Typically governed under state laws, product liability claims are filed against injuries sustained due to a defective product. These lawsuits are mostly associated with complex medical devices required for serious health conditions.
A medical device, by definition of its term, refers to any machine, implant, or monitor that medical practitioners use to treat an injury or illness. Examples of such devices include –
- Implants to restore the function of disabled body parts
- Defibrillators
- Stents
- Contraceptive devices
- Hernia mesh
- Ventilators and CPAP machines
In this article, we will discuss product liability laws under the context of such medical devices – the types and liable parties.
Claims Involved in Medical Product Liability Lawsuits
When an individual or group of individuals is injured by a medical device, the victims can file a personal injury lawsuit against the manufacturer. This litigation proceeds under three different categories –
- Medical devices that were manufactured in a defective manner.
- Medical devices that have sustained a defective design.
- Medical devices that have been marketed in a defective or ethically wrong manner.
Let’s look at each category of the lawsuit in detail.
Defectively-Manufactured Medical Devices
This aspect of the product liability lawsuit deals with medical devices that were manufactured with defects. This means such devices were damaged even before they reached the physician or patient. The reasons behind the defect could be limited to manufacturing or extend to shipping as well.
These lawsuits are typically based on strict liability, which means the plaintiff must only prove that there was a manufacturing defect that led to harm. One example could be the failure to adequately seal implantable medical devices. This usually leads to oxidation and thereby, to premature damage.
As a result, patients could suffer from internal injuries and infections that require surgical aid.
Defectively-Designed Medical Devices
Under this category of medical device product liability claim, plaintiffs allege that despite proper manufacturing, the device has major design flaws. In this case, a medical device often stays on the market for too long before any adverse events are reported.
This is usually because the device gradually breaks over time, causing severe injuries. Defectively designed medical device lawsuits are generally more complex because the entire line of products is considered to be defective.
In most cases, the manufacturer was aware of the device’s flaws but failed to disclose them due to fear of recall. In such cases, the plaintiff’s counsel may need to prove that an alternative (safer) design option was available but the manufacturer shunned it due to the higher costs involved.
An example of such litigation would be the Bard PowerPort lawsuit. This lawsuit is filed against Bard Access Systems Inc. for its catheter port commonly used for dialysis or chemotherapy. Plaintiffs have alleged that the catheter is defective owing to compromised mechanical integrity.
Essentially, the improper mixture of Barium Sulfate used to manufacture the catheters is causing its parts to break and migrate within the body. According to TorHoerman Law, victims have suffered severe injuries like cardiac arrhythmia, tissue perforation, blood clots, ruptured blood vessels, and pulmonary embolisms.
As of now, settlements are pending as the lawsuit is still awaiting its Bellwether trials.
Defectively-Marketed Medical Devices
Every medical device manufacturer is liable to properly disclose any possible side effects of their product. This information is crucial for physicians to ensure patient safety and reduce complication risks.
In some cases, the manufacturer may conceal the dangers in a thirst for profits. It is also possible that the device did not undergo thorough clinical trials before receiving Food and Drug Administration (FDA) approval.
It is only later that the full extent of side effects comes to the surface. In any case, if the manufacturer fails to provide complete warnings on product labels, they can be sued. This aspect of medical device product liability lawsuits also covers hospitals and physicians who fail to inform their patients about the correct use of a device.
An example of this lawsuit would be ZyCal Bioceuticals’ medical device claimed to relieve joint pain and grow bone cartilage. The manufacturer went as far as falsely advertising that its product’s efficacy was scientifically proven. Moreover, ZyCal Bioceuticals even bribed Excellent Marketing Results Inc. to carry out deceptive marketing tactics.
The Federal Trade Commission (FTC) has passed an order to prevent the defendant from false claims. The order also demands that quick settlement notices be delivered to physicians, patients, and other customers of the device.
Who Can Be the Liable Parties?
In most product liability lawsuits filed in the context of medical devices, manufacturers, distributors, and suppliers become the primary defendants. This is especially true in the case of defectively manufactured and designed medical devices.
Since a significant amount of money is generally at stake, the legal battle is often long-drawn and complex. In a select few cases, there may be other liable parties involved. These would include a third-party laboratory responsible for testing the device’s safety.
Furthermore, the manufacturer’s sales representatives may be held liable for neglecting device risks and recommending the product to physicians.
Distinguishing between Defective Devices and Medical Malpractice
Let’s draw a clear distinction between a defective device and a medical malpractice lawsuit. Under the former, the manufacturer is usually the sole liable party (especially when the lawsuit involves manufacturing or design defects).
Medical malpractice cases, on the other hand, are filed against healthcare practitioners who stray from industry standards for diagnosis, treatment, and aftercare.
For instance – despite being aware of certain drug complications, a doctor may fail to inform the patient. This would lead to a breach of duty and care.
The statute of limitations for defective device lawsuits is longer than that for medical malpractice lawsuits across most US states.
To put things into perspective, a defective device lawsuit may have its filing window open for up to five years. However, medical malpractice lawsuit filing may close within one year from the date of the incident.
