Medical devices encompass a broad range of instruments, implants, and products designed to diagnose, monitor, treat, or aid health conditions. Examples include:

Knee implants
Hip implants
Surgical mesh
Heart stents
Etc.

When functioning properly, these devices have transformed healthcare, helping millions regain mobility, relieve pain, and save lives. Numerous companies develop and manufacture these devices, competing to bring innovative solutions to market.

However, the stakes are incredibly high. When a device malfunctions or is defectively designed, the consequences can be severe — causing traumatic injuries, infections, or even death. Understanding the risks and safeguards surrounding medical devices is essential for patients, healthcare providers, and legal professionals alike.

How Are Medical Devices Regulated?

The U.S. Food and Drug Administration (FDA) is the primary regulatory authority overseeing medical devices in the United States. The FDA’s role is to ensure that devices marketed to consumers and healthcare providers are safe and effective. However, the FDA employs two distinct processes for approving medical devices, each with different levels of scrutiny:

1. Pre-Market Approval (PMA) Process

The PMA process, established in 1976, is the most stringent form of FDA approval. It requires manufacturers to conduct extensive clinical studies, submit detailed reports, and undergo a thorough review of the device’s design, components, and manufacturing processes. This rigorous evaluation aims to confirm the device’s safety and effectiveness before it reaches patients.

Despite this stringent process, some devices approved through PMA have still caused injuries or failed once on the market. However, the PMA pathway generally provides the highest assurance of safety compared to the alternative process.

2. Pre-Market Notification Process

The Pre-Market Notification Process is a less rigorous pathway that allows certain devices to be cleared for market based on being “substantially equivalent” to a device already legally marketed before 1976. Essentially, if a manufacturer can demonstrate that their device is similar enough to a pre-existing device, it may bypass extensive clinical testing and detailed review.

Legal Implications of FDA Approval Pathways

The difference between these two approval processes has significant legal consequences for injured patients. In a landmark decision commonly referred to as the Riegel opinion, the U.S. Supreme Court ruled that claims against devices approved through the PMA process are preempted. This means injured patients generally cannot sue manufacturers for defects in PMA-approved devices because the FDA’s approval is considered conclusive.

Conversely, devices cleared through the less stringent process do not enjoy such preemption protections. Patients injured by these devices can still pursue legal claims against manufacturers for defective design, manufacturing errors, or inadequate warnings. This legal distinction leaves a large segment of injured patients with no recourse if their device was PMA-approved, even if it caused serious harm.

Common Types of Defective Medical Devices and Associated Injuries

Several types of medical devices have been at the center of defect litigation in recent years. Here are some notable examples and the issues involved:

Metal-on-Metal Hip Implants

Metal-on-metal (MoM) hip implants were marketed as a breakthrough, especially for younger, more active patients. The idea was that metal components would be stronger and last longer than traditional materials. However, these devices have caused significant problems:

Wear of metal components releases chromium and cobalt ions into the bloodstream.
This metal toxicity can cause pseudotumors (soft tissue masses), infections, and inflammation.
The devices often loosen prematurely, requiring revision surgeries.

Despite previous knowledge about metal toxicity issues with earlier metal hips, manufacturers reintroduced MoM devices in the early 2000s without adequate testing. The FDA eventually issued recalls, such as the high-profile 2010 recall of the DePuy ASR hip implant. However, some devices like the DePuy Pinnacle remain on the market, raising ongoing safety concerns.

Surgical Mesh

Surgical mesh products, particularly transvaginal mesh, have been widely used to treat pelvic organ prolapse and stress urinary incontinence. While surgical mesh has been used for decades, newer mesh devices often lacked sufficient testing for their specific applications.

Problems with these meshes include:

Mesh erosion through vaginal tissue
Chronic pain and infection
Organ perforation

The inadequate warnings and defective designs of many mesh products have led to extensive litigation and regulatory scrutiny.

Other Devices

Other medical devices such as heart stents, pacemakers, and various implants have also been subject to recalls and lawsuits due to manufacturing defects, design flaws, or failure to warn patients of risks.

How Does the FDA Respond to Defective Medical Devices?

Once a medical device is on the market, the FDA monitors its safety through adverse event reports from doctors, patients, and manufacturers. When potential problems arise, the FDA can take several actions:

Safety Alerts: The FDA issues public notifications to healthcare providers and consumers about potential risks or ongoing investigations.
Recalls: Manufacturers may voluntarily recall devices, or the FDA can mandate recalls to remove defective products from use.
Investigations: The FDA may investigate manufacturing facilities, review clinical data, and evaluate the device’s safety profile.

However, the FDA’s system for tracking device failures is often criticized as inadequate. The U.S. lacks a centralized system to monitor device performance over time. This gap can delay recognition of widespread problems and recalls.

Understanding Medical Device Recalls and Defects

It is important to understand that not every recalled device is necessarily “defective” in a legal sense. Recalls may be issued for various reasons, including manufacturing contamination or labeling errors, which may not have caused injury. Moreover, even if a device is defective, that defect may not be the cause of an individual’s injury.

For example, a hip implant may fail due to excess weight or improper placement rather than a manufacturing flaw. Proving causation — linking the defect to the injury — is a critical and often challenging part of any legal claim.

Additionally, the fact that a device was recalled is generally not admissible as evidence in court to prove defectiveness. This legal principle, known as the “subsequent remedial measure” rule, prevents juries from being influenced by a company’s corrective actions taken after an injury.

Types of Legal Claims in Defective Medical Device Cases

When pursuing legal action related to a defective medical device, there are three primary types of claims:

Design Defect: The device’s design is inherently unsafe, even if manufactured correctly. The metal-on-metal hips are a prime example, where the design causes metal wear and toxicity regardless of manufacturing quality.
Manufacturing Defect: The device was improperly made, such as contamination at the manufacturing facility or deviation from specifications affecting a specific batch or unit.
Failure to Warn (Marketing Defect): The manufacturer failed to provide adequate warnings or instructions about the risks of using the device.

Many cases involve multiple claims, as the exact cause of injury may be complex and multifaceted.

What Should You Do If Injured by a Defective Medical Device?

If you suspect that you have been harmed by a defective medical device, the first and most important step is to seek medical attention immediately. Whether the injury is sudden or gradual, proper diagnosis and treatment are essential.

Next, consult your healthcare provider about your symptoms and concerns. Doctors often receive safety alerts and recall notifications from manufacturers and the FDA and may already be aware of issues with certain devices.

It is also advisable to gather detailed information about the device implanted in your body. Surgical records typically include serial or lot numbers identifying the exact product used, which can be crucial in evaluating whether your device has been recalled or is associated with known problems.

Finally, contact an experienced attorney who handles defective medical device litigation. Legal professionals can help determine whether you have a viable claim, navigate complex FDA regulations, and assist in gathering necessary evidence. Many law firms offer free case evaluations to help injured patients understand their rights without upfront costs.

Conclusion

Medical devices have transformed healthcare and improved countless lives. Yet, when these devices are defective, the consequences can be devastating. Understanding how medical devices are regulated, the types of defects and injuries that can occur, and the legal options available is critical for patients and their families.

If you or a loved one has been injured by a medical device, don’t hesitate to seek medical care and legal advice promptly. The complexities of FDA approvals, recall processes, and legal claims require expert guidance to ensure your rights are protected and your health is safeguarded.

Defective Medical Devices – Risks and Legal Recourse

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