Legal Review and Commentary
5-year delay in notifying patient of dental implants recall leads to confidential settlement in Indiana
By Blake J. Delaney, Esq.
Buchanan Ingersoll, Tampa, FL
News: In 1984, a woman received dental implants to replace her temporomandibular joints, connecting the jaw to the skull. More than seven years after the procedure, the Food and Drug Administration (FDA) recalled the brand of dental implants that had been used. However, five more years passed before the surgeon notified the woman of the recall. When the woman finally was notified, she required surgery to remove the damaged and disintegrated implants. The woman filed suit against the surgeon, and the Indiana Supreme Court found that the surgeon had acted negligently as a matter of law. The parties subsequently settled the case for a confidential amount.
Background: A woman consulted an oral and maxillofacial surgeon to treat problems she was experiencing in her jaw. The doctor performed a surgical replacement of the woman's right and left temporomandibular joints, connecting the jaw and skull, using dental implants.
Seven-and-a-half years after the procedure, the FDA recalled the brand of dental implants that had been used. The woman had been experiencing vertigo, neck pain, headaches, fatigue, and insomnia for the last two years, but her family doctor had been unable to identify the source of the symptoms. Pursuant to the recall in 1991, the oral and maxillofacial surgeon received a "Dear Doctor" letter advising him that the particular brand of implants were potentially defective. The FDA's letter informed the surgeon that he should discuss the risk of implant failure with any patients who had received the implants, conduct a clinical follow-up with those patients, and encourage the patients to enroll in the Medic Alert Foundation International Implant Registry. The surgeon was asked to report his compliance to the FDA within 30 days and complete a form with information for each of the implant patients that the surgeon treated or may have treated.
Several months later, the surgeon instructed his staff to search through patient charts to identify patients who had received the implants and inform them of the dangers, but he never responded to the FDA as requested. The surgeon made a second search of patient records two years later in 1994 in an attempt to continue to notify patients. Neither search successfully located the woman's record.
Finally, after two more years, the surgeon found the woman's record in 1996 and notified her of the recall. She came back to the surgeon's office for magnetic resonance imaging (MRI), which revealed that the implants were extensively damaged and had disintegrated. The woman underwent surgery to remove the implant remnants.
The patient and her husband filed suit against the surgeon. They alleged he was negligent for failing to warn her of the dangers associated with that particular brand of implants and for failing to warn her of the recall for more than five years after the FDA's original letter. The plaintiffs argued that the dental surgeon should be strictly liable for their damages due to the surgeon's failure to notify the woman of the FDA recall. The surgeon responded that strict liability would be inappropriate; instead, he maintained that he needed only take reasonable efforts to identify those patients who had received the particular brand of dental implants at issue. Under that standard, the surgeon argued, he should be relieved of liability because the patient's file apparently was moved to another office by mistake in the course of his separation from his former business partner.
The Indiana Supreme Court agreed with the surgeon that imposing strict liability on the doctor would not be appropriate. However, the court found that in light of the five-year delay in notification, no reasonable jury could find that the surgeon had not acted negligently. The court emphasized that because the surgeon was in exclusive control of the woman's records, he should be fairly charged with responsibility for explaining the steps he took to give notice and why they were reasonable under the circumstances. Because the surgeon had failed to carry his burden, the court found, as a matter of law, that the surgeon had breached his duty of care owed to the plaintiffs. Following the high court's judgment, the parties settled the case for a confidential amount.
What this means to you: This case illustrates a couple of issues that are relevant to practitioners on a daily basis. First, the scenario highlights the important effect that failing to maintain records can have on medical professional liability insurance. The original procedure was in 1984, the recall occurred in 1991, the surgery to remove the implants occurred in 1996, and the suit was filed in 1998.
"Depending on whether the physician in this case carried 'occurrence' or 'claims made' medical professional liability insurance, the company through which the insurance was purchased, and carried by the physician in this case, the company through which it was purchased, and the interpretation of 'occurrence' or 'claims made,' there could be coverage issues," suspects Ellen L. Barton, JD, CPCU, a risk management consultant in Phoenix, MD. In this case, for example, the claim was made in 1998, but the acts giving rise to the claim occurred years prior to that. The importance of understanding professional liability insurance policies is vital to ensuring coverage for all potential liability.
"Even more so, however, this case illustrates the importance of maintaining a workable system for medical records and health information records that allows for completeness, accuracy, and accessibility," she says. While one might sympathize with the difficulty of maintaining, intact, a physician office or outpatient treatment center medical record system despite changing personnel and physical relocations, Barton feels there is no excuse for the time delays involved in this case. The physician had a clear duty to maintain complete and accurate medical records and to be able to access them when needed. In addition, the physician never responded to the FDA as requested in 1991. And, while he instructed his staff to search his records, there were two failed attempts before the records were successfully located more than five years after the original search.
The Safe Medical Devices Act (SMDA), which was signed into law in 1990, is an extension of the Medical Device Amendments of 1976, which imposed production, distribution, and sales rules on medical device manufacturers. Barton notes that the SMDA gave the FDA additional power to obtain earlier knowledge of serious device problems, remove defective products from the market more quickly, and track devices from the manufacturer to the consumer. It also expanded reporting already required of manufacturers to hospitals, nursing homes, and outpatient treatment and diagnostic facilities. That portion of the SMDA that required "user reporting" became effective in 1991, and the provision of the law requiring "device tracking" became effective in 1993.
Thus, while it appears that the SMDA would not apply to the facts of this case, Barton feels that the SMDA would have proven its value had it been applicable. Specifically, the "device tracking" portion of the law would have required the physician (working out of a hospital or outpatient treatment facility) to acknowledge receipt of the tracked devices to the manufacturer and to report patient demographic and medical information to the manufacturer upon implanting or use of the device within five working days. In addition, the identity of the "tracked" device, lot and serial numbers, and implantation dates would have to be reported, which would have enabled the manufacturer to trace specified medical devices to patients and to facilitate patient notification and/or device recall. "Clearly, had the SMDA been effective during the relevant time periods of this case, the additional delay of over five years in notification would have been avoided," recognizes Barton.
- St. Joseph Circuit Court (IN), Case No. 71S03-0409-CV-417.