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Ethicon 20/1
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Appeals court upholds $2m pelvic mesh award against Bard
Jan 19, 2016 | Mass Device
By Brad Perriello
A federal appeals court last week upheld a $2 million loss for C.R. Bard(NYSE:BCR) in a product liability lawsuit brought over its Avaulta pelvic mesh. -
Tory MSP criticises 'dismal' Holyrood debates
Jan 19, 2016 | Glasgow South Eastwood Extra
Parliamentary procedures have resulted in "dismal" and "pedestrian" debates at Holyrood, according to a Conservative MSP. -
Patient Power Drives FDA—But Where?
Jan 19, 2016 | Medical Device and Diagnostic Industry
By Jim Dickinson
...In a personal email to CDRH director Jeffrey Shuren, Nonie Wideman, advocate for thousands of women who claim to have been injured by allergic adverse reactions to transvaginal surgical mesh, demanded the recall of all such meshes, not only the pelvic organ prolapse (POP) meshes that FDA had just ordered reclassified into Class III because of inadequate assurance of safety... -
J&J to cut 3,000 jobs in major shakeup—is it a prelude to an acquisition?
Jan 19, 2016 | Healthcare Dive
By Sy Mukherjee
...Johnson & Johnson has had to face a prominent controversy involving its now-defunct Prosima pelvic mesh product... -
J&J Cuts 3,000 Jobs in Medical Device Sector Due To Weak Performance
Jan 19, 2016 | Mesh Medical Device News Desk
By Jane Akre
Johnson & Johnson will cut about 3,000 jobs in its medical device division. The company based in New Brunswick, New Jersey made that announcement Tuesday. -
Missouri Lawyers Weekly Covers MND Exclusion from Sherrer Pelvic Mesh Trial
Jan 19, 2016 | Mesh Medical Device News Desk
By Jessica Shumaker
This is the second article prepared by Missouri Lawyers Weekly on the issue of excluding Mesh News Desk from coverage of the Sheerer pelvic mesh trial.
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Appeals court upholds $2m pelvic mesh award against Bard
Jan 19, 2016 | Mass Device
By Brad Perriello
A federal appeals court last week upheld a $2 million loss for C.R. Bard(NYSE:BCR) in a product liability lawsuit brought over its Avaulta pelvic mesh.
A jury awarded plaintiff Donna Cisson $250,000 in compensatory damages and $1.75 million in punitive damages back in August 2013, in 1 of the 1st of thousands of federal lawsuits to go to trial over pelvic mesh implants. The devices are designed to treat female urinary incontinence and pelvic organ prolapse.
Bard, which recalled the Avaulta product in 2012, appealed the decision to the U.S. Court of Appeals for the 4th Circuit. The company argued that lower court Judge Joseph Goodwin was wrong to exclude evidence of the 510(k) clearance Bard won from the FDA for the mesh and wrong to allow the admission of a Material Safety Data Sheet for the polypropylene resin used to make the Avaulta mesh.
Bard also contended that Goodwin’s jury instructions were improper and that the punitive damages award was excessive. Cisson argued that Georgia’s split-recovery statute, awarding 75% of the punitive damages award to the state, violates the Takings Clause of the 5th Amendment to the U.S. Constitution.
The 4th Circuit appeals court upheld Goodwin on all counts, ruling that the lower court was right not to allow Bard to introduce the 510(k) as evidence.
“The [lower] court expressed concern that subjecting the jury to many hours, and possibly days, of complex testimony about regulatory compliance could lead jurors to erroneously conclude that regulatory compliance proved product safety. In other words, having a ‘mini-trial’ could easily inflate the perceived importance of compliance and distract the jury from the central question before it – whether Bard’s design was unreasonable based on any dangers it posed versus the costs required to avoid them,” the 4th Circuit ruled. “While 510(k) clearance might, at least tangentially, say something about the safety of the cleared product, it does not say very much that is specific. The vast majority of courts have said so, and having been thoroughly briefed not only by the parties but by several amici, we say so again today.”
The appeals court also upheld Goodwin’s decision to allow the MSDS for the polypropylene resin, which explicitly advised that the material was not safe for implantation in humans.
“Doing so, we reverse the district court’s rulings as to the hearsay exceptions. However, we affirm the decision to admit the evidence as non-hearsay, finding that any use of the evidence by the plaintiff that went beyond the limited purpose for which it was admitted as non-hearsay resulted in harmless error and was not prejudicial to Bard’s defense,” the appeals court found.
The court also ruled that Goodwin’s jury instructions were proper and that the damages award was not excessive, and denied Cisson’s challenge to Georgia’s split-recovery statute, awarding 75% of the punitive damages award to the state and the remaining 25% to Cisson.
Bard has 90 days from the Jan. 14 decision to ask the U.S. Supreme Court to review the case, according to court documents
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Tory MSP criticises 'dismal' Holyrood debates
Jan 19, 2016 | Glasgow South Eastwood Extra
Parliamentary procedures have resulted in "dismal" and "pedestrian" debates at Holyrood, according to a Conservative MSP.
Jackson Carlaw criticised the "straitjacketing of spontaneity" during a debate in the Scottish Parliament chamber.Jackson Carlaw criticised the 'straitjacketing of spontaneity' during a debate in the Scottish Parliament chamber
The MSP was speaking on a report by the Public Petitions Committee which set out recommendations aimed at strengthening the parliamentary petitions process.
Mr Carlaw, who sits on the committee, declared himself an "unreserved fan", adding: "I say that as someone who, towards the end of my first parliament in 2011, produced my own report as to why I thought in many other respects the procedures of this parliament are unnecessarily straitjacketing on the spontaneity which there might otherwise be.
"The hideous process by which we have to submit parliamentary questions well in advance to notify ministers of our intent, very often meaning that they no longer have any topicality by the time we ask them.
"The sort of dismal, sort of pedestrian nature of many of our debates in which contributions are weighted by parliamentary representation rather than any interest or knowledge of the subject about which we might be having a conversation.
"But I exempt from that the parliamentary petitions process."
Mr Carlaw said members of the committee were free to pursue petitions "without fear or favour", citing vaginal mesh implants as an example of an issue that had been brought to the fore by petitioners.
Research was commissioned by the committee in May last year as part of its ''watching brief'' on the petitions process.
The committee's resulting recommendations include measures aimed at reaching out to under-represented groups and areas.
Convener Michael McMahon said: "The socio-economic data captured in the research appears to tell us two things.
"The demographic profile of petitioners does not appear to have changed from the profile that was found in work carried out ten years ago and that the profile of petitioners does not reflect the diversity of the general population of Scotland .
"Put simply, the socio-demographic profile skews towards older white men who are relatively affluent and who have been educated to degree level."
Labour MSP and former convener David Stewart said: "We're excellent at representing accountants in Bearsden but perhaps not quite as good at representing artisans in Easterhouse. We need to get out and about more, go round disadvantaged estates."
Parliamentary b usiness minister Joe Fitzpatrick also praised the work of the committee, citing successes such as the petition put forward by the Campaign for Borders Rail.
He said: "It is right and proper that the Parliament regularly reviews its procedures.
"That allows the parliament to examine what has worked well and what it can do better, with the aim of making this parliament the best it can be for the people of Scotland."
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Patient Power Drives FDA—But Where?
Jan 19, 2016 | Medical Device and Diagnostic Industry
By Jim Dickinson
The New Year broke amid an unusually acrimonious election season characterized by a heightened sense of public dissatisfaction with Washington—and among patient advocacy groups that definitely included FDA, especially its devices Center.
By the second week of January, CDRH had picked up on this with the publication of an ambitious manifesto, 2016-2017 Strategic Priorities, that put patient power front and center even as a new group of injured patients was joining others who have recently found new ways of attacking the way the Center protects them.
In a personal email to CDRH director Jeffrey Shuren, Nonie Wideman, advocate for thousands of women who claim to have been injured by allergic adverse reactions to transvaginal surgical mesh, demanded the recall of all such meshes, not only the pelvic organ prolapse (POP) meshes that FDA had just ordered reclassified into Class III because of inadequate assurance of safety.
The women complain of excruciating pain from mesh erosion, degradation, migration, nerve damage, and chronic inflammation leading to autoimmune problems and lasting loss of sexual relations and even physical mobility. “We are aghast that you would not include [stress urinary incontinence] mesh” in the POP reclassification, Wideman told Shuren.
Her approach constitutes the third injured patients’ group (all women) to surface publicly in three months and take up direct attacks on Shuren, CDRH, and the way medical device safety is reviewed and monitored at FDA, especially via the 510(k) process, after power morcellators and the Essure permanent birth control device (PMA), previously reported here.
The mesh patients’ complaints made the same basic point that the other two did: Just because a non-essential device helps a majority of its patients (in this case, about 70% based on published studies), why should its risks be visited upon the minority who can’t be identified until it’s too late and the implants are in place? Device explantation does not restore quality of life, Wideman says.
In each case, FDA’s unarticulated answer seems to be: Because manufacturers and practitioners want to continue making money from these devices.
High-sounding strategy documents have issued from FDA for years, only to be largely forgotten under the weight of the agency’s other business, and CDRH’s “patient power” 2016-2017 Strategic Priorities document is likely to be no different.
“We believe that if CDRH is to successfully achieve a mission and vision in the service of patients, we must interact with patients as partners and work together to advance the development and evaluation of innovative devices, and monitor the performance of marketed devices.” So proclaims the Partner with Patients chapter, in extra-large type.
Calling patients “our most important customer,” the document vows to “establish a foundation to facilitate the development of more patient-friendly information, promote more patient-centric clinical trials, advance benefit-risk assessments that are informed by patient perspectives, promote the use of patient-reported outcome data, and foster access to new devices that meet patients’ needs.”
From there, it gets bolder and bolder:
GOAL: PROMOTE A CULTURE OF MEANINGFUL PATIENT ENGAGEMENT BY FACILITATING CDRH INTERACTION WITH PATIENTS
• By December 31, 2016, establish one or more new mechanisms for CDRH employees to obtain patient input on key pre- and postmarket issues facing CDRH and foster participation of 10 patient groups to participate.
• By December 31, 2017, foster participation of 20 patient groups to participate in these mechanisms.
• By December 31, 2016, 50 percent of CDRH employees will interact with patients as part of their job duties.
• By December 31, 2017, 90 percent of CDRH employees will interact with patients as part of their job duties.
GOAL: INCREASE USE AND TRANSPARENCY OF PATIENT INPUT AS EVIDENCE IN OUR DECISION MAKING
• By September 30, 2016, 50 percent of PMA, de novo and HDE decisions will include a public summary of available and relevant patient perspective data considered.
• By September 30, 2017, 100 percent of PMA, de novo and HDE decisions will include a public summary of available and relevant patient perspective data considered.
• By September 30, 2017, increase the number of patient perspective studies (e.g., evaluating patient reported outcomes or patient preferences) used in support of premarket and postmarket regulatory decisions. (compared to FY 2015 baseline)
To accomplish these goals, CDRH will take several steps including the following:
• Resources permitting, establish in CDRH a patient-focused program responsible for the strategic development and coordination of CDRH’s initiatives to advance patient engagement and the science of patient input throughout the total product lifecycle.
• Convene the Patient Engagement Advisory Committee to discuss high priority topics regarding patient input in the total product lifecycle.
• Identify/define the various pre- and postmarket regulatory uses of patient reported outcome measures (PROMs) and issue a report summarizing current PROM regulatory usage patterns and gaps.
• Work with members of the medical device ecosystem to develop a framework for patient input to inform clinical study design and conduct, with a goal of reducing barriers to patient participation and facilitating recruitment and retention.
• Develop education and training for CDRH staff and industry on the development and use of the science of measuring and communicating patient input throughout the total product lifecycle.
What if, as is highly likely, all this is a bridge too far and CDRH simply can’t do it?
The Center, despite its flowery words in the strategies document, is an ordinary government bureaucracy that hides its real motives whenever it can, especially when user fees are hanging over its head.
For example, when I asked FDA devices press officer Deborah Kotz why the agency had proceeded to reclassify less-common pelvic organ prolapse surgical mesh but exempt identical yet more-common stress urgency incontinence mesh from the same order, she replied: “FDA believes that Class II (general and special controls) provides a reasonable assurance of safety and effectiveness for mesh to treat SUI.”
When I responded, “This isn’t explicit enough. On what does FDA base its belief that Class II provides a reasonable assurance of safety when Wideman has presented literature-based evidence that the adverse effects are the same as for POP mesh?” Kotz fell silent.
Research on the regulations.gov website for this rule revealed a possible answer. During the 2014 gestational process for FDA’s order, the Society of Gynecologic Surgeons had submitted a comment that
“because of widespread confusion among the lay population which has attended the previous FDA advisories, we ask that the FDA further clarify and highlight that use of type 1 monofilament polypropylene surgical mesh for surgical treatment of stress urinary incontinence (i.e., mid-urethral slings) and abdominal pelvic organ repair (i.e., sacral colpopexy) has become the standard of care, that these therapies are not the subject of the advisory letter, and that these products are not being reclassified. This will help to minimize these potential points of confusion for patients, patient advocacy groups and gynecologic surgeons.”
It appears that FDA has followed this advice. Wideman, who runs a website for mesh-injured women atmeshproblems.weebly.com that she says has logged over 6,000 hits, told me that many of the surgical society’s leaders have been and still are preceptors for the mesh manufacturers. FDA’s acquiescence to the society would be a pragmatic trade-off engendering mutual cooperation into the future.
Which makes me wonder, what a wonderful integration could result if industry-affiliated patient networks melded with the pie-in-the-sky vision illuminated in CDRH’s 2016-2017 Strategic Priorities?
Looked at another way, what influence then might an injured minority of patients exert on an agency that doesn’t heed them now?
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J&J to cut 3,000 jobs in major shakeup—is it a prelude to an acquisition?
Jan 19, 2016 | Healthcare Dive
By Sy Mukherjee
Dive BriefJohnson & Johnson announced on Monday that it would be culling 3,000 jobs, or between 4% and 6% of the global workforce in its medical devices division, over the next two years in a major restructuring effort, according to an SEC filing.The company believes that it will achieve somewhere between $800 million and $1 billion in pre-tax cost savings as a result of the restructuring, about $200 million of which is expected to be realized this year and the majority of which should register by the end of 2018.J&J will also also expects to add between $2 billion and $2.4 billion in pre-tax restructuring charges to its books within the next two years, according to the filing. The layoffs will stem from the company's cardiovascular, orthopedics, and surgery device units (leaving the diabetes, diagnostics, and vision care units intact).Dive Insight:
Medical devices make up a huge share of Johnson & Johnson's global business, so these job cuts are a big deal for the firm. A little less than half of the company's total worldwide workforce is in its medical devices unit, meaning the layoffs will amount to a 2-3% overall reduction in global jobs.
As Reuters notes, J&J is already sitting on quite a bit of cash, and these cuts will (over the long term) add to that haul. That has some analysts speculating that the U.S. pharma giant is still in the hunt for an acquisition, potentially to beef up the very medical devices division that it will be trimming over the next several years.
Johnson & Johnson has had to face a prominent controversy involving its now-defunct Prosima pelvic mesh product. At the end of 2015, a Philadelphia jury awarded a woman a $12.5 million judgment in her suit against the company and its device, which faces many other ongoing suits. J&J won its first trial centering on the product last fall.
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J&J Cuts 3,000 Jobs in Medical Device Sector Due To Weak Performance
Jan 19, 2016 | Mesh Medical Device News Desk
By Jane Akre
Johnson & Johnson will cut about 3,000 jobs in its medical device division. The company based in New Brunswick, New Jersey made that announcement Tuesday.
The workforce cutback represents more than 2 percent of J&J employees globally and 4-6% of medical device workers.
“These actions recognize the changing needs of the global medical device market,” said Gary Pruden, chairman of Johnson & Johnson’s medical device unit.
Specifically affected are medical devices in the orthopedics, surgery and cardiovascular business. Not affected are medical devices for consumer use or pharmaceuticals. Medical devices have been noted as one of the weaker performing sectors for investors.
AP reports (here) J&J has been trying to revive sales of DePuy hip implants and Ethicon surgical mesh. By October sales dropped 7.3%. “Restructuring is a positive step,” says a Wells Fargo analyst.
The company will discuss its fourth quarter earnings for 2015 when it meets and releases those figures January 26. The company will have its annual shareholders meeting April 28,2016 in New Brunswick, New Jersey. See more here.
Johnson & Johnson’s Ethicon division represents the highest number of pelvic mesh cases consolidated in federal court in Charleston, WV. As of today, there are 30,665 defective product lawsuits consolidated in this court. The fourth quarter report will tell investors how many additional lawsuits are filed in states courts and around the world from Ethicon’s mesh. In some cases, juries have found the pelvic mesh to be defective. Specifically, the TVT-O (transvaginal tape obturator) remains on the market.
In June 2012, the company quietly removed four meshes from the market, including the Prolift, one of the largest pelvic meshes used to treat pelvic organ prolapse and one of the most difficult to remove.
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Missouri Lawyers Weekly Covers MND Exclusion from Sherrer Pelvic Mesh Trial
Jan 19, 2016 | Mesh Medical Device News Desk
By Jessica Shumaker
This is the second article prepared by Missouri Lawyers Weekly on the issue of excluding Mesh News Desk from coverage of the Sheerer pelvic mesh trial.
The story says it all. Thank youMissouri Lawyers Weekly for allowing me to republish it.
*Update on the case – The defense team for Boston Scientific and C.R. Bard has its turn before the jurors this week and next. The case should go to the jury sometime next week.
Sherrer is an important pelvic mesh trial because one plaintiff has two different pelvic meshes. Certainly this case will be the longest ever presented to a jury. It began December 2, broke for the holiday and resumed January 4, 2016.
A Jackson County circuit judge has denied a web reporter’s request to regain access to a pool camera feed.
In an order filed Wednesday by Judge Robert Schieber, he denied a Dec. 24 motion by Independent News Group LLC., citing reasons previously articulated in court.
“Again, this court’s obligation is to do everything within its power to [ensure] a level playing field and to avoid even the appearance of impropriety,” he wrote. “The camera being utilized in this courtroom during this proceeding is here only because the court, within [its] discretion, allowed it to be a pool camera for the media.”
Independent News Group LLC owns and operates Mesh Medical Device News Desk, a site edited by Florida-based journalist Jane Akre.
Akre had been using a privately-maintained pool camera that provides a live feed of a trial. She was covering a case that involves claims against Boston Scientific and C.R. Bard, makers of transvaginal mesh products that plaintiffs allege have injured women in whom they were implanted.
An early December filing by the company providing the feed, Courtroom View Network, or CVN, said defense attorneys complained to the court about comments left by readers on Akre’s website and asked that CVN’s coverage be suspended.
The company successfully argued it should be allowed to continue, however, CVN terminated Akre’s access to its feed.
Court spokeswoman Valerie Hartman said in an email in December that Judge Robert Schieber decided CVN could remain in the court, but they were to “discontinue access to the advocacy organization.”
Akre hired Jim Griffin of Scharnhorst Ast Kennard Griffin in Kansas City as counsel. He filed a motion seeking to regain access to the camera pool.
He argued in the motion and before Schieber Monday morning that his client did not violate court rules.
“There is also no evidence that Independent News Group’s manner of coverage prejudiced any party’s right or any right of any participant,” the motion said. “No such findings were made on December 7. Nothing about the article posted to the Mesh Medical News Desk by Ms. Akre was threatening or hostile towards either party or its attorney.”
Further, he said the comment at issue was posted by an individual with no affiliation to the website and it could have been posted to any online news article covering the trial. He said there has been no criticism of Akre’s reporting itself.
The company also offered to delete personal comments about Lori Cohen, an attorney from Greenberg Traurig representing Bard; edit future comments to delete personal comments about counsel and not post any contact information for participants in the trial.
At the hearing Monday, Cohen said she did not file in opposition to the motion. She said Akre is continuing to “incite and inspire” readers of her site. She said commenters have compared her to an abortion doctor.
Schieber said at the hearing that information disseminated about proceedings in his courtroom needs to be fair, accurate, balanced and unprejudiced.
In his order, he repeated those sentiments, saying it’s his duty to ensure that occurs.
“This is not a gag order. It is not a blanket prohibition against reporting on this case,” he wrote. “This Court would not do that absent extraordinary circumstances and only then with substantial just cause.”
Schieber added that Akre and others are welcome to attend the trial and report on it.
“However, when the conduit of information is or could be deemed to be a court sanctioned conduit it must be completely neutral in nature,” he said. “This is not a First Amendment issue – it is an appearance of impropriety issue and this Court will guard against that at all costs.”
Griffin declined to comment. Akre did not return a call seeking comment. The case is Sherrer v. Truman Medical Center et al., 1216-CV27879.
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