As technology has rapidly developed over the past several decades, medical devices are more common than ever before. The popularity of these devices has brought about an increase in the number of injuries caused by defects in the products. Unfortunately, the desire to protect individuals from injury caused by devices has created some problems between state laws and federal laws, which both seek to protect individuals from these types of injuries. This layered law making has led to a “too many cooks in the kitchen” problem, where inconsistent laws can actually make redress of injuries more difficult. Below is an overview of claims and laws affecting medical devices:
Strict Product Liability Claims
Medical devices—like all products—must be free from defects. A claim for strict liability requires proving three things. First, that the product was defective. Second, the defect caused an injury to the plaintiff. Third, the defect existed when the product left the control of the defendant. This means that any member of the chain of distribution for a medical device can be sued for the injuries: the manufacturer, the wholesaler, and the retailer. It doesn’t matter that only the manufacturer was responsible for the defect. The law imposes liability on each party that reaps the rewards from the sale of a dangerously defective product. A product can be defective in three ways under Kansas law. These are discussed below.
First, a product must conform to its intended design. If the product contains an irregularity, it is considered defectively manufactured. For example, a pace-maker that electrocutes the patient because of a frayed wire has a manufacturing defect. The pace-maker is not designed to electrocute the patient; it only happened because the device did not conform to the intended design. Proving this type of defect is the simplest of the three types of defects. All that needs to be shown is an irregularity or mistake in making the device. However, these types of defects are the least common source of strict product liability claims because of the increased rigors of quality control used by most manufacturers.
The second way a medical device can be defective is by being defectively designed. A product must not pose more of a risk than a normal consumer would expect. In the context of medical devices, this means that the device poses no more danger than the patient would expect. This can be difficult to prove, but plaintiffs will often do so by showing a reasonable alternative design exists. It should also be noted that a device is not required to be perfectly safe. Instead, a manufacturer can warn of dangers that cannot be mitigated without jeopardizing the usefulness of the device. An example of a design defect is a defibrillator that’s paddle surfaces becomes very hot after three to four uses. Because defibrillators may need to be used consecutively more than four times, this design is unacceptable. A patient could recover for burns by showing that a normal consumer would not expect this danger to exist. To meet this burden, the patient would likely show that different materials could have been used to prevent the problem.
The final way a product can be defective is by having inadequate warnings. A manufacturer has an obligation to warn a patient of non-obvious dangers. However, a manufacturer cannot be expected to warn of all possible dangers. Instead, the law strikes a balance, requiring the manufacturer to warn of foreseeable risks that would render the medical device not reasonable safe. This is a fact-intensive inquiry, and will largely be unclear until a jury decides what is reasonably safe or not.
Prescription drugs and medical devices unavailable without a prescription have a special exception for warnings. The learned intermediary rule applies to these devices and products. In Savina v. Sterling Drug, Inc., the Kansas Supreme Court formally adopted this doctrine, which states that if a manufacturer gives adequate warnings to the doctor, the obligation to provide warnings is satisfied. If the doctor fails to pass along these warnings to the patient, then the claim must be brought against doctor rather than the manufacturer. This rule only applies if two things are true. First, the patient cannot get the device or product without the prescription or permission of the doctor. Second, the product cannot be marketed directly to the consumer. If such advertisements do occur, the obligation to warn is triggered. This is why commercials for such products contain the routine long, drawn out warnings at the end.
Federal Law and State Law Interplay
The potential danger posed by medical devices has prompted both state and federal regulations and laws to protect patients. However, the Supremacy Clause of the Constitution poses a problem when both governments act on the same subject. The Supremacy Clause requires that when a state law and a federal law conflict, the federal law must always prevail—a concept known as federal preemption. In Troutman v. Curtis, the Kansas Supreme Court stated that though laws inconsistent with federal law are preempted, a product liability claim for a defect that is also prohibited by federal regulations is not preempted. This means that failure to provide warnings consistent with federal law can still be the basis of a product liability claim. This line is both thin and difficult to know, however. In Riegel v. Medtronic, Inc., the United States Supreme Court case that held that state product liability claims that sought to serve the same purpose—ensure medical devices are safe—as the federal regulations can still be preempted when the laws take inconsistent approaches to reaching that goal.
Defective medical devices and the injuries they cause are complex. Constitutional law, tort law, and other areas all converge on such claims. The interplay of these diverse areas of law highlight how important experienced and capable legal counsel are for medical device claims. Only when you are sure that your attorney is capable and ready to pursue your claim can you be confident that the responsible parties will be held accountable for your injuries.