Defective Medical Device: Do You Have a Case?
Aug 23, 2023
Injuries and other health complications caused by defective medical devices, such as body monitors, insulin pumps, or body implants, can be grounds for a product liability case. Even though the U.S. Food and Drug Administration (FDA) regulates medical devices, it is not uncommon for a defective device to find its way onto the market.
We trust medical devices recommended to us by doctors. Nonetheless, devices with design defects, manufacturing defects, or marketing strategy flaws can be dangerous. They pose a risk of injury, health complications, or even death. If you have suffered bodily harm or lost a loved one due to the adverse effects of a defective medical device, you may have a justified claim against the manufacturer or any other liable party.
An experienced attorney can help you build a watertight case, go against the pharmaceutical company responsible for your injury, and ensure you receive maximum compensation.
What Constitutes a Defective Medical Device?
A defective medical device is any medical device with a design defect, manufacturing defect, or labeling flaw that makes it unsafe or unfit for its intended use. The three categories that can render a medical device defective include the following:
- Design defect. A design defect occurs when the inherent design of the medical device is flawed, making it unsafe or prone to malfunction even when manufactured and used as intended. This means that the entire line of products with the same design is defective.
- Manufacturing defect. A manufacturing defect refers to an issue that occurs during the production or manufacturing process, leading to a specific unit or batch of devices being defective. It means that a particular product or group of products within a line is flawed rather than the entire line.
- Failure to warn or provide adequate instructions. A medical device may be rendered defective when the manufacturer fails to provide sufficient warnings or instructions regarding its proper use, risks, side effects, or limitations.
When patients suffer harm due to a defective medical device, they may have legal grounds to pursue a defective medical device case in Wyoming.
Signs of a Potential Defective Medical Device Case
The FDA must approve all medical devices, a move meant to cushion patients from the potential adverse effects of defective medical devices. Further, the FDA monitors reports of injuries and other safety issues with medical devices and alerts the public and health professionals to ensure the health and safety of patients and the proper use of these devices.
Despite efforts by the FDA to ensure medical device safety, thousands of patients suffer injuries and other complications due to defective devices. So, what are the things to look out for to know if you have a defective medical device case? Below are some of those.
Unusual or Unexpected Medical Complications From a Device
Medical devices have long been used to help patients live longer and more comfortably. Over time, however, some of these devices have been found to cause unusual or unexpected medical complications in patients. For instance, the transvaginal mesh is an ingenious device for repairing pelvic organ prolapse and treating urinary incontinence in female patients.
Over the years, medical professionals have associated various complications with surgical mesh devices, including:
- Vaginal mesh erosion
- Urinary problems
- Recurrence of pelvic organ prolapse
Recalls or Warnings Issued for the Specific Medical Device
In the event of reports of a defective medical device, the FDA issues a recall — a method of correcting or removing a product that violates FDA regulations. Here are some examples of medical devices that have recently been recalled due to defects:
- Walnut Wearable Smart Thermometer, manufactured by BearCare, Inc., was recalled due to the risk of skin irritation and burns during use.
- Mighty Bliss electric heating pads manufactured by Whele LLC were recalled due to the risk of electric shock, rashes, and skin burns.
- Certain BiPAP machines manufactured by Philips Respironics were recalled due to concerns about potential chemical exposure.
- SafeStar 55 breathing system filters manufactured by Draeger, Inc., were recalled for potential obstructions that may restrict oxygen flow.
Medical Literature or Studies Linking the Device To Adverse Effects
The FDA often allows companies to market their new medical devices sooner than other products through the 510(k) clearance process. However, medical reports may later show that the medical devices are not entirely safe for patients, regardless of their initial efficacy. In the case of surgical meshes, medical studies have shown a long-term recurrence of pelvic organ relapse and complications such as fibrosis, bowel obstruction, and infection associated with using these devices.
Medical literature and studies are crucial in identifying and documenting adverse effects, complications, or failures associated with medical devices. They provide scientific evidence and insights into the safety and effectiveness of devices and can be valuable references for your potential defective device case.
If a substantial body of medical literature or study backs the claim that a particular device harmed you due to its adverse effects, it can strengthen your case and help you recover damages due to your injury.
Failure of the Medical Device To Perform Its Intended Function
A medical device with a design or manufacturing flaw or insufficient warnings regarding its risks or effects may not give the desired results even when used correctly.
For instance, metal-on-metal hip implants were introduced as an alternative to traditional hip replacements, promising increased durability and longevity. However, numerous patients who received these implants experienced significant complications when the devices failed to function properly.
The metal-on-metal hip implants were designed with a ball-and-socket mechanism, where the ball was made of metal and rotated within a metal socket. Over time, friction between the two metal components releases tiny particles into the surrounding tissues and bloodstream, causing adverse reactions and complications. These complications include pain, inflammation, tissue damage, implant loosening, and the need for revision surgeries.
If your metal-on-metal hip implant or any other defective medical device caused complications or injury, speak to medical device lawyers immediately for advice and guidance.
Medical Device Manufacturer's Negligence or Lack of Adequate Testing and Safety Measures
When medical device companies fail to exercise reasonable care in a medical device's design, manufacturing, or testing, it can lead to defects or hazards that pose risks to patients. Such negligence can form the basis for your defective medical device case.
A typical case of manufacturer negligence is DePuy Orthopedics, which paid over $120 million for deceptive marketing claims. Numerous patients who received DePuy ASR hip implants experienced severe complications, such as implant loosening, tissue damage, pain, and the need for revision surgeries. Investigations and subsequent legal proceedings revealed that the manufacturer had been negligent in various aspects.
The design of the ASR hip implants was flawed, and DePuy Orthopedics failed to conduct adequate testing and clinical trials before releasing the implants to the market. Additionally, evidence emerged that the manufacturer was aware of the high failure rate and potential risks associated with the ASR hip implants but failed to take appropriate action early.
Maximize Your Legal Claim Outcomes With the Best Personal Injury Attorney
If you have suffered an injury or complications due to a defective product, it is important that you seek legal help before filing a defective medical device lawsuit. At The Spence Law Firm, we are dedicated to fighting for injured victims who have had their lives adversely affected due to the negligence of a medical device manufacturer.
Our personal injury lawyers have a record of winning cases in court and obtaining fair settlements for victims. We understand the emotional suffering and financial struggles victims and their families endure due to lifelong injuries and complications resulting from defective medical devices. We are based in Wyoming and New Mexico, but we represent victims nationwide and go where needed.
Meet with us.
If you are struggling with a serious injury, or are fighting against seemingly impossible odds against big corporations, insurance companies or the government, call us to speak with our team of trial lawyers who will fight for you. We take no fee unless we earn it by winning your case.