Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements.
Twitter: JjrkCh

Wednesday, May 25, 2016

J&J Sold Pelvic Mesh While Concealing Risks: Washington State Attorney General

  • FOR IMMEDIATE RELEASE: 
May 24 2016  FiDA highlight
Complications left women permanently disabled, in chronic pain
SEATTLE — Attorney General Bob Ferguson filed a consumer protection lawsuit today against Johnson & Johnson, accusing the company of knowingly concealing the risks associated with a surgical mesh designed to treat pelvic floor conditions in women. As a result of Johnson & Johnson’s deception, thousands of Washington women face urinary and defecatory dysfunction, loss of sexual function, chronic inflammation, chronic pain, and risk of chronic infection.
These complications can crop up years after the surgery, and are in many cases irreversible. Removal of the mesh is nearly impossible.
“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,” Ferguson said. “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. This is an unacceptable way of doing business, and I will hold the company accountable.”
The lawsuit alleges thousands of violations of the Washington Consumer Protection Act, due to deceptive informational and marketing materials distributed to consumers and doctors. The attorney general will ask the court to prohibit Johnson & Johnson’s misleading marketing, find the company violated the CPA, and impose the maximum $2,000 civil penalty per violation, in addition to costs, fees and restitution.
The state alleges tens of thousands of violations of the CPA, potentially placing penalties well into the millions of dollars.
Johnson & Johnson is the largest manufacturer and seller of these mesh devices in the U.S. Between 2005 and 2015, the company sold nearly 12,000 mesh devices in Washington.
The mesh is made of woven polypropylene threads, and is marketed to doctors and patients as a way to treat pelvic organ prolapse, or when organs shift from their normal position, and various bladder issues.
The mesh is inserted surgically, and is put into place by pulling it up through the vaginal canal, then through an incision in the vaginal wall, and finally permanently anchoring it in the body to hold up falling organs.
The mesh, its construction and infection-ridden insertion through the vagina have caused chronic infection, chronic inflammation, permanent loss of sexual function, and permanent urinary or defecatory dysfunction. The mesh can shift position and cut through the vaginal wall or into other organs.
One patient shared this about her ordeal:
“I experienced excruciating pain from day one. I felt as though my urethra was being strangled, I couldn’t pee, walking was out of the question, sitting was agony, & I couldn’t lie on my left side due to severe pain and numbness at my left groin area.  Over the course of the next 14 weeks I visited/was admitted to the [hospital] 10 times. … I had no quality of life.  My consultant likened the mesh removal as to ‘trying to remove chewing gum from hair.’  … I still suffer left side groin pain and numbness, buttock pain, sharp pains in my lower stomach and I am less continent now than I was pre-op.” 
A doctor described in a 2009 email to Johnson & Johnson: “I am currently getting a patient to the OR who had an anterior and posterior prolift implanted by another physician.  She will likely lose any coital function as her vaginal length is now 3cm, and there is mesh extruding literally everywhere. … This patient will have a permanently destroyed vagina.”  
The company never told consumers that the mesh can cause, and consumers are likely to experience, chronic foreign body reaction and chronic inflammation as the body constantly fights to rid itself of this foreign material.
The company never told consumers that mesh causes and harbors infection, which can indefinitely live in the small weaves of mesh.
The company never told consumers that severe erosion — or a complication where the mesh moves and protrudes into an organ or through the vaginal wall — causing chronic pain and dyspareunia, or painful intercourse, is a common complication.
One patient said, “[I] had all kinds of problems with chronic pain, bleeding, dyspareunia (even my husband complained of scraping and poking)…The pelvic pain was keeping me awake at night, and the only relief was to sit on a tennis ball. The thought living like that, sitting on a ball, wearing a diaper, splinting my perineum to have a bowel movement, having infrequent and miserable sex, and marital problems was almost more than I could bear.”
And the company never told consumers that this risk of erosion is lifelong, because the implant is permanent, or that erosion can cause chronic pain and injury to sexual partners.
Women who have Johnson & Johnson mesh devices and are experiencing symptoms can contact investigator MaryBeth Haggerty Shaw at MarybethH@atg.wa.gov or contact our Consumer Resource Center at 1-800-551-4636. Complaints can be filed at atg.wa.gov/file-complaint.
This case is being handled by Senior Counsel Lisa Erwin, Assistant Attorneys General Andrea Alegrett and Leilani Fisher. The case has been filed in King County Superior Court.
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The Office of the Attorney General is the chief legal office for the state of Washington with attorneys and staff in 27 divisions across the state providing legal services to roughly 200 state agencies, boards and commissions. Attorney General Bob Ferguson is working hard to protect consumers and seniors against fraud, keep our communities safe, protect our environment and stand up for our veterans. Visit www.atg.wa.gov to learn more.
- See more at: http://www.atg.wa.gov/news/news-releases/ag-files-major-lawsuit-against-johnson-johnson-over-concealed-risks-pelvic-mesh#sthash.V0tz1X8g.Myhh7sWx.dpuf


http://www.atg.wa.gov/news/news-releases/ag-files-major-lawsuit-against-johnson-johnson-over-concealed-risks-pelvic-mesh

Peter Lavallee, Communications Director, (360) 586-0725; PeterL@atg.wa.gov

Unethical Lawyers Exploiting Pelvic Surgical Mesh-Harmed Women

Exposing the underbelly of mass torts litigation

By Alison Frankel May 24, 2016 (FiDA Blog)
(Reuters) – On Monday, Harris County Judge Jeff Shadwick of Houston agreed to stay most discovery in a Vietnamese seafood industry worker’s fraud and conspiracy case against two noted Texas plaintiffs’ lawyers, Robert Hilliard of Hilliard Munoz Gonzales and John Cracken of the Cracken Law Firm.
That’s a shame. The worker, represented by the Tammy Tran Law Firm, alleges that Hilliard and Cracken secretly put up a combined $10 million to fund another Texas plaintiffs’ lawyer, Mikal Watts, when Watts hired investigators to drum up client leads after the 2010 BP Deepwater Horizon oil spill. Watts eventually brought claims against BP on behalf of about 40,000 seafood workers – almost all of whom turned out to be phantom clients. The workers either didn’t exist (one, famously, was actually a dog) or hadn’t authorized Watts’ firm to represent them.
Watts and several other people, including the investigators who supposedly fabricated his client list, have been indicted for attempting to defraud BP and the courts. They are scheduled for trial in July in federal court in Gulfport, Mississippi. Watts, who will be acting as his own defense counsel at the trial, has denied he or anyone else from his office knew their BP docket was a sham. “Generally, in mass tort cases, lawyers representing thousands of clients do not personally meet with, investigate and sign up the case of each individual client,” Watts and his former criminal defense lawyer said in a statement last October. “In the BP oil spill matter, the Watts firm clients were processed by an outside field team.”
The government’s indictment alleges that the outside field team was funded by two other lawyers who wanted a piece of the Watts docket. One invested $3.1 million, the other $7.8 million that was, in turn, supplied by a Texas businessman who regarded the BP litigation as an investment opportunity.
The indictment does not name the lawyers who funded Watts’ client expedition, but Tammy Tran, who represents workers who claim Watts misappropriated their identities, told me in March that she learned the lawyers’ identities from a criminal defense lawyer involved in the Watts prosecution. At the time, lead counsel for Hilliard and Cracken, Richard Mithoff of the Mithoff Law Firm, refused to confirm that his clients funded Watts.
It is now beyond dispute, though, that the two lawyers were somehow involved with Watts. Their motion to stay Tran’s civil suit discloses that Cracken and Hilliard will be called to testify this summer at Watts’ criminal trial. The stay motion uses the passive locution that the lawyers “have been notified” so it’s not clear whether Cracken and Hilliard will be witnesses for the government or for Watts at the Watts trial in Mississippi.
Cracken and Hilliard persuaded the judge in the Houston civil suit to delay most discovery until after he rules on a motion by Cracken and Hilliard to move the case to their home turf in Corpus Christi, Texas. For now, the Vietnamese workers who want to blame Cracken and Hilliard for supposedly enabling Watts’ misuse of their identities will have to wait to find out if evidence backs their accusations.
Why do I say that’s a shame? Because the civil case has the potential to expose the usually unseen mechanics of investing in mass tort litigation. At Watts’ criminal trial, the main event will be the extent to which he and his firm knew their docket was full of ghost claims. Cracken, Hilliard and their alleged investment in Watts’ BP claims will be, at most, a side issue.
But I’ve become increasingly convinced that mass tort litigation funding is profoundly influencing big personal injury cases. Look at the litigation over pelvic mesh, the biggest case – in terms of the raw number of plaintiffs – since asbestos. As my colleague Jessica Dye and I have been reporting for several months, the mesh litigation attracted all kinds of non-lawyer marketers, doctors and funders who saw an entrepreneurial opportunity in claims by women allegedly injured by the devices. Most recently, we reported that one mesh defendant is now claiming it has evidence of a sweeping conspiracy to lure women into needless surgery so that litigation funders could realize bigger returns when their cases settled.
And it’s not just humongous cases like the BP oil spill and the pelvic mesh litigation that have become investment vehicles. Take a look at an article that ran Tuesday in Investment News, discussing platforms for hedge funds and even individual investors to inject capital into personal injury suits. As plaintiffs’ lawyers themselves, Cracken and Hilliard were early to understand the potential upside from investing in Watts’ BP claims (assuming, of course, that they are indeed the unnamed lawyers in the BP indictment). But lots of non-lawyers have now seen the same light.
Maybe outside funding of personal injury claims is a good thing. The vast majority of people who are injured by, say, drugs and medical devices do not bring claims. Proponents of litigation funding argue that additional capital will enable more plaintiffs with legitimate injuries to become aware of litigation and find lawyers to prosecute their cases. Opponents say, of course, that outside money will lead to unfounded claims and further attenuate the relationship between lawyers and their clients. This is a hugely important discussion, especially with nearly 40 percent of all civil litigation in federal court taking place in multidistrict cases in which individual clients have little control over events.
The Houston litigation against Cracken and Hilliard might have added to our understanding of mass torts funding, but not without discovery. Too bad.
For more of my posts, please go to WestlawNext Practitioner Insights

http://blogs.reuters.com/alison-frankel/2016/05/24/exposing-the-underbelly-of-mass-torts-litigation/

Thursday, May 19, 2016

Bayer Essure: Permanent Birth Control Pain

Some women say a permanent birth control is causing permanent pain

Leslie Rhode/KXAN Special Contributor  
Published: May 17, 2016, 9:00 pm Updated: May 17, 2016, 11:03 pm

AUSTIN, TX (KXAN) — Essure, a permanent birth control device, is under scrutiny by the Food and Drug Administration after thousands of women have complained of long-lasting painful effects they say are related to the birth control. The manufacturer, Bayer, estimates about 750,000 women are using Essure, and most of them are in the United States.
After Angela Otwell delivered her second child, she thought long and hard about whether or not she wanted a permanent form of birth control. She says her last pregnancy had complications due to an autoimmune condition, but she claims those health challenges cannot compare to the physical and emotional pain she has endured since she got Essure.
The Belton mom was only 28 years old when she had the birth control device implanted in January 2015. Five months later, she had an ovarian cyst rupture she blames on her birth control.
“Ovarian cysts just feel like someone took a very long metal rod that’s sharpened at the end and takes it and skewers it through your body wherever it is,” said Otwell.
For Otwell, the most frustrating part of her life now is the constant fatigue. She says she has lost a great deal of weight and energy since the day she had the permanent birth control implanted. With two young children still not in school, she says she feels so guilty not being the energetic mom her two children deserve.
“I go to the grocery store and that’s about it. I really want a shot at being a mom. I dream of taking the kids to Disney World or, you know, hiking. I just hope I get that opportunity.”
Atwell isn’t alone.
Felicia Crossland lives with fatigue and pain which she also claims was caused by Essure. The Liberty Hill mother loved the idea that the permanent form of birth control did not require anesthesia and down time like having her tubes tied would, so she opted for the devices after her second child. In the years since, she says she often suffers bloating and severe menstrual pain. By the end of most days, Crossland claims the pain becomes too much to bear.
“What happens most nights is there’s this incredible pain that builds in my pelvis and works its way down in my legs,” explained Crossland. “I would like to say it’s something as simple as a pinched nerve, but I really don’t think it is.”
How Essure Works
Doctors insert the small Essure devices into the fallopian tubes through the cervix. Within three months, scar tissue grows around the coils creating a barrier that prevents sperm from reaching the eggs. According to the company’s website, most women go home 45 minutes after the procedure.

Patients are supposed to go back to the doctor after three months for a confirmation check to make sure Essure is working properly to prevent pregnancy. The manufacturer’s website warns women to use other forms of birth control until they pass the confirmation test. Essure marketing indicates the product is 99 percent effective at “permanently preventing pregnancy.”
The Essure coils are made of materials that include a nickel-titanium alloy, a material used in other medical devices like heart stents. The packaging warns patients with nickel allergies may experience an allergic reaction with symptoms like rash, itching and hives. The coils do not contain hormones.
Essure was approved by the Food and Drug Administration in 2002. At the time, the birth control was manufactured by Conceptus, Incorporated. Bayer acquired Conceptus in 2013. Essure received the FDA’s most stringent review before it was marketed and Conceptus was required to conduct two post-approval studies.
According to FDA records, approximately 10,000 complaints have been filed complaining about health complications related to the use of Essure. Records show most women reported pain/abdominal pain, menstrual irregularities headaches and fatigue. The agency says some people reported more than one problem.
The FDA’s website states, “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.”
On Sept. 24, 2015, the FDA held hearings on the growing number of complaints regarding the adverse effects of Essure. Doctors and patients testified about their experiences with the permanent birth control device.
After the hearing, the FDA ordered Bayer to conduct a post-market study to gather more data about Essure’s benefits and risks. The agency also drafted a boxed warning to make sure a woman knows the risks associated with the product and a patient checklist that doctors review with a woman to make sure she understands the benefits and possible health complications.
Bayer still claims the birth control option is safe for most women and the benefits outweigh the risks.
“The data around the safety and efficacy of Essure has been examined in the company and by the FDA, and the data does not support taking it off the market,” said the Director of US Medical Affairs, Women’s Health Bayer, Dr. Patricia Carney. “Even in the latest statements from the FDA–for the majority of women– essure is a good option.”
The FDA took public comment on the draft box warning and patient checklist for 60 days. That period ended on May 3, 2016.
A bipartisan group of U.S. lawmakers introduced the E-Free Act (H.R. 3920) on Nov. 4, 2015 in hopes of pulling Essure off the market. The bill would require the FDA to withdraw its approval of the permanent birth control.
Living with the Pain
Angela Otwell and Felicia Crossland both say they do not blame their health problems on their doctors who implanted Essure, but rather the device itself.
Otwell and Crossland say they have contacted a new physician who has agreed to remove their birth control devices. Because of the way Essure coils are implanted, the women say the coils cannot be removed without a complete hysterectomy, which is the removal of the uterus.

Both women are waiting on the wording of the FDA’s final boxed warning of Essure, but both wish it would just be removed from the market altogether. There has been no action on the E-Free Act in Washington, D.C.

Wednesday, May 18, 2016

Who is Crazy Now? Pelvic Mesh Device Failures in Australia.

Newcastle man demands hospital records

JOANNE McCARTHY

April 14, 2016, 8:33 a.m.

THEY’RE the women told they’re going crazy – that the excruciating, extraordinary pain in their groins, backs and legs is actually all in their heads.
They’re women who received pelvic mesh implants over more than a decade from 2005 when regulators failed them, and medical devices hit the market without clinical evidence of safety or efficacy.
They’re women like Jane, 66, of Newcastle, who had mesh implanted in November, 2013, to treat prolapse. Twenty months later the pain started.
“First I was getting severe pain in my left side, then it went into my right side, then it was severe back pain. I didn’t know where the pain was coming from,” she said.
She saw doctors. They prescribed painkillers, laxatives and antibiotics for the infections she kept getting, and ran tests which came back negative. By February she was in hospital and her frantic son, Paul, was pulling no punches with doctors.
“They actually told her the pain was all in her head but she’s a different person since this started. This has absolutely broken my mother. They’ve basically experimented on women by putting these things in them, and when the women come looking for help they’re put in the too-hard basket, but no-one’s got the balls to say it,” Paul said.
Jane insists she was not told what kind of mesh device would be used during her surgery.
“I was told it was a mesh but not what brand. I was told nothing else about it and I never questioned anything,” she said.
Paul is close to tears when he describes how his once vibrant mother spends her days. She struggles to leave the house.
“She’s lucky to have one good day in three months,” he said.
He is fighting to get her medical and hospital records to determine what mesh device she received and how her surgery was conducted, as a first step to having the mesh removed.
“I spend most of my time here laying on the lounge, or in bed,” said Jane.
“You’re not living.”
She gave a date in April when another test is scheduled, then gave the kind of statement that horrifies her son: “The way I feel I could be dead by then.”
Toni Shannon is 49.
Three months after she received a mesh device in April, 2014, the inexplicable excruciating pain started. It eventually stopped her from working and left her barely able to walk 50 metres at a time. It also left her devastated by the mental consequences of shockingly severe chronic pain and debilitating fatigue.  “I felt an incredible hopelessness because I could not understand why my once strong body and mind had let me down,” she said.
Before mesh surgery: Toni Shannon and husband Eric four months before pelvic mesh surgery left Mrs Shannon with devastating complications.

The pain came in waves and stabbing bursts – deep burning pain into the bones, muscles and nerves, and jolts of nerve pain “that would stop me in my tracks”.
“It was excruciating groin pain. It was like you had a knife in your vagina with super sharp burning pains that would come with a shock. Absolutely shooting pain. Completely unexpected. Terrifying. I was really thinking, am I going crazy?”
Then there was the shutdown of once normal activities. She needed help showering and dressing. The surfing she had loved for many years was out of the question. Relationships with her husband, family and friends suffered while her life was focused on managing pain and fatigue.
“I felt my life was spiralling out of control and I often thought that dying would be a better option for myself and my family,” she said.

Hospital: Toni Shannon in an American hospital after surgery to have mesh completely removed. She cannot work and has permanent complications.
There were trips to doctors, a trip to America for surgery to completely remove the mesh, and a dawning understanding of controversies about mesh devices which she was unaware of until recently.
She is outraged that her transvaginal mesh surgery – surgery through the vagina – occurred more than two years after the American Food and Drug Administration issued its first serious warnings that complications from transvaginal mesh devices were not rare, and were potentially “life-altering” for women.
She is also outraged that the Australian Therapeutic Goods Administration allowed mesh devices on the market without the clinical evidence required to make drugs available, and that as late as 2012 it reported the likelihood that unskilled doctors, rather than the mesh devices, were responsible for any complications.
Mrs Shannon cried when she spoke about her life today. She is not working, she has lost the fitness and confidence that she was once known for, and she still experiences pain after surgery to remove the mesh that had eroded into her vagina, requiring removal from muscle, nerves, tissue and bone.
She does not know when, or if, she will work again.

Overwhelmed: Caz Chisholm has more than 100 women registered on her Australian Pelvic Mesh Support Group Facebook page launched after her mesh surgery in 2014.
“It’s an unknown future. I was right at the top in my work with a lot of responsibility, but it’s like I’m stuck in a holding pattern. It’s really like a death sentence.”
Carolyn Chisholm is founder of the Australian Pelvic Mesh Support Group.
In January 2014 she was implanted with a mesh device, at almost exactly the same time an American woman was being awarded $US3.27 million in a civil suit over the same device.
The American woman’s court case was told mesh became entangled in her internal organs, eroded through her vagina, caused infections and was unable to be completely removed from her body.
Within three months of surgery Ms Chisholm was experiencing extraordinary, excruciating pain in her groin and legs, debilitating fatigue and a skin disease.
“When I complained of this unbelievable pain I was told it was ‘just healing pain’, but I was freaking out. I was told it was probably not the mesh but I knew it was,” she said.
By November 2014 she started up a Facebook page for women with mesh problems, which became the Australian Pelvic Mesh Support Group. In the past few months Ms Chisholm and 10 other women have paid more than $30,000 each to travel to America and have their mesh completely removed.

In May the women will travel to Canberra to rally against the Therapeutic Goods Administration, which registered the first transvaginal mesh devices for prolapse surgery in Australia in 2004 and 2005, with no evidence of their safety and efficacy for prolapse surgery, and with clear warnings of the need for controlled clinical trials for related mesh devices.



Monday, May 2, 2016

Why Patients Don't Hear About Failed Medical Devices Until It Is Too Late . . .

Media mystery: Why did journalists ignore an important study on a costly, harmful back pain procedure?

April 20, 2016 (FiDA highlight)

Kevin Lomangino is the managing editor of HealthNewsReview.org. He tweets as @KLomangino.

What qualifies as “news” in the topsy-turvy world of health care can be a real head-scratcher sometimes.
A few weeks ago, the New York Times reported in some depth about a two-week, 9-person study of bicyclists headlined, Chocolate Can Boost Your Workout. Really.
Really?
That kind of coverage is exasperating. Especially when you consider that last week, I could find no mainstream news coverage — nada, nothing — about a 10-year, award-winning study that, according to several knowledgeable experts, has tremendous clinical and financial implications for the treatment of back pain in the United States.
The study was titled, “Does provocative discography cause clinically important injury to the lumbar intervertebral disc? A 10-year matched cohort study.”
But that title apparently wasn’t provocative enough for journalists on the health care beat.
It’s a shame the researchers couldn’t find a way to work the word “chocolate” into their study.
High costs and potential for harm
Provocative discography” is a diagnostic procedure that’s used up to 70,000 times a year in the United States at great cost to the health care system. It’s commonly performed on patients with so-called “degenerative disc disease” who are considering spinal fusion surgery — a $40 billion per year industry in the U.S. In an attempt to pinpoint the disc that’s causing problems, the surgeon will typically do a pressurized injection of the suspect disc and one or two non-degenerated control discs.
Experts say that provocative discography has no proven benefit for identifying symptomatic discs and has previously been shown on magnetic resonance imaging to be associated with faster degeneration of injected discs. The new study followed 75 patients who received the injections and compared them to 75 matched controls. The point of the new study was to see whether the disc degeneration seen on MRI would translate into clinically important back pain symptoms.
There was no significant history of back pain in either group when the study began. But the new 10-year data showed that there were more back pain surgeries (16 vs. 4); more frequent sciatica and back pain syndromes, and greater work loss and doctor visits for low back pain in the punctured discs compared to controls.
More pain. More surgery. More costs.
All with a procedure that’s still performed tens of thousands of times a year.
But no news coverage.
An expert asks: “Why would providers perform this test?”
James Rickert, MD, an orthopedic surgeon and contributor to HealthNewsReview.org, called it a “very important study.” The study has limitations, Rickert noted, including the fact that 40 out of the 150 patients were lost to follow-up during the 10-year study period.
“But readers should be aware that a trial of this sort with 10 years of follow up is very compelling evidence of discography’s potential problems,” Rickert says. “Such long term studies are rare,” he adds, and this one should tell readers: “Do not go undergo provocative discography.”
Patients looking for relief are subjected to all sorts of tests but provocative discography is the most invasive, and, typically, causes some insult to structures that are either normal or are not pain generators for the patient.  Add in the low diagnostic yield for patients, why would providers perform this test?
Similarly, Steven Atlas, MD, MPH, another HealthNewsReview.org contributor, likened the issue to a “house of cards” that’s finally beginning to topple. He noted that responses to provocative discography depend upon a variety of factors including the physician’s technique for performing the procedure.
So, not surprisingly, results are not very reliable. We also know that patients who have fusion based upon findings of provocative discography don’t do any better than individuals who have surgery but don’t undergo this test. We also know that patients can report more pain after the procedure, including pain they didn’t have before the procedure. And now we know that there are long-term risks associated with discography.
Mark Schoene, editor of The Back Letter as well as a HealthNewsReview.org contributor, emphasized that the study also threatens companies developing new biologic treatments that might help fix degenerated discs.
Most of these companies are planning to deliver those therapies via disc injection. The compounds they will inject, however, often have large-size molecules and will require large-bore needles—as large or larger than the needles employed in [these] studies. This suggests that these therapies may actually cause harm through the acceleration of disc degeneration.
Schoene said that companies producing these therapies are fearful that the studies may prompt the FDA to alter its safety standards regarding these injections—and order long-term human safety studies. Human studies of these injections would take a decade or more to perform and “could stop this new business in its tracks,” he said.
Few vested interests pushing reduction of unnecessary care
The news media weren’t entirely silent on the issue of back pain last week. The Minneapolis Star Tribune had a hard-hitting exposé on Medtronic’s Infuse bone graft device. It asked why more than a thousand adverse events associated with the device weren’t reported to the FDA.
A handful of stories (HealthDay, WebMD) also reported on a pair of New England Journal of Medicine studies (see here and here) looking at clinical outcomes for spinal fusion surgery. They reported that the more invasive and costly fusion surgery isn’t any better than a simpler surgery known as decompression for patients with pain resulting from spinal arthritis.
But the silence about provocative discography is provocative. With such huge implications, how can this critical study have received no mainstream media coverage? (The study was, after all, the subject of a news release put out by the North American Spine Society that should’ve pinged journalists’ radars.)
Rickert says it mainly comes down to who’s willing and able to invest in publicity for these studies.

“When a clinical trial shows positive results for a test/procedure, the manufacturer deploys an army of salesmen and media specialists and publicists to publicize the data,” Rickert notes. “That doesn’t happen with studies that call existing procedures/tests into question.”

Sunday, May 1, 2016

Settlement Gag Clause: 'Instance of Misconduct' 2005


Bill Would End Gag Clauses That Stifle Victims Who Sue

April 19, 2005|Jordan Rau | Times Staff Writer

SACRAMENTO — Wendy Conner asked a San Diego doctor to smooth over a forehead scar in 2000. But her plastic surgeon injected fat from her abdomen into an artery in her head, permanently blinding her right eye.
Conner sued and eventually settled for what she says was a small sum. As part of that legal agreement, she promised not to turn the doctor in to state authorities. "It's a horrible thing when somebody does something so terrible to you, and then you have to cover for them for the rest of your life," she said.
For decades, negligent doctors and other professionals in California have deterred their victims from reporting them to state regulators by making silence a condition of settling lawsuits. Regulators, consumer advocates and lawmakers say these legally dubious gag clauses are among the most troublesome gaps in California's consumer protection efforts.
They are pressing to ban the stipulations, even though Gov. Arnold Schwarzenegger refused to do so last year. The governor vetoed legislation that had passed with bipartisan support, saying that eliminating gag clauses "does not further the goal of making California more business-friendly."

"The whole practice is just unconscionable, and it deprives executive branch agencies of the information they need to do their job," said Julianne D'Angelo Fellmeth, the state-appointed independent monitor for the Medical Board of California. "I don't understand how the governor didn't see that the first time around."
Conner still will not publicly identify her surgeon even though the medical board in January forced the doctor, Richard M. Escajeda, to surrender his license. Investigators charged that the year after he blinded Conner, Escajeda botched a breast implant surgery in another woman and then failed to anesthetize her properly during a subsequent surgery, causing her to experience the entire painful operation.
There are other reasons besides gag clauses that regulators never learn of lawsuits that could be evidence of professional malfeasance. Court officials and hospitals, for instance, are required by law to report criminal convictions, disciplinary actions and civil judgments against doctors, but Fellmeth's evaluation of the medical board last fall found that many do not.
The problems are not limited to the medical profession. Under state law, attorneys and automobile makers are banned from trying to stop former clients from complaining to regulators, but there are no similar prohibitions for 230 other types of licensed professionals in California.
Democratic lawmakers have resurrected last year's proposal as AB 446, sponsored by the chairwomen of the two legislative panels that oversee the state's professional regulators, Assemblywoman Gloria Negrete McCloud (D-Chino) and Sen. Liz Figueroa (D-Fremont). An Assembly hearing is set for today.
The measure would still allow secret settlements in which plaintiffs promise not to reveal the nature of the case's resolution, including the amount of money paid out. But 2.3 million California professionals -- including accountants, architects and embalmers, as well as healthcare professionals such as doctors, psychologists and nurses -- would face discipline from California's regulatory boards if they were to insert gag clauses that dissuaded plaintiffs from making complaints to authorities.
"Gag clauses in malpractice settlements present unnecessary roadblocks which impede the medical board's investigators from their sworn duty to protect the public," the board president, Mitchell Karlan, said through a spokeswoman. State regulatory boards for 10 other professions endorsed last year's effort to outlaw the provisos.
The strongest opposition has come from builders, engineers and small contractors. They fought last year's proposal and are preparing another campaign to block this year's version.
Richard Markuson, deputy executive director of Consulting Engineers and Land Surveyors of California, a Sacramento-based association, said professionals already are required to report to regulators any large civil lawsuit settlements.
"This would eliminate some of the finality that a settlement could bring to parties in a dispute," Markuson said.
Schwarzenegger agreed, writing in his veto message that "even after the resolution of a civil suit, this bill could still require a licensee to [undergo] a second adjudication before a regulatory body."

It is far from clear that the gag clauses are enforceable. The attorney general's office last year told lawmakers that it believed such clauses cannot be imposed, citing several judicial rulings.
One was a 2000 appeals court ruling that voided a settlement that prohibited customers of a securities agent from reporting misconduct. The court ruled that the inclusion of the confidentiality clause was "not only directly connected to [the agent's] misconduct, but is an instance of misconduct in itself."

Still, advocates and plaintiffs say the pressure to consent to gag clauses often is intense.
  • http://articles.latimes.com/2005/apr/19/local/me-gagorders19

Saturday, April 30, 2016

Public Citizen sues FDA for information on Advisory Panel participants




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Advisory committees furnish expert advice to federal government agencies. The FDA has approximately 50 advisory committees and panels that the agency advice on issues related to FDA-regulated products, such as whether the FDA should approve new medical products, request additional studies, or change a product’s labeling. The FDA posts on its website a roster of the members serving on each advisory committee, frequently accompanied by members’ curricula vitae (CV). The FDA frequently redacts the CVs, however, by blacking out information about the dates of degrees conferred, the names of professional colleagues and mentors, the amounts of grants received from private companies, and the names of unpublished articles. Many of the redactions were unaccompanied by any indication of why, but many were marked to indicate that the FDA believed that the redacted information fell under the Freedom of Information Act (FOIA) exemptions for confidential commercial information and for material the disclosure of which would cause an unwarranted invasion of privacy.

CVs are compiled by individuals specifically for the purpose of sharing information about the individuals’ background. Believing that the redactions based on the FDA’s determination that the information is “confidential” or “private” are thus unjustified under FOIA, and that the information redacted would help the public better to assess the backgrounds, qualifications, and potential biases of advisory committee members, Public Citizen submitted a FOIA request to the FDA in May 2014, in which Public Citizen requested “unredacted” copies of the CVs. As of April 2016, only three of the FDA’s six divisions had responded to the request, and all but one continued to redact information from the CVs.

Public Citizen sued the FDA under FOIA seeking an order compelling the FDA to respond fully to its request, without the redactions that appear to be wholly unjustified. In addition, because FOIA requires agencies to post frequently requested records online and the FDA’s website concedes that advisory committee member CVs are frequently requested, the suit seeks an order requiring the FDA to post unredacted copies of the CVs on its website going forward.