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Sherrer v. Boston Scientific Pelvic Mesh Trial Opening Arguments Underway in Kansas City, MO

logoMND, Dec. 2, 2015 ~ Sherrer v Boston Scientific, Kansas City, Missouri   1216-CV27879

Thanks to Courtroom View Network for live access to this trial!

At this writing the opening arguments are underway in the case of Eve Sherrer in her case against Boston Scientific over her Solyx pelvic mesh.  To complicate matters, two months after she had  the Solyx mesh implanted in October 28, 2010, she had a C.R. Bard Align pelvic mesh implanted because the first mesh did not stop her mild incontinence.

(THIS STORY WILL CHANGE AS MORE INFORMATION COMES IN DURING THE OPENING WHICH BEGAN AT 10 EST TODAY!  PLEASE CHECK BACK AS THE STORY EXPANDS! Tom Cartmell opening about Bard mesh has just been added this evening!))

Judge Robert M. Scheiber,, 16th Judicial Circuit Court, Missouri

Judge Robert M. Scheiber,, 16th Judicial Circuit Court, Missouri

Judge Robert M. Scheiber will hear the case in the 16th Judicial Circuit Court of Missouri courthouse. Jury selection began Monday.

The case is Eve Sherrer v. Truman Medical Center inc. et al Case No. 1216-CV27879. It was filed in state court October 26, 2012.

grant davis for plaintiffAttorneys are Tom Cartmell (Wagstaff & Cartmell, Kansas City, MO),  Joe Bertram, (Bertram & Graf, Kansas City, MO),  Grant Davis, (Davis Bethune & Jones Kansas City, MO).  Shook Hardy & Bacon LLP of Kansas City, MO represents Boston Scientific while CR Bard is represented by Nelson Mullins Riley & Scarborough LLP of Atlanta, GA. 

Boston Scientific is based in Natick, Mass and Cr Bard is based in Murray Hill, New Jersey.

OPENING ARGUMENTS

Attorney Grant Davis said Ms. Sherrer was only mildly incontinent when she was implanted with the Solyx on October 28, 2010.  Only after the Solyx mesh was implanted did she become incontinent.  Her attorney holds up the Solyx to show the jury.  The mesh has two anchor and is implanted in the pelvic region which is nerve rich and vascular, he says in a low-key delivery.Solyx sis system

Boston Scientific says its Solyx single-incision sling system (SIS) is designed to offer a procedure with fewer steps.  ”The mesh carrier tip snap-fits to the delivery device allowing for advanced control with micro-adjustability during placement.”  Additionally the polypropylene mesh is detanged, meaning its edges are looped and not raw resin tips, “to resist deformation” and “to potentially reduce irritation to the anterior urethral wall.”

When the mesh is removed you wouldn’t recognize it, Davis said.  Boston Scientific knew the mesh removal would have to happen. The company knew it was difficult to place the arrow-shaped anchors deep into muscle without causing pain.  They would pull out and not stay in place. If the anchors fail and mesh ingrowth occurs, which it does, the mesh is cemented into the wrong place.

Marlex mesh is NOT medical grade polypropylene, a large exhibit is shown to the jury.  It is followed by:

Medical Application Caution: Do not use this Chevron Phillips Chemical Company LP material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”

In July 2005 Boston Scientific internal document shows it signed a contract with Phillips Sumika where it assumes liability if it buys 10 years of Marlex mesh.  This was before the Solyx was launched.  In signing the letter, Boston Scientific engineer, Doreen S. Rao, said Boston Scientific would do the testing to determine if the mesh was safe for its intended use.

You will NEVER hear Boston Scientific say they were always careful in the way they obtained Marlex mesh, Mr. Davis said.

The mesh is approved by 510(k) process under the FDA which does not require clinical trials to assure safety.  Instead, it relies on the company’s representation that the product is safe.

The safety and effectiveness of the sling for SUI has never been demonstrated~ the slide says shown to the jury.

Boston Scientific has performed extensive testing to support that the material is safe for use as a long term permanent implant device, was the company’s reply.dr peter greenspan

Dr. Greenspan, the implanting physician, is also being sued along with Truman Medical Center Inc. of Kansas City.  In opening arguments, Mr. Davis said Boston Scientific taught Dr. Greenspan in a cadaver course, how to implant the Solyx. Boston provided all of the information he employed in using the device and the doctor said he installed the Solyx according to the teachings of Boston Scientific.

The dozens of pelvic mesh product liability trials heard so far, contend that the mesh is defective in its manufacture and design and in its instructions to physicians, who were kept in the dark about the dangers, therefore, could not provide true informed consent to patients.

NOT IN COMPLIANCE 

Inside the company it was a different story.  Lindsey Woodhull in a September 22, 2010 email writes: “ Technically, since we do not have proper sensitization data on the mesh material, and have not provided a rational for why we do not have that data, we are not in compliance with ISO 10993-1, any revision.”

What does this mean?

ISO is the International Organization for Standardization.  ISO 10993 is the biological evaluation of medical devices. The goal is to protect humans from potential biological risks arising from the use of medical devices. See more here and here.

This may be the first mention of international standards ever presented in a pelvic mesh trial.

Thomas Cartmell, for Plaintiff

Thomas Cartmell, for Plaintiff

BARD’S ALIGN MESH

After a mid-morning break, Tom Cartmell (Wagstaff Cartmell)  took his turn to address the jury about the Bard mesh also the subject of this dual-pelvic mesh trial, the Align S.  This is the first case that address injuries from two implants in one woman, raising the challenge to see if the jury accepts the notion that two meshes cause injury and two companies produce defective mesh.

Cartmell is pleasant and unravels an interesting tale of the history of pelvic mesh. The jury is allowed to take notes.

There are three safety principles jurors must remember, he says.  First, a medical device manufacturer must make sure its device is reasonably safe before it is sold. Second, a reasonable medical device manufacturer should adequately test its products before selling them, especially those that are permanently implanted, and a medical device manufacturer must provide adequate warnings about the risks and dangers associated with that device.  Expect Cartmell to return to these three safety principles throughout the trial.aaMarlex mesh phillips petroleum

Cartmell reminds jurors that heavyweight and small pore mesh was first used in the 1960’s for hernia repair. Hernia mesh is put in the abdomen.  But seeing a potential market, manufacturers were in a race to produce mesh to be used in women, transvaginally, that is, placed through the vagina.

Johnson & Johnson was first with its TVT, marketed in the  U.S. in 1998, and soon other “sling in a box” products were developed. Bard purchased the rights to the Uretex mesh, actually a knockoff of TVT, that the company began selling in 2002. In a neck-in-neck race, Boston Scientific launched  the Advantage sling in 2003.

Roger Darois, VP Bard

Roger Darois, VP Bard

Did Bard ever study the safety of the product to be used in women?  Roger Darois, a VP of Bard, answered ‘No’ in his deposition. The polypropylene used in the Bard pelvic mesh was not medical grade and it was heavy weight and small pore, similar to its hernia-mesh cousin.

Small pores create a scar plate  while blood vessels and fat integrate better into larger pore mesh of 3 cm or more.   The Bard mesh was less than 1 cm and could produce a scar plate that hardens, contracts and encapsulates nerves.  Bard knew this, said Cartmell, but did nothing to make a larger pore pelvic mesh.

The vagina is not the abdomen, he stressed.

Darois is the same person, you may recall, who was instrumental in making sure that the polypropylene supplier, Phillips Sumika, did not know Bard was using the raw resin supplied by the petroleum company for an implantable medical device.  He helped create the dummy company, Red Oaks, as a buffer between the supplier and the medical device maker so the supply chain wouldn’t be interrupted.

This information was first presented in the Cisson trial in 2013. See the MND Cisson trial for that story here.dr richard hill truman medical kansas city

Ms. Sherrer was a 62-year-old nurse working at Truman Medical Center. When her first pelvic mesh implant, the Boston Scientific Solyx, failed, Dr. Richard Hill took out part of the Solyx and implanted the Align over it. That was January 3, 2011. Three months later she started having chronic pain in the lower right quadrant and was referred to pain management.

Eventually she had a mesh removal surgery by world-renowned Dr. Shlomo Raz at UCLA who reported he had to pull pelvic mesh from her obturator and retropubic space and thought he got it all out.  Mesh was found in her inguinal area and Ms. Sherrer later developed a hernia, which was repaired without mesh.

Future surgeries will be needed, said Tom Cartmell including rebuilding her vagina. She continues to see pelvic pain specialist Dr. Erin Carey at Kansas University Hospital.

DEFENSE ARGUMENTS 

       Lori Cohen  and team in Charleston, 2013

Bard attorney, Lori Cohen and team in Charleston, 2013

Appearing in the afternoon for the defense was Boston Scientific’s attorney Robert Adams of Shook Hardy & Bacon LLP. He insisted the Solyx is safe and that Ms. Sherrer had a complicated medical history, including a hysterectomy.

Adams assured jurors that polypropylene mesh has been approved by the Food and Drug Administration. Thee are no risk-free medical devices, he said.

Lori Cohen of Greenberg Traurig said the Align is the “gold standard” for pelvic mesh products.

 

BACKGROUND ON BOSTON SCIENTIFIC

Boston Scientific  has 19,577 cases pending in MDL and numerous other cases filed in state courts around the country. The company has suffered a number of losses and a few wins before a jury. Among them:

*July 2014 – The Albright case, also heard in the same Woburn, Mass courtroom over the Pinnacle pelvic mesh, ended with the first jury decision for the defendant, Boston Scientific.  See MND story on what went wrong here.

*August 2014 – Boston Scientific received a favorable jury verdict in the Maria Cardenas case in Massachusetts where the jury ruled her Obtryx mesh was not defectively designed. See the stories here and here.

*September 2014 – Boston Scientific lost a $73.5 million verdict in the case of Martha Salazar who was implanted with an Obtryx bladder sling.  The jury also found Boston Scientific was “grossly negligent” and included $50 million in punitive damages. That amount was later reduced by half due to tort reform.  See story here.

*November 2014 – A Miami jury delivered a $26.7 million verdict to four women injured by the company’s Pinnacle mesh. See the story here.

*November 2014 –  Boston Scientific lost $18.5 in another jury trial, this one in Charleston, WV where the verdict went to the four plaintiffs plus an additional $1 million in punitive damages. See Tyree v Boston Scientific (2:12-cv-08633) The jurors there too concluded the company acted with “gross negligence.”

*April 2015 – Boston Scientific settled about 3,000 cases for $120 million.

*May 2015 – The jury in the case of Barba v. BSC issued an unprecedented $100 million award in May. That verdict was later reduced by the Delaware federal judge to $10 million and BSC was denied a new trial. See the MND story here.

*May 2015 – The Los Angeles trial of Sanchez v. Boston Scientific settled just before it went to the jury last May (2:12-cv-05762).  See that MND story here.

*October 2015 – In October the jury found for Boston Scientific in a Statesville, North Carolina courtroom in the case of Martha Carlson, who had been implanted with an Uphold pelvic mesh to treat pelvic organ prolapse (POP). The case was a defense pick. See it here.

In April of this year, the company offered to settle 3,000 pelvic mesh cases for $119 million.  See the MND story here. #

16 Comments

  1. kitty says:

    Very nice reporting jane

  2. K says:

    Thank you, Jane!

  3. Payton says:

    Hi Jane,Is there any news that you may have heard on when C.R.Bard cases will be heard or settlement talks in New Jersey. The Last I heard Bard was trying to settle most of its cases.

    • Jane Akre says:

      It’s probably going on quietly behind the scenes. If anyone wants to add their 2 cents here……

      • George says:

        Hello Jane and Payton,

        Received a settlement from Bard/DaVol a year ago, typically in December, so they can use the tax break.

        Agreed to not disclose the amount. They came up with a table that matched mesh medical problems with a settlement amount. My two teams of lawyers got 48%. Total amount was similar to what the six mesh related surgeries have cost to date. Still having problems and more surgery looming as I get strength back from the latest complication and surgery. Two mesh explants were rock hard and loose in my abdomen. Sure getting a settlement was good, as I am disabled, but probably was covered by Bard/DaVol insurance, so was of little financial impact to this huge corporation.

        Sorry no Walt Disney ending for me to report. Would happily return the money, times two, for a healthy body.

        Thanks Jane for your tireless work!

        George

        • Bejah Blue says:

          George, Thank you so much for sharing a little of your life story after settlement wars, how you are feeling, your quality of life, your mood. “They” (The evil others) think we just look for money because that is what they look for in life. In truth we look for some path to the best wellness we can find and the capacity to afford it. If you do not feel well a three masted schooner is not going to bring you much joy to sail. I sense sorrow in your “voice”, and along with that something of the relief that it is over. The now well illustrated story of what the rest of your life will generally be like given these legal and financial realities looms before you. The missing piece is, of course, how you choose to come to terms with all of this, what happiness you can find, what wellness you can try to create for yourself. You are not alone. We hope the worst is over for you now. Stay strong, GOD bless. Embrace whatever happiness you can find and share it so that it lives long.

          Bejah

  4. John says:

    I wonder just how many pelvic mesh products, produced by each manufacturer, are being presented to different juries as the “gold standard”? They can’t ALL be the gold standard unless they are referring to the gold that fills their bank accounts resulting from the sales of these products.

    • Bejah Blue says:

      Good one John. My guess would be that subliminally, that is their take away from that stinking catch phrase “Gold standard”. Hate those catch phrases. Also, this one reminds me yet again that our currency was taken off of the real “Gold standard” by Reagan or some other cowboy (in the 1970’s?) and THAT makes my blood boil. Now we have a currency that is probably not worth much and I can not help but think that whatever it is worth is owned by the Chinese. Do you think Johnson & Johnson cares so long as they are making money? Well, at least we do not need to worry so about our stash of gold bars…because the ones that have not already been shipped offshore, are either lead spray painted gold or do not belong to us any longer. So maybe we can save money guarding what it left of it. Why keep Ft. Knox open at all? Why not just bulldoze it? Because the people like to know it is there, that symbol of America, or what was America. Imagine how upset people would be if it were bulldozed?

      Then there is that other fav catch phrase….”The golden years” which I actually believed in when I was in my 30’s or so. The only thing golden about it for most of us has to do with emptying our bladders or the problems related to doing so. This while that top “1-2%” of the population laughs all the way to the bank.

      Hmmmm….”gold standard”, “golden years”….seems like a sort of theme going here.

      A young woman from Minnesota came to CA and was hired as a secretary at the place I was working and she really thought that the streets in Hollywood/LA/California were “paved with gold”. I am not sure where she got that but can you imagine what these Syrian refugees now clawing at our doors must think about our alleged golden streets? We do not even know who they are…but we do know it is a path to the west for terrorists or radicalized Islamic young people. We need to close our borders folks, just like we need to deny mesh manufacturer’s access to our wombs we need to deny access to our nation to Syrian and other refugees from the Middle East and other dangerous entry points (I’ll bet you wondred how I was going to manage that segway)! There are important lessons in this example even though it is far fetched. We need to protect our nation just as we need to protect our bodies, especially in time of war and make no mistake, this is, all of it, WAR.

      Bejah

  5. Deb says:

    Thank you, Jane, for the updates on the court case…it does help!

  6. karen says:

    If vaginal mesh hard polypropylene plastic belong in women then why are we going to court ?????? Since money is all these corporations think about it should have been planted in everyone , but they picked women to used as guinea pigs.

  7. Still Standing says:

    Women, please understand that Ms. Cohen is doing her job. It could be possible that she does not hold the same belief about the products as those she represents. Many attorneys represent those in trials who they dont completely believe. Try to look at what she does in court as her job, nothing else. The defendants have the legal right to pose questions and put doubt into the minds of the jurors. She is not lodging personal assaults at the victimes and we should not be hurling nasty comments at her. It demeans us.

    • Jane Akre says:

      Agreed, we need to be civil… I will monitor more carefully. Everyone is due a defense, even corporations.

    • Bejah Blue says:

      Oh Dear, I hope this does not refer to something I said, I don’t think so. I agree, of course that attacking defense counsel, outside of extreme circumstances is inappropriate and reflects poorly on us. I like to think we are held to a higher standard and hold ourselves to a higher standard. BUT if I were Ms. Cohen I would decline to represent this defendant and if this firms clientele was consistently entities that engage in what one might call questionable corporate conduct I would seek employment elsewhere, but that’s just me, and just theoretical.

      Bejah

  8. Terri says:

    I honestly believe if EVERY Juror had to view the photos from both Dr. Raz and Dr. Veronkis of the removals, the mesh migration into the vaginal wall ,rectum, bladder, urethra etc. and then read every single pathology report where a huge majority of them clearly show chronic inflammatory cells (host for disaster) the damaged tissue etc I honestly wish every single mesh injured woman could come together and win this battle and prevent this harm from happening to others.

    • Bejah Blue says:

      Totally agree. I am going to guess that the defense would object to any such display for obvious reasons. They really seem to get away with murder. They range of things they are permitted to object to makes my blood boil and I would like to know the justification for each one. I imagine these cases are studied in law schools…probably focusing on how defendant corporations can justify themselves in making such objections and get away with it. When did law schools stop teaching how to do the right thing?

      Bejah

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