When a manufacturer makes a medical device, they have a duty to provide the consumer with a product that works and is safe for its intended use. Specifically, the manufacturer must provide consumers with a product that is neither defectively designed nor manufactured in a defective manner.
If there has been a medical device failure, a defective medical device lawyer can help those who have been injured by the device achieve justice in the form of financial compensation. These lawsuits require attorneys to be well-versed in the area of product liability, especially as it relates to defective medical devices. The Eichholz Law Firm has the expertise necessary to help those affected by these devices bring lawsuits against the manufacturers.
The term “medical device” is incredibly broad and can encompass a large number of different products. It can be something that is designed to help diagnose or treat a medical condition. It can also include something that is implanted inside a patient during surgery. The size of the medical device industry in the U.S. exceeds $150 billion in annual revenues. There are close to 200,000 medical devices on the market at any given time. Medical devices can include:
- Hernia mesh
- Insulin pumps
FDA Recalls of Medical Devices
Every year, the Food and Drug Administration recalls dozens of dangerous medical devices for various defects that can harm patients. Medical device injuries have caused approximately 80,000 deaths in the United States since 2008. Countless others receive injuries from medical devices that range from minor to major.
If one has been harmed by a defective medical device, they are not without recourse. Every year, countless lawsuits are brought against the manufacturers of these devices as well as anyone who is involved in the process of selling the device to the consumer. This is known as a product liability lawsuit. This is the main means that those who are harmed by these devices have of getting justice.
Lawsuits against these manufacturers and others proceed under the theory that consumers are owed a duty by those who make devices for their benefit. This duty consists of many distinct parts. If any aspect of this duty is breached, then the manufacturer or seller may be liable to the purchaser. In some states, the manufacturers are automatically liable if a product is unreasonably dangerous and injures someone. This is known as strict liability.
Outside of strict liability, here are some of the theories under which manufacturers of medical devices may be successfully sued by those injured by the products.
Failure to warn – This occurs when there is a possible side effect that the manufacturer knew or should have known about and they failed to warn purchasers of this danger when they sold the device.
Negligence – The manufacturer owes a duty to the consumer to act as a reasonable company when designing and manufacturing the product. If they fail to uphold this duty and someone is injured, they can be held liable.
Breach of Warranty – This occurs when the manufacturer or seller makes some sort of warranty when selling the product and then the product fails to live up to the warranty.
Misrepresentation/Fraud – This can occur when the seller has made a knowing misstatement in order to induce a purchase of the medical device. This is a relatively high standard to meet.
Types of Defective Medical Device Cases
Defective medical device lawsuits are as complex as any type of product liability lawsuit. There are essential elements to assess to determine what type of defect a device has. It is also crucial to have an attorney who is experienced with these types of cases. To be considered defective, a device must cause an injury to a patient when it is being used correctly and for the right purpose. Defective medical device claims were brought under state laws. Dependent on these laws, the failed devices will assert a breach of warranty, strict negligence, or product liability.
The three main types of device defects are:
This defect happens when there are problems or mistakes made in the design stage. This means that a device could malfunction because it was designed incorrectly.
This defect occurs when there are problems or mistakes made in the manufacturing stage. A medical device may have been designed safely, but a mistake during the manufacturing process could cause the device to become dangerous. Manufacturers are accountable for any malfunctioning devices where the issue can be traced back to where the device was assembled.
This defect is not as obvious as manufacturing or design defects. Marketing defects usually involve a failure to warn, inaccurate warning labels, or false claims of a device.
Who May Be Sued?
When dealing with a defective medical device lawsuit, it is important to know the phrase “stream of commerce.” That is because anyone who is in this stream may be a defendant in a defective medical device lawsuit. It can be a manufacturer, distributor, or marketer of any retail outlet that makes or sells a medical device. For example, if a medical device is available to consumers at a pharmacy, that store may be held liable if the product causes harm to a customer. It is not important to the plaintiff how much of the liability one party has. So long as the plaintiff prevails in the lawsuit, it is up to all of the liable parties to fight it out in court to see how much of the verdict each party must pay.
Specifics of a Defective Medical Device Lawsuit
It is vital to know that lawsuits for medical device injuries are not necessarily easy. Manufacturers often have every incentive to vigorously defend against these claims because admitting liability could lead to massive losses. Chances are that if one person is injured by a medical device, a large class of purchasers have also suffered harm. Then, the company’s share price would suffer dramatically due to the large liability. Thus, companies are required to defend these lawsuits unless there is overwhelming evidence of defects.
Lawsuits will proceed either individually or as part of a class-action suit. Generally, when the harm is common among many people, attorneys will file a class-action suit since all of the plaintiffs are “commonly situated.” However, when there is some difference in circumstances, the lawsuits will proceed individually. In some instances, the lawsuit will be designated as multi-district litigation and will proceed together with many major rulings right up until the actual trial.
Lawsuits for defective medical devices will often require many witnesses as well as scientific evidence to show that the device is defective. The plaintiff will likely need strong expert witnesses to show that there was something wrong with the device. At the same time, the manufacturer will have their own scientific conclusions that demonstrate that their product is safe for the general public. There will be many battles in court over what evidence is admitted for the jury to see.
Some medical device failure lawsuits will result in large jury awards for the plaintiff. If the jury sees that the manufacturer has behaved very badly, it may assess punitive damages. Sometimes, a judge or an appeals court may end up reducing large verdicts.
Contact an Experienced Medical Device Injury Lawyer
The Eichholz Law Firm is experienced in dealing with medical device lawsuits. They have four decades of experience in helping those who have been injured by the actions of others. The Eichholz Law Firm will fight to hold those who place defective medical devices on the market responsible for the consequences of their actions. Call them today to find out how they can help in making sure that financial compensation is received for any injuries that have been suffered.
- FDA. “What is a Medical Device Recall?“, U.S. Department of Health and Human Services, https://www.fda.gov/medicaldevices/safety/listofrecalls/ucm329946.htm. Accessed April 12, 2019.
- FDA. “Medical Device Safety“, U.S. Department of Health and Human Services, https://www.fda.gov/medicaldevices/safety/default.htm. Accessed April 12, 2019.
- FindLaw. “Class Action Cases“, FindLaw, https://litigation.findlaw.com/legal-system/class-action-cases.html. Accessed April 5, 2019.
- Legal Information Institute. “Class Action“, Cornell Law School, https://www.law.cornell.edu/wex/class_action. Accessed April 5, 2019.
- FreeAdvice staff. “Class Action Lawsuits: What They Are and How They Work“, FreeAdvice, https://law.freeadvice.com/litigation/class_actions/class-action-lawsuit.htm. Accessed April 5, 2019.