Peter Mullenix, Esq
Not every patient wants to be fully informed about his or her medical options. For the rest of us, the problem is sifting through the vast amounts of information available to focus on what’s truly significant. Worse, state laws often don’t require doctors to tell patients things that every patient would want to know. For this reason, patient safety advocates around the country are working to improve state laws to require better disclosures for patients. But in the meantime, one of the projects I’m working on (with the Patient Safety Action Network) is to come up with a list of questions patients can ask to help protect themselves, even when the law won’t protect them. You don’t need great laws if you ask the right questions.
The list below is my own, not PSAN’s, and it’s developed from things I’ve learned in my legal practice representing patients injured by medical devices. In thinking about each of those cases, there are common issues that pop up: information that could have been delivered to my clients to give them a chance to avoid the devastating outcome that ultimately led them to my law office. So I’ve tried to put together a set of questions to ask any time a doctor proposes using a medical device on you or someone you love. These are the questions designed to force doctors to show you the red flags that could have saved my clients:
1. Do you mind if I record this conversation with my phone so I can have it to refer to when I do my research?
· Why? If a doctor knows their consent is being recorded, they will have more reason to more fully and fairly
disclose the risks of the procedure. And you won’t have to rely on your memory or your notes when you try to learn more on your own.
2. Has this device ever been subjected to human clinical trials? What information do you have about those
trials? Were they sponsored by the manufacturer?
· Why? The goal is to get the doctor to think about the true quality of the evidence the manufacturer’s sales reps have provided. Often, studies are simply sponsored by manufacturers, who cherry pick results. Or more often, there have never been human trials. Or there have been, but the quality is low because the trial was not prospective, randomized, double-blind, etc.
3. Is the way you want to use the device “off-label”? Are there any warnings or contraindications on the device
· Why? Doctors are not regulated by the FDA the way most of us think they are. Many believe they are free to ignore warnings and contraindications without even telling you.
4. Do you have any written information about this device? What about materials that do not come from the manufacturer?
· Why? One of the ways device manufacturers ease the burden on doctors is to provide the doctors with patient-facing materials. That way the doctors don’t have to go to the work of analyzing the product themselves. But this is obviously biased information.
5. What has been your personal experience with the device? Is there any sort of learning curve? What is the worst outcome you know of that one of your patients has had with the device? What doctor, other than yourself, do you consider to be most experienced in using this device?
· Why? The learning curve issue is real, particularly with devices used to perform surgeries. Doctors want to get over the learning curve, and they need willing patients to do that. But no law requires you to be the guinea pig. Find a doctor who has already made it through the learning curve, and let your doctor practice on someone else.
6. Has the device ever been recalled? Have you ever received a “Dear Doctor” letter related to the device? Have you checked with the hospital on these issues?
· Why? Recalls are far more common than most patients know. Moreover, manufacturers often send out “Dear Doctor” letters to surgeons rather than doing recalls. The problem is, the surgeons don’t always get or pay attention to these letters. Your goal is to force the doctor to both ask and pay attention.
7. What are the risks associated with this device, and do the benefits outweigh those risks? Why?
· Why? Most doctors will do this in abbreviated form. The key is to ask follow up questions and have them give you specific information about each possible alternative. The doctor already knows what he or she wants to use. But if the choice is obvious, the doctor should be able to articulate why to you.
8. What are the alternatives to using this device? How was this done before the device came on the market? Are there similar products from other manufacturers on the market? If so, why this specific device?
· Why? New does not always mean better. Often, newer devices will offer benefits that, in the grand scheme of things, really don’t matter that much. Worse, they will sometimes also bring new risks that the more traditional procedures/older devices help you avoid.
9. Do you expect to have any representatives from the manufacturer present during the procedure? If so, why is that?
· Why? This is another way to find out whether there is a learning curve. Often manufacturers have their sales reps present at surgeries when the doctor is new to the device. Or, they do it when the reps have a particularly strong relationship with the surgeon. That should also raise your eyebrows, because those relationships are often produced by small, repeated, favors, gifts, and sometimes even outright bribes. Sometimes the surgeon has a direct financial incentive to use the device. Sometimes the surgeon has been flown someplace sunny to “learn about the device” on the manufacturer’s dime. These relationships cloud the surgeon’s judgment, meaning you are not necessarily getting a fully objective view about what device is best for you.
10. Have you ever received any gifts or financial benefits from the company that makes this device? What is the name of that company?
· Why? Same as last question. And be particularly thorough on this issue, because the ways companies pamper and pay doctors can be extraordinarily varied. Companies spend an enormous amount of money to make the doctors like them, and they do it for one reason: it works. Then, once you’ve gotten your answer from the doctor, check to see how candid he or she has been by searching for him or her on https://openpaymentsdata.cms.gov/
11. Will you please record the procedure in which you use the device, and send the video to me?
· Why? A doctor who knows he or she is being recorded will be more careful. Plain and simple. I think doctors should be required to offer recordings to patients. But until they do, we should all ask. A doctor who refuses this request needs to explain why. (Imagine if your lawyer told you you were not allowed to watch opening statements or read deposition transcripts. Imagine if your contractor told you you could not be there while the work on your home was done.)
12. What is the cost of this device and will insurance cover it?
· Why? Most doctors do not think they are required to tell you this information if you don’t ask. But if you’ll end up paying thousands more, and there is little actual benefit, it pays to ask the question.
There is no doubt in my mind there are other questions to ask. Probably better ones. But this is a good start, until the laws catch up.