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The Greatest Malpractice Threat of Our Time

Podcast Summary: Victor Cotton MD, JD discusses why genetic testing for hereditary cancers is the greatest malpractice threat of our time. Patients who harbor pathogenic mutations are at very high risk of developing cancer, often at a young age. Unfortunately, despite screening recommendations from numerous professional organizations, the vast majority of these patients have not been tested or identified.

Podcast Transcript

Podcast Subject: The Greatest Malpractice Threat of Our Time

Speaker: Victor R. Cotton, MD, JD

Welcome to the Law & Medicine Podcast. Today’s topic is the greatest malpractice threat of our time.

I recognize that you might be little skeptical about this topic because medical-legal experts are constantly talking about malpractice threats, and none of what they say ever comes to pass. They predicted that thousands of patients would file lawsuits for HIPAA violations, even though HIPAA does not permit patients to file lawsuits. They said that never events would lead to an onslaught of litigation, and I haven’t heard of a single case. And, they said that drug recalls would result in tens of thousands of malpractice lawsuits, even though a prescribing physician cannot be held responsible for a defective drug. So, I understand if you’re skeptical about this topic, but I believe that my concern is valid and when you see the numbers I think you’ll agree.

I’ve written several articles about this topic, the most recent of which was published in February in Medical Economics. And, the area I’m referring to is genetic testing for hereditary cancer.

If we look at just the BRCA gene, the deleterious, cancer causing gene that Angelina Jolie inherited, we know that approximately 1/400 women possess a pathogenic BRCA mutation. In the United States, that equates to about 500,000 women. Each of those women faces a lifetime risk of breast cancer of up to 85% and a risk of ovarian cancer of up to 60%.

Because of the near certainly that these patients will develop cancer, numerous entities, including the the American College of Obstetrics and Gynecology and the US Preventive Services Task Force have issued guidelines recommending that we identify these women. And the process is very simple. All we have to do is take the patient’s family history. And, if it’s positive for certain patterns of cancer, we should recommend that she undergo genetic testing.

And, if the patient tests positive for a pathogenic mutation, she has a number of medical and surgical options for reducing her cancer risk. In terms of impacting these patient’s lives in a positive way, this is enormously beneficial. We’re able to prevent cancers that are almost certain to occur.

So, what’s the malpractice concern? Well, the guidelines and recommendations, which are not at all controversial, have been out for almost 10 years, and we’ve tested only about 15% of patients who meet criteria. Most patients who meet criteria and should be tested have not been tested. And, as a result, most of the women who harbor a pathogenic mutation have not been identified.

To make matters worse, these patients are in everybody’s office. If you do the math, the average family physician has 4 BRCA positive women and the average OB/GYN has 12 BRCA positive patients. And, that’s just BRCA. If we add in Lynch Syndrome, which is a form of hereditary colon and uterine cancer, the numbers more than double because Lynch Syndrome is not only more common, it has a significant impact on both men and women.

So, the concern here is that these patients are in our offices, they have genetic mutations which put them at very high risk of cancer, cancer from which many of them will die, often at a young age, there are multiple guidelines saying that we should identify these people by taking a family history, but we’ve been slow to do so and most patients have not been identified.

And, as you might imagine, the legal cases have started to appear. And, not coincidentally, they all have the same fact pattern: Fact 1 is the patient met criteria for testing based on her family history. Fact 2 is We failed to appreciate this either because we hadn’t taken her family history in many years or we tood it and didn’t recognize the significant, and as a result, we didn’t recommend testing. Fact 3 is the patient is BRCA positive and doesn’t know it. And, fact 4 is she’s now dying of cancer and her oncologist found that she’s BRCA positive.

In my opinion, the only viable defense to that type of lawsuit is to show that genetic testing was, indeed, recommended, but the patient declined to have the test, or couldn’t afford to have the test. If you can show either of those things, then I think you win, but otherwise, you probably lose. And, losing is very expensive because these cases often involve young people who are dying of preventable cancers.

If we do the math, there are about 500,000 women who have a pathogenic BRCA mutation, a million patients who have Lynch Syndrome and if we don’t get ahead of this, most of them will eventually develop cancer. The pent up liability here could easily break the insurance industry many times over. It’s tens of thousands of indefensible, multimillion dollar lawsuits.

I’ve been in the medical legal field for over 20 years, and this is the greatest malpractice threat I’ve ever seen. Fortunately, it is also the most readily solvable. All it requires is for us to take a family history, recommend genetic testing to those patients who meet criteria, and document our efforts.

Thanks for listening to me today.

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