Rochelle & Griffith, LLP

By Robert D. Rochelle, Esq.

In April of 2008, the California Supreme Court in Johnson v. American Standard, Inc. 43 Cal. 4^th 56 (2008) recognized the “sophisticated user” doctrine as a defense to both negligence and strict product liability claims based on failure to warn. The doctrine shifts the duty to warn from the manufacturer or supplier onto the “sophisticated” user who is assumed to be aware of the risks as a result of his or her experience with the product.

Although California Supreme Court in Johnson did not define how much experience the user must be to be “sophisticated”, it is clear that a surgeon, doctor or dentist is the learned intermediary between the manufacturer-supplier and the patient and would be recognized as a sophisticated user who assumes the duty to warn his patient. The courts assume the doctor will either make the appropriate medical decision based on her knowledge of the risks or will pass the warnings on to the patient to make an informed decision.

The Johnson case is the latest in a trend of decisions that act to relieve the manufacturer of a duty to warn the ultimate user (patient) and place that duty on the doctor since the courts correctly assume the doctor is in a superior place to warn the patient who is about to receive treatment and as a knowledgeable professional, he is assumed to know of the dangers and risks in providing such a medical device or treatment regime.

The duty to warn is an outgrowth of the basic right of informed consent for a patient as set forth originally in the 1972 seminal case of Cobbs v. Grant which requires the medical professional to disclose all information relevant to a “meaningful decisional process”. While this might still be the law for the medical decision of whether to perform a particular procedure or not, as a practical matter, can a doctor or dentist, in today’s era of specialization, provide enough information and education to the patient to sufficiently warn a patient and allow that  “meaningful decisional process” to take place as to how that procedure or treatment would take place? As a practical matter, can a doctor involve the patient in the decision making process of which medical device to use?

In reality, the duty to warn and educate as to alternative treatment procedures has become a duty for the dentist or doctor, as a knowledgeable professional, to simply choose the correct device or technique for the intended treatment and to make that decision for the patient based on the current state of medical knowledge.

In essence, the courts will place upon the medical practitioner the duty to stay current with the medical literature in her field of expertise. She will be expected to know of any new product or technique that significantly lowers patient risk as reported in the applicable peer review journals as such a report adds to the collective awareness of the specialist’s area of expertise.

In 2001, a male patient sought treatment from a dentist in San Diego for a root canal treatment. The dentist used sodium hypochlorite solution to clean the root of the tooth and the solution was applied using a positive pressure syringe (not unlike the pressure of a garden hose, but lesser) to inject sodium hypochlorite into the tooth’s root area. However, that typical practice of irrigation under positive pressure in 2001 carried with it the risk of extrusion of the sodium hypochlorie into nearby tissues. If the sodium hypocholite is extruded into surrounding tissue, it interacts with blood vessels and nerves that run in the adjacent tissue. Depending on the amount and concentration, within seconds, the capillary beds rupture producing mild to severe internal hemorrhage resulting in tissue swelling and discoloration. The associated pain varies from mild to severe, and sometimes the nerves undergo a toxic reaction causing the nervous system to be affected in both their control and sensory functions

In the San Diego case, a small amount of the solution escaped from the root canal and entered the apical tissues surrounding the tooth. The plaintiff’s face became immediately swollen and remained so for weeks, causing his eyes to be nearly shut and bruising under his eyes. The plaintiff, the father of young children, had to wear a mask so as not to frighten his children.

At trial, the dentist contended the plaintiff was made aware of the risks of sodium hypochlorite and his experts testified that, as of June, 2001, such an accident was rare and the defendant dentist could not have taken precautionary measures before administering the solution as no alternative technique had yet been identified. The jury found for the dentist. The question is whether such a legal result would be obtained in 2009 in the face of new devices or precautionary measures identified in peer review literature available to the dental practitioner.

It is medically accepted that sodium hypochlorite is safe when limited to the root canal; however, beyond the confines of the root canal, it is extremely toxic to all tissue. Furthermore, the aforementioned hemorrhage can lead to blood clot(s) and infection. While the nervous system failure is a rare occurrence, the injury and resultant physical deformity to the patient can be catastrophic in that the consequential permanent alternation affects the most important and unique physical feature of a person, their face. In addition, the life threatening risk of airway obstruction associated with hypochlorite extrusion during root canal treatment has been reported.

From 2002 through early 2009, a number of peer review articles have pointed out that the use of positive pressure to deliver the sodium hypochlorite in root canal irrigation produces these significant risks that include severe pain, edema, numbness, scarring, and even life-threatening airway obstruction. Not only have these published articles identified the risks of the positive pressure in the use of sodium hypochlorite, they have identified an alternative technique that totally minimizes or eliminates such a serious risk. That technique is the use of negative pressure and these journal articles have also identified a product that provides negative pressure while irrigating to eliminate these risks. The products are commercially available at a cost of about eight dollars ($8).

The Judge in the San Diego dental malpractice case followed the typical procedure to provide the law to the jury in the form of standard jury instructions at the close of the case. Those legal instructions included  that the dentist has the affirmative duty to present information as to the risks and benefits of the root canal treatment, including the use of sodium hypochlorite, to obtain the patient’s informed consent. At that time, there was no argument of an alternative in the manner in which the sodium hypochlorite was delivered to the patient.

Had there been such an alternative delivery method commercially available in 2001 that had different or lesser attendant risks, the patient’s attorney could have argued for the jury to consider whether the patient was given that information, including the minimal cost, and been given the opportunity to choose between the different delivery techniques.  Where the medical practitioner would have been aware of the greater or lesser risks had she merely read a widely distributed journal in her area of expertise, and thereby be informed of the decreased or absent risk of a new device, that doctor has the affirmative duty to discuss that product with the patient. Alternatively, has medical science progressed to the degree of specialization that the doctor has the duty to simply select the new, lesser risk device?

An example of such an newer medical device recently described in the peer review literature is the EndoVac delivery system for endodontic irrigation. Previously, the device utilized for irrigation in the root canal was a simple syringe to introduce sodium hypochlorite into the root canal for irrigation and debridement, an important and standard part of endodontic treatment. While the occurrence of sodium hypochlorite extrusion is uncommon, under any analysis of product liability law, the EndoVac would be the preferred alternative device. It is superior in that, for a minimal cost, it does not sacrifice treatment efficacy and eliminates the risk of severe debilitating injury that can occur from sodium hypochlorite extrusion from positive pressure.

Suppose, in 2009, a jury in a case of a sodium hypochlorite extrusion accident is informed of a new device that has come into the awareness of the dental endodontic specialty by way of standard specialty journal articles. The device is described to irrigate the root canal under negative pressure, thereby drawing up all of the hypochlorite and totally removing the risk of the leakage or extrusion of the hypochlorite into nearly tissues.

The defendant dentist’s expert witness will be forced to admit that the safety and efficacy of this device, the EndoVac, that has been promoted in peer review articles of basic research as well as key journals of their endodontic specialty. The defendant dentist testifies that he made the patient aware of the risks of sodium hypochlorite but admits on cross exam that he choose not to utilize the EndoVac device or make the patient unaware of availability of the device at a minimal cost.

The jury in the two-week trial glances over to plaintiff’s table, where this thirty-five year old mother of two sits in silence. She is attractively dressed, slim, nicely cut hair but has a very distinctive loss of tissue in her left cheek, even after several unsuccessful surgical attempts to correct the deformity. She drools but cannot feel it to wipe it off until her attorney notices and quietly mentions it to her.

That afternoon, the case is coming to a close and the doctor’s expert endodontist, testifying for the defense, admits to having read about the EndoVac and the benefits of such a negative pressure device at a minimal cost of eight dollars. The next morning, the jury is instructed by the judge that under the current law, doctors and dentists have an affirmative duty to either make the appropriate medical decision based on their knowledge of the risks of treatment or must pass the warnings on to the patient to make an informed decision.

When the jury retires to the sanctity of the jury room and discussions begin as to liability of the defendant endodontist, how long will it take before the jury foreperson polls his fellow jurors as to whether this dentist fulfilled her duty to choose the more effective medical device of the negative pressure EndoVac or, as required, warned the patient that this eight dollar device would have alleviated the risk of severe tissue and neurological injury? Will the outcome of that polling result in another verdict for the defense?

Robert Rochelle is an ABOTA trial attorney who has been lead counsel in trials in San Diego, Santa Ana and Riverside Superior Courts and Federal District court.  Practice areas include medical malpractice, probate and trust matters, elder abuse, fraud, personal injury and sexual harassment.