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Ethicon 12/3
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Ethicon Can't Duck Patients' Defect Claims In Mesh MDL
Dec 2, 2015 | Law360
By Sndhu Sindar
Johnson & Johnson's Ethicon Inc. failed Wednesday to defeat design-defect claims brought by West Virginia patients in multidistrict litigation over its mesh product meant to treat stress urinary incontinence, as a federal judge found their state-law claims are not preempted by federal regulators' approval of medical devices. -
Boston Scientific, Bard Must Pay For Mesh Injury, Jury Told
Dec 2, 2015 | Law360
By Brandon Lowrey
A woman who claims defective pelvic mesh implants rendered her incontinent urged a Missouri jury Wednesday to findBoston Scientific and C.R. Bard liable for her injuries, saying the devices caused a litany of problems, including pain, difficulty walking and a "nonfunctional vagina." -
Pelvic Mesh Caused Irreversible Conditions, Pa. Jury Hears
Dec 2, 2015 | Law360
By Dan Packel
Counsel for an Indiana woman with pelvic organ prolapse told a Philadelphia jury Wednesday that a Johnson & Johnsonunit's mesh rendered her unable to have sexual intercourse and caused bladder dysfunction, in the first pelvic mesh case to go to trial in the jurisdiction. -
Boston Scientific Transvaginal Mesh Case Remanded to Florida State Court
Dec 2, 2015 | HarrisMartin Publishing
A West Virginia federal judge has remanded a Boston Scientific transvaginal mesh action to Florida state court, holding that the nondiverse healthcare providers were not fraudulently joined because the claims against them arise from the same transaction. -
Sherrer v. Boston Scientific Pelvic Mesh Trial Opening Arguments Underway in Kansas City, MO
Dec 2, 2015 | Mesh Medical Device News Desk
By Jane Akre
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.
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Ethicon Can't Duck Patients' Defect Claims In Mesh MDL
Dec 2, 2015 | Law360
By Sndhu Sindar
Johnson & Johnson's Ethicon Inc. failed Wednesday to defeat design-defect claims brought by West Virginia patients in multidistrict litigation over its mesh product meant to treat stress urinary incontinence, as a federal judge found their state-law claims are not preempted by federal regulators' approval of medical devices.
U.S. District Judge Joseph Goodwin denied the summary judgment motion by J&J and its Ethicon unit, finding that the injured patients' state-law claims, which target the safety of their mesh products, do not interfere with the U.S. Food and Drug Administrations' approval process for such devices.
His ruling cited the U.S. Supreme Court's 1996 decision in Medtronic v. Lohr, in which the high court found that the 510(k) clearance process for medical devices — which requires new products to demonstrate their "equivalence" to approved ones — doesn't preempt design defect claims brought under state law. Since the approval process emphasizes "equivalence" and not safety, the state law claims are not preempted, Judge Goodwin found.
"A preemption inquiry is not logically triggered unless state law actually poses some impediment to federal law. The defendants’ preemption argument does not pass this basic test." Judge Goodwin said.
"The fact that a medical device would, in the course of its life cycle, come into contact with a state safety requirement and an unrelated federal clearance process is irrelevant for preemption purposes," he added. "Contact is not conflict."
He stressed also that the high court's Lohr decision resonates strongly in these device preemption disputes, because it had "unquestionably determined" that it was not the intention of Congress for the 510(k) process to undermine state tort laws, according to his ruling.
Judge Goodwin's ruling came in a case that consolidates design defect claims in 37 of the roughly 23,000 suits against Ethicon and J&J in the MDL. The 37 suits target Ethicon's Tension-free Vaginal Tape devices, which the patients claim caused problems including pain and injuries that required corrective surgeries.
The consolidated suits involve West Virginia plaintiffs who had surgery in the state to implant the company's TVT mesh device. Because the surgeries all occurred within West Virginia, the suits are subject to the state's relevant laws, Judge Goodwin had said in an earlier ruling upholding his decision to consolidate the cases.
Ethicon and J&J are represented by David B. Thomas of Thomas Combs & Spann PLLCand Christy D. Jones of Butler Snow LLP.
The plaintiffs steering committee is represented by Renee Baggett and Bryan F. Aylstock of Aylstock Witkin Kreis and Overholtz PLC and Thomas P. Cartmell and Jeffrey M. Kuntz of Wagstaff & Cartmell LLP.
The MDL is In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, case number 2:12-md-02327, in the U.S. District Court for the Southern District of West Virginia. -
Boston Scientific, Bard Must Pay For Mesh Injury, Jury Told
Dec 2, 2015 | Law360
By Brandon Lowrey
A woman who claims defective pelvic mesh implants rendered her incontinent urged a Missouri jury Wednesday to findBoston Scientific and C.R. Bard liable for her injuries, saying the devices caused a litany of problems, including pain, difficulty walking and a "nonfunctional vagina."
Grant L. Davis of Davis Bethune & Jones LLC, attorney for plaintiff Eve Sherrer, told jurors during opening arguments Wednesday that his client suffered because Boston Scientific Corp. used a type of mesh in its Solyx implants that shouldn't have been implanted in human beings because there was no safe way to take it out.
"If it needs to come out, they're going to take out nerves, muscle, tissue with it — it actually looks almost like a shish kabob," he said. "When these things finally come out, you wouldn't recognize them because it's flesh all over the sling itself. Boston Scientific knew that the mesh removal would happen and they didn't do anything to make sure it would happen safely."
The case centers on Boston Scientific's Solyx device and Bard's Align device. The defendants argued that the implants are safe and effective, and that other issues, including doctor error, past surgeries and medical problems, caused Sherrer's problems.
Sherrer's attorneys told jurors that the Marlex-brand mesh in both devices wasn't medical grade, and that the devices caused pain and were prone to failing and shifting inside the body. The mesh was not designed or intended for permanent implantation, Davis said.
That fact prompted the mesh manufacturer to refuse to extend its contract with Boston Scientific for use with medical devices, he said. But Boston Scientific cut a deal in which it would buy 10 years' worth of the Marlex mesh at once and would release the manufacturer from liability, Davis added.
The U.S. Food and Drug Administration had expressed concern over potential safety risks with the product in a 522 order, which demanded that Boston Scientific must conduct a post-market surveillance study.
Thomas Philip Cartmell of of Wagstaff & Cartmell LLP said medical device companies, in a race to profit, used mesh designed for abdominal applications for the vagina without testing, despite the fact that the tissue areas are vastly different.
The Marlex mesh destabilized and degraded inside the body because it wasn't intended for medical use, he said.
"This is polypropelene that is supposed to be used for carpet backing. It's supposed to be used for ropes and cords," Cartmell said. "It's not medical-grade polypropelene that they decided to use."
Bard, he said, set up intermediary companies to buy the Marlex resin directly from its manufacturer, Chevron Phillips Chemical, while intentionally keeping it a secret from Chevron Phillips that the materials would be used in medical implants.
Sherrer received her Solyx implant in October 2010. The implant was partially removed, and an Align device implanted in January 2011. Pieces of both devices were removed in April 2014, and she had an additional surgery in August.
The defendants argued that the implants are safe and still on the market today, and that the problems were caused by other factors.
Bard attorney Lori Cohen of Greenberg Traurig LLP said that the company fully complied with FDA standards, and that its device remains the "gold standard" treatment for stress urinary incontinence. The device worked and benefited the patient until a doctor needlessly removed the Align and caused more damage, she said.
She also added that Sherrer had other pelvic floor surgeries dating back to 1997. More surgeries mean more scarring and potential for problems, Cohen said.
Cohen also pointed to Sherrer's other past medical issues, including severe osteoarthritis and degenerative disc disease, among others, as alternative causes for her alleged injuries.
Cohen said Marlex mesh has been implanted into patients for more than five decades, with great success and benefits to patients. The raw materials are also not the same as end-product mesh, she said.
In addition, Bard warned Sherrer's doctor, who, in turn, warned Sherrer, about possible risks of the Align implant, Cohen said.
Sherrer is represented by Joe Scott Bertram and Blair Bertram Matyszczyk of Bertram & Graf LLC; Grant Lavalle Davis and Shawn Foster of Davis Bethune & Jones LLC; Thomas Philip Cartmell, Diane K. Watkins, Andrew N. Faes and Jeffrey M. Kuntz of Wagstaff & Cartmell LLP; and Valley Renshaw and Kaitlyn Jennifer Syring.
Boston Scientific is represented by Robert Thomas Adams, Jon Andrew Strongman, Adrienne Leigh Hernandez, Bryan T. Pratt, Michael J. Kleffner and Matthew David Keenan of Shook Hardy & Bacon LLP.
Bard is represented by Lori Cohen and Cliff Merrell of Greenberg Traurig LLP.
The case is Sherrer v. Boston Scientific, et al., case number 1216-CV27879, in the 16th Judicial Circuit of Missouri. -
Pelvic Mesh Caused Irreversible Conditions, Pa. Jury Hears
Dec 2, 2015 | Law360
By Dan Packel
Counsel for an Indiana woman with pelvic organ prolapse told a Philadelphia jury Wednesday that a Johnson & Johnsonunit's mesh rendered her unable to have sexual intercourse and caused bladder dysfunction, in the first pelvic mesh case to go to trial in the jurisdiction.
Patricia Hammons is accusing J&J and its Ethicon Inc. unit of overlooking negative side effects associated with its Prolift pelvic mesh product and hiding the risks from her implanting surgeon.
Her attorney Shanin Specter of Kline & Specter PC said that the implant's use was avoidable and that Ethicon ignored its internal guidelines in putting Prolift on the market.
“Ethicon rushed to get the product to the market even when complications were occurring to women in its initial premarket testing,” Specter said. “They violated their own internal written standard and kept moving forward anyway.”
He brandished the Prolift packaging — approximately the size of a packet of copy paper — and unfurled the implant before the jurors before detailing the effects of Hammons’ 2009 surgery. An Indian physician implanted the product between her bladder and her vagina in an effort to correct the sagging of her internal organs.
“She basically cannot have sexual relations,” Specter said, adding that “shards” of the product were now embedded in her bladder wall, could not be removed and caused urinary dysfunction.
“They are regrettably untreatable,” he said of these conditions.
Specter constructed an elegant story about the flaws of Prolift’s design, noting that it incorporated far too much mesh with far too few holes, making it harder for healthy tissue to grow around it when implanted. Instead, the construction of the mesh prompted the growth of scar tissue, which contracts over time, pulling the mesh with it, and ultimately causes the vagina to shrink.
He noted that jurors would hear a number of Ethicon and J&J employees testifying in depositions about the flaws of the product and Ethicon’s eagerness to get it to the market to beat the competition.
And he highlighted several other strategies for the treatment of pelvic organ prolapse, including the use of better mesh, which was on the market when the Prolift product was implanted in Hammons.
A lawyer for Ethicon defended the use of Prolift in Hammons’ surgery.
“It was the best product to be used at the time, and it worked,” Susan Robinson ofThomas Combs & Spann PLLC told the jury.
Robinson said that Hammons’ complaints were likely traceable to several other surgeries aimed at treating her condition, including a vaginal hysterectomy.
The defense attorney also told the jurors that pelvic implants made of polypropylene — the material in Prolift — had been evaluated and observed for years since gynecologists began using mesh designed for abdominal hernias in surgeries.
Robinson also defended the deposition testimony of Dr. Michael Heit — who performed two surgeries on Hammons that included removing some of the mesh.
Specter had suggested that Heit reversed his earlier belief that the mesh was flawed because of his financial relationship with Ethicon. Robinson responded that his change in position stemmed from evidence revealed in a follow-up exam.
And Robinson emphasized that the doctor who performed the original implant was certainly aware of the risks.
“A physician who’s been through medical training would be hard pressed to not know about the potential problems,” Robinson said.
The trial is expected to last for two weeks.
Hammons’ case is one of over 180 pending in a mass tort in the Philadelphia County Court of Common Pleas. Four others have been listed for trial. According to plaintiffs counsel in May, there are some 26,000 claims pending against Ethicon in a multidistrict litigation in West Virginia and nearly 8,000 in the consolidated litigation in New Jersey.
The plaintiffs are represented by Shanin Specter, Lee Balefsky, Kila Baldwin and Michelle Tiger of Kline & Specter PC.
The defendants are represented by Susan Robinson of Thomas Combs & Spann PLLC, Matthew Moriarty of Tucker Evans LLP, Molly Flynn of Drinker Biddle Reath LLP, and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
The case is Hammons v. Ethicon Inc. et al., case number 130503913, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia. -
Boston Scientific Transvaginal Mesh Case Remanded to Florida State Court
Dec 2, 2015 | HarrisMartin Publishing
A West Virginia federal judge has remanded a Boston Scientific transvaginal mesh action to Florida state court, holding that the nondiverse healthcare providers were not fraudulently joined because the claims against them arise from the same transaction.
On Nov. 20, Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia further found that at least one common question of law or fact exists between the claims against BSC and the healthcare providers.
Dixie Bartlett was implanted with a BSC “Pelvic Floor Lift and Sling Advantage Kit” to treat her pelvic ...
Subscription required, for full article please see: http://harrismartin.com/article/20152/boston-scientific-transvaginal-mesh-case-remanded-to-florida-state-court/
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Sherrer v. Boston Scientific Pelvic Mesh Trial Opening Arguments Underway in Kansas City, MO
Dec 2, 2015 | Mesh Medical Device News Desk
By Jane Akre
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 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.
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.
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. 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.
DEFENSE ARGUMENTS
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.
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 storieshere 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 theMND story here. #
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