NEW YORK (GenomeWeb) – The first empirical analysis of genetics-related lawsuits showed that despite the rapid growth of the genetic testing industry in recent years, there has been only modest growth in these types of cases. However, industry trends suggest this may not remain the case for long.
Gary Marchant, a law professor at Arizona State University, and Rachel Lindor, a physician and researcher at the Mayo Clinic, scoured the online legal database Westlaw for cases involving genetics issues and found that counter to their expectation, as of the end of 2016, there hadn’t been an explosion in such lawsuits. In a paper published in the Food and Drug Law Journal earlier this year, Marchant and Lindor reported that from 1977 to 2005, there were never more than seven cases decided per year. In nine out of the last dozen years, there were eight or more cases decided annually, but never more than 12 cases.
Out of the 202 lawsuits included in the study, 41 were settled. The plaintiffs won 32 final judgments and 48 interim rulings, while the defendants won 75 final judgments and five interim rulings, coming out to a 50/50 chance of success for either side. However, when the researchers combined the settlements and the rulings, the plaintiffs had a favorable outcome 60 percent of the time. Moreover, based on the cases included in this study, genomic malpractice payments averaged around $5.3 million compared to the $592,283 average payout for medical malpractice cases generally.
Marchant and Lindor's study is notable given the rapid growth of the genetic testing field and the relative dearth of empirical research about the liability risks associated with the implementation of genomic medicine. According to one estimate, 74,000 genetic tests are commercially available today and 14 new tests enter the market daily. Still, it's early days in terms of integrating genomics into everyday medical practice. And because the standards and policies by which doctors, labs, and other stakeholders offer testing, interpret results, and communicate findings to patients and families are still evolving, it opens the door for error and litigation.
"Litigation is becoming a key mechanism for how we deal with risk with a lot of these newer technologies," said Marchant, who is discussing the findings of his study at the Society for Risk Analysis' annual meeting today. "There aren't standards, guidelines, legislation, or regulation for a lot of the new, emerging technologies, so increasingly litigation is being used as a risk management system. That has a lot of pros and cons."
Marchant recently talked with GenomeWeb about these issues and the potential implications of the trends uncovered by this study. Below is an edited transcript of the interview.
You write in the Food and Drug Law Journal piece that the threat of medical malpractice can be a double-edged sword — it can nudge doctors toward adopting best practices and technologies, but it can push them into practicing medicine defensively to avoid lawsuits. Does your research indicate that the greater use of genetic testing in medicine is having either impact?
Not really. What our research shows is that there is much less litigation than we expected. There are a lot of red flags that had us anticipating there'd be a major increase in the amount of litigation being brought. Frankly, if I had to predict ahead of time, I would have said there is an order of magnitude increase in litigation.
In fact, we saw a modest increase, maybe a doubling. Because of the relatively low level of litigation being brought, there isn't a lot of fear, [and] it's not having the effect of pressuring doctors to adopt best practices or causing defensive management.
Going into this research you thought you would see a spike in litigation, but at this point it hasn't materialized. What factors do you attribute to this?
We definitely see an increase, but it's pretty modest and much lower than we expected. The number one factor that we think explains this is plaintiffs' lawyers' decision-making process. We had a couple of workshops where we had plaintiffs' lawyers and medical malpractice defense lawyers in the room talking about these types of cases, and the factor that really shot through to us is that the issues in these cases are complex, involving a new type of science, genetics, which many of these lawyers have not dealt with before. The standard of care is also often unclear in many of these cases.
This is a deterrent to plaintiffs' lawyers investing their own money in bringing many of these cases, because as you know, in most medical malpractice cases, it's the plaintiff's lawyer who is working under a contingency fee arrangement and have to invest their own cash to litigating the case and hiring the experts. They are really taking a gamble, and it's really their decision as to whether to go forward with a case or not. What we've heard from them is that they think this is too complicated for them at this point, they don't have the expertise, and standard of care is not clear enough that they think they can win most of these cases.
Let's get into the empirical study. Based on the 202 genetic testing-related cases you looked at, each side seems to have 50/50 chance of success. But when you combined the cases that were settled and litigated, the plaintiffs had a favorable outcome 60 percent of the time. And the payouts to plaintiffs were significantly higher compared to what's awarded in cases dealing with other areas of medical practice. What long-term impact could these trends have on the plaintiff's bar?
That was a surprising finding of ours that both the likelihood of success was anywhere from threefold to tenfold higher, and the amounts they're getting in terms of the litigated cases are 20 times more than the average amounts paid in standard medical malpractice cases. That might partially be an artifact of plaintiff's lawyers not taking most of these cases and taking only the more lucrative cases. We're getting a selection effect in terms of the cases lawyers are choosing.
But I still think the reality is these types of cases do often involve more fundamental health status of people, where their genetic condition is life threatening. Then, they may in fact be more lucrative cases. These findings may entice more plaintiff's lawyers to say, "Maybe we should get into this game more [because] at least the cases that have been brought so far do pay off."
Certainly, there are a lot of cases out there that aren't being brought. If you look at BRCA testing, only 50 percent of women who meet the criteria for testing were told by their doctors to get tested. So, the other half who meet criteria and didn't get tested, but then go on to develop breast or ovarian cancer, they have an easy medical malpractice case. Same with cystic fibrosis. If doctors are not recommending parents get carrier testing for cystic fibrosis, and they have a baby with this disease, that would be a pretty open and shut easy case. When you look at the statistics, you sort of say, "If I was a plaintiff's lawyer, I'd be looking more at these in the future."
Products like tobacco, fen-phen, and silicone breast implants led to lots of lawsuits, and as a result deterred use of these products. If there is a significant increase in genetic testing-related lawsuits in the future, what do you think the impact will be on genomic medicine?
Litigations follow an exponential growth curve. Again, because plaintiffs' lawyers have to invest a lot of money in getting experts and building cases, they tend to go very slow at first. But once plaintiffs' lawyers are successful, then a lot of other lawyers will jump on the bandwagon. We may still see that in the genomic medicine area. We're still very early in the practice of genomic medicine. It's rolled out a lot slower than people had anticipated. So, we may see that bandwagon effect still in the future.
If it does occur, we'll have both the positive and negative. On the one hand, it'll put a lot more pressure on doctors, many of whom aren't using genomic information properly or at all, to be more advanced in how they use genomic information in their practice. On the other hand, it could really drive a lot of defensive medicine and doctors being reluctant to go into certain areas of medicine if there is such a high liability burden on them. There really is this potential for the good and the bad if there is an exponential increase in litigation.
You point out that for genomic medicine to happen a lot of different stakeholders need to be involved — the doctor, genetics expert, hospitals, drugmakers, testing labs, genetic counselors, and even insurance companies. All these entities could impact the standard of care and be liable for harming the patient. Has your research shown that at this point litigation is being brought against stakeholders other than physicians?
We are seeing a more diverse set of people being sued. Initially, most of the cases were just brought against physicians and hospitals. But more recently, there have been cases against genetic counselors, against testing labs, and there have even been a few cases against nurses. There have been lawsuits against multiple doctors, for example, a specialist and the general practitioner. The standard practice is to sue everybody you can, and in a lot of these recent cases, you'll see long lists of people in terms of who is being sued.
Historically, litigation involving genetics were usually wrongful birth or wrongful life cases in the prenatal area. But your research revealed that plaintiffs are bringing different kinds of claims in their lawsuits. What are some of the other types of lawsuits you're seeing, and what types of errors do they involve?
A real clear observation from our study is that we're not only seeing a modest increase in the total number of cases, but a much greater diversity of cases being brought. Up until about a decade ago, almost every case was a prenatal case involving an ObGyn and a question of what do you tell a patient to get tested for for their fetus. But now we're suddenly seeing an increase in these other kinds of cases, such as the [disease] susceptibility cases, such as the ones involving BRCA genetic testing, where the person is at risk for a disease and the physician fails to recommend testing. We're starting to see pharmacogenetic cases, where the plaintiff has a gene variant that affects the metabolism of a drug, and the doctor fails to take that into account in prescribing that drug or the dose of a drug. We're starting to see cases where the patient has a genetic disease and has symptoms that the doctor fails to diagnose.
Other than failure to diagnose-type errors, I noticed you tracked an increasing number of lawsuits involving test interpretation errors, for example.
A lot of the lab tests are more complicated as testing moves from diagnosing things like Down syndrome to assessing metabolic syndromes and disease predisposition, which involve many different variants. So, the lab reports coming back are more difficult for doctors, particularly those without genetic specialty training, to understand and interpret, and that's introducing a new source of liability. And then, there are cases where doctors sort of mess up, forgetting to return a result sometimes or give the wrong results to the patient or family.
We can divide these into two categories — the simple error-type of case versus the cases where the jury is second guessing the doctor's professional judgment. The first category is clearly errors that should be brought as lawsuits, because the lab or doctor messed up. But the second category, where the jury is second guessing the doctor's judgement with the benefit of hindsight, is something doctors would be worried about and think is unfair.
Cases involving a physician's duty to warn an individual's relatives that they might have a genetic risk factor for a disease are coming up more. Other types of cases that are coming up more and are unique to genomic medicine are those involving incidental findings from genomic testing and statute of limitations. Have you seen any trends in terms of how juries and judges are deciding these novel claims, either in favor of the plaintiff or defendant?
There's not a clear trend, but these are the more complex and newer types of cases. I'm part of another NIH-funded project being led by Vanderbilt University and the University of Minnesota, called the LawSeq Project, where we're looking at the new [legal] issues that are coming up as we move from simple genetics to genomics.
In our [recently published] study, we started to see cases like duty to relatives, how far does that extend and when does it extend to relatives. These types of cases were vanquished when HIPAA was enacted, but now plaintiffs are finding novel ways of bringing cases involving duty to warn other family members. That is unique in genetics, in that genetics is shared among families.
And then, in the case in South Carolina [Williams v Quest/Athena], you're starting to bring up the issue of the duty to revisit test results, which I think is a major issue courts are going to have to deal with in the future. Genetic testing is unique in that the implications of the test results will change over time, because as we get new information those results will be reinterpreted over time. That really raises a unique and novel issue for physicians and labs as to what duty they have to revisit those results.
You mentioned hindsight bias as a factor for juries in deciding genetic testing-related cases. Your research suggests that, on average, it takes around seven years to resolve a genomic malpractice case compared to 3.5 years for other medical malpractice cases. Moreover, because of how long it takes plaintiffs to often realize that they have been injured and may have a cause for litigation, won't hindsight bias be a major issue in genomic medicine?
Hindsight bias has always been a problem in litigation, but because of the time dimension here, [the impact] could be a lot more serious. One of our findings was that the average time to resolving one of these genetic malpractice cases was about twice as long as a regular malpractice case. Usually, in most medical malpractice cases, you can see the problems associated with a doctor's error fairly quickly. But with a genetic issue that the doctor failed to diagnose or detect, [it] could take five or ten years, or even another generation, before you discover the mistake was made.
From one perspective, it's unfair to the plaintiff to be deprived of the right to bring a lawsuit for a mistake they had no way of discovering before the statute of limitations or repose ran out. On the other hand, it's also unfair to the doctors to go back 10 or 20 years and say, "What you did back then was not the standard of care," given hindsight bias and not having clear memories or records of that case. It does present a dilemma with potential unfairness to both doctors and plaintiffs.
Is there anything else about the implications of your research that you wanted to highlight?
I think the big question is whether these types of cases will continue to increase. The fact that there is such a lag in these cases and the fact that genomic medicine is just kicking in now, suggests that while we may not see a major increase in lawsuits yet, it may be coming in the future. It may be some reassurance for doctors now that there hasn't been a huge increase, but if plaintiffs' lawyers start to have some success with these types of cases, I wouldn't bet on it staying this way for the long term.