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. All clinical trials must report all data.
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Twitter: @JjrkCh

Wednesday, September 27, 2017

Get an Unsafe, Ineffective Medical Implant & Lose Your Civil Rights!

September 26, 2017 Press Release
WASHINGTON, DC (September 26, 2017) Congresswoman Rosa DeLauro (CT-03) released the following statement urging Congress to pass the Medical Device Safety Act, which would enhance legal protection for victims of unsafe medical devices. Currently, high risk device manufacturers are protected from being held liable at the state and local levels if their device has received premarket approval from the Food and Drug Administration (FDA).
”One of our government’s most important duties is to keep our people safe from harm, whether it is the food we eat, the medications we take, or the medical devices we use,” said DeLauro. “Too often, that basic mission is going unfulfilled at the FDA. Failure at the FDA has awful consequences, as faulty medical devices have tragically injured, or even killed, thousands of Americans across the country.

“Instead of serving as a steward for public safety, the FDA has put its stamp of approval on these potentially unsafe devices, with manufacturers’ bearing no legal risk when things go wrong,” continued DeLauro. “Even after the FDA knows that these devices put people at risk, it simply will not take them off the market. That is why Congress must immediately pass the Medical Device Safety Act, to arm American families with the necessary tools to hold these companies accountable once and for all. I will not let up in the fight—alongside my colleagues and consumer advocates—to get this life-saving legislation signed into law.”
“The health of thousands of women has been negatively affected by FDA’s lack of proper oversight, specifically with Essure,” said Amanda Rusmisell, Legislative Liaison for the Essure Problems Group. “This product not only impacts women’s quality of life, it also puts an enormous financial strain on them and their families. Despite FDA’s Black Box Warning on Essure and our pleas to take this product off the market, women are still in the dark about its potential dangers— such as hysterectomies, autoimmune diseases, additional surgeries, and life-threatening health effects. That is why the Medical Device Safety Act is so crucial. Women deserve to know about the dangers of this product, and if they are impacted by Essure, they must be able to take action.”

DeLauro is a senior member on the subcommittee responsible for funding the U.S. Food and Drug Administration.

2413 Rayburn House Office Building
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Saturday, September 23, 2017

Definition of a Guinea Pig: Ask the FDA!

FDA fails to enforce requirements
  • by Larry Husten, CardioBrief September 20, 2017 

Pharmaceutical and device companies are often taking advantage of a lenient (or, some would say, negligent) FDA to shirk their obligation to perform timely post-approval studies, a new Perspective published in the New England Journal of Medicine shows.
The topic has gained increasing  visibility and importance as the FDA has granted approval to many new drugs and devices without all the evidence that might ideally be required.For safety as well as efficacy, the FDA has allowed much of the burden of proof to shift from pre-approval to the post-approval period.

But in an analysis of 614 post-approval requirements and commitments imposed by the FDA in 2009 and 2010 (the first full years after the FDA gained the power to require these studies), Steven Woloshin at Dartmouth Institute for Health Policy and Clinical Practice and colleagues showed that only 54% of these studies were completed after 5-6 years. They found that 20% of "required" studies had not been started and 25% were delayed or ongoing as of September 2015.
"It's not a secret that we need a better post-market system," said former FDA Commissioner Robert Califf, now at Duke University. "The good news is that technology is no longer the limiting factor -- it's all about culture, organization and priority setting by policy makers, clinicians and patients and their 'carers' (families and loved ones)."
The authors observed that in many cases there didn't appear to be any good reason for the delays. For instance, more than 5 years after approval of buprenorphine/naloxone film (Suboxone), no protocol had been submitted for assessing the risk of QT-interval prolongation, "even though the design of such studies is highly standardized and participants are observed for a limited period."
"The slow, irregular pace of post-approval studies contrasts starkly with the short, rigid deadlines and other shortcuts used to speed marketing approval," the authors wrote.

The FDA should "do more to ensure that sponsors meet post-approval deadlines," the authors urged. Although the FDA has the power to impose fines or other penalties on companies that fail to live up to their obligations, "to our knowledge, it has never imposed such fines." They also recommend that the FDA set shorter deadlines for post-approval studies.

"Woloshin and colleagues offer some useful insights into the FDA's use of post-approval studies to confirm and further evaluate drugs' safety and efficacy at the time of approval," said Joe Ross of Yale University. "While more than half were completed, many were not. This study is only made possible by the efforts at FDA to provide public transparency of the post-approval requirements, but more information could help the public and the profession understand why certain requirements were not fulfilled, whether these studies were intended to provide key clinical information to inform practice (as opposed to safety info that instead came from another clinical study), and even for those studies that were completed, whether the results were published and made available."
Sanjay Kaul of Cedars-Sinai Medical Center said that it is not unreasonable to shift "the regulatory burden from the pre-approval phase to a life cycle-based approach. However, the success of such an approach is predicated on a rigorous and timely post-approval phase. That 1 in 5 post approval studies had not even been started after 5 to 6 years calls into question the degree to which the changes in the FDA's regulatory authority in 2007 have resolved the challenge of reducing the number of unfulfilled post-approval requirements. This can hardly be reassuring given the 21st Century Cures Act which calls for faster marketing of drugs and devices at the cost of stringent evidentiary standards! Even though the FDA has congress-legislated authority to revoke approval of drugs and devices that failed to confirm clinical benefit on post approval studies, it rarely does so! It is difficult to put the genie back into the bottle."

The "bottom line," said Kaul, is that "marketing drugs and devices faster can only be justified if there are much better post-market data to reliably support efficacy and safety."

Friday, September 22, 2017

J&J ASR Hip Defense Verdict is Overturned in Chicago

Amanda Bronstad, The National Law Journal
September 21, 2017  
A Chicago judge has granted a new trial in one of the only verdicts involving DePuy Orthopaedics Inc.’s ASR XL hip implants.
Tuesday’s ruling by Cook County Circuit Court Judge Deborah Mary Dooling reversed a 2013 defense verdict that came out just before DePuy reached a $2.5 billion global settlement resolving about 8,000 cases. The judge found that a key scientific expert for plaintiff Carol Strum should have been allowed to testify at the trial about the wear on the hip implants. The lawsuits claimed the devices caused pain, grinding or clicking in the hips and high metal content in blood tests.
“He was going to provide objective proof of the amount of metal loss on the device versus the amount that should be lost,” Strum’s lawyer, Peter Flowers, said of the expert, Dr. David Langston. “The lack of objective proof of that certainly played a large role in the ultimate outcome.”
On Thursday, Dooling told both sides to return next week with possible trial dates.

“We believe the verdict arrived at by the jury in 2013 was consistent with the facts in this case,” wrote Stela Meirelles, a spokeswoman for DePuy, which is a subsidiary of New Jersey’s Johnson & Johnson. “DePuy’s actions concerning the product were appropriate and responsible."
The ruling is a big win for the plaintiffs bar, whose scientific evidence and experts at several mass tort trials have been criticized as “junk science.” It has come up in litigation involving Johnson & Johnson’s baby powder, acne drug Accutane and cholesterol drug Lipitor
In her ruling, Dooling relied on a scientific evidentiary test established in Illinois called the Frye standard, named for the U.S. Court of Appeals for the District of Columbia Circuit’s 1923 holding in Frye v. United States. Under the standard, evidence can be admitted that is “generally accepted” in the scientific community. Dooling concluded that her original definition of that field was “too restrictive” and that Langton’s methodologies were generally recognized, even by scientists at the U.S. Food and Drug Administration.
“Surely the FDA, the agency responsible for ensuring safety for patients who have medical devices implanted, would not request a device manufacturer to perform testing that was not generally accepted in the scientific community,” she wrote. 
Strum had the device implanted in 2008 due to arthritis in her left hip. Two years later, DePuy recalled the ASR. After suffering pain, Strum had another surgery in 2011 to replace the implant.
Her case wasn’t the first to go to trial over the ASR hip implant. Months earlier, a jury in Los Angeles awarded $8.3 million to Loren Kransky after finding the ASR was defectively designed. But many lawyers considered that case, which was bumped up for trial due to Kransky’s poor health, to be an outlier. DePuy reached its global settlement before the first bellwether trial in the federal cases began.
But thousands of plaintiffs have been excluded from the deal, which limited payouts to those who had revision surgeries as of Aug. 31, 2013.
As of Sept. 15, there were more than 1,600 cases still pending over ASR hip implants in the federal multidistrict litigation in Ohio, according to the U.S. Judicial Panel on Multidistrict Litigation. Flowers, of Chicago’s Meyers &  Flowers, said dozens of ASR lawsuits remain in Illinois, including Strum’s case, which was excluded from the settlement because it went to trial.
That doesn’t mean it couldn’t settle, rather than go to trial.
“It very well could,” Flowers said. “That remains to be seen.”

Contact Amanda Bronstad at

Thursday, September 21, 2017

J&J Mandamus Writ and the Strange Ruling that Resulted!

Regulatory Capture and Patient Safety Failures

September 20, 2017 7.09am EDT

Disclosure statement
Thomas Joyce has received funding from EPSRC, the FDA and the BOA for his work on metal-on-metal hips. Thomas Joyce does medico-legal consultancy regarding metal-on-hip implants. All income goes to Newcastle University.
Newcastle University provides funding as a member of The Conversation UK.

Thousands of women across the world have been left in terrible pain after being implanted with transvaginal mesh – a device to treat urinary incontinence or prolapse. How did a medical implant that has caused so much damage to these women’s bodies and lives come to be sold?
Most people probably have a good idea of how drugs are tested and approved – through clinical trials and placebos – but they probably don’t know how medical implants make it onto the market. If a headache pill that works for four hours has undergone clinical trials, what about an artificial hip that has to last for 40 years inside you?
The truth is, that for most medical implants, no clinical trials are undertaken. Instead, most medical implants are approved on the basis of “substantial equivalence”. In other words, if your new implant is substantially equivalent to an implant already on the market, then it likely gets approved.
Clearly someone has to decide how close one implant is to another. And in my experience, they can be quite different from each other and still get approved. Indeed, when independently reviewed in the US, the substantial equivalence process was said to give no evidence that “the cleared device was safe or effective”.
Three recent scandals
Many implant makers highlight the regulatory “burden” required to bring a new implant to market. However, despite these regulations, there have been three recent scandals involving medical implants: metal-on-metal hips, breast implants and mesh implants. Arguably, this shows that medical implant regulation isn’t working. At the very least, these scandals have left hundreds of thousands of people worrying about the long-term effects of defective implants in their bodies.

Many thousands of people have been left in pain, perhaps unable to work. Others have seen relationships break down and feel that their lives have been ruined.
There are many heartbreaking stories from patients who were told their lives would be changed for the better, not worse, and it seems reasonable to ask how this situation came about so that it can be prevented in future.
Why do we have these scandals?
I think there are three main factors. First, despite some companies’ claims of a primary responsibility to their patients, most companies exist to make a profit, which means bringing implants to market quickly and selling as many as possible. Why spend money on a long, expensive clinical trial when regulations say you don’t have to?
The second factor is the regulators themselves. These organisations are often guided by their government to work with industry to bring innovative medical implants to market, both to benefit manufacturers (who provide jobs and pay taxes) and patients. If the pull is too much towards industry, this is known asregulatory capture”. This is where a regulator that has been set up to act in the public interest, instead advances the concerns of the sector it is charged with regulating.
It is also interesting to consider the word “innovative”; why do medical implants need to be innovative rather than safer or longer lasting or less expensive? Innovative means that a patent can be obtained, which can then be used to generate income. A safer implant doesn’t appear to carry the same potential financial reward as an innovative implant.
The third factor is a lack of transparency over the approval process. If the implant was approved in the EU, the information is confidential. This makes it very difficult to assess how an implant was tested and what the test results were. So the main judgement on an implant’s performance will come only after implantation – maybe two, five, even ten years down the line. To me, if the implant is deficient, that’s too late. By that time, thousands of people will have been implanted with a substandard device.
How to fix it
Of course, there are ways to make the system work better. For example, there could be phased introduction of new medical implants undertaken at specialist centres where all details of the implants and the procedures are fully tracked. Once the efficacy is shown after a certain amount of time, then the implant could be introduced more widely.
It is also important that regulatory capture is acknowledged. The priority for regulators should be stated as patient safety. If that means regulators stopping medical devices being implanted while patient concerns are investigated, then so be it.
Finally, transparency needs to be improved. We need to know what tests were done on implants and what the results were. With these changes in place, we might make implant scandals a thing of the past, not ongoing news.

Saturday, September 16, 2017

Surgical Mesh: Harm-for-Profit Crimes Against Women

$57.1 Million Verdict Against Johnson and Johnson
$57.1 million was awarded against Johnson & Johnson and Ethicon to Ella Ebaugh, who was implanted with TVT-Secur transvaginal mesh that eroded through her urethra, caused her internal injuries and permanently damaged her urinary system leaving her incontinent. The jury verdict included $7.1 million in compensatory damages and $50 million in punitive damages. The Philadelphia Court of Common Pleas verdict was delivered September 7, 2017, marking the fifth TVM verdict against the mesh manufacturers.
$20 million was awarded to a woman who suffered after multiple surgeries to remove a TVT-Secur mesh implant. On April 28, 2017, the Philadelphia Common Pleas Court jury awarded  $2.5 in compensatory damages and $17.5 million in punitive damages. Plaintiff, Peggy Engleman’s mesh failed within a month of implantation causing pain as the mesh eroded into her tissues leaving shreds of mesh in her body. On May 26, 2017, Sharon Beltz was awarded $2.16 million for injuries caused by Ethicon’s Prolift implanted in 2006. Johnson and Johnson vows to appeal both cases to a higher court.
Transvaginal mesh bellwether trials and settlements are updated as follows:
MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation – Cases are being prepared for trials, dismissals or remands. Total Cases: 38,956 Total Closed: 7718  Past verdicts and settlements include:
  • Mullins, et al. v. Ethicon, Inc., et al., 2:12-cv-02952 (37 TVTs) trial continued
  • Edwards v. Ethicon, Inc., et al., 2:12-cv-09972-  Dismissed
  • Dianne Bellew v. Ethicon, Inc. (Prolift) settled March 6, 2015
  • Carolyn Lewis v. Ethicon, et al. Defense Judgment
  • Huskey v. Ethicon, et al. $3.27 Million Verdict for Plaintiffs
  • Brenda Lehrer v. Ethicon, Inc., et al. (Prolift) Dismissed
MDL No. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation – Settlement announced for all remaining mesh lawsuits in the MDL. Total Cases: 21,127  Total Closed: 17,248
MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation–  Cases are being prepared for trials, dismissals or remands. The court ordered Mandatory Settlement Conferences for unsettled Covidien LP, Sofradim and TSL plaintiffs.  Total Cases: 15,491  Total Closed: 10,452  Past verdicts and settlements include:
  • Wise, et al. v. C. R. Bard, Inc. – Settled
  • Donna Cisson v. Bard, Inc.  – $2 Million Verdict
  • Wanda Queen v. Bard, Inc. 2:11-cv-00012  – Settled
  • Carolyn Jones v. Bard, Inc. 2:11-cv-00114 – Settled
MDL No. 2326 | In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation – Settlements in process with no trials scheduled. Total Cases: 25,029   Total Closed: 15,101   Past verdicts include:
  • Jeanie Blankenship – $4.25 million +  $1 million punitive damages
  • Chris Wilson – $3.75 million +  $1 million punitive damages
  • Carol Campbell – $3.25 million + $1 million  punitive damages
  • Jacquelyn Tyree  – $3.25 million + $1 million punitive damages
  • Juana Betancourt – $6.5 + million
  • Mania Nunez – $6.7 + million; and
  • Margarita Dotres – $6.7 + million;
  • Amal Eghnayem – $6.7 + million
MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation – No trials have been scheduled. The following cases were dismissed: Ailey v. Cook Inc., Watkins v. Cook Inc., et al. Hovey v. Cook Inc., et al.  Total Cases: 629 Total Closed: 123
MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation – . There are no bellwether trials scheduled and the judge is conducting settlement conferences. Total Cases: 2610 Total Closed: 2397
MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation – There are no bellwether trials scheduled. Settlement Program entered 11/2015. Total Cases: 137 Total Closed: 125
Transvaginal Mesh Verdicts 
A chronology of the verdicts, settlements, manufacturers, products, and jurisdictions follows:
  1. 7/12: $5.5 million – Christine Scott – C.R. Bard Avaulta Plus –  CA
  2. 2/13: $11.11 million – Linda Gross – Ethicon/JJ Prolift – NJ
  3. 8/13: $2 million – Donna Cisson – C.R. Bard Avaulta – MDL WV
  4. 2/14: $0 – Carolyn Lewis – Ethicon/JJ TVT-O – MDL WV
  5. 4/14: $1.2 million – Linda Batiste – Ethicon/JJ TVT-O  – TX
  6. 7/14: $0 – Diane Albright – Boston Scientific Pinnacle – MA
  7. 8/14: $0 – Maria Cardenas – Boston Scientific Obtryx – MA
  8. 9/14: $3.27 million – Jo Huskey – Ethicon/JJ TVT-O – MDL WV
  9. 9/14: $73.465 million – Martha Salazar – Boston Scientific Obtryx – TX
  10. 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific Pinnacle – MDL FL
  11. 11/14: $6.7+ million – Margarita Dotres – Boston Scientific Pinnacle – MDL FL
  12. 11/14: $6.7+ million – Mania Nunez – Boston Scientific Pinnacle – MDL FL
  13. 11/14: $6.5+ million – Juana Betancourt – Boston Scientific Pinnacle – MDL FL
  14. 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific Obtryx –  MDL WV
  15. 11/14: $4.75 million – Chris Wilson – Boston Scientific Obtryx – MDL
  16. 11/14: $4.25 million – Carol Campbell – Boston Scientific Obtryx – MDL
  17. 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific Obtryx – MDL
  18. 2/15: Settled – Wise v. Bard in the MDL
  19. 3/15: Settled  – Bellew v. Ethicon (Prolift) in the MDL;
  20. 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle) – CA
  21. 3/15: $5.7 million – Coleen Perry – Ethicon/JJ Abbrevo sling – CA
  22. 5/15: $100 million – Deborah Barda v. Boston Scientific Pinnacle and Advantage Fit – DL
  23. 10/15: $0 – Carol Cavness v. Ethicon/JJ Prosima –  TX
  24. 10/15: $0 – Martha Carlson v. Boston Scientific Uphold – NC
  25. 12/15: $12.5 million – Hammons v. Ethicon/JJ (Prolift) –  PA
  26. 2/16: $0 – Sherrer v. Boston Scientific Solyx and Bard Align – MO
  27. 2/16: $13.5 – Carlino v. Ethicon/JJ (TVT)  – PA
  28. 4/17:  $20.0 million – Engleman v. Ethicon/JJ (TVT Secur) – PA
  29. 5/17: $2.16 million – Betz v. Ethicon/Prolift – PA
  30. 9/17: $57.1 million – Ebaugh v. Ethicon/JJ (TVT-Secur) – PA
TVM Verdicts and Trials
On February 10, 2016, $13.5 million was awarded by a Philadelphia jury in Carlino v. Ethicon. $10 million of that award was for punitive damages. The plaintiff suffered through three TVT sling revision and removal mesh surgeries following her Ethicon/Johnson and Johnson implant. 
This follows a $12.5 million jury verdict in a transvaginal mesh lawsuit against Johnson and Johnson’s Ethicon division on December 22, 2015. A Philadephia jury found that Patricia Hammons suffered injuries from a Prolift pelvic mesh implant, which was removed from the medical device market in 2012. The $12.5 million award included $7 million in punitive damages as the jury heard evidence of Ethicon’s document destruction. 
On February 2, 2016, a Kansas City, Missouri jury awarded nothing to the plaintiff in a Boston Scientific Solyx and C.R. Bard Align case. On October 16th,  2015, the jury awarded nothing to the plaintiff in Martha Carlson v. Boston Scientific in Statesville, North Carolina. On October 5th, 2015, the jury awarded nothing for the plaintiff in Carol Cavness v. Ethicon/ Johnson and Johnson in Dallas, Texas.  
As of August 3rd, 2016, eighteen (18) transvaginal mesh plaintiffs have won trials and the defendants have won six (6). Following the failed status conferences, TVM trials moved forward, resulting in two plaintiffs’ verdicts ranging from $100 Million to $5.7 Million and numerous confidential settlements.  Boston Scientific, Coloplast, AMS and Bard have begun offering settlements. 
A  California jury awarded $5.7 million to Coleen Perry, who was implanted with an Abbrevo sling device. Ms. Perry experienced pain after surgery, but the sling could only be partially surgically removed  because the mesh had grown into the tissues. The jury unanimously awarded $5 million in punitive damages finding Ethicon acted with malice.
Trial began March 2, 2015 in Bellew v. Ethicon in the MDL and settled March 6, 2015 for an undisclosed amount. This case involved removal of a Prolift mesh, a product which had been taken off the medical device market. 
Bard Bellwether Case Settles Before Trial
Wise v. Bard, the bellwether case set for trial February 18, 2015, was settled right before trial for a confidential amount.  On February 12, 2015,  Judge Goodwin appointed Ellen Reisman as Special Master to facilitate settlement negotiations in the Bard MDL. Christine Scott, the first Bard Avaulta Plus plaintiff who endured nine mesh revision surgeries stated, “Thank God, we can finally get the word out to women.”
$26.7 Million and $18.5 Million Verdicts Against Boston Scientific 
$26.7 million and $18.5 million verdicts against Boston Scientific were awarded in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014,  a Charleston, West Virginia jury awarded  $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.
The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include: 
  1. Amal Eghnayem – $6.7 + million;
  2. Margarita Dotres – $6.7 + million;
  3. Mania Nunez – $6.7 + million; and
  4. Juana Betancourt – $6.5 + million
The women in the West Virginia Obtryx sling trial were each awarded between $3.25 million to $4.25 million, plus an additional $1 million each for punitive damages. The Obtryx sling devices are implanted during stress urinary incontinence surgeries and are still on the market. The individual awards for the women in the Obtryx sling trial include: 
  1. Jeanie Blankenship – $4.25 million +  $1 million punitive damages;
  2. Chris Wilson – $3.75 million +  $1 million punitive damages;
  3. Carol Campbell – $3.25 million + $1 million  punitive damages;
  4. Jacquelyn Tyree  – $3.25 million + $1 million punitive damages
Transvaginal Mesh Adverse Events
Click the TVM video link which contains medical legal animation, diagrams and warnings about TVM implants and the transvaginal mesh litigation. Failed Transvaginal Mesh Injury Lawsuit Podcast with Howard L. Nations
Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement. Complications include:
  • erosion through the vaginal tissue
  • mesh contraction
  • mesh extrusion
  • inflammation
  • fistula
  • infection and abscess
  • pain
  • blood loss
  • chronic and acute nerve damage
  • pudendal nerve damage
  • pelvic floor damage
  • scar tissue
  • chronic pelvic pain
  • urinary problems and/or incontinence
  • recurrence of prolapse
  • bowel, bladder, and blood vessel perforation
  • dyspareunia or pain during sexual intercourse
Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications. 
In July 1, 2012, Bard stopped selling the Avaulta Mesh in the United States because the FDA required additional clinical trials and testing.
On June 4, 2012: Johnson and Johnson/Ethicon withdrew four mesh products from the US Market, including its controversial Gynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.
History of Warnings
Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.
Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.
However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that a majority of the transvaginal mesh are based upon this recalled defective device.
On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).
On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.
On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of life over other surgical methods.
On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.
Transvaginal Mesh Products & Manufacturers 
  • Secure
  • Prolift
  • Prolift +M
  • Gynemesh/Gynemesh PS
  • Prosima
  • TVT
  • TVT-Obturator (TVT-O)
  • TVT-Exact
  • TVT-Abbrevo
C. R. Bard
  • Align
  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
  • PelviLace
  • InnerLace
  • Uretex
American Medical Systems 
  • SPARC®
  • Mini-Arc
  • Apogee
  • Elevate
  • Monarc
  • In-Fast
  • BioArc
Boston Scientific
  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Obtryx Transobturator Mid-Urethral Sling System
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System
  • Uphold Vaginal Support System
  • Pinnacle Pelvic Floor Repair Kit
  • Advantage Transvaginal Mid-Urethral Sling System
  • Advantage Fit System
  • Solyx SIS System
  • T-Sling-Universal Polypropylene Sling
  • Aris-Transobturator Sling System
  • Supris-Suprapubic Sling System
  • Novasilk-Synthetic Flat Mesh
  • Suspend-Tutoplast Processed Fascia Lata
  • Exair-Prolapse Repair System
  • Axis-Tutoplast Processed Dermis
  • Restorelle
  • Smartmesh
  • Omnisure
  • Minitape

  • Surgisis

Wednesday, September 13, 2017

Mandamus Denied. The Trial Begins September 18 in Dallas.

Update: September 20, 2017 is the first day of the trial.  September 18 was a pre-trial meeting(lawyers only, no observers) and a questionnaire to potential jurors.

In Re DePuy, 17-10812 (5th Cir. 08/31/2017)

September 12, 2017

  • United States Court of Appeals, Fifth Circuit
  • 17-10812
  • Over 9300 plaintiffs alleged the defendants designed, manufactured and distributed an allegedly defective hip-implant device. Their lawsuits were transferred to the Northern District of Texas by the Judicial Panel on Multi-district litigation. While an MDL court can conduct all pretrial proceedings, it can only try cases over which it had venue without its MDL status, unless the parties otherwise waive arguments regarding venue (a " Lexecon objection"). The parties worked with a special master to identify cases to be tried as "bellweather" cases. The special master's report to the MDL court proposed four trials from a group of eight, and stated that the defendants would not raise Lexecon objections. A first trial, of a single case, resulted in a defense verdict. A second trial, consisting of five cases filed by Texas plaintiffs consolidated as a bellweather trial, resulted in a plaintiffs' verdict. A third trial, consisting of six cases filed by California plaintiffs, resulted in a plaintiffs' verdict. Prior to the third trial, the defendants argued they had only waived their venue objections for the first two trials; the MDL court found that they had waived them for all MDL trials. When the MDL court selected ten cases involving New York plaintiffs for a fourth bellweather trial, the defendants sought a writ of mandamus. The court agreed that the defendants only waived their venue arguments with respect to the first two trials, and that the MDL court erred by declaring a global and permanent waiver to venue and personal jurisdiction. It also held that mandamus relief would otherwise be appropriate, given that the MDL court apparently intended to apply the "waiver" to all trials. But, the court held, the defendants had not shown that they had no other adequate means to obtain relief, because the defendants could appeal from any adverse verdict on personal jurisdiction grounds. The court held that, while the defendants would undoubtedly incur significant defense fees in the trials, this was not a basis upon which to order mandamus The court accordingly denied the petition for a writ of mandamus. In re Depuy Orthopaedics, Inc. Fifth Circuit, No. 17-10812, 8/31/17.

Follow the Money: Justice is on Trial.

By Bexis on August 28, 2017
Today’s guest post is by Reed Smith Houston office associate Curtis Waldo.  Given the Noachic weather down there recently, one might ask “where’s Waldo?”  The answer is safe and sound, if not quite high and dry.  Curt is really dedicated – we offered him more time, but he said he didn’t need it.  In this post, Curt is acting the part of our on-the-scene reporter from last week’s Pinnacle Hip mandamus hearing before the Fifth Circuit.  Since things might move rather quickly (weather permitting) we wanted to bring his report to our readers ASAP.  As always our guest posters are 100% responsible for the content of their posts.  Curt deserves all the credit, and any blame, for what follows.
First, thank you for all the support and well wishes sent to those of us in Southeast Texas riding out Hurricane Harvey.  It is a scary and challenging time, but we will recover.  Two days before Harvey’s arrival, as John Sullivan posted last week, a Fifth Circuit panel in Houston hosted a fascinating oral argument on the writ of mandamus filed by defendants in the Pinnacle hip implant litigation.  As a Reed Smith associate who works three blocks from the courthouse, I was fortunate enough to attend.
The writ has been covered by this blog here and here.  In sum, there are two issues before the court:  (1) did the district court err in holding defendants waived their personal jurisdiction rights?, and (2) if the district court did err, is it the kind of error that warrants the “extraordinary remedy” of a writ of mandamus?  The oral argument was divided about 50-50 between these two questions.  Defendants argue they did not waive their personal jurisdiction rights; plaintiffs argue they did.  Defendants argue a writ of mandamus is appropriate; plaintiffs argue it is not.  The panel was comprised of Judges Jerry Smith, Edith Jones, and Gregg Costa.
First to argue was John Beisner of Skadden Arps for defendants.  Mr. Beisner began with an analogy:  Your acquaintance invites you to dinner once.  You agree.  Your acquaintance invites you to dinner a second time.  You agree.  By agreeing to attend two dinners, have you now agreed to attend all dinners that may be called by the acquaintance in the future?
As tends to happen at oral argument, the judges wasted little time in interrupting.  Judge Smith:  Even if this was error, why a writ of mandamus?  Defendants could wait until the trial concluded and appeal the jurisdiction waiver at that time.
Mr. Beisner’s answer was twofold:  (1) why waste everyone’s time with an unnecessary trial if the appellate court can decide the issue at the outset, and (2) if plaintiff’s waiver theory is believed, defendants have waived their personal jurisdiction rights in 9,300 pending cases, which is exactly the sort of situation that is “not effectively reviewable” by a normal appeal.  As Judge Jones later pointed out, if the plaintiffs and defendants spend $50 million trying cases that are later obviated on appeal, does that $50 million not come straight from the pockets of plaintiffs and defendants, and right into the pockets of lawyers?
While this argument might make sense to anyone who is not a lawyer, Judge Costa pointed out rightly the slippery slope down which that argument might take them—should appellate courts step into district court proceedings at any stage where their input would be dispositive?  One could imagine such a system, but it is not the one we have in the federal courts.  Surely, Judge Costa asked, avoiding expense by itself is not enough to justify mandamus relief?  Mr. Beisner rightly avoided this logical sinkhole and clarified that no, it is not merely the avoidance of expense but also the likelihood of recurrence, which here is profound given the upcoming bellwether trials and thousands of other cases on the horizon where defendants have allegedly waived their constitutional rights.
Moving on to the waiver issue, Mr. Beisner framed the issue as revolving around the interpretation of a single email sent by defendants’ counsel in December 2014.  By agreeing “to allow the Court to select the next round of bellwether cases,” surely defendants were not agreeing to waive their right to object to personal jurisdiction in all 9,300 cases in the MDL and effectively agreeing that all 9,300 cases could be tried in Texas.  This, Mr. Beisner correctly emphasized, was simply not how the MDL process works.  The MDL system is for pre-trial purposes only.
Let us take a moment to consider that in a given day, we may send 100 emails or more, some of which we put more thought into than others.  I have never had one of my emails quoted at length in appellate briefs and dissected by a panel of Fifth Circuit judges, but I can’t imagine it is a good feeling.
Mr. Beisner had to explain why the email at issue referred to “bellwether cases,” and not only the bellwether case that would be tried.  He clarified that the case(s) to be tried in a single bellwether trial came from a larger pool of cases (but still not the 9,300 in the MDL), and it was this slightly larger subset that the email was referring to.  The judges appeared both intrigued and confused at the system used by the district court to select bellwether cases.  I thought Mr. Beisner made his point, but it is hard to say.  In any event, Mr. Beisner came back to his take-home message:  to waive one’s constitutional rights, surely such waiver must be clear and unambiguous, which here it was decidedly not.  Overall, the judges’ questions of Mr. Beisner on the waiver issue were not nearly as hard-hitting as the questions on the propriety of mandamus.
Next it was plaintiffs’ turn, for which plaintiffs turned to Kenneth Starr—former D.C. Circuit judge, solicitor general, law professor, Clinton investigator, and Baylor non-investigator.  Mr. Starr began his argument by quoting the All Writs Act from 1789.  
Unsurprisingly, the panel did not let him finish his quote, and Judge Smith injected with the first question, which similar to his first question during Mr. Beisner’s argument cut to the chase:  Just what exactly are plaintiffs saying defendants waived?  Mr. Starr’s response was blunt:  in theory, defendants had waived their right to object to personal jurisdiction in all 9,300 MDL cases.  Mr. Starr hedged by saying this was only in theory, and plaintiffs did not plan to try 9,300 cases in Texas.  In reality, per Mr. Starr, this was only about the two bellwether trials set in the Northern District of Texas.  Despite Mr. Starr’s reassurances, his answer about the scope of the purported waiver seemed to make the panel uncomfortable.
Judge Jones took the opportunity to highlight what was really at stake—the big “M”.  While she did not say so explicitly, what is really “unreviewable” is the shift in momentum that occurs when a big verdict comes in while an appeal is pending.  Mr. Starr fought back:  This isn’t about momentum or settlement; this is about defendants trying to cut in line.  While the law may be under-developed on the issue of what contacts in a direct file case are sufficient to allow for jurisdiction, mandamus is not the proper vehicle to develop the law.  What is at stake, according to Mr. Starr, is our system of permitting trial courts to conduct trials, and leaving appeals for a later, orderly process.
Mr. Starr got out his talking points on his waiver argument, but it was hard to say he made any impact on the judges here.  Perhaps sensing that his stronger point was the impropriety of mandamus, Mr. Starr highlighted that defendants had an adequate remedy (they could appeal!), and the waiver issue was not so “clear and indistinguishable” as to justify mandamus.  Moreover, Mr. Starr brought up (for the first time by anyone) that a trial was actually set to start in September.  Lawyers and witnesses were ready to go, and his clients wanted their day in court.  Judge Jones countered that while plaintiffs may want their day in court, it would do them no good to have their verdict overturned a year later.

Ultimately it was a fascinating hour of argument—the waiver issue appears to revolve around a couple sentences in a CMO and a lawyer’s email from three years ago.  The mandamus issue cuts to the core of what role appeals courts should play in the federal system.  And overriding all of the argument was the judges’ curiosity and at times bafflement at the MDL system.  MDLs are supposed to encourage efficiency and coordination, but how do we achieve them while at the same time serving other purposes of the judiciary such as a deliberative appeals process, consistency, and finality?  What role should the court assign practical litigation considerations such as settlement momentum?  The courtroom was packed with law clerks and at least one district court judge, and the atmosphere of the courtroom had an academic and suspenseful quality.  Given the upcoming trial date, we should expect a decision soon.