FDA Recalls Mesh Products for Women

(April 17, 2019)  The US FDA announced yesterday that it was recalling all remaining surgical mesh products used on women to treat pelvic organ prolapse (POP).  The FDA said it determined that Boston Scientific and Coloplast, makers of those plastic mesh products, had failed to demonstrate a reasonable assurance of their safety and effectiveness.  That assurance is the premarket review standard that had applied ever since the agency reclassified POP meshes as class III (high risk) in 2016.

That reclassification meant POP mesh makers were henceforth required to submit and obtain approval through premarket approval (PMA) applications.  PMA is the  FDA’s most stringent device review path for marketing medical devices in the US.

The agency said BSC and Coloplast now have 10 days to submit a plan to withdraw their products from the market.

FDA Announcement of April 16, 2019:

“The U.S. Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately. The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP.”

Transvaginal Mesh not FDA Approved

Plastic mesh to treat POP and SUI was never formally approved by the FDA in the usual PMA process.  These meshes were, rather, “cleared” under the auspices of the agency’s 510k program, which allows some devices to reach the market if the agency determines the product in question is substantially equivalent to a product already approved.  In the case of transvaginal mesh (TVM), that comparison has always been shaky at best. Polyurethane or plastic mesh was first used in hernia repair surgery in the mid 1970s, and even then it was shown to cause problems in some people.  The company that made the oil-based plastic product is on record as saying it should never be implanted in the human body, but medical device companies used it anyway, and continue to use it.

FDA Dr. Jeffrey Shuren

Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said, “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”

100,000 + TVM Lawsuits

A multi district litigation court was created to handle more than 100,000 transvaginal mesh lawsuits filed over the plastic devices used to treat POP and SUI.  It was the largest ever MDL ever assembled. Jury trials resulted in several large verdicts for plaintiffs, and several thousands of cases were quietly settled for injured women.  Hundreds of TVM lawsuits are still on file, and more trials are ongoing.

FDA Recalls Mesh Products for Women

One lawyer, David Matthews, who won a large jury verdict in a TVM case and later settled several others, said: “The FDA has finally done what the mesh industry would not do on its own. The adverse event reports, which reflect less than 10% of actual injuries to the women implanted with this product, coupled with multiple large jury verdicts based on expert opinions, has shown the risks of these products far outweigh their benefits, if any. This is yet more evidence that the clearance process for these dangerous products is inadequate.  As lawyers who have been represented those injured by these defective products for more than eight years, we thank the FDA for declaring these plastic devices unfit for use.”

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Pelvic Mesh MDL Closing to New Cases

(July 11, 2018) The pelvic mesh Federal Judge Joseph Goodwinmultidistrict litigation (MDL) court is closing to new cases.  Judge Joseph Goodwin, who oversees the MDL court in Charleston, W. Va., made the announcement last month.

Medical Mesh News Desk reports that the pelvic mesh MDL court was created in January 2012.  At its height, it was handling nearly 105,000 cases. Judge Goodwin issued orders on June 21, 2018 that no more cases would be filed in his federal court.

No More Cases Accepted in MDL 2327
With the MDL closing, any new case filings will need to be in state court, according to the order issued by Judge Goodwin. The judge issued the same order in each of the seven pelvic mesh MDLs filed in his federal court.

Charleston, WV MDL Court Closing
The largest MDL court was established for Ethicon (Johnson & Johnson).  Judge Goodwin wrote in Pretrial Order #304 in the Ethicon MDL #2327, that since January 2018, his court has requested cases no longer be transferred to MDL 2327.

Related:  Johnson & Johnson, Ethicon Mesh Losses Mount

On June 19, 2018, the Judicial Panel on Multidistrict Litigation entered a Minute Order:

“The court ORDERS that plaintiffs may no longer direct file claims against Ethicon, Inc. or Johnson & Johnson or any related entities in the Ethicon MDL (as set forth in PTO # 118) or in any other pelvic mesh MDL assigned to the court.”

The other six MDLs  with the same order include all of the major pelvic mesh makers – C.R. Bard MDL 2187; American Medical Systems MDL 2325; Boston Scientific MDL 2326; Coloplast MDL 2387; Cook Medical MDL 2440; Neomedic MDL 2511.

State Court Cases
Heretofore, it appears that any plaintiff’s lawyer wishing to pursue a newly-signed pelvic mesh case will need to file it in a state court venue, either in the state where the mesh maker is located or in the state where the plaintiff lives.

Mesh News Desk reports that it is not known whether the plaintiff will be able to share in the extensive MDL “Discovery” already gathered to support the MDL cases for trial.  Discovery costs can quickly reach half a million dollars or more in a single case, so the question is an important one. One advantage of an MDL court is that discovery costs can often be shared across several cases, so in theory at least, that cost savings is one advantage of the MDL court which could disappear in the face of any future pelvic mesh litigation pursued in state courts. The MDL system can also decidedly cut trial preparation time.

But before the doors close entirely, the federal West Virginia MDL court will host two Wave trials, Wave 7 and 8, against Ethicon.

Wave 7 and 8 Trials
Wave 8 cases in the Ethicon MDL, the last major trial by the federal MDL court, should be concluded with discovery by October 2018 and made trial ready in a June 13th order by Judge Goodwin.

Ethicon / Johnson & Johnson still faces Wave 7 trials of approximately 150 pelvic mesh-injured women whose cases will be heard in the West Virginia federal court. Final settlement conferences are scheduled for August 1, 2018, with trial set to begin August 14.

The West Virginia MDL once contained 104,749 cases representing plaintiffs filing pelvic mesh cases against seven mesh makers. New cases slowed to a trickle beginning in 2018.

Pelvic Mesh MDL Closing to New Cases

The cases of Carolyn Lewis v. Ethicon; Donna Cisson v Bard; Jo Huskey v Ethicon; Tyree v. Boston Scientific; among others, have all been heard in Charleston since 2012.

Thousands Dismissed with Prejudice for non-revision
In the Ethicon MDL, Medical Mesh News Desk also reported that Judge Goodwin just announced that he was dismissing thousands of cases with prejudice because they were non-revision cases.

In Pretrial Order #293, issued Wednesday, April 11, 2018, Judge Goodwin said that the court would dismiss more than 13,000 Ethicon mesh cases in which the plaintiff has a mesh in place but has not attempted any removal or revision.

That judiciary decision could prove unfortunate for several women. Many suffer from such compromised health that they fear any return to a doctor’s office could leave them in worse shape than if they took their chances with their current condition or injuries.  Any revision or removal surgery can sometimes leave a person in worse shape than she was in before she opted for the revision or removal.

As Jane Akre reports, “There are many reasons a woman may not have her pelvic mesh removed – compromised health, a risk of going under anesthesia, a new complication to her health, a warning from her doctor that the risks of revision outweigh the benefit – all might preclude having a mesh removal.  Now that may count against her.”

“Dismissed with prejudice” usually means that a plaintiff may not bring another legal action with the same claim. “Dismissed with prejudice” usually means that the case is dismissed permanently, with no future recourse for the plaintiff to seek compensation.

A possible silver lining, according to Mesh News Desk, is that Ethicon/JJ has reportedly agreed that plaintiffs with more than one office revision who have trigger point injections, vaginal physical therapy or vaginal Valium will be treated the same as those plaintiffs who undergo revision surgery within five years.

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Johnson & Johnson, Ethicon Mesh Losses Mount

(July 10, 2018) In 31 transvaginal mesh (TVM) trials so far, 22 have concluded with verdicts in favor of plaintiffs.  Eleven (or half) of those verdicts have gone against Johnson & Johnson and Ethicon, which has seen its mesh losses mount faster than any other TVM manufacturer.  J&J has lost five verdicts over its Gynecare Prolift mesh, three for its TVT-O mesh, one for TVT-Abbrevo, one for TVT-Secur, and one for its polypropylene tape used to treat stress urinary incontinence (SUI).

Related:  Transvaginal Mesh Lawsuit

In 2016, the FDA reclassified transvaginal mesh for prolapse repair (but not SUI) as Class III (high risk) medical devices. The reclassification made TVM implants ineligible for FDA’s 510(k) clearance program. That program had previously allowed mesh products on the market without prior clinical trial testing on human beings.  But 510(k) clearance does not amount to FDA approval.  TVM or pelvic mesh devices are not FDA approved.

Johnson & Johnson, Ethicon Mesh Losses Mount

Besides fighting TVM cases in the courts, Johnson & Johnson and other defendants have also quietly settled hundreds of them. As with most settlements, terms are not disclosed and the companies that pay admit no wrongdoing.

Johnson & Johnson (Ethicon) Trials have yielded at least eleven (11) wins for plaintiffs so far. These include:

March 8, 2018 – $35 Million for Plaintiff (Gynecare Prolift)
A U.S. District Court for Northern Indiana jury hit Johnson & Johnson’s Ethicon with a $35 million verdict over its Prolift pelvic mesh. ($10 million in damages and $25 million in punitive damages). Barbara Kaiser and her husband Anton Kaiser sued Ethicon in March 2012 after learning that the Prolift mesh her doctor implanted in 2009 to treat pelvic organ prolapse might be causing her low pelvic pain. The lawsuit petition accused J&J and Ethicon of concealing Prolift problems that included high failure, injury and complication rates, as well as “frequent and often debilitating re-operations.” Prolift “caused severe and irreversible injuries, conditions, and damage to a significant number of women, including plaintiff,” said the complaint.

The Kaisers also alleged that “[Ethicon] consistently under-reported and withheld information (about) Prolift’s propensity to fail and cause injury and complications, and have misrepresented the efficacy and safety of the products through various means and media, actively and intentionally misleading the medical community, patients, and the public at large.”

The Kaisers also alleged. “Defendants actively and intentionally misled and continue to mislead the public, including the medical community, health care providers, and patients, into believing their Prolift is safe and effective. . .”

Dec. 14, 2017 – $15 Million for Plaintiff (Prolift)
A New Jersey woman was awarded $15 million by a Bergen County (New York) Superior Court jury in her transvaginal mesh lawsuit. The verdict followed 2 ½ weeks of trial testimony and nearly a day of jury deliberation. The woman testified that she had been in constant pain since receiving an Ethicon mesh implant. Jurors found the Johnson & Johnson subsidiary had failed to adequately warn her of the risks associated with Ethicon’s Prolift mesh implant. They awarded her $4 million in compensatory damages and $10 million in punitive damages, as well as awarding her husband $1 million for his loss of conjugal affection.

The jury also found Ethicon had failed to provide the woman with adequate safety warnings in regards to the TVT-O mesh implant, but they determined the Prolift mesh alone was responsible for her injuries. (Case No. L-13686-14)

September 6, 2017 – $57 Million for Plaintiff (TVT-Secur)
A Philadelphia jury awarded a woman $57.1 million in damages over a TVT-Secur mesh implant. Ella Ebaugh accused Johnson & Johnson unit Ethicon of making a defective pelvic mesh implant that scarred her urethra and left her incontinent. Her award included $50 million in punitive damages. The jury unanimously backed her claims that two negligently and defectively designed mesh devices had “mutilated” her urethra and left her with little control over her urinary flow.

May 26, 2017 – $2.16 Million for Plaintiff (Prolift)
A Pennsylvania jury awarded $2.16 million to a woman who suffered serious complications from Ethicon, Inc.’s Gynecare Prolift mesh. The verdict came in the Philadelphia Court of Common Pleas. It was the fourth straight loss for Johnson & Johnson and its Ethicon division in a Pennsylvania transvaginal mesh lawsuit. (Case No. 130603835)

April 28, 2017 – $20 Million for Plaintiff (TVT-Secur)
A state-court jury in Philadelphia ordered Johnson & Johnson to pay a New Jersey woman $20 million over a TVT-Secur pelvic mesh. The woman blames J&J’s vaginal-mesh inserts for leaving her in constant pain. The jury concluded that the TVT-Secur was defectively designed and caused Margaret Engleman’s injuries. They awarded her $2.5 million in damages and then hit J&J and Ethicon with $17.5 million in punitive damages.

February 2016 – $13.5 Million for Plaintiff (Polypropylene tape)
A jury in Philadelphia hit Johnson & Johnson subsidiary Ethicon with a $13.5 verdict in the second case involving its pelvic mesh products to go to trial in the city. The Philadelphia Court of Common Pleas jury awarded Sharon Carlino $3.5 million in compensatory damages, $10 million in punitive damages. It found Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective. It also found that Ethicon failed to adequately warn of its risks. Ms. Carlino required three revision surgeries to remove the eroded mesh.

March 4, 2015 – $5.7 Million for Plaintiff (TVT Abbrevo)
A California jury in Los Angeles hit Johnson & Johnson’s Ethicon Inc. unit with a $5.7 million verdict. The jury sided with a woman who claimed her doctor had given her an older, heavier version of a pelvic mesh product that will cause her a lifetime of pain. The jury awarded plaintiff Coleen Perry $700,000 in compensatory damages and $5 million in punitive damages. Ms. Perry had been implanted with Ethicon’s TVT Abbrevo mesh.

December 2015 – $12.5 Million for Plaintiff (Prolift)
A Philadelphia jury ruled Johnson & Johnson must pay $5.5 million to a Pennsylvania woman over its Ethicon unit’s Gynecare Prolift mesh implant. The jury found J&J liable based on the negligence of its scientists in relation to its Prolift pelvic mesh implant. They cited the mesh as the root cause of plaintiff Patricia Hammons’ inability to have sex after it was implanted. The jury later added $7 million in punitive damages.

A Pennsylvania state court judge ruled in 2014 that Johnson & Johnson and other pelvic mesh makers like Boston Scientific and Bard will need to challenge more than 860 product liability lawsuits on a case-by-case basis.

September 2014: $3.3 Million for Plaintiff (TVT-O)
In West Virginia, a federal jury in the MDL court hit Ethicon with a $3.3 million verdict over its TVT-O transvaginal sling. The jury found in favor of plaintiff Jo Huskey on all counts, which included strict liability, design defect, failure to warn, negligence.

April 3, 2014: $1.2 Million for Plaintiff (TVT-O)
A Dallas jury ordered Johnson & Johnson to pay a Texas woman $1.2 million for a defective plastic sling – the TVT-O – which J & J’s Ethicon division makes and markets for stress urinary incontinence. Freese & Goss and Matthews & Associates represented the woman, Ms. Linda Batiste.

February 2013 – $11.11 Million for Plaintiff (Prolift)
A New Jersey jury awarded Linda Gross an $11.11 million verdict in her lawsuit against Johnson & Johnson’s Ethicon over the company’s Prolift vaginal mesh product. Ms. Gross suffered 18 surgeries in repeated attempts to remove the failed mesh and resultant scar tissue. The jury found J&J had failed to warn patients and doctors about the risks of its mesh products and that the company made fraudulent misrepresentations.

Johnson & Johnson TVM Court Wins
Johnson & Johnson settled at least one Prolift trial which had reached the MDL courtroom, and it has won two TVM trials so far. In February 2014, company lawyers were able to have Judge Goodwyn dismiss the case of a Texas woman against Ethicon and J&J (Lewis v. Ethicon/JJ) in a TVT-O case, and a Texas jury awarded nothing in a Nov. 2015 case over a Prosima device that reached trial (Cavness v. Ethicon/JJ). J&J also settled with the plaintiff in at least one TVM case which reached trial in March 2015 (Bellew v. Ethicon/JJ).

Transvaginal Mesh Lawsuits
Today, many thousands of TVM cases remain unresolved, parked in various state courts across the U.S. and in the federal MDL in West Virginia. The overseer of the federal MDL court, Justice Joseph Goodwyn, announced in June 2018 that he will no longer accept new mesh cases. Judge Goodwin has overseen several MDL trials and still has more than 100,000 cases on his books. He has urged the defendants to settle, some have occasionally obliged, but the sheer number of cases in the MDL makes it the largest federal court docket for mass tort litigation since asbestos.

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100,000 Women suing over Gynecological Mesh

(July 7, 2018)  The mainstream media has finally recognized that a huge number of women are suing mesh manufacturers over their plastic products.  A CBS news story reported last month that nearly 50,000 women are suing one mesh maker alone over gynecological mesh.  The polypropylene (plastic) mesh is often used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI),  which affect millions of women.  At least 100,000 women across the country are suing over gynecological mesh.  Many have filed their cases in the multidistrict litigation court in West Virginia.  Several other pelvic mesh lawsuits have been filed in various state courts throughout the country.

Related:  Transvaginal Mesh Lawsuit | Pelvic Mesh

Gynecological Mesh Makers

The CBS news story mentioned only Boston Scientific as a defendant in transvaginal mesh (TVM) cases, though several other gynecological mesh makers also face lawsuits.  Other defendants include Johnson & Johnson (Ethicon), American Medical Systems (AMS), C.R. Bard, Coloplast, and Cook Medical.

Sixty Minutes reported that Boston Scientific faces some 48,000 lawsuits in what has generated the largest multi-district litigation since asbestos. The suits claim mesh can inflict life-changing pain and injury.  Suits against Boston Scientific also claim the company used a mesh product never meant to be put inside the human body.

Related:  Johnson & Johnson Mesh Verdicts Mount 

More than two million American women have received gynecological mesh implants.  All the mesh makers claim their products are safe.

CBS News

CBS News reported the story of one woman implanted with a Boston Scientific gynecological mesh for stress urinary incontinence and also to lift organs that shifted after pregnancy. Gwyn Madsen had a Boston Scientific implant in 2012.

Gwyn Madsen told CBS that the mesh “felt like a cheese grater inside of me.”

Ms. Madsen said she suffered pain which left her barely able to sit or play with her children.  She said, “It felt like the material was pulling on the muscles and I’d get shooting pains.  You almost felt like there was something inside of you that was like sandpaper back and forth, every time you’d walk.”

Boston Scientific, which lost a $73 million verdict over  one of its TVM products following a 2016 trial in Texas, has fought allegations like Ms. Madsen’s for years.  The company told CBS: “Nearly one million women have been successfully treated.  (We) have extensively tested the [plastic] resin to confirm its composition, safety and performance.”

100,000 Women suing over Gynecological Mesh

The American Urogynecological Society – which has embraced the plastic mesh because it is easier to apply than the gold standard suture method for repairing POP or SUI – has also claimed plastic mesh is “safe and effective.”   Many doctors, however, disagree.

Dr. Michael Margolis testified for the woman who won a $73 million verdict in the Texas case.  He told CBS that the women’s mesh causes a chronic inflammatory reaction.  He has removed more than 350 mesh implants.

“The slings I’ve removed are substantially altered in their architecture,” Dr. Margolis told CBS.  “They are shrunk by at least 50% in width.  They are encased in scar tissue. The pores [in the mesh] shrunk substantially.”

Dr. Margolis showed CBS a mesh he removed which had been implanted.  It had shrunk substantially, he said, had folded, contracted, embedded in scar tissue, and was choking off the woman’s urethra.  He said it was half the size it had been upon implant.

Dr. Margolis told Scott Pelley the implant is “not supposed to change.”

Missing from the CBS story and interviews was the fact that Boston Scientific, as well as Johnson & Johnson (Ethicon, American Medical Systems (AMS), and Bard have all lost multi-million-dollar verdicts to women implanted with the companies’ transvaginal mesh products.

FDA:  Serious Adverse Events “not rare”

The story did include the fact that the FDA has issued a damning report regarding TVM mesh.  In 2011, the FDA said that it found mesh used to support organs after pregnancy had resulted in nearly 4,000 “reports of injury, death, and malfunction” and complications including “pain, infection, urinary problems, bleeding and organ perforation.”  The FDA wrote that, “Serious adverse events are not rare.”

Indeed.   At least 100,000 women would apparently agree with that statement.

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Washington State sues Johnson & Johnson Mesh Maker

Washington statemesh image is suing Johnson & Johnson mesh maker Ethicon for defective pelvic mesh sold to Washington women.  The state of Washington vs. Johnson & Johnson, et al. petition, filed May 24, 2016, says J&J sold some 12,000 pelvic or transvaginal mesh devices to unsuspecting Washington women from 2005-2015.

The Washington petition alleges that J&J marketed its mesh products as “new and revolutionary,” claimed that they saved time in the operating room, offered superior outcomes to traditional POP or SUI stitch-surgery methods, and had the advantage of faster recovery times.

The complaint reads, “Defendants made these representations without disclosing to doctors the serious complications their mesh can cause women.”

The petition further states that J&J marketed its mesh products as “improvements over traditional repair methods (i.e. native tissue repair) when they knew such claims were inaccurate.”

Severe, Unavoidable Complications

The petition language is clear and forthright, alleging similar problems about which more than 100,000 women across the country have complained and filed suit:

“Defendants knew at all relevant times that the presence of polypropylene [plastic] in the body and the process of implanting mesh through the vagina could cause severe unavoidable complications. (Defendants) knew these complications are caused by the design and placement of the mesh and cannot be avoided by good surgical technique alone.”

Permanent Disability, Egregious Suffering

The petition alleges that some women become “permanently disabled” from mesh complications, from mesh that can erode and migrate into internal organs, becoming nearly impossible to remove:

“The suffering by these women is even more egregious considering that the underlying condition the mesh is meant to treat is not life threatening. Further, women have a non-mesh surgical alternative [with native tissue] that has been used for decades. Native tissue repair does not pose the same risks as mesh and can be just as effective for treating pelvic floor conditions.”

Mesh misrepresented, adds Risks

The main problem with plastic mesh for women’s pelvic floor repairs is tidily summed up in the complaint section which says J&J misrepresented the safety of its products by failing to disclose risks and complications associated with pelvic floor surgery: “Defendants failed to disclose that their mesh devices carry similar risks as other pelvic floor surgeries and additional risks caused by the mesh.”

All mesh makers have always had a fundamental problem with the very idea of selling a medical device designed to be implanted in an open-contaminated area such as the vagina, which cannot be sterilized, ever. Such a procedure violates the first rule of surgery, that one needs a clean, sterile field of operation.

Contaminated Surgical Procedure

The petition reads: “Although all of Defendants’ products were used in contaminated areas – the vagina, Defendants misrepresented that ‘if the mesh implant is to be used in contaminated areas, it must be only with the understanding that subsequent infection may require its removal.’”

The petition further states that Defendants misrepresented plastic mesh’s risk in other ways, including that mesh causes infection in a cavity that can never be completely sterilized; mesh is not inert as claimed by Defendants, on the contrary, it causes a foreign body reaction; the mesh hardens, contracts, erodes into other body organs, becomes so rigid and distorted that complete mesh removal is extremely difficult or impossible.

The petition details several complications that can result:

• chronic infection
• chronic foreign body reaction
• chronic inflammation
• mesh hardening
• mesh contracture, erosion into other body organs
• mesh exposure (migration of mesh into the vagina)
• mesh extrusion
• mesh degradation (breakdown of mesh particles)
• permanent dyspareunia (inability to have sex)
• chronic pain
• vaginal shortening, stiffness, distortion
• sexual dysfunction
• injury to sexual partners
• urinary and bowel dysfunction
• other lifelong problems

The petition reads: “Mesh removal is the only treatment option for most continuing mesh complications. Removal often requires multiple surgeries, which may or may not resolve complications, and may in fact result in new problems. (Yet) Defendants failed to disclose the lack of a safe and effective means for removal.”

Mesh not FDA Approved

The petition also alleges that J&J and its subsidiaries misrepresented in their informational and marketing materials that their Polypropylene Mesh Products were FDA Approved.  Mesh was never approved. It was only cleared by the FDA 510(k) equivalency process, which fails to verify safety or efficacy of the product in question and does not usually require clinical trials.

J&J and its subsidiaries also stand accused by the petition of failing to disclose adverse events reported by women who had been implanted with transvaginal or pelvic mesh

Washington State sues Johnson & Johnson Mesh Maker

Mr. Bob Ferguson first launched an investigation into J&J’s pelvic or transvaginal mesh implants when a Washington state woman wrote the DA a letter detailing the problems she had with mesh and complaining that she had not been warned of the risks.

Mr. Ferguson filed the petition, which was also signed by Washington State Senior Counsel Elizabeth J. Erwin, Asst. AG Andrea M. Alegrett,  Asst. AG Leilani N. Fisher.

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States sue J&J Transvaginal Mesh Maker

J&J hit with State Lawsuits over Pelvic Mesh

The states of Ethicon_Transvaginal_MeshCalifornia and Washington have filed lawsuits against Johnson & Johnson for false advertising and deceptive marketing of surgical mesh for women. The lawsuits say J&J failed to properly inform patients and doctors of the potential severity of mesh complications.

Washington Woman Blows Whistle

According to Mesh News Desk, the Washington state lawsuit has its roots in 2012 when a Washington woman wrote her attorney general to report that women were not warned about the dangers of mesh, that there was no informed consent, and thousands of women like her were duped into believing that what J&J called a  “minimally invasive” procedure could not end in a lifetime of pain. (Washington Mesh Complaint.)

J&J Concealed Mesh Risks

Attorneys general Kamala D. Harris of California and Bob Ferguson of Washington say Johnson & Johnson knowingly concealed the risks associated with their pelvic mesh products. The mesh in question is designed to treat common conditions in women such as stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The plastic mesh material can cause serious complications including loss of sexual function, chronic pain, infection, permanent urinary or defecatory dysfunction, a devastating impact on quality of life.

The attorneys general launched the lawsuits against J&J and its subsidiary Ethicon Inc. in California and Washington state courts. California alleges violations of the state’s unfair competition and false advertising laws. Washington state charges “tens of thousands of violations” of the state’s consumer protection laws.

Deceptive Practice Charges

California and Washington are both seeking injunctive relief and monetary penalties potentially in the millions of dollars. Harris wrote that her action is meant, “to ensure that J&J stops its deceptive practices.”

Ms. Harris said, “Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products. Johnson & Johnson’s deception denied women the ability to make informed decisions about their health and well-being.”

Mr. Ferguson said in a statement May 24, 2016 that complications can crop up years after surgery and are in many cases irreversible, while mesh removal mesh can be nearly impossible.

Horrific Injuries, Doctors duped

Mr. Ferguson said, “It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson’s deception. They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials.”

J&J Responds

A J&J spokeswoman told Law360 this week that J&J plans to “vigorously defend itself against the allegations.” J&J said in the statement that both states’ lawsuits were “unjustified.”

The J&J statement further said, “The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products. The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research.”

J&J Lawsuit Verdicts Upheld

The states’ lawsuits continue a long series of litigation against J&J over its pelvic mesh products.

In some of the latest developments, in March 2016 a New Jersey appeals court upheld a $11.1 million jury award for a woman who claimed Ethicon’s pelvic mesh caused debilitating nerve pain. The appeals court ruled that ample evidence presented at trial showed that better warnings of the product’s risks might have prevented her injuries.

In April 2016, a Philadelphia jury returned a $13.5 million verdict against J&J and Ethicon in another case brought by a woman who claimed J&J’s mesh implant was defective and that it reduced her to nearly constant pain, discomfort, and sexual dysfunction. J&J appealed that verdict, as it has appealed every pelvic mesh verdict  rendered against it.

States sue J&J Transvaginal Mesh Maker

Both Ms. Harris and Mr. Ferguson said May 24 that in addition to false advertising and deceptive marketing, J&J misrepresented the severity and frequency of common complications, and failed to disclose that its surgical meshes “presented risks not present in alternative treatment options.”

Ms. Harris said that J&J had sold more than 42,000 pelvic mesh devices in California from 2008- 2014. She said the company faces more than 35,000 personal injury lawsuits across the country..

Mr. Ferguson said J&J had sold 12,000 mesh products in Washington state during roughly that same time period. He said he would seek the maximum $2,000 penalty for each violation of Washington’s consumer protection laws.

Law360

Law360 reports the state of California is represented by Kamala D. Harris, Judith A. Fiorentini, Jinsook Ohta, Sanna Singer and Michelle Burkart of the state Attorney General’s Office.

Washington state is represented by Robert W. Ferguson, Elizabeth J. Erwin, Andrea M. Alegrett and Leilani N. Fisher of the state Attorney General’s Office.

The cases are California v. Johnson & Johnson et al., in the Superior Court of the State of California, County of San Diego, and Washington v. Johnson & Johnson et al., in the King County Superior Court in the State of Washington.

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FDA reclassifies Pelvic Mesh as High Risk

The FDA now reclassifies pelvic mesh as high risk. On January 4, 2016,IOM-510k-wordle the FDA announced that transvaginal or pelvic mesh used to treat pelvic organ prolapse (POP) will be reclassified as a high risk or class III device. The mesh previously held “moderate risk” or class II status. (See the FDA Release.)

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Scotland regulates Pelvic Mesh

Unlike the U.S., whereMesh closeup industry calls the shots and regulators mostly abide with business, the Scottish government has moved to regulate transvaginal or pelvic mesh treatment options offered to women with pelvic organ prolapse and stress urinary incontinence.

The UK Daily Record reported this week that three of four mesh procedures used routinely in Scottish hospitals will no longer be recommended by doctors. Scotland seems truly interested in protecting women at the expense of mesh makers, rather than the other way around, U.S. style.

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Plaintiff’s Pelvic Mesh Expert Testimony continues

DALLAS – Ethicon_Transvaginal_MeshMesh News Desk reported that plaintiff’s expert Dr. M (name withheld to avoid red herring arguments from defense counsel) continued to testify for a second day, September 29, 2015. It would be the final day of the Plaintiff’s case in Cavness v. Ethicon (Cavness v. Kowalczyk et al., case # DC-14-04220).

A California urogynecologist and mesh removal expert, Dr. M  continued his testimony about the pelvic mesh implanted in the plaintiff. He opined that the pain she continues to experience three years after her April 2012 implant is the same chronic pain felt by thousands of other women with pelvic mesh implants.

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Pelvic Mesh contracts, shrinks, degrades – Expert

Day 6 – Sept. 28, 2015 – J&J fails its Credo with Pelvic Meshof the latest trial against Ethicon in Dallas brought testimony from Dr. M (name withheld to prevent defense lawyers’ red herring arguments), a urogynecologist from the San Francisco bay area, double board certified in Ob-Gyn and Urogynecology. Dr. M testified that he has done more than 25,000 surgical procedures, including 5,000 to 6,000 for stress urinary incontinence and the rest – some 14,000 – related to POP (pelvic organ prolapse). He also performs about six surgeries a week to remove plastic mesh from women.

Note: Much of this story comes from Mesh News Desk.

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