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I've captured and interrogated one of fertility doctors’ enemies…a lawyer.
But this one’s on your side.
Matthew Maruca has served as General Counsel for Inception Fertility since 2019, and he’s here to walk you through the legal threats and legislative currents shaping the future of fertility care.
While this episode isn’t legal advice, Matt brings insight into how reproductive health is being fought for, and fought against, in the courtroom and the legislature.
In this episode, Matt covers:
- What’s behind the rise in lawsuits and how they’re modeled after personal injury cases
- The emerging legislative strategies from think tanks like the Heritage Foundation
- Which reproductive treatments are being targeted (like PGT)
- How to draft your consent forms to reduce liability
- The #1 thing providers can do to protect themselves from unnecessary litigation
- How to keep your premiums down when litigation is on the rise.
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Matthew Maruca (00:03)
The increase in litigation from, there's groups of plaintiffs attorneys who have fixed their attention on the reproductive health space, IVF clinics in particular. I've been the Chief Legal Officer of Inception for over six years now coming on my seventh year. And the amount of litigation that we see and the folks that are willing to take a claim and run with it has increased quite a bit.
Griffin Jones (00:42)
Fertility doctors, I have captured and interrogated one of your sworn enemy, the lawyers. But you like them when they're on your side, don't you? Let me give the disclaimer that I don't know that I have to give, but I feel like I should give. Nothing in this episode is legal advice. Nothing establishes a client-attorney relationship with my guest, Matthew Maruca, who has served as general counsel for Inception Fertility since 2019. He also helps out with the Fertility Providers Alliance. So if you're looking to join a trade organization like that,
Google Fertility Providers Alliance or hit me up and I might be able to make an intro. If you want legal advice from Matt, if you want his cell phone number and just be able to buzz him anytime you have a question like his docs do, well then you got to go work for Inception, man. I don't know what to tell you. That's a benefit for working for those guys and gals, I guess. But Matt does give you free insights on two main categories. The first half of this episode is about the legislative landscape currently concerning reproductive health. The second half is about the rise in litigation against fertility providers and practices.
On the legislative front, Matt talks about emerging doctrine from think tanks like the Heritage Foundation that's starting to give a united front to bills being introduced. Stiff restrictions on things like PGT, embryo creation and storage, and imposes onerous reporting requirements. How Alabama is actually one of the most favorable states for ART right now. Who'da thunk.
On the litigation side, Matt shares how plaintiff's attorneys are pulling from the playbooks of the personal injury firms. Yes, the marketing tactics, the way they price that the plaintiff doesn't make any money unless they get lots of money out of you, all that kind of stuff. How practices can limit the claims they have to pay when suits are filed against them. The most important factor regarding consent forms, what individual providers can do to bring down their malpractice premiums, the number one thing providers can do to deter unnecessary lawsuits, you might find it counterintuitive. Enjoy this free, non-legal, non-advice with Inception Chief Legal Officer Matt Maruca.
Griffin Jones (03:18)
Mr. Maruca, Matt, welcome to the Inside Reproductive Health podcast.
Matthew Maruca (03:22)
Thanks so much. Glad to be here.
Griffin Jones (03:24)
What are you most concerned about with regards to the legal landscape and the fertility world right now?
Matthew Maruca (03:32)
There's really two things from the last couple of years that have been evolving. The increase in litigation from, there's groups of plaintiffs attorneys who have fixed their attention on the reproductive health space, IVF clinics in particular. I've been the,
Chief Legal Officer of Inception for over six years now coming on my seventh year. And the amount of litigation that we see and the folks that are willing to take a claim and run with it has increased quite a bit.
So that's one major area for me. And then of course, as an industry watching the evolution of the public policy space and the fact that in the post Roe
the Dobbs decision world and the intense focus in the political realm on IVF. That's taken up a big chunk of my time in the last couple of years. And those two things occupy a lot of my time at the moment.
Griffin Jones (04:33)
That second area, the post Roe area, that personhood or is there more to it than just personhood legislation?
Matthew Maruca (04:42)
Yeah, it's been very interesting. It's not a person who has a big part of it. There's a big push for that. What I'm seeing and what I, what I think a lot of my fellow general counsel's chief legal officers are, are, sort of seeing there's, there's been a, an evolution of the pro-life movement in trying to figure out how to be sort of both pro IVF, and pro-life at the same time. And.
I think what we've seen, especially since the Alabama court decision in 2024, that really brought this entire issue to the spotlight, especially in last year's presidential election and various other races, was that there's this uncomfortable space of being both pro-life and figuring out how to be
pro-IVF. And so what I think we're seeing is this evolution towards how they're going to live with, how the sort pro-life movement is going to live with a place where 80 % or so of the American public are in support of maintaining IVF sort of in the way it's currently practiced. And I think if we look at
the sort of things that happened in this year's state legislative sessions. We see this sort of percolating movement of sort of making incremental inroads into trying to figure out what sort of restrictions they can, that they can get sort of political traction with. And one of those things is personhood, as you mentioned, but we're also seeing, you know,
folks advocating for restrictions on the number of embryos that can be created, restrictions on the use of genetic testing, in particular PGT, which has also been something that's been, there's now a great deal of litigation around PGT to sort of tie it back to the other area of increased litigation across the industry. We're seeing proposals to impose
really onerous reporting requirements on IVF clinics. We haven't seen anything pass yet, but I know in Texas, for example, there was a bill that was proposed that would create an incredibly onerous system of reporting requirements about how many embryos are created, how many developed into blastocysts, what were the ultimate disposition of the blastocysts, what were the reasons given for
for the disc, if they were discarded or they weren't used for implantation, what were the reasons for that? And I think a lot of it ties back to some of the thought leaders in the sort pro-life movement, especially places like the Heritage Foundation, who have been beating this drum that IVF is somehow not regulated, this narrative that's just false about IVF creating this
you know, needlessly creating this huge number of embryos that ultimately get discarded. That PGT is there to, you know, to do trait selections and create, you know, you know, sort of Uber race of people. And, you know, a lot of it's not really accurate. Some of the principles that are being, you know, pushed are not really based on
sort of accurate information. And so what I've found is in working with groups like FPA, the Fertility Providers Alliance, which for folks who don't know is a coalition of IVF clinics and IVF networks that have come together to promote the protection of IVF. what we're finding is that countering some of that
those narratives around needlessly creating embryos and that PGT is creating a super race can really get folks to sort of see that these are not as acute concerns as are presented in some of the literature out there.
Griffin Jones (08:32)
So do you think, maybe the answer is both, is the implication that this dance of trying to marry pro-life and pro-IVF is introducing elements that further restrict IVF, like limits to PGT, like limits to creation of embryos and these onerous reporting requirements, or is it that, is the bigger implication that
they're writing laws that are really unclear and that it's going to take a case and then a review of that case and so forth to establish case law as to what these different laws might mean.
Matthew Maruca (09:11)
Yeah, interesting question. So, I mean, think if we, we strip it back, right, the, the, the, underlying, you know, goal is I think to limit the number of embryos that are destroyed ultimately, right? That are, that are not used in, in, for a transfer, that are never quote, you know, given a chance at life. And they use sort of inflammatory statements that they're these cryogenic.
nurseries, right, and deeming the embryos to be children, regardless of the sort of stage of development. And in terms of what we've seen from proposed legislation, they do range from things that are sort of somewhat unclear. There was a Texas law that was proposed that talked about that if an embryo was transplanted, the patient had to intend to bring it, to have it transferred. was just
you know, it was very unclear what they were really trying to get at with that legislation. there is a whole other, you know, there were quite a few bills that were proposed that really were sort of crystal clear, right? Whether they were personhood statutes, like we saw proposed in multiple states. There was some bills in Tennessee that were crystal clear. They only wanted to be able to create four embryos at a time. And they wanted to basically ban the use of PGT.
You know, the silver lining is that a lot of those, you know, very few, what I'll call anti-IVF legislative proposals got any traction really anywhere. And I think that the Trump administration with its executive order earlier this year that had directed his domestic policy council to come up with ways to expand access to IVF. I think it made it more politically difficult for folks that are
sort of within that aligned with that sort of pro-life movement to get the kind of political traction that they needed to pass these laws. But there were quite a few things that, you know, that were ultimately proposed that could have had, you know, significantly negative impacts on IVF. But, on the flip side, we look at places like Georgia and Tennessee where
laws were passed that clarified that IVF is legal and are now sort of enshrined in law in both those states that folks should have access to IVF. And those were passed with wide margins of bipartisan support. So there's an element that is sort of anti-IVF, but the real laws that were getting passed have been largely positive. And I think we're all sort of waiting with bated breath to see
what the Trump executive order is ultimately going to, is going to do. I've heard a lot of rumors about things that it might be doing. But I think, I don't really think anybody knows just yet what it's going to look like. And it seems like, you know, we should find out here relatively soon what that's, you know, what that's ultimately going to look like.
Griffin Jones (11:51)
take us through the nature of lawmaking doctrine. Is it the case that we're just gonna continue to see different types of laws being introduced by disparate groups in different areas? Or is there sort of orthodoxy that emerges from people like the Heritage Foundation that you mentioned that they sort of lay out what the doctrine is and then that gets adopted by various groups that
that fall into rank and file.
Matthew Maruca (12:20)
Yeah, that's great. Great question. I think it's the latter. What I saw this year was that the legislation that got proposed, that you could really tie it back to some of the public policy statements that came out from folks like Emma Waters at the Heritage Foundation. There's a handful of policy statements that they've issued. And you can draw, whether it's a direct line or dotted line, back to a lot of the policy statements there to a lot of the legislation.
that was getting proposed. you know, what I think we're going to see emerge and, I could be wrong about this, but, but if you look at, the opposition to Roe versus Wade, right, for, almost 50 years, we saw concerted efforts, to slowly erode the scope of, of, of, of, of access to abortion. And I could sort of see a similar, you know,
approach developing in the IVF realm where right now there's not the political capital to really restrict IVF or, mean, certainly nothing that would outright ban it. Even personhood statutes aren't necessarily fatal, right? We know that a state like Louisiana has had a basically juridical personhood statute for 40 years and IVF is practiced every day in the state of Louisiana. you know, I
I think there's a long fight ahead and I think we're going to see this periodically. There's people with very strongly held beliefs around what this means. And I think we're going to see them get more organized and start to use the think tanks and public grassroots support to try to...
know, make inroads to sort of slowly limit things that they find objectionable.
Griffin Jones (14:10)
Are there things that providers and practices should be doing now beyond advocacy? Dr. Srinivasan and Dr. Stephanie Gustin would be calling on people to join them in advocacy. I mean, even at a documentation level, before these laws are made, are there things that providers and practices should and can be doing to protect themselves or do they have to just wait?
to see whatever laws might be passed.
Matthew Maruca (14:41)
think in some ways you have to wait and see. You know, if there's, because there's, there's, there's so many different types of, of proposals out there. You know, something that might limit the number of embryos created. I mean, that's just gonna, you can't sort of get anticipate exactly how, I mean, you'll know what that the implication is if the law gets passed. But right now it would be not the proper way to practice medicine to start limiting.
the number of embryos that you're creating, right? And I really think that the most important thing that everyone in the industry can do is educate because some of the proposals and the policy statements are based on incorrect understanding of what we do. And really in a lot of ways, how what we do is mimicking in some ways natural processes, right? For example, this
this notion that a massive number of unused embryos are being created is, I think you can draw it back to this idea that somehow in natural reproduction, you have sex and you get fertilized once and that's it. There's one egg, one sperm, one embryo, one baby. And that math is not correct, right? I there's a reason why people say you need to try for six months, you need to try for a year.
And, you know, studies have shown that, you know, patients, there are embryos that are, there's eggs that are fertilized in multiple times in the, you know, in those attempts and they don't, they don't result in pregnancies. They don't, you know, for natural reasons. And that, you know, PGT in many ways is designed to help us select, right, to avoid miscarriages that would have otherwise happened naturally, whether the patient even knew that there was a miscarriage, right? If they're so.
you know, I think the stats were that, you know, for a 35 year old woman, that it's likely that, that, that if in there trying to per per create naturally, there's probably almost eight embryos that are created before there's a, there's a healthy child. And that would be just totally normal, natural, you know, reproduction. And when we have spoken to legislators about that fact, it's like a light bulb goes off. So, wait a minute. IVF is not this.
you know, Frankenstein monster thing where we're creating all these unnecessary, there's an attrition rate in the lab that mirrors the attrition rate in natural reproduction. And when you explain that to folks, they start to understand that, you know, what we're doing is not unnatural. It's, you know, it's still based on the same biological principles as natural reproduction. And so that starts to erode.
some of the basis for some of the objections to IVF. And so that's why I think education is really super important. And when I've worked with the FPA public policy team and we've spoken with legislators at the state level and at the federal level, the approach has been, hey, we wanna demystify some of the things that we do. We wanna explain what PGT is used for. It's used to avoid miscarriage. It's not used to select traits to have, you know,
to have these designer babies. It's to prevent the patient from having to undergo a emotionally and physically painful miscarriage. When we create embryos, it's not just for the heck of it. We're creating embryos because there's an attrition rate in the lab. And we need for us to have success rates and to make the IVF process, which is a difficult one, to make it as
I don't want to say easy, to limit the extent of the difficulties in IVF, we want to have the best tools available. And that means being able to create several embryos at a time and be able to do a PGT screening. And that's the best way to practice medicine that's in our patient's best interest. And so to stay really focused on how do we provide the best medical care? How do we help patients build families?
families that they want. And when you say to a legislator who might be inclined to, know, to, to think about these sort of restrictions, which in some ways on their face sound reasonable, right? Don't create a million number as you don't need say, actually do need, you know, several to make, to make one child and that, and nature does too. and that's, you know, that's that, that message I think really resonates and it makes, it, it takes the.
It takes some of the sort of emotion out of it and makes folks realize that what we're doing is in our patient's best interest. And it's fundamentally pro-life. We are out there to create the families that our patients want. And that message really resonates.
Griffin Jones (19:06)
And when you're working on all of this, you're not just working for Inception and Prelude in this context. mean, they're sort of lending you out. They're lending you out to Fertility Providers Alliance, or they're letting you go speak to legislators, that doesn't just benefit them. It benefits anybody who practices Fertility. What has that been like? What's the collaborative experience been like, both working for Inception and Prelude?
working with everybody outside of it.
Matthew Maruca (19:33)
Yeah, it's been great. think, you know, I'm proud, you know, as an industry, I think we've come together to advocate for our patients and for access to the highest quality care, right? The United States has the absolute best success rates from IVF anywhere in the world. And in many ways, that's because we have right now a relatively favorable regulatory environment that lets us practice at the highest level. you know, there's
Lots of reasonable restrictions. And obviously, um, if we make mistakes, there's a whole court system to keep us in check. And there's folks who've made their whole livelihoods out of keeping us in check. Um, but, um, but, but, but the public policy advocacy work and watching, you know, my, my, you know, colleagues from other networks, from other clinics come together through, you know, through places like FPA. I know ASRM has a, you know, a robust public policy arm.
work a lot with ASRM, work with Resolve. But as an industry, we brought together the voices from both the provider, the clinic, the patient experience, and to speak to legislators. it's been some of the more rewarding work I've done in my whole career, let alone at Inception. And we meet very regularly the sort of GCs and chief legal officers for the various networks and other clinics.
sit on the legislative affairs subcommittee for FPA. We share our notes. We talk about what we can do. I went on behalf of FPA to DC this year with the FACT coalition, which is an industry group of suppliers and like Cooper Surgical. And we met with legislators on the Hill and spoke on behalf of our...
of our industry groups. And I think when we speak as an industry and we speak on behalf of our patients, our voices are that much stronger. And so it's been really rewarding to be a part of that process and to see that it makes real world changes. FPA and other industry groups, SRM, Resolve, I think were very successful in the last year of.
promoting legislation that was protective of IVF and educating lawmakers about the potential harm of proposed legislation that could limit IVF.
Griffin Jones (21:48)
This is a philosophical question, so I might be taking you back to undergrad philosophy, or maybe lawyers think about this all the time, but can law anticipate technology in a way that is actually productive and proactive, or does the technology really need to manifest itself before realistic laws can be made? Because you're talking about, people are concerned about
designer babies being made. Well, it's not really happening with this. It's not happening with PGTA. But it could happen with CRISPR however many years down the road, right? is nobody's doing that now. is it, can it be productive for lawmakers to say we want to get ahead of this? Or do
Or do you, when that happens, they end up writing laws that are just completely asinine because they're not based in real world applications. And I could see erring on either side. You want to get ahead of nuclear energy. So, and all the bad things that could happen, you know, be made from weapons, et cetera, et cetera. But you don't really know how the technology is going to be used or the second and third order consequences that might be positive that you're eliminating. How do you think about that?
How should lawmakers think about that?
Matthew Maruca (23:14)
Yeah, that's a great question. I think there's some issues that are in tension with each other as you think about the... mean, the legislative process is inherently slow and deliberative and it takes a long time to get a bill passed. It may take multiple legislative sessions and technology is rapidly...
evolving and you don't want to create a regulatory environment that stifles the sort of innovation. So I think that if you look over the sort of the history of things, it's typically that the legislation lags behind the technology. And I think in some ways that's by design because we don't want to tie the hands of legislators. But I think of things like
restrictions on the use of stem cells and I haven't studied it, I do think in areas like that where there were some restrictions that did sort of get ahead of the technology. And I would be interested to know about how much scientists have felt like that may have tied their hands, but I think it's probably a benefit to the feature of our sort of legislative process of requiring
approval in multiple chambers and being beholden to constituents and that it is slow and thoughtful and it tends to lag a little bit behind innovation because we want a country that can be innovative. I think it's really hard for folks to have that kind of foresight to draft really careful legislation that's anticipating things.
that don't ultimately stifle innovation.
Griffin Jones (24:52)
Tell us about the increased litigation you've been seeing. Do you mean against practices and providers?
Matthew Maruca (24:58)
Yeah, against practices and providers. know, it certainly seems like a whole industry of plaintiffs' attorneys have sprung up around suing IVF providers. And I think we've seen patients become a bit more litigious over the last several years. You know, we've found patients that...
Um, think there's, um, expectations of, uh, know, of, of perfection, right? mean, we, work in an industry that, um, doesn't have perfect success rates, um, and managing expectations is difficult. Um, but yeah, but I, mean, I, I've definitely, you know, we've just seen, I think, uh, of, of an, an increase in litigation. was, I was looking at an interesting stat the other day that, um,
that Wall Street money has really poured into just plaintiffs' attorneys in general across the country, regardless of industry and the sort of personal injury space, and not just in MedMal, but slip and falls. And you can't drive down the highway without seeing a dozen billboards for accidents. And the litigation industry in this country is absolutely massive. And that's not just in the IVF
I think it's just a litigious society and there's a lot of vested interests in perpetuating the litigation process. And I think it's infected all manner of,
of industries, including IVF. And I think we just have a difficult spot for us because it's hard for a, you know, at the end of the day, it's a compelling case to jury to say, you know, I lost my chance at having a child. And there's been some jury verdicts out there that have set the bar high for what a lot of patients think are
the damages they should be awarded if there's an issue. And I think it's just made it more difficult in the last few years to manage that.
Griffin Jones (27:03)
How big of an increase and maybe you don't have hard numbers to know, but do you have any sort of sense like, like you said, even in the six, seven years since you've been head council at Inception, you've seen this, is it like a 10 % increase, 50 % increase? Do you have any way of being able to gauge how many more cases are being brought forth?
Matthew Maruca (27:25)
Yeah, that's great. haven't, you know, really broken down the numbers. I'm really speaking more anecdotally. And I've spoken with other folks in the industry have seen the same trend, but it's significant. it's become a cost of owning an IVF clinic. have to just sort of accept that it's...
It's part of the business that...
Griffin Jones (27:49)
If you
were a betting man, is there any chance that this could be a temporary fad or do you think this is the new normal?
Matthew Maruca (27:58)
I think, I think it's the new normal. I think if you look, if you look at what happened in Alabama, for example, you know, when they sort of co course corrected for the, the, the, the court ruling that, that ruled that, embryos in cryogenic storage were effectively children for the purposes of their wrongful death statute. rather than
change the law with respect to sort of deeming them to be children, they implemented a broad civil and criminal immunity related to the destruction of embryos. they ultimately, with that sort of legislative approach, have, I think, made it more difficult in the state of Alabama to bring this type of litigation. And so if we see a proliferation of that kind of
of regulatory regime, right? If legislators decide they want to implement a more robust regulatory framework for managing IVF, but then also implement sort of these sort of civil immunity provisions, that might change things. But I think it is generally the new normal now to just see an increase in litigation.
Griffin Jones (29:07)
That civil immunity that was passed in Alabama, does that make it, would you say that that makes it harder to litigate reproductive health cases in Alabama than baseline now?
Matthew Maruca (29:19)
Yes, it does. Yeah. They, mean, in some ways, Alabama became one of the more favorable places to practice IVF after they changed that, after they changed the law.
Griffin Jones (29:29)
would have saw that one coming, huh? What types of cases are you seeing being brought forth? it stuff about gamete swaps? Is it just about a lack of informed consent? Like, thought that I had a 100 % chance of getting pregnant and then I had two failed IVF cycles. What types of cases are you seeing specific?
Matthew Maruca (29:30)
Mm-hmm.
Yeah, I mean, look, IVF is a human process, right? And embryologists are working in the lab are humans and, mistakes can happen. A hand can slip and something falls out of the dish.
there will always be some human element involved in the lab, which means there's almost always going to be some risk of mistakes that get made. a lot of the litigation revolves around just something happened in the lab that was unexpected. We've also seen things like folks bringing suits on consumer protection grounds. We had a...
I had a claim that alleged that discussion, basically had alleged that the statistics, that SART statistics may have been misleading and that the failure to fully inform around potential success rates was effectively a consumer protection violation. don't see that necessarily as a
there, there were definitely some legal questions about whether that is a colorable claim under that particular state's law and whether or not that really should have been brought as a medical negligence case that matter didn't get litigated to that, to that point. but, folks were getting creative about the types of, of claims. mean, you see, we see breach of contract claims. You see, you know, all relating to this sort of same issue around, you know, the loss of tissue of some sort.
But you see a lot of creativity of the plaintiff's attorneys to bring any claim they think could possibly stick.
Griffin Jones (31:16)
What do you find that clinics, providers still aren't doing enough of to protect themselves or maybe advice that you would have thought would have been heeded by now, not your clinics and providers, obviously somebody else's, but what mistakes do you still see people making?
Matthew Maruca (31:35)
You know, I think the most important thing that clinics and providers and labs can do is take ownership when something has gone wrong and make sure that the patient is focused on the remediation and trying to get them pregnant, try to redress that situation as fast as you can.
take owner, if you've made a mistake, I mean, I take ownership of it. I can't tell you how often I said, look, you know, your hand slipped in the lab. it let's, let's focus on doing right by the patient. Let's let's, you know, let's, let's do everything we can to get that patient, the child that they intended to come here to get. and not necessarily worry about the litigation, let the lawyers worry about the litigation, stay focused on the patient, stay focused on getting them to where they intended to be.
And I think if providers take that approach and try to maintain trust and care with the patient and stay focused on the patient, that can work wonders for risk mitigation when it comes to litigation.
Griffin Jones (32:37)
feel like that's an insight that I wouldn't necessarily expect from Allura because maybe it's counterintuitive, but I would think that many providers would be worried about incriminating themselves by making it right. they're worried that, oh, and now I'm just giving them plenty of evidence for their discovery if they come back to sue me.
Matthew Maruca (32:51)
I think.
Right.
And that's the fine line you have to walk. sometimes it's hard to do an honest mistakes. They happen all the time. And I don't care if you're a huge lab or a small operation. mean, mistakes are going to happen. And I think patients understand that.
And if you take the steps to say, am so sorry, we obviously try to do everything we can to avoid this, but this is what happened and this is what we're gonna do to fix the situation for you and make sure that you take ownership of it and you try to it right by the patient. I think that outweighs the...
in most cases, not every case, but in most cases, that's going to outweigh the risk that you have of some negative inferences in the litigation from having taken ownership of it. I studies have shown that patients are much more likely to litigate against providers who appear that they don't care or are evasive around things that went wrong. And they're much less likely to litigate against
a physician that likes them and is really trying to do right by them. And so I constantly tell our providers, please just take care of that patient and make them feel the love. mean, call them, follow up with them until they're almost annoyed that you're giving them too many touches. Because at the end of the day, we're in a service business. We're trying to help them build their families. I know from...
From Inception's perspective, we really try to stay focused on the patient experience. so when that also extends to if something has gone wrong and we try to stay focused on the solution, stay focused on trying to the family that that patient wants.
Griffin Jones (34:49)
How about consents and contracts? When you walk into a new practice, you feel like, okay, they've really buttoned up from what I used to see when I walked into a new practice six or seven years ago, or are there still common mistakes that people are making with their contracts, their consents, and if so, what are those?
Matthew Maruca (35:07)
That's a question. I think SART has done an excellent job. And I think most places really default towards the SART consents. think it's the, where I think sometimes things can be lacking are those outlier situations where you have...
some unique situation that just doesn't easily fit into a consent form. And so I think you just have to deal with those sometimes on a case by case basis. My team at Inception, we sort of are routinely called upon to craft a consent form on a sort of one off basis. I will say the thing that I think that is the most important in drafting consent forms is to use plain language.
I've often come into a situation of, you have looked at a form where obviously the, whether it's the lab, someone in the lab or a physician has drafted something to use that is, you know, very scientific, very medical focused. you know, the informed part of informed consent means that, you you really need someone to understand.
Griffin Jones (36:12)
that the other person is picking up what you're putting down.
Matthew Maruca (36:14)
Yeah, it's not just a question of having all the right stuff on the page. It has to be presented in a sort of plain language. And so a lot of times, you know, from our process is, you know, start from the complicated and then try to summarize that into a way that's really digestible that anybody that that picks this up should be able to have a good sense of what the risks and benefits benefits are. And I think I think
you my recommendation would always be you should be fulsome in describing, you know, the risks and benefits, but you should also really be focused on making sure it's in plain enough language that the patients can actually understand it. Because I think you run the risk of it being so technical that, you know, it just becomes a signature on a page and it's not really informed if it's not easily understood.
Griffin Jones (37:05)
Many of the people listening are practice owners and almost all of them, if they're independent practice owners, won't have in-house legal counsel. Do you recommend a sort of routine legal audit, quarterly or semi-annually or annually, you might do forensic accounting once a year to have someone make sure that your books are actually balanced and that
that nobody's stealing from you and that everything is actually accounted for, you might do something like that with cybersecurity. Is there an equivalent to that in law that you would recommend to practice owners? And if so, what are they doing in an audit like that?
Matthew Maruca (37:46)
Yeah, that's great question. I mean, I think taking a look at your consent forms every couple of years, you know, making sure that, you know, if SART has updated their forms that you, you you implement an update based on that. From a risk mitigation perspective, you know, I think really focusing on having a good QA, QC process in the lab and working with your lab directors to make sure that
that you've, you know, that, that as issues happen, that you're taking corrective action, that you're updating protocols, routinely, and that you're sort of learning from your mistakes that you're implementing, you know, the best practices you can, in terms of, you know, monitoring tanks in terms of, of, of just processes within, within the lab with documentation within the lab.
and I, you I would encourage, you know, one of the great benefits that we have as, as a large network is, you know, our, our, our lab steering committee is extremely active. Our lab directors, you know, meet regularly, they share best practices, they develop, you know, you know, protocols. and so if, if you are an independent, you know, I would make sure that you're still plugged into the industry that you, you you, you have conversations and, know, obviously you've got to be careful around.
know, privilege issues if there's mistakes, but at the same time, you know, I think, you know, sharing and learning best practices can be, you know, really helpful. And having a good, and then, you know, in terms of, you know, for preventing issues and then having a good, you know, a good approach to if something does go wrong of knowing how to, how to manage it. And like I said, going back to making sure that patient is
you well taken care of, that you step in immediately to try to address the patient and get them back to where they expected to be. I think that, you know, having a good plan in place for those couple of things are probably the best risk mitigation approaches that I could recommend.
Griffin Jones (39:48)
Are there things that individual providers can and should be doing to bring down their malpractice premiums?
Matthew Maruca (39:55)
you know, I would say having really good protocols around, you know, your discard protocols, you know, having it's, it's, to make mistakes in the, in a discard process, discard the wrong patients, embryos, or to discard the wrong, the wrong embryos, I would say having a really rigorous process to make sure you don't, have a forced error in that regard would be one place. Cause that to me,
that's really entirely driven by the right procedures and protocols and making sure that your discard consent forms are really clear. You're discarding every embryo, all tissue stored after this date or these specific tissue or really not allowing lots to be split to be discarded, but having a really clear process for discards I think would be one place to just
I could see that as a network, we've implemented a lot of protocols to make sure that there's double witnessing, that it's extremely well documented, that the documents are extremely clear about what is being discarded. So that's one sort of low hanging fruit area that can really, I think, mitigate a lot of risk. sometimes mistakes happen in the lab, but to have like
To me, this is one where you can develop really good practices to avoid something that it's really hard to defend. If you discard the wrong embryos, there's no defense to it, right? So it's all about preventative management.
Griffin Jones (41:23)
Have these plaintiffs, attorneys taken a page out of the personal injury law firms in terms of their client recruitment and advertising and the way they price their services? Every city you see, hurt on the sidewalk, give me a call and there's an easy remember number and then.
Matthew Maruca (41:37)
Absolutely.
Griffin Jones (41:44)
It's you don't have to pay a nickel unless we make money for you. Are they doing the same things here where, you don't have to pay us a retainer fee. It's either you win. so that eliminates the barrier to entry or greatly reduces it for the client, that plaintiff. then are they targeting people with Facebook ads or social media ads or...
there are other places where they're going after IVF patients to try to get these cases.
Matthew Maruca (42:13)
Absolutely. Yeah, all of
the above. The playbook right out of personal injury. There's online ads, targeted media. There's contingent fee cases, so the patients pay nothing. It's entirely contingent on a successful recovery. So it's a whole industry.
Griffin Jones (42:29)
Are there ways that counsel for practices can deter that or maybe it's just your reputation and success record? Like those ambulance chaser firms look at you guys and they're that's Maruga. He's kicked our ass five times already. We're going to lose money on that one. Are there ways that counsel can deter those types of frivolous cases?
Matthew Maruca (42:54)
no, no, I don't. There's ways that you can limit the potential recovery, right? You want it, you know, I think the there that there's not, there's nothing you can do to stop, plaintiff's attorneys from, you know, wanting to develop a book of business or an expertise in a particular area. but I think the good risk mitigation would be to take care of the patient. Like I said before,
And then make sure that you have a process in place for a QA, QC process, as I talked about before, so that you learn from your mistakes and that you don't have a repetition of the same sorts of issues, that you have proper documentation of protocols. If you have a protocol, you have to follow it to a T. And you can avoid the excess
sort of damages that can come when someone has really competent counsel and they're going to look at all of your records, they're going to double check every protocol, they're going to make sure that you follow your protocols to a T, they're going to make sure that if this sort of thing has happened before that, if this is the fifth time that this mistake for this exact same thing has happened over and over again, they're going to say, hey, we should get special exemplary punitive damages here. This was egregious, right? This was
No reasonable clinic would have ever done anything like this. And so having your sort of house in order from a QA, QC perspective, I think can limit a worst case scenario where you'd expose yourself to, you know, the kind of excessive damages that, that could really, you know, push out of business.
Griffin Jones (44:34)
whether it's potential litigation or the legislative landscape, as you look ahead, what do you want providers to think about? Maybe it's things that you find yourself having to continually remind them of or misconceptions that they might have that you need to educate them about, or maybe it's something else. But as you look ahead, what do you really want providers to be conscious of?
Matthew Maruca (45:01)
You know, I've in the last couple of years and in the last six months in particular, I think the public policy space has been has been a real area of focus for me. And I think I go back to what we kind of talked about at the beginning of educating and being a a resource for patients and others out, you know, who are looking at IVF and maybe don't have
expertise in the area and might, you know, draw conclusions about what we do that aren't necessarily accurate. And I think, I think being, you know, being educators to, to everyone that, touches, you know, IVF, I think is a really helpful way. Cause I can't tell you when we've sat down with legislators and explained to them, you know, the reality of what IVF is doing. It's like a light bulb goes off.
And they start to see that like, you're not, this industry is not like the Heritage Foundation would seem to suggest. Like this is not the Wild West. These folks are not out there just creating embryos so that they can later destroy them. So I think being an educator sort of at all times is really helpful. I think it helps with the patients too, right? Like you talk about the risk.
mitigation factors, like setting proper expectations is really important for your patients. And that just goes back to being an educator about, what, what, what we can and can't do and what the likelihoods of success are. And that's going to avoid these crazy, you know, you know, you're going to have your patient in the right frame of mind. You're, not going to try to bring, consumer protection, you know, allegations against you. so I think, I think being a constant educator is, is really.
be my, my, my recommendation, you know, across the board.
Griffin Jones (46:45)
Matt Maruca, thank you very much for coming on the Inside Reproductive Health Podcast.
Matthew Maruca (46:50)
Thank you very much, I enjoyed it.
Matt Maruca
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