Many of you are asking, “how did I end up here?”, referring to the system in the courts known as Multidistrict Litigation. It’s a good question and has taken over one federal court in Charleston, West Virginia for seven years as well as the life of one federal judge, The Honorable Joseph Goodwin. Hopefully, coverage on Mesh News Desk will provide some historical context on how the MDL has handled the mesh litigation.
What is Mesh Litigation MDL?
On this page you will find a number of helpful articles from your editor concerning the MDL process and how the multidistrict litigation was formed and why. Skip straight to a story that answers your question. from the links below:
- What’s Wrong with the MDL System of Conflict Resolution? (June 27, 2017)
- What’s Wrong with the MDL System of Conflict Resolution, Part 2
- What is Multidistrict Litigation? (December 16, 2016)
- Cook Medical Joins Federal Transvaginal Mesh Lawsuits in WV (June 18, 2013)
- 21,000 Mesh Cases Filed in Federal Transvaginal Mesh Litigation (May 24, 2013)
- Mesh Injury Lawsuits to be Consolidated in 3 MDLs in West Virginia (February 7, 2012)
- Upcoming Miami Hearing on Transvaginal Mesh Litigation and Consolidation (January 12, 2012)
- Plaintiffs Want Mesh Lawsuits Centralized (December 22, 2011)
What’s Wrong with the MDL System of Conflict Resolution? Part One
Mesh Medical Device News Desk, Part One, June 27, 2017 – University of Georgia School of Law professor, Elizabeth Burch, is not a fan of multidistrict litigation or MDLs. Burch studies mass torts, such as the Kugel mesh case, and is currently working on a book about the MDL system.
According to her research, collecting data from 72 product liability pending as of May 2013, 70 law firms had attorneys who were named to five or more leadership roles in the MDLs. Calling them “repeat players,” Burch writes that 16% of the involved law firms held nearly 54% of all leadership positions.
What’s created is a two-edge sword.
This is Part One, Please follow up with Part Two here.
On one hand, high-stakes multidistrict litigation is managed by lead lawyers with trial experience who are best equipped to bring cases to settlement. On the other hand, the judges are relatively powerless to police these private settlements created by the MDL.
Q: Akre – The MDL steering committees, you call them repeat players since the same law firms represent 63% of all mass torts. How do they get into those enviable positions?
A: ”The judge is the one who decides who will lead the litigation. There are a lot of different methods to decide. Some will say – pick your own people and bring me the consensus and the judge then confirms the slate. The slate could be heavily populated with people who have done this before.
“They have the pull and capital to get everyone to vote for them.
“Long before there even is an MDL they are posturing so they know the most about a particular lawsuit.”
Q: Should that be a concern for the plaintiff?
A: “On one hand repeat players have done this before.
“After litigation against JNJ (Johnson & Johnson), you have lawyers who have dealt with them on talc, strategy, hip implants, and that’s the upside.
“The downside potentially is you have repeat players on both the defense and plaintiff side. JNJ uses the same lawyer over and over again and they deal with each other and may develop a quid pro quo relationship.
“I don’t want to say they go into a back room, but you develop these working relationships where “You know what I need….”
“The plaintiff lawyers negotiate to increase their common benefit fees, so every plaintiff agrees to settle also agrees to the increased fees they’ve negotiated with the defendant.
“The defendant, in return, can negotiate for things it wants. You want finality, for example. You can have a walkaway provision, where basically it says, ‘Unless we get x percentage of the plaintiffs to agree to this, we walk away from the deal and the deal is off. ‘ That ranges from 85% to 100% of plaintiffs who must agree to the deal.
“Some of the provisions aimed at the lawyers say you must recommend this deal to 100% of your clients. Some plaintiffs might not be in the same boat, but by agreeing to this settlement, you’re agreeing to recommend it to everybody!
“Some other settlements say if you have a client who doesn’t want to settle you have to drop them like a hot potato. It’s unethical yet it’s done. That’s the tit-for-tat I’m talking about.”
Q: In the mesh MDL the common benefit fund is 5% and Judge Goodwin has not specified who is to fund it. Most plaintiffs are told they must pay the 5%. At the same time MDL lawyers are charging plaintiffs 40%. Are these costs excessive?
A: “Different states set caps on what an attorney can charge. I don’t know where 40% came from. Thirty-three percent is typically the norm.
“With a common benefit fund, every plaintiff has to put 5% into the kitty. Some lead attorney are also forcing them to pay to package claims together.
“If I’m in Athens, Georgia, I represent only five plaintiffs, and Bard says I will only settle if you bring me 1,000, I can’t do that.
“The lead lawyers are charging them between 25% of individual attorney fees to process claims together on top of 5% common benefit fee.
“The problem comes when I try to figure out how to best represent my client. The only way to settle is to pay $3,000 a case and I can’t go to trial then and I can’t press for a better settlement. I have no leverage, you’re stuck in huge MDL yet you can’t do anything other than package for a small settlement.
“In theory the Plaintiff fees – if I charge you a 30% fee and lead lawyers are charging me. It should come out of the attorneys’ fees. There have been judges who have stepped in and cut individual attorney fees, for example in Vioxx, Judge Fallon and Zyprexa litigation. They’ve gone in and said your individual lawyer has not done 40% worth of work, it’s an unjust fee and I will come in and cut it.”
Q: Is it fair to say you’re not a fan of the MDL system?
A: “I’m not a fan of how they are handled. Some judges do a better job of policing the repeat player than others. But there are systemic problems in MDLs. One example – there was litigation on Propulsid, an earlier MDL and in my database.
“The lawyers recovered over $22 million in common benefit fees. There were over 6,000 claimants in the MDL proceeding. The lawyers negotiated a strict process for settlement. First, a panel of doctors decide on causation. As soon as you opt into the settlement, you don’t know if you will recover, but you’ve given up your right to sue in court.
“Of those 6,000 plaintiffs, 38 recovered money…they recovered $6.5 million in total. The lead lawyers made over $22 million, $8 million went to Canada’s program and $8 million to the Louisiana Public Health Initiative, since Judge Fallon is in Louisiana.
“Only $6.5 million went to the plaintiffs. The rest of the fund went back to JNJ, the defendant. The lawyers said that was the template for all mass torts. And they never tried to get the products off the market.”
Multidistrict Litigation – Is it Working for Transvaginal Mesh Cases? Part 2
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?
A: “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.”
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 #262
Common Benefit Work Order #262, June 23, 2017
What is Multidistrict Litigation?
Mesh Medical Device News Desk, December 16, 2016 ~ MDL, Multidistrict Litigation. Readers of Mesh Medical Device News Desk have been hearing about the court where most of the transvaginal mesh cases are consolidated. But what is the MDL and how did it get started?
In early January 2012, the number of transvaginal pelvic mesh cases filed in various state courts was growing. All of the injured women claimed the mesh had caused injuries, some life altering. Many had revision surgeries to remove eroded mesh. Others had surgeries to attempt to have the mesh removed.
Regardless most of the women who decided to file lawsuits decided they were suffering from a multitude of injuries and that they did not receive informed consent.
Mesh Lawsuits Consolidated In West Virginia
A three-judge panel met in Miami and decided the cases should be consolidated in multidistrict litigation (MDL) in the federal court in Charleston, West Virginia where it would join similar cases pending against C.R. Bard filed two years earlier.
Multidistrict litigation is a fairly new way to deal with mass torts.
In 1968, Congress was responding to over 25,000 claims pending in 36 different federal courts alleging a nationwide antitrust conspiracy by the manufacturer of electrical equipment.
The Judicial Panel on Multidistrict Litigation (JPML) 28 U.S.C. § 1407, also known as the MDL Panel, was formed. Made up of judges from different judicial circuits, they convene around the country to determine whether civil cases with common questions of fact should be consolidated into federal district courts under one judge.
The goal was to streamline pretrial proceedings by avoiding inconsistent lower court rulings, allowing individual actions to move through the courts more quickly.
The initial MDLs involved defective products, airplane crashes, investment fraud and patent infringements, among others. Some of the better known MDLs are Vioxx, fen-phen and asbestos.
7 Defendants, 97,000+ Cases
Unlike Vioxx, which had one manufacturer, Merck, and resulted in a $4.85 billion settlement, the pelvic mesh litigation has grown to include seven defendants and more than 97,000 cases, closing in on the longest-lasting largest MDL of asbestos with 121,000 civil cases.
Judge Joseph Goodwin was assigned to oversee the cases eventually naming the seven manufacturers – Boston Scientific, American Medical Systems, Ethicon (Johnson & Johnson), C.R. Bard, Coloplast, Cook Medical and Neomedic.
Does MDL Tip The Scales Of Justice?
Some plaintiffs feel that multidistrict litigation unfairly favors the defendant corporation. A plaintiff may be precluded from litigating in her home state, which might be the forum of her choice and convenience.
A bellwether trial, so named for the lead male sheep who wore a bell to lead the flock, is selected from within the MDL to test legal theories before a jury and gives both sides the relative value of the cases.
The Role Of Bellwether Trials
Unless chosen to be a bellwether trial, individual plaintiffs receive much less attention in an MDL and must agree to whatever settlements are forthcoming as a result of those bellwether trials.
Bellwether cases generally lead to settlements but that has not been the case with many of the pelvic mesh manufacturers.
Johnson & Johnson, Boston Scientific and C.R. Bard have offered limited settlements, based on a point system of injury. The larger the mesh and the more surgeries, the higher her settlement amount.
Federal Judge Defines Case “Waves” To Streamline Process
While the questions of fact are the same – is this a product that was defectively designed and manufacturer? Were the instructions to the end user / doctor insufficient, essentially defective? Were there promises made by industry and its sales reps to doctors a breach of warranty? Should the companies be punished with punitive damages?
Because we have so many companies, Judge Goodwin has begun to consolidate even further, grouping cases in “Waves” with similarities, such as a single trial for Boston Scientific and its Obtryx pelvic mesh.
No one ever envisioned a mass tort this big and no doubt the chapter on pelvic mesh, its success and failures will be one for the history books for decades to come. ###
Cook Medical Joins Federal Transvaginal Mesh Lawsuits In WV
June 18, 2013 ~ Just call it Multidistrict Litigation No. 2440.
As if more than 23,386 lawsuits (as of June 12) filed against synthetic transvaginal mesh makers were not enough, cases filed against Cook Medical have just been added to the multidistrict litigation (MDL) consolidated in one federal court in West Virginia.
Cook is now the sixth mesh manufacturer whose product liability lawsuits are set to be heard in the federal court in Charleston.
JPML Consolidates Mesh Litigation Further
On June 11, the Judicial Panel on Multidistrict Litigation (JPML) ordered the transfer of 13 complaints naming Cook Medical from eight different districts to now be overseen by the Honorable Judge Joseph. R. Goodwin.
The other manufacturers include Ethicon (Johnson & Johnson), Boston Scientific, American Medical Systems, Coloplast and C.R. Bard.
C.R. Bard Bellwether Trial On The Way
On July 8, the first of four bellwether cases against C.R. Bard is scheduled to go to trial.
Last June C.R. Bard lost a case filed by Christine Scott in California state court. Bard was ordered to pay Scott and her husband $5.5 million. That decision has been appealed by Bard.
Cook Medical makes the Surgisis Biodesign Tension-Free Urethral Sling, Surgisis Biodesign Anterior Pelvic Floor Graft, Surgisis Biodesign Posterior Pelvic Floor Graft, Cook Urological Stratasis Urethral Sling or Stratasis Tension Free Urethral Sling.
Here is their website.
Polypropylene v. Biologic Mesh
While most of the vaginal mesh products causing complications are made from polypropylene (PP), Cook has positioned itself as a specialist in biologic grafts, or dermis-based mesh. The Surgisis sling is made using the small intestines of a pig. Women implanted with Cook Medical mesh allege debilitating problems such as pain, erosion, nerve damage, contraction and infection, among other complications.
The company says it is infection-resistant making it safer than other mesh.
Cook Medical prepared a Special Report in 2007, Dispelling Myths About Biologic Grafts. It largely talks about the new evolution of biologic mesh used for hernia repair combining the “best attributes of biologic grafts and synthetic mesh.”
Multidistrict litigation is the consolidation of lawsuits in one federal district court when there is a common question of fact. The judicial panel votes to transfer and consolidate similar cases so that they can move through the court more efficiently.
The first Pretrial Order (here) states a pretrial conference will be held August 1, 2013.
Cook Medical, Press release 2006
21,000 Mesh Cases Filed in Transvaginal Mesh Litigation
May 24, 2013 ~ A meeting in Charleston, West Virginia yesterday, where about 20,000 transvaginal mesh lawsuits have been consolidated, yielded a tentative tolling agreement.
Under law, a tolling agreement suspends for a period of time, the statute of limitations. In this case, the July, 2013 two-year statute of limitations date will be extended a number of months. That means potential plaintiffs who think it may be too late to file a case against any of the five mesh makers will have extra time to file.
The ruling was issued to avoid a log jam of mass filings in the federal court by those trying to make some deadline.
How A Tolling Of The Statute Of Limitations Could Affect You
If you are thinking of filing a case with one of the law firms involved in litigation here, it is suggested to fill out the necessary papers to move it along. The website has a listing of the rulings and the various law firms involved. These are likely the firms of trial lawyers who do the legwork to prepare a case.
Smaller firms may eventually pass your case to one of these larger firms.
Multidistrict litigation (MDL) allows for cases from all over the country to be heard by one judge, in this case The Honorable Judge Joseph R. Goodwin, to allow for consistent rulings so cases can move through the courts more quickly. They can still be tried individually but the MDL addresses all of the housework such as depositions and the filing of motions that precedes an actual jury trial.
The five defendants are Ethicon (Johnson & Johnson), C.R. Bard, American Medical Systems, Boston Scientificand Coloplast.
Here is the So. District of West Virginia website and the number of cases filed as of May 22, 2013.
MDL No. 2187 C.R. Bard, Inc. with 3,349 cases filed.
MDL No. 2325 American Medical Systems (AMS), Inc. with 6,781 cases filed.
MDL No. 2387 Coloplast Corp. with 420 cases filed.
TOTAL # cases filed in MDL= 21,257
Mesh Injury Lawsuits to be Consolidated in 3 MDLs in West Virginia
February 7, 2012 ~ Breaking News! Within the hour the Judicial Panel on Multidistrict Litigation (MDL) ruled that three pending and separate MDL actions against three synthetic mesh manufacturers should be heard in the Southern District of West Virginia.
The MDL claim 2187 is being heard by Chief Judge Joseph R. Goodwin in the Southern Federal District of West Virginia.
Transvaginal Mesh MDL Gets A Whole Lot Bigger
Earlier this year, a series of lawsuits against several top surgical mesh makers and distributors were combined and now three other cases, MDL 2325, 2326 and 2327, will be consolidated with MDL 2187, so Judge Goodwin will now be handling the bulk of transvaginal mesh lawsuits in the nation.
Altogether Judge Goodwin will hear 82 pending lawsuits filed in federal courts around the country against American Medical Systems, 22 cases against Boston Scientific Corp., as well as 36 actions against Ethicon, Inc.
Judge Goodwin’s court already oversees lawsuits filed against C.R. Bard from Avaulta mesh injuries. The plaintiff attorneys argued in Miami on January 26, that claims by the injured women are substantially similar and Judge Goodwin is familiar with the Bard Avaulta mesh injuries and will understand how to handle claims where multiple mesh devices from different manufacturers were used on the same female patient.
Attorney Henry Garrard, managing partner of the Georgia law firm Blasingame, Burch, Garrard & Ashley, P.C., is the plaintiff’s lead counsel in the Avaulta MDL. He along with other law firms, filed motions last November seeking the transfer of the cases to the Southern District of West Virginia. Garrard also argued for the transfer before the judicial panel in Miami on January 26.
“We argued, and the panel agreed, that centralization of these cases was appropriate because they share factual issues arising from what we believe are similar defects in these pelvic mesh products,” Garrard said.
“Our law firm looks forward to working with other law firms from across the country in moving ahead with these cases and pursuing relief for the women and families that have been harmed by transvaginal mesh products,” Garrard said.
Creating “An Even Playing Field”
Jonathan Orent of Motley Rice tells MDND its a fair result.
“We’ll know what the ground rules are so there will be consistency of application of the law and an even playing field. I’m optimistic this will cut down on years of litigation,” he said.
The women all claim injuries following surgery with synthetic transvaginal mesh which range from intense pain, disability, mesh erosion and shrinkage, nerve damage, and infection, among other injuries.
The Food & Drug Administration (FDA) has received more than 4,000 reports of injuries to women who received the permanent synthetic mesh implants by the manufacturers to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
How Multidistrict Litigation (MDL) Works
An MDL is a special procedure in which noncriminal cases are consolidated into one court. An MDL is different from a class action lawsuit in that the MDL allows those injured to file individual product liability lawsuits while at the same time the plaintiffs share discovery and experts and benefit from a uniform set of rules and rulings.
The consolidation of cases cuts down on the cost of bringing an action forward for each individual plaintiff. One judge oversees discovery and rules and procedures while the cost of duplicating documents for thousands of plaintiffs is reduced making litigation more cost and time effective.
There must be common questions of facts pending in federal courts around the country.
Upcoming Miami Hearing On Transvaginal Mesh Litigation & Consolidation
JANUARY 12, 2012 ~ A growing number of women from around the country who are plaintiffs in transvaginal mesh litigation have a court date of Wednesday, January 26 in Miami. The Judicial Panel on Multidistrict Litigation (MDL) is set to hear requests by plaintiff attorneys to have thousands of defective mesh lawsuits consolidated in the same federal court.
Here is the Notice of Hearing.
The proceeding will consider whether the injured women should have their cases centralized before the U.S. District Court for the Southern District of West Virginia before Chief Judge Joseph R. Goodwin.
Plaintiffs Claim Severe Mesh Injuries
The women all claim injuries following surgery with synthetic transvaginal mesh which range from intense pain, disability, mesh erosion and shrinkage, nerve damage, and infection, among other injuries.
The companies named in lawsuits include Boston Scientific Corp., American Medical Systems (acquired by Endo Pharmaceuticals Holdings), and Ethicon(Johnson & Johnson). The Food & Drug Administration (FDA) has received more than 4,000 reports of injuries to women who received the permanent implants to treat pelvic organ prolapse and incontinence which have led to hundreds of lawsuits, background story here.
The plaintiffs argue that claims by the injured women are substantially similar and Judge Goodwin is familiar with the Bard Avaulta mesh injuries and will understand how to handle claims where multiple mesh devices from different manufacturers were used on the same female patient.
How MDL Could Affect Your Case
An MDL is a special procedure in which noncriminal cases are consolidated into one court. An MDL is different from a class action lawsuit in that the MDL allows those injured to file individual product liability lawsuits while at the same time sharing discovery and experts and to benefit from a uniform set of rules and rulings.
An MDL cuts down on the cost of bringing a case forward. One judge oversees discovery, rules and procedures while the cost of duplicating documents for thousands of plaintiffs is reduced making litigation more cost and time effective.
There must be common questions of facts pending in federal courts around the country to have the cases consolidated.
The Judicial Panel on Multidistrict Litigation meets in various cities to decide which request should be consolidated.
Benefits of MDL
For a large corporation an MDL is cheaper and allows fewer expert depositions, decreasing the change the person with knowledge will be inconsistent.
In an MDL, the damage amount awarded will be tailored to the individual’s damages they suffered as opposed to a class action where everyone is awarded the same amount regardless of their injury.
Plaintiff attorneys say that the costs of bringing the case forward is reduced for each plaintiff because the various law firms representing the women will be allowed to share the information they uncover during the discovery process in documents and depositions with the defendants, in this case the mesh makers. And a MDL does not preclude a woman suffering from damages from transvaginal surgical mesh to end up having her own trial.
Mesh Lawsuit Basics
The product liability litigation charges the companies knew or should have known their products were defective in their manufacture, their design and in their marketing materials in a failure to warn the public about the potential dangers.
The public became aware about the dangers of defective surgical mesh on July 13, 2011 when the FDA issued a safety notification warning that complications from the plastic petroleum-based mesh are “not rare” and questioning whether mesh provides any benefit over non-mesh surgery for pelvic organ prolapse and incontinence.
FDA Eyes Increased Risk Designation For Mesh
As recently as January 4, 2012, the FDA said in a notification
“Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.”
A Class III designation would have required mesh manufacturers to conduct premarket approval, scientific studies for safety and efficacy on the permanent transvaginal mesh implant before they reach consumers. Presently mesh is a Class II device and those safety assurances are not required.
Plaintiffs Want Mesh Lawsuits Centralized
DECEMBER 22, 2011 –The Athens Georgia law firm of Blasingame, Burch, Garrard & Ashley, P.C. has filed a motion to have various plaintiffs from around the country centralize their defective transvaginal surgical mesh litigation in one federal court – the Southern District of West Virginia.
The three separate but related motions ask for actions against three different manufacturers to be moved to the U.S. District Court for the Southern District of West Virginia before Chief Judge Joseph R. Goodwin.
The action would allow similar lawsuits brought by other law firms to join the litigation reducing the cost of gathering evidence, and eliminating the time and effort that goes into duplicative discovery.
Law Firm Files Petition For Centralization
The request in the form of a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation according to a December 21 news release (here).
The law firm says Southern District Judge Joseph R. Goodwin is already familiar with the issues because of the Avaulta MDL (multidistrict litigation).
If the three separate motions are granted, 83 cases around the country against American Medical Systems (Endo Pharmaceuticals Holdings), 41 against Ethicon (Johnson & Johnson), and 30 against Boston Scientific Corp. would be consolidated. Attorney Henry Garrard has been involved in transvaginal mesh issue since 2006 and is currently the lead counsel in the Avaulta multidistrict litigation.
Judge Goodwin has since October 2010, overseen pretrial proceedings in the Avaulta (C.R. Bard) Pelvic Support Systems Product Liability Litigation (MDL No. 2187).
Product Liability Lawsuits
Product liability or defective product lawsuits allege that a product was defective in its manufacture, its design or in a failure to warn. If the defect existed when the product was manufactured, it is possible that just one select group of product will be defective.
On the other hand, if there is a design flaw, the entire line might be dangerous to use and cause harm to the user. A marketing defect generally under reports or misreports information about the product. The defendant, in this case the mesh manufacturers, are liable when they are shown the product is defective.
Multidistrict litigation (MDL) is consolidated before a “transferee judge” in one court. Plaintiff cases remain individually active and each plaintiff can have access to the defendant’s materials and witnesses gathered during the discovery process. This reduces the work of the court and should bring a settlement sooner. Settlements are tailored to the damage the individual plaintiff has suffered and the number of plaintiffs in the MDL.