FDA Issues Final Guidance for Warning about Medical Device Problems

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

FDA Relays Policy for Notifying Public about Medical Device Adverse Events

The U.S. Food and Drug Administration (FDA) has issued its final guidance outlining its policy for notifying the public about medical device “emerging signals”, which encompasses information about adverse events or suspected adverse events. Medical device complications are the subject of many lawsuits. Generally, plaintiffs in these lawsuits allege that the medical device caused the adverse event and that manufacturers failed to warn patients or their physician about the risks.

Parker Waichman LLP has decades of experience representing clients in lawsuits involving allegedly defective drugs and medical devices. The firm continues to offer free legal consultations to individuals with questions about filing a lawsuit.

Per the FDA guidance, an emerging signal includes information about a marketed medical device that supports a new or causal link to an adverse event, or a set of adverse events. Information considered as emerging signals have been evaluated by the FDA, and the agency has determined that this information affects a device’s benefit-risk profile.

There are risks and benefits with virtually all drugs and medical devices. Patients and their doctors choose a treatment option in which the benefits outweigh the risks, based on the available knowledge. The benefit-risk profile of a medical device can change over time. After a device is approved and marketed, for example, the FDA may receive numerous reports of an adverse event associated with a medical device. Communicating emerging signals in a timely manner can help prevent health problems and facilitate more effective treatment decisions.

Criteria for Communicating Emerging Signals

The FDA final guidance lists the following criteria considered when notifying the public about medical device adverse events:

• Likelihood (probability) of the harmful event(s)
• Magnitude (severity), duration, and reversibility of the harmful event(s)
• Magnitude of the benefit (e.g., the degree to which a given condition, symptom or function is improved and whether the device provides life-sustaining or life-saving benefits)
• The quality of the data or information
• The strength of the evidence of a causal relationship between the use of a device and the adverse event
• Extent of patient exposure (e.g., how broadly is the device used, the duration of exposure, including whether the device is intended to be permanently implanted)
• Whether there is a disproportionate impact on vulnerable patient populations (e.g., children, pregnant women, elderly, cancer patients, chronically ill patients, at-home/unmonitored patients)
• Potential for preventing, identifying, monitoring or mitigating the risk
• Availability, risks, and benefits of alternative therapies
• Potential for patients to not receive treatments they should even in light of the new information
• Implications for similar or related devices (e.g., multiple models from multiple manufacturers)
• Anticipated time for completion of FDA’s assessment of the available information and development of recommendations
• Accuracy and availability of information already in the public domain

The final guidance says the FDA should strongly consider notifying the public about an emerging signal when all the following statements apply:

• the information supports a new causal association, or a new aspect of a known association (e.g., increased rate or severity of event or reduced benefit), between a medical device and one or more adverse events or clinical outcomes
• the available evidence is of sufficient strength
• the information could have important clinical implications for patient management decisions and/or could it significantly alter the known benefit-risk profile of the device

Emerging signals do not encompass “[i]nformation that is unconfirmed, unreliable, or lacks sufficient strength of evidence,” the guidance states.

Medical Device Litigation and 510(k)

Many device makers face litigation alleging their devices caused harm to patients; plaintiffs allege that the manufacturer knew or should have known about the risks but failed to warn. Some of these devices were approved without clinical testing for safety or efficacy because they were approved through 510(k), a route in which manufacturers do not need to submit information showing that their devices are safe and effective. Device makers only need to show that their devices are “substantially equivalent” to a previously approved device. 510(k) is not intended for high-risk devices. Due to a loophole, however, some devices classified as “high-risk” were cleared through 510(k); metal-on-metal hip implants are a prime example. Transvaginal mesh devices, classified initially as “moderate-risk”, were also approved through 510(k). The FDA reclassified the devices earlier this year to “high-risk”, meaning mesh makers must now prove their products are safe and effective to gain approval.

Filing a Personal Injury Lawsuit

Parker Waichman is a national personal injury law firm that represents clients in drug and medical device lawsuits. Our goal is to ensure patient safety and hold manufacturers liable in situations where they failed to warn patients and physicians about the risks associated with a drug or medical device. Misrepresenting the safety of a medical product puts patients at risk. If you or someone you know suffered a drug or medical device injury and want to learn more about filing a personal injury lawsuit, contact our firm today by filling out our online form or calling 1-800-YOURLAWYER (1-800-968-7529).