Ethicon Media Monitoring 12/19/2016

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Mesh implants still used in Scotland despite suspension

   Dec 19, 2016 | BBC

   By Lucy Adams
   
   
   Hundreds of mesh implant operations have been performed in Scotland despite ministers recommending the suspension of their use.
2. New Jersey court upholds $11 million verdict in state's first pelvic mesh case

   Dec 16, 2016 | Consumer Affairs

   By Amy Martyn
   
   
   Pelvic mesh, or trans-vaginal mesh, the controversial medical device made famous by those late-night infomercials that personal injury attorneys use to seek victims, is slowly facing its day in court, or thousands of days to be exact.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Mesh implants still used in Scotland despite suspension

   Dec 19, 2016 | BBC

   By Lucy Adams

   Hundreds of mesh implant operations have been performed in Scotland despite ministers recommending the suspension of their use.

   Figures obtained by the BBC show that 404 women have received mesh and tape implants since the health secretary called for the suspension in June 2014.

   The Scottish government said the position had been made clear.

   Those boards still using mesh implants said they discussed all the potential risks with patients before surgery.

   The procedure is used to ease incontinence and pelvic prolapse.

   Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants. But some have suffered painful and debilitating complications.

   In 2014 a number of campaigners gave evidence to the Holyrood Petitions Committee. Several of them were in wheelchairs - unable to walk because of surgical complications.'Deeply troubled'

   As a result, the then Health Secretary Alex Neil wrote to health boards requesting a suspension in the use of mesh implants by the NHS in Scotland pending an investigation into their safety.

   He told MSPs he was "deeply troubled" by the issue.

   Since then, Greater Glasgow and Clyde has used the implants more than any other health board - with 178 mesh and mesh tape implants. NHS Lothian have performed 146 mesh and tape implants.

   A number of health boards - including Grampian, Ayrshire and Arran, and Tayside - have stopped using mesh implants altogether.

   The figures obtained by the BBC show some health boards continued their use in the past 12 months - even after Health Secretary Shona Robison re-issued calls for their use to be suspended and apologised to women left with complications.

   NHS Borders, Fife, Dumfries and Forth Valley have used a very small number of mesh implants since the "moratorium".

   Gillian Watt, from Renfrew, had a mesh implant in 2011.

   "They were giving me a hysterectomy", she said. "They said they'd just lift my bladder whilst I was in. I thought it would fix me but it has completely destroyed my life. I lost my job, my career. Everything."

   Gillian is now 47 years old. She lives in almost constant pain and has to use crutches or a wheelchair if she needs to walk any distance.

   "I can't even go round the supermarket," she said.

   She has since had three operations to try to remove the mesh but has been told it will be impossible to fully reverse the procedure as it is now adhered to her organs.

   The worst thing, she said, is not being able to fully look after her one-year-old granddaughter.

   "When I went there was nothing about side effects," she added. "Nothing at all. They said they would just fix me.

   "I just can't believe the health boards are still using mesh. How can they do that when two health secretaries told them to stop? I went to an appointment with my friend's 19-year-old daughter who has bladder problems and they started talking about using it. She's just 19."

   The review, commissioned in 2014, is not yet complete, but research looking at the use of mesh and tape over the past 20 years - commissioned by NHS Scotland's Information Services Division (ISD) - is due to be published this week.

   Hundreds of women are suing health boards and manufacturers over the use of the implants.

   Lindsay Bruce, of Thomsons solicitors, has more than 140 clients taking cases.

   She said: "This is a global health scandal and one of the largest-scale health scandals we have ever seen.

   "I don't know why health boards are continuing to use mesh but we know that since the moratorium a number of women have been offered mesh implants or have had mesh implants.

   "A number have since suffered complications.

   "We know because a number of these women are now involved in litigation. My concern is that the numbers are just going to keep rising because the health boards keep using mesh."

   A Scottish government spokesman said: "We've made clear that health boards should consider suspending the use of the synthetic mesh products in surgery for pelvic organ prolapse and stress urinary incontinence.

   "However, if women are experiencing very distressing symptoms and want to proceed then the Scottish government agreed that, in these circumstances, the service should still be offered.

   "This is clearly a matter between the clinician and the patient and the procedure is only undertaken with the informed consent of the patient, following a full explanation and discussion of the potential risks. Since 2013/14, we've seen a significant decline in such procedures taking place across Scotland."

   The Medicines and Healthcare products Regulatory Agency (MHRA) has the final say on the use of mesh implants on a UK-wide basis.

   In 2014, it said its research showed that, while a small number of women had experienced distressing effects, the benefits of these tapes and meshes outweighed the risks and could help in dealing with upsetting conditions such as urinary stress incontinence and pelvic organ prolapse.

   Dr David Farqhuarson, medical director of NHS Lothian, said: "In all cases we discuss the treatment options available to our patients, ensuring that they are aware of the risks involved in any of our surgical procedures.

   "Where a patient wishes to go ahead with a mesh implant a thorough consultation process follows.

   "This involves the patient spending additional time in clinic to discuss their care and to ensure that they are prepared, educated and informed about the different options available to them before proceeding."

   A spokeswoman from Greater Glasgow and Clyde said it continued to offer mesh implants to "certain patients who meet the clinical criteria for this procedure".

   She added: "At their initial outpatient appointment all patients who are assessed and require mesh procedures have the opportunity to fully discuss the risks and benefits of treatment options with their consultant before they are listed for surgery.

   "In addition, they are given the patient information booklet provided by the Scottish government."

   http://www.bbc.com/news/uk-scotland-38343274
   

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2. New Jersey court upholds $11 million verdict in state's first pelvic mesh case

   Dec 16, 2016 | Consumer Affairs

   By Amy Martyn

   Pelvic mesh, or trans-vaginal mesh, the controversial medical device made famous by those late-night infomercials that personal injury attorneys use to seek victims, is slowly facing its day in court, or thousands of days to be exact.

   Tens of thousands of lawsuits have been filed against device makers like Johnson & Johnson’s subsidiary Ethicon over mesh products. The suits describe horrific side effects patients say they experienced from the implant.Cases stalled in two courts

   So many cases concerning mesh have been filed that the courts have consolidated thousands of the complaints in two courts, one in West Virginia and another in New Jersey under a system called Multi-District Litigation. But rather than more efficiently manage the case load, plaintiffs and personal injury attorneys complain that the consolidation has only caused the cases to drag slowly along.

   “This is probably the most complicated MDL in history,” plaintiffs’ attorney Robert Salim told a legal publication last year. Though Johnson & Johnson is the largest purveyor of mesh, several other companies also sell the product and are similarly facing lawsuits. Even cases in which different mesh-producing defendants are named have been consolidated under the same system. “Over 80,000 cases have been filed, which means over 25 percent of every civil case in America is in mesh MDLs,” Salim added.

   Mesh, a permanent surgical implant made of plastic, is in theory supposed to offer a net-like support system for women suffering from either pelvic organ prolapse or incontinence. Instead, however, women and some doctors critical of the product say it causes horrendous physical pain, destroys patients' sex lives, and can even worsen incontinence.

   Because the product was designed to be a permanent implant, there is no simple way to remove it. Small nonprofits and patient advocates like Aaron Thornton have raised money to fund expensive mesh removal surgery for women.Fight over the first mesh case finally ends

   But some plaintiffs, the few lucky enough to have actually seen their cases go to trial, are winning major victories in the court system. Linda Gross, a nurse from South Dakota, is the first woman to have her suit against Johnson & Johnson heard in a New Jersey court room. She filed her lawsuit against Johnson & Johnson in 2008, but her trial did not go before a jury until 2013.

   In her testimony Gross reportedly told jurors: “Who you see standing here now is not who I was,... I was eager and energetic, loved to go to work, loved to participate in church activities, school activities.” Her implanting surgeon later performed three surgeries on her to remove the mesh and cure her pain, jurors learned. They ultimately sided against Johnson & Johnson and awarded Gross $11.1 million dollars.

   Johnson & Johnson has been appealing that landmark ruling ever since. Finally, over eight years after she filed the lawsuit, New Jersey’s Superior Court this month made a definitive ruling in Gross’ favor. On December 7, New Jersey’s superior court declined to hear an appeal of Gross’ $11.1 million award, effectively ending Johnson & Johnson’s fight to overturn the jury’s verdict.

   "We are disappointed that the Supreme Court of New Jersey has denied the petition for certification and will not be considering the important issues we raised," Kristen Wallace, representative for Johnson & Johnson’s subsidiary Ethicon, told reporters in a statement.Jury's verdict stands

   The decision follows a ruling that New Jersey’s superior court made in March 2016, finding no merit in Ethicon’s arguments to overturn the jury’s verdict.

   Ethicon’s mesh product for pelvic organ prolapse, the Prolift Pelvic Floor Repair System, was approved by the Food and Drug Administration under a process called 510(K) clearance, which the judges note, “does not require clinical trials but requires the company to compare its product to one already on the market...” The 510(K) clearance system is problematic to independent researchers, including those on a 2011 Institute of Medicine Panel which called the process "fatally flawed."

   Emails and documents presented at Gross’ trial, reviewed again in March by the New Jersey superior court judges, showed that company executives documented serious side effects caused by Prolift, as well as concerns that Prolift was actually not so similar to anything already on the market.

   "Clearly, for most physicians, the Prolift procedure will be a deviation from what they are currently doing,” Ethicon wrote in 2005.

   https://www.consumeraffairs.com/news/new-jersey-court-upholds-11-million-verdict-in-states-first-pelvic-mesh-case-121616.html
   

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