Your Duty to Warn and Inform
This OLA-sponsored guide addresses what you need to know to protect yourself, your practice, and your patients.
By Alex Yoho, ABOM

Are you unclear about the term "Duty to Warn"? In reality, it boils down to whatever a jury/judge thinks it is, but
a reasonable definition would be:

Duty to Warn is an obligation or responsibility to provide notice of a known hazard to any person who may come into contact with it. A product manufacturer or any seller has a duty to warn buyers (by warning labels, special instructions, etc.) if the manufacturer knows (or should have known) of an unsafe condition either inherent in the product or which may arise through foreseeable uses of the product, and to advise users of any precautions they should take.

To discuss how this affects you and your practice, we've sought the advice of two experts on the subject. Pamela Miller, OD, FAAO, JD, maintains a solo optometric practice in Highland, Calif., and was invaluable in developing the OLA Duty to Warn package that is currently under revision. Our second expert, Daniel Torgersen, is with Walman Optical and is also technical director for the Optical Laboratories Association (OLA) and vice chairman of the committee to revise the ANSI Z87.1 standard for safety lenses.

Q. What brought about optical's interest in the duty to warn?

Torgersen: It was prompted by a 1987 case where a rancher, who had been wearing glass lenses that broke, was injured and sued the optometrist. Back then, polycarbonate wasn't widely known, and there were no photochromics, the feature the farmer particularly wanted, in poly. It was determined that the practitioner was responsible for providing information on product options.

In response, the OLA, working with Dr. Miller and Joe Bruneni, developed the Duty to Warn kit, which is now distributed by OLA laboratories. Though the OLA and its labs do not have a responsibility in this area, the program was developed as a service to help practitioners provide the correct information to patients.

Q. We think about duty to warn in reference to kids and sports, but are there areas practitioners are neglecting?

Dr. Miller: Under the duty to warn, you have an obligation to try to meet the patient's needs. Problems occur because one Rx can't fit all needs. We typically only think of children as having these needs, but it's true of people of all ages. And, what you have to look at is the patient's needs, not his or her ability to pay--that's irrelevant, and your job is to lay it all out.

One area that we tend to overlook is contact lens patients. This is a serious problem because those contact lens patients still have vision care needs when it comes to sports, safety, and sun protection. In addition, they may be wearing over corrections for computer or near vision needs.

We also sometimes forget that older patients may be very active. They may be active playing golf, which is fairly high risk, or they may be in a care facility, where they're more prone to falling down, and that certainly has the potential for harm. So, we have that segment of the population.

Q. With the advent of Trivex by PPG, will the duty to warn change?

Where you start running into problems is in the areas where you don't do inquiries or don't do them correctly. When it comes to athletics, for example, don't just ask if they are involved in sports, but also be sure to determine in what sports they are involved.

And, when it comes to computers, ask how many hours a day they spend on it. You can gather this information on a patient questionnaire or you can do it verbally, and then transcribe it onto the record sheet.

Torgersen: When the original program was developed, it identified polycarbonate as the lens material of choice since it was far and away the most impact resistant lens material available. A couple of years ago, Trivex was developed by PPG. When testing showed the material to possess exceptional impact resistance, the OLA determined that rather than recommend particular lens materials, it would be more appropriate to identify a test protocol which would qualify a material as a high impact material.

The test chosen is the one embodied in the ballistic test for high impact resistance materials that is in the draft for the new ANSI Z87.1, which is tentatively slated to be finalized around July 2003. You can't reference a test that doesn't have any public availability, so the Duty to Warn program changes have been put on hold until the Z87.1 draft edition has been finally ratified, publicized, and distributed.

Q. So, how will the OLA package change?

Torgersen: It has most of the same elements as the original Duty to Warn program, except, rather than identifying a material by name--whether it's poly, or Trivex, or XYZ material--it says that if there is a need because of the usage of the eyewear to provide exceptional impact resistance, you should select a material that passes this particular test.

The practitioner would then tell the patient that the current two materials that pass this test are Trivex and polycarbonate. Though the materials recommended may change from time to time, the package will not need to mention the name of any particular material. It just references the test that qualifies the material to be classified as high impact resistant.

So, rather than attempting to rank them as one being better than the other, it will simply explain that a high impact material is one that passes this test.

Dr. Miller: Yes, practitioners need to understand that, though everyone along the chain can get sued, some entities will be dropped from a suit if they are not legally responsible for damages suffered. For example, a lab might be included in a lawsuit because, of course, the perception is that the lab has the money, which is not true.

As long as they made the eyewear correctly, they won't be held liable. In other words, when you're talking about a duty to warn, you're looking more at the dispenser, doctor, or optician who is in direct patient contact.

Q. Do we need to document, or if we give patients the information, is that enough?

Torgersen: The responsibility is to inform, and the warning is simply included in the information. Once the patient has been informed, the practitioner's duty has been fulfilled.

Documentation is the whole thing. Courts have typically held that if it isn't written, it isn't done. So you have to document it, and the fundamental premise is that you have to provide information to enable the user--your patient--to make an informed decision.

Whether you call it a warning or informational piece, the requirement is that you provide the information, you document that you gave it to them, and you document that they made a selection. They are free to use any material they want, but they need to do that on an informed-consent basis.

Q. How do different practices handle it?

Torgersen: Some of the practices we work with are religious in their application and documentation of this type of program.

On the opposite end, there are practices that do nothing. And, unfortunately, what will spur people on in these
practices is the same thing that spurred people to action on the first go-round--someone will be involved in litigation, and it will be publicized that there was a large award by the jury to some plaintiff.

Dr. Miller: The challenge for a high-volume practice is that there is often
little time to get to know your patients and develop life-long relationships with them, so you can lose the time to follow duty-to-warn practices, too.

There are things that you can do, however. For example, use signage such as what the Polycarbonate Lens Council has made available that says, "We recommend the use of polycarbonate lenses." Also, have information--things like the OLA's Lens Menu and perhaps a small sports or safety display--out where patients can see them.

Q. When you come right down to it, isn't the duty to warn and inform a lot like lifestyle dispensing?

Torgersen: The only difference between lifestyle dispensing and duty to warn or inform is the documentation that the practitioner keeps. Otherwise, it's the same thing--an assessment of how you're going to use this eyewear and the activities both recreational and vocational you're involved in, and then making a recommendation based upon that information.

If you're working with a grandmother who's main activity is knitting, there's probably no reason to recommend anything but CR 39. But if you have a young, athletic person who should have several pair of glasses for various activities--and they refuse saying "I can only afford one pair"--then you better recommend they use polycarbonate or Trivex lenses in a good frame to afford themselves some additional protection.

Dr. Miller: You have to make a decision somewhere along the line about how you're going to live your life. What is the right thing to do? How would you like to be treated? To me that's the bottom line. Whether you're an ophthalmologist, an optometrist, or a dispensing optician, it doesn't make any difference. You care about people, and that's what the duty to warn is talking about. It's not that I'm going to stay out of litigation; it's that I care about my patient.

Perhaps the duty to warn should be called the "I care about my patient package." But whatever you call it,
just don't forget to write down what you told the patient.