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Liability For Defective Medical Devices

Defective medical devices, image of a ventilator machine.The number of medical devices used to help diagnose, treat, or cure a patient is endless. A medical device is any apparatus, instrument, machine, implant, appliance, software, material, or other similar agents that are manufactured to be used for a medical purpose.

From pacemakers to ventilators and insulin pumps to hip implants, medical devices have saved endless lives. However, when these devices are improperly or negligently manufactured, what was first meant to save or improve a life, can in turn put lives at risk.

Defective medical devices can cause serious harm. When they do, someone must be held liable and the victims should be compensated for any financial, emotional, or psychological distress caused by the error.

In This Article:

Injuries Caused By Defective Medical Devices

Physicians rely on medical devices to function the way they are intended to and patients might have to trust a medical device enough for it to be surgically implanted in their bodies. When a medical device does not function properly, it can cause serious harm, injury, and even death to a patient. Some injuries caused by defective medical devices include:

  • illness
  • organ failure
  • misdiagnosis
  • corrective surgeries
  • lost limbs
  • brain damage
  • failed surgeries
  • loss of sight or hearing

The list goes on. One flaw or malfunction can lead to catastrophic problems to the delicate systems in our bodies or the intricate work of a medical professional. When patients are injured due to defective medical devices, those at fault must be held accountable. Not only to seek justice for the victims but to help prevent others from suffering the same injuries.

Liability For Defective Medical Devices

Liability for defective medical devices is a complex and multifaceted issue that often stems from errors in the manufacturing process. When a specific medical device is marred by mistakes in its production, it can result in unforeseen problems that are absent in the broader product line.

Manufacturing defect claims for medical devices typically operate under the legal principle of strict liability. This means that the injured party, such as a patient or healthcare provider, must only demonstrate that a defect exists in the device and that this flaw directly caused harm. Strict liability simplifies the burden of proof which focuses on the product’s defects and their consequences rather than establishing negligence.

In some cases, liability may extend beyond the manufacturer in cases where a medical device is damaged during transportation. If a device becomes compromised en route, responsibility may shift to other entities within the distribution chain. This may include distributors, wholesalers, or even the transportation company involved.

Identifying the precise point of failure in the distribution process becomes crucial in allocating liability accurately. Fortunately, an experienced product liability attorney will have the skills and tools required to determine who is liable in a defective medical device claim.

Types of Medical Device Defects

There are three types of medical device defects that can cause harm to a patient: manufacturing defects, design defects, and warning defects.

Manufacturing Defect

A medical device with a manufacturing defect is fabricated incorrectly such as with poor workmanship or use of the wrong materials. A manufacturing error can result in a defect that impacts several devices or individual devices.

Even the smallest error can result in major consequences for a patient. A defective medical imaging device, for example, can result in an incorrect or even missed diagnosis.

An added layer to the manufacturing of a medical device is its distribution. Issues in how a device is distributed can also lead to defects. Damage can occur during shipping or any movement at the hospital.

Design Defects

Design defects in medical devices pose significant challenges as they stem from inherent flaws in the product’s model rather than issues with individual devices. These defects occur when a device, used as intended, either performs its function poorly or causes harm to the user.

Manufacturers are expected to identify any risk in the design of their device and anticipate potential breakdowns of the product over time. A manufacturer may conceal issues or hesitate to recall defective devices for profit reasons.

Knowingly allowing consumers to use faulty medical devices is not only wrong but is also a crime and can result in punitive damages for any at-fault parties. These cases highlight the importance of stringent quality control and ethical practices in the medical device industry to ensure patient safety.

Warning Defects

Sometimes, a medical device will come with some risks. But in these cases, the benefits of the medical device far outweigh those risks. However, patients and physicians should still be informed of the possibility of such effects.

A warning defect is when a medical device is marketed without the proper warning of any known risks of that product or without clear instructions on how to properly use the device.

Medical devices that can often have a warning defect include defibrillators, implants, or contraceptive devices, to name a few. Sometimes, a medical professional or hospital may be liable for a warning defect if they do not provide their patient with proper instructions on how to use the device.

Medical Device Recalls

The Food and Drug Administration (FDA) is responsible for regulating medical devices. Any problems or defects with medical devices should be reported to the FDA at which point they may decide to recall the device to protect patients and medical professionals.

The FDA has been known to recall defective devices such as hip replacement systems, pacemakers, hernia mesh, shoulder pin pumps, and hip or knee replacements. Class 1 recalls are considered the most severe and most likely to cause serious injury and even death.

Here are a few examples of Class 1 recalls issued by the FDA for defective medical devices in 2023 alone that have caused serious injury.

  • Intra-Aortic Balloon Pumps (IABP)
  • COVID-19 Antigen Rapid Tests
  • Glucose Monitoring Systems
  • Triage Cardiac Panels
  • Emergency and Transport Ventilators
  • Implantable Cardioverter Defibrillators
  • Reactive Skin Decontamination Lotion Kits

When to Contact a Defective Medical Device Lawyer Help?

Defective medical device cases can be very complex as it can be difficult to establish liability. A defective medical device lawyer who is an expert in product liability law can give injured patients the best chance of seeking justice for their suffering.

At Disparti Law Group Accident & Injury Lawyers, we are determined to fight for patients’  rights. If you’ve been injured by a defective medical device, you may be owed compensation for the harm caused by the faulty product.

Manufacturers and other parties tasked with safely producing and delivering medical devices should be held accountable. Contact us today for a FREE consultation or call (312) 355-3183.

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