Preview Newsletter
Ethicon Media Monitoring 1/11/2019
-
Surgeons fear pelvic mesh lawsuits will spook patients
Jan 10, 2019 | AP (In The Washington Post)
By Gene Johnson
Doctors who specialize in female pelvic medicine say lawsuits by four states, including Washington and California, over products used to treat pelvic floor disorders and incontinence might scare patients away from the best treatment options — or maybe even push the products off the market. -
Doctors hit back at women in chronic pain from vaginal mesh implants: They say the life-changing risks were well within the limits of any surgery and slam lawsuit for 'scaring away other patients'
Jan 11, 2019 | Daily Mail
By Mia de Graaf
Tens of thousands of women are suing the makers of vaginal mesh implants that left them in chronic pain. -
Pa. Judge Won't Toss Mesh Trial After Three-Week Delay
Jan 10, 2019 | Law 360
By Matt Fair
A Pennsylvania state judge has refused to throw out an ongoing pelvic mesh injury trial based on what a Johnson & Johnson unit said was an unreasonable three-week delay in the proceedings over the holidays and the court's improper ex parte communications with jurors.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Surgeons fear pelvic mesh lawsuits will spook patients
Jan 10, 2019 | AP (In The Washington Post)
By Gene Johnson
Doctors who specialize in female pelvic medicine say lawsuits by four states, including Washington and California, over products used to treat pelvic floor disorders and incontinence might scare patients away from the best treatment options — or maybe even push the products off the market.
Sixty-three Washington surgeons signed a letter to state Attorney General Bob Ferguson , arguing his consumer-protection lawsuit against Johnson & Johnson and its Ethicon Inc. subsidiary is off-base. The lawsuit says the companies failed to disclose risks associated with the products, but in their letter the doctors said they were never deceived and that the case is based on a misconception about how they assess dangers posed by medical procedures.
"We have served on national and regional medical societies in women's health," wrote Dr. Jeffrey Clemons, a pelvic reconstructive surgeon in Tacoma. "It is astonishing to us that the AG is proceeding with this lawsuit without first availing themselves of the significant experience and expertise of this group."
Doctors in California are drafting a similar letter to Attorney General Xavier Becerra, and the president of the American Urogynecologic Society, which represents 1,900 medical professionals, has issued a statement expressing some of the same concerns.
Clemons and two other doctors who signed the Washington letter have been retained by defense counsel as consultants in the case, but Clemons said he wrote it without payment or assistance from Johnson & Johnson.
At issue is "transvaginal mesh" — plastic mesh products that are implanted to correct a variety of pelvic floor disorders.
They came on the U.S. market in the late 1990s to treat stress urinary incontinence — a condition triggered by physical activity like coughing, sneezing or running that is common and sometimes debilitating in women after childbirth. The treatment involves using a thin mesh strip, called a "mid-urethral sling," to support the urethra, the tube that carries urine away from the bladder.
The products were so successful — one of the most significant advances in women's health in recent decades, the physicians said — that companies began developing similar mesh products to treat another condition, called pelvic organ prolapse.
In such cases, pelvic organs such as the uterus and bladder drop from their normal position due to muscle weakening. A sheet of mesh can be used to support the pelvic floor.
However, treating pelvic organ prolapse with mesh proved problematic after those products were introduced in 2004. They were more likely to bring serious complications, including permanent incontinence, severe discomfort and an inability to have sex.
The U.S. Food and Drug Administration issued warnings in 2008 and 2011, and companies pulled most of the transvaginal mesh products for organ prolapse from the market.
Tens of thousands of women have filed liability claims against Johnson & Johnson and other companies, with some saying they knew nothing about the potential complications.
The doctors say Washington's lawsuit conflates the acceptable risks of using pelvic mesh to treat incontinence with the less tolerable risks of using it for pelvic organ prolapse. They're worried it could force mid-urethral slings off the market, though the attorney general's office says that's not the goal.
Washington, California, Kentucky and Mississippi are pursuing lawsuits that claim Johnson & Johnson deceived doctors and patients, and that the surgeries ruined some women's quality of life. They say product marketing brochures and instruction pamphlets should have contained much more detail about the risks.
The company updated its instruction pamphlets in 2015 — effectively admitting the earlier versions were inadequate, Washington state says.
"The purpose of our lawsuit is to require Johnson & Johnson to disclose to doctors and patients the serious risks associated with surgical mesh," Ferguson said in an emailed statement. "Johnson & Johnson knew about these risks for years and misrepresented them for more than a decade, even as it sold thousands of these devices in Washington."
Washington's lawsuit seeks fines for each alleged violation of the state's Consumer Protection Act, an amount that could easily run into the millions. The attorney general's office also wants to bar Ethicon from representing that its surgical mesh is superior to traditional treatments, such as repair using the patient's tissue, and it says a key question is whether the pamphlets could have deceived the least sophisticated surgeons, not the most sophisticated.
In their letter last month, the surgeons insist they were never misled — nor could they have been, because they don't rely on a company's marketing materials or instruction pamphlets to divine the risks of medical devices.
Instead, the letter said, they rely on their education, journals, conferences, textbooks and other unbiased sources, and they counsel their patients accordingly.
In declarations filed in King County Superior Court, some said Ethicon paid for them to undergo training that fully explored the devices' risks, and others said they learned about the uses and risks from those specially trained doctors.
Clemons and the other surgeons do not dispute that some women have suffered complications from the use of mesh to treat incontinence, but they say any surgery has risks, and the risks of that procedure are well within accepted norms. Millions of women worldwide have been treated with mid-urethral slings.
The letter cited a recent large study of the English National Health Service database that found complications prompted the removal of mesh slings in just 1.4 percent of patients within the first year after surgery, 2.7 percent within five years and 3.3 percent within nine years.
In fact, Clemons said, the mid-urethral sling has become the "gold standard" among surgical options for stress urinary incontinence because it offers better outcomes than other types of surgery, can be performed on heavier patients who otherwise would be ineligible for surgery, and requires less cutting and recovery time.
The Washington Attorney General's Office said in a court filing the fact that doctors obtain also risk information elsewhere does not excuse the companies from ensuring their instructional pamphlets are "truthful and complete."
The office agreed that many women have had positive outcomes with the devices and said it does not seek to restrict access to them.
Nevertheless, the state is relying on an expert witness, Dr. Bruce A. Rosenzweig, a gynecologist at Rush University Medical Center in Chicago, who insisted in a deposition that polypropylene mesh is an "unsafe material to be placed permanently in the female pelvis." That position is contrary to the scientific literature, according to the surgeons' letter.
Clemons is a retired Army colonel who spent a decade as the chief of urogynecology and pelvic reconstructive surgery at Madigan Army Medical Center. He serves on the board of the American Urogynecologic Society and has performed about 1,250 mid-urethral sling surgeries; he used to cut his own mesh slings before Ethicon's came on the market.
After filing the lawsuit, the Washington Attorney General's Office tried to recruit him as an expert witness, he said. Although he is a fan of Ferguson's Democratic politics — Clemons donated $550 to his re-election campaign last month — he declined.
"I'm not anti-Bob Ferguson at all," Clemons said. "I just disagree with him on this."
https://www.washingtonpost.com/business/surgeons-fear-pelvic-mesh-lawsuits-will-spook-patients/2019/01/10/d43cda60-1536-11e9-ab79-30cd4f7926f2_story.html?utm_term=.a28782882f97
-
Jan 11, 2019 | Daily Mail
By Mia de Graaf
Tens of thousands of women are suing the makers of vaginal mesh implants that left them in chronic pain.
Some are incontinent, some with permanent pelvic pain, many say it ruined their marriages, their ability to work, their relationship with their children.
Those who've filed lawsuits accuse the device makers of duping doctors into performing and recommending operations that could not be reversed, had clear risks, with the capacity to cause life-long, agonizing side effects.
But in an unexpected turn, a group of doctors has hit out at the victims and their lawyers.
The union of 63 Washington surgeons signed a letter to state Attorney General Bob Ferguson, who is fronting the lawsuit against Johnson & Johnson, declaring that all surgeries carry risks, they were not misled, and the risks associated with vaginal mesh are not out of the ordinary for a medical device.
The lawsuit says the companies failed to disclose risks associated with the products.
But in their letter, the doctors said they were never deceived and that the case is based on a misconception about how they assess dangers posed by medical procedures.
'We have served on national and regional medical societies in women's health,' wrote Dr. Jeffrey Clemons, a pelvic reconstructive surgeon in Tacoma. 'It is astonishing to us that the AG is proceeding with this lawsuit without first availing themselves of the significant experience and expertise of this group.'
Doctors in California are drafting a similar letter to Attorney General Xavier Becerra, and the president of the American Urogynecologic Society, which represents 1,900 medical professionals, has issued a statement expressing some of the same concerns.
Clemons and two other doctors who signed the Washington letter have been retained by defense counsel as consultants in the case, but Clemons said he wrote it without payment or assistance from Johnson & Johnson.
At issue is 'transvaginal mesh' — plastic mesh products that are implanted to correct a variety of pelvic floor disorders.
They came on the U.S. market in the late 1990s to treat stress urinary incontinence — a condition triggered by physical activity like coughing, sneezing or running that is common and sometimes debilitating in women after childbirth. The treatment involves using a thin mesh strip, called a 'mid-urethral sling,' to support the urethra, the tube that carries urine away from the bladder.
The products were so successful — one of the most significant advances in women's health in recent decades, the physicians said — that companies began developing similar mesh products to treat another condition, called pelvic organ prolapse.
In such cases, pelvic organs such as the uterus and bladder drop from their normal position due to muscle weakening. A sheet of mesh can be used to support the pelvic floor.
However, treating pelvic organ prolapse with mesh proved problematic after those products were introduced in 2004. They were more likely to bring serious complications, including permanent incontinence, severe discomfort and an inability to have sex.
The U.S. Food and Drug Administration issued warnings in 2008 and 2011, and companies pulled most of the transvaginal mesh products for organ prolapse from the market.
Tens of thousands of women have filed liability claims against Johnson & Johnson and other companies, with some saying they knew nothing about the potential complications.
The doctors say Washington's lawsuit conflates the acceptable risks of using pelvic mesh to treat incontinence with the less tolerable risks of using it for pelvic organ prolapse. They're worried it could force mid-urethral slings off the market, though the attorney general's office says that's not the goal.
Washington, California, Kentucky and Mississippi are pursuing lawsuits that claim Johnson & Johnson deceived doctors and patients, and that the surgeries ruined some women's quality of life. They say product marketing brochures and instruction pamphlets should have contained much more detail about the risks.
The company updated its instruction pamphlets in 2015 — effectively admitting the earlier versions were inadequate, Washington state says.
'The purpose of our lawsuit is to require Johnson & Johnson to disclose to doctors and patients the serious risks associated with surgical mesh,' Ferguson said in an emailed statement. 'Johnson & Johnson knew about these risks for years and misrepresented them for more than a decade, even as it sold thousands of these devices in Washington.'
Washington's lawsuit seeks fines for each alleged violation of the state's Consumer Protection Act, an amount that could easily run into the millions. The attorney general's office also wants to bar Ethicon from representing that its surgical mesh is superior to traditional treatments, such as repair using the patient's tissue, and it says a key question is whether the pamphlets could have deceived the least sophisticated surgeons, not the most sophisticated.
In their letter last month, the surgeons insist they were never misled — nor could they have been, because they don't rely on a company's marketing materials or instruction pamphlets to divine the risks of medical devices.
Instead, the letter said, they rely on their education, journals, conferences, textbooks and other unbiased sources, and they counsel their patients accordingly.
In declarations filed in King County Superior Court, some said Ethicon paid for them to undergo training that fully explored the devices' risks, and others said they learned about the uses and risks from those specially trained doctors.
Clemons and the other surgeons do not dispute that some women have suffered complications from the use of mesh to treat incontinence, but they say any surgery has risks, and the risks of that procedure are well within accepted norms. Millions of women worldwide have been treated with mid-urethral slings.
The letter cited a recent large study of the English National Health Service database that found complications prompted the removal of mesh slings in just 1.4 percent of patients within the first year after surgery, 2.7 percent within five years and 3.3 percent within nine years.
In fact, Clemons said, the mid-urethral sling has become the 'gold standard' among surgical options for stress urinary incontinence because it offers better outcomes than other types of surgery, can be performed on heavier patients who otherwise would be ineligible for surgery, and requires less cutting and recovery time.
The Washington Attorney General's Office said in a court filing the fact that doctors obtain also risk information elsewhere does not excuse the companies from ensuring their instructional pamphlets are 'truthful and complete.'
The office agreed that many women have had positive outcomes with the devices and said it does not seek to restrict access to them.
Nevertheless, the state is relying on an expert witness, Dr. Bruce A. Rosenzweig, a gynecologist at Rush University Medical Center in Chicago, who insisted in a deposition that polypropylene mesh is an 'unsafe material to be placed permanently in the female pelvis.' That position is contrary to the scientific literature, according to the surgeons' letter.
Clemons is a retired Army colonel who spent a decade as the chief of urogynecology and pelvic reconstructive surgery at Madigan Army Medical Center. He serves on the board of the American Urogynecologic Society and has performed about 1,250 mid-urethral sling surgeries; he used to cut his own mesh slings before Ethicon's came on the market.
After filing the lawsuit, the Washington Attorney General's Office tried to recruit him as an expert witness, he said. Although he is a fan of Ferguson's Democratic politics — Clemons donated $550 to his re-election campaign last month — he declined.
'I'm not anti-Bob Ferguson at all,' Clemons said. 'I just disagree with him on this.'
https://www.dailymail.co.uk/health/article-6578395/Physicians-hit-women-blighted-vaginal-mesh-implants.html
-
Pa. Judge Won't Toss Mesh Trial After Three-Week Delay
Jan 10, 2019 | Law 360
By Matt Fair
A Pennsylvania state judge has refused to throw out an ongoing pelvic mesh injury trial based on what a Johnson & Johnson unit said was an unreasonable three-week delay in the proceedings over the holidays and the court's improper ex parte communications with jurors.
J&J subsidiary Ethicon Inc., which is facing the latest in a string of trials in Philadelphia over its allegedly defective pelvic mesh implants, said in a filing at the beginning of the month that it had been prejudiced both by a three-week pause during the middle of the plaintiff's case and by comments Judge Kenneth Powell made to the jurors about the importance of the proceeding.
But Judge Powell shot down the arguments in a written order Monday as he noted that he rejected a mistrial motion from the company orally back in mid-December.
The judge did not comment on the company's arguments in issuing the order.
The trial involves allegations that defects in three mesh implants that Suzanne Emmet received to treat urinary incontinence caused the products to erode through the soft tissue in her pelvis and into her vaginal cavity.
It is the eighth case over alleged defects in Ethicon mesh products to go to trial in the Philadelphia County Court of Common Pleas.
Juries in five of the previous proceedings have returned verdicts in favor of plaintiffs, resulting in total damages of more than $100 million against Ethicon.
Emmet's case kicked off at the beginning of December, but ran into an unforeseen delay a little more than a week later when one of the jurors reported an illness that would keep her out of court for at least two days.
In response, according to court filings, Judge Powell decided to adjourn the case temporarily and allow the proceedings to pick back up in January — with another three weeks of testimony expected — after the holiday season concluded.
When the judge explained the rationale for the delay to jurors, court records said he stressed the importance of the panel committing to stick out the full three weeks upon their return.
"Needless to say, you've heard the amount of money that people get paid to come in and testify," the judge said of the expert witnesses slated to take the stand. "It's expensive to try these cases, and this is a substantial case. This is a mass tort case. This is not a bump in the back of a fender."
But Ethicon said Judge Powell's handling of the schedule prejudiced the company.
In the case of the delay, the company said a three-week pause in the proceedings improperly allowed the jury "to ruminate for that long of a period on testimony and exhibits that reflect only questions from and documents shown by plaintiffs' counsel."
The company said it had not yet had a chance to question any live witnesses during the trial at the time the case was adjounred.
Regarding Judge Powell's comments to the jury, Ethicon said his statement about the expense associated with expert witnesses suggested the trial was more important to the plaintiffs' side than to the defense.
"The clear implication of the statement was that plaintiffs have invested a lot of money in the case because it is 'substantial,'" Ethicon said. "There was no attempt to portray the case as important to both sides, and because the jury heard from only one expert, an expert paid by plaintiffs, these statements could only have been understood to relate to the plaintiffs' case."
But Emmet's attorneys countered by saying the full transcript revealed that Judge Powell specifically said the trial was "an important case to both sides" and he warned the jury to keep an open mind since they hadn't heard any of the defense's case yet.
The proceedings picked back up on Monday, and are expected to run through the next two weeks.
An attorney for Emmet declined to comment Thursday. A representative for Ethicon did not immediately respond to a request for comment.
Emmet is represented by Thomas Kline, Kila Baldwin, Lee Balefsky, Tracie Palmer, Elia Robertson and Thomas Bosworth of Kline & Specter PC.
Ethicon is represented by Kenneth Murphy, D. Alicia Hickok, Melissa Merk and Molly Flynn of Drinker Biddle & Reath LLP, Joseph O'Neil of Campbell Conroy & O’Neil PC, Anita Modak-Truran of Butler Snow LLP, and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
The case is Suzanne Emmet et al. v. Ethicon Inc. et al., case number 1307001495, before the Court of Common Pleas of Philadelphia County, Pennsylvania.https://www.law360.com/articles/1117139/pa-judge-won-t-toss-mesh-trial-after-three-week-delay
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested