An Unusual Side Effect

In the January Risk Management column, I covered various issues related to antibiotic prescriptions and the need for proper documentation. I discussed how a known side effect of drugs such as Clindamycin, along with amoxicillin and Keflex, was a factor in a case involving Clostridium difficile (C. diff). Of course other drugs are used in dentistry that may have unusual side effects, which, though relatively rare, can still cause problems. This column will describe a drug used by the subject general dentist for many years and in many cases without complications until the case below, which turned out to be significant.

Case Report
A longtime 49-year-old male patient presented to his general dentist with a complaint of pain in the lower right mandible. Following a problem-focused examination, X-rays and diagnostic testing, the need for endodontic therapy was determined on tooth No. 31. Root canal treatment was started immediately on the tooth. The dentist determined that an infection was present, so Cipro (ciprofloxacin hydrochloride), an antibiotic the subject dentist had used successfully many times before to treat root canal-related infections, was prescribed.

The patient returned one month later, and the root canal procedure was completed. The subject dentist found out five days later that the patient had sustained tendon rupture in both knees while running and required surgical reconstruction. The patient returned ten days later for crown cementation, three months later for a checkup and six months later for his regular checkup. Nothing was said to the dentist about issues following the tendon reconstruction surgery, and the patient remained cordial and had no qualms about coming back to the dentist several times following the root canal procedure and Cipro prescription.

The patient was an avid runner and did some research on his own, apparently noticing something about Cipro that ultimately generated litigation. As a result, just over one year after the Cipro prescription and tendon rupture, the patient retained a lawyer and the subject dentist received a letter claiming negligence in prescribing Cipro because it caused the tendon rupture as a side effect. The patient, through the lawyer, demanded compensation for the alleged injuries and compensation for lost wages while he recovered from surgery.

Legal Proceedings
I investigated the claim and found that the subject dentist had appropriately prescribed Cipro to several patients in the past, including the one making the claim, without any difficulties. We determined that the use of Cipro in that circumstance fell within the standard of care. The dentist explained that he had determined through his own research, and with the recommendation of an MD/DDS oral and maxillofacial surgeon, that Cipro was very effective in treating the bacteria often associated with endodontic infections.

We initially denied liability, and a notice of intent to commence action was sent to the dentist by the lawyer three months after the initial letter. The dentist did not want the case to go to court and requested that we make efforts to settle.

One of the known risks listed on Cipro drug inserts is tendon rupture. Expert witnesses retained by the patient stated that “it is extremely well documented in the scientific literature that Cipro increases the risk for tendon ruptures.” Two physicians opined that the injury was a direct result of taking Cipro. One of these opined that the patient would be impaired for the remainder of his life. A physical therapist gave the patient a fair prognosis to return to near normal activity levels.

An interesting argument raised by the patient’s attorney was that the subject dentist should have given the patient a handout similar to what pharmacists provide when you pick up a prescription. Had the patient been given this handout or told beforehand that tendon rupture was a possible side effect, he would have refused to take the drug. Since this case, other plaintiffs’ lawyers have also argued that dentists should furnish a drug information sheet along with the prescription.

Before the actual lawsuit was filed, negotiations ensued, and the case was ultimately settled for an amount well under policy limits (but substantial nonetheless). The patient and his wife, who also was listed as a plaintiff, both signed a release of all claims form, and the payment was made to them and to their attorney. They agreed not to take the claim any further.

Points to Ponder

1. As a result of this claim, we created several drug information sheets for dentists to give to patients for antibiotics prescriptions or any other classes of drugs. You can create your own forms by obtaining information on use, side effects and contraindications for the drugs you commonly use from several sources, including pharmacists near your office. You may not think it is the standard of care to use these forms, but attorneys will criticize you if you do not.
2. Cipro is indeed an effective drug for situations such as endodontic infections, but this case illustrates the importance of knowing all the side effects of the drugs you prescribe and making sure they won’t have an adverse effect on a patient’s lifestyle or health.
3. Plaintiffs’ lawyers often will obtain experts with extreme opinions to support their clients’ claim. As mentioned previously, the expert will take the position that all dentists must provide a drug information sheet with every prescription. In addition, some emergency room physicians are dismayed and may try to strengthen the patient’s claim by backing up the patient’s contention that they were not told about any potential side effects of the specific prescribed antibiotic.
4. Unfortunately, subsequent treating physicians often will take a patient’s word for something and be critical without checking with the prescribing dentist. This attitude also helps the plaintiff’s attorney make their case. 

Richard C. Engar, DDS, FAGD, is CEO of Professional Insurance Exchange Mutual Inc., a Utah-based professional liability insurance carrier created by Utah dentists in 1978. He currently maintains a faculty position with the University of Utah School of Dentistry. Contact him at impact@agd.org.