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)
- Pelvic Mesh Trials Ahead (May 31, 2017)
- Appeals Court Backs Boston Scientific Win In North Carolina Pelvic Mesh Lawsuit (May 10, 2017)
- AMS Pelvic Mesh Lawsuits Settled & Dismissed By The Hundreds (June 9, 2016)
- Lawsuits Scheduled For Ethicon’s Physiomesh Hernia Mesh (October 25, 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 In West Virginia Court (September 17, 2013)
- Mississippi Court Upholds Ethicon Win In Mesh Warning Lawsuit (August 8, 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
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
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.
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.
Just The Latest In A Long List Of Ethicon Mesh Withdrawals
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. ###
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.
The case was remanded back to state court on Friday, April 11.
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 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:
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.