Liability for Defective Medical Devices

Many Americans rely on medical devices to deal with health conditions and medical complications. In fact, according to Consumer Reports, tens of millions of Americans live with medical devices implanted in their bodies, such as artificial joints, heart defibrillators, and surgical mesh. Medical devices are designed to alleviate a medical problem or improve a medical condition, and many medical devices go a long way in improving patients’ health and well-being.

Unfortunately, in some instances, a medical device carries a number of significant and serious side effects, rendering the medical device harmful to the patient. For instance, vaginal mesh implants, which were designed to correct pelvic organ prolapse, have been linked to a number of serious injuries, including infections, pain, and other complications. In 2008, the FDA warned consumers that the implants were associated with complications, but that such complications were rare. Just two years ago, in 2010, the FDA reported a substantial increase in the number of injuries reported.

Similarly, metal-on-metal hip implants, such as the Stryker Rejuvenate and ABG II, have been linked to a number of serious medical problems, including corrosion and so-called “fretting” at the neck and stem junctions; metallosis from chromium, titanium, or cobalt particles entering the bloodstream after significant fretting; avascular necrosis (impaired blood supply to the bone, leading to bone death, and other complications); hypothyroidism; osteolysis (dissolution of the bone); severe inflammation and swelling; infection; joint dislocation; and allergic responses. In many cases, the medical complications were so severe that a revision surgery was necessary.

Certain medical devices have been known to be more likely to cause bodily injury or death, including:

  • Defective Cosmetic Implants
  • Defibrillators
  • Heart Stents
  • Intrathecal Drug Pumps
  • Knee and Hip Implants
  • Pacemakers
  • Surgical Instruments
  • Ventilators

Who Is Liable for Dangerous or Defective Medical Devices?

Like all manufacturers, medical device engineers and manufacturers have an obligation to provide safe medical devices to the public. Before a medical device is approved by the U.S. Food and Drug Administration (FDA), it must undergo testing and studies. Unfortunately, the testing and approval process is inadequate in some cases and not all potential problems are caught during this phase. As a result, dangerous medical devices can make their way into the marketplace. According to Consumer Reports, “for most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue. Often, the only safety ‘testing’ that occurs is in the bodies of unsuspecting patients—including two of the three people whose stories are told in this report.”

If a medical device is found to be dangerous or defective, the manufacturer has an obligation to remove the unsafe product from the market and correct any safety issues. The failure to do so could result in product liability.

How Can a Product Liability Lawyer Help?

The Chicago medical product liability attorneys at Cogan & Power are dedicated to protecting consumers from unsafe products, including unsafe pharmaceuticals and dangerous medical devices. If you or a family member has been injured, or a loved one has died, as a result of an unsafe drug or a defective medical device, please contact our office at (312) 477-2500 to schedule a free consultation to discuss a possible product liability or medical malpractice lawsuit.