MEDICAL DEVICE RECALLS

Each year, there are millions of medical device units involved in Class I medical device recalls, initiated by the U.S. Food and Drug Administration (FDA). Many of these devices are put to market under a pre-approval process and not properly tested before they eventually cause injuries to American consumers and recipients.

All too often, defective medical devices are recalled only after they cause serious health problems to patients and face lawsuits for producing, marketing and distributing dangerous products to the public.

According to a recent Stericycle recall report, medical device recalls are increasing and becoming more common—one of the bigger defect trends is defective device software. Other common device recalls involve mislabeling, out-of-spec production, and quality issues.

The FDA and product safety advocates have urged medical device manufacturers to improve their quality assurance through better pre-market testing and post-market management of recalls and defects. Medical institutions and doctors should establish a parallel process for monitoring manufacturers’ releases of devices and software updates.

The United States FDA may initiate a “recall” when a device manufacturer takes a correction or removal action to address a problem with a medical device that is deemed hazardous or violates FDA law. Recalls most often occur when a medical device is defective, or poses health risks.

With medical devices, a recall usually does not mean that you can return the product to the company. In implanted devices, for example—knees, hips, shoulders, abdominal mesh—the situation is more complex and may involve implant replacements and revision surgeries. When an implanted device has the potential to fail unexpectedly, companies may recommend that patients remove the device.

Recalls can lead to the following types of actions:

• Inspecting the device for problems
• Repairing the device
• Adjusting settings on the device
• Re-labeling the device
• Destroying the device
• Notifying patients of a problem
• Monitoring patients for health issues

Many of the medical devices on the market may be inadequately tested, and victims and attorneys have the right to file claims against negligent companies. When a company injures patients with defective medical devices, lawsuits may be necessary to restore financial losses and other damages incurred.

Joe Lyon is a highly-rated medical device lawyer who has successfully represented individuals throughout the country in complex product liability litigation. The Lyon Firm works with medical specialists and engineers to determine the root cause of medical device failures. 

Types of Medical Device Recalls

Recalls are classified into three categories by the FDA to indicate the relative degree of hazard presented by the medical device. The classes are described as such:

• Class I—there is a reasonable probability that the use of the device will cause serious adverse health consequences or death.
• Class II—the use of the device may cause temporary or medically reversible adverse health consequences. The probability of serious adverse health consequences is remote.
• Class III—the use of the medical device is not likely to cause adverse health consequences.

Types of medical devices recalled in the last few years include:

• Hernia Mesh
• Breast Implants
• Transvaginal Mesh Implants
• Defibrillators
• Catheters
• Hip Replacements
• Knee Implants
• Heart Pumps
• Shoulder Replacements
• Bone Grafts
• Ventilators
• CPAP Devices
• IVC Filters

Complications Caused by Recalled Medical Devices

The FDA maintains a database that records thousands of adverse event reports associated with medical devices. Some patients may face greater health risks than others, though device implants almost always carry some level of complication risk. Common injuries and complications of defective medical devices include:

• Severe Infection
• Revision Surgery
• Chronic Pain
• Bone Fracture
• Metallosis
• Allergic reaction
• Nerve Damage
• Formation of cysts or pseudo-tumors
• Perforation of organs
• Device Migration
• Erosion of material
• Auto Immune Disorders
• Unwanted Pregnancies
• Wrongful Death

FDA Device Recalls

Although the U.S. Food and Drug Administration (FDA) is charged with ensuring medical devices are properly tested, device recalls have shown that defects are increasingly common. Medical Device manufacturers have been successful in their lobby to relax FDA approval provisions, and many devices are released without proper testing.

Due to loopholes in the FDA approval process for new medical devices, each year dozens of defective medical products injure American patients.

As a victim, you may take legal action, hire a medical device lawyer, and force medical device companies to claim responsibility and compensate for any injury caused. It is critical to make a product liability claim in a timely manner, because the Statutes of Limitations for injured clients can affect your case.

1. Safety Alert—this is a more serious recall which requires the responsible company to issue a notification to device users if its use poses a risk of substantial harm. If the use of the device causes probable adverse health consequences or death, a safety alert is issued.
2. Device Enhancement—device enhancements are meant to improve the performance or quality of a device. An enhancement is not necessarily intended to remedy a violation or defect, however, the FDA may closely monitor the reasons for the change.
3. Inappropriate Labeling—quite often a medical device will be produced with labels that are considered false or misleading. If it fails to display adequate directions for proper use, the device could be recalled for inappropriate labeling.
4. Non-compliance with FDA Regulations—if a manufacturer or distributor fails to comply with FDA law, and if an incorrect move is taken toward correcting or removing a marketed device, a recall is likely.
5. Failure to Meet Specifications—misrepresentation of a medical device is considered a crime. If a device fails to meet a represented specification or doesn’t perform as represented and lacks qualities it is said to possess, this constitutes a recall.
6. Correction—Corrections are actions taken by a company producing and marketing medical devices to deal with a dangerous product without physically removing the device. This may include modification, repair, relabeling, adjustment or inspection (including patient monitoring).
7. Market Withdrawal—Withdrawals, in most cases, involve no FDA violation, but the device is withdrawn for repair, equipment adjustments and normal stock rotation.
8. Routine Servicing—this may include replacing parts at the culmination of their normal life expectancy. Manufacturers and distributors may need to execute calibration, replace batteries, and respond to normal wear of a product.
9. Stock Recovery—Recoveries usually involve correcting and removing any device that is yet to be marketed or one that is still under the direct control of the manufacturer. A device could still be found on the manufacturer’s premises without having been released or among units involved in a removal or corrective action.

Medical Device Malfunction

The majority of the recalls—over 90 percent—were due to manufacturing defects. With the device recalls also come related adverse events and injuries associated with defective devices. Several devices on the market can be high risk if they malfunction, and it is estimated that only a few percent of all adverse events get reported.

A Medical Device Safety Action Plan from the U.S. Food and Drug Administration (FDA) aims to reduce the requirements to report adverse events, which would potentially put more pressure on device manufacturers and create a safer medical environment. The Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health describes how the safety agency will improve safety, better detect safety risks, and keep doctors and patients better informed. The goals include:

• Establishing a more robust medical device patient safety net
• Exploring regulatory options to streamline and modernize timely implementation of post-market mitigations
• Spurring innovation toward safer medical devices
• Advancing medical device cybersecurity

Medical Device Recalls Lawsuits

Due to safety pitfalls in the FDA approval process for new medical devices, many defective products injure American consumers each year. As a result, injured patients and experienced product liability attorneys are forcing medical device companies to claim responsibility and compensate the many victims.

Modern medicine can save lives, and new technology has the potential to improve the quality of life for millions of patients with various conditions. However, when medical device manufacturers design, produce and distribute dangerous and defective products, they may be liable for serious and permanent injury caused by a product defect. Lawsuits and class action settlements throughout the country have demonstrated that medical device companies are responsible for injuries, and plaintiffs have been rightly compensated for pain and suffering, lost wages, medical expenses and other damages.

Surgeons and patients rely on the expert and ethical manufacturing of medical device products. But perhaps the medical community needs to take a closer look at the risk-reward ratio between common medical devices and the possible complications that are known with certain products.