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The purpose of a medical device is to help patients, but it should also be understood that all products have risks. However, a medical device manufacturer needs to be responsible enough to make a reasonably safe product. To explain simply, the benefits must outweigh the risks.

A device manufacturer may be held responsible for defective manufacturing, negligent design, and failing to warn of the potential serious health effects associated with it. They may also be held accountable for failing to following FDA rules. The best medical device lawyers can help the victims to claim their damage awards once they have been wrongly affected by the devices or drugs.

The United States Food and Drug Administration (FDA) defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is responsible for

  • Diagnosing, preventing, treating, or curing disease; or
  • Physically influencing the human body’s function or structure

Under the legal theory of products liability, a manufacturer or distributor of a medical device can be hold accountable for injuries caused by a defect which renders the device they made dangerous. This is categorized under “design defect”. Almost any single unit of a device with a design defect is absolutely unfit for use.

A “manufacturing defect” is one which has a fault during the actual production of a device. The defect may not affect all units, because the conditions can vary during assembly. If a medical device company advertises a device for an improper use, it is categorized under “marketing defect.”

Many products liability cases are under the “strict liability,” holding a manufacturer or distributor accountable for damages caused by a dangerous medical device, even when there is no proof of negligence or fault. A plaintiff actually needs only to prove the defect and the dangerous properties of the device, and show damages.

If you are injured by a drug or a medical device, you need to first figure out who is responsible for the injury. There are a number of people who could be liable, starting from the manufacturer of the drug or device, to the doctor who prescribed it, or the pharmacist who sold it to you. Each of these people has obligations toward you under the law. Visit bernsteinmarshall.com/ or dial 844-875-4747 to know more about the services and how they can help.