An Overview on Medical Devices Law

If you use a medical device, you know how beneficial they can be. Unfortunately, sometimes the tools that are meant to help us can harm us instead. You may have heard about recalled medical devices or class actions and wondered if these issues apply to you. What you should do if you’ve been harmed by a medical device?

You may have a number of legal options. The following will help you understand recalls and medical device lawsuits as you decide whether to speak with a lawyer.

Regulation of Medical Devices

A medical device is any type of device intended for medical purposes. They can be as simple as a tongue depressor or scalpel, or as complex as pacemakers and artificial joints.

The U.S. Food and Drug Administration (FDA) is the federal agency responsible for regulating firms that manufacture or import medical devices in the United States. The FDA uses a regulatory framework that classifies medical devices in three categories:

• Class I devices such as tongue depressors, oxygen masks, or scalpels
• Class II devices such as blood transfusion kits, syringes, pregnancy tests
• Class III devices are implantable devices or high-risk devices such as pacemakers and defibrillators

FDA regulations increase from Class I to Class III. For example, Class I devices generally don’t require premarket notification. Class II devices generally do require premarket notification. Class III devices require premarket approval.

Medical Devices in Clinical Trials

The Investigational Device Exemption (IDE) allows the device to be used in clinical trials in order for the manufacturer to collect safety data about the new device needed in the premarket approval application (PMA).

The FDA also engages in post-market surveillance to assess the device after its release in the market. Additionally, through its Quality System Regulation, the FDA sets good manufacturing practices for the methods and facilities used in producing medical devices, from designing to labeling.

Medications and drugs are not considered medical devices and are thus regulated differently. A defining characteristic of a medical device is that it does not accomplish its primary purpose through chemical reactions in the body.

Medical Device Recalls

When there is a problem with a medical device, medical device manufacturer notify the FDA through the Medical Device Reporting program (MDR). Companies or manufacturers will typically recall the product to correct or discontinue it. If the recalled device is an implant, it does not always need to be removed from the patient, but medical providers generally reach out to patients to discuss their options.

When the manufacturer recalls the device, the FDA then notifies the public. Legally speaking, the FDA can require companies to recall medical devices—but this is rare as companies generally do voluntary recalls. In the event that a company refuses to recall something that has been associated with serious problems or death, the FDA will force it to.

Personal Injuries from Medical Devices

If you were injured by a medical device, you may consider bringing a personal injury lawsuit. Manufacturers can be liable for personal injury when:

• The device was defective when it was manufactured
• There are dangerous side effects
• The device was improperly marketed

These cases would be brought under a products liability lawsuit. You might also be able to hold other parties liable including labs, sales reps, or providers, depending on the jurisdiction you are in and the parties’ roles in your injury.

Another legal route you can consider is a medical malpractice lawsuit. These cases allege that your medical provider did not act in accordance with the appropriate standard of care in the medical profession, leading to your injury. These cases are often brought against surgeons and their staff or the physician the prescribed the device that caused your injury.

Unfortunately, some medical device injuries can tragically lead to death. In these cases, spouses or heirs of the deceased can bring a wrongful death lawsuit. The parties in these suits will generally be the same as in the other types of cases discussed previously.

Finding the Right Attorney for Your Needs

If you were injured by a medical device, you will need to prove your case using medical records and interviewing doctors, medical staff, and scientists. Much of this information can be hard to understand, and it can be beneficial to have an experienced lawyer involved. Your lawyer will know how to get the records you need, the best legal case to bring, who you should interview, and what the applicable law and regulatory requirements are.

A lawyer will be able to anticipate problems with your case and advise on how to approach them. They will also keep track of deadlines and file all the paperwork with the necessary courts and agencies. This gives you fewer things to worry about.

Visit the Super Lawyers directory to find a lawyer with experience in medical device law.