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Medicolegal Perspectives in Salivary Gland Diseases
This chapter will address and compare how medical malpractice is proved in the United States and Germany, the prevalence and characteristics of malpractice claims involving salivary gland surgery, and what you can do to decrease your chances of being sued and to increase your chances of a successful outcome if a lawsuit is filed.
General Considerations
In the United States, health insurance is a patchwork of private andgovernment programs. There are an estimated 50 million uninsured Americans. The United States presently has the highest per capita expenditures on health care in the world. Germany has a universal health insurance program managed by the government.
Malpractice premiums paid by the otolaryngologist–head and neck surgeon in the United States vary by region. The rates paid in Philadelphia, Pennsylvania, in 2004, for example, are approximately $70,000.00 per year for $1 million of insurance for a single event. The otolaryngologist–head and neck surgeon in Germany pays approximately US$2000 per year for US$3 million coverage for personal injuries and US$300,000 coverage for special and financial damages.
In the United States, a malpractice attorney often handles cases only for the plaintiff (patient) or the defendant (physician). In Germany, a malpractice attorney is often active for patients as well as doctors. Legal professional fees for a plaintiff’s settlement in the United States and Germany are different. In a $100,000settlement in the United States, the plaintiff’s attorney would receive a previouslyagreed upon percentage (could be more or less than one third) of the total amount plus reimbursement for expenses. Some states have statutes setting a ceiling on the percentage that the plaintiff’s attorney may take in certain circumstances. In Germany, a settlement of US$10,000 would go to the patient minus expenses. The patient would pay one third of expenses, and the physician would pay two thirds. If the costs for the patient’s and physician’s attorney were each US$2000 and court costs were US$1000 (total expenses US$5000), the patient would subtract one third of US$5000 from the total of US$10,000.
How Medical Malpractice Is Proved
Unlike Germany, where the malpractice law is the same throughout thecountry, there is no national medical malpractice statute in the United States. Each of the 50 states has its own medical malpractice laws. However, all states (and Germany) use a fault-based system of liability, which means something more than a bad result is necessary for the plaintiff to prevail in a lawsuit. That something more is usually negligence.
To win a medical negligence suit, the plaintiff must prove four major elements: (1) that the physician had a duty or obligation to practice within the standard of care, usually shown by the presence of a professional relationship; (2) that the physician failed to meet the applicable standard of care; (3) that the patient suffered damages or injury; and (4) that the physician’s failure to meet the applicable standard of care caused the patient’s injury or damages.
Similarly, in Germany, the plaintiff must prove that the doctor committed malpractice, that he or she suffered damage, and that there is a causal relation between the act of malpractice and the damage.
The plaintiff has the burden of proving his or her case by a preponderance of the evidence, which means the plaintiff must prove only that the defendant physician more likely than not breached the standard of care in a manner causing injury to the plaintiff. In Germany, the plaintiff has the burden of objectively proving that medical treatment was incorrect or that insufficient information was provided to the patient beforethe procedure.
The standard of care requires that the physician use the degree of skill and care that the reasonably prudent physician would use in the same or similar situation. In the United States, the testimonies of the expert witnesses are critical aspects ofthe malpractice case. In most circumstances, an expert witness is required to testify asto both the applicable standard of care and the defendant’s specific failures to meetthat standard. The attorneys for the parties retain and arrange payment for the expert witnesses who will testify specifically on behalf of either the plaintiff or the defendant. In some cases, a defendant may serve as his or her own expert witness. A jury or a judge hearing evidence without a jury must sort out the conflicting testimony of the expert witnesses in a single trial and reach a conclusion as to the liability of the defendant. Theparties have decided whether the trier of fact will be a judge alone or a jury.
This sharply contrasts with the German system, in which the judge decides when expert assistance is needed and then selects the expert and defines his or her role. Although a party may provide an expert, if the opposing party contends he or she is wrong, the judge will appoint an expert. The parties may make the case so difficult that the judge cannot solve the problems with his or her own knowledge and will appoint an expert. In most German malpractice cases, there is only one expert, rather than the battle of experts so characteristic of the U. S. case. Unlike the United States, in which there is a single trial in which the lawyers present evidence previously gathered in a long periodof discovery, the German trial may consist of a series of hearings. The trier of fact is always the judge. There is no jury.
Expert witnesses review medical records and other documents in the particular case and render an opinion based on their education, knowledge, and experience. Textbooks, journal articles, manufacturer’s instructions and recommendations, standards and guidelines set by professional organizations, and written institutional policies and procedures may also play a role.
The qualifications of an expert witness in the United States may be challenged by the opposing party. The judge then decides whether the expert is qualified to testify. If the expert testifies, the weight given to that expert’s testimony will be up to the trier of fact.
Most states have some exceptions to the requirement for expert witness testimony. The defendant’s own testimony admitting a breach of the standard of care or the defendant’s violation of a criminal or civil statute may eliminate the need for expert witness testimony. If it is determined that the finder of fact can call upon his or her own knowledge, experience, and wisdom to determine and apply the appropriate standard of care without an expert, in some states, expert testimony may not be required under the “common knowledge” doctrine. When the circumstances in the case provide no credible explanation for the events in the absence of someone being negligent, the doctrine of res ipsa loquitur (the thing speaks for itself) may also apply in some states and eliminate the need for expert witnesses. Although some state statutes specifically describe permitted exceptions to the requirement of an expert witness, others do not. In Germany, there is no requirement that there be expert testimony.
In claims of a lack of informed consent, whether expert testimony is required depends on the state. In states that use a physician-based standard, expert testimony is required to determine whether the defendant has met the standard of care in obtaining the plaintiff’s consent. Expert testimony is not required in states that use a reasonable patient standard. In those states, the question of whether the doctor has disclosed risks a reasonable patient would find material is left up to the trier of fact.1 The German system uses bothof these standards.
Obtaining the patient’s informed consent for surgery is an essential process. The physician who will perform the surgery cannot delegate his or her legal obligation to advise the patient of the nature and purpose of the recommended procedure, the possible risks of the procedure, and the alternatives to the procedure. Recently, in some states, informed consent has also encompassed a requirement that the physicians disclose differential success rates, their “batting averages.” Recordings of subjective estimates and impressions of the doctor do not have to be made in Germany.
In the German system, the doctor in attendance has a duty to inform thepatient about the extent and range of the intended treatment, the associated risks, and the possible alternatives and/or new methods or techniques if recognized and certified fortreatment in Germany. A lack of information or false information has legal consequences only if a typical treatment risk occurs and the doctor failed to mention this possibility in advance.
The question of whether the allegedly negligent act caused the plaintiff’s injury also generally requires expert testimony in the United States. Many states require “but for” causation, which means that if the injury to the plaintiff would not have occurred “but for” the defendant’s wrongful act, then the defendant’s act can be judged tobe the cause of the plaintiff’s injury. In other states, the trier of fact can conclude that the defendant caused the plaintiff’s injury if the defendant’s act wasa “substantial factor” in bringing about the plaintiff’s injury. In Germany, the judge normally does not require an expert witness on causation.
If malpractice is found, the trier of fact also determines the amount of damages to be awarded. In the United States, most damages are compensatory, which meansthe plaintiff may be compensated for past and future medical expenses, past and future loss of earning potential and income, and pain and suffering. When gross negligence is found, punitive damages may also be awarded. Unlike compensatory damages, they may not be covered by the physician’s malpractice insurance. Although a German judge may award compensatory damages, which include pain and suffering, there are no punitive damages.
A small number of U. S. malpractice cases actually go to trial. Alternatives to trial include settlement and arbitration, which is a more informal presentation of evidence to one or more court-appointed or party-selected, neutral arbitrators, who make a decision, which may or may not be binding and final depending on the state and the circumstances. Of the cases that go to trial, few result in a written judicial opinion.
This differs from the German system, in which the judge first tries to reach a compromise between the parties. The majority of the cases are completed out of court. If that fails, a series of hearings may follow, with the judge deciding each case ina written judgment containing full findings of fact and the application of the law.
Prevalence and Characteristics of Malpractice Claims Involving Salivary Gland Diseases
More than 20 professional liability insurers in the United States report information about their closed malpractice claims to the Physicians Insurers Association of America (PIAA), the largest repository of medical malpractice claims’ data in the world. The statistics below are from PIAA’s comprehensive analysis of malpractice data.
PIAA showed a total of 79 malpractice claims relating to salivary glandsurgery during the period from January 1, 1985, through June 30, 2003. The largest numberof claims (27) related to benign neoplasms of the salivary gland. Nineteen of these claims were for improper performance of a treatment or procedure. The remaining claims were for “no medical misadventure,” which means that no medical mishap or real medical incident occurred, but suit was brought anyway; performance of a nonindicated or contraindicated procedure; delay in referral; and one for intubation problems. Most claims involved minor or significant permanent injury. Although none of these cases went to trial, 14 of the 27 claims (52%) resulted in indemnity payments to the plaintiff, with the average payment ranging from $4000 to $300,000.2 Another large category of claims (21 claims) related tomalignant neoplasms of the salivary gland. The most frequent allegation of malpractice inthis category was diagnosis error (14 claims), but there were other claims of no medical misadventure, improper performance, and one for surgical foreign body retained. Most of these cases resulted in death, but some reported lesser injuries. One death case was triedor arbitrated and resulted in a judgment for the defendant doctor. Indemnity payments were made in only two claims, with payments of $45,000 and $100,000.2
Another large category for malpractice claims (21 claims) is classifiedas “other excision of salivary gland lesion.” Improper performance of the procedure (nine claims) and diagnosis error (five claims) were the most frequent allegations of malpractice, but there were also claims of procedure not performed, delay in performance, and procedure performed when not indicated or when contraindicated. Most of the claimed injuries were either major temporary injuries or minor permanent injuries. Two caseswere tried or arbitrated: One involved an insignificant injury and resulted in a judgmentfor the doctor; the other claimed a minor permanent injury and resulted in a $45,000 award. A total of 15 of the 21 claims (71%) resulted in payments, which ranged from $3000 to $800,000.2
Four claims related to incision of the salivary gland. The most frequent allegation was improper performance. One case resulted in a judgment for the defense. One claim paid $509,604. Two claims were dismissed without payment. There was also no payment in a claim related to “salivary gland or duct disease resulting in incision of the salivary gland.”2
Five claims related to “salivary gland or duct disease resulting in other excision of the salivary gland lesion.” One resulted in an award of $45,000 to a plaintiff with a minor permanent injury. Payment was also made in two other cases, with the average indemnity ranging from $3000 to $75,000.2
In Germany, diagnosis errors and treatment errors are frequent claims. However, the amount of money awarded by the judge is usually significantly lower than theU. S. awards, with most awards ranging between US$1000 and US$100,000.
Injury to the facial nerve is probably the most frequent injury claimed in salivary gland surgery malpractice cases. An examination of 53 malpractice cases in which facial nerve injury occurred between 1985 and 2000 revealed that 9 arose from benign neoplasms of the parotid, 1 from malignant neoplasm of the parotid, and 15 from non-neoplastic disease of the parotid or other benign conditions of the head and neck.3
Successfully defending a case in which the facial nerve is severed or damaged during surgery is particularly challenging and often does not have the desired result, as exemplified by the following cases.
In a 2000 case, an oral surgeon’s defense that he was not trained or experienced in parotid gland surgery was unsuccessful. He had performed surgery to remove a mass that he thought was attached to the temporomandibular joint. It turned out that it originated in the parotid gland and adhered to the temporomandibular joint. When the mass and parotid gland tissue were removed at surgery, branches of the facial nerve were dissected, causing permanent damage.
The plaintiffs alleged that the oral surgeon breached the standard of care by incising directly into the soft tissue and circling the mass without identifying the facial nerve. The defendant admitted he did not see the parotid gland or the facial nerves during surgery.
Awarding a total of $650,000, the judge, who heard the case without a jury, stated that “any physician in any specialty had a duty to identify the facial nerves and insure that they were not cut.”4
A plaintiff’s facial nerve was severed, causing permanent partial facial paralysis during surgery to remove a parotid tumor. At the 1992 trial, it was undisputed that it was negligent to sever the facial nerve during surgery in which the tumor was located in the superficial layer of the parotid gland. Plaintiff’s expert witness further testified that it was negligent to fail to observe that the nerve had been severed before closing the facial tissue. The defendant testified that he and his assistants had failed to notice that the nerve had been severed seven eighths of the way through, but observed that the nerve appeared thin and that there was no response when the trunk of the nerve was electrically stimulated. The jury award of $950,000 was upheld on appeal.5
In a 1991 case, an otolaryngologist performed a partial parotidectomy because of concern that two rapidly developing and tender lumps behind the ear might be malignant. At surgery, the doctor had difficulty identifying the inferior branch of the facial nerve. The superior branch of the facial nerve was not identified or isolated. The defendant removed both “lumps” and surrounding portions of the parotid gland. Before closing, he stimulated the exposed nerve, and only the lower half of the plaintiff’s face moved. Upon awakening, the plaintiff showed signs of facial paralysis.
Plaintiff’s expert witness testified that defendant should have used four preoperative diagnostic procedures—computed tomography (CT) scan, magnetic resonance imaging (MRI), sialogram, and fine-needle biopsy—and that these would have shown the lumps were inflammatory, not malignant, and surgery would not have been required. In addition, plaintiff’s expert testified that defendant had failed to meet the standard of care because he had identified only the lower division of the facial nerve, rather than its main trunk and both upper and lower divisions. The jury’s total verdict of $608,330 was affirmed on appeal.6
A plastic surgeon was sued when the plaintiff’s facial nerve was severed during surgery to remove a lump in plaintiff’s cheek. Plaintiff’s expert witness contended that the defendant failed to locate the nerve during surgery and failed to refer the patient to a specialist when he determined the lump was deeper than expected. The defendant admitted that he had cut the nerve but denied that his actions had breached the standard of care. A jury awarded $283,000 in 2000.7
In a 1978 California case, plaintiff was referred to a head and neck surgeon for an inflamed nasal cyst. The surgeon discovered a second lump below her ear and diagnosed a parotid gland tumor. Because of concern about possible malignancy, he recommended removal. The plaintiff was reluctant to have surgery because she had had the lump for at least 10 years, and it had never bothered her. The doctor discussed the nature and risks of the surgery and urged that she have surgery within 6 months. After obtaining a second opinion that confirmed the first opinion, she consented to surgery.
A parotidectomy was performed by the head and neck surgeon. During surgery, the facial nerve was unintentionally severed before it was identified. The surgeon removed the cyst and sutured the nerve back together. The patient, who suffered permanent facial paralysis, left the defendant’s care and sought treatment elsewhere.
At trial, plaintiff’s experts testified that the unintentional severing of the facial nerve before identifying it was a breach of the standard of care. The defendant’s experts testified that an accidental cutting of the facial nerve was within the standard of care. The defendant testified that any surgeon who performs enough parotidectomies is bound to cut a nerve by mistake, and this time “my number came up.”
The jury found for the defendant. However, the appeals court reversed the judgment on the ground that the jury had incorrectly been instructed on contributory negligence based on the defense attorney’s closing argument that the plaintiff had chosen to leave the defendant’s care after the injury and sought incompetent medical assistance. He argued that she could have avoided her present condition if she had continued to treat with the defendant surgeon.8
Not all cases involve facial nerve injury. In a 1977 case, the issue was whether the defendant surgeon had negligently severed a major blood vessel during surgery to biopsy a lesion on the right side of the mandible. Laboratory analysis later confirmed that the tissue removed was part of a salivary gland inclusion cyst.
While closing, the assistant surgeon noticed blood oozing from the operative site. He applied pressure and continued suturing. A few minutes later, the oozing had still not stopped. The surgeon inspected the oozing and found substantial swelling beneath the tongue. Swelling increased, and a nasal tracheal tube was inserted. During insertion, the patient inhaled the contents of his stomach into his lungs and bronchi. In spite of flushing to remove as much vomitus as possible, his condition continued to deteriorate. A tracheostomy was required, followed by placement on a respirator for 6 days. During that time, he developed a heart arrhythmia and a bronchial mucous plug requiring surgical removal. The plaintiff recovered and returned to work a couple of months later.
Plaintiff’s expert testified that the defendant breached the standard of care by perforating the medial cortical plate of the mandible and lacerating either the lingual artery or the sublingual branch of the lingual artery. The defense expert witness testified that it was unlikely that the sublingual artery was damaged and attributed the bleeding to the abundant venous blood supply characteristic of salivary glands. Additionally, he testified that the cyst in the plaintiff’s jaw was an anatomical abnormality and may have contained an abnormal blood supply.
Trying the case without a jury, the court found that the bleeding and swelling in plaintiff’s mouth was caused by damage to one or more of the blood vessels supplying the cyst, and that there was no evidence that the defendant’s drilling of the bone and curettage of the glandular tissue deviated from the standard of care. Finding in favor of the defendant, the court dismissed the complaint.9
In 1998, a defendant otolaryngologist was performing a parotidectomy to remove a tumor. The Penrose drain, which was placed, broke off during removal. The remaining piece of drain was discovered several years later during resection surgery for a suspected recurrent tumor.
Plaintiff’s expert testified that the defendant breached the standard of care by failing to inspect the end of the drain and noting that approximately a 1-inch piece had broken off. The defense expert witness testified that the standard of care did not require inspection of the drain unless breakage was suspected. Even if it had been inspected, he believed it would have been difficult to see. The defendant further contended that plaintiff’s pain was caused by a neuroma, not the drain. After an hour’s deliberation, the jury returned a verdict in favor of the defendant.10
Plaintiffs often allege a lack of informed consent in cases involving the salivary gland and facial nerve injury. A 1993 California case demonstrates the importance of documenting the discussion of risks in obtaining informed consent. A 43-year-old female, who had suffered from recurrent infections of her parotid gland, underwent a partial parotidectomy. A year later, she had a complete parotidectomy, in which her left facial nerve was severed, causing permanent facial paralysis.
Plaintiff testified that she had not received information about alternative treatments. However, the defendant, an otolaryngologist, testified that plaintiff had been given treatment options but decided to proceed with the surgery. The court found that the record supported a finding that she had not only been informed of available treatment options, but also several alternative treatments had been attempted before surgery was performed.
The plaintiff also testified that she had not been warned of the risk of facial nerve paralysis. The doctor testified otherwise and had noted in the medical record: “Procedure and potential complications explained, i. e., facial nerve paralysis.”
The court found that the plaintiff’s testimony was not credible and that she had failed to prove that the doctor had breached his duty of care. The judge, hearing the case without a jury, found in favor of the defendant doctor.11
How to Prevent a Malpractice Suit, or Increase the Chances of Winning If Sued
In both Germany and the United States, effective patient communication, including informed consent, and documentation are two things the surgeon must do to help prevent malpractice suits or to increase the chances of winning in the event of beingsued.
One of the major causes of medical malpractice lawsuits is a communication breakdown between the physician and the patient. A 1997 study used audiotapes to document different conversational behaviors between physicians who had never been sued and those with a history of malpractice claims.12 The study found no association between the content of the doctor–patient conversation and malpractice claims, but found a strong link between lawsuits and how the content was presented. Orienting the patient about what to expect and being sure that information and instructions given were understood made a difference. The study also showed that physicians who had not been sued spent slightly longer with patients (8.3 minutes vs 15 minutes). The author concluded, “By practicing a few simple communication techniques, many physicians could significantly reduce their risk for malpractice claims.”12
To help prevent a communication breakdown: listen carefully to the patient; exhibit empathy and respect for the patient; address the patient’s fears and concerns; provide an opportunity for the patient to ask questions, then answer the questions honestly; inform the patient about treatment options, alternatives, and possible risks; and involve the patient in all medical care decisions, including treatment for a complication.
Documentation of what was discussed in obtaining informed consent is critical in the United States. Without that documentation, what was said often becomes merely the patient’s word against the doctor’s. Good documentation, which corroborates the doctor’s testimony, could well be the difference between a verdict for the plaintiff or the defendant doctor.
In Germany, documentation is equally vital. Before the procedure or treatment, the patient is provided with a detailed information sheet, which he or she signs. If the required information is not given to the patient, the patient’s consent may be inoperative. Doctors must always document their diagnostic and therapeutic measures, as well as the patient’s signed information sheet. Any deviation from standard treatments, and especially the reason for doing so, must be clearly written.
Documentation is an essential factor in winning any malpractice suit. Illegible, inaccurate, incomplete, and, worst of all, altered records may result in a loss in an otherwise defensible case. Records should never be altered in the face of a lawsuit. Although some malpractice cases may be difficult to defend, an attempted cover-up is almost impossible to defend.
The use of electrophysiologic intraoperative facial nerve monitoring has not been proven to reduce the risk of temporary or permanent facial nerve dysfunction (see Chapter 15 for an expanded discussion). It therefore is not the standard of care for parotid surgery, particularly for parotid surgery involving a mobile, small, superficial lobe neoplasm. Nonetheless, there is a 21% reported reduction in malpractice litigation in parotidectomy cases, where there was inadvertent injury to the facial nerve, when nerve monitoring was incorporated in the procedure.13
Unfortunately, in today’s legal climate, not all malpractice casesmay be prevented even when the surgical care is exemplary. When litigation cannot be prevented, the surgeon’s good rapport with the patient, effective communication, and complete and accurate documentation will increase the chances of successfully defending thelawsuit.
REFERENCES
1. Furrow, B Greaney, T Johnson, S Jost, T Schwartz, R.Health Law (Hornbook Series). St. Paul, MN: West Group; 2000: 313–315, 317
2. Data Sharing System. Rockville, MD: Physicians Insurers Assocation of America; 2004. Information used by permission
3. Lydiatt, DD. Medical malpractice and facial nerve paralysis. Arch Otolaryngol Head Neck Surg 2003; 129: 50–53
4. Zutaut v Gallup, No. CV-00–284 (Me Super October 25, 2000) (LEXIS, 236)
5. Gentile v Ongsiako, 579 NYS2d 87 (AD 1 Dept 1992)
6. Mosley v Owens, 816 P2d 1198 (Ore App 1991)
7. Wallace v Coers, No. 17–176645–98 (Dist Tx 2000), reported in Jury Verdict Research
8. LeMons v Regents of University of California, 21 Cal 3d 869 (Sup Ct 1978)
9. Foster v United States of America, No. 73 Civ 4310 (JMC), 1977 US Dist LEXIS 14396 (SDNY, August 19, 1977)
10. Cordova v Bridger, No. 55579 (Ca Super March 26, 1998) (13 TD 3rd 15)
11. Hanna v United States of America, 845 F Supp 1390 (ED Cal 1993)
12. Levinson, W Roter, DL Mullooly, JP Dull, VT Frankel, RM. Physician–patient communication: the relationship with malpractice claims among primary care physicians and surgeons. JAMA 1997; 277 (7): 553–559
13. Lowry, TR Gal, TJ Brennan, JA. Patterns of use of facial nerve monitoring during parotid gland surgery. Paper presented at: Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery; September 20, 2004, New York
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