, pacemakers, or transvaginal mesh need more treatment or surgeries to remove the defective devices.

When Is a Medical Device Recall Necessary?

You may wonder when a medical device recall is necessary. According to the FDA, it will issue a recall in five situations. These situations include the following:

• False or misleading labels and packaging
• Medical device safety issues
• Violations of FDA regulations
• Adverse event (severe injury or death)
• Inadequate instructions or directions for use

Once the FDA learns that one of the above issues exists, it will begin the recall process.

Medical Device Recall Process

The recall process for defective or dangerous medical devices is complex. One of the significant problems with the process is that it can take months or longer for the public to learn of a new recall.

The following steps outline the formal process for medical device recalls in the U.S.:

• Recalls usually start when a manufacturer, physician, provider, or patient identifies a safety issue with a particular device. The person discovering the issue reports it or flags it to the FDA. If the manufacturer is the one to find the safety issue, they have ten days to notify the FDA. They may learn of the defect through clinical trials, patient complaints, or other third-party notifications.
• Once the FDA receives the notification, they enter it into the MAUDE (Manufacturer and User Facility Device Experience) database.
• The FDA measures the risk and weighs it against the danger thresholds.
• If the risk/danger is severe, the FDA sends a letter to medical professionals, healthcare institutions, and patients to let them know they have initiated the recall process.
• The FDA will issue a public recall safety alert or recall notice in instances where the risk is extremely serious or deadly.
• The FDA and the manufacturer/distributor must track the affected patients and notify them of the safety issue.
• The manufacturer must then track down the units that have the defect using lot numbers. They must also register the device as defective or dangerous with the FDA using the product's Unique Device Identification (UDI) number.

Factors the FDA Considers When Issuing a Recall

The FDA doesn't issue a recall for every device with a safety risk. They balance the benefits of the product against the potential harm.

When balancing the usefulness and risks, the FDA considers several factors, including:

• Severity of risk
• Number of defective/dangerous units
• Rate of occurrence
• Total number of devices in an identified lot number
• Number of patients affected

If the FDA determines a severe danger exists after considering the above factors, they will do one of two things. They may issue a recall, allowing the manufacturer to fix the issue. Or they may begin a removal action and demand that the manufacturer remove it from the market.

This can become tricky when the dangerous device is an implant. In these cases, the patients and doctor must determine if it's worth removing the implant or taking their chances that they won't get hurt.

Examples of the Recall Process Taking Too Long

Because of the lengthy recall process, there are times when patients are at risk for longer than is necessary. Two prime examples are the recall of Philips' sleep apnea machine and ventilators and Medtronic's heart wave ventricular assist device.

In April of 2021, Philips realized that there was a problem with their sleep apnea machines. They learned that the foam used to reduce noise in the machine would break down. When this happened, patients could inhale or ingest foam pieces.

Unfortunately, the company didn't start the recall process until June 2021. There were anywhere from 3 to 4 million units on the market. The company had no way of knowing which machines were defective.

They also needed help to identify the affected patients. When the product recall began, many people got sick. This caused many patients to file personal injury lawsuits against Philips.

Issues with Medtronic's device, which was an implant, were even more challenging to resolve. The manufacturer and the FDA took several months to determine if they needed a recall. In the meantime, patients remained at risk.

Does a Recall Mean the Manufacturer Is Liable?

Some people assume that recalled products automatically qualify for legal action. While a recall can offer supporting evidence, it is likely not enough to form the entire basis of a legal claim. Nor does it mean the company will be immune from liability when they issue a recall.

The purpose of a recall is to keep patients and consumers safe. This is why the FDA publicizes recall information. The goal is not to punish the manufacturers of medical devices.

If you file a lawsuit after a medical device injures you, your attorney will still have to prove fault. The courts will consider the fact that the FDA recalled the device. But, they will not base their decision solely on that fact.

What To Do if the FDA Recalls Your Medical Device

If your medical device is subject to an FDA recall, you should consult with three different professionals as soon as possible.

1. Your doctor: Since your device will no longer work, you must review your options. You may need more surgery to replace the defective device.
2. Your health insurance company: Find out what it will cover and what you must pay out of pocket.
3. An attorney: You may be able to sue the medical device manufacturer if it was not careful enough in designing and creating the product.

Product liability for medical devices is a complicated field. A lawsuit against a medical device manufacturer would involve the manufacturer, your consulting doctor, a surgeon, and the FDA. Many patients have filed class action lawsuits against these manufacturers for similar injuries. You can file an individual claim or join the open class action.

Need More Help? Speak With An Attorney Today

Manufacturers of medical devices must get premarket approval (PMA) for new products. Once this happens, patients should be able to count on the safe device. Unfortunately, some medical devices are defective or unsafe, even with the recall process.

Contact a personal injury attorney today if you believe a defective or dangerous medical device injured you.