Shook Partner Adrienne Byard and Shook alum Alyse Zadalis discuss the effects of litigation targeting women's health medications and medical devices.
Mass tort litigation often targets beneficial medicines and medical devices. When gender-specific, far more lawsuits take aim at women’s health products.
This is easy to see when you look at the millions of dollars invested into lawsuit advertising to amass swaths of potential plaintiffs. This pattern goes back decades. In fact, it’s difficult to find a women’s health product that has not been targeted by this type of mass tort litigation.
I’m Adrienne Byard, a partner at Shook, Hardy & Bacon.
And I’m Alyse Zadalis, an associate at Shook. We are a 130-year-old premiere trial firm with 13 offices across the country and in London. We are speaking to you today from Kansas City, Missouri.
For the next few minutes, Alyse and I are going to discuss some of the overarching legal issues that manufacturers of women’s health, medicines and medical devices face and Shook’s role as an industry leader in defending women’s health litigation.
Adrienne, you’ve spent your entire career working on litigation involving allegations against women’s health medications and medical devices. What are some of the factors that show that women’s health products are, in fact, targeted more frequently for litigation as opposed to others?
We look at what’s called multidistrict litigation, which are consolidated federal court proceedings, slightly different than class actions. Looking at that data, we see that four of five of the largest MDLs—multidistrict litigations—in the court system today focus on women’s health products. We think that by virtue of the fact that women have more interaction with the healthcare system than men. We know that women are spending about a third more on healthcare than men. This a good thing in that it suggests we’re doing more to support our health, but we also think that it’s probably a consequence of the desire to support a healthy pregnancy, and by the same token, efforts to avoid an unplanned pregnancy. The bottom line, though, is that there is a lot of money in women’s health.
Right. Like you said, women’s health litigation is a lucrative business for the plaintiff’s bar—and I say “business” intentionally. We all know that these litigations don’t grow organically. There are many layers and different types of specialized law firms within the plaintiff’s bar that each do their part to grow the number of plaintiffs.
That starts with these lead generation firms that specialize in using marketing and advertising tactics to amass a portfolio of potential plaintiffs. They don’t litigate these cases. Instead, they package them as leads and sell these leads to the plaintiff’s firms that do the actual litigation. We see this reflected in litigation advertising, too. I know, for example, that these lawsuits are more heavily advertised on daytime television, when women are statistically more likely to be at home.
Turning from this, though, Adrienne, how is science play a role in these litigations?
That’s a really, really important question, Alyse. We start with the proposition that a lawsuit is only as valuable as the damages. Most of these matters are handled by plaintiff’s lawyers on a contingency fee basis, so there’s an incentive by the lawyer to make sure that the client’s costs are increased, that the client’s calculation of damages is greater.
There is business, then, in phony science. The medical treatment is important, but the diagnosis is also important to the entrepreneurial plaintiff’s lawyer. We see, when we look back at the history of women’s health, serial episodes of mass screening of women for alleged injuries that may not have even been causally connected to the medicine or the device.
Even if there were a relationship between this alleged injury and the medicine or the device, we see plaintiffs diagnosed with that injury—by doctors complicit in these programs—who didn’t actually have that problem. We hear about women diagnosed with a heart valve defect based on these phony mass screenings, being told that they have a problem with their heart. We saw women diagnosed with silicone breast disease when the science that was allowed to proceed outside of the courtroom slowly, eventually, disproved the existence of that condition, period. So women were undergoing unnecessary screenings, women were being told that they had a diagnosis that they may not have, and potentially treated in ways that were actually more damaging to their health than the medicine that they were taking or the medical device that they had in place.
Part of the problem here is that from the plaintiff’s lawyer’s valuation of the case, a case where a product is still in place, for a medical device, is worth much less than a case where the product has been removed or taken out. The same thing is true for a woman taking the medicine still, versus not taking the medicine. So there’s an incentive to have that product taken out or have that women discontinue the medicine. Historically, in these types of lawsuits, the science may catch up to demonstrate that the drug or device did not even actually cause the harmful effect that was alleged.
This is all really interesting, because the public messaging from these plaintiff’s law firms is that they are the defenders of women—they are the defenders of women’s health. But when you kind of pull the curtain back a little bit, you actually see that the firms are the ones driving up the damages, and they’re the ones who are generating these costs, all to fill their own pockets. And this is just one of many tactics that these law firms use to promote and drive these lawsuits. But what is the overall effect, Adrienne, on women and the healthcare space that’s devoted to women?
Alyse, that’s a very good question. The publicity surrounding the fear for the lawsuits can oftentimes cause more, greater harm than the alleged risk at issue. We see women who have refused to take a medication or stopped taking it without consulting a doctor. In [pelvic mesh litigation], plaintiff’s lawyers were providing women with lists of doctors that they should go and see to have the device removed when the doctor that they had consulted with and cared with over the course of their reproductive life was not making that recommendation to them. So the litigation can result in harmful effects to the individual woman, but on a more macroscopic level, the litigation can drive out products that are beneficial. Those products can be removed from the marketplace; there can no longer be a business incentive to continue marketing the product based on the public reaction to the litigation. In the end, women’s access to medication and devices is reduced. There are certain indications and spaces where there are few or no options for certain conditions today in large part because of lawsuits.
And what is Shook’s role in the women’s health litigation space, Adrienne?
For over 60 years, we’ve been litigating in the women’s health space. Nearly half of our firm is made up of female attorneys—and not just female attorneys, but female litigators. Shook has at its disposal a powerhouse of what I like to call the “next gen” trial lawyers—these are largely diverse lawyers and women.
In the history of our firm we defended over 40 women’s health products, so we see this repetition in the tactics and the themes. We also have over 120 full-time science and research analysts: PhDs and nurses that partner with us to understand where the science really is—and where the science is being propounded by the other side is phony—and helping us really understand the story of the moment where the woman and the doctor choose together to make a good choice for her health.
We also do a lot in the space of risk assessment, public policy and regulatory counseling. We’re helping marshal businesses from the idea to the marketplace, potentially to the acquisition of a new product, to that merger or that transition, and telling them how things can look on the front end of those decisions that will help with the almost inevitable eventuality in the women’s health space that you will be sued. We’re also trying to reform these laws and better inform the public perception of what the true impact—the true public health costs—are of these lawsuits through our public policy counseling, and then working closely with regulatory agencies and our clients to make sure that we have the protection from these federal programs that ought to exist for manufacturers who are trying to offer options for women.
We take that experience from the moment the business is looking at a product all the way through to the first lawsuits and trial. We have tried more than 150 cases to juries to verdict in the last five years, and we’ve first-chaired more than 50 lawsuits in the past three years. These are not small damages cases, as we’ve mentioned; these are cases where there is a lot at stake, not just for the individual lawsuit for the company but also for what future options remain available to women.
Thank you guys for so much for listening to today and learning about women’s health litigation for us. Thank you so much for the enlightening conversation, Alyse.
Thank you, Adrienne, this has been great.