Investigating Adverse Medical Device Events: A Three-Step Approach

Medical device firms—whether OEMs or contract manufacturers—may face their own unwelcome drama when confronting patient allegations of product malfunction or defect. In such settings, managers at device firms can relate to Friday’s desire for “just the facts.”

Capturing the facts—favorable or unfavorable—is vital to assessing a device firm’s vulnerability to liability and tort claims. At stake are thousands or millions of dollars from settlements, jury awards and legal costs. Mounting an effective early investigation of an adverse medical device outcome is the foundation for early defense or resolution. Lawsuits against manufacturers of catheters, ear implants, hip screws and other products foreshadow huge needs to gather facts to assess the presence of defects or adverse outcomes that may be due to other factors.

Facts win or lose product liability cases. If there are favorable facts, device firms want to capture those as quickly as possible, before the investigative trail grows cold. With the passage of time, memories dim, key witnesses disperse and physical evidence may degrade or be destroyed. If facts are bad, device firms may not necessarily want to capture them (more on this later) but at least be aware of them to know whether successful defense or compromise resolution is the more prudent course. Unlike fine wine, the ability to fact-find after an adverse medical outcome does not improve with age.

Want to win medical product liability claims? The foundation of winning often lies in a good investigation. Let’s look at three practical tips to help device firms navigate the fact-finding process:

Step No. 1: Take Control. Typically, a medical device firm first learns of an incident, potential claim or a full-blown claim through a hospital, physician or patient complaint, either by phone or mail. A disadvantage for medical device firms is that they rarely are the first to learn of an adverse event involving one of their products.

As kids, we likely heard the saying, “Possession is nine-tenths of the law.” In that vein, a key step in investigating is to obtain the product involved in the accident or injury. This way, the investigator—the manufacturer, insurer, claim adjuster or outside counsel— can examine it early and assess whether an adverse outcome was due to genuine device failure or to some other factor, such as a failure to read or heed the instructions, sloppy doctor technique or poor patient selection.

Often, the consumer/patient owns the product. Astute manufacturers will make it easy and attractive for customers to return products that have been involved in an adverse outcome. The techniques include:

• Requesting the product’s return, so that it can be examined and allow the company a chance to make sure no further accidents occur
• Offering to exchange the old product for a new one
• Offering to refund the purchase price in exchange for returning the product
• Facilitating product return by offering to pick it up and pay shipping-and-handling charges (consider the ease of Amazon.com’s “one-click” ordering system as the epitome)
• Offering a premium, such as another product, or discount off a future purchase.

These gestures are no guarantees but may help regain possession of the device in question. They also build customer goodwill and lower odds of facing a formal claim for damages. In the final analysis, though, it is up to product buyers—patients/consumers—to decide whether to return the product. Realism must temper hope here, thoug. If patients refuse these inducements, the device company has a tougher job getting early access to the product for examination and testing. Persistence and creativity may pay off in this case, however.

Step No. 2: Safeguard the Product. Once you get the product, tag it and keep records of when and where you store it for chain-of-custody purposes.

Do not test the product without first clearing it with your insurer or legal counsel. They may want safeguards in place to make sure that test results are privileged, especially if the test results turn out to be unfavorable. “Privileged” communications means that they are confidential and do not have to be divulged or disclosed. Failure to preserve this privilege can devastate the defense of a medical device claim.

In a lawsuit against a motorized three-wheeled scooter, the plaintiff claimed that the unit flipped and tipped while ascending an incline. The scooter passenger—an elderly woman—suffered a fatal head injury. Deep into the litigation, the product liability insurer learned that the manufacturer had—post accident—conducted a homemade experiment to re-enact the accident. Neither the product liability insurer nor the defense attorney knew of this “testing.” While the test’s scientific validity was questionable, the insurer feared that the re-enactment—which was not protected by attorney-client privilege—would have to be disclosed and might undermine its liability defenses.

The moral of the story: Conduct proper tests, and be mindful of the legal issues.

Step No. 3: Focus on Product Identification. If you cannot obtain the product in question, the next best option is to gain access to it to inspect it. Hospitals may be agreeable to allowing­ access to a device that is associated with an adverse patient outcome. A product inspection should aim to:

• Record the model, lot and serial numbers
• Confirm or rule out the identity of the actual product manufacturer
• Capture good color photographs
• Check for signs of product abuse, misuse or shoddy maintenance. For example, a worn, scuffed or jury-rigged product condition may imply certain defenses that the manufacturer can employ.

Often, despite best efforts, a device manufacturer may not be able to obtain the product. Perhaps the end users do not trust the manufacturer enough to relinquish possession, or they realize that it could be a crucial piece of evidence. If the claim is not yet a lawsuit, a personal injury attorney may be reluctant to relinquish the product, lest someone else lose or alter it. Sometimes no one has the device because it has been lost, destroyed, discarded or consumed.

Often, the medical device inspection occurs at the office of a lawyer. In other cases, the product inspection may be in the home of the claimant/consumer. Or the device inspection may be at a hospital or a physician’s office. After the device manufacturer gets permission, it helps having the inspection under the direction of legal counsel and performed with a technical or product representative from the manufacturer.

Typically, such individuals have a high degree of technical and product expertise. They will know what to look for in assessing whether or not a product incident involves a device defect or malfunction, or is due to other causes.

These three steps will lay a strong foundation for product liability defense and may provide sufficient ammunition to keep you out of court. Joe Friday never had to deal with the U.S. Food and Drug Administration, investigative TV journalism, or a resourceful plaintiff’s bar. Focusing on getting“just the facts” may minimize a device firm’s necessity to engage with these constituencies and lay the foundation for either a successful defense or early claim resolution.

Kevin Quinley is vice president, risk services, for Berkley Life Sciences LLC. The views expressed here do not constitute legal advice, are his own and do not necessarily reflect those of Berkley Life Sciences or its customers. You can reach him at [email protected].