Devices Lawyer

Our dangerous devices lawyers are currently handling cases against medical device manufacturers for the list of devices in the table below. If you are looking to file a claim, you should contact our team of dedicated attorneys as soon as you are ready.

Click the name of a device in the Medical Device List to learn more information about injuries caused by the medical product, as well as information about FDA recalls, class action lawsuits, and settlements.

What is a Medical Device?

A medical device is any instrument, apparatus, appliance, software, material, or other article used by patients and consumers for the purpose of:

  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease;
  • Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or handicap;
  • Investigation, replacement, or modification of the anatomy or of a physiological process;
  • Control of conception (birth control devices).

What Are Some Examples of Medical Devices?

A list of common medical devices used by patients and consumers today includes:

What is a Defective Medical Device Lawsuit?

A “defective medical device lawsuit” is phrase referring to cases filed in court against manufacturers for harm caused by a medical device failure that led to serious injury or death. These are also referred to as “product liability cases,” which is another legal term for lawsuits filed against medical device companies that design, produce, and sell defective products.

Defective medical device lawsuits can be filed as an individual case for one person, but are often filed as class action lawsuits for a large group of people. A person injured by medication can join the class action lawsuit and make a claim for a settlement. However, anyone looking to file a lawsuit for a defective or dangerous medical device should work with an experienced lawyer.

The FDA recently announced that it was strengthening its testing protocols for manufacturers of reusable medical devices. This news comes after the UCLA superbug scandal involving contaminated endoscopes.

The new testing procedures will apply to new devices seeking FDA approval, not to those already on the market. It will apply only to the following new reusable medical devices:

  • Reusable medical devices that are initially sterile and require the user to clean/disinfect/sterilize the device for subsequent patient use.
  • Reusable medical devices that are initially non-sterilized but then require the user to clean/disinfect/sterilize the device for initial and subsequent patient use.
  • Reusable medical devices intended to be reused only by a single patient and intended to be reprocessed between each use.
  • Single-use medical devices initially supplied as non-sterile to the user, and requiring the user to process the device prior to its use.

The stricter guidelines will require manufacturers of reusable medical devices to be responsible for providing labeling that provides adequate directions for use and preparation of the medical device for repeated use. The FDA will also require the makers of the devices to provide sufficient scientific validation of the reprocessing of the medical devices. So, for example, the makers of devices like the maligned endoscopes need to provide data proving that the device can actually be properly cleaned and disinfected by hospital staff.

If a company does not meet the stricter testing requirements, the FDA can order the device to be recalled or can order a stop in distribution. An experienced attorney can help to explain how a recall can impact a dangerous devices case.

Superbug Led to Change in Testing Procedures

The changes to the testing procedures come after the agency received flak for the infections and exposure caused by the improperly or insufficiently sterilized endoscopes – infamous now for the multiple superbug cases. Improperly cleaned medical devices are a serious threat in hospitals because they not only expose people to a variety of germs and diseases, but they put those individuals with compromised immune systems at greater risk. These patients often will succumb to diseases or infections that would normally not have a fatal result because of their weakened medical state. It is imperative that hospitals maintain the highest levels of cleanliness in all of their facilities and products.

The FDA’s acknowledgement of this growing problem is reflected in their decision to revise the testing protocols. It had been investigating the issue with regards to the hard-to-clean duodenoscopes as early as 2009, but at the time it was believed hospital staff were simply not following the proper cleaning process. By 2013, however, it became more clear that the process was in fact being followed by the users (hospital staff) and instead something was fundamentally wrong with the process or the device itself. The superbug fiasco merely reinforced that belief.

What are the Legal Requirements for Suing a Medical Device Company?

Most lawsuits against medical device companies allege that a person was injured or suffered serious injury or death due to a medical device failure or the improper design of the device.

The laws in the United States require that produce manufacturers disclose all serious complications of a device and warn consumers about the potential risks and side-effects of a specific product.

People harmed by a dangerous or defective device have the legal right to a settlement against the device maker with help of a lawyer.

What is Needed to Win a Medical Device Lawsuit?

In order to win compensation and receive a settlement against a medical device company, the plaintiff and their attorney must prove that:

  • The specific medical device implanted during a specific period of time. Medical records and surgery reports are used to prove this requirement.
  • The person suffered the “signature injury,” or type of complication that is asserted in the lawsuit. Typically, a case can be filed when a large number of people have the same or similar injury, rather than a single isolated patient. Again, medical records are used to prove the type of injury or harm.
  • The person suffered damages as a result of the harm caused by the defective device. Damages can include pain and suffering, disability, lost wages, and medical expenses. In cases involving death, damages can be awarded under the wrongful death laws.

How Much are the Settlements in Medical Device Cases?

The settlement amount for each person participating in a medical device lawsuit depends on a number of factors.

The factors include the type of harm suffered, the degree in which the person has matched the case criteria, the number of people in the lawsuit, and the total amount of the settlement.

Many lawsuits have classifications and systems for grading the factors for each lawsuit participant and then assigning a dollar settlement amount based upon those various factors.

The amount that an individual plaintiff will receive is not determined until after the pharmaceutical company has agreed to pay a specific total settlement amount.

Call a Devices Lawyer to Learn More

Our attorneys do not charge any legal fees to file your device lawsuit or add your claim to an existing class action lawsuit. You will not be charged any legal fees unless you receive a settlement and our fees will be deducted from your settlement amount.

To get started on your case, call a devices lawyer at our firm today.

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    Sources and References
    1. Recalls.
    2. FDA Drug Recalls.
    3. FDA Device Recalls. 
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