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NARRATOR: This is Big Pharma, a podcast with Howard L.
Nations, a national pharmaceutical litigation specialist with clients in all
50 states, and an inductee into the National Trial Lawyers Hall of Fame.
Welcome to the program.
SHELLEY BLAS: This is Big Pharma, a podcast with Howard L. Nations, a national pharmaceutical litigation specialist. I'm Shelly Blas.
Also with me today is Carolyn St.
Clair, an attorney and nurse associated with The Nations Law Firm, representing women suffering from failed transvaginal mesh.
MALE NEWS ANNOUNCER: And good evening to you. Thanks for being with us here at 5 o'clock, I'm Jim Scott.
FEMALE NEWS ANNOUNCER: And I'm Tami Mlcock.
Our top story, legal and medical professionals from across the country are paying very
close attention to a groundbreaking verdict that just happened here in Bakersfield.
For the first time in the nation, a jury has awarded a local couple $5.5 million
against a maker of a medical implant claiming they new their product was unsafeā¦
BLAS: On this program we will cover the $5.5 million jury verdict in California involving the transvaginal mesh. Thank you for joining us.
Mr. Nations, Ms. St. Clair.
CAROLYN ST. CLAIR: Good to be here.
HOWARD NATIONS: Glad to be with you.
BLAS: This $5.5 million dollar jury verdict, this case involved a woman named Christine Scott, 53 years old, from Bakersfield,
California who in 2008 had a transvaginal mesh device implanted to treat occasional urinary incontinence.
With many women, including Christine, the mesh failed.
NATIONS: This is a very interesting case.
The first question we get on this case from our more than 2,000 clients is how did this case get to trial so fast.
This is a single case that was filed in California four years ago, and it was
filed before all of the cases were moved into multi-district litigation.
What is happening now is that all cases that are filed now go into federal court into multi-district litigation in West Virginia.
The second question we get is why this sum of money? That seems like a very large recovery.
The answer to that is this case if very different from most of the cases we see because in her case, she
had seven surgical repairs and she still has a prognosis of future damage for the rest of her life.
So that is why there is a $5 million verdict to her.
The next interesting point about this was the loss of consortium claim in which the husband was awarded $500,000 individual damages to him.
Carolyn, why don't you explain the loss of consortium claim in the transvaginal mesh case?
ST. CLAIR: Well the husband got $500,000 awarded by the jury because of his feelings between the
wife - it has to do with the interpersonal relationship between the spouse and the husband.
But the husband was actually injured.
Many husbands have told us that it feels like they are - the experience is
akin to a brillo pad when they are having *** intercourse with the wife.
So they actually sent us pictures of the damage that they have had.
So these are the reasons that the husband now has such an interesting loss of consortium claim.
It's not only the loss of love and support and advice and counsel that you get
between in the martial relationship, its actual physical injury to the husband.
BLAS: As we know, the FDA has reported that there have been thousands of reports of mesh failures with health complications, erosion of the mesh into
surrounding tissue, pain, infection, continuing and worsening urinary incontinence, scarring and as we mentioned before, pain during intercourse.
And we know that this is a permanent implant not meant to be removed or replaced so surgeries or therapies to address the
serious health complications that occur as a result of the mesh's failure may or may not help women who are suffering.
NATIONS: The fundamental problem with the mesh is that it not only leads to all this catastrophe and destroying
the mental health of women as well as the physical pain that they endure, but it also doesn't work.
It doesn't work for what it is designed for. It's a terrible, terrible product and it's an unnecessary product to use.
We have several categories of damage from the many clients that we have.
Basically we get into the category of women who have had surgeries and they've
reached a point where they can live with the continuing problems and the pain.
We get another category of our clients who have had surgeries and they are going to have to have additional surgeries and additional surgeries.
I was reviewing a file recently where our client has had seven revision surgeries and she is
not at the end of the road yet, she's still going to have additional revision surgeries.
Then we have a category of clients who have not yet had surgery and they are going to be scheduled for it in the near future.
Then we have a category of clients who are experiencing pain and they are experiencing difficulties, and
the problems that they are having, the problems for which they originally got the mesh implant continue.
And then there is the, possibly the worst category, which is the women who have the transvaginal mesh and
they have unbelievable pain, unbelievable disability from it, and they are not a good candidate for surgery.
So they can't have their first revision, or their second revision or their third, they can't have any revision.
They are simply destined to live with this pain, and with all the difficulty that they have, mental aguish,
physical disability, the inability to have intercourse with their spouse, and still an increasing problem
with the urinary incontinence, the problems that brought them to the doctor in the first place.
Those are the ladies that have the worst situation because the mesh is so embedded,
or it is such a complete mess inside their body that they can't go in and replace it.
BLAS: How then can a woman who suspects transvaginal mesh failure find out?
NATIONS: Well actually, its complicated because there are numerous manufacturers with numerous products and they
first thing we have to do is product identification so that we'll know which manufacturer we are dealing with.
And it can be even more complicated than that with revision surgeries because it is possible that you have a manufacturer of a transvaginal
mesh that was put in initially, taken out and revision and a different one from a different manufacturer was put in its place.
And when you get into three and four and five revisions, this can be very complicated.
The way we find out is we take a medical authorization from you, we obtain your medical
records, and we look in the medical records to find out the exact location of the bar code.
Because there is supposed to be a bar code that is taken directly off of the product.
So we go through the process of identifying the bar code, identifying the manufacturer and then finding out exactly
who the defendant in your case will be because the case is handled differently depending upon who the defendant is.
So by obtaining your medical records, we can answer the question for those of you who are not
sure if you have a transvaginal mesh problem or if you even have a transvaginal mesh in place.
We can find that out for you by obtaining your medical records and determining A. Do you have a transvaginal mesh,
B. Who is the manufacturer of it, and C. Is this the source of your difficulties?
We have doctors who analyze these records with us so we can determine exactly what your problem is and exactly who caused it.
BLAS: So Howard, with everything that you just mentioned, this type of pharmaceutical device case, where you are going
against a huge manufacturer, this doesn't sound like the kind of case that a local lawyer can handle, is that correct?
NATIONS: Well that is correct for this reason: we get a lot of referrals from local lawyers who have one case signed up or two
cases or three cases signed up because this is multi-district litigation and its not going to be handled in your local court.
So if you go to your local lawyer, even if he is a local personal injury lawyer and he doesn't do pharmaceutical litigation, and he takes your
case and files it down at your local courthouse it will be removed to federal court and from federal court it will be sent to West Virginia
where it will be part of multi-district litigation which involves thousands and thousands of cases that have been put together in front of
one judge and is being handled by pharmaceutical litigation experts for the defense and pharmaceutical litigation experts for the plaintiff.
So if your local lawyer gets to West Virginia, he or she will not know anybody,
they will not know him and you can't get anybody to pay any attention to you.
In the multi-district litigation, there is strength in numbers and we have over 2,000 clients right now and we
will have a lot more than that before this matter is resolved so that when we sit down to deal with the defense,
they know who we are because we have been doing this for a number of years and we've been successful at it.
So they know exactly who we are, the judge knows who we are, and everyone involved in this knows who we are, and we will have our say, we will
get our mediation, we will get our negotiation, and if it comes down to it, we are perfectly capable of trying a pharmaceutical litigation case.
BLAS: If I have a transvaginal mesh case, will my case go to trial?
NATIONS: Well, unlike the Christine Scott case which did go to trial in California, very,
very few cases will be tried, out of the tens of thousand of transvaginal mesh cases.
About five cases will be chosen for trials, and those cases may or may not be tried.
But if they are, they will be tried in West Virginia in the federal court there and the
likelihood that you are going to be one of those cases is about 1 out of 20,000 or so.
But the trial is not necessary for you to get the advantage of the MDL trials.
Because what happens is this, the huge advantage to the MDL for an individual plaintiff is two things, number
one, you cannot possibly afford to prosecute a case, a single case of your own against the big manufacturers.
They are spending millions and millions and millions of dollars to defend these cases.
They have teams of untold numbers of lawyers who are reviewing millions of pages of documents right now to defend these cases.
And for you to trial and go to trial against them in a one single case, it
would cost you more to prosecute the case than the amount of your recovery.
So what happens is when you join together with thousands and thousands of other people, then at the end of the case the judge says,
okay 1% of your recovery or 2% of your recovery, whatever the judge decides, will be taken out to go to pay those common expenses.
So 1% of your recovery is a very nominal sum to pay to sue a large manufacturer. So that helps you considerably to prosecute your case.
And you get the advantage of all the people putting together all their money and all their expenses and all their
lawyers and putting it together into a plaintiffs' steering committee, and doing all the work and reviewing all
these millions of pages of documents, hiring and retaining and preparing experts and presenting experts.
All that is paid for cooperatively by all of the plaintiffs, but you get the advantage of every single bit of it in your individual case.
The plaintiffs' steering committee is in the business of establishing liability on each of the individual
defendants, on each of the devices, regardless of when they were revised, when the new warnings came out.
That's why this is so complicated, but that is the job of the plaintiffs' steering committee, is to establish that liability.
Now, here is the second big advantage to you in an MDL: we will handle your case in the MDL, but when it comes
time to talk about settling your case, to mediate your case, we will prepare your case individually, we will
negotiate it individually, and we will settle it individually even though we have thousands of clients.
The thousands of clients is a huge benefit to you because there is definitely strength in numbers.
So the more cases I have, the stronger the docket I have, the more credibility
I have, and the more the defense bar has to deal with me and with your case.
So, in the mediation process, we will review your case, we will get your medical records, we will prepare your
case individually, we will have it reviewed by a medical team, we will then negotiate it and we will settle it.
If it doesn't settle then, if we don't get settled in the MDL, which is most unlikely because the whole purpose of the
MDL is to resolve these cases, but if it doesn't get settled in the MDL, we will come back and we will try your case.
We are perfectly capable of trying these cases. We've been doing it for years with considerable success.
BLAS: Carolyn, what final advice do you have for these women who may possible have a transvaginal mesh?
ST. CLAIR: Well the symptoms that they should be looking for are whether they are having pelvic pain, vaginal pain, if there is
erosion into the tissues, if they are having the feeling like the brillo pad that has been described by so many spouses and loved
ones, if they've got any kind of urinary incontinence that is continuing, if they have a recurrence of a pelvic prolapse, if they
have urinary tract infections, these are all some of the many explanations that have been attributed to the transvaginal mesh.
NATIONS: Carolyn, what advice do you have for the women that are experiencing the symptoms that you
just described their doctor has not identified those symptoms as arising out of the transvaginal mesh?
ST. CLAIR: Well many of the women have gone to an Ob/GYN, their Ob/GYN for their annual pap and they are
experiencing all these symptoms that are related to the transvaginal mesh but the Ob/GYN is not trained
to know that that is part of the urogynecologist problem and the urogynecologist will that make diagnosis.
So the women either need to go get a second opinion from the urogynecologist who actually did
the surgery or another one who is proficient in that area, rather than relying on their Ob/GYN.
NATIONS: Well there is the additional problem,
Carolyn, that a number of our clients who turned out to have transvaginal mesh implanted and their problems arose out of transvaginal
mesh were not told that by their doctors because a lot of doctors do not want to tell their patient that all these problems that you
are having and the failure to correct your incontinence or the prolapse problem are from the mesh that I implanted in you last year.
ST. CLAIR: We're not suing the doctors, they are not part of this litigation. We are only going after the manufacturers.
The doctors would have never implanted this mesh in their clients had they had any idea that it was a dangerous and defective product.
BLAS: So, Carolyn, I have a transvaginal mesh implant and I am going in for surgery. Is there any advice that you can give to the women out there?
ST. CLAIR: Oh yes, definitely contact us. We need to preserve that evidence, we need that mesh preserved.
Tell everyone that you can related to this hospitalization that you are undergoing.
The person in the holding area, the anesthesiologist, the nurse, make sure they put a big note on your chart that they retain the evidence for us.
So contact us immediately, we will send a notice to the hospital to preserve that mesh, but you also
need to tell them to make sure that that's not tossed off the surgical field and into the garbage.
NATIONS: The other problem that we are having in obtaining the mesh is most people don't realize that when you are a patient in the hospital and
you have a medical device, but there is a representative from the manufacturing company in the surgical suite at the time of your surgery.
So the mesh that is being explanted may be picked up and destroyed by the manufacturer's rep in
the surgical suite unless you've taken exactly the right steps to prevent that from happening.
So if you contact us before you go in to surgery, we will put the hospital on notice, and the doctor and the
anesthesiologist, and we will send them an explantation kit with full instructions on what is exactly to be done
with the mesh so that it is properly maintained, properly preserved and it is sent directly to our expert witnesses
where it will be kept as part of the chain of custody and we can avoid evidence problems with it in the future.
BLAS: Carolyn, what is the future prognosis for these women who have had these revision surgeries?
ST. CLAIR: Well unfortunately it is very bleak for most of the clients.
They've had to have diapers, they've had to have catheterizations, some have even had an interstim device.
So unless they really get this taken care of, they're going to have disability in the future and some even can no longer work.
They are going to be disabled and have loss of wages.
And unfortunately, so many of these women cannot pay their medical bills now, they are fearful of the medical
bills they are going to have in the future, they don't know what the future holds for them as far as being
able to work, so it's a really sad situation for so many of our clients but we're here to help them.
NATIONS: From your background in the medical field, since you had years of experience as a nurse before you became a lawyer, was there a safer
alternative design that was used in the medical field before we got to transvaginal mesh that would have avoided this entire transvaginal mesh problem?
ST. CLAIR: Oh absolutely. They still use cadaver tissue, they also can use the woman's own tissue, or they can just simply stitch.
There is also something that is made from a pork product that is very typical of using
in any of these SUIs, stress urinary incontinence, or pelvic organ prolapse procedures.
NATIONS: When the defense reaches the point that they understand that they have no place to hide, and they fully understand and
accept the fact that we are able to prove that this is a defectively designed product, and that this product is the direct cause
of the problems and the surgeries that our clients are experiencing, at that point they will come to the table for mediation.
And we are well known in the pharmaceutical industry and we will be one of the first groups that will be able to mediate these cases.
However, mediation is still a ways down the road unfortunately. But the complexity of this litigation is such that there is just no way around that.
However, it is extremely important because of the statute of limitations, and because of the potential for statute of limitations
problem in your particular case that would block you from prosecuting your case successfully, it is absolutely essential that you
should contact a lawyer immediately to see about getting your case on file to stop the running of the statute of limitations.
So call us. We will be glad to review your case and advise you as to your legal rights and how you should proceed from this point forward.
NARRATOR: You've been listening to Big Pharma, with Howard L. Nations, a national pharmaceutical litigation specialist. Thanks for joining us.