Over 100,000 women have filed personal injury lawsuits over complications caused by transvaginal mesh patches. Thousands more men and women are pursuing similar claims against the manufacturers of hernia mesh products.
Mesh Lawsuits Move Forward In Court
Here at MND, your editor has been chronicling the mesh mess for nearly a decade, bringing readers around the world the latest information on patients who are pursuing justice against the globe’s largest medical device manufacturers.
- Judge Goodwin Pushes 23K Pelvic Mesh Cases To Conclusion (February 5, 2018)
- Mesh Past & Present (January 7, 2018)
- September Brings Renewed Life In Mesh Litigation (September 1, 2017)
- Pelvic Mesh Trials Ahead (May 31, 2017)
- Appeals Court Backs Boston Scientific Win In North Carolina Pelvic Mesh Lawsuit (May 10, 2017)
- C.R. Bard Sold For $24 Billion, Transvaginal Mesh Maker With 15K Lawsuits (April 24, 2017)
- Physiomesh Hernia Mesh Cases May Be Transferred To Georgia (March 20, 2017)
- February Brings New Life In Mesh Litigation (February 5, 2017)
- AMS Pelvic Mesh Lawsuits Settled & Dismissed By The Hundreds (June 9, 2016)
- Lawsuits Scheduled For Ethicon’s Physiomesh Hernia Mesh (October 25, 2016)
- Atrium Medical C-Qur Hernia Mesh Lawsuits Moving Forward (July 10, 2016)
- Kugel Mesh Lawsuits Still Being Filed After Recall & Settlement (September 18, 2014)
- J&J Named In Another Hernia Mesh Lawsuit (April 15, 2014)
- Hernia Mesh Lawsuit Filed Against Atrium Medical Corporation (March 11, 2014)
- Hernia Mesh Lawsuit Filed In West Virginia Court (September 17, 2013)
- Mississippi Court Upholds Ethicon Win In Mesh Warning Lawsuit (August 8, 2012)
- C.R. Bard Loses $5.5 Million In Landmark Vaginal Mesh Lawsuit (July 24, 2012)
- Three Lawsuits Join Hundreds (October 25, 2011)
On this page, you’ll find an archive of your editor’s most popular pieces on mesh litigation. You’ll find legal updates on litigation involving every major mesh manufacturer, from Endo Pharmaceutical’s subsidiary AMS to Johnson & Johnson’s Ethicon. To skip to a story, click on a link above.
Clear The Decks – Judge Goodwin Pushes 23K Pelvic Mesh Cases To Conclusion!
Mesh Medical Device News Desk, February 5, 2018 ~ It’s time to clear the decks of the MDL and Judge Goodwin’s orders show he has run out of patience after six years of pelvic mesh litigation that continues to linger in his federal courtroom.
Be ready to try your cases by this fall, his new orders say!
There is a clear sense of urgency and impatience in the new orders issued by Judge Joseph Goodwin who is overseeing in excess of 104,000 pelvic mesh cases filed in his Charleston, WV district court.
Judge Goodwin announced at this time last year that it was time to clear the decks of this MDL (multidistrict litigation) which was created in January 2012 by the Judicial Panel on Multidistrict Litigation.
It’s not supposed to go on forever. An MDL is supposed to ease pre-trial proceedings so plaintiffs can have a speedy resolution of their case. In the few bellwether trials, the relative value of a case is supposed to be established.
That hasn’t happened yet, so now it’s time and the federal judge is giving both sides a strong shove.
Federal Judge Urges 23,000+ Lawsuits Forward
The four orders affect 23,202 pelvic mesh cases filed by women implanted with polypropylene mesh to treat incontinence and pelvic organ prolapse.
“These orders are not good for either side,” commented someone with knowledge of the court.
Boston Scientific, AMS, Bard & Ethicon Cases Affected
In four of the largest mesh maker actions, thousands of cases have been put into “Waves” or groupings for pre-trial proceedings. Once discovery is completed they can be transferred to a federal court of proper venue or remanded back to the court from which it was transferred so they can be tried.
The four include Boston Scientific, American Medical Systems, Bard and Ethicon.
What’s unclear is how future pelvic mesh product liability cases will be handled. Those meshes that remain on the market are still being used by medical societies and called the “gold standard” of care.
ETHICON (Johnson & Johnson)
Ethicon– Wave 8 is created in Pretrial order #280 for 13,200 Ethicon cases! Both sides must be ready for trial this fall! Both sides will meet September 3, 2018 to submit joint venue recommendations, where the trial will take place. Judge Goodwin will set the trial dates.
Cases can transfer out of West Virginia and into a state venue, where it was originally filed or New Jersey where J&J calls home.
Cases in the process of settling may be removed from the list and settled and women with meshes from more than one manufacturer may be relieved of some of the deadlines in that case.
Ethicon has 39,350 cases filed in the MDL with 12,716 listed as closed. That means it has the smallest percentage of closed or resolved pelvic mesh cases.
C.R. Bard must have its cases ready for trial by the end of October and like Ethicon it is limited as to the number of experts one may call. Treating physician depositions are limited to 4 and depositions must take no longer than three hours. Requests for production of documents is limited to ten. Wave 7 will be the final Wave of the Bard cases and includes 2,876 plaintiffs!
At this time Bard has 15,548 cases filed with 11,047 listed as closed.
AMS – American Medical Systems (now owned by Endo) has never had a trial, so very little discovery exists. That has not stopped Judge Goodwin from setting Wave 3 of AMS cases, entered as Pretrial order #249 January 30, 2018. October 26, 2018 is the deadline to complete expert motions and both sides should be ready to go to trail. The venues will be decided by September 3, 2018 and 952 women are affected. AMS currently has 21,165 cases filed in the MDL with 19,524 listed as closed.
In its settlement documents, AMS requires lawyers to agree not to bring any more cases against the manufacturer. See the AMS Master Settlement here.
Complicating matters, Endo International Plc is facing nightmares of debt and falling generic medicine prices and its opioid painkiller Opana is the focus of federal litigation. Its stock is perilously low and there is speculation of bankruptcy. As of November, the company agreed to pay $3.5 billion to handle its 46,000 mesh lawsuits but the dollars may not be enough.
Last August, AMS agreed to pay $775 million to close out outstanding pelvic mesh claims in the U.S. and internationally.
Boston Scientific Wave 4 will be formed and ready for trial also at the end of October. 6,174 women fall under this order.
Coloplast Waves 1, 2, and 3 are awaiting an update as to which have not been resolved or dismissed.
Cook stopped having cases referred into the West Virginia MDL last September. There are 632 cases filed in the Cook product liability litigation and 137 filed in Neomedic which appear to be resolving since they are talking about dividing common benefit dollars and no discussion of trials.
U.S. District Court, Southern District of West Virginia
AMS Master Settlement, Freese & Goss 2013
Mesh Past & Present
Mesh Medical Device News Desk, January 7, 2018 ~ So the MDL (multidistrict litigation) was established by the Judicial Panel on Multidistrict Litigation in Miami January 2012. Today there are more than 104,000 defective product, also known as product liability cases filed in the MDL federal court in Charleston, WV.
Here is a brief summary of where we are today.
Johnson & Johnson has the largest number of cases in the MDL, more than 39,000 recently, followed by Boston Scientific, more than 25,000, then AMS (American Medical Systems) more than 21,000, then C.R. Bard 16,000, followed by Coloplast, Cook and Neomedic.
You can go to Sodistrictofwv.com and pull up the most current numbers easily by clicking on the manufacturer and then on numerical list of cases. You can also put your name in the search bar to ull up your case and case number. You will need a Pacer account to read the complaint.
Cases are still being filed, for example, from August to November 2017 there were nearly 800 cases added. That’s because pelvic mesh is still being used.
In fact, the American Urogynecologic Society (AUGS) still calls incontinence mesh the “Gold Standard” and touts its use. That is difficult to believe since the majority of cases filed calling the implants defective, are for “slings” another word for incontinence mesh.
The larger mesh for pelvic organ prolapse (POP) has met a different fate. J&J took its Prolift off the market and most manufacturers quietly discontinued their POP meshes. They were causing devastating problems and are nearly impossible to remove.
FDA Classifies POP Mesh As High Risk
In January 2016, the FDA decided to reclassify POP mesh as Class III or High Risk, which is probably where it should have been in the first place, not moderate risk. The FDA gave manufactures 30 months to prove the safety and efficacy or stop selling POP mesh. That takes us to the fall of 2019. The thought is that’s the end of POP mesh because it really can’t be proven problem free, even in the most experienced hands.
As you probably know, most medical devices do not go through the same scrutiny as drugs before cleared for sale. The FDA simply requires paperwork stating that the medical device is the “substantial equivalent” to one already in commerce. There are no requirements for clinical trials and years of study to prove safety and efficacy. In essence, the FDA is allowing the manufacturers to regulate themselves.
As the FDA found out in 2008 when it issued its first warning, there were thousands of complaints of injury being reported to the antiquated FDA site to register complaints- called the MAUDE database, which would scare away anyone. You need to know the regulatory language and most people find it unusable. Three years later, the FDA issued a second public health notification that complications were “not rare” reversing itself on the 2008 warning.
Other than that, the FDA did nothing except hold an expert panel in September 2011 that concluded POP mesh was a problem but slings were not. It took until 2016 for the FDA to reclassify POP mesh as high risk or Class III and even then, the agency gave manufacturers the benefit by allowing 30 months for the stuff to remain on the shelves and presumably used.
The Institute of Medicine, in a report, said the FDA clearance requiring only the Substantial equivalence test, is antiquated and should be abolished.
Trials have proven that the mesh is defective, that the warnings were inadequate and that the manufacturers violated their warranty and in some cases, state consumer laws.
We also have thousands of people in New Jersey, Bergen Co who are lined up for lawsuits naming CR Bard and Ethicon as well as cases in Los Angeles naming Boston Scientific and more than 100 in Philadelphia against defendant Ethicon and Boston Scientific.
Here is a list of the cases so far.
Meshes found defective in a court of law are still on the market and the predicate device remains, even when it is removed from the market.
It’s impossible to know how many people have died from mesh implants. Hernia mesh, made from the same polypropylene, is not looked at as a cause of death even when there is a colon nick and sepsis results. Look up hernia death in the FDA MAUDE database and you will see numerous reports of sepsis.
Often the infection finally undermines the immune system and kills a person. Again, mesh is not mentioned because no one is looking at that as a cause of death, not yet anyway.
UCLA is doing data gathering on autoimmune reactions to mesh, which it seems to incite in some people. The polypropylene mesh seems to hold onto bacterial contamination, incites a foreign body reaction and can create a biofilm colony using the mesh as a host. Many women report additional autoimmune complications to their pain of fibromyalgia, brain fog, rashes etc….
The MDL system has resulted in a few verdicts that are resulting in settlements by manufacturers, but the amount offered isgenerally very low and law firms are taking up to 40% of any settlement dollars. Some women are ultimately left with less than the law firm, after 40% and expenses are subtracted and she is loaded with liens and medical expenses.
Meshes found defective in a court of law are still on the market and the predicate device remains, even when it is removed from the market. ###
September Brings Renewed Life In Mesh Litigation
Welcome September from Mesh Medical Device News Desk~ Mesh News Desk has been carefully watching the proceedings that are public, many of your settlements are not, and the sense is that we are nearing an end to unsustainable litigation.
Just two weeks ago, mesh manufacturer Johnson & Johnson was hit with a $417 million loss in its talcum powder litigation, which is another product liability front for this healthcare giant with hundreds more cases waiting in the wings.
So far J&J has lost $48 million in pelvic mesh litigation in the Philadelphia Court of Common Pleas alone. That does not include the multidistrict litigation gathered in Charleston, WV or individual state trials.
Since the company says “sustainability” and “putting people first” is its motto, it’s tough to understand how hundreds of millions of dollars in losses before juries can be defined as “sustainable.”
Just “Get Meaner Lawyers”
Maybe they could follow the advice of one shareholder at the April’s gathering in New Brunswick, New Jersey and just “get meaner lawyers.”
No doubt J&J has the best lawyers money can buy, mean or not.
J&J is the focus this month because the company is the last large mesh manufacturer to offer mass settlements. J&J also has more mesh product liability cases, 55,000, according to its latest SEC federal government filing. Polypropylene mesh has been used for about twenty years to make pelvic mesh implants which are permanent. The mesh was not tested and for many, doesn’t only fail to work but causes life-altering complications.
Mesh News Desk (MND or MMDND) has been covering the issues surrounding pelvic and hernia mesh for five years now. Please enter your search terms in the Search Bar to do research and if you click on the headers such as “Legal” “News” “Medical” you will see stories filed under that topic.
Please do not use your last names when you comment! You can also post anonymously, making up a name.
MND is NOT a legal referral service!
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J&J and Boston Scientific are also facing a host of new trials set for the end of this year and 2018. Stay tuned.
Congratulations for all of the media coverage gathering overseas. Still, that is not the case in the U.S. for some unknown reason.
Many of you call asking questions of MND. While I’m happy to help and often do, looking up your case, answering questions, even though I’m not an attorney or doctor, I cannot possibly get back to all of you. I apologize. Call again if you need to talk. You should consult with your doctor or lawyer for their expertise as these pages are not meant to substitute for professional opinions.
So many hernia-injured folks contact me as well. I ask them to contact Bruce Rosenberg, hernia mesh injured patient advocate. Best to text him at 954-701-5094. He may be able to direct you medically.
Please learn what kind of mesh you have, the type and manufacturer. Please stay actively involved in your case. In some cases, plaintiffs have been dropped because they moved and their law firm could no longer find them, at least not easily.
Please be kind to each other….thank you.
Jane Akre, Editor
Pelvic Mesh Trials Ahead
Mesh Medical Device News Desk, May 31, 2017 ~ So far this 2017, the litigation in transvaginal mesh cases filed around the country seems to be picking up steam.
This comes after a long lull in proceedings.
Judge Joseph Goodwin had hoped to have the massive Mass Tort in his West Virginia court wrapped up by March. He had let out a long leash hoping both sides would come to the settlement table, but no progress was made that was evident to the patiently waiting plaintiffs.
Upcoming TVM Trials
So here is a schedule of transvaginal mesh cases ahead that MND has been able to ascertain. Please add your case here if we have missed any.
Trial locations are in various state courts as well as Bergen County, New Jersey, Philadelphia, Pennsylvania and Los Angeles.
There are 182 transvaginal mesh cases awaiting trial in the Philadelphia Court of Common Pleas, naming defendants, Johnson & Johnson/ Ethicon, Boston Scientific and Bard.
The next trials scheduled that show Trial Date Certain are
June 19, 2017 – Blockus, vs Tissue Science Laboratories, Secant Medical, Prodesco, Ethicon Women’s Health and Urology, Case no. 130700707, Kline Specter.
**UPDATE** The Blockus trial has been moved to November!
July 31, 2017 ~ Ebaugh, v Ethicon Women’s Health and Urology, v Prodesco, Ethicon, Gynecare, Johnson & Johnson, Secant Medical, Case No. 130700866, Kline Specter
Other trials scheduled for 2017 include:
- July 2017 – Boston Scientific trial in Los Angeles, Mostyn Law
- October 30, 2017 – Plaintiff v C.R. Bard, Bergan Co New Jersey, Mazie Slater
- November 27, 2017 – Plaintiff v Ethicon, Bergen Co, NK, Mazie Slater
2018 Cases Set for Trial in Philadelphia
- January 22, 2018 – Bagwell v Johnson & Johnson, trial date certain
- January 22, 2018 – Hespe v Boston Scientific, trial date certain
- February 5, 2018 – Berry v Johnson & Johnson, trial date certain
- February 18, 2018 – Carson v Johnson & Johnson, trial date certain
- March 19, 2018 – Collins v Johnson & Johnson, trial date certain
- April 2, 2018 – Dawson v Johnson & Johnson, trial date certain
- April 16, 2018 – Eicholtz v Johnson & Johnson, trial date certain
- April 30, 2016 – Ely v Johnson & Johnson, trial date certain
- May 14, 2018 – Brenda French, trial date certain
- May 29, 2018 – Lemieux v Johnson & Johnson, trial date certain
Philadelphia Court of Common Pleas- Pelvic Mesh Case List
C.R. Bard Sold For $24 Billion, Transvaginal Mesh Maker With 15K Lawsuits
Mesh Medical Device News Desk, April 24, 2017 ~ C.R. Bard to be sold for $24 billion.
Sunday it was announced that Becton Dickinson (BD) and Company (NYSE BDX) will acquire C.R. Bard for $317.00 per common share in cash and stock. The agreement totals $24 billion.
As was the case when AMS was sold to Endo International, the acquiring company generally buys the liability or outstanding lawsuits as well.
C.R. Bard Faces Tens Of Thousands Of Mesh Lawsuits
Additionally there is a New Jersey state MDL with 130 remaining cases on the docket, according to a status report (here) issued in April. (Master Docket No. BER-L-17717-14, Superior Court of New Jersey, Bergen Co.)
The New Jersey Pelvic Mesh Cases are listed here and includes thousands of cases filed against another New Jersey company, Johnson & Johnson (Ethicon).
Becton Dickinson, a Franklin Lakes, N.J.- based medical device giant, offers products to treat diabetes, anesthesia care and diagnostics. BD announced it would improve its ability to offer products that reduce the chance of hospital-acquired infections. Bard offers devices in urology, oncology and vascular.
The deal should be closed this fall and USA Today reports, after regulatory and shareholder approval. This is the fourth largest acquisition of the year and the largest in the U.S. Together the companies have about $16 billion in annual revenues and 65,000 employees. BD hopes to accelerate growth into China and internationally.
Bard’s CEO will join BD’s board of directors.
C.R. Bard faced its first bellwether case in August 2013 with the D. Cisson trial. MND story here.
Cisson was awarded $2 million by a Charleston, WV jury. That case was precedent setting because it was the first in a decade to allow the state of Georgia to collect 75% of the punitive damage award of $1.75 million. In 1987, Georgia added that provision as part of tort reform in 1987, to discourage lawsuit.
Federal Judge Denies Plaintiff & Defendant Motions
On January 20, 2015, Judge Goodwin denied the plaintiffs’ motion to declare that Georgia’s law regarding punitive damages unconstitutional.
Bard also wanted punitive damages reduced from $1.7 million to $250,000. That too was denied.
In 2015, Bard agreed to settle 3,000 mesh cases for $200 million. In 2014, Bard agreed to a $21 million settlement to resolve 500 defective product lawsuits.
Bard, based in Georgia, manufactures various medical devices including:
Avaulta Plus™ BioSynthetic Support System
Avaulta Solo™ Synthetic Support System
Pelvitex™ Polypropylene Mesh
Appeals Court Backs Boston Scientific Win In North Carolina Pelvic Mesh Lawsuit
Mesh Medical Device News Desk, May 10, 2017 ~ An appellate court on Tuesday affirmed a lower court decision in the pelvic mesh lawsuit of Martha Carlson.
It too rejected her failure to warn claim, citing she didn’t prove that Boston Scientific failed to provide an adequate warning about the potential risks of the Uphold mesh.
Mesh Survivor Loses Uphold Trial Appeal
Martha Carlson lost her pelvic mesh lawsuit in October, 2015, before a Statesville, North Carolina jury. (Ramona Winebarger et al v. Boston Scientific, No. 5:15-cv-00057-RLV-DCK)
In 2010, Ms. Carlson, 65, was implanted with the Uphold Vaginal Support System, a mesh to treat pelvic organ prolapse (POP), and began having complications such as recurrent pelvic organ prolapse, pain, incontinence, dyspareunia, urinary and bowel problems.
Court Dismisses Failure TO Warn Claim
She alleged neither she nor her doctor received adequate warnings.
Carlson’s case was initially filed in the MDL in Charleston, WV before Judge Joseph Goodwin. Her attorneys alleged a defective design, breach of warranty and a failure to warn.
In the early stages, lawyers for Boston Scientific were successful in throwing out her failure to warn claim in summary judgment. They alleged she did not present evidence that any inadequate warnings caused her injuries.
Here is a Mesh News Desk story on the Carlson trial.
On Tuesday, May 9, the Fourth Circuit Court of Appeals, based in Los Angeles, affirmed the lower court decision. Read it here.
Did Boston Scientific Fail To Warn Patient?
Carlson’s physician, Dr. Michael Kennelly, when deposed, said any warnings from Boston Scientific were inadequate. Ms. Carlson also testified that, if she had known that the mesh “could result in life changing conditions, [she] would not have agreed to the procedure.”
Lawyers for Boston Scientific argued that Dr. Kennelly did not read or rely on the Directions for Use, which accompany the mesh, and therefore did not rely on allegedly-inadequate warnings.
That’s when the Goodwin court awarded summary judgment to BSC.
North Carolina Trial Leaves Critical Evidence Out
The case was then transferred to a Raleigh, North Carolina district court for trial on the claims of defective product. That court too would not consider a failure to warn claim even though plaintiffs’ counsel provided additional excerpts from the implanting doctor’s deposition that he did read the Directions for Use.
Under North Carolina law, under a failure to warn claim, the plaintiff must prove the defendant unreasonably failed to provide an adequate warning and that failure to warn was the proximate cause of her damages. Also, the product must pose a substantial risk of harm without an adequate warning when it is sold.
Plaintiffs’ counsel provided additional evidence of a failure to warn, but that was considered too little too late.
“Appellant woefully failed to meet her burden of production in opposition to summary judgment to establish a triable issue of fact as to the proximate cause,” wrote the Fourth Circuit.
Marlex Is “Impure,” Dangerous, Survivor Claims
According to her trial brief, the polypropylene used to make the Uphold is “impure, non-medical-grade” known as Marlex that “shrinks, hardens, bunches and degrades,” in the body. The weave is so small that bacteria is entrapped and so are nerves, resulting in pelvic pain.
After a partial removal attempt, Ms. Carlson says the mesh broke apart into small pieces.
Marlex resin is issued by Chevron Phillips. Its Material Safety Data Sheet says it is not to be used in implantable medical devices that come in contact with internal bodily fluids or tissues.
See the Martha Carlson Trial Brief.
Carlson lost on the remaining claim of a defective product at trial. She was represented by William Louis Hurlock of Mueller Law of of Austin, Texas. BSC was represented by Shook Hardy & Bacon.
Her lawyers immediately filed an appeal that went to the Fourth Circuit to try and reinstate the failure to warn claim and to approve the motion to reconsider. Ultimately that court affirmed the lower court’s decision, denying a motion to reconsider, despite Ms. Carlson’s citation to additional excerpts of her doctor’s deposition.
Physiomesh Hernia Mesh Cases May Be Transferred To Florida
Mesh Medical Device News Desk, March 20, 2017~ Physiomesh is the latest focus of defective product litigation and the number of cases keeps growing. So much so that multidistrict litigation may consolidate cases, filed in state courts around the country, into one mass tort or MDL in Florida or Illinois.
It is the latest, greatest mass tort that has the attention of mesh plaintiffs’ lawyers. Physiomesh is the polypropylene hernia mesh that is composed of layers and made by Johnson & Johnson. It was taken off the market last year by the maker and since then, product liability lawsuits have been filed.
The latest Motion filed will transfer all cases to the Middle District of Florida or to the Southern District of Illinois. Read it here.
The Center Of Gravity
Filed March 9, 2017 before the Judicial Panel on Multidistrict Litigation (JPML), plaintiffs’ lawyers want to know where the Physiomesh cases should be heard. An MDL (multidistrict litigation) consolidates cases for pretrial proceedings.
Women injured by transvaginal mesh generally complain that, after 40% of any settlement dollars is paid to MDL law firms, there is little left to take care of their many needs in the future. An MDL will generally force both sides into a settlement after a few bellwether trials, but that amount may be considerably less than a jury award in compensatory damages.
Transvaginal mesh cases (nearly 100,000 of them) were consolidated in federal court in Charleston, West Virginia before Judge Joseph Goodwin in January 2012. Read more about the mesh MDl here.
For some reason, the majority of the pending Physiomesh cases are filed in the southeast U.S. The southeast is the “center of gravity” for these cases.
Plaintiffs Suggest Florida, Illinois As Proper MDL Courts
The motion suggests the Middle District of Florida as the proper forum for coordinated and consolidated pretrial proceedings. Plaintiffs’ attorney suggest Judge James D. Whittemore, Susan C. Bucklew Judge Paul G. Byron as all well-suited to preside.
The alternative selection could be the Southern District of Illinois before Judge David R. Herndon.
Physiomesh Hernia Mesh – The Latest Mass Tort
Physiomesh Flexible Composite, is a synthetic hernia mesh designed, manufactured and sold by Ethicon, a division of Johnson & Johnson. It is composed of five distinct layers, two layers of Monocryl (polyglecaprone-25) film covered by two underlying layers of PDS (polydioxanone) film which coats the polypropylene (PP) mesh.
This is a unique design to Physiomesh and has never been used before.
Ethicon promised doctors the multi-layer coating would prevent or at least minimize adhesion and inflammation while at the same time facilitating incorporation of the mesh into the abdomen.
Physiomesh Design Creates Risk Of Complications, Plaintiffs Say
In filing their lawsuits, the Plaintiffs say they will show the multi-layers instead prevent adequate incorporation of the mesh into the body and added to a number of serious complications. The polypropylene mesh was not strong enough to withstand forces of the abdomen and that can a result in a hernia through the mesh itself or a recurrent hernia and/or rupture.
Additionally, the mesh may deform.
Physiomesh was withdrawn from the market voluntarily by Johnson & Johnson in May 2016. The lawsuits hope to prove that J&J did so because of the severity and frequency of Physiomesh complications.
Patients Claim Severe Injuries
The plaintiffs civil action claims the mesh was defectively designed and/or manufactured and the defendants failed to provide appropriate warnings about the dangers of Physiomesh. The injuries suffered are serious and permanent and can lead to additional surgeries, medical expenses and unresolved medical complications. For spouses, they are seeking loss of consortium.
So far there have been 18 patients who have filed civil actions after they were implanted with Physiomesh and they are pending in 9 federal districts.
Where Are Physiomesh Lawsuits Filed?
There are six in the Middle District of Florida, two in the Southern District of Illinois, two in the Northern District of Georgia, two in the District of Colorado, one action in the middle District of Georgia, one action in the District of South Carolina, one action in the Eastern District of Kentucky, one action in the District of Massachusetts, one action in the Northern District of Oklahoma and one in the District of New Jersey.
Since there were more than 330,000 Physiomesh devices sold worldwide and half of those were sold in the U.S., it is predicted there could be hundreds if not thousands of additional cases filed in the near future.
These actions should be consolidated is the argument by the plaintiffs attorneys including Henry Garrard (Blasingame), Douglas Kreis (Aylstock), Joesph Osborne and Don Migliori (Motley Rice) because they all involved similar product liability design defect and inadequate Warnings by the manufacturer.
“Having a single judge preside over the pretrial proceedings in these case would promote efficiency and economy by avoiding duplicative discovery from similarly situated claimants who have asserted common product liability claims, will prevent potentially inconsistent pretrial rulings regarding factual and legal issues common to all cases, and will help preserve the resources of the parties, their counsel and the judiciary by eliminating redundancy of effort.”
Here is the Southern District of Illinois, including the city of Springfield.
Here is the Middle District of Florida would include Ft. Myers, Jacksonville, Ocala, Orlando and Tampa.
Video on Physiomesh- Hollis law
February Brings New Life In Mesh Litigation
Hello February ~ Those of you who are socked in with winter, I’m sorry. When it hits 60 degrees in Florida, we complain and get out our sweaters. But spring lies ahead and so does movement in this Mesh Mess.
Mesh News Desk (MND or MMDND) has been covering the issues surrounding pelvic and hernia mesh for five years now. If you are new to the issues surrounding the controversy, please visit the search bar or click on the topics. You will find a world of coverage. You may want to start with Resources and our Facebook page. For those of you who contribute, thank you for being so thoughtful. It keeps us going!
Please do not use your last names when you comment! You can also post anonymously, making up a name.
Multi-District Litigation Proceeds
There are now in excess of 100,000 lawsuits that have been filed in Charleston, West Virginia by women who’ve had complications with their transvaginal mesh used for pelvic organ prolapse or to treat incontinence (100,731 as of Jan 31).
Judge Joseph Goodwin, overseeing the multidistrict litigation, reportedly wants it to be concluded and soon. He is sending cases back to state courts and will conduct trials with large numbers of plaintiffs at one time! Fasten your seat belt.
One would assume with those numbers, that now exceed the number of asbestos cases filed in the largest MDL ever, the media coverage would be heard. Some women would like to target various news outlets for multiple contacts which is a very good idea.
Since settlements have not been forthcoming from Johnson & Johnson/ Ethicon, let the trials begin again.
In February in Philadelphia, the Sullivan case against Boston Scientific will be heard, (Feb 27) then on March 6th, 25 or so women from West Virginia will have their day in court- all at the same time! The details on how that will work logistically have yet to be determined, however it did work with four plaintiffs in a Miami courtroom with Judge Goodwin and defendant Boston Scientific in 2015. Each woman was awarded several million dollars after being injured by the Pinnacle pelvic mesh.
There is a steady stream of cases planning to be litigated in Philadelphia Court of Common Please, most against J&J.
Patients Unhappy With Legal Representation
Many of you contact me unhappy with your law firm and the paltry settlement you have been offered. I always say if you have the most severe injuries such as pudendal nerve injuries, there are probably other law firms who will take your case. You must fire your first law firm first, and that’s the quandary you will find yourself in. I always tell folks I’m not a lawyer or a doctor. Any law firm willing to take on these cases, it might be an excellent time to advertise on Mesh News Desk. There will be no shortage. Since November, the MDL has added 3,500 new cases!
So many hernia-injured folks contact me as well. I ask if they know their manufacturer. Most do not. You need your medical records to find out a) what type of mesh and b) who makes it. There are a few hernia mesh law firms willing to take your case, especially now if you have Physiomesh or C-Qur, but there may be others.
Polypropylene is the bottom line for both transvaginal mesh and hernia mesh. Some day we may determine that it is bio-incompatible in some bodies, for any use, but we are not there yet.
MND is NOT a legal referral service!
The longer mesh makers wait – the more evidence amasses that life-long compensation will be required for those impacted by polypropylene mesh. The autoimmune registry continues at UCLA, Please enter your autoimmune reactions to mesh here.
For those of you who asked, editorial assistant, Brewie, who was born with a compromised liver, finally lost his struggle on January 11 th. He was jaundiced and losing the fight. Poor little guy. We miss him.
Your emails are never shared unless you request. Providing your email may result in enrollment in the newsletter. Thank you all! Hang in there friends. A new year, renewed determination!
Jane Akre, Editor
AMS Pelvic Mesh Lawsuits Settled & Dismissed By The Hundreds
Mesh Medical Device News Desk, June 9, 2016 ~ Six hundred pelvic mesh lawsuits dismissed in one work week.
Unlike the snail’s pace of federal pelvic mesh litigation, Mesh News Desk has learned that over the last work week, 673 product liability lawsuits concerning pelvic mesh made by American Medical Systems (AMS) have been settled and dismissed.
Settlement Value Range: $9,000 – $200,000
According to the language in the dismissal notices, the cases have been resolved or settled for an unknown amount, though women reporting to Mesh News Desk say their settlements range from $9,000 to approximately $200,000.
After legal fees of approximately 33.3% to 40% are subtracted, along with any loans, hospital, doctor bills, the settlement amount is reduced by about half.
Hundreds of cases have been dismissed by Judge Joseph Goodwin, overseeing multidistrict litigation (MDL) in Charleston, WV or by joint motion filed by plaintiff and defendant law firms.
“..they have compromised and settled all claims between them in these actions, including all counterclaims, cross-claims and third party claims.”
In some of the lawsuits, AMS is the only defendant in the listed actions. See # Doc 2359, June 2, 2016, dismissing 42 cases. Dismissing a case with prejudice means it cannot be refiled in the future.
In other cases where the woman received more than one pelvic mesh, the AMS claim will be removed from its docket but the action will remain active on the docket for Boston Scientific, Ethicon (Johnson & Johnson), or C.R. Bard, the other major mesh manufacturers.
See Doc # 2358, June 2, 2016, transferring cases overseen by Clark, Love and Hutson to Boston Scientific.
Since the first of May, there have been more than 50 other Petitions to dismiss, which presumably contain hundreds of other AMS lawsuits that have settled.
Over 20,000 AMS Cases, But No Bellwether Trials
As of today, AMS is still listed as having 20,199 active cases on the docket in the MDL. The company never had a bellwether trial to test legal theories before settlement talks began.
Judge Goodwin encouraged other mesh makers to follow the lead of AMS settlements, but so far, none have done so.
AMS urology products was purchased in April 2011 by Endo International PLC, with headquarters in Dublin, Ireland. Timing was everything. The purchase occurred on the eve of a tsunami of pelvic mesh lawsuits. So many so that multidistrict litigation (MDL) to consolidate cases was formed in January 2012 and has swelled to 93,000 lawsuits filed against seven manufacturers, AMS among them. ###
Lawsuits Scheduled For Ethicon’s Physiomesh Hernia Mesh
Mesh Medical Device News Desk, October 25, 2016 ~ The first lawsuits have been scheduled for the Ethicon Physiomesh, a hernia mesh used for repairs. The hernia mesh has been removed from the global market after reports it degraded inside patients and did not function as intended.
Medical professionals had until September 16, 2016 to return unused Physiomesh hernia mesh for a full refund after the product was recalled by its manufacturer, Ethicon, a division of Johnson & Johnson. Ethicon issued a recall of Physiomesh last May after studies showed it failed when used in hernia surgeries when compared to other similar hernia meshes.
Ethicon Withdraws Physiomesh From Global Market
The mesh was used in laparoscopoic and ventral and inguinal hernia repair surgeries.
The voluntary recall was conducted by Ethicon, the U.S. Food and Drug Administration and its European counterparts.
Two unpublished studies, one in the Danish Medical Registry and the other in the German Medical Registry, suggested its failure rate for laparoscopic ventral hernia surgeries were higher than the other meshes used on patients in these registries.
“The recurrence/reoperation rates (retrospectively after laparoscopic ventral hernia repair using Ethicon Physiomesh compositve Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
Physiomesh is made of polypropylene but the studies found it broke down in its structure, allowing the hernia to recur or cause bacterial infections and swelling at the surgery site, requiring another surgery. Ethicon suggests surgeons replace it with Proceed surgical mesh, Prolene, Prolene Soft, or Ultrapro mesh, all made by Ethicon.
No Efficacy Or Safety Trials
Physiomesh was marketed after clearance under the FDA’s 510(k) process in April 2010, which does not require clinical trials for safety and efficacy.
Physiomesh is made of a flexibile composite mesh “composed of nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh.”
Ethicon developed Physiomesh Open, the latest version of the mesh, and it was introduced in 2014. Both meshes were marketed following the fast tracked 510(k) approval process by the FDA. Physiomesh Open is not involved in this recall.
On its website Ethicon claims, “ Physiomesh Open is built on the proven technology of the #1 selling tissue-separating mesh Open Flexible Composite Mesh, and optimized for open ventral hernia repair.”
Physiomesh Lawsuits Filed
A number of lawsuits have already been filed. Matthew Huff was implanted with Physiomesh in 2013 to repair a ventral hernia. In July 2015, he developed severe abdominal pain, fever, chills, nausea and redness. He was treated for an infection and two abscesses and an intestinal fistula. His case is set for January 22, 2018 in the Southern District of Illinois. Case No. 3:16-cv-00368.
Another product liability lawsuit was filed in the U.S. District Court Middle District of Florida September 22nd claims the mesh is defective and caused her persistent abdominal pain, diminished bowel motility and bowel obstruction.
Here is an adverse event report submitted to the FDA that says the mesh pulled away from the abdominal wall resulting in a second surgery.
In June 2012, Ethicon removed four transvaginal meshes from the market- Prolift, ProliftM+, TVT Secur and Prosima Pelvic Floor Repair System. The company said the removal was for business reasons. ###
Atrium Medical C-Qur Hernia Mesh Lawsuits Moving Forward
Mesh Medical Device News Desk, July 10, 2016 ~ This article is Sponsored Content written by Brett Vaughn, RN, BSN, and JD of the Hollis Law firm, of Overland Park, Kansas, about Atrium Medical Hernia Mesh and specifically its C-Qur hernia mesh.
As many of you readers know, unlike transvaginal mesh, there are few law firms in the US that are willing to take on hernia mesh cases and with one million hernia surgeries a year, there are many patients experiencing complications who are looking for answers.
If you have hernia mesh and are experiencing complications, please obtain your medical records so you can manage your health care and complications.
Mesh Medical Device News Desk reports among all of the different mesh manufacturers, there is a growing number of lawsuits filed against Atrium Medical Corporation. The lawsuits allege severe personal injuries resulting from the failure of the Atrium C-Qur hernia mesh.
Lawsuits against Atrium and their C-Qur hernia mesh are currently pending in federal courts in Texas, Florida and New Hampshire, with more lawsuits likely to be filed in the near future.
These suits open another chapter for Atrium Medical, operating out of Hudson, New Hampshire, with its parent company, Maquet, based in Germany.
What’s emerging is a long, tangled story of legal and regulatory problems surrounding the C-Qur line of hernia mesh products.
The C-Qur hernia mesh gained FDA approval through the FDA 510(k) program in 2006, which allowed Atrium to skip thorough pre-market studies. In order to gain 510(k) approval, Atrium had to prove that its mesh was substantially similar to a previously approved mesh.
Just like most transvaginal meshes, Atrium’s C-Qur hernia mesh is made from polypropylene, the polymer plastic that’s known to shrink, cause a foreign body reaction, become infected and erode.
Atrium’s hernia mesh began being implanted at a much higher rate nationwide after Atrium signed a three-year national contract with Premier Inc. in 2010. Premier is a group purchasing organization (GPO), which supplies over one-thousand hospitals. GPOs are the only type of company in which kickbacks are actually legal.
Legislation was passed a few decades ago with the intent of allowing smaller hospitals to join together in order to increase their purchasing power, thus driving down prices (similar to how insurance works). It has evolved into companies like Premier.
The agreement was for Atrium to provide its hernia mesh in bulk at cheap prices. Premier would then supply its member hospitals with Atrium’s hernia mesh. The member hospitals would typically have to agree to only use Atrium’s hernia mesh. After Atrium was one year into its contract with Premier, Maquet Cardiovascular bought Atrium for over one-half billion dollars.
Shortly after Atrium was acquired by Maquet, the FDA issued a warning letter to Atrium Medical in 2012. The warning letter noted that the manufacturing and sterilization process for the C-Qur hernia mesh was altered without proper test being conducted. The FDA also cited multiple instances of C-Qur hernia mesh infections that the company failed to investigate and report.
The most disturbing revelation was that the FDA found numerous instances of human hair being embedded into Atrium’s sterile medical devices.
In 2013, Atrium issued a class II recall on the C-Qur mesh. Even though there was a recall, none of Atrium’s hernia mesh products were actually pulled from the market. Atrium simply wrote a letter notifying doctors to be aware that the mesh’s coating could stick to the packaging and peel off the mesh itself. The purpose of the the coating is to prevent the polypropylene portion of the mesh from coming into direct contact with a patient’s organs.
Several studies have investigated the complications associated with Atrium’s C-Qur hernia mesh. A study conducted in Belgium had to be stopped early because of an unacceptably high rate of C-Qur hernia mesh infections.
A separate study also experienced infections in nearly every C-Qur hernia mesh that was implanted.
Recently, the FDA sued Atrium and Maquet for introducing adulterated medical devices into interstate commerce.
The FDA was granted a permanent injunction against the facility that manufacturers the C-Qur hernia mesh. Atrium’s hernia mesh was not pulled off the market though.
Many providers have discontinued using the C-Qur hernia mesh; however, it is still being implanted at some hospitals.
Injuries related to Atrium’s hernia mesh can take years to manifest. These injuries include infection, bowel perforation, bowel resection, additional surgeries, severe pain, rejection of the mesh and abdominal rashes.
Mesh Medical Device News Desk will continue to follow this story and provide updates as this litigation progresses. There is also additional information about the Atrium C-Qur hernia mesh available at the Hollis Law Firm. #
Kugel Mesh Lawsuits Still Being Filed After Recall & Settlement
Mesh Medical Device News Desk, September 18, 2014 ~ According to an article in Lawyers and Settlements lawsuits are still being filed against the maker of the Kugel Hernia Mesh.
Mesh manufacturer C.R. Bard offered a $184 million settlement more than three years ago to some 3,000 Kugel mesh implanted patients. The U.S. Food and Drug Administration began the Kugel recall in 2005 and followed up with two more in 2006 and 2007.
Some patients may be experiencing delayed complications which can include pain, infection, hernia recurrence, sepsis, adhesion, bowel obstruction, according to the FDA.
First Round Of Kugel Litigation Ended In $184M Settlement
The first Kugel hernia mesh lawsuit resulted in a $1.5 million award to plaintiff Christopher Thorpe and sometime after that the mesh manufacturer agreed to the larger settlement. Product liability claims alleged the Kugel mesh was defective because the memory recoil ring broke or could break causing fistulas and abscesses and punctures in the patient’s abdomen.
After the FDA recall, the Kugel mesh was allegedly made stronger and put back on the market.
See Trudy Thomas’ story on her Kugel mesh patch and removal as well as litigation problems here.
Richard Howden had a hernia patch made by Ethicon and his life has never been the same. See the story here.
Did Legal Strategy Fail Mesh Survivors?
Many patients injured by Kugel mesh voice dissatisfaction to Mesh News Desk with how low their settlements ranged, starting around just $5,000. That may be due to the fact that plaintiffs’ lawyers focused their defective product arguments on the ring inside the hernia product and not the mesh itself.
Kugel Mesh Hernia Patch Products Liability Litigation, case number 07-md-01842, US District Court for the District of Rhode Island.
Dr. Bruce Ramshaw, the current president of the American Hernia Society tells MDND that he believes we are just seeing the tip of the iceberg in hernia repair injuries to patients. With about a million procedures a year, even with a one percent complication rate, that leaves 10,000 patients a year with severe complications.
According to the FDA, the most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, bowel obstruction. In some cases mesh can contract and migrate and perforate other organs or the bowel, causing sepsis.
FDA on Hernia Surgical Mesh Implants
FDA- Kugel Recall 2004
Kugel Cases Still Being Filed
Lawyers and Settlements on Bard Kugel Mesh
Hernia repair: Secrets Patients Should Know
J&J Named In Another Hernia Mesh Lawsuit
Mesh Medical Device News Desk, April 15, 2014 ~ Plaintiff Richard McLaughlin filed his lawsuit in California’s Central District last February. Although his mesh, made by Johnson & Johnson, was used for hernia repair, the allegations are the same as mesh used for pelvic organ prolapse – that the mesh is defective, that the instructions were missing or misleading, that the company is liable for his injuries and inability to work.
Hernia mesh is made from polypropylene (PP), a petroleum-based plastic. It has been used for decades and was generally regarded as safe, but some individuals have had ongoing complications since their implant.
Since prolapse in a woman’s pelvic floor was also considered a form of hernia, the same PP mesh was later adapted for use as transvaginal mesh (TVM).
Lawsuit Blames J&J Mesh For Severe Injuries
In this case, Richard McLaughlin was implanted with PP hernia mesh on December 30, 2011 at the Los Alamitos Medical Center in Los Alamitos, California by Denise Joseph-Brown, M.D., who is also named as a defendant in the lawsuit. Here is the lawsuit:
His lawsuit says he has suffered severe bodily and mental injury, is in pain and has lost his income. His wife, Eve, has lost her husband and is also a named Plaintiff in the action. Toby Ellis of Agnew Brusavich (here) is the attorney for the Mclaughlin’s.
“The scientific evidence shows that the polypropylene material from which the Product is made is biologically incompatible with human tissue and promotes a negative immune response in a large subset of the population implanted with the Products, including Plaintiff.”
The product can become infected via bacterial contamination and cause chronic inflammation. Biomechanical issues that result include shrinkage, contracting, creeping, and deforming of the mesh.
The defendant should have known but yet continued to promote the product as safe and effective, even as no long-term trials had been conducted to assure safety and efficacy.
This is a defective product action and alleges negligence in its design, manufacturing, packaging and selling of the hernia mesh, defective warranty, a breach of warranty, as well as loss of consortium for the wife. The action seeks punitive damages and also includes a medical negligence claim against the doctor.
This is the latest in a number of hernia mesh claims now being filed. See Mesh News Desk on the last lawsuit filed against Atrium Medical for its ProLoop hernia mesh here.
Hernia Mesh Lawsuit Filed Against Atrium Medical Corporation
By Dan C. Bolton and Farid Zakaria, Keller, Fishback & Jackson LLP ~ The law firm of Keller, Fishback & Jackson LLP recently filed a lawsuit in California federal court on behalf of a forty-six year old man injured by a hernia mesh product. The lawsuit alleges claims of product liability, negligence, and fraud against Atrium Medical Corporation (Atrium), the mesh manufacturer, and seeks compensatory and punitive damages. This is believed to be the first case in California filed against Atrium for one of its hernia mesh products.
The plaintiff, a resident of New Jersey, underwent double inguinal hernia repair in 2011 with the ProLoop, a surgical mesh made of a type of plastic called polypropylene. He suffered serious complications after the surgery, including constant and excruciating pain in his groin, pelvic organ damage, nerve damage, the inability to have sexual intercourse, as well as anxiety and depression. Despite undergoing additional surgery some 18 months later to remove the implants, today he still suffers from lasting health problems.
The ProLoop mesh is a non-absorbable three-dimensional plug composed of knitted rows of polypropylene with multiple protruding loops. Polypropylene hernia mesh presents many of the same risks as transvaginal mesh, another dangerous medical device impacting thousands of women in the United States and currently the subject of nationwide litigation.
Both products have undergone minimal regulatory scrutiny under a legal framework that does not require the submission of safety and efficacy data to the Food and Drug Administration.
ProLoop Warnings “Grossly Inadequate,” Attorneys Say
The lawsuit points out that Atrium’s warnings concerning ProLoop are grossly inadequate and violate the manufacturer’s duty to warn of the dangers of mesh. In the Instructions for Use, Atrium states only that inflammation, infection, mechanical disruption, and adhesion are potential side effects.
Polypropylene hernia mesh is frequently used in hernia repair surgery, though it is not always necessary given the high likelihood of complications. Despite relentless marketing by manufacturers, many doctors steer away from polypropylene mesh and use a mesh free procedure called the Shouldice technique to repair hernia. The Shouldice technique has been used for decades and has low rates of failure.
High Complication Rates
Manufacturers have touted mesh for hernia repair as safe and effective, but published research has found high rates of serious complications.
One researcher observed there have been many “reports of various degrees of degradation … stress cracking and mesh shrinkage along with infection, chronic inflammation and the stimulation of sclerosis [hardening of tissue].” The researcher concluded, “Based on available evidence the polypropylene used for surgical treatment of various structural defects is not inert after implantation in the human body.”
Mesh Deformation & Chronic Pain
In fact, a debilitating consequence of hernia repair with mesh is inguinodynia, or chronic groin pain. This condition results from the deformation of mesh following implantation, the persistent foreign body reaction to mesh, and nerve entrapment in the mesh.
The medical literature reports an extraordinarily high rate of chronic groin pain after hernia repair with mesh – in some reports approaching 50%, and even higher in others. Moreover, as the mesh degrades in the human body, small flakes of polypropylene can lead to infection and irritation, and severe pain as the body tries to rid itself of the foreign material.
Despite the abundance of scientific and medical information published in the literature relating to the dangerous properties and serious risks of polypropylene mesh, the plaintiff asserts that the defendants have made a deliberate decision to ignore these dangers, to aggressively market the ProLoop, and to paint a misleading picture of its safety and efficacy in the product literature.
Dan C. Bolton is Of Counsel and Farid Zakaria is an associate in the Los Angeles office of Keller, Fishback & Jackson LLP. The firm represents plaintiffs nationwide in pharmaceutical and medical device cases, including hernia and transvaginal mesh litigation. Mr. Bolton oversees the pharmaceutical and medical device practice. Mr. Zakaria has a background in molecular and cell biology.
Hernia Mesh Lawsuit Filed In West Virginia Court
Mesh Medical Device News Desk, September 17, 2013 ~ Rosemary S. Roberts has filed a negligence lawsuit against C.R. Bard for injuries she suffered from the hernia mesh implanted in her in 2004, reports the West Virginia Record.
It was filed August 22 in Kanawha Circuit Court in Charleston, West Virginia, the same city where more than 30,000 lawsuits have been filed alleging defective transvaginal mesh, nearly 5,000 cases against Bard alone.
Composix & Ventralex Hernia Mesh
Roberts received the Bard Composix Mesh and Ventralex Hernia Patch. Dr. Roland E. Hamrick Jr. was repairing a ventral hernia at the Charleston Area Medical Center. The same doctor also used a Bard Ventrio to patch a spigelian hernia in July, 2011, according to the report.
Roberts claims she is experiencing physical pain and suffering and has permanent and substantial physical injuries and deformity. So far she has had had multiple surgeries and is expected to undergo more. She alleges lost income and significant medical costs as well as a loss of the enjoyment of life.
She is seeking both compensatory and punitive damages and is represented by Thomas F. Basile of Charleston. The case number is 13-C-1609.
No Health Warning
Unlike transvaginal mesh, also made of plastic polypropylene, there is no Food and Drug Administration Health Notification or Safety Warning for hernia mesh. The agency does list hernia mesh complications as:
- Adverse reactions to the mesh
- Adhesions (when loops of the intestines adhere to the mesh or each other)
- Injuries to nearby organs, nerves or blood vessels
- Additional complications with or without mesh can include infection, chronic pain and hernia recurrence
An FDA update says “Most of the complications reported to us so far have been associated with mesh products that have been recalled and are no longer on the market.”
The most famous hernia mesh recall was the Bard Composix Kugel hernia patch. But it was redesigned and reintroduced to the market after more than 2,000 defective product lawsuits were filed against C.R. Bard.
The Proceed surgical hernia mesh made by Ethicon had 18,270 lots recalled in January 2006 when the polypropylene delaminated from the mesh opening up the patient to the possibility of fissures and adhesions.
AlloDerm, was recalled by LifeCell Corporation in September 2005, when it was determined that about one-quarter of those implanted with the donated human/cadaver skin mesh had complications including infection and rejection.
The remainder of mesh recalls have been limited to small numbers of mesh due to sterility compromises during the manufacturing process or mislabeled lots.
Tip Of The Iceberg
Dr. Bruce Ramshaw, the current president of the American Hernia Society tells MDND that he believe we are just seeing the tip of the iceberg in hernia repair injuries to patients. With about a million procedures a year, even with a one percent complication rate, that leaves 10,000 patients a year with severe complications.
According to the FDA, the most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, bowel obstruction. In some cases mesh can contract and migrate and perforate other organs or the bowel, causing sepsis.
West Virginia Record
FDA on Hernia Surgical Mesh Implants
FDA- Kugel Recall 2004
Lawyers and Settlements on Bard Kugel mesh
Mississippi Court Upholds Ethicon Win In Mesh Warning Lawsuit
Mesh Medical Device News Desk, August 8, 2012 ~ An appeals court ruling in Mississippi has upheld a lower court dismissal of a $10 million vaginal mesh case against Johnson & Johnson’s Ethicon division.
The United States Court of Appeals Fifth Circuit filed the decision August 2, 2012 in the case against Ethicon by Deborah and Michael Smith.
Mississippi Appeals Court Dismisses Mersiline Mesh Case
Deborah Smith had a hysterectomy in 2001 along with pelvic organ prolapse which required additional surgery. Dr. Phillip Barksdale of the Women’s Hospital in Baton Rouge, Louisiana did the abdominal sarcoplexy April 12, 2002 using Mersilene mesh made by Ethicon, a division of Johnson & Johnson (J&J).
The court noted that the mesh had a package insert that said “No significant adverse clinical reactions to MERSILENE mesh have been reported. The use of nonabsorbable MERSILENE mesh in a wound that is contaminated or infected could lead to fistula formation and/or extrusion of the mesh.”
Dr. Barksdale said he was familiar with Mersilene mesh and had used it hundreds of times and was aware of the risks involved.
Severe Side Effects & Complications
Deborah Smith experienced pain, vaginal discharge and by July of 2006 she was diagnosed with vaginal mesh erosion, sinus tract formation, pain, adhesions and rectocele. She was admitted to the hospital and stayed for five weeks. Smith became sick with sepsis (infection), renal insufficiency, pneumonia and respiratory failure.
The Smiths filed their complaint on October 16, 2007 in federal court in the Eastern District of New York which was later transferred to the Southern District of Mississippi. They claimed negligence, strict liability, breach of implied warranty of merchantability, breach of express warranty and loss of consortium. They had requested damages in the amount of $10 million.
Strike The Experts
The court noted the Smiths submitted the names of three experts on the day of a deadline. The witnesses included the expert testimony of Drs. Stuart Hart, Kyle Wohlrab, Robert Lloyd Goldstein, and William A. Hyman.
Ethicon argued the names were not sufficient and that the reasons those persons had been chosen needed to be stated under federal law. Ethicon layers filed numerous motions to strike the Smith’s expert witnesses based on lack of timeliness. The court also concluded the expert witnesses did not provide “factual support or reasons for their conclusions.”
Court Takes Issue With Expert Testimony
Drs. Hart and Wohlrab had stated they believed Mersilene mesh caused vaginal erosion.
“Dr. Hart’s medical report did not address the actual question at issue in this case, which is not whether the Mersilene mesh caused Smith’s injuries, but whether the warning provided by the manufacturer in the Mersilene mesh documentation was sufficient and whether any inadequate warning caused Smith’s injuries.”
The defective product lawsuit was dismissed by the lower court in favor of Ethicon. The Smiths filed an appeal of that order on the basis that certain experts were not allowed to testify on their behalf. In addition, the Smiths also appealed being ordered to pay some legal fees to Ethicon for the alleged late filings.
The appellate court found the lower court’s evidentiary rulings were not an abuse of discretion and the Smiths did not factually state the inadequacy of the Mersilene warning and whether an adequate warning would have prevented the doctor from using Mersilene mesh.
An inadequate warning or a failure to warn can be one additional component of a defective product or product liability case.
The Learned Intermediary Doctrine
The court granted Ethicon’s summary judgment dismissing the case based on the “learned intermediary” defense.
The Mississippi court cited the “learned intermediary doctrine” as “a manufacturer of a prescription drug has no duty to warn the end user of the drug’s possible adverse effects.” In other words, the physician is the end user, the “learned intermediary” between the patient and manufacturer and the duty to warn stops with him or her.
The Mississippi rule also applies to medical devices.
Since the product label said there were “No significant adverse clinical reactions to Mersilene mesh,” the Smiths dug into the FDA database and found that that was not true. There had been eight adverse event reports prior to 2002 of injuries associated with Mersilene mesh, three of which resulted from tears in the mesh.
The Smiths had argued that information should have been on the mesh product warning on the package and if it had been, Dr. Barksdale would not have used Mersilene mesh.
Dr. Barksdale testified that he was aware of the risks of Mersilene but still thought the mesh was the best option for Mrs. Smith. If the doctor is the end user, that ends the argument if he was aware of some of the warnings.
The Smiths were ordered to pay the legal costs of Ethicon’s responses to late paperwork and ordered to pay costs to Ethicon.
Civil Action No. 3:08cv245 HTW-LRA
Mississippi Southern District Court
U.S. Court of Appeals 5th Circuit:
Background on Mesh production, UC Denver:
C.R. Bard Loses $5.5 Million In Landmark Vaginal Mesh Lawsuit
“Thank You God. We can finally get the word out to women.”
Those are the words of Christine Scott, 53, a former runner who had a vaginal mesh implant to treat stress urinary incontinence in 2008. After that her health went downhill as the synthetic mesh eroded into her colon.
Huge Victory For Mesh Patients Everywhere
KGET-TV 17 in Bakersfield reported late Monday night (here) that the Bakersfield woman won a $5.5 million lawsuit she filed against mesh maker C.R. Bard. In the product liability action, Scott said she had the Avaulta Plus Biosynthetic Support System to correct some urine leakage, but it left her in chronic pain, incontinent, and unable to have intercourse.
“I don’t know if I have one or 100 surgeries ahead,” she said to the tv station.
The jury returned the verdict late Friday in Kern County Superior Court before Judge William Palmer. Scott told jurors she could only urinate with a catheter for five months. She then had to undergo eight additional removal surgeries. The Avaulta remains in her body as many surgeons feel the permanent implants cannot be safely removed.
The jury awarded Scot $5 million and her husband $500,000 for the loss of their relationship.
The lawsuit is a landmark victory and the first of its kind in the nation against a major mesh manufacturer. There are another 650 mesh cases pending against C.R. Bard and thousands pending against five other mesh manufacturers consolidated in multidistrict litigation.
Tested On Rabbits & Sheep
Attorney Elaine Houghton said, “ They tested this on they tested 16 rats 12 rabbits 4 sheep and by their own research the next living product this went into was a women.”
Houghton and her law partner, Gene Lorenz represented Scott.
KGET reports Bard stopped selling the Avaulta medical device on July 1, 2012 in the United States because the FDA wanted more clinical trials done.
The Bakersfield woman said the hardest part was having to keep quiet watching women continue to be hurt. In 2010 an estimated 200,000 women had synthetic mesh implanted to treat stress urinary incontinence. The actual complication rate is unknown since the U.S. does not monitor medical devices after they are implanted.
Synthetic meshes used to treat incontinence are petroleum-based polypropylene. They are considered a Class II medical device and manufacturers are not required to conduct clinical trials for safety and efficacy before they are marketed.
When I got that verdict it was, Thank you God. Now we can do something,” said Scott.
FDA: Complications “Not Rare”
Scott filed a lawsuit against Bard and her doctor in January, 2009. In October 2008, the U.S. Food and Drug Administration filed the first of two Safety Notifications warning the public that there was a degree of “rare” but “serious” complication association with mesh placement in some women. One year ago, the federal agency revised that notification and said that complications were “not rare.”
Many doctors have assumed that the FDA warnings primarily focus on synthetic transvaginal mesh for pelvic organ prolapse, not incontinence. This judgment flies in the face of that assumption.
Scott says she will start a support group. Patient Right to Know.org for people who have questions about surgical mesh.
C.R. Bard of Murray Hill, New Jersey plans to appeal. The Avaulta Plus is no longer sold in the U.S. but is sold globally. #
Three Lawsuits Join Hundreds
Mesh Medical Device News Desk, October 25, 2011
Boston Scientific Pinnacle Pelvic Floor Repair Kit Lawsuit Filed
According to a story in About Lawsuits.com, a woman from Louisiana has filed a lawsuit against Boston Scientific after she says she was injured and debilitated by the Pinnacle Pelvic Floor Repair Kit made by Boston Scientific.
The woman, Minnie V. Mann, says in her complaint that the synthetic mesh is defectively designed, the basis for a product liability lawsuit that was filed in U.S. District Court for the Western District of Louisiana on October 5. Mann claims she received the implant in January 2010 to treat incontinence and vaginal vault prolapse. She says she has experienced emotional distress, past and future medical expenses, pain and suffering, disability, and the loss of the enjoyment of life.
Complications “Not Rare” For TVM Patients
Boston Scientific is one of nine companies that make synthetic pelvic mesh. An FDA notification on July 13, 2011 questioned for the first time whether surgical mesh for transvaginal repair of POP (pelvic organ prolapse) is more effective than traditional repair that involves non-mesh or sutures. And it said serious complications associated with surgical mesh are “not rare”.
Complications may include mesh eroding through the vagina, pain, infection organ perforation, urinary problems and bleeding, a recurrence of the symptoms and nerve damage, among other symptoms.
The FDA in its advisory said abdominally placed mesh had lower rates of complications compared to transvaginal POP surgery through the vagina.
Procedures, Lawsuits & Boston Scientific Recall
Despite the warnings about 75,000 woman had transvaginal mesh surgery last year. There are about 600 lawsuits filed against various manufacturers.
There was a recall of about 540 Boston Scientific Pinnacle kits in August 2011 because of a defect that allowed the needle to detach during surgery because of low tensile strength between the needle and the suture in the pre-packaged mesh kits. Here is the recall notification.
In September, an FDA advisory panel met to determine whether synthetic surgical mesh for pelvic organ prolapse should be reclassified to a high-risk Class III medical device, which would require premarket approval. The panel has yet to make recommendations to the FDA, which usually follows its experts’ advice.
Two Women Sue Boston Scientific Over Allegedly Painful Implants
The Patriot Ledger reports two new federal lawsuits have been filed against Boston Scientific Corp., just the latest of a long line of actions filed over the medical device synthetic mesh. Plaintiffs Veronica Rector of Tennessee and Rosemary Robinson of Kansas are represented by Cambridge lawyer William Hunt.
The lawsuits were filed in Boston federal court, October 19, Wednesday. Both women say they are permanently injured by the Pinnacle or Advantage mesh made by Boston Scientific.
Anderson Hospital & Monarc Maker Sued Over Mesh Implant
The Madison St. Clair Record reports that a Madison County woman, Susan Tallerico and her husband, Richard, have filed a lawsuit against a hospital and doctor who treated her with surgical mesh to treat incontinence. The suit was filed September 27, in Madison County Circuit Court against American Medical Systems, the maker of the Monarc mesh, Dr. Travis L. Bullock, and Anderson Hospital, in Maryville, Illinois, owned by Southwestern Illinois Health Facilities Inc.
Ms. Tallerico says she sought treatment for urinary incontinence two years ago and Dr. Bullock improperly implanted the Monarc synthetic mesh which has causes Tallerico numerous and ongoing medical problems. The couple say they have spent more than $200,000 in medical bills and are seeking compensation for loss of consortium and court costs. The Circuit Court Case Number is 11-L-970 and Tallerico is represented by Michael Aschenbrener of Chicago and Mark Mueller of Austin, Texas.