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Defective Medical Device

Injured by Defective Medical Devices? A Cook County Product Liability Lawyer Can Explain Legal Options

New medical devices that improve healthcare and quality of life find their way into hospitals and doctor’s offices at a dizzying pace. Every day, the Food and Drug Administration (FDA) seems to approve a new system or method of assisting recovery from a variety of diseases and afflictions. But how safe are they, and what happens when defective medical devices make it to market? We trust the FDA to assure that these new medical marvels improve our health and will not harm us. But it doesn’t always work out that way. When it doesn’t, victims may need to contact a Cook County product liability lawyer about legal options.

Medical device manufacturers – like all makers of goods – sometimes rush their products to market to maximize profits. In their haste, at times they cut corners in design, development, assembly and testing that become apparent later when they harm patients. A few of the most prominent of the many examples include:

  • Metal hip, knee and elbow prosthetics
  • Drug-coated stents
  • Pacemakers and defibrillators
  • IUDs
  • Transvaginal and other surgical mesh products
  • Robotic surgical devices
  • Chemicals used in dialysis procedures

The FDA Approval Process and How Manufacturers Circumvent it

In many cases of FDA approval of a medical device, the manufacturer must demonstrate that “adequate and well-controlled” clinical trials were conducted in order to assure the device’s safety and effectiveness. This is known as premarket approval.

However, depending on the device’s intended use, sometimes getting it approved by using a “substantial equivalent” classification of an already-approved device means premarket approval standards are much lower than if it is (and should be) introduced as a device with unique properties and functions. This is a dramatic oversimplification of how FDA device approval works. But it illustrates that there are many exceptions and few clear-cut standards in the FDA approval process that defective medical devices can slip through the cracks to injure or kill unwary patients. These are the conditions under which most FDA device recalls occur. And how many people are harmed in the interim?

Product liability claims Cook County product liability lawyers file on behalf of patients who have been harmed by defective medical devices or defective treatment can be based on:

  • Defective manufacturing of a device or treatment process: Though the product was supposed to be created and used in a certain way, somewhere along the line, it may have been damaged, manufactured improperly or relies on components that make it dangerous. The many Granuflo and Naturalyte lawsuits due to these defective chemical filtering agents used in all dialysis procedures are attributed to many injuries and deaths associated with a long-approved medical process.
  • A design defect: The device is manufactured properly, but there are design flaws that make it dangerous. The danger does not need to be immediately apparent. And many times, it is discovered when the apparatus is used in ways it was not initially intended. These defective product cases hinge on the fact that the device, while being used in ways not initially intended, exposes design “defects” that suggest the other ways its uses do not meet the standards for these supplemental applications.
  • Insufficient instructions warnings: This occurs if there are unsuitable instructions on device operation or no warnings as to the results of unreasonable safety.

All of the above conditions can constitute manufacturing negligence and provide a solid foundation for a defective product civil claim or lawsuit.

Defective medical devices can cause severe pain, infections and wrongful deaths. The only practical solution is to remove the device from the patient or to discontinue immediately its use. But how are these subsequent injuries treated?

Sometimes – like when harm is caused by a surgical mesh product that has disintegrated and been absorbed by the patient’s body, complete removal is next to impossible. Patients who have been harmed by defective medical products need many corrective surgeries and lengthy rehabilitation and suffer from accompanying pain and suffering.

If you or a family member have been injured by a defective medical device, Buttafuoco and Associates’ experienced Cook County product liability lawyers offer a free consultation. Contact us anytime by calling 1-800-NOW-HURT or fill out our online contact form.