A Medical Device Harmed You. Was It a Defective Product or a Doctor’s Mistake?

September 10, 2025

A medical device malfunction becomes a medical malpractice claim when a healthcare provider’s negligence in using, implanting, or monitoring the device causes you harm. This is different from a product liability claim, where the device itself is defective due to a design or manufacturing flaw.

The challenge is that these two issues frequently overlap; a provider might misuse a device that also has an underlying defect. Proving what happened requires a deep investigation into the provider’s actions, the device’s history, and FDA data, which shows millions of device-related injuries and malfunctions are reported.

A successful claim provides compensation for your medical bills, lost income, and suffering.

If you have a question about an injury involving a medical device, call Wapner Newman for a free consultation at (215) 569-0900.

Key Takeaways for Medical Device Injury Claims

• Your injury may be a medical malpractice or a product liability claim. The right legal path depends on whether the harm was caused by a provider’s mistake or a defective device.
• The doctor and the manufacturer might both be at fault. It is common for a provider’s error to overlap with a device defect, which requires a detailed investigation to assign responsibility.
• Proving your case requires specific evidence and expert testimony. A consent form does not prevent you from filing a claim for negligence, and an FDA recall is strong evidence but does not guarantee a win.

The Core Distinction: Was It the Tool or the Person Using It?

You’ve been injured, and a medical device was involved. But it’s unclear who is responsible. Was it the company that made the device, or the doctor who recommended and used it?

Two Potential Paths to Justice:

• Product Liability: This focuses on the device itself being unsafe. Think of it like a car being sold with faulty brakes. The responsibility lies with the manufacturer.
• Medical Malpractice: This focuses on the actions of the healthcare provider. To use the same analogy, this is like a mechanic installing the brakes incorrectly, causing a crash. The responsibility lies with the provider.

When Does the Blame Fall on the Manufacturer? Exploring Product Liability

A manufacturer is held responsible even if they weren’t necessarily negligent. This legal concept is called “strict liability” It means that if they release a defective product that causes harm, they are responsible.

There are three main ways a medical device is defective:

• Design Defects: The flaw is in the blueprint. The device, even when made perfectly, is inherently unsafe for its intended use.
  Example: A type of hip implant that is designed in such a way that it sheds microscopic metal particles into the patient’s body over time.
• Manufacturing Defects: The design is safe, but an error during production makes a specific device or batch of devices dangerous.
  Example: A batch of pacemakers is contaminated with a substance at the factory, causing them to fail prematurely.
• Failure to Warn (or “Marketing Defects”): The manufacturer fails to provide adequate instructions or warn doctors and patients about known, non-obvious dangers.
  Example: The maker of an infusion pump knows its software may glitch if certain settings are used together but fails to include a clear warning in the user manual. This issue is a known concern, with infusion pumps being involved in a high number of adverse event reports.

When Does a Device Issue Become Medical Malpractice?

Medical malpractice occurs when a healthcare provider’s actions deviate from the accepted “standard of care,” causing you harm. The standard of care is a legal concept that simply means the level of skill and caution that a reasonably competent provider in a similar field would use in the same situation.

Even if a device is perfectly designed and manufactured, a provider is negligent in how they use it. Examples include:

• Improper Implantation or Technique: A surgeon implants a spinal cord stimulator in the wrong position, causing nerve damage.
• Selecting the Wrong Device: A doctor recommends a heart valve that is inappropriate for the patient’s specific condition and age.
• Failure to Monitor the Patient: A nurse fails to notice the alarms on a patient’s glucose monitor, leading to a dangerous blood sugar event.
• Ignoring Signs of Device Failure: A doctor dismisses a patient’s complaints of pain following a knee replacement, when in fact the device is failing.
• Inadequate Training: A hospital allows a provider to use a complex surgical robot without confirming they have completed the necessary training, resulting in an error during a procedure.

What if Both the Device and the Doctor Are at Fault?

It is not uncommon for liability to be shared between the manufacturer and the healthcare provider. These situations are complicated, but it does not prevent you from seeking justice.

Consider this scenario: A manufacturer buries a known risk in the fine print of a device’s manual (failure to warn), and a surgeon, in a rush, fails to properly sterilize the device before implantation (breach of the standard of care). The patient develops a severe infection. In this case, both parties may hold some responsibility for the final outcome.

How Do You Prove Your Case?

Whether pursuing a malpractice or product liability claim, the injured party must provide evidence to prove their case. Our firm handles the process of gathering the evidence needed to establish what happened.

To Prove Medical Malpractice, We Must Show:

• Duty: A doctor-patient relationship existed.
• Breach: The provider’s care fell below the accepted standard.
• Causation: The provider’s breach directly caused your injury.
• Damages: You suffered measurable harm (medical bills, lost wages, pain, etc.).

Note: In both Pennsylvania and New Jersey, malpractice claims generally require a “Certificate of Merit” or “Affidavit of Merit,” which is a document from a qualified medical professional stating that the provider’s care was negligent.

To Prove Product Liability, We Must Show:

• The medical device had a design, manufacturing, or warning defect.
• This defect was the cause of your injury.
• You suffered measurable harm.

Frequently Asked Questions about Medical Device Malfunctions

What if the FDA recalled the device that harmed me?

A recall is strong evidence that a device may be defective, but it does not automatically win your case. We still must prove that the specific defect addressed by the recall was the direct cause of your specific injury.

I signed a consent form before my procedure. Does that prevent me from suing?

No. A consent form informs you of the known and disclosed risks of a procedure. It does not give a provider permission to act negligently or use a defective device. You cannot consent to malpractice.

My doctor said the device just “malfunctioned.” How is that different from an “injury”?

The FDA tracks these separately. A “malfunction” means the device failed to meet its performance specifications or perform as intended. An “injury” means the patient was harmed. A malfunction does not always cause a reported injury, but it is a key piece of evidence showing that a device was faulty.

Your Path to Accountability Starts with Wapner Newman

We regularly help families in Pennsylvania and New Jersey hold negligent medical providers and device manufacturers accountable. The sooner we begin investigating and preserving evidence, the stronger your case will be.

To discuss what happened and learn how we help, call Wapner Newman today at (215) 569-0900.