By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
Leaving a foreign object (sometimes referred to as a “retained foreign body” or “RFB”) in a patient, such as a sponge, clamp, forceps, surgical needle, guide wire, part of a surgical instrument or other paraphernalia commonly used in surgical, examination, or other diagnostic procedures, does not necessarily mean that the physician has committed an act of negligence or that the physician will be disciplined by the Board of Medicine (BOM) or Department of Health (DOH). There are many defenses in such a case and many incidents which do not constitute negligence. However, as a preliminary matter, the law does seem to stack the deck against the physician in such cases.
Medical Negligence Statutes.
Section 766.102(3)(b), Florida Statutes (previously Section 768.45, Florida Statutes),
The existence of a medical injury does not create any inference or presumption of negligence against a health care provider, and the claimant must maintain the burden of proving that an injury was proximately caused by a breach of the prevailing professional standard of care by the health care provider. . . . However, the discovery of the presence of a foreign body, such as a sponge, clamp, forceps, surgical needle, or other paraphernalia commonly used in surgical, examination, or diagnostic procedures, shall be prima facie evidence of negligence on the part of the health care provider.
Grounds for Disciplinary Action Against a License.
Chapter 456, Florida Statutes, applies to all health professionals who are licensed by the Florida Department of Health (DOH). Section 456.072(1), Florida Statutes, which provides the grounds for possible discipline of any licensed health professional contains a subsection (cc), which provides the following as a basis for disciplinary action:
Leaving a foreign body in a patient, such as a sponge, clamp, forceps, surgical needle, or other paraphernalia commonly used in surgical, examination, or other diagnostic procedures. For the purposes of this paragraph, it shall be legally presumed that retention of a foreign body is not in the best interest of the patient and is not within the standard of care of the profession, regardless of the intent of the professional.
Applicable to Others than Just Surgeons and Physicians.
We typically envision objects such as clamps or lap pads (“sponges”) being left in a patient after surgery. Note, however, these provisions of the law could apply equally to a nurse practitioner’s leaving a broken needle in a patient or a dentist’s leaving a burr or broken probe in a patient.
Res lpsa Loquitur.
Many surgeons and other physicians who are charged with such an allegation just give up, do not defend themselves, and agree to accept punishment from their professional board. The statutes quoted above are, basically, a restatement of the common law rule known as “res ipsa loquitur in medical malpractice cases.
The term “medical injury” in the statute refers to an injury sustained as a direct result of medical treatment or diagnosis, and does not encompass injuries totally unrelated thereto. Thus, when a plaintiff establishes that the injury is outside the scope of medical treatment or diagnosis, and the facts and circumstances attendant to the injury are such that, in light of past experience, negligence is the probable cause and the defendant is the probable actor, the doctrine of res ipsa loquitur is applicable.
In Florida, there is a Florida law that is set forth within Chapter 456, Florida Statutes. Chapter 456 of Florida Statutes applies to all health professionals who are licensed by the Florida Department of Health (DOH).
Many surgeons and other physicians who are charged with such an allegation just give up, do not defend themselves, and agree to accept punishment from their professional board.
Florida Cases on Retained Foreign Objects.
Archer v. Maddux, 645 So. 2d 544 (Fla. 1st DCA 1994) a surgeon left a tube in a patient after surgery by accident. The trial court dismissed the case because there was no affidavit from a medical expert corroborating that medical negligence had occurred that had been filed before the running of the statute of limitations. The Court of Appeal upheld the dismissal of the case.
DeAlmeida v. Graham, 524 So. 2d 666 (Fla. 4th DCA 1987), a surgeon left a Kelly clamp inside of a patient.
Moreover, the provision of Fla. Stat. ch. 766.102(4) that discovery of a “foreign body” such as surgical paraphernalia is prima facie evidence of negligence, is clearly inapplicable in a case where the mesh was intentionally placed in patient’s body as part of her treatment, and like screws, plates, pacemakers, and/or artificial joints was intended to permanently remain in her body. (Kenyon v. Miller, 756 So. 2d 133 (Fla. 3d DCA 2000)
Smith v. Zeagler, 116 Fla. 628, 157 So. 328 (1934)
It is negligence per se for a surgeon to leave a sponge in an abdominal incision made in his patient in the course of his performance of a surgical operation upon such patient. The burden of showing due care is upon a surgeon who leaves a sponge enclosed in a wound after the performance of an operation, and he cannot relieve himself from liability unless the sponge was so concealed that reasonable care on his part would not have disclosed it, and conditions were such that, in his professional judgment, a special exploration for the sponge would have endangered the safety of the patient. Where a patient’s condition is critical and the paramount requirement is complete the operation in the shortest possible time, the failure to remove a sponge may be an accidental and excusable ship or inadvertence that is not actionable negligence, depending upon the circumstances of the case, the burden being on the physician to show to the satisfaction of the jury that the particular act was not blame-worthy because of the supervening necessity to complete the operation without delay.
The authorities are legion to the effect that it is negligence [***3] per se for a surgeon to leave a sponge in an abdominal incision made in his patient in the course of his performance of a surgical operation upon such patient. Ruth v. Johnson, 172 Fed. 191; Reeves v. Lutz, 179 Mo. App. 61, 162 S.W. Rep. 280; Rayburn v. Day, 126 Oregon 135, 268 Pac. Rep. 1002; Wynne
v. Harvey, 96 Wash. 379, 165 Pac. Rep. 67; Harris v. Fall, 177 Fed. 79, 27 L.R.A (N.S.) 1174; Moore v. Ivey (Texas Civ. App.), 264 S.W. Rep. 283; 21 R.C.L. 388.
The burden of showing due care is upon a surgeon who leaves a sponge enclosed in a wound after the performance of an operation, and he cannot relieve himself from liability unless the sponge was so concealed that reasonable care on his part would not have disclosed it, and conditions were such that, in his professional judgment, a special exploration [*631] for the sponge would have endangered the safety of the patient. Davis v. Kerr, 239 Pa. 351, 86 Atl. Rep. 1007, 46 L.R.A. (N.S.) 611.
Adverse Consequences of Accepting Discipline in a RFB Case.
Many health professionals agree to accept punishment from their professional board without realizing the harsh consequences. Any disciplinary action will be reported to the National Practitioner Data Bank (NPDB). If you are reported to the NPDB or another health care data base, you could have issues obtaining hospital privileges, state licenses, you may be excluded from the Medicare and Medicaid Programs, and it could also affect your ability to work in the health care field. Additionally, similar actions will be taken against any licenses you have in other states.
Shared Responsibility Between Surgeon and Hospital Staff.
Most hospitals have internal policies and procedures which make it a shared responsibility between the surgeon and the hospital’s staff (especially surgical technicians and operating room nurses) to safeguard against leaving foreign objects in patients.
The Health Law Firm has successfully defended physicians and other licensed health care professionals in administrative investigations and patients complaints relating to retained foreign bodies.
For more information on how we can help you in situations such as this, visit our Areas of Practice page on our website.
Contact Experienced Health Law Attorneys.
The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.
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About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
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