Defective Medical Devices

There are many reasons a medical device may be defective, ranging from defects from the manufacturing process to damage during shipment to medical errors by the doctor. As more companies seek to manufacture medical devices offshore to cut costs, the number of injuries and deaths are correlatively on the rise. Lax controls for testing and strained governmental oversight contribute to defective medical device injuries and fatalities. 

pacemaker medical device

How Common are Defective Medical Device Injuries?

The FDA requires mandatory reporting of injuries and deaths associated with medical devices to help track patterns and identify defective devices that pose severe risks to consumers. However, the records are not always complete. 

According to StatNews, a review of medical device reports since 2008 revealed more than 1.7 million injuries and 83,000 deaths over ten years. The most common medical devices that cause injuries are mesh implants, hip prosthetics, spinal stimulators, cardiac defibrillators, and insulin pumps. 

What are the Most Common Types of Medical Device Injuries?

Depending on the type of device, safety testing can be insufficient to prevent injuries or secondary complications. Some of the most common injuries include:

  • Infections
  • Organ damage or loss
  • Allergic reactions
  • Stroke and heart attack
  • Bone or tissue damage
  • Chronic conditions
  • Permanent damage and disability

If a medical device is subject to a recall by the FDA, it is crucial to follow the instructions provided as soon as possible to avoid further complications.

Is it Difficult to Win a Claim Against a Medical Device Manufacturer?

Yes, cases against large medical device manufacturers are virtually impossible for one person to pursue. This is because you must establish negligence in the design and manufacture of the product. The case would cost millions to tens of millions of dollars to pursue to match one of these large companies’ resources.

How can I Win a Case Against a Medical Device Manufacturer?

A case against a drug company or medical device manufacturer can be won if thousands of plaintiffs were also injured and their attorneys join together to pool expenses and resources in the case. This is called a class action lawsuit. A class-action lawsuit might have already been filed for a particular drug or medical device, in which case you can join the lawsuit at little or no cost to you.

Drug and medical device manufacturers are large companies with extensive resources, which makes it possible for them to develop, manufacture, and market such products. However, this fact makes it more difficult to sue them. The case must prove that drug or medical device manufacturers are liable for injury caused by using their product to be successful.

How can I Prove Liability in a Defective Medical Device Case?

You can prove liability in one of three ways. The first case is if there was an error in the medical device manufacturing process so that it was not prepared or manufactured as intended. Another instance that may prove liability is if the medical device was manufactured correctly but has an unreasonably dangerous design. 

Finally, you can win a case if you can prove that the manufacturer did not adequately warn of all dangers known at the time of manufacture and distribution. This includes hazards that were not known but should have been known. Manufacturers warning the physicians that prescribe the drugs is sufficient; they do not need to warn consumers directly.

However, a doctor has a duty to warn their patients about potentially harmful side effects and complications associated with medical devices and pharmaceutical drugs. If a doctor does not adequately warn their patient, it may be a case of medical malpractice. Only an attorney can help you determine who is liable and the course of legal action that should be taken. 

Is Investigation Necessary in a Defective Medical Device Case?

Yes, an investigation is necessary in cases regarding drugs, medical devices, or medical implants. However, investigation in these sorts of cases is more research-focused than other cases that rely heavily on gathering evidence and medical experts’ testimony. Attorneys must be aware of scientific research done on the product and its associated risks. It is also vital to investigate established causation between the product and different injuries and diseases.

Why is it Difficult to Prove Causation in a Defective Medical Device Case?

It is difficult to prove causation in drug, medical device, and medical implant cases. In addition to establishing that the product was not correctly designed, manufactured, or designed, you have to prove that a flaw in this process causes your injury. This is the most challenging part, and the only way to establish causation is through scientific evidence. Research must have been done on the drug or medical product that indicates that the drug, implant, or medical device causes the plaintiff’s disease.

How to find a Defective Medical Device Attorney in Tampa

Darrigo & Diaz’s team has successfully represented numerous defective medical device cases over more than 20 years in service to the Tampa area. Please call Darrigo & Diaz today at (813) 774-3341 to immediately discuss your case with an expert defective medical device attorney. You can also set up a complimentary consultation with us online.

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