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 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.
Attorneys 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.
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.
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.
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.
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.
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.
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.
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.
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. #