Will Practice Guidelines Provide Malpractice Defense?

By James F. Holzer, JD

Argus, February, 1994

Once again, the White House has fired up its campaign to sell the President’s health care reform package in 1994. A small but important piece of his proposal attempts to deal with the adverse effects of malpractice litigation on physicians. Among other ideas, the plan calls for the Department of Health and Human Services to develop a medical liability pilot project that will make selected clinical practice guidelines a defense tool for physicians accused of malpractice.

The concept is based on a five-year program under way in Maine involving four specialties: anesthesiology, emergency medicine, OB/GYN and radiology. Effective Jan. 1, 1992, 20 practice guidelines created by specialty advisory committees were given the full force and effect of state law. Although the initial goals of the Maine Liability Demonstration Project were to address problems of rising health care costs and limited access to care, the primary focus now appears to be on getting physicians to voluntarily comply with appropriate clinical standards and consequently to reduce the practice of defensive medicine.

To encourage physician participation, the law provides that doctors who opt into the program can use the guidelines as an affirmative defense in a malpractice action to formally demonstrate their compliance with the appropriate standard of care, presumably without the need for expert testimony. Most significant, however, is a provision of the law prohibiting the plaintiff from using the same practice guideline as evidence of physician noncompliance unless it already has been introduced into evidence by the defendant doctor.

Proponents of the new statute argue that this essentially provides doctors with immunity from litigation in selected instances. Opponents, including some malpractice defense attorneys, assert that it is a constitutional challenge waiting to happen. The White House, understandably, likes this idea better than imposing a controversial cap on noneconomic damages which, to no one’s surprise, the plaintiff’s bar is aggressively fighting.

Implications for Ophthalmologists

According to a recent report on the Maine project by the General Accounting Office (GAO), the guidelines adopted by the state advisory committees were essentially chosen from standards and guidelines written and disseminated by national specialty societies. The GAO report also cited the potential medicolegal use of practice guidelines on a broader scale being developed through DHHS’s Agency for Health Care Policy and Research (AHCPR) and by other states such as Florida, which is looking at implementing up to 50 guidelines in areas of “high medical utilization and high cost.”

If not already, ophthalmology soon will be asked to participate in similar efforts to apply specialty-specific practice guidelines to resolve or curtail malpractice litigation. The Academy’s ongoing work in developing Preferred Practice Patterns (PPPs) no doubt will be of growing interest to federal and state lawmakers entertaining pilot programs similar to Maine’s. Despite the thoroughness and high quality of PPPs, it will be more important than ever to remind policymakers that, like many practice guidelines, PPPs are not intended to “… be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed at obtaining the best results.”

As mentioned earlier, the federal government through the AHCPR has been developing and disseminating practice guidelines that, theoretically, could serve as a basis for future standards to be used in medical liability claims. Six guidelines have been developed by AHCPR so far, including one on Cataract in Adults: Management of Functional Impairment (see Ophthalmology, August 1993 Supplement). The agency plans to develop 10 additional guidelines during 1994. Given the proliferation of guidelines (more than 1,300 nationwide) by this and other groups, it is essential to remember that not all guidelines can or should be recognized as having potential use in court or in risk management activities.

The current explosion of guidelines has confused and occasionally derailed risk management efforts to address medical liability problems. Guidelines not developed exclusively for medical liability problems may focus on many broad and diverse aspects of clinical practice well beyond those narrow areas that give rise to medical liability claims. This essentially was confirmed in the Maine project where officials believed that the guidelines, intended in part for liability problems, had to be easy for physicians to use and to demonstrate compliance. Most were only a few pages long and were targeted to define problems or treatments.

Can Practice Guidelines Affect Liability Claims?

The vast majority of Maine physicians from the four specialties elected to participate in the demonstration project despite concern by some insurance officials that liability would increase if plaintiffs eventually were permitted to use the guidelines in court. According to the GAO, most doctors who agreed to participate believed the guidelines were reasonable and merely reflected the way they already were practicing. Others believed the project would reduce claims and ultimately the cost of premiums. Given recent predictions reported in American Medical News that premiums could climb 5% to 15% during the coming year, experimenting with these nontraditional reforms may be well worth a second look by all specialties.

The Physician Insurers Association of America (PIAA), an organization of the country’s major doctor-owned professional liability carriers, including OMIC, recently declared its support of pilot projects that test practice guidelines, provided they are not put into effect on a broader basis until proven to be worthwhile. The organization believes the federal role should be limited to studying projects under way.

As of September 1993, the GAO could find no examples of the Maine guidelines having affected malpractice litigation in the state. Defense attorneys, however, suggest that the guidelines most likely will impact the state’s pretrial screening process. Specifically, if the independent panel required in Maine to initially review all malpractice claims determines that the defendant physician followed a practice guideline, this might discourage the plaintiff attorney from taking the case to trial.

Needless to say, practice guidelines as applied to medical liability claims raise the specter of “cookbook medicine.” Arguments against the development and use of such guidelines include:

1. Plaintiff lawyers might use the writtenstandards to sue more physicians.
2. The guidelines are inflexible and fail to address the unique clinical circumstances of each case.
3. Medicine has done fine so far without formal practice guidelines.

In defense of guidelines for potential use in litigation, the following should be considered:

1. In OMIC’s six-year history involving more than 400 claims, there has not been a successful attempt by a plaintiff to introduce an Academy PPP or similar guideline at trial.
2. Guidelines that are carefully crafted for liability control purposes generally will allow for appropriate deviations and exceptions to preserve the physician’s right to render care in the best interests of the patient.
3. Careful development of consensus-based guidelines for potential use by physicians in defending liability claims may reduce certain types of recurring preventable mishaps and eliminate the proliferation of profiteering medical experts.

For more information on the Maine Liability Demonstration Project, write the U.S. General Accounting Office, P.O. Box 6015, Gaithersburg, MD 20884-6015, and ask for publication GAO/HRD-94-8 Medical Malpractice: Maine’s Practice Guidelines.

The Role and Way of the Expert Witness

By Jerome W. Bettman Sr., MD

Argus, February, 1995

At some point during their professional life, many ophthalmologists are asked to serve as expert witnesses. While most are willing to testify in defense of a colleague, many hesitate to accept cases on behalf of the plaintiff. An individual is not required to serve as an expert witness; however, the foundation of democracy depends upon access to a fair trial. There are several reasons why experts should be willing to testify for either side.

First, if honest and informed ophthalmologists are not available, attorneys will use someone else, possibly a “hired gun” who will say almost anything in return for a sizable advance payment. Second, it enhances an expert’s credibility to be willing to testify honestly for either side. Third, plaintiffs, like defendants, are entitled to an honest and unbiased opinion. Fourth, the great majority of claims are without merit. A trustworthy expert evaluating a case which has little prospect of success may be able to persuade the plaintiff’s attorney to drop the matter at an early stage, thereby saving considerable money, time and psychological trauma for both sides.

The Role of the Expert Witness

The expert witness has two functions: to testify regarding the standard of care, and to testify whether it is probable that the procedure was the cause of the claimed injury. A general guide to the community standard is whether a reasonable minority of reputable physicians would have done the same. “Reputable” in this context simply means not disreputable. It does not have to be what the majority would do, but certainly it should be more than what a very few individuals would do. The standard of care must be that which was accepted at the time the alleged act occurred; any changes in the standard since that time are irrelevant.

It is important for ophthalmologists who serve as experts to understand the philosophical differences between medicine and law. In medicine, the goal is to arrive at the diagnosis and best therapy through open discussion among colleagues, often at grand rounds. The law attempts to determine responsibility by having each side present its best arguments, negating the arguments of the opposition, and having an impartial jury or judge determine which side is probably correct. Under the adversarial system of law, it would be a mistake for a witness to openly discuss all aspects of a matter because this could introduce considerable bias in favor of the opposing side. Each question must be answered honestly, but responses should be limited to what is required to answer the question and not amplified with “ands” or “buts.”

The Expert at the Deposition

The deposition should be considered a continuous cross-examination, part of the discovery process during which the opposing attorney attempts to determine what impression the expert will make in the courtroom if the case goes to trial. The attorney uses this opportunity to lay the groundwork to discredit the expert witness when similar questions are asked in trial. An attorney may ask the same question in several different ways and later in trial ask it in a manner that indicates the expert is contradicting himself or herself. The more the expert says during the deposition, the more likely the opposition will be able to infer that there is a contradiction in the testimony.

An expert should avoid stating that any one or two pieces of literature or individuals are the definitive authorities. There are many authorities in ophthalmology. It is unwise to refer to a particular article or book during testimony or to review it in preparation. Literature is regarded as “hearsay” unless the expert refers to it.

The Expert at the Trial

A trial is a contest of impressions. If the jurors’ reaction is, “I would like to have this expert as my ophthalmologist,” they will attach great weight to the expert’s statements. If their reaction is the reverse, the expert’s statements will be ineffectual.

The expert should state openly, but not arrogantly, his or her qualifications as an expert, e.g., training, experience, academic status and publications. Besides being a specialist in the field of medicine in question, an expert should be honest, objective and impartial. While testifying, the expert ophthalmologist should explain the matter to the jury clearly and patiently as though teaching a beginning medical student. Both scientific and lay terminology should be used — the former so the record will show what the expert means, and the latter so the jury will understand it.

During the cross-examination, the opposing attorney may try to confuse the witness by asking long, compound hypothetical questions describing every aspect of the patient. Usually, there will be one portion of the question the witness does not agree with. Answer that portion separately. The attorney may use intimidation to anger the witness or be disarmingly pleasant in an attempt to lull the witness into saying something spontaneous and inappropriate.

Guidelines for the Expert Witness

Whether testifying on behalf of the plaintiff or the defendant, these guidelines will make the experience less stressful:

1. Always tell the truth; do not exaggerate or make statements that cannot be substantiated.
2. Do not allow an attorney to influence your testimony by putting words in your mouth or encouraging you to state more precise numbers and percentages than you feel comfortable with.
3. Do not volunteer information that is not asked. If something occurs to you that seems important, meet with your attorney during the recess to determine whether it is wise to bring it up during the redirect examination.
4. Do not help the opposing attorney by asking, “Do you mean ‘X’ or do you mean ‘Y’?” You will then be asked both.
5. Listen carefully to the entire question before answering. Never interrupt, and do not answer a compound question until it is broken into its component parts. If you do not understand a question, ask that it be repeated.
6. Do not hesitate to say you don’t know the answer to a question. Never guess at an answer. Opinions are acceptable, guesses are not.
7. Avoid mentioning any book, article or individual as an authority.
8. Thoughout the trial, periodically look at the jury. Eye contact is the essence of believability.

When to Report “Free Servicing” of Patients to Data Bank

 By Paul Weber, JD

Argus, July, 1995

Occasionally, a patient may ask an ophthalmologist to waive or refund a fee following a poor clinical outcome or a perceived poor clinical outcome. These situations, sometimes called “free servicing,” are in some instances reportable to the National Practitioner Data Bank (Data Bank). They also may raise legal and insurance coverage issues, which go beyond the scope of this article.

Recently, the Data Bank changed and clarified some of its reporting requirements regarding fee waivers and refunds. Waiving a fee or choosing not to bill a patient should not be reported to the Data Bank.

For example, if a patient with a documented history of asthma and allergies has a severe reaction to a topical medication and is willing to accept waiver of the fee as “settlement,” that waiver is not reportable to the Data Bank. Likewise, if the practitioner waives a fee or chooses not to bill a patient for services relating to repair or treatment of a complication, that also is not reportable.

However, a fee waiver may not actually “settle” a claim unless the patient signs a binding release of claims. Before drafting such a release, seek the advice of your liability carrier because releases can compromise liability insurance coverage. In many cases, an informal (non-binding) fee waiver can help defuse a litigious situation.

A fee refund is somewhat more complicated for reporting purposes. If an individual practitioner makes a refund out of personal funds, it is not reportable to the Data Bank. However, if a corporate entity (including solo incorporated practitioners) makes a refund, that payment is reportable to the Data Bank unless the refund is made solely on behalf of the entity, such as a hospital, clinic or group practice. Always consult with an attorney or your insurance carrier to distinguish whether a refund is being made on behalf of an entity or an individual practitioner.

Finally, a refund of a fee paid by an entity (not out of personal funds) is reportable only if the refund arises from a written complaint or claim demanding monetary payment for damages. The written complaint must be based on the ophthalmologist’s provision of, or failure to provide, health care services. A written complaint or claim includes the filing of a lawsuit for medical negligence or simply a letter from a patient or the patient’s attorney demanding money for damages related to the practitioner’s provision of health care services. However, if the patient orally demands and receives a refund, this does not have to be reported to the Data Bank. As with a fee waiver, a fee refund may not actually “settle” a claim, but it may help defuse a litigious situation.

For more information, call the Data Bank Help Line, 800-767-6732. OMIC insureds may call the OMIC Risk Management Hotline, 800-562-OMIC, ext. 4, for more information about the Data Bank reporting requirements and other issues affecting their practice.

Close Door On Liability

 By Dean C. Brick, MD

Argus, September, 1995

Increasingly, ophthalmologists are being asked to practice more efficiently to remain competitive in the new health care arena. Many time-saving strategies allow physicians to provide quality care. However, using pre-dictated operative report forms to save time carries potential liability risks.

The importance of complete and accurate medical records cannot be overemphasized. A poor surgical result linked with an incomplete operative note may lead to liability regardless of the standard of care practiced. Because jurors often are evaluating an incident from two to 10 years after it occurred, they must rely heavily on the medical record. A complete and accurate record becomes indispensable for the defense since the ophthalmologist probably has little independent memory of the surgery.

Standard Forms Help Defend and Define Level of Care

Admittedly, using a standard pre-dictated form saves considerable time over dictating a new report for each procedure. For routine procedures such as a cataract operation, it may seem reasonable to use a pre-dictated report because most operations are very similar. The ophthalmologist can take the time to include on the form all the subtle nuances of the procedure employed, establishing a record that may actually help defend and define the appropriate surgical skill and level of care. When dictating individual reports, a surgeon may be too hurried to pay attention to these details.

If the case proceeded exactly as in the pre-dictated report, this is an acceptable and defensible method. However, if it is discovered that the surgery varied in any way, the surgeon may appear sloppy, careless, and rushed when the operative report is later presented in court and found to be exactly the same as all of the physician’s other cataract surgery reports.

Customize Reports for Each Patient

If an ophthalmologist encounters problems during a procedure, the medical record should reflect the clinical complexity of the case and indicate that the physician provided the proper professional attention. The appearance that careful attention was not given can be devastating if a surgery the ophthalmologist thought went well ends up in court because of an unexpected postoperative complication.

Ophthalmologists who use standard operative reports may want to customize each one by adding notes specific to the patient. For example, document that a specific viscoelastic was used to protect the endothelium in a patient with an endothelial dystrophy or that a procedure was changed in a particular manner because of the density of the nucleus. A reviewer may doubt the veracity of the entire report if it does not mention that a peripheral iridectomy was performed when one obviously was present postoperatively. The surgeon’s recognition of and response to any type of complication needs to be included in the report. If the procedure varied in any way, dictate the report individually or add a section to the pre-dictated form noting the change. Any dictation or writing regarding the operation should be done immediately following the procedure. Beware, however, that it can appear self-serving and defensive if the ophthalmologist drafts an excessively detailed report after recognizing a complication, stating that the patient was informed preoperatively of the possibility of that specific complication.

Proceed With Caution

While it may be tempting to use pre-dictated operative notes, the few minutes saved may result in much more time spent in court trying to defend an incomplete record that all too obviously resembles the other patient reports dictated by the ophthalmologist.

If an accepted complication is associated with a poor outcome and a malpractice action results, the surgeon may lose an otherwise defensible case if the plaintiff’s attorney convinces the jury of a “cover-up.” To be safe, pre-dictated reports should provide for a narrative of any problems encountered. Do not depend solely on a “stock” pre-dictated report.

Dos and Don’ts Following Notice of a Claim

 By Jerome W. Bettman Sr., MD

Digest, Fall, 1995

A chilling letter arrives at your office:

Dear Doctor:

My client, who has been under your care for the past 10 months, has suffered loss of vision and pain in her right eye due to your neglect, improper therapy, and medical negligence. It might be possible to reach a settlement of this matter if you telephone my office promptly.

Very truly yours,

Plaintiff’s attorney

What should you do if you receive such a letter? First, do not go into shock. These allegations are probably not a reflection of your ability to practice ophthalmology or your character. You are one of a large group of ophthalmologists, the majority of whom are excellent practitioners, who have had a claim brought against them. Approximately one in six physicians are sued every year in this country. Among OMIC insureds, 6 to 7% will incur a claim over the next year.

Second, do not think that you are going to lose your life savings or that your children will not be able to attend college. The vast majority of claims against physicians never come to trial and those that do are usually won by the defense.

However, it is important to realize that certain imprudent actions by a physician after receiving notice of a claim may actually encourage a plaintiff’s attorney to proceed with a claim that otherwise might have been dropped, and it may make defense of the case more difficult.

Notify Your Insurance Carrier

The most important first step you can take is to contact your insurance carrier immediately. It is a good idea to make this contact even if there is only a threat of a claim. Your insurance company will not penalize you for this; in fact, all carriers encourage their insureds to contact them early so they can provide advice and support. Speak to your carrier’s attorney or claims agent; their advice and services can be invaluable.

If and when a lawsuit is filed, your carrier will be responsible for assigning a medical malpractice defense attorney to your case. Upon reporting a claim or lawsuit to OMIC or your carrier, insureds will be asked to forward a complete copy of the patient’s medical record. This is necessary so the records can be reviewed to determine if there is any basis to the patient’s claims.

Do not discuss any aspect of the case with anyone other than a representative of the carrier or, if a law firm has been assigned to handle the matter, to the attorney representing you.

Do not contact the patient’s attorney. If an attorney representing the patient attempts to contact you, refer him or her to your insurance carrier. The attorney knows what he or she wants; you do not. Do not contact the patient. After a formal claim is filed, the patient becomes a legal adversary. If the patient contacts you, the best approach is to simply state in a friendly manner that in light of the fact that a claim has been made, your attorney advises you not to discuss the case. The patient might even request that you proceed with his or her care. It is probably better to decline, although there are some defense attorneys who believe that continuing the physician-patient relationship can be advantageous. The better decision, however, is to offer to give the patient the names of other ophthalmologists who can provide care and to make a summary of the patient’s records available to the new ophthalmologist upon proper request.

If you must discuss the case with subsequent or current treating physicians, limit your discussions to the medical facts surrounding the patient’s care and treatment, and refrain from discussing any medical-legal issues.

Never Alter the Medical Record

The plaintiff’s attorney no doubt will request a copy of your records. It is mandatory that you comply with this request, but be sure that you have the patient’s signed permission to release the records. Take the records out of the file yourself and go through them to be certain no extraneous material is included. Maintain, absolutely, the integrity of the patient’s medical record. Under no circumstances should you alter the records in any way. Even though you might think that a change made in the most skillful manner will not be detected, it will be. Most records have been copied previously for insurance purposes. If the plaintiff’s attorney gets a copy of these original records and can prove that the records were later altered, you will most certainly lose your case.1

After the record has been copied for the plaintiff, start a new one. Keep the original record in a safe and secure location. Do not place correspondence from OMIC or your attorney in the patient’s medical record. Start a legal file which you maintain separately from the medical record.

Do not investigate the medical literature relevant to this case unless advised to do so by your attorney. Such an investigation can bring unfavorable literature into evidence. An article or book may state something favorable to your case on one page but something unfavorable on another page. Literature is considered hearsay in the law and is not admitted into evidence unless you refer to it. You will probably be asked by the opposing attorney what literature you have read in conjunction with the case.

Do not talk or write about the case to other physicians, your office staff, or acquaintances. They really are not that interested in the specifics of the case, and if the matter does come to trial, there is potential embarrassment if you have to admit that you discussed it with third parties who may be called to testify.

Seek Support for Malpractice Stress Syndrome

Do speak to medical colleagues and others who are significant figures in your life about the stress you are feeling if you perceive that you are emotionally troubled by the suit. This is a time to benefit from sources of support within your family, church, and friends.2 A malpractice stress syndrome has been recognized. Defendant physicians may develop a negative self-image, feel misunderstood, or have decreased self-confidence. A lawsuit has great emotional impact, and the physician may experience anger, tension, depression, irritability, insomnia, decreased appetite, and difficulty in concentration. In some areas of the country, self-help groups have been organized for physicians involved in litigation. The sharing of experiences with others who have been involved in suits can be helpful.3

OMIC’s claims staff works closely with insureds during the course of a claim or lawsuit. Insureds are encouraged to contact their OMIC claims representative if they have any questions or need assistance. Additional support and guidance during this trying time can be found in the recently published Litigation Handbook for The Ophthalmologist. Jointly created by OMIC Claims Committee members and defense attorneys, this booklet gives a comprehensive overview of the litigation process. A complimentary booklet is sent to OMIC insureds who incur a lawsuit or who request a copy. Others may obtain the booklet by contacting the OMIC Risk Management Department at 800-562-4652. The cost is $10 for members of the American Academy of Ophthalmology and $15 for nonmembers.

Notes:

Bettman JW and Demorest BH. Practice Without Malpractice in Ophthalmology. Ophthalmic Mutual Insurance Co., San Francisco. 1995: 73-76.

Anderson RL. Discovery and Deposition, in Bettman & Tennenhouse (eds.), Medicolegal Aspects of Ophthalmology. Int. Ophthal. Clinics: Little, Brown & Co., Boston. Winter 1980: 68-69.

Richards B. Doctors Seek Crackdown on Colleagues Paid for Testimony in Malpractice Suits. Wall Street Journal. Nov. 2, 1988: B1.