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. Medical devices are our specialty, but we can also potentially find cases involving other types of FDA-regulated products. Medical devices are our specialty, but we can also potentially find cases involving other types of FDA-regulated products.

We cannot guarantee specific outcomes, verdict amounts, the novelty or level of competition associated with our case ideas, or what evidence we will find. Legal outcomes depend on many factors beyond our control, and while we're skilled at finding evidence where it exists within the available pre- and post-market data, the extent of discoverable evidence varies by case. We specialize in identifying opportunities with minimal existing competition, but we cannot control whether other firms will independently discover the same issues or whether future recalls or media coverage will attract additional attention. We can and do make predictions based on our knowledge and expertise, and we'll advise you of those in advance, but they are professional assessments, not guarantees. We also cannot guarantee that we'll identify every company connected to a particular device—companies don't always report their suppliers or relabeling activities as required, and some databases only contain current-year data. However, we're very good at what we do, and we know many unconventional places to look to find that information.

Our services are non-refundable. However, client satisfaction is important to us. If you're not satisfied with the value we've delivered, please contact us immediately at raw@rawphd.com. If we've made an error or failed to deliver what we promised, we'll work with you to make it right. We're committed to delivering value and welcome your feedback—positive or constructive—at any stage of our engagement.

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.

We don't offer exclusive rights to case ideas. The customizable nature of our services and the unpredictable nature of device litigation make exclusivity impractical. What appears to be a niche case today could become tomorrow's major recall or front-page news, suddenly attracting multiple firms.

However, we take steps to help minimize competition for our clients:
• We continuously identify new case opportunities—there's no shortage of defective medical devices
• When feasible, we try to spread case ideas geographically and space them out over time
• We try to avoid or minimize reselling the same case idea close in time or to multiple attorneys in a single area, though we cannot guarantee this due to factors beyond our control (such as attorneys changing firms or geographic areas)
• We tailor searches to each client's specific experience and preferences

Our focus is finding unique opportunities with strong potential and minimal existing competition. While we can't guarantee you'll be the only firm pursuing a particular device issue, we can help you find promising cases that aren't yet widely known.

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.

Yes. While our case-finding services identify potentially defective devices (which primarily benefits plaintiffs' attorneys), our evidence-finding and expert witness services can help both sides.

How we can help defense attorneys:

Our objective analysis of FDA data may show:
• The device in question has a safety profile comparable to similar devices
• There's no pattern of similar adverse events in FDA databases
• The evidence suggests user error rather than device defect
• The manufacturer provided adequate warnings and instructions

We can also help defense attorneys representing medical device companies assess settlement value by providing objective analysis of:
• The strength of the evidence against their client
• Patterns in FDA data that may affect litigation strategy
• Whether similar cases are likely to emerge

Our approach:

We follow the evidence wherever it leads. We will not misrepresent data to favor either side. If the FDA data shows a serious device problem, we won't downplay it. If the data shows the device is safe, we won't exaggerate risks.

We do not simultaneously represent opposing parties in the same litigation. However, we work with both plaintiffs and defense attorneys across different cases, depending on what the evidence supports.

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 15 regarding expert availability and FAQ 16 regarding pricing for expert services.

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.