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What Makes a Faulty Medical Device “Defective” — and When Can You Sue For It

St. Louis Lawyers Protecting Victims of Faulty Medical Devices

Medical devices are frequently found at the center of product liability claims; and often, these transform into major mass tort lawsuits. These claims are based on the fact that the device was unreasonably dangerous. But, what does that mean in terms of “defect,” and how is something deemed “dangerous” in the first place?

Surprisingly, most of the products that find themselves amidst a lawsuit later have not been approved by the Food and Drug Administration (FDA). The manufactures use what is called the 510(k) process to get fast track approval.  All the manufacturer has to do is claim the product is like a product already on the market.  If the FDA agrees the manufacturer does not have to perform clinical trials to prove the product is safe and effective.  When this process is used and the product turns out to be defective these manufacturers are liable for any injuries that are caused because of the dangers and defects of their product. Personal injury attorneys can hold these companies accountable, and even help you receive compensation to cover things like additional medical costs, lost wages, and pain and suffering.

Terms to Understand

When you hear that a product is defective, you will hear a host of other terms alongside it. These terms are what play a role in determining the defective “factor,” and also the viability of your potential claim.

  1. Statute of Limitations – Even if a medical device is defective, you are barred on time by the law. You only have a specific number of years past the discovery of the injury and/or defect. After that, it doesn’t matter if the manufacturer was grossly negligent. You cannot file a claim outside the statute of limitations. This is why it is imperative that you speak with a product liability attorney experienced in handling mass torts if you suspect that you were injured by a defective product.
  1. Inherently Dangerous – In order to sue a manufacturer for a defective medical product, you must first show that the product was inherently dangerous. This means that the product naturally presented a grave risk for danger despite special care, or even following the instructions for that product.

Is the Manufacturer Liable?

Not all issues mean that the manufacturer would be liable for your injuries. Instead, there are injuries, but the manufacturer didn’t necessarily portray negligence or play a role in those injuries. In order for the manufacturer to be liable, certain circumstances must be present:

  • The device was defectively manufactured, designed or it did not contain adequate warnings of its dangers.
  • That the manufacturer knew of the dangers in the product and did not change the design or adequately warn.
  • The product was inappropriately marketed for a use other than that which it was originally created for or approved by the FDA to do.

Third Parties Can Be Liable, Too

In addition to the manufacturer, there may be instances where third parties are also liable for your injuries. This would include:

  • Testing and certifying laboratories
  • Pharmacies
  • Physicians, hospitals, or clinics that used the defective device
  • Sales representatives
  • Retailers that sold the device
  • Wholesalers and distributors

Exploring Your Options After a Defective Medical Device Causes Injury

If you have been injured because of a defective medical device, you will want to contact a medical malpractice attorney immediately. An attorney can assess not only if you have a case, but identify potential third parties that are equally responsible for your injury, losses, pain, and suffering. Schedule a consultation today with the attorneys at Carey, Danis & Lowe. We will meet with you over a no-obligation consultation – so, schedule yours by calling us toll-free at 877-678-3400 or request more information online.