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Ethicon Media Monitoring 6/30/2017
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Multidistrict Litigation – Is It Working for Transvaginal Mesh Cases?
Jun 30, 2017 | Mesh Medical Device Newsdesk
The Multidistrict Litigation (MDL) system allows a select few law firms (about 70) to the top positions in the court structure, no matter where it is based. -
What’s Added to Plastic Mesh?
Jun 29, 2017 | Mesh Medical Device Newsdesk
By now readers may understand that most mesh, whether for hernia repair or to treat prolapse and/or incontinence, is made of the plastic polypropylene (PP). -
Fife medical negligence claims top £85 million
Jun 29, 2017 | Fife Today
By Maggie Miller
NHS Fife is currently battling 74 live claims arising out of alleged medical negligence, it has emerged. -
Greenberg Traurig
Jun 29, 2017 | Daily Report
One of the biggest wins for Greenberg Traurig's mass torts/products liability team was a complete defense verdict for client C. R. Bard in the closely-watched pelvic mesh trial in the 16th Judicial Circuit of Missouri.
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Multidistrict Litigation – Is It Working for Transvaginal Mesh Cases?
Jun 30, 2017 | Mesh Medical Device Newsdesk
Part Two – Mesh Medical Device News Desk, June 29, 2017 ~ The Multidistrict Litigation (MDL) system allows a select few law firms (about 70) to the top positions in the court structure, no matter where it is based.
An MDL is like a class action in that plaintiffs with substantially similar complaints against an allegedly defective product are consolidated in one court.
In the case of transvaginal mesh, the MDL is in Charleston West Virginia where more than 103,000 cases have been filed before Judge Joseph Goodwin.
According to research done by Professor Burch from the University of Georgia Law School, lawyers from these firms “repeat players,” because they know the ropes, can litigate the cases, but also form relationships with the defense team. Both sides know what the other needs in terms of settlement.
Professor Burch says while individual law firms seek settlements for their clients, lawyers with fewer clients are not usually in such an advantageous position to negotiate and often have to partner with the “repeat players,” to help their clients.
Settlements are private, so a judge in an MDL cannot override a decision as he can with a class action settlement, which is public, and the judge does not have the authority to make sure that law firms are not enriching themselves at the cost of their clients.m
Here is Part Two of our discussion. See Part One here.
Mesh News Desk Editor, Akre Q: -How is the MDL system different from class actions and how might a class benefit the plaintiff?
Burch, A – “The MDL is not certified as a class action, the NFL is an exception.
“I think we should start to file these issues as a class actions. They all have Ethicon in common so let’s try the common questions that relate to the defendant – What did they know and do and when did they know it – to litigate those as a class. Then remand cases to individual courts for individual hearings on specific causation.
“The judge signs off on the settlement. The judge awards attorney fees there may be some medical monitoring on a state by state basis.
“And class actions can be appealed.”
“Unlike a class action settlements, in which Rule 23 requires searching judicial inquiry to determine if the settlement is fair, non-class settlements are private contracts. Attorneys may be tempted to cross the line and ethical boundaries to achieve finality.”
Q: -For the women who’ve been given no option but to agree to a low-ball settlement, can anything can be done?
“For these women, my best piece of advice is to alert Judge Goodwin to what’s happening. These are private settlements and he’s not reviewing them, he is not taking a position, so maybe he doesn’t know what is going on.
“He’s so pro settlement, the MDL panel has the power to remand cases but in the past they’ve not done so without the recommendation of Judge Goodwin.”
Q: – Many women tell me their lawyer never talks to them.
A: – “They never do. Sometimes calls to fancy law firms don’t go to New York. You go to a call center in Dothan, Alabama in a warehouse. Operators are doing the intake form then it’s forwarded to the law firm. For many, it’s a volume business. It’s happening in the Granuflo litigation also. ”
Q: – Can’t lead lawyers within the MDL also work with a plaintiffs’ chosen counsel to best represent the client/injured?
A: – “Lead lawyers replace parties chosen counsel and promote settlement with little oversight. The appointment of repeat playersmay complicate genuine consent through inadequate representation.
“Dictatorial attorney hierarchies fail to adequately represent the spectrum of claimants’ diverse interests.
“Repeat players trade in influence to increase their fees, collude on private deals with little incentive to derail the lucrative settlement they negotiate.”
Q: – You suggest appointing diverse attorneys who represent heterogeneous clients, encouraging dissent from non-lead counsel?
A: – “Yes. The basic ideas are that all the pressures in our system push lawyers to conform. No one wants to object, they don’t become the squeaky wheel and they don’t get leadership positions. Introduce diverse leaders. Encourage judges to think about adequate representation.
“If you have a class action over hip implant, separate who had had it and who hadn’t had it. DePuy ASR litigation settled revised cases. Non-revised weren’t included in the settlement and can’t get remanded, they are no longer rep the non-revisables and they are languishing in the proceeding. You need someone representing the non-revisables. We need a separate deal for them.
“Once you appoint these leaders, if there is a conflict, no one has accounted for, if someone raises it, they should become a lead lawyer and serve alongside them to rep that group. You have to incentivize people to speak up to get on leadership positions, otherwise you have the same thing over and over again.”
Q: – The MDL was supposed to be for pretrial purposes only but only 2.9% of cases remand back to their original districts. Why?
A: – “Lead lawyers and steering committees conduct discovery, disseminate information draft motions, negotiate settlements and try bellwether cases. They may be more interested in pleasing judges, fostering reciprocity among fellow attorneys and positioning themselves for future appointments, than advancing plaintiffs’ interests. Lead attorney hierarchies have more influence today. They hire the experts, conduct discovery, call meetings, and act as spokespersons for all of the plaintiffs. The individually hired attorney has no power to appoint or discharge the leaders who are in charge other clients’ cases while deterring dissent from nonconforming lawyers.
Lack of remands is part of the problem. You can’t threaten to take to trial unless it’s picked a bellwether cases. That rarely happens. The plaintiff is at a disadvantage.”
LEARN MORE:As if on cue, Judge Goodwin has issued Court order #262 specifying how the law firms on the Common Benefit Fee & Cost Committee will be paid.
Included in it are orders from as early as 2012 establishing committees, criteria for applying to the MDL and the fee committee protocol.Accounting firm Smith Cochran Hicks, PLLC will play a major role in distributing the common benefit dollars, 5% of every plaintiffs’ case. See Order #262Common Benefit Work Order #262, June 23, 2017
http://www.meshmedicaldevicenewsdesk.com/multidistrict-litigation-working-transvaginal-mesh-cases/
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Jun 29, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, March 7, 2017~ By now readers may understand that most mesh, whether for hernia repair or to treat prolapse and/or incontinence, is made of the plastic polypropylene (PP).
But you may not know about the additional chemicals that are introduced with polypropylene mesh.
There is no other way to say it – polypropylene (PP) is a cheap plastic mesh material and a dominant polymer used by the medical device industry.
Besides pelvic and hernia mesh, uses include catheters, tubing, syringes, and contact lenses. And PP use for medical devices is predicted to grow, despite the indications it might not be biocompatible.
Any chemical handled by workers as part of industrialized production is accompanied by a Materials Safety Data Sheet or MSDS. It is required by OSHA, the Occupational Health and Safety Administration.
The MSDS for polypropylene (PP) resin states clearly it is not to be made into implantable medical devices.
What does industry know that patients do not?
In 2011, Dr. Donald Ostergard, past president of the American Urogynecologic Society (AUGS), told its members that “mesh is not inert.”
Mesh is able to incite an inflammatory response or foreign body reaction in the body. In other words, there is a continuing process of change and degradation. Electronic microscopy showed the deep cracks in the PP as it degrades in the body. It can shrink up to 50 percent.
Without chemical additives to slow the process, PP was seen to degrade in live animal tests (Liebert, 1976) and that degradation process occurred as soon as a few days after implantation.
An added antioxidant retarded the degradation process.
That insight, opened the door to a chemical smorgasbord of additives to PP mesh, the effects of which are unknown.
CHEMICAL ADDITIVES TO MESH
According to testimony from the September 2014 case of Huskey v. Ethicon, (2:12-cv-05201), filed in the Southern District of West Virginia, the proprietary formulation of Ethicon/ Johnson & Johnson’s Prolene (PP) show the addition of Procol LA-10, a lubricant to help reduce tissue drag and promote tissue passage.
Santonox is an added antioxidant. Its role is to protect the resin from thermal oxidation during the extrusion process during the making of sutures or threads.
Also added is the lubricant, Calcium Stearate.
Chemical polymer expert Dr. Shelby Thames, brought in as an expert for Johnson & Johnson, testifiedthat DL TDP, also known as dilauralthiodipropionate, is an added antioxidant that improves the long-term storage of the resin, reducing any impact of oxygen or ultraviolet light. See the background story on MND here.
A copper-based pigment is added to make the mesh more visible in the body.
The U.S. Food and Drug Administration (FDA) clears PP mesh for market and we know from inside those clearance documents that PP mesh implants are exposed to ethylene oxide (EtO) gas, a low-temperature sterilization agent.
EtO is considered toxic by the Environmental Protection Agency and a carcinogen. Exposure is regulated by the EPA in the workplace under the rules of OSHA.
Europe is light years ahead of the U.S in these concerns.
In May 2016, the European Parliament and EU Council of Ministers agreed to limit the use of devices that contain carcinogenic, toxic, mutagenic or hormone-disrupting properties.
That would include plastics.
The effort there comes after a disaster in France when a manufacturer used industrial grade silicone to fill breast implants.
The EU data will list all implantable devices that are on the market.
The U.S. has yet to establish a national database for medical devices that go wrong, though the MAUDE database is a start. Reporting can be voluntary, the database is difficult to decipher and adverse event reports often go first to the manufacturer, which can under FDA guidance decide if the complication is related to its medical device or not. ###
http://www.meshmedicaldevicenewsdesk.com/whats-added-plastic-mesh/
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Fife medical negligence claims top £85 million
Jun 29, 2017 | Fife Today
By Maggie Miller
NHS Fife is currently battling 74 live claims arising out of alleged medical negligence, it has emerged.
The statistics, which have come to light after a Freedom of Information request submitted by the Press, show that, if successful, the region’s insurers would have to potentially pay out a whopping £85,422,000 in compensation payments and legal bills.
The health board also revealed that, over the past financial year, the region admitted liability in four cases and paid out £2,752,788.
Across the UK hundreds of women are taking legal action against NHS boards and the makers of mesh implants used in gynaecology to treat pelvic organ prolapse and incontinence after childbirth – and Fife is no different.
Claims also focus on Cameron Hosital in Windygates with claimants citing inadequate nursing care in the Balcurvie Ward and the Balgonie Ward.
Other claims regarding obstetrics include medication errors/problems with medication.
Failure in ante-natal care.
Injury/damaged caused during procedure.
Failure/delay in referring to hospital.
Procedure carried out without consent.
Failure to adequately monitor first stages of labour.
Failure to make timely response to abnormalities in FHR.
Failure to carry out proper examination following birth.
In other departments, including emergency care and planned care, claims include but are not restricted to:
Failure/delay in diagnosis and treatment.
Failure to carry out medical investigations.
Procedures carried out without consent.
Surgical foreign body left in situ.
Contraction of bacterial infection.
Medication errors/problems with medication.
Assault by patient
http://www.fifetoday.co.uk/news/fife-medical-negligence-claims-top-85-million-1-4490377
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Jun 29, 2017 | Daily Report
One of the biggest wins for Greenberg Traurig's mass torts/products liability team was a complete defense verdict for client C. R. Bard in the closely-watched pelvic mesh trial in the 16th Judicial Circuit of Missouri. Plaintiff Eve Sherrer sued Bard and co-defendant Boston Scientific for injuries she claimed were caused by the implantation of a Boston Scientific Solyx device, followed by its replacement with a Bard Align device, to treat her stress urinary incontinence. Plaintiff challenged the adequacy of the design of the two devices and of the warnings that accompanied them. The plaintiff requested $28 million in compensatory damages, claiming that the companies' pelvic mesh implants rendered her incontinent and suffering from pain and other ailments. The plaintiff also sought punitive damages against both defendants.
Greenberg Traurig's lawyers argued that Align is safe and effective as designed, that its warnings were appropriate and that plaintiff's pain complaints were most likely the result of osteoarthritis and other conditions unrelated to the product.
A major development in the case was the discovery, midway through trial, of a very early mesh implant procedure that plaintiff had undergone long before the procedures at issue in this lawsuit. Plaintiff and her experts had steadfastly denied that this earlier procedure had ever been performed. This long-hidden fact seriously damaged the credibility of plaintiff and her witnesses.
In other cases, the firm represented Alcon Laboratories Inc. (Alcon) and Sandoz Inc. (Sandoz) and several related entities in a series of statewide and nationwide putative class actions in various federal courts around the country. The suits allege that Alcon, Sandoz and other manufacturers of prescription eye drops dispense drops at volumes that are larger than the average capacity of the human eye, resulting in waste, which forces patients to purchase additional bottles of medication. In March 2016, the firm won a motion to dismiss for its clients and the other manufacturers based on lack of standing by the plaintiffs in the matter in New Jersey.
The firm said in its nomination materials that a midtrial discovery of surprising evidence was a key to your victory over a suit claiming faults in your client's pelvic mesh product. How often does a midtrial surprise come up, and how'd this one come about?
Trial lawyers rarely see the types of surprises that may change the direction of a case anymore, but these jewels can be uncovered with diligence and ingenuity. It is important to keep your eyes open for these opportunities and stay nimble throughout trial so that you can seize on any potential game-changing information when it presents itself. In this instance, the plaintiff was suing our medical device client for injuries allegedly caused by one of its vaginal meshes. During discovery, she mentioned an earlier procedure from 1997 but couldn't recall the doctor or facility. During my cross-examination of her, she named the town where she had received the procedure. Our team called every medical facility in the town and were able to get records to prove that this earlier procedure involved mesh (another company's), a fact which both the plaintiff and her expert denied and which turned out to be the only mesh inside of her. To the extent the plaintiff was critical of mesh and believed it was the source of her problems (which we denied), it was not our client's product.
What is the biggest challenge of "parachuting" into cases just weeks before trial, and how do you overcome it?
We have developed a reputation for being able to plunge into trial on short notice, based largely on our ability to mobilize quickly with a tried and tested team of professionals. We have a solid trial-ready team made up of not just lawyers, but nurses, technology consultants, paralegals and legal assistants and we are "all hands on deck," up to and through trial. We were actually retained in late March for a case that's scheduled to go to trial next month in a "judicial hellhole" jurisdiction. The challenge is not so much in managing the logistics or absorbing a new case. Rather, the biggest challenge is that, in many instances, we do not have time or the opportunity to put our personality or flavor on the case. Frequently by the time we inherit the case, most of the evidence, deposition testimony, experts and themes have already been developed. The cases are usually worked up quite well by experienced firms, but they may not necessarily mirror our style.
What would you consider a crisis in litigation, and what's your advice on how to manage one?
The most typical crisis situations include significant press scrutiny or "trying the case in the media," concurrent recalls or regulatory activity or even a rogue ex-employee or whistleblower. Any of these can negatively amplify the litigation and create distractions from the real issues. These crises may be unavoidable, however, and therefore we strive to be proactive and prepared with a contingency plan. For example, in large litigations where these crises are likely to arise, we work with the client's PR team as they develop a ready-to-go media plan for dealing with press inquiries. Additionally, it is our goal to anticipate and be prepared to respond to any recall or regulatory activity and make sure our litigation defenses coalesce with the client's regulatory response. We also take efforts at the outset to identify any problem witnesses and to mitigate their impact where we can. Crisis management is a necessary part of defending the client and its reputation, and when done well can head off future or follow-on litigation.
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