Editor’s note: This article is the first in a two-part series on liability for failed implants. The second article appeared in the April issue of AAOS Now.
In recent years, catastrophic failures have been associated with several orthopaedic implants. Issues with biologics, such as bone morphogenic protein, also have been reported. This article explores several of the potential liability aspects of failed implants. For example, what is an orthopaedic surgeon’s legal exposure and medical liability with a failing or failed implant in patients in his or her practice? We have extensive experience treating patients with failed implants, representing plaintiffs in court, and providing expert witness testimony regarding failed implants. Having an implant fail in a patient is not malpractice per se, but a good starting point would be to define a malpractice claim before delving into the individual issues.
Components of a malpractice suit
Briefly, for medical malpractice to be considered, an injured patient must show that the physician acted negligently in rendering care and that such negligence resulted in injury. To do so, four legal elements must be proven:
- a professional duty owed to the patient
- breach of such duty
- injury caused by the breach
- resulting damages
Implanting a device that is widely known in the orthopaedic community to have had issues would breach one’s professional duty. Conversely, a breach would not occur if a surgeon had used an implant with a heretofore unremarkable adverse outcome history. Thus, use of a Food and Drug Administration (FDA)-approved implant as intended is not negligence. Furthermore, if an implant fails, that does not necessarily indicate malpractice. It is worth noting for would-be implant inventors that a recent total hip system with catastrophic failures had only FDA 510K approval instead of full approval granted after completion of multiphase clinical trials. The significance of this technical point is that both FDA approval pathways permit patient use; however, once issues arose, the manufacturer with the 510K implant was responsible for all monetary damages and revision expenses.
To establish negligence, a patient must prove the four elements of duty, breach, causation, and injury. Meeting all four is the universal requirement to prove a tort claim involving negligence. When a licensed healthcare provider is targeted, there must also be proof that the breach stemmed from a deviation from the standard of care. The definition of standard of care is the degree of care expected from a minimally competent physician in the same specialty and under the same circumstances. Standard of care changes—the standard today will be different tomorrow. So, a new standard today cannot be applied to an implant put in 10 years ago if the standard then was different. We all can have 20-20 hindsight, but that would not be a valid test of a case’s merit.
Physicians must be proactive and understand what influences standard of care, outside of their education and experience. Examples of such influences include registry data outside the United States (Wales Registry or Australian Registry); FDA updates or adverse event reporting and advisories on the subject matter; peer-reviewed literature; information uncovered in product liability litigation concerning a product utilized in the physician’s practice that becomes public, such as an article in The New York Times; and health hazard warnings or recalls directly from a manufacturer that arrive at the physician’s practice and of which the physician becomes aware. Furthermore, additional liability may be imposed for lack of informed consent at the time of the procedure and may extend if information is later acquired that may affect the health and welfare of the patient. Informed consent is more than simply getting a patient to sign a written consent form. Rather, it’s the process of communication between the patient and the physician that results in the patient’s written authorization to undergo the original procedure, while acknowledging and weighing the then-known risks and complications.
Thoughtful documentation of good clinical care and the informed consent process will discourage many plaintiffs’ lawyers from accepting cases. Conversely, poor or no documentation of even the best clinical care can make a physician an attractive target. The adage “you must talk to your patient” has less weight in court than talking to the patient and the “chart” (by documenting the discussion). This duty arguably extends to a physician informing a patient when he or she becomes aware that, based on newly acquired information, the patient is at an additional or increased risk of injury.
Elements needed to bring a malpractice suit
In a malpractice suit, four legal elements must be proven:
- A professional duty owed to the patient: Professional duty begins when the professional provides a medical or surgical service or procedure.
- Breach of such duty: Failure to ensure patient safety and confidentiality would be a duty breach.
- Injury caused by the breach: Administration of a medication despite a known allergy by the patient with an ensuing death would be an extreme form of injury.
- Resulting damage: As noted above, one example would be a fatal reaction to a medication in a patient with a known allergy.
To prove negligence, the patient must prove duty, breach, causation, and injury. Other elements also play a role in such cases, including:
- Standard of care is defined as the degree of care expected of a minimally competent physician in the same specialty and under the same circumstances. Standard of care changes—the standard today will be different tomorrow. The standard used must be at the time of the event, not today.
- Thoughtful documentation of good clinical care and the informed consent process will discourage many plaintiffs’ lawyers from accepting cases.
Daniel Schlatterer, DO, MS, is a member of the AAOS Medical Liability Committee and vice chair of the orthopaedic residency program at WellStar Atlanta Medical Center.
Richard Schlueter, JD, is a partner at Childers, Schlueter & Smith LLC in Atlanta. He can be reached at email@example.com.