Defective Medical Devices

Fort Lauderdale Defective Medical Device Attorneys

The personal injury attorneys at Levine & Glassman, P.A. are dedicated to representing clients who have been affected by defective or dangerous medical devices and products in the Southeast Florida Metropolitan Area of Fort Lauderdale / Miami / West Palm Beach, throughout Florida, and nationally. In cases regarding defective medical devices, experienced representation is necessary to prove the case and secure compensation. Contact Levine & Glassman today by calling (954) 332-6100 or submitting your case via our contact form to discuss your case with an experienced attorney.

What is a medical device, exactly?

A medical device is defined as any instrument, machine, apparatus, implant, or other object intended to treat or prevent a disease or condition. This description is a very broad one and includes everything from basic items like tongue depressors to complex products and procedures like pacemakers and LASIK. A defect in many of these products can cause serious complications for the patient; below are some of the more common offenders:

• ASR XL Acetabular System
• Stents
• Defibrillators
• Pacemakers
• Infusion and Pain Pumps
• Knee Implants
• Hip Replacements
• Syringes
• Tissue Transplants
• Contraceptive Devices
• Breast Implants
• LASIK Procedure

Regardless of the complexity or importance of a device, it must follow certain regulations set in place by the FDA's Center for Devices and Radiological Health (CDRH).

What does the Center for Devices and Radiological Health have to do with me?

The CDRH sets and enforces safety standards and regulations for medical devices throughout the nation, and they test every medical product that goes to market against these standards for safety and effectiveness. Every device you see in your visit to the doctor's office has gone through the CDRH's approval process. If a device fails to perform according to the standards, the FDA can request that the manufacturer issue a voluntary product recall. If that manufacturer doesn't comply, the FDA itself will issue the recall.

If you've received an injury as a result of a defective medical device, it's likely that it hasn't been approved by the CDRH yet. Often, these products are allowed to be used while in the process of approval, so a potentially defective product could be in use without approval.

What kind of injuries do these products cause?

Given the broad blanket definition of "medical device", these types of injuries suffered as a result of a defective medical device can vary greatly. Usually, each device will have a "signature injury" that results specifically from misuse or defect in that particular item. This signature injury will be well-established in medical literature, and an expert witness can attest to its existence should you suffer from that type of injury.

Often, an injury of this type is incurred because the product just didn't work. If a pacemaker fails to regulate cardiac rhythm and a heart attack occurs as a result, the pacemaker manufacturer could be liable for that heart attack. An implantable defibrillator that malfunctions could send painful electric shocks throughout the patient's body, and a hip replacement implant could separate from the bone, requiring a second hip replacement surgery.

How does a defective medical device make it to market?

There are three classifications of medical devices based on their importance and risk of injury to the consumer. These classifications determine the amount of regulation a device must be subject to in order to go to market. Medical devices are classified as follows:

• Class I: Minimal Risk - A device in this classification presents little danger to a patient, and most are exempt from regulations. 47% of all medical devices fall under this classification, which includes things like bandages, thermometers, bedpans, and stethoscopes.
• Class II: Standard Utility - These devices provide a medical utility that is essential to treating the actual condition, but pose minor danger to patients. This classification comprises 43% of the overall medical device total and includes devices like powered wheelchairs, needles and suture material, and X-Ray machines.
• Class III: Life Sustaining / High-Risk - A Class III device sustains or supports life, is implanted in the patient, or otherwise poses significant danger to the patient. 10% of medical devices are Class III, which includes implantable pacemakers, breast implants, and defibrillators.

Under Section 510(k) of the 1976 Federal Food, Drug, and Cosmetic Act, any non-exempt medical device requires Premarket Notification (PMN) before it can be marketed. In this notification, a device must be proven to be "substantially equivalent" to an existing product on the market, meaning that it is equally safe and effective.

A new product or procedure that differs from anything currently on the market, however, has no comparison for substantial equivalence. These products must submit to a Premarket Approval (PMA) in order to be marketed. This process requires significant human clinical trial data for approval. Most Class III devices must undergo this type of approval.

Sometimes, however, a product passes tests based on clinical trials, but causes complications based on unforeseen circumstances that didn't come up during the trial. Many defective products on the market fall under this category, and they manage to cause significant damage to patients.

Levine & Glassman, P.A. - Florida Medical Device Defect Lawyers

The attorneys at Levine & Glassman, P.A. are experienced in dealing with medical devices that cause patients more harm than help throughout Florida and the United States. Our clients depend on these medical devices to provide the services that they are designed to provide, and a serious defect can cause them injury and betray their trust in the health care industry. If you've experienced harm as a result of a defective medical device, contact the attorneys at Levine & Glassman for a free consultation. Our line is open for your call.

Defective Medical Device Information Center

FDA 501(k) Premarket Notification Releasable Database - Currently pending premarket notifications for medical devices

FDA Premarket Approval Releasable Database - High-risk medical devices that are still awaiting market approval by the FDA

MAUDE - Manufacturer and User Facility Device Experience - Search available records of adverse effects from medical devices

FDA Medical Product Recall List - Database containing current and archived medical product recalls

FDA MedWatch Safety Information Databases - Contains safety alerts and information regarding potential injuries from medical products