Dangerous Medical Devices

If you or a loved one have been harmed by a dangerous, defective medical device, you may be able to take legal action and sue for damages and other related expenses.

What are Dangerous Medical Devices?

From surgical mesh to artificial joints, medical device implants can be key to helping patients live or cope with various ailments and injuries. While the vast majority of medical devices are effective and safe to use, the unfortunate reality is that there are no officially regulated testing procedures to ensure their safety. If there is an issue with a device, oftentimes that issue isn’t uncovered until it is implanted. 

The Federal Drug Administration (FDA) has clearly communicated standards for safety when it comes to these devices, but dangerous and defective products can and do find their way to hospitals and into the bodies of patients. It’s not uncommon for medical devices to be recalled after they have already been implanted in thousands of patients.

Patients who are harmed or injured by these devices are faced with pain and suffering, mounting medical costs, and even lost wages if they are unable to work as a result. It’s a terrible position to be in, and victims of dangerous medical devices are well within their legal rights to file a lawsuit claim against manufacturers. If you or a loved one were harmed by a dangerous medical device, a quick, no-cost case review from Join the Many can help you understand if your situation qualifies for current or future litigation. Then, we can carefully match you with a law firm that specializes in cases like yours.

What is a Defective Medical Device?

Defective Medical Device

Victims of defective medical devices can file lawsuit based on one or a combination of claims:

Defective design: Manufacturers can be held liable for patient injuries if there is a flaw in the design process of the medical device. In this scenario, the entire line of devices is considered dangerous if they were all produced based on the original, defective design. 

Manufacturing defect: Sometimes, errors during the manufacturing or production process can lead to harmful defects in medical devices. In these cases, defects tend to affect a few device lots, versus the entire line. 

Warning or labeling defects: Just like drug manufacturers must clearly print side effect warnings and usage instructions on pill bottles, device manufacturers must clearly warn of any potential hazards related to the device, including how it can affect certain patients or surgical procedures. Labels, marketing materials, and any paperwork must include details on side effects, drug interactions, allergies, etc. If not, the manufacturer can be held liable for injuries.

What is a Defectively Designed Medical Device?

Defectively Designed Medical Device

Despite the FDA’s safety standards for medical devices, the organization does not review design plans before devices go into production. It’s possible for a medical device to be inherently dangerous based on its design, yet still manufactured and sold. 

Perhaps a manufacturer did not account for the device breaking down over time, or didn’t consider a particular risk in the device blueprint. When this happens, many people won’t know it’s defective until it begins causing harm to patients.

While these devices can be recalled, that does not undo the damage caused in patients they’ve already been implanted in. Manufacturers are ultimately responsible for the safety of their products. They can and should be held liable for defective designs. 

In some instances, victims of defectively designed medical devices have successfully claimed the makers were aware of the flaws in design, but chose to conceal findings or delay market removal for the sake of turning a profit. Design defect claims usually involve proving that there was a safer design alternative that would not have imposed a much greater cost to manufacturers.

What is a Defectively Manufactured Medical Device?

Defectively Manufactured Medical Device

It’s also possible for a medical device to be properly designed, but become defective and dangerous during the manufacturing process. This includes production, shipping, or even storage in the hospital or doctors office. When holding companies liable for defective manufacturing, any part of the distribution chain can be subject to a claim. 

In cases of defectively manufactured medical devices, it’s generally accepted that the defect only impacts specific lots of product, and are not present in the entire device line. Devices that are damaged en route to their final destination can also fall under the defective manufacturing claim. 

In cases of defective manufacturing, plaintiffs usually only need to prove strict liability–meaning they only need to prove there was a defect, and that defect caused them harm.

What is a Defectively Marketed Medical Device?

Defectively Marketed Medical Device

When a medical device manufacturer does not include adequate warnings or usage instructions for their products, they can be held liable for a defectively marketed device. Even if the device was designed and manufactured without flaw, failure to provide these warnings spells trouble for the companies responsible.

Manufacturers are legally required to warn patients of possible dangers related to use of the device, and they should provide adequate instructions on appropriate use. If a manufacturer does not do this, they can be held liable under a theory of failure to warn. In some cases, doctors, hospitals, and other health care providers could also be held liable for suggesting a patient use a defectively marketed device.

Can I File a Dangerous Medical Device Lawsuit?

medical device lawsuit

If you were harmed by a defective, dangerous device, you may have grounds to file a lawsuit against the manufacturers. Keep in mind your lawsuit can include a combination of the claims covered here. Requirements can vary by state, but generally, a successful lawsuit must prove:

  • The dangerous medical device is defective in some way
  • The defective condition caused your injuries, or death to a loved one
  • The product was in the same condition when it reached you, as compared to when it left the control of the manufacturer
  • You used the device in accordance with the manufacturer’s instructions or intentions, so you did not misuse it

Do I Need a Lawyer for My Dangerous Medical Device Lawsuit?


Defective medical device lawsuits are extremely complex, and the requirements around them–including statutes of limitations–can vary widely from state to state. An experienced lawyer can help you navigate all of this, as well as helping you prove the facts of your case.

The legal system can be a confusing, frustrating place, but a qualified attorney is your best resource when it comes to claiming compensation for your injury. But even finding a trustworthy firm with a successful track record can be daunting. 

When you request a case review from Join the Many, we can help you determine if you may qualify for a settlement and make it easy to gather any records needed to prove your case. Then, we can connect you with the best law firm for your situation.

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