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NEW* Cisson $2 Million Verdict Will Stand

U.S. District Court, Charleston, W.V.

U.S. District Court, Charleston, W.V.

Judge Joseph Goodwin has ruled the $2 million jury award in the Donna Cisson case will stand.

The August 2013 case against C.R. Bard over its defective Avaulta pelvic mesh was the first jury trial among the seven manufacturers whose cases have been consolidated in this Charleston, WV courtroom.  Judge Joseph Goodwin is overseeing mutidistrict litigation concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse (POP).

Bard requested a new trial saying it did not receive fair treatment during the Cisson trial.  In a ruling January 20,  Judge Goodwin denied C.R. Bard’s motion for a new trial. See  Cisson Doc #485.

Bard Avaulta Mesh, Miklos and Moore website

Bard Avaulta Mesh, Miklos and Moore website

He also refused to find unconstitutional a Georgia rule that requires the Cissons to pay 75 percent of the $1.7 million punitive award to the state.

Background

Donna Cisson Facebook page

Donna Cisson Facebook page

You may recall Donna Cisson, a resident of Georgia, was implanted with a Bard Avaulta Plus mesh in May 2009. She complained of chronic pain and permanent injuries.

On August 15, 2013 the jury returned a verdict in favor of Ms. Cisson along with a $2 million award. Of that, $250,000 was for pain and suffering while $1,750 was a punitive award.

See background story here.

Bard then filed a motion for a new trial.

Lori Cohen, attorney for Bard

Lori Cohen, attorney for Bard

Bard had claimed it did not have a fair trial because excluded from trial was 510(k) approval evidence.

The 510(k) FDA approval does not guarantee safe and effective devices are put on the market so was deemed to be inapplicable in this case.  The company also said that it did not have a fair trial because the Material Safety Data Sheet (MSDS) was admitted into evidence. That sheet which accompanies the raw resin supplied by the petroleum company, Phillips Sumika, to make polypropylene, had an explicit warning the material was not to be made into an implantable medical device:

“Do not use this Phillips Sumika Polypropylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.” 

See the background on how Bard executives skirted this restriction by forming a dummy company, Red Oak.

Judge Joseph Goodwin

Judge Joseph Goodwin

Judge Goodwin writes, “This secretive conduct in an effort to sidestep the MSDS warnings suggests reprehensible conduct, weighing against remittitur.”

Bard also complained to Judge Goodwin that it deserved a new trial because plaintiffs asserted the company failed to perform pre-market human clinical testing.  The plaintiffs presented “evidence to demonstrate that the device did not function as intended, and that it proximately caused Ms. Cisson’s injuries.

Therefore the jury instructions on causation or on a design defect claim do not require a new trial, writes Judge Goodwin. “The arguments advanced in support of a new trial are unpersuasive.”

Georgia Tort Reform

Also on January 20, 2015, Judge Goodwin denied the plaintiffs’ motion to declare that Georgia’s law regarding punitive damages unconstitutional.  Georgia’s statute says seventy-five percent of a punitive damage award belongs to the treasury of the state through the Office of the State Treasurer, in this case Georgia. Georgia added that provision as part of the Tort Reform Action of 1987.  See background story on the award here.

Bard also wanted punitive damages reduced from $1.7 million to $250,000. That too was denied.

LEARN MORE:

Bard is facing 10,610 more cases at this writing. See the MDL here

http://www.wvsd.uscourts.gov/mdl2187/caseviewlist.aspx

See more at Law 360 here. 

See more on the Cisson case here

http://meshmedicaldevicenewsdesk.com/75-of-cisson-punitive-damages-goes-to-georgia

and here

http://meshmedicaldevicenewsdesk.com/75-of-cisson-punitive-damages-goes-to-georgia

 

10 Comments

  1. sandy says:

    thank you Jane for this uplifting new news I sent a new wind is blowing and I hope that it will continue across all medical companies to see that we all are learning about their lives and your deception and it’s time to just stand up and pay the women what they deserve god bless you my dear for all you do you are an angel without you in this website I would have never learned what was killing me god bless you for your endless work in the mesh news arena please pray that this might be the year does these companies finally realize what they did wrong and that US women might just be able to find new hope your the bestest Jane

  2. sandy says:

    I am sorry their lies and deception. Hopefully Judge Goodwin eyes will be open also as he sees the cover up that these companies did and the toxic chemicals they put in our bodies let’s pray that God finally steps in

  3. Tammy says:

    Praise God, for Judge Goodwin’s knowledge and wisdom. Wish we had more judges with his heart. Thank you Jane, for your hard work and willingness to report on this topic. My prayers are with the the women and families with mesh problems. Thank the Lord, for the truth being seen.

  4. Betty Scott says:

    Yeah!!! The same so called doctor also implanted my mesh, he filled my pelvis with mesh three implants!! I think I am slowly dying from an immune problem, wouldn’t you think it was caused form this crap!!!! I worked with him and trusted him, now he being the good guy and giving testimony for our side!! His name is Brian Raybon from Toccoa, Ga. Stephens County Hospital, biggest mistake of my life!! He now also goes to Athens, Ga and still implants mesh, Miklos and Moore did the same thing for AMS, they are in Atlanta.

    • Jane Akre says:

      Interestingly he was an expert witness for the plaintiffs in the Boston Scientific case in Miami!

    • Marian Meguiar says:

      Dear Betty,

      I had my mesh put in April 2011, shortly afterward they said it was not good. I had no idea although I had problems from day one. I too am in Georgia. I had my mesh removed September 2014 by Dr. Hulse of Ellijay, Georgia. He is the best. I still have some problems but he thinks I will always have some problems. My mesh was from Boston Scientific and implanted in Lakeland, Florida (Drs. from Watson Clinic in Lakeland). I am so sorry for all women suffering because companies thought only of the Almighty Dollar and not how it would affect the recipients. I also want to thank Jane for her coverage and keeping us all informed. Hoping she will be in Charleston, W. Virginia on the 29th for the Pretrial Hearing Judge Goodwin has ordered. My attorney said six companies have been ordered to be present. Boston Scientific is one of them. Good luck.

      Marian

  5. David says:

    It is refreshing to see that the Honorable Judge Goodwin appears to be a U.S. Federal Judge interested in both THE TRUTH and upholding the integrity of his court (by considering the following case evidence, and in so doing, accurately characterizing the Defendant C.R. Bard, Inc., et al.’s conduct as: “reprehensible”), when he wrote: “This secretive conduct in an effort to sidestep the MSDS warnings suggests reprehensible conduct, weighing against remittitur.”

    In my case against this same Defendant (DAVID SCHMIDT vs. C.R. BARD, INC., et al., CASE # 2:11-CV-00978-PMP-PAL), however, the Honorable Judge Philip M. Pro of the United States District Court, District of Nevada was unwilling to consider this same evidence (as laid out in the following August 19, 2013, MEMORANDUM IN SUPPORT OF PLAINTIFF DAVID SCHMIDT’S MOTION TO RECONSIDER COURT’S ORDER GRANTING DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT):

    12. Prior to Plaintiff’s implant surgery and as early as 2004, Defendants were aware that the polypropylene pellets used to manufacture the Bard 3DMax Mesh were not to be used in permanent, implantable human medical devices via warnings from the polypropylene pellet manufacturer. Furthermore the manufacturer’s warnings also stated that the product may decompose if subjected to thermal processing or chemicals in the human body. (See Material Safety Data Sheet, attached hereto as Exhibit 6)

    13. Defendants ignored this warning and continued to use the pellets to make their mesh products, including the Bard 3DMax Mesh.

    14. Furthermore, Defendant Davol’s Vice President of Research and Development, Roger Darois, stated in email correspondence dated March 25, 2004 that Defendants’ use of the polypropylene should be hidden from other suppliers:

    “IMPORTANT…these suppliers will likely not be interested in a medical application due to product liability concerns. We purchase our polypropylene monofilament from an extrusion supplier who purchases the resin directly from the resin manufacturers. Thus, it is likely that they do not know of our implant application. Please do NOT mention Davol’s name in any discussions with these manufacturers. In fact, I would advise purchasing the resin through a 3rd party, not the resin supplier to avoid a supply issue once the medical application is discovered.” (See Plaintiffs’ Motion for Leave to Take the Supplemental Deposition of Roger Darois and the Deposition of Dan LaFever, attached hereto as Exhibit 7)

    15. In fact, Defendants created a separate entity, Red Oak Sales Company, to purchase the polypropylene resin so the resin supplier would not suspect it was being used to create permanent, implantable human medical devices in contravention of the supplier’s warnings. (See Exhibit 7, Page 3).

    16. Another company in the supply chain, Shakespeare, refused to supply Defendants with any additional polypropylene monofilaments once it learned of the warnings on the Material Safety Data Sheet. However, instead of being concerned for the eventual recipients of their medical devices, Defendant was only worried about meeting its supply demands and avoiding a disruption in their supply chain. (See Exhibit 7, Page 4). Defendant Bard’s General Counsel, Jack Myers, went so far as to offer Shakespeare indemnity if Shakespeare would agree to supply Bard with additional monofilament. Shakespeare refused. Id.

    —-

    Judge Pro stated, in his July 22, 2013 ORDER* granting the Defendant’s Motion for Summary Judgment, that the Defendant had “acted as a reasonably prudent medical device manufacturer” (even after “having read and considered Plaintiff Schmidt’s Motion to Reconsider Court’s” July 22, 2013 ORDER,** Judge Pro was still unwilling to consider the evidence of the case***). Apparently this Defendant’s understood “reprehensible conduct” in the state of West Virginia, is considered to be the actions of “a reasonably prudent medical device manufacturer” in the state of Nevada (or out in “the wild, wild west,” where the benefits of the law, are subjective to a judge’s preferential opinion of which facts he will consider, for the side he chooses to benefit).

    * http://docs.justia.com/cases/federal/district-courts/nevada/nvdce/2:2011cv00978/81705/143

    ** http://docs.justia.com/cases/federal/district-courts/nevada/nvdce/2:2011cv00978/81705/157

    *** Judge Pro stated he was not swayed “that Plaintiff’s hernia repair could have been accomplished without use of the 3DMax Mesh.” (Important to note: Judge Pro did not say ANY surgical mesh –in general but SPECIFICALLY indicated 3DMax Mesh –in particular). And, as the explant surgeon estimated that about 5% of the implants remain non-recoverable because of the risk of removal from critical groin structures – while also stating he saw no evidence of a hernia – how was my hernia “repair” able to be “accomplished” (with 95% of the implants recovered), if not for the particularities of “the design of the 3DMax Mesh in question…“to have resulted in: “the legal cause of the injuries [as] alleged by Plaintiff”?

    In my opinion, Judge Pro failed (in his role as a judge) to even fundamentally comprehend, when he wrote: “on April 18, 2007, Plaintiff David Schmidt underwent laparoscopic bilateral hernia repair surgery during which a 3DMax Mesh was inserted by surgeon Scott Gabriel, M.D.,” that Dr. Gabriel inserted two 3DMax Mesh devices into my groin, and consequently, the case of DAVID SCHMIDT vs. C.R. BARD, INC., et al. was for the defective design of TWO 3DMax Mesh devices.

    What CASE # 2:11-CV-00978-PMP-PAL evidenced: the failure of “a reasonably prudent medical device manufacturer” to have refrained from marketing a non-inert, polypropylene mesh device (made of polypropylene pellets which are “not to be used in permanent, implantable human medical devices”), but instead chose to fraudulently purport that their 3D mesh device was fit for its intended use (Bard 3DMax Mesh is dependent on the scarification response to remain fixated in place – a response that the defendant is unable to even predict, as stated on their behalf by David Ciavarella, M.D., in his February 24, 2010 letter to me****…a “staying in place prediction” that is not even possible for the FDA too also predicate, with a non-inert, polypropylene mesh device’s unpredictable, in vivo performance), while also made of heavyweight polypropylene mesh,*****and also of three-dimensional design –with mechanical pressures in the groin understood to result in higher incidences of chronic groin pain for patients.

    **** http://meshmedicaldevicenewsdesk.com/a-gold-standard-for-hernia-repair-and-the-patients-post-surgical-understanding-of-unreasonable-mesh-device-and-procedural-risks

    ***** Continuing on in the August 19, 2013, MEMORANDUM IN SUPPORT OF PLAINTIFF DAVID SCHMIDT’S MOTION TO RECONSIDER COURT’S ORDER GRANTING DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT):

    18. Dr. Heniford [formed American Hernia Society President] published a [2007] DVD describing the negative effects of heavyweight meshes such as Defendants’ 3D Max Mesh prior to the implantation of the product in Plaintiff. (See The Benefits of Lightweight Meshes In Ventral Hernia Repair DVD1, attached hereto, in part, as Exhibits 15 and 16) :

    DR. HENIFORD: . . . “The first mesh used in contemporary surgery was a heavy weight polypropylene that was invented in the 1950s, and essentially since then is almost unchanged. When we first started looking at this in the laboratory, we felt that this mesh was overengineered. Do you think the surgeon that invented heavy weight polypropylene in the 1950s had any idea how strong the abdominal wall was? Did he have any idea how much pressure could generate inside the abdomen?

    “Over the last decade or so, and specifically over the last half dozen years, a lot of, I guess, research has gone into figuring out the basic engineering of the abdominal wall. We now know how much pressure someone can generate inside the abdomen lifting weights, doing normal activities, and even, I guess, super-normal activities . . . So that mesh would be at least six times stronger than it needs to be.

    “One of the big negatives of the heavy weight mesh is that it truly is a foreign body. Every foreign body develops an inflammatory response, and the more foreign body, the greater the inflammatory response, typically. This is absolutely true for heavy weight polypropylene. When you look at 40x magnification, in these vacuoles where actually the mesh fibers used to be, what you will see is giant cells, giant white cells, and many, many white cells and inflammatory cells surrounding this mesh.

    “And does it ever go away? You see this at a week, you see this at four months, and you see this sitting here. And actually information statistically never changes. This mesh is chronically and constantly under attack. This is a pristine piece of heavy weight polypropylene, that looks very nice. This mesh was removed from a patient approximately one year after it had been implanted, and looking at it you can see how broken it is. When you start to study meshes like this, and more than just one mesh like this, what you see is that the meshes become oxidized. They shrink, they become more brittle. This mesh was described as 11 by 14 centimeters. It now is about the of 2-1/2 centimeters wide and about 7 centimeters high. It also is hard as a stone. For the most part, there is nothing about this mesh that is physiologic.

    “. . . All of these meshes shrank because of their inflammatory response, and the more inflammation, the more contraction of the mesh, more contraction of the wound that we see, the meshes becomes stiffer. And, again, you can see how stiff this mesh is.

    “This is a mesh tumor, and you can see what it looks like on the back table, how hard this mesh is, and you can picture why you can feel this mesh with essentially every abdominal movement. As a surgeon, if I fix a hernia with a heavy weight polypropylene mesh, and do not have recurrence, but the patient is able to feel that mesh for the rest of their life, the next 20, 30, 40, 50 years, then have I really done something for that patient long-term? The inflammation never goes away. There is never a decrease in the inflammation around the heavy weight meshes, and the meshes become very brittle, very firm, and it is, unfortunately, a lasting problem for the rest of the patient’s life . . .

    “NARRATOR: Studies have shown that light weight mesh triggers less of an inflammatory response and many patients can actually feel the difference.

    “DR. HENIFORD: Their mesh conforms to the abdominal wall, is flexible, is soft, and has good incorporation, without the long-term disadvantages of a heavy weight and the inflammation prone stiff mesh. When you break these meshes down, not only by their weight, but also by the pore size, heavy weight mesh at 95 grams per meter squared, mid-weight mesh at approximately half that, at 45 grams per meter squared, and light weight mesh, nearly one-quarter the weight of the heavy weight mesh at 28 grams per meter squared, what you will also see is that the pore size increases, dramatically, .6 millimeters, 10.4 millimeters and 5 millimeters, which allows for better tissue ingrowth, and also what we have seen in our laboratory is an improved vasularization of the mesh.

    “One study that we did here looking at over 300 patients where we put heavy weight polypropylene in their abdomen, 36 percent of our patients stated they could feel the mesh and it limited their activities . . . There really is not a reason to use a heavy weight polypropylene in the human body. The mesh is much, much stronger than it needs to be. And to say, well, this is the mesh I’ve always used, is not an excuse to continue to use it.

    “DR. HENIFORD: The undersurface of the mesh, where the small intestine, large intestine, other visceral, will be touching the mesh, you want to protect it, so you wouldn’t have tissue ingrowth from the intestine, fistula formation.

    NARRATOR: Because polypropylene is hydrophobic, it can be problematic to use a tissue barrier that is also hydrophobic.

    DR. HENIFORD: . . . Heavy weight polypropylene almost always can be seen on a CAT scan, either due to its thickness or the chronic inflammation around the mesh. In the light weight polypropylene, you are almost never able to see the mesh.”

    —-

    How was Judge Pro even able to conclude that: “although polypropylene mesh devices have been utilized in hernia surgery for many years, Schmidt experienced a rare and severe inflammatory reaction to the 3DMax Mesh device,” when the explant surgeon, although claiming during his disposition he did not even know what device he explanted, was able to recognize a heavyweight mesh (apparently only by the patients’ response alone to a heavyweight mesh)? What is indeed rare, is when a patient left to experience this as high as a 63% chronic pain rate documented in medical literature (which follows the modern mesh hernia repair: the standard of care or the best surgeon/manufacturer practice of reckless, indiscriminate surgical mesh and patient abuse), is able to find a surgeon willing to address the reason for his/her chronic pain (but of course not for the premeditative industry infliction of that pain).

    The case of DAVID SCHMIDT vs. C.R. BARD, INC., et al., in my opinion, was a gross miscarriage of justice carried out by the U.S. District Court, District of Nevada –and by Judge Philip M. Pro in particular, which I believe, sought to cover-up the historical truth: the surgical mesh industry has been deceptively, predatorily targeting unsuspecting patients “…for many years,” via use of its regressively trained surgeon perpetrators.

  6. kitty says:

    These dissertations are hard to follow-‘Howe er someone might be listening.

  7. Diane Elliott says:

    Prayers for David Schmidt, I HEAR YOU! MAY GOD BLESS YOU! I PRAY YOU WILL HAVE ANOTHER DAY IN COURT!

    • David says:

      Thank you Diane for your kind words of support and for listening. I believe I will still have my day in court, in which the evidence against C.R. Bard, Inc., et al. will be allowed to be presented (the five specific design defects of Bard 3DMax Mesh), and their subsequent negligence in defectively designing their device will be established as a matter of fact.

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