Defective medical devices present serious risks for patients. Just how big—and how severe—is the problem? Consider this from the U.S. Food and Drug Administration (FDA):
“Each year, the FDA receives over two million medical device reports of suspected device-associated deaths, serious injuries, and malfunctions.”
While the FDA goes on to emphasize that not all of these medical device reports (MDRs) necessarily reflect defect-related issues, it is nonetheless clear that medical device defects are far more common than they should be.
This means that defective medical devices have a major impact on patient safety.
Given the substantial risks involved, why don’t medical device manufacturers do more to avoid selling defective devices? In many cases, the answer is simply that it is most profitable to get a new medical device on the market as quickly as possible.
How Can Patients and Their Families Protect Themselves?
With this in mind, how can patients and their families protect themselves? What can patients, parents, spouses and other loved ones do to minimize the risk of device-related complications?
Equally important, what can patients, parents, spouses and other loved ones do when they only learn about a medical device defect when it’s already too late?
Unfortunately, in many cases, it simply isn’t possible for patients and their loved ones to gather the information they need to make informed decisions. The information they need simply isn’t available. If a medical device manufacturer hasn’t identified (or hasn’t disclosed) risks associated with its device—and if no adverse events have been reported—there may be no way to know that undergoing an implant procedure could lead to serious or fatal complications.
This is why product liability laws exist. These laws allow patients and families to hold defective medical device manufacturers accountable—and these laws apply regardless of whether a manufacturer could (and arguably should) have done more to protect patient safety. In cases involving serious or fatal complications from defective medical devices, product liability laws allow patients and their families to:
- Find Out What the Manufacturer Knew (and When It Knew It) – When a patient or family member files a lawsuit against a medical device manufacturer, this provides access to the legal process known as “discovery.” During the discovery process, plaintiffs can review the manufacturer’s internal records (and obtain testimony from the manufacturer’s personnel) in order to learn about the device’s history, its pre-market and post-market testing, and any risks of which the manufacturer was aware.
- Examine the Device’s Design and Manufacturing Records for Evidence of Defects – Medical device defects can result from either: (i) flaws in their design; or, (ii) flaws in the manufacturing process. Through the discovery process, plaintiffs can gain access to the records they need to identify potential design and manufacturing defects. If a manufacturer’s internal records show that a medical device is defective, these records can be powerful evidence in support of a claim for liability.
- Hire Experts to Explain Why the Device is Defective and Why the Defect is Dangerous – Typically, analyzing a medical device manufacturer’s design and manufacturing records will involve engaging an expert who is familiar with the relevant technology. In product liability cases targeting medical device manufacturers, patients and families can hire experts to provide the insights they need (and law firms generally cover the cost of paying these experts during the litigation process).
- Pursue Claims Based on Failure to Warn – Along with design and manufacturing defects, patients and families can also file product liability claims for “failure to warn.” In these cases, liability is based on the manufacturer’s failure to disclose risks—whether known or unknown—related to the implantation and use of a medical device. Even if the device largely functions as intended, if it presents undisclosed risks, this can provide clear grounds to take legal action.
- Seek Full Compensation for Their Financial and Non–Financial Losses – Product liability laws entitle patients and families to seek full compensation for their financial and non-financial losses resulting from medical device defects. This includes present and future medical expenses and other out-of-pocket costs, lost earnings, pain and suffering, loss of consortium, and loss of enjoyment of life. In the aggregate, these losses can be substantial, and this makes it imperative for plaintiffs and their families to engage an experienced law firm that can help maximize their chances of securing a settlement or verdict.
While product liability laws allow patients and families to hold medical device manufacturers accountable, filing a product liability lawsuit is not an easy process. In fact, it is extremely complicated. But, engaging an experienced law firm costs nothing out-of-pocket in this scenario, and taking legal action can be well worth it if it means holding the manufacturer accountable.
How Product Liability Lawsuits Can Help Improve Patient Safety
Engaging a law firm to file a product liability lawsuit can be well worth it for another reason as well: Holding defective medical device manufacturers accountable reduces the risk that they will make the same mistake again. In this way, product liability lawsuits can help improve patient safety, in addition to providing financial compensation to patients and their families.
Product liability lawsuits can also help raise awareness of the risks associated with defective medical devices. The more patients and families who come forward, the greater the chances that other patients and families (and healthcare providers) will learn about the risks associated with the device in question before it is too late. In some cases, lawsuits can trigger recalls, FDA warnings, and other remedial actions—and these can all help inform healthcare providers and protect patients going forward as well.
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