Legal Question in Medical Malpractice in California

Deviation from FDA guidelines

There is a wonderful wound healing product on the market x 10+ years. I support it's use when appropriate. The manufacturers guidelines, based on research, and subsequently approved under these guidelines by the FDA, are being breached by many, many hospitals and providers across the country, with no scientific evidence to support their decision. Both manufacturer and FDA indicate decreasing frequency of dressing changes could result in development of retained foreign body, abscess, infection, damage to newly developed tissue and increase patient pain. The reason for the breach is clinician convenience and/or cost containment. As a nurse specialist in this field,I have just been told that the new facility policy moves application and management of this particular product responsibility to my outpatient clinic. We are open 5 days a week, and closed on holidays. There is no plan for back up coverage, I am not on call. I am concerned for patient safety AND for MY personal liability in the management of these patients, under the guidelines of my facility. This product as with many others, is known to have complications when evidentiary guidelines are not followed. Is there any way to protect my patients and myself?


Asked on 2/17/06, 9:40 pm

1 Answer from Attorneys
Robert F. Cohen Law Office of Robert F. Cohen

Re: Deviation from FDA guidelines

Is there a hand-out you can give to the patient regarding regular change of dressing (if that's the issue)? Can the product's salesperson come up with some literature to provide to the patient? Can your staff take specialized training if that's the issue? Full disclosure is always the best bet, especially if it's in writing and the patient signs off on the disclosure.

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Answered on 2/23/06, 3:14 am


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