[author: Maria Fleming]*

Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or physician is liable can be extremely complicated and difficult. That is why having an experienced product liability lawyer is absolutely essential in order for victims of defective medical devices to receive compensation.

Types of Device Defects

There are three main types of defects that incur liability in manufacturers, distributors and suppliers:

• Design defects, in which an inherent design flaw makes the device defective or dangerous. Many hip replacement manufacturers, such as Stryker and Smith & Nephew, have been held liable for their production of metal-on-metal (MoM) hip replacement devices. Though intended to be sturdier and longer-lasting than plastic-on-metal implants, the metal parts grinded together. This was found to deposit metal fragments into surrounding tissue, leading some patients to develop metal poisoning (metallosis). This also caused the devices to fail quicker than their plastic-on-metal counterparts.
• Manufacturing defects, in which something goes wrong during the construction of the device that can lead to potentially dangerous defects. Since 2021, prosthetics manufacturer Exactech has voluntarily recalled hundreds of thousands of artificial knee, ankle and hip implants due to off-specification vacuum bags used to store polyethylene tibial inserts. These defective bags may have caused polyethylene inserts to oxidize before the end of their stated shelf life. This thins the polyethylene, making it more vulnerable to accelerated wear by delamination, in turn leading to pain and swelling, mobility issues, difficulty bearing weight, and stiffness, as well as osteolysis (bone loss), fractures, and dislocation, among other complications.
• Defects in marketing, in which the device was marketed with improper instructions and negligently failed to include a proper warning of any latent dangers. This is also known as “failure to warn” or warning defect. For example, as of September 2022, there were over 24,000 lawsuits pending against hernia mesh manufacturers like Ethicon and Atrium Medical Corp., alleging improper device labeling and failure to warn patients and doctors of the risk of mesh failure, a potentially life-threatening complication. Another example is the host of litigation against hair and cosmetics companies alleging they failed to warn consumers of the dangers of toxic ingredients such as parabens, a class of endocrine disrupting chemical (EDC) that is linked to increased cancer risk.

Strict Liability

Generally, a manufacturer is strictly liable for any illness or injury caused by a defective product. This means the company is legally responsible for a patient’s damages or injuries, even if they did not act with fault or negligence. A plaintiff suing under strict liability law only needs to prove that the device had a defect, that the defect made the device unreasonably dangerous, and that the defect actually and proximately caused the injury.

Other partially liable parties may include the laboratory tasked with conducting safety tests on the device, sales representatives of the manufacturer, and healthcare providers if they fail to inform their patients of potential risks and neglected to give them instructions on how to use a device.

Common Defenses and Barriers to Litigation

There are a number of defenses in defective products litigation that a plaintiff and their attorney must be able to navigate.

The manufacturer may argue the unforeseeable use doctrine, under which the manufacturer must prove the victim misused the device in an unforeseeable way. Fortunately for plaintiffs, this rarely applies, since the misuse must be extreme. A patient harmed after turning up the motor on their CPAP machine too high, for instance, is not unforeseeable misuse.

A manufacturer may also argue preemption in an attempt to bar lawsuits. Under this doctrine, medical device makers who submit to FDA regulations cannot be held accountable to state laws. In other words, state courts can’t require a manufacturer to go against regulations set forth by the FDA, which is a federal administration. Given how state laws vary, the outcomes of the preemption argument are mixed.

A notable instance of a successful preemption defense is the case of Stephanie Yates. After she suffered a stroke while using Ortho Evra’s birth-control patch, she sued the manufacturers, arguing that they could have reduced the amount of estrogen in the patch to make it safer. This change could not have been made without FDA approval, and the state could not order that the manufacturers alter the amount of estrogen in the patch. The makers were therefore found not liable to Yates under the preemption doctrine.

Product liability law is further complicated by the legal gray area surrounding off-label use of medical devices. While the FDA prohibits manufacturers from promoting a medical device for off-label use, physicians are legally allowed to use the device off-label at their discretion. For example, mixing and matching hip and knee implant components from different manufacturers is an effective off-label use for some patients.

Off-label use can make it difficult to determine who is liable for damages when complications arise, however. Under the “learned intermediary” doctrine, a manufacturer has fulfilled its duty of care when it provides all necessary information about on-label use of a medical device to a learned intermediary—e.g., a prescribing physician—who will interact directly with the patient. This means a manufacturer has no duty to warn the individual patient of potential risks associated with the device. The doctrine further asserts the causation defense, which states that a manufacturer’s failure to warn did not cause the plaintiff’s injuries if the physician was aware of the risks of off-label use from another source.

Compensation May Be Available

Despite how some doctrines are designed to shield pharmaceutical companies and drug manufacturers from liability, defective product claims often result in compensatory and punitive damages for the plaintiff. Hip and knee implant failure, for one, may require revision surgery, which is costlier, more complex, and has a higher risk of post-operative complications such as loss of mobility and chronic pain. Compensation is available for these economic and non-economic losses. Punitive damages vary widely by state and circumstances. It is therefore vital to have the help of an experienced personal injury attorney to navigate the complicated world of product liability law and ensure a plaintiff gets the maximum compensation they deserve.

*Senior Associate