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Defective Medical Devices: Product Liability or Medical Malpractice?

By September 4, 2015August 8th, 2018Medical Malpractice


Thousands of medical devices are used every day to help improve patients’ health. When one fails and causes harm, it may result in either a product liability claim, a medical malpractice claim, or both. Defective medical equipment can include prosthetic devices, implants, stents, defibrillators, diagnostic equipment, standard hospital supplies, visual and hearing aids, and contraception devices.

A fairly recent and well known example is the surge of lawsuits against Johnson & Johnson’s DePuy ASR metal hip replacements. Among other potential health concerns, this product was cited for releasing metallic debris into the body, causing a painful and possibly fatal condition called metallosis.

Transvaginal mesh complications have triggered a substantial number of lawsuits as well. Organ perforation and mesh erosion are two potential hazards involved in transvaginal mesh implantation. In 2013, Johnson & Johnson was found liable for failure to warn a patient’s doctor of the possible dangers. Defective medical devices such as these may fall under the category of product liability or medical malpractice.

Medical Devices That May Be Considered Defective

To constitute a defective product claim, the failed medical device must be categorized by one of the following situations:

  • The medical product is somehow damaged in the manufacturing process, during shipping, or at the healthcare facility. In this case, only the one damaged device malfunctions.
  • The medical product is designed with an innate flaw. In this category, all medical equipment within the same line of product is flawed.
  • The medical product is marketed improperly. A failure to warn consumers and, in this case, medical professionals and patients, is the most common marketing mistake. Defective marketing also includes inadequate or misleading instructions for use.

In the case of product liability, fault may be found anywhere within the chain of distribution. This includes any or all of the following parties:

  • Manufacturer – With medical devices and equipment, this is typically a large company.
  • Testing laboratory – This can either be part of the manufacturing company or an independent laboratory hired by the company.
  • Sales representative – Sales representatives are employed by the manufacturing company to liaison with healthcare professionals. They inform physicians about the latest developments and are responsible for recommending proper use.
  • Retail supplier –The bottom level in the chain of distribution, beneath physicians and other medical professionals, this category includes pharmacies and other types of retail suppliers.

Medical Malpractice Involving Defective Medical Devices

Medical malpractice may be involved if there is proof that the manufacturing company or sales representative fulfilled their responsibility to educate and warn the healthcare personnel on proper use and potential issues. In this case, the physician who recommended the use of the medical equipment may be held liable if he or she does not present potential dangers or proper instructions to the injured patient. Though the level of liability is dependent upon the particular type of equipment, medical malpractice can range from misdiagnosis to use of defective implants. The hospital, clinic, or healthcare facility may be considered liable as well, as either part of the chain of distribution in a product liability case or as part of a medical malpractice claim. Again, this depends on the particular circumstances of the case.

Carey, Danis & Lowe – St. Louis Personal Injury Lawyers

Injuries from defective medical equipment can be life-altering, expensive, financially and psychologically overwhelming, and sometimes life-threatening. In recent years, common issues have involved defective pacemakers, Mirena IUDs, and Da Vinci surgical robots. If you have suffered injuries due to one of these products, or from any other type of defective medical equipment, it is in your best interest to seek legal representation as soon as possible. At Carey, Danis & Lowe, our legal team has extensive experience with medical malpractice and defective medical devices. We will thoroughly assess your unique circumstances to provide the best legal strategy for you. Contact us today for a free consultation.