Frequently Asked Questions

Our services appear to be novel, and we are not a lead generation service. Lead generation services typically look for potential plaintiffs or clients for cases you've already found, such as people who believe they have been injured in a certain way by a particular type of device. The "case" is the device that caused harm and the injury, and that's what we find. For defective device cases, mass torts, and MDLs, we find the potentially defective, adulterated, or misbranded device and identify the issue and potential patient outcomes (i.e., the harm). We can also find potential instances of fraud by device companies and suspected bad actors (i.e., potential False Claims Act cases). We uncover these cases by searching, mining, and analyzing FDA data, as well as data and information from other sources, from both qualitative and quantitative perspectives.

We specialize in finding two main types of cases involving medical devices: 1) Potentially defective, adulterated, or misbranded devices. I.e., cases in which there appears to be a potential issue with the devices themselves or how they are being labeled or marketed. 2) Various forms of fraud. Some common examples include devices that appear to have been FDA cleared or approved based on falsified premarket testing (caveat: see FAQ 12 below), class 2 and 3 devices being sold en masse without FDA clearance or approval (including via major channels and as part of seemingly FDA-cleared products), and instances where CMS appears to have paid for defective, adulterated, or misbranded devices.

No. While we work hard to provide the best quality services we can, we are unable to offer any guarantees. For example, we cannot guarantee a particular outcome or verdict amount. Additionally, while we are very skilled at finding evidence where it exists within the available pre- and post-market data, and have insider knowledge that often helps us succeed, we cannot make any guarantees as to what evidence, if any, we will find. We can and do frequently make predictions based on our knowledge and expertise, and we will advise you of those in advance, but they are not intended to be guarantees. We also cannot guarantee that we will be able to find every company that is or was connected to a particular device. Companies don't always report their suppliers or their relabeling activities like they are supposed to, and certain databases only contain the current year's data. However, we are very good at what we do, and we know of many ways and unconventional places to look to find that information.

No, we cannot offer refunds for our services. However, if an issue arises, please reach out and discuss it with us. If we have made a mistake or failed to deliver value, we will do whatever we reasonably can to make it right. We want all our clients to be happy and are always striving to deliver value and improve our services. We welcome constructive feedback, positive or negative.

Yes, and yes, with a caveat. Our insider knowledge is a great starting point to guide our searches. It improves both our efficiency and our odds of success (i.e., finding the most promising cases and evidence). It cannot be used as evidence, but it informs our searches and allows us to more reliably predict whether a particular search is likely to be fruitful. We also have insider knowledge of some of the device companies and testing labs with a history of fraud, and from that, we know where to look and what to look for, although a FOIA request or discovery may be required (see FAQ 12 below). Metaphorically speaking, we know where the proverbial bodies are buried, but we still need to go and dig them up to be able to provide you with reliable, usable evidence.

We are not a lead generation service or a marketing firm. Dr. Weintraub, our Founder and CEO, is involved in patient advocacy work that includes helping to raise awareness of medical device issues and assisting patients who were harmed by medical devices. As part of this work, she organizes and participates in Facebook groups and may help patients find attorneys in their geographical area who may be able to represent them. Promoting a particular attorney or law firm would create a conflict of interest, and thus, we cannot specifically recommend you or your firm over others. However, if you engage our services, and a patient who could be a potential plaintiff in a case we've found for you happens to enlist Dr. Weintraub's assistance in locating an attorney, she would (with your permission) disclose to that patient that we are working with you on cases like theirs, without making any comments or representations about your professional skills. Dr. Weintraub is also ethically obligated to provide the names of all other attorneys and firms within that geographical area who appear to take similar cases. Thus, we do not specifically find plaintiffs or clients for attorneys, but some of our patient advocacy work connects potential plaintiffs or clients with attorneys.

We provide a short report that is intended to serve as a starting point and basic summary of the potential case. It will specify the potential issue, device type and model(s), company, product code, device class, populations affected (i.e., demographics of potential plaintiffs), and harm/patient outcomes. It will also include an overview of the preliminary evidence based on a cursory search (e.g., whether there are recalls for the affected devices, adverse event reports, potentially related recalls, etc., and how many our brief search identified), as well as why we think it could be a big and promising case. We will identify apparent trends and provide charts, where relevant and applicable. We may also share some of our insider knowledge from our FDA experience to give you an idea of some additional evidence that we believe exists, potential investigational avenues, and areas to cover in discovery or FOIA requests. These suggestions and insights, where we have them, are not intended to be exhaustive, detailed, or inclusive of everything we might know. Our goal is to present the potential case, show you why we think it's worth pursuing, and get you (or us) started. From there, you can choose to either engage our research, analysis, and evidence-finding services to do a deeper dive, or you can do some or all of the investigation on your own, or a combination thereof. The case-finding pricing only covers the preliminary report (i.e., the case idea) and a copy of the data from our preliminary search (i.e., the evidence upon which our preliminary analysis is based). Additional services (e.g., the "deeper dive" and evidence-finding services) may be priced under a different pricing structure. Please contact us to discuss your needs and our pricing.

Absolutely! We love doing bespoke searches. The more specific you are about your needs, the more confident we can be that we're meeting them. If you're looking for something specific and want a case that fits certain parameters, we can perform a custom preliminary search that's tailored to your parameters. For example, if you want us to look for a case that has a recall and/or a particular type or model of device or patient outcome that you have experience with, we can do that. Please feel free to reach out and discuss your needs with us.

Yes, we do perform a new search and analysis with every case-finding request, unless specifically instructed otherwise. For example, if an attorney seeks multiple closely related ideas and wants to minimize costs, we may perform additional analyses on a single set of search results when feasible. This ensures that our prospective case ideas are as strong as possible and based on the most current data. We aim to deliver value.

No, we are unable to offer exclusivity for our case ideas, but we do try to avoid creating competition when feasible (more on that below). We considered offering exclusivity, but determined that it would be logistically difficult due to the customizable nature of our services, the tendency of attorneys and their cases to move from firm to firm, and the overlap between devices, companies, issues, etc. Hypothetically, if we had already sold an exclusive case idea to Attorney A involving a specific device, and Attorney B subsequently requested a custom search for case ideas involving that same device, we would be in a tough spot if we didn't see any other promising case ideas for that model. Ethically, we couldn't tell Attorney B that we didn't see any promising cases involving that device. And we would hurt our business (and be lying) if we falsely told Attorney B that we couldn't perform the search due to resource constraints. However, if we were to tell Attorney B the truth: that we couldn't perform that search due to a pre-existing exclusivity contract, that would tell Attorney B that there is a potential case and that it's an attractive enough case that another attorney wanted it all to themselves. Attorney B would likely try to find the case, potentially with the help of another company that wasn't bound by the exclusivity contract with Attorney A. The outcome for Attorney A would likely be the same as if we had sold the same case idea to Attorney B, but at a cost to our business. Depending on how many attorney Bs exist in this hypothetical world, that cost to our business could end up being substantial, with no net benefit to the attorneys who want exclusivity.

We can't predict with certainty what will catch attorneys' attention in the future or what additional information will come out. What may seem like an idea that's niche enough for us to be able to offer exclusivity today could be tomorrow's front-page news or high-profile recall that suddenly every attorney specializing in defective medical devices wants in on. While we have built our brand around our ability to uncover unique ideas (relatively speaking) with strong potential and minimal competition, we are also a service. Not every attorney wants to take the road less traveled. Whatever type of path you seek to traverse, we are here to help you find it. We need to be able to do that for all who want our services.

We implement several measures to try to avoid creating or shifting competition. First, we are constantly on the lookout for new case ideas, and there is no shortage of defective medical devices in the U.S. Post-market surveillance isn't just our job; it's also a hobby and a passion. However, as we acknowledged previously, every attorney's needs are unique. Our latest idea may not be the best fit for the next attorney who reaches out looking for a potential case. Therefore, whenever feasible, we also try to spread our ideas around geographically and space them out temporally. I.e., when possible, we try to avoid or minimize "reselling" the same case idea close in time or to multiple attorneys in a single area. That's just good for business. It makes our services more attractive. It's also better for the patients we try to help.

Yes, and yes! We primarily focus our case-finding efforts on Class 2 devices because we are aware of that verdict and its implications. We won't sell you a case idea for a Class 3 device unless you specifically request one, or without running it by you first, if we find one that seems particularly compelling and supported by a recall or evidence of fraud. You are always welcome to give us parameters for the type of case you are looking for.

In most cases, no. There is a limited number of FOIA-redacted premarket submissions that the FDA has released to the public, which we can find and locate for you. Otherwise, you would need to get those either in discovery or via a FOIA request. We are happy to assist you with identifying submission numbers and making FOIA requests. We are also currently working to establish a relationship with the FDA's FOIA office. Stay tuned for updates.

No. We are a separate company. However, we are a Device Events affiliate, and we frequently work closely together (see the About Us section for more details). Our respective companies offer companion solutions. Device Events is primarily a software company. We are a research and analysis service that uses their software regularly, among other applications and databases, to find and support cases and provide guidance to companies, hospitals, and medical providers. Simply put, if you want the answers and cases delivered to you, all wrapped up in a proverbial bow, that's what we offer. If you employ data analysts or are skilled in data analysis and are willing to do some or all of the legwork yourself, and you want a sleek, innovative tool that will enable you to find many of the answers, check out Device Events. For a discount on Device Events subscriptions and services, put or mention "Referred by RAWPhD" in your message or call to Device Events.

No. We do use it extensively as it allows us to simultaneously search several of the FDA databases at once without restrictions on the number of results. However, we also routinely use numerous other FDA/government databases, as well as private databases to which we pay to subscribe.

Our expert witness network consists primarily of subcontractors who have expertise in one or more of the areas listed on our homepage. Dr. Rachel Weintraub, our Founder and CEO, provides some expert witness services in several of the areas listed. She is currently the only expert in our network who is not a subcontractor. See FAQ 17 regarding pricing for expert services and FAQ 16 regarding expert availability.

Our expert witness services are subject to availability. We are well-connected and proactive about expanding our network, but we don't have an unlimited number of experts. That said, we will never charge for services that we are unable to provide. Additionally, if we do not have an expert that you need in our network, or do not have an expert who will be available for your trial, we are happy to assist you in locating an expert outside of our network at no cost. Please reach out to inquire about expert witness availability.

Our pricing for our case-finding services depends on your specific needs and requests, as well as the case idea that we provide. We will try to work within your budget whenever possible. All of our research, analysis, and evidence-finding services follow an hourly rate plus retainer pricing structure, although we can still work to keep you advised along the way and set limits to stay within your budget. Pricing and pricing structures for our expert witness services may vary. Most of our expert witnesses are subcontractors who set their own rates and prices. If you are interested in any of our services, please contact us to discuss your needs and our pricing and availability.

You can pick and choose! Our case-finding, evidence-finding/research and analysis, and expert witness services are all priced separately and may follow different pricing structures, depending on your needs and situation. While we are proud to offer a one-stop/full-service solution, you are never obligated to use everything we offer. If you just want us to help with some of the research while you do the rest yourself, we can absolutely do that for you under an hourly pricing structure, typically with a retainer. Additionally, with our expert witness services, most of our experts are subcontractors who set their own pricing, which means that you can use as few or as many (subject to availability) of our experts as you'd like.

The pricing structure and rate/price will be based on the complexity of your specific needs and our ability to predict the amount of work that will be involved in advance. Please contact us to discuss your needs and obtain an estimate.

Yes.

Yes! Our primary focuses are our case- and evidence-finding services, but we also work with inventors who want help complying with the FDA's regulatory requirements and dealing with the FDA.