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Ethicon Media Monitoring 2/6/2018
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Filter MDL Puts FDA Clearance Evidence Back On The Table
Feb 6, 2018 | Law 360
By James Beck
... Then, in pelvic mesh litigation, rulings began to change the law on the premise that, because the United States Supreme Court in Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), had held that §510k clearance was not preemptive -
Modern day suffragettes join a rally at the House of Lords with Sling The Mesh for 100 years of Votes for Women
Feb 5, 2018 | Cambs Times
By John Elworthy
Women’s campaign group Sling The Mesh is staging a modern day suffragette rally to tie in with the 100th anniversary of when women were first given the right to vote in the UK. -
Now post-baby mesh operation is linked to superbug infections: Patients with the implant are increasingly becoming resistant to antibiotics
Feb 6, 2018 | The Daily Mail
... Like thousands of other women whose stories have been highlighted by Good Health, Annette has suffered as a result of surgery for post-childbirth incontinence, where a plastic mesh is inserted to support the bladder.
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Filter MDL Puts FDA Clearance Evidence Back On The Table
Feb 6, 2018 | Law 360
By James Beck
As we first wrote about back in 2013, U.S. Food and Drug Administrationcompliance evidence generally — and the fact of a medical device’s clearance as “substantially equivalent” in safety and effectiveness to a predicate device under §510k of the Medical Device Amendments (now 21 U.S.C. §360c(f)(1)(A)) specifically — had for decades been admissible evidence in product liability litigation involving FDA-regulated drugs and devices. In 2013 we found a half dozen §510k cases directly on point.[1]
Then, in pelvic mesh litigation, rulings began to change the law on the premise that, because the United States Supreme Court in Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), had held that §510k clearance was not preemptive — that is, not entitling a defendant to judgment as a matter of law — it was not even relevant in product liability litigation.
This argument turned on taking a phrase from Lohr out of context — “[T]he 510(k) process is focused on equivalence, not safety” (id. at 493) — and applying it in the evidence context.
As we had pointed out, so doing was contrary to the Supreme Court’s Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), decision holding that §510(k) clearance was intended “to ensure ... that medical devices are reasonably safe and effective” (id. at 349-50). In recent blog posts we have pointed out that the FDA now considers §510k clearance to involve considerations of safety and effectiveness, and that (for a variety of reasons) the continued viability of Lohr itself is open to question.
Nonetheless, defendants in mesh litigation have largely been deprived of well-established FDA compliance evidence, and based on the capacious abuse of discretion standard applicable to evidentiary decisions at trial, such rulings have been upheld on appeal.[2]
Last week, however, another MDL judge considered the admissibility of §510k evidence, and held it admissible, flatly rejecting the mesh decisions.[3] In IVC Filters, Judge David Campbell allowed the defendant’s “FDA defense,” ruling that the jury should be allowed to hear about §510k devices’ FDA pedigree.[4] Such evidence was doubly relevant under relevant state law:
· “Georgia courts have adopted a risk-utility analysis for design defect claims. ... One of the many factors a jury may consider in its reasonableness determination is the manufacturer’s compliance with federal regulations.”[5]
· “The evidence is also relevant to Plaintiff’s punitive damages claim. Under Georgia law ... [c]ompliance with federal regulations is not sufficient to preclude an award of punitive damages, but it is probative.”[6]
Coincidentally, Cisson also purported to interpret Georgia law, but reached a diametrically opposite conclusion.
IVC Filters rejected the false equivalence between preemption and relevance, and mesh courts’ misapplication of Lohr:Plaintiffs note, correctly, that the 510(k) process focuses on device equivalence, not device safety. [Lohr citation omitted.] But this does not render evidence of the 510(k) process irrelevant to the reasonableness of [the defendant’s] conduct. The FDA grants 510(k) clearance only where the device “is as safe and effective as a [predicate device] and does not raise different questions of safety and efficacy than the predicate device.” Safe Medical Devices Act of 1990, Pub. L. No. 101-629, § 12(a)(1)(A)(ii). The 510(k) process may not speak directly to the applicable standard of care ... but it does have probative value in the determination of this action.[7]
The excuses given for exclusion in Cisson, the jury giving clearance undue weight and a possible “mini-trial” regarding compliance, could “be adequately addressed without excluding relevant evidence to the detriment of Defendants.”[8] Reasonable “time limits” for each side’s evidence would prevent FDA issues from devolving into any “mini-trial.”[9] On the merits:
Both sides, through appropriate expert testimony or other admissible evidence, will be permitted to tell the jury about the role of the FDA in its oversight of medical device manufacturers, the regulatory clearance process for devices such as IVC filters and [the defendant’s] participation in the 510(k) process and its compliance (or lack thereof) with that process.[10]
“[A]ny potential confusion” did not require exclusion, but only “a limiting instruction regarding the nature of the 510(k) process.”[11] Indeed, IVC Filters correctly observed that the issue of jury confusion more likely cuts the other way — in favor of admission of FDA evidence:
[T]he absence of any evidence regarding the 510(k) process would run the risk of confusing the jury as well. Many of the relevant events in this case occurred in the context of FDA 510(k) review, and much of the evidence is best understood in that context. Attempting to remove any references to the FDA from the trial would risk creating a misleading, incomplete and confusing picture for the jury.[12]
“[I]f the evidence was half-baked, containing some references to the FDA but not explaining what role the FDA played with respect to the [IVC] filters, the jury would be left to speculate about the FDA’s involvement and conclusions.”[13]
Until IVC Filters, we had feared that a single mass tort, under a discretionary standard of review and with the unwillingness of appellate courts to require MDL do-overs, could tilt the evidentiary playing field towards what IVC Filters cogently described as “a misleading, incomplete and confusing picture for the jury” that excluded §510k clearance evidence that previously been admissible almost as a matter of course.
Now our side has a clearly articulated and compelling opposing view to argue.
James Beck is senior life sciences policy analyst at Reed Smith LLP. He handles complex personal injury and product liability litigation, and has overseen the development of legal defenses, master briefs and dispositive motions in numerous mass torts. He blogs regularly on drug and device product liability for the Drug and Device Law blog.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
[1] Block v. Woo Young Medical Co., 937 F. Supp.2d 1028, 1047 (D. Minn. 2013); Placencia v. I-Flow Corp., 2012 WL 5877624, at *6 (D. Ariz. Nov. 20, 2012); Musgrave v. Breg Inc., 2011 WL 4620767 (S.D. Ohio Oct. 3, 2011); Pritchett v. I-Flow Corp., 2012 WL 1340384, at *5 (D. Colo. April 18, 2012); Miller v. Stryker Instruments, 2012 WL 1718825, at *9 (D. Ariz. March 29, 2012); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1964337, at *7 (D. Minn. June 29, 2007); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 658 (E.D. Pa. 1995); Strum v. Depuy Orthopaedics Inc., 2013 WL 3184765, at *1 (Ill. Cir. March 8, 2013).
[2] See Eghnayem v. Boston Scientific Corp., 873 F.3d 1304, 1317-18 (11th Cir. 2017); In re C.R. Bard Inc., MDL No. 2187, Pelvic Repair Systems Products Liability Litigation, 810 F.3d 913, 921-22 (4th Cir. 2016) (“Cisson”); but see Winebarger v. Boston Scientific Corp., 2015 WL 5567578, at *7 (W.D.N.C. Sept. 22, 2015) (rejecting MDL rulings and admitting §510k clearance evidence in mesh case).
[3] See In re Bard IVC Filters Products Liability Litigation, 2018 WL 582542 (D. Ariz. Jan. 29, 2018).
[4] Id. at *2.
[5] Id. at *2 (citation omitted).
[6] Id.
[7] Id. at *2 (citation omitted). See also Id. at *3 n.2 (a preemption decision does “not address[] any evidentiary issue” and even as to preemption “the 510(k) process can in some circumstances preempt state law claims”) (citations omitted).
[8] Id. at *3.
[9] Id. at *4.
[10] Id.
[11] Id.
[12] Id.
[13] Id.https://www.law360.com/trials/articles/1008693/filter-mdl-puts-fda-clearance-evidence-back-on-the-table
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Feb 5, 2018 | Cambs Times
By John Elworthy
Women’s campaign group Sling The Mesh is staging a modern day suffragette rally to tie in with the 100th anniversary of when women were first given the right to vote in the UK.
Around 50 members of the group, led by our journalist Kath Sansom, are travelling from across Britain to join a protest outside the House of Lords.
They will be calling on the Government to hear their voice with a slogan: “100 years of votes for women, now hear our voice, Sling The Mesh.”
The group began in June 2015 with 20 women, today it has 5,400 members.
One of the mesh injured women attending is Annette Power, of Cambridgeshire, who is following in the footsteps of her grandmother who was one of the original suffragettes.
Annette is close to becoming antibiotic resistant and is at risk of sepsis because of a mesh implant given to her to treat mild stress incontinence.
Following the protest women will join Lord Phillip Hunt inside the House of Lords as he calls on ministers to suspend mesh implants pending the outcome of a Government audit, announced last week.
Lord Hunt said: “Pelvic mesh is routinely used in the UK. So many women have suffered as a result and it is time for the Government to take action now by suspending its use.”
A survey of 570 women in Sling The Mesh shows when pelvic mesh implants go wrong there is a “shocking extent of injuries.”
Chair of the All Party Parliamentary Group on Surgical Mesh Implants, Owen Smith MP said: “These results are truly heart-breaking and show the shocking extent of the suffering some women are facing following mesh implant surgery. Many of the issues detailed in the survey are life-changing and cannot be ignored.
“Until we have a clear understanding of the long term risks and benefits of mesh, its use should be suspended.”
The survey shows seven out of ten women lose their sex lives and six out of ten suffer depression.
One in seven lose their marriage/partners.
A third give up work .
More than half suffer constant urinary infections and one in 20 are becoming antibiotic resistant.
Kath Sansom of Sling The Mesh said: “A century ago Government heard the political voices of women, so in 2018 it is time they heard our voices to stop the biggest women’s health disaster since Thalidomide.
“Our survey shows the personal devastation when women suffer mesh implant complications. We have women in the group who are suicidal, who don’t want to carry on because the pain is so intense. Yet previously they led healthy lives.
“Surgeon societies know there are big problems as 18 specialist mesh centres have been set up across England. Also conferences are being held on how to deal with mesh litigation.”
• The rally is on Tuesday February 6 which will be 100 years since the Government passed the Representation of the The People’s Act giving women over 30, with certain property ownership criteria, the right to vote for the first time.
http://www.cambstimes.co.uk/news/sling-the-mesh-joins-rally-for-100-years-of-votes-for-women-rally-outside-parliament-1-5383273
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Feb 6, 2018 | The Daily Mail
· Thousands of victims claim to have been left on the brink of suicide from mesh
· The procedure is often dished out by surgeons following childbirth problems
· Some women have had to take antibiotics for so many years due to complications and have become resistant to the drugs
· Annette Power, 56, fears that she'll be at risk of dying due to blood poisoning
· Campaigners have welcomed the decision to investigate the usage of mesh
For more than a decade, Annette Power has had to take antibiotics at almost every mealtime.
‘I got through them like Smarties,’ says Annette. ‘I’ve had permanent infections for about 16 years — I’d finish one course of antibiotics on a Friday, the pain would come straight back and on the Monday I’d be given another course to start.’
She’s now been told standard oral antibiotics won’t work any more, and she’ll need more powerful antibiotics intravenously. ‘And when the intravenous ones stop working, I’ll be at risk of blood poisoning and that will just kill me off,’ she says.
Like thousands of other women whose stories have been highlighted by Good Health, Annette has suffered as a result of surgery for post-childbirth incontinence, where a plastic mesh is inserted to support the bladder.
An estimated 100,000 women in the UK have had the procedure (sometimes for womb prolapse rather than incontinence) and while many have had no problems, others have experienced crippling side-effects as the mesh has disintegrated into razor-sharp slivers that can become embedded in soft tissue, causing agonising pain and chronic infections.
‘I want to have the mesh taken out but it’s broken up inside me and the disturbance of extracting it could set up a worse infection,’ says Annette, 56, a former occupational therapist from Stilton, Cambridgeshire.
Just before Christmas, Chrissy Brajcic, 42, a mother of two from Canada who’d been chronicling her struggle with multi-drug-resistant infection following pelvic mesh surgery, died from sepsis.
‘After going septic I’m now getting respect and being treated well by doctors,’ Chrissy wrote in one of her final Facebook posts. ‘All it took was dying to get better care and better pain management.’
Suzy Elneil, a gynaecologist in London who specialises in removing the disintegrated mesh, says around 15 per cent of her patients have some antibiotic resistance. ‘It’s only a matter of time before we start seeing the same problems here as led to the death of the lady in Canada,’ she warns.
Urological surgeon Mohammed Belal of the Queen Elizabeth Hospital, Birmingham, has also seen mesh patients with multi-drug-resistant infections. ‘So far we have been able to treat the worst infections by removing the mesh,’ he says.
The Royal College of Obstetricians and Gynaecologists acknowledged a risk of antibiotic resistance, but insists that used correctly, the mesh is effective.
‘There is a risk of infection, but this remains low and recurrent infections are rare,’ their patient safety spokesman Tim Hillard, told Good Health.
Last week, the Department of Health caved in to pressure from the All Party Parliamentary Group on Surgical Mesh Implants, and 3,400 injured women from pressure group Sling The Mesh, and agreed to a national audit of mesh patients. This will also show how many are receiving intravenous antibiotics in hospital.
While the results are due in April, a survey of more than 500 Sling The Mesh members last month suggested 10 per cent had developed resistance to up to five routinely used antibiotics. ‘For many of these women, the prospect of no effective antibiotic treatment is frankly terrifying,’ said Kath Sansom the pressure group’s founder.
Until 2002, Annette, a mother of two grown-up children, had been healthy. But like one in four 40-year-olds who’ve had children, she suffered from stress incontinence, leaking urine when she ran or jumped. After the operation to insert the mesh she developed the first of countless infections.
‘For years I was told the pain and infection had nothing to do with the mesh,’ says Annette who can now only walk a few hundred yards. Her husband John, 66, died three years ago, and she is now with a new partner, but has been unable to have sex for six years.
‘Last November I was told there were no more types of tablet antibiotic available to me, I am resistant to all of them. I either have to get through infections without them or go into hospital for intravenous treatment.’
The mesh is now banned in New Zealand and its use restricted in Australia, and today hundreds of Sling The Mesh protesters are expected at Westminster demanding an outright ban here, too.
http://www.dailymail.co.uk/health/article-5355859/Post-baby-mesh-operation-linked-superbug-infections.html
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