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Ethicon Media Monitoring 2/11/2019
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Boston Scientific redesigns, upsizes mesh sling system for men with stress urinary incontinence
Feb 8, 2019 | Fierce Biotech
By Conor Hale
Boston Scientific has launched a redesign of its mesh sling system, a surgical implant for relieving stress urinary incontinence in men, to make it easier to place and available to a broader population of men. -
Boston Scientific, Coloplast transvaginal meshes in spotlight as FDA panel nears
Feb 11, 2019 | MedTech Dive
By Maria Rachal
FDA is seeking better evidence to assess how safety and effectiveness outcomes for pelvic organ prolapse (POP) patients from native tissue repairs stack up against those from certain transvaginal mesh implants, the subject of class action lawsuits and international regulatory scrutiny for more than a decade. -
No Jackpot in Philadelphia's First Talc-Asbestos Trial; Judge Rules Plaintiff Has No Evidence
Feb 8, 2019 | Forbes (also in The Pennsylvania Record)
By Nicholas Malfitano
...Just last week, a jury awarded $25 million in punitive damages as part of a $41 million verdict in a pelvic mesh case. Defendants have vowed to appeal.
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Boston Scientific redesigns, upsizes mesh sling system for men with stress urinary incontinence
Feb 8, 2019 | Fierce Biotech
By Conor Hale
Boston Scientific has launched a redesign of its mesh sling system, a surgical implant for relieving stress urinary incontinence in men, to make it easier to place and available to a broader population of men.
Positioned through a minimally invasive procedure, the sling compresses, moves and supports the urethra, helping the bladder to fully close. The most common causes of stress incontinence in men include complications following surgery and prostatectomies.
The company’s AdVance XP system includes a chevron-shaped anchoring mechanism for additional stability, as well as a longer sling length to accommodate larger patient anatomy, following discussions with urologists to identify patient needs, the medtech giant said.
The new features aim to reduce slippage of the device following its placement or during physical activity, including changes to the mesh weave to help uniformly distribute the load.
According to Boston Scientific, the AdVance XP system has been used in the treatment of more than 20,000 patients globally, ahead of its U.S. launch. The company estimates about a half-million men worldwide suffer from stress urinary incontinence, with between 8,000 and 9,000 slings being implanted annually.
Boston Scientific also offers transvaginal mesh implants for treating stress urinary incontinence in women. The company has been the subject of adverse event lawsuits numbering in the tens of thousands related to its pelvic mesh products, as have other manufacturers in the medical device industry.
https://www.fiercebiotech.com/medtech/boston-scientific-redesigns-upsizes-mesh-sling-system-for-men-stress-urinary-incontinence
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Boston Scientific, Coloplast transvaginal meshes in spotlight as FDA panel nears
Feb 11, 2019 | MedTech Dive
By Maria Rachal
FDA is seeking better evidence to assess how safety and effectiveness outcomes for pelvic organ prolapse (POP) patients from native tissue repairs stack up against those from certain transvaginal mesh implants, the subject of class action lawsuits and international regulatory scrutiny for more than a decade. A randomized controlled clinical trial is needed to compare the benefit/risk and safety of mesh products compared to native tissue treatment to repair POP, according to documents released ahead of a meeting of the obstetrics and gynecology device advisory panel Feb. 12.
In conjunction with shifting the devices to the highest-risk Class III review category in 2016, FDA required manufacturers seeking to remain on the market to submit premarket approval applications, a step taken by Boston Scientific and Danish company Coloplast.
Citing a review of medical literature and more than 11,000 adverse event reports, agency staff noted that "evidence from RCTs demonstrate that at 12, 24 and 36 months, safety outcomes favor native tissue repair." FDA is seeking expert input on study design, including how to weigh anatomical versus subjective factors, what constitutes an optimal patient population and physician training.Dive Insight:
Surgical mesh has been used for decades, with the first transvaginal product for pelvic organ prolapse repair officially cleared as a Class II device by FDA in 2002. The implants are used as reinforcement when muscles and tissue of the pelvic floor weaken and displace, often years after child birth.
Between January 2008 and October 2018, the agency found 10,391 Medical Device Reports citing serious injury, 806 citing device malfunction, and 77 citing death related to the products. FDA also noted that its review found mesh erosion or exposure occurs for between roughly 11% to 18% of patients who undergo mesh-based repair.
FDA flagged issues surrounding surgical mesh for transvaginal repair of POP in a 2008 public health notification. Adverse effects include pelvic pain, infection, bleeding and vaginal scarring, and a JAMA study publishedin January said women who experience these complications may be at higher risk for new-onset depression or self-harm.
The agency argues that safety and effectiveness outcomes for mesh products must be studied beyond 12 months, with follow up to examine long-term adverse events and durability.
"The FDA understands that patients and physicians may be willing to take on greater safety risk with increased likelihood or magnitude of effectiveness (e.g., patients with recurrent prolapse). Because this device type is an implant, the FDA believes that favorable/benefit risk should be established long term," FDA said in a document released Friday morning.
In 2011, FDA issued a safety communication and followed it up with a risks/benefits consideration meeting, from which the agency went on to issue 131 orders for postmarket surveillance studies to 34 manufacturers, most of whom chose to instead cease marketing their products, FDA said. In 2014, FDA issued proposed orders to reclassify the devices, which became official in 2016.
PMA applications to remain on the market were due by July 5, 2018. All manufacturers of products for posterior prolapse exited the market, while Boston Scientific and Coloplast moved forward with anterior prolapse devices.
FDA said there are currently four ongoing studies for five devices, results of which FDA will consider in evaluating safety and effectiveness of Boston Scientific Uphold LITE, Boston Scientific Xenform, and Coloplast Restorelle DirectFix Anterior.
Coloplast in prepared materials argued that "patients and surgeons need options," which Boston Scientific echoed in saying that treatment options ought not be considered "one-size-fits-all." Boston Scientific also said its required postmarket surveillance studies "demonstrate improved efficacy and fewer complications compared to much of the literature presented during the 2011 FDA panel meeting" and that the company's mesh devices "demonstrate a favorable benefit/risk profile for properly chosen patients in the hands of properly trained surgeons."
Notably absent from PMA consideration is Johnson & Johnson, whose Ethicon pelvic meshes have resulted in at least 37,000 product liability claims against the company, according to a recent quarterly regulatory filing.
The American Urogyencologic Society, among the professional group presenters, affirmed its support for continued market availability of these devices in its prepared testimony released ahead of the meeting.
The group said restricting products from the market would adversely impact registries that have been set up to compare outcomes from different types of mesh and that in decreasing access to regulated devices, the medical community would lose the benefit of having "surveillance and benchmarking analyses."
"If mesh devices marketed for prolapse were to be removed, we would lose the ability to use Unique Device Identifiers it is likely that some surgeons would, in their advocacy for their patients, feel the need to return to practice of devising their own techniques, which would curtail our ability to perform device surveillance and benchmarking analyses," the society wrote.
More broadly, FDA called out technologies related to women's health as among the important focuses of last year's Medical Device Safety Action Plan. FDA said it wants to build a public-private registry network to better capture real world evidence.
https://www.medtechdive.com/news/boston-scientific-coloplast-transvaginal-meshes-in-spotlight-as-fda-panel/547651/
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No Jackpot in Philadelphia's First Talc-Asbestos Trial; Judge Rules Plaintiff Has No Evidence
Feb 8, 2019 | Forbes (also in The Pennsylvania Record)
By Nicholas Malfitano
Companies facing million-dollar lawsuits in Philadelphia can celebrate today, as what would have been the first talc-related asbestos trial held in the city has seen a judge cut off the plaintiff’s case before it could ever get to a jury.
On February 7, Philadelphia County Court of Common Pleas Judge Kenneth Powell granted a motion for summary judgment from Theresa M. Mullaney of Kent & McBride, counsel for defendant Colgate-Palmolive Company.
This comes after Powell refused to let the plaintiff’s expert testify that Cashmere Bouquet-brand cosmetic talcum powder, made by Colgate, caused Sally Brandt’s mesothelioma - a deadly cancer linked to asbestos exposure.
Powell’s one-page order granted the defense’s renewed request for judgment, filed after Powell disqualified the plaintiff’s expert, Dr. James Millette.
“Now that Dr. Millette’s testing opinions have been excluded, Ms. Raterman (an industrial hygienist testifying for the plaintiff) has no foundation for her opinion, and Plaintiffs have no other expert testimony that could create a triable issue on the question of whether Colgate’s product caused Ms. Brandt’s disease,” Mullaney wrote in Colgate’s motion.
Despite a debate over the science, talc-asbestos cases have resulted in stunning verdicts around the country.
Most notable of these is a $4.7 billion verdict in St. Louis against Johnson & Johnson on behalf of 22 women who were diagnosed with ovarian cancer.
Legal Newsline previously reported that the plaintiffs’ attorney, Mark Lanier of Texas, used unorthodox props like a block of cheese to convince the jury that the science was on his side.
Verdicts in Philadelphia have been a concern for business and legal reform groups. Just last week, a jury awarded $25 million in punitive damages as part of a $41 million verdict in a pelvic mesh case. Defendants have vowed to appeal.
The city has long been a target for pharmaceutical lawsuits from out-of-state plaintiffs, as its Complex Litigation Center houses thousands of Risperdal and Xarelto cases.
The Brandt talc case dates back to December 31, 2015, and was filed by Charles Brandt of Duncannon, as executor of the estate of Sally Brandt against Bon-Ton Stores, Inc. (doing business as “Pomeroy’s Department Store”) of York; Charles B. Chrystal Company of New York City; Colgate-Palmolive Company of Harrisburg; Whittaker Clark & Daniels of Newark, N.J.; and Imerys Talc America, Inc. of Wilmington, Del.
The case alleged that Sally developed mesothelioma from Cashmere Bouquet-brand cosmetic talcum powder, manufactured by Colgate. This causation argument was supported by opinions from four experts, geologist Sean Fitzgerald, pathologist Ronald Gordon, industrial hygienist Raterman and pathologist John Maddox.
Fitzgerald and Gordon both previously stated that they claimed to have found asbestos in test samples of Cashmere Bouquet talcum powder.
However, after a Frye hearing, their opinions were deemed unreliable due to “numerous methodological flaws” in their research and excluded from future testimony on September 25, 2017.
As a result, Colgate-Palmolive filed a motion for summary judgment on November 16, 2017, arguing that the exclusion of Fitzgerald and Gordon’s opinions ensured the plaintiffs had no evidence to create a triable issue of fact that Sally was exposed to asbestos through using Cashmere Bouquet-brand talc, and that this caused her mesothelioma.
Plaintiff counsel, the Locks Law Firm of Philadelphia and Waters & Kraus of Dallas, countered that Raterman’s opinion of Sally being exposed to asbestos fibers at levels “significantly greater than background concentrations” led to an increased risk of her developing mesothelioma.
Though this perspective relied partially on the excluded research and testing of Fitzgerald, plaintiff counsel claimed it was supported by other evidence - specifically, air test sample results from non-testifying expert witness Dr. James Millette.
This led the Court initially to deny Colgate's motion for summary judgment on Oct. 2 of last year. However, the Court later excluded Millette’s airborne concentration opinions on Feb. 1, ensuring they would not be considered “of record” in the case – and thus, leading Colgate to renew its motion for summary judgment on Feb. 6.
“Where the plaintiff fails to proffer evidence to create a triable issue as to whether she was frequently and regularly exposed to significant airborne concentrations of asbestos from the defendants’ product, summary judgment is warranted,” the defense motion for summary judgment read, in part.
“Here, even assuming arguendo that the Cashmere Bouquet talcum powder that Ms. Brandt used contained some level of asbestos – and it did not – plaintiff cannot support a claim against Colgate, because they have no evidence that could establish that Ms. Brandt was exposed to airborne concentrations of asbestos from the product at levels sufficient to cause her disease.
“As plaintiffs have no competent, admissible evidence that Ms. Brandt was exposed to asbestos from Cashmere Bouquet cosmetic talcum powder at levels sufficient to cause her disease, summary judgment is warranted.”
The summary judgment motion further argued that the Court, in excluding Millette’s testing opinions, “substantially changed the status of the case, warranting renewed consideration of Colgate’s summary judgment motion.”
https://www.forbes.com/sites/legalnewsline/2019/02/08/no-jackpot-in-philadelphias-first-talc-asbestos-trial-judge-rules-plaintiff-has-no-evidence/#1f181f264216
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