Preview Newsletter
Ethicon Media Monitoring 12/18/2018
-
Georgia Law Prof Launches Study on Litigant Satisfaction in Women's Health MDLs
Dec 17, 2018 | Law.com
By Max Mitchell
Many law review articles have been written about the procedural challenges for lawyers and judges when it comes to handling multidistrict litigation, but few studies have focused on what hurdles litigants may face when their cases are part of large consolidated actions. -
Are women more likely to be harmed by medical device failures?
Dec 17, 2018 | ICIJ
By Ben Hallman
A year-long investigation of the $400 billion medical device industry by the International Consortium of Investigative Journalists reveals how lax regulation has allowed under-tested devices to flow into the market, and to remain there, even after grisly problems emerge. -
Mesh implants: Man speaks of procedure's devastating impact
Dec 17, 2018 | BBC News
...In September, Scotland's health boards were told to halt the use of vaginal mesh implants in surgery, after calls for an inquiry and an outright ban. -
Hernia Mesh – What Should You Ask?
Dec 17, 2018 | The Legal Examiner
By Jane Akre
...Some doctors in the pelvic mesh litigation abandoned their patients when the patient had complications, then said publicly they didn’t have patients with complications!
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Georgia Law Prof Launches Study on Litigant Satisfaction in Women's Health MDLs
Dec 17, 2018 | Law.com
By Max Mitchell
Many law review articles have been written about the procedural challenges for lawyers and judges when it comes to handling multidistrict litigation, but few studies have focused on what hurdles litigants may face when their cases are part of large consolidated actions.
One law professor is looking to change that with a study she is undertaking that seeks to hear from litigants who have brought a claim through the MDL process.
University of Georgia School of Law professor Elizabeth Chamblee Burch is performing a study focusing on women’s health MDLs, including the pelvic mesh litigation, the talc litigation and the litigations involving birth control drugs, like Yasmin/Yaz. The study consists of a questionnaire meant to gauge the satisfaction of litigants when it comes to the various aspects of the system they may have interacted with, such as judges, lawyers or third-party litigation funders. Burch has set Jan. 8 as the deadline for litigants to take part in the survey.
According to Burch, the last study done focusing on the experience of the plaintiffs in mass litigations was done in 1989. Although her study is focusing on products that deal with women’s health issues, she said the narrow focus should give insight into the satisfaction of plaintiffs in MDLs as a whole.
“It just struck me that there are so many products aimed at women,” she said.
Burch said the study is designed somewhat like a customer satisfaction survey, but aimed at the civil justice system at large. The questionnaire, Burch said, branches off like a choose-your-own adventure story, where the questions are tailored to gauge the satisfaction at each possible twist that a case can take, like whether the litigant ever appeared before the judge, whether their case was referred to multiple attorneys, whether third-party financial agreements were involved and whether the litigant had to go through a post-settlement claims administration process.
“The hope is to figure out if we can pinpoint the satisfaction, or dissatisfaction,” she said. ”I really don’t want to just get people who are disgruntled. If there are aspects people are happy about, I absolutely want to know that.”
In the short term, Burch said she is hoping the research will lead to a law review article, but in the long term, she said she hopes the research serves as a launching pad for a larger in-depth study that will become a book.
However, Burch said she has run into difficulty so far, both from lawyers and from the litigants, when it comes to participation. Some litigants, she said, are suspicious and have accused her of working with or being funded by attorneys involved in the litigation. The project, she said, is being funded entirely by the university. Attorneys, she said, also haven’t appeared eager to pass the word along about the study.
“Nobody really wants you to look under the hood. Nobody much has an incentive to get people to participate,” she said.
A glance into the social media pages dedicated to women who underwent pelvic mesh procedures might give some indication why, as many commenters report difficulty getting in touch with attorneys and feeling largely left out of the process. An attorney involved in the pelvic mesh litigation also recently took the unusual step of criticizing several of his colleagues, accusing them of taking on more cases than they could handle and then settling the cases for cheap.
Although many complaints express dissatisfaction with the system as a whole, Burch said she hopes the study will help tease out exactly where the problem areas might be.
With more than 100,000 women involved at its peak, the pelvic mesh MDL was one of the largest consolidated actions ever, according to mass tort attorneys. It is far from the first large-scale litigation where claimants have been openly frustrated with the system—in particular, the $1 billion class settlement the NFL reached regarding former players with concussion-related injuries has also recently come under scrutiny.
When asked whether dissatisfaction typically always increases the larger the litigation is, or whether dissatisfaction appears to be increasing on the whole, Burch said she can’t say for sure, but the study may help provide an answer in the future.
“We don’t have a baseline,” Burch said. “We don’t know how happy people used to be.”
https://www.law.com/dailyreportonline/2018/12/17/study-aims-to-gauge-litigant-satisfaction-in-womens-health-mdls-404-23884/
-
Are women more likely to be harmed by medical device failures?
Dec 17, 2018 | ICIJ
By Ben Hallman
A year-long investigation of the $400 billion medical device industry by the International Consortium of Investigative Journalists reveals how lax regulation has allowed under-tested devices to flow into the market, and to remain there, even after grisly problems emerge. Time and again, our Implant Files reporting led us to devices made for women, and to women who were injured when an implant fractured, ruptured, triggered an autoimmune reaction or otherwise didn’t work as intended.
Yet a seemingly basic question — whether there is a pain and suffering gender gap — remains vexingly tough to answer.
After reviewing the histories of dozens of problematic devices, and talking to hundreds of patients, this much is clear: women were disproportionately harmed in many of the scandals that have plagued the industry in recent years.
Regulators, under heavy pressure from women-led patient groups – angered that their concerns have often been dismissed by doctors and by health authorities – are scrambling to make reforms. And while there is no way to determine whether more women are injured or killed than men in terms of absolute numbers, studies show that many medical implants pose a higher risk to women than men.
“Women have higher complication rate, and need to be treated differently,” says Rita Redberg, a cardiologist and medical device researcher at the University of California, San Francisco.
The best source for gender-specific data on injuries and deaths linked to medical devices should be the U.S. Food and Drug Administration. The FDA collects that information in “adverse event” reports filed by manufacturers, doctors and others when a device has harmed a patient – or has experienced a malfunction that would lead to harm if it were to recur. An ICIJ analysis of this data identified more than 83,000 deaths and 1.7 million injuries linked to medical devices.
Yet the FDA won’t make gender information public. An agency spokeswoman told ICIJ that revealing gender or age would violate patient confidentiality rules and that more broadly, “conclusions can not be drawn” about sex-specific differences in adverse event rates, because the reports themselves often contain unverified and incomplete information.
There are large gender differences in device usage – heart devices, for example, skew male – so it’s not clear whether or not the data would show a gender divide. But the FDA has issued statements that seem to acknowledge a problem, at least of perception.
On Nov. 20, the FDA announced that the agency will be “focusing on addressing clinical questions on device therapies that are unique to women.”
Asked by ICIJ what prompted the declaration, a spokeswoman pointed to previous agency communications, including a pledge to “improve the quality and efficiency of real-world evidence generation, specifically for technologies used to address women’s health” in light of “several significant medical device safety issues [that] have involved devices intended for women’s health uses.”
Those “significant” issues concern medical disasters that have wrecked the lives of tens of thousands of women.
Vaginal mesh, used to treat incontinence and hold prolapsing organs in place, has pierced sensitive tissue and caused infections in thousands of women. Josephine Kilroy, a former taxi driver, told The Irish Times, an ICIJ partner, that the mesh implant she received to treat a bladder problem a decade ago caused her so much pain that she was essentially homebound. “It has taken my whole life from me,” she said.
Breast implants can leak, rupture and collapse. They are also linked to a rare form of cancer and a range of autoimmune disorders.
Dawn Criss, a breast implant patient and bookkeeper who lives near Edmonton, Alberta, is one of more than 2,400 people to have responded so far to an ICIJ survey. Four years ago, she began to experience pain, itching and other discomforts in her breasts, she said in an interview this week.
Doctors found associated anaplastic large cell lymphoma (BIA-ALCL) in her left breast, her medical records show. Symptoms from colitis, an autoimmune disorder she suffers from that causes inflammation in the colon, disappeared almost completely after the implants were removed, she said.
Essure coils are a sterilization device that have damaged reproductive organs and triggered allergic reactions in thousands of women worldwide. El Confidencial, another ICIJ partner, told the story of María Ángeles, a Spanish women who died in May from complications stemming from a hysterectomy after she was implanted with Essure.
These devices are associated with huge numbers of patients: More than 10 million people have received breast implants over the last decade, and more than 1 million have gotten Essure, which as of the end of this year will have been pulled from the market in every country. Hundreds of thousands have had a mesh implant. There is no comparable group of male-focused products with these kinds of widespread problems.
Even many devices used by all genders appear to harm women more often than men.
Women who received a Thoratec HeartMate II, an implant that pumps blood out of the left side of the heart in patients that have suffered heart failure, were three times as likely as men to have a stroke in the pre-approval studies. Women who underwent hip replacement surgery were found to have a 29 percent higher rate of hip implant failure than men — and also experience a “remarkable and significant” increase in hypersensitivity to metals used in hip implants.
Higher complication rates don’t necessarily mean devices shouldn’t be used in women. Heart pumps and other cardiac devices save and extend lives, and artificial hips help people walk again. But patients should be apprised of the risks, and doctors must factor in elevated risks when recommending a course of care, health experts say.
Redberg said there are procedures that she would recommend for men that she would not advise for women. A continuing problem, she said, is that women are often underrepresented in many clinical trials.
In dozens of interviews with ICIJ reporters and our partners, women said that when they complained of illnesses and maladies they believed were tied to an implant, they weren’t believed.
One of those women was Laura DiCarlantonio, who by December of 2017 was exhausted, suffered persistent aches and pains and had flu-like symptoms that seemed to never go away, she told ICIJ. Four years earlier she had breast implants after a mastectomy. A scan revealed a rupture in one of the silicone implants — yet her plastic surgeon refused to acknowledge her symptoms or the evidence of a rupture.
Months passed while she researched her options. She had the implants finally removed in May.
In her book Doing Harm, released earlier this year, journalist Maya Dusenbery describes an “unconscious and systemic” bias that affects the care women receive.
“Women’s voices are not granted the same authority in doctors’ offices,” she told ICIJ. The majority of people suffering autoimmune disorders are women, yet the records abound of doctors turning women away when they complain of pains and other hard-to-pin-down ailments that are the hallmark of many autoimmune illnesses, Dusenbery said.
Dusenbery, whose book emerged from research after she was diagnosed with rheumatoid arthritis in her 20s, realized how fortunate she was to have gotten an early diagnosis.
“The medical profession needs to recognize that needless delays in diagnosing women is a really big blind spot,” she said.
https://www.icij.org/blog/2018/12/are-women-more-likely-to-be-harmed-by-medical-device-failures/
-
Mesh implants: Man speaks of procedure's devastating impact
Dec 17, 2018 | BBC News
A man who had a mesh implant following a hernia said it has had a devastating impact on his life.
Graham Robertson, who had hernia surgery in 2007, said he has had serious health complications following the procedure.
The British Hernia Centre said complications were very rare.
In September, Scotland's health boards were told to halt the use of vaginal mesh implants in surgery, after calls for an inquiry and an outright ban.
Mr Robertson told Radio Scotland he has been living with pain, mobility and mental health problems for over a decade.
He said he has been on a "gambit" of medications to try to keep the pain at bay.Exacerbated
"About four years ago, I started to have other more serious complications and increased pain; I had things like IBS, folliculitis, epididymitis, pain when making bowl movements, dysejaculation and pain that made sex prohibitive.
"Couple that also with mobility problems caused by the pain, because of course it's a pivotal point in your body."
He said that further treatment has made his situation worse, and as a result his mental health has been impacted: "I sought help and tried to get some other treatments which in my view exacerbated the problem.
"I've been on and off antidepressants. Any doctor will probably tell you that chronic pain and antidepressants go hand in hand.'Dismissal', 'denial', 'confusion'
Mr Robertson said he felt "dismissed" by his doctor: "I think he said at the time 10% of people who had the operation had problems with it afterwards, when of course when I got the operation originally that percentage was only 3%.
"He had the opportunity to investigate what was going on, but pretty much dismissed me out of hand, so much so that I had to complain to the NHS in order to begrudgingly get another consultation.
After four surgical consultations, he feels the responses have ranged "from dismissal to denial, and now confusion".
"I think my doctors is in agreement that the device has failed in some way or something has certainly failed with the repair.
"The doctors or surgeons look at it as if the hernia has not returned then that's a success to them and the hernia's not returned so...
"The latest surgeon has said almost with a kind of shrug of the shoulders, 'We can try and take it out, but it may cause more damage and the chances are that you could lose your testicles'."
Dudley Rogg, of the British Hernia Centre, said: "I fully sympathise with all the people who believe mesh has caused them these post operative problems. However, there is another side to the story."
He said the procedure, which was introduced 30 years ago, replaced a technique from the 1800s.
"Nobody is disputing Graham's problems, they are there... The sort of problems that Graham and others are reporting in relation to their hernia repairs existed before mesh was ever used...
"The number of successful mesh operations is beyond compare.
"The statistics for post-operative complications were something up to 60% with the old techniques... We've brought those statistics down to a fraction of 1%"What's the issue with transvaginal mesh implants?
Labour MSP Neil Finlay is concerned that this experience mirrors the problems some patients had with transvaginal mesh.
He said: "What I see looks very much like a repetition of the issues that came up during transvaginal mesh.
"Listening to Graham is very similar to listening to some of the women six years ago, where clinicians didn't believe them. People were experiencing excruciating pain...
"Many of them were told 'This is all in your head. This is nothing to do with the mesh', and six years on, off relentless campaigning, we got to a position where mesh has clearly been identified now as being a global health scandal."
https://www.bbc.com/news/uk-scotland-46591850
-
Hernia Mesh – What Should You Ask?
Dec 17, 2018 | The Legal Examiner
By Jane Akre
By now, most people have heard that there are thousands of product liability lawsuits filed against the makers of permanent polypropylene (PP) mesh implants for both hernias and pelvic repair.
Some of the biggest names in Big Pharma are among them – Johnson & Johnson and its Ethicon division, Boston Scientific, C.R. Bard, American Medical Systems, Coloplast, Caldera, Cook Medical, and Neomedic.
Two hernia meshes in particular and the focus of a growing number of cases being filed to take to trial or settled.
Atrium C-Qur and Ethicon’s Physiomesh, are the focus of two courts consolidating cases into MDLs or multidistrict litigation, and other brands and names will likely follow. Since most are made out of polypropylene, they all carry the same risks of infection and pain.
Despite the lawsuits, mesh is still it is being offered as a first line treatment for a hernia repair.
So what do you ask if you are told you need Hernia Mesh?
Here are some suggested questions to ask your doctor if you are offered a hernia repair using mesh.
Your first question might be – Can you do a non-mesh repair and if you can, am I a candidate? Unfortunately someone who has had previous repair attempts that were unsuccessful, who smokes or who is obese, may have weak connective tissue. In some cases the doctor feels using a mesh as a reinforcement is the last resort. Is that the case with you?
Does your doctor only do mesh-reinforced hernia repairs? Can he do a Desarda or Shouldice repair with no mesh? If you have a portion of your external oblique membrane taken for support, how long will your recover be? How many non-mesh repairs has he done? You want to choose a provider who understands alternatives to the traditional mesh repair.
What is the mesh you use made of? Answer: polypropylene (PP), biologic or composite or coated. Even biologic (pig, cow or cadaver) or coated generally merge with a PP base. If your doctor says its “Marlex” or Prolene” or Gynemesh, it’s all polypropylene! Make sure you do not allow them to confuse you.
Does your doctor believe polypropylene mesh can harbor bacteria and infection? Has he had those complications and how does he deal with them? Polypropylene tends to harbor bacteria and infection, as all mesh can. Removing a permanent implant is very difficult so know what your doctor is telling you.If you are being told it’s a “New Mesh” just how is it new? Does it have larger pores? Is it made from cadavers? Is it polypropylene (PP), the most common material for hernia repair, or is it a composite of PP and ePTFE, polyester, plain ePTFE, biological mesh, or a hybrid mesh? How are they different?What is the brand name of the product you use? Who makes it? How long have you been using it? (Answer: See how honest and up front the provider is). Does his/her hospital buy this particular mesh and why?
What is your relationship with the mesh manufacturer? Answer: Look up Dollars for Doctors prior to your appointment. A database from ProPublica, it has documented the financial relationship between doctors and the manufacturers. While that does not indicate this is a bad doctor, you might want to discuss his/her relationship with industry. Does it influence the doctor’s opinions?
How can receiving $1 million a year NOT influence your opinion of a product? But that is for you and your doctor to decide.
If I have a complication will you still be my doctor and help me resolve the issues? Some doctors in the pelvic mesh litigation abandoned their patients when the patient had complications, then said publicly they didn’t have patients with complications! While you obviously cannot get this doctor to give you an unconditional assurance, at least see what he says and ask how he has dealt with other patients with complications in the past. If he says he doesn’t have any, the red flag may be waving. Again, you decide.
https://herniamesh.legalexaminer.com/health/medical-devices-implants/hernia-mesh-what-should-you-ask/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested