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Defective Medical Devices

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Millions of Americans use medical devices, for a variety of purposes. Medical devices help patients monitor and regulate everything from heart rhythms and blood glucose levels to fertility and eyesight. Patients with pacemakers, defibrillators and other devices that monitor the function of vital organs rely on these mechanisms to keep them alive. When one of these devices fails, it can place the patient in grave danger.

In recent years, a multitude of medical devices — most of them pacemakers and implantable cardioverter defibrillators (ICDs) — have been declared defective and recalled. Thousands of people have been injured and some have died as a result of these defects. Among the makers of recently recalled devices are some of the nation's leading medical device manufacturers, including Guidant Corporation* and Medtronic, Inc.

If you suspect you or someone you love has been harmed by a Medtronic pacemaker, Medtronic ICD, Guidant Pacemaker, Guidant ICD or other defective medical device, you may benefit from the assistance of a personal injury lawyer. A qualified personal injury attorney specializing in product liability will be able to assess your case and help you determine whether you are likely to obtain compensation by filing a lawsuit.

Medical Device Laws

Numerous federal and state laws and regulations exist to protect consumers from defective medical devices and other faulty products. These laws vary significantly between different jurisdictions, and this can affect the direction of your case. Depending on where you live and the facts surrounding your case, your lawyer may base the strength of your case on any number of legal theories.

Strict liability. The area of law that governs defective products is called product liability. Cases involving product liability revolve around the concept of strict liability, which means that the plaintiff does not have to prove that the defendant acted negligently. In cases where strict liability applies, the fact that a product is defective suffices to hold the manufacturer and or distributors of the product liable. Over the years, thousands of plaintiffs have brought the companies responsible for the production and distribution of defective medical devices to justice — and obtained monetary compensation, sometimes in the form of a settlement — through product liability lawsuits.


Negligence. In some case where strict liability applies, negligence can also be cited. For example, if the plaintiff in a product liability case can show that the defendant committed negligent errors that led to harm, this may strengthen the case.

Other theories. Some patients have sued medical device manufacturers citing the fact that they deceived the Food and Drug Administration (FDA) or violated the agency's instructions for proper production of the device. Breach of warranty is yet another type of claim used in product liability cases.

ICDs May Not Benefit Women

Implantable cardioverter defibrillators (ICDs) may not be helpful to women with advanced heart failure, according to a recent report published in Archives of Internal Medicine. Women account for about 30 percent of ICD recipients.

While the benefits of ICDs are supported by numerous clinical trials, data on women is scarce. “Implantable cardioverter-defibrillators are being implanted in hundreds of thousands of women without substantial evidence of benefit, apparently based on the assumption that, to paraphrase the old saying, ‘What's good for the gander is good for the goose,’” said Rita F. Redberg, MD, editor of the publication, in an editorial accompanying the report.

These findings are very disconcerting — not only because hundreds of thousands of women have ICDs but, more disturbingly, because tens of thousands of ICDs have been declared defective and recalled in recent years.

Source: American Medical Association (AMA)


In summary, depending on the facts and circumstances surrounding your case, a defective medical device lawsuit may draw from a number of laws and/or legal theories that can lend credibility to your case. Only a personal injury lawyer with knowledge of the current laws can determine the best course of action in your case. Statutes of limitations apply in many states, so it is important that you contact a lawyer as soon as possible if you feel you have been harmed by a defective medical device.

Types of Claims and Compensation

The type of claim filed by your attorney depends on the particular circumstances of your case. If you personally have been harmed, your attorney may recommend filing a personal injury claim. If the person who files such a claim dies, certain family members may be eligible to file a survivor claim in order to continue the case, as well as a wrongful death claim seeking compensation for expenses related to the death and future loss of income and companionship. These claims are often rolled into one case.

If your case is successful, you may receive monetary compensation for the following expenses and factors, among others:

  • Medical expenses
  • Rehabilitation
  • Lost wages
  • Pain and suffering
  • Loss of companionship
  • Other related damages

In addition, if the jury finds that the defendant acted in a particularly egregious manner, you may be awarded punitive damages, which are meant to penalize the defendant and prevent other parties from committing similar offenses in the future.

Do You Need a Lawyer?

Because laws vary significantly by state, your case will likely hinge on your state's laws. In addition, a recent Supreme Court ruling relating to medical device law may affect your case. As a result, the only way to know if you have a case for sure is to contact a personal injury lawyer or evaluate fatal injury attorneys who specialize in cases involving medical devices.

* Guidant Corporation has now merged with Boston Scientific.