MEDICAL RISK ASSESSMENTS IN THE COVID-19 ERA: LESSONS FOR DRUG AND MEDICAL DEVICE DEFENDANTS

Originally published in Law360, June 12, 2020

As the COVID-19 pandemic drags on in the United States, there are potentially many changes in attitudes and behaviors that could take place in the American population. The experience of quarantine, economic uncertainty, and the unprecedented health risks all could contribute to unique changes in society.

One area in which a change might occur is in risk-taking attitudes and behaviors, especially in a medical context. Will people be more willing to take risks, given the desire to maintain somewhat of a normal lifestyle during the pandemic? Or, will the fear created by the dangers of the virus cause people to adopt a more conservative approach? The answers to these questions could be especially useful for defendants in pharmaceutical or medical device cases where jurors are asked to decide whether the use of a medicine or medical treatment was worth the risk.

We recently conducted a study in order to assess if attitudes are changing in the area of medical risk-taking. We compared our results from June 2020 to a similar study from 2011 to determine if these attitudes had changed since the COVID pandemic struck the United States.

Participants (N = 275) were recruited from Amazon’s Mechanical Turk and paid a small incentive to complete the survey. The sample was predominantly white (n = 214), ranged in age from 19 to 71 (average = 38), and included more men (n = 168) than women (n = 106). Most participants were employed full-time (n = 197) and were well-educated (241 had at least some college with 159 holding a four-year degree).

Participants completed a modified version of the Domain-Specific Risk-Taking Scale (DOSPERT). The DOSPERT scale measures participant reactions (on a 1 to 7 scale) to the perception of risk (not at all risky to extremely risky), perception of benefit to self (no benefits at all to great benefits) and likelihood to engage (extremely unlikely to extremely likely) in a wide range of activities. Participants were randomly assigned to provide their reactions to 2 of these 3 categories for all six items on the medical risk domain subscale1 which included the following activities: give blood, take allergy medication, donate a kidney, participate in a clinical trial, get a knee replacement, and receive general (instead of local) anesthesia. In addition, participants answered questions on two additional items: taking an experimental vaccine for COVID-19 and taking medication that treats a dangerous condition with the risk of a serious side effect.

The table below illustrates the changes in attitudes between 2011 and June 2020:

In all cases, people perceive the risk of medical behaviors as increasing. It is difficult to determine how much of the increased riskiness is attributable to COVID-19 since the control study is from 2011, but it is reasonable to assume that people are more concerned about engaging in activities in doctor’s offices or hospitals given the added risk of coming in contact with the virus. There are many other potential causes of this perception or risk, of course, but COVID-19 is likely one contributor.

The benefit of engaging in these activities was perceived as greater in the majority of the items. Additionally, for most of the activities where greater immediate benefit to the person engaged in the behavior was perceived, there is a greater likelihood that individuals will engage in the behavior. But when the benefit is not immediate (participating in clinical trials) or not beneficial for the person engaging in the activity (blood and kidney donations), there was no increase in the likelihood of engaging in the behavior.

The changes in attitudes in behaviors can be summarized in the following categories:

No change in willingness to engage in behavior: When risk is perceived as higher and benefit to self is lower (donate blood).

No change in willingness to engage in behavior: When risk is higher and the perceived benefit is long-term (clinical trials).

No change in willingness to engage in behavior: When risk is higher and no change in benefit to self (donate kidney).

Increased likelihood of engaging in behavior: When Increase in perceived benefit to self in the shorter term (allergy medicine, general anesthesia, knee replacement).

The last category is important because it suggests that people are willing to engage in activities that they see as riskier if they perceive a short-term benefit to themselves. They are willing to take chances, but not to simply help someone else; the risk-taker must benefit as well.

An important lesson here for attorneys defending drugs or medical devices is that the defendant is almost always going to start “behind” in the case since jurors perceive medical activities as more dangerous than they did in less than a decade ago. There likely will be a presumption at the start of trial that the drug or device is dangerous, which is a difficult hurdle for the defendant to overcome.

However, it is possible to overcome this hurdle if there is enough perception of short-term benefit. Even though the perception of risk is high, short-term benefits to the patient can help jurors overcome this hurdle and create a belief that if the juror was confronted with the choice about whether to take a drug or use a medical device they would engage in the treatment.

The danger of focusing too much on the second column of the table (perceived benefit) is that the hindsight bias can often turn a potentially positive view of a drug or device into one that is negative. Since the plaintiff in the case was seriously harmed by the drug or device it is easy for jurors to believe that in hindsight it really was not beneficial.

As a result, one consideration for trial strategy is to focus the jurors thoughts on the third column—would I have engaged in that behavior and more importantly, did the plaintiff have a choice to make and subsequently decide taking the drug or using the device was worth the risk? And, wasn’t that their choice to make? Directing the jury to the decision-making process and the right to make that choice could help minimize the singular focus on “benefit,” which can be wiped out by the negative outcome experienced by the plaintiff.

In addition to the comparative data gathered in both 2011 and 2020, we also asked two additional questions about medical risk-taking behavior that were not posed in 2011. Without historical data, we compared the responses to these questions to the 2020 responses regarding the other six attitudes and behaviors. The results of these comparisons can be seen the table below:

When compared to the six activities in the first table, the perceptions of risk in taking an experimental vaccine for COVID-19 and taking medication treating a dangerous condition with the risk of a serious side effect were quite high (and higher than the other categories, on average). People are very nervous about experimental vaccines (maybe because of the claims Bill Gates will implant a tracking chip when the vaccine is administered) and they are also very concerned about taking a medication that provides a treatment for a serious problem but has a risk of significant side effects.

The perceived benefit of these two activities was rated around the midpoint of the six activities. So, each activity was perceived as somewhat beneficial, but not tremendously helpful. The result of these two findings is not surprising: people are less likely to engage in these behaviors. People are more fixated on the risks of vaccines and treatments and the benefits are simply not great enough (or perceived to be great enough) to outweigh the perception of significant risks.

The implication for defendants in drug and device cases is significant. The risk of taking medications is perceived as high and the benefit is not being recognized. Given that the risk is seen as high for most medical activities, focusing on improving the perception of benefit is likely to have more success and will help push jurors to judge that receiving the treatment is both beneficial and something they would do if in a situation like the plaintiff.

It is important to continue monitoring these attitudes and behaviors as the COVID-19 pandemic continues to persist in the Unites States. Our plan is to redo parts of this survey next year to see if the attitude shifts continue to persist or become even more exaggerated if restrictions are reinstituted and the number of cases continues to grow. It will be useful to examine other domains as well to see how jurors’ attitudes are changing during this (hopefully) once-in-a-lifetime event.

1Butler, S. et al. (2012). A medical risk attitude subscale for DOSPERT. Judgment and Decision Making, 7, 189-195. Available at http://journal.sjdm.org/11/111228/jdm111228.pdf.