Medical devices play a key role in caring for people of all ages. The majority of the time, the devices do exactly that, performing as expected in a safe and reliable manner.

Other times, though, medical devices may enter the market with defects from the design or manufacturing process, or with false marketing. These devices can harm their users by malfunctioning or misleading them.

If you believe that negligence on the part of a medical manufacturing company led to injuries for you or a family member, consider receiving guidance from a Sayville defective medical devices lawyer.

The team at Gacovino, Lake & Associates, P.C. is ready to help you pursue compensation for your medical bills, pain, and suffering. Call us at (631) 600-0000.

Types of Medical Devices That Can Malfunction

When considering whether you have a case of a malfunctioning medical device, it may be helpful to think about the kinds of devices that could result in a lawsuit. These may include:

  • Hip replacement hardware
  • Knee replacement hardware
  • Hernia mesh hardware
  • Vascular stents
  • Pain pumps
  • Heart device implants
  • Breast implants

If you believe a medical device you were using caused your injuries due to negligent design, distribution, or marketing, a Sayville defective medical devices lawyer from our team at Gacovino, Lake & Associates, P.C. can assist you with your case.

Determining Negligence

In a medical device lawsuit, you and your attorney will be looking to show that the manufacturer acted in a negligent manner. This does not mean you have to prove that the maker of the device purposefully intended to cause harm. You simply must show that the manufacturer could have taken a different action to prevent the injuries.

Negligence in this type of case may reference the regulation of medical devices established by the U.S. Food & Drug Administration (FDA). This negligence may include:

Defect in Design

When the manufacturer does not follow proper procedures in designing a product, it could lead to a fatal flaw in the final product when the manufacturer finally releases it in the future.

Perhaps the manufacturer did not follow the proper steps in designing the product, rushing to bring it to the market. It is also possible that the designers did not make the instructions on the design clear for the manufacturing team, leading to an error in the final product.

Any of these situations could fall under the definition of negligence, as the designer could have fixed them well before the consumer received the product.

Defect in Testing

Although the FDA will oversee testing of the majority of new medical devices in the development phase, some companies may falsify testing results or skip key steps in testing, resulting in a potential flaw in the improperly tested product.

Defect in Manufacturing

If the manufacturer of the device uses impure ingredients when making the device, this could lead to a malfunctioning medical device. For example, if the manufacturer used impure plastics, they could break when the consumer uses the device.

If the quality control team does not catch an error along the assembly line, this also could lead to a defective product’s release to the public, potentially leading to additional injuries.

Lack of Truth in Marketing

When marketing a medical device, the manufacturer must follow multiple quality system regulation labeling requirements, including:

  • Clearly stating the intended use
  • Stating warnings for potential risks
  • Listing directions for safe use
  • Listing directions for safely storing the unit

Additionally, the manufacturer cannot make unsubstantiated claims about the product’s capabilities.

What To Do If Your Medical Device Injures You

If you believe your use of a dangerous medical device injured you, we recommend you take the following steps:

Contact Your Doctor

If you are experiencing medical issues because of the malfunctioning medical device, you should contact your doctor immediately. The doctor may want to examine the effects of your use of the defective device and may suggest a new course of treatment for your injuries or illness.

Check For an FDA Recall

The FDA lists medical devices that it has deemed defective and recalled so that the manufacturer can make repairs to the devices.

A medical device manufacturer may be required to notify their customers in the event of a recall so that they can stop using the product and avoid the possibility of suffering an injury. If the manufacturer did not notify you, this may be considered an act of negligence.

File a Report

Regardless of whether a recall exists for the device, you should file a report with the FDA. If the FDA is already investigating the manufacturer, your report could be a key piece of evidence.

If no investigation is ongoing, the FDA may choose to start one after receiving your report.

Additionally, a copy of this report may be used as evidence in your personal injury lawsuit.

For more information on how to complete these steps, contact Gacovino, Lake & Associates, P.C. at (631) 600-0000.

Let Us Work on Your Behalf

Malfunctioning medical products can cause quite a bit of stress for you and your family. Not only do you have to deal with the possibility of additional injuries and illnesses that the broken product causes, but your doctor may need to redesign treatment for the original condition.

If you are the victim of a defective medical device in Sayville, Gacovino, Lake & Associates, P.C. may be able to help you. Let a Sayville defective medical devices lawyer from our team handle the lawsuit against the product’s manufacturer while you focus on your health and your family.

Call us today at (631) 600-0000 for a free review of your case.