Defective Medical Devices2018-01-18T16:41:02+00:00

NJ Defective Medical Devices Lawyers

Nearly 130 million Americans visit the emergency department, plus another 100.7 million hospital visits and 35 million people treated and discharged, every year. Every patient who enters the hospital or physician’s office trusts the medical professionals—and their medical devices—with his or her life.

But unfortunately, defective medical devices are a serious concern for medical professionals and patients alike. If a medical device is improperly designed, poorly manufactured, or incorrectly labeled, it can cause an adverse reaction, serious injury, or even death.

The term “Medical devices” covers a wide variety of objects, ranging from the very high-tech to the average stethoscope. The FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar [object]…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.”

Medical devices that have been subject to recalls or legal trouble in the recent past include:

  • Defibrillators
  • Stents
  • Implants
  • Contraceptive devices
  • Ventilators
  • Anesthesia machines

Manufacturers, importers, and facilities using medical devices are required to report device-related adverse events and product defects to the U.S. Food and Drug Administration. The FDA receives several hundred thousand reports every year of device-associated deaths, injuries, and malfunctions. (More detailed information about the reported defects is available on the FDA website.) According to a study of FDA data, there were 45 recalls of defective medical equipment in 2010—an increase of 27 recalls compared to the year 2008.

If you or a loved one has suffered due to a defective medical device, contact Maggiano, DiGirolamo & Lizzi today. Holding the guilty party accountable is the only way to ensure that safety standards are met in the future and minimize the risk of adverse events. Schedule your free and confidential consultation as soon as possible to start on the road to recovering your losses.

What Are the Types of Defective Medical Devices?

Defective medical devices fall under the umbrella of products liability, which holds manufacturers, designers, and sellers accountable for putting defective and/or unsafe products on the market.

In products liability, there are three major categories of defective products:

Defectively manufactured medical devices are devices that were designed correctly but manufactured improperly. Devices can be considered defectively manufactured due to mistakes at the manufacturing location, problems with shipping, or damage that occurred somewhere along the supply chain.

Medical devices with a defective design are devices that were manufactured according to faulty specifications. A device’s design can be defective in many ways, including failure to account for wear and tear, which results in the device breaking down unexpectedly.

Defectively marketed medical devices are devices without proper warnings, instructions, or recommendations for use. Manufacturers are required to appropriately label all medical devices and include appropriate warnings or instructions for safe use. Defective marketing includes both the failure to provide product warnings and the failure to provide adequate or substantial product warnings. If a lack of proper instructions or warnings causes a device-related injury, there could be grounds for a product liability suit.

Who is Liable in a Defective Medical Device Case?

The chain of supply for medical devices can be extremely complicated, and assigning fault can be even more so. Depending on the nature of the defect, different parties will come into play, and the defective product could be attributed to more than one individual.

The possible defendants in a defective medical product case include:

  • Manufacturer: the (typically large) company that is responsible for manufacturing the product can be found liable liable if it defectively produced a medical device.
  • Medical sales representative: Sales representatives represent device manufacturers to meet with medical professionals about the manufacturer’s new devices. If the sales representative recommended the product that injured you (or failed to provide certain information about the hazards of the product), he or she could be found liable.
  • Doctor: Medical professionals are required to provide you with adequate instructions and warn you of dangers before using the medical device; failure to do so could open him or her up to liability if you are injured as a result.
  • Testing laboratory: If a new medical device is tested at a private testing laboratory, the lab could be found liable for failing to identify the defective product before it entered the market.
  • Medical facility: As part of the system that brought you to the defective device, the hospital or clinic you were treated at could be found liable for your injuries.
  • Retailer: If you purchased the medical device from a medical supply store, pharmacy, or drugstore independent of the medical facility, the retailer could be found liable for distributing defective products.

Each case is unique, and the best way to determine defendants in your particular case is to consult an experienced product liability lawyer.

What Must You Prove in a Defective Medical Device Case?

In order to win a case involving defective medical devices, you must prove:

  • You were injured
  • The medical device was defective in one of the ways detailed above
  • The defect was the proximate cause of your injury

The statute of limitations for a personal injury case is two years in the state of New Jersey. In other words, you have two years from the date of the injury (or, if the injury did not come on suddenly, two years from the date you noticed the injury) to file suit. Failure to file suit within the two-year window will prevent your case from being heard in court.

Contact a Defective Medical Device Attorney

Defective medical devices are a serious concern for patients and medical professionals alike. Careful design, calculated manufacturing specifications, and safety standards are in place for a reason—to protect doctors and those seeking medical care.

Maggiano, DiGirolamo & Lizzi understand the severity of a defective medical device. They will work tirelessly to identify the liable party and hold it accountable for breaching the trust of patients and doctors. If you or a loved one has suffered serious injury due to a defective medical device, contact Maggiano, DiGirolamo & Lizzi today to schedule a free and confidential consultation.