Defective Medical Devices

NJ Defective Medical Device Lawyers

Representing NJ clients in medical products liability claims

Medical devices such as hip and knee implants, pacemakers, and birth control devices can improve the quality of life for some people when the device is working as it should. When a medical device is defective, it can cause devastating injuries that ruin the lives of the people who have them. When a defective medical device is implanted, or causes adverse reactions, sometimes additional surgeries are necessary to remove the defective device. If you or someone you care about has been injured because of a defective medical device, you may have grounds for legal action to recover compensation.

At Eichen Crutchlow Zaslow, we hold the pharmaceutical manufacturers accountable when their defective products cause injury and death to unwitting consumers. When these massive corporations prioritize profit over people, we make sure that the people who suffer injuries receive fair compensation for their losses. You are welcome to schedule a free consultation with an experienced New Jersey products liability lawyer to discuss your case today.

What is a products liability claim?

If you have a medical device implanted such as a replacement knee or hip, and you discover that the product is defective or is malfunctioning, you may consider taking legal action against the manufacturer to recover compensation for your injuries and other losses.

You would work with a knowledgeable New Jersey products liability attorney who will help you hold the responsible party liable for your injuries either through a settlement with the at-fault party’s insurance company or through a civil trial.

Types of product liability claims

There are three general categories for product liability claims based on what went wrong with the product to cause your injury:

  • Design defects. The product defect is related to the design.
  • Manufacturing defect. In these claims, the defect occurs in the process of making or building the item.
  • Marketing defect (also referred to as “failure to warn”). This defect is in the manufacturer’s failure to adequately warn the consumer about an inherent danger that could occur when the product is used according to instructions.

Medical device recalls

The Food and Drug Administration (FDA) recalls defective medical devices on a regular basis. Sometimes there have been reports of injuries. In other cases, insufficient test trials have come to light, calling into question the safety of the medical devices. When medical treatments do not have the expected effect or when a patient using a medical device becomes unexpectedly worse, or dies, it is reasonable to question the integrity of that device.

The FDA describes a medical device recall as the process of correcting or removing a product when a company discovers that there is a problem with it. Recalls occur when a defective medical device poses a risk to health, or when it is both defective and a risk to health. A recall might mean that the problem with the device can be corrected, but if it is a device that has been implanted in the patient’s body, the device manufacturers may direct doctors to contact the patient to discuss the risks of removing it or leaving it alone.

The manufacturer of the defective medical device can initiate a recall, or the FDA can require that a company issue a recall. The FDA may assign a recall classification, which indicates the relative degree of risk:

  • Class I: There is a reasonable chance that the product could cause health problems or death.
  • Class II: The product could cause a temporary or reversible health problem with a slight chance of causing a health problem or death.
  • Class III: The product is not likely to cause any health problems or injury.

The FDA maintains a medical device recall database, and it keeps the public informed through a weekly enforcement report, which contains updates about recalls. The FDA also published press releases and public notices about recalls, market withdrawals, and safety alerts.

According to the Association for the Advancement of Medical Instrumentation (AAMI), medical device recalls surged an unprecedented 126% encompassing 208 million units in the first quarter of 2018, which exceeds the total number of units recalled for the entirety of the previous year. AAMI reports that medical device software, which was responsible for 78 of the 343 recalls, is part of a trend. The next most common reasons for medical device recalls were:

  • Mislabeling (73 recalls)
  • Quality issues (46 recalls)
  • Being outside of specifications (33 recalls)

One of the issues with medical device software problems is because the devices are becoming increasingly complex and they rely on the software to function, but the software is increasingly susceptible to cybersecurity vulnerabilities.

Examples of defective medical devices

Potentially dangerous medical devices subject to FDA safety alerts and manufacturer recalls in recent years have included:

  • A range of knee, hip, and other joint replacement devices, including implants from DePuy Orthopaedics and Stryker Orthopaedics
  • Power morcellator, a medical device used during laparoscopic surgeries, increases the risk of the spread of undiagnosed cancerous tissue.
  • Defective cardio defibrillator and pacemaker implanted under the skin to treat irregular heartbeat
  • Arrow International Inc. (subsidiary of Teleflex Inc.), Multi-Lumen venous catheterization Set with Blue FlexTip ARROW Gard catheter
  • Certain Covidien Shiley adult tracheostomy tubes
  • Ikaria INOmax DS drug delivery system
  • Respironics Inc., Trilogy 100, 200, and 202 ventilators
  • Smiths Medical Medfusion Model 4000 syringe infusion pump
  • Mirena IUD
  • Transvaginal mesh implants
  • Hernia mesh implants
  • Bair IVC filters

Many others have been recalled in recent years. Other medical devices might be shown to be defective because of manufacturing defects, even if the devices do not appear on any recall lists. If you had surgery or were recently hospitalized, you might not even know what medical devices were used to treat you, but you have the right to know.

How do I know if I have a valid product liability claim in NJ?

You have the right to know whether you have a viable product liability claim against one or more responsible parties. You also have the right to know who made decisions that may have resulted in your injury caused by a defective medical device. Was the responsible party your doctor or a hospital administrator, a medical device manufacturer, or a government entity?

At Eichen Crutchlow Zaslow, LLP, we review potential medical malpractice and product liability cases on behalf of people who may have suffered serious harm because of negligence of another person or company.  Our NJ product liability attorneys will gladly answer all of your questions and discuss your potential injury claim and explain how we can help determine what your next step should be toward pursuing compensation for your injuries.

Hurt by a defective medical device? Call Eichen Crutchlow Zaslow, LLP

Eichen Crutchlow Zaslow, LLP provides legal advice and representation to clients in medical malpractice, personal injury, and wrongful death matters throughout New Jersey. Call our office at 732-777-0100 or contact us online to arrange a free consultation with an experienced New Jersey product liability lawyer at an office near you in Edison, Toms River, and Red Bank.