OMIC Encourages Prompt Reporting of Endophthalmitis in Patients given Brilliant Blue G (BBG)

An alert was released this week by the American Academy of Ophthalmology (AAO) and the Food and Drug Administration (FDA) regarding the use of Brilliant Blue G for eye surgery. (See below) OMIC encourages policyholders who report cases to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program to also call OMIC’s Risk Management Hotline to report the incident and for advice on mitigating risks associated with the event.   Hotline: OMIC’s ophthalmic risk management hotline receives thousands of calls each year from policyholders and their employees in every region of the country. Policyholders and their staffs should know that any time they encounter a difficult situation, they can call an OMIC Risk Manager for help. OMIC’s risk management hotline is confidential from other OMIC Departments and Risk Management staff does not discuss any issues raised through the hotline with anyone else..Records are kept within a secure document imaging system and access to files are limited to Risk Management/Legal staff only.

Policyholders should encourage staff members to use this policyholder benefit whenever needed.

Call (800) 562-6642 then press 4.

UPDATE: FDA Clarifies Its Recall of Brilliant Blue G for Eye Surgery
 

The U.S. Food and Drug Administration issued additional clarifications this week regarding a March 19 recall of Brilliant Blue G (BBG). The FDA recommends that ophthalmologists immediately quarantine and return only any remaining Brilliant Blue G product that was received from Franck’s Compounding Lab in Ocala, Fla.

Prior quarantine recommendations had not been specific to that compounding laboratory.

Academy members are asked to report any cases of post-procedural fungal or bacterial endophthalmitis that occurred in the last six months that are associated with eye surgery in which BBG was used. Reports should be made to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Online at www.fda.gov/MedWatch/report.htm; or

Call 800.332.1088 to request a reporting form and return to the address on the pre-addressed form, or submit by fax to 800.332.0178.

AAO/FDA Alert:

The Academy is assisting the U.S. Food and Drug Administration, the U.S. Centers for Disease Control and Prevention and state and local health agencies with an ongoing public health investigation. The FDA has received reports of fungal endophthalmitis in patients who were given Brilliant Blue G (BBG) during eye surgeries. Clinicians in several states have reported adverse events. The BBG was supplied by Franck’s Compounding Lab in Ocala, Fla. The pharmacy issued a recall of all lots of BBG on March 9.

Brilliant Blue G is not an approved drug in the United States. The FDA recommends that all Brilliant Blue G be immediately quarantined and returned. This includes all lots of BBG received from Franck’s Pharmacy. To assist with this investigation, Academy members are asked to report any cases of post-procedural fungal or bacterial endophthalmitis that occurred in the last six months that are associated with eye surgery in which BBG was used. Reports should be made to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Online at www.fda.gov/MedWatch/report.htm; or
• Call 800.332.1088 to request a reporting form and return to the address on the pre-addressed form, or submit by fax to 800.332.0178.

For more information, contact the Academy’s Governmental Affairs Office at 202.737.6662.

Understanding the Basic Rules of Advertising

By Amy B. Angert, JD

[Argus, December, 1993]

Ophthalmologists who advertise their services often face confusing legal and ethical restrictions. Advertising professional services is different from advertising commercial products or services. Puffery or exaggeration, common in advertising nonprofessional services or goods, is prohibited in the medical arena. In fact, such advertising may be considered deceptive and subject the ophthalmologist to fines or licensing investigations. It is essential for the ophthalmologist to understand the basic rules governing medical advertising and to weigh the benefits against the possible risks.

What Is Physician Advertising?

Ophthalmic professional advertising consists of communications to the public, prospective or current patients, professionals or other people for the purpose of soliciting or encouraging the use of the physician’s services. Advertising may be verbal or written and includes magazine or newspaper ads, telephone directory displays, radio and television spots, promotional flyers, leaflets and brochures. The advertising for which an ophthalmologist can be held responsible includes those ads placed directly by the practitioner as well as communication for the ophthalmologist’s services disseminated by other entities such as hospitals or clinics. In other words, the ophthalmologist is liable for any method that promotes the use of the physician’s services which the ophthalmologist is directly or indirectly responsible for placing.

Who Regulates Advertising?

A multitude of federal and state entities monitor and enforce advertising rules and regulations. One premise common to all regulatory entities: physician advertising must be truthful and not misleading. Advertisements may not directly or indirectly make false claims or misrepresent material facts. Likewise, they must not omit essential or material facts, and any claims made in advertisements must be able to be substantiated. Unfortunately, these basic premises are deceptively simple and often are more difficult to implement than they appear.

The goal of all advertising regulation is to prevent the use of undue influence or coercion regarding the need for ophthalmic care. It is believed that medical advertising has greater potential to influence because target groups may be seriously ill, infirm or suffer from impaired judgment, predisposing them to believe exaggerated claims or promises. Or, advertising may target vulnerable groups that are incapable of critically evaluating the advertisement itself. Medical advertising must not be false, deceptive or misleading.

Federal and state antitrust laws protect physicians who want to truthfully advertise their services. The Federal Trade Commission is primarily responsible for enforcing federal antitrust laws; state attorneys general enforce state antitrust laws. Medical associations are prohibited from impeding truthful advertising by physicians.

The basic premise of these laws is the idea that truthful advertising benefits people by making them better informed. The U.S. Supreme Court in a series of opinions has ruled that truthful advertising is protected under the U.S. Constitution’s First Amendment right to free speech.

These protections extend only to truthfuladvertising. Untruthful advertising is not protected by state or federal antitrust laws or by the First Amendment. If an ad is deemed false or deceptive, the physician may be subject to federal or state action, including litigation or substantial fines.

Physician advertising is evaluated from legal as well as ethical perspectives. Laws, in the form of statutes or administrative rules, generally are enforced by state boards of medicine or state attorneys general. Investigations by these entities are confined to determining the legality of the ad and the disciplinary action required.

Ethical scrutiny is often more subjective and less specific than legal scrutiny. Frequently, it is the province of national, state and local medical associations that publish guidelines or opinions to assist practitioners in their advertising practices. Some have panels available to review their members’ ads and to offer guidance in meeting ethical requirements. Inquiry and disciplinary action generally are confined to evaluating whether the practice is ethical and what remedial action is required.

Ophthalmologists with specific questions regarding the legal or ethical sufficiency of an advertisement should consult an attorney experienced in this area. OMIC’s Risk Management Department, the Academy’s Ethics Unit, state boards of medicine, or local ophthalmic medical societies also may be able to provide guidance.

Hidden Pitfalls

In addition to meeting ethical and legal restrictions, the ophthalmologist must consider the impact of advertising on the patient. While advertising generally has produced more informed and better educated patients, the treating ophthalmologist may have to contend with a patient who already has misconceptions or unrealistic expectations as a result of the physician’s or anyone else’s advertising.

If the ophthalmologist does not identify these misconceptions or unrealistic expectations as they relate to the patient’s circumstances, the physician may be hindered in future informed consent discussions. If this patient sustains a poor or less than perfect outcome from a procedure, even if it is well within the range of outcomes accepted for that treatment regimen, the patient will be dissatisfied and may feel deceived. Dashed expectations often are the driving force behind litigation. The patient needs to know at the outset, before care is rendered, what result is reasonable to expect in the face of his or her particular circumstances. If the case is a difficult one, the ophthalmologist should encourage the patient to get a second opinion.

Ophthalmologists who advertise also must consider how their ad will sound to a jury. Any good plaintiff’s attorney will subpoena ads generated from a doctor’s office and exploit their impact at trial. Plaintiffs often will claim they were seduced or influenced by representations made in the doctor’s advertising. Such claims have tremendous jury appeal and can, in fact, be the decisive factor between a defense verdict and a jury award.

Consider the ophthalmologist who advertises that laser surgery for treatment of cataracts or glaucoma is safe, harmless and painless. Not only does the ad violate federal and state truthful advertising rules, but it also runs afoul of ophthalmic ethical guidelines. The ad is false, deceptive and misleading. The promise of painless surgery is a lure to attract patients who fear conventional surgery. To patients, such a statement implies that the entire event is painless and fails to address the possibility of postoperative complications, the pain associated with the anesthetic injection, or normal postoperative discomfort. Claiming that the procedure is safe is misleading or even outright false. The patient may construe the claim to mean that the procedure is entirely without risk or safer than other options. Claims of safety may influence the patient’s choice over another equally viable alternative procedure. This ophthalmologist would have difficulty defending such a claim in a courtroom even if the physician had advised the patient of the inherent risks associated with the procedure because the seductive message generated by the ad probably would outweigh any informed consent the doctor might claim the patient made.

Any ophthalmologist who advertises should consider how the ad text would sound to a jury in the face of claims of alleged negligence or lack of informed consent. If the ad claims cannot be substantiated, if they overreach in their claims or are subject to multiple interpretations, the ad should be revised or rejected.

Ethical and Risk Management Issues Related to Advertising and Marketing

By Susan H. Day, MD

[Digest, Summer, 1996]

As competition increases and reimbursements decrease, more ophthalmologists are turning to advertising and marketing to maintain their patient base. Lacking experience or education in these areas, ophthalmologists usually rely upon marketing agencies or examples from other physicians for ad style and content. In any given community, printed advertisements can be found that attempt to offset or respond to previously run ads of perceived competitors; however, an ophthalmologist has to be careful not to respond to a deceptive or unethical ad by running one that is equally misleading.

Business Values Replace Traditional Values of Medicine

With the advent of refractive surgery, marketing efforts have increased as ophthalmologists declare their services in this new arena. Invariably, the subject of marketing surfaces whenever ophthalmologists attend courses or receive brochures pertaining to refractive surgery. A flurry of marketing activity by the companies manufacturing excimer lasers speaks to the perceived importance of advertising in order to be successful in the field of refractive surgery. Such marketing efforts are in large part conceived from the business aspect of refractive surgery: a service is being sold. The traditional values of medicine — the patient comes first; above all, do no harm; do what is in the best interest of the patient — do not appear to be the driving principle in this process. This shift in priorities increases one’s exposure to claims of lack of informed consent brought by patients who feel they are being “sold” a service rather than being given accurate information about a medical or surgical procedure.

The ethics of advertising within the medical profession has changed dramatically over the past 50 years. Expressly forbidden in some codes as “derogatory to the dignity of the profession,” ¹ advertising gained legitimacy in 1982 as a consequence of the Federal Trade Commission’s suit against the American Medical Association, which still restricted advertising in its Code of Ethics.² Future codes of ethics, such as the one adopted by the American Academy of Ophthalmology (AAO) in 1983, reflect this changed legal posture toward advertising. Historically, advertising has been used more by the medical specialist than the generalist,³ and this continues to be the case today if one can judge by virtually any urban yellow pages.

The goal of advertising is to sell a product or service. When limited to a message of either informational or educational objectives, truthful advertising with respect to medical services can serve a purpose to the general public. Problems may arise, however, when claims of superiority are made. This self-serving need of advertising is in conflict with the physician’s foremost responsibility to the patient.⁴ In addition, claims of superiority may raise the standard of care from one of the reasonably prudent physician to that of the superior physician, a more difficult standard for the physician to meet and a defense attorney to defend in court.

The power of word-of-mouth satisfaction from treated patients has been underscored as effective advertising by many⁵ and should not be ignored as an ophthalmologist reviews marketing options. Nevertheless, advertising remains a right of individuals, and professional organizations can offer only ethical perspectives on content. Insurance companies, however, have taken a proactive stance regarding the marketing of certain procedures, especially refractive surgery and CO₂ laser skin resurfacing. As a condition of receiving coverage for these procedures, OMIC insureds must agree to submit their advertisements to OMIC for approval prior to placing them in the newspaper, or on radio or television, etc. This approval process is a service that protects not only the individual insured but the Company as a whole from the increased exposure of malpractice claims that include deceptive or unethical ads.

Ethical Guidelines May Be Used in Court

Any advertising effort is an extension of an ophthalmologist’s practice. As such, ethical principles must be upheld. Truth, respect for a patient’s choice, doing what is right for the patient, and doing no harm are the cornerstones of ethical medicine, whether the service offered is cataract surgery, chemotherapy, or refractive surgery. To practice ethically is the key to a rewarding practice in medicine. Additionally, if these ethical principles are not upheld, they may spell disaster when a physician’s marketing becomes an issue in a lawsuit.

Through its Code of Ethics and advisory opinions on advertising, the AAO has provided guidelines on communications to the public. These guidelines call upon the integrity of the ophthalmologist rather than providing specific language to use or avoid. This design nevertheless is powerful and enforceable.

Furthermore, these guidelines have been relied upon by courts as relevant standards in lawsuits against ophthalmologists.

1. Communications must be accurate.
2. Communications must not be deceptive.
3. Communications should avoid appeals to anxieties and vulnerabilities.
4. Communications should not create unjustified expectations.
5. Communications should provide a realistic assessment of risks, benefits, and alternatives.
6. Communications should never misrepresent credentials.
7. Communications should not make claims of superiority that cannot be objectively substantiated.
8. All paid communication must be acknowledged.

Other national organizations, including the AMA and American Society of Cataract and Refractive Surgery, have very specific guidelines as well. Specific rules are outlined for such topics as use of patient testimonials, fee-related matters, claims of exclusivity of training or expertise, and promotion of equipment, devices, or drugs limited to those approved by the FDA. It is prudent to give these guidelines to anyone involved with the marketing of your practice.

Risk Management Pitfalls

Advertisements for medical services carry a greater responsibility than advertisements for cars, cable television, or athletic shoes. The professional nature of our services, the gap of knowledge between the potential patient and the physician, and the vulnerability of the potential patient contribute to the responsibility accompanying the privilege of being a physician. The AAO’s Ethics Committee is frequently called upon to review advertisements sent by patients or other physicians. Several areas have been identified as recurrent, potentially problematic areas. Often, an ophthalmologist will respond in one or more of the following manners in defense of his or her advertisement. The ethical and risk management pitfalls of these defenses are thus reviewed here.

I never approved the ad.
The responsibility for an advertisement rests with the individual ophthalmologist. An ophthalmologist cannot pass blame on to a marketing agent, an office business manager, or other party who has acted on the physician’s behalf.

All I did was copy what my crosstown competitor did in his/her advertisement.
Two wrongs do not make a right! The ethical or risk management issues do not take such arguments into account; each is judged on singular merit or lack thereof.

Of course I’m a pioneer/internationally renowned/ most experienced.
Claims of superiority place an added risk management burden on an ophthalmologist who has chosen to advertise in such a fashion. Such claims may be difficult to substantiate in a court of law.

The university/HMO advertises like this. I’m just trying to keep up.
Advertising by institutions has become increasingly popular. Understandably, the individual ophthalmologist often feels compelled to join in the fray. The rules — both ethical and legal — apply to each, and as such, the individual must maintain his or her own standards.

For the ophthalmologist already employed by or entertaining the possibility of employment by a larger institution, care must be undertaken to understand what rights the physician has in relationship to potential advertising campaigns.

Conclusion

Ethical behavior in conjunction with prudent risk management not only reduces the risk of malpractice litigation; it also assures that ophthalmologists incorporate principles into their practice that improve the overall quality of patient care.

Notes

1. Reiser SJ, Dyck AJ, Curran WJ. Ethics in Medicine, Historical Perspectives and Contemporary Concerns. MIT Press, Cambridge. 1982: 31.
2. AMA v. FTC. 455 US 676 (1982).
3. Martensen RL. Physician Advertising. JAMA. 1994: 1623.
4. Packer S. Physician Advertising. The Ethical Ophthalmologist: A Primer. American Academy of Ophthalmology. 1993: 123-24.
5. Hunkeler JD. Keeping an ethical eye on medical marketing.Wall Street Journal. 30 March 1995.

Managed Care Gatekeepers and Your Potential Liability

By Richard A. Deutsche, MD

[Argus, September, 1991]

A managed care gatekeeper refuses to authorize your prescribed treatment plan for a patient. What should you do?

As the physician, you must be the advocate for your patient, or face potential liability. A landmark court case in California illustrates the point.

An elderly patient who participated in a Medicaid program which employed pre-authorization gatekeeping was admitted to a hospital for vascular surgery. The pre-admission authorization was good for 10 days. The patient developed complications and her surgeon requested approval for an 8-day extension. The gatekeeper approved an extension of only four days, at which time the patient was discharged. Further complications arose at home which resulted in amputation of her leg.

Claiming that the cost containment mechanism was the proximate cause of her amputation, the plaintiff sued Medi-Cal. A jury awarded her $500,000. The verdict was reversed on appeal, however. Although there were procedures to contest the gatekeeper’s decision, the surgeon failed to appeal the denial to a Medi-Cal reviewer. The court found the surgeon responsible since he alone discharged the patient.

In this case, total responsibility (and presumably any resulting liability) remained with the physician. The court did imply that if the physician had adequately protested the health plan’s decision, responsibility might arguably have shifted to Medi-Cal, the managed health care provider. But, if a doctor complies with an HMO’s decision that is contrary to his or her medical opinion, the physician would in all likelihood bear the ultimate liability for any injuries that the patient may sustain.

As a general rule, physicians owe the same legal duty, and are essentially held to the same standard of care with respect to each patient they treat, regardless of reimbursement arrangements. Consequently, a treating ophthalmologist who disagrees with the gatekeeper regarding the need for treatment or a procedure is obligated to treat the patient according to the appropriate clinical standard of care. If the ophthalmologist fails to provide treatment because the HMO refuses authorization, the physician may likely be exposed to a malpractice claim if a patient injury occurs.

Treating physicians still have an unqualified legal duty to HMO subscribers, even though gatekeepers may pressure them to make unsound medical decisions. Many state statutes regarding managed health care systems may limit somewhat these corporations from liability directly arising from medical malpractice. An ophthalmologist who does not protest limitations imposed by a third party payor when medical judgement dictates otherwise cannot avoid ultimate responsibility for the patient’s care. When there is a conflict between a physician and the managed health care system over the quality of patient care, the physician must uphold the patient’s interest.

In summary, if you recommend a test or procedure which the managed health care system will not approve you should carefully consider the following risk management guidelines:

• Inform the patient of the potential consequences of not having the test, procedure or treatment performed.
• Appeal the gatekeeper’s denial, informing the third party of the consequences of not having the test or procedure.
• Document these actions in the patient’s chart, including copies of letters to the patient and the managed health care provider.
• Be your patient’s advocate for the highest standard of care.

Hold Harmless Clauses May Increase Physician’s Liability

By Ross E. Stromberg, Esq., and Ann K. Bowman, Esq.

[Digest, Spring, 1993]

Given the complexities of today’s health services market, ophthalmologists need to understand the extent of the liability they assume upon entering into contracts with governmental agencies, hospitals, nursing homes, health plans and other third parties. Physician contracts with these third party providers and payers often contain hold harmless, exculpatory, or indemnification clauses. These clauses attempt to shift responsibility for economic harm or liability from one party to another. Sometimes such contract provisions are one-sided, where only one party indemnifies the other; in other cases, the contract provides cross or mutual indemnification where both parties indemnify each other.

Hold harmless clauses can drastically increase an ophthalmologist’s potential professional liability by making it possible for either party to the contract to recover the damages against the other in actions which otherwise could not be sustained.

Significantly, the liability created by these clauses is not covered by a physician’s standard liability policy and coverage can only be purchased at a much higher rate, if at all. An insurer must be able with some degree of certainty to compute the risks it may incur from a particular clause so it can control the cost of defending claims. Since it is often difficult to calculate the inherent risk in such clauses, insurers generally will not insure a physician’s hold harmless liability.

Ironically, where each party has its own liability insurance and no hold harmless clause has been agreed to, standard insurance policies will cover most situations that arise involving their insured. Where both parties have insurance and a hold harmless clause is potentially in effect, however, the ultimate result is “the ridiculous situation of the parties adding to their insurance costs merely to get the same protection they would have had from their usual insurance had there been no liability or hold harmless clause in the contract.”¹

Spotting the Clauses

Hold harmless clauses take a variety of forms. Some clauses only require the physician/indemnitor to indemnify the third party/indemnitee for claims resulting from the physician’s own negligence. Other clauses attempt to require the physician to indemnify the third party/indemnitee for claims arising from that provider’s negligence or harmful act.

Typical hold harmless clauses may be constructed as follows: “Physician will indemnify and hold us harmless from loss, damage or cost (including reasonable attorneys’ fees) arising from all of Physician’s willful, wrongful or alleged wrongful acts or omissions under this contract.” Or, “Physician shall indemnify and hold us harmless from any and all liability, loss, damage, claim or expenses of any kind and of whatever nature, including all costs and attorney fees, arising out of the performance of this Contract and for which Physician is solely responsible.”

A clause need not actually contain the words “hold harmless” or indemnify.” Clauses containing language such as “to assume all risks of [certain accidents]” and “this is a release from [certain claims]” also have generated liability.²

Liability is Potentially Vast

Where a clause is written broadly, and no limiting terms have been introduced into the contract, an ophthalmologist consenting to an agreement with a third party opens the door to a host of claims, including those for personal injuries, libel and slander, copyright infringement, contract defaults, employee claims, tax liabilities, the direct and indirect expense of the other provider in doing business, and indirect and consequential damages including interest and loss of profits. An ophthalmologist’s personal assets are put at risk as a result of hold harmless and other indemnity provisions because the physician’s professional liability policy usually does not cover such actions.

Defending a claim by the other party to an agreement containing a hold harmless clause or other indemnification provision can be expensive, regardless of whether the physician is trying to prove the provision is unenforceable or that it should be construed differently from the meaning alleged by the third party. Moreover, an ophthalmologist has no guarantee that litigation will be successful as there is law supporting both sides of the issue.

Review All Contracts for Hold Harmless Clauses

Ophthalmologists should, with the assistance of an attorney or insurance expert, conduct an immediate and careful review of any and all contracts to see if they contain indemnification provisions. In addition, physicians should ask an attorney to prepare a standard clause to replace all overreaching indemnification provisions to which the provider is a party. Discrimination and precision in choosing words is essential to achieving protection from far-reaching liability provisions.

If you are currently in an agreement containing a hold harmless clause, don’t panic. Indemnity or hold harmless provisions in contracts are interpreted according to the general rules governing the formation, validity and construction of all contracts. Thus, these provisions are to be fairly and reasonably construed to ascertain each party’s intention and purpose in entering the contract.

In most cases, ophthalmologists will find their insurance policies do not cover the unlimited liabilities that can be assumed by the physician under a contract containing a hold harmless clause. Hold harmless clauses and similar indemnification provisions have been recognized as efforts to duplicate and supplement the protection traditionally afforded by insurance policies. What most insured parties may not realize is that these clauses effectively require their insurance companies to assume the larger and unknown risks of other health care providers, including hospitals and HMOs. Insurance companies know that such entities generally are equipped to insure themselves or to purchase separate coverage for their liabilities, and conclude that it makes poor economic sense to widen their exposure when coverage is readily and appropriately available elsewhere.

Eliminate or Modify Clause

Because this article merely summarizes the law in this area and does not purport to offer legal advice, ophthalmologists should seek an attorney’s assistance in reviewing contracts and in preparing, if necessary, a proposed standard clause or other language to help reduce the risk of exposure.

Often, the ophthalmologist is in an unequal bargaining position with respect to the other provider, particularly when the physician is requesting use of the provider’s facilities or seeking to join a provider network (as where a physician contracts with a hospital or an HMO). Where possible, however, the physician should try to convince the other party to permit a reasonable and equitable clause to replace the far-reaching provisions in some hold harmless clauses. Modifying key phrases in the indemnification provisions is essential to limiting liability. Clause language that is broad and general creates the most difficulties because it offers the most room for adverse interpretation; careful detailing is the way to go.

If some form of indemnification clause must remain in the contract, the following rules and suggestions for modifying the clause may minimize physician liability:

Use Restrictive, Specific Language

• If possible, limit the application of the clause only to the physician’s own negligence.
• Insist that the other entity indemnify for its negligence in return because each party is best able to control its own risks.
• If a clause includes a provision for liability for willful acts or omissions by the physician, modify the clause to include only wrongful acts or omissions so that rightful acts or omissions do not burden the physician.

Obtain Other Insurance Policies

• Require both parties to the contract to obtain and maintain separate, appropriate insurance policies, and to show evidence of such coverage prior to the contract being signed.
• In cases of a mutual hold harmless clause, each party should attempt to obtain insurance naming both parties and protecting each from claims of bodily injury, death or property damage arising from the activities of the physician or other party, or their respective agents, servants or employees, associated with the contract.

Notes:

1. Potamkin L, Plotka NL. Indemnification against tort liability-the “Hold Harmless” clause-its interpretation and effect upon insurance. 92 U Pa L Rev 347. 1944:365-69.
2. Beecher NB, Richardson CH. The harm in hold harmless clauses. 19 Colo Law 1081. 1990.