AAOS Now

Published 6/1/2012
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James W. Ogilvie, MD

New Device and New Procedure Liability

The practice of medicine is constantly changing. To provide optimum care orthopaedic surgeons must be willing to change and advance as well. Innovative procedures and devices, combined with continuing medical education, are the basis for improving medical care in orthopaedic surgery.

The implementation and use of innovative devices and procedures, however, carry potential liabilities that orthopaedic surgeons should understand and be ready to address.

FDA approval status
The U.S. Food and Drug Administration (FDA) regulates devices and biologics—but not the practice of medicine. FDA approval is a decision on safety and efficacy that does not translate into all clinical decisions. The practice of orthopaedics, for example, may involve the use of devices and medicines that are FDA-approved for a specific application as well as those that may not have specific approval. FDA-approval status is not a designation for standard of care.

For example, simply because the FDA has approved the use of an antibiotic for the treatment of otitis media does not mean the antibiotic has been approved for the treatment of other infections. Nor does it imply that the antibiotic would be ineffective or dangerous in other clinical applications. Physician-directed (off-label) use of devices, procedures, and biologics in practice does not automatically lead to liability.

Similarly, an orthopaedist may believe that the best treatment option for a patient may be a new product or procedure, even though the product or procedure has not yet been supported by Level 1 evidence or received FDA approval. It would be appropriate to implement these products based on medical education and clinical judgment, provided certain conditions are met.

For instance, the use of pedicle screws may have been studied and approved for a specific pathology, but that should not imply they are ineffective or dangerous when applied to another disorder. However, the reasons for using the device must be properly documented, the patient must be informed and consent, and the documentation must include a note that the information was given and consent received.

Documentation
Orthopaedists who implement physician-directed off-label treatment have certain ethical and legal responsibilities. Before implementing the treatment, orthopaedists should ask themselves the following questions:

  • Am I fully aware of the regulatory status?
  • Is my decision sound and defensible medicine?
  • Have I considered other options?
  • Have I adequately informed the patient of my thought process and decision and received the patient’s consent to proceed?

Answering these questions and documenting appropriately in the medical record provides protection in case an adverse event results.

If the drug or device includes a “black box warning”—an FDA warning in a black box on the product packaging signifying that medical studies indicate that the drug or device carries a significant risk of serious or even life-threatening complications—the physician’s level of responsibility for using it is higher than normal. In these situations, orthopaedists should ask themselves the following questions:

  • Am I aware of the black box status?
  • Why am I recommending use of the device now? Have I exhausted all other treatment options?
  • Have I informed the hospital or ethics committee?
  • Does the patient and/or family understand?
  • Again, documentation is essential.
  • Litigation

If a lawsuit is filed, orthopaedists can expect that all of the previous questions will appear in a discovery deposition. Addressing them prospectively with documentation in the medical record will simplify the defense strategy.

It is not negligence to use new products or new procedures. Even if the adverse events resulting from the physician-directed off-label use are not necessarily due to the product’s FDA-approval status, appropriate documentation at the time the decision is made will help protect against that presumption.

Prescribing a novel pharmaceutical is different from performing the first robotically controlled knee arthroplasty or posterior vertebral column resection. Few, if any, statutory definitions exist of the acceptable experience required to employ new procedures or technologies. Hospitals or credentialing committees may have certain criteria to satisfy Joint Commission regulations, but they are often vague and not always respected in legal proceedings if it does not suit the plaintiff’s strategy.

Often asked deposition questions include the following:

  • Have you done this procedure before and if so, how many have you done?
  • How did you become qualified to perform this procedure? Did you read a company brochure? Attend a course with hands-on experience? Visit an experienced surgeon? Have a mini-fellowship of several days?
  • Does your patient understand your status and is that conversation documented?

However challenging, these areas will be thoroughly explored if a lawsuit is filed. Surgeons are legally defined as the “skilled intermediary.” If a poor outcome results with a new procedure, the focus will be on whether the surgeon has adequately fulfilled his or her responsibility to meet that definition. Responses based on pride or arrogance will not enhance the defense.

Summary
Implementing new technology enables orthopaedic professionals to continue improving patient care. At times, this involves taking on the risk of using new products or procedures or applying physician-directed off-label use of current products.

Such actions are appropriate if the surgeon clearly communicates the status of the product or technique with the patient and has appropriate documentation. The responsibility of orthopaedic surgeons to provide the best therapy requires a focused, organized approach and documented communication with each patient.

James W. Oglivie, MD, is a member of the AAOS Medical Liability Committee. He can be reached at jwogilvie@msn.com