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Ethicon 5/25
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Washington, California Sue Johnson & Johnson Over Vaginal Mesh Implants
May 24, 2016 | AP (In The Wall Street Journal)
By Gene Johnson
Washington state and California sued Johnson & Johnson on Tuesday, saying that for years the company misrepresented the risks of vaginal mesh implants it sold to repair pelvic collapse. -
California sues Johnson & Johnson over marketing for pelvic mesh
May 24, 2016 | Reuters
By Jessica Dye
California has accused Johnson & Johnson of failing to warn doctors and patients about the severity and frequency of complications associated with its pelvic mesh devices. -
Calif., Wash. Hit J&J With State Lawsuits Over Pelvic Mesh
May 24, 2016 | Law360
By Steven Trader
California and Washington state have both sued Johnson & Johnson for false advertising and deceptive marketing of a surgical mesh product for women, saying the company failed to inform both patients and doctors of severe potential complications, according to statements by the states’ attorneys general on Tuesday. -
*Latest News* AG Lawsuits says J&J Deceptively Marketed Pelvic Mesh in Washington, California!
May 24, 2016 | Mesh Medical Device News Desk
She was just one person who was mesh-injured. “Susan” cannot be named because she is involved in litigation, but in 2012 she filed a complaint with her home state of Washington, specifically the State Attorney General’s Consumer Protection Division. -
Johnson & Johnson hid risks of pelvic mesh, suit alleges
May 24, 2016 | Consumer Affairs
By James R. Hood
A lawsuit by the State of Washington accuses Johnson & Johnson of knowingly hiding the risks of surgical mesh used to treat pelvic floor conditions in women. -
California AG sues Johnson & Johnson over pelvic mesh implants
May 25, 2016 | CBS 8
California Attorney General Kamala Harris filed a lawsuit in San Diego Superior Court Tuesday against Johnson & Johnson, alleging false advertising and deceptive marketing of its surgical mesh products for women. -
Exposing the underbelly of mass torts litigation
May 24, 2016 | Reuters
By Alison Frankel
...Look at the litigation over pelvic mesh, the biggest case – in terms of the raw number of plaintiffs – since asbestos -
FDA approved high-risk women's health devices without proper data: Study
May 23, 2016 | Fierce Medical Devices
By Emily Wasserman
Some high-risk women's health devices were approved without proper data, according to a recent study. The findings point to a need for increased oversight from the agency, researchers said. -
Endo strikes back at medical funders in vaginal mesh cases: Reuters
May 23, 2016 | Fierce Medical Devices
By Emily Wasserman
Endo ($ENDP) has agreed to shell out billions to settle most of the cases claiming injuries from its vaginal mesh devices. But don't expect the company to pay inflated damages for women who were encouraged to pursue unnecessary removal surgeries, it said. -
Five hurdles to overcome when planning a medical device trial
May 23, 2016 | Mass Device
By John Lehmann
The planning stage is critical to the success of any clinical trial. It sets expectations for how your team will work together to collect data, monitor results, protect human subjects and much more.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Washington, California Sue Johnson & Johnson Over Vaginal Mesh Implants
May 24, 2016 | AP (In The Wall Street Journal)
By Gene Johnson
Washington state and California sued Johnson & Johnson on Tuesday, saying that for years the company misrepresented the risks of vaginal mesh implants it sold to repair pelvic collapse.
In the latest legal actions over the problem-prone devices, Attorneys General Bob Ferguson of Washington and Kamala Harris of California accused the New Jersey-based health care giant of neglecting to tell patients and doctors about the risks and occurrences of dire, sometimes irreversible complications. Those include urinary dysfunction, loss of sexual function, constipation and severe pain.
“For many victims, their health and their quality of life were forever changed as a result of this deception,” Mr. Ferguson told a news conference. “Sitting upright, lying on their side, walking all became incredibly painful. ... These women were robbed of their ability to live and work in the way they once did.”
Patients have already filed tens of thousands of lawsuits against mesh manufacturers, including New Jersey-based Johnson & Johnson, Massachusetts-based Boston Scientific and Ireland-based Endo International. In 2014, Endo said it would pay $830 million to settle more than 20,000 personal injury lawsuits. Johnson & Johnson faces more than 35,000 lawsuits, Ms. Harris said.
The plastic mesh is used to treat pelvic organ prolapse, a condition that involves organs such as the bladder, bowel and uterus shifting, often after childbirth, a hysterectomy or menopause. In response to thousands of injuries from the mesh, the U.S. Food and Drug Administration early this year re-labeled the products high risk instead of moderate and announced new federal scrutiny for them. The agency had already concluded that women getting vaginal mesh have more complications than women who undergo traditional surgery with stitches.
In an emailed statement, Johnson & Johnson subsidiary Ethicon Inc., which marketed the mesh, called the lawsuits unjustified.
“The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” the company said. “The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research.
“Ethicon is concerned that the attorneys general’s decision to file its lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence.”
California and Washington led a group of 46 states and the District of Columbia in investigating the company’s practices. California’s lawsuit alleges false advertising and deceptive marketing. In a news release, Ms. Harris noted that Johnson & Johnson sold nearly 790,000 of the devices nationwide from 2008 to 2014, including more than 42,000 in California.
Washington’s lawsuit alleges tens of thousands of violations of the state’s consumer protection law and seeks penalties that could reach well into the millions of dollars. Mr. Ferguson said Johnson & Johnson sold 12,000 of the devices in Washington but never told patients the mesh can cause chronic inflammation as their body rejects the foreign material; that the mesh harbors infections that can live indefinitely in its small weave; or that the mesh frequently protrudes into an organ or through the vaginal wall, in a condition called “erosion.”
http://www.wsj.com/articles/washington-california-sue-johnson-johnson-over-vaginal-mesh-implants-1464135609?mg=id-wsj
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California sues Johnson & Johnson over marketing for pelvic mesh
May 24, 2016 | Reuters
By Jessica Dye
California has accused Johnson & Johnson of failing to warn doctors and patients about the severity and frequency of complications associated with its pelvic mesh devices.
According to the lawsuit filed by the state's attorney general on Tuesday, J&J and its Ethicon unit falsely marketed the devices as a safe and superior option to non-mesh treatments for pelvic floor disorders, when it was aware that they could cause pain, bleeding, loss of sexual function and other side effects.
"Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products," California Attorney General Kamala Harris said in a statement. Her office led a multi-state investigation into J&J's mesh products, which included 46 states and the District of Columbia.
The lawsuit seeks monetary penalties and an order halting any unfair advertising for mesh.
J&J said in a statement that the lawsuit was "unjustified" and could discourage women from seeking treatment for incontinence symptoms.
"The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products," said spokeswoman Samantha Lucas.
J&J is one of several manufacturers that sold the devices to treat conditions like stress urinary incontinence and pelvic organ prolapse in women. Those companies are facing tens of thousands of individual lawsuits from plaintiffs who said they were injured by the mesh's poor design and substandard materials, which plaintiffs say led to serious complications that require surgery to repair.
According to California's attorney general, J&J sold more than 787,000 pelvic mesh devices in the United States from 2008 until 2014, including more than 42,000 in California.
Also on Tuesday, Washington state's attorney general, Bob Ferguson, filed a similar consumer-protection lawsuit against J&J over its marketing of pelvic mesh devices.
Over the past several years, the devices have come under increasing scrutiny by regulators as well as private litigants. The U.S. Food and Drug Administration says it has received thousands of reports of complications in connection with mesh used to treat pelvic organ prolapse.
Earlier this year, the Food and Drug Administration said it was reclassifying mesh used to treat pelvic organ prolapse transvaginally from class II, or moderate risk, to class III, for high-risk devices, which will require manufacturers to submit extensive data to establish the devices' safety.
http://www.reuters.com/article/us-johnson-johnson-mesh-lawsuit-idUSKCN0YF2LC
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Calif., Wash. Hit J&J With State Lawsuits Over Pelvic Mesh
May 24, 2016 | Law360
By Steven Trader
California and Washington state have both sued Johnson & Johnson for false advertising and deceptive marketing of a surgical mesh product for women, saying the company failed to inform both patients and doctors of severe potential complications, according to statements by the states’ attorneys general on Tuesday.
Attorneys general Bob Ferguson of Washington and Kamala D. Harris of California say Johnson & Johnson knowingly concealed the risks associated with their product, which is designed to treat common conditions in women such as stress urinary incontinence and pelvic organ prolapse but can lead to serious complications including loss of sexual function, chronic pain and infection, permanent urinary or defecatory dysfunction and a “devastating impact on overall quality of life.”
The states launched complaints against J&J and its subsidiary Ethicon Inc. in California and Washington state courts, with California alleging violations of the state’s unfair competition and false advertising laws and Washington alleging “tens of thousands of violations” of the state’s consumer protection laws.
Both states are seeking injunctive relief and monetary penalties potentially in the millions of dollars “to ensure that J&J stops its deceptive practices,” as Harris wrote.
“Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products,” Harris said in a statement. “Johnson & Johnson’s deception denied women the ability to make informed decisions about their health and well-being.”
These complications can crop up years after the surgery and are in many cases irreversible, as removal of the mesh is nearly impossible, Ferguson said in a statement Tuesday.
“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.”
The company said in the statement both lawsuits were unjustified, and a spokeswoman told Law360 J&J plans to “vigorously defend itself against the allegations.”
“The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” the statement said. “The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research.”
The states’ lawsuits were only the latest in a string of litigation J&J has faced over its pelvic mesh.
In late March, a New Jersey appeals court upheld a $11.1 million jury award to a woman who claimed Ethicon’s pelvic mesh caused debilitating nerve pain, saying ample evidence presented at trial showed that better warnings of the product’s risks might have prevented her injuries.
A month earlier, a Philadelphia jury returned a $13.5 million verdict against J&J and Ethicon in a separate case brought by a woman who claimed the company’s faulty mesh implant produced near constant pain, discomfort and an inability to have sex. J&J has appealed.
Both state attorneys general said Tuesday that besides false advertising and deceptive marketing, J&J also misrepresented the severity and frequency of common complications and failed to disclose that its surgical mesh devices “presented risks not present in alternative treatment options.”
Harris said that J&J had sold more than 42,000 mesh devices in the state between 2008 and 2014, and that the company faces over 35,000 personal injury lawsuits nationwide.
Ferguson said J&J had sold 12,000 mesh products in his state during about that same time and said he would seek to impose the maximum $2,000 penalty for each violation of the state’s consumer protection laws.
California is represented by Kamala D. Harris, Judith A. Fiorentini, Jinsook Ohta, Sanna Singer and Michelle Burkart of the state Attorney General’s Office.
Washington is represented by Robert W. Ferguson, Elizabeth J. Erwin, Andrea M. Alegrett and Leilani N. Fisher of the state Attorney General’s Office.
Counsel information for J&J wasn’t immediately available.
The cases are California v. Johnson & Johnson et al., in the Superior Court of the State of California, County of San Diego, and Washington v. Johnson & Johnson et al., in the King County Superior Court in the State of Washington.http://www.law360.com/articles/799926/calif-wash-hit-j-j-with-state-lawsuits-over-pelvic-mesh
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*Latest News* AG Lawsuits says J&J Deceptively Marketed Pelvic Mesh in Washington, California!
May 24, 2016 | Mesh Medical Device News Desk
She was just one person who was mesh-injured. “Susan” cannot be named because she is involved in
litigation, but in 2012 she filed a complaint with her home state of Washington, specifically the State Attorney General’s Consumer Protection Division.Susan told the office about her mesh injuries, about how there was no warning about the dangers of mesh, no informed consent and about how thousands of women were also duped into believing a “minimally invasive” procedure could cause a lifetime of pain.
After years of investigation, today Washington State AG Bob Ferguson announced his office is filing a lawsuit against Johnson & Johnson for deceiving the public and the state about the safety of its pelvic
mesh implants, a violation of the state’s Consumer Protection Act (CPA).The suit asks 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 fines alone could reach tens of millions of dollars, and for the company, the revelations are something J&J tried to keep from the public.
The Washington State AG announced the action today as did the attorney
general for California Kamala Harris, also alleging deceptive trade practices and violations of consumer protections.The allegations are New Jersey-based Johnson & Johnson and its Ethicon division failed to tell patients and doctors about the risks of pelvic mesh implants, made of polypropylene and used to shore up sagging organs or to treat incontinence. As a result, thousands of women were implanted who today suffer in some cases, irreversible complications including pain, repeated infections, nerve damage and an end to their sex lives.
“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.”*Latest News* AG Lawsuits says J&J Deceptively Marketed Pelvic Mesh in Washington, California!
Washington State AG Bob FergusonMesh Medical Device News Desk, May 24, 2016 ~ She was
just one person who was mesh-injured.“Susan” cannot be named because she is involved in
litigation, but in 2012 she filed a complaint with her
home state of Washington, specifically the State Attorney General’s Consumer Protection Division.Susan told the office about her mesh injuries, about how there was no warning about the dangers of mesh, no informed consent and about how thousands of women were also duped into believing a “minimally invasive” procedure could cause a lifetime of pain.
After years of investigation, today Washington State AG Bob Ferguson announced his office is filing a lawsuit against Johnson & Johnson for deceiving the public and the state about the safety of its pelvic
mesh implants, a violation of the state’s Consumer Protection Act (CPA).The suit asks 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 fines alone could reach tens of millions of dollars, and for the company, the revelations are something J&J tried to keep from the public.
Kamala Harris AG California
The Washington State AG announced the action today as did the attorney
general for California Kamala Harris, also alleging deceptive trade practices and violations of consumer protections.The allegations are New Jersey-based Johnson & Johnson and its Ethicon division failed to tell patients and doctors about the risks of pelvic mesh implants, made of polypropylene and used to shore up sagging organs or to treat incontinence. As a result, thousands of women were implanted who today suffer in some cases, irreversible complications including pain, repeated infections, nerve damage and an end to their sex lives.
“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.”
Washington State estimates 12,000 women there were implanted with J&J pelvic mesh. California believes there are 42,000 Ethicon mesh-implanted women there while J&J sold nearly 790,000 of its mesh implants from 2008 to 2014.
California and Washington led a group of 46 states and the District of Columbia in investigating the company’s practices. There is no word tonight whether other states also plan to file consumer protection violation lawsuits against J&J.
In a statement to Associated Press, J&J denies it did anything wrong and calls the lawsuits unjustified.
“The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” the company said. “The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research.
“Ethicon is concerned that the Attorneys General’s decision to file its lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence.”
However, the mesh to treat stress urinary incontinence has already been found to be defective in several jury trials around the country and is falling out of favor with some doctors.
There are in excess of 120,000 defective product lawsuits naming pelvic mesh made by seven manufacturers, filed by injured women in courts around the U.S.
Johnson & Johnson is facing about 45,000 lawsuits, more than another other defendant. Additionally, the company is facing similar defective product actions filed overseas including Scotland, Canada, Israel, Australia, among other countries.
Mesh used to treat pelvic organ prolapse or POP, has been quietly removed from the market by J&J. The FDA announced this year it will require testing for safety and efficacy before POP mesh can be marketed. Mesh for SUI remains on the market and is still referred to as “The Gold Standard” by medical societies, many of which are led by doctors who have financial arrangements with mesh manufacturers.
J&J introduced the TVT (transvaginal tape) in the U.S. in 1998, followed by the TVT-O (obturator), TVT-Secur, TVT Exact, TVT Abbrevo, Prolift, Prolift M+, Prisima and Artisyn. None of the mesh underwent clinical trials but that did not stop the company from proclaiming it was safe and effective.
Susan tells MND, “Maybe it will inspire others to file complaints with their Attorney General’s Offices. It took courage to make the call. I did not want to discuss my vagina or my leaky bladder with anyone, let alone a strange man. I was so angry when I discovered that the mesh could not be seen with MRI, x-ray or any other technology that my rage overtook my shame. My rage gave me the courage to make the call to a Senior Assistant Attorney General. He had not heard of mesh and he didn’t watch TV so was unaware of the mesh adds. I gave him the lowdown. He was about to retire so he did nothing with the information. Lisa Erwin, Assistant Attorney General, replaced him. Lisa Erwin and her Investigator, Mary Beth Haggerty-Shaw took the ball and ran with it. Now, once again, we have a courageous man of integrity (AG Robert Ferguson) who is stepping out to fight Goliath in the pharmaceutical industry. I am crying tears of joy today. “
SPECIFIC ALLEGATIONS
The complaint can be found here. Violations include:The Washington AG complaint states several violations of the Consumer Protection Act including assurances of safety and effectiveness of defendants mesh products even though that had not been validated in clinical trials.Compensating sales reps and doctors to contact hospitals and conduct presentations as well as direct to consumer marketing based on false assurances.Mesh was misrepresented to consumers as “soft and pliable and “a new and revolutionary surgical procedure,” while the company failed to disclose that it could incite foreign body reactions, shrink, fold, create bacterial colonies resistant to antibiotics, degrade, erode and oxidize.The company misrepresented the pelvic mesh for SUI and POP had been “FDA approved” which indicates some oversight. In reality, the FDA does not regulate most medical devices other than to require a predicate device been named that is the “substantial equivalent.”The Defendant did not include the dangers of mesh in its instructions for use (IFU). The risk of dyspareunia (painful sex) was not included until 2015; the risk of infection was included in 2012.
http://www.meshmedicaldevicenewsdesk.com/jj-facing-deceptive-marketing-lawsuits-washington-california/
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Johnson & Johnson hid risks of pelvic mesh, suit alleges
May 24, 2016 | Consumer Affairs
By James R. Hood
A lawsuit by the State of Washington accuses Johnson & Johnson of knowingly hiding the risks of surgical mesh used to treat pelvic floor conditions in women.
Complications from insertion of the mesh left women permanently disabled and in chronic pain, the lawsuit filed by Washington Attorney General Bob Ferguson charges.
“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 complications include urinary and defecatory dysfunction, loss of sexual function, chronic inflammation, chronic pain, and risk of chronic infection. The complications can crop up years after the surgery, and are in many cases irreversible, Ferguson said. Removal of the mesh is nearly impossible.
One patient quoted in the lawsuit described her experience this way:
“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.” Tens of thousands
The lawsuit alleges tens of thousands of violations of the Washington Consumer Protection Act, due to deceptive informational and marketing materials distributed to consumers and doctors. Ferguson is seeking a fine of $2,000 for each violation plus costs, fees, and restitution.
Johnson & Johnson is the largest manufacturer and seller of the mesh devices in the U.S. 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 lawsuit alleges that 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.https://www.consumeraffairs.com/news/johnson-johnson-hid-risks-of-pelvic-mesh-suit-alleges-052416.html
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California AG sues Johnson & Johnson over pelvic mesh implants
May 25, 2016 | CBS 8
California Attorney General Kamala Harris filed a lawsuit in San Diego Superior Court Tuesday against Johnson & Johnson, alleging false advertising and deceptive marketing of its surgical mesh products for women.
The complaint alleges that Johnson & Johnson neglected to inform both patients and doctors of possible severe complications and misrepresented the frequency and severity of risks.
California co-led a multi-state investigation, involving 46 states and the District of Columbia, into Johnson & Johnson's surgical mesh products for women, and is seeking injunctive relief and monetary penalties.
Johnson & Johnson, based in New Jersey, did not immediately respond to a request for comment.
Harris, who is running for a U.S. Senate seat, alleged that "Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products."
"Johnson & Johnson's deception denied women the ability to make informed decisions about their health and well-being," Harris alleged. "My office will continue to hold companies accountable for misleading consumer and patients for financial gain."
The surgical mesh device is designed to treat common health conditions in women such as stress urinary incontinence and pelvic organ prolapse. The lawsuit alleges that Johnson & Johnson misrepresented the safety of the devices by concealing the possibility of serious and irreversible complications caused by mesh, including permanent pain with intercourse and/or loss of sexual function, chronic pain, permanent urinary or defecatory dysfunction, and a potentially devastating impact on overall quality of life.
The suit further alleges that Johnson & Johnson knew about potential risks and side effects prior to the launch of its mesh products, yet omitted that information from educational and marketing materials provided to doctors and patients.
According to the lawsuit, Johnson & Johnson sold 787,232 devices nationally from 2008 to 2014, including more than 42,000 in California in that time period. Worldwide, more than 2 million women have been implanted with the mesh products, the suit says.
In addition to the lawsuit filed today, Johnson & Johnson faces more than 35,000 personal injury lawsuits in state and federal court related to the surgical mesh products, Harris said.
http://www.cbs8.com/story/32055777/california-ag-sues-johnson-johnson-over-pelvic-mesh-implants
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Exposing the underbelly of mass torts litigation
May 24, 2016 | Reuters
By Alison Frankel
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 theMithoff 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.
http://blogs.reuters.com/alison-frankel/2016/05/24/exposing-the-underbelly-of-mass-torts-litigation/
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FDA approved high-risk women's health devices without proper data: Study
May 23, 2016 | Fierce Medical Devices
By Emily Wasserman
Some high-risk women's health devices were approved without proper data, according to a recent study. The findings point to a need for increased oversight from the agency, researchers said.
Scientists at Northwestern University looked at 18 high-risk devices approved by the FDA from 2000 to 2015, including those for menstrual flow reduction, contraception and fetal monitoring. Four of the devices were approved even though they did not show efficacy in clinical trials, according to results published recently in the journal Obstetrics and Gynecology.
Six of the devices included in the study were not required to undergo post-market studies to monitor their safety. Three devices were eventually withdrawn from the market, and of those three, two were not reviewed by experts on the FDA's obstetrics and gynecology advisory committee. The other product was reviewed but not recommended for approval by the panel.
"Devices are a huge part of the medical care that we provide women on a daily basis," study first author Dr. Jessica Walter, a resident in Northwestern University's Department of Obstetrics and Gynecology, said in a statement. "We found that there's an opportunity to increase the burden of proof required for a device to be approved for public use."
The team's findings show that the FDA's approval process for women's devices "has a lot of weaknesses," senior author Steve Xu, a resident in dermatology at Northwestern University, said in a statement. Researchers pointed to the example of Bayer's controversial birth control implant, Essure.
The device was approved in 2002, but has since come under scrutiny for causing serious problems in pregnant women. Regulators also got flak for approving the implant with only short-term evidence and insufficient post-market follow-up, study authors said.
The FDA said that it would reevaluate Essure after getting complaints of grave side effects and injuries. In February, the agency slapped the product with a black-box warning.
Fallout from approved devices such as Essure points to a need for more stringent medical device regulation, the team said, even as lawmakers are calling for opposite action.
The 21st Century Cures Act, which passed in the House of Representatives last May, would decrease medical device regulation. If approved by the Senate, the legislation would "broaden the definition of the 'valid scientific evidence' manufacturers need in order to prove medical benefit" for a device, Walters said. This could lead to more device approvals with less clinical safety evidence, she added.
The FDA should seek more advice from its expert advisory committees and use higher quality studies before approving products, the team said. "I think some stakeholders believe that increasing regulation means stifling innovation, and that if we make it harder for these devices to be approved potentially life-changing devices will have a higher barrier to actually getting to market. But that hasn't necessarily been shown in the literature," Walter said.
http://www.fiercemedicaldevices.com/story/fda-approved-high-risk-womens-health-devices-without-proper-data-study/2016-05-23
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Endo strikes back at medical funders in vaginal mesh cases: Reuters
May 23, 2016 | Fierce Medical Devices
By Emily Wasserman
Endo ($ENDP) has agreed to shell out billions to settle most of the cases claiming injuries from its vaginal mesh devices. But don't expect the company to pay inflated damages for women who were encouraged to pursue unnecessary removal surgeries, it said.
The company's American Medical Systems unit (AMS) is striking back at "a pyramid of businessmen, doctors and lawyers" who lured women into procedures to remove the implants and inflate their damages claims, it said in a West Virginia federal court filing seen byReuters. AMS has evidence that at least four patients were pushed into getting surgeries that their own doctors did not recommend--and that funding was arranged by a lending company that worked with physicians.
The lenders, physicians and attorneys were "orchestrating the exploitation of unsophisticated medical and legal consumers and seeking to perpetuate a fraud," AMS said in its May 12 filing. Hundreds of other women may have also been coerced into the procedures, and the company should not have to pay for the surgeries, it said.
Now, AMS--which has stopped selling its implants--is trying to get court authorization to obtain more testimony from members of the alleged network,Reuters reports. A spokeswoman for Endo declined to comment to the news outlet.
The network is not owning up to any wrongdoing. Law Firm Headquarters, a Florida-based marketing company, told the news outlet that it acted in the best interests of patients who couldn't afford or access medical care.
AMS claims that Law Firm Headquarters perpetuated an "illicit enterprise" by pushing patients toward an intermediary, which then connected women with physicians who profited off removal surgeries.
But Law Firm Headquarters said that AMS is just avoiding its own liability by pointing fingers. The company's "tactics will only delay resolution of these cases, to the further detriment of those who have been injured," Abbe Lowell, an attorney for Law Firm Headquarters, told Reuters.
Endo is trying to lay its vaginal mesh saga to rest. In October 2014, the company said it would add $400 million to its $1.2 billion liability reserve to resolve "substantially all" suits over implants sold by AMS. The company will fund the payments through 2017, settling more than 10,000 suits for an average of $48,000 apiece.
"These settlements will allow us to continue to invest in the growth of our business segments and pursue accretive M&A opportunities. We believe these settlements will also allow the AMS business to continue its return to growth and enhance focus on the operations and profitability of this leading medical device franchise," Endo CEO Rajiv De Silva said at the time.
Last year, Endo said that it had "compromised and settled all claims" in about 360 cases in 12 joint motions to dismiss in a West Virginia federal court. The settlement included 30 cases with claims against other vaginal mesh makers such as Boston Scientific ($BSX) and C.R. Bard ($BCR).
http://www.fiercemedicaldevices.com/story/endo-strikes-back-medical-funders-vaginal-mesh-cases-reuters/2016-05-23
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Five hurdles to overcome when planning a medical device trial
May 23, 2016 | Mass Device
By John Lehmann
The planning stage is critical to the success of any clinical trial. It sets expectations for how your team will work together to collect data, monitor results, protect human subjects and much more.
The inherent complexity of a medical device trial and the fact that it requires surgical implantation makes it especially critical to get these foundational elements right from the start. If a problem occurs, a second surgery may be necessary.
Recent high-profile recalls have spawned class-action lawsuits due to complications that occurred from a follow-up surgery, forcing the FDA to take action. In recent years, for instance, concerns over the surgical mesh required to repair pelvic organ prolapse transvaginally have prompted the FDA to strengthen the requirements mesh manufacturers must meet to demonstrate safety and effectiveness.
Most clinical professionals beginning a medical device trial are keenly aware of these issues, adding to the hurdles they must overcome before the trial even begins. Failing to clear these hurdles can slow momentum, delay approval or even compromise the integrity of the study if they aren’t addressed.
This infographic illustrates five of the most common hurdles medical device researchers are likely to face when planning a clinical trial and how to overcome them.
Researchers will inevitably encounter some of these challenges, but they don’t have to derail the study. A complex medical device trial simply requires them to take additional precautions when it comes to training their staff, reviewing data and monitoring the study. It requires vigilance to the smallest details, as there is no margin of error. Something as simple as using an outdated consent form can lead to an FDA warning letter.
That’s why device makers must do their due diligence to carefully assess anyone who touches the trial, ensure they are properly trained and create a system of checks and balances. A more in-depth look at FDA documentation protocols can be found in this whitepaper, Documentation in Device Studies.
The number of moving parts that make up a clinical trial, particularly one for medical devices, can be overwhelming—so much so that they can stall a trial before it even begins.
This infographic explores five of the most common hurdles clinical researchers are likely to face when planning a trial and how to overcome them.
http://www.massdevice.com/five-hurdles-overcome-planning-medical-device-trial/
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