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Cox v. Paul6/14/2005
We hold that a health care provider who receives notice of possible dangerous side effects of a treatment is not strictly liable for failure to warn a patient who received the treatment from the provider, but may be held liable for failure to make reasonable efforts to warn the patient. If there is credible evidence that the patient did not receive notice, it is the burden of the provider to establish that reasonable steps were taken. In this case, the provider did not carry that burden.
Factual and Procedural Background
In 1983, Suzan Cox consulted Dr. William Paul, an oral and maxillofacial surgeon, for problems in her temporomandibular joints which connect the jaw to the skull. On March 20, 1984, Paul performed a surgical replacement of Suzan's right and left temporomandibular joints using Vitek dental implants. After the surgery, Suzan underwent a course of physical therapy and enjoyed an uneventful recovery. Suzan's last appointment with Paul was on June 18, 1984. In late 1989, Suzan began to experience vertigo, neck pain, headaches, fatigue, and insomnia. The severity of these symptoms "escalated" with each year, but her family doctor could not identify their source.
In September 1991, the Food and Drug Administration announced a recall of Vitek implants. As is customary in recalls, Paul received a "Dear Doctor" letter advising that Vitek implants were potentially defective. The FDA requested that doctors discuss the risk of implant failure with their 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 FDA also requested that doctors respond within thirty days, informing the FDA through Medic Alert, of the actions that they had taken, and complete a form with information for each of the Vitek implant patients the doctor had or may have had.
In early 1992 Paul instructed his staff to search his patient charts, identify patients who had received the implants, and inform them of the dangers. The record contains no indication that Paul responded to the FDA as requested. Paul's staff performed a second search in 1994. Paul explains that he conducted this second search "simply to try and be thorough and continue to try to notify patients." Suzan's record was not identified in either the 1992 or the 1994 search.
In 1996, Suzan was identified by Paul's office as a Vitek patient under circumstances not revealed by the record. She was then notified of Vitek issues. Paul testified that he does not know why Suzan was not identified until 1996. He hypothesizes that her file might not have been in his office at the time of the two "sweeps" of his records. Paul explains that he had been in a partnership with Dr. David Harris, but the two separated and Paul started an individual practice near the end of 1989, before he received the "Dear Doctor" letter. Paul points out that when the separation occurred, charts were divided between the two doctors, so it is possible that Suzan's chart had been moved to Harris's office. Paul states that he does not know whether Suzan's chart was ever actually moved to Harris's office or how her chart came to his attention in 1996. After Paul's staff notified Suzan, she met with Paul who recommended that she have an MRI. The MRI revealed that Suzan's Vitek implants were extensively damaged and had disintegrated. In November 1996, she underwent surgery to remove the implant remnants.
Suzan and her husband filed a complaint against Paul in January 1998, alleging that Suzan was injured as a result of Paul's breach of his duty to warn her of the dangers associated with Vitek. The Cox
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