Speak out Against Mesh - Publicly Or Confidentially
First off, my sincere thanks to all of you who have reached out to me and shared your litigation experiences either over the phone or through the procedural justice survey. I've learned so much from each of you and am so grateful to you all for taking the time to help me grasp the scope of the harm that mesh has wrought.
I've been writing about how courts deal with mass torts like those over mesh since 2004, but so much of what I know is just theory. If academics don't understand what's happening on the ground and how these cases affect real people, then there's no way for us to propose and help implement changes that fix things that are actually broken (rather than what we assume the problems might be).
One thing I've heard often is that litigants are afraid to speak out because their attorneys have counseled them not to. Often times, it's for good reason: defendants may try to use things that you've said publicly or on social media against you in a deposition if a story has inconsistencies.
But this can leave plaintiffs feeling voiceless. So, I've compiled a short list of ideas for ways that you can speak out. Some are public, like filing with the FDA, while others are private and confidential.
1) Submit your comments to the FDA Advisory Committee by January 27, 2019 - Public.
The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee is the name of the FDA committee holding the meeting on February 12. That committee provides advice and recommendations to the FDA about the way it regulates pelvic mesh.
The FDA is creating a docket for public comment (FDA-2018-N-4395). You can submit comments that will appear on that docket and will be provided to the Committee before it meets in February.
In order to do so, you need to submit those comments on or before January 27, 2019. Comments submitted after January 27 but before February 11 will still appear on the docket and be considered by the FDA, but will not be provided to the Committee. So, submit early.
Click on this link and follow the instructions given. Note that the link does not work if you try to open it using a Safari browser; use Firefox, Chrome, or Explorer instead.
When I followed the comment rabbit trail (it took a little doing to find the exact agency and comment page), I saw that only 24 comments have been received (that's up slightly from when I last posted about this, but not much). The link I've provides should take you exactly where you need to go without having to go through the same hoops I did.
2) Take the Procedural Justice Survey as soon as possible - private and confidential.
I am conducting a procedural justice study on women's health mass torts like pelvic mesh and would really love to add your voice to the over 200 I've heard from so far. I am a law professor at the University of Georgia and am an expert on the procedures that courts use to resolve mass torts. I'll use your comments to form the backbone of recommendations that I make to the judges handling mesh cases and the many mass torts that will come in the future. If you have ideas--I'm all ears.
Your identity will be kept confidential and nothing that you tell me will affect your case in any way. Nothing that I ask is covered by attorneys' "gag" orders. I am focused on your feelings about the process, and am not seeking confidential information.
Nevertheless, if you'd prefer not to include your name on the survey (which, again, would be kept confidential), you can send that to me separately via email (email@example.com) or I can ask you the questions over the phone. Names just allow me to confirm your eligibility to participate in the study by cross-checking court records.
If there are things I should know that I haven't asked you about or if there's something that you want to share with me, just email me. My firstname.lastname@example.org address is not subject to open records act requests like my university email address is, so I suggest that you use that one, but I will receive it either way.
So, please take the survey. You can skip any questions that you'd rather not answer and the whole thing will take you around 20 minutes. Like the FDA comment website, it tends not to work with Safari, but does work with Firefox, Chrome, and Explorer.
3) Submit adverse events to the FDA - public.
Patients, healthcare professionals, and manufactures can all submit reports of adverse events. Here is a link to the form you can use to submit a problem to the FDA. And here's the FDA's Q&A page.
4) Send your attorney a victim impact statement - private.
From what I'm hearing, many of the attorneys that plaintiffs originally contacted have sold their cases to another attorney or partnered with an attorney who handles lots of mesh cases. Many women feel like numbers, not people. So, sending your attorney an account of the ways that mesh has changed your life might help--at least if it gets read.
Other ideas? Send them to me and I'll update this post.