The last place you want to end up is in court. Discover how you can protect your laboratory.

Transcription

1 By Cassandra Corcoran The last place you want to end up is in court. Discover how you can protect your laboratory. Most of you spend your days in the dental laboratory dealing with the details: millimeters, ratios and the stroke of a porcelain brush. Vision enhanced by a pair of loupes, you zero in on the dental restoration in your hands checking for quality, confirming correct occlusion and ensuring it is as close to perfect as possible. But how often do you turn that discerning gaze to the legal side of your business, specifically product liability? If you re sitting there trying to recall the answer to that question, then it s been too long. 16 Journal of Dental Technology April 2011

2 Liability claims can pull you out of your laboratory and into your lawyers office, if you re lucky. If not, you could find yourself in front of a judge with a ticked off dentist or patient across the courtroom, claiming you should be held liable for a failed dental restoration. Think it can t happen to you? So did Lee Culp, CDT. In 2009, Culp was slapped with a civil lawsuit concerning a restoration he manufactured for a dentist client in New Jersey. According to Culp, he manufactured the restoration to the dentist s vague specifications even though the dentist said in legal filings that Culp had not. The case was sent back to Culp s Mosaic Studios several times with the instructions being to make the teeth bigger and prettier, according to Culp. The patient claimed she suffered multiple function and esthetic problems from the final restoration. The case was eventually dismissed a week before the case was set to go to court but not before Culp had experienced significant and expensive legal headaches. It s time to turn your detail-oriented gaze inward toward your dental laboratory. In this article, JDT will help you get started down the road to protecting your laboratory against product liability claims. However, there are several other areas in which your laboratory can be vulnerable, so after reading this cover story sit down with your laboratory team to ensure you are doing everything you can to protect your laboratory and then make an appointment with qualified experts (including your attorney and insurance agent) to make sure you are properly covered. NADL offers the following information to commercial dental laboratories as general guidance. Dental laboratories should obtain their own legal advice based on their unique facts and circumstances, and the law of the jurisdiction in which they reside. That said, the biggest piece of advice NADL can give is to follow directions. Use manufacturer guides for the material you re using. If you get called into a situation where you do something counter to their guidelines, you ve potentially expanded your liabilities, said NADL executive Director Bennett Napier, CAE. Documentation is the key. Let s get right to the most commonly asked questions about dental laboratory product liability. What is a dental laboratory's responsibility if there is a product recall? To carefully follow the instructions provided in the recall and not to continue to use the products that are the subject of the recall until the situation is rectified, said NADL general counsel David Evans. Can a dental laboratory be held liable for a product defect? If the defect is obvious and discoverable by the laboratory, then yes, it is possible for the laboratory to bear responsibility if it uses, and passes on the product to the dentist customer; at the same time however; the dentist has a duty to inspect the appliance for discoverable apparent defects, and to reject it and send it back to the laboratory, said Evans. According to NADL s Guidelines for Commercial Dental Laboratories on Litigation, while a dentist is primarily concerned with restoring a patient s mouth to a healthy condition, a dental laboratory is primarily concerned with the sale of dental prosthetic appliances. Therefore, a court may impose liability on the dental laboratory for defective goods. Like everything at your laboratory, due diligence is the key. Every laboratory owner should, to the best of his or her ability, be informed about any product recalls or problems. The U.S. Food and It s time to turn your detail-oriented gaze inward toward your dental laboratory. NADL Guidance Available NADL members can buy copies of the association s Guidelines for Commercial Dental Laboratories on Litigation by visiting NADL s online store at April 2011 Journal of Dental Technology 17

3 QS/GMP and You Dental laboratories must establish quality system/good manufacturing practices. The components of QS/GMPs include: Determination of applicability and FDA registration. Assignment of management responsibility. Competency and training of personnel. Defining of purchasing controls. Identification and traceability of patient contact materials. Production and process controls. Acceptance of final product. Review of non-conforming product. Corrective and prevention action procedures. Control of labeling and packaging. Handling, storage, distribution and installation of materials and finished items. Records retention and control. Source: JDT Unbound s Risky Business by Mary Borg Drug Administration has ruled that manufacturers are ultimately responsible for the products they produce. However, if the manufacturer sends customers a recall notice, you need to act accordingly by going back to your usage lot and batch numbers, which FDA s quality standards and good manufacturing processes requires you keep, to determine if any of your restorations are affected by the recall, then act accordingly. If you don t you could be opening your laboratory up to legal troubles. Total product recalls are infrequent in our industry, but they do happen. What is more frequent is manufacturers notifying dental laboratories of performance problems with a material. For example, it s more about is this particular material prone to cracking. The manufacturer guidelines say it's going to last 24 years and it's only lasting 24 months, Napier said. You need to know this information because you will have clients come back and say you need to remake this. It becomes The key is to keep a document chain to show that the dentist approved a change to the prescription. a risk management issue and you need to alter your protocol quickly in order to minimize what it will cost to rectify the problem. Can a dental laboratory be held liable if they use a different product than specified on the dentist's prescription? The best practice is for a dental laboratory to carefully follow the dentist's prescription and not to substitute materials or products, unless disclosure is made to the dentist customer and approval is obtained. Product substitution can possibly lead to laboratory liability, said Evans. If the laboratory has substituted materials, then it has failed to perform according to the specific terms of the agreement and the dentist has a cause of action for breach of contract, according to the guidelines, and even the fact that the substitution was reasonable may not vindicate the laboratory. That doesn t mean you can t talk with the dentist and recommend a different product be used. For example, if the prescription calls for product A, but you know from experience that product A isn t the best fit for the restoration, you can, and should, call to confer with the dentist. The key is to keep a document chain to show that the dentist approved a change to the prescription. If not, you may be vulnerable to legal trouble for using a different product than was prescribed. It s not just civil suits you need to worry about in this instance. Consider alloy usage. Though rare, there have been occasions when a non-precious metal will be used in place of a prescribed highnoble alloy. That can be considered fraud and result in criminal penalties. If a dentist is sued by a patient, can the dentist or patient, also bring the dental laboratory into the suit? It is not uncommon for a dentist who has been sued by a patient to cross claim against the dental laboratory, claiming that the laboratory caused the problem or injury. The patient has a direct relationship with the dentist, not the laboratory, so he or she cannot typically sue the laboratory directly, said Evans. If the dentist or patient can prove negligence on the part of the dental laboratory that caused an injury, then yes, it is possible for the laboratory to be held liable. And as Culp s case proved, laboratory owners have been sued. His may be one of the most visible cases of this, but Napier has talked with many 18 Journal of Dental Technology April 2011

4 laboratory owners who have been pulled into legal cases when a patient sues a dentist. Most of (the cases) are settled out of court so people assume that it doesn t happen very often, but that s a bad assumption, Napier said. Laboratory owners have settled out of court and I think it happens more often then people think. The best way to protect your laboratory is to follow the prescription and document, document, document. Your records should reflect any conversations you or a member of your staff had with the dentist (verbal and written), as well as the quality systems and good manufacturing processes applied to the restoration. Another important part of documentation is certification showing the technician who manufactured the restoration is qualified as a Certified Dental Technician or has received specialized training to work with the specific material. If you re winging it, and it looks like it, your liability can increase, Napier said. There is only one person in the chain that is licensed and that s the dentist, laboratory owners have to do something to prove they are as competent as the dentist. If you are utilizing an outsource dental laboratory (offshore or domestic) what is your liability if something goes wrong with a restoration? If there is damage to the restoration or injury to the patient, the dentist or dental laboratory that You may be vulnerable to legal trouble for using a different product than was prescribed. Case Studies In Case A, a patient sued his dentist for a defective set of dentures. The laboratory that originally made the dentures had gone out of business and the NADL member laboratory repaired the dentures after the patient had some problems with them. The patient sued both the dentist and the repairing laboratory claiming that his wife was neglecting him because he didn t have any teeth. The laboratory owner termed the suit absurd and the court dismissed it because there was no basis for the claim. In Case B, the patient sued the dental laboratory, his dentist and his oral surgeon after the oral surgeon removed his two remaining teeth without seeking prior approval from the dentist. The laboratory had made a full set of dentures, without room for the two teeth, after the dentist prescribed a complete denture for the patient. The oral surgeon failed to check with the dentist before fitting the dentures. Instead, he just removed the teeth so that the denture would fit the mouth. The laboratory admitted its mistake with the denture, but it was the oral surgeon who caused the permanent damages to the patient. The laboratory could easily have corrected the denture to suit the patient s condition. After the suit was filed, the laboratory owner retained an attorney and participated in settlement talks. However when the patient sought a large settlement from the laboratory, the owner refused payment because the laboratory had done nothing wrong. The laboratory owner believed that the patient must have settled the case with the oral surgeon because the laboratory owner had not heard anything in more than a year. In Case C, a patient sued a laboratory and dentist, claiming that the appliance did not fit properly, that the laminates were pulling off and that the color was wrong. The case settled out of court. In Case D, a patient sued his dentist and the laboratory after the dentist cemented a bridge into the patient s mouth and the patient then swallowed it. All parties settled out of court in this case as well. Case E involved a patient s reaction to materials contained in the appliance. There too, the case settled and the laboratory admitted no liability. As is common in these cases, the relatively high cost of the litigation prompted the parties to settle the case. In Case F, a member laboratory reported a case that did go to trial, the court issued a judgment against the laboratory. However, the laboratory attributed this outcome to the facts of the case. According to the laboratory, the patient was a poor single mother who had been abandoned by her dentist and the sympathetic judge was looking for a source of recovery for the patient. The patient s original dentist had used non-precious materials rather than gold which had been requested by the patient. Because the laboratory was the only source from which the patient could recover, the judge held it liable even though the member laboratory had remade the whole case for the patient at no charge. Once the court learned that the member laboratory remade the case from gold for free, it reduced the amount of judgment against the laboratory. The laboratory considered appealing the case, but its insurance company urged against this course of action because an appeal would have cost more than paying the judgment. The case was not appealed. Source: NADL Guidelines for Commercial Dental Laboratories on Litigation April 2011 Journal of Dental Technology 19

5 Get more on Unbound No one has covered dental laboratory regulations, requirements and how to protect your laboratory more than the Journal of Dental Technology and JDT Unbound. Go to Unbound (www. jdtunbound.com) to search the archives for the answers to your questions. outsourced the appliance will be the target for a claim, and stand between the patient and the outsourced laboratory. The dentist or laboratory could, in turn, bring the outsourced laboratory into the dispute, but it is unlikely either could simply be able to point to the outsourced laboratory and deny or avoid any responsibility, said Evans. The key phrase here is documented due diligence. You need to be able to show that the outsource laboratory, to the best of your knowledge, is a trusted vendor that has quality standards and good manufacturing processes in place. You should have records showing that you visited the site to confirm this information or have an affidavit on file from the outsource laboratory attesting that the laboratory has quality systems in place and follows good manufacturing processes. The reality is a dentist is going to go after you because that s who they gave the prescription to, said Napier. The accountability belongs to the person who shipped it off to an outsource laboratory. If it was a foreign lab it may be difficult to collect any financial pentalties (or have judgements placed against them), so if the outsource laboratory is a foreign laboratory, the The key phrase here is documented due diligence. domestic laboratory is going to take the brunt of the lawsuit. This is also true for outsourcing to another domestic laboratory as they are further down the supply chain. When it comes to protecting your laboratory against product liability cases, there are obviously more questions than we can answer here. NADL strongly encourages you to comply with all state and federal regulations, be sure you re covered adequately by insurance and consult an attorney. The stakes are too high to take it lightly. For a dental laboratory to be guilty of breach of contract or negligence, the laboratory must have been at fault in some way, according to NADL s guidelines. Under strict product liability theory, however, one who sells a defective product unreasonably dangerous to the user or consumer, is subject to liability for physical harm caused thereby, if the seller is in the business of selling such a product, and it reaches the ultimate user without substantial change. This rule applies even though the seller has exercised all possible care (no negligence) and has completed with specifications provided (no breach of contract). Under strict liability, difficulty in discovering defects is no defense. As always, the best defense is a strong product liability offense with due diligence, documentation and implementation of quality standards and good manufacturing processes. Check Yourself Sure, we re a litigious society, but you can protect your laboratory. NADL recommends you: 1. Ensure you re meeting FDA QS/GMP standards, which you can do in a variety of ways including having your laboratory become DAMAS certified, earning a Certified Dental Laboratory designation or staffing each department with at least one Certified Dental Technician. 2. Don t be a non-registered laboratory operating in a state that requires registration. 3. Comply with state and federal laws and regulations. 4. Have adequate insurance (product liability, business insurance, etc.). Contact NADL at to get more information about its affiliate program with Meadowbrook Insurance Co., that can benefit your laboratory. 5. Create a collaborative relationship with your material suppliers. Seek out training about new material and equipment, maintaining adequate training and following recommended guidelines. 20 Journal of Dental Technology April 2011