Medical devices are at the forefront of cutting-edge technology. They help people manage conditions such as heart disease, diabetes, and joint replacements. Devices such as pacemakers and insulin pumps can also improve people’s quality of life and aid in recovery.
However, design flaws or manufacturing defects in medical devices can cause serious injuries. If this happens, you may be able to recover damages from the device manufacturer through a medical device products liability lawsuit. This article will discuss how to prove liability in an injury claim related to a defective medical device.
What are Medical Devices?
A medical device is any instrument, tool, implant, implement, machine, or other apparatus used to treat, diagnose, or monitor a health condition. All kinds of healthcare professionals utilize medical devices every day when rendering treatment to patients, such as physicians, nurses, technicians, homecare workers, dentists, and many other healthcare providers. According to the World Health Organization (WHO), there are more than 2 million different kinds of medical devices available on the world market.
Medical Devices and Product Liability Cases
In product liability cases, medical devices that are often involved typically have the potential for malfunction or defects that can lead to harm. In these cases, lawsuits typically focus on defects in design, manufacturing, or insufficient warnings about potential risks. Some common examples include:
- Implants — Devices like hip replacements, pacemakers, synthetic bone implants, and breast implants are frequently involved due to issues with materials, design flaws, or improper manufacturing that can cause complications for patients.
- Defibrillators—Malfunctions in automated external defibrillators (AEDs) or implantable cardioverter defibrillators (ICDs) can cause harm by failing to deliver proper shocks.
- Surgical Instruments — Tools like scalpels, forceps, or staplers can become defective, leading to unintended injury during procedures.
- Infusion Pumps — Devices used to administer medication or fluids can malfunction, leading to overdoses, underdoses, or incorrect medication being administered.
- Ventilators — These life-saving devices, especially those used in intensive care or emergency situations, can be involved in liability cases if they fail to function properly.
Types of Defects
In product liability cases, defects that can lead to harm are typically categorized into three main types: design defects, manufacturing defects, and marketing defects (also known as failure to warn). Each type of defect can cause harm, and the responsible parties – designers, manufacturers, or marketers – can be held liable for any injuries caused by these defects.
Design Defect
These occur when a product is inherently dangerous or flawed due to its design, even if it is manufactured correctly. The defect exists from the outset, and the entire product line may be affected.
Manufacturing Defect
These happen when a product is designed correctly but is improperly manufactured or assembled. The defect typically affects only a small number of products in a batch or production run.
Marketing Defect (Failure to Warn)
These occur when a product is sold without adequate warnings or instructions or when it is marketed in a misleading way that fails to inform the consumer of potential risks. These can include products lacking proper safety warnings, such as medications that don’t disclose side effects or power tools that don’t indicate the danger of improper use.
Theories of Product Liability
In product liability law, there are three primary theories under which a plaintiff can hold a manufacturer, distributor, or seller liable for harm caused by a defective product.
Strict Liability
Under strict liability, a defendant can be held responsible for a defective product regardless of whether they were negligent or at fault. The key issue is whether the product was defectively designed, manufactured, or marketed in a way that made it unreasonably dangerous to the consumer.
Strict liability applies even if the defendant followed all proper safety standards or exercised due care. The focus is on the defect itself and its inherent danger.
Negligence
Negligence occurs when a manufacturer, seller, or distributor fails to exercise reasonable care in a product’s design, production, or handling, leading to harm. In these cases, the plaintiff must show that the defendant owed a duty of care, breached that duty, and caused injury due to the breach. For example, if a company cuts corners in its manufacturing process, resulting in defective products that harm consumers, it may be held liable for negligence.
Breach of Warranty
This theory involves failing to meet the manufacturer’s or seller’s promises or guarantees regarding the product’s safety, performance, or quality. Warranties can be express (explicitly stated) or implied (inferred by law).
A breach of warranty occurs when the product fails to meet these assurances, leading to harm. For instance, if a manufacturer claims a product is “child-safe” but it causes injury, the consumer may claim a breach of warranty.
Were You Harmed by a Defective Medical Device? Let Pullano & Siporin Guide You Through the Legal Process With Confidence.
If you’ve been injured by a defective medical device, don’t navigate the complexities of a product liability claim alone. At Pullano & Siporin, we have the experience and expertise to take on medical device manufacturers and ensure you obtain full compensation and the justice you deserve.
Our team is dedicated to thoroughly investigating your case, identifying key evidence, and holding negligent manufacturers accountable for the harm their products cause. With a proven track record in medical device litigation, we will fight tirelessly to ensure your rights are protected.
Contact us today for a free consultation.
